Contents User Manual corpuls3 ii ENG - Version 4.0 – P/N 04130.2 This user manual has been compiled to provide users with information necessary for safe and trouble-free operation, use on patients and maintenance of corpuls3 and corpuls3T. All persons dealing with use, maintenance and troubleshooting must read and implement this user manual.
Corpuls 3 User Manual Pdf - User Manual corpuls3 - Frank's Hospital Workshop
and corpuls3
User Manual
ENG - Version 4.0 P/N 04130.1
Contents
User Manual corpuls3
This user manual has been compiled to provide users with information necessary for safe and troublefree operation, use on patients and maintenance of corpuls3 and corpuls3T. All persons dealing with use, maintenance and troubleshooting must read and implement this user manual.
If in this user manual the corpuls3 is mentioned, the information is valid for all functions and all product variants, unless indicated otherwise.
In addition to this user manual, the currently applicable ordinances and the generally accepted engineering principles as well as national regulations for occupational health and safety and accident prevention must be complied with.
The corpuls3 complies with the basic standards as specified in Annex I of the "Medical Device Directive 93/42/EC of the Commission". The corpuls3 is a medical product class IIb. In the UMDNS (Universal Medical Device Nomenclature System) the corpuls3 has the code 17-882.
GS Elektromedizinische Geräte G. Stemple GmbH Hauswiesenstrasse 26 86916 Kaufering Germany
For a patient/user/third party in the European Union and in countries with identical regulatory regime (Regulation 2017/745/EU on Medical Devices); if, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and/or its authorised representative and to your national authority.
All rights reserved, particularly rights of reproduction and distribution as well as translation.
Subject to technical modifications, mistakes and printing errors.
The rights to the trademarks and registered trademarks named remain with the originators and the holders of the respective trademark rights.
No part of the user manual may be reproduced, saved, processed, copied or circulated by means of electronic systems in any form whatsoever without the written agreement of GS Elektromedizinische Geräte G. Stemple GmbH.
ii
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Service Address
In case of enquiries, please contact:
Contents
Address of the sales and service partner
Information on the authorised service and sales partners can also be found on the following website: www.corpuls.com
ENG - Version 4.0 P/N 04130.2
iii
Contents iv
User Manual corpuls3
Versions of the corpuls3 user manual
Issue 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Table 1-1
Date
User manual version
06/2007
ENG V1.1 04130.2
08/2007
ENG V1.2 04130.2
11/2007
ENG V1.3 04130.2
07/2008
ENG V1.4 04130.2
07/2009
ENG V1.5 04130.2
12/2009
ENG V1.6 04130.2
11/2010
ENG V1.7 04130.2
07/2011
ENG V1.8 04130.2
10/2011
ENG V1.9 04130.2
07/2012
ENG V2.0 04130.2
06/2013
ENG V2.1 04130.2
05/2014
ENG V2.2 04130.2
02/2015
ENG V2.3 04130.2
07/2017
ENG V3.0 04130.2
02/2019
ENG V3.1 04130.2
02/2020
ENG V3.2 04130.2
2020-0707 ENG V4.0 04130.2
Versions of the User manual
Supplements to the corpuls3 user manual
Version Date
Description
A
04/2010 Supplement of the alarm
messages
A
05/2010 New defib keyboard
A
03/2011 Interval Measurement NIBP
A
07/2011 Night vision mode
A
03/2017 Supplement of the alarm
messages
A
07/2017 Parameter Race, Recording of
RTD tracks
A
2019-05-08 Printer intensity
A
2019-11-15 Priority of DE lead
A
04/2010 Supplement of the alarm
messages
Table 1-2
Supplements to the User manual
Software version 1.1.0 1.2.0 1.3.0 1.4.1 1.5.0 1.6.0 1.7.0 1.8.0 1.9.0 2.0.0 2.1.0 2.2.2 2.3.2 3.0.3 3.1.0 3.2.0 4.0.0
User manual version
DE V1.4 - 04130.1 DE V1.5 - 04130.1 DE V1.6 - 04130.1 DE V1.7 - 04130.1 DE V1.7 - 04130.1 DE V1.8 - 04130.1 ENG 2.3 - 04130.2
Version Software
1.4 1.5 1.6
1.7.0
1.7.2
1.8.0
2.3.51
ENG 2.3 - 04130.2 2.3.61
GER 3.1 - 04130.1
GER 3.1 - 04130.1
DE V1.4 - 04130.1 DE V1.5 - 04130.1 DE V1.6 - 04130.1
3.0.5, 3.1.1
3.1.3
1.4 1.5 1.6
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Contents
Compatibility of software versions
corpuls3 version 4.0.0
corpuls cpr version 1.2.0
Warning
Delayed therapy due to incompatibility!
Compression-synchronised therapy can only be implemented in combination with a corpuls cpr, as a connection to other chest compression devices is not possible.
ENG - Version 4.0 P/N 04130.2
v
Contents vi
User Manual corpuls3
Table of Contents
1
Safety ................................................................................................................................1
1.1
General........................................................................................................................... 1
1.2
Operating Staff ............................................................................................................... 1
1.2.1
Restrictions of Use of Therapeutic Functions ........................................................... 1
1.2.2
Maintenance ............................................................................................................ 2
1.3
Related Documents......................................................................................................... 2
1.4
Information Labels, Warning Labels and Symbols on the Device..................................... 2
1.5
Warnings ........................................................................................................................ 3
1.6
Special Types of Risk ..................................................................................................... 4
2 2.1 2.2 2.3 2.4
Appropriate Use .................................................................................................................5 Intended Use .................................................................................................................. 5 Appropriate Use.............................................................................................................. 5 Non-intended Use ........................................................................................................... 6 Indications and Contraindications................................................................................... 7
3
Introduction .......................................................................................................................9
3.1
Components.................................................................................................................... 9
3.2
Device Design ............................................................................................................... 10
3.2.1
Pairing (Connection Authorisation) ......................................................................... 12
3.2.2
Monitoring Unit ...................................................................................................... 14
3.2.3
Patient Box and Accessory Bag .............................................................................. 16
3.2.4
Defibrillator/pacer ................................................................................................. 19
3.2.5
Defibrillator/Pacer SLIM ........................................................................................ 20
3.2.6
Brackets ................................................................................................................ 21
3.3
Description of the Monitoring, Diagnostic and Therapeutic Functions ........................... 22
3.3.1
Monitoring and Diagnostic Functions...................................................................... 22
3.3.2
Therapeutic Functions............................................................................................ 23
3.4
Alarm Management ...................................................................................................... 25
3.4.1
Alarm Signals at the Monitoring unit...................................................................... 26
3.4.2
Alarm Signals at the Patient box............................................................................ 29
3.5
Energy Management ..................................................................................................... 30
3.5.1
Battery Operation................................................................................................... 30
3.5.2
Mains Operation..................................................................................................... 32
4
General Operating Instructions .........................................................................................35
4.1
Operating- and Screen Elements .................................................................................. 35
4.1.1
Operating Elements and LEDs on the Monitoring Unit ............................................. 35
4.1.2
Basic Structure of the Screen Pages on the Monitoring Unit .................................. 39
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Contents
4.1.3
Operation via Touchscreen (only corpuls3T)........................................................... 43
4.1.4
Patient box screen ................................................................................................. 44
4.1.5
Control Keys and LEDs on the Patient Box.............................................................. 45
4.1.6
Control Key and LEDs on the Defibrillator/Pacer .................................................... 46
4.1.7
Control Key and LEDs on the Defibrillator/Pacer SLIM ........................................... 47
4.2
Switching On and Off .................................................................................................... 48
4.2.1
Switching On.......................................................................................................... 48
4.2.2
Switching off.......................................................................................................... 49
4.3
Menu Control ................................................................................................................ 51
4.3.1
Softkey context menu ............................................................................................ 51
4.3.2
Parameter Context Menu and Curve Context Menu ................................................. 52
4.3.3
Main menu ............................................................................................................. 54
4.3.4
Configuration dialogue ........................................................................................... 55
4.4
Disconnecting and Connecting Modules ........................................................................ 56
4.4.1
Disconnecting the Monitoring Unit from the Defibrillator/Pacer ............................. 56
4.4.2
Disconnecting the Patient Box from the Monitoring Unit......................................... 57
4.4.3
Connecting the Patient Box to the Monitoring Unit ................................................. 58
4.4.4
Connecting the Monitoring Unit to the Defibrillator/Pacer ...................................... 59
4.4.5
Removing the Patient Box from the Compact Device............................................... 60
4.5
Accessory Bag.............................................................................................................. 61
4.5.1
Fitting the Accessory Bag ...................................................................................... 61
4.5.2
Packing the Accessory Bag .................................................................................... 62
4.6
Inserting the Device into the Brackets .......................................................................... 65
4.6.1
Defibrillator/Compact Device Bracket .................................................................... 65
4.6.2
Monitoring Unit Bracket ......................................................................................... 66
4.6.3
Charging bracket Patient box ................................................................................. 67
5
Operation Therapy.........................................................................................................68
5.1
Therapy Electrodes for Defibrillation and Pacing .......................................................... 68
5.1.1
Types of Therapy Electrodes .................................................................................. 68
5.1.2
Connecting the Electrode Cable.............................................................................. 70
5.1.3
Removing the Shock Paddles from their Holders and Re-inserting them ................ 71
5.2
Preparing the Patient for Defibrillation, Cardioversion and Pacer Therapy.................... 72
5.3
Defibrillation in AED Mode ............................................................................................ 73
5.3.1
Information on the AED Mode ................................................................................. 73
5.3.2
Defibrillation in AED mode with corPatch Electrodes.............................................. 77
5.3.3
Defibrillation in AED Mode with Shock Paddles ...................................................... 78
5.4
Manual Defibrillation and Cardioversion ....................................................................... 80
5.4.1
Information on Manual Defibrillation and Cardioversion ......................................... 80
5.4.2
Manual Defibrillation with corPatch Electrodes...................................................... 83
ENG - Version 4.0 P/N 04130.2
vii
Contents viii
User Manual corpuls3
5.4.3
Manual Defibrillation and Cardioversion with Shock Paddles ................................. 83
5.4.4
Manual Defibrillation and Cardioversion with Shock Spoons .................................. 85
5.4.5
Manual Defibrillation and Cardioversion of Neonates and Children ........................ 86
5.5
External Pacer .............................................................................................................. 88
5.5.1
Information on the External Pacer.......................................................................... 88
5.5.2
Preparing the pacer function ................................................................................. 90
5.5.3
Starting the Pacer Function.................................................................................... 92
5.6
Metronome ................................................................................................................... 96
5.6.1
Information on the Metronome............................................................................... 96
5.6.2
Starting the Metronome ......................................................................................... 97
5.7
CPR Feedback............................................................................................................... 98
5.7.1
Information on CPR Feedback ................................................................................ 98
5.7.2
Preparing CPR Feedback ...................................................................................... 100
5.7.3
Working with CPR Feedback ................................................................................. 101
5.7.4
corPatch CPR summary ........................................................................................ 102
5.7.5
preShock CPR ...................................................................................................... 102
5.8
Display of corpuls cpr Parameters ............................................................................. 103
5.9
Compression Synchronised Therapy with the corpuls cpr ........................................... 103
5.9.1
Therapy Control of the corpuls cpr via the corpuls3............................................. 104
5.9.2
Configuration of Therapy Parameters of the corpuls cpr ...................................... 105
5.9.3
Compression Synchronised Therapy in AED mode ................................................ 105
5.9.4
Compression Synchronised Therapy in Manual Mode ........................................... 106
6
Operation Monitoring and Diagnosis............................................................................. 107
6.1
Information on Monitoring and Diagnosis ................................................................... 107
6.2
Monitoring Trends ...................................................................................................... 108
6.3
Monitoring ECG ........................................................................................................... 109
6.3.1
Information on ECG Monitoring............................................................................. 109
6.3.2
Colour coding of ECG leads .................................................................................. 110
6.3.3
Preparing ECG Monitoring .................................................................................... 110
6.3.4
Performing ECG Monitoring .................................................................................. 112
6.3.5
Adapting the Representation of the ECG Curve ..................................................... 114
6.3.6
Heart Rate Monitoring .......................................................................................... 116
6.4
Recording, Measuring, Printing and Interpreting a Diagnostic ECG.............................. 116
6.4.1
Information on Diagnostic ECG ............................................................................. 116
6.4.2
Preparing the Patient for a D-ECG ........................................................................ 117
6.4.3
Recording and Measuring a Diagnostic ECG ......................................................... 120
6.4.4
Representative Cycle ........................................................................................... 125
6.5
Longterm ECG ............................................................................................................. 127
6.5.1
Information on Longterm ECG............................................................................... 127
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Contents
6.5.2
Preparing Longterm ECG ...................................................................................... 127
6.5.3
Performing Longterm ECG .................................................................................... 128
6.6
Oximetry Monitoring (Option) ...................................................................................... 129
6.6.1
Information on Oximetry Monitoring ..................................................................... 129
6.6.2
Extended Oximetry Monitoring .............................................................................. 130
6.6.3
Preparing Oximetry Monitoring............................................................................. 131
6.6.4
Performing Oximetry Measurement ...................................................................... 132
6.6.5
Adjusting the Representation of the Oximetry Parameters ................................... 134
6.6.6
Monitoring Pulse Rate and Perfusion Index .......................................................... 134
6.7
CO2 Monitoring (option)............................................................................................... 135
6.7.1
Information on CO2 Monitoring ............................................................................. 135
6.7.2
Preparing CO2 Monitoring ..................................................................................... 136
6.7.3
Disposable Adapter for CO2 Endotracheal Tube incl. Insert for Neonates ............. 138
6.7.4
Performing CO2 Measurement .............................................................................. 139
6.7.5
Adjusting the Representation of the CO2 Values.................................................... 140
6.7.6
Monitoring Respiratory Rate................................................................................. 141
6.8
Non-invasive Blood Pressure Monitoring (option) ....................................................... 141
6.8.1
Information on NIBP Monitoring ........................................................................... 141
6.8.2
Preparing Blood Pressure Monitoring................................................................... 145
6.8.3
Performing Individual Blood Pressure Measurement ............................................ 146
6.8.4
Performing Blood Pressure Interval Monitoring.................................................... 147
6.9
Invasive Blood Pressure Monitoring (IBP) (Option) ...................................................... 148
6.9.1
Information on IBP Monitoring.............................................................................. 148
6.9.2
Preparing Invasive Blood Pressure Monitoring ..................................................... 149
6.9.3
Performing Invasive Blood Pressure Monitoring ................................................... 151
6.10
Temperature Monitoring (Option) ................................................................................ 152
6.10.1 Information on Temperature Monitoring ............................................................... 152
6.10.2 Preparing Temperature Monitoring....................................................................... 152
6.10.3 Performing Temperature Monitoring..................................................................... 153
7
Configuration.................................................................................................................. 154
7.1
Configuring the System .............................................................................................. 155
7.1.1
General System Settings (User DEFAULT) ............................................................. 155
7.1.2
Configuration of Views ......................................................................................... 157
7.1.3
Printer settings .................................................................................................... 160
7.1.4
Configuration of the Fax Transmission (User DEFAULT)......................................... 165
7.2
Configuration of the Monitoring Functions .................................................................. 165
7.2.1
ECG Monitoring..................................................................................................... 166
7.2.2
Oximetry .............................................................................................................. 167
7.2.3
CO2....................................................................................................................... 169
ENG - Version 4.0 P/N 04130.2
ix
Contents x
User Manual corpuls3
7.2.4
IBP ....................................................................................................................... 170
7.2.5
CPR Feedback ...................................................................................................... 171
7.3
Alarm Configuration.................................................................................................... 172
7.3.1
Configuring Alarm Settings .................................................................................. 172
7.3.2
Alarm Limit Settings ............................................................................................ 173
7.3.3
Setting Alarm Limits for Monitoring Functions Manually ...................................... 173
7.3.4
Setting the Alarm Limits for Monitoring Functions Automatically ......................... 175
7.4
Advanced settings (for persons responsible for the device) ....................................... 176
7.4.1
Authorisation for Persons Responsible for the Device .......................................... 176
7.4.2
General System Settings (Person responsible for the device) .............................. 176
7.4.3
Configuration of Manual Events (Persons Responsible for the Device) ................. 180
7.4.4
Configuration of the Defibrillation Function (Persons Responsible for
the Device)........................................................................................................... 181
7.4.5
Filter Settings (Persons Responsible for the Device) ............................................ 183
7.4.6
Alarm Configuration (Persons Responsible for the Device) ................................... 185
7.4.7
Basic Configuration of the Views (Persons Responsible for the Device)................ 187
7.4.8
Configuration of Master Data (Persons Responsible for the Device) ..................... 188
7.4.9
Configuration of ECG Measurement and ECG Interpretation (Persons
Responsible for the Device) ................................................................................. 189
7.4.10 Demo Mode (Persons Responsible for the Device)................................................ 192
7.4.11 Data Protection Settings (Persons responsible for the device) ............................. 193
7.4.12
Configuration of the Metronome and CPR feedback (Persons Responsible for the Device) ................................................................................. 194
7.4.13
Configuration of Non-Invasive Blood Pressure Measurement (NIBP) (Persons Responsible for the Device)................................................................... 196
7.4.14 Printer Settings (Persons Responsible for the Device).......................................... 198
8
Data Management .......................................................................................................... 199
8.1
Creating a Patient File ................................................................................................ 199
8.2
Event Key ................................................................................................................... 200
8.3
Handling Data............................................................................................................. 200
8.4
Master data ................................................................................................................ 201
8.5
Browser Key ............................................................................................................... 202
8.5.1
Protocol ............................................................................................................... 202
8.5.2
Mission Browser .................................................................................................. 205
8.6
Analysis of the Data with corpuls.manager REVIEW .................................................... 207
8.6.1
Recording of Realtime Data (RTD) tracks ............................................................. 207
8.7
Screenshot ................................................................................................................. 207
8.8
Insurance card reader (option) ................................................................................... 207
9
Telemetry 3.0 ................................................................................................................. 209
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Contents
9.1
Configuration of Telemetry (Persons Responsible for the Device) ............................... 210
9.1.1
Installing the SIM Card......................................................................................... 211
9.1.2
Configuration GSM modem ................................................................................... 211
9.1.3
Configuration GPRS connection ............................................................................ 212
9.1.4
WLAN interface configuration............................................................................... 212
9.1.5
Saving telemetry connections (Phonebook) .......................................................... 213
9.2
Configuration of Telemetry Services (Persons Responsible for the Device)................. 214
9.2.1
Configuring a connection to corpuls.web LIVE...................................................... 216
9.2.2
Configuration of fax transmission ........................................................................ 217
9.2.3
Configuration of mission upload........................................................................... 217
9.3
Configuration of (W)LAN networks .............................................................................. 218
9.3.1
Manual network settings...................................................................................... 220
9.4
Data transmission options .......................................................................................... 220
9.4.1
Live Data Transmission to corpuls.web LIVE......................................................... 221
9.4.2
Sending a D-ECG .................................................................................................. 222
9.4.3
Manually uploading missions to an FTP server..................................................... 223
9.4.4
Manually Establishing a Connection to the Mobile Network.................................. 224
9.5
Bluetooth.................................................................................................................... 224
9.5.1
Configuring a Bluetooth® data interface (Persons Responsible for the
Device)................................................................................................................. 224
9.5.2
Configuring Bluetooth® connections ..................................................................... 226
9.5.3
Establishing and interrupting a Bluetooth® connection ........................................ 227
9.5.4
Data management via Bluetooth®......................................................................... 228
9.5.5
Bluetooth connection with corpuls cpr................................................................. 229
9.6
Offline mode............................................................................................................... 229
9.7
webMessage............................................................................................................... 229
10
Maintenance and Tests ................................................................................................... 231
10.1
General Information.................................................................................................... 231
10.2
Function checks ......................................................................................................... 232
10.2.1 Daily Checks of the Device ................................................................................... 233
10.2.2 Monthly Functional Test ....................................................................................... 237
10.3
Automatic Selftest...................................................................................................... 240
10.4
Regular Maintenance Work ......................................................................................... 240
10.4.1 Technical Safety Check ........................................................................................ 240
10.4.2 Metrological Check .............................................................................................. 240
10.4.3 Repair and Service............................................................................................... 241
10.5
Loading the printer paper ........................................................................................... 241
10.6
Replace battery .......................................................................................................... 243
10.7
Cleaning, Disinfection and Sterilisation ...................................................................... 243
ENG - Version 4.0 P/N 04130.2
xi
Contents xii
User Manual corpuls3
10.7.1 Recommended Cleaning- and Disinfecting Agents................................................ 244
10.7.2 Monitoring Unit, Patient Box and Defibrillator/Pacer ............................................ 245
10.7.3 Shock paddles ..................................................................................................... 246
10.7.4 Baby shock electrodes ......................................................................................... 247
10.7.5 Therapy master cable .......................................................................................... 247
10.7.6 Cable for monitoring functions............................................................................. 247
10.7.7 Oximetry sensor ................................................................................................... 248
10.7.8 CO2 sensor ........................................................................................................... 248
10.7.9 NIBP Cuffs and connecting hose .......................................................................... 248
10.7.10 IBP transducer cable............................................................................................ 248
10.7.11 Temperature sensor............................................................................................. 249
10.7.12 Accessory Bag, Carrying Strap and Backpack Carrying Strap............................... 249
10.7.13 Charging brackets and MagCode connectors........................................................ 249
10.8
Approved Accessories, Spare Parts and Consumables ................................................ 249
11 11.1 11.2 11.3
Procedure in Case of Malfunctions.................................................................................. 250 Device alarms............................................................................................................. 250 Troubleshooting and Corrective Actions...................................................................... 265 Notifications Message Line and Information in the Protocol ....................................... 276
Appendix A B C D E F G H I J K L M N O P Q
...................................................................................................................................... 289 Symbols ..................................................................................................................... 289 List of Abbreviations................................................................................................... 296 Checklist Functional Check ......................................................................................... 297 Factory Settings ......................................................................................................... 298 Technical Specifications............................................................................................. 308 Biphasic Defibrillator.................................................................................................. 326 Safety Information...................................................................................................... 332 ECG Analysis during Semi-automatic Defibrillation (AED mode) .................................. 335 corpuls3 HYPERBARIC (HBO) ....................................................................................... 338 Major performance characteristics............................................................................. 339 Guidelines and Manufacturer's Declaration ................................................................ 340 Warranty .................................................................................................................... 345 Protection Rights and Patents .................................................................................... 346 Disposal of the Device and Accessories...................................................................... 347 Note on Data Protection.............................................................................................. 348 List of Illustrations ..................................................................................................... 349 List of Tables.............................................................................................................. 354
Index ...................................................................................................................................... 357
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Contents
ENG - Version 4.0 P/N 04130.2
xiii
Contents
User Manual corpuls3
Conventions
The following conventions apply in this user manual:
Key
[Softkey] "Menu item" "Submenu item"
"Alarm message"
VERBAL MESSAGE
Operating instruction/ information
Key on monitoring unit, patient box and defibrillator/pacer
Softkey on the monitoring unit
Menu items of the main menu and parameter and curve context menus
Messages for physiological and technical alarms on the monitoring unit and patient box
Spoken operating instructions and alarm messages in the AED mode
Operating instructions and information in the message line of the monitoring unit
xiv
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Safety
1 Safety
1.1 General
corpuls3 HYPERBARIC
The corpuls3 may only be operated if:
· in technically perfect condition; · used as intended (see chapter 2 Appropriate Use, page 5); · the instructions of this user manual are followed. Malfunctions must be eliminated immediately (see chapter 11 Procedure in Case of Malfunctions, page 250).
If in this user manual the corpuls3 is mentioned, the information is valid for all functions and all product variants, unless indicated otherwise.
For the product variant corpuls3 HYPERBARIC read and understand Appendix I corpuls3 HYPERBARIC (HBO), page 338.
1.2 Operating Staff
The corpuls3 may only be operated by trained medical staff of for example hospitals, doctor's offices and emergency medical services, as well as of authorities and public safety organisations. The qualified staff must be · trained in proper handling, use and operation of the device and of the approved accessories as well
as be · trained in basic and advanced resuscitatory measures (BLS and ALS).
Instructing person The initial instruction and training on the device must be performed by the manufacturer or by authorised personnel.
1.2.1 Restrictions of Use of Therapeutic Functions
Refresher courses in therapeutic use
Use of the therapeutic functions (defibrillation, cardioversion and pacing) is restricted to qualified and authorised staff.
The manufacturer recommends that persons who use the therapeutic functions of the device should take part in refresher courses regularly. The operating company/operator is responsible for offering such refresher courses.
ENG - Version 4.0 P/N 04130.2
1
Intended Use
User Manual corpuls3
1.2.2 Maintenance
Maintenance work may only be performed by persons who are appropriately trained and authorised by the manufacturer. Non-observance and loss of perfect technical condition due to this will result in invalidation of claims under the warranty.
1.3 Related Documents
To guarantee safe and trouble-free operation, read the respective accompanying documents of the accessories.
1.4 Information Labels, Warning Labels and Symbols on the Device
Read the user manual
Read the additional instructions in the user manual
USB port (Devices up to 09/2010) BF (body floating, defibrillation-proof): An insulated application component of this type is approved for external and internal use on the patient CF (cardiac floating, defibrillation-proof): An insulated application component of this type is authorised for use directly on or in the patient's heart
Equipotential bonding
Protection class IP55
2 Symbol for 2nd generation of radio module (hardware)
Symbol for a 3rd generation module which is incompatible with 2nd or 1st generation modules due to hardware modifications. Approved for operation in a multiplace hyperbaric chamber for hyperbaric oxygen therapy (HBO) (option). NOT approved for monoplace hyperbaric chamber.
MagCode connector is NOT approved for operation in a hyperbaric chamber for hyperbaric oxygen therapy (HBO).
Insurance card reader (Option)
Antenna symbol; indicates that the device is emitting non-ionising radiation.
The WEEE symbol (Waste Electrical and Electronic Equipment) indicates that the device should be returned to the manufacturer for proper disposal and recycling.
2
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Safety
Table 1-1
CE symbol; the number indicates the competent notified body.
The RCM (Regulatory Compliance Mark) indicates a device's compliance with applicable ACMA (Australian Communications and Media Authority) technical standards for telecommunications, radiocommunications or broadcasting equipment.
M-LNCS needs a 15-pole intermediate cable. Make sure that the oximetry sensor is compatible with the oximetry intermediate cable.
Medical product
Indicates that the item is a medical device.
Repackaging
To identify that a modification to the original medical device packaging configuration has occurred.
Importer
Indicates the entity importing the medical device into the locale.
Distributor
Indicates the entity distributing the medical device into the locale.
Unique Device Identifier
Indicates a carrier that contains Unique Device Identifier information.
Information Labels, Warning Labels and Symbols on the Device
Fig. 1-1 Sample rating plates
Warning
1.5 Warnings
A number of actions during the operation of the corpuls3 carry risks for patients, users and third parties. Such actions are indicated by warning notices in this user manual. The following symbols are used:
"Warning" denotes a dangerous situation. If the warning is not heeded, extremely severe or fatal injuries or substantial material damage may occur.
Caution
"Caution" denotes a possibly dangerous situation. If not heeded, minor injuries or slight material damage may occur.
Note These paragraphs contain information which must be read and understood.
ENG - Version 4.0 P/N 04130.2
3
Intended Use
User Manual corpuls3
1.6 Special Types of Risk
Electric shock EMC
The defibrillator emits powerful electrical energy. Severe injuries or death may result if the defibrillator is not used in accordance with this user manual.
· Familiarise yourself with the device and this user manual. The defibrillator must not be opened. Internal components may carry high voltages.
· If a fault is suspected, have the device checked by the authorised sales and service partner and, if necessary, repaired.
The defibrillator may cause electromagnetic interference, particularly during charging and on triggering the defibrillation shock.
The functioning of devices operated in the vicinity may be compromised.
· Check the effects of the defibrillator on other devices, preferably before an emergency occurs. Electromagnetic fields of other devices may invalidate the ECG readings.
ECG analysis may be impaired. It may be impossible to trigger a defibrillation shock or pacer pulse.
· Read and follow the instructions for operation of the device in chapter 2 Appropriate Use, page 5 in addition to the safety warnings during use.
It is essential to read and follow the safety information in the appendix G (from page 289).
4
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Intended Use
2 Appropriate Use
2.1 Intended Use
The corpuls3 is intended · for measurement and monitoring of vital functions as well as · defibrillation, cardioversion or cardiac pacing of patients in the preclinical and clinical field by qualified medical staff trained in the use of the device. The following monitoring- and diagnostic functions are available: · ECG · Diagnostic ECG · CPR Feedback
Optional: · Oximetry (SpO2) · Extended oximetry (SpCO®, SpHb, SpMet®) · Capnometry (CO2) · Temperature (Temp) · Non-invasive blood pressure monitoring (NIBP) · Invasive blood pressure monitoring (IBP)
2.2 Appropriate Use
The corpuls3 is intended for use in emergency services on location, in an ambulance, in air rescue vehicles (fixed- or rotary wing aircraft), in the emergency room or similar areas of a hospital. It is also intended to be used during transport of a patient. According to IEC 60601-1-2, the corpuls3 is intended for use in areas of home health care and in professional healthcare institutions. The corpuls3 is approved for monitoring in operating diagnostic X-ray units (e. g. computed tomography). Exempt from this is the oximetry option, because the readings might be falsified. When equipped with the HBO (hyperbaric oxygen therapy) option, the corpuls3 is approved for operation in a multiplace hyperbaric chamber up to 3 barg and an oxygen concentration of < 23%. Intended use of corpuls3 includes the use of accessories which are · approved by the manufacturer (see chapter 10.8 Approved Accessories, Spare Parts and
Consumables, page 249) and · appropriate for the function and patient.
ENG - Version 4.0 P/N 04130.2
5
Intended Use
User Manual corpuls3
Warning
Defibrillation protection for patients, user and third parties cannot be guaranteed, if accessories other than those authorised by the manufacturer are used.
The therapeutic functions of defibrillation, cardioversion and pacer must only be performed with constant monitoring of the patient. If monitoring functions are performed, the patient's condition must also be regularly monitored even when the alarm function is enabled.
Note The corpuls3 and the corpuls3T are devices of their own whose modules are not interchangeable.
The monitoring unit of the corpuls3 (P/N 04100) may only be used in combination with the patient box (P/N 04200) and the defibrillator/pacer (P/N 04300) or the defibrillator/pacer SLIM (P/N 04301).
The monitoring unit of the corpuls3T (P/N 04101) may only be used in combination with the patient box (P/N 04201) and the defibrillator/pacer (P/N 04302).
2.3 Non-intended Use
The corpuls3 is not intended for
· operation in the vicinity of readily inflammable substances, · setup and operation under the influence of strong electromagnetic fields, which occur in the direct
vicinity of radio masts, switched-on nuclear magnetic resonance tomography units, high voltage installations and overhead power lines, · operation in the vicinity of therapeutic radiation units (e. g. tumor treatment), · operation in a monoplace hyperbaric chamber (option HBO), · operation in a multiplace hyperbaric chamber with more than 3 barg and/or more than 23 % oxygen concentration (option HBO). · operation in combination with a high frequency surgical device. The pacer function must not be used near high frequency surgical devices or microwave therapy devices.
Batteries have to be inserted in the individual modules at all times.
Defibrillation and cardioversion must not be performed without protective measures (see chapter 5.3.1 Information on the AED Mode, page 73 and 5.4.1 Information on Manual Defibrillation and Cardioversion, page 80):
· on a metal surface; · on a wet surface.
Operating place
The defibrillator must only be used for defibrillation and cardioversion and must not be used as a stimulation current device or as a pacer.
Performing therapeutic functions without eye contact with the patient and thus without visual contact with the device that is near the patient is considered non-intended use.
Use of accessories on corpuls3 which are not approved by the manufacturer is not considered to be intended use.
The pacer may only be used as a transcutaneous pacer. The pacer must not be used as an intracardial defibrillator.
6
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Intended Use
The corpuls3 may not be used simultaneously on two or more patients. Do not use the therapy master cable corpuls3 SLIM/corpuls1 (P/N 04326.0BA) as extension cable for the therapy master cable at the defibrillator/pacer (P/N 04300). Likewise, the therapy master cable corpuls3 SLIM/corpuls1 must not be combined with a second therapy master cable corpuls3 SLIM/corpuls1.
Note Modules of the corpuls3 (P/N 04100, 04200, 04300 and 04301) must not be used in combination with modules of the corpuls3T (P/N 04101, 04201 and 04302).
Warning
Avoid using the device in immediate vicinity of other devices or stacked with other devices, because this could lead to faulty operation. If use as described above is nevertheless necessary, observe the device and other devices to ensure correct functioning.
The manufacturer cannot accept any liability for damage occurring as a result of failure to use corpuls3 as intended.
2.4 Indications and Contraindications
The corpuls3 may only be operated by trained medical staff of e. g. hospitals, doctor's offices and emergency medical services, as well as of authorities and public safety organisations who are familiar with basic patient monitoring, assessment of vital functions, cardiologic intensive therapy and the use of the device.
Use of the therapeutic functions (defibrillation, cardioversion and pacing) is restricted to qualified and authorised staff.
The corpuls3 is used mainly with patients exhibiting symptoms of cardiac arrest or posttraumatic patients. The device may also be used for monitoring one or several vital parameters if those are (optionally) available in the device.
The corpuls3 can be used in paediatric and adult patients. The use of a defibrillator in AED mode is not recommended for patients of less than 12 months of age.
Field of medicine Defibrillation, AED
Indication
Shockable cardiac arrest (resuscitation) Ventricular fibrillation Tachycardias
Defibrillation, manual
Shockable cardiac arrest (resuscitation) Ventricular fibrillation Tachycardias
Cardioversion
ENG - Version 4.0 P/N 04130.2
Certain atrial and ventricular arrhythmias
Contraindication
Normal ECG rhythm Spontaneous respiration Palpable pulse or other indications of spontaneous circulation Pulseless electrical activity (PEA) Asystole Patient < 12 month old
Normal ECG rhythm Spontaneous respiration Palpable pulse or other indications of spontaneous circulation Pulseless electrical activity (PEA) Asystole
Non-cardiovertable patient statuses and heart rhythms
7
Intended Use
User Manual corpuls3
Field of medicine Pacer
Indication
Transcutaneous pacing in tachy/bradycardial arrhythmias
ECG, basic and diagnostic
Oximetry Capnometry NIBP IBP Temperature CPR Feedback
Monitoring and recording of ECG and heart rate of adults, children and neonates with or without cardiac dysfunctions. Vital parameters to be monitored, deviating/conspicuous/missing vital parameters
Cardiac arrest (resuscitation)
Table 2-1
Indications and Contraindications
Contraindication Normal ECG rhythm Asystole Ventricular fibrillation n/a
n/a n/a n/a n/a n/a < 8 years old If cardiac massage is contraindicated
Field of medicine
Body area
Defibrillation, AED
Thorax, heart, skin
Defibrillation, manual
Thorax, heart, skin
Cardioversion
Thorax, heart, skin
Pacer
Thorax, heart, skin
ECG, basic and diagnostic Thorax, extremities, skin
Oximetry
Extremities
Capnometry
Head (airways)
NIBP
Extremities
IBP
Whole body
Temperature
Whole body
CPR Feedback
Thorax, skin
Table 2-2
Body areas of application
8
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Introduction
3 Introduction
3.1 Components
Monitoring, diagnostic and therapeutic functions
Documentation function
The corpuls3 is a portable device with a modular structure which can be used
· as a defibrillator/monitor or
· as a full patient monitor in its own right. The corpuls3 provides comprehensive monitoring, diagnostic and therapeutic functions for treatment of emergency and intensive-care patients. Especially as part of the resuscitation of emergency patients, defibrillations, cardioversions or pacer therapies can also be performed, in addition to the monitoring of vital parameters.
Up to 6 leads can be displayed on the screen at the same time. A 12-lead ECG function allows the user a comprehensive ECG diagnosis, which can be optionally supplemented by ECG analysis software.
Further monitoring functions include oxygen saturation measurement (pulse oximetry), carbon dioxide measurement (capnometry) and temperature measurement, in addition to non-invasive and invasive blood pressure monitoring. The recorded measuring values can be displayed both numerically and as a curve. Configurable alarms draw the user's attention to current changes in the patient's condition. All measured values or logs can be printed out on paper.
The corpuls3 has extensive documentation functions for internal recording of events, alarms and logs. These can be transferred to external systems for further processing and archiving.
Fig. 3-1
Compact device
1 Accessory bag 2 Printer
Tilting the device
When equipped with the original defibrillator/pacer (P/N 04300), the corpuls3 can be tilted vertically up to 30°. With the defibrillator/pacer unit SLIM (P/N 04301), this is not possible.
Depending on the mission conditions, the monitor can be adjusted to the appropriate visual angle.
ENG - Version 4.0 P/N 04130.2
9
Introduction
The system can be divided into the following three modules:
· Monitoring unit · Patient box · Defibrillator/pacer
User Manual corpuls3
Fig. 3-2
Individual modules
1 Monitoring unit 2 Patient box 3 Defibrillator/Pacer
3.2 Device Design
Usage options
Radio connection Infrared connection
Note Note
The three modules monitoring unit, patient box and defibrillator/pacer can operate via an infrared connection or, if separated, via radio connection.
The connection status is shown on the screen of the monitoring unit (see Table 4-2, page 40) and the patient box (see Table 4-3, page 44).
Communication between the modules in semi-modular and modular use is performed by radio up to a distance of 10 m in open terrain.
In the connected mechanically state, the modules communicate via an optical infrared connection.
If the radio connection is interrupted, the modules have to be connected to each other mechanically. The corpuls3 switches automatically from radio connection to infrared connection in this case.
The antenna of the radio unit in the patient box is located at the top. In case the antenna is shadowed, for example by metallic or metallised objects, the maximal reach of the radio connection may be reduced. This may happen, for example, when the patient box is placed between the patient's legs on the stretcher. If possible, choose a position for the patient box that allows unimpeded view to the other modules.
10
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Introduction
Note The corpuls3 and the corpuls3T are devices of their own whose modules are not interchangeable.
The monitoring unit of the corpuls3 (P/N 04100) may only be used in combination with the patient box (P/N 04200) and the defibrillator/pacer (P/N 04300) or the defibrillator/pacer SLIM (P/N 04301).
The monitoring unit of the corpuls3T (P/N 04101) may only be used in combination with the patient box (P/N 04201) and the defibrillator/pacer (P/N 04302).
The following combinations are possible:
Device Design
1. Compact device: All three modules are connected mechanically.
corpuls3
corpuls3T (Defibrillator/pacer SLIM)
2. Semi-modular use: Monitoring unit and patient box are connected, defibrillator/pacer is disconnected. 3. Semi-modular use: Monitoring unit and defibrillator/ pacer are connected, patient box is disconnected.
4. Modular use: Monitoring unit, patient box and defibrillator/ pacer are disconnected mechanically.
Fig. 3-3 Usage options of the modular corpuls3
ENG - Version 4.0 P/N 04130.2
11
Introduction
User Manual corpuls3
The following combinations are possible when used as a stand-alone patient monitoring system: 1. Compact monitor: Monitoring unit and patient box are connected mechanically.
2. Modular use:
Monitoring unit and patient box are disconnected.
3. Patient box:
Patient box in stand-alone use for temporary initial monitoring.
Fig. 3-4 Usage options of the modular corpuls3 as a patient monitoring system
3.2.1 Pairing (Connection Authorisation)
The modules of the corpuls3 can be connected to form a functional unit by means of two procedures: · Pairing and · Ad-hoc connection
Note Pairing Ad-hoc connection
The corpuls3 thus provides the option of substituting individual modules of one compact device for individual modules of the same type from another corpuls3.
It is not possible to connect a monitoring unit to more than one patient box or one defibrillator/pacer at the same time.
Pairing is a connection authorisation that enables the communication between wirelessly connected modules.
An ad-hoc connection allows the use of mechanically connected modules without having to perform a pairing beforehand.
12
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Introduction
Prerequisite
Note Note Labelling of the radio modules
For both procedures the following prerequisites apply: 1. For a pairing, monitoring unit, patient box and defibrillator/pacer have to be equipped with radio
modules of the same type (hardware version). 2. If this is not the case, if the hardware version of the radio modules is different (1st and 2nd
generation), those modules can only form an ad-hoc connection. 3. For both a pairing and for an ad-hoc connection all modules have to be equipped with an identical
software version. As of July 2011 the corpuls3 comes equipped with a 2nd generation radio module. This new radio module is not compatible with those of the 1st generation.
As of July 2017 the corpuls3 comes equipped with 3rd generation hardware. These are not compatible with those of the 1st or 2nd generation.
The corpuls3 modules with the 2nd and 3rd generation radio module are labelled with a number symbol. This symbol is attached at the following places:
· Monitoring unit: at the front side, top left, · Patient box: on top, · Defibrillator/pacer: at the rear side, on top, · Defibrillator/pacer SLIM: at front side, top left.
2
The number symbol indicates a 2nd- or 3rd-generation module.
Starting a pairing
To start a pairing, proceed as follows:
1. Connect the monitoring unit, the patient box and, if present, the defibrillator/pacer mechanically. 2. The following options are available:
a) The message Perform pairing? appears. Confirm the message by pressing the softkey [Start].
b) The message Perform pairing? does not appear: Select in the main menu "System" "Start Pairing".
3. The message Pairing successful appears on the screen of the monitoring unit. The three modules now are paired. The corpuls3 is ready for operation via radio connection.
Starting an ad-hoc connection
To start an ad-hoc connection, proceed as follows: 1. Connect modules mechanically. 2. Do not confirm the message Perform pairing?.
The message Ad-hoc connection [MODULE], e g. Ad-hoc connection P-box or Ad-hoc connection Defib appears on the screen of the monitoring unit. The corpuls3 is ready for operation.
Note The connection status is shown by symbols in the status-/alarm line in the upper right corner of the monitoring unit (see Table 4-2 Module connection status, page 40 and Appendix A Symbols, page 289).
Note If a new pairing is performed between a monitoring unit and a patient box or with another compact device, the previously saved radio connection authorisation to the patient box or to the defibrillator/pacer is automatically deleted.
Caution
When connecting different patient boxes by ad-hoc connection, there can be inconsistent entries in the data management.
ENG - Version 4.0 P/N 04130.2
13
Introduction
User Manual corpuls3
Caution Warning
During an ad-hoc connection a radio connection to other modules is not possible.
If two modules connected by an ad-hoc connection are separated, a radio connection to the original patient box and defibrillator/pacer is automatically re-established.
3.2.2 Monitoring Unit
Fig. 3-5
Monitoring unit
1 Screen 2 Function keys Alarm and Event 3 LED Power supply/State of charge 4 On/Off key with LED Operating status 5 Defibrillation mode function keys 6 Insurance card reader 7 Jog dial and alarm light 8 Function keys for navigation 9 Print key 10 Operating mode keys 11 Printer 12 Softkeys
The monitoring unit is the central user interface of corpuls3. The monitoring unit comprises the screen (item 1), the printer (item 11) and the insurance card reader (item 6, option), as well the jog dial (item 7), the function keys (items 2, 5, 8 and 9), the operating mode keys (item 10) and the softkeys (item 12).
The jog dial is used to navigate in the main menu, the parameter and curve context menus and in the display areas on the screen.
14
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Introduction
Softkey assignments Interfaces
An alarm light is integrated into the jog dial.
The monitoring-, pacer- and mission browser functions can be selected directly by pressing the operating mode keys.
Softkey assignment varies depending on the selected function. Softkey assignments are described in the chapters dealing with the respective functions.
Fig. 3-6 shows the interfaces at the monitoring unit.
Fig. 3-6
Monitoring unit, rear view
1 Cover for LAN interface (option) 2 SIM card slot (slot for SIM card tray) 3 Contact element with patient box 4 Infrared interface with patient box 5 Infrared interface with defibrillator/pacer 6 Charging cable magnetic plug socket 7 Contact element with defibrillator/pacer
ENG - Version 4.0 P/N 04130.2
15
Introduction
3.2.3 Patient Box and Accessory Bag
User Manual corpuls3
Fig. 3-7
Patient box (illustration may differ)
1 Sensor interfaces 2 Multifunction key 3 Multifunction LED operating status/HR/alarm 4 On/Off key 5 LED Power supply/State of charge 6 Screen 7 Microphone 8 Acoustic alarm (pulse signal indicator) 9 Infrared interface with monitoring unit 10 Contact element with monitoring unit
The patient box monitors and records the monitoring sensor signals. The sensors of the various monitoring functions are connected to it.
The patient box can be used as a stand-alone unit (without the monitoring unit) for patient monitoring. The screen (item 6) on the patient box shows the following:
· The readings of the monitoring functions, · Physiological and technical alarms, · Heart rate is visually represented by an LED (item 3).
16
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Patient Box Interfaces
Right-hand side
Introduction
Fig. 3-8
Patient Box Interfaces, right hand side
1 CO2: sensor for capnometry 2 NIBP: sensor for non-invasive blood pressure monitoring 3 Temp-1: temperature sensor 4 Temp-2: temperature sensor 5 P3 P4: sensor for invasive blood pressure monitoring (channels 3 and 4) 6 P1 P2: sensor for invasive blood pressure monitoring (channels 1 and 2) 7 CPR: CPR feedback sensor
Left-hand side
Fig. 3-9
Patient Box Interfaces, left hand side
1 USB port (devices up to 09/2010) 2 Oximetry: interface for oximetry sensor 3a CF: Slot for CompactFlash® card for data storage 3b Fixed cover over CF card 4 ECG-D: complementary ECG diagnostic cable 5 ECG-M: ECG monitoring cable
ENG - Version 4.0 P/N 04130.2
17
Introduction
User Manual corpuls3
Caution
At the moment, connecting USB devices or cables to the USB port is not allowed.
Accessory Bag
An accessory bag is available for the patient box (P/N 04221.1). The accessory bag is used to store the preconnected cables as well as the sensors and ECG electrodes, so that they are quickly accessible during use.
Fig. 3-10
Patient Box with Accessory Bag
1 Patient box 2 Accessory bag
Chapter 4.5 Accessory Bag, page 61 contains information on installing and packing the accessory bag.
18
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
3.2.4 Defibrillator/pacer
Introduction
Fig. 3-11
Defibrillator/Pacer
1 Equipotential bonding pin with insulating cap 2 Shock paddle 3 On/Off key 4 Therapy master cable with plug 5 Cable socket with test contact 6 Stand and storage compartments 7 Contact element with monitoring unit 8 Infrared interface with monitoring unit
9 Compartment for corPatch electrodes
The therapy electrodes have to be connected to the therapy master cable (Fig. 3-11, item 4). The therapy master cable can be wound around the socket (Fig. 3-11, item 5). The plug can be lodged in the socket for storage.
Via the equipotential pin (Fig. 3-11, item 1) equipotential bonding can be performed in clinical use. For this, the insulating cap has to be removed and the cable of the equipotential bonding device has to be connected to the equipotential bonding pin.
The shock paddle marked with the green label APEX must be positioned in the right-hand shock paddle holder to ensure that the twistproof plug connector on the therapy master cable is correctly aligned. For guidance, identical labels for the APEX and STERNUM shock paddle are located on the side of the defibrillator/pacer. The plug can be lodged in the socket for storage.
The stand (Fig. 3-11, item 6) additionally serves as a storage compartment for electrode gel and razors, etc.
The angle of the defibrillator/pacer (not the SLIM) can be tilted vertically (30°) to achieve an optimal view of the screen during use.
Note The requirements from IEC 60601-1 for medical electric systems have to be taken into account.
ENG - Version 4.0 P/N 04130.2
19
Introduction
User Manual corpuls3
3.2.5 Defibrillator/Pacer SLIM
The defibrillator/pacer SLIM differs from the previous defibrillator/pacer only in terms of form, size and weight. The basic functions are identical.
Fig. 3-12
Defibrillator/Pacer SLIM
1 Carrying handle and lock 2 Therapy socket 3 Contact element with monitoring unit 4 Infrared interface with monitoring unit 5 Equipotential bonding pin with insulating cap 6 On/Off key
The therapy electrodes have to be connected to the therapy socket (Fig. 3-12, item 2). Via the equipotential pin (Fig. 3-12, item 5) equipotential bonding can be performed in clinical use. For this, the insulating cap has to be removed and the cable of the equipotential bonding device has to be connected to the equipotential bonding pin.
Note The requirements from IEC 60601-1 for medical electric systems have to be taken into account.
20
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Introduction
3.2.6 Brackets
Various brackets, with and without power supply, are available for the device in compact, semi-modular or modular use.
Fig. 3-13
Brackets
1 Defibrillator/compact device bracket 2 Monitoring unit bracket 3 Patient box bracket
How to insert the modules into the brackets is described in chapter 4.6 Inserting the Device into the Brackets, page 65.
Note The defibrillator/compact device charging bracket has to be installed vertically (not on the floor or the ceiling), to ensure sufficient contact with the MagCode connector via gravity.
Bracket
Bracket for defibrillator/ compact device
Monitoring Unit Bracket
Use Defibrillator/pacer and all modules connected mechanically to the defibrillator/pacer
Monitoring unit and patient box connected mechanically to the monitoring unit
Bracket for patient Patient Box box
Table 3-1
Brackets and power supply options
Power supply 12 V DC No power supply
12 V DC No power supply 12 V DC No power supply
The charging brackets can also be connected to voltages other than 12 V DC using DC/DC or AC/DC converters.
ENG - Version 4.0 P/N 04130.2
21
Introduction
User Manual corpuls3
3.3 Description of the Monitoring, Diagnostic and Therapeutic Functions
3.3.1 Monitoring and Diagnostic Functions
The corpuls3 has the following monitoring and diagnostic functions:
· ECG · Diagnostic ECG · CPR Feedback
Optional:
· Oximetry (SpO2) · Extended oximetry (SpCO®, SpHb, SpMet®) · Capnometry (CO2) · Temperature (Temp) · Non-invasive blood pressure monitoring (NIBP) · Invasive blood pressure monitoring (IBP)
ECG With the 4-pole ECG monitoring cable, the bipolar extremity leads according to Einthoven (I, II, III) and the unipolar extremity leads according to Goldberger (aVR, aVL, aVF) can be recorded and displayed on the monitor.
Diagnostic ECG
By combining the 4-pole ECG monitoring cable with the complementary 6-pole ECG diagnostic cable (chest wall leads according to Wilson (V1-V6)), 12 channels can be displayed simultaneously. This enables a comprehensive ECG diagnosis which can be supported by the ECG measurement HES® Light and an optional ECG analysis software.
CPR Feedback
During resuscitation, the CPR feedback option monitors the current compression rate and -depth of the thorax compressions by means of the corPatch CPR sensor. Speech- and text messages signal to the user whether the quality of the thorax compressions is sufficient or can be optimised.
Oximetry and extended oximetry options
Besides the peripheral pulse rate (PR), oximetry measures the perfusion index (PI) and the arterial oxygen saturation (SpO2). Extended oximetry options (available only with with Masimo Rainbow SET® Technology) include measurement of the methemoglobin level (SpMet®) and, depending on the used oximetry sensor, the level of carboxyhemogolobin (SpCO®) in percentage or the level of total hemoglobin (SpHb) in g/dl or mmol/l. Up to 6 parameter fields can be configured for display of numeric values. A curve field can display the oximetry plethysmogram.
Capnometry
The capnometer, which operates according to the mainstream method, measures the CO2 concentration in the patient's expiratory breath in real time. The CO2 concentration, measured in mmHg or kPa, can be displayed on the screen as a capnogram. The corpuls3 allows use of capnometry in intubated and nonintubated patients. The patient's respiration rate is measured as an additional parameter.
Temperature Up to two temperature values can be measured by means of temperature sensors and displayed as numerical values: body core temperature rectally and/or oesophageally and surface temperature.
22
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Introduction
Non-invasive blood pressure measurement
(NIBP) Invasive blood pressure
measurement (IBP)
The non-invasive blood pressure function (NIBP) allows blood pressure monitoring on one extremity. A selection of operating modes for adults, children and infants is available.
The invasive blood pressure function (IBP) allows the invasive measurement of various different pressures as part of intensive medical care of the patient. These include, among others, arterial pressure, central venous pressure and intracranial pressure, etc.
Two interfaces are available which can be assigned as single channels or as double channels, respectively. Consequently, up to four different invasive pressure measurements can be performed simultaneously. The recorded pressure values can be displayed on the screen either as numerical parameters and/or as a curve.
3.3.2 Therapeutic Functions
corpuls3 provides the following therapeutic functions: · Defibrillation · Cardioversion · Pacer therapy
Defibrillation and Cardioversion
The defibrillator which operates with the corpuls3-specific biphasic pulse has two operating modes: · Automatic external defibrillation (AED mode) · Manual defibrillation and cardioversion (manual mode)
Fig. 3-14 Biphasic defibrillation pulse 6/4 (qualitative representation)
Note By default, the biphasic defibrillation impulse 6/4 is set. Upon request, the biphasic defibrillation impulse 4/3 can be configured by a service technician.
ENG - Version 4.0 P/N 04130.2
23
Introduction
U [V]
User Manual corpuls3
t [ms]
Fig. 3-15 Biphasic defibrillation pulse 4/3 (qualitative representation)
Defibrillation electrodes Energy selection
Warning
In AED mode, the user is assisted by an automated ECG analysis, verbal instructions (configurable) and a metronome (configurable). The defibrillation pulse is triggered by the user.
The algorithm of the AED mode is governed by the current recommendations.
In manual defibrillation mode, the user has full freedom of action and decision-making. The metronome (configurable) is available in this mode as well.
Defibrillation can be performed with corpuls3 using plate electrodes, so-called shock paddles, disposable adhesive electrodes, so-called corPatch electrodes and internal shock spoons.
There are three different options for selecting energy in manual mode:
· Softkeys The softkeys allow a choice of predefined energy settings (depending on which electrodes are connected, e. g. for adults 50 J, 100 J, 150 J, 200 J).
· Jog dial The jog dial allows selection of 2 J, 3 J, 4 J and 5 J and subsequently in 5 J-increments up to a maximum energy of 200 J.
· Shock paddles By short-circuiting the shock paddles, the energy can be selected by pressing the release buttons. This function allows the same energy selection as with the jog dial.
A cardioversion may lead to fibrillation or asystole. When performing a cardioversion, mind the following:
· The ECG has to be stable with a heart rate of at least 60/min. · The synchronisation mode has to be set to SYNC. · The QRS marks (triangles) have to mark each QRS complex. Do NOT rely on the QRS-/pulse
tone alone. · The shock release has to be effected according to valid guidelines. · To release a shock, the Shock key at the monitoring unit or the buttons at the shock
paddles have to be held down until a shock is released.
24
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Introduction
Pacing
FIX DEMAND
OVERDRIVE function
By electrical stimulation of the heart muscle, the external pacer of corpuls3 can supplement, positively influence or completely take over its function. The pacer emits pacing pulses to the patient's heart muscle through the corPatch electrodes attached to the chest/back.
With the pacer function, the FIX and DEMAND operating modes are available as well as the function OVERDRIVE.
In the FIX operating mode, the heart muscle is stimulated regardless of the patient's own heart rate.
The pacer only stimulates in DEMAND mode when the patient's own heart rate falls below the pre-set pacing frequency. The automatic R-wave recognition prevents pacing during the vulnerable phase of the heart.
The OVERDRIVE function allows manual reduction of a patient's high heart rate. The maximum pacing frequency is f 300/min.
Frequency and intensity
Pacing frequency FIX operating mode
Pacing frequency DEMAND operating mode
Pacing frequency OVERDRIVE function
Intensity
Minimum 30 /min 30 /min 30 /min 10 mA
Maximum 150 /min 150 /min 300 /min 150 mA
Increments 5 /min 5 /min 1 /min 5 mA
Table 3-2
Frequency and intensity
3.4 Alarm Management
The alarm management of the corpuls3 classifies all alarms into three different priorities, into physiological and technical alarms as well as into active and non-active alarms.
Priorities High-priority alarms warn the user of immediate lethal or irreversible injuries of the patient or of malfunctions in the device. High-priority alarms cannot be interrupted by medium-priority- or lowpriority alarms.
Medium-priority alarms alarms warn the user of immediate reversible injuries of the patient or of minor malfunctions in the device. Medium-priority alarms cannot be interrupted by low-priority alarms. Highpriority alarms always take precedence over medium-priority- or low-priority alarms.
Low-priority alarms warn the user of minor injuries of the patient that may occur later or of minor limitations to the functionality of the device. High- and medium-priority alarms always take precedence over low-priority alarms.
Physiological and The physiological alarms are displayed if measured values exceed or fall below the pre-set limit values technical alarms of the alarm. Technical alarms are displayed, if there is a malfunction in the device. If the corpuls3 is in
AED- or manual defibrillation mode, the physiological alarms are not signalled.
If the alarming is disabled for an individual alarm, pertaining active alarms will be confirmed automatically.
Note The physiological and technical alarms and the necessary troubleshooting measures are listed in chapter 11 Procedure in Case of Malfunctions, page 250.
Active and non-active alarms
Alarms are active, if the conditions that trigger the alarm are present. If alarms are confirmed by pressing the Alarm key, they are no longer indicated in the status-/alarm line. Some alarms, however, are still listed in the alarm history as non-active for information, even if the conditions that trigger the alarm have been remedied.
ENG - Version 4.0 P/N 04130.2
25
Introduction
User Manual corpuls3
Alarm signals at monitoring unit and
patient box
Covert mode
The corpuls3 issues visual alarm signals at the monitoring unit and at the patient box. If there is no connection between the monitoring unit and the patient box, acoustic alarm signals are issued at both modules. If there is a connection, acoustic alarms are issued only at the monitoring unit.
No alarm signals are issued at the defibrillator/pacer. Alarms of the defibrillator/pacer are signalled at the monitoring unit.
If the covert mode function is enabled, all signalisations of the device via speakers (start-up tone, speech messages, ready signal, key tones, alarms etc.) as well as the lightening up of the jog dial are completely disabled. It is recommended to use this function only for special surroundings and not for everyday missions. All alarms can still be viewed in the alarm history on the monitoring unit.
Warning
Using the Covert Mode requires particular diligence and attention of the user, as otherwise it can lead to serious or lethal injuries of the patient. In this device mode, the user must have direct eye contact to the patient and the device at all times.
Clinic mode
The clinic mode is intended for corpuls3 devices that are used in a hospital. After this function has been enabled by the user OPERATOR, low priority alarms are repeated every 30 s until they are confirmed. High- and medium priority alarms are unchanged. All alarms can still be viewed in the alarm history on the monitoring unit.
Warning
Potential danger due to inappropriate alarm presettings in area of application! If the user operates the device in an area of application other than the usual, the alarm settings may cause misunderstandings. Adjust alarm settings.
3.4.1 Alarm Signals at the Monitoring unit
Physiological and technical alarms are signalled at the monitoring unit via the status-/alarm line, the vital parameter field, the jog dial and by acoustic signals. The positions of the operation- and display elements are described in chapter 4.1 Operating- and Screen Elements, page 35.
Alarm signal in the status-/alarm line
Fig. 3-16
Alarm messages in the alarm history
- The symbol indicates an alarm.
- The number in brackets indicates the number of active alarms (here 4 alarms)
- The number of exclamation marks indicates the priority of the alarm (!!! high; !! medium; ! low)
- The colour of the status-/alarm line indicates the priority of the alarm (red high; yellow medium; blue low)
- The alarm is displayed as a text message together with the pre-set limit value.
Pressing the Alarm key once opens the alarm history which lists the last 8 alarms. The individual alarms can be confirmed by pressing the Alarm key again. In this case, the most recent alarm message is deleted from the status-/alarm line of the monitoring unit and from the screen of the patient box.
26
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Introduction
Warning
Delayed recognition of critical patient status! The alarm functions "Alarm OFF" and "Autolimits" can also be operated remotely with the corpuls.mobile REMOTE App. This may cause a delay in recognising critical patient status. Keep direct eye contact to the patient at all times.
Sorting of alarm history
Note Note
In the alarm history all active and non-active alarms are displayed that have not yet been confirmed; with the alarms being sorted top-down from active (top) to non-active (bottom). Within the active and non-active alarms, the alarms are sorted by priority and then in descending order by the time of their occurrence.
The alarm history can contain up to 256 alarms. Preferably these should be confirmed as soon as possible. If more than 256 un-confirmed alarms accumulate, the oldest alarm is overwritten.
Certain technical alarms are displayed in red type. These alarms cannot be deleted from the status/alarm line and alarm history.
Alarm signal in parameter field displayed in inverted colours:
Fig. 3-17 Inverted parameter field
- This display appears only for physiological alarms. - The parameter field can only be displayed in inverted colours when the display of this parameter
field is configured. - The parameter field remains in inverted colours for as long as the measured value falls below or
exceeds the pre-set limit value or until the alarm for this measured value is disabled. This applies regardless of whether the alarm message in the status-/alarm line has been confirmed by pressing the Alarm key or not.
Alarm signal via the jog dial:
Fig. 3-18
Jog dial
1 Not illuminated 2 Illuminated to indicate an alarm
- The alarm with the currently highest priority is indicated by the colour blue, yellow or red (in older devices only red) as well as by the flashing speed of the jog dial.
- The priority of the alarm determines the flashing speed. The flashing speed increases with the priority.
ENG - Version 4.0 P/N 04130.2
27
Introduction
User Manual corpuls3
Warning
The acoustic alarm sounds: - The alarm with the highest priority is signalled acoustically. - The type of sound helps the user to differentiate between low-, medium- and high-priority alarms.
Non-recognition of alarm conditions Set the volume of the acoustic alarm so that it cannot fail to be heard in loud environments.
Minimal volume Volumee
The minimal volume can be configured by the user OPERATOR to prevent that alarms are not heard in loud surroundings. The user cannot set the volume lower than the minimal volume defined by the user OPERATOR.
Alarm suspension
If the Alarm key is pressed for more than 3 s, physiological alarms can be suspended briefly or, depending on the configuration set by the operator, also permanently. Prerequisite is that this has been configured accordingly in the settings (see chapter 7.4.6 Alarm Configuration (Persons Responsible for the Device), page 185). If the alarm suspension has been activated, it can also be deactivated again by pressing the Alarm key for more than 3 s.
Note If for one parameter the alarm has been disabled by selecting "Alarm OFF and the parameter field is no longer displayed, the alarm will automatically be re-enabled.
Defibrillation mode Only technical alarms are displayed in defibrillation mode. Physiological alarm limits are not monitored. No physiological alarm events are saved in defibrillation mode.
Warning
The patient must not be left unattended when defibrillation mode is selected.
Configuration of alarms
Situation after switching on
Manual and automatic configuration as well as all further settings (saving, volume, etc.) with reference to the alarm function of the monitoring unit can be found in chapter 7.3 Alarm Configuration, page 172.
After switching on, the settings entered by the person responsible for the device apply. Differing alarm settings are only saved permanently if the user has the appropriate authorisation.
Warning
Night vision goggle (NVG/NVIS)-compatible monitoring units differ from the above description as follows:
· The illumination of the jog dial for signalling an alarm is not red but cyan (light-blue). · The maximum brightness of the illumination of the jog dial is only 5% of the regular
configuration. · The signalling of an alarm via the jog dial is not visible in daylight and difficult to see in the
twilight. · The representation of colours on the screen differs. Due to this, signal colours may not be
recognised as such.
28
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Introduction
3.4.2 Alarm Signals at the Patient box
Physiological and technical alarms are signalled on the patient box in various ways: Alarm message on the patient box screen:
Fig. 3-19 Alarm message on the patient box screen
- The symbol indicates an alarm.
- The number in brackets indicates the number of active alarms (here 1 alarm).
- The number of exclamation marks indicates the priority of the alarm (!!! high; !! medium; ! low)
- The alarm is displayed as a text message together with the pre-set limit value and the timestamp of the alarm.
The individual alarms can be confirmed by pressing the Multifunction key once. If a radio connection to the monitoring unit exists, the most recent alarm message is deleted from the status-/alarm line and alarm history of the monitoring unit and from the screen of the patient box.
Configuration of alarms
Situation after switching on
The acoustic alarm sounds: Acoustic alarms are only signalled, if no radio connection to the monitoring unit exists. If a connection to the monitoring unit exists, the acoustic alarm only sounds on the monitoring unit; the alarm on the patient box is suspended.
The alarm limits can be modified on the monitoring unit. Manual and automatic configuration in addition to further settings pertaining to the alarm function can be found in chapter 7.3 Alarm Configuration, page 172.
After switching on, at first the settings entered by the person responsible for the device apply. Differing alarm settings are only saved permanently if the user has the appropriate authorisation.
ENG - Version 4.0 P/N 04130.2
29
Introduction
User Manual corpuls3
3.5 Energy Management
Influence of the modular structure
Energy management is of paramount importance owing to the modular structure of the corpuls3.
The corpuls3 and the individual modules can be operated on battery alone or on 12 V DC power supply or via a separate charger (only 230 V AC).
3.5.1 Battery Operation
Identical lithium-ion batteries
Empty or faulty batteries Note Note
Note Remaining running time
display
The three modules of corpuls3 each have their own lithium-ion battery. The batteries are identical and have an integrated microchip which records the history of use.
Each of these batteries can be replaced manually and without use of tools. Exchanging the batteries for one another within the corpuls3 is also possible. Information on replacing the batteries can be found in chapter 10.6 Replace battery, page 243.
When the modules of the corpuls3 are connected mechanically (compact device or semi-modular use), the energy is drawn from the battery with the currently highest state of charge. If the state of charge is identical in all batteries, the corpuls3 accesses all available batteries equally.
If only a low level of charge remains in the battery of one module, it is possible to access the energy reserves of the other batteries by connecting this module to one or both other modules.
If the state of charge of a battery is less than 20 %, an alarm message for the respective module is triggered.
To guarantee a sufficient charge, the corpuls3 has to be inserted into the charging bracket or connected to the external charger.
One battery with adequate charge is sufficient to operate the device reliably as compact device.
Energy exchange or mutual charging between the batteries does not occur.
The corpuls3 as well as the individual modules can be operated on battery, directly on 12 V DC or via a separate charger (230 V AC).
The corpuls3 is only intended for use with all three batteries inserted.
To be able to offer the user the maximum possible safety, the corpuls3 calculates the remaining running time and indicates this in minutes. In calculating the remaining running time, the device takes the current energy consumption into account.
The remaining operating time is displayed in the status-/alarm line of the monitoring unit (Fig. 3-20).
Fig. 3-20
Remaining running time of the corpuls3 in the current operating status
1 Battery symbol and remaining running time in minutes
30
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Introduction
In case of modular use of the patient box, the remaining running time of the patient box, taking into account the current energy consumption, is displayed (Fig. 3-21).
1
Fig. 3-21
Remaining running time of the patient box
1 Battery symbol and remaining running time in minutes
Alternatively, the state of charge of the batteries in percent can be viewed in the system info. Select in the main menu "System" "Info".
Battery charging Battery maintenance
Since each module has a charge controller, it can be charged individually and independently from the other modules.
Furthermore, in compact or semi-modular use, the system can also be charged by only one magnetic contact. In this case, the charging time is independent of whether only one or several modules are simultaneously charged by an external power supply.
During charging, the corpuls3 system can be operated.
Special maintenance of the batteries is not required. Nevertheless, charging and/or operating under extreme temperatures should be avoided as far as possible. This and extreme temperature fluctuations limit the service life of lithium-ion batteries. It is therefore recommended to charge the batteries within a temperature range from 12°C to 40°C. Periodic replacement of the batteries after 3 years is recommended.
Operating time
· Compact device: · Patient box: · Monitoring unit:
· Defibrillator/Pacer:
approx. 7-10 hours approx. 4-6 hours approx. 4 hours (at 70% background illumination) up to 200 shocks at 200 J
Charging time
· From 0 to 80 %:
approx. 1 hour
· From 0 to 90 %: approx. 1.5 hours
· From 0 to 100 %: approx. 2 hours
Note The batteries have an internal protection which could delay or interrupt the charging process at ambient temperatures of higher than 50°C.
ENG - Version 4.0 P/N 04130.2
31
Introduction
User Manual corpuls3
3.5.2 Mains Operation
Operation with 12 V DC Use of a mains charger
The compact device and each individual module can be operated directly with 12 V DC.
In combination with a multi-range mains charger, the compact device and the individual modules can also be connected to and operated with voltage sources of 100 V to 250 V AC. Operation with the mains charger on a source of alternating current functions regardless of whether no batteries, empty batteries or faulty batteries are used.
Note The corpuls3 and the AC converter form a medical electric system.
State of charge display The current state of charge of the batteries is displayed on the status-/alarm line of the monitoring unit (Fig. 3-22).
Fig. 3-22 Display of the current state of charge of the batteries on mains operation
1 Symbol for mains connection and state of charge of the batteries in percent
Charging brackets The voltage can also be supplied by the three available charging brackets: · Compact device bracket 12 V DC (P/N 04400) · Monitoring unit wall mounting bracket 12 V DC (P/N 04401) · Patient box bracket 12 V DC (P/N 04402)
Charging during operation
Magnetic contact field
These brackets can also be connected to voltages sources other than 12 V DC via DC/DC or AC/DC converters.
If batteries are present in the device, they will be charged during use.
Each of the three modules has its own magnetic contact field for power supply. The flow of energy only begins when the corresponding magnetic mating component (magnetic clip or bracket supplied with voltage) is applied in the correct position (observe groove). The magnetic clip releases itself automatically if the pulling force becomes excessive and so prevents damage to the connector and the cable.
The connection (item 1, Fig. 3-23) on the defibrillator/pacer is used for power supply of
· the entire device in compact use, · the defibrillator/pacer and the monitoring unit in semi-modular use or · the defibrillator/pacer in modular use.
32
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Introduction
2
Fig. 3-23
1 Compact device, power supply (illustration may differ)
1 Power supply connection 2 Magnetic clip
Fig. 3-24
Monitoring unit, power supply
1 Power supply connection 2 Magnetic clip
ENG - Version 4.0 P/N 04130.2
33
Introduction
User Manual corpuls3
Fig. 3-25
Patient box, power supply (illustration may differ)
1 Power supply connection 2 Magnetic clip
34
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
General Operating Instructions
4 General Operating Instructions
4.1 Operating- and Screen Elements
The corpuls3T, available as of version 4.0 allows, in addition to the jog dial, operation via touchscreen (see chapter 4.1.3 Operation via Touchscreen, page 43).
4.1.1 Operating Elements and LEDs on the Monitoring Unit
Fig. 4-1
Monitoring unit, operating elements and LEDs
1 Alarm key 2 Event key 3 On/Off key 4 LED Power supply/State of charge 5 Operating status LED 6 Defibrillation mode function keys 7 Insurance card reader (option) 8 Jog dial and alarm light 9 Function keys for navigation 10 Print key 11 Operating mode keys 12 Softkeys
ENG - Version 4.0 P/N 04130.2
35
General Operating Instructions
User Manual corpuls3
On/Off key
The following modules are switched on or off by pressing the On/Off key on the monitoring unit: · all modules during use as a compact device; · the monitoring unit and all the modules connected mechanically to the monitoring unit during semi-modular use;
During modular use only the monitoring unit is switched on with the On/Off key, but all modules are switched off with it. Chapter 4.2 Switching On and Off, page 48 contains further information on switching on and off.
Status LEDs The status LEDs of the monitoring unit indicate the power supply or the state of charge of the batteries in addition to the operating status of the device:
LED
power supply/
state of charge (item 4)
LED
operating status (item 5)
green
orange green
- Battery is fully charged - Device is connected to the mains
- Battery is being charged
- Device is switched on
Function keys, defibrillation The defibrillation and cardioversion functions are called up by pressing the defibrillation mode function mode keys (item 6) (see also chapter 5 Operation Therapy, page 68).
AED
Analyse MMaannuuealll Energy
or
The red AED key selects the operating mode "automated external defibrillation". The corpuls3 can be switched on by pressing the AED key. In this case the operating mode is immediately available.
The red Analyse key selects the operating mode "automated external defibrillation" or starts the ECG analysis.
The grey Manual key or the Energy key selects the operating mode "manual defibrillation". The corpuls3 can be switched on by pressing the Manual key. In this case the operating mode is immediately available.
CLhaadregne Charge or
The Charge key selects the operating mode "manual defibrillation" or initiates the charging process.
Table 4-1
Shock or
The Shock key triggers a defibrillation shock in AED- or manual mode. It is positioned centered, as it is valid for both modes.
Keyboard layout defibrillation keys (modifications possible)
36
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
General Operating Instructions
Jog dial
With the jog dial, it is possible to:
· navigate on the display; · open a parameter context menu or curve context menu pertaining to a parameter or curve and
adjust settings (see chapter 4.3.2 Parameter Context Menu and Curve Context Menu, page 52); · open the main menu of the device and adjust settings (see chapter 4.3.3 Main menu, page 54); · adjust numerical values in defibrillation mode and pacer mode; · adjust settings in the configuration dialogue (see chapter 4.3.4 Configuration dialogue, page 55).
Operating mode keys The different operating modes are selected by pressing the following keys (Fig. 4-1, item 11): Monitor The Monitor key selects the monitoring functions (monitoring mode)
Pacer Browser
The Pacer key switches to pacer mode
The Browser key starts printing of the log. If the Browser key is held down for more than 3 seconds, the mission browser opens.
Back and Home function The function keys Back and Home (Fig. 4-1, item 9) are used to control the device: keys
The Back key returns to the next menu level up or undoes the last selection.
1.
2. Locking and unlocking the keyboard and touchscreen
The Home key switches to the basic status of the respective mode and leaves menus completely by skipping several levels. By pressing the Home key, the lock of keyboard and touchscreen can also be engaged:
a) Hold down the Home key and confirm the confirmation prompt "Lock input device?" by briefly pressing the softkey [All] or [Touch]. The message "Touch display locked" or "All locked" appears.
b) To unlock, press softkey [Unlock].
Note The softkey [Touch] only locks the touchscreen, the softkey [All] locks all keys, softkeys and the touchscreen. With pressing the softkey [Unlock], however, everything is unlocked, even if only the touchscreen was locked before.
Note If a key is pressed while input lock is active, the message text "Input device locked - Hold down HOME key to unlock" appears. Deactivate keyboard lock immediately to avoid delaying necessary operating steps on the device.
Note The input lock does not apply to the red or green button at the shock paddles. A discharge of energy via shock paddles is possible despite an activated input lock.
Print key Pressing the Print key (Fig. 4-1, item 10) starts the real-time printout of the curves. Pressing the Print key again interrupts every running print job (log, D-ECG, real-time printing).
Softkeys
The time span after which the printer stops automatically can be pre-set in the printer configuration. For further information on printout configuration see chapter 7.1.3 Printer settings, page 160.
