Mindray BIO Medical electronics TMS6016 Telemetry Monitoring Transmitter User Manual h39887 21 operator s manual
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Telemetry Monitoring Transmitter h39887 21 operator s manual
user manual
TMS-6016
Telemetry Monitoring System
Operation Manual
I
CE Marking
The telemetry monitoring system bears CE mark indicating its conformity with the
provisions of the Council Directive 93/42/EEC concerning medical devices and
fulfils the essential requirements of Annex I of this directive.
The telemetry monitoring system is in radio-interference protection class B in
accordance with EN55011.
The product complies with the requirement of standard EN60601-1-2
“Electromagnetic Compatibility – Medical Electrical Equipment”.
Revision History
This manual has a revision number. This revision number changes whenever the
manual is updated due to software or technical specification change. Contents of this
manual are subject to change without prior notice. Revision 1.0 is the initial release
of the document.
Version number: 2.1
Release time: November 2006
© 2005 - 2006 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights
reserved.
WARNING
z Federal Law (USA) restricts this device to sale by or on the order of a
physician.
II
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter
called Mindray) owns the intellectual property rights to this product and this manual.
This manual may refer to information protected by copyrights or patents and does
not convey any license under the patent rights of Mindray, nor the rights of others.
Mindray does not assume any liability arising out of any infringements of patents or
other rights of third parties.
Mindray intends to maintain the contents of this manual as confidential information.
Disclosure of the information in this manual in any manner whatsoever without the
written permission of Mindray is strictly forbidden. Release, amendment,
reproduction, distribution, rent, adaption and translation of this manual in any
manner whatsoever without the written permission of Mindray is strictly forbidden.
and are the registered trademarks or trademarks owned by
Mindray in China and other countries. All other trademarks that appear in this
manual are used only for editorial purposes without the intention of improperly
using them. They are the property of their respective owners.
Contents of this manual are subject to changes without prior notice.
III
Manufacturer’s Responsibility
All information contained in this manual is believed to be correct. Mindray shall not
be liable for errors contained herein nor for incidental or consequential damages in
connection with the furnishing, performance, or use of this manual.
Mindray is responsible for safety, reliability and performance of this product only in
the condition that:
All installation operations, expansions, changes, modifications and repairs of
this product are conducted by Mindray authorized personnel; and
The electrical installation of the relevant room complies with the applicable
national and local requirements; and
This product is operated under strict observance of this manual.
Warranty
This warranty is exclusive and is in lieu of all other warranties, expressed or implied,
including warranties of merchantability or fitness for any particular purpose.
Exemptions
Mindray's obligation or liability under this warranty does not include any
transportation or other charges or liability for direct, indirect or consequential
damages or delay resulting from the improper use or application of the product or
the use of parts or accessories not approved by Mindray or repairs by people other
than Mindray authorized personnel.
This warranty shall not extend to
Any Mindray product which has been subjected to misuse, negligence or
accident; or
Any Mindray product from which Mindray's original serial number tag or
product identification markings have been altered or removed; or
Any product of any other manufacturer.
IV
Return Policy
In the event that it becomes necessary to return a unit to Mindray, follow the
instructions below.
1. Obtain a return authorization.
Contact the Mindray Service Department and obtain a Mindray Customer Service
Authorization Number. The Mindray Customer Service Authorization Number must
appear on the outside of the shipping container. Return shipments will not be
accepted if the Mindray Customer Service Authorization Number is not clearly
visible. Please provide the model number, serial number, and a brief description of
the reason for return.
2. Freight policy
The customer is responsible for freight charges when this product is shipped to
Mindray for service (including any relevant customs fees or other freight related
charges).
3. Return address
Please send the part(s) or equipment to the address offered by Customer Service
Department.
Contact Information
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial Park,
Nanshan, Shenzhen 518057 P.R. China
Tel: +86 755 26582479 +86 755 26582888
Fax: +86 755 26582934 +86 755 26582500
Website: www.mindray.com
EC-Representative: Shanghai International Holding Corp. GmbH (Europe)
Address: Eiffestraße 80, 20537 Hamburg Germany
Tel: 0049-40-2513175
Fax: 0049-40-255726
V
Preface
Manual Purpose
This manual contains the instructions necessary to operate the telemetry monitoring
system safely and in accordance with its function and intended use. Observance of
this manual is a prerequisite for proper product performance and correct operation
and ensures patient and operator safety.
This manual is based on the maximum configuration and therefore some contents
may not apply to your telemetry monitoring system. If you have any question, please
contact us.
This manual is an integral part of the product. It should always be kept close to the
equipment so that it can be obtained conveniently when needed.
Intended Audience
This manual is geared for clinical professionals who are expected to have a working
knowledge of medical procedures, practices and terminology as required for
monitoring of critically ill patients.
Illustrations
All illustrations in this manual serve as examples only. They may not necessarily
reflect your monitoring setup or data displayed on your telemetry monitoring
system.
Conventions
Italic text is used in this manual to quote the referenced chapters or sections.
The terms danger, warning, and caution are used throughout this manual to
point out hazards and to designate a degree or level or seriousness.
VI
FOR YOUR NOTES
1
Contents
1 Safety.................................................................................................................... 1-1
1.1 Safety Information ...................................................................................... 1-2
1.1.1 Dangers ......................................................................................... 1-3
1.1.2 Warnings........................................................................................ 1-3
1.1.3 Cautions......................................................................................... 1-4
1.1.4 Notes ............................................................................................. 1-5
1.2 Equipment Symbols .................................................................................... 1-6
1.3 Reference Literature.................................................................................... 1-8
2 Overview .............................................................................................................. 2-1
2.1 General ........................................................................................................ 2-2
2.1.1 Intended Use.................................................................................. 2-2
2.1.2 Contraindications .......................................................................... 2-3
2.1.3 Components................................................................................... 2-3
2.1.4 Functions ....................................................................................... 2-3
2.2 Product Overview........................................................................................ 2-4
2.2.1 Telemetry Transmitter ................................................................... 2-4
2.2.2 Telemetry Receiver ....................................................................... 2-6
2.3 About the CMS ........................................................................................... 2-8
2.3.1 Main Screen .................................................................................. 2-8
2.3.2 Auxiliary Screen in Single-Screen Mode.....................................2-11
2.3.3 ViewBed Screen .......................................................................... 2-12
3 Installation and Maintenance............................................................................. 3-1
3.1 Installation................................................................................................... 3-2
3.1.1 Unpacking and Inspection ............................................................. 3-2
3.1.2 Environmental Requirements........................................................ 3-3
3.1.3 Power Requirements ..................................................................... 3-3
3.1.4 Computer Requirements................................................................ 3-4
3.1.5 Installation..................................................................................... 3-5
3.1.6 Starting the system ........................................................................ 3-6
3.1.7 Shutting down the system ............................................................. 3-7
3.2 Maintenance ................................................................................................ 3-8
3.2.1 Inspection ...................................................................................... 3-8
3.2.2 Cleaning ........................................................................................ 3-9
3.2.3 Disinfection and Sterilization.......................................................3-11
Contents
2
4 Using Transmitters.............................................................................................. 4-1
4.1 Installing and replacing batteries................................................................. 4-2
4.2 Switching on/off the transmitter.................................................................. 4-3
4.3 Wearing the transmitter ............................................................................... 4-3
5 Routine CMS Operation..................................................................................... 5-1
5.1 Nurse call .................................................................................................... 5-2
5.2 Event ........................................................................................................... 5-2
5.3 STANDBY mode ........................................................................................ 5-2
5.4 Patient Management.................................................................................... 5-3
5.4.1 Admitting a Patient........................................................................ 5-3
5.4.2 Editing patient information ........................................................... 5-4
5.4.3 Discharging a Patient..................................................................... 5-5
5.5 Alarm Setup ................................................................................................ 5-6
5.5.1 Alarm Setup .................................................................................. 5-6
5.5.2 Alarm Volume ............................................................................... 5-7
5.5.3 Pause alarm ................................................................................... 5-8
5.5.4 Alarm Latching ............................................................................. 5-8
5.5.5 Turning off alarm sound................................................................ 5-9
5.6 Review ...................................................................................................... 5-10
5.7 Record ....................................................................................................... 5-14
5.8 Print........................................................................................................... 5-15
6 ECG Monitoring.................................................................................................. 6-1
6.1 Preparation .................................................................................................. 6-2
6.2 Electrode Placement.................................................................................... 6-3
6.3 ECG Monitoring.......................................................................................... 6-8
6.3.1 ECG waveform.............................................................................. 6-8
6.3.2 ECG parameter.............................................................................. 6-9
6.3.3 ECG Setup................................................................................... 6-10
6.3.4 ECG lead type ..............................................................................6-11
6.3.5 ECG Primary and Secondary Leads............................................ 6-12
6.3.6 Waveform display settings .......................................................... 6-12
6.3.7 Filter mode .................................................................................. 6-12
6.3.8 Pace Pulse detection.................................................................... 6-13
6.3.9 HR alarm ..................................................................................... 6-13
6.4 ST Analysis ............................................................................................... 6-14
6.4.1 General ........................................................................................ 6-14
6.4.2 ST setup....................................................................................... 6-15
6.4.3 ST measurement points ............................................................... 6-16
6.5 Arrhythmia Analysis ................................................................................. 6-17
6.5.1 Overview ..................................................................................... 6-17
6.5.2 Arrhythmia analysis setup........................................................... 6-18
6.5.3 Arrhythmia alarm setup............................................................... 6-19
Contents
3
6.5.4 Arrhythmia alarm review ............................................................ 6-20
6.5.5 Arrhythmia relearn ...................................................................... 6-21
6.5.6 Arrhythmia troubleshooting ........................................................ 6-22
6.6 Maintenance and Cleaning ........................................................................ 6-22
7 SpO2 Monitoring ................................................................................................. 7-1
7.1 Principle of SpO2 Measurement.................................................................. 7-2
7.2 Monitoring Procedure ................................................................................. 7-2
7.3 SpO2 Measurement...................................................................................... 7-3
7.3.1 SpO2 parameter area...................................................................... 7-3
7.3.2 SpO2 Setup .................................................................................... 7-4
7.4 Measurement Limitations............................................................................ 7-5
7.5 Warnings ..................................................................................................... 7-6
8 Troubleshooting................................................................................................... 8-1
9 Accessories........................................................................................................... 9-1
10 Appendices......................................................................................................... 10-1
A. Product Specifications............................................................................... 10-2
A.1 Safety Specifications................................................................... 10-2
A.2 Environmental Specifications...................................................... 10-2
A.3 Power Specifications................................................................... 10-3
A.4 Hardware Specifications ............................................................. 10-4
A.5 Data Display, Recording and Saving........................................... 10-4
A.6 Alarms and Indicators ................................................................. 10-5
A.7 Wireless Transmission................................................................. 10-5
A.8 ECG Specifications ..................................................................... 10-6
A.9 SpO2 Specifications..................................................................... 10-8
B. EMC........................................................................................................ 10-10
C. Symbols and Abbreviations..................................................................... 10-15
C.1 Units .......................................................................................... 10-15
C.2 Symbols..................................................................................... 10-16
C.3 Abbreviations ............................................................................ 10-17
Contents
4
FOR YOUR NOTES
1-1
1 Safety
1.1 Safety Information ...................................................................................... 1-2
1.1.1 Dangers ......................................................................................... 1-3
1.1.2 Warnings........................................................................................ 1-3
1.1.3 Cautions......................................................................................... 1-4
1.1.4 Notes ............................................................................................. 1-5
1.2 Equipment Symbols .................................................................................... 1-6
1.3 Reference Literature.................................................................................... 1-8
Safety
1-2
1.1 Safety Information
The safety statements presented in this chapter refer to the basic safety information
that the operator of the Telemetry monitoring system shall pay attention to and abide
by. There are additional safety statements in other chapters or sections, which may
be the same as or similar to the followings, or specific to the operations.