The softkeys (Fig. 4-1, item 12) are assigned different functions, depending on the current operating mode or selected dialogue. The current function is displayed in the softkey line.
ENG - Version 4.0 P/N 04130.2
37
General Operating Instructions
User Manual corpuls3
Alarm key
By pressing the Alarm key (Fig. 4-1, item 1), the alarm history of all physiological and technical alarms is called up. All the alarms which have occurred appear in this list with their time of occurrence.
1. Press the Alarm key to retrieve the alarm history. 2. Press the Alarm key to confirm the alarm. 3. Repeat step 2 until all alarms have been confirmed.
Note Severe technical alarms reported by the alarm system cannot be deleted from the alarm history. Those are marked in red type.
Physiological alarms can be suspended for a selected period of time (up to 120 s or permanently) (see chapter 7.4.6, Alarm Configuration (Persons Responsible for the Device), page 185) by holding down the Alarm key for approx. 3 s. Technical alarms cannot be suspended.
Note Event key
For the alarm suspension, a maximum period of 60 seconds is recommended (see also chapter 7.4.6 Alarm Configuration (Persons Responsible for the Device), page 185).
If the Event key (Fig. 4-1, item 2) is pressed briefly, a time stamp is saved which marks the current ECG data and parameter values. Based on this marking, this data can subsequently be located in the data memory, viewed and assessed. The message Event recorded appears in the message line.
If the Event key is held for more than 3 s, the event list with pre-configured events appears (see chapter 8.2 Event Key, page 200).
38
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
General Operating Instructions
4.1.2 Basic Structure of the Screen Pages on the Monitoring Unit
The screen has the following structure:
Fig. 4-2
Monitoring unit, example of basic structure of the screen pages
1 Status-/alarm line 2 Parameter area 3 Curve and display area 4 Message line 5 Softkey line
Note The colours of the parameters and curves in the illustrations of this user manual may differ from the actual display.
Status-/alarm line
The following data are displayed in the status-/alarm line (Fig. 4-2, item 1):
· Physiological and technical alarms · Patient's name (editable) · Time and deployment time alternating every 5 seconds · Symbols for telemetry-functions · State of charge of the batteries on mains operation · Remaining running time of the device on battery operation · Connection status of the modules
Connection status
Meaning
All three components are connected mechanically and communicate via the infrared optical interface.
ENG - Version 4.0 P/N 04130.2
39
General Operating Instructions
User Manual corpuls3
Connection status (((
Meaning
Monitoring unit and defibrillator/ pacer are connected mechanically and communicate via the infrared optical interface. The patient box is disconnected mechanically, but there is a radio connection with the patient box.
Monitoring unit and patient box are connected mechanically and communicate via the infrared optical interface. The defibrillator/ pacer is disconnected mechanically, but there is a radio connection with the defibrillator/ pacer.
(((
All components have a radio connection.
x
Table 4-2
The defibrillator/ pacer was not switched on together with the corpuls3 and therefore is not available currently.
All three components are connected mechanically and communicate via the infrared optical interface. A radio connection is not possible, because all three components are connected with an ad-hoc-connection.
Monitoring unit and patient box are connected mechanically and
communicate via the infrared optical interface.
x
A radio connection is not possible, because both components are connected with an ad-hoc-connection.
The defibrillator/ pacer is disconnected; there is no radio
connection to the defibrillator/ pacer.
Monitoring unit and defibrillator/ pacer are connected mechanically and communicate via the infrared optical interface. A radio connection is not possible, because both components are connected with an ad-hoc-connection. The patient box is disconnected; there is no radio connection to the patient box.
Module connection status
Note Parameter area Curve and display area
Message line Softkey line View configuration
The wave symbol or the bar symbol flashes for as long as the device is attempting to establish a connection, but has not yet been able to do so.
If the radio connection is interrupted, the modules have to be connected to each other mechanically. The corpuls3 switches automatically from radio connection to infrared connection in this case.
The measured parameters and the configured alarm limits are displayed in the parameter area (Fig. 4-2, item 2) of the display.
Up to 6 curves of measured values of monitoring functions can be displayed in the curve and display area (Fig. 4-2, item 3) of the display.
If the device is in defibrillation- or pacer mode, the parameters of the respective operating mode are displayed in the bottom half of the display.
In case of a diagnostic ECG, all 12 leads are displayed simultaneously as curves.
In the message line (Fig. 4-2, item 4) of the screen, additional interactions with the user interface are displayed, e. g. to enter the PIN code for the OPERATOR user level or to enter patient data).
The current function assignment of the softkeys is displayed in the softkey line (Fig. 4-2, item 5).
Further options of the structure of the screen page can be configured (see chapter 7.1.2 Configuration, page 157).
40
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
General Operating Instructions
Fig. 4-3
Screen page, example with horizontal and vertical parameter area
1 Status-/alarm line 2 Parameter area 3 Curve and display area 4 Message line 5 Softkey line
Inverting screen colours Monitor
If necessary under particular lighting conditions, the screen can be displayed in inverted video. If the Monitor key is held down for more than 3 seconds, the screen display is inverted (see also chapter 7.1.1 General System Settings (User DEFAULT), page 155). Furthermore, it is possible to invert the screen via the system settings:
1. Select in the main menu "System" "Settings". The configuration dialogue opens.
2. In the configuration group "Display" select the configuration field "Colours" "Inverted". 3. Press the softkey [OK].
ENG - Version 4.0 P/N 04130.2
41
General Operating Instructions
User Manual corpuls3
Fig. 4-4 Inverted video display of the screen (colours may differ)
Screen Night vision goggle (NVG/NVIS)-compatibility
The corpuls3 is optionally available as a night vision goggle (NVG/NVIS)-compatible variant (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249). This variant emits less light than normally so that in-flight or military purpose operation of the corpuls3 when using night vision goggles is possible.
For this, the display of the screen of night vision goggle (NVG/NVIS)-compatible devices can be inverted specifically for use with night vision goggles via the system settings (see chapter 7.1.1 General System Settings (User DEFAULT), page 155):
1. Select in the main menu "System" "Settings". The configuration dialogue opens.
2. In the configuration group "Display" select the configuration field "Colours" "Night". 3. Press the softkey [OK].
42
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
General Operating Instructions
4.1.3 Operation via Touchscreen (only corpuls3T)
The corpuls3T, available as of version 4.0 allows, in addition to the jog dial, operation via touchscreen. The touchscreen is divided into active areas. Tapping on an active area opens a pertaining menu, tapping on a neutral area closes it:
Fig. 4-5
Touchscreen, active areas are highlighted in colour
1 Active area Alarm history, yellow 2 Active area Parameter context menu, blue 3 Active area Curve context menu, green 4 Main menu, red, can only be opened with the jog dial 5 Checkbox in configuration dialogue 6 Multiple options in configuration dialogue, activated 7 Active area Softkey context menu, pink
Alarm history Note
Context menus
Main menu Configuration dialogue
Softkeys
The alarm history can be opened by tapping (corresponds to the first pressing of the Alarm key), if an alarm exists. However, alarms can be only confirmed with the jog dial or by pressing the Alarm key.
For the Event key there is no active area, but after holding down the Event key, a pre-configured event can be selected by tapping (see chapter 8.2 Event Key, page 200).
The options in the curve-, parameter and softkey context menus can be selected by tapping. Binary options (e.g. Alarm ON/Alarm OFF) are confirmed directly by tapping. The symbol for the jog dial indicates that there are multiple values that can be scrolled through with the jog dial and confirmed by pressing the jog dial (see also chapter 4.3.2 Parameter Context Menu and Curve Context Menu, page 52).
The main menu can only be opened with the jog dial, in the corpuls3T as well as in the previous device. The corresponding submenus, however, can be opened by tapping.
The options in the configuration dialogues can be selected by tapping. Checkboxes are selected or deselected directly by tapping. For multiple options (e.g. number values) the bold type indicates that there are multiple values that can be scrolled through with the jog dial and confirmed by pressing the jog dial.
The softkeys can be selected by tapping, but for entering e.g. names the characters/number still have to be scrolled through and selected with the jog dial. For information on the softkey context menu see also chapter 4.3.1 Softkey context menu, page 51.
ENG - Version 4.0 P/N 04130.2
43
General Operating Instructions
User Manual corpuls3
Caution
Impairment or malfunction due to wetness/contamination! When operating the touchscreen with wet hands or with the presence of (salt)water, blood or other contaminations, the touchscreen may malfunction or not function at all (ghost touches). Operate the touchscreen with dry hands. If necessary, lock and wipe off the touchscreen.
Note To lock the touchscreen, hold down the Home key and confirm the confirmation prompt "Lock input device?" by pressing the softkey [All] or [Touch].
Note If the touchscreen function is not available, the user may operate the device via jog dial and keys at any time.
4.1.4 Patient box screen
The patient data are displayed on a separate screen during modular use. The screen has the following structure:
1 2
3
Fig. 4-6
Patient box, displays on the screen (illustration may differ)
1 Connection status with the monitoring unit 2 Remaining running time of the patient box on battery operation 3 Display of a selected vital parameter
For the status of the network connection (item 1) of the patient box, the following conditions exist:
Connection status
))
Meaning The patient box has a connection with the monitoring unit
Table 4-3
X
The patient box does not have a connection with the monitoring unit
Module connection status
The remaining running time is not displayed if the patient box is operated on an external mains charger. Note The screen of the patient box may appear darker in night vision goggle (NVG/NVIS)-compatible devices.
44
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
General Operating Instructions
4.1.5 Control Keys and LEDs on the Patient Box 1 23
Fig. 4-7
4
Patient box, control keys and LEDs (illustration may differ)
1 On/Off key 2 LED Power supply/State of charge 3 Multifunction LED operating status/HR/alarm 4 Multifunction key
On/Off key The patient box is switched on or off during modular use by pressing the On/Off key (item 1).
LED power supply/ state of
charge
The state of charge LED (item 2) indicates the power supply or the state of charge of the battery:
LED
power supply/
state of charge
green orange
- Battery is fully charged - Device is connected to the mains
- Battery is being charged
Multifunction LED Multifunction key
The multifunction LED (item 3) flashes in step with the heart rate when ECG electrodes or the SpO2 sensor are connected. If no electrodes or no SpO2 sensor are connected, it indicates the operating status of the patient box. Furthermore, physiological and technical alarms are indicated by flashing up.
By pressing the multifunction key (item 4), the next parameter being currently measured is displayed.
If alarms are displayed on the screen of the patient box, they can be confirmed by pressing the multifunction key.
ENG - Version 4.0 P/N 04130.2
45
General Operating Instructions
4.1.6 Control Key and LEDs on the Defibrillator/Pacer
User Manual corpuls3
Fig. 4-8
Defibrillator, control key and status LEDs
1 On/Off key 2 Operating status LED 3 LED Power supply/State of charge
On/Off key
Status LEDs on defibrillator
By pressing the On/Off key (item 1), the defibrillator is switched on or off during modular use.
The status LEDs of the defibrillator/pacer module indicate the power supply or state of charge of the battery as well as the operating status of the device:
LED
power supply/
state of charge (item 3)
LED
operating status (item 2)
green
orange green
- Battery is fully charged - Device is connected to the mains
- Battery is being charged
- Device is switched on
46
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
4.1.7 Control Key and LEDs on the Defibrillator/Pacer SLIM
General Operating Instructions
Fig. 4-9
Defibrillator SLIM, control key and status LEDs
1 On/Off key 2 LED Power supply/State of charge 3 Operating status LED
On/Off key
Status LEDs on defibrillator
By pressing the On/Off key (item 1), the defibrillator is switched on or off during modular use.
The status LEDs of the defibrillator/pacer module indicate the power supply or state of charge of the battery as well as the operating status of the device:
LED
power supply/
state of charge (item 3)
LED
operating status (item 2)
green
orange green
- Battery is fully charged - Device is connected to the mains
- Battery is being charged
- Device is switched on
ENG - Version 4.0 P/N 04130.2
47
General Operating Instructions
User Manual corpuls3
4.2 Switching On and Off
4.2.1 Switching On
Compact device Press the On/Off key on the monitoring unit. All modules are switched on.
Switching on in defibrillation mode
AED
MMaannuueall l
Press the
or
key on the monitoring unit.
The corpuls3 either starts in AED mode or in manual defibrillation mode, respectively.
Semi modular use
1. Press the On/Off key on the monitoring unit. The monitoring unit and the module connected mechanically to it are switched on.
2. Press the On/Off key on the module which is not connected mechanically. This module is switched on.
Modular use Press the On/Off key on all individual modules. The modules are switched on independently.
Connecting modules When a switched-off module is connected mechanically to a switched-on module, it switches on automatically.
Note When a (new) battery is inserted in a module, this module can switch on automatically.
Note A certain amount of time is required to achieve operational status after switching on. It is therefore recommended to switch on the corpuls3 as soon as possible.
Warning
If the alarm message "ß-SW-NOT FOR PAT. USE" appears after the device is switched on, the software of one or all modules is a betaversion.
Using this version on a patient is prohibited. Contact your authorised sales and service partner.
Warning
If the alarm message "ONLY FOR TEST" appears after the device is switched on, the software of one or all modules is a test version.
Using this version on a patient is prohibited. Contact your authorised sales and service partner.
48
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
General Operating Instructions
4.2.2 Switching off
Compact device 1. Press the On/Off key on the monitoring unit. All modules are switched off if the softkey [OK] is pressed after the confirmation prompt appears.
Fig. 4-10 Confirmation prompt before switching off
(Semi) modular use
Press the On/Off key on the monitoring unit. All modules connected with the Monitoring unit mechanically or by radio are switched off if the softkey [OK] is pressed after the confirmation prompt appears.
Defibrillator/patient box
The defibrillator and patient box can be switched off independently without having an influence on the remaining modules by pressing the On/Off key. To do so, keep the On/Off key on the defibrillator or patient box depressed for 3 seconds.
Cancelling switch-off Upload mode
The switch-off process of the monitoring unit and the connected modules can be cancelled by pressing the softkey [Cancel]. This confirmation prompt disappears by itself if no action is taken within approx. 10 seconds and the monitoring unit and the connected modules remain switched on. To confirm the switching off process, press the softkey [OK].
If the option "Mission upload" is enabled and configured, pressing the softkey [OK] starts the upload of missions recorded on the CF card to the configured server, before the device is switched off.
Fig. 4-11 Upload screen
ENG - Version 4.0 P/N 04130.2
49
General Operating Instructions
User Manual corpuls3
Switching off in pacer mode
If the upload should be skipped and the corpuls3 should shut down immediately, press the softkey [Now].
1. Press the On/Off key as described above. The confirmation prompt "Switch off pacer? - Power off?" appears.
Fig. 4-12 Switching off with pacer active
2. If the unit is to be switched off even though the pacer is active, press softkey [OK]. If the unit is not to be switched off, press softkey [Cancel].
Switching off in case of
system crash
Warnings on switching off
In case of a system crash of one of the modules or of the compact device, the device can be switched off with the On/Off key. For this, the On/Off key at the monitoring unit (or at the individual modules) has to be held down (at least for 8 seconds) until the module switches off. Subsequently, the module can be restarted with the On/Off key. It is not necessary to remove the battery.
If no connection with the patient box and/or defibrillator/pacer exists at the time of switching off the monitoring unit or if a timing problem exists between the modules, this is indicated to the user by the message "Check modules":
Fig. 4-13 Warning on switching off
In this case, separate the modules and check whether all modules have been shut down. If this is not the case, switch off the modules which have not been switched off by pressing the respective On/Off key.
50
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
General Operating Instructions
4.3 Menu Control
The menus are controlled with the jog dial, softkeys and the function keys Back and Home. There are four different menu types: · Softkey context menu · Parameter context menu or curve context menu · Main menu of the device · Configuration dialogue
4.3.1 Softkey context menu
The softkey context menu allows fast access to menu items that are relevant for the corresponding softkey.
Four softkey context menus are available:
· QRS (monitoring mode): activation of the QRS-/pulse tone and fast access to volume control. The volume control always starts with the position "Off" and can be advanced position by position by pressing the corresponding softkey several times.
· Views (monitoring mode): fast access to a pre-configured views. · Trend (monitoring mode): Trend curves of the vital parameters. · Metronome (only in defibrillation mode): fast access to mode selection
Softkeys QRS and Views
To open the softkey context menu, press the softkey [QRS] or [Views].
For the softkey context menu [QRS], the volume control always starts with the position "Off" and can be advanced position by position by pressing the corresponding softkey several times. In the softkey context menu [Views], a pre-configured view can be selected.
Fig. 4-14 Example for softkey context menu
Softkey The softkey [Trend] opens a softkey context menu. The user can choose between the trend view which [Trend] displays the trend curves of the vital parameters from the switching on of the device ("Graphic") or the
trend browser in table form ("Table").
ENG - Version 4.0 P/N 04130.2
51
General Operating Instructions
User Manual corpuls3
Up to 6 curves can be displayed in the trend view (by default the parameters HR, SpO2, PR and NIBP are displayed). Further parameters to be displayed or the timespan (Auto, 30 - 480 min.) over which the trends are displayed can be adjusted via the curve context menu. To return to the realtime curves, press the softkey [Curves] or press the key Monitor, Back or Home. The trend browser in table form can also be opened from the mission browser (see chapter 8.5.2 Mission Browser, page 205).
4.3.2 Parameter Context Menu and Curve Context Menu
Parameter context menus and curve context menus only contain menu items that are relevant for the highlighted field. They can be called up for parameter fields and curve fields and open directly in the highlighted field. Proceed as follows to open a parameter context menu or curve context menu and adjust settings: 1. Rotate the jog dial to highlight the required parameter field or curve. 2. Press the jog dial to open the parameter context menu or curve context menu of the highlighted
parameter field or curve. The first line of the parameter context menu or curve context menu is highlighted.
Fig. 4-15 Parameter context menu (illustration may differ)
52
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
General Operating Instructions
Fig. 4-16 Curve context menu
3. If another value is to be assigned to the parameter field or the curve field for display, press the jog dial and select the required parameter by rotating.
4. Press the jog dial again to confirm selection of the required parameter. 5. Select further parameters of the parameter context menu or curve context menu by rotating the
jog dial and confirm by pressing the jog dial.
Press the Home key to quit the parameter context menu or curve context menu.
Note If a new curve is selected in the curve context menu, the curves are sorted automatically in ascending order.
ENG - Version 4.0 P/N 04130.2
53
General Operating Instructions
User Manual corpuls3
4.3.3 Main menu
To select the main menu of the device and adjust settings, proceed as follows: 1. Press the jog dial to open the main menu of the device.
Fig. 4-17 Main menu
2. Select the required item in the main menu by rotating the jog dial and confirm by pressing the jog dial.
3. Select the required menu item in the submenu by rotating the jog dial and confirm by pressing the jog dial.
4. The configuration dialogue opens.
54
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
General Operating Instructions
4.3.4 Configuration dialogue
To adjust settings in the configuration dialogue, proceed as follows:
Fig. 4-18 Configuration dialogue
1. Open the configuration dialogue (see chapter 4.3.3 Main menu, page 54). 2. Rotate the jog dial to highlight the required configuration field. 3. Press the jog dial to select the highlighted configuration field. 4. Select the required settings by repeatedly rotating and pressing the jog dial.
Note A setting (numerical value, text or symbol) can be modified if · the respective line is highlighted; · the setting is displayed in bold type. See chapter 7 Configuration, page 154 for information on the possible settings.
5. Access another tab of the configuration pages by pressing the corresponding softkey. 6. To confirm the settings and close the configuration dialogue, press the softkey [OK].
To retain the previous settings and close the configuration dialogue, press the softkey [Cancel].
ENG - Version 4.0 P/N 04130.2
55
General Operating Instructions
User Manual corpuls3
4.4 Disconnecting and Connecting Modules
Caution
Risk of delayed therapy In general, the separating or connecting of modules should be avoided
· during defibrillator- or pacer therapy, · when missions are being uploaded or · when verbal instructions (AAMs) are being played, as the brief loss of communication between the modules can lead to an interruption and delay of the therapy.
4.4.1 Disconnecting the Monitoring Unit from the Defibrillator/Pacer
Note This procedure applies regardless of whether the patient box is connected to the monitoring unit or not.
1. Grasp the monitoring unit by the carrying handle and pull both snap locks simultaneously forwards and upwards with your thumbs (item A) or push them rearwards and downwards (item B).
2. Tilt the monitoring unit forwards (item C) and remove upwards (item D).
B A
D C
Fig. 4-19 Disconnecting the monitoring unit from the defibrillator/pacer (illustration may differ)
56
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
B A
General Operating Instructions
D C
Fig. 4-20 Disconnecting the monitoring unit from the defibrillator/pacer SLIM (illustration may differ)
4.4.2 Disconnecting the Patient Box from the Monitoring Unit
1. Grasp the monitoring unit by the carrying handle and press the snap lock of the patient box downwards (item A).
2. Tilt the patient box rearwards (item B) and remove from the monitoring unit (item C).
B
C
A
Fig. 4-21 Disconnecting the patient box from the monitoring unit (illustration may differ)
ENG - Version 4.0 P/N 04130.2
57
General Operating Instructions
User Manual corpuls3
4.4.3 Connecting the Patient Box to the Monitoring Unit
1. Position the patient box with the screen facing the monitoring unit. 2. Fit the patient box at the bottom on the monitoring unit (item A):
The recesses (item 3) of the patient box engage in the two pins (item 5) of the monitoring unit. The connection coding (item 6) on the monitoring unit fits into the recess (item 4) on the patient box. 3. Tilt the patient box towards the monitoring unit (item B) until the closure at the top (item 2) of the patient box audibly engages in the catch on the monitoring unit (item 1). 4. Make sure that the patient box is engaged in both the pins and recesses at the bottom and in the closure at the top.
Caution
Fig. 4-22
Connecting the patient box to the monitoring unit (illustration may differ)
1 Catch 2 Closure 3 Recess 4 Connection coding recess 5 Pins 6 Connection coding
Before connecting the modules, make sure that there are no metallic objects, e. g. conductive foils, between the individual modules.
58
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
General Operating Instructions
4.4.4 Connecting the Monitoring Unit to the Defibrillator/Pacer
Note This procedure applies regardless of whether the patient box is connected to the monitoring unit or not. 1. Raise and tilt the monitoring unit forwards. 2. Fit the monitoring unit onto the defibrillator/pacer at the bottom (item A): Both pins (item 4) of the monitoring unit engage in the two recesses (item 3) on top of the base of the defibrillator/pacer. 3. Tilt the monitoring unit towards the defibrillator/pacer (item B) until the closures at the top (item 1) of the monitoring unit audibly engage in the recesses (item 2) on the defibrillator/pacer.
Fig. 4-23
Connecting the monitoring unit to the defibrillator/pacer (illustration may differ)
1 Closure 2 Recess for closure 3 Recess on top of base 4 Pins
Caution
Fig. 4-24
Connecting the monitoring unit to the defibrillator/pacer SLIM (illustration may differ)
1 Closure 2 Recess for closure 3 Recess on top of base 4 Pins
Before connecting the modules, make sure that there are no metallic objects, e. g. conductive foils, between the individual modules.
ENG - Version 4.0 P/N 04130.2
59
General Operating Instructions
User Manual corpuls3
4.4.5 Removing the Patient Box from the Compact Device
1. Grasp the monitoring unit by the carrying handle and pull both snap locks simultaneously forwards and upwards with your thumbs or push them rearwards and downwards.
2. Tilt the monitoring unit with the patient box forwards (item A) (see chapter 4.4.1 Disconnecting the Monitoring Unit from the Defibrillator/Pacer, page 56).
3. Push the snap lock of the patient box downwards.
4. Tilt the patient box backwards and remove upwards from the monitoring unit (item B) (see chapter 4.4.2 Disconnecting the Patient Box from the Monitoring Unit, page 57).
5. Tilt the monitoring unit towards the defibrillator/pacer until the closures at the top of the monitoring unit audibly engage in the recesses on the defibrillator/pacer (see chapter 4.4.4 Connecting the Monitoring Unit to the Defibrillator/Pacer, page 59).
A
B
C
Fig. 4-25 Removing the patient box from the compact device (illustration may differ)
A B C
Fig. 4-26 Removing the patient box from the compact device with defibrillator/pacer SLIM
60
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
General Operating Instructions
4.5 Accessory Bag 4.5.1 Fitting the Accessory Bag
1. Insert the patient box (item 1) into the protective cover (item 6). 1
3
4
4
3
2
6
7
5
Fig. 4-27 Accessory bag and patient box, front view (illustration may differ)
1 Patient box 2 Accessory bag 3 Lateral press stud 4 Rear press stud 5 Right-hand bag 6 Protective cover 7 Left-hand bag
2. Insert the two flaps with the lateral press studs (item 3) laterally from the patient box. 3. Open the zip fasteners of the left-hand and right-hand bags (items 5 and 7) and press the lateral
press studs firmly in place inside on the upper sides of the bags. 4. Close the rear press studs (item 4) on the protective cover.
ENG - Version 4.0 P/N 04130.2
61
General Operating Instructions
User Manual corpuls3
Fig. 4-28 Accessory bag with patient box, rear view (illustration may differ) Newer accessory bags do no longer have press studs, but are closed with hook and loop fasteners. Note Older accessory bags with press studs do not fit onto the defibrillator module SLIM.
4.5.2 Packing the Accessory Bag
Caution
When inserting the sensor cables and ECG cables, make sure that the plugs snap in place beyond the perceptible pressure point.
Fold (gather in loops) but do not roll up the connected cable to avoid damage to the cable and allow rapid removal during mission without forming knots.
Inserting cables on right-hand side
Fig. 4-29 Inserting the plugs on the right-hand side of the patient box
62
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
General Operating Instructions
Right-hand bag
Accessories
Temperature sensor (item 1)
NIBP cuff (item 2)
CO2 sensor (item 4) CO2 intermediate cable (item 3) CO2 adapter, mainstream (item 5) corPatch CPR sensor
corPatch CPR intermediate cable
Table 4-4
Contents of right-hand bag
Position Outermost pocket Wide elastic band at the side of outermost pocket Left-hand pocket on central section Right-hand pocket on central section Elastic band below the patient box interfaces Inner pocket Inner pocket
Fig. 4-30 Contents of right-hand bag (illustration may differ)
Note Only connect the temperature sensor to the patient box after attaching it to the patient to avoid false alarm messages that indicate excessively low temperature.
ENG - Version 4.0 P/N 04130.2
63
General Operating Instructions
Connecting cables on left-hand side
User Manual corpuls3
Fig. 4-31 Connecting the plugs on the left-hand side of the patient box
Left-hand bag
Accessories
4-pole ECG monitoring cable (item 1)
Pack of ECG electrodes (item 2)
Oximetry intermediate cable (item 3)
Oximetry finger sensor (item 4)
Complementary 6-pole ECG diagnostic cable (item 5)
Strain relief for right-angle plug (item 6)
Table 4-5
Contents of left-hand bag
Position Outermost pocket Left-hand pocket on central section Right-hand pocket on central section Elastic band on central section On the left next to the patient box interfaces
Fig. 4-32 Contents of left-hand bag (illustration may differ)
64
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
General Operating Instructions
4.6 Inserting the Device into the Brackets
4.6.1 Defibrillator/Compact Device Bracket
Insertion
Fit the recesses at the bottom of the defibrillator onto the pins of the defibrillator/compact device bracket (item A). The lock on the bracket engages automatically.
If the bracket is equipped with a power supply, the defibrillator and all the modules connected to it will be charged.
B
A
Fig. 4-33
12 Inserting the compact device into the bracket (Illustration may differ)
1 Defibrillator/Pacer power supply contact area 2 Integrated magnetic clip
Removal Pull the handle upwards (item B; in older brackets a loop) and remove the defibrillator/compact device from the bracket.
Note Check the contact areas of the defibrillator/pacer (item 1) and the bracket (item 2) regularly for contamination or foreign material, particularly metallic items.
Note Remove the defibrillator/compact device within approx. 10 s after pulling the handle, since the bracket automatically locks again.
Note The defibrillator/compact device charging bracket has to be installed vertically (not on the floor or the ceiling), to ensure sufficient contact with the MagCode connector via gravity.
ENG - Version 4.0 P/N 04130.2
65
General Operating Instructions
User Manual corpuls3
4.6.2 Monitoring Unit Bracket
Insertion The monitoring unit is inserted into the bracket in the same manner as it is connected to the defibrillator/pacer (see chapter 4.4.4 Connecting the Monitoring Unit to the Defibrillator/Pacer, page 59):
Note This procedure applies regardless of whether the patient box is connected to the monitoring unit or not.
1. Raise and tilt the monitoring unit forwards. 2. Fit the monitoring unit onto the bracket at the bottom:
Both pins of the monitoring unit engage in the two recesses of the bracket (item A). 3. Tilt the monitoring unit towards the bracket at the top until the closures at the top of the
monitoring unit audibly engage in the recesses on the bracket (item B).
B
A
Fig. 4-34 Inserting the monitoring unit into the bracket (Illustration may differ)
Removal
The monitoring unit is removed from the bracket in the same manner as it is disconnected to from the defibrillator/pacer (see chapter 4.4.1 Disconnecting the Monitoring Unit from the Defibrillator/Pacer, page 56):
1. Grasp the monitoring unit by the carrying handle and pull both snap locks simultaneously forwards and upwards with your thumbs or push them rearwards and downwards.
2. Tilt the monitoring unit forwards and remove upwards.
66
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
General Operating Instructions
4.6.3 Charging bracket Patient box
Insertion 1. Position the patient box as shown in Fig. 4-35. 2. Fit the patient box with its bottom side onto the long part of the charging bracket (item A): The recesses on the patient box engage in both pins (item 4) on the charging bracket. The connection coding (item 5) fits in the recess (item 3) on the patient box. 3. Tilt the patient box upwards to the charging bracket (item B) until the lock audibly engages at the patient box. 4. Make sure that the patient box is engaged in the guides and the closures. 5. Connect the safety belt below the patient box and pull tight (not illustrated).
Fig. 4-35
Inserting the patient box into the charging bracket (ceiling installation)
1 Lock 2 Closure 3 Connection coding recess 4 Pins 5 Connection coding 6 Loop
Removal 1. Disconnect the safety belt (not illustrated in Fig. 4-35). 2. Firmly hold the patient box and pull the loop (item 6) (item C). 3. Remove the patient box from the bracket.
ENG - Version 4.0 P/N 04130.2
67
Operation Therapy
User Manual corpuls3
5 Operation Therapy
5.1 Therapy Electrodes for Defibrillation and Pacing
5.1.1 Types of Therapy Electrodes
Note With the introduction of the corPatch easy pre-connected therapy electrodes (P/N 05120.1), for adults (P/N 04324.3), Pediatric (P/N 05120.2) and Pediatric Extended (P/N 05120.3), the higher limits for the body weight of patients have been set. The operational safety as well as medical effectiveness of the therapy electrodes is guaranteed.
Various therapy electrodes are available for defibrillation and pacing:
Therapy electrodes Shock paddles
Baby shock electrodes (Adapters for shock paddles)
corPatch easy electrodes (disposable electrodes)
Internal shock spoons (sterilisable)
Application field
Defibrillation, Cardioversion, ECG monitoring
Defibrillation, Cardioversion, ECG monitoring
Defibrillation, cardioversion, ECG monitoring Pacing
Defibrillation, Cardioversion, ECG monitoring
Patient groups Adults/children
Neonates/infants up to max. 5 kg body weight
Adults/children Neonates/infants
Adults/children Neonates/infants
Table 5-1
Therapy electrodes for defibrillation and pacing
Shock paddles
Baby shock electrodes
corPatch easy electrodes
Internal shock spoons
The shock paddles can be used for defibrillation, synchronised cardioversion and for ECG monitoring (DE recording). For using the shock paddles with the defibrillator/pacer SLIM, an intermediate adapter cable is needed.
Defibrillation, synchronised cardioversion and ECG monitoring of neonates and infants is performed with baby shock electrodes (adapters) which are fitted onto the shock paddles. The energy is automatically reduced at a ratio of 10:1 if the adapters are fitted (see chapter 5.4.5 Manual Defibrillation and Cardioversion of Neonates and Children, page 86).
corPatch easy electrodes are already connected to an electrode cable and only need to be connected to the therapy master cable of the defibrillator/pacer. The corPatch easy electrodes pre-connected for the defibrillator/pacer SLIM can be pre-connected even before opening the package.
The internal shock spoons consist of the shock spoon-electrodes and the handles. Before use the electrodes have to be screwed onto the handles. The handles are already connected to an electrode cable and only need to be connected to the Y-adapter cable of the defibrillator/pacer.
68
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
Therapy electrode detection
The corpuls3 automatically detects the connected therapy electrodes and, if necessary, adjusts the maximum energy to be released (e.g. with corPatch easy Pediatric , shock spoons, etc.). In case this automatic detection is impaired, the user is shown a confirmation dialogue in which the connected electrode type can be selected manually. This function so ensures optimal patient protection at all times.
Warning
To guarantee a defibrillation protection for patients, users and third parties, use exclusively the accessories indicated in the list of authorised accessories (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249).
Warning Warning
Caution Warning Caution Caution
Before releasing the shock, make sure that there is no risk for users or third parties. Electrical shock from defibrillator use can lead to arrhythmias, ventricular fibrillation or asystole.
The following safety instructions which can also be found on every pouch of the corPatch electrodes have to be complied with when using the corPatch electrodes:
· Do not crush, bend, or fold corPatch electrodes or store them under heavy objects. · Do not open pouch until ready for use. · Do not use corPatch electrodes if gel is dry. · Do not use additional gel on corPatch electrodes. · Do not overlap corPatch electrodes. · Use separate ECG electrodes when performing non-invasive pacing. · Do not touch the patient during defibrillation. · Do not discharge shock paddles through corPatch electrodes. · Keep corPatch electrodes clear of any other electrodes or metal parts in contact with the
patient. Not following these instructions for the corPatch electrodes or any other misuse or misapplication of the corPatch electrodes may result in severe patient burns or ineffective therapy.
Do not use corPatch electrodes if · the packaging is damaged or opened; · the expiry date indicated on the packaging has passed; · the electrode is damaged or the connecting lug is bent.
Burn injuries or non-effective therapy for the patient! Avoid contact between body parts of the patient, such as exposed skin on the head or limbs, with conductive fluids such as gel, blood, saline, and metal objects such as bed frames or stretchers.
Replace corPatch electrodes for adults at the latest after: · 24 hours or 50 shocks; · 8 hours of continuous operation in pacer mode.
When placing the corPatch electrodes on the patient's skin, make sure that no air pockets are included inside the adhesive surface. If necessary, shave. Apply corPatch electrodes from the centre outwards.
ENG - Version 4.0 P/N 04130.2
69
Operation Therapy
User Manual corpuls3
Warning
Before using the shock spoons, read and understand the additional user manual (P/N 04137.02).
5.1.2 Connecting the Electrode Cable
To connect the therapy electrodes, connect the corresponding plug (item 2 or item 3 in Fig. 5-1) to the therapy master cable (item 1). To disconnect, pull back the red sliding sleeve at the therapy master cable and pull apart the plugs. The plug connectors are twistproof. When using the defibrillator/pacer SLIM the intermediate cable (item 5) has to be connected to the therapy socket (item 4) at the rear side of the defibrillator/pacer SLIM.
Electrode type
Defibrillator/pacer
Shock paddles and shock spoons
Connect the plug of the shock paddles or shock spoons (item 2) to the plug of the therapy master cable (item 1) of the defibrillator/pacer. The connection must snap into place perceptibly.
corPatch easy electrodes
3
(only P/N 04324.1 and 04324.2)
Connect the plug (item 3) of the corPatch easy electrodes to the plug of the therapy master cable (item 1) of the defibrillator/ pacer. The connection must snap into place perceptibly.
Intermediate cable and corPatch easy electrodes (only P/N 05120.1, 05120.2 and 04324.3)
Connect the plug (item 5) correctly orientated (item 1) to the therapy socket (item 4) of the defibrillator/pacer SLIM or to the therapy master cable.
Fig. 5-1
Connecting the therapy electrode cables (illustration may differ)
1 Therapy master cable with plug and red sliding sleeve 2 Plug of shock paddles and shock spoons 3 Plug of corPatch easy electrodes 4 Therapy socket 5 Plug of corPatch intermediate cable
Note For orientation and correct connection of the plugs, a raised nub is palpable on both the red sliding sleeve and the plug of the therapy electrodes (only P/N 04324.1 and 04324.2). When oriented correctly, the electrodes are easy to connect.
Note For using the shock paddles with the defibrillator/pacer SLIM, an intermediate adapter cable is needed (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249).
Caution
Do not use the therapy master cable corpuls3 SLIM/corpuls1 (P/N 04326.0BA) as extension cable for the therapy master cable at the defibrillator/pacer (P/N 04300). Likewise, the therapy master cable corpuls3 SLIM/corpuls1 must not be combined with a second therapy master cable corpuls3 SLIM/corpuls1.
70
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
Caution
If the electrode plug is turned the wrong way and connected by force to the therapy master cable, there will be a malfunction in the paddle interface and an alarm message will be issued.
The plug connector has to be disconnected and checked for damage. If no damage is visible, connect the plug connector again, oriented correctly.
5.1.3 Removing the Shock Paddles from their Holders and Re-inserting them
Removing the shock paddles
To remove the shock paddles from their holders at the defibrillator/pacer, proceed as follows: Prerequisite: The defibrillator/pacer is equipped with shock paddle holders. 1. Rotate the shock paddles by approx. 20° towards the front (item A) or towards the rear (item B). 2. In this position pull the shock paddles away from the device (item C).
A
B
C
Fig. 5-2 Removing the shock paddles from their holders
Re-inserting the shock paddles
Note
To re-insert the shock paddles, push them into the holders until they both perceptibly engage.
The shock paddle with the green button (APEX) is to be placed in the right-hand holder and the shock paddle with the red button (STERNUM) in the left-hand holder. For guidance, corresponding information labels are placed above the holders.
ENG - Version 4.0 P/N 04130.2
71
Operation Therapy
User Manual corpuls3
Caution
5.2 Preparing the Patient for Defibrillation, Cardioversion and Pacer Therapy
As a side effect of the defibrillation, a reddening of the skin and, in case of excessive hair, burn injuries may occur.
Warning
Recording of the ECG with therapy electrodes or via the 4 pole ECG monitoring cable is impaired if the skin is contaminated, wet or sweaty or in case of excessive hair.
Preparing the patient
Before therapeutic measures can be performed, the patient has to be prepared:
1. Remove clothes from the patient's upper body. 2. Remove any item of jewelry that is located close to or between the two therapy electrodes. 3. Remove excessive hair so that the conductive surface of the therapy electrodes has full contact
with the skin. 4. Clean and dry the skin before using therapy electrodes.
Patient impedance
With attached therapy electrodes, the patient impedance is measured by the device and displayed in inverted colours as "OK", "LOW" or "HIGH" in defibrillation mode.
When the impedance is too low or too high, the shock release is blocked. When using the shock spoons, shock release is possible also in case of low impedance.
High impedance is displayed in case of:
· excessive hair, · contaminated skin, · shock paddles not completely wetted with electrode gel, · too little contact pressure of the shock paddles, · wrong position of the corPatch electrodes, · Air pockets included when attaching corPatch electrodes.
Low impedance is displayed in case of:
· use of too much electrode gel on the shock paddles, · too little distance between the therapy electrodes, · wet patient skin, · technical problems with the electrode cable.
Warning
On metallic and/or wet surfaces the following protective measures have to be taken during defibrillation:
· Release of the shock in semi-modular operation (only when using corPatch electrodes) with sufficient safety distance to patient;
· Placing the patient on a dry stretcher or non-conductive surface before defibrillation.
72
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
5.3 Defibrillation in AED Mode 5.3.1 Information on the AED Mode
AED After pressing the AED key the following screen structure appears:
Fig. 5-3
AED mode, initial screen (illustration may differ)
1 Status-/alarm line 2 Parameter area 3 Current ECG (derivation II/DEauto) 4 Configurable curve area 5 Automatic pre-set energy 6 Metronome 7 Softkey [Energy] for energy settings 8 Patient impedance 9 Operating instruction 10 State of charge 11 Softkey [Connect] to start a Bluetooth connection 12 Softkey to cancel the charging 13 Time since last shock in numbers and as pie chart 14 Number of shocks since switching on the device 15 Time since defibrillation mode was launched
When corpuls3 is in AED mode, the user is guided through a standardised resuscitation protocol. The algorithm is governed by the current recommendations.
Note By default, the biphasic defibrillation impulse 6/4 is set. Upon request, the biphasic defibrillation impulse 4/3 can be configured by a service technician.
Note The use of a defibrillator in AED mode is not recommended for patients of less than 12 months of age.
ENG - Version 4.0 P/N 04130.2
73
Operation Therapy
User Manual corpuls3
AED mode for children
If no special paediatric AED device is available for patients aged between 1 and 8 years, it is recommended to use the defibrillator in AED mode with corPatch electrodes (Pediatric or Pediatric Extended).
The boot-up time of the corpuls3 is reduced if the corpuls3 is switched on directly in AED mode by pressing the AED key.
The curve field in the first line of the screen is pre-set and cannot be configured. There, the ECG recorded by the respective therapy electrodes is displayed, switching automatically between IIauto and DEauto. The switch between IIauto and DEauto only occurs when a valid ECG signal is present and not when the cable is connected. Lead DE is displayed preferentially.
corPatch electrodes: Shock paddles:
DEauto lead, recorded via corPatch electrodes
Einthoven lead IIauto, recorded via ECG electrodes and 4-pole ECG monitoring cable or DEauto lead, recorded via shock paddles, if no 4-pole ECG monitoring cable is connected
The value of ECG amplitude is set to 10 mm/mV. Automatic ECG amplitude control is disabled. The following keys are available to operate the device in AED mode:
1. AED 2. Analyse 3. Shock
Fig. 5-4 AED mode function keys
When using corPatch electrodes, the shock is released by pressing the Shock key at the monitoring unit. When using the shock paddles, the shock is released by pressing both buttons at the shock paddles.
Charging tone During the charging process, the rising pitch of the charging tone (configurable by the user OPERATOR) indicates the progress of charging acoustically and serves as a warning to bystanders.
The charged defibrillator can be discharged internally by pressing the softkey [Cancel].
Audio recording
In AED mode, a configurable audio recording option is available which is disabled by default. If the audio recording option is enabled by the person responsible for the device, all surrounding noises are recorded (see chapter 7.4.4 Configuration of the Defibrillation Function (Persons Responsible for the Device), page 181).
Softkey [Energy] In AED mode, the option energy settings is available which is disabled by default. If the option is enabled by the person responsible for the device, the softkey [Energy] is available, which activates the energy selection via jog dial.
Auto Analyse
In AED mode, the option "Autostart" is available which is disabled by default. If the option is enabled by the person responsible for the device, the ECG analysis starts automatically after 3 seconds warning time and the speech- and text message "Do not touch patient - Analysing heart rhythm".
74
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
The symbol "Auto Analyse" besides the defibrillation mode indicates that the option is activated. Starting the analysis manually by pressing the Analyse key is still possible.
Fig. 5-5
Symbol Auto Analyse activated
CPR timer
As of software version 3.2 the functionality of the display "Time since last shock (last)" has been extended: The CPR timer is started by pressing the Analyse key or Charge key and runs in the background, even if the user changes to another mode.
To reset the CPR timer (starting the CPR cycle again), press the softkey [Cancel] or [Cont.CPR]. After the ECG analysis (result negative) and after the shock is delivered or aborted (30 s ready-for-shock-period passed or by user or due to technical problems), the CPR timer is reset automatically. If the option is enabled by the person responsible for the device, the remaining time of the CPR cycle (2 or 3 minutes) can be displayed as a pie chart.
Softkey [Connect] As of software version 3.2 it is possible to establish a Bluetooth connection with a corpuls cpr.
Warning Warning Warning
Fig. 5-6
Symbol for connected corpuls cpr in pie chart
In each individual case the trained user determines the progress of treatment according to medical requirements. The procedure shown here reflects the operating possibilities of the device.
Implanted pacer! Irreversible damage to myocardium due to placement of therapy electrodes over the pacer unit. Examine if there is an implanted pacer. Do not place therapy electrodes directly over the pacer unit. After an external defibrillation, observe the pacer patient and have the implanted pacer checked.
Implanted pacer! In patients with an implanted pacer, it is possible that shockable ECG rhythms or arrhythmias will only be detected to a limited extent. Check the pulse of the patient to make sure that the device does not measure the frequency of the implanted pacer.
ENG - Version 4.0 P/N 04130.2
75
Operation Therapy
User Manual corpuls3
Warning Warning Warning Warning Warning
If the connection status of the corpuls3 is changed during an ECG analysis in AED mode (from radio connection to mechanical connection or vice versa), the ECG analysis will be aborted. In this case, start the ECG analysis again.
Equipment which is not defibrillation-proof must be disconnected from patients during defibrillation.
If for a defibrillation the electrodes of the 4-pole ECG monitoring cable are connected to the patient, the complementary 6-pole ECG diagnostic cable has to be either connected to the patient completely, safely stored in the accessory bag or disconnected from the patient box.
In defibrillation mode, no physiological alarms are indicated or saved. Technical alarms are indicated visually and acoustically.
Must not be used with conscious patients! Electric shock with defibrillator use can lead to the following adverse effects in patients, users and third parties: Arrhythmias, ventricular fibrillation or asystole. Do not use the corpuls3 if the patient is conscious. Even in conscious patients, ventricular fibrillation or ventricular tachycardia can be detected.
76
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
5.3.2 Defibrillation in AED mode with corPatch Electrodes
When using corPatch electrodes, the ECG is obtained and the analysis is performed via the corPatch electrodes attached to the patient (indicated as DE). An additional 4-pole ECG monitoring cable is not needed.
AED
1. To start the AED mode, press the AED key.
2. Prepare the patient (see chapter 5.2 Preparing the Patient for Defibrillation, Cardioversion and Pacer Therapy, page 72).
3. Check the package of the corPatch electrodes for damage and check the expiry date.
4. Attach corPatch electrodes to the patient, as shown on the electrode package.
5. If configured, select the required energy level with the jog dial or via the softkeys and confirm by pressing the jog dial (see chapter 7.4.4 Configuration of the Defibrillation Function (Persons Responsible for the Device), page 181).
Analyse
6. To start the ECG analysis, press the Analyse key. If the option "Autostart" is enabled, the ECG analysis starts automatically after 3 seconds warning time and the speech- and text message "Do not touch patient - Analysing heart rhythm".
7. During the charging process, the rising pitch of the charging tone (configurable by the user OPERATOR) indicates the progress of charging acoustically and serves as a warning to bystanders. With the message "Deliver shock" and the ready-signal, the device indicates that the defibrillation can be performed.
Performing a 8. defibrillation
9.
To perform defibrillation, hold down the Shock key until the shock has been delivered.
If the shock has been released successfully, the message Shock performed is shown. Afterwards, a shock protocol is printed automatically.
10. The message Shock not recommended indicates that the defibrillation cannot be performed and that the Shock key is locked.
11. Continue with the standardised or locally valid resuscitation protocol. To reset the CPR timer (starting the CPR cycle again), press the softkey [Cancel].
Analyse
12. The message Press Analyse indicates that the Analyse key should be pressed again to perform an ECG analysis.
Warning
During ECG analysis, it is essential to avoid external commotion and vibration. Keep the patient lying down calmly.
Do not touch the patient.
It is essential to discontinue artificial respiration during ECG analysis. This leads to false analysis results since the periodic expansion of the chest may simulate an ECG rhythm.
Note With the introduction of the corPatch easy pre-connected therapy electrodes (P/N 05120.1), for adults (P/N 04324.3), Pediatric (P/N 05120.2) and Pediatric Extended (P/N 05120.3), the higher limits for the body weight of patients have been set. The operational safety as well as medical effectiveness of the therapy electrodes is guaranteed.
Note The CPR rhythm can be supported acoustically by activating the metronome via the softkey [Metronome].
Note If the corpuls3 detects a shockable rhythm, the defibrillator starts charging. If the corpuls3 detects a non-shockable rhythm during further analysis, the defibrillator aborts charging and discharges internally. The user has to re-start analysis.
Note The selected energy level is available for 30 seconds after charging. If no shock has been generated during this time, the device is discharged internally.
ENG - Version 4.0 P/N 04130.2
77
Operation Therapy
User Manual corpuls3
5.3.3 Defibrillation in AED Mode with Shock Paddles
To perform a defibrillation in AED mode with shock paddles, an ECG must be obtained for analysis via the ECG electrodes and the 4-pole ECG monitoring cable.
AED
Analyse
1. To start the AED mode, press the AED key.
2. Prepare the patient (see chapter 5.2 Preparing the Patient for Defibrillation, Cardioversion and Pacer Therapy, page 72).
3. Place all four ECG electrodes of the 4-pole ECG monitoring cable on the patient (see chapter 6.3 Monitoring ECG, page 109).
4. Completely wet the electrode surfaces of the shock paddles with defibrillation electrode gel.
5. If configured, select the required energy level with the jog dial or via the softkeys and confirm by pressing the jog dial (see chapter 7.4.4 Configuration of the Defibrillation Function (Persons Responsible for the Device), page 181).
6. To start the ECG analysis, press the Analyse key or one of the buttons at the shock paddles. If the option "Autostart" is enabled, the ECG analysis starts automatically after 3 seconds warning time and the speech- and text message "Do not touch patient - Analysing heart rhythm".
7. During the charging process, the rising pitch of the charging tone (configurable by the user OPERATOR) indicates the progress of charging acoustically and serves as a warning to bystanders. With the message "Deliver shock" and the ready-signal, the device indicates that the defibrillation can be performed.
8. Place the APEX shock paddle (Fig. 5-7, item 1) on the lower left of the thorax beside apex of the heart (5th ICS).
9. Place the STERNUM shock paddle (Fig. 5-7, item 2) to the right of the sternum.
2 1
Fig. 5-7
Applying the shock paddles
1 Position of the APEX shock paddle 2 Position of the STERNUM shock paddle
78
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
Performing a 10. Hold down both shock paddle buttons until a shock has been released. By pressing the shock
defibrillation
paddle buttons a confirmative tone sounds. If the shock has been released successfully, the
message Shock performed is shown. Afterwards, a shock protocol is printed automatically.
11. The message Shock not recommended indicates that the defibrillation cannot be performed and that the buttons at the shock paddles are locked.
12. Continue with the standardised or locally valid resuscitation protocol. To reset the CPR timer (starting the CPR cycle again), press the softkey [Cancel].
Analyse 13. To start the ECG analysis, press the Analyse key or one of the buttons at the shock paddles again.
Warning
During ECG analysis, it is essential to avoid external commotion and vibration. Keep the patient lying down calmly. Do not touch the patient.
It is essential to discontinue artificial respiration during ECG analysis. This leads to false analysis results since the periodic expansion of the chest may simulate an ECG rhythm.
Warning
Make sure that no defibrillation electrode gel gets into the insulation area between the electrode surface and the handle. Only use defibrillation electrode gel intended for this purpose.
Note If the paddles have not been used for some time, the paddle buttons have to be pressed repeatedly.
Note The selected energy level is available for 30 seconds after charging. If no shock has been generated during this time, the device is discharged internally.
Note For safety reasons, when using shock paddles, the keys Charge and Shock on the monitoring unit are blocked. The charging and release of the defibrillation shock can only be triggered via the shock paddle buttons.
Note Energy selection can be performed by connecting both electrode surfaces of the shock paddles (shortcircuiting). To decrease the energy, briefly press the APEX shock paddle button. To increase the energy, briefly press the STERNUM shock paddle button.
Note The CPR rhythm can be supported acoustically by activating the metronome via the softkey [Metronome].
ENG - Version 4.0 P/N 04130.2
79
Operation Therapy
User Manual corpuls3
5.4 Manual Defibrillation and Cardioversion
5.4.1 Information on Manual Defibrillation and Cardioversion
Note MMaannuueall l
In the manual defibrillation mode of corpuls3, the users have full freedom of action and decision-making concerning operation of the defibrillator. They have to assess the ECG and can, depending on the patient, select the necessary energy and trigger the defibrillation- or cardioversion shock.
By default, the biphasic defibrillation impulse 6/4 is set. Upon request, the biphasic defibrillation impulse 4/3 can be configured by a service technician.
After pressing the Manual key the following screen structure appears:
Fig. 5-8
Manual defibrillation, initial screen (illustration may differ)
1 Status-/alarm line 2 Parameter area 3 Current ECG (derivation II/DEauto) 4 Configurable curve area 5 Pre-set energy 6 Metronome 7 Softkey [Sync] for synchronisation settings 8 Patient impedance 9 Operating instruction 10 State of charge 11 Softkey [Connect] to start a Bluetooth connection 12 Softkey [Cont.CPR] for continuing CPR measures 13 Time since last shock in numbers and as pie chart 14 Number of shocks since switching on the device 15 Time since defibrillation mode was launched
80
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
The curve field in the first line of the screen is pre-set and cannot be configured. There, the ECG recorded by the respective therapy electrodes is displayed, switching automatically between IIauto and DEauto. The switch between IIauto and DEauto only occurs when a valid ECG signal is present and not when the cable is connected. Lead DE is displayed preferentially.
corPatch easy electrodes & shock spoons
Shock paddles:
DEauto lead, recorded via corPatch electrodes
Einthoven lead IIauto, recorded via ECG electrodes and 4-pole ECG monitoring cable or DEauto lead, recorded via shock paddles, if no 4-pole ECG monitoring cable is connected
Amplification of the ECG curves is 10 mm/mV. Automatic ECG amplitude control is disabled.
The boot-up time of the corpuls3 is reduced if the corpuls3 is switched on directly in manual defibrillation mode by pressing the Manual key.
Persons responsible for the device can pre-set the energy level with the function Auto Energy. This energy level is automatically available when the device is switched to manual defibrillation mode for the first time (see chapter 7.2 Configuration of the Monitoring Functions, page 165).
The following keys are available to operate the device in manual mode:
1. Manual 2. Charge 3. Shock
Fig. 5-9 Function keys for manual defibrillation and cardioversion
When using corPatch electrodes or shock spoons, the shock is released by pressing the Shock key at the monitoring unit. When using the shock paddles, the shock is released by pressing both buttons at the shock paddles.
The charged defibrillator can be discharged internally by pressing the softkey [Cancel].
Cardioversion settings are adjusted via the softkey [Sync]. The following settings are available:
· Auto Sync: · Sync: · Async
If QRS complexes are detected, the corpuls3 synchronises the shock release automatically for a cardioversion. If the corpuls3 does not detect QRS complexes within one second, the shock is released without synchronisation.
If QRS complexes are detected, the device synchronises the shock release for a cardioversion. If no QRS complexes are detected, a cardioversion or defibrillation is not possible.
The defibrillation is performed only asynchronously. In this mode, a cardioversion is not possible.
ENG - Version 4.0 P/N 04130.2
81
Operation Therapy
User Manual corpuls3
Warning Warning
Warning Warning
Impaired synchronisation due to artefacts! In synchronous defibrillation with shock paddles without the 4-pole ECG monitoring cable, the positioning of the paddles can cause ECG artifacts that may impair synchronisation. Pay special attention to good contact and detection of regular QRS complexes.
A cardioversion may lead to ventricular fibrillation or asystole. When performing a cardioversion, mind the following:
· The ECG has to be stable with a heart rate of at least 60/min. · The synchronisation mode has to be set to SYNC. · The QRS marks (triangles) have to mark each QRS complex. Do NOT rely on the QRS-/pulse
tone alone. · The shock release has to be effected according to valid guidelines. · To release a shock, the Shock key at the monitoring unit or the buttons at the shock
paddles have to be held down until a shock is released.
Equipment which is not defibrillation-proof must be disconnected from patients during defibrillation and cardioversion.
If for a defibrillation the electrodes of the 4-pole ECG monitoring cable are connected to the patient, the complementary 6-pole ECG diagnostic cable has to be either connected to the patient completely, safely stored in the accessory bag or disconnected from the patient box.
Warning
No physiological alarm events are displayed and saved in defibrillation mode. Technical alarms are indicated visually and acoustically.
Audio recording CPR timer
In manual mode, a configurable audio recording option is available which is disabled by default. If the audio recording option is enabled by the person responsible for the device, all surrounding noises are recorded (see chapter 7.4.4 Configuration of the Defibrillation Function (Persons Responsible for the Device), page 181).
As of software version 3.2 the functionality of the display "Time since last shock (last)" has been extended: The CPR timer is started by pressing the Analyse key or Charge key and runs in the background, even if the user changes to another mode. To reset the CPR timer (starting the CPR cycle again), press the softkey [Cancel] or [Cont.CPR]. After the ECG analysis (result negative) and after the shock is delivered or aborted (30 s ready-for-shock-period passed or by user or due to technical problems), the CPR timer is reset automatically. If the option is enabled by the person responsible for the device, the remaining time of the CPR cycle (2 or 3 minutes) can be displayed as a pie chart.
82
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
5.4.2 Manual Defibrillation with corPatch Electrodes
When using corPatch electrodes, the ECG is obtained via the corPatch electrodes attached to the patient (indicated as DE). Via additionally attached ECG electrodes and the 4-pole ECG monitoring cable, further leads can be displayed in the configurable second curve field (see chapter 6.3 Monitoring ECG, page 109).
MMaannuueall l CLhaadregne
1. To start the manual defibrillation mode, press the Manual key.
2. Prepare the patient (see chapter 5.2 Preparing the Patient for Defibrillation, Cardioversion and Pacer Therapy, page 72).
3. Check the package of the corPatch electrodes for damage and check the expiry date.
4. Attach corPatch electrodes to the patient, as shown on the electrode package. Select the required energy level with the jog dial or via the softkeys and confirm by pressing the jog dial.
5. To start the charging process, press the Charge key. The charging process takes approximately 5 seconds depending on the selected energy setting. During the charging process, the rising pitch of the charging tone (configurable by the user OPERATOR) indicates the progress of charging acoustically and serves as a warning to bystanders.
6. Wait until the message Ready for shock is displayed on the screen and the ready-signal is sounding. The device is ready for releasing a defibrillation shock.
7. Hold down the Shock key until the shock is delivered to perform defibrillation or cardioversion.
8. If the shock has been released successfully, the message Shock performed is shown. Afterwards, a shock protocol is printed automatically, if configured by the user OPERATOR.
9. Continue with the standardised or locally valid resuscitation protocol. If the option "Reminder Man." is configured by the operator, the message "Assess heart rhythm" appears 2 or 3 minutes after readiness for shock ended.
10. To reset the CPR timer (starting the CPR cycle again), press the softkey [Cont.CPR].
Note With the introduction of the corPatch easy pre-connected therapy electrodes (P/N 05120.1), for adults (P/N 04324.3), Pediatric (P/N 05120.2) and Pediatric Extended (P/N 05120.3), the higher limits for the body weight of patients have been set. The operational safety as well as medical effectiveness of the therapy electrodes is guaranteed.
Note The CPR rhythm can be supported acoustically by activating the metronome via the softkey [Metronome].
If the jog dial is pressed in manual defibrillation mode, the energy selection at the monitoring unit is Note only possible via the softkeys. Press the Manual key again, to be able to select the energy level with the
jog dial.
Note The selected energy level is available for 30 seconds after charging. If no shock has been generated during this time, the device is discharged internally.
5.4.3 Manual Defibrillation and Cardioversion with Shock Paddles
When using shock paddles, the ECG is obtained via the shock paddles pressed to the patient's thorax (indicated as DE). Via additionally attached ECG electrodes and the 4-pole ECG monitoring cable, further leads can be displayed in the configurable second curve field (see chapter 6.3 Monitoring ECG, page 109).
Note Obtaining the ECG via the ECG electrodes and the 4-pole ECG monitoring cable (as explained in the following) assures a better signal quality than via the shock paddles.
ENG - Version 4.0 P/N 04130.2
83
Operation Therapy
User Manual corpuls3
MMaannuueall l
1. To start the manual defibrillation mode, press the Manual key.
2. Prepare the patient (see chapter 5.2 Preparing the Patient for Defibrillation, Cardioversion and Pacer Therapy, page 72).
3. Place all four ECG electrodes of the 4-pole ECG monitoring cable on the patient (see chapter 6.3 Monitoring ECG, page 109).
4. Completely wet the electrode surfaces of the shock paddles with defibrillation electrode gel.
5. Select the required energy level with the jog dial or via the softkeys and confirm by pressing the jog dial.
6. To start the charging process, briefly press one of the shock paddle buttons and release. The charging process takes approximately 5 seconds depending on the selected energy setting. If enabled, the rising pitch of the charging tone indicates the progress of charging acoustically and serves as a warning to bystanders.
7. Wait until the message Ready for shock is displayed on the screen and the ready-signal is sounding. The device is ready for releasing a defibrillation shock.
8. Place the APEX shock paddle (Fig. 5-10, item 1) on the lower left of the thorax beside apex of the heart (5th ICS).
9. Place the STERNUM shock paddle (Fig. 5-10, item 2) to the right of the sternum.
2 1
Fig. 5-10
Applying the shock paddles
1 Position of the APEX shock paddle 2 Position of the STERNUM shock paddle
Performing a 10. Hold down both shock paddle buttons until a shock has been released. By pressing the shock
defibrillation/
paddle buttons a confirmative tone sounds.
cardioversion 11. If the shock has been released successfully, the message Shock performed is shown.
Afterwards, a shock protocol is printed automatically, if configured by the user OPERATOR.
12. The message Shock not recommended indicates that the defibrillation cannot be performed and that the buttons at the shock paddles are locked.
13. Continue with the standardised or locally valid resuscitation protocol. If the option "Reminder Man." is configured by the operator, the message "Assess heart rhythm" appears 2 or 3 minutes after readiness for shock ended.
14. To reset the CPR timer (starting the CPR cycle again), press the softkey [Cont.CPR].
Energy selection via the shock paddle buttons
By short circuiting the shock paddles the energy selection via the shock paddle buttons is enabled. This function enables the energy selection with the jog dial in 5 J increments. With the baby shock electrodes attached, this energy selection is not possible.
84
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
Warning
Electric shock Make sure that no defibrillation electrode gel gets into the insulation area between the electrode surface and the handle. Only use defibrillation electrode gel intended for this purpose.
Warning
Ineffective shock therapy For an effective shock release, a pressure of approx. 8 kg is necessary in adult patients. Press the shock paddles firmly onto the patient's thorax when the shock is triggered. Keep both shock paddle buttons depressed until the shock is delivered.
Note If the paddles have not been used for some time, the paddle buttons have to be pressed repeatedly.
Note The CPR rhythm can be supported acoustically by activating the metronome via the softkey [Metronome].
Note If the jog dial is pressed in manual defibrillation mode, the jog dial is blocked and the energy selection at the monitoring unit is only possible via the softkeys. Press the Manual key again, to be able to select the energy level with the jog dial.
Note The selected energy level is available for 30 seconds after charging. If no shock has been generated during this time, the device is discharged internally.
Note For safety reasons, when using shock paddles, the keys Charge and Shock on the monitoring unit are blocked. The charging and release of the defibrillation shock can only be triggered via the shock paddle buttons.
Note Energy selection can be performed by connecting both electrode surfaces of the shock paddles (shortcircuiting). To decrease the energy, briefly press the APEX shock paddle button. To increase the energy, briefly press the STERNUM shock paddle button.
5.4.4 Manual Defibrillation and Cardioversion with Shock Spoons
Warning
Before using the shock spoons, read and understand the safety and preparation notices in the manual (P/N 04137.02).
When using shock spoons, the ECG is obtained via the shock spoons pressed to the patient's heart. It is, however, recommended to obtain the ECG via the 4-pole ECG monitoring cable (see chapter 6.3 Monitoring ECG, page 109).
Note Obtaining the ECG via the ECG electrodes and the 4-pole ECG monitoring cable (as explained in the following) assures a better signal quality than via the shock paddles.
Note When using shock spoons, the energy available is limited by the device to a maximum of 50 J.
ENG - Version 4.0 P/N 04130.2
85
Operation Therapy
User Manual corpuls3
MMaannuueall l CLhaadregne
1. To start the manual defibrillation mode, press the Manual key.
2. Place all four ECG electrodes of the 4-pole ECG monitoring cable on the patient (see chapter 6.3 Monitoring ECG, page 109).
3. Screw sterile shock spoons of the correct size into the sterile shock spoon holders.
4. Select the required energy level with the jog dial or via the softkeys and confirm by pressing the jog dial.
5. To start the charging process, press the Charge key. The charging process takes approximately 5 seconds depending on the selected energy setting. If enabled, the rising pitch of the charging tone indicates the progress of charging acoustically and serves as a warning to bystanders.
6. Wait until the message Ready for shock is displayed on the screen and the ready-signal is sounding. The device is ready for releasing a defibrillation shock.
7. Hold down the Shock key until the shock is delivered to perform defibrillation or cardioversion.
8. If the shock has been released successfully, the message Shock performed is shown. Afterwards, a shock protocol is printed automatically, if configured by the user OPERATOR.
9. Continue with the standardised or locally valid resuscitation protocol. If the option "Reminder Man." is configured by the operator, the message "Assess heart rhythm" appears 2 or 3 minutes after readiness for shock ended.
10. To reset the CPR timer (starting the CPR cycle again), press the softkey [Cont.CPR].
Note If the jog dial is pressed in manual defibrillation mode, the energy selection at the monitoring unit is only possible via the softkeys. Press the Manual key again, to be able to select the energy level with the jog dial.
Note The selected energy level is available for 30 seconds after charging. If no shock has been generated during this time, the device is discharged internally.
5.4.5 Manual Defibrillation and Cardioversion of Neonates and Children
Warning
With the baby shock electrodes the defibrillation energy is automatically reduced. The energy reduction is effected at a ratio of 1:10, i.e. one tenth of the energy set in defibrillation mode.
If, for example, an energy level of 200 J is selected, the shock is released with an energy of just 20 J.
Defibrillation electrodes
For the defibrillation and cardioversion of neonates and children, various types of defibrillation electrodes are available:
· Baby shock electrodes (as adapters for shock paddles, up to 5 kg body weight maximum) · corPatch easy electrodes Pediatric and Pediatric Extended up to 25 kg body weight maximum · corPatch easy electrodes for adults from 10 kg or 20 kg body weight · corPatch easy pre-connected electrodes from 20 kg body weight
corPatch easy electrodes When using corPatch easy electrodes Pediatric and Pediatric Extended, the energy available is limited Pediatric by the device to a maximum of 100 J.
86
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
Connecting baby shock 1. Fit the baby shock electrodes (item 2) onto the shock paddles (item 1) and press until the curved
electrodes
edge engages perceptibly.
1
2
2
1
3
3
Fig. 5-11
Connecting baby shock electrodes
1 Shock paddles for adults 2 Baby shock electrodes 3 Diode for functional test
2. Perform a functional test: Trigger a 10 J shock with short-circuited baby shock electrodes. The two diodes (item 3) light up. If the diodes do not light up, check the connections and repeat the functional test.
3. Further procedure as described in chapter 5.4.3 Manual Defibrillation and Cardioversion with Shock Paddles, page 83.
Note If the shock is aborted while using baby shock electrodes, the message Shock performed might be shown.
Caution
Short-circuit the baby shock electrodes away from your body during the functional test.
ENG - Version 4.0 P/N 04130.2
87
Operation Therapy
User Manual corpuls3
5.5 External Pacer 5.5.1 Information on the External Pacer
By electrical stimulation of the heart muscle, the external pacer of corpuls3 can supplement, positively influence or completely take over its function. Applying the The pacer emits pacing pulses to the patient's heart muscle via the corPatch electrodes attached to the corPatch electrodes thorax. The corPatch electrodes are placed in the anterior and posterior position in this case. Different operating modes enable the user to adapt the treatment individually for each patient. Access control to pacer The user OPERATOR can block the access to the pacer mode by means of a PIN code. One has to make mode sure that the code is known to authorised users, as otherwise pacer therapy is not possible. By pressing the Pacer key the device activates the pacer mode:
Fig. 5-12 Pacer function
1 Pacer key
Note For a reliable suppression of pacer impulses, the 4-pole ECG monitoring cable has to be used.
Note In lead DE no pacer recognition can be performed, because the ECG curve DE cannot display pacer spikes.
Note The corpuls simulator can be used for the daily and monthly function checks. For safety reasons, the corpuls simulator shows the DE lead in pacer mode and therefore is only partially suitable for the simulation of pacer therapy.
Warning Caution
In patients with an implanted pacer, it is possible that shockable ECG rhythms or arrhythmias will only be detected to a limited extent.
Functional error due to interference This may result in signal interference with the pacer. Do not operate the device in pacer mode near high frequency surgical devices.
Caution 88
The patient must not remain unattended when using the external pacer. ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
The basic settings when using the device in pacer mode for the first time are:
· Intensity: 0 mA · Frequency: 70/min · Operating mode: DEMAND
Pacer pulse identification
The moment of stimulation is marked by a green vertical line (spike) in the ECG curves. A small lozenge symbol is located under each spike. In addition, a large lozenge symbol is flashing in the upper left corner of the curve field.
The lozenge symbol in the upper left corner indicates the stimulation impulse of an implanted pacer.
Fig. 5-13 Pacer pulse identification
Note Connecting and disconnecting ECG electrodes may lead to the detection of false-positive pacer pulses. If this occurs, the device briefly displays pacer pulses, although the patient does not have an implanted (internal) pacer.
Message "STIM" The pacer mode is indicated by the message "STIM" in the upper left corner of the curve field.
When stimulation is performed, the message "STIM" is flashing. When "STIM" is permanently displayed, the pacer is switched on (e. g. in DEMAND mode in a frequency range in which no stimulation is necessary), but is not active (no stimulation). Only when the pacer is switched off or paused, the message "STIM" is not displayed.
The pacer continues to operate in monitoring mode.
If the user
· presses the On/Off key or · switches to defibrillation mode while the pacer is running, a confirmation prompt appears, warning that the pacer is active. Switching off the pacer or switching to defibrillation mode can be confirmed by pressing the softkey [OK] or aborted by pressing the softkey [Cancel].
ENG - Version 4.0 P/N 04130.2
89
Operation Therapy
User Manual corpuls3
Note As long as the pacer is active, the corpuls3 cannot be switched off or switch to defibrillator mode without a prior confirmation prompt.
The pacer can only be operated when corPatch electrodes are connected to the therapy master cable. The pacer is switched off automatically if a cable is removed while running in pacer mode.
Note If no ECG cable is connected to the patient box, the DEMAND mode cannot be selected. The confirmation prompt Switch pacer to FIX mode? appears.
5.5.2 Preparing the pacer function
FIX Operating mode In FIX operating mode, pacing is performed with a fixed frequency, regardless of the patient's own heart rate.
Warning
The pacer function and the ECG recording function are compromised if adhesion of the corPatch electrodes or ECG electrodes is impaired due to contaminated skin or excessive hair.
Note Only use corPatch electrodes indicated in the list of approved accessories. The corPatch electrodes must no longer be used after the expiry date indicated on the packaging has passed.
1. Prepare the patient (see chapter 5.2 Preparing the Patient for Defibrillation, Cardioversion and Pacer Therapy, page 72).
2. If necessary, prepare ECG monitoring (see chapter 6.3.3 Preparing ECG Monitoring, page 110). If the pacer mode is called up for the first time, a picture and the message "Recommended electrode placement" appears. To close the message, press softkey [OK].
Fig. 5-14 Pacer, Recommended electrode placement
3. Place the blue-labelled corPatch electrode on the back beside the vertebral column beneath the shoulder blade (item 1).
4. Place the red-labelled corPatch electrode on the thorax at the level of the bottom third of the sternum (between 4th and 5th ICS) (item 2).
5. Connect the corPatch electrodes to the therapy master cable.
90
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
Caution
Less effective pacer therapy!
Pacer therapy with the corPatch electrodes in APEX/STERNUM position can be attempted. If this, however, has no effect on the heart rhythm of the patient, it is recommended to attach the corPatch electrodes in anterior/posterior position (if adhesion is still sufficient).
If necessary, use fresh corPatch electrodes.
DEMAND mode In DEMAND operating mode, pacing is only performed when the patient's own heart rate is below the pre-set pacing frequency.
Note In DEMAND mode, the ECG has to be obtained via ECG electrodes and the 4-pole ECG monitoring cable addition in to the corPatch electrodes.
If no valid ECG is present (e.g. because the 4-pole ECG monitoring cable is not connected to the patient box), an alarm is triggered, the pacer therapy stops and the confirmation request "Switch pacer to FIX mode?" appears. If the user confirms with the softkey [Yes], the therapy is continued in FIX mode. If the softkey [No] is pressed, the therapy remains paused. If the user does not react, the confirmation request disappears after 10 s and the pacer shows the initial screen. If within this time, a valid ECG is detected again, therapy is continued in DEMAND mode.
OVERDRIVE function With the OVERDRIVE function, a patient with a high-frequency cardiac rhythm is restored to a normalfrequency cardiac rhythm.
ENG - Version 4.0 P/N 04130.2
91
Operation Therapy
5.5.3 Starting the Pacer Function
Preparing the device Prerequisite: Device is switched on.
Pacer
1. Press the Pacer key to run the pacer function. The following screen structure appears:
User Manual corpuls3
Fig. 5-15
Pacer, initial screen
1 Heart rate parameter field 2 Current ECG (derivation II/DEauto) 3 Configurable curve field 4 Pacer operating mode 5 Selected intensity 6 Softkey assignment 7 Operating instruction 8 Selected frequency
Note
FIX or DEMAND operating mode
The pacer always starts in DEMAND operating mode.
1. If the operating mode FIX is indicated, press the softkey [Mode]. If DEMAND operating mode is to be used, connect the ECG monitoring cable and continue with step 4.
2. Press the softkey [FIX] to select FIX operating mode. 3. Press the softkey [Freq.] and select the required frequency with the jog dial. 4. Press the softkey [Intens.] and select the required intensity with the jog dial.
Note The pacing frequency can be adjusted in 5/min increments within the range of 30/min to 150/min. Note The pacing intensity can be adjusted from 0 to 10 mA and then in 5 mA increments up to 150 mA.
Warning 92
Pacing begins automatically as soon as an intensity of more than 0 mA is selected. ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
Warning Warning
Regularly check effectiveness of the pacer by checking the central pulse.
In patients with an implanted pacer, it is possible that shockable ECG rhythms or arrhythmias will only be detected to a limited extent.
Fig. 5-16 Pacer, selecting the intensity
Pause pacing Continue pacing
End pacing
If necessary, press the softkey [Pause] to interrupt pacing. Confirm with the question Pause pacing? with the softkey [Yes].
If pacing has been paused, press the softkey [Continue pacing] to continue pacing. Confirm with the question Continue pacing? with the softkey [Yes].
To end the current pacing, press the softkey [Off]. Answer the confirmation prompt Switch off pacer? with the softkey [Yes] to end pacing and to reset the pacer (DEMAND, 0 mA, 70/min).
Warning
The procedure described below is a recommendation from the manufacturer. Qualified users will determine the progress of treatment on their own account.
Prerequisite:
· Operating mode DEMAND is called up, · Heart rate is over 70/min · ECG electrodes are attached and the ECG monitoring cable is connected. · Appropriate therapy electrodes are connected.
ENG - Version 4.0 P/N 04130.2
93
Operation Therapy
User Manual corpuls3
OVERDRIVE function 1. Press the Pacer key to run the pacer function. 2. Press the softkey [Mode] to leave the operating mode DEMAND.
3. Press the softkey [OVR] to select the OVERDRIVE function. The pacing frequency will be automatically adjusted to a value just below the patient's frequency.
4. Press the softkey [Intens.] and select an intensity value between 60 and 100 mA.
Fig. 5-17 Pacer, OVERDRIVE function
5. Press the softkey [Freq.] and gradually increase the frequency until the pacer stimulates regularly ("STIM" flashes in the curve field of lead II). Pacing only starts when the patient's heart rate is exceeded.
6. If the pacing pulses are not followed by a contraction of the heart muscle, press the softkey [Intens.] and increase the intensity until the stimulation threshold is reached and the heart rate permanently follows the pacing frequency.
7. Press the softkey [Freq.] and decrease the frequency until the required heart rate is achieved.
8. If necessary, repeat step 6 and 7.
Pause pacing Continue pacing
End pacing
If necessary, press the softkey [Pause] to interrupt pacing. Confirm with the question Pause pacing? with the softkey [Yes].
If pacing has been paused, press the softkey [Continue pacing] to continue pacing. Confirm with the question Continue pacing? with the softkey [Yes].
To end the current pacing, press the softkey [Off]. Answer the confirmation prompt Switch off pacer? with the softkey [Yes] to end pacing and to reset the pacer (DEMAND, 0 mA, 70/min).
Warning
Regularly check effectiveness of the pacer by checking the central pulse.
94
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
Warning
If the defibrillator/pacer battery enters a low state of charge in pacer mode while the modules are being operated separately from one another, a alarm message "Battery low" appears on the screen.
If the defibrillator/pacer battery is almost completely discharged and the defibrillator/pacer will soon switch off, the alarm message "Check pacer" appears.
In both cases, immediately connect the modules mechanically or connect the defibrillator/pacer to a mains power supply.
Warning
If the monitoring unit loses the network connection in pacer mode due to the defibrillator/pacer being out of range, this will be indicated visually and acoustically on the screen and by the alarm message "Check pacer". Pacing will be continued, but pacer alarms and errors cannot be displayed. In this case, the modules must be brought immediately within an adequate range or reconnected mechanically.
Warning
All four ECG electrodes of the 4-pole ECG monitoring cable must be connected to the patient.
If the electrodes of the complementary 6-pole ECG diagnostic cable are to be used additionally, all 6 electrodes must be connected to the patient and the connector must be plugged into the patient box. No electrode must be left unattached.
For safety reasons, if a defibrillation is performed with shock paddles, it is not permitted that the complementary 6-pole ECG diagnostic cable is pre-connected to the patient box and none of the electrodes are attached.
Caution
Possible delayed therapy
Do not operate the defibrillator/pacer module out of range of the monitoring unit/patient box. If switching to another therapy mode is not possible, bring the modules into radio range or connect them mechanically.
Note To avoid unintentional switching off of the defibrillator/pacer, the On/Off key has to be held down for at least 3 seconds for switching off.
Note If the battery on the monitoring unit is replaced during operation in pacer mode, the pacer has to be called up again.
ENG - Version 4.0 P/N 04130.2
95
Operation Therapy
User Manual corpuls3
5.6 Metronome
5.6.1 Information on the Metronome
Autostart Metronome
The corpuls3 comes with a metronome (smartMetronome) that supports the user acoustically during CPR. Configurations of the metronome are set according to the current scientific recommendations of international associations for resuscitation.
The user OPERATOR can configure that the metronome is started automatically when a therapy mode is called up. This setting can be configured separately for the AED- and for the manual mode (see chapter 7.4.12 Configuration of the Metronome and CPR feedback (Persons Responsible for the Device), page 193).
The corpuls3 emits a series of compression- and ventilation tones (configurable) via the speakers. The tone sequence signals to the user in what rhythm to perform thorax compressions and when to perform ventilation.
There are two different tone signals:
· Compression tone
· Ventilation tone
Compression tone Ventilation tone
The compression tone consists of a rhythmic tone sequence. Thorax compressions should follow this. To signal the upcoming ventilation phase, the five last compression tones of the sequence are higher pitched than the preceding ones.
The ventilation tone consists of two tone sequences which are signalling the inhalation and exhalation. The ventilation tone is signalled twice in a row.
Note Metronom settings
The factory settings of the metronome are configured at 100 thorax compressions per minute. This value can be altered by the person responsible for the device (see chapter 7.4.12 Configuration of the Metronome and CPR feedback (Persons Responsible for the Device), page 193).
The metronome has the following 6 settings that can be selected in defibrillation mode via the softkey context menu:
Metronome modes
Explanation
Off
The metronome is deactivated.
Adult 30:2
Standard resuscitation protocol for adults Proportion: 30 thorax compressions; 2 ventilations.
Adult cont.
Continuous thorax compressions in adults, (e. g. if patient is intubated)
Child 30:2
Standard resuscitation protocol for children Proportion: 30 thorax compressions; 2 ventilations.
Child 15:2
Standard resuscitation protocol for children Proportion: 15 thorax compressions; 2 ventilations.
Child cont.
Continuous thorax compressions in children, (e. g. if patient is intubated)
Table 5-2
Metronome modes
96
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
5.6.2 Starting the Metronome
Preparing the device
Prerequisite: The device is in AED- or manual defibrillation mode. 1. Press the softkey [Metronome] repeatedly until the required mode is selected.
Fig. 5-18 Softkey context menu metronome
2. To change the volume of the metronome signals, mark the field "Volume" and confirm by pressing the jog dial.
3. Select the required volume by turning the jog dial.
4. To confirm the settings and close the configuration dialogue, press the jog dial.
Note If the user switches to monitoring mode during CPR, the metronome function stays active. The metronome can be deactivated via the softkey [Metr. off].
Note The QRS-/pulse tone is deactivated automatically when the metronome function is active.
Warning
The metronome pauses at reaching readiness for shock in AED or manual defibrillation mode.
After the shock has been released or 10 s after readiness for shock without releasing the shock, the metronome resumes signalling the compression tone.
Caution
During ECG analysis in AED mode the metronome pauses. If subsequently no shock is recommended, the metronome resumes signalling the compression tone.
Caution
By selecting the pacer mode, the metronome is deactivated.
ENG - Version 4.0 P/N 04130.2
97
Operation Therapy
User Manual corpuls3
5.7 CPR Feedback
5.7.1 Information on CPR Feedback
If a corPatch CPR sensor is used, the rate and depth of a thorax compression can be measured by the corpuls3. During resuscitation, the users are provided important information on the quality of the current thorax compressions, so that they can react immediately and take corresponding measures. Among the information are the display of the current rate as well as the curve progression of the current thorax compressions. Speech- and text messages, as well as the colour of the bars in the CPR curve signal to the user whether the quality of the thorax compressions is sufficient (green bars) or can be optimised (red bars). For this, three different speech- and text messages are available: · "Push harder" · "Good compressions" · "Fully release" The speech- and text message "Push harder" is played, if the recommended depth of the thorax compressions has not been reached. It is repeated at an interval of 7 seconds until the recommended depth of the thorax compressions has been reached or exceeded and the speech- and text message "Good compressions" is played. The message "Fully release" is played as a reminder for recalibration of the sensor. It can be deactivated in the configuration dialogue "Defib - CPR Feedback".
Message The user OPERATOR can deactivate the spoken message "Fully release" (see chapter 7.4.12 "Fully release" Configuration of the Metronome and CPR feedback (Persons Responsible for the Device), page 193).
Speech- and text messages will not be played, if
· the metronome is in ventilation phase, · during the ECG analysis in AED mode, · the device is ready to shock or · the resuscitation is finished.
corPatch CPR summary (printout)
After deployment of the corPatch CPR feedback sensor the corpuls3 calculates and stores a statistical evaluation from the collected data. If the user OPERATOR has enabled this option (see chapter 7.4.12 Configuration of the Metronome and CPR feedback (Persons Responsible for the Device), page 193), the corPatch CPR summary can be printed out on the corpuls3 via the main menu or the mission browser and so allows a direct mission debriefing for users. The printout contains various quality parameters and graphical summaries of the respective resuscitation mission.
If necessary, the used measuring unit can also be adjusted in the context menu or the configuration dialogue.
Note The CPR Feedback system is available in AED and manual defibrillation mode as well as in monitoring mode (configurable).
Note The use of CPR feedback is not recommended for patients with a body weight below 20 kg.
Note The CPR feedback will be available in devices as of May 2013. Older devices can be retrofitted. For further information, please contact your authorised sales and service partner.
98
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
Note The CPR self-test (accessible at user level Operator) only checks the functionality of the CPR module, not that of the CPR sensor or the CPR intermediate cable.
Note The corPatch CPR sensor is a disposable article.
Note The corPatch CPR sensor is covered under one or more of the following U.S.A. patents: 7,074,199; 7,108,665; 7,429,250; 8,147,433; 7,220,235.
Warning
To guarantee a defibrillation protection for patients, users and third parties, exclusively use the accessories indicated in the list "Authorised Accessories".
Caution
The thorax compressions are also represented in green if they exceed the recommended depth.
Caution Caution Caution
The detection of the rate and depth of the thorax compressions can be compromised by vibrations.
Do not use corPatch CPR sensors if · the packaging is damaged or opened; · the expiry date indicated on the packaging has passed; · the sensor is damaged.
Used corPatch CPR sensors have to be replaced by a new corPatch CPR sensor after 24 hours at the latest, to avoid side effects such as reddening and skin irritation.
Caution Warning
The patient's condition has to be assessed by the users themselves, independent of the CPR feedback.
During the phase between compressions, the user has to make sure that the pressure is completely relieved from the thorax. Otherwise, there can be false-negative feedback.
ENG - Version 4.0 P/N 04130.2
99
Operation Therapy
User Manual corpuls3
5.7.2 Preparing CPR Feedback
How to handle the corPatch CPR sensor is described in the following. 1. Connect the corPatch CPR sensor (item 1) to the corPatch CPR intermediate cable (item 2) leading
to the patient box.
Fig. 5-19 Connecting the corPatch CPR sensor to the corPatch CPR intermediate cable
2. Tear open the package of the corPatch CPR sensor along the markings. 3. Remove the protective foil from the corPatch CPR sensor, so that the corPatch CPR sensor can be
attached to the patient's thorax as shown in the illustration.
Fig. 5-20 CPR feedback, attaching the corPatch CPR sensor
100
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
5.7.3 Working with CPR Feedback
Prerequisite: Device is switched on and in manual mode. The CPR feedback system starts automatically when the corPatch CPR sensor is applied. A picture and a message appear, showing the recommended position of the corPatch CPR sensor (see Fig. 5-20). To close the message, press softkey [OK]. The display of the application help can be disabled by the user OPERATOR.
1. If necessary, select a curve field for displaying the compression progression (CPR) and call up the curve context menu.
2. Assign the CPR curve to the selected curve field. 3. If necessary, select a parameter field for displaying the CPR rate and call up the parameter
context menu. 4. Assign the CPR rate to the selected parameter field. 5. If necessary, select in the main menu "Defib" "CPR" and further adjust the configurations of
the CPR Feedback system.
Fig. 5-21
CPR feedback
1 Parameter field CPR rate 2 Reference range of compression depth 3 Curve field CPR 4 Operating instruction
Note If necessary, the used measuring unit and the reference range of compression depth (adult or child) can be adjusted in the curve context menu. The measuring unit can also be adjusted in the configuration dialogue.
Note Outside the specified measuring range (70/min - 150/min) the CPR rate displays invalid values: two dashes in the parameter field and a dashed line in the curve field.
ENG - Version 4.0 P/N 04130.2
101
Operation Therapy
User Manual corpuls3
Caution
The thorax compressions are also represented in green if they exceed the recommended depth.
Caution
The detection of the rate and depth of the thorax compressions can be compromised by vibrations.
Warning
During the phase between compressions, the user has to make sure that the pressure is completely relieved from the thorax. Otherwise, there can be false-negative feedback.
5.7.4 corPatch CPR summary
A retrospective CPR evaluation can be printed out on the corpuls3 via the mission browser. The printout contains various quality parameters and graphical summaries of the respective resuscitation mission. The option can be disabled by the user OPERATOR.
5.7.5 preShock CPR
The user OPERATOR (person responsible for the device) can configure a preShock CPR phase (see chapter 7.4.4 Configuration of the Defibrillation Function (Persons Responsible for the Device), page 181). With this functionality, the user can perform a certain amount of compressions after AED analysis (if a shockable rhythm was detected) before the defibrillation shock is released. Thereby the preShock pause is shortened and the chances for success of the shock are increased. The prompt for preShock CPR is only visual. Note As soon as the charging process is finished the defibrillator signals readiness to shock by issuing the ready-signal. The user has to perform the configured number of compressions until the defibrillator prompts the shock release. Note If there is a connection between the corpuls3 and the corpuls cpr the preShock CPR phase is always 8 s, independent of how long the preShock CPR phase has been configured by the operator. Note The preShock CPR phase should not be interrupted.
Warning
Before releasing the shock, make sure that there is no risk for users or third parties. Electrical shock from defibrillator use can lead to arrhythmias, ventricular fibrillation or asystole.
102
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
5.8 Display of corpuls cpr Parameters
If the corpuls3 is connected via Bluetooth with a corpuls cpr, these parameters can be displayed in parameter fields of the corpuls3: · mCPR mode · mCPR compression depth · mCPR rate and · Battery charging status of the corpuls cpr
Fig. 5-22
Display of corpuls cpr parameters
1 mCPR mode 2 mCPR compression depth 3 mCPR rate 4 Battery charging status of the corpuls cpr 5 Symbol for connected corpuls cpr
Warning
5.9 Compression Synchronised Therapy with the corpuls cpr
Compression synchronised therapy with the corpuls cpr contributes to the optimisation of the resuscitation work-flow. It is also possible to operate the corpuls cpr via the corpuls3 to achieve even shorter hands-off-times and therefore an optimal coordination of both devices. The user can operate or configure the corpuls cpr directly at any time.
Delayed therapy due to incompatibility! Compression-synchronised therapy can only be implemented in combination with a corpuls cpr, as a connection to other chest compression devices is not possible.
ENG - Version 4.0 P/N 04130.2
103
Operation Therapy
User Manual corpuls3
Warning Caution Caution
Delayed therapy due to malcommunication between the devices! If there is no or faulty communication between the corpuls3 and the corpuls cpr (operation via the corpuls3), the alarm "Check corpuls cpr" appears (see also chapter 11.1 Device alarms, page 250). If the error cannot be remedied promptly, both devices have to be operated manually.
Ineffective mCPR Therapy! A defibrillation shock can cause the patient to slip and therefore to a changed pressure point which can result in ineffective mCPR therapy. The user always has to observe the patient and correct the position of the stamp if necessary.
Crush injury due to the corpuls cpr stamp! If configured accordingly, the corpuls cpr performs preShock CPR compressions for 8 s, stops when a shock is released and then starts automatically with compressions again. This can lead to patient or user injury. The user has to be aware of the current configuration and keep parts of the body away from the stamp while therapy is in progress.
To perform compression-synchronised therapy with a corpuls cpr, the following conditions have to be met:
· corpuls cpr and corpuls3 are switched on and connected via Bluetooth (see chapter 9.5.5 Bluetooth connection with corpuls cpr, page 229).
· The patient is in therapy position, i.e. positioned under the corpuls cpr, the locking lever has been opened and closed (see also corpuls cpr user manual).
· The patient is prepared (see chapter 5.2 Preparing the Patient for Defibrillation, Cardioversion and Pacer Therapy, page 72).
· Therapy electrodes are prepared and placed on the patient.
5.9.1 Therapy Control of the corpuls cpr via the corpuls3
Prerequisite: The patient is in therapy position, i.e. positioned under the corpuls cpr, the locking lever has been opened and closed (see also corpuls cpr user manual). The corpuls3 is in defibrillation mode (AED/Manual) and has a connection to the corpuls cpr.
Starting therapy 1.
Pausing/stopping 2. therapy
Press softkey [Start mCPR]. The corpuls cpr starts therapy. Press softkey [Stop mCPR]. The corpuls cpr pauses therapy.
104
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Therapy
5.9.2 Configuration of Therapy Parameters of the corpuls cpr
Prerequisite: The corpuls3 is in defibrillation mode (AED/Manual) and has a connection to the corpuls cpr.
Note The therapy parameters on the corpuls cpr can only be changed in single steps via the softkeys. The jog dial cannot be used for this.
1. Setting compression 2.
depth 3. Setting compression 4.
rate 5. Setting therapy mode 6.
7. 8.
Press softkey [Set.mCPR]. Press softkey [Depth]. Set the required compression depths by pressing the softkeys [+] and [-]. Press softkey [Rate]. Set the required compression rate by pressing the softkeys [+] and [-]. Press softkey [Mode]. Set the required therapy mode by pressing the softkeys [+] and [-]. To retain the previous settings and close the configuration dialogue, press the softkey [Cancel].
5.9.3 Compression Synchronised Therapy in AED mode
Note If there is a connection between the corpuls3 and the corpuls cpr the preShock CPR phase is always 8 s, independent of how long the preShock CPR phase has been configured by the operator.
AED
Analyse
1. To start the AED mode, press the AED key.
2. If configured, select the required energy level with the jog dial or via the softkeys and confirm by pressing the jog dial (see chapter 7.4.4 Configuration of the Defibrillation Function (Persons Responsible for the Device), page 181).
3. To start the ECG analysis, press the Analyse key. If the corpuls cpr is already running at this point, the therapy is paused for the analysis.
If a shockable rhythm is detected, the corpuls cpr automatically performs preShock CPR compressions for 8 s and pauses, if the user holds down the Shock key to release a shock.
If the shock has been released successfully, the message Shock performed is shown and the corpuls cpr resumes therapy.
Note If the Shock key is pressed too briefly, the corpuls cpr stops only for a short time and continues thorax compressions after the Shock key is released.
ENG - Version 4.0 P/N 04130.2
105
Operation Therapy
User Manual corpuls3
5.9.4 Compression Synchronised Therapy in Manual Mode
MMaannuueall l CLhaadregne
1. To start the manual defibrillation mode, press the Manual key. 2. Select the required energy level with the jog dial or via the softkeys and confirm by pressing the
jog dial. 3. If the corpuls cpr is already running at this point, press the softkey [Stop mCPR].
The corpuls cpr stops therapy. The message "Assess heart rhythm" is displayed. 4. Analyse the heart rhythm. 5. If a shockable rhythm is detected, press the softkey [Start mCPR]. 6. Press softkey [Cont.CPR].
The corpuls cpr resumes therapy. The message "Device is performing compressions" is displayed. 7. To charge the defibrillator press the Charge key. 8. Hold down the Shock key or both shock paddle buttons until a shock has been released. The corpuls cpr stops in a neutral position until the shock has been released. If the shock has been released successfully, the message Shock performed is shown and the corpuls cpr resumes therapy.
Note If the Shock key is pressed too briefly, the corpuls cpr stops only for a short time and continues thorax compressions after the Shock key is released.
106
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
6 Operation Monitoring and Diagnosis
6.1 Information on Monitoring and Diagnosis
The corpuls3 offers comprehensive options for monitoring vital parameters and for diagnosis of critical patients. The device starts automatically in monitoring mode when it is switched on. Press the Monitor key to switch from the therapeutic mode to monitoring mode.
Fig. 6-1
Selection of the monitoring and diagnostic function
1 Monitor key
ENG - Version 4.0 P/N 04130.2
107
Operation Monitoring and Diagnosis
User Manual corpuls3
6.2 Monitoring Trends
Softkey The softkey [Trend] opens a softkey context menu. The user can choose between the trend view which [Trend] displays the trend curves of the vital parameters from the switching on of the device ("Graphic") or the
trend browser in table form ("Table").
Up to 6 curves can be displayed in the trend view (by default the parameters HR, SpO2, PR and NIBP are displayed). Further parameters to be displayed or the timespan (Auto, 30 - 480 min.) over which the trends are displayed can be adjusted via the curve context menu. The trend browser in table form can also be opened from the mission browser (see chapter 8.5.2 Mission Browser, page 205).
Fig. 6-2 Trend curves
Transfer of trend data base
Size of parameter fields
in trend mode
Other parameters can be selected via the curve context menu. To return to the realtime curves, press the softkey [Curves] or press the key Monitor, Back or Home.
The trend curves and the trend table are printed out in the protocol by default. To print out the trend curves and/or the trend table separately, select in the main menu "Printer" "Trend page".
The corpuls3 allows to transfer the complete trend data base to corpuls.web LIVE. So, the consulting doctor using corpuls.web LIVE can review the whole development and gain an overview of the patient`s status.
Even if the view "Big 4", "Big 6" or "Big 8" is selected in monitoring mode, in trend mode the big parameter fields are displayed in their normal size.
108
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
6.3 Monitoring ECG
6.3.1 Information on ECG Monitoring
The ECG monitoring function of corpuls3 allows routine monitoring of heart rhythm and heart rate. Configurable alarms alert the user to current changes in the ECG.
To record the ECG as part of monitoring a 4-pole monitoring cable or corPatch electrodes are necessary.
With the 4-pole ECG monitoring cable, the bipolar extremity leads according to Einthoven (I, II, III) and the unipolar extremity leads according to Goldberger (aVR, aVL, aVF) can be recorded and displayed on the monitor. Simultaneous display of up to 6 ECG leads maximum is possible.
Note For a reliable suppression of pacer impulses, the 4-pole ECG monitoring cable has to be used.
Note In lead DE no pacer recognition can be performed, because the ECG curve DE cannot display pacer spikes.
Warning
To guarantee a defibrillation protection for patients, users and third parties, use exclusively the ECG monitoring cables itemised in the list of authorised accessories (see chapter 10.8, Approved Accessories, Spare Parts and Consumables, page 249).
Warning
Additional use of a nerve stimulator may modify or completely suppress the ECG representation. In some cases, the ECG of an implanted pacer is displayed instead.
Warning
In patients with an implanted pacer, it is possible that shockable ECG rhythms or arrhythmias will only be detected to a limited extent.
To check the ECG cables for functional readiness, the use of the optionally available ECG cable tester is recommended (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249).
Note The depolarisation wave is a spatial unit, i.e. that the beginning of one wave is not visible in all derivations at the same time. Isoelectric sections at the beginning of an QRS complex are treated as part of the following significant wave. Analogously, isoelectric segments at the end of the QRS complex are incorporated into the previous significant wave.
ENG - Version 4.0 P/N 04130.2
109
Operation Monitoring and Diagnosis
User Manual corpuls3
6.3.2 Colour coding of ECG leads
According to DIN EN 60601-2-25, two codes apply for colour coding ECG lead cables. As a rule, code 1 is generally used in the European region and code 2 in the American region.
Lead
Extremities (according to Einthoven and Goldberger)
CODE 1
(conventionally used in the European region)
Electrode labelling
Colour coding
R
Red
CODE 2
(conventionally used in the American region)
Electrode labelling
Colour coding
RA
White
L
Yellow
LA
Black
F
Green
LL
Red
Chest wall
C
(according to
Wilson)
C1
White
V
White/Red
V1
Brown Brown/Red
C2
White/Yellow
V2
Brown/Yellow
C3
White/Green
V3
Brown/Green
C4
White/Brown
V4
Brown/Blue
C5
White/Black
V5
Brown/Orange
C6
White/Violet
V6
Neutral
N
Black
RL
Table 6-1 ECG lead colour coding
Brown/Violet Green
Note For all representations of the ECG leads in this operating manual see CODE 1 (conventionally used in Europe).
6.3.3 Preparing ECG Monitoring
The ECG can be recorded with the following cables: · 4-pole ECG monitoring cable,
(for leads I, II, III, aVR, aVL and aVF) and · complementary 6-pole diagnostic cable,
(for leads V1 to V6) as a supplement to ECG monitoring (for positioning of ECG electrodes C1 to C6, see chapter 6.4.2 Preparing the Patient for a D-ECG, page 117)
110
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
Note The quality of the ECG recordings also depends on the ECG electrodes used:
· Only use ECG electrodes indicated in the list of approved accessories (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249).
· Do not use ECG electrodes whose expiry date indicated on the packaging has passed. · Only use ECG electrodes of the same type that originate from an identical production process (batch).
Warning
The ECG function is compromised if adhesion of the electrodes is impaired due to contaminated skin or excessive hair.
Preparing the device
Positioning the ECG monitoring cable
Prerequisite: Device is switched on.
1. Remove excessive hair on the thorax so that the conductive surface of the corPatch electrodes has full contact with the skin.
2. Clean the skin on the thorax before applying the ECG electrodes if necessary. 3. Attach the ECG electrodes to the ECG monitoring cable. 4. Place all four ECG electrodes of the 4-pole ECG monitoring cable on the patient:
· Red ECG electrode: right arm; shortened: under the right clavicle (Fig. 6-3, item 1)
· Yellow ECG electrode: left arm; shortened: under the left clavicle (Fig. 6-3, item 2)
· Green ECG electrode: left leg; shortened: in the area of the left inguinal fold, central to the axis of the leg (Fig. 6-3, item 3)
· Black ECG electrode: right leg; shortened: in the area of the right inguinal fold, central to the axis of the leg (Fig. 6-3, item 4)
1
2
4
3
Fig. 6-3
ECG monitoring, applying the ECG electrodes (shortened form)
1 Position of the red ECG electrode 2 Position of the yellow ECG electrode 3 Position of the green ECG electrode 4 Position of the black ECG electrode
ENG - Version 4.0 P/N 04130.2
111
Operation Monitoring and Diagnosis
User Manual corpuls3
Note Connecting and disconnecting ECG electrodes may lead to the detection of false-positive pacer pulses. If this occurs, the device briefly displays pacer pulses, although the patient does not have an implanted (internal) pacer.
Note For a D-ECG, alternative positions are possible, but the morphology of the ECG can be changed. To check the ECG cables for functional readiness, the use of the optionally available ECG cable tester is recommended (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249).
6.3.4 Performing ECG Monitoring
The ECG is displayed in the following manner: · Up to 6 leads can be displayed on the screen at the same time.
· The flashing heart symbol indicates a QRS complex.
· The 20 Hz indicator shows that the 20 Hz filter is active. · Identification of a QRS complex indicated by a QRS marker can be configured (see chapter 7.2.1
ECG Monitoring, page 166). · The lozenge symbol indicates pacing pulses of an implanted pacer. · The heart rate can be displayed in a parameter field. The alarm limits can be configured.
Fig. 6-4
ECG monitoring, initial screen
1 Heart rate parameter field 2 20 Hz indicator 3 ECG curves
1. Adapt the representation of the ECG curve, if necessary (see chapter 6.3.5 Adapting the Representation of the ECG Curve, page 114).
2. Configure the device alarms, if necessary (see chapter 7.3 Alarm Configuration, page 172).
112
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
Note If necessary, adapt individual alarm limits manually.
Warning
Risk of wrong diagnosis
The use of the 20 Hz filter in monitoring causes distortions in the ECG that can be misinterpreted. A diagnosis should only be made on the basis of a diagnostic ECG.
Note Note Printing ECG curves
QRS-/pulse tone and QRS mark are generated independently and may deviate slightly from each other.
If individual ECG curves are failing, check the ECG electrodes and the ECG cable.
The ECG curves can be printed out with the integrated printer. For further information on printout configuration see chapter 7.1.3 Printer settings, page 160.
Every real-time printout has the designation "REALTIME PRINTOUT" on the first page. To start or stop real-time printing press the Print key.
Fig. 6-5 Real-time printout, section
mV-mark Markings for folding
The millivolt mark (in form of a rectangular impulse) is located at the left margin of the curve field (mVmark). Its height depends on the set amplification of the ECG curve. The mV mark shows an amplitude height of 0.5 or 1 mV for comparison, so that the amplitude of the ECG curve displayed can be determined.
The real-time printout has vertical markings on the upper and lower edges that help to fold the printout quickly. The folded printout fits the width of a standard sheet of paper (DIN A4) and can be attached there for documentation.
Caution
At temperatures below zero °C the alarm "ECG electrode [X] loose" can be impaired.
ENG - Version 4.0 P/N 04130.2
113
Operation Monitoring and Diagnosis
User Manual corpuls3
6.3.5 Adapting the Representation of the ECG Curve
Selecting leads
Up to 6 leads can be displayed simultaneously. The number of the curves displayed can be configured (see chapter 7.1.2 Configuration, page 157).
1. Select the curve to be adapted and open the curve context menu (see chapter 4.3.2 Parameter Context Menu and Curve Context Menu, page 52).
Fig. 6-6 ECG monitoring, adapting the curves
2. Select the required lead in the curve context menu and confirm. The required lead is displayed. 3. Repeat steps 1 and 2 for further curves if necessary.
Amplitude mV-mark
The amplitude of the displayed ECG curves can either be adjusted automatically by the device or adjusted manually (see chapter 7.2.1 ECG Monitoring, page 166).
With automatic adjustment, the device selects the amplification so that the ECG curve with the greatest amplitude overwrites 50% of the area available on the screen. Consequently, individual greater ECG swings can be displayed as well.
With manual adjustment, the amplification affecting the amplitude display can be selected (x 0.25 / x 0.5 / x 1 / x 2).
In the D-ECG preview, the amplification factor can be selected with the softkeys [Ampl+] and [Ampl-].
The millivolt mark (in form of a rectangular impulse) is located at the left margin of the curve field (mVmark). Its height depends on the set amplification of the ECG curve. The mV mark shows an amplitude height of 0.5 or 1 mV for comparison, so that the amplitude of the ECG curve displayed can be determined. The millivolt mark is also shown on the paper printout on the left besides the ECG curve.
114
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
Note The selected amplification applies to all ECG curves displayed.
1. Select the ECG curve and open the curve context menu. 2. Select the required amplification in the curve context menu and confirm.
The ECG curve will be displayed with the required amplification. Once the selection has been made, the program leaves the curve context menu automatically.
Sweep speed
The sweep speed of the screen representation can be selected for the configured ECG curves. The following sweep speeds can be configured: · 12.5 mm/s · 25 mm/s · 50 mm/s
Note ECG Filter
The selected sweep speed applies to all ECG curves displayed.
1. Select the ECG curve and open the curve context menu. 2. Select the required sweep speed in the curve context menu and confirm. The ECG curve is
displayed with the required sweep speed. Once the selection has been made, the program leaves the curve context menu automatically. The device adjusts the ECG filters automatically. The filters can be modified manually if necessary for displaying the ECG curve.
The default setting of the ECG filter in monitoring mode is 0.5 - 25 Hz. Additionally, muscle contractions of the patient can be filtered out of the ECG by means of the 20 Hz filter. The 20 Hz filter can be activated or deactivated via the curve context menu.
Warning
Risk of wrong diagnosis
The use of the 20 Hz filter in monitoring causes distortions in the ECG that can be misinterpreted. A diagnosis should only be made on the basis of a diagnostic ECG.
The quality of the ECG depends among other factors on the ECG filter settings. See chapter 7.4.5 Filter Settings (Persons Responsible for the Device), page 183 for information on the filter settings.
See chapter 11 Procedure in Case of Malfunctions, page 250 for instructions on improving the ECG quality.
ENG - Version 4.0 P/N 04130.2
115
Operation Monitoring and Diagnosis
User Manual corpuls3
6.3.6 Heart Rate Monitoring
In addition to the ECG curves, the heart rate is evaluated and displayed on the screen when monitoring the ECG. 1. To display the heart rate, select the parameter field and open the parameter context menu (see
chapter 4.3.2 Parameter Context Menu and Curve Context Menu, page 52). 2. Select heart rate in the parameter context menu and confirm. The heart rate is displayed in the
parameter field. 3. By means of the parameter context menu for the heart rate, the VT/VF alarm can be enabled
"VT/VF alarm ON" or disabled "VT/VF alarm OFF".
Fig. 6-7
Heart rate parameter field
1 Current heart rate in 1/min 2 Symbol for switched-on alarms 3 Upper alarm limit 4 Lower alarm limit
Note Beyond the specified limits of 18/min or 300/min the heart rate cannot be calculated correctly.
6.4 Recording, Measuring, Printing and Interpreting a Diagnostic ECG
6.4.1 Information on Diagnostic ECG
Hannover ECG System HES®
In cooperation with internationally renowned cardiologists, HES® has been developed and refined continuously since 1968. A large number of leading medical equipment manufacturers integrate this algorithm into their medical products.
Based on a 12 lead ECG, HES® Light performs a ECG measurement of the diagnostic ECG. On the printout, the results are clearly arranged in tables that can help with interpretation and diagnosis during a mission.
Optionally, HES® Light can be complemented by an extendend version of HES®. The corpuls3 then issues a therapy suggestion based on the results of the "corpuls S"or "corpuls ACS" therapy algorithms. With these, the user can make early on tactical decisions as to which hospital to send the patient to or what emergency measures to perform immediately.
116
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
Caution
HES® and the two measurement and interpretation algorithms corpuls ACS or corpuls S may yield different results in some cases. This is due to differences in focus of these algorithms, their sensitivity and specificity, as well as operator configuration.
Representative Cycle
HES® Light and HES® identify a "Representative cycle" from the diagnostic ECG. From this representative cycle the measurement tables are compiled which are necessary for an ECG interpretation (see chapter 6.4.4 Representative Cycle, page 125). The representative cycle can be printed out with the diagnostic ECG. For further information on printout configuration see chapter 7.1.3 Printer settings, page 160.
Abbreviations for ECG Measurement/ EKG Interpretation
For an overview of the used abbreviations, see Appendix B List of Abbreviations, page 296.
With the complementary 6-pole ECG diagnostic cable, Wilson's 6 unipolar thoracic wall leads (V1-V6) can be recorded. In combination with the ECG monitoring cable, 12 leads can be displayed simultaneously.
The screen shows a complete preview of all 12 leads which can be printed on paper with the internal printer of the corpuls3. The format and duration of the printout can be configured in size and length. For further information on printout configuration see chapter 7.1.3 Printer settings, page 160.
Note To check the ECG cables for functional readiness, the use of the optionally available ECG cable tester is recommended (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249).
Warning Warning Caution
The user/physician is always responsible for correct diagnosis and therapy.
Additional use of a nerve stimulator may modify or completely suppress the ECG representation. In some cases, the ECG of an implanted pacer is displayed instead.
The preview of the D-ECG on the screen serves only to check the individual ECG leads, the signal quality and possible arrhythmias. A diagnosis of the D-ECG must be based on the printout of the D-ECG.
6.4.2 Preparing the Patient for a D-ECG
The diagnostic ECG is recorded with the following cables: · 4-pole ECG monitoring cable,
(for leads I, II, III, aVR, aVL and aVF) and · 6-pole complementary ECG diagnostic cable,
(for leads V1 to V6)
ENG - Version 4.0 P/N 04130.2
117
Operation Monitoring and Diagnosis
User Manual corpuls3
Preparing the patient 1. Remove excessive hair, so that the conductive areas of the therapy electrodes can have full contact with the skin.
2. Clean and dry the skin before applying the ECG electrodes.
Positioning the ECG 3. Place all four ECG electrodes of the 4-pole ECG monitoring cable on the patient:
monitoring cable
· Red ECG electrode: right arm (Fig. 6-8, item 1)
· Yellow ECG electrode: left arm (Fig. 6-8, item 2)
· Green ECG electrode: left leg (Fig. 6-8, item 3)
· Black ECG electrode: right leg (Fig. 6-8, item 4)
1
2
4
3
Fig. 6-8
Diagnostic ECG, applying the ECG electrodes (1)
1 Position of the red ECG electrode 2 Position of the yellow ECG electrode 3 Position of the green ECG electrode 4 Position of the black ECG electrode
118
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
Positioning the 4. Place all 6 ECG electrodes of the complementary ECG diagnostic cable on the patient's thorax:
complementary ECG diagnostic cable
· Red V1-ECG electrode: 4th intercostal space, right parasternally · Yellow V2-ECG electrode: 4th intercostal space, left parasternally
· Brown V4-ECG electrode: 5th intercostal space, left medioclavicular line
· Green V3-ECG electrode: between V2 and V4 on the 5th rib
· Black V5-ECG electrode: front left axillary line at the level of V4
· Violet V6-ECG electrode: middle left axillary line at the level of V4
Fig. 6-9
Diagnostic ECG, applying the ECG electrodes (2)
1 Position of the red V1-ECG electrode 2 Position of the yellow V2-ECG electrode 3 Position of the green V3-ECG electrode 4 Position of the brown V4-ECG electrode 5 Position of the black V5-ECG electrode 6 Position of the violet V6-ECG electrode
Note Connecting and disconnecting ECG electrodes may lead to the detection of false-positive pacer pulses. If this occurs, the device briefly displays pacer pulses, although the patient does not have an implanted (internal) pacer.
Note The ECG monitoring interfaces ECG-M and ECG-D are specified as CF (cardiac floating). The patient connections are fully insulated and defibrillation-proof.
Note The quality of the ECG recordings also depends on the ECG electrodes used:
· Only use ECG electrodes indicated in the list of approved accessories (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249).
· Do not use ECG electrodes whose expiry date indicated on the packaging has passed. · Only use ECG electrodes of the same type that originate from an identical production process (batch). Note To check the ECG cables for functional readiness, the use of the optionally available ECG cable tester is recommended (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249).
Warning
The ECG function is compromised if adhesion of the electrodes is impaired due to contaminated skin or excessive hair.
ENG - Version 4.0 P/N 04130.2
119
Operation Monitoring and Diagnosis
User Manual corpuls3
6.4.3 Recording and Measuring a Diagnostic ECG
1. If possible, ask the patients to hold their breaths (for approx. 10 s) while ECG is obtained. 2. Press the softkey [D-ECG]. A preview of all 12 ECG leads is displayed on the screen.
Fig. 6-10 Diagnostic ECG, preview screen
3. Check in the preview if all ECG leads are written.
4. Check in the preview if the signal quality of the leads is acceptable.
5. If the signal quality of one or several leads is poor, check electrode contact and electrode positioning and take appropriate measures (see chapter 11 Procedure in Case of Malfunctions, page 250).
The user OPERATOR can set the sweep speed of the ECG in the D-ECG preview (see chapter 7.2.1 ECG Monitoring, page 166). With the option "10s preview", the sweep speed is 6.25 mm/s, so that the complete 10 s segment of the ECG can be viewed at one glance. If this option is deselected, the same sweep speed as in monitoring view is used.
Note If individual ECG curves are failing, check the ECG electrodes and the ECG cable.
6. When the message "Ready for D-ECG" appears in the preview, press the softkey [Start]. The ECG recorded up to this moment is discontinued and saved.
7. The configuration dialogue for entering the patient's sex and age opens. The configuration dialogue has to be confirmed with the softkey [OK].
8. If required, further settings for the D-ECG can be configured with the softkey [Config.].
9. With the softkey [Print] the D-ECG is printed out for diagnosis (see Fig. 6-12 page 122) and with the softkey [Send] it is sent.
Printout of 12,
10. To run another preview on the monitor, press the softkey [Cont.].
120
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
11. To quit the preview and to switch to monitoring mode, press the softkey [Cancel].
Fig. 6-11 D-ECG, options
Caution
HES® and the two measurement and interpretation algorithms corpuls ACS or corpuls S may yield different results in some cases. This is due to differences in focus of these algorithms, their sensitivity and specificity, as well as operator configuration.
Filter setting
After calling up the preview, the diagnostic ECG is automatically started with the diagnostic filter setting, e. g. 0.05 -150 Hz. The filter bandwidth is displayed in the right corner at the bottom of the preview screen. It is possible, however, to switch to an alternative diagnostic filter setting, e.g. 0.05 40 Hz. For this purpose press the softkey [Filter]. HES® Light and HES® are not affected by these filter settings.
Warning
If the factory setting of the filters is changed, the representation of the ECG can be affected. As a consequence, wrong interpretation of the ECG is possible, which may result in inadequate treatment.
Note Amplification settings
To increase diagnostic safety, the message "ECG FILTER ACTIVE - INTERPRETABILITY MAY BE AFFECTED" is printed for the user on the printout if the ECG is changed by filter settings and thus the interpretability is limited.
After calling up the preview, the diagnostic ECG is automatically started with the amplification factor x1. By pressing the softkey [Ampl+] or [Ampl-], the amplification factor can be adjusted (x2, x1, x0.5, x0.25). If the amplification factor is changed, the preview starts again.
Note If no patient data is to be entered at the moment, the prompt for the patient data can be skipped with the softkey [OK]. The device automatically assumes a male patient, aged 35, for ECG interpretation.
Note If the patient data have already been entered by means of the insurance card reader (option), only the patient's sex has to be entered manually to perform ECG measurement and ECG interpretation.
Caution
Patient and insuree have to be one person, otherwise the results of the ECG analysis can be misinterpreted.
Note ECG measurement and ECG interpretation requires approx. 2-3 seconds.
Note The person responsible for the device (user OPERATOR) can configure, whether an alarm/message should inform the user of findings like "Abnormal ECG", "STEMI" or "NSTEMI" already during the ECG analysis.
Note If the corpuls3 is connected with a fax server or with corpuls.web LIVE, the D-ECG is simultaneously printed and sent when the softkey [Print] is pressed (see chapter 9.2 Configuration of Telemetry Services (Persons Responsible for the Device), page 214).
Note Via the mission browser (see chapter 8.5.2 Mission Browser, page 205), a diagnostic ECG from an old mission can be sent or printed later on.
ENG - Version 4.0 P/N 04130.2
121
Operation Monitoring and Diagnosis
User Manual corpuls3
Fig. 6-12 Printout of 12-lead ECG (illustration may differ)
Note The D-ECG printout contains the trend values of the last minute at the time the softkey [Print] is pressed. For this reason the D-ECG recorded may originate from an earlier time.
Printer settings for D- The format and the duration of the D-ECG printout can be configured with the softkey [Config.]. For ECG further information on printout configuration see chapter 7.1.3 Printer settings, page 160.
Note Every printed D-ECG is documented as an event in the log.
122
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
Fig. 6-13 D-ECG printout of the representative cycle with HES® Light (illustration may differ)
ENG - Version 4.0 P/N 04130.2
123
Operation Monitoring and Diagnosis
User Manual corpuls3
Fig. 6-14 D-ECG printout with ECG analysis and ECG interpretation HES® (option) (illustration may differ)
124
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
Coded Explanation In case no therapy suggestion can be made for certain reasons, HES® provides a coded explanation. See the following list for relevant codes:
Type Localisation of complexes
QRS Typing Wave recognition
Table 6-2
Code Explanation
100 More than 30 QRS complexes found. 110 Too few QRS complexes found. 120 Too much line frequency noise (50 Hz). 300 Too few QRS complexes for QRS typing. 602 The ECG contains only QRS complexes that have been triggered by the
pacer. No measurement or diagnostics possible. 604 The intrinsic QRS complexes are rejected for averaging by the program. No
measurement or diagnostics possible. 615 Too much line frequency noise (50 Hz). 620 Extreme line frequency noise (50 Hz). Coded Explanations by HES®
6.4.4 Representative Cycle
To support the physician with the diagnosis, the corpuls3 compiles a representative cycle on the basis of the diagnostic ECG. The representative cycle offers a visualisation of the "typical" ECG complex and represents the basis for ECG measurement and interpretation for HES® Light and HES®. For this, the recorded ECG complexes are analysed with regard to their morphology.
ECG complexes with a similar dominant morphology are averaged mathematically and then represented visually.
If individual ECG complexes differ from the morphology of others, these are marked (see Table 6-3) and not included into the representative cycle. The intervals between the R-peaks (R-R interval) are denoted by a dash "-".
Designation + -
2, 3, 4 X, U
! P T O B R
V
Table 6-3
Explanation Dominant ECG complex included for averaging. Schematical distance between two ECG complexes. Extrasystole, type 2, 3 or 4. Excluded due to technical problems, e. g. malfunction, unidentified aberrant form. Pacer pulse detected (Spike). Excluded due to deviating P-contours. Excluded due to deviating T-contours. Excluded due to deviating P- and T-contours. Excluded due to base line fluctuations. Excluded due to a too small/large distance to earlier or following cycle. Measurement error possible! Excluded due to ECG complex being located too much outside of the examined interval (P- or T-wave partially missing). Criteria of the representative cycle
Typing diagram Conclusions about the rhythm of a recording of just 10 s length require an analysis of every available ECG complex and every previous or following R-R-interval.
ENG - Version 4.0 P/N 04130.2
125
Operation Monitoring and Diagnosis
User Manual corpuls3
For the plausibility check of the conclusions about the rhythm and as an aid for the quality check, the ECG measurement/interpretation program HES® issues a rhythm- and typing diagram that represents the cycle sequence of the ECG complexes in an abbreviated form (see page 123, Fig. 6-13, item 1). Each ECG complex is represented by a symbol. The distance between the symbols represents - on a greater raster - the R-R-interval.
Example 1: +--+--+--+--+--+--+--+--+--+ Fig. 6-15 Rhythm- and typing diagram for a regular sinus rhythm
This representation means that 9 ECG complexes of the same morphology have been found in the recorded ECG and have been averaged for a "Representative cycle". The distance between the ECG complexes was roughly the same (regular distance -).
Example 2: +--+-2---+--+-2---+-P---+--+ Fig. 6-16 Rhythm- and typing diagram for a sinus rhythm with two compensated ventricular and one
compensated supraventricular extrasystole
In this representation 10 ECG complexes have been found. The complexes 1, 2, 4, 5, 7, 9 and 10 represent the main type, from which the "Representative cycle" for diagnosis has been averaged.
The ECG complexes number three and six ("2") deviate from the main type in their QRS morphology and have a shortened distance to the previous complex and a prolonged R-R-interval to the following normal complex (+). This fact indicates two monomorphous ventricular extrasystoles and the text message should contain corresponding advice.
Complex number eight ("P") has a shortened distance to the previous complex (+) and a prolonged distance to the following normal complex (+).
"P" means that only the P-wave, but not the QRS-T of the respective ECG complex deviates from the normal cycle. In conjunction with the prematurity and subsequent prolongation of the R-R-interval, one concludes an atrial extrasystole and expects corresponding advice in the text message.
Note In general, a visual check of the rhythm- and typing diagram as well as a check of the fiducials should be integral part of the quality check of the computerised ECG evaluation.
Note For further information, the HES® ECG manual is available in German and English. The manual can be obtained from your authorised sales and servicepartners.
Warning
Every ECG printout must be checked by a doctor and only becomes medical evidence with the signature of the doctor.
126
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
6.5 Longterm ECG
6.5.1 Information on Longterm ECG
Views of the longterm ECG
Cascade
With the longterm ECG function of the corpuls3, the user is able to monitor the ECG lead II (or DE) over the whole course of the mission, either during the mission or afterwards. This allows an evaluation of the quantity of cardiac dysrhythmias or the detection and printout of infrequent dysrhythmias.
There are two views for the longterm ECG:
· View with monitoring function of the current mission or
· View in the longterm ECG browser. Both views have a curve area showing lead IIauto or DEauto as a cascade over four curve fields. The area above the cascade shows the time specification of the point in time currently selected, the zoom specification in mm/s and the timeline.
The longterm ECG with monitoring function displays a horizontal parameter area and one curve field of the current patient monitoring. The parameter area shows as a default HR, SpO2, PR, NIBP and CO2, the curve field lead II. These settings can be configured via the respective context menu.
In the longterm ECG browser that can be opened via the mission browser (see chapter 8.5.2 Mission Browser, page 205), longterm ECGs from already finished missions can be opened and printed out. The area above the longterm ECG shows the mission data, patient data and total length of the selected mission.
The time specification refers to the beginning of the cascade. The yellow bar on the timeline can be moved with the jog dial. The required resolution of the longterm ECG can be selected via the zoom function.
6.5.2 Preparing Longterm ECG
Prerequisite for the longterm ECG is a 4-pole ECG monitoring cable connected to the patient (see chapter 6.3.4 Performing ECG Monitoring, page 112). If no 4-pole ECG monitoring cable is present, the DE-lead (if connected) will be recorded. If both lead II and lead DE are present, only lead DE is recorded. The switch between IIauto and DEauto only occurs when a valid ECG signal is present and not when the cable is connected. Lead DE is displayed preferentially.
ENG - Version 4.0 P/N 04130.2
127
Operation Monitoring and Diagnosis
User Manual corpuls3
6.5.3 Performing Longterm ECG
Monitor
1. Press the Monitor key. 2. Press the softkey [LT-ECG]. The longterm ECG with monitoring function is displayed.
Fig. 6-17 Longterm ECG with monitoring function
3. Softkey [LT-ECG] is active (highlighted). 4. Select the required point in time on the timeline with the jog dial. 5. Select the required resolution of the longterm ECG with the softkeys [Zoom+] or [Zoom-]. 6. Press the softkey [Print] to print out the longterm ECG displayed. 7. Pressing the softkey [LT-ECG] again deactivates the softkey and the parameter fields or the curve
field can be selected with the jog dial and configured via the context menus. 8. Press the softkey [Close] to leave the view of the longterm ECG.
Note On the printout of the longterm ECG, the individual designations of the IBP curves are not printed.
128
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
6.6 Oximetry Monitoring (Option)
6.6.1 Information on Oximetry Monitoring
Oximetry is a non-invasive monitoring method for continuous measurement of the arterial oxygen saturation (SpO2), in the blood. The specific reduction in the absorbance of oxygenated and deoxygenated haemoglobin is measured with light of different wavelengths by means of a photo sensor. Comparison of the values yields the SpO2 values as percentage. Additionally, the oximetry measures the peripheral pulse rate (PR) per minute and the perfusion index (PI) in percentage.
Note The vital parameters SpMet, SpCO and SpHb of the oximetry option are only available for corpuls3 devices that are equipped with Masimo Rainbow SET® Technology (see chapter 6.6.2 Extended Oximetry Monitoring, page 130).
To increase patient safety and to be able to guarantee measurement accuracy, Masimo sensors and intermediate cables were equipped with X-CAL technology. The corpuls3 supports this function and issues alarms of different priorities to indicate that the sensor will expire soon (low priority) or that the sensor is expired (medium priority).
Two parameter fields for display of the numerical measurement values can be configured. The oximetry plethysmogram (pleth) can be displayed in a curve field.
The signal intensity is a quality criterion for the capturing of measurement values. The signal intensity is measured and displayed as a horizontal bar in the parameter field SpO2 (see page 132 Fig. 6-20, item 1).
Warning
The alarm limits must be verified every time the oximeter is used to ensure that these are appropriate for the patient currently being monitored.
Note If necessary, adapt individual alarm limits manually.
Note If for SpO2 the alarm has been disabled or the lower alarm limit has been changed and then the parameter field is no longer displayed, the alarm will automatically be re-enabled and the alarm limit set to the default value.
Warning
If the accuracy of the oximetry measurement does not seem plausible (e. g. due to influences of movement, bright sunlight, Xenon OP lamps or due to photodynamic therapy with bilirubin lamps) check first of all whether there is any acute change in the patient's vital signs. Subsequently check whether the pulse oximeter works correctly. Refer to the list of approved accessories (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249) for a ambient shield ensuring interference-free measurement.
Warning Caution
The oximeter may not be operated in the vicinity of ionising (radioactive) radiation, as this may falsify the readings.
Refer to the list of approved accessories (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249) for approved sensors from the company Masimo. Sensors from other manufacturers are not supported by the device and are not permissible.
ENG - Version 4.0 P/N 04130.2
129
Operation Monitoring and Diagnosis
User Manual corpuls3
Note The license agreement allows an extension of the available oximetry measuring options which can be activated by a service technician.
Note Masimo SET oximetry sensors can only be used in combination with an adapter cable (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249).
Note A low confidence of the measured value is indicated by a question mark instead of the alarm symbol in the upper right corner of the parameter field.
Note After connecting the oximetry sensor the oximeter calibrates automatically. This procedure may take up to 120 seconds for the oximetry measurement, during which an hourglass symbol is displayed in the upper right corner of the parameter field.
Note See the manufacturer's operating manual for further information. These manuals must be read carefully before use.
Note For additional information on operating the sensor see Appendix G Safety Information, page 332. Note The oximeter is covered under one or more of the following U.S.A. patents: 5,758,644, 6,011,986,
6,699,194, 7,215,986, 7,254,433, 7,530,955. Other applicable patents are listed at: www.masimo.com/patents.htm No implied license Purchase or possession of this Masimo SET® Oximeter confers no express or implied licence to use the device with any non-approved sensors or cables that would fall, alone or in combination with this device, under any patent in reference to this device.
6.6.2 Extended Oximetry Monitoring
Extended oximetry monitoring options (available only with Masimo Rainbow SET® Technology) include measurement of the methemoglobin level (SpMet) and, depending on the used oximetry sensor, the level of carboxyhemogolobin (SpCO) or the level of total hemoglobin (SpHb) in the blood. Comparison of the values of oxygenated and deoxygenated hemoglobin yields the respective SpO2-, SpCO- and SpMet values as percentage and, depending on the configuration of the oximetry sensor, the SpHb value in g/dl or mmol/l.
Warning
Increased SpHb value: SpHb values above normal tend to increase the level of SpO2. The level of increase corresponds approximately to the amount of SpHb that is present.
Warning
Increased SpMet value: The SpO2 value may be decreased by levels of SpMet of up to approximately 10% to 15%. At higher levels of SpMet the levels of SpO2 may tend to read in the low to mid 80s. When elevated levels of SpMet are suspected, a blood sample should be analysed (CO-Oximetry).
Note Simultaneous measurement of SpCO and SpHb is not possible, due to different sensor types (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249).
Note It is recommended to connect SpHb sensors to the corpuls3 only if needed, to avoid premature expiration of the sensor.
Note For additional information on operating the sensor see Appendix G Safety Information, page 332.
130
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
Warning Warning Warning
6.6.3 Preparing Oximetry Monitoring
Handling of a oximetry finger sensor is described below.
Read and understand the warning notices of the oximetry sensor manufacturer (see Appendix G Safety Information, page 332).
Wrong measurement results Avoid to place the oximetry sensor on the same extremity as an NIBP cuff for non-invasive blood pressure monitoring, a catheter or an intravascular access.
Skin damage With temperatures of more than 41°C one has to take care that the sensor is applied without excessive pressure, especially in patients with sensitive skin.
1. Connect the oximetry sensor to the intermediate cable and to the patient box.
3
2
1
Fig. 6-18 Connecting the oximetry sensor on to the intermediate cable (Illustration may differ) 2. Attach the oximetry sensor to a finger/toe according to the manufacturer's instructions.
Caution
Fig. 6-19 Oximetry monitoring, attaching the oximetry sensor The maximum application time of an oximetry sensor at one measurement site is 4 hours.
ENG - Version 4.0 P/N 04130.2
131
Operation Monitoring and Diagnosis
User Manual corpuls3
6.6.4 Performing Oximetry Measurement
Oximetry measurement begins automatically after the sensor has been attached.
1. If necessary, select the curve field for displaying course of SpO2 measurement (pleth) and open the curve context menu.
2. Assign the plethysmogram to the selected curve field. 3. If necessary, select the parameter field for displaying oximetry values and open the parameter
context menu. 4. Assign SpO2 monitoring to the selected parameter field.
Fig. 6-20
Oximetry monitoring, configured screen (illustration may differ)
1 Bar for display of the signal intensity 2 Current SpO2 value in percent 3 Hourglass symbol 4 Lower alarm limit 5 Symbol for switched-on alarms 6 Pleth curve (plethysmogram) 7 Current SpMet value in percent 8 Current SpHb value in g/dl
5. Check if the wave form of the pleth curve is displayed without artefacts.
6. If artefacts or a low signal intensity are displayed, correct the position of the oximetry sensor on the finger. See chapter 11 Procedure in Case of Malfunctions, page 250 for information on improving the signal.
7. If necessary, select in the main menu "Oximetry" "Settings" and adjust further oximetry configurations (available only with Masimo Rainbow SET® Technology).
132
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
Printing the The pleth curve can be printed out with the integrated printer. For further information on printout plethysmogram configuration see chapter 7.1.3 Printer settings, page 160.
To start or stop real-time printing press the Print key.
Fig. 6-21 Pleth monitoring, section of a printout
Averaging Time
FastSat® Sensitivity
Stability of measured SpO2 values is in general an indicator for good signal quality. The stability of the measured values is influenced by the averaging mode used. The longer the averaging time, the more stable the readings will be. This is due to a dampened response as the signal is averaged over a longer period of time than this would be the case with shorter averaging times. Longer averaging times delay the response of the oximeter and reduce the measured variations of SpO2 and pulse rate.
The FastSat® mode tracks rapid changes in arterial SpO2 saturation with high fidelity. This allows for even more accurate and safe patient monitoring during the intubation phase. The mode FastSat® can be enabled via the parameter context menu.
The sensitivity of the oximeter can be adjusted to the needs of the particular patient monitoring situation in three levels (called modes in the following). The following modes are available:
· Mode "Normal": This is the recommended sensitivity for typical monitoring situations in which patients are monitored continuously, as e. g. intensive care units.
· Mode "Adaptive Probe Off Detection (APOD)": This is the recommended sensitivity for situations where there is a high probability of the sensor becoming detached from the patient. It is also the suggested mode for care areas where patients are not visually monitored continuously. APOD offers a safe and fast detection of erroneous pulse rate and arterial oxygen saturation readings when a sensor becomes inadvertently detached from a patient due to excessive movement.
· Mode "Maximum Sensitivity (MAX)": This level of sensitivity is recommended for patients with low perfusion in general or when the low perfusion message is displayed on the screen in APOD or normal sensitivity mode. This mode is only recommended for care areas where patients are continuously monitored visually. When a sensor becomes detached from a patient, it will have compromised protection against erroneous pulse rate and arterial saturation readings.
Warning
When using the maximum sensitivity mode (MAX), the sensor-off-detection may be compromised. If the device is in this mode and the sensor becomes detached from the patient, false readings may occur due to environmental noise such as light, vibration and excessive air movement.
ENG - Version 4.0 P/N 04130.2
133
Operation Monitoring and Diagnosis
User Manual corpuls3
6.6.5 Adjusting the Representation of the Oximetry Parameters
Changing the sweep The sweep speed of the display on the screen can be selected for the pleth curve. speed The following sweep speeds can be configured: · 12.5 mm/s · 25 mm/s · 50 mm/s
1. Select the pleth curve and open the curve context menu. 2. Select the required sweep speed in the curve context menu and confirm.
Once the selection has been made, the program leaves the curve context menu automatically.
6.6.6 Monitoring Pulse Rate and Perfusion Index
During oximetry monitoring, the pulse rate (PR) and the perfusion index (PI) are also evaluated and displayed on the screen. The perfusion index is calculated as the relation of arterial pulsatile signal to the non-pulsatile signal component. It serves to check the plausibility of the SpO2 value and is indicated in 0.02% to 20%. The alarm limits of the pulse rate are configurable (see chapter 7.3.3 Setting Alarm Limits for Monitoring Functions Manually, page 173).
Note If necessary, adapt individual alarm limits manually.
1. If necessary, select the parameter field for display of the pulse rate or the perfusion index and open the parameter context menu.
2. Assign the pulse rate or the perfusion index to the selected parameter field.
Fig. 6-22
Pulse rate parameter field
1 Current pulse rate in 1/min 2 Symbol for switched-on alarms 3 Upper alarm limit 4 Lower alarm limit
134
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
Warning Warning Warning
6.7 CO2 Monitoring (option)
6.7.1 Information on CO2 Monitoring
CO2 monitoring allows recording of the end-expiratory, end-tidal CO2 concentration (EtCO2) and provides information on ventilation, haemodynamics and metabolism in both intubated and non-intubated patients. The semi-quantitative measurement method uses infrared technology and is based on the assumption that there is no CO2 present in the patient's inspiratory respiratory gas. Due to a condensation-repellent special coating in the disposable adapter, the capONE measurement system from the manufacturer NIHON KOHDEN does not require a warm-up phase and is therefore ready for measurement in 5 seconds maximum. The capnometer, which operates according to the mainstream method, measures the CO2 concentration in the patient's expiratory breath in real time. The CO2 concentration, measured in mmHg or kPa, can be displayed on the screen as a capnogram in a curve field. The corpuls3 allows use of capnometry in intubated and non-intubated patients. The patient's respiration rate (RR) is measured as a further parameter.
Falsified readings By putting mechanical stress on the sensor or the sensor cable, the CO2 readings can be falsified. Do not bend or pull at the sensor or sensor cable, or subject to similar mechanical stress.
Do not perform CO2 monitoring near high frequency surgical devices. This may result in signal loss so that the patient can no longer be monitored.
The capnometer in corpuls3 is an additional function for intensive monitoring. Other vital parameters and clinical symptoms must be minded when using the capnometer on the patient.
Warning Warning
To guarantee safe use and to prevent cross infections, disposable articles are to be used only once.
Risk of asphyxiation The nasal/-oral adapter shall only be used on patients tolerating the adapter. The oral breath collector may come loose under extreme conditions and could be aspirated. The oral breath collector is radiolucent.
Warning
False readings
Do not use CO2 monitoring in connection with re-inhalation anaesthesia systems. Re-inhaled carbon dioxide can lead to false low readings.
Caution
For capnographic monitoring of patients under 3 years of age or with a body weight of 10 kg, the disposable adapter for CO2 endotracheal tube incl. insert for neonates has to be used (see chapter 6.7.3 Disposable Adapter for CO2 Endotracheal Tube incl. Insert for Neonates, page 138).
ENG - Version 4.0 P/N 04130.2
135
Operation Monitoring and Diagnosis
User Manual corpuls3
Note See the manufacturer's operating manual for further information.
No implied license Purchase or possession of this device confers no express or implied licence to use the device with any non-approved sensors or cables that would fall, alone or in combination with this device, under any patent in reference to this device.
Note Sensors and accessories by Nihon Kohden are covered under one or more of the following U.S.A. patents: 6,258,040; 7,462,154; 7,455,644; 7,445,602; 7,455,644; 7,445,602; 8,430,095; 8,636,956; 9,486,598; 9,655,543; 9,775,541.
Sensors and accessories by Nihon Kohden are covered under one or more of the following European patents: 2,196,236; 2,236,079.
Caution
Only use sensors and adapters indicated in the list of approved accessories (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249).
6.7.2 Preparing CO2 Monitoring
1. Attach the appropriate disposable adapter to the capONE sensor (item 3). Fig. 6-23 shows the three nasal adapters, Fig. 6-24 the endotracheal tube adapter.
Fig. 6-23
CO2 monitoring, nasal adapter
1 CO2 disposable nasal adapter (YG-120T) 2 CO2 disposable nasal/oral adapter (YG121-T) 3 capONE sensor 4 CO2 disposable nasal/oral adapter,
adaptable to an O2 cannula (YG-122T)
136
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
Fig. 6-24
CO2 monitoring, disposable endotracheal tube adapter
1 Respirator/ventilation bag connection 2 CO2 sensor connection 3 Endotracheal tube connection (YG-111T)
2. Attach the CO2 sensor to the patient according to the manufacturer's instructions:
· Position the sensor cable behind the ears (Fig. 6-25, item 1) and slide the fastening ring (Fig. 6-25, item 2) loosely towards the chin.
· Attach the disposable adapter to the nose with the adhesive tape provided for this purpose (Fig. 6-25, item 3).
· The oral breath collector (Fig. 6-25, item 4) must not be more than 10 mm away from the lower lip.
3
3
1
Warning
4
2
2
Fig. 6-25
Fitting the disposable CO2 nasal(/oral) adapter on the patient
1 Cable positioning 2 Fastening ring 3 Adhesive tape 4 Oral breath collector
The CO2 sensor and the patient box or CO2 sensor and intermediate cable must not be connected or disconnected during operation.
ENG - Version 4.0 P/N 04130.2
137
Operation Monitoring and Diagnosis
User Manual corpuls3
6.7.3 Disposable Adapter for CO2 Endotracheal Tube incl. Insert for Neonates
Intended Use
The disposable adapter for CO2 endotracheal tube incl. Insert for neonates (P/N 04234.12) is intended for capnographic monitoring of the respiration in neonates and small children with a body weight of less than 12 kg. The adapter consists of two components: Disposable adapter for CO2 endotracheal tube, main stream, capONE (P/N 04234.119) and an insert for neonates. By using the adapter in the system as a whole (adapter, mechanical ventilation aid, endotracheal tube), the total dead space volume is reduced by approx. 1 ml.
For information on the use, consult the instructions for use by Nihon Kohden as well as the user manual of the disposable adapter for CO2 endotracheal tube incl. Insert for neonates (P/N 04230.10).
Note The disposable adapter for CO2 endotracheal tube incl. Insert for neonates is a medical product that may only be used by medical personnel trained regularly on the product.
Note The disposable adapter for CO2 endotracheal tube incl. Insert for neonates is not intended for use in combination with ventilators.
Warning
Malfunction due to contamination/damage!
In case of contamination/damage of/to the adapter with blood, bronchial secretion or similar or contamination/damage of the transparent measuring window (item 2) and in combination with the disposable adapter for CO2 endotracheal tube incl. Insert for neonates, the sensor may supply wrong readings.
The disposable adapter for CO2 endotracheal tube incl. Insert for neonates has to be exchanged or removed immediately, to guarantee continued ventilation by connecting the endotracheal tube with the ventilation aid.
Warning
Limited functionality/Risk of infection!
The disposable adapter for CO2 endotracheal tube incl. Insert for neonates is an unsterile disposable article. To guarantee safe use and unlimited functionality and to prevent cross infections, the article must only be used once.
Caution
Restrictions of Use The disposable adapter for CO2 endotracheal tube incl. Insert for neonates may only be used if:
· it is in perfect condition; · it is used as intended (see Purpose of Device): · it is used exclusively with non-active ventilation aids; · the instructions in the IFU by Nihon Kohden as well as in the user manual for the disposable
adapter for CO2 endotracheal tube incl. Insert for neonates (P/N 04230.10) are taken into account.
138
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
6.7.4 Performing CO2 Measurement
Measurement begins automatically after the sensor has been attached. 1. Select the curve field for display of CO2 trend and open the curve context menu. 2. Assign CO2 monitoring to the selected curve field (capnogram). 3. Select the parameter field for display of the end-expiratory CO2 concentration and open the
parameter context menu. 4. Assign CO2 monitoring to the selected parameter field.
Fig. 6-26
CO2 monitoring, configured screen
1 Current end-expiratory CO2 concentration in mmHg 2 Symbol for switched-on alarms 3 Upper alarm limit 4 Lower alarm limit 5 CO2 curve (capnogram)
Note If necessary, adapt individual alarm limits manually.
Note If the curves appear to be cut off at the top, check the scaling and set to an appropriate option (see chapter 7.2.3 , page 169).
Printing the capnogram The CO2 curve can be printed out with the integrated printer. For further information on printout configuration see chapter 7.1.3 Printer settings, page 160.
ENG - Version 4.0 P/N 04130.2
139
Operation Monitoring and Diagnosis To start or stop real-time printing press the Print key.
User Manual corpuls3
Fig. 6-27 CO2 monitoring, section of a printout
Note The CO2 nasal(/oral) disposable adapter may be used no longer than 24 hours. Note After monitoring is finished, fixate the CO2 sensor in the holder.
6.7.5 Adjusting the Representation of the CO2 Values
Changing the sweep speed
The sweep speed of the display on the screen can be selected for the configured curves. The following sweep speeds can be configured:
· 3.13 mm/s · 6.25 mm/s · 12.5 mm/s · 25 mm/s
1. Select the CO2 curve and open the curve context menu.
2. Select the required sweep speed in the curve context menu and confirm. Once the selection has been made, the program leaves the curve context menu automatically.
Changing the scale
If the curves appear to be cut off at the top, check the scaling and set to an appropriate option.
1. Select the CO2 curve and open the curve context menu or 2. Select the CO2 parameter field and the parameter context menu. 3. Select the required scale in the context menu and confirm. Once the selection has been made, the
program leaves the context menu automatically.
Changing the unit
CO2 values can be displayed either in the measuring unit mmHg or in kPa.
1. Select the CO2 curve and open the curve context menu or 2. Select the CO2 parameter field and the parameter context menu. 3. Select the required measuring unit in the context menu and confirm. Once the selection has been
made, the program leaves the context menu automatically.
140
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
6.7.6 Monitoring Respiratory Rate
With CO2 monitoring, respiration rate (RR) is also assessed and can be displayed on the screen. 1. Select the parameter field for display of respiration rate (RR) and open the parameter context
menu. 2. Assign respiration rate to the selected parameter field.
Fig. 6-28
Respiratory rate parameter field
1 Current respiration rate in 1/min 2 Symbol for switched-on alarms 3 Upper alarm limit 4 Lower alarm limit
Note If necessary, adapt individual alarm limits manually.
6.8 Non-invasive Blood Pressure Monitoring (option) 6.8.1 Information on NIBP Monitoring
The NIBP technology integrated in corpuls3 is an OEM module from Sun Tech Medical Inc., Morrisville, NC, USA. Further information: www.suntechmed.com.
Non-invasive blood pressure monitoring (NIBP) is used for routine monitoring of the blood pressure on an extremity. The pressure of a pulse wave in the blood is measured with the oscillometry method.
The systolic, diastolic and mean blood pressure values are recorded as measured values and displayed on the screen as a numerical value in mmHg. By configuring automatic intervals, continuous automatic monitoring is possible. A selection of predetermined settings (initial pressure) for adults, children and neonates is available.
The blood pressure monitoring system consists of the blood pressure cuff and the connecting hose which connects the cuff to the interface at the patient box.
The measurements can either be performed as individual measurements or automatically at configurable intervals (1 to 60 minutes).
Operating place1.
The position of the user during operation is near the patient and the device.
The corpuls3 can indicate the results of non-invasive blood pressure measurement and the current settings on a separate user interface. This enables rapid access to the most important functions via softkeys during use. Moreover, the value last measured is shown in a configurable parameter field.
ENG - Version 4.0 P/N 04130.2
141
Operation Monitoring and Diagnosis
User Manual corpuls3
One can choose between two views:
· Large view (Fig. 6-29) · Trend view (Fig. 6-30) The large view shows the last value measured in large numbers. To obtain a list of the last five measurements, it is possible to change to the trend view. Both views always indicate the time of measurement and a quality indicator.
NIBP quality indicator
The quality indicator consists of 3 star symbols which indicate good measurement quality when filled, poor quality when displayed as an outline. The quality indicator is displayed on the NIBP user interface, in the parameter fields "NIBP" and "NIBP sys", in the trend browser and on printouts of NIBP values. The quality indicator is transferred together with the NIBP values via telemetry and Bluetooth and can be displayed in corpuls.web LIVE and corpuls.manager REVIEW.
Note For paediatric and adult patient populations, blood pressure measurements made with this device are equivalent to those obtained by trained observers using the cuff/stethoscope auscultatory method within the limits prescribed by ANSI/AAMI SP10:2002(R)2008 (mean error difference of ± 5 mmHg or less, standard deviation of 8 mmHg or less) as well as EN1060-4:2004 and ISO 81060-2:2009.
Warning
Measuring errors due to interferences
The device is designed to function in the presence of a normal ECG sinus rhythm. With some heart dysfunctions (e.g. branch bundle block, arrhythmias, atrial fibrillation, ventricular fibrillation, premature atrial- or ventricular contraction, arteriosclerosis, presence of a pacer) as well as in case of poor perfusion, pregnancy (pre-eclampsia, pregnancy hypertension), diabetes, kidney diseases, advanced age of the patient or movement of the patient (shaking, the chills etc.) the non invasive blood pressure module may not be able to get correct measurement values.
Take into account interferences when assessing the measurement, if necessary, measure manually.
Warning
Delayed effect of emergency drugs If the blood pressure cuff is placed on an extremity into which an intravascular access has already been inserted, this may affect the administration of drugs. In this case, the blood pressure cuff should be used on another extremity, if possible.
Warning
Impairment of intravascular therapy or -monitoring If the blood pressure cuff is placed on an extremity into which an intravascular access or another monitoring sensor has already been inserted, this can impair their function. In this case, the blood pressure cuff should be used on another extremity, if possible.
Caution
Measuring errors due to interferences
The measuring site, the position of the patient (standing, sitting or laying down), exertion and the physical condition of the patient (stress, urge to urinate, ingestion of coffee or nicotine) can influence the measurement.
The middle of the cuff should be at the level of the heart. During the measurement, the patient should sit or lie calmly and relaxed, back and arm supported, legs not crossed, feet flat on the floor. The patient should not talk or tense the arm musculature. Ideally, the patient can spend 5 min in calm before the measurement.
Take into account interferences when assessing the measurement, if necessary, measure manually.
142
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
Caution Caution Caution Caution
Measuring errors due to interferences Microwave radiation in the immediate vicinity may interfere with the function of the device. Eliminate interferences, if possible. Take into account interferences when assessing the measurement, if necessary, measure manually.
Measuring errors due to interferences Interferences influencing the blood pressure cuff (sensor) or other components can lead to erroneous measurements. Such interferences can be caused by strong acoustic pressure, or e.g. by extreme vibrations during patient transport. Take into account interferences when assessing the measurement, if necessary, measure manually.
With temperatures outside the specified limits, the measurements may not be reliable (see Table A-10, page 309).
Only use NIBP cuffs mentioned in the list of approved accessories (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249).
To open the NIBP user interface, press the softkey [NIBP] in monitoring mode. By default, the NIBP user interface starts in the large view:
Fig. 6-29 NIBP user interface in large view
ENG - Version 4.0 P/N 04130.2
143
Operation Monitoring and Diagnosis Press the softkey [View] to switch to the trend view.
User Manual corpuls3
Fig. 6-30 NIBP user interface in trend view
Three operating modes can be set with the softkey [Mode]:
· Adult · Child · Neonate
Depending on the operating mode the initial pressure of the measurements is pre-set on the device:
· adult: · child: · neonate:
180 mmHg 120 mmHg 90 mmHg
The initial pressure automatically adapts to the patient after the first measurement. This can be changed manually with the softkey [Initial] and with the jog-dial within the following pressure range (see also chapter 7.4.13 Configuration of Non-Invasive Blood Pressure Measurement (NIBP) (Persons Responsible for the Device), page 196):
· adult: · child: · neonate:
120 - 280 mmHg 80 - 170 mmHg 60 - 140 mmHg
NIBP quality indicator
The selected pressure limit is marked with an arrow on the pressure scale. The pressure scale always shows the current pressure in the NIBP cuff.
The quality of the performed measurement is indicated by up to 3 star symbols in the NIBP user interface.