DANGER
z Indicates an imminent hazard situation that, if not avoided, will result in
death, serious injury or property damage.
WARNING
z Indicates a potential hazard situation or unsafe practice that, if not
avoided, could result in death, serious injury or property damage.
CAUTION
z Indicates a potential hazard or unsafe practice that, if not avoided, could
result in minor personal injury or product/property damage.
NOTE
z Provides application tips or other useful information to ensure that you
get the most from your product.
Safety
1-3
1.1.1 Dangers
There are no dangers that refer to the product in general. Specific “Danger”
statements may be given in the respective sections of this operation manual.
1.1.2 Warnings
WARNING
z The telemetry monitoring system is intended for use by trained clinical
professionals in specific situations. Any operations of the system by
unauthorized or untrained person are prohibited.
z Check the system and accessories each time before use. Make sure they
function properly and safely.
z Possible fire or explosion hazard if used in the presence of flammable
anesthetics.
z Be sure to set the alarm according to the patient’s conditions. Make sure
the system sounds when an alarm is present.
z Opening the receiver housing may present a risk of electric shock. All
servicing and future upgrades to this system must be performed by
personnel trained and authorized by Mindray only.
z Do not come into contact with patients during defibrillation. Otherwise
serious injury or death could result.
z When the system is used in conjunction with electro-surgery unit (ESU),
patient safety must be ensured.
z Dispose of the packaging material, observing the applicable waste
control regulations and keeping it out of children’s reach.
z The telemetry receiver must be connected to a properly installed power
outlet with protective earth contacts only. If the installation does not
provide for a protective earth conductor, disconnect the receiver from
the power line and operate it on battery power, if possible.
z This system generates, uses and radiates radio-frequency energy, and if
is not installed and used in accordance with this manual, may cause
interference to radio communication.
z Operation of this system in a residential area may cause interference, in
which case, at their own expense, must take whatever measures may be
required to correct the interference.
z The telemetry transmitter is an IPX3 device. Never immerse the telemetry
transmitter in water or other liquids such as cleaning solutions.
Safety
1-4
1.1.3 Cautions
CAUTION
z To ensure patient safety, use only parts and accessories specified in this
manual.
z Remove the batteries if you do not intend to use the transmitter for a
long period of time.
z Disposable devices are intended for single use only. They should not be
reused as performance could degrade or contamination could occur.
z At the end or its service life, the product described in this manual, as well
as its accessories, must be disposed of in compliance with the
guidelines regulating the disposal of such products. If you have any
questions concerning disposal of the product, please contact us.
z Magnetic and electrical fields are capable of interfering with the proper
performance of the system. For this reason make sure that all external
devices operated in the vicinity of the system comply with the relevant
EMC requirements. Mobile phone, X-ray equipment or MRI devices are a
possible source of interference as they may emit higher levels of
electromagnetic radiation.
z Before connecting the receiver to the power line, check that the voltage
and frequency ratings of the power line are the same as those indicated
on the unit’s label or in this manual.
z Install or carry the transmitter properly to avoid damage caused by drop,
impact, strong vibration or other mechanical force.
z Signal transmission can be disturbed when the patient passes concrete
walls or elevator doors.
z High quality alkali batteries are recommended. Remove the batteries
when the transmitter is not in use.
z Although the transmitter and receiver are chemically resistant to most
common hospital cleaners and non-caustic cleaners, different cleaners
are not recommended and may stain the transmitter and receiver. Many
cleaners must be diluted before use.
Safety
1-5
1.1.4 Notes
NOTE
z Keep this manual close to the Telemetry monitoring system so that it can
be obtained conveniently when necessary.
z For detailed introductions of the central monitoring system, refer to the
accompanying operation manual of the central monitoring system. In
case you find contradicting contents of the two operation manuals, this
manual supercedes that of the central monitoring system.
z Choose a location that affords an unobstructed view of the system and
easy access to the operating controls.
z The instructions of this manual are based on the maximum
configuration. Some of them may not apply to your system.
Safety
1-6
1.2 Equipment Symbols
Attention: Consult accompanying documents (this manual).
Power on
Power off
Alternating current (AC)
Type CF applied part. The unit displaying this symbol
contains an F-type isolated (floating) patient part providing a
high degree of protection against shock, and is suitable for
use during defibrillation.
TYPE BF applied part
Equipotential terminal
Non-ionizing electromagnetic radiation
Network connector
Antenna interface
Communication status
Safety
1-7
Manufacture date
Serial number
European community representative
This mark means that this device is fully in conformance
with the Council Directive Concerning Medical Devices
93/42/EEC. The number adjacent to the CE marking (0123)
is the number of the EU-notified body that certified meeting
the requirements of Annex II of the Directive.
The following definition of the WEEE label applies to EU
member states only.
This symbol indicates that this product should not be treated
as household waste. By ensuring that this product is disposed
of correctly, you will help prevent bringing potential negative
consequences to the environment and human health. For
more detailed information with regard to returning and
recycling this product, please consult the distributor from
whom you purchased it.
* For system products, this label may be attached to the main
unit only.
Safety
1-8
1.3 Reference Literature
1. EN60601-1/IEC60601-1: Medical electrical equipment part 1: General
requirements for safety
2. IEC60601-1-2, Medical electrical equipment part 1-2: General requirements for
safetyCollateral standard: Electromagnetic compatibility-Requirements and
tests
3. Medical Device Directive 93/42/EEC.
2-1
2 Overview
2.1 General ........................................................................................................ 2-2
2.1.1 Intended Use.................................................................................. 2-2
2.1.2 Contraindications .......................................................................... 2-3
2.1.3 Components................................................................................... 2-3
2.1.4 Functions ....................................................................................... 2-3
2.2 Product Overview........................................................................................ 2-4
2.2.1 Telemetry Transmitter ................................................................... 2-4
2.2.2 Telemetry Receiver........................................................................ 2-6
2.3 About the CMS ........................................................................................... 2-8
2.3.1 Main Screen................................................................................... 2-8
2.3.2 Auxiliary Screen in Single-Screen Mode.....................................2-11
2.3.3 ViewBed Screen .......................................................................... 2-12
Overview
2-2
2.1 General
The telemetry monitoring system comprises several telemetry transmitters, a
telemetry receiver, an antenna array, the central monitoring system software and
certain accessories. It features:
Compact size and light weight.
Long battery life.
Reliable signal reception.
Easy expandability.
Powerful central monitoring system software.
2.1.1 Intended Use
The intend use of Telemetry Monitoring System is to monitor Electrocardiogram
(ECG), Heart Rate (HR), PR (Pulse Rate), Saturation of Pulse Oxygen (SpO2) for
adult and pediatric patients via radio frequency within a defined coverage area in
health care facility setting. The information can be displayed, stored and printed.
WARNING
z If the accuracy of any value displayed on the screen of the Telemetry
monitoring system’s screen is questionable, first determine the patient’s
vital signs by alternative means and then verify that the Telemetry
monitoring system is working correctly.
z The physiological waves, parameters and alarms displayed on the
system screen are for doctor’s reference only to make diagnoses. They
can not be directly used as the basis for clinical treatment.
z The system transmits data through wireless connection. Risk of data
loss is possible. Keep a close eye on the critical patient.
z One transmitter is to be use on one patient only.
Overview
2-3
2.1.2 Contraindications
None.
2.1.3 Components
The system comprises several telemetry transmitters, a telemetry receiver, an
antenna array, the central monitoring system software, ECG cable and SpO2 module.
2.1.4 Functions
The system provides information on the following parameters.
ECG Heart rate (HR)
3-channel of ECG waveforms
Arrhythmia and ST segment analysis
Pace analysis (PACE)
SpO2 Oxygen saturation (SpO2)
Pulse rate (PR)
In addition, the system provides such functions as alarms, freeze, review and
recording.
Overview
2-4
2.2 Product Overview
2.2.1 Telemetry Transmitter
Figure 2-1 Transmitter – front view
Figure 2-2Transmitter – rear view
Figure 2-3 Transmitter – top view
1. ECG connector
Connects the designated ECG cable (3-lead or 5-lead).
2. SpO2 connector
Connects the designated SpO2 module or the special configuration cable.
3. Nurse Call Button
To call a nurse during monitoring, press the Nurse Call Button on the transmitter.
This sends the call to the Central Motoring System (hereinafter called as CMS).
7
6
8
2
1
43
5
Overview
2-5
4. Event Button
Press the Event Button on the transmitter if the patient feel uncomfortable. This
sends the event to the CMS.
5. LED Indicator
The LED flashes green when the transmitter works correctly.
The green LED is on when instructions are in transmission.
The LED flashes red if one of the patient leads has fallen off the patient;
The LED flashes yellow when batteries in the transmitter are low.
The red LED is on when the transmitter is conducting a self-test.
6. SN label
The last four digits of the serial number of the transmitter will be used as the
transmitter ID to be displayed in the central monitoring system.
7. Battery door
It covers the battery compartment.
8. Hanging hole
If you want to hang the transmitter, hang it by this hole.
WARNING
z Do not use the patient cable or the power cord to move or lift the
transmitter. It might cause the transmitter to fall, which might damage
the transmitter or injure the patient.
Overview
2-6
2.2.2 Telemetry Receiver
Figure 2-4 Receiver – front view
Figure 2-5 Receiver – rear view
1. Communication indicator
A green LED that indicates the communication status.
It flashes frequently when the communication is normal.
It stops flashing when the communication is ceased.
It is off when the initialization failed or something is wrong with the
hardware.
2. Power indicator
A green LED that indicates the power status.
It is on when the receiver is powered on.
It is off when the receiver is powered off.
7
7
2
1
3,4,5
6
8
Overview
2-7
3. AC power input connector
You can power on/off the receiver by pressing this button.
4. Power switch
Place the switch in “┃”to switch on the power , in “〇”to switch off the power.
5. Fuse holder
Open the cover to replace the fuse. The fuse shall be 5TT/1.6A.
6. Equipotential Grounding connector
When the telemetry receiver and other equipment are to be used together, their
equipotential grounding terminals should be connected together, eliminating the
potential difference between them.
7. Antenna connector
The receiver has two antenna connectors, respectively marked 1 and 2.
8. Network connector
For network connection through an RJ45 connector.
WARNING
z Accessory equipment connected to this system must be certified
according to the respective IEC standards (e.g. IEC 60950 for
information technology equipment and IEC 60601-1 for medical
electrical equipment). Furthermore all configurations shall comply with
the valid version of the system standard IEC 60601-1-1. Any person who
connects additional equipment to the signal input port or signal output
port is responsible to ensure that the system complies with the
requirements of the valid version of the system standard IEC 60601-1-1.
If in doubt, contact our company or customer service.
Overview
2-8
2.3 About the CMS
By analyzing and calculating the ECG signals collected from the telemetry
transmitter, the CMS is intended to display the ECG waveforms and the values of
HR, SpO2 and PR. Besides, the CMS is intended to show status information for the
transmitter and receiver as well as prompt information for the alarms coming from
the transmitter and receiver.
2.3.1 Main Screen
The CMS supports two display modes: single-screen and dual-screen. For the
dual-screen mode, a dual-head card is needed for connecting two displays to the host,
respectively called primary display and secondary display. The figure below shows
the main screen (default screen) under the single-screen mode.
Figure 2-6 Main Screen
1. System name
1 2 3 4
5
67
Overview
2-9
2. System start time: displays the time when the system starts.
3. System prompt area: Displays the prompts coming from the system itself. If
more than one prompt occur, they will be displayed circularly.
4. Current time: displays the current time.
5. Patient window: displays the waveforms and parammeters coming from a
transmitter.
6. Main menu buttons: contains the functional buttons that enable you to perform
various system setups. For details, see the figure below:
Figure 2-7 Main Menu Buttons
No. Menu name Description
1
Auto Arrange: Allow you to re-assign patients to patient windows in a
top-to-bottom, left-to-right format by order of importance (or
by alarm level).
2 Admit Patient: Allow you to enter the Admit Patient auxiliary screen.
3
System Setup: Allow you to enter the System Setup auxiliary screen. For
details, refer to the central monitoring system’s Operation
Manual.
4
History Review: Allow you to enter the History Review auxiliary screen. For
details, refer to the central monitoring system’s Operation
Manual.
5 Help: Allows you to enter the Help auxiliary screen
6 Main Screen: Allow you to return to the Main Screen.
7. System icons: For details, see the figure below:
Figure 2-8 Icons
12345
1 2 3 4 5 6
Overview
2-10
No Icon name Icon Description
Indicates that the system sound is turned on
Indicates that the alarm is silenced.
1 Sound
Indicats that the alarm sound is totally turned off.
Indicates that the printer is normal;
Indicates that no printer is connected;
2 Printer
Indicates a printer error;
Indicates the recorder is normal;
Indicates that the recorder is under self test;
3 Recorder
Indicates that no recorder is connected or there is a
communication error;
It flashes when there is a new transmitter trying to connect
the CMS.
4 Connecting
Not flash when no new telemetry transmitter is connected;
Indicates that the network is normal;
5 Network
Indicates that the network is interrupted.
Note
z Auto Arrange may change the sequence of current beds.
z Chaning screen layout will trigger Auto Arrange and may change the
sequence of current beds as a result.
Overview
2-11
2.3.2 Auxiliary Screen in Single-Screen Mode
Figure 2-9 Auxiliary Screen in Single-Screen Mode
In the single-screen mode, you can enter an auxiliary screen by clicking on the
“Main menu” button, system icon or patient window. As shown in the figure above,
the auxiliary screen will occupy the lower half part of the main screen and the
system will automatically adjust the size and number of “patient windows”.
Note:
z The waveform data on the monitoring system are not stored by default. If
necessary, select the waveforms you want to store from the Waveform
Saving dialog box of the Display Setup screen.
Overview
2-12
2.3.3 ViewBed Screen
In the single screen mode, you can view a single patient through the ViewBed screen
by clicking in its “Patient window”. The ViewBed screen occupies the lower half
part of the Main Screen and presents an enlarged view of the information displayed
in the “Patient window” you have selected.
1. Patient information area 2. Physiological alarm area 3. Sound icons
4. Technical alarm area 5. Button area 6. Waveform area
7. Parameter area 8. Telemetry icons
Figure 2-10 Viewbed screen
1 25
67
843
Overview
2-13
Telemetry icons
No. Icon name Icon Function description
1 Nurse call The icon flashes if the nurse call button on the transmitter
has been pressed.
2 Event
The icon flashes if the event button on the transmitter has
been pressed.
3 Battery
energy
This icon indicates the battery status.
Green － The battery energy is normal.
Yellow － The battery energy is low.
Red － The battery energy is about to die and only can
last for 2 to 6 hours (ECG only).
4 Signal
strength
This icon indicates the signal strength.
Green － The received signal is normal.
Yellow － The received signal is weak.
Red － No signal received.
5 Transmitter
ID
TEL
XXXX It indicates the ID of the transmitter.
NOTE
z If the battery icon appears red, install new batteries in time. Keeping
using the old battery may lead to communication failure.
Overview
2-14
Button area
No. Icon name Icon Function description
1 Alarm pause Pause the alarm for 2 minutes.
2 STANDBY Entering or exiting the STANDBY mode.
3 Freeze Used to freeze and unfreeze waveforms
4 Show alarm
high/low limits
Used to show/hide alarm high/low limits for all
physiological parameters, with the alarm high
limits above the alarm low limits to the right of
the physiological parameters
5 Show Dynamic
Short Trend
Used to show/hide the dynamic short trend of
each physiological parameter.
6 Set Module Order
Used to open the Set Module Order window, in
which, you can set the display order of
modules. The default module order is: ECG,
SpO2.
7 Record
Used to open the Record dialog, in which you
can select your desired waveforms, record time
span, waveform speed and grid.
8 Show multi-lead
ECG
Enables the simultaneous monitoring of 7-lead
ECG waveforms if you use a 5-lead set.
9 Show OxyCRG Used to show/hide OxyCRG.
10 Show NIBP groups
Used to show/hide NIBP groups (so far this
function is not supported by the Telemetry
monitoring system).
11 Alarm Setup
Used to enter the Alarm Setup tab sheet, in
which you can set parameter alarms and
arrhythmia alarms.
1 2 3 4 5 6 7 8 9 10 11
3-1
3 Installation and Maintenance
3.1 Installation................................................................................................... 3-2
3.1.1 Unpacking and Inspection ............................................................. 3-2
3.1.2 Environmental Requirements........................................................ 3-3
3.1.3 Power Requirements ..................................................................... 3-3
3.1.4 Computer Requirements................................................................ 3-4
3.1.5 Installation..................................................................................... 3-5
3.1.6 Starting the system ........................................................................ 3-6
3.1.7 Shutting down the system ............................................................. 3-7
3.2 Maintenance ................................................................................................ 3-8
3.2.1 Inspection ...................................................................................... 3-8
3.2.2 Cleaning ........................................................................................ 3-9
3.2.3 Disinfection and Sterilization.......................................................3-11
Installation and Maintenance
3-2
3.1 Installation
WARNING
z The Telemetry monitoring system should be installed by Mindray
designated personnel. The copyright of the CMS software is solely
owned by Mindray. No organization or individual shall juggle, copy or
exchange it in any form or by any means without due permission.
3.1.1 Unpacking and Inspection
Before removing the system components from their packaging, inspect the
packaging for signs of damage. In case of any damage, contact the carrier or our
company immediately.
If the packaging is intact, remove the system and accessories from the packaging
carefully and check if every item on the Packing List has been received without
mechanical damage. If you have any question, contact Mindray Customer Service
Department immediately.
CAUTION
z Please save the packaging materials for future transport or storage use.
WARNING
z Dispose of the packaging material, observing the applicable waste
control regulations and keeping it out of children’s reach.
z The system may be contaminated by microorganism during transport,
storage and use. Verify the packaging, especially the packaging for the
single use accessories, is intact. In case of any damage, contact the
carrier or our company immediately.
Installation and Maintenance
3-3
3.1.2 Environmental Requirements
The operating environment of this system must meet the requirements specified in
the section A.2 Environmental Specifications.
The environment where the CMS is installed should be reasonably free from noises,
vibration, dust, and corrosive or flammable and explosive substances. Moreover, to
maintain good ventilation, at least 2 inches clearance around the system should be
left.
To ensure reliable communication, do not use radio equipment (e.g. walkie-talkies,
radio controller) or large power electrical equipment (such as paper cutter) around
the system. Keep the system away from the radio or television station. Contact us if
you have any questions regarding the electromagnetic environment.
Before operation, make sure the receiver and transmitter are free from condensation.
This can form when the system is moved from one place to another, and is exposed
to moisture and differences in temperature.
NOTE
z The system transmits data through wireless connection. External radio
frequency interference may result in missing waveforms occasionally.
Contact us for any questions regarding the electromagnetic
environment.
3.1.3 Power Requirements
The power applied to the system must meet the requirements specified in the section
A.3 Power Specifications.
WARNING
z Make sure the system works in the specified environment and powered
by the required power supply. Incompliance with the environmental and
power requirements may compromise the system performance and even
damage the system.
Installation and Maintenance
3-4
3.1.4 Computer Requirements
If you have only purchased the central monitoring system software from us, you
need to prepare a computer system meeting the following requirements to install the
software.
Computer requirements
Component Requirements
CPU/Memory/Hard disk No less than 2.0G/512M/40G
Display 17 inch LCD; 1280*1024.
Operating system Microsoft Windows 2000 or Microsoft Windows XP。
Printer Windows compatible.
Sound system Sound card/speaker
Built-in speakers (either in the LCD or the computer),
whose volume will not be easily tampered with, are
recommended.
Others CD-ROM, display card(if you have chosen the two-display
configuration, make sure your display card supports two
displays), network card, at least 2 RS232 ports, at least 1
parallel port, at least two USB ports, keyboard and mouse.
Installation and Maintenance
3-5
3.1.5 Installation
To ensure reliable performance, the system is to be installed by authorized personnel
only. To relocate the system, be sure to contact us first.
WARNING
z If the system is connected to another electrical instrument and the
instrument specifications cannot tell whether the instrument
combination is hazardous (e.g. due to summation of leakage currents),
you should consult our company or experts in the field to ensure the
required safety of all instruments concerned.
z Do not use the three wire-to-two wire adaptor.
z To avoid incidental power failure, do not use the outlet controlled by a
wall switch.
z The system can only be updated by the authorized personnel.