144
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
Caution
Measurement error due to noisy ECG signal In the following situations, the functionality of the quality indicator can be impaired: · Noise in the ECG signal (interference) · Some types of arrhythmias (irregular ECG signal) · Cuff on leg (pulse delay tolerance) · Measurement in children (pulse delay tolerance) If the quality indicator shows no or just 1 star symbol, check the fit and position of the cuff or the positioning of the arm and correct, if necessary. If necessary, the user can disable the RMT function in the NIBP settings.
SunTech R-wave Motion Tolerance (RMT)-Technology uses the monitoring ECG signal to qualify the validity of oscillometric pulses for an enhanced level of motion tolerance on patients in transport situations.
6.8.2 Preparing Blood Pressure Monitoring
NIBP monitoring on the upper arm is described below: 1. Select the NIBP cuff which is appropriate for the patient's arm girth. 2. Connect the NIBP cuff to the connecting hose, if necessary. 3. Tightly fit the deflated NIBP cuff around the patient's exposed upper arm so that it firmly
surrounds the arm. The NIBP cuff should not exert any pressure on the blood vessels. The NIBP cuff must not fit too loosely. The lower edge of the NIBP cuff should be positioned approx. 2 cm above the crook of the arm.
Caution
Fig. 6-31 NIBP monitoring, attaching the NIBP cuff
Poor perfusion in neonates due to inappropriate patient mode If an inappropriate patient mode with to high cuff pressure is used on neonates, this can lead to poor perfusion. When using NIBP cuffs for neonates, select the patient mode "Neonate".
ENG - Version 4.0 P/N 04130.2
145
Operation Monitoring and Diagnosis
User Manual corpuls3
Caution Caution Caution Caution Caution
Poor perfusion due to wrong handling A too high cuff pressure due to a bent hose or too frequent measurements can lead to poor perfusion in patients. Make sure by observation that the blood circulation is not impaired in the patient.
Injury due to wrong handling Do not apply the cuff over a wound or at the arm on the side where a mastectomy has been performed.
Measurement error due to wrong handling The INDEX-arrow printed on the NIBP cuff must fit within the designated area (RANGE), also printed on the NIBP cuff. If this is not possible, a larger or smaller NIBP cuff has to be used.
Measurement error due to wrong handling When performing the measurement, make sure that the NIBP cuff is on the level of the heart. The marking "ARTERY" printed on the inside of the cuff has to be aligned centrally and with the arrow pointing down to the arteria brachialis. The distance between the elbow joint and the NIBP cuff has to be 2 cm.
Measurement error due to wrong handling Avoid squeezing, bending or reducing the diameter of the pressure hose connected to the NIBP cuff.
6.8.3 Performing Individual Blood Pressure Measurement
Caution
Measurement error due to wrong initial pressure
Before starting the NIBP measurement, make sure that the selected initial pressure is appropriate for the patient.
Adjust the initial pressure of the monitoring at approx. 30 mmHg above the expected systolic value or use the default settings.
1. In monitoring mode press the softkey [NIBP]. 2. Press the softkey [Mode] repeatedly until the required mode "Adult", "Child" or "Neonate" appears. 3. To start an individual measurement, press the softkey [Start]. 4. The NIBP cuff is inflated and measurement is performed automatically. 5. A measurement in progress can be interrupted with the softkey [Stop].
Note Immediately after the measurement the softkeys are greyed out. Another measurement is possible only after 5 seconds.
146
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
To additionally display the measured value in a parameter field exit the NIBP user interface with the softkey [Close].
1. Select a parameter field for display of the non-invasive blood pressure and open the parameter context menu.
2. Assign NIBP monitoring to the selected parameter field. 3. Alternatively, individual parameter fields can be configured to display the systolic (NIBP sys),
diastolic (NIBP dia) and the mean arterial (NIBP MAP) pressure values.
Fig. 6-32
NIBP monitoring parameter fields
1 Systolic value 2 Diastolic value 3 Symbol for switched-on alarms 4 NIBP quality indicator 5 Mean arterial pressure 6 Upper alarm limit 7 Lower alarm limit
Note If necessary, adapt individual alarm limits manually.
6.8.4 Performing Blood Pressure Interval Monitoring
Warning
Make sure that the blood circulation is not impaired in the extremity to which the NIBP cuff is attached.
Note If a time value for interval monitoring is configured and the checkbox "Enabled" is ticked, (see chapter 7.4.13 Configuration of Non-Invasive Blood Pressure Measurement (NIBP) (Persons Responsible for the Device), page 196), the automatic interval measurement begins immediately when the softkey [Start] is pressed.
To configure interval monitoring manually, proceed as follows:
1. In monitoring mode press the softkey [NIBP]. 2. Press the softkey [Mode] repeatedly until the required mode "Adult", "Child" or "Neonate" appears. 3. Press the softkey [Auto]. The softkey [Auto] remains selected. 4. Change the interval with the softkey [Interv.] or leave at default value. 5. To start an interval measurement press the softkey [Start].
ENG - Version 4.0 P/N 04130.2
147
Operation Monitoring and Diagnosis
User Manual corpuls3
While the first interval measurement is performed, the inscription above the softkey [Auto] shows four dashes. After that, a countdown above the softkey [Auto] shows the remaining time until the next interval measurement. This countdown is also displayed in the parameter field on the left below "NIBP". It is no longer necessary to call up the NIBP user interface to see if an interval measurement is active. Also, a clock symbol alternating with the alarm symbol in the upper right corner of the parameter field indicates that the interval measurement is active and that an automatic measurement is being prepared.
Fig. 6-33
NIBP parameter field with active interval measurement
1 Countdown for the interval measurement 2 Clock symbol
6. To quit the interval measurement, press the softkey [Auto]. A measurement in progress can be interrupted with the softkey [Stop].
If the NIBP measurement is interrupted, the inscription above the softkey [Auto] shows four dashes instead. The pressure in the NIBP cuff is then released immediately.
Note During the interval measurement it is possible to perform an individual measurement manually at any time between two automatic interval measurements by pressing the softkey [Start].
6.9 Invasive Blood Pressure Monitoring (IBP) (Option)
6.9.1 Information on IBP Monitoring
With the IBP function, various pressures can be measured within the context of intensive medical care. This includes, among others, arterial pressure, central venous pressure or intracranial pressure.
Two interfaces are available which can be assigned as single channels or as double channels, respectively. For usage as a double channel, an IBP-Y-adapter cable is needed. Consequently, up to four different invasive pressure measurements can be performed simultaneously. The recorded pressure values can be displayed on the screen either as numerical parameters and/or as a curve.
The following table gives an overview of the current assignment:
Connection
P1 P2 P3 P4
Assignment
Single pressure channel Double pressure channel
"P1"
"P1" and "P2"
"P3"
"P3" and "P4"
Table 6-4
IBP monitoring, pressure channel assignment
148
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
Special convertible adapters for transducer cables from established manufacturers are available for the corpuls3. The following transducers are approved for use with the adapter cables 04233.02 and 04233.04: B.Braun Combitrans, Becton Dickinson DTXPlus, Codan/pvb DPT-6000er/-8000er Series, Codan/pvb xtrans DPT-9000er Series, Edwards TruWave PX600er Series (only 1-fold), Smiths/Medex LogiCal.
Your sales representative can inform you which types of transducers can be connected. The list of accessories (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249) contains approved accessory equipment for IBP monitoring.
Caution
The corpuls3 may not be used simultaneously on two or more patients.
Note For further information see the operating instructions from the manufacturer of the transducer system.
Note The following description of invasive blood pressure monitoring only takes into account the operating steps pertaining to the corpuls3 and not the handling of the individual transducer systems. Read and follow the operating instructions and accompanying documents of the respective manufacturer.
Note When using the IBP cables, take care to provide strain relief by making a small loop. If the IBP cables are not used, disconnect them from the patient box and store in the accessory bag.
Note Disposable items of the transducer system must not be re-used under any circumstances. Read and follow the operating instructions and accompanying documents of the respective manufacturer.
6.9.2 Preparing Invasive Blood Pressure Monitoring
1. Connect the plug of the first transducer cable to the "P1 P2" socket at the patient box. 2. Connect the plug of the second transducer cable to the "P3 P4" socket at the patient box if one or
more invasive pressure measurements are to be taken. 3. Open the transducer system to balance the static and atmospheric pressure.
ENG - Version 4.0 P/N 04130.2
149
Operation Monitoring and Diagnosis
User Manual corpuls3
4. Perform zero calibration of the transducer cable: Select in the main menu "IBP" "Calib. P {measuring channel}" and confirm the calibration with the jog dial (for further information, see chapter 7.2.4 IBP, page 170).
Fig. 6-34 IBP calibration
5. Repeat steps 3 to 4 to calibrate further transducer cables. 6. If auto-scaling of the display of the pressure channel is not required, adjust the display range in
the main menu "IBP" "Settings" (for further information see chapter 7.2.4 IBP, page 170).
Note The message "NON CAL" in the parameter field and/or in the curve field indicates an uncalibrated measuring channel (P {measuring channel}). No alarm is triggered and no measuring channel trend is recorded.
Note Atmospheric pressure must be present on the transducer during calibration.
Note Calibration is completed after approx. 5 seconds. In case of an error, a technical alarm is triggered. In this case, sources of error are to be eliminated and the calibrating measures to be repeated, if necessary.
Note If no transducer is connected or if the transducer is loose, the technical alarm "IBP P[X] sensor loose" is triggered. The prerequisite in this case is that a transducer has already been connected and calibrated previously.
Note The shunt valve of transducer should be positioned approximately at the level of the right atrium (approximately in the area of the middle axillary line).
During cranial pressure measurement, the shunt valve should be aligned with the upper edge of the ear. Any deviation from the prescribed position may invalidate the values.
Note The hydraulic system of the transducer must be de-aerated before invasive pressure measurement is performed. Read and follow the operating instructions and accompanying documents of the respective manufacturer.
150
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
6.9.3 Performing Invasive Blood Pressure Monitoring
1. Invasive blood pressure monitoring starts automatically after application of the transducer(s). 2. Select the curve field for display of the pressure curves and assign the corresponding pressure
curve (P1-P4) via the curve context menu. 3. If necessary, select a parameter field for display of the invasive pressure measurements and
assign the corresponding P value (P1-P4) via the parameter context menu. 4. If required, assign a designation of the measuring site to the parameter- or curve field:
IBP: Invasive (Blood-) Pressure AP: Arterial blood pressure VP: Venous blood pressure ICP: Intracranial pressure
Note If necessary, adapt individual alarm limits manually.
Fig. 6-35
IBP monitoring, configured screen
1 Symbol for switched-on alarms 2 Current arterial pressure in mmHg 3 Current venous pressure in mmHg 4 Current systolic and diastolic pressure in mmHg 5 Current mean arterial pressure in mmHg 6 Current intracranial pressure in mmHg 7 Pressure curves (P1 and P3) in mmHg
The pressure curves can be printed out with the integrated printer. For further information on printout configuration see chapter 7.1.3 Printer settings, page 160.
ENG - Version 4.0 P/N 04130.2
151
Operation Monitoring and Diagnosis To start or stop real-time printing press the Print key.
User Manual corpuls3
Fig. 6-36
IBP monitoring, section of a printout
Invasive blood pressure curve P1
6.10 Temperature Monitoring (Option)
6.10.1 Information on Temperature Monitoring
Temperature
Temperature monitoring enables continuous measurement and monitoring of the body core temperature (e. g. in a hypothermic patient) or the surface temperature of the skin (e. g. following therapeutic hypothermia in the post-resuscitation phase).
Up to two temperature values can be measured by means of temperature sensors and displayed as numerical values: body core temperature rectally and/or oesophageally and surface temperature.
Caution
Only use YSI sensors of the series 400 or sensors compatible with those,as indicated in the list of approved accessories (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249).
The measurement range lies between 12.0°C and 50.0°C. The temperature is displayed in °C. Temperature values outside the measurement range are indicated as "--.-".
Caution
If temperatures below 12°C are measured the alarm "[X] sensor loose" may be issued.
Note For further information read the operating instructions of the temperature sensor's manufacturer.
6.10.2 Preparing Temperature Monitoring
1. Connect the plug of the first temperature sensor to the "Temp-1" socket at the patient box.
2. Connect the plug of the second temperature sensor to the "Temp-2" socket at the patient box, if a second temperature is to be measured.
3. If necessary, put the protective cover over the temperature sensor and insert the sensor esophageally, rectally or tympanally or place on the surface on the skin and fixate with tape.
152
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Operation Monitoring and Diagnosis
6.10.3 Performing Temperature Monitoring
Measurement begins automatically after the sensor has been attached. 1. Select the parameter field for display of the first temperature value and open the parameter
context menu. 2. Assign T1 monitoring to the selected parameter field.
Fig. 6-37
Temperature monitoring parameter field
1 Current temperature value in °C 2 Symbol for switched-on alarms 3 Upper alarm limit 4 Lower alarm limit
Note If necessary, adapt individual alarm limits manually.
3. If measurement of a second temperature value is necessary, select the parameter field of the second temperature value and open the parameter context menu.
4. Assign T2 monitoring to the selected parameter field.
ENG - Version 4.0 P/N 04130.2
153
Configuration
User Manual corpuls3
7 Configuration
Various different settings of the corpuls3 can be configured: · System settings · Monitoring functions (ECG, Oximetry, CO2, NIBP, IBP) · Alarms · Advanced settings (for persons responsible for the device)
Note The corpuls3 has user administration. Certain settings are therefore only accessible for users with a higher authorisation level (such as persons responsible for the device or service technicians). For default users, certain configuration fields are greyed out and cannot be selected. The access to certain functions as e. g. manual defibrillation or pacer therapy can be restricted via PIN number by the person responsible for the device.
Note Permanent saving of changes in the configuration can only be performed with the corresponding authorisation. If modifications made are not saved in the system settings (see chapter 7.4.2 General System Settings (Person responsible for the device), page 176), all the adjustments will be lost when the corpuls3 is switched off.
Note The corpuls3 always starts at the user level DEFAULT. The configuration dialogues are opened with the jog dial by navigating in the main-/submenu (see chapter 4.3.3 Main menu, page 54). The settings are selected and confirmed with the jog dial (see chapter 4.1.1 Operating Elements and LEDs on the Monitoring Unit, page 35).
154
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
7.1 Configuring the System
7.1.1 General System Settings (User DEFAULT)
The following general system settings can be configured: · Time/Date · Screen settings/Display · Master data 1. Select in the main menu "System" "Settings".
The configuration dialogue opens.
Configuration
Fig. 7-1 System settings, user level DEFAULT
2. Select the required setting with the jog dial. Table 7-1 shows the possible values.
3. To confirm the settings and close the configuration dialogue, press the softkey [OK]. To retain the previous settings and close the configuration dialogue, press the softkey [Cancel].
Note Some configuration fields can only be edited if the user has the necessary authorisation. They are greyed out for the user DEFAULT.
Note Settings can only be configured when the modules are connected mechanically or in range via radio connection.
ENG - Version 4.0 P/N 04130.2
155
Configuration
User Manual corpuls3
Field Time/Date
Screen
Setting Set time Set date UTC offset
Autom. DST
Brightness Dim mode AutoDim Colours
Table 7-1 Values for system settings
Values Hours:minutes DD.MM.YY Hours:minutes Enabled, disabled 0 (dark) to 10 0 (dark) to 10 Off, 1 to 15 min default/night/ inverted
Increments 0-23:00-59 from 2000 0±12:00-59 -
1 1 1
Note The UTC offset (time zone) and the automatic daylight saving time (DST) have to be configured before setting the time. The UTC and time are printed on the protocol. For the UTC offset and the time, the unchanged minutes also have to be confirmed with the jog dial. Only then the changed hour is saved with the softkey [OK].
Note The UTC offset can now be configured from -12:00 to +13:45 hours. So, selection of the correct time zone is possible worldwide.
Screen
The following settings are possible for the display:
· brightness level of the backlit screen (not in nightvision mode). · dimmed brightness level for energy saving (not in nightvision mode). · time interval after which the screen switches from normal to dimmed in the absence of operating
actions or alarms (not in nightvision mode). · Default, night or inverted video display on the screen.
Note The corpuls3 never switches to AutoDIM (energy saving) mode in defibrillation-, pacer- or nightvision mode.
Via the configuration page "Master" the master data can be edited (see chapter 8.4 Master data, page 201).
The UTC offset can now be configured from -12:00 to +13:45 hours. So, selection of the correct time zone is possible worldwide.
156
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
7.1.2 Configuration of Views
The following settings can be configured: · number and type of the curves displayed · number and type of the parameters displayed · pre-set views
Curves 1. Select in the main menu "Signals" "Curves". The configuration dialogue opens.
Configuration
Fig. 7-2 Displaying curves
2. In the field "Lines" in the group "Settings" the required number of lines (3 to 6 lines) can be selected. The selected number of curves is displayed on the monitor.
3. Select the field "Reset default" to set the configuration back to the last settings before opening this configuration dialogue. Changes can so be undone without having to close the configuration dialogue.
4. Select the required ECG leads and curves of the monitoring functions Pleth, CO2, IBP and CPR for display on the monitor.
5. To confirm the settings and close the configuration dialogue, press the softkey [OK]. To retain the previous settings and close the configuration dialogue, press the softkey [Cancel].
ENG - Version 4.0 P/N 04130.2
157
Configuration
Parameters 1. Select in the main menu "Signals" "Parameters". The configuration dialogue opens.
User Manual corpuls3
Fig. 7-3 Displaying parameter fields
2. Select the arrangement of the parameters in the group "Settings" for the following fields: · none, · horizontal, · vertical, · horizontal and vertical, · Big 4, · Big 6, · Big 8,
3. Select the field "Reset default" to set the configuration back to the last settings before opening this configuration dialogue. Changes can so be undone without having to close the configuration dialogue.
4. Select the parameters to be displayed. With the option "Big 6" or "Big 8", only one curve can be displayed, as the entire screen is used to display the big parameter fields. With the option "Big 4", 2 or 3 curves can be displayed.
5. To confirm the settings and close the configuration dialogue, press the softkey [OK]. To retain the previous settings and close the configuration dialogue, press the softkey [Cancel].
158
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
All available parameters can be displayed in "Big 4", "Big 6" or "Big 8" view with a corresponding larger font, their respective colours, designations and alarm parameters remain the same.
Fig. 7-4 Big parameter fields
Selecting 1. Select in the main menu "Signals" "Views".
pre-configured views
The configuration dialogue opens.
Fig. 7-5 Selecting pre-set views 2. Select the required configured view with the jog dial and press to confirm.
ENG - Version 4.0 P/N 04130.2
159
Configuration
User Manual corpuls3
3. To confirm the settings and close the configuration dialogue, press the softkey [OK]. To retain the previous settings and close the configuration dialogue, press the softkey [Cancel].
Note The views for the defibrillator- and pacer mode can only be adjusted if the user switches first to defibrillator- or pacer mode.
Note Configured views can only be permanently saved in the system settings by the person responsible for the device (user authorisation required) (see chapter 7.4.7 Basic Configuration of the Views (Persons Responsible for the Device), page 187).
7.1.3 Printer settings
Curves 1. Select in the main menu "Printer" "Curves". The configuration dialogue opens.
Fig. 7-6 Printer setting "Same as screen"
2. If in the group "Settings" the checkbox "Same as screen" is ticked, the curves currently displayed on the screen are printed. The remaining areas of the configuration dialogue are greyed out (see Fig. 7-6).
160
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
3. Deactivate the checkbox "Same as screen" to enable selection of ECG leads, Pleth-, CO2-, IBP- or CPR curves.
4. Select required ECG leads and curves.
Fig. 7-7 Selecting printer curves
Note In real-time printing, up to 6 curves can be printed simultaneously one below the other.
Every real-time printout has the designation "REALTIME PRINTOUT" on the first page.
5. In the field "Speed" in the group "Settings", select the sweep speed and the time interval after which the printer should stop printing automatically (see Table 7-2 for the values).
Field Settings Table 7-2
Setting
Values
Speed
6.25 mm/s to 50 mm/s
AutoOff
Off, 10 to 300 s
Same as screen
Enabled, disabled
Values for printer settings
Increments 6.25/12.5/25/50 mm/s 10 s -
ENG - Version 4.0 P/N 04130.2
161
Configuration
Printer settings Trends 1. Select in the main menu "Printer" "Trend".
and Protocol
The configuration dialogue opens.
User Manual corpuls3
Fig. 7-8 Printer settings Trend and Protocol
2. To obtain in the protocol a chronological list of minute mean values of vital parameters in table form, tick the checkbox "Trend table" in the group "Protocol".
3. If the protocol should contain the trend curves of the vital parameters, tick the checkbox "Trend curve" in the group "Protocol".
4. If the checkbox "Same as screen" in the group "Trends" is ticked, the vital parameters currently displayed on the screen are printed in the protocol. If this checkbox is not ticked, up to 13 parameters included in the trend table can be selected manually.
5. Use the field "Interval" in the group "Trends" to select the intervals at which the minute mean values are logged.
6. Use the field "Average" in the group "Trends" to set the averaging interval. The values are collected and averaged over the period of time configured here (arithmetic mean value).
Group
Setting
Values
Increments
Trend table
Enabled, disabled
-
Protocol
Trend curve
Enabled, disabled
-
Trends
Same as screen Interval
Enabled, disabled
Interval 1 min to 60 min
1, 5 and 30 min
Average
10 s to 60 s
5, 15 and 30 s
Table 7-3
Values for trend settings
7. To confirm the settings and close the configuration dialogue, press the softkey [OK]. To retain the previous settings and close the configuration dialogue, press the softkey [Cancel].
162
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
Printing individual trend pages
Trend symbols in the protocol
Note Note
To enable printing of the trend values as a single page:
1. Select in the main menu "Printer" "Trend page". For the trend the minute mean values of the parameters are saved. One minute mean value is calculated from all measured values within one minute as the arithmetic average.
If in the trend table on the protocol printout one parameter value bears an exclamation mark (e. g. for HR: 60!), this indicates that within this interval an alarm limit was exceeded or the value fell below the alarm limit.
If at one timestamp one parameter value shows a question mark (e. g. for HR: ?), this indicates that within the last minute no mean value could be saved due to technical reasons. This is the case, for example, if at the time of printout the monitoring unit is out of range (radio connection) of the patient box.
If at one timestamp one parameter value shows two dashes (e. g. for NIBP: --), this indicates that within the last minute no mean value could be detected and saved.
The printout of the trendpage contains the trend value of the last minute before the Print key was pressed. The recorded trend values may therefore originate from an earlier point in time.
If the markings signalling the end of the paper roll become visible, a paper jam is possible with a selected printer speed of 6.25 mm/s.
Printing the D-ECG
To adjust the settings for the D-ECG printout, proceed as follows:
1. Select in the main menu "Printer" "D-ECG". The configuration dialogue opens.
Fig. 7-9 Printer settings for D-ECG
ENG - Version 4.0 P/N 04130.2
163
Configuration
User Manual corpuls3
Field
Setting
Values
12-lead ECG Rep. cycle Global info Speed
12 lead ECG printout
Printout of the representative cycle
Printout of diagnosis Sweep speed of the D-ECG
ECG Format
Printout format
Duration Order
Duration/length of the printout of one ECG block
Classic placement of ECG curves or according to Cabrera
Add. copy
Prints out another copy
Measuring table (option)
Adds the measuring table of interpretation to the printout
Suggestion (option)
Adds a therapy suggestion to the printout
Table 7-4
Values for the D-ECG printout
Enabled, disabled Enabled, disabled Enabled, disabled 25 mm/s, 50 mm/s 2x6 4x3 3 to 10 s
Classic, Cabrera Enabled, disabled Enabled, disabled Enabled, disabled
Increments
1 s
2. To have the 12 lead ECG included in the protocol, tick the checkbox "12-lead ECG" in the group "Format".
3. To display the representative cycle, tick the checkbox "Rep. cycle" in the group "Format". 4. Select the D-ECG speed on the printout. 5. Select the printout format:
· 2 x 6: Two blocks of 6 ECG leads each are printed. · 4 x 3: Four blocks of three ECG leads each are printed. 6. Select the duration of the ECG block. 7. Select the order of the ECG curves on the D-ECG printout: · Classic: Leads I, II, III, aVR, aVL, aVF. · Cabrera: Leads aVL, I, -aVR, II, aVF, III. 8. To print out an additional copy of the D-ECG, tick the checkbox "Add. copy". 9. Optional: Add the measuring table of interpretation to the printout. 10. Optional: Add the therapy suggestion to the printout. 11. To confirm the settings and close the configuration dialogue, press the softkey [OK]. To retain the previous settings and close the configuration dialogue, press the softkey [Cancel].
164
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
corPatch CPR summary (printout)
Adjusting the printer intensity
After deployment of the corPatch CPR feedback sensor the corpuls3 calculates and stores a statistical evaluation from the collected data. If the user OPERATOR has enabled this option (see chapter 7.4.12 Configuration of the Metronome and CPR feedback (Persons Responsible for the Device), page 193), the corPatch CPR summary can be printed out on the corpuls3 via the main menu or the mission browser and so allows a direct mission debriefing for users. The printout contains various quality parameters and graphical summaries of the respective resuscitation mission.
As of software version 3.0.5 the user DEFAULT can adjust the intensity of the printer. This may e.g. be necessary after inserting a new role of printer paper, if the letters are printed too thin or too fat and are illegible.
1. Select in the main menu "Printer" "Settings". The configuration dialogue opens.
2. Select in the group "Printer" the field "Intensity" with the jog dial and choose a value between 0 and 20.
Note By default, the value 10 is set.
Field Intensity Table 7-5
Values 0 -20 Adjusting the printer intensity
7.1.4 Configuration of the Fax Transmission (User DEFAULT)
Settings for Fax Transmission (option)
The following settings can be configured by the user DEFAULT for transmitting a fax: · Enabling and disabling of the GSM connection (aircraft mode) · Selection of the sweep speed for the representation of the D-ECG on the fax machine.
7.2 Configuration of the Monitoring Functions
The settings of the following monitoring functions can be configured:
· ECG · SpO2 · SpMet (available only with with Masimo Rainbow SET® Technology) · SpCO (available only with with Masimo Rainbow SET® Technology) · SpHb (available only with with Masimo Rainbow SET® Technology) · PR · PI · CO2 · NIBP · IBP · CPR Feedback
ENG - Version 4.0 P/N 04130.2
165
Configuration
7.2.1 ECG Monitoring
The following settings can be selected: · ECG Display · Dynamic QRS-/Pulse tone (option) · 20 Hz filter
General settings 1. Select in the main menu "ECG" "Settings". The configuration dialogue opens.
User Manual corpuls3
Fig. 7-10 ECG settings
2. Select the settings. Table 7-6 shows the possible values.
Field
Setting
Speed
Screen
Amplitude QRS marker
Auto curve
Enabled
QRS/Pulse tone
Dynamic Volume
QRS tone
20 Hz filter
Enabled
Table 7-6
Values for ECG setting
Values 12.5 mm/s, 25 mm/s, 50 mm/s Auto; x 0.25; x 0.5; x 1; x 2 Enabled, disabled Enabled, disabled Enabled, disabled Enabled, disabled 3 to 10 Tone 1 to tone 4 Enabled, disabled
166
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
Auto curve Dynamic QRS-/Pulse
Tone
Note 20 Hz filter
After connecting the 4-pole ECG monitoring cable (to patient and patient box) the ECG curve of lead DE appears automatically on the screen if a valid ECG is detected.
If the pitch of the pulse tone should indicate a change in oxygen saturation (SpO2 value), tick the checkbox in the "Dynamic" field. With this option, for example a decrease of the oxygen saturation can be detected early on acoustically. Deselecting the QRS tone disables the dynamic pulse tone as well (see chapter 7.2.2 Oximetry, page 167).
The dynamic QRS-/Pulse tone is only available, if the device is equipped with the oximetry (SpO2) option. If not, the field is greyed out.
By means of the 20 Hz filter, muscle contractions of the patient can be filtered out of the ECG. In monitoring mode, the 20 Hz filter can be enabled or disabled via the curve context menu.
Warning
Risk of wrong diagnosis
The use of the 20 Hz filter in monitoring causes distortions in the ECG that can be misinterpreted. A diagnosis should only be made on the basis of a diagnostic ECG.
Note To increase diagnostic safety, the message "ECG FILTER ACTIVE - INTERPRETABILITY MAY BE AFFECTED" is printed for the user on the printout if the ECG is changed by filter settings and thus the interpretability is limited.
7.2.2 Oximetry
Settings 1. In the main menu, select "Oximetry" "Settings". The configuration dialogue opens.
Fig. 7-11 Settings for oximetry monitoring
ENG - Version 4.0 P/N 04130.2
167
Configuration
User Manual corpuls3
2. Select the settings. Table 7-7 shows the possible values.
Field
Setting
Sweep speed Curve
Auto curve
Enabled
Pulse tone
Mode SpHb Table 7-7
Dynamic Volume Pulse tone FastSat
Averaging Sensitivity Unit Values for oximetry Monitoring
Values
12.5 mm/s, 25 mm/s, 50 mm/s
Enabled, disabled
Enabled, disabled
Enabled, disabled
3 to 10
1 to 4
Enabled, disabled
2-4 s, 4-6 s, 8 s to 16 s
Max., Norm, APOD
g/dl, mmol/l
Increments
-
-
1
2
Dynamic Pulse Tone
If the check box "Auto Curve" is ticked, the pleth curve will be displayed on the screen as soon as valid oximetry values are measured.
If the pitch of the pulse tone is supposed to change as a function of oxygen saturation, tick the checkbox in the field "Dynamic". With this option, a decrease of the oxygen saturation can be detected early on acoustically. If a 4 pole ECG monitoring cable is connected additionally, the pitch of the QRS-/pulse tone indicates the level of the oxygen saturation.
3. To confirm the settings and close the configuration dialogue, press the softkey [OK]. To retain the previous settings and close the configuration dialogue, press the softkey [Cancel].
Note Some settings are only available with the Masimo Rainbow SET® Technology. Note For information on the settings see chapter 6.6.4 Performing Oximetry Measurement, page 132.
168
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
7.2.3 CO2
Setting 1. Select in the main menu "CO2" "Settings". The configuration dialogue opens.
Configuration
Fig. 7-12 Settings for CO2 monitoring
2. Select the settings. Table 7-8 shows the possible values.
3. To confirm the settings and close the configuration dialogue, press the softkey [OK]. To retain the previous settings and close the configuration dialogue, press the softkey [Cancel].
Field
Setting
Values
Sweep speed
3.13 mm/s, 6.25 mm/s, 12.5 mm/s, 25 mm/s
Curve
Scale
0-60 mmHg, 0-80 mmHg, 0-100 mmHg 0-8.0 kPa, 0-10.7 kPa, 0-13.3 kPa
Auto curve
Enabled, disabled
Current unit
Unit
mmHg, kPa
Table 7-8
CO2 monitoring values
Auto curve Scale
If the check box "Auto curve" is ticked, the CO2 curve will be displayed on the screen as soon as valid CO2 values are measured.
The corpuls3 allows to adjust the amplitude of the etCO2 curve to 60 mmHg, 80 mmHg or 100 mmHg. This ensures that even with increased etCO2 values the capnogram is displayed completely. The scaling can be changed directly in the curve context menu. If the curves appear to be cut off at the top, check the scaling and set to an appropriate option.
ENG - Version 4.0 P/N 04130.2
169
Configuration
7.2.4 IBP
Setting 1. Select in the main menu "IBP" "Settings". The configuration dialogue opens.
User Manual corpuls3
Fig. 7-13 Settings for IBP monitoring
2. Select the settings. Table 7-9 shows the possible values.
Field
Setting
Values
General Speed
12.5 mm/s, 25 mm/s, 50 mm/s
Scale P curve
Auto; 0 to 30; 0 to 60; 0 to 120; 0 to 180; 0 to 300 -10 to 10; -20 to 20; -30 to 30; -40 to 40; -50 to 50
Auto curve
Enabled, disabled
Table 7-9
Values for IBP monitoring
Scale Auto curve
Note Calibration
Note
Depending on the measurement site (e. g. arterial, central venous, intracranial) the printing area must be scaled accordingly.
If the check box "Auto Curve" is ticked, the IBP curve will be displayed on the screen as soon as the IBP sensor is connected to the patient box and the corresponding measuring channel is calibrated.
The function "Auto curve" does not work for negative pressure values.
1. In the main menu, select "IBP" "Calib. P {measuring channel}" of the respective pressure channel.
2. Calibration is performed automatically. In case the calibration cannot be performed correctly, the alarm "IBP calibration error" appears.
The IBP channel can be calibrated directly in the context menu of the pertaining parameter field. After calibration of the channel, the IBP curve is displayed automatically (Auto curve).
170
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
7.2.5 CPR Feedback
Setting 1. Select in the main menu "Defib" "CPR". The configuration dialogue opens.
Configuration
Fig. 7-14 Settings for CPR feedback
2. Select required settings. Table 7-10 shows the possible values.
Field
Setting
Audio AAM
AED Volume
Audio metronome
Compress. tone Vent. tone
Table 7-10
Values for CPR feedback
Values Enabled, disabled 3 10 3 10 Off; 3 10
Audio AAM Audio metronome
In AED mode the spoken messages (AAM Acoustic Advisory Mode) can be enabled or disabled and the volume of the messages can be configured.
The volume of the compression tone and ventilation tone can be adjusted as required.
For further settings of the metronome and CPR feedback see chapter 7.4.12 Configuration of the Metronome and CPR feedback (Persons Responsible for the Device), page 193.
ENG - Version 4.0 P/N 04130.2
171
Configuration
7.3 Alarm Configuration 7.3.1 Configuring Alarm Settings
1. Select in the main menu "Alarms" "Settings". The configuration dialogue opens.
User Manual corpuls3
Fig. 7-15 Alarm settings
2. Select the required setting with the jog dial. Note The user cannot set the volume lower than the minimal volume defined by the user OPERATOR.
The alarm for the occurrence of a ventricular tachycardia (VT) or a ventricular fibrillation (VF) can be disabled.
Group Alarming VT/VF
Table 7-11
Setting Volume Alarm
Settings for the VT/VF alarm
Values
3 - 10
Enabled, disabled
3. To confirm the settings and close the configuration dialogue, press the softkey [OK]. To retain the previous settings and close the configuration dialogue, press the softkey [Cancel].
172
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
7.3.2 Alarm Limit Settings
If the value of a vital parameter falls below or exceeds the limit values, an alarm is triggered if the following conditions are met: · Device is not in defibrillation mode. · Alarm mode is set to "Alarm ON":
- Select the parameter field of the vital parameter and open the parameter context menu. Select "Alarm ON" in the parameter context menu.
Note If for one parameter the alarm has been disabled by selecting "Alarm OFF and the parameter field is no longer displayed, the alarm will automatically be re-enabled. The alarm limits for vital parameters can be adjusted manually by the user or automatically by the device: 1. Automatically in the parameter context menu with the menu item "Autolimits"; 2. Manually or automatically in the main menu.
7.3.3 Setting Alarm Limits for Monitoring Functions Manually
1. In the main menu, select "Alarms" "Limits". The configuration dialogue opens.
Fig. 7-16 Alarm limits
2. Select the alarm limits of the corresponding parameter. 3. Select and confirm the alarm limits.
ENG - Version 4.0 P/N 04130.2
173
Configuration
User Manual corpuls3
Note The actually available value range indicated in Table 7-12 depends on the selected upper and lower limit values, as the upper and lower limits may not overlap. Setting extreme alarm limits may render the alarm system useless.
Function HR 1/min SpO2 % PR 1/min SpCO % SpHb g/dl SpHb mmol/l
Lower limit --; 25 to 150 --; 65 to 98 --; 25 to 100 --; 0 to 99 --; 5.0 to 12.0 --; 3.1 to 7.4
SpMet %
--; 0.1 to 99.5
NIBP mmHg sys --; 50 to 150
NIBP mmHg dia --; 10 to 80
CO2 mmHg CO2 kPa RR 1/min
--; 10 to 80 --; 1.3 to 10.7 --; 5 to 40
T1 °C
--,- ; 30 to 40 *)
T2 °C
--,- ; 30 to 40
P1 to P4 mmHg sys
--; -50 to 200
P1 to P4 mmHg dia --; -50 to 200
Table 7-12
Values for alarm limits
Upper limit --; 70 to 250 --; 90 to 99 --; 70 to 235 --; 1 to 99 --; 10 to 22 --; 6.2 to 13.7
--; 1 to 99.5
--; 100 to 250 --; 50 to 120 --; 15 to 100 --; 2.0 to 13.3 --; 15 to 80 --,- ; 35 to 42 *) --,- ; 35 to 42
--; 0 to 300
--; 0 to 300
Increments 5 1 5 1 0.1 0.1 0.1 (0-2) 0.5 (2-100) 5 5 1 0.1 1 0.1 0.1
1 (-50 to 30) 5 (30 to 300)
*) For temperature measurements on the body surface, the limit values must be adjusted accordingly.
4. To confirm the settings and close the configuration dialogue, press the softkey [OK]. To retain the previous settings and close the configuration dialogue, press the softkey [Cancel].
174
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
7.3.4 Setting the Alarm Limits for Monitoring Functions Automatically
Fig. 7-17 Setting automatic alarm limits
1. Select in the main menu "Alarms" "Autolimits". The corpuls3 sets alarm limits automatically depending on the current patient readings. A configuration dialogue with all the automatically set alarm limits appears (see page 173 Fig. 7-16).
2. To confirm the settings and close the configuration dialogue, press the softkey [OK]. To retain the previous settings and close the configuration dialogue, press the softkey [Cancel].
If necessary, adapt individual alarm limits manually.
ENG - Version 4.0 P/N 04130.2
175
Configuration
User Manual corpuls3
7.4 Advanced settings (for persons responsible for the device) 7.4.1 Authorisation for Persons Responsible for the Device
Authorisation
In contrast to the user DEFAULT, the user OPERATOR has a higher authorisation level to perform configurations. The different user levels are protected by access codes.
1. Select in the main menu "System" "Login". The following prompt appears:
Fig. 7-18 Code prompt
2. Enter the 4-digit access code for the user "OPERATOR" with the softkeys. To enter the figures 5 to 9 press the softkey []. The message "User OPERATOR logged in successfully" appears.
Note The corpuls3 always starts at the user level DEFAULT. Note The 4-digit access code can be chosen by the users themselves (see chapter 7.4.2 General System
Settings (Person responsible for the device), page 176). The factory setting on delivery is: · 2-2-2-2 for the person responsible for the device (OPERATOR); · 1-1-1-1 for user DEFAULT.
Note It is recommended to change the access codes for the person responsible for the device (OPERATOR) and if appropriate for the restricted access to manual defibrillation (MAN. DEFIB.) and pacer (PACER) on commissioning the device, in order to prevent misuse.
Caution
The corpuls3 may only be used on patients if the user DEFAULT is logged in. In the higher user level for user OPERATOR, the application on patients is not allowed.
7.4.2 General System Settings (Person responsible for the device)
General system settings
Persons responsible for the device can adjust the following settings in addition to those described in chapter 7.1.1 General System Settings (User DEFAULT), page 155:
· Language · Configuration · Access codes · Authorisation for "MAN. DEFIB." and "PACER" · Mains filter · CF card
176
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
1. Select in the main menu "System" "Settings". The configuration dialogue opens.
Configuration
Fig. 7-19 System settings (persons responsible for the device)
2. Select the required setting with the jog dial. Table 7-13 shows the possible values.
Field
Setting
Language
German
Time/Date
Set time Set date UTC offset
Autom. DST
Store
Configuration
Load Reset default
Values
German English, etc.
Hours:minutes
DD.MM.YY (from 2000)
Hours:minutes
Enabled, disabled
Store? Yes Store? No
Load? Yes Load? No
Reset default? Yes Reset default? No
Export Import
Export? Yes Export? No
Import? Yes Import? No
Increments 0-23:00-59 0±12:00-59 -
-
-
ENG - Version 4.0 P/N 04130.2
177
Configuration
User Manual corpuls3
Field
Setting
Values
Brightness
0 (dark) to 10
Screen
Dim mode AutoDim
0 (dark) to 10 Off, 1 to 15 min
Colours
default/Night/ inverted
Manual event
Audio recording
Enabled, disabled
Screenshot
Enabled, disabled
Access codes
Change
Default, Man. Defib, Pacer Operator
Reset default
Default, Man. Defib, Pacer Operator
Export
Enabled, disabled
Authorisation
Man. Defib.
Enabled, disabled
Pacer
Enabled, disabled
Mains filter
Frequency
50 Hz, 60 Hz
CF card
Format
Format? Yes Format? No
Phone book
Export
Export? Yes Export? No
Import
Import? Yes Import? No
Table 7-13 Values for system settings (persons responsible for the device)
Increments 1 1 10 4 digits, 0-9, Increments of 1
-
-
3. To save, load or reset the adjusted settings, select the required option with the jog dial and press to confirm.
Saving the configuration
Loading configuration
Resetting the configuration
All the settings configured, except date and time, must be saved if they are to be available the next time the corpuls3 is switched on.
The "Load" function allows a reset to the last version saved while device is running. So the device does not have to be switched off to undo temporary changes to the settings.
With the "Reset default" function, the corpuls3 is reset to the factory settings (see also Appendix D Factory Settings, page 298).
178
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
Exporting the configuration
Importing the configuration
Audio recording and screenshots
The function "Export" allows the export of the configuration settings that were saved last onto the CF card. So, configurations once defined can be transferred to another corpuls3. The GSM PIN, the BT PIN and the APN password, some master data (transport type, Radio ID, EMS location, callback phone, medical team, device ID) (see also chapter 8.4 Master data, page 201) are not exported. In case of a software update all saved configurations remain unchanged.
The configuration (telemetry settings, W/LAN network settings, IP addresses, GSM/GPRS data), the internal phonebook (corpuls.web LIVE, e-mail, fax, BT addresses), access codes for the users "DEFAULT", "OPERATOR", "MAN. DEFIB." and "PACER" as well as some master data (organisation, organisation phone) can be exported to the CF card and imported to other corpuls3 devices with the function "Import". After importing the configuration settings, the corpuls3 has to be restarted in order for the new configuration to take effect.
If the audio recording option is enabled, pressing the Event key additionally stores a 15 second recording of the surrounding sounds (5 s before and 10 s after pressing the key). The volume of the audio recording is fixed. The audio recording appears as manual event in the protocol. Furthermore, by pressing the Event key with the screenshot option enabled, a picture file can be saved that shows the screen at the time of the event. The audio recording and the screenshots can be played and viewed with the software corpuls.manager REVIEW (see chapter 8.6 Analysis of the Data with corpuls.manager REVIEW, page 207).
Caution
Function error due to incompatible configuration
When importing a configuration, the device does not check if the configuration is compatible (e.g. newer or older SW version). Import only configurations from devices with the same software version.
Changing the access codes
Note
Resetting access codes
Formatting the CF card Exporting and importing
the phonebook
The user OPERATOR can manually change the access codes for the - user DEFAULT, - restricted access use of the of the manual defibrillation (MAN. DEFIB.) - restricted access use of the of the pacer (PACER) and - for the person responsible for the device (OPERATOR). For this purpose, a 4-digit access code has to be selected and repeated.
It is recommended to change the access codes for the person responsible for the device (OPERATOR) and if appropriate for the restricted access to manual defibrillation (MAN. DEFIB.) and pacer (PACER) on commissioning the device.
The user OPERATOR can reset the access codes for the user DEFAULT, for restricted access to manual defibrillation (MAN. DEFIB.) and pacer (PACER) and for the user OPERATOR to the factory settings. For this purpose, a confirmation prompt must be confirmed with the softkey [OK].
If the access code for the user OPERATOR is no longer known, the authorised corpuls sales and service partner can reset the access codes to factory settings (see also Appendix D Factory Settings, page 298).
The function "Format" allows the user to format the CF inserted in the device. After formatting, a reboot is recommended.
The phonebook is part of the configuration export, but can also be exported or imported separately from one corpuls3 to another via the CF card.
ENG - Version 4.0 P/N 04130.2
179
Configuration
User Manual corpuls3
7.4.3 Configuration of Manual Events (Persons Responsible for the Device)
Pre-configured events For easier documentation of medical measures (administration of drugs, intubation etc), the user OPERATOR can pre-configure and deposit up to 14 manual events:
1. Select in the main menu "System" "Events". The configuration dialogue opens.
Fig. 7-20 Event configuration (persons responsible for the device)
The first and the last event are fixed as "Generic" and "Cancel Last" and therefore appear greyed out and cannot be edited. 2. Enter the name of the event with the jog dial (16 characters) and confirm by pressing the softkey
[Enter]. 3. Repeat to configure other events. 4. To configure Event 9 to 15, press the softkey assigned to the tab "Events 2". 5. To close the configuration dialogue, press the softkey [OK].
To add pre-configured events to the protocol for documentation, see chapter 8.2, Event Key, page 200.
180
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
7.4.4 Configuration of the Defibrillation Function (Persons Responsible for the Device)
Manual defibrillation mode
Pacer operation
Persons responsible for the device can configure further defibrillation function settings in addition to those described in chapter 5.3.1 Information on the AED Mode, page 73 and chapter 5.4.1 Information on Manual Defibrillation and Cardioversion, page 80.
The general use of manual defibrillation can be restricted by an access code. If this option is enabled, the user needs to enter the access code "MAN. DEFIB." (see chapter 7.4.2 General System Settings (Person responsible for the device), page 176), to be able to defibrillate manually.
The general use of pacing can be restricted by an access code. If this option is enabled, the user needs to enter the access code "PACER" (see chapter 7.4.2 General System Settings (Person responsible for the device), page 176), to be able to use the pacer function.
Warning
The access code for the manual defibrillation mode must always be known to authorised users. If not, the patient can only be defibrillated in the AED mode with the corresponding energy restrictions.
Auto Energy
Reminder for analysis Manual energy selection
in AED mode preShock CPR Audio recording Autostart Analysis Shock Protocol
Disconnection signal
Note Charging tone
When accessed for the first time, the manual defibrillation mode and the AED mode can be used with an automatically pre-set energy level. If the energy level is then changed during the mission, the new energy level remains available when the manual defibrillation mode is accessed again. Different energy levels can be pre-set for use in adults and children.
If in the group "Reminder Man." the checkbox "Analyse" is selected, the message "Assess heart rhythm" appears 2 or 3 minutes (depending on the selected resuscitation protocol) after the last shock.
In AED mode, manual energy selection can be enabled by de-selecting the checkbox "Locked". So the user of the corpuls3 has the same energy selection range as in manual defibrillation mode. The ECG analysis is performed with the algorithm of the AED mode.
For the preShock CPR function, the number of acoustic compression signals can be configured. Additionally, the metronome can be enabled.
In AED and manual defibrillation mode, audio recording can be enabled. If this option is enabled, all surrounding noises are recorded while the device is in the corresponding mode. After the mission, the audio files are available on the CF card.
In AED mode, the option "Autostart" is available which is disabled by default. If the option is enabled by the person responsible for the device, the ECG analysis starts automatically after 3 seconds warning time and the speech- and text message "Do not touch patient - Analysing heart rhythm".
If the checkbox in the group "Shock Protocol" in the defibrillator settings is selected, a protocol containing information on the patient, vital parameters, ECG-curve, selected energy, patient impedance and released energy is printed automatically after a defibrillation. This feature is enabled by default in the factory settings and can be disabled by the operator.
If the corpuls3 is to be used exclusively as a compact device or in semi-modular mode (monitoring unit and defibrillator/pacer unit connected, patient box separated, see Fig. 3-3), the person responsible for the device can configure a disconnection signal. In this case, if the monitoring unit is disconnected from the defibrillator/pacer unit, after a pre-set amount of time, an acoustic signal is given (so that no module is accidentally left behind).
Under certain conditions, the disconnection signal may render the verbal instructions given in AED mode unintelligible.
As an additional safety feature, the rising pitch of the charging tone indicates the progress of charging acoustically and serves as a warning to bystanders.
ENG - Version 4.0 P/N 04130.2
181
Configuration
Settings 1. Select in the main menu "Defib" "Settings". The configuration dialogue opens.
User Manual corpuls3
Fig. 7-21 Defibrillation function settings (persons responsible for the device)
2. Select the settings. Table 7-14 shows the possible values.
Group
Settings
Adult Auto energy man.
Child
Reminder Man.
Analyse
Auto energy AED
Adult Child
Locked
preShock CPR
Compress. Metronome
Recording
AED Man. Defib.
Shock Protocol
Enabled
Values
Off, 2, 3, 4, 5, 10, 15 to 200 J
Off, 2, 3, 4, 5, 10, 15 to 100 J
Enabled, disabled
2, 3, 4, 5, 10, 15 to 200 J
2, 3, 4, 5, 10, 15 to 100 J
Enabled, disabled
None, 8, 10, 15, 20
Enabled, disabled
Enabled, disabled
Enabled, disabled
Enabled, disabled
182
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
Group Disconn.-signal
Charging tone Table 7-14
Settings
Values
Enabled
Off, 5, 10, 30, 60 s
Volume
3 10
Tone
Tone 1 to tone 4
AED
Enabled, disabled
Man. Defib.
Enabled, disabled
Values for defibrillation function configuration
3. To confirm the settings and close the configuration dialogue, press the softkey [OK]. To retain the previous settings and close the configuration dialogue, press the softkey [Cancel].
7.4.5 Filter Settings (Persons Responsible for the Device)
ECG monitoring Settings
Persons responsible for the device can adjust further settings in addition to those described in chapter 7.2.1 ECG Monitoring, page 166.
1. Select in the main menu "ECG" "Settings". The configuration dialogue opens.
Fig. 7-22 Filter settings for ECG (persons responsible for the device)
ENG - Version 4.0 P/N 04130.2
183
Configuration
User Manual corpuls3
2. Select the settings. Table 7-15 shows the possible values.
Fields
Settings
Values
Monitoring
Low pass High pass
25 Hz; 40 Hz; 150 Hz 0.05 Hz; 0.25 Hz; 0.5 Hz, 0.67 Hz
20 Hz filter
Enabled
Enabled, disabled
Diagnostic
Low pass
40 Hz, 150 Hz
D-ECG preview
10s preview
Enabled, disabled
Table 7-15 Filter setting for monitoring ECG, diagnostic ECG (persons responsible for the device)
The frequencies for the low pass and high pass filters for ECG monitoring (Monitoring) and the low pass filter for the D-ECG (Diagnostic) can be adjusted.
Note The filter settings for the DE lead are pre-configured and fixed to 0.5 to 25 Hz. Note The filter value of the high pass filter corresponds to the lower limit frequency of the filter.
The filter value of the low pass filter corresponds to the upper limit frequency of the filter.
Warning
The filter settings modify the representation of the ECG curves.
High pass filter Low pass filter
20 Hz filter
The high-pass filter suppresses interference in the lower frequency range of the ECG curve. The 0.67 Hz filter is particularly effective to suppress baseline wandering.
The low pass filter suppresses interference in the upper frequency range of the ECG curve. This interference (artefacts) may be caused by a muscle tremor.
By means of the 20 Hz filter, muscle contractions of the patient can be filtered out of the ECG. In monitoring mode, the 20 Hz filter can be enabled or disabled via the curve context menu.
Warning
Risk of wrong diagnosis
The use of the 20 Hz filter in monitoring causes distortions in the ECG that can be misinterpreted. A diagnosis should only be made on the basis of a diagnostic ECG.
Note To increase diagnostic safety, the message "ECG FILTER ACTIVE - INTERPRETABILITY MAY BE AFFECTED" is printed for the user on the printout if the ECG is changed by filter settings and thus the interpretability is limited.
Note For information pertaining to the configuration of ECG measurement and ECG interpretation, see chapter 7.4.9 Configuration of ECG Measurement and ECG Interpretation (Persons Responsible for the Device), page 189.
184
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
7.4.6 Alarm Configuration (Persons Responsible for the Device)
Alarm settings
In addition to the settings described in chapter 7.3.1 Configuring Alarm Settings, page 172, persons responsible for the device can configure the following settings in the alarm configuration:
· Creating an event in the protocol in case of alarms · Configuring the settings for alarm suspension (15-120 s or permanently)
Settings 1. Select in the main menu "Alarms" "Settings". The configuration dialogue opens.
Fig. 7-23 Alarm settings (persons responsible for the device)
2. Select the settings. Table 7-16 shows the possible values.
ENG - Version 4.0 P/N 04130.2
185
Configuration
User Manual corpuls3
Fields
Alarming
Alarm system VT/VF Table 7-16
Settings
Values
Alarm OFF
perm.; 15 s; 30 s; 45 s; 60 s; 75 s, 90 s; 105 s; 120 s
Create event
Enabled, disabled
Reminder signal
Enabled, disabled
Volume
310
Min. volume
310
Covert mode
Enabled, disabled
Clinic mode
Enabled, disabled
Alarm
Enabled, disabled
Alarm settings (persons responsible for the device)
Create event Alarm suspension
If this function is enabled, every alarm will be listed as an event in the protocol.
If the Alarm key is pressed for longer than 3 s, physiological alarms can be briefly suspended or disabled. Prerequisite is that this is configured accordingly in the settings (Alarm OFF). If the alarms are disabled, a reminder signal in form of a single tone is sounded every 60 seconds. The reminder signal can be disabled by the operator. The volume of the alarm system can be adjusted.
Note For the alarm suspension, a maximum period of 60 seconds is recommended.
Minimal volume Volume Covert mode
The minimal volume can be configured by the user OPERATOR to prevent that alarms are not heard in loud surroundings. The user cannot set the volume lower than the minimal volume defined by the user OPERATOR.
If the covert mode function is enabled, all signalisations of the device via speakers (start-up tone, speech messages, ready signal, key tones, alarms etc.) as well as the lightening up of the jog dial are completely disabled. It is recommended to use this function only for special surroundings and not for everyday missions. All alarms can still be viewed in the alarm history on the monitoring unit.
Warning
Using the Covert Mode requires particular diligence and attention of the user, as otherwise it can lead to serious or lethal injuries of the patient. In this device mode, the user must have direct eye contact to the patient and the device at all times.
Clinic mode Note
The clinic mode is intended for corpuls3 devices that are used in a hospital. After this function has been enabled by the user OPERATOR, low priority alarms are repeated every 30 s until they are confirmed. High- and medium priority alarms are unchanged. All alarms can still be viewed in the alarm history on the monitoring unit.
For ECG measurement/interpretation there are several ACS alarms available that can be enabled or disabled individually by the person responsible for the device (see chapter 7.4.9 Configuration of ECG Measurement and ECG Interpretation (Persons Responsible for the Device), page 189).
186
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
7.4.7 Basic Configuration of the Views (Persons Responsible for the Device)
Basic configuration of the views
Preconfiguration of the views
Persons responsible for the device can pre-set 6 views as basic configuration and permanently save these in the system settings.
These views are available to user DEFAULT in each mission, but cannot be modified by them. For that, a higher authorisation level is necessary.
1. Select in the main menu "Signals" "Views". The configuration dialogue opens.
Fig. 7-24 Pre-setting views (illustration may differ)
2. Select the required view with the jog dial and press the Back key to save the currently configured view (do not press the jog dial to confirm, only select the required field with the jog dial).
3. A tick is entered in the check box in the top right corner of the selected view. 4. To confirm the settings and close the configuration dialogue, press the softkey [OK].
To retain the previous settings and close the configuration dialogue, press the softkey [Cancel]. 5. The setting is only permanently available if the configuration is saved in the system settings (see
chapter 7.4.2 General System Settings (Person responsible for the device), page 176).
Note The views for the defibrillator- and pacer mode can only be adjusted if the user switches first to defibrillator- or pacer mode.
Note Instead of using numbers to designate individual views, these views can also be assigned names by the user (approx. 13 characters maximum).
ENG - Version 4.0 P/N 04130.2
187
Configuration
To enter a name for a view, proceed as follows: 1. Select in the main menu "Signals" "Edit Views".
The configuration dialogue opens.
User Manual corpuls3
Fig. 7-25 Entering a name for a view
2. Enter the name of the view with the jog dial. Press softkey [Enter] to confirm. 3. To confirm the settings and close the configuration dialogue, press the softkey [OK].
To retain the previous settings and close the configuration dialogue, press the softkey [Cancel].
7.4.8 Configuration of Master Data (Persons Responsible for the Device)
Master data Persons responsible for the device may configure and permanently save master data in the corpuls3 (see chapter 8.4 Master data, page 201):
Information Transport type Radio ID
Location Callback phone Medical team Organisation Phone Device ID
Description Type of transport, e. g. "emergency vehicle" Identification of a radio subscriber in a radiocommunication area, e. g. "FD x-city 1-83-2" Location of corpuls3 Mobile phone number, e. g. for enquiries to the team Names of the medical team Operator of corpuls3, e. g. "x-city fire brigade" Telephone number of the operator Operator's internal device name, e. g. "Defi no. 7"
Table 7-17 Master data (persons responsible for the device)
188
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
Configuration of master data
The following steps are required to enter the master data:
1. Select in the main menu "System" "Settings". 2. Press softkey [Master]. 3. Select the required master data information with the jog dial. 4. Enter the required data and confirm by pressing the softkey [OK]. 5. Save configuration (see chapter 7.4.2 General System Settings (Person responsible for the device),
page 176).
Fig. 7-26 Entering master data (persons responsible for the device)
The user DEFAULT can modify some of these master data during the mission, but cannot permanently save these changes (see chapter 8.4 Master data, page 201).
7.4.9 Configuration of ECG Measurement and ECG Interpretation (Persons Responsible for the Device)
Settings for ECG measurement and ECG interpretation (option)
Persons responsible for the device can set the following configurations:
· Filters (Monitoring and Diagnostic) · ECG measurement/interpretation therapy algorithm · AMI and IMI parameter settings for the corpuls S therapy algorithm · ECG measurement/interpretation settings and alarms for the corpuls ACS therapy algorithm
(following ESC guidelines).
Abbreviations for ECG Measurement/ EKG Interpretation
For an overview of the used abbreviations, see Appendix B List of Abbreviations, page 296.
The configuration dialogue shows the following settings for the D-ECG with the ECG measurement and ECG interpretation option:
ENG - Version 4.0 P/N 04130.2
189
Configuration
User Manual corpuls3
Fig. 7-27 Configuration of ECG measurement and ECG interpretation (persons responsible for the device)
Table 7-18 shows the possible values:
Group
Field
Setting
Value
D-ECG preview
10s preview
Enabling/disabling the 10 s preview with 6.25 mm/s
Enabled, disabled
Therapy
Algo.
Selection of the measurement/interpretation method
corpuls S, corpuls ACS
AMI corpuls S
IMI
Limit for AMI Limit for IMI
500 2500 µV increments of 100 µV
300 2500 µV increments of 100 µV
corpuls ACS NSTEMI
Optional activation of an NSTEMI therapy suggestion for corpuls ACS
Enabled, disabled
STEMI
Indicates the result "STEMI" of the corpuls ACS algorithm
Enabled, disabled
STEMI possible
Indicates the result "STEMI possible" of Enabled, disabled the corpuls ACS algorithm
ACS alarms
Abnormal ECG
Indicates the result "Abnormal ECG" of Enabled, disabled the corpuls ACS algorithm
NSTEMI
Indicates the result "NSTEMI" of the corpuls ACS algorithm
Enabled, disabled
NSTEMI possible
Indicates the result "NSTEMI possible" Enabled, disabled of the corpuls ACS algorithm
Table 7-18
Values for configuration, ECG measurement and ECG interpretation
190
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
10 s preview with 6.25 mm/s
corpuls S AMI and IMI
As an alternative to the existing D-ECG preview which shows all curves with a speed of 6.25 mm/s, the D-ECG preview can also show the curves with the same speed as in monitoring mode. The user OPERATOR can enable or disable this option.
The corpuls3 creates a therapy suggestion with the corpuls S therapy algorithm which evaluates, among other items, ST deviations. If the ST deviations are significant enough, implementation of the PCI protocol is recommended.
Two limit values can be set for the sum of ST values measured during the D-ECG. These limits are designated AMI and IMI and represent the degree of sensitivity for deciding in favour of a therapy recommendation. The AMI limit (in V) applies in the event of an anterior infarction, the IMI value in the event of an inferior infarction.
If the ECG interpretation by corpuls3 indicates a myocardial infarction and if the sum of the specific ST values exceeds the pre-set limits for AMI or IMI, the device suggests performing a PCI therapy.
The following values are recommended for AMI and IMI:
AMI: 800 V IMI: 600 V
corpuls ACS Option NSTEMI
Note Note
As an alternative to corpuls S the corpuls3 generates with the therapy algorithm "corpuls ACS" a therapy suggestion that follows the guidelines of the ESC. Based on changes in the ECG, the algorithm differentiates between a STEMI, NSTEMI (optional) or a normal ECG rhythm.
If the checkbox "NSTEMI" in the group "corpuls ACS" is selected, the device also issues NSTEMI therapy suggestions.
The algorithm also checks the ECG for the presence of the Wolff-Parkinson-White (WPW) syndrome, of intraventricular excitation propagation disorders, of an implanted pacer, of QRS intervals longer than 120 ms and of a left bundle branch block. In these cases, if enabled, the alarm/message "Abnormal ECG" is issued.
The person responsible for the device (user OPERATOR) can configure, whether an alarm/message should inform the user of findings like "Abnormal ECG", "STEMI" or "NSTEMI" already during the ECG analysis.
As the corpuls ACS algorithm closely follows the ESC guidelines, it is recommended for measurement and interpretation of a D-ECG.
Note A licence is required for the use of the ECG measurement and ECG interpretation options. Please contact your authorised service and sales partner to obtain this licence.
Note Information on the installed version of the ECG measurement and ECG interpretation program can be found in the system info. It is listed in the "Options" field in the line "ECG interpretation".
ENG - Version 4.0 P/N 04130.2
191
Configuration
User Manual corpuls3
Fig. 7-28 ECG measurement and ECG interpretation version in system info
7.4.10 Demo Mode (Persons Responsible for the Device)
Demonstration at trainings
Activating the demo mode
Deactivating the demo mode
The user OPERATOR can activate the demo mode for training purposes. This mode shows curves and parameters and demonstrates all functions and possible configurations.
1. Select in the main menu "System" "Demo". 2. In the message line the text "Demo mode on" appears.
3. The screen shows curves and parameters from the internal memory.
To deactivate the demo mode, the corpuls3 has to be switched off and on again. Alternatively, select again in the main menu "System" "Demo". The confirmation prompt "Leave Demo mode Power off?" appears. To leave the demo mode and switch off the device, press softkey [OK]. To stay in demo mode, press softkey [Cancel].
Warning
The use of the demo mode during patient care is strictly forbidden. The demo mode may only be used for training purposes.
Warning
If the corpuls3 is currently in demo mode and should be used for patient care, the device has to be restarted first.
192
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
7.4.11 Data Protection Settings (Persons responsible for the device)
Selection of Data Parameter Race
Persons responsible for the device can configure which data from the health insurance card or manually entered data should be available in the corpuls3 on the screen, on the printout or for telemetry. The telemetry settings are valid for Bluetooth®-, GSM-, WLAN and LAN connections.
As of software version 3.0, the person responsible for the device can activate the option of recording the patient's race, which is particularly of interest for research purposes.
Configuration For the configuration the following steps are necessary: 1. Select in the main menu "Patient" "Settings".
Fig. 7-29 Settings for the insurance card reader (persons responsible for the device)
2. Select the required information with the jog dial and press to confirm. 3. To record the parameter "race" in the patient data, select the checkbox "Enabled" in the group
"Race". 4. To define a default race, select required information in the field "Default". The following races can
be selected: African, Caucasian, Pacific, Asian, Native Am, Unknown, -- (no selection). 5. Save configuration (see chapter 7.4.2 General System Settings (Person responsible for the device),
page 176).
Symbol A monitoring unit that is equipped with an insurance card reader (option) can be recognised by the card insurance card reader symbol at the card slot.
ENG - Version 4.0 P/N 04130.2
193
Configuration
User Manual corpuls3
7.4.12 Configuration of the Metronome and CPR feedback (Persons Responsible for the Device)
Advanced Metronome Settings
Persons responsible for the device can select advanced settings for the metronome and for the CPR feedback system in order to adapt to local variations of resuscitation algorithms. For this purpose, the · Compression frequency and the · Duration of the ventilation phases can be configured for adults and children.
Algorithm The person responsible for the device can adapt the resuscitation protocol to locally applicable variations. Besides the currently valid guidelines, a 3 min-resuscitation protocol is available.
For configuration, proceed as follows: 1. Select in the main menu "Defib" "CPR".
Fig. 7-30 Extended settings for CPR feedback
2. Select the required metronome- or CPR feedback settings with the jog dial and confirm. 3. Select the required setting and confirm with softkey [OK].
194
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
4. Save configuration (see chapter 7.4.2 General System Settings (Person responsible for the device), page 176).
Field
Setting
Values
Compress.
Compression frequency
80 120 1/min increments of 5 1/min
Adult
Vent. 30:2
Duration of ventilation at 3 6 s
ratio 30:2
increments of 1 s
Compress.
Compression frequency
80 140 1/min increments of 5 1/min
Child
Vent. 15:2
Duration of ventilation at 3 8 s
ratio 15:2
increments of 1 s
Vent. 30:2
Duration of ventilation at 3 8 s
ratio 30:2
increments of 1 s
Algorithm
Interval
Duration of the resuscitation protocol
2 min; 3 min
CPR depth
Unit Release
Selection of the length unit
The spoken message Fully release can be disabled
cm; in Enabled, disabled
CPR summary
Printout
Printout of the CPR
Enabled, disabled
feedback summary can be
disabled.
Application note Show note
The application note for the CPR feedback sensor can be enabled.
Enabled, disabled
AED
Enabled, disabled
Audio AAM
CPR Feed. Monitor CPR Feed. Man.
CPR Feed. AED
Spoken messages can be disabled in the individual modes.
Enabled, disabled
Enabled, disabled Enabled, disabled
Volume
Setting the volume
Off, 3-10
Audio metronome
Compress. tone Vent. tone
Configuration of the metronome sounds
3-10 Off, 3-10
Autostart metr.
AED Man. Defib
Automatic start of the metronome when calling up a therapy mode
Automatic start of the metronome when calling up a therapy mode
Off; Adult 30:2; Adult cont.; Child 30:2; Child 15:2; Child cont.
Off; Adult 30:2; Adult cont.; Child 30:2; Child 15:2; Child cont.
Table 7-19
Values for metronome settings
Unit The unit of the reference range for the compression depth can be switched from centimetres to inches.
ENG - Version 4.0 P/N 04130.2
195
Configuration
User Manual corpuls3
Message The user OPERATOR can deactivate the spoken message "Fully release" (see chapter 7.4.12 "Fully release" Configuration of the Metronome and CPR feedback (Persons Responsible for the Device), page 193).
CPR summary Application note
CPR Feedback
Audio AAM
Autostart Metronome
If the checkbox "Printout" is selected, the CPR summary can be printed out for mission debriefing via "Printer" "CPR summary" or via the mission browser.
The CPR feedback system starts automatically when the corPatch CPR sensor is applied. A picture and a message appear, showing the recommended position of the corPatch CPR sensor (see Fig. 5-20). To close the message, press softkey [OK]. The display of the application help can be disabled by the user OPERATOR.
The spoken message of the CPR feedback can be disabled or enabled separately for AED-, manual and monitoring mode. The text in the message line is still displayed and is recorded for the option CPR summary.
The user OPERATOR can configure that the metronome is started automatically when a therapy mode is called up. This setting can be configured separately for the AED- and for the manual mode.
Settings
7.4.13 Configuration of Non-Invasive Blood Pressure Measurement (NIBP) (Persons Responsible for the Device)
Persons responsible for the device can configure advanced settings for interval settings, the initial mode and the initial pressure.
1. Select in the main menu "NIBP" "Settings". The configuration dialogue opens.
Fig. 7-31 NIBP settings 196
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Configuration
2. Select the settings. Table 7-20 shows the possible values.
Field
Setting
Automatic
Interval Enabled
Initial mode
Patient
Initial pressure
Adult Child Neonate
RMT
Enabled
Table 7-20 Values for NIBP monitoring
Values
1 min, 2 min, 3 min, 5 min, 10 min, 15 min, 30 min, 60 min
Enabled, disabled
Adult
Child
Neonate
120 to 280 mmHg
80 to 170 mmHg
60 to 140 mmHg
Enabled, disabled
Increments
--
-
10 10 10 -
3. Select the required interval for automatic NIBP measurement. 4. If the checkbox "Enabled" is ticked, automatic interval measurement will be activated when the
NIBP menu is called up and the softkey [Start] is pressed. 5. To confirm the settings and close the configuration dialogue, press the softkey [OK].
To retain the previous settings and close the configuration dialogue, press the softkey [Cancel].
Note NIBP monitoring is performed in the mode that was last selected: "Adult", "Child" or "Neonate".
R-wave Motion Tolerance
SunTech R-wave Motion Tolerance (RMT)-Technology uses the monitoring ECG signal to qualify the validity of oscillometric pulses for an enhanced level of motion tolerance on patients in transport situations. Particularly in case of motion artefacts (shivering, convulsions), weak pulse and certain types of arrhythmias, the quality of the NIBP measurement is optimised. The user can disable the function "RMT" curves in the NIBP settings.
Test menu For further information on maintenance and tests of the corpuls3 that goes beyond the scope of this user manual, please contact the service technicians of an authorised corpuls sales and service partner.
ENG - Version 4.0 P/N 04130.2
197
Configuration
User Manual corpuls3
7.4.14 Printer Settings (Persons Responsible for the Device)
Settings Feed Speed
Persons responsible for the device can configure the feed speed for printing event ECGs and the shock protocol.
1. Select in the main menu "Printer" "Settings". The configuration dialogue opens.
Fig. 7-32 Settings feed speed (persons responsible for the device)
2. Select the settings. Table 7-21 shows the possible values.
Fields
Settings
Values
Event ECG
Speed
12.5 mm/s, 25 mm/s
Printout
Intensity
0-20
Table 7-21 Settings feed speed of event ECG (persons responsible for the device))
Adjusting the printer intensity
At 12.5mm/s 10 seconds before and after the event are printed. At 25mm/s 5 seconds before and after the event are printed.
See chapter 7.1.3 Printer settings, page 160.
198
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Data Management
8 Data Management
8.1 Creating a Patient File
Switching on/off the corpuls3
Test Mission
A new data record is automatically created each time the corpuls3 is switched on (new mission).
An unambiguous mission number is generated, which is printed in the first line on the first page of each printout. In addition, the time and date are automatically logged.
If instead of therapy electrodes a testbox/testload or a corpuls simulator is connected or the plug is lodged in the socket, the device asks if the mission should be marked as a test mission. If the user confirms by pressing the softkey [Yes], the Patient ID is displayed as "TEST".
For as long as the corpuls3 is in use, all the saved data will be assigned to this mission and saved on the CompactFlash® card (see chapter 8.3 Handling Data, page 200).
The entered data can be modified or completed during the mission. Changes made to the data set are marked in the protocol printout.
For entering changes, select "Patient" "Edit Data" in the main menu.
Fig. 8-1 Entering patient data
Note The age of the patient is automatically calculated when the date of birth is entered and cannot be edited. If no date of birth is entered, the age can be edited.
Note The information pertaining to the insurance card can only be imported via the insurance card reader and cannot be edited. To do so, the window "Patient - Edit Data" has to be closed.
ENG - Version 4.0 P/N 04130.2
199
Data Management
User Manual corpuls3
As of software version 3.0 it is possible to use the parameter "Race" in the patient data. The field "Race" is only available, if the option has been activated by the user OPERATOR (see chapter 7.4.11 Data Protection Settings (Persons responsible for the device), page 193).
8.2 Event Key
Audio recording and screenshots
Selecting events
The corpuls3 has the key Event located in the top left-hand corner of the monitoring unit.
If the Event key is pressed briefly, a time stamp is saved which marks the current ECG data and parameter values. Based on this marking, this data can subsequently be located in the data memory, viewed and assessed. The message Event recorded appears in the message line.
If the audio recording option is enabled, pressing the Event key additionally stores a 15 second recording of the surrounding sounds (5 s before and 10 s after pressing the key). The audio recording appears as manual event in the protocol. Furthermore, by enabling the screenshot option, a screen copy at the time of the event can be saved as a picture file. The audio recording and the screenshots can be played and viewed with the software corpuls.manager REVIEW (see chapter 8.6 Analysis of the Data with corpuls.manager REVIEW, page 207).
If the Event key is held for more than 3 seconds, the event list appears, in which the first entry "Generic" is marked automatically. With the jog-dial the user can select pre-configured events and add them to the mission protocol. To confirm a selected list entry, press the jog dial. The message Event [TEXT] recorded appears in the message line. To delete the last event, select "Cancel Last" and confirm.
If no pre-configured event has been chosen, the entry "Cancel Last" is greyed out.
Fig. 8-2 Selecting pre-configured events
Note By pressing the Event key briefly or by holding down the Event key for more than 3 seconds and selecting the event "Generic", a time stamp is saved which marks the current ECG data. If another pre-configured event is selected, no ECG data are saved, only an event is added to the protocol.
8.3 Handling Data
The CompactFlash® card of the patient box is the central memory location for all recorded data. Insert the CompactFlash® card with the corpuls3 label (incl. memory capacity) facing towards the user and following the direction of the arrows into the card slot at the left-hand side (seen from the front) of the patient box. If necessary, remove the accessory bag.
200
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Data Management
Note If the CompactFlash® card is full (1000 missions or more) or not inserted into the patient box, the corpuls3 cannot record either a long-term ECG or a diagnostic ECG. Consequently, these data are missing when a log is created.
Note The current date and time of the mission have to be deposited in the corpuls3 to enable a later allocation of mission data.
Caution
Make sure that only an original corpuls3 CompactFlash® card (P/N 04236.3) with sufficient memory capacity is used (minimum 50 MB, if audio recording is disabled).
Using other CompactFlash® cards may result in safety-critical system malfunctions or the voiding of warranty.
Note Save the contents of the CompactFlash® card to a PC at regular intervals on external storage media.
Note If the alarm message "CF card error" is displayed, the data should be saved on a computer. Then, the CF card must be re-formatted (see chapter 7.4.2 General System Settings (Person responsible for the device), page 176).
Caution
Risk of system errors Never insert or remove the CompactFlash® card during the mission. Only insert or remove the CompactFlash® card when the patient box is switched off.
Uploading missions to a If the checkbox "Enabled" in the group "Mission upload" is ticked and a connection is established, the server recorded missions can be uploaded automatically to an FTP server after the mission is finished and the
device is switched off.
8.4 Master data
Master data
Persons responsible for the device can configure and save master data (see chapter 7.4.8 Configuration of Master Data (Persons Responsible for the Device), page 188).
These master data are partly contained in the D-ECG printout. If a D-ECG is transmitted to the hospital by fax (option), this D-ECG can be identified unambiguously by means of these master data.
Some of these master data can be modified by the user DEFAULT:
Information Transport type Radio ID
Location Callback phone Medical team
Explanation Type of transport, e. g. "emergency vehicle" Identification of a radio subscriber in a radiocommunication area, e. g. "FD x-city 1-83-2" Location of the rescue vehicle Mobile phone number, e. g. for enquiries to the team Names of the medical team
Table 8-1
Master data
ENG - Version 4.0 P/N 04130.2
201
Data Management
User Manual corpuls3
Note These modifications are not saved and only apply to the current mission. After the corpuls3 has been switched off, the master data, originally configured by the person responsible for the device, apply once again.
Changing master data
The following steps are required to modify the master data: 1. Select in the main menu "System" "Settings". 2. Press softkey [Master] 3. Select the required master data information with the jog dial. 4. Enter the required information and confirm by pressing the softkey [Enter]. 5. Confirm by pressing the softkey [OK].
Fig. 8-3 Entering master data
8.5 Browser Key
8.5.1 Protocol
The corpuls3 automatically generates a log which can be printed out by pressing the Browser key. Browser
Each log printout has the word "PROTOCOL" on the first page. The log consists of an overview with data specific to the mission, person and device in addition to a chronological list (see Table 8-2, page 203). If a protocol is printed during the mission, this is saved as the manual event "Protocol printout" in the chronological event list.
202
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Data Management
The log overview contains the following data:
Data Mission
Printout Mission start UTC Patient
Patient ID
Case number
Date of birth (Age)
Sex Weight Height Vital parameter
Device Radio Medical team Callback phone Filter Software version
Explanation Mission number; generated automatically when switching on the device Time of protocol printout Date and time at switch-on of the device Universal Time Coordinated Last name, first name: Can be edited via the main menu "Patient" "Edit Data". Identification number Can be edited via the main menu "Patient" "Edit Data". Intra-hospital identification number Can be edited via the main menu "Patient" "Edit Data" or via an optional barcode scanner Can be edited via the main menu "Patient" "Edit Data". The age is calculated automatically when the date of birth of the patient is entered. Can be edited via the main menu "Patient" "Edit Data". Can be edited via the main menu "Patient" "Edit Data". Can be edited via the main menu "Patient" "Edit Data". Trend values of the last minute before the protocol printout (minute mean values) Identification number of the device Radio call name of the team Names of the medical team Mobile phone number, e. g. for enquiries to the team Filter settings for ECG- and mains filter Current software version (e.g. REL-3.0.0_C3_BP)
Table 8-2
Log overview
The entries in the chronological list all have the same structure and contain the time stamp, the precise designation and the ECG number of the event.
The following example shows an extract from a printed protocol:
ENG - Version 4.0 P/N 04130.2
203
Data Management
User Manual corpuls3
Fig. 8-4 Example of an ECG in the protocol at the time of an event
The following entries are included in the chronological list:
· alarms, physiological and technical (configurable, see chapter 7.4.6 Alarm Configuration (Persons Responsible for the Device), page 185)
· beginning and end of mission · defibrillation events with selected energy level, measured energy, impedance and selected
defibrillation mode · printer actions (protocol printout; real-time printout; D-ECG printout, shock protocol printout) · corpuls3 switch-on time · internal software errors · Manual events · Pacer events · Switch to monitoring mode
mV-mark Markings for folding
Note Note
The millivolt mark (in form of a rectangular impulse) is located at the left margin of the curve field (mVmark). Its height depends on the set amplification of the ECG curve. The mV mark shows an amplitude height of 0.5 or 1 mV for comparison, so that the scale of the ECG curve displayed can be set in relation.
The real-time printout has vertical markings on the upper and lower edges that help to fold the printout quickly. The folded printout fits the width of a standard sheet of paper (DIN A4) and can be attached there for documentation.
Do not separate or connect the modules while the protocol is being printed, otherwise parts of the printout will be missing.
If no CompactFlash® card is present while using the corpuls3 or if the inserted card is full, no complete protocol printout can be made.
If the checkbox in the group "Shock Protocol" in the defibrillator settings is selected, a protocol containing information on the patient, vital parameters, ECG-curve, selected energy, patient impedance and released energy is printed automatically after a defibrillation. This feature is enabled by default in the factory settings and can be disabled by the operator.
The mission data of the ventilator Medumat Transport of the company WEINMANN Emergency Medical Technology GmbH + Co. KG can be printed out on the corpuls3 by means of the Bluetooth® interface.
204
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Data Management
8.5.2 Mission Browser
Browser
If the Browser key is pressed for more than 3 s, the mission browser opens. The mission browser gives an overview of all the missions saved on the CompactFlash® card and its current free memory capacity. The missions are listed chronologically, with the most recent mission on top of the list. The mission browser makes it possible to print out the protocol of a mission, the trend data or the available D-ECGs and longterm ECGs several times or at a later point in time. D-ECGs from an old missions can also be sent later on.
Additionally the corPatch CPR summary can be printed out. The mission contents in the column "Data" are represented by symbols.
Symbol Diagnostic ECG Indicates that the mission contains D-ECG data.
Symbol Resuscitation
Indicates that the mission contains CPR data.
Symbol Defibrillation
Indicates that the mission contains defibrillation data.
Table 8-3
Symbols for mission contents
Fig. 8-5 Mission browser
The individual missions can be identified based on the following data:
· Unit application number (mission)
· Time/Date · Patient name (Pat. ID) · Sex (m/f) · Age
· Weight · Height · Symbol for D-ECG · Symbol for CPR · Symbol for defibrillation
ENG - Version 4.0 P/N 04130.2
205
Data Management
User Manual corpuls3
Note Note Note D-ECG Browser
The required mission can be selected with the jog dial. It is then possible to print the log by pressing the softkey [Protocol].
The softkey [Trend] opens the trend browser of the selected mission. The softkey [Config.] opens a configuration dialogue, in which the displayed trend parameters can be selected or deselected via checkbox.
The current mission is always shown on top of the list, independent from time and date.
A protocol that has been compiled with an older software version cannot be printed at a later point. The softkey [Protocol] is greyed out in this case.
The intended use of the operation browser and of the D-ECG browser is limited to the analysis of the mission after monitoring of the patient.
With the jog dial those missions that contain one or more D-ECGs can be selected and opened in the DECG browser by pressing the softkey [D-ECG]. The available D-ECGs can be selected individually and printed out by pressing the softkey [Print].
Fig. 8-6 D-ECG Browser
Sending later Longterm ECG browser
With the softkey [Send], the marked D-ECG can be sent later on (see chapter 9.4.2 Sending a D-ECG, page 222). .
With the softkey [LT-ECG] the longterm ECG can be opened in the longterm ECG browser and printed out at a later point in time (see also chapter 6.5 Longterm ECG, page 127).
206
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Data Management
8.6 Analysis of the Data with corpuls.manager REVIEW
The data saved on the CompactFlash® card (device software version 1.7.2 or higher) can be viewed, further processed and analysed with the PC software program corpuls.manager REVIEW (version 1.3 or higher). Note Information regarding the use of corpuls.manager REVIEW can be found in a separate user manual for corpuls.manager REVIEW (P/N 04135.02). Note Information regarding data protection can be found in Appendix O Note on Data Protection, page 348.
8.6.1 Recording of Realtime Data (RTD) tracks
As of software version 3.0 the user OPERATOR can select every parameter displayed on the corpuls3 to be recorded on the CF card. The recording of real-time data tracks is particularly of interest for research purposes.
1. Select in the main menu "Signals" "Record". 2. Select the parameters to be recorded.
Note It is recommended to record a maximum of 8 RTD tracks simultaneously, because due to the recording the data volume of the mission increases significantly and there may be gaps in the data if more than 8 tracks are recorded simultaneously.
8.7 Screenshot
Printing a screenshot
If the Print key is pressed for more than 3 seconds, a screenshot is printed out. It shows the screen contents at the time of the printout. The following further information is contained on the printout:
· Date and time of the screenshot printout · Unit application number (mission) · User level · Serial number of the monitoring unit · Software version of the corpuls3 · Charging status of the batteries in percent (in this order: patient box, monitoring unit,
defibrillator/pacer)
Note In addition to the printout of the screen copy, an image file is saved on the CF card. The screenshot can be viewed with the software corpuls.manager REVIEW (see chapter 8.6 Analysis of the Data with corpuls.manager REVIEW, page 207).
8.8 Insurance card reader (option)
The insurance card reader allows to read out the patient data stored on the insurance card of the patient so that they are available to the data management in the corpuls3.
The patient data can be completed or changed during the mission by manually entering information. Persons responsible for the device can configure and save permanently which patient data from the
ENG - Version 4.0 P/N 04130.2
207
Data Management
User Manual corpuls3
insurance card should be displayed, printed or sent by the corpuls3 (see chapter 7.4.11 Data Protection Settings (Persons responsible for the device), page 193).
1. Insert the insurance card (with the chip oriented towards the front of the monitoring unit) into the insurance card reader on the right-hand side of the monitoring unit.
Fig. 8-7 Readout of patient data from insurance card reader
2. With the softkeys [OK] and [Edit] the data set from the insurance card can be accepted or edited. 3. Press the softkey [Print] to print out the data set from the insurance card and save the data set.
Alternatively, patient data that are not greyed out, can also be entered manually. For this, select "Patient" "Edit Data" in the main menu.
The data set from the insurance card can be deleted from the corpuls3. For this, select "Patient" "Erase data" in the main menu.
Caution
Patient and insuree have to be one person, otherwise the results of the ECG analysis can be misinterpreted.
Note The insurance card reader is currently only available for customers in Germany, Austria, Switzerland, Belgium, Estonia, Italy and France. Further countries are available upon request.
Symbol A monitoring unit that is equipped with an insurance card reader (option) can be recognised by the card insurance card reader symbol at the card slot.
208
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Data Management
9 Telemetry 3.0
Configuration Telemetry (Option)
Persons responsible for the device can set the following configurations:
· Activation and configuration of data interfaces · GSM modem · GPRS interface · LAN interface · WLAN interface · Bluetooth interface
· Activation and configuration of telemetry services · corpuls.web LIVE (Live data, D-ECG upload) · D-ECG transmission (Fax) · Mission upload to FTP server
· Configuration of W/LAN networks · Configuration of telemetry connections (phonebook) · Configuration of Bluetooth connections.
Offline mode
The corpuls3 has an offline mode. This mode disables all external connection technologies (WLAN, LAN, GSM, Bluetooth) at once. External connection technologies are radio connections for communication with external receivers. Internal connection technologies are the radio connections between the modules of the corpuls3.
To disable all radio connections (internal and external), the device has to be operated in offline modes and as a compact device.
The airplane symbol in the status-/alarm line indicates that the offline mode is active. Apart from the offline mode, it is possible to disable data interfaces individually.
ENG - Version 4.0 P/N 04130.2
209
Data Management
User Manual corpuls3
9.1 Configuration of Telemetry (Persons Responsible for the Device)
Configuration of data 1. Select in the main menu "Telemetry" "Settings".
interfaces
The configuration dialogue opens.
Fig. 9-1 Telemetry settings (Persons responsible for the device)
Table 9-1 shows the possible values:
Group GSM GPRS
(W)LAN
Field Enabled PIN APN User Password
Enabled
Region
Setting
Value
Enables or disables aircraft mode
Enabled, disabled
Code number
Numbers from 0-9
Access point to the data net Numbers, symbols and letters
User name
Numbers, symbols and letters
Authentication (user-definable Numbers, symbols and letters combination)
Activation of the W/LAN interface
Enabled, disabled
Country codes for W-LAN regional settings
AU, AT, BE, BR, CA, CN, CY, CZ, DK, EE, FI, FR, DE, GR, HK, HU, IS, IN, ID, IE, IL, IT, JP, KR, LV, LT, LU, MY, NL, NZ, NO, PL, PT, SG, SK, ZA, ES, SE, CH, TW, TH, TR, GB, US*
* List of countries see appendix D Table A-35, page 319.
210
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Data Management
Group Table 9-1
Field
Setting
2.4 GHz
Enabling or disabling the frequency band
5 GHz
Enabling or disabling the frequency band
Configuration values, telemetry
Value
Enabled, disabled
Enabled, disabled
2. In the group "GSM" the user can enable or disable the GSM interface and enter the PIN of the mobile communications provider (see chapter 9.1.2 Configuration GSM modem, page 211).
3. In the group "GPRS" the user can enter the APN and, if intended by the mobile communications provider, enter the user name and password for login to the data net (see chapter 9.1.3 Configuration GPRS connection, page 212).
4. In the group "(W)LAN" the user can enable or disable the (W)LAN interface and select the regionally approved frequency bands via country code (list of countries see Appendix D, Table A-35, page 319) or enable/disable individual frequency bands.
Note In some countries certain frequency bands are nor approved, therefore the user OPERATOR can disable the 2.4 GHz- and the 5 GHz frequency band individually. Operators are responsible for complying with restricted use regulations in their region/country.
9.1.1 Installing the SIM Card
For telemetry transmissions you need a SIM card and a PIN number from your mobile network service provider. The SIM card must be inserted in the SIM card slot on the rear side of the monitoring unit (see page 15, Fig. 3-6 Monitoring unit, rear view).
The PIN must be deposited in the telemetry settings in the group "GSM" (see chapter 9.1.2 Configuration GSM modem, page 211).
9.1.2 Configuration GSM modem
To configure the GSM modem, proceed as follows:
1. Select in the main menu "Telemetry" "Settings". 2. Enter the 4-digit PIN in the group "GSM" and confirm. The PIN is assigned by your mobile
communication provider. 3. To confirm the settings and close the configuration dialogue, press the softkey [OK].
To retain the previous settings and close the configuration dialogue, press the softkey [Cancel]. Note If in the group "GSM" the checkbox "Enable" is not selected, the field "PIN" and the group "GPRS" are
greyed out and cannot be edited.
Note The maximum length of the PIN is four digits. With SIM cards without PIN, the PIN code "0000" has to be entered.
Note If a wrong PIN has been entered and transmission has been attempted three times in a row, the SIM card will be locked. Fax transmission is then no longer possible. In that case, the SIM card can only be unlocked by inserting it into an external mobile phone and entering the PUK there.
Note Using a double SIM card (depending on your mobile communications provider also called twin SIM card, dual SIM or multi SIM card), is only possible if other user devices with the pertaining SIM cards are off. So it is not possible to operate several SIM cards of one mobile communications contract at the same time. So it is not possible to operate several SIM cards of one mobile communications contract at the
ENG - Version 4.0 P/N 04130.2
211
Data Management
User Manual corpuls3
same time. The operator of the device has to make sure beforehand that the operation of the SIM card used in the corpuls3 cannot be interrupted. Note As of software version 3.0, the former import-/export function for phonebook entries (= telemetry connections) via the SIM card is no longer supported. The import and export of telephone entries is only possible via the CF card. Depending on the selected mobile provider and on the network configuration, there are different ways to enter the internet address or IP address (with or without "www"). Ask your corpuls.web LIVE administrator for help.
9.1.3 Configuration GPRS connection
To configure the GPRS connection, proceed as follows: 1. Select in the main menu "Telemetry" "Settings". 2. Enter the APN (Access point name) in the group "GPRS" and confirm. 3. For the log-in to the data net via GPRS, enter the user (user name) and confirm. 4. Enter password and confirm. 5. To confirm the settings and close the configuration dialogue, press the softkey [OK].
To retain the previous settings and close the configuration dialogue, press the softkey [Cancel]. Note If in the group "GSM" the checkbox "Enable" is not selected, the field "PIN" and the group "GPRS" are
greyed out and cannot be edited. Note The respective valid APN is assigned by your mobile communications provider. Note The log-in with user name for access to the data service is only designated for a few mobile
communication networks. For further information please contact your mobile communications provider. Note In the corpuls3, all characters are in UTF-8 code.
9.1.4 WLAN interface configuration
To configure the WLAN interface, proceed as follows: 1. Select in the main menu "Telemetry" "Settings". 2. Select in the group "(W)LAN" the corresponding country code (List of countries see Appendix D
Table A-35, page 319). 3. If necessary, disable the frequency band that is not approved for current use. 4. To confirm the settings and close the configuration dialogue, press the softkey [OK].
To retain the previous settings and close the configuration dialogue, press the softkey [Cancel]. Note In some countries certain frequency bands are nor approved, therefore the user OPERATOR can disable
the 2.4 GHz- and the 5 GHz frequency band individually. Operators are responsible for complying with restricted use regulations in their region/country. Note If both the 2.4 GHz- and the 5 GHz bands are disabled, a WLAN connection is not possible.
212
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Data Management
9.1.5 Saving telemetry connections (Phonebook)
Note The settings described in the following have to be saved in the system settings in the group "Configuration" in order to be available permanently. 1. Select in the main menu "Telemetry" "Connections". The configuration dialogue opens.
Fig. 9-2 Telemetry connections (Persons responsible for the device)
2. Select "Add destination" by pressing the jog dial. 3. Enter the recipient`s name. 4. Enter the recipient type. 5. Enter the recipient`s e-mail address, phone number, internet address or IP address. 6. Press softkey [Enter] to confirm. 7. To confirm the settings and close the configuration dialogue, press the softkey [OK].
To retain the previous settings and close the configuration dialogue, press the softkey [Cancel]. There are up to 50 memory locations available for saving telemetry connections. Note If more than 20 new entries are created at once, saving will take longer. Note In the corpuls3, all characters are in UTF-8 code. There are 4 options for recipient type:
· FAX-S · CWEB · CWEB AUTO · E-mail
ENG - Version 4.0 P/N 04130.2
213
Data Management
User Manual corpuls3
Exporting and importing the phonebook
Note
The saved phonebook entries (= telemetry connections) are part of the configuration export, but can also be exported/imported separately for backup purposes or transfer to other corpuls3 devices via the CF card (see chapter 7.4.2 General System Settings (Person responsible for the device), page 176).
As of software version 3.0, the former import-/export function for phonebook entries (= telemetry connections) via the SIM card is no longer supported. The import and export of telephone entries is only possible via the CF card.
9.2 Configuration of Telemetry Services (Persons Responsible for the Device)
1. Select in the main menu "Telemetry" "Services". The configuration dialogue opens.
Fig. 9-3 Configuration of Telemetry Services
Table 9-2 shows the possible values:
Group
Field
Enabled
corpuls. web
Interface TCP d. port UDP d. port Connection
Reconnect
Setting
Connection with the corpuls.web LIVE server
Interface by means of which the connection to the server is established
Network protocol
Network protocol
Procedure when the connection to the server is initiated
Number of repeated attempts to establish connection
Value Enabled, disabled Fast, GSM, (W)LAN, G,(W)L, (W)L,G Numbers from 0-9 Numbers from 0-9
Manual, Startup
Off; 3; 5; 10; Infinite
214
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Data Management
Group D-ECG Fax
Mission upload
Mission storage Table 9-2
Field
Setting
Value
Auto upload
Automated sending of a D-ECG to the CWEB AUTO Address in the phonebook
Enabled, disabled
Enabled
Sending a D-ECG via fax
Enabled, disabled
Interface
Interface by means of which the
Fast, GSM, (W)LAN,
connection to the server is established G,(W)L, (W)L,G
Speed
D-ECG speed at fax transmission
25 mm/s, 50 mm/s
Server address Network address of the server
Numbers, symbols and letters
TCP port
Network protocol
Numbers from 0-9
Enabled
Automatic upload of missions from the Enabled,
CF card to a server
disabled
Interface
Interface by means of which the
Fast, GSM, (W)LAN,
connection to the server is established G,(W)L, (W)L,G
Server address Network address of the server
Numbers, symbols and letters
Target path
Directory path for uploading
Numbers, symbols and letters
TCP port
Network protocol
Numbers from 0-9
Reconnect
Number of repeated attempts to establish connection
Off; 3; 5; 10
User
User name
Numbers, symbols and letters
Password
Authentication (user-definable combination)
Numbers, symbols and letters
Printout
Enabling/disabling of the mission upload protocol printout
Enabled, disabled
Mode
Storing a certain number of missions or None, Count, Time for a period of time
Interval
Period of time for which the missions should remain on the CF card
1, 2, 3, 4, 5, 6, 7 days
Missions
Number of missions that should remain 10, 25, 50, 100, 150,
on the CF card
200
Configuration of Telemetry Services
Connection to corpuls.web LIVE server Automatic Upload of D-
ECG
Note
Fax configuration
In the group "corpuls.web" the connection to the corpuls.web LIVE server can be activated and configured (see chapter 9.2.1 Configuring a connection to corpuls.web LIVE, page 216).
If the checkbox "Auto upload" in the group "D-ECG" is ticked and a connection is established, the recorded D-ECG is automatically sent to a corpuls.web LIVE server by pressing the softkey [Print]. It is not necessary to press the softkey [Send] as well.
The option "Auto upload" does only work with connections to corpuls.web LIVE.
In the group "Fax" the sweep speed for the D-ECG and the connection to the fax server can be configured (see chapter 9.4.2 Sending a D-ECG, page 222)
ENG - Version 4.0 P/N 04130.2
215
Data Management
User Manual corpuls3
Note Configuration Mission upload
Note
For information on the network address of the fax server contact your system administrator or fax server administrator.
The user OPERATOR can configure that recorded missions are uploaded automatically to an FTP server (e.g. a corpuls.manager ANALYSE server) when the device is switched off (see chapter 9.2.3 Configuration of mission upload, page 217).
The login data (user name and password) for access to the FTP server will be assigned by the respective system administrator.
Note For information on the network address of the FTP server contact your system administrator or FTP server administrator.
Note In the corpuls3, all characters are in UTF-8 code.
9.2.1 Configuring a connection to corpuls.web LIVE
1. Select in the main menu "Telemetry" "Services". 2. If necessary, select checkbox "Enable" to activate the service. 3. In the field "Interface" select how the connection to the serve should be established.
a) Fast: the interface that has established a connection to the server first will be used. b) GSM: the connection is established via GSM interface. c) (W)LAN: the connection is established via WLAN interface. d) G, (W)L: first the connection is attempted via GSM, then via (W)LAN. e) G, (W)L: first the connection is attempted via (W)LAN, then via GSM. 4. Enter the standard TCP port and confirm. 5. Enter the standard UDP port and confirm. 6. To configure the method of establishing a connection: a) Select "Manual" in the field "Connection", to start the connection manually via the main menu. b) Select "Startup" in the field "Connection" if the connection should be established
automatically while the corpuls3 is booting. For this setting, a "CWEB Auto"-phonebook entry has to be created beforehand, in which the IP address of the respective corpuls.web LIVE server is entered (see chapter 9.1.5 Saving telemetry connections (Phonebook), page 213). 7. Select the required setting with the jog dial and confirm. 8. In the field "Reconnect" can be determined if and how often the corpuls3 should automatically reconnect if the connection has been broken (e. g. if the GSM network is not available). Select the required setting and confirm.
Note
Automatic Upload of DECG Note
For information on the network address of the corpuls.web LIVE server contact your system administrator or corpuls.web LIVE server administrator.
If the checkbox "Auto upload" in the group "D-ECG" is ticked and a connection is established, the recorded D-ECG is automatically sent to a corpuls.web LIVE server by pressing the softkey [Print]. It is not necessary to press the softkey [Send] as well.
The option "Auto upload" does only work with connections to corpuls.web LIVE.
216
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Data Management
9.2.2 Configuration of fax transmission
Fax configuration
In the group "Fax" the following fields can be configured for the D-ECG and the connection to the fax server:
1. Select the sweep speed for the D-ECG transmission (25 mm/s or 50 mm/s) and confirm. The user DEFAULT can change the speed settings during the mission.
2. Enter the network address of the server (IP address or domain) and confirm.
3. Enter the TCP port and confirm.
9.2.3 Configuration of mission upload
1. Tick the checkbox "Enabled" in the group "Mission upload". 2. Enter the server address and confirm. 3. Enter the target path and confirm. 4. Enter the TCP port and confirm. 5. In the field "Reconnect" can be determined if and how often the corpuls3 should automatically
reconnect if the connection could not be established or has been broken. Select the required setting and confirm. 6. For the log-in to the FTP server enter the assigned login data and confirm. 7. With the checkbox "Printout" the printout of the mission upload protocol can be enabled or disabled. If the checkbox is selected, there is always a printout. If the checkbox is deselected, there is only a printout if the transmission has failed. 8. With the option "Mission storage", the user OPERATOR can configure how long the missions or how many missions should remain on the CF card when the corpuls3 is switched off.
Note The login data (user name and password) for access to the FTP server will be assigned by the respective system administrator.
Note For information on the network address of the FTP server contact your system administrator or FTP server administrator.
Note If too many missions remain on the CF card and the device stores new missions, the CF card may overflow (alarm messages "CF card almost full" or "CF card full").
Note In the corpuls3, all characters are in UTF-8 code.
ENG - Version 4.0 P/N 04130.2
217
Data Management
9.3 Configuration of (W)LAN networks
Configuration of (W)LAN networks
To configure a (W)LAN network, proceed as follows:
1. Select in the main menu "Telemetry" "Networks". The configuration dialogue opens.
User Manual corpuls3
Fig. 9-4 Add network
218
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
2. Select "Add network" by pressing the jog dial. The configuration dialogue opens.
Data Management
Fig. 9-5 Configuring a network
3. Enter a name for the network. 4. Select the network type. Note It is possible to configure up to 4 WLAN networks, but only 1 LAN network.
5. Select mode. a) With the option "DHCP", an IP address is assigned automatically to the corpuls3. Proceed with step 6. b) With the option "Manual", the formerly greyed-out fields are now displayed and can be edited (see chapter 9.3.1 Manual network settings, page 220).
6. Enter the SSID* (Service Set Identifier = in general the name of the router). 7. Select encryption type. 8. Enter password. 9. To save, press softkey [Accept].
To delete data, press softkey [Delete].
Note Already configured WLAN networks can be copied with the softkey [Copy] (see Fig. 9-4) and then adapted to save time with the configuration.
Note With the softkey [Prio], a priority can be assigned to the configured WLAN network. The corpuls3 tries first to establish a connection with the priority-1 network, then with the priority-2 network, and so on.
ENG - Version 4.0 P/N 04130.2
219
Data Management
User Manual corpuls3
9.3.1 Manual network settings
To configure the network manually, proceed as follows: 1. Perform step 1-5b of chapter 9.3. 2. Enter an IP address in the field "IP address" and confirm. 3. Enter an IP address in the field "Network mask" and confirm. 4. Enter an IP address in the field "Default gateway" and confirm. 5. Enter an IP address in the field "DNS server prim" (primary DNS server) and confirm. 6. If available, enter an IP address in the field "DNS server sec." (secondary DNS server) and confirm.
Note It is possible to configure up to 4 WLAN networks, but only 1 LAN network.
9.4 Data transmission options
The corpuls3 offers the following possibilities for transmitting data via telemetry:
· Live data transmission to corpuls.web LIVE · D-ECG transmission · Mission upload to an FTP server(see chapter 9.4.3 Manually uploading missions to an FTP server,
page 223) · Data transmission to external systems via Bluetooth® data interface (option) · Receiving webMessages
D-ECG transmission Note
Live data transmission
The corpuls3 can send a complete report of a 12-lead ECG recording (diagnostic ECG) to a fax server, an e-mail address or to the corpuls.web LIVE server via the optionally available modem or the W/LAN interface.
The corpuls3 has an offline mode. This mode disables all external connection technologies (WLAN, LAN, GSM, Bluetooth) at once. The airplane symbol indicates that the offline mode is active.
Via the modem (option) or the WLAN/LAN interface (option) the corpuls3 can send the following date live, in real time, to a data server:
· Patient- and master data, · Curves and vital parameters, · D-ECGs and events, · Trends.
Server connection
By means of the software application corpuls.web LIVE (option), the server can be accessed from any place via internet and the data can be viewed live.
If the corpuls3 is connected to a server, the symbol "Server connection" is displayed in the status/alarm line.
Bluetooth® connection
If a connection via the Bluetooth® data interface is established to external systems (as e. g. a Tablet-PC for documentation) the symbol "Bluetooth® connection"is displayed in the status-/alarm line.
Depending on the status there are additional markings of the above described symbols for telemetry connections. A detailed description can be found in Appendix A Symbols, page 289.
220
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Data Management
Note Information regarding data protection can be found in Appendix O Note on Data Protection, page 348.
Note Saving changes to the basic configuration permanently is reserved to the person responsible for the device (see chapter 7.4.2 General System Settings (Person responsible for the device), page 176).
The representation of the curves (sweep speed) for fax transmission of the D-ECG can be set in the telemetry services settings at 25 mm/s or 50 mm/s (Only for Fax-G).
9.4.1 Live Data Transmission to corpuls.web LIVE
Mobile network connection
To carry out a live data transmission, proceed as follows:
1. Check if the symbol "Mobile network connection" is displayed in the status-/alarm line. If not, establish a connection manually (see chapter 9.4.4 Manually Establishing a Connection to the Mobile Network, page 224).
WLAN connection LAN connection
2. If the device is connected via a W/LAN interface instead, check if the symbol "WLAN connection" or "LAN connection (IP address assigned)" is displayed in the status-/alarm line. To configure the W/LAN interface, see chapter 9.1.4 WLAN interface configuration, page 212.
"Server connection 3. Check if the data connection between the corpuls.web LIVE server and the corpuls3 is already established and the symbol "Server connection" is displayed permanently.
Now all data shown on the display of the corpuls3 are transferred live.
4. To abort the current live data transmission select "Telemetry" "Disconnect" in the main menu.
During the live data transmission all therapeutic and monitoring functions of the corpuls3 can be used without limitations. The observer of the live data using corpuls.web LIVE can see the same parameters and curves that are currently displayed on the connected corpuls3.
Live transmission of DECGs
If the user of the corpuls3 records a D-ECG, it is transferred live to the server and can immediately be reviewed via corpuls.web LIVE. The user of corpuls.web LIVE receives a notification in case of an incoming D-ECG.
Transfer of trend data base
The corpuls3 allows to transfer the complete trend data base to corpuls.web LIVE. So, the consulting doctor using corpuls.web LIVE can review the whole development and gain an overview of the patient`s status.
If the connection could not be established or if the live data transmission was aborted, this is being signaled via diverse symbols and alarms in the status-/alarm line.
The protocol records status messages of the live data transmission as event. For a list of possible events see chapter 11.3 Notifications Message Line and Information in the Protocol, page 276. In case of malfunctions see also chapter 11.2 Troubleshooting and Corrective Actions, page 265 and Appendix A Symbols, page 289.
Note Depending on the settings on the corpuls.web LIVE server, the system time set on the corpuls3 is synchronised by the corpuls.web LIVE server before the transmission of mission data. The time change is logged in the mission protocol of the corpuls3.
Note If the connection is interrupted during data transmission, the D-ECG may nevertheless have been transferred completely. The accuracy of the transferred data is guaranteed in this case as well.
Note Via the mission browser, D-ECGs from the current mission can be sent again, see chapter 8.5.2 Mission Browser, page 205.
ENG - Version 4.0 P/N 04130.2
221
Data Management
User Manual corpuls3
9.4.2 Sending a D-ECG
Prerequisite: The CF card is inserted. 1. Activate the preview of the D-ECG in monitoring mode and start recording (see chapter 6.4.3
Recording and Measuring a Diagnostic ECG, page 120). Note Before sending the D-ECG, the patient data should be entered so that the D-ECGs received can be clearly
assigned to the patient treated. 2. After the message "D-ECG measured" is displayed, press the softkey [Send]. The phonebook (= telemetry connections) appears.
Fig. 9-6 Phonebook (= telemetry connections)
3. The destination can be entered in two ways: a) Select a pre-configured destination with the jog dial and confirm by pressing the jog dial, or a) Select the entry "Manual destination" and enter the data manually with the jog dial and confirm by pressing the softkey [Enter].
Note In the corpuls3, all characters are in UTF-8 code.
While the data connection is being established, the symbol "Connect" is flashing.
While the D-ECG transmission is running, the symbol "D-ECG transmission" is flashing in the status/alarm line. By pressing the softkey [Cancel] the monitoring mode for patient monitoring can be called up again. The ECG transmission is carried out in the background. If the ECG transmission has been finished successfully, this is indicated by the confirmation tick on the symbol.
222
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Data Management
Caution
If a D-ECG recording is started without an inserted CF card or with a full/defective CF card, the alarm
message "CF card missing" and the message "CF card currently not available" appear and the softkey [Send] is greyed out. Sending the D-ECG is not possible, because no connection to the server can be established.
D-ECG transmission failed
If the D-ECG transmission is interrupted for technical reasons (e. g. insufficient reception quality or
interruption of the radio connection) the alarm message "D-ECG transmission error" is displayed. In case of malfunctions see also chapter 11.2 Troubleshooting and Corrective Actions, page 265, and Appendix A Symbols, page 289.
Note Via the mission browser, D-ECGs from the current mission can be sent again, see chapter 8.5.2 Mission Browser, page 205.
9.4.3 Manually uploading missions to an FTP server
Uploading missions to a server
If feature is configured (see chapter 9.2.3 Configuration of mission upload, page 217), the upload of recorded missions to an FTP server can be started manually:
1. Select in the main menu "Telemetry" "Mission upload". The confirmation prompt "Upload missions?" appears.
Fig. 9-7 Confirmation prompt for mission upload
2. If the recorded missions are to be uploaded to an FTP server and the current mission finished, press softkey [OK]; If the current mission should be continued, press softkey [Cancel].
3. The upload screen appears, indicating the progress of the upload, e.g. "Uploading mission [NUMBER] of [NUMBER]" (see also chapter 4.2.2 Switching off, page 49).
4. When all missions have been uploaded successfully, a "MISSION UPLOAD PROTOCOL" is printed, indicating the time and date of the upload, the connection data (FTP Server, TCP port, User, FTP Path), reconnection settings, status of the upload, the termination criteria (if applicable) and the mission numbers of the uploaded missions.
5. With the checkbox "Printout" the printout of the mission upload protocol can be enabled or disabled. If the checkbox is selected, there is always a printout. If the checkbox is deselected, there is only a printout if the transmission has failed.
6. The device switches off.
Note Missions that have been uploaded successfully will be deleted from the CF card.
Note If the mission upload is interrupted, before all missions are transferred completely, the upload is resumed at a later point in time.
Note The exact procedure of the automatic mission upload is described in chapter 4.2.2 Switching off, page 49.
ENG - Version 4.0 P/N 04130.2
223
Data Management
User Manual corpuls3
9.4.4 Manually Establishing a Connection to the Mobile Network
Symbol If the modem has sufficient reception intensity, this is indicated by the symbol "Mobile network Mobile network connection" in the status-/alarm line of the corpuls3.
connection
Establishing a connection manually
If the telemetry services are not configured to connect automatically when the corpuls3 is switched on (see chapter 9.2.1 Configuring a connection to corpuls.web LIVE, page 216), the connection can be established manually:
1. Select in the main menu "Telemetry" "Connect". 2. While the connection is being established, the symbol "Mobile network connection" is flashing in
the status line.
3. When the symbol "Mobile network connection" is displayed permanently, the mobile network connection is established.
Depending on which transmission mode is selected, different symbols will appear in the status line next to the symbol "Mobile network connection" (see Appendix A Symbols, page 289).
Note The duration of establishing a connection may vary according to network quality.
Note Under certain conditions data transmission may be interrupted due to low signal strength of the mobile communications network.
Note In areas near national borders the mobile communications networks may overlap, so it may be necessary to enter the international area code as well to be able to contact the recipient. In this case, adapt to your country-specific settings (e.g. "+49 9876 54321" or "0049 9876 54321").
Note At locations where radio signals are shadowed for technical reasons (e.g. inside a flat), low signal levels may occur in mobile phone reception. In this case, select a better position for the monitoring unit, e.g. near a window.
9.5 Bluetooth
Bluetooth® data interface (option)
The corpuls3 can wirelessly import and export data via the optional Bluetooth® data interface (P/N 04211). For example, with the radio module in the patient box process data of a corpuls3 mission can be transferred to external documentation systems (e. g. a tablet PC, ePCR systems) but data also be received from other systems (e. g. a ventilator, corpuls cpr).
Mode "Discovery" To have the the corpuls3 send its identification via Bluetooth, select in the main menu "Bluetooth" "Discovery".
9.5.1 Configuring a Bluetooth® data interface (Persons Responsible for the Device)
Bluetooth® data interface
Activating the data interface
Persons responsible for the device can set the following configurations:
· Activation of the Bluetooth® data interface (option) · Configuration of the device PIN (option) · Configuration of the data protection PIN · Data management (Transferring/deleting mission data, editing patient- and master data, formatting
the CF card) To establish a radio connection with external devices, the device PIN has to be configured and the Bluetooth® data interface has to be activated.
224
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Bluetooth® Settings 1. In the main menu, select "Bluetooth" "Settings". The configuration dialogue opens.
Data Management
Fig. 9-8 Bluetooth settings (Persons Responsible for the Device) 2. To activate the Bluetooth data interface, select the checkbox "Enable". 3. Configure the device PIN.
Note If the default PIN is changed by the user OPERATOR, the new PIN must be made known to the user.
4. To configure the data protection PIN, enter a 4-digit number.
Table 9-3 shows the possible values:
Group Bluetooth MAC address Ventilator
Field Enabled PIN Data protect
--
Events Trends
Setting
Enabling or disabling Bluetooth® data interface
Device PIN for connections with other Bluetooth® devices. Further user-defined PIN that grants access to modify mission data via Bluetooth. The MAC address is the unambiguous identification number of the corpuls3 that has to be used to connect the corpuls3 to other Bluetooth® devices.
Data that can be printed out via a Bluetooth connection on the printer of the corpuls3.
Values Enabled, disabled Numbers from 0-9 Numbers from 0-9
Fixed
Enabled, disabled Enabled, disabled
ENG - Version 4.0 P/N 04130.2
225
Data Management
User Manual corpuls3
Group Quick select Table 9-3
Field
Setting
Values
AED Man. Defib.
Allows to enable or disable the softkey [Connect] in defibrillator mode AED or Man. Defib..
Enabled, disabled
Enabled, disabled
Values for Bluetooth® configuration
Data protection PIN MAC address Ventilator
Quick select Note
To be granted access to modify mission data on the CF card (see chapter 9.5.4 Data management via Bluetooth®, page 228), another four-digit data protection-PIN has to be configured beforehand by the user OPERATOR.
The MAC address is the hardware address of the Bluetooth module and serves as identification of the device in a network. The MAC address cannot be changed.
In case of a connection to a ventilator (e.g. Weinmann MEDUMAT Transport), the corpuls3 can, according to configuration, print out the events and trends received from the ventilator and save them on the CF card. The stored data can be evaluated with the software corpuls.manager REVIEW (see chapter 8.6 Analysis of the Data with corpuls.manager REVIEW, page 207).
Allows to enable or disable the softkey [Connect] in defibrillator mode AED or Man. Defib.. If the option is disabled, no Bluetooth connection to a corpuls cpr can be established.
If a Bluetooth connection to a corpuls cpr already exists, the softkey [Connect] is greyed out.
9.5.2 Configuring Bluetooth® connections
Bluetooth®-connections 1. Select in the main menu "Bluetooth" "Connections". The configuration dialogue opens.
Fig. 9-9 Bluetooth connections (persons responsible for the device) 2. Select "Add destination" by pressing the jog dial.
226
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Data Management
3. Enter device name. 4. Enter MAC address of the device to be connected (can be requested from the manufacturer). 5. Enter the device PIN of the device to be connected (can be requested from the manufacturer). 6. Press softkey [Enter] to confirm. 7. To confirm the settings and close the configuration dialogue, press the softkey [OK].
To abort data entry and close the configuration dialogue, press softkey [Cancel].
Connection authorisation (Pairing)
A maximum of 20 Bluetooth connections can be saved.
If the Bluetooth® data interface is activated, the corpuls3 can receive automatically an connection authorisation for a connection with an external documentation system, if this system has the same PIN. This procedure is also called "Pairing".
With the softkey [Scan], the user can search for corpuls devices that are in discovery mode.
9.5.3 Establishing and interrupting a Bluetooth® connection
Establishing a Bluetooth® connection
To establish a Bluetooth® connection, proceed as follows:
1. In the main menu, select "Bluetooth" "Connect". The overview of pre-configured Bluetooth® connections opens.
Symbol Bluetooth® Data interface
Fig. 9-10 Bluetooth connections
2. Select the device to be connected with the jog dial and confirm by pressing the jog dial. 3. To search for devices:
a) Press softkey [Scan]. The window shows the message "Scanning...". If there are devices in the vicinity in discovery mode, these are listed.
ENG - Version 4.0 P/N 04130.2
227
Data Management
User Manual corpuls3
b) Select the device to be connected with the jog dial and confirm by pressing the jog dial. If the connection cannot be established with the default PIN, the corpuls3 shows an entry dialogue. Proceed with step 6.
4. To enter a manual destination, select with the jog dial "Manual destination".
5. Enter the name and the device ID of the device to be connected (can be requested from the manufacturer or be read out via NFC chip).
6. Enter the device PIN of the device to be connected and confirm.
Note
Bluetooth® connection failed
A Bluetooth connection to several corpuls cpr devices is not possible.
The message "BT connected: [DEVICE]" appears and the symbol for "Bluetooth® connection" is displayed in the status-/alarm line.
Depending on the status there are additional markings of the above described symbols for telemetry connections. A detailed description can be found in Appendix A Symbols, page 289.
If the Bluetooth® connection is interrupted for technical reasons (e. g. insufficient reception quality or interruption of the radio connection) the message "BT connection failed" is displayed. In case of malfunctions see also chapter 11.2 Troubleshooting and Corrective Actions, page 265 and Appendix A Symbols, page 289.
Interrupting a Bluetooth® connection
1. To abort the current Bluetooth® connection, select "Bluetooth" "Disconnect" with the jog dial in the main menu. If several devices are connected, a configuration dialogue with a list of devices appears. The device that should be disconnected can be selected.
2. The message "BT disconnected: [DEVICE]" is displayed.
The protocol records status messages of the Bluetooth® connection as event. For a list of possible events see chapter 11.3 Notifications Message Line and Information in the Protocol, page 276.
9.5.4 Data management via Bluetooth®
The following actions can be performed via password-protected Bluetooth commands:
· Transferring or deleting mission data from the CF card · Editing patient- and master data · Time synchronisation · Calling up longterm ECGs pertaining to an event · webMessage function · Formatting the CF card
For example, to edit the above mentioned data from an ePCR device, the user has to enter the data protection PIN which was configured beforehand (see chapter 9.5.1 Configuring a Bluetooth® data interface (Persons Responsible for the Device), page 224). Note Only the following master data can be edited: Transport type, Radio ID, Location, Callback phone and Medical team.
228
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Data Management
9.5.5 Bluetooth connection with corpuls cpr
The corpuls3 can connect with the corpuls cpr via Bluetooth. So, common missions can be evaluated retrospectively with corpuls.manager REVIEW. To establish a connection with a corpuls cpr manually (see chapter 9.5.3 Establishing and interrupting a Bluetooth® connection, page 227). From the moment of the Bluetooth connection, the mission data of the corpuls cpr are transferred to the corpuls3 and stored on the CF card. The data are uploaded together with the corpuls3 mission at the mission upload. The currently set parameter values can be displayed in the parameter fields of the corpuls3 (see chapter 7.1.2 Configuration, page 157). With the softkey [Connect] the user can establish the Bluetooth connection directly in defibrillator mode. This feature can be enabled by the operator.
9.6 Offline mode
The corpuls3 has an offline mode. This mode disables all external connection technologies (WLAN, LAN, GSM, Bluetooth) at once. To enable the offline mode, proceed as follows: 1. Select in the main menu "Telemetry" "Offline mode".
The airplane symbol in the status-/alarm line indicates that the offline mode is active. 2. To disable the offline mode, select in the main menu "Telemetry" "Offline mode".
All connection technologies are enabled again. Apart from the offline mode, it is possible to disable data interfaces individually.
9.7 webMessage
The webMessage function allows unidirectional communication between corpuls.web LIVE and corpuls3. The user of corpuls.web LIVE can send a message to the medical personnel using the corpuls3 (teleconsultation). The corpuls3 can display and print the received messages. The respective status of the message (received/read/printed) is reported back to corpuls.web LIVE. The function webMessage can also be used via Bluetooth interface. Incoming webMessages are displayed as low-priority alarms in the alarm-/status line. The message New webMessage No. [NUMBER] received appears in the message line.
Fig. 9-11 Incoming webMessage
The webMessage can be opened immediately with the softkey [Open] or later via the main menu "Printer" "webMessage".
If there are several webMessages in the In-box, these can be paged through with the softkeys [ ] or [ ].
ENG - Version 4.0 P/N 04130.2
229
Data Management
User Manual corpuls3
Fig. 9-12 Printing a webMessage
Printing a webMessage The received webMessages can be printed out on the integrated printer, either individually with the softkey [Print] or all at once with the softkey [Print All]. For further information on printout configuration see chapter 7.1.3 Printer settings, page 160. The printout can be stopped with the Print key.
Note When starting a new mission (e.g. after restarting the device), all received webMessages of the former mission are deleted.
Caution
The display of webMessages can cover other important information on the screen. Users have to make sure that they are always sufficiently informed about the health status of the patient.
230
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Maintenance and tests
10 Maintenance and Tests
10.1 General Information
Visual and Function Check
Regular maintenance and testing guarantee permanent functional and operational readiness of the corpuls3.
Therefore, make sure that the device and the accessories are in good working condition before each mission by performing visual and function checks on the corpuls3 at regular intervals.
This way, electrical and mechanical malfunctions may be either prevented or detected early on and eliminated quickly. If difficulties occur during the visual and function check, see chapter 11 Procedure in Case of Malfunctions, page 250 for specific measures to take. Follow the instructions.
Warning
If the malfunction cannot be remedied with these measures, please inform customer service. In extreme cases, it may be necessary to take the corpuls3 out of commission.
Regular checks
For guidance, a checklist for standardised testing of the corpuls3 is included in Appendix B of this user manual.
The following schedule for maintenance and tests shows recommended intervals for performing checks. Compliance with legal regulations relating to safety and metrological checks must be guaranteed. Furthermore, it is recommended to schedule regular function checks at the location of the corpuls3 (rescue equipment, location, hospital, etc.) to guarantee full operational readiness at all times.
For further information on maintenance and testing of the corpuls3 that go beyond the contents of this user manual, contact the service technicians of an authorised sales and service partner.
Daily/ per shift After use* As required * Monthly Annually Every 2 years If faulty
Measure
Complete function check Visual check User test/device checklist Cleaning the corpuls3 Disinfecting the corpuls3 Shock paddles Module connection test Technical Safety Check (STK) Metrological check (MC) Table 10-1 Maintenance intervals
ENG - Version 4.0 P/N 04130.2
X X X
X
X X X
X
X
X
X X
X X
X
X X
X
X
X
X
X
231
Maintenance and tests
User Manual corpuls3
*Manufacturer's recommendation
10.2 Function checks
Function checks performed by the user guarantee permanent functional and operational readiness of the corpuls3. It is an important supplement to the automatic self test performed internally in the corpuls3. Depending on the frequency of use of the corpuls3, it is recommended that you perform the function check at least once a day, for example at the beginning of a shift.
The complete function check of the corpuls3 is divided into:
· function check of the corpuls3 · Function check of the power supply · Function check of the accessories
Function check of the device
Function check of the power supply
Checking accessories
Function check of the corpuls3 comprises a visual inspection of the outer housing and a function check of the functionalities/options of the corpuls3.
The function check of the power supply informs the user about the current state of charge of the batteries.
Function check of the accessories and consumables guarantees the operational readiness of all equipment required during use of the corpuls3. Furthermore the accessories are visually checked for defects and completeness.
If no correct result is achieved on performing the function checks, read the explanations and measures in chapter 11 Procedure in Case of Malfunctions, page 250.
232
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Maintenance and tests
10.2.1 Daily Checks of the Device
For a function check of the compact device, all the modules of the corpuls3 must be connected mechanically. The mechanical connections have to be heard to click into place. The following measures must be taken:
Warning
Before using the testbox (P/N 04310), the testload (P/N 04312) or the corpuls simulator (P/N 04311) the cable has to be checked for damage. If there is damage, the testbox/testload or the corpuls simulator may not be used under any circumstances.
Daily check Description Switching on
Measures by the user Press the On/Off key.
Correct result The start logo appears
Internal self test
The corpuls3 performs None a test of the internal functions
Module connection test
The jog dial briefly illuminates at the beginning. The screen is illuminated. Curve and parameter fields are displayed. The state of charge of the batteries is displayed
in percent or in minutes of remaining running time. The device is sufficiently charged. Connection status of the modules is displayed.
Communication between modules
Separating all modules Re-connecting all modules
Shock paddles
In the status-/alarm line the connection status changes from bar symbol to wave symbol.
In the status-/alarm line the connection status changes from wave symbol to bar symbol.
No error message is issued.
Check function of the shock paddle buttons.
Check the functionality of the shock paddle buttons at the defibrillator/pacer SLIM.
Press the shock paddle buttons a few times to ensure perfect functionality.
Deliver a shock (see below: Function check of defibrillator/pacer)
Connect the shock paddles to the therapy master cable at the defibrillator/pacer SLIM.
Press the shock paddle buttons a few times to ensure perfect functionality.
Deliver a shock (see below: Function check of defibrillator/pacer)
By pressing the shock paddle buttons a confirmative tone sounds.
Energy is internally discharged via the test contacts.
No error message is issued.
By pressing the shock paddle buttons a confirmative tone sounds.
No error message is issued.
ENG - Version 4.0 P/N 04130.2
233
Maintenance and tests
User Manual corpuls3
Daily check Description Defibrillator/ pacer Function check of the defibrillator/ pacer
Function check of the defibrillator/ pacer SLIM
Measures by the user
Correct result
When using shock paddles: Insert shock paddles into the shock paddle
holder. The shock paddles must be heard to click into place. Connect the shock paddle cable to the therapy master cable. Select the manual mode of the defibrillator. Select an energy of 200 J. Charge energy. Deliver shock. Also check reserve shock paddles, if necessary.
When using corPatch electrodes: Insert the plug of the therapy master cable
into the test contact socket at the cable base. Select the manual mode of the defibrillator. Select an energy of 200 J. Charge energy. Deliver shock.
For the function check the testbox (P/N 04310), the testload (P/N 04312) or the corpuls simulator (P/N 04311) is needed: Make sure that a 1.5 V battery is inserted in
the testbox/corpuls simulator. Switch on testbox/corpuls simulator. Connect testbox/testload/ corpuls simulator to
the therapy socket. Confirm the message "Mark mission as
test mission?" by pressing the softkey [Yes]. Select the manual mode of the defibrillator. For the testload, select an energy of 50 J (max. 100 J). For the testbox/ corpuls simulator, select an energy of 200 J. Charge energy. Deliver shock. On the printout of the shock protocol is the message Test successful or Test failed. After performing the function check, switch off testbox/testload/ corpuls simulator and remove it from the defibrillator/pacer SLIM.
By pressing the shock paddle buttons a confirmative tone sounds.
Energy is internally discharged via the test contacts.
No error message is issued.
Energy is internally discharged via the test contact socket.
No error message is issued.
Energy is internally discharged via the testbox/testload/ corpuls simulator.
No error message is issued.
234
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Maintenance and tests
Daily check Description Printer
Measures by the user
Correct result
Function check of the printer
Power supply
Check if sufficient printer paper is available. Check if the marking indicating the end of the
paper roll (red stripe) is visible. Run a test printout, e.g. a screenshot. Check if an replacement roll is present.
A strip of paper is issued.
The marking indicating the end of the paper roll is not yet visible. It is recommended to load a new roll of paper as soon as it is visible.
The appearance of the type is completely legible and of good quality.
A replacement roll is present.
State of charge check of the batteries of the corpuls3 as compact device
Connect all modules of the corpuls3 (compact device).
Connect corpuls3 to the mains supply (either via the charging bracket or and external mains charger).
Switch on the corpuls3 and check the state of charge of the batteries (percentage) in the status-/alarm line after the booting process.
· State of charge of the battery is greater than 30 %.
If the corpuls3 probably will be used at low ambient temperatures (e.g. in the cold season) the state of charge should be more than 50 % (at room temperature).
Check the remaining running time of the individual modules
Separate all corpuls3 modules in the switched-on state.
Remove the charging cable of the mains charger or remove the module from its charging bracket.
Check the predicted remaining running time of the monitoring unit and patient box in the status-/alarm line.
· The remaining running time of the modules is more than 120 minutes.
Table 10-2
Daily check of the device
Visual check of the corpuls3 and the accessories
Presence and serviceability of
corpuls3
Measures by the user Check the complete corpuls3 for alterations
Batteries
corPatch intermediate cable (if available) corPatch electrodes (adult and Pediatric )
Check if each module of the corpuls3 has a battery inserted.
Check if the corPatch intermediate cable is present and undamaged.
Check if at least two pairs of serviceable corPatch electrodes are present.
Check if the packaging of the corPatch electrodes is undamaged.
Check if the expiry date of the corPatch electrodes has passed.
Correct result
No objections
All modules of corpuls3 have a battery.
The corPatch intermediate cable is present and undamaged. At least two pairs of corPatch electrodes are
present. The packaging of the corPatch electrodes is
undamaged. The expiry date has not passed.
ENG - Version 4.0 P/N 04130.2
235
Maintenance and tests
User Manual corpuls3
Visual check of the corpuls3 and the accessories
Presence and serviceability of
Measures by the user
Correct result
Shock paddles
Remove shock paddles.
Completely unwind the therapy master cable from the socket.
Inspect shock paddles and therapy master cable for damage.
Check if replacement shock paddles are present.
Shock paddles and therapy master cable are not damaged.
Replacement shock paddles are present. All in all, no damage is detectable.
Baby shock electrodes Check if the baby shock electrodes are present, clean and undamaged.
Baby shock electrodes are present, clean and undamaged.
Electrode gel for defibrillation
Estimate if the quantity of electrode gel is sufficient for the next mission.
Sufficient electrode gel incl. replacement tube is present.
ECG adhesive electrodes
Check if sufficient ECG adhesive electrodes for recording the monitoring and diagnostic ECG are present.
Check if the ECG adhesive electrodes are dried out or the expiry date has passed.
Store the ECG adhesive electrodes protected from air.
Sufficient ECG adhesive electrodes are present for the next mission.
The ECG adhesive electrodes are not dried out.
The expiry date of the ECG adhesive electrodes has not passed.
Oximetry inter-mediate cable and sensors
Check if the oximetry intermediate cable and the oximetry sensors are present and undamaged.
Oximetry intermediate cable and oximetry sensors are present and undamaged.
Disposable CO2 adapters
Check if two of every kind of disposable CO2 adapters are present and undamaged.
Two of every kind of disposable CO2 adapters are present and undamaged.
corPatch CPR sensors
Check if at least two pairs of functional corPatch CPR sensors are present.
Check if the packages of the corPatch CPR sensors are intact.
Check if the expiry date of the corPatch CPR sensors has passed.
At least two pairs of functional corPatch CPR sensors are present.
The packages of the corPatch CPR sensors are intact.
The expiry date of the corPatch CPR sensors has not passed.
NIBP cuff and hose
Check if the NIBP cuff and -hose are present NIBP cuff and -hose are present and
and undamaged.
undamaged.
IBP transducers
Check if IBP transducers are present and undamaged.
IBP transducers are present and undamaged.
Temperature sensors
Check if the temperature sensors are present Temperature sensors are present and
and undamaged.
undamaged.
CompactFlash® card
Check if the CompactFlash® card is inserted into the patient box.
The CompactFlash® card is inserted into the patient box.
Switching off
On/Off key
Press the On/Off key. Confirm the switch-off with the softkey [OK].
"Power OFF?" appears in the message line. The screen shows the shutdown image. The corpuls3 is switched off.
Table 10-3
Daily visual check of the corpuls3 and the accessories
236
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Maintenance and tests
10.2.2 Monthly Functional Test
Monthly functional test (in addition to the daily check)
Description
Measures by the user
Correct result
ECG monitoring
Function check of the ECG monitoring cable and the complementary ECG diagnostic cable
Connect the ECG cables to the ECG cable tester corpuls3 (P/N 04224), the testbox (P/N 04310), to an ECG simulator or to a volunteer. For optimal results, select an amplification of x0.5.
If the heart rate or the ECG are not displayed in a parameter- or curve field, assign the display to a parameter- or curve field.
The ECG is displayed as expected in the configured curve fields.
Defibrillator/ pacer
Function check of the See Daily Checks of the Device,
--
defibrillator/ pacer
Defibrillator/Pacer
If necessary, also test pacer function.
Function check of the defibrillator/ pacer SLIM Oximetry Function check of oximetry measurement
Capnometry Function check of CO2 measurement
See Daily Checks of the Device,
--
Defibrillator/Pacer
If necessary, also test pacer function.
Attach oximetry sensor with intermediate cable to a finger.
If the SpO2-, SpCO-, SpHb-, SpMet value, the pulse rate, the perfusion index or the plethysmogram are not displayed in a parameter or curve field, they may be not configured. Select the display in a parameter or curve field.
The oximetry values are displayed in one or more parameter field.
The pulse rate is displayed in a parameter field (PR).
The plethysmogram is displayed in a curve field.
Connect a disinfected airway adapter to the CO2 sensors and attach the connecting cable to the patient box.
Breathe in and out through the adapter several times.
If the CO2 value, respiration rate or the capnogram is not displayed in a parameter or curve field, they may be not configured. Select the display in a parameter or curve field.
The CO2 value is displayed in a parameter field. The respiration rate (RR) is displayed in a
parameter field. The capnogram is displayed in a curve field.
ENG - Version 4.0 P/N 04130.2
237
Maintenance and tests
User Manual corpuls3
Monthly functional test (in addition to the daily check)
Description
Measures by the user
Correct result
Temperature measurement
Function check of temperature measurement
Connect a temperature sensor to the patient box.
If the temperature value is not displayed in a parameter field, it may be not configured. Select the parameter field in which the value should be shown.
Take the temperature sensor into your hand.
Display of the room temperature.
The temperature measuring value increases when the temperature sensor is in your hand.
Non-invasive blood pressure measurement
Function check of noninvasive blood pressure monitoring
Perform a blood pressure measurement on a volunteer subject with the NIBP cuff.
If the non-invasive blood pressure value is not displayed in a parameter field, it may be not configured. Select the parameter field in which the value should be shown.
The blood pressure is displayed in a parameter field.
Invasive blood pressure measurement
Ability to calibrate the transducer
Test the ability to calibrate the transducer. To do this, expose the transducer to atmospheric pressure.
In the main menu, select "IBP" "Calib. P {measuring channel}".
After successful calibration a pressure of 0/0 mmHg is displayed.
Function check of invasive blood pressure measurement
Various transducers have equipment for a functional test. Perform the functional test according to the operating instructions for the transducer.
If the measured value of invasive blood pressure is not displayed in a parameter or curve field, it may be not configured. Select the display in a parameter or curve field.
An invasive blood pressure is displayed in the parameter or curve field after the functional test is complete.
The displayed pressure curve shows scaling.
CPR Feedback
Function check of the CPR feedback
The selftest performed when selecting "Defib" "CPR test" (user level OPERATOR) only checks if the CPR module is functional.
To test the CPR function and the CPR sensor, select the manual mode of the defibrillator.
Connect the corPatch CPR sensor to the corPatch CPR intermediate cable leading to the patient box.
Move the CPR sensor up and down, approx. at compression rate.
If the CPR rate or -curve are not displayed in a parameter- or curve field, it is possible that the configuration has not been set. Assign the display to a parameter- or curve field.
The compression rate (CPR rate) is displayed in a parameter field.
The CPR curve is displayed in a curve field.
Speech- and text messages "Push harder", "Good compressions", and "Fully release" are played.
Memory card
238
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Maintenance and tests
Monthly functional test (in addition to the daily check)
Description
Measures by the user
Correct result
Check the memory space on the CompactFlash® card.
Check in the operation browser whether there is sufficient memory space for further missions.
A free memory space of at least 25% is indicated.
Alarm function test
Checking visual and auditory alarm signals.
Connects sensors for the parameter to be checked.
Change upper or lower alarm limits to provoke an alarm.
Visual and auditory alarm signals are issued.
Table 10-4
Monthly functional test
ENG - Version 4.0 P/N 04130.2
239
Maintenance and tests
User Manual corpuls3
10.3 Automatic Selftest
Selftest
The corpuls3 performs a complete system check each time it is switched on. This internal automatic self test checks the system components.
If error messages appear during automatic self-test, these are displayed in the status-/alarm line and listed in the event history. These error messages can be confirmed by pressing the Alarm key.
10.4 Regular Maintenance Work
10.4.1 Technical Safety Check
Pursuant to § 11 MPBetreibV (Medical Device Operators' Ordinance, applicable to the Federal Republic of Germany), operators must ensure that their devices are subject to regular safety checks. Violations of this regulation may have consequences under penal law.
Pursuant to Sec. 11 para. 4 MPBetreibV, the technical safety checks are only considered as performed and consequently valid if performed by the manufacturer or by a specialist company according to the manufacturer's specifications.
The corpuls3 has to be subject to a safety check every 12 months. The scope of this check is based on the corresponding test regulation and checklist.
10.4.2 Metrological Check
Caution
Pursuant to § 14 MPBetreibV (Medical Device Operators' Ordinance, applicable to the Federal Republic of Germany), it is mandatory to perform metrological checks every 2 years on the non-invasive blood pressure (NIBP) and temperature measurement functions.
For all further measurement functions included in the corpuls3 (ECG, Oximetry, CO2, IBP), regular metrological checks are recommended.
If a malfunction is suspected, it is mandatory to perform metrological checks.
In states outside Germany, the national regulations or those based on EC directives concerning the scope and timely performance of metrological checks.
Metrological checks may only be performed by authorised personnel with calibrated measuring devices, measurement standards and simulators.
240
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Maintenance and tests
Warning
10.4.3 Repair and Service
Any inspection-, maintenance- and cleaning tasks other than those listed in chapter 10.2 Function checks, page 232 may only be performed by authorised technicians.
The defibrillator must not be opened. Internal components may carry high voltages. Failure to observe this may result in severe injuries or death. If a fault is suspected, have the device checked by the authorised sales and service partner and, if necessary, repaired.
Repair and service may only be performed by authorised sales and service partners. If technical repairs are not performed by trained technicians instructed by the manufacturer, this many result in damage to the corpuls3 and loss of any claim under the warranty of GS Elektromedizinische Geräte G. Stemple GmbH. To avoid transport damage when dispatching devices, care should be taken to ensure they are suitably packed. Ideally, the original packaging should be used. A packaging instruction is available from GS Elektromedizinische Geräte G. Stemple GmbH upon request.
10.5 Loading the printer paper
The printer paper has a marking in form of a red stripe at its edge indicating the end of the paper roll. It is recommended to load a new roll of paper as soon as this marking is visible.
2 B
Fig. 10-1
A 1
Opening the printer flap
1 Locking lever 2 Printer flap
Note To avoid damage to the printer flap, the monitoring unit, when disconnected from the defibrillator/pacer, should be placed on a flat surface to load the printer paper.
ENG - Version 4.0 P/N 04130.2
241
Maintenance and tests
User Manual corpuls3
1. Pull the locking lever (item 1) of the printer flap slightly downwards to unlock (item A) the printer flap (item 2) and open it downwards (item B).
1
B
4
A
3
2
Fig. 10-2 Printer
1 Roll of paper 2 Paper roll holder (2x) 3 Transport reel 4 Printer flap
2. Push the paper roll holder on both sides slightly outwards (item A) to remove the roll of paper. 3. Insert a new roll of paper into the holder (item 2) so that the end of the paper has its printed side
facing upwards and forwards. 4. Pull (item B) the paper forwards over the edge of the printer flap (item 4) and hold. 5. Pull the locking lever (item 1) of the printer flap slightly downwards, then swivel the printer flap
upward and close the printer compartment. 6. Make sure that the locking hooks at the printer flap are firmly engaged on both sides.
Note Always tear off the paper upwards on the cutting edge to avoid paper jams or other printing problems. Note Always close the printer flap with the locking lever pulled, otherwise there may be mechanical damage.
242
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
10.6 Replace battery
Maintenance and tests
AB
Fig. 10-3
Changing the battery (monitoring unit)
1 Locking clip 2 Battery 3 Connection coding
The battery of the patient box is located at the bottom of the housing.
The battery of the defibrillator/pacer is likewise located at the bottom of the housing. To replace the battery, it must be tilted rearwards as far as possible.
The battery of the defibrillator/pacer SLIM is located at the left side.
At all modules the batteries are replaced as follows:
1. Pinch together (item A) the two locking clips (item 1) on the battery (item 2) and pull out the battery (item B).
2. Insert a new battery in the opening until it is heard to click into place on both sides. 3. Make sure that the locking clips on both sides are firmly engaged. 4. Check if the battery is fully charged. Note Due to a bevelled edge the battery can only be inserted in one way.
Note When a (new) battery is inserted in a module, this module can switch on automatically.
If the module cannot be switched on after changing the battery, remove battery and after waiting approx. 20 seconds, insert again.
Note For changing the battery on the patient box first switch it off and then change the battery within approx. 30 seconds. Under certain circumstances, the set time/date may be lost.
10.7 Cleaning, Disinfection and Sterilisation
After every application or use, all used components must be cleaned and disinfected. The respective accepted standards of hygiene for handling and disinfecting equipment contaminated with bodily fluids must be observed. The locally valid regulations for disposal of infectious waste and material contaminated with bodily fluids must be observed.
ENG - Version 4.0 P/N 04130.2
243
Maintenance and tests
User Manual corpuls3
Caution
Caution Caution
Damage caused by wrong cleaning and disinfection! Can impair the functions of the corpuls3 and the accessories or lead to damage to the material (formation of fissures, material fatigue). · To remove dirt or stains use clean cloths or soft brushes exclusively. · Only use cleaning- and disinfecting agents recommended by the manufacturer or other cleaning
and disinfecting agents with equivalent substance groups. · Take notice of possibly deviating application instructions of the manufacturer of the cleaning and
disinfecting agents. · Never immerse the modules of the corpuls3 and accessories in cleaning/disinfection liquids, only
apply on the surface. · Do not let fluids penetrate into the plug connections. · Do not clean/disinfect the modules of the corpuls3 and accessories by machine and do not
sterilise them in an autoclave, under pressure or with gas.
Cancellation of the cleaning/disinfection effect Never mix different cleaning-/disinfection agents, because there can be interactions between the substances that can cancel out their cleaning/disinfection effects. Rinse with clear water between the application of different cleaning or disinfecting liquids.
Damage due to use of wrong disinfection agents! Can impair the functions of the corpuls3 and the accessories or lead to damage to the material (formation of fissures, material fatigue). Do not use disinfectants based on the following active ingredients: · Alkyl amine compounds. · Phenolic compounds. · Halogen-releasing compounds. · Strong organic acids.
10.7.1 Recommended Cleaning- and Disinfecting Agents
The following disinfectants of PAUL HARTMANN AG (Bode Chemie) have been tested by the manufacturer and are recommended for effectiveness and material compatibility:
Disinfectants
Active ingredients
Maximum concentration (% w/w)
Mikrobac Virucidal Tissues Bacillol 30 Foam
Dismozon plus Kohrsolin FF
Microbac Forte
Benzalkonium chloride aliphatic amines fatty alcohol polyglycolether Propanol Alkylamine propylglycine Ethanol Propan-2-ol Peroxides (Oxygen based) Alcohols Ammonium chlorides Polyglycol ether Amines
0.25 (mixed concentration)
>=3 - <10 >=0.25 - <1 >=10 - <20 >=10 - <=20 3.2 (Mixed concentration)
3 (Mixed concentration)
4 (Mixed concentration)
Table 10-5
Disinfectants, active ingredients with concentration
Note When using other disinfectants, make sure those belong to the same group of active substances.
244
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Maintenance and tests
10.7.2 Monitoring Unit, Patient Box and Defibrillator/Pacer
Warning
Risk of electrical shock Switch off the modules and disconnect from power supply before cleaning.
Cleaning/ 1. Separate the compact device into the three modules. disinfecting 2. Unplug all the cables on the patient box. the corpuls3 3. Remove the patient box from the accessory bag.
4. Disconnect the shock paddles from the therapy master cable and remove from the defibrillator holders.
5. Cleaning the corpuls3: Wipe off visible and coarse dirt from the outer surfaces of the three modules with a moist disposable tissue. Disinfecting the corpuls3: Clean all surfaces with a disposable tissue soaked in disinfection agent. Disinfect all surfaces with an appropriate disinfectant. Comply with the contact time of the disinfection agent as indicated by the manufacturer and let dry completely. To remove any disinfectant residues, wipe with a soft cloth soaked in clean water and then allow to dry.
6. Wipe the infrared interfaces of the monitoring unit with a cloth (see Fig. 10-4, item 1 and item 2).
Fig. 10-4
Monitoring unit, infrared interfaces
1 Infrared interface 2 Infrared interface
7. Wipe the infrared interface of the patient box with a cloth (see Fig. 10-5, item 1).
ENG - Version 4.0 P/N 04130.2
245
Maintenance and tests
User Manual corpuls3
Fig. 10-5
Patient box, infrared interface
1 Infrared interface
8. Wipe the infrared interface of the defibrillator/pacer with a cloth (see Fig. 10-6, item 1).
Fig. 10-6
Defibrillator/Pacer, infrared interface
1 Infrared interface
10.7.3 Shock paddles
Cleaning
1. Clean the cable, shock paddle handles and the electrode surface with soap solution. Make sure that
· no residual electrode gel remains on the electrode plates or between the electrode plates and the paddle handles;
· the electrode surface is not scratched; · no moisture penetrates into the plug interfaces. 2. Dry the plug connection thoroughly.
Disinfection
Disinfect the electrode plates of the shock paddles with a disposable wipe soaked in disinfectant. Disinfect all surfaces with an appropriate disinfectant. Observe the application time of the disinfectant in accordance with the manufacturer's instructions and let dry completely. To remove any disinfectant residues, wipe with a soft cloth soaked in clean water and then allow to dry.
Warning
Do not immerse the shock paddles in liquid.
246
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Maintenance and tests
10.7.4 Baby shock electrodes
Cleaning
1. Clean the cable and the electrode surface with soap solution. Make sure that
· no residual electrode gel remains; · the electrode surface is not scratched; · no moisture penetrates into the plug interfaces. 2. Dry the plug connection thoroughly. 3. keep contact springs clean.
Disinfection
Disinfect the electrode plates of the shock paddles with a disposable wipe soaked in disinfectant. Disinfect all surfaces with an appropriate disinfectant. Observe the application time of the disinfectant in accordance with the manufacturer's instructions and let dry completely. To remove any disinfectant residues, wipe with a soft cloth soaked in clean water and then allow to dry.
Warning
Do not immerse the baby shock electrodes in liquid.
10.7.5 Therapy master cable
Cleaning 1. Clean the therapy master cable with soap solution. Prevent moisture entering the plug connector.
2. Dry the plug connection thoroughly.
Disinfection
Disinfect the therapy master cable with a disposable wipe soaked in disinfectant. Disinfect all surfaces with an appropriate disinfectant. Observe the application time of the disinfectant in accordance with the manufacturer's instructions and let dry completely. To remove any disinfectant residues, wipe with a soft cloth soaked in clean water and then allow to dry.
10.7.6 Cable for monitoring functions
Cleaning 1. Clean the following cables with soap solution: · ECG monitoring cable · Complementary ECG diagnostic cable · corPatch CPR intermediate cable · CO2 intermediate cable · Oximetry intermediate cable
2. Prevent moisture entering the plug connectors. 3. Dry the plug connections thoroughly.
Disinfection
Disinfect the indicated cables with a disposable wipe soaked in disinfectant. Disinfect all surfaces with an appropriate disinfectant. Observe the application time of the disinfectant in accordance with the manufacturer's instructions and let dry completely. To remove any disinfectant residues, wipe with a soft cloth soaked in clean water and then allow to dry.
ENG - Version 4.0 P/N 04130.2
247
Maintenance and tests
User Manual corpuls3
10.7.7 Oximetry sensor
Caution
Do not immerse oximetry sensors and cables in liquids. No liquid must enter the sensor components or plugs.
Cleaning Disinfection
Read and follow the operating instructions from the Masimo company enclosed with the oximetry sensors.
1. Disinfect the oximetry sensors and oximetry cables with a disposable wipe soaked in disinfectant. Disinfect all surfaces with an appropriate disinfectant. Observe the application time of the disinfectant in accordance with the manufacturer's instructions and let dry completely.
2. Let dry the oximetry sensors and oximetry cables thoroughly. To remove any disinfectant residues, wipe with a soft cloth soaked in clean water and then allow to dry.
10.7.8 CO2 sensor
Caution
Never apply liquid directly to the sensors.
Cleaning 1. Moisten a soft cloth with an alcohol-based cleaning solution. 2. Wipe the surface with the cloth.
Note Avoid scratches on the surface of the CO2 sensors. Measurement can be impaired and/or rendered impossible by a scratched surface.
10.7.9 NIBP Cuffs and connecting hose
Cleaning Disinfection
Clean the connecting hose and NIBP cuff with soap solution.
Disinfect the NIBP cuffs with a disposable wipe soaked in disinfectant. Disinfect all surfaces with an appropriate disinfectant. Observe the application time of the disinfectant in accordance with the manufacturer's instructions and let dry completely. To remove any disinfectant residues, wipe with a soft cloth soaked in clean water and then allow to dry.
Caution
Make sure no (disinfecting) liquid from the connecting hose reaches the NIBP socket at the patient box.
10.7.10 IBP transducer cable
Cleaning Disinfection Sterilisation
Read and follow the manufacturer's operating instructions enclosed with the IBP transducer.
248
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Maintenance and tests
10.7.11 Temperature sensor
Cleaning Disinfection Sterilisation
Read and follow the operating instructions from the YSI company enclosed with the temperature sensor.
10.7.12 Accessory Bag, Carrying Strap and Backpack Carrying Strap
Cleaning and Disinfection
Clean the accessory bag, carrying strap or backpack carrying strap with a medium brush and soap or tarpaulin cleaner. Put in a disinfectant solution. Subsequently wash the accessory bag, carrying strap or backpack carrying strap in the washing machine (30 °C) using a laundry net and (liquid) detergent for delicates. Do not use the spin cycle. If possible, allow to air dry completely. Treat with impregnating spray. If necessary, treat the zippers with dry-film lubricant (silicone spray).
10.7.13 Charging brackets and MagCode connectors
Cleaning
If the two metal contacts in the contact field are oxidised (black), the device can no longer be charged. Clean the contact fields of the MagCode connectors (at the charging brackets, the AC adapter cable or at the DC connector cable) with a glass fibre brush.