CAUTION
z To avoid sudden power failure, UPS is recommended.
NOTE
z The provided network cable is for connection with the PC only. For
connection with the hub, please use the parallel network cable.
Installation and Maintenance
3-6
3.1.6 Starting the system
Follow the procedure below to start the system.
1. Switch on the UPS, if any.
2. Switch on the printer and speakers.
3. Switch on the computer and display.
4. Enter the password to log on the central monitoring system.
5. The central monitoring system will run a self-test and beeps if the test result is
normal. The central monitoring system will then enter the main screen.
6. Press the power switch on the back of the receiver to switch it on. The receiver
will beep and the status indicator and power indicator will be lit.
7. Check the central monitoring system to make sure the receiver is on line.
8. Install batteries into the transmitters and connect the accessories (ECG cable,
SpO2 module). When data transmission begins, the status indicator on the
receiver will flash.
9. Check the central monitoring system to make sure the transmitters are on line.
10. Now the system has been started and you can monitor the patients as instructed
by this operation manual.
NOTE
z If the computer beeps during the startup of the computer or the operating
system, refer to the instructions for use of the computer for solutions.
Installation and Maintenance
3-7
3.1.7 Shutting down the system
Follow the procedure below to shut down the system.
1. Make sure you do not want to monitor the patients any more
2. Save or delete the patient data as prompted by the central monitoring system.
3. Click on the “System Setup” button.
4. Click on the “General Setup” tab and then click on the “Shutdown” button.
5. The system will check if any patient is being monitored
If no patients are being monitored, it enters the next step
If there are still patients being monitored, it will pop up a message box to ask
you to confirm the operation. You can either click on “Yes” enter the next step,
or click on “No” to s save data and discharge the patients and then repeat the
above procedures.
6. The system will pop up a message box to confirm the operation. Click on “Yes”
and then enter the password, if any, to shut down the system.
7. Switch off the computer and the peripheral devices.
8. Switch off the transmitters and reciver.
9. Switch off the UPS, if any.
CAUTION
z The hospital without a stable power supply should use a UPS to supply
power to the CMS. The UPS must not be turned off by force. In case of a
power failure, the system should be shut down by following the above
shutdown procedure before the UPS is depleted. If the system has a
sudden power interruption, system failure may occur, the system may
be unable to work normally next time, or even serious result may result.
Installation and Maintenance
3-8
3.2 Maintenance
WARNING
z Failure on the part of the responsible hospital or institution employing
the use of the central monitoring system to implement a satisfactory
maintenance schedule may cause undue system failure and possible
health hazard.
3.2.1 Inspection
Regular maintenance
To ensure reliable system performance, the system shall be inspected by qualified
personnel when the system
Has not been used yet.
Has been running continuously for 6 to 12 months
Has been repaired or updated.
The inspection shall cover
Whether the envrionment and power meet the requirements.
Whether the power system is properly grounded.
Whether the insulation of the power cable isfine.
Whether the electromagnetic envrionment meets the requriements.
Whether the battery contacts of the transmitters are fine.
Whether there are phsical damages on the housing, buttons, connectors and
accessories.
Whether only the specified accessories are being used.
Whether the system clock is accurate.
Whether the sound/visual alarms can function properly.
Whether the transmitter frequecy is accurate.
Whether the antenna array is well connected.
If you find any damage or problem, do not use the system. Contact engineers of your
hospital or our service engineers immediately.
Installation and Maintenance
3-9
3.2.2 Cleaning
WARNING
z Be sure to shut down the system and disconnect all power cords from
the outlet before cleaning the system.
The system should be cleaned on a regular basis. If there is heavy pollution in your
place or your place is very dusty and sandy, the system should be cleaned more
frequently. Before cleaning the system, consult your hospital’s regulations for
cleaning, disinfecting and sterilizing system.
The exterior surfaces of the system may be cleaned with a clean and soft cloth,
sponge or cotton ball, dampened with a non-erosive cleaning solution. Drying off
excess cleaning solution before cleaning the system is recommended. Following are
examples of cleaning solutions:
Diluted soap water
Diluted ammonia water, diluted sodium hyoichlo (bleaching agent)
Hydrogen peroxide (3%)
Ethanol, Isopropanol.
NOTE
z The above-recommended reagents are for general cleaning only. We
make no guarantee of its effectiveness for use as a means to control
contagious diseases.
To avoid damage to the system, follow these rules:
ALWAYS dilute the solutions according to the manufacturer’s suggestions;
ALWAYS wipe off all the cleaning solution with a dry cloth after cleaning;
NEVER SUBMERGE the system into water or any cleaning solution, or
POUR or SPRAY water or any cleaning solution on the system;
NEVER permit fluid run into the casing, switches, connectors, or any
ventilation openings in the system;
NEVER use abrasive materials (such as steel wool or silverpolish) and strong
solutions such as acetone and acetone–based cleaners.
Installation and Maintenance
3-10
CAUTION
z Failure to follow these rules may melt, distort, or dull the finish of the
case, blur lettering on the labels, or cause system failures
NOTE
z Consult relevant instructions before cleaning the accessories.
Installation and Maintenance
3-11
3.2.3 Disinfection and Sterilization
WARNING
z Disinfection or sterilization may cause damage to the system; therefore,
when preparing to disinfect or sterilize the system, consult your
hospital’s infection controllers or professionals.
Sterilization or disinfection may cause damage to the transmitter and receiver. We
recommend that you sterilize and disinfect them only when necessary as determined
by your hospital’s policy. We also recommend that the products being sterilized and
disinfected be cleaned first
Use these recommended disinfecting agents are alcohol based (ethanol 70%,
isopropanol 70%) or aldehyde based materials.
CAUTION
z ALWAYS dilute the solutions according to the manufacturer’s
suggestions or use the lowest possible concentration.
z NEVER pour liquid onto the system and its accessories during cleaning,
or NEVER submerge any part of the system.
z NEVER allow any disinfecting agent to remain on the surfaces of the
system and its accessories—wipe it off immediately with a dry cloth.
z NEVER use EtO or formaldehyde disinfecting agents.
z NEVER use the autoclave method or high-temperature disinfection of the
system and its accessories.
Installation and Maintenance
3-12
FOR YOUR NOTES
4-1
4 Using Transmitters
4.1 Installing and replacing batteries................................................................. 4-2
4.2 Switching on/off the transmitter.................................................................. 4-3
4.3 Wearing the transmitter ............................................................................... 4-3
Using Transmitters
4-2
4.1 Installing and replacing batteries
The transmitter is powered by two AA batteries. To install the batteries:
1. Pull the battery door backwards until it clicks. Then lift the door to expose the
battery compartment.
2. Follow the marked polarities to install two AA batteries.
3. Lower the battery door and push it forward until it clicks.
4. The transmitter will beep a moment later and the LED will be lit (first green
and then red).
WARNING
z Do not use batteries with physical damages.
z Follow governmental requirements to dispose of batteries. Do not
disassemble, burn or short circuit the batteries.
NOTE
z When the CMS give alarms for low battery energy, install new batteries in
time. Keeping using the old batteries may result in repeated re-start of
the transmitter.
Using Transmitters
4-3
4.2 Switching on/off the transmitter
Controlled by the software, the transmitter can be switched on/off automatically.
When the batteries are installed, the transmitter runs a self test and gives one beep.
The LED is illuminated green and red alternatively and then extinguished. Now the
transmitter is ready for use.
If all ECG leads are off and the SpO2 module is not connected, the transmiiter will
be automaticcly shut down after 10 minutes. In such state, the transmitter sends no
data and the battery life can be as long as over 10 days.
To return to normal operating state, you can do any of the following:
Connect any ECG lead
Insert the SpO2 module
Press any key
Reinstall the batteries
Be sure to remove the batteries if the transmitter is not to be used for a long time.
4.3 Wearing the transmitter
You can wear the transmitter using either a rope or a non-fabric cloth bag.
To use the rope, make sure the rope can bear a continuous pulling force of 1
Kg.
To use the non-fabric cloth bag, be sure to tie the bag to your body. Movement
of the bag may result in lost connection of the ECG cable.
Be sure to disinfect the bag timely and adequately. A bag shall not be repeatly used
for too many times.
Using Transmitters
4-4
FOR YOUR NOTES
5-1
5 Routine CMS Operation
5.1 Nurse call .................................................................................................... 5-2
5.2 Event ........................................................................................................... 5-2
5.3 STANDBY mode ........................................................................................ 5-2
5.4 Patient Management.................................................................................... 5-3
5.4.1 Admitting a Patient........................................................................ 5-3
5.4.2 Editing patient information ........................................................... 5-4
5.4.3 Discharging a Patient..................................................................... 5-5
5.5 Alarm Setup ................................................................................................ 5-6
5.5.1 Alarm Setup .................................................................................. 5-6
5.5.2 Alarm Volume ............................................................................... 5-7
5.5.3 Pause alarm ................................................................................... 5-8
5.5.4 Alarm Latching ............................................................................. 5-8
5.5.5 Turning off alarm sound................................................................ 5-9
5.6 Review ...................................................................................................... 5-10
5.7 Record ....................................................................................................... 5-14
5.8 Print........................................................................................................... 5-15
Routine CMS Operation
5-2
5.1 Nurse call
The CMS shows graphic nurse call acknowledge buttons for individual patients. The
Nurse Call Acknowledge Button is: “ ”
Once the “Nurse Call” button has been pressed, the icon will flash and the
system will ring for a certain period.
If you click on the icon, it will be cleared and the ring will be interrupted.
If the “Nurse Call” option at the “Alarm Setup” screen has been activated, the
current call will be recorded by the recorder.
Besides, this call will be stored in the “Alarm Review”. For details about
alarm review, refer to the central monitoring system’s Operation Manual.
5.2 Event
The CMS shows graphic Event Buttons for individual patients. The Event Button is
“”
Once the “Event Button” has been pressed, the icon will flash and the system
will sound a ring.
If you click on the icon, it will be cleared.
If the “Event” option at the “Alarm Setup” screen has been activated, the
current call will be recorded by the recorder.
Besides, the event will be stored in the “Alarm Review”. For details about
alarm review, refer to the central monitoring system’s Operation Manual.
5.3 STANDBY mode
In case you want to replace the electrode, replace the batteries, or stop monitoring a
patient for a moment, you may switch the transmitter to the STANDBY mode to
avoid false alarms.
The central monitoring system provides independent STANDBY mode for each
monitor. In the STANDBY mode, all the received patient information will still be
saved and once you have exited the STANDBY mode, you can continue monitoring
the patient without re-admitting the patient.