10.8 Approved Accessories, Spare Parts and Consumables
Warning
The current list can be found at www.corpuls.world/en/service/approved-accessories.html. For further information, consultancy and sales, please contact your authorised sales and service partner.
Defibrillation protection for patients, user and third parties cannot be guaranteed, if accessories other than those authorised by the manufacturer are used.
Caution
Using accessories that are not approved by the manufacturer can result in increased electromagnetic emissions or reduced electromagnetic immunity of the device and lead to faulty operation.
ENG - Version 4.0 P/N 04130.2
249
Procedure in case of malfunctions
User Manual corpuls3
11 Procedure in Case of Malfunctions
11.1 Device alarms
The following table lists all alarms of the device with their priority and describes the cause of the malfunction as well as how to eliminate it. If these remedies should, against expectations, not be effective the device may be defective. Contact authorised sales and service partners.
Alarm message [X] sensor loose T[X] sensor loose
Abnormal ECG
Battery low Battery low
Priority
Technical patient alarm Medium priority
Technical patient alarm High priority
System alarm High priority
Battery temperature high System alarm
Battery temp. high
Medium priority
Bluetooth connect. failed System alarm
BT conn. fail.
Medium priority
CF card almost full CF almost full
System alarm Low priority
Explanation/Measure
"X" stands for a temperature channel from 1 to 2. The sensor indicated has come loose from the measuring site at the body or from the intermediate cable. Check the sensor and reconnect if necessary. Measured temperatures of below 12°C may also trigger this alarm.
Configurable warning in case the ECG measurement/interpretation algorithm "corpuls ACS" detects the presence of the Wolff-Parkinson-White (WPW) syndrome, of intraventricular excitation propagation disorders, of an implanted pacer, of QRS intervals longer than 120 ms or of a left bundle branch block in the ECG.
The state of charge of the battery is less than 20 % of the total charge of the module. Connect the respective module to a power supply as soon as possible.
The battery charging process lead to a great increase of temperature inside the battery (> 60°C). The corpuls3 or the respective module was possibly exposed to high temperatures. See appendix E Technical Specifications, page 308. Interrupt charging process by disconnecting the corpuls3 from the mains power or from charger. If necessary, let the corpuls3 cool down or bring device to a cooler environment. Contact authorised sales and service partners, if necessary.
The connection attempt to another device via Bluetooth interface failed.
The current capacity of the memory card (CompactFlash® card) amounts to less than 20% of the memory capacity or the number of missions is more than 999. Remove the memory card (CompactFlash® card) and save the contents on another storage medium (e. g. PC). Delete the data at regular intervals once they are no longer required. If the CF card is full, the mission data are no longer recorded.
250
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Alarm message
CF card error CF card error
Priority
System alarm Low priority
CF card full CF card full
System alarm Low priority
CF card missing CF card missing
System alarm Low priority
Check 4-pole ECG cable Check 4-pole cable
Check 6-pole ECG cable Check 6-pole cable
Check battery Check battery
System alarm Medium priority
System alarm Medium priority
System alarm Medium priority
Check corpuls cpr
System alarm Medium priority
Check pacer
System alarm High priority
Explanation/Measure
The memory card (CompactFlash® card) is not correctly formatted. Remove the memory card and back up the contents on other storage media (e. g. PC). Format according to chapter 8.3 Handling Data, page 200. The memory card (CompactFlash® card) is faulty. The mission data of the current or of future missions are no longer recorded.
Remove the memory card (CompactFlash® card) and save the contents on another storage medium (e. g. PC). Delete the data at regular intervals once they are no longer required. The mission data of the current or of future missions are no longer recorded.
The memory card (CompactFlash® card) is not correctly inserted in the drawer of the patient box. The memory card (CompactFlash® card) is missing. The mission data of the current or of future missions are no longer recorded.
The 4-pole ECG monitoring cable is not connected correctly or the cable is defective. Check the respective cable and reconnect if necessary.
The 6-pole ECG cable is not connected correctly or the cable is defective. Check the respective cable and reconnect if necessary.
The battery has to be checked as soon as possible and replaced, if necessary. Contact authorised sales and service partners.
The corpuls3 has sent a command to the corpuls cpr and not received an answer via Bluetooth from the corpuls cpr after 3 s. The locking lever at the corpuls cpr is still open, Close the locking lever so the therapy can be started. General device check.
The pacer is stimulating, but there is no connection between the monitoring unit and the defibrillator/pacer. The wireless communication between the patient box and the monitoring unit/defibrillator has been interrupted or could not be established: Make sure that the distance between the modules is not more than 10 m and that no barriers are compromising the radio connection. Use corpuls3 as a compact device if necessary. Communication in the connected state between the patient box and monitoring unit/defibrillator is cut off or could not be established: Check if one of the two infrared interfaces is covered or dirty. If necessary, use corpuls3 with radio connection. If necessary, contact your authorised sales and service partner.
ENG - Version 4.0 P/N 04130.2
251
Procedure in case of malfunctions
User Manual corpuls3
Alarm message
Check plug therapy cable
Check printer paper
CO2 < [NUMBER] mmHg CO2 > [NUMBER] mmHg CO2 < [NUMBER] kPa CO2 > [NUMBER] kPa CO2 apnoea CO2 apnoea CO2 cable loose CO2 cable loose CO2 sensor loose CO2 sensor loose
Connect therapy electr.
Covert mode CPR cable loose CPR cable loose CPR sensor activ. CPR sen. activ. CPR sensor expired CPR sen. exp. CPR sensor loose CPR sensor loose CPR sensor not activ. CPR n. activ.
Priority
System alarm High priority
System alarm Medium priority
Physiological patient alarm Medium priority Technical patient alarm High priority System alarm Medium priority System alarm High priority
System alarm High priority
High priority
System alarm Medium priority System alarm Medium priority System alarm Medium priority System alarm Medium priority System alarm Medium priority
Explanation/Measure The connectors of the therapy master cable and the therapy electrodes have been connected while turned the wrong way by 180 degrees and have to be checked for damage. If no damage is visible, connect the electrode plug again to the therapy master cable, oriented correctly. If the alarm message persists or damage is visible, the corpuls3 is not functioning correctly and must not be used. Contact authorised sales and service partners. Open the paper flap. Check if the roll of paper in the printer is used up (marking is visible) and insert a new roll of paper. If there is a paper jam, pull the paper wound around the paper roller carefully off the roller with both hands. Close the paper flap and tear off the paper upwards on the cutting edge. The measured carbondioxide level exceeds/falls below the upper/lower alarm limit. Check the patient's vital signs. Check alarm limit settings.
An apnoea has been detected. Check respiration.
The cable indicated is not connected to the patient box. Check the respective cable and reconnect if necessary. The sensor indicated is not correctly connected or has come loose from the endotracheal tube adapter or its holder. Check the respective sensor and secure again if necessary. Connect the corPatch electrodes or shock paddles to the therapy master cable of the corpuls3. If the alarm message persists, connect immediately the reserve corPatch electrodes. This alarm message indicates that the device is in covert mode for stealth operations and that all acoustic and visual alarm signals have been disabled. The cable indicated is not connected to the patient box. Check the respective cable and reconnect if necessary.
The sensor has been activated.
The sensor is expired and has to be exchanged with a new one.
The sensor indicated has come loose from the intermediate cable. Check the sensor and reconnect if necessary. The sensor has not been activated. For correct use, the sensor has to be activated.
252
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Alarm message
CPR sensor-NOT F. PAT. USE CPR-NO PAT. USE
Priority
System alarm Medium priority
System alarm D-ECG transmission error
Low priority
Def. Oxi adhes. sensor Def. Oxi adh. sen.
System alarm Medium priority
Defect. Oxi sensor Defect. Oxi sensor
Defective IBP cable Defect. IBP cable
System alarm Medium priority
System alarm Medium priority
Defective Oxi cable Defect. Oxi cable
System alarm Medium priority
Defib temperature high [X]
System alarm High priority
Defibrillator alarm
System alarm High priority
Defibrillator failure (3)
System alarm High priority
Defibrillator failure [X]
System alarm High priority
ECG cable (4-pole) loose 4-pole cable loose
ECG cable (6-pole) loose 6-pole cable loose
System alarm Medium priority
System alarm Medium priority
ECG electrode [X] loose Electr. [X] loose
Technical patient alarm
Medium priority
Explanation/Measure
Using this sensor on a patient is prohibited. Contact authorised sales and service partners.
The device is already sending a D-ECG to the server. The transmission of another D-ECG to the server has failed. corpuls.web LIVE cannot forward the D-ECG (no forwarding rule configured).
The adhesive sensor is defective or has expired. The sensor LED's have to be aligned directly over each other at the measuring site.
The sensor is defect or not connected correctly. Disconnect sensor and connect again. If the sensor LED does not flash, the sensor has to be exchanged.
The IBP cable is not connected correctly or the cable is defective. Check the respective cable and reconnect if necessary.
The intermediate cable is defective or not connected correctly. Disconnect intermediate cable and connect again. If the sensor LED does not flash, the intermediate cable has to be exchanged.
"X" stands for a failure number from 1 to 2. The defibrillator was very frequently charged within a short period. Avoid too frequent internal discharges.
The corpuls3 still functions correctly, but should however be checked by a service technician as soon as possible. Contact authorised sales and service partners.
Internal error. The corpuls3 is possibly not functioning correctly and must not be used. Contact authorised sales and service partners.
"X" stands for a failure number from 1 to 7. The corpuls3 is possibly not functioning correctly and must not be used. Contact authorised sales and service partners.
Check if the 4-pole ECG monitoring cable is connected correctly to the patient box.
Check if the complementary 6-pole ECG diagnostic cable is connected correctly to the patient box.
,,X" stands for a an electrode L/LA, F/LL, R/RA or N/RL. Connect the clip of the 4 pole ECG monitoring cable to the loose ECG electrode (see chapter 6.4.2 Preparing the Patient for a D-ECG, page 117). Check ECG electrodes. Make sure that all clips are correctly connected to the contacts and/or the ECG electrodes are perfectly placed on the patient's skin.
ENG - Version 4.0 P/N 04130.2
253
Procedure in case of malfunctions
User Manual corpuls3
Alarm message
Priority
ECG electrode [X] loose Electr. [X] loose
Technical patient alarm
Medium priority
ECG electrodes loose ECG electr. loose
ECG failure (x) ECG failure [X]
Technical patient alarm Medium priority
System alarm High priority
Error CO2 module Error CO2 module
System alarm High priority
Error CPR sensor Error CPR sen.
System alarm Medium priority
Error CPR sensor/module System alarm
Error CPR sen./mod.
Medium priority
Error ECG module Error ECG module
Error GSM module
Error IBP module Error IBP module
System alarm High priority System alarm Low priority System alarm Medium priority
Error insurance card
System alarm Low priority
Error NIBP hardware NIBP HW error
System alarm Medium priority
Error NIBP module Error NIBP module
System alarm Medium priority
Explanation/Measure
"X" stands for a an electrode number from V1 to V6. Connect the clip of the 6 pole ECG monitoring cable to the loose ECG electrode (see chapter 6.4.2 Preparing the Patient for a D-ECG, page 117). Check ECG electrodes. Make sure that all clips are correctly connected to the contacts and/or the ECG electrodes are perfectly placed on the patient's skin.
More than one ECG electrode are not connected to the patient. Check ECG electrodes.
"X" stands for a failure number from 2 to 5. The corpuls3 is possibly not functioning correctly and must not be used. Contact authorised sales and service partners.
Check the CO2 sensor. Measures according to need: attach CO2 sensor to patient, attach CO2 sensor to CO2adapter or put CO2 sensor into its holder in the accessory bag. Remove foreign body on the surface of the CO2 sensor if necessary. If the alarm message persists, the measuring option mentioned is faulty. Contact authorised sales and service partners.
The sensor mentioned is faulty and has to be replaced. If necessary, contact your authorised sales and service partner.
Check the CPR sensor and the CPR intermediate cable and replace, if necessary. If the alarm message persists, the measuring option mentioned is faulty. Contact authorised sales and service partners.
The corpuls3 is possibly not functioning correctly and must not be used. Contact authorised sales and service partners.
The GSM module is faulty. Contact authorised sales and service partners.
The measuring option mentioned is faulty. Contact authorised sales and service partners.
The insurance card was not recognised/ could not be read. Take the insurance card out of the corpuls3 and check if it was inserted with the chip oriented towards the front. Only German, Austrian, Swiss and insurance cards and Belgian ID-cards are supported. The reading process may take up to 10 seconds.
Wait up to 20 seconds. to start measurement. The softkeys are greyed out as long as the selection is not available. If the patient is not in a critical condition, restart the corpuls3. Check if the patient as a palpable pulse.
If the patient is not in a critical condition, restart the corpuls3. Check if the patient as a palpable pulse. Perform manual measurement.
254
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Alarm message
Priority
Error T[X] Error T[X]
System alarm Medium priority
Error temperature module Error temp module Failure HES data transmis.
Fax connect. not possible
Fax connection busy
System alarm Medium priority
Low priority
System alarm Low priority System alarm Low priority
Fax transmission failed
System alarm Low priority
System alarm GPRS authorisation failed
Low priority
GPRS link error
System alarm Low priority
GSM network not avail.
System alarm Low priority
HR < [NUMBER]/min HR > [NUMBER]/min
Physiological patient alarm
High priority
HW conflict [MODULE]
System alarm Low priority
IBP calibration error IBP calibr. error
IBP P[X] cable loose [X] cable loose
System alarm Medium priority
System alarm Medium priority
Explanation/Measure
"X" stands for a temperature channel from 1 to 2. The measuring channel mentioned is defect. Contact authorised sales and service partners.
The measuring option mentioned is faulty. Contact authorised sales and service partners.
Transmission of HES data has failed.
Possibly a wrong fax number has been dialled. Repeat dialing.
The fax machine of the recipient is busy. Try to repeat fax transmission at a later time.
Fax transmission was not successful. Repeat procedure. Contact authorised sales and service partners, if necessary.
No GPRS service available for this SIM card. Wrong APN configured or connection with the GSM network aborted. Repeat attempt to establish connection.
The APN is not configured or has not been saved. Configure APN anew and save configuration. Contact your mobile communications provider for the respective current APN.
The reception quality is too low. No connection to the mobile communications network can be established. If possible, select a location with better reception. If necessary, repeat procedure at a later time.
The measured heart rate exceeds/falls below the upper/lower alarm limit. Check the patient's vital signs. Check alarm limit settings.
"MODULE" stands for either the monitoring unit, patient box or defibrillator/pacer. The radio connection authorisation (Pairing) has failed. Due to different hardware versions the modules used can only be used as compact device with an ad-hoc connection. If necessary, contact your authorised sales and service partner.
The calibration of the invasive pressure channel has failed. Repeat calibration.
"X" stands for an IBP sensor P1 to P4. The cable indicated is not connected to the patient box while the device tries to calibrate the respective pressure channel. Check the respective cable and reconnect if necessary.
ENG - Version 4.0 P/N 04130.2
255
Procedure in case of malfunctions
User Manual corpuls3
Alarm message
IBP P[X] sensor loose [X] sensor loose
Priority
Technical patient alarm Medium priority
Insurance card reader n. System alarm
a.
Low priority
Invalid Oxi adhes. sensor System alarm
Inv. Oxi adh. sen.
Medium priority
Invalid Oxi cable Invalid Oxi cable
Invalid Oxi sensor Inval. Oxi sensor Invalid user settings Inval. settings
Low confidence [X] Low conf. [X]
System alarm Medium priority
System alarm Medium priority System alarm Medium priority
Technical patient alarm Low priority
Low perfusion [X] Low perf. [X]
Technical patient alarm
Low priority
Module restarts Module restarts
New webMessage
NIBP automeas. failed Auto-NIBP fail.
System alarm High priority System alarm Low priority System alarm Medium priority
NIBP cuff overpressure NIBP cuff overpr.
System alarm Medium priority
Explanation/Measure
"X" stands for an IBP sensor P1 to P4. The sensor indicated is not correctly connected to the transducer system or intermediate cable. The sensor is being calibrated. Check the respective sensor and secure again if necessary.
The insurance card reader could not be initialised. If the patient's condition is not critical, re-start the corpuls3. If the alarm message persists, contact authorised sales and service partners.
A wrong adhesive sensor is used or the adhesive sensor is defective or has expired. The sensor has to be replaced by a correct one. The sensor LED's have to be aligned directly over each other at the measuring site.
A wrong intermediate cable is used or the intermediate cable is defective or has expired. The intermediate cable has to be replaced by a correct one or a new one.
A wrong sensor is used or the sensor is defective or has expired. The sensor has to be replaced by a correct one.
The loaded settings do not correspond to the imported settings. The corpuls3 uses factory settings.
"X" stands for the vital parameters PI, PR, SpCO, SpHb, SpMet or SpO2. PI measurement is not possible. Make sure that the correct sensor is used. Check if the sensor is functional. If necessary, replace sensor.
"X" stands for the vital parameters SpCO, SpHb or SpMet. The measured signal is too weak. Make sure that the patient lies calmly during the measurement and that there is no commotion caused by the vehicle. Select another measurement site.
Alarm message shown on the screen of the monitoring unit or patient box. The respective module restarts due to a software error.
Message for the user that a webMessage concerning the current mission has been arrived (see chapter 9.6, page 229).
Perform manual measurement. If the error persists, contact sales and service partner.
Make sure that the patient does not lie on the hose or on the cuff. Make sure that the correct cuff size is used. Make sure that the hose is not bent or pinched. Make sure that the cuff is attached correctly.
256
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Alarm message NIBP dia < [NUMBER] mmHg NIBP dia > [NUMBER] mmHg NIBP inflating impossible NIBP no inflation
NIBP measurem. aborted NIBP meas abort.
NIBP measurement failed NIBP meas failed
NIBP no signal NIBP no signal
NIBP noisy/erratic signal NIBP noisy sig.
NIBP not calibrated NIBP not calibr. NIBP out of range NIBP out of range
NIBP pneumatic blockage NIBP pneum block
NIBP safety off NIBP safety off
Priority Physiological patient alarm Medium priority
System alarm Medium priority
System alarm Medium priority
System alarm Medium priority
Technical patient alarm Medium priority
Technical patient alarm Medium priority
System alarm Medium priority Technical patient alarm Medium priority
System alarm Medium priority
System alarm Medium priority
Explanation/Measure
The measured diastolic blood pressure exceeds or falls below the upper/lower alarm limit. Check the patient's vital signs. Check alarm limit settings.
Make sure that the hose is not bent or pinched. Make sure that the patient does not lie on the hose or on the cuff. Make sure that the cuff is attached correctly.
Wait up to 20 secs. to start measurement. The softkeys are greyed out as long as the selection is not available. If the patient is not in a critical condition, restart the corpuls3. Check if the patient as a palpable pulse.
Check if the cuff hose is properly connected, the cuff hose is not bent, artefacts have occurred during measurement, the NIBP cuff was properly applied or another application error is present. Repeat measurement.
Make sure that the patient lies calmly during the measurement and that there is no commotion caused by the vehicle. Make sure that the cuff is attached correctly. Make sure that the correct cuff size is used. Apply the cuff directly at the arm.
Make sure that the patient lies calmly during the measurement and that there is no commotion caused by the vehicle. Make sure that the cuff is attached correctly. Make sure that the correct cuff size is used. Apply the cuff directly at the arm.
The measuring option mentioned is not calibrated. Contact authorised sales and service partners.
The measured pressure cannot be displayed because it is beyond the range of the device.
Make sure that the patient does not lie on the hose or on the cuff. Make sure that the correct cuff size is used. Make sure that the hose is not bent or pinched. Make sure that the cuff is attached correctly.
Check the status of the patient. Try measurement again. Make sure that the patient lies calmly during the measurement and that there is no commotion caused by the vehicle. Make sure that the cuff is attached correctly.
ENG - Version 4.0 P/N 04130.2
257
Procedure in case of malfunctions
User Manual corpuls3
Alarm message NIBP sys < [NUMBER] mmHg NIBP sys > [NUMBER] mmHg NIBP weak signal NIBP weak signal
No APN entered
No battery inserted No batt. inserted
No conn. to Defib Defibrillator N/A
No conn. to Monitor Monitor N/A
Priority Physiological patient alarm Medium priority Technical patient alarm Medium priority
System alarm Low priority
System alarm High priority
System alarm High priority
System alarm High priority
Explanation/Measure
The measured systolic blood pressure exceeds or falls below the upper/lower alarm limit. Check the patient's vital signs. Check alarm limit settings.
Make sure that the patient lies calmly during the measurement and that there is no commotion caused by the vehicle. Make sure that the cuff is attached correctly. Make sure that the correct cuff size is used. Apply the cuff directly at the arm.
The APN is not configured or has not been saved. Configure APN anew and save configuration. Contact your mobile communications provider for the respective current APN.
The battery in the respective module is missing. Insert a battery and/or connect the modules together to be able to call on the energy reserves of the other modules if the corpuls3 is to be operated as a mobile device.
Check if the module is switched on. Wireless communication between the defibrillator and monitoring unit/patient box is cut off or could not be established. Make sure that the distance between the modules does not exceed 10 m and that no obstacles impair the connection. Use corpuls3 as a compact device if necessary. Communication in the connected state between the defibrillator and monitoring unit/patient box is cut off or could not be established. Check if one of the two infrared interfaces is covered or heavily soiled. If necessary, use corpuls3 with radio connection. If necessary, contact your authorised sales and service partner.
Check if the module is switched on. Wireless communication between the defibrillator and monitoring unit/patient box is cut off or could not be established. Make sure that the distance between the modules does not exceed 10 m and that no obstacles impair the connection. Use corpuls3 as a compact device if necessary. Communication in the connected state between the defibrillator and monitoring unit/patient box is cut off or could not be established. Check if one of the two infrared interfaces is covered or heavily soiled.
258
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Alarm message
Priority
No conn. to P-Box
System alarm High priority
No connection [to DEVICE] System alarm
BT conn. lost
Medium priority
No ECG cable
System alarm High priority
No ECG cable (Pacer)
System alarm High priority
No GSM PIN configured
System alarm Low priority
No Oxi adhesive sensor No Oxi adh. sen.
System alarm Medium priority
No Oxi sensor No Oxi sensor
No Oxi sensor
NSTEMI
NSTEMI possible ONLY FOR TEST ONLY FOR TESTS
System alarm Medium priority
System alarm Low priority
Technical patient alarm High priority Technical patient alarm High priority
System alarm High priority
ENG - Version 4.0 P/N 04130.2
Explanation/Measure
Check if the module is switched on. Wireless communication between the defibrillator and monitoring unit/patient box is cut off or could not be established. Make sure that the distance between the modules does not exceed 10 m and that no obstacles impair the connection. Use corpuls3 as a compact device if necessary. Communication in the connected state between the defibrillator and monitoring unit/patient box is cut off or could not be established. Check if one of the two infrared interfaces is covered or heavily soiled.
The connection to a Bluetooth device has been lost. "DEVICE" stands for an external device like e.g a ventilator, blood gas analysis device, corpuls1, corpuls cpr or any other device that can communicate with the corpuls3. Try to establish the connection again.
The corpuls3 is in AED mode with the shock paddles connected and the 4 pole ECG monitoring cable is not connected to the patient box. Connect the 4-pole ECG monitoring cable.
The pacer is stimulating in DEMAND mode, but there is no 4-pole ECG cable connected or individual ECG electrodes are loose. Check if the 4-pole ECG monitoring cable is connected correctly to the patient box. Check ECG electrodes. Make sure that all clips are correctly connected to the contacts and/or the ECG electrodes are perfectly placed on the patient's skin.
The PIN belonging to the SIM card has not been configured. Configure the PIN.
The cable of the adhesive sensor is not connected or not connected correctly. The sensor LED's have to be aligned directly over each other at the measuring site.
The sensor cable is not connected or not connected correctly. Disconnect sensor cable and connect again. If the sensor LED does not flash, the sensor has to be exchanged.
The SIM card is missing. The SIM card is not correctly inserted in the drawer of the monitoring unit. Insert the SIM card in the drawer in the monitoring unit.
Configurable warning in case the ECG measurement/interpretation algorithm "corpuls ACS" detects a "NSTEMI" in the ECG. Check the therapy suggestion printed on the D-ECG.
Configurable warning in case the ECG measurement/interpretation algorithm "corpuls ACS" detects a possible "NSTEMI" in the ECG. Check the therapy suggestion printed on the D-ECG.
The software of the module has been released only for test purposes. Using this module on a patient is prohibited. Contact authorised sales and service partners.
259
Procedure in case of malfunctions
User Manual corpuls3
Alarm message
Oxi adhes. sensor expired Oxi adh. sen. exp.
Oxi cable expired Oxi cable exp. Oxi cable loose Oxi cable loose Oxi failure (X) Oxi failure (X) Oxi sensor expired Oxi sensor exp. Oxi sensor loose Oxi sensor loose
Oxi: Calibrating Oxi: Calibrating
Oxi: Check conn. to P-box Oxi: Check conn.
Oxi: Demo tool Oxi: Demo tool
Oxi: Interference Oxi: Interference
Oxi: Low perfusion Oxi: Low perfusion
Oxi: SpO2 only mode Oxi: SpO2 only
P(X) < [NUMBER] mmHg P(X) > [NUMBER] mmHg
Priority
System alarm Medium priority
System alarm Medium priority System alarm Medium priority Technical patient alarm Medium priority System alarm Medium priority Technical patient alarm Medium priority
System alarm Low priority
System alarm Medium priority
System alarm Medium priority
Technical patient alarm Medium priority
Technical patient alarm Medium priority
System alarm Medium priority
Physiological patient alarm High priority
Explanation/Measure
The adhesive sensor is defective or expired and has to be exchanged with a new one. The sensor LED's have to be aligned directly over each other at the measuring site.
The intermediate cable is expired and has to be exchanged with a new one.
The cable indicated is not connected to the patient box. Check the respective cable and reconnect if necessary.
"X" stands for a failure number from 1 to 10. The measuring option mentioned is faulty. In this case contact your authorised sales and service partner.
The sensor is expired and has to be exchanged with a new one.
The sensor indicated has come loose from the measuring site at the body or from the intermediate cable. Check the respective sensor and reconnect if necessary.
After attaching the sensor, the oximeter calibrates automatically. This process, indicated by an hourglass symbol in the upper right corner of the parameter field, can take up to 120 s for SpCO-, SpHb- and SpMet measurement.
The sensor- or intermediate cable is not connected or not connected correctly. Disconnect sensor- or intermediate cable and connect again. If the sensor LED does not flash, the intermediate cable has to be exchanged.
For demonstration purposes, a demo sensor has been connected. For measurement of patient data, the sensor has to be exchanged for a real sensor.
Too strong ambient light on the patient (sensor). The light source has to be removed or reduced. Protect sensor from light. Attach sensor at another site.
The measured signal is too weak. Make sure that the patient lies calmly during the measurement and that there is no commotion caused by the vehicle. Select another measurement site.
If the calibration of the parameters SpCO, SpMet and SpHb is not possible, the corpuls3 switches to SpO2-only mode. By disconnecting and re-connecting the sensor at the measuring site, calibration is started anew.
"X" stands for the invasive pressure channel 1-4. The measured pressure exceeds or falls below the upper/lower alarm limit. Check the patient's vital signs. Check alarm limit settings.
260
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Alarm message Pacer circuit open
Pacer failure
Priority System alarm High priority
System alarm High priority
Pacer high impedance
Technical patient alarm
High priority
Pacer short circuit Pacing not possible Pairing failed
System alarm High priority
System alarm High priority
System alarm Low priority
Explanation/Measure
Make sure that all cables and connecting plugs are connected correctly. Make sure that the corPatch electrodes are placed correctly.
The pacing therapy must be checked immediately. The corpuls3 is possibly not functioning correctly and must not be used. Contact authorised sales and service partners.
The electrical resistance of the patient (impedance) is to high for the selected settings. An intensity for stimulation has been selected that cannot be reached with the impedance present. Make sure that the corPatch electrodes are tightly and completely attached to the patient's skin. In case of excessive hair on the patient, shave the required area on the skin. If necessary, use new corPatch electrodes. To perform a pacer therapy adaequate for the patient, a higher stimulation intensity must be selected. Perform medical measures as needed.
The corPatch electrodes must be placed at a sufficient distance to allow pacing. Make sure that the corPatch electrodes do not touch each other. Make sure that there is no conductive connection between the corPatch electrodes (e. g. wetness).
The corpuls3 is possibly not functioning correctly and must not be used. Contact authorised sales and service partners.
The connection authorisation (Pairing) has failed. For further information see chapter 3.2.1 Pairing (Connection Authorisation), page 12). Contact your authorised sales and service partner.
System alarm Phonebook update failed
Low priority
The memory location of the phonebook cannot be written on.
If the memory location is the SIM card, check the SIM card. Older SIM cards that only support less than 20 phonebook entries should be replaced with newer ones.
If the memory location is the corpuls3, contact your authorised sales and service partners.
Phonebook upload failed
PR < [NUMBER]/min PR > [NUMBER]/min
System alarm Low priority
Physiological patient alarm High priority
The phonebook source cannot be read. If the phone book source is the SIM card, check the SIM card. Older SIM cards that only support less than 20 phonebook entries should be replaced with newer ones. If the phonebook source is the corpuls3, contact your authorised sales and service partners.
The measured pulse rate exceeds/falls below the upper/lower alarm limit. Check the patient's vital signs. Check alarm limit settings.
ENG - Version 4.0 P/N 04130.2
261
Procedure in case of malfunctions
User Manual corpuls3
Alarm message
Printer paper jammed
Printer temp. too high Printer temp. high Printer voltage too low Printer volt. low
Printout aborted
Radio conn. N/A Radio conn. N/A Replace battery Replace battery Risk of overheating [X]
RR < [NUMBER]/min RR > [NUMBER]/min Selftest failed Server access denied
Server connection error
Priority
System alarm Medium priority
System alarm Medium priority System alarm Medium priority
System alarm Medium priority
System alarm Low priority
System alarm High priority
System alarm High priority
Physiological patient alarm High priority System alarm High priority System alarm Low priority
System alarm Low priority
Explanation/Measure
The paper has become jammed during the printing process. Open the paper flap and remove the paper jam. To do this, pull the paper slowly and carefully forwards, close the paper flap and tear the paper off on the cutting edge. The printer speed is configured to 6.25 mm/sec and the marking indicating the end of the paper roll is visible.
The printing head is currently too hot and printing is not possible. Leave monitoring unit to cool down, if possible.
Alarm message shown on the screen of the monitoring unit and patient box. The battery charge of the monitoring unit is too low or the battery is missing, so that printing is currently not possible. Charge monitoring unit or insert into a charging bracket.
The connection between monitoring unit and patient box was interrupted during the printing process. Reduce the distance between the modules or Connect modules mechanically.
A radio module is faulty. The corpuls3 can only be used as a compact device with an ad-hoc connection. Contact authorised sales and service partners.
The battery has to be checked immediately and replaced, if necessary. The corpuls3 is possibly not functioning correctly and must not be used. Contact authorised sales and service partners.
"X" stands for a failure number from 1 to 2. Defibrillation was performed on the test contacts (1= in the shock paddle holder) (2= in the cable socket) too frequently in succession. Avoid further defibrillations on the test contacts.
The measured respiration rate exceeds or falls below the upper/lower alarm limit. Check the patient's vital signs. Check alarm limit settings.
The corpuls3 is possibly not functioning correctly and must not be used. Contact sales and service partners.
The corpuls3 does not have the necessary license to connect to the server. User name and/or password are wrong or not known to the server.. Contact authorised sales and service partners.
The connection to the server has been interrupted. The server cannot be reached. The server has refused the connection. The server has not responded in time to device request. The device has not responded in time to server request. The server is not able to receive D-ECG data. The server is not able to forward the D-ECG. Internal server error.
262
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Alarm message
Shock aborted
SIM card error
SIM card locked
SpCO < [NUMBER] % SpCO > [NUMBER] % SpHb < [NUMBER] g/dl SpHb > [NUMBER] g/dl SpHb < [NUMBER] mmol/l SpHb > [NUMBER] mmol/l SpMet < [NUMBER] % SpMet > [NUMBER] %
SpO2 < [NUMBER] % SpO2 > [NUMBER] %
ß-SW-NOT FOR PAT. USE ß SW-NO PAT. USE
STEMI STEMI possible
Priority
System alarm High priority
System alarm Low priority
System alarm Low priority
Physiological patient alarm Medium priority
Physiological patient alarm Medium priority
Physiological patient alarm Medium priority
Physiological patient alarm Medium priority
System alarm High priority
Technical patient alarm High priority Technical patient alarm High priority
Explanation/Measure
The shock could not be delivered. Check correct position of therapy electrode. Repeat shock delivery if necessary. The event is documented in the protocol. If the message persists, contact your authorised sales and service partners, there could be a hardware defect. In this case, the device has to be taken out of commission.
The corpuls3 does not recognise the SIM card. Make sure that the SIM card is correctly inserted and not dirty.
If data transfer is repeated several times in spite of a wrong PIN, the SIM card will be locked. Data transfer will now no longer be possible even after entry of the correct PIN on corpuls3. Remove the SIM card from corpuls3 and replace with a clear card. A locked card can be unlocked in a mobile telephone by entering the PIN2/PUK/PUK2 ("super PIN") (PIN: Personal Identification Number; PUK: Personal Unblocking Key) If the SIM card cannot be unlocked, first contact your mobile communications provider and then, if necessary, your authorised sales and service partner.
The measured carbonmonoxide level exceeds/falls below the upper/lower alarm limit. Check the patient's vital signs. Check alarm limit settings.
The measured haemoglobin level exceeds/falls below the upper/lower alarm limit. Check the patient's vital signs. Check alarm limit settings.
The measured methaemoglobin level exceeds/falls below the upper/lower alarm limit. Check the patient's vital signs. Check alarm limit settings.
The measured oxygen saturation exceeds/falls below the upper/lower alarm limit. Check the patient's vital signs. Check alarm limit settings.
The software of the module is a beta version. Using this module on a patient is prohibited. This beta software has been released only for testing purposes, as the functions are implemented, but have not been tested completely. Contact authorised sales and service partners.
Configurable warning in case the ECG measurement/interpretation algorithm "corpuls ACS" detects a "STEMI" in the ECG. Check the therapy suggestion printed on the D-ECG.
Configurable warning in case the ECG measurement/interpretation algorithm "corpuls ACS" detects a possible "STEMI" in the ECG.
Check the therapy suggestion printed on the D-ECG.
ENG - Version 4.0 P/N 04130.2
263
Procedure in case of malfunctions
User Manual corpuls3
Alarm message
Priority
SW conflict [MODULE]
System alarm High priority
SYND CLK error SYND CLK error
System alarm High priority
Explanation/Measure
"MODULE" stands for either the monitoring unit, patient box or defibrillator/pacer. The connection authorisation (Pairing) has failed. Due to different software versions the modules cannot be connected. For further information see chapter 3.2.1 Pairing (Connection Authorisation), page 12). Contact authorised sales and service partners.
The automatic synchronisation in manual defibrillation mode does not work. No shock can be released. Contact authorised sales and service partners.
SYND TEST error SYND TEST error
System alarm High priority
A hardware fault exists in the defibrillator. The corpuls3 is not functioning correctly and must not be used. Contact authorised sales and service partners.
T(X) < [NUMBER] °C T(X) > [NUMBER] °C
Physiological patient alarm
Medium priority
System alarm Ther. electr. detect. error High priority
Therapy electrodes loose
Technical patient alarm
High priority
Time/Date invalid Time/Date inv. VT/VF possible
Wrong GSM PIN
System alarm Low priority Technical patient alarm High priority
System alarm Low priority
System alarm Wrong therapy electrodes
High priority
Table 11-1 264
Alarm messages, alphabetical
"X" stands for a temperature channel from 1 to 2. The measured temperature exceeds/falls below the upper/lower alarm limit. Check the patient's vital signs. Check alarm limit settings.
The therapy electrodes are not connected correctly to the therapy master cable. Check the connection of the plugs and adjust if necessary. Use replacement therapy electrodes (see also chapter 5.1.1 Types of Therapy Electrodes, page 68) If the message persists, contact authorised sales and service partners.
Check all connections of the corPatch electrodes. Connect corPatch electrodes to the patient. Check contact of corPatch electrodes with skin. If necessary, re-connect all connections of the corPatch electrodes. If the alarm message persists, connect immediately the reserve corPatch electrodes.
The set time or the set date are invalid. Set the correct time/date.
There is possibly an arrhythmia in form of a ventricular tachycardia (VT) or a ventricular fibrillation (VF). Analyse the ECG or perform an ECG interpretation in the AED mode.
The PIN belonging to the SIM card is unknown to the corpuls3. The SIM card in the corpuls3 was possibly replaced. Data transmission must not be repeated, to avoid that the SIM card is locked. Contact the persons responsible for the device.
In AED mode, non-suitable therapy electrodes are connected to the therapy master cable. The corpuls3 is in pacer mode and the shock paddles are connected. Connect corPatch electrodes
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
11.2 Troubleshooting and Corrective Actions
The following table lists possible malfunctions and describes the cause of the malfunction as well as how to eliminate it. If these remedies should, against expectations, not be effective the device may be defective. Contact authorised sales and service partners.
Malfunction
Possible cause
The loudspeaker of the monitoring unit is too faint or inaudible.
The loudspeaker volume has been selected too low.
The opening of the loudspeaker is dirty.
The loudspeaker of the
The disconnection signal of the
monitoring unit is buzzing in defibrillator/pacer unit is activated.
modular or semi-modular use.
The acoustic signal transmitter of the patient box is too faint or inaudible.
The acoustic signal transmitter volume has been selected too low.
The opening of the acoustic signal transmitter is dirty.
The time is incorrectly displayed.
The time is not correctly set.
The date is incorrectly displayed.
Time/date invalid
The date is not correctly set.
A date before the release of the current software was entered.
Functions such as D-ECG, LTECG and NIBP not available (greyed softkeys).
Internal error.
LT-ECG not available
corpuls3 starts with a black screen and the headline "corpuls3 Software Update Mode"
Patient box and/or defibrillator/pacer are/is switched off.
No CompactFlash® card is inserted.
No original CompactFlash® card inserted.
The CompactFlash® card is full.
The jog dial was pressed during switching on or is blocked.
Configuration export failed The configuration was not saved.
Configuration import failed
The configuration file has been written with a different software version.
Table 11-2
General malfunctions
Explanation/corrective action Set the volume to a readily audible value (see chapter 7.3 Alarm Configuration, page 172). Clean the opening of the loudspeaker
For information on the disconnection signal see chapter 7.4.4 Configuration of the Defibrillation Function (Persons Responsible for the Device), page 181. Set the volume to a readily audible value (see chapter 7.3 Alarm Configuration, page 172). Clean the opening of the acoustic signal transmitter.
Set the time correctly (see chapter 7.1.1 General System Settings (User DEFAULT), page 155).
The permanent setting can only be made by user OPERATOR.
Correctly set the date (see chapter 7.1.1 General System Settings (User DEFAULT), page 155).
Enter the date correctly (see chapter 7.4.2 General System Settings (Person responsible for the device), page 176)
Switch off the corpuls3 and restart. If the problem persists, contact your authorised sales
and service partners. Switch on patient box and/or defibrillator/pacer.
Insert CompactFlash® card correctly. Only use original corpuls3-CompactFlash® cards.
Delete the data on the CompactFlash® card and re-insert. Make sure that the jog dial can be turned and is not
blocked. Switch off the corpuls3 by pressing the On/Off key for
at least 8 s and restart. The configuration has to be saved before exporting. Contact sales and service partners.
ENG - Version 4.0 P/N 04130.2
265
Procedure in case of malfunctions
User Manual corpuls3
Malfunction
Error message "No
connection to
Defibrillator Unit "
Possible cause The defibrillator/pacer is outside the radio range.
Foreign body in front of the infrared interface.
The monitoring unit cannot be switched on (operation as a compact device).
Malfunction in the network connection. The On/Off key on the monitoring unit has been held down for longer than 8 s.
Modules cannot connect
Foreign body in front of the infrared
(operation as compact unit). interface.
Connection authorisation (Pairing) does not take place (message text "Pairing failed - Retry?")
Radio connection range low. Operation of disconnected modules only possible at short range.
The radio unit in the patient box is shadowed by metallic or metallised objects, by people or body parts of the patient.
Possibly a technical defect.
Explanation/corrective action
Check if the defibrillator module is switched on. Reduce the distance between the modules or Connect modules mechanically.
Check if foreign bodies are located in front of infrared interfaces on individual modules.
Remove foreign bodies. If necessary, clean the infrared interfaces.
Disconnect the monitoring unit from the defibrillator/pacer and the patient box.
Check if the defibrillator/pacer and patient box are switched on.
Switch on the monitoring unit again by pressing the On/Off key.
Check if foreign bodies are located in front of infrared interfaces on individual modules.
Remove foreign bodies. If necessary, clean the infrared interfaces. If necessary, use the corpuls3 with radio connection. Contact sales and service partners.
Check if all modules are switched on. Repeat pairing. If the problem persists, contact your authorised sales
and service partners.
The antenna of the radio unit in the patient box is located at the top. If possible, choose a position that allows unimpeded view to the other modules.
Put patient box to an upright position or use appropriate bracket.
Remove metallic or metallised objects.
Connect modules mechanically. Contact sales and service partners.
Table 11-3
Network malfunctions
Malfunction
No shock is triggered in spite of pressing the shock buttons on the shock paddles.
Possible cause
The shock paddle buttons were pressed too briefly.
The shock paddles are faulty.
Charging the defibrillator takes too long.
State of charge of the battery is low.
266
Explanation/corrective action
Deliver shock again. Hold the shock paddle buttons down for at least 1
second in manual defibrillation mode.
Replace the shock paddles, use corPatch electrodes in the meantime.
Contact sales and service partners.
Connect the defibrillator to an external power supply if possible.
Connect the defibrillator with the other modules to be able to access their energy reserve.
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Malfunction
Possible cause
Explanation/corrective action
Charging the defibrillator is not possible.
The surrounding temperature is too low (< -10 °C) and the conditions "battery charge > 70%" and "operation as compact device" are not met.
Keep the device sufficiently charged.
At low temperatures, use the therapeutic functions only when operated as compact device.
It is not possible to trigger the shock via corPatch clip electrodes.
The corPatch clip electrodes are not Check the cable and plug interfaces. properly connected.
Table 11-4
Malfunctions during defibrillation
Malfunction
Possible cause
Pacing via corPatch clip electrodes is not possible.
The corPatch clip electrodes are not properly connected.
Table 11-5
Malfunctions during stimulation (pacer)
Explanation/corrective action Check the cable and plug interfaces.
Malfunction
The ECG recorded via the ECG electrodes is of poor quality.
Possible cause
Explanation/corrective action
The ECG electrodes used have passed the expiry date.
Only use ECG electrodes whose expiry date printed on the packaging has not passed.
ECG electrodes from different manufacturers are used.
Only use ECG electrodes from the same manufacturer.
The ECG electrodes are dried out.
Do not use ECG electrodes stored outside the packaging for a prolonged period or with the packaging open.
Do not use ECG electrodes exposed to the sun or excessive ambient temperatures for a prolonged period.
Read and follow the instructions for storage on the electrode packaging.
The contact between the ECG electrodes and the patient's skin is poor.
Check the contact of the electrodes on the patient's skin. In particular the green and the black electrode of the 4 pole ECG monitoring cable.
Remove excessive hair from the patient's skin.
Clean the sites for attaching the ECG electrodes to the skin with a substance containing alcohol.
Use new ECG electrodes.
The clip of the 4 pole ECG monitoring cable is not connected properly to the ECG electrodes.
Check the clip of the ECG cable connected to the ECG electrodes. In particular the green and the black electrode of the 4 pole ECG monitoring cable.
In the environment are sources of electrical interference.
If possible, remove or switch off sources of electrical interference.
ECG filter settings or mains filter not Check the ECG filter setting for monitoring and
correct.
diagnostic.
Check the mains filter settings.
ENG - Version 4.0 P/N 04130.2
267
Procedure in case of malfunctions
User Manual corpuls3
Malfunction
The selected or more ECG curves are not displayed.
Possible cause
The contact between the ECG electrodes and the patient's skin is poor.
The clip of the ECG cable is not correctly connected to the ECG electrodes.
The ECG cable is not connected.
No signal data is received.
The connection to the patient box is possibly cut off.
Only one single ECG curve is displayed.
The contact between the red/yellow ECG electrodes and the patient's skin is poor.
The clip of the ECG cable is not connected properly to the red/yellow ECG electrodes.
D-ECG printout is not legible ECG recording impossible due to external interferences
HES analysis issues an error See Table 6-2, page 125 code
The QRS-/pulse tone is inaudible.
Acoustic reproduction of the QRS/pulse tone is not enabled.
The loudspeaker of the monitoring unit is not enabled.
The loudspeaker volume has been selected too low.
The opening of the loudspeaker is dirty.
Table 11-6
Malfunctions during ECG monitoring
Explanation/corrective action Check the contact of the electrodes on the patient's skin. Check in particular the ECG electrode of the curve affected. Connect the clip of the ECG cable to the ECG electrodes. Check in particular the ECG electrode of the curve affected. Plug the ECG cable into the appropriate socket (ECG-M or ECG-D). Check the connection status and reduce the distance between the monitoring unit and patient box or connect the modules mechanically, if necessary.
Check the contact of the electrodes on the patient's skin, in particular of the electrodes connected to the red and yellow clip of the ECG cable. Connect the clip of the ECG cable to the ECG electrodes. Check in particular the red and yellow clip of the ECG cable. Record the D-ECG again
Record the D-ECG again
Press the left softkey [QRS] in monitoring mode.
Activate the loudspeaker of the monitoring unit (see chapter 7.2.1 ECG Monitoring, page 166). Set the volume to a readily audible value (see chapter 7.2.1 ECG Monitoring, page 166). Clean the opening of the loudspeaker
Malfunction
The oximetry value is not displayed.
The pleth curve is not displayed.
The PR value is not displayed.
The oximetry values are imprecise.
The oximetry values appear implausible.
Possible cause
The oximetry sensor is not correctly placed on the patient's body.
The appropriate oximetry sensor is not used.
The oximetry sensor is dirty.
The measurement site on the patient is dirty or disturbed by other influences (fungal infection/nail polish).
The oximetry intermediate cable is not connected to the patient box.
Explanation/corrective action
Position the oximetry sensor according to the indications in the operating instructions of the sensor manufacturer.
Use an oximetry sensor suitable for the patient's age and weight.
Clean the oximetry sensor (see chapter 10.7.7 Oximetry sensor, page 248,). Rotate the finger sensor by 90°. Clean the measurement site (e. g. remove nail polish) Choose another measurement site.
Make sure that the oximetry intermediate cable is connected to the "Oximetry" socket on the patient box.
268
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Malfunction Table 11-7
Possible cause
Explanation/corrective action
The oximetry sensor is not connected to the oximetry intermediate cable.
Make sure that the oximetry sensor is connected to the oximetry intermediate cable.
M-LNCS needs a 15-pole intermediate cable.
Make sure that the oximetry sensor is compatible with the oximetry intermediate cable.
No signal data is received.
The connection to the patient box is possibly cut off.
Reduce the distance between the monitoring unit and the patient box.
Strong ambient light disturbs the measurement (e. g. in case of strong sunshine, operating theatre lights with xenon light sources, in case of photodynamic therapy with bilirubin lamps, etc.)
Protect the oximetry sensor by using opaque material against ambient light.
Physical movements by the patient Secure the oximetry sensor. Eliminate the cause on the interfere with the measurement. patient's part if possible.
Perfusion at the selected measurement site is poor.
Select another measurement site.
The oximetry sensor is attached too Loosen the oximetry sensor. tightly.
Electromagnetic interferences interfere with the measurement (e. g. electrosurgical devices).
Operate the sensor at a distance from cables of electrosurgical devices if possible.
The patient has dysfunctional haemoglobin.
Take measures according to medical indication.
Intravascular pigments in the patient's blood interfere with the measurement (e. g. methylene blue).
Take measures according to medical indication.
Venous pulsations interfere with the Select another measurement site. measurement.
The sensor is positioned on an extremity on which an inflated blood pressure cuff, an arterial catheter or an intravenous access is located.
Position the sensor on another extremity. Select another measurement site.
The patient has hypotension, severe Take measures according to medical indication. anaemia or hypothermia.
The patient has a cardiac arrest or Take measures according to medical indication. is in shock.
Malfunctions during oximetry monitoring
ENG - Version 4.0 P/N 04130.2
269
Procedure in case of malfunctions
User Manual corpuls3
Malfunction
Possible cause
Explanation/corrective action
NIBP monitoring cannot be started.
The connection to the patient box is possibly cut off.
Check, if the patient box is switched on.
Check the connection status of the modules and reduce the distance between the monitoring unit and the patient box if necessary.
When operating as compact device, check the infrared interfaces.
The NIBP cuff and/or the hose are possibly not correctly connected.
Check if the NIBP cuff and/or the hose are correctly connected. Apply the countermeasures required if necessary.
NIBP monitoring keeps being The NIBP cuff is possibly trapped
interrupted.
and cannot be inflated.
Free the extremity involved, completely remove clothing and restart monitoring.
Excessive movement at the extremity monitored leads to artefacts in the measurement.
Make sure that the extremity involved is in the resting position during monitoring.
The NIBP measurement values Too large/too small NIBP cuffs are Use the correct NIBP cuff size.
do not seem plausible.
being used.
The NIBP cuff cannot be completely inflated.
The NIBP cuff or the hose system are possibly damaged.
Use a new NIBP cuff.
The connection between the NIBP cuff and the patient box is possibly cut off.
Check the connecting hose between the NIBP cuff and the patient box.
Replace the hose if necessary.
The connecting hose of the The closure of the plug has not been Check the plug closure
NIBP cuff becomes loose from closed properly the patient box
Exchange the plug if defective. Use a new connecting hose.
The closure opens when the connecting hose is moved
For those cases, a fixing ring is available as spare part. Contact your authorised sales and service partner.
Table 11-8
Malfunctions during NIBP monitoring
Malfunction
The CO2 value is not displayed.
The CO2 curve is not displayed.
The RR value is not displayed.
Possible cause
The CO2 sensor is not correctly positioned on the airway adapter.
The CO2 sensor and/or airway adapter is dirty.
The CO2 intermediate cable is not connected to the patient box.
The CO2 sensor is not connected to the CO2 intermediate cable.
No signal data is received. The connection to the patient box is possibly cut off.
Explanation/corrective action
Position the CO2 sensor according to the indications in the operating instructions of the manufacturer of the sensor and airway adapter.
Clean the CO2 sensor and airway adapter (see chapter 10.7.8 CO2 sensor, page 248).
Make sure that the CO2 intermediate cable is connected to the "CO2" socket on the patient box.
Make sure that the CO2 sensor is connected to the CO2 intermediate cable.
Check, if the patient box is switched on. Check the connection status and reduce the distance
between the monitoring unit and the patient box if necessary. When operating as compact device, check the infrared interfaces.
270
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Malfunction The CO2 curve is interrupted sporadically for a short time by a dashed line. The CO2 curve appears to be cut off at the top. Expiratory CO2 cannot be detected.
Measured ETCO2 value is inaccurate or unstable.
Measured ETCO2 value is lower than the true value
Possible cause Self calibration of the CO2 module
Explanation/corrective action
The CO2 module performs a calibration. No measures necessary.
The CO2 value is greater than the configured scaling.
Set a wider scaling range.
Nasal tube of the nasal adapter is obstructed.
When the nasal tube is obstructed with secretions, the sensor cannot detect the expiratory CO2.
Replace the nasal adapter with a new one.
Nasal tube is removed or not properly inserted in the nostril.
When the nasal tube is not properly inserted in the nostril, the sensor cannot detect the expiratory CO2.
Reattach the nasal adapter correctly.
A nasal adapter is used for a patient The nasal adapter cannot detect the orally expiratory
exhibiting oral breathing.
CO2.
Use an other adapter.
The ambient light is too bright, thereby making measurement impossible.
Protect the CO2 sensor against ambient light by using opaque material.
The sensor has just been attached to the patient.
Immediately after the attachment, the photo detector drifts due to the patient body temperature.
Wait for several minutes until the photo detector temperature stabilises.
Long time measurement in an extremely high humidity environment, such as humidified respiratory gas or simultaneous use of a nebuliser.
In an extremely high humidity environment, the transparent membranes inside the nasal adapter are exposed to water droplets in which the moisture of the respiratory gas has condensed. The transparent membranes may get damaged and lose its anti-fogging performance because of the water droplets. This may cause unstable and/or inaccurate measurement.
Periodically check the condition of the nasal adapter, and if necessary, replace the nasal adapter with a new one.
Be aware that the nasal adapter cannot be used for more than 24 hours.
Blood or mucus adheres to the
Not enough infrared light is transmitted through the
transparent membranes of the nasal nasal adapter airway.
adapter.
Replace the nasal adapter with a new one.
Window of the photo detector and light emitter are dirty.
Not enough infrared light is transmitted through the nasal adapter airway.
Clean the sensor according to the operator's manual (see chapter 10.7.8 CO2 sensor, page 248).
Environmental temperature changes rapidly.
The output of the photo detector drifts due to the rapid temperature change.
Wait until the photo detector temperature stabilises.
Patient breathing is very rapid and/or irregular.
The measured value may be inaccurate because the patient respiration rate is beyond the sensor performance.
ENG - Version 4.0 P/N 04130.2
271
Procedure in case of malfunctions
User Manual corpuls3
Malfunction
Measured ETCO2 value is higher than the true value.
Oral expiratory CO2 is low or not detected even though the YG-121T or YG-122T nasal adapter is attached
Sensor comes off easily with body movement.
Possible cause
Explanation/corrective action
CO2 is mixed with the inspiration (e. g. when simultaneously using hyperventilation masks).
capONE measurement is based on the assumption of no CO2 gas in inspiration (semi-quantitative method). Therefore, when CO2 gas mixes in the inspiration, the measured value will be lower than the true value. If the inspiration contains e. g. 1 mmHg of CO2 gas, the measured ETCO2 value will be 10% less than the true value.
Patient's ventilatory volume is extremely low.
Due to the dead space (1.2 ml), CO2 may mix in the inspired air of patients with low ventilatory volume.
capONE measurement is based on the assumption of no CO2 gas in inspiration (semi-quantitative method). Therefore, when CO2 gas mixes in the inspiration, the measured value will be lower than the true value.
Measurement is performed in a low pressure environment without pressure compensation (e. g. at high altitude).
cap-ONE is affected by atmospheric pressure. For every 15 hPa decrease in pressure, the measured value is 1 mmHg lower than the true value.
Simultaneous use of an anaesthesia measuring instrument with volatile anaesthetic agents.
capONE is affected by volatile anaesthetic agents and produces a higher value than true value. The difference from the true value is as follows:
Gas
Concentration
Difference
Halothane
4%
+1 mmHg
Enflurane
5%
+1 mmHg
Isoflurane
5%
+2 mmHg
Sevoflurane 6%
+3 mmHg
Desflurane
24%
+7 mmHg
Dry mixed gas with 5% (38 mmHg) CO2- and N2-balance, under 1 kPA
N2O anaesthesia is used.
capONE is affected by N2O gas and produces a higher value than the true value.
Oral breath collector is too far from the lip.
The expiratory CO2 cannot be effectively detected when the oral breath collector is too far from the patient's lip.
Adjust the angle of the oral breath collector and keep the oral breath collector no less than 1 cm from the lower lip.
cap-ONE is attached to a patient who has a deformed mouth and exhales CO2 from the corner of the mouth.
The oral breath collector cannot accumulate sufficient expiratory CO2 so the expiratory CO2 may be low or not detected.
Sensor is not properly attached to the patient as shown in the operator's manual.
· Hook the sensor cables over both ears and slide the adjustment ring towards the patient's chin.
· Attach the nasal adapter to the nose with the provided surgical tape.
Sensor cable cannot be hooked over Attach the sensor cables to both cheeks (if possible, on
the ears.
the cheek bones) with the provided surgical tape.
272
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Malfunction
Possible cause
Explanation/corrective action
Surgical tape for fixing the nasal adapter cannot be attached on the nose.
Wrap the surgical tape around both sides of the cable near the nose, and attach the cable on the cheek bone with the surgical tape.
Distorted capnogram when Nasal oxygen cannula is inserted using a nasal oxygen cannula. into the patient's nostrils.
Oxygen is directly administered into the patient's nostrils and expiratory CO2 accumulates in the nasal tube which may distort the capnogram.
Attach the nasal oxygen cannula as shown in the operator's manual.
Oxygen flow rate is too high.
If the oxygen flow is too high it affects the expiratory CO2 and distorts the capnogram, especially at the end of expiration at which the expired volume decreases.
Set the oxygen flow rate lower than 5 l/min. if there is no contraindication from a medical point of view.
Patient's ventilatory volume is extremely low.
The expiratory CO2 is easily affected by oxygen and the capnogram may become inaccurate.
A nasal oxygen cannula not authorised by Nihon-Kohden is used.
If oxygen is administered from an undesirable direction via a non-authorised O2 cannula it may affect the expiratory CO2.
Use an authorised nasal oxygen cannula (e. g. oxygen cannula "V923", Nihon-Kohden, P/N MKD-02-capONE).
For further authorised oxygen cannulae contact the manufacturer Nihon-Kohden (www.nihonkohden.com) or an corpuls sales and service partner.
Nasal oxygen cannula comes Nasal oxygen cannula is not
off easily
attached to the patient.
The oxygen cannula must be attached with surgical tape for stable measurement.
A nasal oxygen cannula not authorised by Nihon-Kohden is used.
The nasal oxygen cannula might not be firmly attached to the nasal adapter.
Use an authorised nasal oxygen cannula (e. g. oxygen cannula "V923", Nihon-Kohden, P/N MKD-02-capONE).
For further authorised oxygen cannulae contact the manufacturer Nihon-Kohden (www.nihonkohden.com) or an corpuls sales and service partner.
Table 11-9
Malfunctions during CO2 monitoring
Malfunction
The temperature value is not displayed.
Possible cause
The temperature sensor is not connected to the patient box.
No signal data is received. The connection to the patient box is possibly cut off.
The temperature value appears implausible.
The temperature sensor is faulty.
Table 11-10
Malfunctions during temperature monitoring
Explanation/corrective action
Make sure that the plug of the temperature sensor is connected to one of the two sockets "Temp-1" or "Temp-2".
Check the connection status and reduce the distance between the monitoring unit and the patient box if necessary. If this error occurs when operating as compact device, check the infrared interfaces. Contact authorised sales and service partners, if necessary.
Replace the temperature sensor with a new one.
ENG - Version 4.0 P/N 04130.2
273
Procedure in case of malfunctions
User Manual corpuls3
Malfunction
Possible cause
Explanation/corrective action
The invasive pressure values are not displayed.
The invasive pressure curve is not displayed.
The pressure recorder (transducer) cable is not connected to the patient box.
No signal data is received.
The connection to the patient box is possibly cut off.
Make sure that the cable of the pressure recorder is connected to one of the two sockets "P1 P2" or "P3 P4".
Check the connection status and reduce the distance between the monitoring unit and the patient box if necessary.
The pressure channel is not calibrated.
Calibrate the pressure channel.
Table 11-11
Malfunctions during IBP monitoring
Malfunction
Possible cause
Explanation/corrective action
No printout follows in spite of The roll of paper in the printer is
pressing the Print key.
used up.
Insert a new roll.
The paper has become jammed during the printing process.
Open the paper flap and pull the paper wound around the paper roller carefully off the roller with both hands.
Close the paper flap and tear off the paper upwards on the cutting edge.
The paper has become wound around the printer roller.
Open the paper flap and pull the paper wound around the paper roller carefully off the roller with both hands.
Close the paper flap and tear off the paper upwards on the cutting edge.
The paper is not correctly inserted. Insert the paper correctly (see chapter 10.5, Fig. 10-2, page 242).
The printout is of poor quality. The printing head is possibly dirty. Clean the printing head carefully with an alcoholimpregnated cloth.
The printer flap is not fully locked. Firmly lock the printer flap on both sides (see chapter 10.5 Loading the printer paper, page 241).
Other than original corpuls3 printer To guarantee problem free functionality, only use original
paper has been used.
corpuls3 printer paper.
The temperature of the surroundings The corpuls3 should not be exposed to extremely low or is beyond the specified limits for the high temperatures for too long. device (+5 °C to 50 °C)
No event ECG is available on No CompactFlash® card is inserted. Insert CompactFlash® card correctly. Only use original
printing the protocol.
corpuls3-CompactFlash® cards.
The CompactFlash® card is full.
Save the data on another data carrier and then delete the data on the CompactFlash® card and reinsert it.
The CompactFlash® card cannot be read.
The CompactFlash® card is not formatted correctly or no original corpuls3 CompactFlash® card was used. Use a correctly formatted original corpuls3 CompactFlash® card.
No original corpuls3 CompactFlash® It is essential to use the original corpuls3 CompactFlash®
card was used.
cards for safety reasons.
274
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Malfunction
Possible cause
Explanation/corrective action
When printing out the protocol, instead of parameter values there are question marks.
There are no minute mean values yet.
Print the protocol at a later point of time, if possible.
The printout contains 6 ECG curves of the DE-recording with a dashed line or dashed test signal.
The booting process of the corpuls3 Wait until the corpuls3 has booted completely. is not yet finished.
The printer dispenses paper in The corpuls3 falsely assumes a
an uncontrolled way.
paper jam.
Press the Print key again.
If the paper dispensal cannot be stopped, open the printer flap or switch the device off and on again.
The printer flap has come loose from its lock.
Excessive use of strength when opening the printer flap.
The corpuls3 has been dropped with the printer flap open.
Check if there is visible damage to the printer flap, printer roll or the hinges.
If there is no visible damage, position the corpuls3 on its side and let the printer flap click into place in its guide rails carefully.
If the problem persists, contact your authorised sales and service partners.
Table 11-12
Printer malfunctions
Malfunction
corpuls3 cannot be switched on.
Possible cause
There is no connection to the power supply.
The patient box or defibrillator is already switched on.
The defibrillator/ pacer, monitoring unit, patient box cannot be switched on.
Charging is not possible in spite of mechanical connection of the magnetic clip.
The battery discharges very rapidly.
There is no connection to the power supply. No batteries are inserted or the batteries are flat. A foreign body is present on the magnetic contact surface (e. g. a paperclip).
The battery shows signs of wear.
Table 11-13
Malfunctions in energy management
Explanation/corrective action Connect the mains charger. For operation as compact device insert at least one charged battery. Separate corpuls3 into its three modules and check whether the patient box or the defibrillator are switched on (see Status LEDs, page 36). If this is not the case, switch on the remaining devices individually. Connect the mains charger.
For operation as compact device insert at least one charged battery. Remove the foreign bodies from the contact surfaces.
Replace the battery if necessary. If the module cannot be switched on after changing the battery, remove battery and after waiting approx. 20 seconds, insert again.
ENG - Version 4.0 P/N 04130.2
275
Procedure in case of malfunctions
User Manual corpuls3
11.3 Notifications Message Line and Information in the Protocol
The notifications marked by `- -` do not require further explanation, as they are self-explanatory. The measure to be taken is to follow the instruction given in the notification. The following notification texts can be shown on the display and/or are printed out in the protocol (in alphabetical order*):
Notification in the message line and information in the protocol
(W)LAN got IP [NUMBER] ... in progress ...
[MODULE] powered on [TEXT] marked as ([TEXT]) [TEXT] marker removed [TEXT] user is forbidden in Demo mode [TEXT]: Checking files [VITAL PARAMETER] -[VITAL PARAMETER] ? [VITAL PARAMETER] [NUMBER] ! [VITAL PARAMETER] [NUMBER] ? [VITAL PARAMETER] [NUMBER] ?!
Abnormal ECG
Ad-hoc connection [MODULE]
Ad-hoc mode -Upload not possible Alarm end;([TEXT]) Alarm suspension activated Alarm suspension deactiv. All locked All unlocked Already in phone book Analysing heart rhythm
Explanation/Measure
Event in the protocol indicating that an IP address has been assigned to the connection.
Message in the message line indicating that formatting the CF card or import or export of device configurations currently running.
Event in the protocol, recording the switching on of the patient box, the monitoring unit or the defibrillator/pacer.
--
--
Message in the message line indicating that in demo-mode can only be run when the user is logged in at "OPERATOR" level. To log in as "DEFAULT" user when the demomode is running, the device has to be switched off and rebooted.
"TEXT" stands for the Mission ID
Event in the protocol, recording that for the vital parameter no value has yet been measured.
Event in the protocol, recording that the vital parameters could not be documented.
Event in the protocol, recording that the issued vital parameter has exceeded or fallen below an alarm limit.
Event in the protocol, recording that the issued vital parameter is not reliable.
Event in the protocol, recording that the issued vital parameter is not reliable but also has exceeded or fallen below an alarm limit.
Configurable warning in case the ECG measurement/interpretation algorithm "corpuls ACS" detects the presence of the Wolff-Parkinson-White (WPW) syndrome, of intraventricular excitation propagation disorders, of an implanted pacer, of QRS intervals longer than 120 ms or of a left bundle branch block in the ECG.
The Ad-hoc connection with the patient box or the defibrillator/pacer has been established.
Message in the message line indicating that the mission(s) recorded on the CF card cannot be uploaded, because the modules of the corpuls3 have no connection authorisation (Pairing).
Event in the protocol, recording that the alarm mentioned has ended.
--
--
Indicates that the touchscreen and the keys are locked.
Indicates that the touchscreen and the keys are unlocked.
--
--
276
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Notification in the message line and information in the protocol
Assess heart rhythm
BT connected: [DEVICE]
BT connected: [DEVICE]
BT connection failed
BT connection not possible Calibration P[NUMBER] in progress Calibration P[NUMBER] successful Cancel Last Can't read data...
CF card currently not available
Charging
Charging not possible
Check defibrillator settings Check energy settings of defibrillator
Explanation/Measure
Spoken instruction and message in the message line after one resuscitation cycle.
Message in the message line after the connection to another Bluetooth® device has been interrupted. "DEVICE" stands for a ventilator (e. g. Weinmann Medumat Transport) or another input device (e. g. a tablet PC).
Message in the message line after the connection to another Bluetooth® device has been established. "DEVICE" stands for a ventilator (e. g. Weinmann Medumat Transport) or another input device (e. g. a tablet PC).
Message in the message line after the connection to another Bluetooth® device has failed. Check the Bluetooth® connections.
Spoken instruction and message in the message line indicating that there is already a Bluetooth connection to a corpuls cpr. To connect to a different corpuls cpr, disconnect the existing connection and establish a new connection.
Message in the message line indicating that the indicated IBP channel is being calibrated.
Message in the message line indicating that the calibration of the indicated IBP channel has been successful.
Last entry in the event list. If this event is selected and confirmed with the jog dial, a time stamp is saved and the event "Event recorded" appears in the mission protocol.
Message in the curve area in Trend mode indicating that data cannot be read.
Currently no data can be saved on or read from the CompactFlash® card. Check if a CompactFlash® card is inserted. In modular operation: reduce the distance between the monitoring unit and the patient box, if necessary. Connect the modules, if necessary.
Message in the message line that the defibrillator is being charged. Wait until the charging process is finished and the defibrillator signals readiness to shock by issuing the ready-signal.
A technical error occurred. The temperature of the charging generator has exceeded a limit value due to several discharges. Leave the corpuls3 to cool down. If the problem persists, contact your authorised sales and service partners.
--
--
ENG - Version 4.0 P/N 04130.2
277
Procedure in case of malfunctions
User Manual corpuls3
Notification in the message line and information in the protocol
Check modules
Check/change therapy electrodes and cable
Circuit open - Check pacer electrodes Code changed Code invalid - Retry? Code mismatch - Retry? Configuration loaded Configuration reset Configuration stored Confirm alarms
Connect defibrillator and monitoring unit
Connect ECG cable Connect pacer cable Connect therapy electrodes Connected to corpuls cpr Connecting to server Connection error Continue pacing? Copy entry? CPR depth [NUMBER]-[NUMBER] cm
278
Explanation/Measure
If there is no connection between the monitoring unit and the patient box and/or the defibrillator/pacer at the time of switch-off or if there is a timing problem between the modules, this is communicated to the user by a message on the display. In this case, separate the modules and check whether all modules have been shut down. If this is not so, switch off the still running modules via the respective On/Off key (hold down for 3 seconds). The therapy electrodes are not connected correctly to the therapy master cable. Check the connection of the plugs and adjust if necessary. Use replacement therapy electrodes (see also chapter 5.1.1 Types of Therapy Electrodes, page 68) If the message persists, contact your authorised sales and service partners. The corPatch electrodes are not connected correctly to the patient or they have a too high resistance to the patient's skin. Stimulation is not possible. Check the expiry date of the electrodes, if they are dried out and if they are placed correctly on the patient. Confirmation that the access code has been successfully changed. -The verification of the new access code did not match the earlier entry. To repeat the process, confirm the prompt and enter the access code again. ---Message in the status-/alarm line that the alarm messages contained in the following alarm list can be confirmed after the user has acknowledged them and has taken the resulting measures on the patient. Message in the message line of the monitoring unit. The wireless communication between the defibrillator and the monitoring unit/patient box has been interrupted or could not be established: Make sure that the distance between the modules is not more than 10 m and that no barriers are compromising the radio connection. Use corpuls3 as a compact device if necessary. -User prompt to connect the therapy master cable to the therapy electrodes. Connect the corPatch electrodes or shock paddles to the therapy master cable of the corpuls3. If the alarm message persists, connect immediately the reserve corPatch electrodes. -Status message during mission upload. Status message during mission upload. User prompt to confirm the continuation of stimulation (pacer therapy). Confirmation prompt if the selected network configuration should be copied. The user changed the alarm limits of the CPR depth in centimetres.
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Notification in the message line and information in the protocol
CPR depth [NUMBER]-[NUMBER] in
CPR test failed
CPR test successful
CPR unit cm
CPR unit in
D-ECG ([NUMBER]) not saved ([NUMBER])
D-ECG ([NUMBER]) saved D-ECG fax sent D-ECG printout D-ECG transmission finished D-ECG transmission started Defibrillation only possible in manual mode Defibrillator activated (AED) Defibrillator activated (Man.) Defibrillator deactivated Delete entry? Deleted missions: Demo mode off Demo mode on Device is performing preShock CPR
Explanation/Measure
The user changed the alarm limits of the CPR depth in inches.
Message in the message line indicating that the self test of the CPR module has failed. Check the connections of the sensor and intermediate cable and adjust if necessary. Use replacement corPatch CPR sensor If the message persists, contact your authorised sales and service partners. Message in the message line indicating that the self test of the CPR sensor has been successful. Event in the protocol indicating that the user has changed the displayed CPR unit to centimetres. Event in the protocol indicating that the user has changed the displayed CPR unit to inches. The recorded D-ECG could not be saved because the CF card is possibly full, the CF card is possibly not inserted correctly the CF card is possibly faulty or the writing process onto the CF card has failed. After deleting or exchanging the CF card, repeat the process. If the problem persists, contact your authorised sales and service partners. Event in the protocol that a D-ECG has been saved. The number of the D-ECG is shown in brackets. Confirmation that the fax has been successfully sent. Event in the protocol, recording that a D-ECG has been printed out. Event in the protocol, recording that a D-ECG has been successfully sent to the server. Event in the protocol indicating that the transmission of the D-ECG has started. User prompt to switch from AED mode to manual defibrillation mode. The therapy electrodes used are not authorised for use in AED mode.
Event in the protocol that the defibrillator has been activated in AED mode.
Event in the protocol that the defibrillator has been activated in manual defibrillation mode. Event in the protocol, recording the leaving the defibrillator mode. Confirmation prompt if the selected network configuration should be deleted. -The DEMO mode has been switched off. The DEMO mode has been switched on. Check if curves and parameters are displayed. --
ENG - Version 4.0 P/N 04130.2
279
Procedure in case of malfunctions
User Manual corpuls3
Notification in the message line and information in the protocol
Disconnect defibrillator and monitoring unit
Do not touch patient
Do not touch patient Analysing heart rhythm ECG analysis result;>>> %sShock not recommended ECG analysis result;>>> %sShock recommended ECG analysis started ECG FILTER ACTIVE INTERPRETABILITY MAY BE AFFECTED
Electrode
Energy delivered Energy selected Energy selection [NUMBER] J Enter Bluetooth PIN: [NUMBER] [NUMBER] [NUMBER] [NUMBER] Enter code: [NUMBER] [NUMBER] [NUMBER] [NUMBER] Enter new code: [NUMBER] [NUMBER] [NUMBER] [NUMBER] Error GSM module
Error in device (BIM)
Error in device (DEFI)
Error in device (MAN-BIM)
Event [TEXT] recorded
Event recorded Export failed
Export successful
Explanation/Measure
Message in the message line of the monitoring unit. Communication in the connected state between the patient box and monitoring unit/defibrillator is cut off or could not be established: Check if one of the two infrared interfaces is covered or dirty. The ECG analysis is being performed. Do not touch or move patient. Follow the instructions on the display. Spoken instruction and message in the message line indicating that analysis is running.
Event in the protocol, recording the result of the ECG analysis.
Event in the protocol, recording that an ECG analysis has been performed in AED mode. Notice on the ECG printout that a filter was used and that the printout is not suitable for diagnosis.
Entry in the shock protocol indicating which type of electrode was used for the shock: Shock paddles, corPatch electrodes, shock spoons, unknown electrodes, etc. Entry in the shock protocol indicating the energy level actually delivered in Joule. Entry in the shock protocol indicating the energy level selected for the shock in Joule. Event in the protocol, recording the energy selected. --
User prompt to enter the access code.
User prompt to enter a new access code.
-The corpuls3 is not functioning correctly and must not be used. Contact authorised sales and service partners. The corpuls3 is not functioning correctly and must not be used. Contact authorised sales and service partners. The corpuls3 is not functioning correctly and must not be used. Contact authorised sales and service partners. Event in the protocol indicating that a pre-configured manual event (e. g. intubation, etc.) has been recorded. -Message in the message line indicating that the export of the configuration has failed. Message in the message line indicating that the export of the configuration has been successful.
280
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Notification in the message line and information in the protocol
Fax connect. not possible
Fax transmission aborted
Formatting CF card (State:[NUMBER])
Formatting CF card failed
Formatting CF card successful
Fully release
Generic
Good compressions GPRS authorisation failed GPRS link error GSM disconnecting GSM got IP connection GSM initiation successful GSM link detected GSM modem at [NUMBER] baud is a [TEXT] GSM modem disabled GSM modem IP connecting:;PLMN [NUMBER], LAC [NUMBER], cell ID [NUMBER], RSSI [NUMBER] GSM network not avail.
Hardware conflict [MODULE] Pairing impossible
Explanation/Measure
Possibly a wrong fax number has been dialled. Repeat dialing. Status indication during fax transmission Event in the protocol indicating that the CF card has been formatted. "NUMBER" indicates that the formatting has been successful (1) or has failed (2). This message is only shown in monitoring mode. Message in the message line indicating that the formatting of the CF card has failed. This message is only shown in monitoring mode. Message in the message line indicating that the formatting of the CF card has been successful. This message is only shown in monitoring mode. Spoken instruction and message in the message line indicating that the thorax of the patient has to be released fully at regular intervals in between the thorax compressions. First entry in the event list, marked by default. If this event is selected and confirmed with the jog dial, a time stamp is saved and the event "Event recorded" appears in the mission protocol. Spoken instruction and message in the message line indicating that the recommended depth of the thorax compressions has been reached or exceeded. --Event in the protocol indicating the GSM connection is being terminated. --Event in the protocol indicating that a GSM connection has been established. Event in the protocol indicating that a modem of a certain type with a data transmission rate of x baud has been detected. -Event in the protocol indicating that a GSM connection has been established and with which parameters.
-The connection authorisation (Pairing) has failed. Due to different hardware versions the modules cannot communicate via radio connection. To start an ad-hoc connection, connect the modules mechanically and do not confirm the message Perform pairing?. The modules can now communicate via the infrared interface. If the problem persists, contact authorised sales and service partners.
ENG - Version 4.0 P/N 04130.2
281
Procedure in case of malfunctions
User Manual corpuls3
Notification in the message line and information in the protocol
High impedance
Hyperbaric pressure %.1f bar Impedance Import failed Import successful - Please reboot Impulse duration Input device locked - Hold down HOME key to unlock Keyboard locked Keyboard locked - Hold down HOME key to unlock Keyboard unlocked Last event deleted Leave Demo mode - Power off? Lock input device? Lock keyboard? Mark mission as test mission? Max. current Mean current Metronome adult [TEXT] Metronome child [TEXT] Mission ended Mission started Mission upload aborted Mission upload finished Mode New card
Explanation/Measure
The electrical resistance of the patient (impedance) is to high for the selected settings. An intensity for stimulation has been selected that cannot be reached with the impedance present. Make sure that the corPatch electrodes are tightly and completely attached to the patient's skin. In case of excessive hair on the patient, shave the required area on the skin. If necessary, use new corPatch electrodes. To perform a pacer therapy adaequate for the patient, a higher stimulation intensity must be selected. Perform medical measures as needed. Event in the protocol indicating that the hyperbaric compensation has been changed. Entry in the shock protocol indicating the impedance measured in Ohm. Message in the message line indicating that the import of the configuration has failed. Message in the message line indicating that the import of the configuration has been successful. The corpuls3 has to be switched off and rebooted. Entry in the shock protocol indicating the duration of the shock in milliseconds. Indicates that the touchscreen and/or the keys are locked.
Keyboard lock has been engaged.
--
Keyboard lock has been disengaged. Event in the protocol indicating that the last manual event has been deleted. Message in the message line indicating that for leaving the Demo mode the corpuls3 has to be switched off. User prompt to confirm the locking of the keyboard/touchscreen.
User prompt to confirm or prevent that the current mission is marked as a test mission.
Entry in the shock protocol indicating the maximum current delivered in Ampere. Entry in the shock protocol indicating the average current delivered in Ampere. Event in the protocol, recording the switching on, switching off and the mode of the metronome.
Event in the protocol indicating the ending time of the device mission. Event in the protocol indicating the starting time of the device mission. Status message during mission upload. Status message during mission upload. Entry in the shock protocol indicating the defibrillation mode used for the shock: manual or AED. An insurance card has been recognised.
282
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Notification in the message line and information in the protocol
New code invalid - Retry? NIBP result: [NUMBER]/[NUMBER] ([NUMBER]) mmHg NIBP R-wave gating switched off NIBP R-wave gating switched on No APN entered No CF card - Upload not possible
No connection to defibrillator unit
No connection to patient box
No ECG cable in DEMAND mode No shock [NUMBER] J ([NUMBER] J), [NUMBER] Ohm ([TEXT])
NSTEMI
NSTEMI possible
Pacer active - D-ECG not available
Explanation/Measure
User prompt to re-enter the new access code, if the repetition was wrong.
Result of the NIBP measurement in the protocol.
Event in the protocol indicating that the option R-wave Motion Tolerance (R-wave gating) has been disabled.
Event in the protocol indicating that the option R-wave Motion Tolerance (R-wave gating) has been enabled.
--
Message in the message line indicating that no CF card is inserted from where missions could be uploaded.
Message in the message line of the monitoring unit. The wireless communication between the defibrillator and the monitoring unit/patient box has been interrupted or could not be established: Make sure that the distance between the modules is not more than 10 m and that no barriers are compromising the radio connection. Use corpuls3 as a compact device if necessary. Communication in the connected state between the patient box and monitoring unit/defibrillator is cut off or could not be established: Check if one of the two infrared interfaces is covered or dirty.
Message in the message line of the monitoring unit. The wireless communication between the patient box and the monitoring unit/defibrillator has been interrupted or could not be established: Make sure that the distance between the modules is not more than 10 m and that no barriers are compromising the radio connection. Use corpuls3 as a compact device if necessary. Communication in the connected state between the patient box and monitoring unit/defibrillator is cut off or could not be established: Check if one of the two infrared interfaces is covered or dirty.
For operating the pacer in DEMAND mode the 4-pole ECG monitoring cable has to be connected to the patient and to the corpuls3.
Event in the protocol indicating that a shock could not be delivered completely. "NUMBER" indicates, respectively, the selected energy, the actually delivered energy (in brackets) and the impedance of the patient. "TEXT" (in brackets) indicates the selected defibrillation mode: AED or manual.
Configurable warning in case the ECG measurement/interpretation algorithm "corpuls ACS" detects a "NSTEMI" in the ECG. Check the therapy suggestion printed on the D-ECG.
Configurable warning in case the ECG measurement/interpretation algorithm "corpuls ACS" detects a possible "NSTEMI" in the ECG. Check the therapy suggestion printed on the D-ECG.
The pacer of the corpuls3 is activated and the selected intensity is more than 0 mA. A D-ECG cannot be performed under these circumstances.
ENG - Version 4.0 P/N 04130.2
283
Procedure in case of malfunctions
User Manual corpuls3
Notification in the message line and information in the protocol
Pacer error - Pacing off
Pacer frequency [NUMBER]/min selected Pacer intensity [NUMBER] mA selected Pacer mode [TEXT] selected Pacer mode activated Pacer mode deactivated Pacer off Pacer pause [NUMBER] Pacing Pacing not possible
Pairing failed - Retry?
Pairing in progress... Pairing successful Patient data accepted Patient data changed [TEXT] Patient data erased Patient data not accepted Pause Pause pacing? Perform CPR
Explanation/Measure
An error occurred during pacer therapy. The pacer is switched off. Stimulation is interrupted. Treat patient and take measures as needed. Contact authorised sales and service partners.
Event in the protocol, recording the pacer frequency selected.
Event in the protocol, recording the pacer intensity selected.
Event in the protocol, recording the switch between the pacer modes FIX and DEMAND. (No alarm!) The pacer menu has been called up. The pacer menu has been closed. Confirmation that the pacer has been switched off and is not stimulating. Event in the protocol, recording how long the pacer therapy has been interrupted. Message in the message line that the pacer is running. The corpuls3 is possibly not functioning correctly and must not be used. Contact authorised sales and service partners. The connection between the modules could not be established. Connection authorisation (Pairing) has failed. Pairing has to be performed again so that the modules can be used together. It is necessary to confirm the question if the pairing should be performed again. Confirm in order to repeat pairing. For further information see chapter 3.2.1 Pairing (Connection Authorisation), page 12). If pairing fails repeatedly, the corpuls3 is possibly not functioning correctly and must not be used. Contact authorised sales and service partners. The connection authorisation is being established. The connection authorisation has been issued successfully. The modules can be used together. The insurance card data have been accepted. The insurance card data have been changed. The changes have been performed manually (man.), via the insurance card reader (Card), via the Bluetooth interface (BT) or via corpuls.web LIVE (cweb). The insurance card data have been erased. The insurance card data have not been accepted. Message in the message line that the pacer therapy has been interrupted. Continue pacer therapy if necessary. User prompt to confirm the pausing of stimulation (pacer therapy). Perform cardio-pulmonary resuscitation (CPR). Follow the instructions on the screen.
284
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Notification in the message line and information in the protocol
Perform pairing?
Power off? Press Analyse
Press shock paddle buttons again
Protocol printout Push harder Reading data... Reconnect therapy electrode cable Recording failed - Check CF card Re-enter new code: [NUMBER] [NUMBER] [NUMBER] [NUMBER] Reset code? Scan failed Scanning... Select energy Select energy / Charge energy Select frequency Select intensity Select intensity/frequency
Select mode
Server connection request
Server disconnected Server not found
Shock [NUMBER] J ([NUMBER] J), [NUMBER] Ohm ([TEXT])
Explanation/Measure
Two modules have been connected that do not have a connection authorisation (Pairing). Start if these modules are to receive a connection authorisation and the existing connection authorisation should be deleted. User prompt to confirm the switching off of the corpuls3. -Press shock paddle buttons again, up to 5 times. Use replacement therapy electrodes (see also chapter 5.1.1 Types of Therapy Electrodes, page 68) If the message persists, contact your authorised sales and service partners. Event in the protocol, recording that a protocol has been printed out. Spoken instruction and message in the message line indicating that the recommended depth of the thorax compressions has not been reached. Message in the curve area in Trend mode indicating that data are being read. The corpuls3 is not functioning correctly and must not be used. Contact authorised sales and service partners. Data recording is not possible. Check if the CompactFlash® card is inserted correctly. User prompt to re-enter the new access code.
Confirmation prompt asking if the access code of the user level should be reset to factory settings. ---Message in the message line that the user should select another energy level or start the charging of the set energy level by pressing the Charge key. -To begin pacer therapy, select intensity. To begin pacer therapy, select intensity and frequency. Message in the message line in pacer mode after pressing the softkey [Mode]. Select the operating mode of the pacer. The user has sent data/an D-ECG to the server. The selected phonebook entry, the IP address and type of connection (Fax-S, E-Mail, CWEB, CWEB AUTO) are added to the event in the protocol. Event in the protocol indicating that the connection to the server has been terminated. Event in the protocol indicating that the connection to the server has been lost or could not be established. Time stamp and status indication of a performed defibrillation in the protocol. The selected energy, the effectively released energy (in brackets) and the impedance in Ohm are indicated. Indication of the defibrillation mode used.
ENG - Version 4.0 P/N 04130.2
285
Procedure in case of malfunctions
User Manual corpuls3
Notification in the message line and information in the protocol
Shock [NUMBER] J ([NUMBER] J), [NUMBER] Ohm ([TEXT]); sync mode selected: [TEXT], applied:[TEXT]
Shock aborted
Shock aborted - Perform CPR
Shock not recommended
Shock performed Shock performed - Perform CPR Shock protocol printout Short circuit - Check electrodes SIM card error
Software conflict [MODULE] Separate modules
Start ECG
STEMI
STEMI possible
Stop ECG Storing failed Storing successful Switch off pacer? Switch off pacer? - Power off? Switch off pacer? - Upload missions?
Explanation/Measure
Event in the protocol indicating that a shock has been delivered. "NUMBER" indicates, respectively, the selected energy, the actually delivered energy (in brackets) and the impedance of the patient. "TEXT1" (in brackets) indicates the selected defibrillation mode: AED or manual. "TEXT2" (in brackets) indicates the selected and applied sync mode: Sync, Async or Auto. The shock could not be delivered. Repeat shock delivery if necessary. The event is documented in the protocol. If the message persists, contact your authorised sales and service partners, there could be a hardware defect. In this case, the device has to be taken out of commission.
-The result of the ECG analysis is that a shock is not recommended. Perform medical measures as needed. If necessary, continue with cardio-pulmonary resuscitation. Defibrillation energy has been released. Check vital signs and continue cardio-pulmonary resuscitation if necessary.
--
A shock protocol has been printed out.
The therapy electrodes have an electric connection (short circuit). Make sure that the therapy electrodes do not touch.
-The connection authorisation (Pairing) has failed. Due to different software versions, the modules cannot be connected and have to be separated from each other. For further information see chapter 3.2.1 Pairing (Connection Authorisation), page 12). Contact authorised sales and service partners. Starting time of the recorded ECG in the protocol.
Configurable warning in case the ECG measurement/interpretation algorithm "corpuls ACS" detects a "STEMI" in the ECG. Check the therapy suggestion printed on the D-ECG. Configurable warning in case the ECG measurement/interpretation algorithm "corpuls ACS" detects a possible "NSTEMI" in the ECG. Check the therapy suggestion printed on the D-ECG. --
---
Confirmation prompt asking if the stimulation should be interrupted and the corpuls3 should switch to manual or AED defibrillation mode.
Confirmation prompt asking if the stimulation should be ended and the corpuls3 should be switched off. User prompt to confirm switching off the pacer, uploading the missions and switching off the device.
286
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Procedure in case of malfunctions
Notification in the message line and information in the protocol
Sync mode applied
Sync mode selected
Synd setting: [TEXT] System clock was adjusted;([NUMBER] -> [NUMBER]) System Power-down in [NUMBER] sec Test failed Test successful
Therapy electrodes loose
Time To shut down device press On/Off key Touch display locked Touch display unlocked Transferred missions:
Twisted paddle plug
Unlock input device? Unlock keyboard? Upload missions? Uploading mission [NUMBER] of [NUMBER] User [TEXT] logged in successfully UTC offset;([NUMBER] -> [NUMBER]) VT/VF alarm OFF VT/VF alarm ON webMessage opened No. [NUMBER] webMessage opened No. [NUMBER];[TEXT]
Explanation/Measure
Entry in the shock protocol indicating the sync mode (sync, async or auto) actually used for the shock. Entry in the shock protocol indicating the sync mode (sync, async or auto) selected for the shock. The synd setting has been changed in manual mode to Async, Auto or Sync.
--
Count-down indicating the remaining time until the corpuls3 shuts down.
Entry in the shock protocol. Entry in the shock protocol. Check all connections of the corPatch electrodes. Connect corPatch electrodes to the patient. Check contact of corPatch electrodes with skin. If necessary, re-connect all connections of the corPatch electrodes. If the alarm message persists, connect immediately the reserve corPatch electrodes. Entry in the shock protocol indicating the time at which the shock was released. --
Indicates that the touchscreen is locked. Indicates that the touchscreen is unlocked. -The connectors of the therapy master cable and the therapy electrodes have been connected while turned the wrong way by 180 degrees and have to be checked for damage. Confirmation prompt asking if the keyboard lock should be disengaged.
User prompt to confirm or abort the uploading of missions. Status message during mission upload.
Message in message line and event in the protocol, at which user level the user has logged in. Event in the protocol, recording that the time zone settings have been changed.
----
--
ENG - Version 4.0 P/N 04130.2
287
Procedure in case of malfunctions
User Manual corpuls3
Notification in the message line and information in the protocol
Explanation/Measure
webMessage printout No.
--
[NUMBER]
webMessage printout No.
--
[NUMBER];[TEXT]
webMessage received No.
--
[NUMBER]
webMessage received No.
--
[NUMBER];[TEXT]
Which therapy electrodes are used on the patient?
Warning that the type of therapy electrode cannot be determined. The user has to confirm the type of electrode that is connected to the device (shock paddles, shock spoons, corPatch easy Adult or corPatch easy Pediatric ) by pressing the corresponding softkey.
If the wrong electrode type was chosen accidentally, disconnect the therapy electrode and then connect again. The selection of the therapy electrode appears again.
WLAN connected;[NUMBER] dB SNR, [NUMBER]
Event in the protocol indicating that a connection has been established with a WLAN module, indicating the signal-to-noise ratio in dB and the SSID of the WLAN network.
WLAN disconnected
--
WLAN module detected
Event in the protocol indicating that a WLAN module has been detected.
WLAN searching for networks --
Wrong GSM PIN
--
Table 11-14
Notifications in the message line and information in the protocol
288
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Appendix
A Symbols
Read and follow the instructions in the user manual
Read and follow the instructions in the user manual
Read the additional instructions in the user manual
USB port (in preparation)
BF (body floating, defibrillation-proof) An insulated application component of this type is authorised for external and internal use on the patient CF (cardiac floating, defibrillation-proof) An insulated application component of this type is authorised for use directly on or in the patient's heart
Equipotential bonding
Protection class IP55
APEX Marking for positioning the shock paddles on the patient and on corpuls3 STERNUM Marking for positioning the shock paddles on the patient and on corpuls3 LED: corpuls3 or module is charging on external power supply On/Off key
ENG - Version 4.0 P/N 04130.2
289
Appendix 290
User Manual corpuls3
On/Off key (patient box and defibrillator/pacer)
Home key/Input lock
Back key
Print key
Event key
Alarm key
Multifunction key (patient box) Display in parameter field: alarm enabled Display in status-/alarm line: alarm message
Display in status-/alarm line: Alarm disabled (Covert mode)
Display in parameter field: physiological alarm disabled
Display in parameter field: Alarm suspended Clock symbol:
- In the NIBP parameter field: indicates that the NIBP interval measurement is active and an automatic measurement will be performed soon.
- In the message line: Marks the time of day (displayed alternating with the current mission time).
- As symbol in parameter field Time. Symbol in parameter field Stopwatch. Hourglass symbol
- In parameter field: Oximetry sensor is calibrated. - In the message line: Marks the current mission time (displayed
alternating with the time of day). ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
In the oximetry parameter field: The question mark symbol is displayed instead of the alarm symbol, if the confidence of the measured value is low.
Display in the upper curve field: flashes in step with the QRS complex rhythm (also in blue colour for PR)
Display in the upper curve field: flashes in step with the rhythm of an internal pacer
Monitoring Unit
Patient Box
Defibrillator/Pacer
Battery
QRS tone off
QRS-/pulse tone, volume 4
)
QRS-/pulse tone, volume 6
))
QRS-/pulse tone, volume 8
)))
QRS-/pulse tone, volume 10
Jog dial
Jog dial, field highlighted
Function selected (configuration dialogue)
Lower alarm limit (configuration dialogue)
Upper alarm limit (configuration dialogue)
Field which can only be edited with special user authorisation (configuration dialogue). In this case: editing not possible.
ENG - Version 4.0 P/N 04130.2
291
Appendix 292
User Manual corpuls3
Field which can only be edited with special user authorisation (configuration dialogue). In this case: editing possible.
Antenna symbol shows the site of the radio transmitter in the patient box on the accessory bag
2
Symbol for 2nd generation of radio module (hardware)
Symbol for a 3rd generation module which is incompatible with 2nd or 1st generation modules due to hardware modifications.
Status of the battery. Battery fully charged.
Status of the battery. The number of bars shows the state of charge of the battery.
Status of the battery. The number of bars shows the state of charge of the battery.
Status of the battery. The number of bars shows the state of charge of the battery.
Status of the battery. Battery is empty.
Mains operation, battery is being charged
Mains operation, battery is fully charged.
The airplane symbol indicates that the offline mode is active.
Flashing: the GPRS connection is being established. Permanent: GSM/GPRS connection is established. GSM/GPRS connection not possible. Error in GSM module (e. g. wrong PIN, no PIN configured, etc.)
GSM/GPRS connection has been disconnected by user.
Flashing: the LAN connection is being established. Permanent: LAN connection is established.
LAN connection not possible.
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3 ENG - Version 4.0 P/N 04130.2
Appendix
LAN connection has been disconnected by user. Flashing: the WLAN connection is being established. Permanent: WLAN connection is established. Number of bars indicates the quality of the connection. WLAN connection is established. Number of bars indicates the quality of the connection. WLAN connection is established. Number of bars indicates the quality of the connection. WLAN connection is established. Number of bars indicates the quality of the connection. WLAN connection not possible.
WLAN connection has been disconnected by user. Flashing: Connection to corpuls.web LIVE server is being established. Permanent: Connection to corpuls.web LIVE server is established. Connection to corpuls.web LIVE server failed Permanent: Connection to corpuls.web LIVE server has been disconnected by user. Flashing: the Bluetooth® connection is being established. Permanent: Bluetooth® connection is established (Data connection to external systems) Bluetooth® connection not possible.
Bluetooth® connection has been disconnected by user.
D-ECG transmission is running.
D-ECG transmission was successful.
D-ECG transmission failed.
D-ECG transmission has been cancelled by user.
293
Appendix 294
User Manual corpuls3
Monitoring unit with insurance card reader (option)
Approved for operation in a hyperbaric chamber for hyperbaric oxygen therapy (HBO) (option)
MagCode connector is NOT approved for operation in a hyperbaric chamber for hyperbaric oxygen therapy (HBO).
The WEEE symbol (Waste Electrical and Electronic Equipment) indicates that the device should be returned to the manufacturer for proper disposal and recycling.
CE symbol; the number indicates the competent notified body.
Antenna symbol; indicates that the device is emitting non-ionising radiation.
The RCM (Regulatory Compliance Mark) indicates a device's compliance with applicable ACMA (Australian Communications and Media Authority) technical standards for telecommunications, radiocommunications or broadcasting equipment. Indicates that the mission contains D-ECG data.
Indicates that the mission contains CPR data.
Indicates that the mission contains defibrillation data.
Indicates the quality of the NIBP measurement: The quality indicator consists of 3 star symbols which indicate good measurement quality when filled, poor quality when displayed as an outline. M-LNCS needs a 15-pole intermediate cable. Make sure that the oximetry sensor is compatible with the oximetry intermediate cable. Symbol for connected corpuls cpr.
Symbol for shock in defibrillation modes: number of shocks or time since last shock (last) Symbol for time since defibrillation mode was launched.
Medical product Repackaging
Indicates that the item is a medical device.
To identify that a modification to the original medical device packaging configuration has occurred.
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Importer
Distributor
Table A-1
Unique Device Identifier Symbols
Indicates the entity importing the medical device into the locale.
Indicates the entity distributing the medical device into the locale.
Indicates a carrier that contains Unique Device Identifier information.
ENG - Version 4.0 P/N 04130.2
295
Appendix
B List of Abbreviations
ACS AMI APN cWEB DHCP DNS ePCR ESC GSM GPRS HES® IMI IP LAC LAN mCPR NSTEMI PCI PIN PLMN PUK RSSI RMT RTD SIM SSID STEMI TCP UDP Table A-2
Acute Coronary Syndrome Anterior Myocardial Infarction Access Point Name corpuls.web LIVE server Dynamic Host Configuration Protocol Domain Name System Electronic Patient Care Record European Society of Cardiology Global System for Mobile Communications General Packet Radio Service Hannover ECG System Inferior Myocardial Infarction Internet Protocol Location Area Code Local Area Network Mechanical thorax compressions Non-ST-Elevation Myocardial Infarction Percutaneous Coronary Intervention Personal Identification Number Public Land Mobile Network Personal Unblocking Key Received Signal Strength Indication R-wave Motion Tolerance Realtime data, recording of vital parameter signals Subscriber Identity Module Service Set Identifier ST-Elevation Myocardial Infarction Transmission Control Protocol User Datagram Protocol List of Abbreviations
User Manual corpuls3
296
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
C Checklist Functional Check
A function check of the corpuls3 must be performed each time you start duty. The function check guarantees unrestricted function and readiness for use of the corpuls3 and is an important addition to the automatic self tests performed internally in the corpuls3 (see also chapter 10.2 Function checks, page 232).
The following checklist serves as a suggestion for complementation of local documents.
1. Perform the function check as described in chapter 10 Maintenance and Tests, page 231. Tick completed checks on the checklist.
corpuls3 function checklist Date: Shift: Location or department: Rescue vehicle: Automatic selftest Visual check of the device parts and accessories. ECG cables (4-pole and 6-pole) corPatch electrodes (present and not expired) CO2 sensor and 2 adapters Oximetry sensor and intermediate cable Temperature sensor Shock paddles (in reserve) Baby shock electrodes Printer paper present in printer compartment Function check of the device Charging bracket (charging active) Defibrillator (Testbox/Testload, corpuls simulator) Communication between modules Space for comments
Performed by: Device name or serial number:
ECG electrodes CPR feedback sensor and intermediate cable present NIBP cuff and hose IBP transducers present Disposable razor Intermediate cable Electrode gel Spare roll of printer paper
Printout of a screenshot State of charge of modules Telemetry (Check network connection)
Table A-3 Function checklist (sample)
ENG - Version 4.0 P/N 04130.2
297
Appendix 298
User Manual corpuls3
D Factory Settings
The corpuls3 is delivered with a factory configuration to which the device can be reset at any time by the person responsible for the device.
The factory settings include general system settings, as well as pre-set views and alarm limits.
General settings
Field
System Language Selection Time/Date Autom. DST Screen Brightness Dim mode AutoDim Colours Manual event Audio recording Screenshot Access codes Export Authorisation Man. Defib. Pacer Mains filter Frequency
Signals - Curves DE I II II/DE III aVR aVL aVF
Value/Setting
English
Disabled
7 3 5 min Default
Disabled Disabled
Disabled
Disabled Disabled
50 Hz
Disabled Disabled Disabled Enabled Enabled Disabled Disabled Disabled
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Field -aVR V1 V2 V3 V4 V5 V6 Pleth CO2 CPR P1 P2 P3 P4 Lines
Signals - Parameters HR SpO2 PR PI SpCO/SpHb SpMet CO2 CPR rate RR NIBP NIBP sys NIBP MAP NIBP dia P1 P1 sys P1 MAP P1 dia P2 P3 P4 T1
ENG - Version 4.0 P/N 04130.2
Appendix
Value/Setting Disabled Disabled Disabled Disabled Disabled Disabled Disabled Enabled Enabled Disabled Disabled Disabled Disabled Disabled 4
Enabled Enabled Enabled Disabled Disabled Disabled Enabled Disabled Disabled Enabled Disabled Disabled Disabled Disabled Disabled Disabled Disabled Disabled Disabled Disabled Disabled
299
Appendix 300
Field T2 Time Stopwatch mCPR rate mCPR depth mCPR mode mCPR batt. Settings Mode
Signals - Views View 1
Printer - Curves Settings Speed AutoOff Same as screen
Printer - Trend Protocol Trend table Trend curve Trends Same as screen Interval Average
Printer - D-ECG Format 12-lead ECG Rep. cycle Global info Speed ECG Format Duration Order Add. copy HES® Pro Meas. table
User Manual corpuls3
Value/Setting Disabled Disabled Disabled Disabled Disabled Disabled Disabled
Horizontal
Enabled
25 mm/s Off Enabled
Enabled Enabled
Enabled 5 min 60 s
Enabled Enabled Enabled 50 mm/s 2x6 5 s classic Disabled
Enabled ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Field Suggestion
Telemetry - Settings GSM Enabled PIN GPRS APN User Password LAN/W-LAN Enabled Region 2.4 GHz 5 GHz Telemetry - Services corpuls.web Enabled Interface TCP d. port UDP d. port Connection Reconnect D-ECG Auto upload Fax Enabled Interface Speed Server address TCP port Mission upload Enabled Interface Server address Target path TCP port Reconnect
ENG - Version 4.0 P/N 04130.2
Appendix
Value/Setting Enabled
Disabled --
----
Enabled DE Enabled Enabled
Enabled Fast 10 0 Manual Off
Disabled
Enabled Fast 50 mm/s -0
Disabled Fast --21 3
301
Appendix 302
Field User Password Printout Mission storage Mode Interval Missions
Bluetooth - Settings Bluetooth Enabled PIN Data protect Ventilator Events Trends Quick select AED Man. Defib.
ECG - Settings Screen Speed Amplitude QRS marker Auto curve QRS/Pulse tone Enabled Dynamic Volume QRS tone Monitoring Low pass High pass 20 Hz filter Enabled Diagnostic Low pass D-ECG preview
User Manual corpuls3
Value/Setting --Enabled
None 3 days 50
Enabled 6673 --
Enabled Enabled
Enabled Enabled
25 mm/s x1 Enabled Disabled
Enabled Disabled 4 Tone 2
25 Hz 0.5 Hz
Disabled
150 Hz
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Field 10s preview Therapy Algo. corpuls S AMI IMI corpuls ACS NSTEMI ACS alarms STEMI STEMI possible Abnormal ECG NSTEMI NSTEMI possible
Oximetry - Settings Curve Speed Auto curve QRS/Pulse tone Enabled Dynamic Volume Pulse tone Mode FastSat Averaging Sensitivity SpHb Unit
CO2 - Settings Curve Speed Scale Auto curve Current unit Unit
ENG - Version 4.0 P/N 04130.2
Appendix
Value/Setting Enabled
corpuls ACS
600 µV 400 µV
Disabled
Disabled Disabled Disabled Disabled Disabled
25 mm/s Enabled
Enabled Disabled 4 Tone 4
Disabled 8s Normal
g/dl
6.25 mm/s 0 - 60 Enabled
mmHg
303
Appendix 304
Field
NIBP - Settings Automatic Interval Enabled Initial mode Patient Initial pressure Adult Child Neonate RMT Enabled
IBP - Settings General Speed P1 - P4 curve Scale Auto curve
Defib - Settings Auto energy man. Adult Child Reminder Man. Analyse Auto energy AED Adult Child Locked preShock CPR Compress. Metronome Recording AED Man. Defib. Analyse AED Autostart
User Manual corpuls3
Value/Setting
5 min Disabled Adult 180 mmHg 120 mmHg 90 mmHg Enabled
12.5 mm/s Auto Enabled
200 J 50 J Enabled 200 J 50 J Enabled none Disabled Disabled Disabled Disabled
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Field Shock Protocol Enabled Disconn.-signal Enabled Volume Tone Charging tone AED Man. Defib.
Defib CPR Feedback Adult Compress. Vent. 30:2 Child Compress. Vent. 15:2 Vent. 30:2 Algorithm Interval CPR cycle CPR depth Unit Release CPR summary Printout Application note Show note Audio AAM AED CPR Feed. Monitor CPR Feed. AED CPR Feed. Man. Volume Audio metronome Compress. tone Vent. tone Autostart metr. AED
ENG - Version 4.0 P/N 04130.2
Appendix
Value/Setting
Enabled
Off 7 Tone 1
Disabled Disabled
100 /min 4 s
100 /min 4 s 4 s
2 min Enabled
cm Enabled
Enabled
Disabled
Enabled Enabled Enabled Enabled 10
10 10
Off 305
Appendix
User Manual corpuls3
Field Man. Defib
Patient - Settings
Screen/Printout/Telemetry
Name, last name
Address
Date of birth
Status
Insuree number
Insurance
Insurance No.
Card Number
Race
Enabled
Default
Table A-4
General Settings
Value/Setting Off
Enabled Enabled Enabled Enabled Enabled Enabled Enabled Enabled
Disabled --
General alarm settings
Field
Alarming Alarm OFF Create event Reminder signal Volume (minimum and maximum for the respective alarm priority)
Min. volume
Alarm system Covert mode Clinic mode
VT/VF Alarm Table A-5
General alarm settings
Value/Setting
120 s Enabled Enabled 3 10: - High priority (62 dB 86 dB) - Medium priority (55 dB 81 dB) - Low priority (50 dB 75 dB)
Disabled Disabled
Enabled
306
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Pre-set Alarm Limits
Measurement value HR 1/min
SpO2 % PR 1/min SpCO % SpHb g/dl SpHb mmol/l SpMet % CO2 mmHg RR 1/min NIBP mmHg P1 - P4 mmHg T1 °C T2 °C
Table A-6
Pre-set alarm limits
50
90 50 10 6.2 30 8 sys 80 dia 40 sys 80 dia 50 34.0 34.0
120
120 10 17 10.6 3 50 18 sys 200 dia 100 sys 180 dia 100 39.0 39.0
Pre-set Views
A selection of 6 different configured views is available:
View 1: View 2:
View 3: View 4-6: Defibrillator Pacer: Table A-7
Curves: Parameters: Curves: Parameters:
Curves: Parameters: Curves: Parameters: Curves: Parameters: Curves: Parameters: Pre-set views
ECG leads II/DE, III; Pleth; CO2 HR, SpO2, PR, NIBP, CO2 (horizontal presentation) ECG leads II/DE, III; Pleth; CO2 HR, SpO2, PR, NIBP, CO2 (horizontal presentation) T1, T2 (vertical presentation) ECG leads II/DE, III, aVR, aVL; Pleth; CO2 HR, SpO2, PR, NIBP, CO2 (horizontal presentation) ECG leads II/DE, III; Pleth; CO2 HR, SpO2, PR, NIBP, CO2 (horizontal presentation) ECG leads II/DE, III HR, SpO2, PR, NIBP, CO2 (horizontal presentation) ECG leads II/DE, CO2 HR, SpO2, PR, NIBP, CO2 (horizontal presentation)
ENG - Version 4.0 P/N 04130.2
307
Appendix
User Manual corpuls3
E Technical Specifications
General Technical Specifications
Dimensions (without accessory bag, H x W x D in cm)
Monitoring Unit
29.5 x 30.5 x 12
Patient Box
13.5 x 26.5 x 5.5
Defibrillator/pacer
29 x 30 x 19
Defibrillator/Pacer SLIM
22 x 28 x 12
Compact device
36 x 30.5 x 23
Compact device SLIM
29.6 x 30.5 x 19.5
Charging bracket Compact device and Defibrillator/pacer
20 x 26.5 x 8
(Charging) bracket monitoring unit
21 x 23 x 11.5
(Charging) bracket patient box
6.5 x 10 x 17.5
Table A-8
Dimensions
[11.6 x 12.0 x 4.7 inches] [5.3 x 10.4 x 2.1 inches] [11.4 x 11.8. x 7.5 inches] [8.7 x 11 x 4.7 inches] [14.1 x 12.0 x 9.0 inches] [11.6 x 12.0 x 7.7 inches] [7.9 x 10.4 x 3.1 inches]
[8.2 x 9.0 x 4.5 inches] [2.5 x 3.9 x 6.9 inches]
Weight (incl. battery, without accessories in kg)
Monitoring Unit
2.7
Monitoring unit corpuls3T
2.79
Patient Box
1.0 - 1.3
Defibrillator/pacer
3.7 (without shock paddles)
Defibrillator/Pacer SLIM
2.3
Compact device
7.4 (basic configuration)
Compact device SLIM
6.0 (basic configuration)
Table A-9
Weight
Environmental requirements Operating temperature
Battery
Defibrillator -10 °C to +55 °C: -20 °C to -10 °C:
-20 °C to +55 °C: 0 °C to +55 °C: 0 °C to +45 °C: -20°C to +55°C +5°C to +55°C
Without limitations Prerequisite: battery charged more than 70% and used as compact device) Pacer, ECG monitor, display Oximetry, NIBP, temperature, IBP CO2 Temperature at discharge Temperature at charge
308
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Environmental requirements
Storage temperature
Device
-40°C to +70°C
Battery
+10°C to +30°C
Transient temperature
-20°C 55°C
Warm-up time
1 h 50 min (storage temperature -40°C, ambient temperature 20°C)
Cool-down time
1 min (storage temperature +70°C, ambient temperature 20°C)
Relative humidity
Up to 95% (without condensation)
Protection class
IP55 (dust- and splash proof)(charging bracket excepted)
Range of ambient pressure
Compact device
576 - 1060 hPa
Capnometer
700 - 1060 hPa
Operating panel
Splash proof keypad
Table A-10
Environmental requirements
Energy management/power supply
Internal power supply
Modules with exchangeable, chargeable battery (lithium-ion battery) All three module are equipped with identical lithium-ion batteries.
Battery capacity
4.4 Ah at 7.4 V nominal voltage
Battery size (H x W x D in cm)
4.2 x 4.6 x 7.6
[1.7 x 1.8 x 3 inches]
Battery weight (in kg)
0.25
[0.55 lbs]
Charge current, max. per battery
3 A
Output current, max. per battery
· 4.4 A (continuous operation)
· 10 A (for 10 s)
External power supply
Valid input voltage range
Min. 10 V, typ. 12 V, max. 14 V
Protection of the on-board power supply, 12 V
15 A, time lag fuse (additional consumers on-board not taken into account)
AC adapter corpuls3
Output power, max.
108 W
Nominal voltage
12 V
Output current, max.
9 A
Classification by protection type against electrical shock when operated via mains charger (according to IEC 60601-1): Protection class I
Power consumption (typical) Max. power consumption (device operation without 20 W
of the compact device
battery- and defibrillator charging)
Max. Power consumption (device operation and battery charging)
100 W
Max. Power con-sumption (device operation and defibrillator charging, 5 s ± 2 s)
108 W
Battery charging time
0 - 80% 0 90% 0 - 100%
approx. 1 h approx. 1.5 h approx. 2 h
ENG - Version 4.0 P/N 04130.2
309
Appendix
User Manual corpuls3
Energy management/power supply
Operating time
Compact device:
7 - 10 h (depending on settings and operational demands)
Patient box:
approx. 4-6 h
Monitoring unit:
approx. 4 h
Defibrillator:
approx. 200 shocks at 200 Joules
Maximum storage period for new rechargeable batteries (in days)
At 30% battery capacity before storage and within a temperature range from 10 °C 30 °C
Battery in module
Battery outside of module
20
400
At 100% battery capacity before storage and within a temperature range from 10 °C 30 °C
Battery in module
Battery outside of module
60
550
These are the optimum storage conditions for the rechargeable battery. If storage conditions differ, this may result in a reduction in the capacity of or damage to the rechargeable batteries.
Recommended periodic battery exchange
Every 3 years
Table A-11
Energy management/power supply
Warning
To avoid the risk of electric shock, connect the AC adapter only to a mains voltage supply with a protective conductor.
Alarm Management
Characteristic of alarm signal High priority
Number of impulses
10
Impulse duration
90 ms
Interval of impulses
50 ms (190 ms)
Frequency of impulses
523 Hz, 659 Hz, 784 Hz, 1047 Hz
Interval
10 s
Colour of LED
Red
Flashing frequency of LED
2 Hz
Duty cycle of the LED
40% on
Table A-12
Alarm management
Medium priority 3 130 ms 250 ms 523 Hz, 659 Hz, 784 Hz 20 s Yellow 0.5 Hz 40% on
Low priority 20 190 ms 250 ms 523 Hz, 659 Hz
n/a Cyan n/a 100% on
Reminder signal 1 110 ms n/a 3.5 kHz
60 s White n/a 110 ms
The maximal delay until alarming for ECG, pulse oximetry, NIBP, IBP and CO2 is 5 s; for temperature and perfusion index 30 s ± 3 s. The maximal delay until alarming for loose ECG electrodes is 30 s.
310
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Screen
Type Screen size, visible
Screen definition Angle of view
Backlighting Sweep speed
Curves
Measurements
Table A-13
Screen
Description/Explanation 8.4" colour display, transflective with 800 Cd/m2 backlighting Width: 171 mm [6.7 inch] Height: 128 mm [5.0 inch] 640 pixels horizontal, 480 pixel vertical, VGA Horizontally: 160° Vertically: 140° Lifetime approx. 15,000 h ECG, Pleth, IBP curve: 12.5; 25; 50 mm/s CO2 curve: 3.13; 6.25; 12.5 mm/s Up to 6 simultaneous curves In diagnostic ECG mode 12 simultaneous curves All measured values can be displayed on the screen
Touchscreen
Type
Screen size, visible
Screen definition
Table A-14
Touchscreen
Description/Explanation Capacitive TFT touch display, protected by PMMA protection plate 800 Cd/m2 Backlighting Width: 171 mm [6.75 inch] Height: 129.8 mm [5.11 inch] 640 pixels horizontal, 480 pixel vertical, VGA
Printer
Printing method Print definition
Paper speed
Number of curves for real-time printout Printer paper
Operating temperature
Table A-15
Printer
Description/Explanation High definition thermo printer head 8 pixels/mm (amplitude axis) 16 pixels/mm (time axis) with 25 mm/s Real-time printout: 6.25; 12.5; 25 and 50 mm/s Diagnostic ECG: 25 mm/s and 50 mm/s 1 to max. 6 curves simultaneously Thermo active, roll Width 106 mm, length 22 m -5°C to 50°C
ENG - Version 4.0 P/N 04130.2
311
Appendix
User Manual corpuls3
Character encoding
Character encoding
Table A-16
Character encoding
Description/Explanation UTF-8
ECG
Amplifier input Frequency response Input impedance Common mode rejection (CMRR)
Dynamic range Max. electrode offset voltage Scanning frequency Digital definition Detection of implanted pacer Electrode detection (ECG) according to IEC 60601-2-27 Active noise cancellation (RL) ECG memory (1-lead recording of lead II or shock paddle ECG)
Event memory
Table A-17
ECG
Description/Explanation Type CF, insulated > 5 kV, defibrillation-proof 0.05 bis 150 Hz (-3 dB) > 100 M 4-pole ECG monitoring cable and complementary 6-pole ECG diagnostic cable: > 90 dB ± 350 mV (signal voltage) (12 Bit) ± 350 mV (input offset) 500 Hz 3.2 V/Bit 20 mV/ 0.2 ms. 80 nA (maximum current)
1 nA (maximum current) During the mission Per 60 min ECG (lead II) and trend-recording a data memory of approx. 1 MB is required Storage space is limited by the capacity of CompactFlashTM card All events Per manual event a data memory of approx. 324 KB, per diagnostic ECG of approx. 280 kB is required Storage space is limited by the capacity of CompactFlashTM card
Lead
4-pole ECG monitoring cable
4-pole ECG monitoring cable and complementary 6-pole ECG diagnostic cable
Table A-18
Leads
I, II, III, aVR, aVL, aVF, -aVR
I, II, III, aVR, aVL, aVF, -aVR, and additional V1 to V6
Heart rate Heart rate display Heart rate detection Accuracy
18/min to 300/min Arithmetic averaging of 6 selected R-R intervals from the last 9 beats Better than ± 1 %
312
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Heart rate
Deviation
Less than ± 1 %
Maximal T-wave rejection capability according to IEC 60601-2-27
0.6 mV
Accuracy of the heart rate display and comportment A1 Ventricular bigeminy: 80/min in case of arrhythmias according to IEC 60601-2-27 A2 Slow changing ventricular bigeminy: 60/min
A3 Fast changing ventricular bigeminy:127/min
A4 Bidirectional systoles: 92/min
Response time of the heart rate after changes in heart rate according to IEC 60601-2-27
Abrupt increase in heart rate after 5 s (80/min to 120/min) Abrupt decrease in heart rate 4 s (80/min to 40/min)
Alarm time for tachycardia according to IEC 60601-2- VT/VF 1 mV, 206/min: 7 s
27
VT/VF 2 mV, 206/min: 7 s
VT/VF 0.5 mV, 206/min : 9 s
VT/VF 2 mV, 195/min: 7 s
VT/VF 4 mV, 195/min: 7 s
VT/VF 1 mV, 195/min: 7 s
Alarm delay
Up to 9 s
Table A-19
Heart rate
Caution
Only use recommended ECG cables, mentioned in the `list of approved accessories' (chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249).
Caution
ECG electrodes, minimum demands:
A certificate of biocompatibility according to ISO 10993-1 is required.
The ECG electrodes must have an as short as possible recovery period after defibrillation. This must be verified by a test according to EN 60601-2-27, § 51.102. To achieve a short recovery time of the ECG after a defibrillation, only the ECG electrodes mentioned in the `list of approved accessories' (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249) are recommended.
ECG with therapy electrodes
Amplifier input
Frequency response Input impedance Common mode rejection (CMRR) Dynamic range Max. electrode offset voltage
Description/Explanation Type CF insulated > 5 kV, defibrillation-proof (corPatch electrodes) Type BF insulated > 5 kV, defibrillation-proof (shock paddles) 0.5 to 25 Hz (-3dB) (fixed) > 10 M > 80dB ± 10.24 mV (signal voltage) 500 mV (input offset)
ENG - Version 4.0 P/N 04130.2
313
Appendix
User Manual corpuls3
Scanning frequency
Digital definition
Impedance measurement DE
Table A-20
Shock paddle ECG
Description/Explanation 400 Hz 5 V/Bit (12 Bit) 85 µA (42 kHz)
Caution
Do not use the therapy master cable corpuls3 SLIM/corpuls1 (P/N 04326.0BA) as extension cable for the therapy master cable at the defibrillator/pacer (P/N 04300). Likewise, the therapy master cable corpuls3 SLIM/corpuls1 must not be combined with a second therapy master cable corpuls3 SLIM/corpuls1.
Defibrillator General
Output
Insulated application (insulation voltage > 5 kV The type is determined by the kind of shock electrodes used.
Table A-21
Output
Electrodes for external defibrillation: External shock paddles (type BF): Shock paddles for adults Baby shock electrodes (adapter for shock paddles; energy reduction 1:10) Disposable defibrillation/pacing electrodes (type CF): corPatch easy electrodes Shock spoons (type CF)
Conductive area External shock paddles
corPatch easy electrodes
Shock spoons
Table A-22
Conductive area
Shock paddles Baby shock electrodes corPatch easy corPatch easy pre-connected corPatch easy Pediatric Size A Size B Size C 46.60 cm²
53 cm² 16.6 cm² approx. 81 cm² approx. 87 cm² approx. 42 cm² 11.00 cm² 18.25 cm²
Defibrillation, cardioversion Charging status indicator Ready for shock Delay time between R-wave and shock impulse Energy level display Synchronisation
314
Description/Explanation Display of text "Charging" on the screen Ready-signal and display of text "Ready for shock" on the screen typical 15 ms, max. 35 ms
In digits on the screen Manual defibrillation: Automatic and manual synchronisation as well as asynchronous
defibrillation. Operation mode is displayed on screen. AED mode: always asynchronous mode
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Defibrillation, cardioversion Internal discharge
Test Defibrillator
Table A-23
Defibrillation
Description/Explanation
0.5 s after shock release with high impedance Manual defibrillation: 30 s after reaching the status of ready for shock, if none of the
shock paddle buttons has been pressed in the meantime. AED mode: 30 s after the message "Deliver shock" appears
Built-in test resistor for shock testing: 50 Ohm Test resistor built in cable socket and in shock paddle holder
Biphasic Defibrillator
Description/Explanation
Energy levels for manual and AED defibrillation with shock paddles or corPatch easy electrodes and shock spoons
2, 3, 4, 5, 10, 15 to 200 J for adults 2, 3, 4, 5, 10, 15 to 100 J for children with corPatch easy electrodes Pediatric
or Pediatric Extended 2, 3, 4, 5, 10, 15 to 50 J with shock spoons (only in manual defibrillation mode) Fine adjustment of energy level in steps of 5 Joules
(delivered energy to 50 ) Interim values can be set with jog-dial Direct selection of energy levels via softkeys Adults: 50, 100, 150, and 200 Joules Children: 25, 50, 75 and 100 Joules
Number of shocks per battery load (fully charged)
Approx. 200 shocks with 200 J (with the battery of the defibrillator alone)
Manual defibrillation: Charging time to max. energy (with a fully charged battery)
5 s, ± 2 s
Manual defibrillation: Charging time to max. energy after release of 15 shocks
5 s, ± 2 s (no difference to fully charged battery)
Manual defibrillation:
Less than 25 s
Charging time to max. energy after switch on
of corpuls3
AED mode: Max. time from start of ECG analysis to `Ready for shock`
Less than 12 s
AED mode: Max. time from start of ECG analysis to `Ready for shock' after release of 15 shocks with max. energy
Less than 12 s (no difference to fully charged battery)
AED mode: Max. time from switch on to `Ready for shock'
Less than 30 s
Impulse waveform
Biphasic, positive rectangular waveform 6 ms. (90 % energy) negative rectangular waveform 4 ms. (10 % energy) (4/3 ms impulse configurable by service technician)
ENG - Version 4.0 P/N 04130.2
315
Appendix
User Manual corpuls3
Patient impedance range within which a shock can be delivered
Accuracy of delivered energy on an impedance of 50
Table A-24
Biphasic defibrillator
Non-invasive Pacer
Output Pacing frequency
Intensity of pacing current
Impulse duration Operating modes OVERDRIVE frequency
Maximum delay between synchronisation impulse and energy release
Measurement mode
Table A-25
Non-invasive pacer
Description/Explanation corPatch easy electrodes > 15 to 600 Shock paddles > 15 to 600 Shock spoons >0 to 600 Better than ± 10 %
Description/Explanation
Insulated application part Type BF, insulation voltage > 5 kV
30/min. to 150/min (adjustable in steps of 5/min.)
in OVERDRIVE mode 30/min. to 300/min. (adjustable in steps of 1/min.)
0 to 150 mA (0-10 mA, then adjustable in increments of 5 mA)
40 ms. (rectangular current impulse)
FIX and DEMAND mode and OVERDRIVE function
Heart rate of the patient minus 10/min. and if necessary rounded down to the next smaller number divisible by 5.
Example:
Heart rate = 179/min,
Overdrive frequency = 165/min.
6.7 ms
Oscilloscope according to IEC 60601-2-4 210.104
Impulse suppression according to IEC 60601-2-27
Rise time
Amplitude 2.5 mV
5.0 mV
0.010 µs
38 µs
16 µs
0.050 µs
38 µs
16 µs
0.100 µs
38 µs
16 µs
0.500 µs
38 µs
15 µs
1.000 µs
38 µs
15 µs
5.000 µs
35 µs
11 µs
10.000 µs
31 µs
7 µs
50.000 µs
4 µs
0 µs
100.000 µs
0 µs
0 µs
Table A-26
Impulse suppression according to IEC 60601-2-27
8.3 mV
9 µs 9 µs 9 µs 8 µs 8 µs 4 µs 0 µs 0 µs 0 µs
16.7 mV
4 µs 4 µs 4 µs 3 µs 3 µs 0 µs 0 µs 0 µs 0 µs
The voltages for impulse amplitudes itemised in Table A-26 refer to the internal patient voltage. The measured impulse widths are rectangular impulses.
316
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
CPR Feedback
Function principle Displayed parameters
Measurement range
Measurement interval Operating temperature (sensor) Storage temperature (sensor) Relative humidity (sensor) Storage humidity (sensor) Interface to sensor Sensor dimensions (H x W with foam padding) Sensor weight (with cable) Sensor weight (without cable) Accuracy
Table A-27
CPR Feedback
Description/Explanation Acceleration sensor Combined curve for display of compression depth and compression frequency CPR rate (compression rate) 70 to 150 compressions per minute 1.9 cm to 10.16 cm [0.75 inches 4.0 inches] Continuous -10°C to +60°C -30°C to +65°C Up to 93% (without condensation) Up to 93% (without condensation) Type BF, defibrillation-proof 101 mm x 64 mm [4.0 x 2.5 inches]
50.2 g 28.8 g ± 3 compressions per minute ± 0.635 cm [0.25 inches]
Storage Requirements on the CF card
Description/Explanation
Average mission (mission length 60 min, 12-lead ECG, 1 audio recording (15 s), 1 screenshot)
Approx. 3 MB Depending on the length of a mission and the number of recorded Events and D-ECGs as well as on how many parameters are monitored, the mission files may be larger.
Table A-28
Storage requirements on the CF card
Bluetooth interface
Description/Explanation
Version
Bluetooth Stack 2.0
Bluetooth class (Emission/Transmission power)
Class 2
Frequency band
2.4 GHz
Effective radiated power [according to IEC60601-1- typ. 0 dBm = 1 mW 2]
Modulation type
FHSS
Effective data rate
HF data rate: max. 704 kbps, Interface data rate: 9.6 kbps to 921.6 kbps
Table A-29
Bluetooth interface (option)
ENG - Version 4.0 P/N 04130.2
317
Appendix
User Manual corpuls3
2G GSM/GPRS (option)
Standard/Frequency bands
Output
Table A-30
2G GSM/GPRS (option)
Description/Explanation GSM/GPRS: 850/900/1800/1900 MHz 33/30/30 dBm
3G GSM/GPRS/EDGE/UMTS/HSPA+ (option)
Description/Explanation
Standard/Frequency bands
850/ 900 / 1800 / 1900 MHz (Band 1, 2, 4, 5, 8, 9, 19)
UMTS/HSPA+: 900/2100 MHz GSM/EDGE: 900/1800 MHz
Output
UMTS/HSPA+: 24/24 dBm GSM/EDGE: 27/30 dBm
Table A-31
3G GSM/GPRS/EDGE/UMTS/HSPA+ (option)
4G LTE/UMTS/HSPA+/GSM/GPRS/EDGE (Option)
Standard/Frequency bands
Output
Table A-32
4G LTE (Option)
Description/Explanation
GSM/GPRS/EDGE: 900/1800 MHz UMTS/HSPA+: 900/2100 MHz LTE: 700/800/900/1800/2100/2600 MHz
GSM: 26 / 27 / 30 dBm UMTS: 24 dBm LTE: 23 dBm
LAN-Interface (Option)
Default Table A-33
LAN interface (option)
Description/Explanation IEEE 802.3/802.3u-100Base-TX/10Base-T
WLAN-Interface (Option)
Standards Frequency bands reception Preferred frequency or frequency band
Description/Explanation IEEE 802.11 a/b/g/n 2401 2495 GHz 4.91 5825 GHz Defined by Router/Access Point
318
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Band width of the individual channels
Transmission power
Table A-34
WLAN interface (option)
Description/Explanation
IEEE 802.11 a IEEE 802.11 b IEEE 802.11 g IEEE 802.11 n IEEE 802.11 a IEEE 802.11 b IEEE 802.11 g IEEE 802.11 n
20 MHz 22 MHz 20 MHz 20/ 40 MHz 20.3 dBm = 107 mW 17.6 dBm = 57.5 mW 15.2 dBm = 33.1 mW 6.0 dBm = 4 mW
Regulations for WLAN use (in accordance with Directive 2014/53/EU for Radio Equipment) - Wireless Access Systems including Radio Local Area Networks (WAS/RLANs) - Throughout the European Union the following restrictions apply: (depending on the enabled WLAN-frequency-ranges)
1.) 2410 2480 MHz: NO restrictions 2.) 5150 5350 MHz: Restricted to indoor use 3.) 5470 - 5725 MHz: NO restrictions
Country codes for W-LAN regional settings
AU
Australia
HU
Hungary
NO
Norway
AT
Austria
IS
Iceland
PL
Poland
BE
Belgium
IN
India
PT
Portugal
BR
Brazil
ID
Indonesia
SG
Singapore
CA
Canada
IE
Ireland
SK
Slovakia
CN
China
IL
Israel
ZA
South Africa
CY
Cyprus
IT
Italy
ES
Spain
CZ
Czech Republic
JP
Japan
SE
Sweden
DK
Denmark
KR
Korea, Republic of
CH
Switzerland
EE
Estonia
LV
Latvia
TW
Taiwan,
FI
Finland
LT
Lithuania
TH
Thailand
FR
France
LU
Luxembourg
TR
Turkey
DE
Germany
MY
Malaysia
GB
United Kingdom
GR
Greece
NL
Netherlands
US
United States
HK
Hong Kong
NZ
New Zealand
Table A-35
Country codes for W-LAN regional settings
Oximetry (Option SpO2, SpCO, SpHb, SpMet, manufacturer Masimo)
Amplifier
Alarm
SpO2
Description/Explanation
Type BF, insulated > 5 kV, defibrillation-proof
Lower alarm limit: 65 to 98 % Upper alarm limit: 90 to 99 %
ENG - Version 4.0 P/N 04130.2
319
Appendix
User Manual corpuls3
Description/Explanation
PR
Lower alarm limit: 25 to 100/min
Upper alarm limit: 70 to 235/min
Updating frequency of display (SpO2, PR and 1 Hz PI)
Band width
0.5 Hz to 6 Hz
Measurement range
SpO2:
1% - 100%
SpHb:
0 - 25 g/dl
PR:
25/min - 240/min
PI:
0.02 - 20 % (disposable sensors)
0.05 - 20 % (reusable sensors)
Calibrated measurement range
SpO2:
70% bis 100%
PR:
25/min bis 240/min
PI:
0.1 to 20 %
Calibration
Calibration by reference measurements by means of fractional saturation measuring on pulse oximetric haemoglobin oxygen saturation with dyshaemoglobin-free blood.
Definition
SpO2: PR: SpCO: SpMet: SpHb: PI:
0.1 % 1/min 0.1 % 0.1 % 0.1 g/dl 0.01 %
Accuracy
Oxygen saturation measurement
70% to 100%, static measurement 2% 70% to 100%, measurement in motion 3%
Pulse rate measurement
Static measurement 3 BPM Measurement in motion 5 BPM
SpCO
3 %
SpHb
1.0 g/dl
SpMet
1.0%
Oxygen pulse waveform
Normalised curve
Alarm delay
SpO2
Lower alarm limit
Up to 16 s
Upper alarm limit
Up to 18 s
PR
Lower alarm limit
Up to 12 s
Upper alarm limit
Up to 17 s
SpCO
Up to 54 s
SpMet
Up to 59 s
SpHb
Up to 125 s
Table A-36
Oximeter (Option SpO2, SpCO, SpHb, SpMet, manufacturer Masimo, Masimo SET® technology
Caution
Only use the recommended sensors and intermediate cables. Any accessories other than those itemised in the `list of approved accessories' (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249) are not permitted.
320
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Non-invasive Blood Pressure Measurement Module NIBP (Optional, manufacturer SunTech Medical, Inc.)
Application field Measurement mode Measurement range
Description/Explanation
Adults, children, neonates and premature infants
Oscillometrical principle
Adults: systolic: diastolic: MAP:
40 to 260 mmHg 20 to 200 mmHg 26 to 220 mmHg
Children systolic: diastolic: MAP:
40 to 160 mmHg 20 to 120 mmHg 26 to 133 mmHg
Neonates: systolic: diastolic: MAP:
40 to 130 mmHg 20 to 100 mmHg 26 to 110 mmHg
Measuring interval during automatic measurement
1, 2, 3, 5, 10, 15, 30, 60 min. duration between the start of two measurements
Measurement
Automatic/manual
Output
Application part Type BF
Pressure sensor
Semi conductor sensor
Measurement range of pressure sensor
Up to 300 mmHg
Pressure decrease rate
Varies, depending on heart rate, cuff pressure and cuff volume.
Maximum selectable initial pressure for adults
Adjustable in configuration dialogue 120 - 280 mmHg Factory settings at 160 mmHg
Maximum selectable initial pressure for children
Adjustable in configuration dialogue 80 - 170 mmHg Factory settings at 120 mmHg
Maximum selectable initial pressure for neonates
Adjustable in configuration dialogue 60 - 140 mmHg Factory settings at 90 mmHg
Screen definition
1 mmHg
Display accuracy
± 3 mmHg between 0 mmHg - 300 mmHg (in the range of 0°C - 50°C and an air humidity of 15 % - 95 %)
Maximum delay time until alarm
1.5 s
Test
According to IEC 80601-2-30:2018
Non-invasive blood pressure instruments, part 1 and part 3
Table A-37
Non-invasive blood pressure measurement module (Option NIBP, manufacturer SunTech Medical, Inc.)
Caution
Only use the recommended NIBP-cuffs and hoses. Any accessories other than those itemised in the `list of approved accessories' (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249) are not permitted.
ENG - Version 4.0 P/N 04130.2
321
Appendix
User Manual corpuls3
Invasive Blood Pressure Measurement Module IBP (Option)
Amplifier Number of interfaces Transducer sensitivity Upper limit frequency Scanning frequency Digital definition Measurement range Display range ( in mmHg)
Description/Explanation Type CF, insulated > 5 kV, defibrillation-proof 2 x 2 (4 channels at 2 interfaces) 5 V/V/mmHg 20 Hz 100 Hz per channel 0.5 mmHg/Bit -50 to 300 mmHg Negative display range -10 to 10, -20 to 20, -30 to 30, -40 to 40, -50 to 50
Accuracy
Validation Alarm delay Table A-38
Positive display range 0-30, 0-60, 0-120, 0-180, 0-300
The combined effects of sensitivity, repeatability, non-linearity, drifts and hysteresis are within ± 4 % of the reading taken or ± 0,5 kPa (± 4 mmHg), whichever is bigger.
Medanco® Mediserve 200
Up to 13 s
Invasive blood pressure measurement module IBP (Option)
Caution
Only use the recommended blood pressure transducers. Any accessories other than those itemised in the `list of approved accessories' (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249) are not permitted.
Option Temperature
Amplifier Temperature sensor Measurement iteration Display range Measurement accuracy Limits of calibration errors
Minimum measurement time
Maintenance interval
Alarm delay
Measuring mode
Table A-39
Temperature (option)
Description/Explanation Type BF, insulated > 5 kV, defibrillation-proof YSI 401D (rectal and oesophageal), manufacturer: YSI company 12 measurements per second 12°C to 50°C 0.1 K ± 0.1 K (25°C to 45°C) ± 0.2 K (other) 1 min Every 2 years (as part of the metrological checks) Up to 30 s Direct mode
322
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Caution
Only use the recommended YSI probes of the 400 series or probes that are compatible with those. Any accessories other than those itemised in the `list of approved accessories' (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249) are not permitted. A certification of biocompatibility according to ISO 10993-1 is required.
Capnometer (optional, capONE, manufacturer Nihon Kohden)
Function principle
Displayed parameters
Measuring quantity Measurement range
Display range
Screen definition Measurement interval Measurement mode
Standby time (warm-up phase) Response time Operating temperature Barometric pressure Automatic compensation for barometric pressure Relative humidity Calibration
Interface to sensor Sensor size (H x W x D) Sensor weight (with cable) Sensor weight (without cable) Protection class Diameter of the connector of airway adapter Accuracy (based on an atmospheric pressure of 1 mmHg and without CO2 in the inhaling phase)
Description/Explanation
Semi quantitative measurement with infrared technology: This measurement mode is based on the assumption that the inhalatory air mixture does not contain any CO2.
CO2-concentration as filled waveform (capnogram) CO2-value (EtCO2) Respiration rate
CO2 partial pressure
CO2 partial pressure 0 to 100 mmHg; 0 to 13.33 kPa
Respiration rate
Lower limit: 3 1/min Upper limit: 150 1/min
CO2 partial pressure 1 to 100 mmHg; 0.1 to 13.33 kPa
Respiration rate
Lower limit: 3 1/min Upper limit: 150 1/min
CO2 partial pressure 1 mmHg; 0.1 kPa
Continuous
Optical in mainstream mode (also suitable for sidestream applications)
Approx. 5 s
Approx. 500 ms
0 - 45 °C
70 - 106 kPa
No
30 - 95% (without condensation)
Automatic continuous self calibration; no manual calibration necessary
Type BF, defibrillation-proof (EN 60601-1; IEC 60601-1)
22 mm x 11 mm x 11 mm
< 40 g
< 10 g
IP 54
15 mm
± 4 mmHg ( 40 mmHg) ± 10% of reading value (40 mmHg < CO2 76 mmHg) ± 12% of reading value (76 mmHg < CO2 100 mmHg)
ENG - Version 4.0 P/N 04130.2
323
Appendix
User Manual corpuls3
Description/Explanation
Accuracy (based on an atmospheric pressure of 0.13 kPa and without CO2 in the inhaling phase)
Accuracy respiration rate
± 0.53 kPa ( 5.33 kPa) ± 10 % of reading value (5.33 kPa < CO2 10.13 kPa) ± 12 % of reading value (10.13 kPa < CO2 100 kPa)
1/min
Air humidity during storage
10 to 95% (without condensation)
Alarm delay
Up to 5 s
Data sample rate
20 Hz
Method for calculating endtidal readings
Calculated from the maximum CO2 partial pressure in exhalation.
Table A-40
Capnometer (Option CO2, manufacturer Nihon Kohden, cap-ONE)
Sea level
Temperature
CO2 (mmHg)
Pressure (hPa) Sea level () Height (m)
Pressure (hPa) 20
40
60
100
1013.25
25
20
1013.3
20
40
60
100
500
956.5
20.9
41.8
62.7
104.5
1000
902.4
21.8
43.7
65.5
109.2
1500
850.8
22.8
45.6
68.5
114.1
2000
801.6
23.8
47.7
71.5
119.2
2500
754.7
24.9
49.8
74.7
124.5
3000
710.0
26.0
52.0
78.0
129.9
3500
667.6
27.1
54.3
81.4
135.6
4000
627.2
28.3
56.6
84.9
141.5
Table A-41 Height compensation, quantitative effect due to barometric pressure on the CO2 value
Deviations due to negative effects of gases and steam
Gas or steam
Concentration Deviation relative to a measured CO2 value of 38 mmHg
Oxygen (O2)
100%
- 1.3 mmHg
Nitrous oxide (N2O)
80%
+ 6.5 mmHg
Halothane
4%
+ 0.6 mmHg
Enflurane
5%
+ 1.5 mmHg
Isoflurane
5%
+ 1.7 mmHg
Sevoflurane
6%
+ 2.7 mmHg
Desflurane
24%
+ 6.6 mmHg
Dry mixed gas with 5% (38 mmHg) CO2- and N2-balance, under 1 kPA
Table A-42
Deviations due to negative effects of gases and steam
324
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Disposable Adapter for CO2 Endotracheal Tube incl. Insert for Neonates
Length Max. diameter Weight Reduction of dead space volume in the system as a whole Operating temperature Storage temperature
Description/Explanation 61 mm 22 mm approx. 13.2 g
-1 ml (in the system as a whole)
0°C to 45°C -20°C to +65°C
Table A-43
Disposable Adapter for CO2 Endotracheal Tube incl. Insert for Neonates
Caution
Only use the recommended sensors and adapters. Any accessories other than those itemised in the `list of approved accessories' (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249) are not permitted.
ENG - Version 4.0 P/N 04130.2
325
Appendix
User Manual corpuls3
F Biphasic Defibrillator Shockwave
The waveform of the shockwave is comprised of a positive rectangular waveform of 6 ms. duration and a negative rectangular waveform of 4 ms. duration, which contains 10% of the energy of the positive waveform. The amplitude of the waveforms is adjusted automatically to the patient's impedance.
Biphasic defibrillator waveform 200 J of energy delivered to various impedances
Fig. A-1 Biphasic defibrillator impulse 6/4
326
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Fig. A-2 Biphasic defibrillator impulse 4/3 Note By default, the biphasic defibrillation impulse 6/4 is set. Upon request, the biphasic defibrillation
impulse 4/3 can be configured by a service technician.
Pacer impulse
Fig. A-3 Pacer impulse
ENG - Version 4.0 P/N 04130.2
327
Appendix
User Manual corpuls3
Shock Release Synchronisation
Manual defibrillation and cardioversion are automatically performed synchronously. If no R-waves are detected in the ECG (e. g. in case of fibrillation), a shock will immediately be delivered asynchronously when the shock button is pressed (shock release).
Further information regarding manual defibrillation and cardioversion can be found in chapter 5.4 Manual Defibrillation and Cardioversion, page 80.
Warning
A cardioversion may lead to fibrillation or asystole. When performing a cardioversion, mind the following:
· The ECG has to be stable with a heart rate of at least 60/min.
· The synchronisation mode has to be set to SYNC.
· The QRS marks (triangles) have to mark each QRS complex. Do NOT rely on the QRS-/pulse tone alone.
· The shock release has to be effected according to valid guidelines.
· To release a shock, the Shock key at the monitoring unit or the buttons at the shock paddles have to be held down until a shock is released.
Protective Function of the Safety Shock Paddles
Every safety shock paddle possesses a protective electrode between the handle and the application electrode surface. The protective electrodes of both shock paddles are connected to one another inside corpuls3. Consequently, during defibrillation with wet or dirty shock paddles, no dangerous current can flow from one electrode over the body of the user to another electrode, since this current is diverted by the protective electrodes.
328
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Precision of the Energy Released (6/4 Defibrillation impulse)
Selected energy (in
Joule)
2 3 4 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 105 110 115 120 125 130 135 140 145 150 155 160 165 170 175 180 185 190 195 200 Table A-44
Nominal energy released in comparison to patient impedance
Load impedance (in Ohm)
25
50
75 100 125 150 175
1.9 2.2 2.2 2.3 2.2 2.1
2
2.9 3.2 3.3 3.2
3
3
2.9
3.9 4.3 4.2 4.1 4.1 3.9 3.8
4.8 5.3 5.2 5.2 4.9 4.8 4.6
9.5 10.3 10.2 10 9.8 9.5 9.1
15
16
16
16
15
14
14
19
21
21
20
20
19
19
24
26
26
25
24
24
23
28
31
31
30
29
28
27
33
36
36
35
33
32
31
37
41
40
39
38
36
35
42
46
46
44
42
41
39
46
52
51
50
48
46
44
50
56
55
54
52
50
48
55
61
61
59
57
54
52
60
66
66
64
60
59
56
64
71
70
70
67
63
61
68
76
75
73
71
67
65
72
80
80
79
75
72
69
77
86
85
84
81
76
74
82
90
90
88
85
80
78
86
95
95
93
89
84
82
90 100
99
97
93
89
87
94 105 105 102 98
94
90
99 109 110 106 102 97
94
103 114 114 112 109 104 100
107 119 120 117 113 108 102
112 123 125 120 118 111 109
116 128 129 124 122 117 112
121 133 133 130 126 122 117
124 137 138 133 132 124 120
129 143 144 140 136 130 124
133 147 149 145 141 134 128
137 152 152 150 144 138 132
142 156 157 156 149 143 138
146 161 162 161 152 148 141
149 166 167 163 160 151 145
153 170 172 169 164 157 148
157 175 176 175 168 158 153
159 180 181 179 173 165 156
162 185 186 183 177 168 163
163 190 192 187 182 174 167
164 194 196 191 187 179 173
Precision of the energy released (6/4 defibrillation impulse)
ENG - Version 4.0 P/N 04130.2
Precision
± 3J ± 3J ± 3J ± 3J ± 3J ± 3J ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15%
329
Appendix 330
User Manual corpuls3
Precision of the Energy Released (4/3 Defibrillation impulse)
Selected energy (in
Joule)
2 3 4 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 105 110 115 120 125 130 135 140 145 150 155 160 165 170 175 180 185 190 195 200 Table A-45
Nominal energy released in comparison to patient impedance
Load impedance (in Ohm)
25
50
75 100 125 150 175
1.9 2.3 2.2 2.3 2.3 2.1 2.0
2.8 3.3 3.4 3.1 3.0 2.8 2.8
3.9 4.4 4.4 4.2 4.0 3.8 3.5
5.1 5.5 5.3 5.3 4.8 4.6 4.3
9.5 10.6 10.5 10.1 9.8 9.4 8.8
15
17
16
16
15
14
13
20
22
21
20
20
18
18
24
27
26
25
24
23
22
29
32
31
30
29
27
26
33
37
36
35
33
31
30
37
42
40
39
37
35
33
42
47
46
44
42
40
37
46
52
51
49
46
44
42
51
57
55
53
50
48
46
56
61
60
58
55
52
49
60
67
66
63
59
56
53
65
72
70
68
65
61
58
69
77
75
72
69
64
61
73
81
80
77
73
69
65
78
86
85
82
78
74
70
82
92
90
87
82
77
74
87
96
95
91
86
81
77
91 101
99
96
91
86
82
95 107 105 101 96
90
85
101 111 110 106 100 93
89
104 116 115 111 106 99
94
108 120 119 115 109 102 96
113 125 124 120 114 107 102
117 130 129 124 118 111 105
122 135 134 130 123 116 109
126 139 139 134 127 119 111
130 145 145 140 131 123 117
135 149 149 144 136 129 121
138 154 153 148 140 132 125
143 159 158 154 145 136 128
147 164 163 159 148 140 133
150 169 168 162 154 143 136
154 174 173 168 159 149 140
158 179 178 172 163 151 144
161 183 182 177 167 156 147
165 188 187 181 171 160 152
167 194 193 186 176 165 155
168 199 197 192 181 170 161
Precision of the energy released (4/3 defibrillation impulse)
Precision
± 3J ± 3J ± 3J ± 3J ± 3J ± 3J ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15% ± 15%
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Precision of the Energy Released for Shock Spoons (6/4 Defibrillation impulse)
Selected energy (in
Joule)
2 5 10 20 30 40 50 Table A-46
Nominal energy released in comparison to patient impedance
Precision
Load impedance (in Ohm)
10
15
20
25
50
100 150
1.4 1.4 1.7 1.7 2.1
2
1.7
± 3J
3.9
4
4.5 4.9 5.5 5.2 4.7
± 3J
8.2 8.6 8.8 9.2 10.7 10.6 9
± 15 %
17.3 18.4 19 19.4 21.8 22.4 19.2
± 15 %
25.8 27.7 28.5 29.6 33.3 32.1 29.1
± 15 %
34.6 36.1 39.1 40.3 44.3 45 39.7
± 15 %
45.8 46.4 49.5 50.2 55.4 55.3 49.9
± 15 %
Precision of the energy released for shock spoons (6/4 defibrillation impulse)
Precision of the Energy Released for Shock Spoons (4/3 Defibrillation impulse)
Selected energy (in
Joule)
2 5 10 20 30 40 50 Table A-47
Nominal energy released in comparison to patient impedance
Precision
Load impedance (in Ohm)
10
15
20
25
50
100 150
1.5 1.5 1.7 1.7 2.2 2.1 2.0
± 3J
4.0 4.2 4.5 4.9 5.6 5.5 5.2
± 3J
8.8 9.2 9.0 9.2 11.2 11 10.2
± 15 %
18.1 19.4 20.2 20.8 22.8 23.7 22.6
± 15 %
26.4 28.6 29.5 31.3 34.5 33.4 32.7
± 15 %
36.8 37.7 39.8 40.8 45.9 45.8 43.3
± 15 %
46.3 49.6 49.2 51.2 57.7 56.1 54.7
± 15 %
Precision of the energy released for shock spoons (4/3 defibrillation impulse)
ENG - Version 4.0 P/N 04130.2
331
Appendix
User Manual corpuls3
G Safety Information
Warning
Failure to observe this safety information may result in injuries to the patient and users.
General
· The corpuls3 is not intended for operation in the vicinity of readily inflammable anaesthetics or other flammable substances, particularly in an oxygen-rich environment.
· The corpuls3 must not be stored or operated near a magnetic resonance imaging (MRI) unit. · The corpuls3 must not be operated near ionising (radioactive) radiation intended for therapeutic purposes. · To avoid stumbling or the patient, user or third parties being entangled in or strangled by cables, they should be led around
the patient, as all medical implements. · When connecting intermediate cables and sensors, make sure there are no foreign objects between the plug connections.
Alarm function
· Do not leave the patient unattended in the following cases: - If the alarm function is deactivated or - Defibrillation mode is called up.
· In case of unsupervised monitoring of vital parameters, it is recommended that you monitor a further vital parameter with another independent monitoring system.
· The option for monitoring measured values may be disabled when switching on the corpuls3 (see chapter 7 Configuration, page 154). Therefore make sure that the alarms are correctly configured.