Routine CMS Operation
5-3
In the STANDBY mode, no waveforms or data will be dsiplayed, analyzed, stored or
recorded and all the audio/visual alarms will be paused. The screen will only display
the nurse call icon, event icon, battery indicator and signal strength indicator. The
waveform area will display “STANDBY”.
To enter the STANDBY mode, click on below the patient window, or click on
at the viewbed screen. Repeat the step to exit the STANDBY mode.
5.4 Patient Management
5.4.1 Admitting a Patient
If a transmitter is powered on but its patient is not list in the connected patient list of
the CMS, you can admit the patient by following these steps:
1. Click on the “Admit Patient” button. The following “Connected patient”list will
be displayed.。
Figure 5-1 Admitting patients
2. Select the connection record corresponding to that transmitter;
3. Input the office, bed number, medical ID and name of that patient into the
“Patient Info” area at the right side. You can input more patient information by
dragging the vertical scroll bar;
4. Click on the “Admit Patient” button;
5. After the patient has been admitted, the corresponding record will turn gray.
Routine CMS Operation
5-4
5.4.2 Editing patient information
1. Enter the “Patient Management” tab sheet;
To enter the “Patient Management” tab sheet, you can click in the patient window
for a spot patient or on the block in the non-spot patient window for a non-spot
patient, and then select the “Patient Management” tab from the multiple tabs as
shown below.
Figure 5-2 Editing patient information
2. In this tab sheet, you can modify such information:
Office: Office where the patient receives treatment;
Bed NO: Patient bed number;
Medical ID: Patient medical ID;
Name: Patient name;
Gender: Patient gender (available options: MALE and FEMALE);
Patient Type: Patient type (available options: ADU, PED and NEO);
Birthday: Date of birth (selected from the drop-down timetable);
Admit Date: Date when the patient is hospitalized;
PACE: Pace (available options: ON and OFF);
Address: Patient address;
Postcode: Patient address’s post code;
TEL: Patient’s phone number;
Height: Patient height;
Weight: Patient weight;
Blood Type: Patient blood type (available options: A, B, AB, O and NA.
NA represents unknown);
BSA: Body surface area (automatically calculated by the system);
Doctor Name: Name of the doctor.
3. Click on the “Modify” button after modifying the patient information.
Routine CMS Operation
5-5
5.4.3 Discharging a Patient
Discharging a patient is to terminate monitoring a patient before admitting a new
patient. You can discharge a patient from the CMS by following these steps:
1. Enter the “Patient Management” tab sheet;
To enter the Patient Management tab sheet, you can click in the patient window for a
spot patient or on the block in the non-spot patient window for a non-spot patient,
and then select the “Patient Management” tab from the multiple tabs as shown
below.
Figure 5-3 Discharging patients
2. Click on the “Discharge” button. The following dialog box will be displayed;
Figure 5-4 Discharge patients
3. Select either Data Items and Data to be saved or Discharge Without Saving
Data;
4. Click on the “Continue Discharging” button. The system will automatically
perform each step shown in the figure below:
Routine CMS Operation
5-6
Figure 5-5 Discharging patients
5.5 Alarm Setup
5.5.1 Alarm Setup
Clicking on the button in the ViewBed screen will enter the “Alarm Setup” tab
sheet, in which you can set the parameter alarms and arrhythmia alarms.
Figure 5-6 Alarm Setup screen
Take the HR as an example, you can use the keyboard to modify its alarm high/low
limits after clicking on ALM HI or ALM LO, as well as use the mouse to make a
selection after clicking on Alarm Level, Alarm On or Record On-Off.
Besides, you can view Alarm High Limit Max/Min as well as Alarm Low Limit
Max/Min by dragging the horizontal scroll bar. These values are factory-defaulted
values and cannot be modified by the users. Take the HR as an example, its alarm
high limit set by the users must be within the minimum and maximum alarm high
limits.
Routine CMS Operation
5-7
5.5.2 Alarm Volume
By clicking on “System Setup” then “General Setup”, you can enter the following
tab sheet. The CMS provides 10 volumes. You can drag the Volume Control key to
your desired volume. While dragging the Volume Control key, the volume
corresponding to the key location will be displayed below.
Figure 5-7 Alarm volume
In the figure above, you can enable or disable silencing alarms by ticking the
“Silence check” box.
Indicates that silencing alarms is disabled;
Indicates that silencing alarms is enabled;
NOTE
z In the silenced status, the system will give the “Alarms Silenced”
message, and the icon will appear on the main screen. If a new
alarm occurs, the alarms silenced status will be automatically released.
Volume
control
key
Routine CMS Operation
5-8
5.5.3 Pause alarm
To pause alarms, click on below the patient widow and then select “Pause
Alarm”, or click on at the viewbed screen to pause all alarms for 2 minutes.
When the alarms are paused:
The sound icon will appear .
All audio alarms will be silenced. No alarm will be responded or saved.
The remaining alarm pause time will be displayed in the physiological alarm
area.
When the pause times out, all alarms will be reactivated. You can also click on the
“Pause Alarm” icon to reactivate the alarms.
5.5.4 Alarm Latching
You can select the alarm latching function when it is necessary to make the alarm
information of a specific patinent remain on the screen. Click the patient window or
the ECG parameter area in the viewbed window to enter the “Parameter Setup”
screen. Then you can enable or disable the alarm latching function through the
checkbox before “Alarm Latching”.
Enable alarm latching. The system provides the alarm latching
function.
Disable alarm latching. The system fails to provide the alarm
latching function.
When the alarm latching function is enabled, if an alarm occurs, the alarm area
displays the alarm event and the time when the alarm occurs simultaneously. In the
case of multiple alarm events, the alarm information will be displayed circularly.
You can also put the mouse inside the alarm area to display all alarm in a list.
Note
z When “Alarm Pause” is selected, the information of larm latching will be
disabled automatically.
z When alarm latching is enabled, up to 64 alarm events can be displayed
in time order. If there are over 64 alarm events, only the latest 64 alarm
events are displayed. You can view all alarm events on the alarm review
screen.
Routine CMS Operation
5-9
5.5.5 Turning off alarm sound
You can totally turn off the alarm sound as needed. At the “General Setup” screen,
click on “User Setup”. Enter the password as prompted by the message box that
pops up on the screen and then click on “OK” to enter the “User Setup” screen.
Figure 5-8 User setup - Alarm
Click on the “Alarm” tab and then tick the “Audio alm off” check box to turn off the
alarm sound.
: Alarm sound turned on；
: Alarm sound turned off.
In the Audio alarm off status, the sound icon . will appear The CMS will turn off
all the alarm sounds only without affecting other alarm manifestations or other
sounds.
To resume the alarm sound, you can also click on the icon to enter the volume
setup screen and then resume the alarm sound from there.
Routine CMS Operation
5-10
NOTE
z Pay attention to the icon. When it appears, it means the alarm sound
has been totally turned off. Be careful with this function.
z All the alarm sounds will be resumed after re-boot of the CMS.
5.6 Review
You can review the dynamic short trends, waveforms, trends and alarms of a
currently monitored patient from the CMS.
Dynamic Short Trend
Clicking on the button in the ViewBed screen will show graphic short trends
for each parameter module. The figure below shows the short trends of HR and
SpO2, whose colors and order are subject to their respective parameter modules.
Figure 5-9 Dynamic Short Trend
Routine CMS Operation
5-11
Waveform Review
Clicking on the “Wave Review” tab will enter the following tab sheet, through
which you can view up to 72 hours of full-disclosure waveforms. Before reviewing
waveforms, you have to select the waveforms to be saved in the “Display Setup”
screen. Click “Waveform Saving” to enter the waveform saving screen. Select the
desired waveform and then exit. For details, refer to the central monitoring system’s
Operation Manual.
1. Waveform area 2. Parameter area 3. Current time 4. Caliper 5. Time bar
Figure 5-10 Wave Review Tab Sheet
Note
z Select the waveform to be saved on the “Display Setup” screen before
performing waveform review. Otherwise, waveform review is disabled.
1 2 5
3 4
Routine CMS Operation
5-12
Trend Review
Clicking on the “Trend Review” tab will enter the following tab sheet, through
which you can store and review up to 240 hours of trend data. Change of trends can
be observed through the trend graph and trend table. You can switch between the
trend table and trend graph by simply clicking on their buttons.
Figure 5-11 Trend Graph
Figure 5-12 Trend Table
Parameter
Routine CMS Operation
5-13
Alarm Review
Clicking on the “Alarm Review” tab will enter the following tab sheet, through
which you can view all alarm parameters and waveforms of a patient.
1 Alarm list 2 Alarm parameter area 3 Alarm waveform area
Figure 5-13 Alarm Review Tab Sheet
1. Alarm list: displays alarm status (locked or not), time, message, level, and
description;
2. Alarm parameter area: displays all parameter values for each alarm time;
3. Alarm waveform area: displays relevant parameters’ waveforms within ±8
seconds around the alarm time;
Select an alarm from the Alarm list, and you will view its corresponding parameter
values and waveforms in the Alarm parameter area and Alarm waveform area.
1 2 3
Routine CMS Operation
5-14
5.7 Record
The CMS can be equipped with a thermal recorder which, with a separate power
supply, is connected with the host of the CMS via the general interface.
The CMS can print out the following information through the recorder:
Recording Patient Information
1. Enter the “Patient Mgt” tab sheet;
2. Make sure that the patient information is correct;
3. Click on the “Record” button. The patient information will be printed out
through the recorder.
Recording Waveforms
1. Enter the “Wave Review” tab sheet;
2. Click on the “Record” button;
3. Select a maximum of 2 waveforms, waveform speed and grid from the pop-up
dialog box;
4. Select “OK”. The selected waveforms will be printed out through the recorder.
Recording Alarms
1. Enter the “Alarm Review” tab sheet;
2. Select an alarm from the alarm list;
3. Click on the “Record” button. From the pop-up dialog box, you can select a
maximum of 2 waveforms and grid;
4. Select “OK”. The selected waveforms will be printed out through the recorder.
Recording Real-time Waveforms
1. Enter the “ViewBed” tab sheet;
2. Click on the Record icon at the upper right corner;
3. Select a maximum of 2 waveforms, record time, waveform speed and grid from
the pop-up dialog box;
4. Click on “OK”. The selected waveforms will be printed out through the
recorder.
Recording Real-time Alarms
If a parameter generates an alarm when its alarm switch is set to “ON”, the central
monitoring system will automatically initiate a real-time alarm recording.
Routine CMS Operation
5-15
5.8 Print
For printing reports, the CMS can be equipped with a laser printer, which with a
separate power supply, is connected to the CMS via the general interface. For
instructions about the printer, refer to the accompanying documents provided with
the printer.