· Heart rate is only monitored when all electrodes of the ECG monitoring cable or the corPatch electrodes are connected to the patient.
· Check the settings of the alarm limits before each monitoring phase. · Set the volume of the acoustic alarm so that it cannot fail to be heard in loud environments.
Defibrillator
· Make sure that both electrode surfaces of the shock paddles are completely wetted with gel. · The shock paddles must be kept away from other electrodes and/or metal components which are in contact with the patient. · Do not touch the patient during defibrillation. · Make sure that body parts of the patient, such as uncovered skin on the head or extremities, do not touch any metal
components, bed frames or a stretcher to avoid creating any unintended current paths for the defibrillation pulse. · During defibrillation with the 4-pole ECG monitoring cable connected, make sure that all electrodes are attached to the
patient. · During defibrillation with self-adhesive corPatch electrodes Pediatric or Pediatric Extended energy values higher than
100 Joules are prevented by the device due to coding of the electrodes. · In patients with an implanted pacer, detection of shockable rhythms or arrhythmias by the semi-automatic defibrillator in AED
mode may be limited. · The shock paddles and their handles must be cleaned thoroughly after each use. · Defibrillation with other devices is allowed, if the following security measures are taken:
All electrodes of the 4 pole ECG monitoring cable and the complementary 6 pole ECG diagnostic cable connected to the corpuls3 have to be attached to the patient. Unused electrodes must not lie around (see chapter 5.3.3 Defibrillation in AED Mode with Shock Paddles, page 78 and chapter 5.4.3 Manual Defibrillation and Cardioversion with Shock Paddles, page 83). In case of shock release these represent a hazard to the user or other persons.
Pacer
· The pacer must not be operated near high frequency surgical devices or microwave therapy devices.
ECG monitor
· Conductive parts of the ECG electrodes, cables and the plug devices connected to them should not touch any conductive parts including the ground.
· Note the possible risk to the patient during use of several devices from the accumulation of leakage currents. · To achieve as short a recovery time as possible of the ECG after defibrillation, we recommend the disposable ECG electrodes
332
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
which are itemised in the list of accessories (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249). GS Elektromedizinische Geräte G. Stemple GmbH cannot undertake any guarantee in this respect for other disposable ECG electrodes. · If no electrical connection exists between the patient and an electrode of the ECG monitoring cable and/or complementary ECG diagnostic cable, the corpuls3 will issue the alarm message "ECG electrode [X] loose". The alarm message "ECG electrode [X] loose" can be impaired in case of temperatures below the freezing point. If the connection to the black electrode of the 4-pole ECG monitoring cable is cut off, under certain circumstances no alarm may be given. · A nerve stimulator e. g. a brain pacer can modify the ECG on the screen and printer or even completely suppress it.
Masimo SET® pulse oximeter
· This user manual, the warnings and safety information, the operating instructions for the accessories and all preventive information and specifications must be read before use.
· The oximeter must not be used as an apnoea monitor (not authorised for monitoring patients who suffer from sudden respiratory arrest, e. g. during sleep).
· The oximeter should constitute an early warning system. If the trend is towards an insufficient oxygen supply to the patient, blood samples should be analysed by a blood gas analysis device to determine the patient's factual condition.
· Do not use any damaged oximetry sensors and particularly no oximetry sensors with open optical components. · Do not place the oximetry sensor on the same limb as an NIBP cuff for non-invasive blood pressure monitoring, a catheter or
an intravascular access. The cuff pressure influences pulse oximetry during all pressure measurements. An object in the vessel (e. g. infusion needle) may impair perfusion and thereby affect the measurement. · The oximetry sensor must not be fixed to the body in such a way that it influences perfusion or injures the skin. Tissue damage may be caused by incorrect use and application when the oximetry sensor is bound to tightly. Check the sensor surface as described in the instructions for use, to avoid injuries to the skin surface and to guarantee the correct position and adherence of the sensor. · To avoid measuring errors, the sensor must be protected from outside light, particularly in rapidly changing lighting conditions. This applies especially to open systems in contrast to the finger sensors. · The oximeter requires a measurable pulse wave to determine measurement values. If no pulse or only a weak pulse is detected, incorrect measured values may be calculated. · Pulse rate measurement is based on the optical detection of a peripheral flow pulse. Due to this, certain arrhythmias cannot be detected. The oximeter may not be used as substitute for an ECG-based device for arrhythmia analysis. · Very low oxygen saturation levels (SpO2) may cause inaccurate readings of SpCO- and SpMet. · Severe anaemia may cause faulty SpO2 readings. · A synthetic modification of the haemoglobin may cause erroneous SpHb readings. · The measured values may likewise be incorrect if pronounced movement artefacts occur. · The measurement values only lie within the specified range of accuracy (see appendix E, Technical Specifications, page 308) if the signal intensity is sufficient. · Factors which cause unpaired venous returns may likewise result in pulsation. · The measurement may be impaired by an excessively high proportion of dysfunctional haemoglobin, such as carboxyhaemoglobin or methaemoglobin. Likewise, colourants and raised bilirubin levels in the blood may impair the accuracy of the measurement. · The oximeter or the oximetry sensors must not be used during magnetic resonance tomography (MRT). Induced currents could possibly cause fires. The MRT image could be negatively affected by the Masimo SET® oximeter. The accuracy of the oximetry measurement may be impaired by the magnetic resonance tomograph. · The oximeter may be used during defibrillation. Measurements performed subsequently may be inaccurate for a short time. · Also read and understand the warnings in the operating instructions accompanying the different oximetry sensors. · SpO2 is empirically calibrated to functional arterial oxygen saturation in healthy adult volunteers with normal levels of carboxyhaemoglobin (COHb) and methaemoglobin (MetHb). An oximeter cannot measure elevated levels of COHb or MetHb. Increase in either COHb or MetHb will affect the accuracy of the SpO2 measurement. · High-intensity, extreme lights (including pulsating strobe lights) directly on the sensor may prevent the oximeter from obtaining readings. · Interfering substances: Carboxyhaemoglobin may erroneously increase SpO2 readings. The level of increase is approximately equal to the amount of carboxyhaemoglobin present. Colourants or any substance containing colourants that change the usual blood pigmentation may cause erroneous readings. · Inaccurate SpO2 readings can be caused by: · For increased COHb: COHb levels above normal tend to increase the level SpO2. The level of increase is approximately equal to the amount of COHb that is present. NOTE: High levels of COHb may occur with a seemingly normal SpO2. When elevated levels of COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed. · For increased MetHb: the SpO2 may be decreased by levels of MetHb of up to approximately 10% to 15%. At higher levels of SpMet the levels of SpO2 may tend to read in the low to mid 80s. When elevated levels of MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.
ENG - Version 4.0 P/N 04130.2
333
Appendix
User Manual corpuls3
· A functional tester cannot be utilized to assess the accuracy of the oximeter or any sensors. · Elevated levels of methemoglobin (MetHb) will lead to inaccurate SpO2 and SpCO measurements. · Elevated levels of carboxyhaemoglobin (COHb) will lead to inaccurate SpO2 measurements. · Elevated levels of total bilirubin may lead to inaccurate SpO2, SpMet, SpCO and SpHb measurements. · Very low arterial oxygen saturation (SpO2) levels may cause inaccurate SpCO and SpMet measurements. · Severe anaemia may cause erroneous SpO2 readings. · Hemoglobin synthesis disorders may cause erroneous SpHb readings. · If using oximetry during full body irradiation, keep the sensor out of the radiation field. If the sensor is exposed to the
radiation, the reading might be inaccurate or the device might read zero for the duration of the active radiation period. · Additional information specification to Masimo sensors, including information about parameter/measurement performance
during motion and low perfusion, may be found in the sensor's Directions for Use (DFU). · The oximeter may not be operated in the vicinity of ionising (radioactive) radiation, as this may falsify the readings. · The Masimo SET Technology with Masimo sensors has been validated for no motion accuracy in human blood studies on
healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70100% SpO2 against a laboratory CO oximeter and ECG monitor. This variation equals ±1 standard deviation and encompasses 68% of the population. · The Masimo SET Technology with Masimo sensors has been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO oximeter and ECG monitor. Rubbing and tapping motions were performed at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm. This variation equals ±1 standard deviation and encompasses 68% of the population. · The Masimo SET technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals ±1 standard deviation and encompasses 68% of the population. · The Masimo SET technology with Masimo sensors has been validated for pulse rate accuracy for the range of 25 - 240 bpm in bench top testing against a Biotek Index 2 simulator. This variation equals ±1 standard deviation and encompasses 68% of the population. · SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation in the range of 8-17 g/dl SpHb against a laboratory CO-oximeter. This variation equals ±1 standard deviation and encompasses 68% of the population. The SpHb accuracy has not been validated with motion or low perfusion.
Invasive blood pressure measurement
· Monitoring with two or more transducers: If two or more blood pressure transducers are connected to the corpuls3 for monitoring, these must all be connected to the patient. If one of the transducers is not connected to the patient and lies open or hangs free, this may provide unintended current paths during defibrillation. Use transducers with specified insulation (5 kV DC).
· Carefully read and follow the operating instructions of the transducers you are using. · If non-invasive blood pressure monitoring is also performed on the same limb during invasive blood pressure monitoring, the
non-invasive monitoring will negatively affect the measurement results of the invasive measurement. · Per connection socket at the patient box two transducer ports are merged. These are not insulated from each other (P1 and
P2, P3 and P4). · Invasive blood pressure measurement is not protected against high frequency surgical devices or microwave therapy devices.
Temperature measurement
· Carefully read and follow the operating instructions of the temperature sensor that you are using.
Table A-48
Safety information
334
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
H ECG Analysis during Semi-automatic Defibrillation (AED mode)
Procedure The ECG analysis is performed by a program which analyses the ECG in up to three blocks of 4 seconds with the following result:
· Shock recommended
· Shock not recommended The analysis is performed in each of the three blocks and these individual assessments are subsequently weighted.
Maximum duration of ECG analysis (12 s)
Start Block 1 (4 s)
Block 2 (4 s)
Table A-49 Duration of the maximum ECG analysis
Block 3 (4 s)
Result Refractory time (8 s)
If two of the three blocks yield the result "Shock recommended", the overall result is "Shock recommended". If two of the three blocks yield the result "Shock not recommended", the overall result is "Shock not recommended".
If the result "Shock recommended" is determined after 8 or 12 seconds, a refractory time of 8 seconds begins. The result is not revised during the refractory time, so the user can place the shock paddles on the patient and release a shock without having to worry that readiness to shock will be cancelled due to the disturbances caused by doing so. This refractory time can only be interrupted if another analysis is started by the user.
To avoid wasting time, some procedures in the process will be accelerated if the expected result is certain at an early stage:
ECG analysis
Result
Shock recommended
Shock recommended
Start Block 1 (4 s)
Block 2 (4 s)
Charging
Table A-50 Acceleration of the ECG analysis process
Shock recommended
(e. g. 200 Joule)
Refractory time (8 s)
Ready for shock
If the first block yields the result "Shock recommended", the device will immediately begin to charge energy, to reduce the amount of time from beginning of analysis to readiness to shock.
If the overall outcome is already determined after two analysis blocks with a positive result, the third will be omitted and readiness to shock will begin as soon as the device has finished charging.
The following are defined as shockable rhythms:
· Ventricular fibrillation · Ventricular tachycardia, rate > 180/min
ENG - Version 4.0 P/N 04130.2
335
Appendix
User Manual corpuls3
Origin of the data Scope of the measurements
ECG database for validation of the analysis software
The ECG data used originate from recordings from the Creighton University Ventricular Tachyarrhythmia Database1 2 3 as well as from the Massachusetts Institute of Technology Beth Israel Hospital (MIT-BIH) Malignant Ventricular Arrhythmia Database 4 5 6. These were recorded with common patient monitors similar to the corpuls3.
Application on validation of the analysis software
A total of 1816 16-s long measurements from ECG sections which constitute a representative crosssection of all ECGs have been included for validation of the analysis software. These measurements were classified by a cardiologist with regard to ECG rhythms and shockability. The threshold between an asystole and a VF was set at an amplitude of 200 V and the threshold between a shockable and a nonshockable VT at a heart rate of 180/min.
The measurements contained in this database were not used for development.
Performance goals for arrhythmia analysis algorithms (artifact free) as recommended by the American Heart Association7.
Rhythms
Shockable Coarse VF (Amplitude > 200 µV) Rapid VT (rate > 180 /min) Nonshockable NSR AF, SB, SVT, heart block, idioventricular, PVCs Asystole Table A-51 Classification table Abbreviations:
Test sample size total (required minimum) 736 (250) 591 (200) 145 (50) 1058 (230) 480 (100 arbitrary) 392 (30 arbitrary)
Observed performance
92.22 % 100 %
98.75 % 99.49 %
186 (100 for safety)
91.40 %
VF, Ventricular fibrillation VT, Ventricular tachycardia NSR, Normal sinus rhythm AF, Atrial fibrillation/-flutter
SB, Sinus bradycardia SVT, Supraventricular tachycardia PVCs, Premature ventricular contractions
1 Goldberger AL, Amaral LAN, Glass L, Hausdorff JM, Ivanov PCh, Mark RG, Mietus JE, Moody GB, Peng C-K, Stanley HE. PhysioBank, PhysioToolkit, and PhysioNet: Components of a New Research Resource for Complex Physiologic Signals. Circulation 101(23):e215-e220 [Circulation Electronic Pages; https://ahajournals.org/doi/10.1161/01.CIR.101.23.e215]; 2000 (June 13).
2 Nolle FM, Badura FK, Catlett JM, Bowser RW, Sketch MH. CREI-GARD, a new concept in computerized arrhythmia monitoring systems. Computers in Cardiology 13:515518 (1986)
3 See https://physionet.org/content/cudb/1.0.0/]
4 Goldberger AL, Amaral LAN, Glass L, Hausdorff JM, Ivanov PCh, Mark RG, Mietus JE, Moody GB, Peng C-K, Stanley HE. PhysioBank, PhysioToolkit, and PhysioNet: Components of a New Research Resource for Complex Physiologic Signals. Circulation 101(23):e215-e220 [Circulation Electronic Pages; https://ahajournals.org/doi/10.1161/01.CIR.101.23.e215]; 2000 (June 13).
5 Greenwald SD. Development and analysis of a ventricular fibrillation detector. M.S. thesis, MIT Dept. of Electrical Engineering and Computer Science, 1986.
6 See also https://physionet.org/content/vfdb/1.0.0/
7 Kerber, Richard E. (1997): Automatic external defibrillators for public access defibrillation. Recommendations for specifying and reporting arrhythmia analysis algorithm performance, incorporating new waveforms, and enhancing safety. A Statement for Health Professionals From the American Heart Association Task Force on Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. With assistance of Lance B. Becker, Joseph D. Bourland, Richard O. Cummins, Alfred P. Hallstrom, Mary B. Michos, Graham Nichol et al. Dallas, TX: American Heart Association (Scientific statement).
336
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Assessment and Results
Decision-making reliability of the ECG analysis programme Sensitivity and specificity The quality of an ECG analysis programme is determined by the values sensitivity and specificity.
Performance indicators
For the evaluation of the performance of the algorithm the following performance indicators were defined. According to the recommendation of the AHA, test-ECGs of the "intermediate" class are not included in the calculation of sensitivity or specificity.
a = number of correct positive decisions b = number of false positive decisions c = number of false negative decisions d = number of correct negative decisions
Result
Value (Defibrillator/pacer)
a
715
b
33
c
43
d
1025
Total
1816
Table A-52 Results
Value (Patient box) 710 44 48 1014 1816
This therefore yields: Defibrillator/pacer
Patient Box
Sensitivity = a/(a+c)=0.9433 Specificity = d/(b+d) =0.9688 False positive ratio = b/(b+d)=0.0312 Positive predictive value = a/(a+b)= 0.9559 Sensitivity = a/(a+c)=0.9366 Specificity = d/(b+d) =0.9584 False positive ratio = b/(b+d)=0.0416 Positive predictive value = a/(a+b)=0.9416
ENG - Version 4.0 P/N 04130.2
337
Appendix
User Manual corpuls3
I corpuls3 HYPERBARIC (HBO)
Operation in hyperbaric chamber up to 3 barg and
23% a max. oxygen concentration
Note
The product variant corpuls3 HYPERBARIC is approved for operation in a multiplace hyperbaric chamber during hyperbaric oxygen therapy (HBO) up to an overpressure of 3 barg and a maximum oxygen concentration of 23%.
For further information that go beyond this appendix, please contact the manufacturer or their authorised sales and service partners.
When the door of the hyperbaric chamber is closed, the reach of the radio connection towards modules outside the chamber is reduced.
Caution
There can be changes in the measured values of non-invasive blood pressure measurement (option) during the build-up and decrease of pressure inside the pressure chamber. Do not perform NIBP measurements during the diving phases.
Caution Warning Warning
There can be changes in the measured values of CO2 monitoring (option), because the CO2 partial pressures are changing under pressure.
Charging the monitoring unit and the patient box inside the pressure chamber is only allowed via the charging bracket for monitoring unit, P/N 04401.041. The use of MagCode connectors and charging brackets with integrated MagCode is forbidden for charging the monitoring unit, the patient box and the defibrillator/pacer. The red cover over the magnetic contact fields may not be removed.
When administering oxygen via inhalation mask or nasal cannula or when using a ventilation bag with reservoir, make sure that no oxygen accumulates above the corPatch electrodes. When defibrillation is imminent, the oxygen supply has to be shut off.
Warning
The use of swivelling adapters (swivelling adapter 35 °, P/N 04406.01 and swivelling adapter 60 °, P/N 04406) is forbidden inside the pressure chamber.
Warning Warning
The protection of the power supply for the charging bracket for the monitoring unit, P/N 04401.041 has to be minimum 6 A and maximum 10 A.
To guarantee safe operation of the device in a hyperbaric chamber, exclusively use the materials itemised in the list of accessories approved for operation in hyperbaric chamber (see chapter 10.8 Approved Accessories, Spare Parts and Consumables, page 249). Modules, batteries and accessories without HBO certificate may not be used in combination with HBO certified modules, batteries and accessories.
338
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
J Major performance characteristics
The essential performance of the corpuls3 and its optional accessories is:
· Defibrillation, synchronous cardioversion and AED therapy decision · Pacer therapy · ECG monitoring, diagnosis, heart rate and alarms · SpO2 monitoring, pulse rate and alarms · CO2 monitoring, respiration rate and alarms · NIBP monitoring and alarms · IBP monitoring and alarms · Temperature monitoring and alarms · Mounting in vehicle
Appendix
ENG - Version 4.0 P/N 04130.2
339
Appendix
User Manual corpuls3
K Guidelines and Manufacturer's Declaration
Electromagnetic emission
The corpuls3 is intended for operation in the electromagnetic environment indicated below. The operator or the user has to make sure that the corpuls3 is used in such an environment.
Emission measurements
Compliance
Electromagnetic environment - guidelines
HF emissions in accordance with CISPR 11 Group 1
The device uses HF energy only for its internal function. Consequently, its HF emission is very low and it is unlikely to interfere with neighbouring electronic devices.
HF emissions in accordance with CISPR 11
Emission of harmonic oscillations in accordance with IEC 61000-3-2
Voltage fluctuations/flicker in accordance with IEC 61000-3-3
Class B Class A
Complied with
According to IEC 60601-1-2, the corpuls3 is intended for use in areas of home health care and in professional healthcare institutions and those which are directly connected to the public mains supply.
Table A-53
Electromagnetic emission
Electromagnetic interference immunity
The corpuls3 is intended for operation in the electromagnetic environment indicated below. The operator or the user has to make sure that the corpuls3 is used in such an environment.
Interference immunity tests
IEC 60601 test level
Compliance level
Electromagnetic environment guidelines
According to IEC 60601-1-2, the corpuls3 is intended for use in areas of home health care and in professional healthcare institutions and those which are directly connected to the public mains supply.
Electrostatic discharge (ESD) in accordance with IEC 61000-4-2
± 8 kV Contact discharge
± 15 kV Air discharge
± 8 kV Contact discharge
± 15 kV Air discharge
Floors should be made of wood, concrete or metal or be covered with ceramic tiles. If the floor is covered with synthetic material, the relative humidity should be at least 30%.
Rapid transient electrical interference/bursts in accordance with IEC 61000-4-4
± 2 kV for mains connection
± 1 kV for SIPS/SOPS
± 2 kV for mains connection
± 1 kV for SIPS/SOPS
The quality of the power supply should correspond to that of a typical business or hospital environment.
Surges according to IEC 61000-4-5
± 1 kV normal mode voltage
± 2 kV common mode voltage
± 1 kV normal mode voltage
± 2 kV common mode voltage
The quality of the power supply should correspond to that of a typical business or hospital environment.
340
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Electromagnetic interference immunity
Voltage dips, brief interruptions and fluctuations in the power
· 0 % UT for ½ period
supply in accordance with · 0 % UT for IEC 61000-4-11
1 period
Not applicable
· 70 % UT for 25 periods
· 0 % for 250 periods
Magnetic field of the supply frequency (50/60 Hz) in accordance with IEC 61000-4-8
30 A/m
30 A/m
Note: UT is the mains alternating voltage before application of the test level
Table A-54
Electromagnetic interference immunity part 1
The device is always operated with a battery buffer. The user must ensure that the battery in the corpuls3 always remains adequately charged.
The corpuls3 must not be operated near a switched-on MRI unit (magnetic resonance imaging).
Electromagnetic interference immunity
The corpuls3 is intended for operation in the electromagnetic environment indicated below. The operator or the user has to make sure that the corpuls3 is used in such an environment.
Interference immunity tests
IEC 60601 test level
Compliance level
Electromagnetic environment guidelines
d = 1.2 P Conducted HF interference · 3 Veff outside the ISM · 3 Veff outside the ISM
according to IEC 61000-4-
bands
bands
6 · 6 Veff within the ISM · 6 Veff within the ISM
bands
bands
10 Veff
3 Veff
150 kHz to 80 MHz outside
the ISM bandsa
Radiated HF interference according to IEC 61000-43
10 V/m 80 MHz to 2.7 GHz
3 V/m
d = 4.0 P
ECG, oximetry monitor:
d = 4.0 P
for 80 MHz to 800 MHz
d = 7.7 P
for 800 MHz to 2.5 GHz
With magnetic forces of > 3 V/m, disturbances in the ECG signal may selectively occur.
ENG - Version 4.0 P/N 04130.2
341
Appendix Electromagnetic interference immunity
10 V/m
20 V/m
27 V/m
28 V/m 9 V/m
27 V/m
28 V/m 9 V/m
342
User Manual corpuls3
Defibrillator/Pacer: no unintentional change in condition
d = 1.2 P
for 80 MHz to 800 MHz
d = 2.3 P
for 800 MHz to 2.5 GHz Defibrillator: no unintentional energy release
d = 0.6 P
for 80 MHz to 800 MHz
d = 1.2 P
for 800 MHz to 2.5 GHz
P being the maximum nominal output of the transmitter in watts (W) according to the transmitter manufacturer's indications and d being the recommended protection distance in metres (m).b
The magnetic force of stationary radio transmitters should be lower than the level of complianced for all frequencies according to an on-site testc
Interference is possible in the vicinity of devices that bear the following pictorial symbol:
Fig. A-4 Radio transmitter 380 MHz - 390 MHz TETRA 400 430 MHz 470 MHz GMRS 460, FRS 460 704 MHz -787 MHz LTE Band 13, 17
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Electromagnetic interference immunity 28 V/m
28 V/m
800 MHz - 960 MHz
GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5
28 V/m
28 V/m
1700 MHz 1990 MHz
GSM 1800, CDMA 1900, GSM 1900, DECT, LTE Band 1/3/4/25, UMTS
28 V/m
28 V/m
2400 MHz 2570 MHz
Bluetooth, WLAN 802.11 b/g/n, RFID 2450, LTE Band 7
9 V/m
9 V/m
5100 MHz- 5800 MHz WLAN 802.11 a/n
Comment 1: At 80 MHz and 800 MHz, the higher frequency range applies
Comment 2: These guidelines may not be applicable in all cases. Propagation of electromagnetic variables is influenced by absorption and reflection via buildings, objects and people.
a The ISM frequency bands (for industrial, scientific and medical applications between 150 kHz and 80 MHz) are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz.
b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range of 80 MHz and 2.5 GHz are intended to reduce the likelihood that portable/mobile communication devices will be able to cause interference if they are unintentionally brought into the patient area. For this reason, the additional factor 10/3 is applied in calculating the recommended protection distances in these frequency ranges.
c The magnetic force of stationary transmitters, such as base stations of mobile telephones and mobile terrestrial radio devices, amateur radio stations, AM and FM radio and television transmitter can theoretically not be determined in advance. To establish the electromagnetic environment with regard to stationary transmitters, a study of the location should be considered. If the measured magnetic force at the location at which the corpuls3 is used exceeds the above mentioned compliance level, the corpuls3 must be observed to verify function as intended. If unusual performance characteristics are observed, additional measures may be required, such as a modified orientation or another location for the corpuls3.
d Above the frequency range of 150 kHz to 80 MHz the field strength must be less than 3 V/m.
Table A-55
Electromagnetic interference immunity part 2
Recommended protection distances between portable/mobile HF communication devices and the corpuls3
The corpuls3 is intended for operation in an electromagnetic environment in which radiated HF interference is controlled. The operator or the user of the corpuls3 can help to prevent electromagnetic interference by keeping minimum distances between portable/mobile HF communication devices (transmitters) and the corpuls3, as recommended below according to the maximum output of the communication device.
Nominal output of the transmitter
in W
150 kHz to 80 MHz outside the ISM bands
Protection distance according to transmission frequency in m
150 kHz to 80 MHz in the ISM bands
When used as a monitor
80 MHz to 800 MHz
800 MHz to 2.7 GHz
d = 1.2 P d = 4.0 P d = 4.0 P d = 7.7 P
ENG - Version 4.0 P/N 04130.2
343
Appendix
User Manual corpuls3
Recommended protection distances between portable/mobile HF communication devices and the corpuls3
0.01
0.12
0.40
0.1
0.38
1.3
1
1.2
4.0
10
3.8
13
100
12
40
When used as a defibrillator/pacer
0.40
0.77
1.3
2.4
4.0
7.7
13
24
40
77
Defibrillator: no unintentional energy release
80 MHz to 800 MHz
800 MHz to 2.7 GHz
80 MHz to 800 MHz
800 MHz to 2.7 GHz
d = 1.2 P d = 2.7 P d = 0.6 P d = 1.2 P
0.01
0.12
0.27
0.06
0.12
0.1
0.38
0.66
0.15
0.38
1
1.2
2.7
0.6
1.2
10
3.8
6.6
1.5
3.8
100
12
27
6.0
12
For transmitters, whose nominal output is not indicated in the table above, the distance can be determined using the equation which corresponds to the respective column, with P being the nominal output of the transmitter in watts (W) according to the transmitter manufacturer's indication.
Comment 1 The ISM bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz.
Comment 2 To calculate the recommended protection distance of transmitters in the ISM frequency bands between 150 kHz and 80MHz and in the frequency range between 80 MHz and 2.7 GHz, an additional factor of 10/3 is used to reduce the likelihood that a portable/mobile communications device brought into the patient area will result in interference.
Comment 3 These guidelines may not apply in all situations. Propagation of electromagnetic waves is influenced by absorption and reflection via buildings, objects and people.
Subject to technical modifications.
Table A-56
Recommended protection distances
Warning
Portable HF communication devices should not be used at a closer distance than 30 cm (12 inches) from the corpuls3. Non-compliance can lead to a reduction of the essential performance of the corpuls3.
344
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
L Warranty
In addition to the statutory warranty conditions in Germany, the manufacturer offers a limited manufacturer's warranty on material defects and manufacturing faults. The scope of the warranty can be viewed in the respective guarantee conditions of the relevant sales and service partners.
This warranty concludingly regulates the legal relationship between the purchaser and GS Elektromedizinische Geräte G. Stemple GmbH. Further damage claims are excluded, unless liability is prescribed by law.
Excepted from the warranty are wear parts, errors and damages that are the result of improper handling, faulty storage or installation and extraneous causes, such as transport damage, damage caused by impact, reparations and changes carried out by a non-authorised third party. The claim under the warranty shall be void as well if accessories are used that were not purchased from GS Elektromedizinische Geräte G. Stemple GmbH or an authorised sales partner. Software support (except updates) is not covered under the warranty.
In case of a defect and further warranty and guarantee handling please contact your authorised sales and service partner or the manufacturer.
The manufacturer shall only accept liability for user and operating safety of the device if maintenance, safety checks, repairs, additions and new settings were performed by the manufacturers themselves or persons specifically authorised by the manufacturer.
Additionally, the general terms and conditions of the company GS Elektromedizinische Geräte G. Stemple GmbH shall apply in the current version until further amendment. The general terms and conditions are available at GS Elektromedizinische Geräte G. Stemple GmbH upon request.
ENG - Version 4.0 P/N 04130.2
345
Appendix
User Manual corpuls3
M Protection Rights and Patents
The corpuls3 and some of its accessories are protected by patents either applied for and/or already granted. Consequently, possession or purchase of this device does not automatically confer licence to use this device with spare parts or accessories (cables, sensors, etc.) which, alone or in combination with this device, infringe applicable patents for this device or patents of individual components which are used with this device.
It is therefore not permitted to, e. g: · dismantle parts of the corpuls3 and use them for other purposes. · replicate components or accessories.
The corpuls3 and its accessories may not be modified without permission of the manufacturer.
Goods are mentioned in this user manual without mention of any existing patents, samples or trademarks.
corpuls® is a registered trademark of GS Elektromedizinische Geräte G. Stemple GmbH.
®
is a registered trademark of GS Elektromedizinische Geräte G. Stemple GmbH.
346
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
N Disposal of the Device and Accessories
To further preservation and protection of the environment, avoidance of pollution and recycling of raw materials, the European Commission issued a directive decreeing that electrical and electronic devices have to be taken back and correctly disposed of or recycled by the manufacturer. Devices marked with this symbol therefore may not be disposed of in the normal waste within the European Union. The same is true for disposable consumables, such as e. g. electrodes. Please ask your local authorities, your sales and service partner or the manufacture for information on correct disposal.
Information on the disposal of packaging The packaging of our devices is an integral part of our product. The packaging has been especially developed for our product and therefore in general is optimally suited for shipping. In case you have to ship your device within or after the guarantee period to our service team, the original packaging is the best protection from transport damage.
Manufacturer's Keep the original packaging for as long as you have the device in your possession! recommendation
If, however, you want to dispose of the packaging or if it is an external packaging used by us, you may dispose of it by means of your regional institutions (recovered paper container, recycling centre, paper collection etc).
ENG - Version 4.0 P/N 04130.2
347
Appendix
User Manual corpuls3
O Note on Data Protection
During the operation of the corpuls3, personalised data for service provision and patient care is being saved or transferred in encrypted form under strict adherence to the directives 95/46/EC (Data protection), 2002/58/EC (Data protection for electronic communication) as well as other relevant directives, ordinances and legislation.
348
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
P List of Illustrations
Fig. 1-1 Fig. 3-1 Fig. 3-2 Fig. 3-3 Fig. 3-4 Fig. 3-5 Fig. 3-6 Fig. 3-7 Fig. 3-8 Fig. 3-9 Fig. 3-10 Fig. 3-11 Fig. 3-12 Fig. 3-13 Fig. 3-14 Fig. 3-15 Fig. 3-16 Fig. 3-17 Fig. 3-18 Fig. 3-19 Fig. 3-20 Fig. 3-21 Fig. 3-22 Fig. 3-23 Fig. 3-24 Fig. 3-25 Fig. 4-1 Fig. 4-2 Fig. 4-3 Fig. 4-4 Fig. 4-5 Fig. 4-6 Fig. 4-7 Fig. 4-8 Fig. 4-9 Fig. 4-10 Fig. 4-11 Fig. 4-12 Fig. 4-13 Fig. 4-14 Fig. 4-15 Fig. 4-16 Fig. 4-17
ENG - Version 4.0 P/N 04130.2
Sample rating plates ...................................................................................................... 3 Compact device .............................................................................................................. 9 Individual modules ....................................................................................................... 10 Usage options of the modular corpuls3 ........................................................................ 11 Usage options of the modular corpuls3 as a patient monitoring system ....................... 12 Monitoring unit ............................................................................................................. 14 Monitoring unit, rear view............................................................................................. 15 Patient box (illustration may differ) .............................................................................. 16 Patient Box Interfaces, right hand side ......................................................................... 17 Patient Box Interfaces, left hand side........................................................................... 17 Patient Box with Accessory Bag.................................................................................... 18 Defibrillator/Pacer........................................................................................................ 19 Defibrillator/Pacer SLIM ............................................................................................... 20 Brackets ....................................................................................................................... 21 Biphasic defibrillation pulse 6/4 (qualitative representation) ....................................... 23 Biphasic defibrillation pulse 4/3 (qualitative representation) ....................................... 24 Alarm messages in the alarm history ........................................................................... 26 Inverted parameter field............................................................................................... 27 Jog dial ........................................................................................................................ 27 Alarm message on the patient box screen .................................................................... 29 Remaining running time of the corpuls3 in the current operating status ...................... 30 Remaining running time of the patient box ................................................................... 31 Display of the current state of charge of the batteries on mains operation .................. 32 Compact device, power supply (illustration may differ) ................................................ 33 Monitoring unit, power supply ...................................................................................... 33 Patient box, power supply (illustration may differ) ....................................................... 34 Monitoring unit, operating elements and LEDs.............................................................. 35 Monitoring unit, example of basic structure of the screen pages ................................. 39 Screen page, example with horizontal and vertical parameter area ............................. 41 Inverted video display of the screen (colours may differ) ............................................. 42 Touchscreen, active areas are highlighted in colour..................................................... 43 Patient box, displays on the screen (illustration may differ)......................................... 44 Patient box, control keys and LEDs (illustration may differ) ........................................ 45 Defibrillator, control key and status LEDs..................................................................... 46 Defibrillator SLIM, control key and status LEDs ............................................................ 47 Confirmation prompt before switching off .................................................................... 49 Upload screen .............................................................................................................. 49 Switching off with pacer active .................................................................................... 50 Warning on switching off .............................................................................................. 50 Example for softkey context menu................................................................................ 51 Parameter context menu (illustration may differ) ......................................................... 52 Curve context menu ...................................................................................................... 53 Main menu.................................................................................................................... 54
349
Appendix 350
User Manual corpuls3
Fig. 4-18 Fig. 4-19
Fig. 4-20
Fig. 4-21 Fig. 4-22 Fig. 4-23
Fig. 4-24
Fig. 4-25 Fig. 4-26
Fig. 4-27 Fig. 4-28 Fig. 4-29 Fig. 4-30 Fig. 4-31 Fig. 4-32 Fig. 4-33 Fig. 4-34 Fig. 4-35 Fig. 5-1 Fig. 5-2 Fig. 5-3 Fig. 5-4 Fig. 5-7 Fig. 5-8 Fig. 5-9 Fig. 5-10 Fig. 5-11 Fig. 5-12 Fig. 5-13 Fig. 5-14 Fig. 5-15 Fig. 5-16 Fig. 5-17 Fig. 5-18 Fig. 5-19 Fig. 5-20 Fig. 5-21 Fig. 5-22 Fig. 6-1 Fig. 6-2 Fig. 6-3
Configuration dialogue ................................................................................................. 55 Disconnecting the monitoring unit from the defibrillator/pacer (illustration may differ) ........................................................................................................................... 56 Disconnecting the monitoring unit from the defibrillator/pacer SLIM (illustration may differ) ................................................................................................................... 57 Disconnecting the patient box from the monitoring unit (illustration may differ) .......... 57 Connecting the patient box to the monitoring unit (illustration may differ) ................... 58 Connecting the monitoring unit to the defibrillator/pacer (illustration may differ) ........................................................................................................................... 59 Connecting the monitoring unit to the defibrillator/pacer SLIM (illustration may differ) ........................................................................................................................... 59 Removing the patient box from the compact device (illustration may differ) ................ 60 Removing the patient box from the compact device with defibrillator/pacer SLIM ............................................................................................................................. 60 Accessory bag and patient box, front view (illustration may differ) .............................. 61 Accessory bag with patient box, rear view (illustration may differ) .............................. 62 Inserting the plugs on the right-hand side of the patient box ....................................... 62 Contents of right-hand bag (illustration may differ) ..................................................... 63 Connecting the plugs on the left-hand side of the patient box...................................... 64 Contents of left-hand bag (illustration may differ) ....................................................... 64 Inserting the compact device into the bracket (Illustration may differ) ........................ 65 Inserting the monitoring unit into the bracket (Illustration may differ) ......................... 66 Inserting the patient box into the charging bracket (ceiling installation) ...................... 67 Connecting the therapy electrode cables (illustration may differ) ................................ 70 Removing the shock paddles from their holders ........................................................... 71 AED mode, initial screen (illustration may differ) ......................................................... 73 AED mode function keys ............................................................................................... 74 Applying the shock paddles.......................................................................................... 78 Manual defibrillation, initial screen (illustration may differ)......................................... 80 Function keys for manual defibrillation and cardioversion............................................ 81 Applying the shock paddles.......................................................................................... 84 Connecting baby shock electrodes ............................................................................... 87 Pacer function .............................................................................................................. 88 Pacer pulse identification............................................................................................. 89 Pacer, Recommended electrode placement........................................................ 90 Pacer, initial screen ..................................................................................................... 92 Pacer, selecting the intensity ....................................................................................... 93 Pacer, OVERDRIVE function ........................................................................................... 94 Softkey context menu metronome ................................................................................ 97 Connecting the corPatch CPR sensor to the corPatch CPR intermediate cable ............ 100 CPR feedback, attaching the corPatch CPR sensor ..................................................... 100 CPR feedback ............................................................................................................. 101 Display of corpuls cpr parameters.............................................................................. 103 Selection of the monitoring and diagnostic function................................................... 107 Trend curves .............................................................................................................. 108 ECG monitoring, applying the ECG electrodes (shortened form) .................................. 111
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Fig. 6-4 Fig. 6-5 Fig. 6-6 Fig. 6-7 Fig. 6-8 Fig. 6-9 Fig. 6-10 Fig. 6-11 Fig. 6-12 Fig. 6-13
Fig. 6-14
Fig. 6-15 Fig. 6-16
Fig. 6-17 Fig. 6-18
Fig. 6-19 Fig. 6-20 Fig. 6-21 Fig. 6-22 Fig. 6-23 Fig. 6-24 Fig. 6-25 Fig. 6-26 Fig. 6-27 Fig. 6-28 Fig. 6-29 Fig. 6-30 Fig. 6-31 Fig. 6-32 Fig. 6-33 Fig. 6-34 Fig. 6-35 Fig. 6-36 Fig. 6-37 Fig. 7-1 Fig. 7-2 Fig. 7-3 Fig. 7-4 Fig. 7-5 Fig. 7-6 Fig. 7-7 Fig. 7-8
ENG - Version 4.0 P/N 04130.2
ECG monitoring, initial screen..................................................................................... 112 Real-time printout, section......................................................................................... 113 ECG monitoring, adapting the curves .......................................................................... 114 Heart rate parameter field.......................................................................................... 116 Diagnostic ECG, applying the ECG electrodes (1)......................................................... 118 Diagnostic ECG, applying the ECG electrodes (2)......................................................... 119 Diagnostic ECG, preview screen .................................................................................. 120 D-ECG, options............................................................................................................ 121 Printout of 12-lead ECG (illustration may differ) ......................................................... 122 D-ECG printout of the representative cycle with HES® Light (illustration may differ) ......................................................................................................................... 123 D-ECG printout with ECG analysis and ECG interpretation HES® (option) (illustration may differ) .............................................................................................. 124 Rhythm- and typing diagram for a regular sinus rhythm ............................................ 126 Rhythm- and typing diagram for a sinus rhythm with two compensated ventricular and one compensated supraventricular extrasystole ................................ 126 Longterm ECG with monitoring function ...................................................................... 128 Connecting the oximetry sensor on to the intermediate cable (Illustration may differ) ......................................................................................................................... 131 Oximetry monitoring, attaching the oximetry sensor ................................................... 131 Oximetry monitoring, configured screen (illustration may differ) ................................ 132 Pleth monitoring, section of a printout ....................................................................... 133 Pulse rate parameter field.......................................................................................... 134 CO2 monitoring, nasal adapter .................................................................................... 136 CO2 monitoring, disposable endotracheal tube adapter............................................... 137 Fitting the disposable CO2 nasal(/oral) adapter on the patient.................................... 137 CO2 monitoring, configured screen ............................................................................. 139 CO2 monitoring, section of a printout .......................................................................... 140 Respiratory rate parameter field ................................................................................ 141 NIBP user interface in large view ............................................................................... 143 NIBP user interface in trend view ............................................................................... 144 NIBP monitoring, attaching the NIBP cuff ................................................................... 145 NIBP monitoring parameter fields............................................................................... 147 NIBP parameter field with active interval measurement ............................................. 148 IBP calibration............................................................................................................ 150 IBP monitoring, configured screen.............................................................................. 151 IBP monitoring, section of a printout .......................................................................... 152 Temperature monitoring parameter field .................................................................... 153 System settings, user level DEFAULT .......................................................................... 155 Displaying curves ....................................................................................................... 157 Displaying parameter fields........................................................................................ 158 Big parameter fields................................................................................................... 159 Selecting pre-set views .............................................................................................. 159 Printer setting "Same as screen" ............................................................................... 160 Selecting printer curves ............................................................................................. 161 Printer settings Trend and Protocol ............................................................................ 162
351
Appendix 352
User Manual corpuls3
Fig. 7-9 Fig. 7-10 Fig. 7-11 Fig. 7-12 Fig. 7-13 Fig. 7-14 Fig. 7-15 Fig. 7-16 Fig. 7-17 Fig. 7-18 Fig. 7-19 Fig. 7-20 Fig. 7-21 Fig. 7-22 Fig. 7-23 Fig. 7-24 Fig. 7-25 Fig. 7-26 Fig. 7-27
Fig. 7-28 Fig. 7-29 Fig. 7-30 Fig. 7-31 Fig. 7-32 Fig. 8-1 Fig. 8-2 Fig. 8-3 Fig. 8-4 Fig. 8-5 Fig. 8-6 Fig. 8-7 Fig. 9-1 Fig. 9-2 Fig. 9-3 Fig. 9-4 Fig. 9-5 Fig. 9-6 Fig. 9-7 Fig. 9-8 Fig. 9-9 Fig. 9-10 Fig. 9-11 Fig. 9-12 Fig. 10-1
Printer settings for D-ECG........................................................................................... 163 ECG settings ............................................................................................................... 166 Settings for oximetry monitoring ................................................................................ 167 Settings for CO2 monitoring ........................................................................................ 169 Settings for IBP monitoring......................................................................................... 170 Settings for CPR feedback .......................................................................................... 171 Alarm settings ............................................................................................................ 172 Alarm limits................................................................................................................ 173 Setting automatic alarm limits ................................................................................... 175 Code prompt ............................................................................................................... 176 System settings (persons responsible for the device)................................................. 177 Event configuration (persons responsible for the device) ........................................... 180 Defibrillation function settings (persons responsible for the device) .......................... 182 Filter settings for ECG (persons responsible for the device) ....................................... 183 Alarm settings (persons responsible for the device)................................................... 185 Pre-setting views (illustration may differ) .................................................................. 187 Entering a name for a view......................................................................................... 188 Entering master data (persons responsible for the device)......................................... 189 Configuration of ECG measurement and ECG interpretation (persons responsible for the device) ............................................................................................................ 190 ECG measurement and ECG interpretation version in system info ............................... 192 Settings for the insurance card reader (persons responsible for the device).............. 193 Extended settings for CPR feedback ........................................................................... 194 NIBP settings.............................................................................................................. 196 Settings feed speed (persons responsible for the device)........................................... 198 Entering patient data .................................................................................................. 199 Selecting pre-configured events................................................................................. 200 Entering master data .................................................................................................. 202 Example of an ECG in the protocol at the time of an event ......................................... 204 Mission browser ......................................................................................................... 205 D-ECG Browser ........................................................................................................... 206 Readout of patient data from insurance card reader .................................................. 208 Telemetry settings (Persons responsible for the device) ............................................ 210 Telemetry connections (Persons responsible for the device) ...................................... 213 Configuration of Telemetry Services ........................................................................... 214 Add network ............................................................................................................... 218 Configuring a network ................................................................................................ 219 Phonebook (= telemetry connections) ........................................................................ 222 Confirmation prompt for mission upload..................................................................... 223 Bluetooth settings (Persons Responsible for the Device) ............................................ 225 Bluetooth connections (persons responsible for the device)....................................... 226 Bluetooth connections ................................................................................................ 227 Incoming webMessage ............................................................................................... 229 Printing a webMessage............................................................................................... 230 Opening the printer flap ............................................................................................. 241
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Fig. 10-2 Fig. 10-3 Fig. 10-4 Fig. 10-5 Fig. 10-6 Fig. A-1 Fig. A-2 Fig. A-3 Fig. A-4
Printer ........................................................................................................................ 242 Changing the battery (monitoring unit) ....................................................................... 243 Monitoring unit, infrared interfaces ............................................................................ 245 Patient box, infrared interface.................................................................................... 246 Defibrillator/Pacer, infrared interface ........................................................................ 246 Biphasic defibrillator impulse 6/4 .............................................................................. 326 Biphasic defibrillator impulse 4/3 .............................................................................. 327 Pacer impulse ............................................................................................................ 327 Radio transmitter ....................................................................................................... 342
ENG - Version 4.0 P/N 04130.2
353
Appendix 354
User Manual corpuls3
Q List of Tables
Table 1-1 Table 1-2 Table 2-1 Table 2-2 Table 3-1 Table 3-2 Table 4-1 Table 4-2 Table 4-3 Table 4-4 Table 4-5 Table 5-1 Table 5-2 Table 6-2 Table 6-3 Table 6-4 Table 7-2 Table 7-3 Table 7-4 Table 7-5 Table 7-6 Table 7-7 Table 7-8 Table 7-9 Table 7-10 Table 7-11 Table 7-12 Table 7-13 Table 7-14 Table 7-15
Table 7-16 Table 7-17 Table 7-18 Table 7-19 Table 7-20 Table 7-21 Table 8-1 Table 8-2 Table 9-1 Table 9-2 Table 9-3 Table 10-1
Versions of the User manual...........................................................................................iv Supplements to the User manual....................................................................................iv Indications and Contraindications................................................................................... 8 Body areas of application ............................................................................................... 8 Brackets and power supply options .............................................................................. 21 Frequency and intensity ............................................................................................... 25 Keyboard layout defibrillation keys (modifications possible) ........................................ 36 Module connection status............................................................................................. 40 Module connection status............................................................................................. 44 Contents of right-hand bag........................................................................................... 63 Contents of left-hand bag............................................................................................. 64 Therapy electrodes for defibrillation and pacing .......................................................... 68 Metronome modes ........................................................................................................ 96 Coded Explanations by HES®....................................................................................... 125 Criteria of the representative cycle ............................................................................ 125 IBP monitoring, pressure channel assignment ............................................................ 148 Values for printer settings.......................................................................................... 161 Values for trend settings ............................................................................................ 162 Values for the D-ECG printout ..................................................................................... 164 Adjusting the printer intensity .................................................................................... 165 Values for ECG setting ................................................................................................ 166 Values for oximetry Monitoring ................................................................................... 168 CO2 monitoring values ................................................................................................ 169 Values for IBP monitoring ........................................................................................... 170 Values for CPR feedback ............................................................................................ 171 Settings for the VT/VF alarm ...................................................................................... 172 Values for alarm limits ............................................................................................... 174 Values for system settings (persons responsible for the device) ................................ 178 Values for defibrillation function configuration .......................................................... 183 Filter setting for monitoring ECG, diagnostic ECG (persons responsible for the device) ....................................................................................................................... 184 Alarm settings (persons responsible for the device)................................................... 186 Master data (persons responsible for the device)....................................................... 188 Values for configuration, ECG measurement and ECG interpretation .......................... 190 Values for metronome settings................................................................................... 195 Values for NIBP monitoring......................................................................................... 197 Settings feed speed of event ECG (persons responsible for the device)) ..................... 198 Master data ................................................................................................................ 201 Log overview .............................................................................................................. 203 Configuration values, telemetry.................................................................................. 211 Configuration of Telemetry Services ........................................................................... 215 Values for Bluetooth® configuration ........................................................................... 226 Maintenance intervals ................................................................................................ 231
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Table 10-2 Table 10-3 Table 10-4 Table 10-5 Table 11-1 Table 11-2 Table 11-3 Table 11-4 Table 11-5 Table 11-6 Table 11-7 Table 11-8 Table 11-9 Table 11-10 Table 11-11 Table 11-12 Table 11-13 Table 11-14 Table A-1 Table A-2 Table A-4 Table A-5 Table A-6 Table A-7 Table A-8 Table A-9 Table A-10 Table A-11 Table A-12 Table A-13 Table A-14 Table A-15 Table A-16 Table A-17 Table A-18 Table A-19 Table A-20 Table A-21 Table A-22 Table A-23 Table A-24 Table A-25 Table A-26 Table A-27 Table A-28
Daily check of the device............................................................................................ 235 Daily visual check of the corpuls3 and the accessories.............................................. 236 Monthly functional test............................................................................................... 239 Disinfectants, active ingredients with concentration................................................... 244 Alarm messages, alphabetical.................................................................................... 264 General malfunctions ................................................................................................. 265 Network malfunctions ................................................................................................ 266 Malfunctions during defibrillation............................................................................... 267 Malfunctions during stimulation (pacer) ..................................................................... 267 Malfunctions during ECG monitoring ........................................................................... 268 Malfunctions during oximetry monitoring.................................................................... 269 Malfunctions during NIBP monitoring.......................................................................... 270 Malfunctions during CO2 monitoring............................................................................ 273 Malfunctions during temperature monitoring.............................................................. 273 Malfunctions during IBP monitoring............................................................................ 274 Printer malfunctions................................................................................................... 275 Malfunctions in energy management .......................................................................... 275 Notifications in the message line and information in the protocol .............................. 288 Symbols ..................................................................................................................... 295 List of Abbreviations................................................................................................... 296 General Settings......................................................................................................... 306 General alarm settings ............................................................................................... 306 Pre-set alarm limits ................................................................................................... 307 Pre-set views ............................................................................................................. 307 Dimensions................................................................................................................. 308 Weight ........................................................................................................................ 308 Environmental requirements ....................................................................................... 309 Energy management/power supply............................................................................. 310 Alarm management .................................................................................................... 310 Screen........................................................................................................................ 311 Touchscreen ............................................................................................................... 311 Printer ........................................................................................................................ 311 Character encoding .................................................................................................... 312 ECG 312 Leads ......................................................................................................................... 312 Heart rate................................................................................................................... 313 Shock paddle ECG....................................................................................................... 314 Output ........................................................................................................................ 314 Conductive area.......................................................................................................... 314 Defibrillation .............................................................................................................. 315 Biphasic defibrillator .................................................................................................. 316 Non-invasive pacer..................................................................................................... 316 Impulse suppression according to IEC 60601-2-27 ..................................................... 316 CPR Feedback............................................................................................................. 317 Storage requirements on the CF card ......................................................................... 317
ENG - Version 4.0 P/N 04130.2
355
Appendix
User Manual corpuls3
Table A-29 Table A-30 Table A-31 Table A-32 Table A-33 Table A-34 Table A-35 Table A-36
Table A-37
Table A-38 Table A-39 Table A-40 Table A-42 Table A-43 Table A-44 Table A-45 Table A-46 Table A-47 Table A-48 Table A-53 Table A-54 Table A-55 Table A-56
Bluetooth interface (option)........................................................................................ 317 2G GSM/GPRS (option)................................................................................................ 318 3G GSM/GPRS/EDGE/UMTS/HSPA+ (option) ................................................................ 318 4G LTE (Option)........................................................................................................... 318 LAN interface (option) ................................................................................................ 318 WLAN interface (option).............................................................................................. 319 Country codes for W-LAN regional settings ................................................................ 319 Oximeter (Option SpO2, SpCO, SpHb, SpMet, manufacturer Masimo, Masimo SET® technology.................................................................................................................. 320 Non-invasive blood pressure measurement module (Option NIBP, manufacturer SunTech Medical, Inc.) ............................................................................................... 321 Invasive blood pressure measurement module IBP (Option)........................................ 322 Temperature (option).................................................................................................. 322 Capnometer (Option CO2, manufacturer Nihon Kohden, cap-ONE)................................ 324 Deviations due to negative effects of gases and steam .............................................. 324 Disposable Adapter for CO2 Endotracheal Tube incl. Insert for Neonates .................... 325 Precision of the energy released (6/4 defibrillation impulse) ..................................... 329 Precision of the energy released (4/3 defibrillation impulse) ..................................... 330 Precision of the energy released for shock spoons (6/4 defibrillation impulse) ......... 331 Precision of the energy released for shock spoons (4/3 defibrillation impulse) ......... 331 Safety information...................................................................................................... 334 Electromagnetic emission........................................................................................... 340 Electromagnetic interference immunity part 1............................................................ 341 Electromagnetic interference immunity part 2............................................................ 343 Recommended protection distances ........................................................................... 344
356
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Index
4
4/3 Defibrillation impulse.......................... 23, 73, 80, 327
6
6/4 Defibrillation impulse.......................... 23, 73, 80, 327
A
Accessories .................................................................. 249 Accessory bag
installation ................................................................ 61 packing...................................................................... 62 Accessory Bag................................................................ 18 Cleaning .................................................................. 249 ACS ECG measurement/interpretation .......................... 296 Ad-hoc connection see connection authorisation ................................... 12 AED mode Compression synchronised therapy........................ 105 Information ............................................................... 73 malfunctions ........................................................... 266 with corPatch electrodes .......................................... 77 AED Mode with Shock Paddles ................................................... 78 Alarm limits automatic setting.................................................... 175 manual setting ........................................................ 173 Alarm management....................................................... 25 Alarm management, technical specifications.............. 310 Alarm suspension .......................................................... 28 AMI see ECG measurement/interpretation.................... 296 APN Configuration .......................................................... 296 Auto Curve CO2 ................................................................. 139, 169 ECG ......................................................................... 167 IBP ........................................................................... 170 Oximetry ................................................................. 168 Auto Energy................................................................. 181
ENG - Version 4.0 P/N 04130.2
B
Baby shock electrodes .................................................. 87 Cleaning .................................................................. 247 Connecting................................................................ 87 Disinfection............................................................. 247 Sterilisation............................................................. 247
Backpack carrying strap Cleaning .................................................................. 249
Basic structure of the screen pages .............................. 42 Batteries
charging .................................................................... 31 Maintenance ............................................................ 31 remaining running time display................................ 30 Battery operation.......................................................... 30 Beta software Beta version...................................................... 48, 263 Biphasic defibrillator ................................................... 326 technical specifications........................................... 315 Blood pressure monitoring, invasive (IBP) information............................................................. 148 Performing.............................................................. 151 preparation............................................................. 149 Blood pressure monitoring, non-invasive (NIBP) information............................................................. 141 malfunctions........................................................... 270 Performing individual measurement...................... 146 Performing interval monitoring .............................. 147 preparation............................................................. 145 Bluetooth Data protection PIN .................................224, 225, 226 Bluetooth data interface Configuration.......................................................... 224 Bluetooth interface Technical specifications .......................................... 317 Bracket compact device......................................................... 65 monitoring unit......................................................... 66 patient box ............................................................... 67 Brackets ........................................................................ 21 Browser Key ................................................................ 202
357
Appendix
User Manual corpuls3
C
Cable for monitoring functions Cleaning .................................................................. 247 Disinfection ............................................................. 247
Capnometer, technical specifications ......................... 323 Capnometry................................................................... 22 Cardioversion ................................................................ 23 Carrying strap
Cleaning .................................................................. 249 Changing the scale
CO2 monitoring....................................................... 140 Changing the unit of CO2 monitoring.......................... 140 Character encoding
Technical specifications .......................................... 312 Charging brackets
Cleaning .................................................................. 249 Charging tone
see Defibrillation..........74, 77, 78, 83, 84, 86, 181, 183 Check
Accessories ............................................................. 237 Complete device ..................................................... 233 Consumables........................................................... 237 Power supply.......................................................... 235 Checklist Functional Check..................................................... 297 Checks ......................................................................... 232 Classification UMDNS ....................................................................... ii Cleaning............................................................... 243, 249 Cable for monitoring functions ............................... 247 CO2 sensor.............................................................. 248 Defibrillator............................................................. 245 Disinfection ............................................................. 247 IBP transducer cable ............................................... 248 Monitoring unit....................................................... 245 NIBP Cuffs ............................................................... 248 Oximetry sensor...................................................... 248 Patient box.............................................................. 245 Shock paddles ................................................. 246, 247 Therapy master cable ............................................. 247 CO2 monitoring adjusting representation of the CO2 values ........... 140 Changing the scale .................................................. 140 changing the unit .................................................... 140 information ............................................................. 135
358
Insert for neonates ................................................. 138 malfunctions........................................................... 270 Monitoring respiration rate.................................... 141 Performing.............................................................. 139 preparation............................................................. 136 CO2 sensor Cleaning .................................................................. 248 Compact device............................................................... 9 brackets insertion/removal ................................... 65 CompactFlash® card.................................................... 199 Compression synchronised therapy AED mode ............................................................... 105 Compression Synchronised Therapy Manual Mode ......................................................... 106 Configuration .............................................................. 154 Data interfaces ....................................................... 210 Export ..................................................................... 179 Import..................................................................... 179 Telemetry ............................................................... 210 Telemetry services.................................................. 214 Configuration dialogue ................................................. 55 Connection authorisation Ad-hoc connection ................................................... 12 Pairing....................................................................... 12 Consumables Defibrillator ............................................................ 249 Control menu ........................................................................ 51 Conventions .................................................................. xiv corPatch electrodes AED mode ................................................................. 77 manual defibrillation ................................................ 83 corpuls cpr Therapy control via corpuls3 .................................. 104 Therapy parameters ............................................... 105 corpuls.web LIVE Configuration.......................................................... 215 Country codes WLAN interface ...................................................... 319 CPR Feedback................................................................ 22 Technical specifications .......................................... 317 Using....................................................................... 101 Creating a Patient File ................................................. 207 Curve context menu...................................................... 52 cWEB
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
see Telemetry ......................................................... 296
D
Data Analysis ................................................................... 207 Processing ............................................................... 207
Data archiving ............................................................. 200 Data interfaces
Configuration .......................................................... 210 Data management
Insurance card reader ............................................. 207 Data Management ...................................................... 199 Data transmission
see Telemetry ......................................................... 221 D-ECG
Additional printout ................................................. 206 D-ECG Browser ............................................................ 206 Defibrillation ......................................................... 23, 328
Charging tone...............74, 77, 78, 83, 84, 86, 181, 183 Deliver shock................................................... 234, 335 Ready for shock......................83, 84, 86, 314, 315, 335 Ready-signal...............................77, 78, 83, 84, 86, 277 Defibrillation automatic (AED) see AED mode ........................................................... 73 Defibrillation impulse 4/3 ........................................................ 23, 73, 80, 327 6/4 ........................................................ 23, 73, 80, 327 Defibrillation, manual malfunctions ........................................................... 266 with corPatch easy electrodes .................................. 83 with shock paddles ................................................... 83 with shock spoons..................................................... 85 Defibrillation, manual see Manual mode ...................... 80 Defibrillator Accessories ............................................................. 249 Cleaning .................................................................. 245 Components................................................................ 9 Consumables........................................................... 249 Spare parts.............................................................. 249 switching off ............................................................. 49 switching on .............................................................. 48 technical specifications ........................................... 314 Defibrillator, biphasic .................................................. 326 technical specifications ........................................... 315 Defibrillator/Pacer......................................................... 19
ENG - Version 4.0 P/N 04130.2
control key................................................................ 46 LEDs .......................................................................... 46 Defibrillator/Pacer SLIM................................................ 20 control key................................................................ 47 LEDs .......................................................................... 47 Deliver shock see Defibrillation ............................................ 234, 335 Diagnostic ECG .............................................................. 22 information............................................................. 116 preparation............................................................. 117 Recording................................................................ 120 Diagnostic functions...................................................... 22 Dimensions ................................................................. 308 Disconnection signal ................................................... 181 Disinfectants ............................................................... 244 Disinfection ................................................................. 243 Cable for monitoring functions............................... 247 IBP transducer cable ............................................... 248 Oximetry sensor ..................................................... 248 Shock paddles ................................................. 246, 247 Temperature sensor ............................................... 249 Disposal....................................................................... 347 Packaging................................................................ 347 Dynamic QRS/pulse tone see QRS-/pulse tone, dynamic................................ 168
E
ECG................................................................................ 22 diagnosis................................................................. 116 ECG cable tester ..............................109, 112, 117, 119 ECG filter settings ................................................... 115 Filter settings .......................................................... 184 Longterm ECG......................................................... 127 Monitoring.............................................................. 109 Technical specifications .......................................... 312 with therapy electrodes ......................................... 313
ECG analysis ................................................................ 335 ECG cable tester...................................109, 112, 117, 119 ECG filter settings........................................................ 115 ECG measurement
corpuls ACS ............................................................. 116 corpuls S ................................................................. 116 ECG measurement/interpretation ACS ......................................................................... 296 AMI ......................................................................... 296
359
Appendix
User Manual corpuls3
codes....................................................................... 125 HES .......................................................................... 296 IMI........................................................................... 296 NSTEMI ................................................................... 296 PCI ........................................................................... 296 STEMI ...................................................................... 296 ECG monitoring adaptation of the ECG plot ..................................... 114 information ..................................................... 107, 109 malfunctions ........................................................... 267 Performing .............................................................. 112 preparation ............................................................. 110 Printing curves ........................................................ 113 Electrodes Connecting the cable ................................................ 70 Defibrillation electrodes ........................................... 68 Electromagnetic emission .......................................... 340 End of paper roll.......................................... 163, 235, 262 Energy management ..................................................... 30 lithium-ion battery............................................ 30, 309 malfunctions ........................................................... 275 technical specifications ........................................... 309 Energy selection ............................................................ 24 Energy selection, automatic see Auto Energy ...................................................... 181 Environmental requirements ...................................... 308 Event key ..................................................................... 200 Export Configuration .......................................................... 179 Extended Oximetry........................................................ 22 External pacer technical specifications ........................................... 316
F
Factory settings ........................................................... 298 Fax Server
Configuration .................................................. 215, 217 Fax transmission
see Telemetry ......................................................... 217 Filter setting ........................................................ 115, 184 Folding................................................................. 113, 204 Function check
Power supply .......................................................... 232 Function Check
Accessories ............................................................. 232
360
Device ..................................................................... 232
G
General terms and conditions..................................... 345 GPRS
APN ......................................................................... 211 Configuration.......................................................... 211 Password ................................................................ 211 User name .............................................................. 211 GSM Configuration.......................................................... 211 PIN .......................................................................... 211 GSM 2G technical specifications........................................... 318 GSM 3G technical specifications........................................... 318
H
Heart rate monitoring ................................................. 116 HES
ECG measurement/interpretation.......................... 296 Hyperbaric chamber ....................................................... 2
see Monoplace hyperbaric chamber .......................... 6 see Multiplace hyperbaric chamber ........................... 2
I
IBP transducer cable Cleaning .................................................................. 248 Disinfection............................................................. 248 Sterilisation............................................................. 248
IMI see ECG measurement/interpretation ................... 296
Import Configuration.......................................................... 179
Information labels........................................................... 2 Insurance card reader ................................................. 207 Interfaces
monitoring unit......................................................... 15 patient box ............................................................... 17 Invasive blood pressure monitoring (IBP) ..................... 23 malfunctions........................................................... 274 Inverted video display................................................... 41
L
LAN interface
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
technical specifications ........................................... 318 Lithium-ion battery ............................................... 30, 309 Live data transmission
see Telemetry ......................................................... 221 Loading the printer paper ........................................... 241 Longterm ECG.............................................................. 127
Performing .............................................................. 128 preparing ................................................................ 127 Longterm ECG browser ............................................... 127 LTE 4G Technical specifications .......................................... 318 LT-ECG Browser ........................................................... 206
M
MagCode connectors Cleaning .................................................................. 249
Main menu .................................................................... 54 Mains operation ............................................................ 32 Maintenance ............................................................... 240
General ................................................................... 231 Schedule ................................................................. 231 Malfunctions ............................................................... 250 Manual Mode Compression Synchronised Therapy....................... 106 Manufacturer .............................................................. 365 Marking paper roll....................................... 163, 235, 241 Master data ................................................................. 201 configuration .......................................................... 188 Menu types ................................................................... 51 configuration dialogue .............................................. 55 curve context menu .................................................. 52 main menu ................................................................ 54 parameter context menu.......................................... 52 Softkey context menu ............................................... 51 Menu, control................................................................ 51 Metronome Settings ..................................................................... 96 Starting ..................................................................... 97 Millivolt mark .............................................. 113, 114, 204 Minute mean values............................................ 162, 203 Mission upload Configuration .......................................................... 216 Modules .......................................................................... 9 connection ................................................................ 56 disconnection............................................................ 56
ENG - Version 4.0 P/N 04130.2
infrared connection .................................................. 10 radio connection............................................10, 29, 40 usage options ........................................................... 10 Monitoring blood pressure................................................ 141, 148 CO2 ......................................................................... 135 ECG ................................................................. 107, 109 Oximetry ................................................................. 129 temperature ........................................................... 152 Monitoring functions .................................................... 22 Alarms ............................................................ 332, 334 Monitoring pulse rate and perfusion index, Oximetry monitoring .............................................................. 134 Monitoring respiratory rate ........................................ 141 Monitoring unit Alarm configuration.................................................. 28 Alarm signals ............................................................ 26 Basic structure of the screen pages.......................... 39 bracket insertion/removal ..................................... 66 Cleaning .................................................................. 245 connection to defibrillator/pacer ............................. 59 disconnection from defibrillator/pacer .................... 56 interfaces.................................................................. 15 LEDs .......................................................................... 35 operating elements .................................................. 35 power supply ............................................................ 33 Touchscreen ....................................................... 35, 43 Monitoring Unit ............................................................ 14 Monoplace hyperbaric chamber..................................... 6 Multiplace hyperbaric chamber.................................. 2, 6 mV-mark ......................................................113, 114, 204
N
Neonate insert Technical specifications .......................................... 325
Network connection................................................................ 44 Troubleshooting ..................................................... 266
NIBP Cuffs Cleaning .................................................................. 248 Disinfection............................................................. 248
NIBP Views .................................................................. 142 NIBP, Technical specifications..................................... 321 Non-invasive blood pressure monitoring (NIBP)........... 23 NSTEMI
361
Appendix
User Manual corpuls3
ECG measurement/interpretation .......................... 296
O
Operating disconnection and connection of modules ............... 56
Operating- and screen elements ................................... 35 Operating instructions................................................... 35 Operation
automatic defibrillation ............................................ 73 General ..................................................................... 35 Manual defibrillation ................................................ 80 monitoring and diagnostic functions ...................... 107 Therapy ..................................................................... 68 Touchscreen........................................................ 35, 43 Oximetry........................................................................ 22 Oximetry monitoring ................................................... 129 adjusting display ..................................................... 134 Averaging time........................................................ 133 Extended ................................................................. 130 FastSat® .................................................................. 133 malfunctions ........................................................... 268 Performing .............................................................. 132 preparation ............................................................. 131 Sensitivity................................................................ 133 Oximetry Monitoring information ............................................................. 129 Oximetry -Monitoring monitoring pulse rate and perfusion index............. 134 Oximetry sensor Cleaning .................................................................. 248 Disinfection ............................................................. 248 Oximetry, technical specifications............................... 319
P
Pacer ............................................................................. 25 malfunctions ........................................................... 267
Pacer therapy ................................................................ 89 Pacer, external
Preparing pacer function .......................................... 90 Starting pacer function ............................................. 92 technical specifications ........................................... 316 Pairing see connection authorisation ................................... 12 Parameter context menu .............................................. 52 Patents ........................................................................ 346
362
Patient box Alarm signals ............................................................ 29 bracket insertion/removal ..................................... 67 Cleaning .................................................................. 245 connection to the monitoring unit ........................... 58 control keys .............................................................. 45 disconnection from the monitoring unit .................. 57 interfaces.................................................................. 17 LEDs .......................................................................... 45 power supply ............................................................ 33 removal from the compact device............................ 60 Screen ....................................................................... 44
Patient Box.................................................................... 16 Patient box screen ........................................................ 44 Patient data, entry ...................................................... 199 PCI
see ECG measurement/interpretation ................... 296 Power supply ................................................................ 33 Printer ......................................................................... 241
malfunctions........................................................... 274 technical specifications........................................... 311 Printer paper empty.....................................163, 235, 241 Protocol printout ........................................................ 202 Pulse tone see QRS-/Pulse tone ............................................... 303 Pulse tone, dynamic.................................................... 168 see QRS-/Pulse tone ............................................... 167
Q
QRS QRS Marker .................................................... 166, 302 QRS-/Pulse tone ............................................. 166, 302
QRS-/Pulse tone QRS-/Pulse tone, dynamic .............................. 167, 168
Qualified staff ................................................................. 1
R
Radio connection see Modules ........................................................... 266
Ready for shock see Defibrillation ................... 83, 84, 86, 314, 315, 335
Ready-signal see Defibrillation ....................... 77, 78, 83, 84, 86, 277
Real-time printout .......................................113, 161, 311 Recycling ..................................................................... 347
ENG - Version 4.0 P/N 04130.2
User Manual corpuls3
Appendix
Refractory time ........................................................... 335 Regular checks............................................................. 231 Remaining running time display, batteries.................... 30 Representative Cycle ................................................... 125 Reset
Reset configuration......................................... 177, 178 Reset default................................................... 177, 178
S
Safety Defibrillator................................................................. 4 General ....................................................................... 1 Maintenance ............................................................... 2 Operating staff ............................................................ 1 Safety information .................................................. 332
Screen Night ......................................................................... 42 see Inverted video display ........................................ 41 Technical specifications .......................................... 311
Screenshot................................................................... 207 Selftest ........................................................................ 240 Service Address .............................................................. iii Settings
alarms ..................................................................... 154 monitoring functions .............................................. 154 system settings ....................................................... 154 Shock paddles AED Mode ................................................................. 78 Cleaning .................................................................. 246 Disinfection ............................................................. 246 manual defibrillation................................................. 83 Removing from holders ............................................ 71 Sterilisation ............................................................. 246 Shock Protocol............................................................. 181 Shock spoons manual defibrillation................................................. 85 SIM card ...................................................................... 211 Softkey context menu ................................................... 51 Spare parts .................................................................. 249 Special Types of Risk........................................................ 4 STEMI ECG measurement/interpretation .......................... 296 Sterilisation ................................................................. 243 IBP transducer cable ............................................... 248 Temperature sensor ............................................... 249
ENG - Version 4.0 P/N 04130.2
Switching off ................................................................. 49 Switching on.................................................................. 48 Symbols................................................................2, 3, 289
T
TCP Configuration.......................................................... 296
Technical specifications 4G LTE..................................................................... 318 Alarm management ................................................ 310 battery .................................................................... 309 Bluetooth interface ................................................ 317 capnometer ............................................................ 323 Character encoding ................................................ 312 CPR Feedback ......................................................... 317 defibrillator............................................................. 314 ECG ......................................................................... 312 energy management .............................................. 309 GSM 2G................................................................... 318 GSM 3G................................................................... 318 LAN interface .......................................................... 318 Neonate insert........................................................ 325 NIBP ........................................................................ 321 oximetry ................................................................. 319 power supply .......................................................... 309 Touchscreen ........................................................... 311 WLAN interface ...................................................... 318
Technical Specifications ECG with therapy electrodes .................................. 313 printer..................................................................... 311 Screen ..................................................................... 311
Telemetry.................................................................... 209 APN ......................................................................... 296 Configuration.......................................................... 210 Connections............................................................ 213 Data transmission ................................................... 221 D-ECG transmission ................................................ 217 Entering e-mail address .......................................... 213 Entering internet address ....................................... 213 Entering IP address ................................................. 213 Entering phone number ......................................... 213 Live data transmission ............................................ 221 Networks ................................................................ 218 Settings ................................................................... 221 TCP.......................................................................... 296
363
Appendix
User Manual corpuls3
UDP ......................................................................... 214 Telemetry services
Configuration .......................................................... 214 Temperature ................................................................. 23 Temperature monitoring
information ............................................................. 152 malfunctions ........................................................... 273 Performing .............................................................. 153 preparation ............................................................. 152 Temperature sensor Cleaning .................................................................. 249 Disinfection ............................................................. 249 Sterilisation ............................................................. 249 Test software Test version............................................................... 48 Tests General ................................................................... 231 Therapeutic Functions............................................. 22, 23 Therapy control corpuls cpr .............................................................. 104 Therapy electrodes........................................................ 68 Therapy master cable Cleaning .................................................................. 247 Disinfection ............................................................. 247 Therapy parameters corpuls cpr .............................................................. 105 Touchscreen ............................................................ 35, 43 Technical specifications .......................................... 311 Trademarks ................................................................. 346 Trend ........................................................................... 164 Trend curve ................................................................. 162 Trend table .................................................................. 162 Trouble shooting and remedying malfunctions during oximetry monitoring.................................... 268 Troubleshooting Network .................................................................. 266
Troubleshooting and remedying malfunctions Defibrillation........................................................... 266 during CO2 monitoring ........................................... 270 during IBP monitoring............................................. 274 during pacing .......................................................... 267 during temperature monitoring ............................. 273 General ........................................................... 265, 266 printer..................................................................... 274
Troubleshooting and remedying malfunctions during ECG monitoring ...................................................... 267
Troubleshooting and remedying malfunctions in energy management .......................................................... 275
U
UDP Configuration.......................................................... 214
UMDNS see Classification ........................................................ ii
User and operational safety........................................ 345
V
Ventricular fibrillation ................................................. 172 Ventricular tachycardia ............................................... 172 Views............................................................157, 298, 307 Visual and Function Check .......................................... 231 VT/VF alarm ................................................................ 172
W
Warning labels ................................................................ 2 Warning Notices and Symbols ........................................ 3 Warranty ..................................................................... 345 Warranty conditions ................................................... 345 Weight ........................................................................ 308 WLAN interface
Country codes......................................................... 319 Technical specifications .......................................... 318
364
ENG - Version 4.0 P/N 04130.2
GS Elektromedizinische Geräte G. Stemple GmbH
Hauswiesenstrasse 26
86916 Kaufering
Germany
Tel.:
+49 8191 65722-0
Fax:
+49 8191 65722-22
Website: https://corpuls.world
Gaubatz Corinna Adobe PDF Library 10.0