Printing Patient Information
1. Enter the “Patient Mgt” tab sheet;
2. Make sure if the patient information is correct. If not, click on the “Modify”
button to correct them;
3. Click the icon on the “Print” button and select “Print Setup” to complete
print setups as prompted;
4. Click the icon on the “Print” button and select “Print Preview” to preview
the printout;
5. Click on the “Print” button.
Printing Trend Graph or Trend Table
1. Enter the “Trend Review” tab sheet;
2. Set the resolution and start time;
3. Click the icon on the “Print” button and select “Print Setup” to complete
print setups as prompted;
4. Click the icon on the “Print” button and select “Print Preview” to preview
the printout;
5. Click on the “Print” button.
Printing Waveforms
1. Enter the “Wave Review” tab sheet;
2. Select the current review time;
3. Click the icon on the “Print” button and select “Print Setup” to complete
print setups as prompted;
4. Click the icon on the “Print” button and select “Print Preview” to preview
the printout;
5. Click on the “Print” button.
Routine CMS Operation
5-16
Printing Alarms
1. Enter the “Alarm Review” tab sheet;
2. Select an alarm from the alarm list;
3. Click the icon on the “Print” button and select “Print Setup” to complete
print setups as prompted;
4. Click the icon on the “Print” button and select “Print Preview” to preview
the printout;
5. Click on the “Print” button.
6-1
6 ECG Monitoring
6.1 Preparation .................................................................................................. 6-2
6.2 Electrode Placement.................................................................................... 6-3
6.3 ECG Monitoring.......................................................................................... 6-8
6.3.1 ECG waveform.............................................................................. 6-8
6.3.2 ECG parameter.............................................................................. 6-9
6.3.3 ECG Setup................................................................................... 6-10
6.3.4 ECG lead type ..............................................................................6-11
6.3.5 ECG Primary and Secondary Leads............................................ 6-12
6.3.6 Waveform display settings .......................................................... 6-12
6.3.7 Filter mode .................................................................................. 6-12
6.3.8 Pace Pulse detection .................................................................... 6-13
6.3.9 HR alarm ..................................................................................... 6-13
6.4 ST Analysis ............................................................................................... 6-14
6.4.1 General ........................................................................................ 6-14
6.4.2 ST setup....................................................................................... 6-15
6.4.3 ST measurement points ............................................................... 6-16
6.5 Arrhythmia Analysis ................................................................................. 6-17
6.5.1 Overview..................................................................................... 6-17
6.5.2 Arrhythmia analysis setup........................................................... 6-18
6.5.3 Arrhythmia alarm setup............................................................... 6-19
6.5.4 Arrhythmia alarm review ............................................................ 6-20
6.5.5 Arrhythmia relearn ...................................................................... 6-21
6.5.6 Arrhythmia troubleshooting ........................................................ 6-22
6.6 Maintenance and Cleaning........................................................................ 6-22
ECG Monitoring
6-2
6.1 Preparation
1. Skin preparation
The quality of ECG information displayed on the monitor is a direct result of the
quality of the electrical signal received at the electrode. Proper skin preparation is
necessary for good signal quality at the electrode. A good signal at the electrode
provides the monitor with valid information for processing the ECG data. Choose
flat, non-muscular areas to place electrodes. Following is a suggested guideline for
skin preparation:
Shave hair from sites, if necessary.
Gently rub skin surfaces at sites to remove dead skin cells
Wash sites with soap and water (never use ether or pure alcohol, because this
increases skin resistance).
Dry the skin completely before applying the electrodes.
2. Attach the ECG lead to the electrodes prior to placement;
3. Place the electrodes on the patient. Use electrode gel prior to placement only if
pre-gelled electrodes are not used
4. Make sure the monitor is turned on and is ready for monitoring.
ECG Monitoring
6-3
6.2 Electrode Placement
WARNING
z Use only the specified ECG cable for monitoring.
z When applying electrodes or connecting cables, make sure they are not
connected to any conductive part or the ground. Verify that all ECG
electrodes, including neutral electrodes, are securely attached to the
patient.
z Skin irritation may result from the continuous application of the ECG
electrodes. These should be checked each day. If there is an indication
of excess skin irritation, replace the electrodes or change the location of
the electrodes every 24 hours.
z Do not touch the patient, bed or instrument during defibrillation.
WARNING
z Interference from a non-grounded instrument near the patient and ESU
interference can cause inaccuracy of the ECG waveform.
z Always dispose of, or recycle electrodes properly to prevent from
environment contamination.
z Verify the lead fault detection prior to the start of monitoring. Unplug the
ECG cable from the ECG connector and the screen should display the
error message “ECG LEAD OFF” and an audible alarm should be
activated.
5-Leadwire Electrode Placement
Following is the configuration per the American standard (AHA) when using five
leadwires:
RA (right arm) electrode — directly below the clavicle and near the right
shoulder;
LA (left arm) electrode — directly below the clavicle and near the left
shoulder;
RL (right leg) electrode — on the right lower abdomen;
LL (left leg) electrode — on the left lower abdomen;
V (precordial) electrode — on the chest.
ECG Monitoring
6-4
Figure 6-1 5-lead electrode placement
For a 5-lead configuration, place the V electrode at one of the locations shown in
Figure 6-2.
V1: On the 4th intercostal space at the right sternal border;
V2: On the 4th intercostal space at the left sternal border;
V3: Midway between V2 and V4 electrodes;
V4: On the 5th intercostal space at the mid-clavicular line;
V5:On the left anterior axillary line, horizontal with V4;
V6: On the left mid-axillary line, horizontal with V4;
V3R-V6R: On the right side of the chest in positions corresponding to those
on the left;
VE: Over the xiphoid process;
ECG Monitoring
6-5
For posterior V electrode placement, place the V electrode at one of the following
locations
V7: On posterior chest at the left posterior axillary line in the fifth intercostal
space;
V7R: On posterior chest at the right posterior axillary line in the fifth
intercostal space.
Figure 6-2 V Electrode placement
The chart below shows the label used to identify each leadwire. Included also is its
associated color code per American (AHA) and European (IEC) standards.
American Standard European Standard
Label Color Label Color
RA White R Red
LA Black L Yellow
LL Red F Green
RL Green N Black
V Brown C White
ECG Monitoring
6-6
Electrode Placement with a 3-Lead Set
Following is the configuration per the European standard when using three
leadwires:
R (right arm) electrode — directly below the clavicle and near the right
shoulder;
L (left arm) electrode — directly below the clavicle and near the left
shoulder;
F (left leg) electrode — on the left lower abdomen.
Figure 6-3 Electrode placement
The chart below shows the label used to identify each leadwire. Included also is its
associated color code per American (AHA) and European (IEC) standards.
ECG Monitoring
6-7
Characteristics of a Good Signal
As shown in Figure 6-4, the normal QRS complex should exhibit the following
characteristics.
Tall and narrow with no notches.
R-wave should be tall, completely above or below the baseline.
Pacer pulses should be smaller than the R-wave height.
T-wave should be less that 1/3 of the R-wave height.
P-wave should be much smaller than the T-wave.
Figure 6-4 Standard ECG waveform
To display a 1-millivolt calibration pulse on the ECG wave, re-install the transmitter
batteries and then the transmitter will automatically generate the square waveforms
for calibration.
NOTE
z To obtain accurate calibrate waveform, set the filter mode to EXTEND.
See 6.3.7 Filter mode for more information regarding the filter mode.
z When calibrating the system, do not count the overshoot on the
waveform edge.
ECG Monitoring
6-8
6.3 ECG Monitoring
6.3.1 ECG waveform
1 2 3 4
Figure 6-5 ECG waveform area
1. Channel lead
2. Channel 1 gain
3. Channel 1 operation mode
4. Channel 1 ruler
5. Channel 1 display area
6. Channel 2 display area
7. Channel 3 display area.
5
6
7
ECG Monitoring
6-9
6.3.2 ECG parameter
Figure 6-6 ECG parameter area
1. Heart rate (HR)
2. Upper limit of HR
3. Lower limit of HR
4. PACE indicator
5. STII indicator
6. STI indicator
7. PVC indicator
8. ST alarm indicator
9. PVC alarm indicator
1
2
3
4
5
6
7
8
9
ECG Monitoring
6-10
6.3.3 ECG Setup
Click on the “ECG” tab of the viewbed window to enter the “Para Setup” screen.
Figure 6-7 ECG Setup screen
Click on the “Other Setup…” button to enter the “Other Setup” screen.
Figure 6-8 Other Setup screen
ECG Monitoring
6-11
6.3.4 ECG lead type
The system can automatically recognize the connected ECG cable and the central
monitoring system can display the type accordingly.
When a 3 leadwire cable is connected, the central monitoring system will display the
waveform of lead II.
When a 5 leadwire cable is connected, the central monitoring system will display the
waveforms of leads II, I and V by default. To view the waveform of leads III, aVR,
aVL and aVF, click on to switch to the 7 lead display mode, as the figure below
shows.
Figure 6-9 7-lead display mode
To exit the 7 lead display mode, click on again.
The leads are displayed in a fixed manner, which cannot be adjusted by the user. See
the table below for details.
ECG cable ECG channel ST analysis Collecting lead Calculating lead
3 leadwire ECG Channel 1 STII II －
ECG Channel 1 STII II
ECG Channel2 STI I
5 leadwire
ECG Channel3 － V
III, aVR, aVL,
aVF
ECG Monitoring
6-12
6.3.5 ECG Primary and Secondary Leads
The system uses ECG primary and secondary leads to calculate heart rate and to
analyze & detect arrhythmia. Secondary lead is set only when the transmitter is
configured with 5-lead measurement. Setting a secondary lead decides which
additional lead is used for arrhythmia analysis.
Choose the primary and secondary leads featuring the following:
The QRS complex is completely above or below the baseline instead of
biphase.
The QRS complex is tall and narrow.
Both P wave and T wave are less than 0.2 mV.
To select a lead for primpary or secondary one, enter the ECG parameter setup
screen and choose the appropriate lead in the “Primary Lad” and “Secondary Lead”
options.
If you are using 3-lead system, the primary lead is II and the secondary lead null by
default. You can not make changes to them.
If you are using 5-lead system, the primary lead is II and the secondary lead I by
default. You can make changes to them when necessary.
6.3.6 Waveform display settings
At the “Other Setup”screen, you can set the sweep speed and gain of the displayed
waveforms.
The system provides two sweep speeds 12.5mm/s and 25mm/s. In the 7 lead display
mode, the sweep speed is fixed to 25mm/s.
The system provides 4 gains for the ECG waveforms, ×0.25 (2.5mm/mV), ×0.5
(5mm/mV), ×1 (10mm/sV), ×2 (20mm/mV). If you want to view the details of the
displayed waveforms, select a large gain; if you find incomplete waveform, select a
small gain.
6.3.7 Filter mode
The system provides 3 filter modes EXTEND, MONITOR (default) and SURGERY.
You can select the desired filter mode at the “Others” window of the “Parameter
Setup” screen. The selected filter mode applies to all channels.
You should select the filter mode according to your own needs.
Patient movement will disturb the waveform signals. To obtain a stable and clear
ECG Monitoring
6-13
waveform, you can select the MONITOR or SURGERY mode. However, certain
significant diagnostic information may be lost during the filtering process.
For ST analysis, you should select the EXTEND to obtain a better low-frequency
response and more accurate ST analysis results.
6.3.8 Pace Pulse detection
You should activate the PACE detection function when monitoring a patient wearing
a pace-maker.
The pace pulse detection function is deactivated by default.
Click on the “Patient Mgt” tab to enter the “Patient Mgt” screen, select “ON” or
“OFF” and then click on “Modify” to activate or deactivate pace detection.
A pace pulse, when detected, is indicated by “︱” above the ECG waveform.
WARNING
z Certain pace pulses are hard to reject and those pulses may be counted
as QRS complex, hence leading to wrong HR readings or failure to
diagnose certain arrhythmia symptoms. Be sure to keep a close eye on
the patient wearing a pace-maker.
NOTE
z When PACE is set to ON, the system does not detect PVC-related
arrhythmia (including PVCs) resulting from pacemaker but still analyzes
the normal QRS complex.
z When the patient is not wearing a pacemaker, set PACE to OFF.
z When PACE is set to ON, missed beat (MIS) alarm is reported as pacer
not captured (PNC) or pacer not paced (PNP).
6.3.9 HR alarm
In the HR area of the “ECG Para Setup”screen, you can set alarm switch, alarm
level, alarm limits, etc.
ECG Monitoring
6-14
6.4 ST Analysis
6.4.1 General
ST analysis is deactivated by default.
When ST analysis is activated, the system will automatically select the
EXTEND filter mode.
You can set the monitor to MONITOR or SURGERY mode. However, the ST
numerics might be severely distorted in these modes.
ST analysis can be conducted by measuring the rising or falling part of the ST
segment. The ST numerics are displayed in STII and STI parameter areas.
ST-II indicates the result of ST analysis of lead II and ST-I that of lead I.
You can view the trend graph and data of the ST analysis through the review
function.
ST measurement unit: mV (milivolt).
ST numeric: positive numeric means rising and negative numeric means
falling.
ST measurement range: -2.0 mV to +2.0 mV.
NOTE
z When ST segment monitoring is activated, the filter mode is set to
EXTEND automatically to obtain effective low-frequency response, so as
to ensure the accuracy of ST segment measurement.
ECG Monitoring
6-15
6.4.2 ST setup
In the ST Analysis area of the “Para Setup”screen, you can adjust settings related to
ST analysis. Be sure to select “ON” for the “ST Analysis” option.
Figure 6-10 ST setup screen
ECG Monitoring
6-16
6.4.3 ST measurement points
Selecting “Define ST Point >>” opens the following window.
Figure 6-11 Defining ST points
As shown above, the “Define ST Point” window shows the QRS complex template.
Two vertical lines indicate the positions of the ISO and ST points.
ISO: It is the base point, used to indicate the baseline point of the ST analysis.
ST: It is the ST measurement point.
The two measurement points, ISO and ST, should be adjusted if the patient’s HR or
ECG morphology changes significantly. You can select the ISO or the ST option in
the window and then rotate the control knob to adjust its position.
Figure 6-12 ST measurement point
As shown above, the peak of the R wave is the reference point for ST measurement.
R wave
Pwave T wave
ISO ST measurement point
ST value
ECG Monitoring
6-17
The ST measurement value for a beat complex is equal to the vertical difference
between the two measurement points.
NOTE
z Abnormal QRS complex is not considered in ST analysis.
6.5 Arrhythmia Analysis
6.5.1 Overview
In clinical application, arrhythmia analysis is used to:
Detect the change of heart rate and premature ventricular beat.
Store the arrhythmia events and the alarm information generated.
The medical professionals can use the arrhythmia analysis to evaluate patients’
condition (such as heart rate, PVCs frequency, rhythm and ectopic beat) and give
proper treatment.
The arrhythmia analysis of the system has the following characteristics:
Up to 14 types of arrhythmia analysis.
Applicable to the monitoring of either a patient with a pacemaker or without.
Activated by default.
Capability of raising the doctor’s attention to the patient’s heart rate, by
measuring and classifying the arrhythmia and the abnormal heartbeat and
triggering the alarm.
ECG Monitoring
6-18
6.5.2 Arrhythmia analysis setup
On the parameter setup screen, you can set arrhythmia analysis and PVC alarm. For
arrhythmia analysis, you must first set “ARR Analysis” to “ON”.
Dual lead analysis mode is used for arrhythmia analysis. You can set the channel for
arrhythmia anlysis on the parameter setup screen. For details, refer to 6.3.5 ECG
Primary and Secondary Leads.
Figure 6-135 ARR analysis setting
ECG Monitoring
6-19
6.5.3 Arrhythmia alarm setup
On the “Alarm Setup” screen, select “ARR Alarm Setup” to enter the screen as
shown below:
Figure 6-146 ARR alarm setup
NOTE
z In default status, the ASYSTOLE, VFIB/VTAC and Ventricular RUN alarms
are ON, while other ARR alarms are OFF.
On the ARR alarm setup screen, you can change alarm level, alarm on-off, record
on-off. When it is necessary to change the alarm threshold, you can make the
relevant settings on the ARR alarm threshold setup screen. Click the ARR alarm
limit setting scrren to pop up the following screen:
Figure 6-1 ARR alarm limit setup
ECG Monitoring
6-20
You can adjust the alarm thresholds and click QUIT after making changes. If the
input threshold exceeds the alarm range, the prompt “XX exceeds the alarm range.
Please input again” displays.
6.5.4 Arrhythmia alarm review
You can view the arrhythmia alarm information on the alarm review screen. On the
auxiliary screen, click the alarm revirew tab sheet to open an alarm review window.
Then you can review all alarm parameters and waveforms of the patient.
By selecting arrhythmia for alarm type and all levels for alarm level, you can view
the arrhythmia alarm information of the patient.
ECG Monitoring
6-21
6.5.5 Arrhythmia relearn
The arrhythmia algorithm generates arrhythmia template through relearning.
To view the arrhythmia waveform template, click the arrhythmia relearn button on
the ECG parameter setup screen to enter the following window:
Figure 6-2 ARR relearn
To start arrhythmia relearn manually, click the arrhythmia relearn button on the
parameter setup screen. During the relarning process, the ECG parameter area
displays “ARR learning”, which disappears automatically when the learning finishes.
The arrhythmia waveform template screen is refreshed.
Arrhythmia relearn is activated automatically if:
ECG monitoring is switched on.
The HR calculation channel is changed manually.
Patient category is changed
Lead off ends.
NOTE
z Arrhythmia relearn can be activated only when the primary lead is
normal and the ECG waveform is of good quality.
z Arrhythmia relearn can be activated automatically under certain
circumstances.
.
ECG Monitoring
6-22
6.5.6 Arrhythmia troubleshooting
In the case of false heart rate, cardiac arrest, and ventricular fibrillation, do the
following to troubleshoot the problems:
Check the site where the electrode is placed.
Check whether the patient skin is well prepared.
Check the amplitude of the ECG signal. If the signal amplitude is too low,
replace the electrode or adjust the position to place the electrode.
View the arrhythmia relearn template and start an arrhythmia relearn process
if necessary.
6.6 Maintenance and Cleaning
WARNING
z Before cleaning the ECG cable, be sure to disconnect the monitor from
the ECG cable, or shut down the system and disconnect all power cords
from the outlet.
z If the ECG cable is damaged or aged, replace with a new one.
Cleaning
The exterior surfaces of the ECG cable may be cleaned with a soft cloth, dampened
with the alcohol, and then be air-dried or dried with a clean dry cloth.
Disinfection
Disinfection may cause damage to the system. We recommend the disinfection be
contained in the hospital’s servicing schedule only when necessary. The system
should be cleaned prior to disinfection.
7-1
7 SpO2 Monitoring
7.1 Principle of SpO2 Measurement.................................................................. 7-2
7.2 Monitoring Procedure ................................................................................. 7-2
7.3 SpO2 Measurement...................................................................................... 7-3
7.3.1 SpO2 parameter area...................................................................... 7-3
7.3.2 SpO2 Setup .................................................................................... 7-4
7.4 Measurement Limitations............................................................................ 7-5
7.5 Warnings ..................................................................................................... 7-6
SpO2 Monitoring
7-2
7.1 Principle of SpO2 Measurement
SpO2 monitoring is a non-invasive technique used to measure the amount of
oxygenated haemoglobin and pulse rate by measuring the absorption of selected
wavelengths of light. The light generated in the probe passes through the tissue and
is converted into electrical signals by the photodetector in the probe. The SpO2
module processes the electrical signal and displays on the screen digital values for
SpO2 and pulse rate.
7.2 Monitoring Procedure
Follow the procedure as below:
1. Power on the telemetry monitoring system.
2. Attach the sensor to the proper site on the patient.
3. Plug the connector of the sensor extension cable into the SpO2 connector on the
telemetry transmitter.
The SpO2 sensor selection and placement depend on the patient type. When
choosing a site for a sensor, refer to the directions for that sensor.
SpO2 Monitoring
7-3
7.3 SpO2 Measurement
7.3.1 SpO2 parameter area
When the sensor and cable are correctly connected, the SpO2 numeric will be
displayed to the right of the ECG waveform, as the figure below shows.
Figure 7-1 SpO2 parameter area
1. SpO2 value
2. Upper limit of the SpO2 value
3. Lower limit of the SpO2 value
4. Pulse rate
5. Upper limit of the pulse rate
6. Lower limit of the pulse rate
If the HR source is set to “SpO2” or “All”,SpO2 numeric will be displayed in the HR
area.
1 4
2
3
5
6
SpO2 Monitoring
7-4
CAUTION
z The following factor may interfere with SpO2 measurement:
z Excessive light (suggestion: cover the sensor with something
non-transparent.)
z EM interference.
z Excessive patient movement.
z Presence of such substance as Hb-CO, Met-Hb or dye dilution chemicals.
7.3.2 SpO2 Setup
Click on the parameter area of the viewbed screen to enter the parameter setup
screen. Click on “SpO2” to enter the SpO2 setup screen.
Figure 7-2 SpO2 setup screen
To obtain more alarm settings, click on “Alarm setup” at the lower left corner of the
screen.
SpO2 Monitoring
7-5
7.4 Measurement Limitations
If the SpO2 reading seems incorrect, check the patient with another method, and then
check the system and SpO2 module. The following factors may interfere with the
SpO2 measurement:
Use of inappropriate SpO2 sensor.
High-frequency interference, or interference from ESU connected to the
system;
Oximeters and oximetry sensors used during magnetic resonance imaging
(MRI) scanning. Induced current could potentially cause burns;
Intravascular dye injections;
Excessive patient movement;.
Excessive ambient light;
Improper sensor installation or incorrect sensor placement on the patient
Sensor temperature (optimal temperature is between 28°C and 42°C);
The sensor is placed on a limb that is attached to a blood pressure cuff, arterial
catheter, or intravascular line;
Concentration of dysfunctional hemoglobin such as carboxyhemoglobin and
methemoglobin;
SpO2 too low;
Poor circular perfusion of the applied part;
Shock, anemia, low temperature and application of vasomotor all reduce the
arterial blood flow and may affect the pulse oximetry measurement
The absorption of oxyhemoglobin (HbO2) and deoxyhemoglobin to the light of
special wavelength may also affect SpO2 measurement. If there exist other
substances (like carbon hemoglobin, methemoglobin, methylene blue and indigo
carmine) absorbing the light of the same wavelength, they may result in false or low
SpO2 readings.
SpO2 Monitoring
7-6
7.5 Warnings
WARNING
z The SpO2 value might be overestimated in the presence of Hb-CO,
Met-Hb or dye dilution chemicals.
z Do not use the SpO2 sensor if it’s packaging or the sensor is damaged.
Return them to the distributor or manufacturer.
z Verify sensor cable fault detection before beginning monitoring. Unplug
the SpO2 sensor cable from the connector. The screen displays the
prompt information “SpO2 SENSOR OFF” and the audible alarm is
activated.
z Do not tangle the sensor cable around the ESU cable.
z Do not place the sensor on the limb where an arterial catheter or
intravascular line is already placed.
WARNING
z Do not perform SpO2 and NIBP measurements on the same limb
simultaneously. Obstruction of blood flow during NIBP measurements
may adversely affect the reading of the SpO2 value.
z Prolonged and continuous monitoring may increase the risk of burns at
the site of the sensor. It is especially important to check the sensor
placement, and ensure proper attachment on neonates and patients of
poor perfusion or skin sensitive to light. Check the sensor location every
2 to 3 hours and move to another location if the skin deteriorates. More
frequent examinations may be required for different patients.
8-1
8 Troubleshooting
Troubleshooting
8-2
Common Technical Alarms
Alarm meesages Description Recommended action
BAT. VOLTAGE
LOW
The transmitter batteries
are about to die.
Replace the batteries.
RF No Signal The receiver has not
received valid signal in
the past 5 seconds.
Check the transmitter batteries.
Check whether the transmitter is in the
power-saving mode.
Check if the patient is out of the range.
Check if the antenna array is well
connected.
Check if the ECG cable is connected.
RF Interference The receiver has received
3 consecutive wrong
frames.
Check if the patient is at the edge of
the transmitting range; check if the
patient is in an elevator or behind a
reinforced concrete wall; check if there
is strong RF interference.
Wrong ID The received data coming
from a transmitter not
belonging to the system.
Check if there are other telemetry
monitoring system working in the area.
If so, contact the service engineer to
reconfigure the frequency.
Offline The receiver cannot be
connected to the central
monitoring system.
Check if the receiver is on.
Check if the network cable is well
connected.
ECG NOISE Noise found on the ECG
waveform.
Check if the ECG cable tangles with
the cables of other devices.
ECG SIGNAL
SATURATION
The receiver found the
ECG signal too large.
Check the electrodes of the ECG cable.
Check if the elctrodes are in good
contact with the skin.
Wrong
transmitter
button pressed.
The receiver found a
button has been pressed
for 10 seconds.
Check if the button is pressed by a
foreign object or jammed.
Transmitter
restarting
repeatedly.
The receiver batteries are
about to die.
Replace the batteries.
9-1
9 Accessories
WARNING
z Use the accessories specified in this chapter. Use of accessories other
than the specified may lower system performance or damage the
system.
Accessories
9-2
Accessories PN
3-lead AHA leadwire, snap-on 0010-20-12441
3-lead IEC leadwire, snap-on 0010-20-12442
5-lead AHA leadwire, snap-on 0010-20-12443
5-lead ICE leadwire, snap-on 0010-20-12444
Monitoring electrode (10 electrodes per pack) 0010-10-12304
Mindray SpO2 module and extension cable. 0152-30-39939
512D SpO2 Sensor (Finger Clip Sensor) 512D-30-90200
ES-3212-9/envitec (Ear Clip Sensor) 0010-10-12392
Disposable SpO2 Sensor for Adults (>30kg) 0010-10-12202
Disposable SpO2 Sensor for Pediatrics (10 - 30kg) 0010-10-12203
Disposable SpO2 Sensor for Infants (3 - 20kg) 0010-10-12204
Disposable SpO2 Sensor for Adults 0010-10-12333
Power cord (American standard) DA8K-10-14452
Power cord (English standard) DA8K-10-14453
Power cord (Indian standard) 0000-10-10903
Three-wire power cord 509B-10-05996
Transmitter bag 0152-10-39878
Network cable 0000-10-11009
Silica gel plug 0152-20-39707
10 Appendices
A. Product Specifications............................................................................... 10-2
A.1 Safety Specifications ................................................................... 10-2
A.2 Environmental Specifications...................................................... 10-2
A.3 Power Specifications ................................................................... 10-3
A.4 Hardware Specifications ............................................................. 10-4
A.5 Data Display, Recording and Saving........................................... 10-4
A.6 Alarms and Indicators ................................................................. 10-5
A.7 Wireless Transmission................................................................. 10-5
A.8 ECG Specifications ..................................................................... 10-6
A.9 SpO2 Specifications..................................................................... 10-8
B. EMC........................................................................................................ 10-10
C. Symbols and Abbreviations..................................................................... 10-15
C.1 Units .......................................................................................... 10-15
C.2 Symbols..................................................................................... 10-16
C.3 Abbreviations ............................................................................ 10-17
P/N: 0152-20-39887 (2.1)
A. Product Specifications
A.1 Safety Specifications
Type of protection against
electric shock
Transmitter: I
Receiver: Internal power source
Receiver: I
Degree of protection
against electric shock
ECG: CF (defibrillation proof)
SpO2: BF
Receiver: B
Mode of operation Continuous
Degree of protection
against hazards of ignition
of flammable anesthetic
mixtures
Not suitable
Degree of protection
against harmful ingress of
water
Transmitter: IPX3 (IEC 529)
Receiver: ordinary
A.2 Environmental Specifications
Operating temperature 0 to 40℃
Operating humidity 15 to 95%, noncondensing
Operating altitude 70.0 to 106.0kP
Storage temperature -20 to 60℃
Storage humidity 10 to 95%, noncondensing
Storage altitude 22.0 to 107.4kPa
P/N: 0152-20-39887 (2.1)
A.3 Power Specifications
Transmitter
Battery voltage range 2 to 3.4VDC
Power type Two AA size, 1.5V alkaline batteries
Switch control
modePower ON/OFF
The transmitter is switched on when the batteries are
installed.
If all ECG leads are off and the SpO2 module is not
connected for 10 minutes, the transmiiter will be
automaticcly shut down. To return to normal operating state,
you can do any of the following:
Connect any ECG lead
Insert the SpO2 module
Press any key
Reinstall the batteries
Continuous battery
operating time (typical)
ECG: 96h
ECG+SpO2 (Mindray): 36h
ECG+SpO2 (NONIN): 48h
Power-saving: 240h
Receiver
Input voltage 100 to 240 VAC (±10%)
Frequency Range 50/60 Hz (± 3 Hz)
Power Consumption <60VA
P/N: 0152-20-39887 (2.1)
A.4 HardwarePhysical Specifications
Transmitter
Size 62×96×26 mm (width×height×depth)
Weight <140g (excluding the batteries, ECG leads and SpO2
module)
Battery
compartmentButtons
Battery door installed; polarity protected. Nurse call, Event
mark
Battery compartment Attached Battery door, polarity protected
Receiver
Size 278×116×300mm (width×height×depth)
Weight <7 kg
Cooling Natural cooling by convection
Antenna connector Quantity: 2
Impedance: 50 ohm
Connector type: TNC, female
NetworkEthernet interface Protocol: IEEE 802.3
Speed: 10M/100M (self-adaptive)
Connector type: RJ45
A.5 Data Display, Recording and SavingStorage
Patient windowsMaximal
mornitoring beds
Single screen: maximum 16 windows.
Double screens: maximum 32 windows. beds
Recorder/printer Thermal recorder
WINDOWS compatible printer
Recording type Real-time recording
Timed recording
Alarm-triggered recording
Remotely triggered recording (transmitter buttons)
Waveform
savingstorage/review
72 hours for each patient (3 lead)
P/N: 0152-20-39887 (2.1)
Trend
savingstorage/review
240 hours for each patient
Event
savingstorage/review
720 events for each patient.
A.6 Alarms and Indicators
Alarms ECG, ST, ARR, SpO2, signal quality, battery energycapacity,
system failure.
Alarm type High priority, intermediatemedium priority, low priority,
error message; in compliance with EN475.
Alarm pause 2 minutes; independent for each patient.
Alarm recording Automatic
Battery indicator Graphic indicator; independent for each patient.
RF Signal strength
indicator
Independent for each patient.
Transmitter status
indicator
Operating/power-saving mode, lead-off, low-battery, button
response, transmitter failure.
A.7 Wireless Transmission
Transmitter
Operation frequency range 189 to 196MHz or 420 to 470MHz; selectable by software. 608
to 614MHz (WMTS band) , Programmable
Effective radiation
powerRF Output Power
Typical 1mW (0dBm); configurable by software. 4 mW ERP,
typical
Frequency error +/-3 PPM
Occupied Bandwidth <16 kHz
Transmitting antenna ECG cable
Receiver
ReceptionReceiver
sensitivity
-110 dbm
Covering rangeAntenna 100 m(visual distance to the antenna)Two antennae array
P/N: 0152-20-39887 (2.1)
diversity space diversity, automatic selection per signal strength
Antennae Two antennae; automatic selection per signal strength
Antenna System
RF Frequency Range
A.8 ECG Specifications
ECG
Lead type 3-lead (1 channel): II
5-lead (3 channels): I, II, III, aVR, aVF, aVL, V, 7-lead display
Lead recognition Automatic 3/5 lead recognition.
Dynamic rangeMaximum
Input
±5mV
Polarization voltage ±300mV
Input impedance >20Mohm(10Hz)
Sweep speed 12.5mm/s, 25mm/s, 50mm/s
ECG gain 2.5mm/mV, 5mm/mV, 10mm/mV, 20mm/mV
Frequency response EXTEND: 0.105 to 40Hz
MONITOR: 0.5 to 40Hz
SURGERY: 1 to 20Hz
CMRR >105dB
Input Impedance >20M (10Hz)
QRS Detection 200uV
SensitivityNoise 200uV< 30 uV p-p
Defibrillation proofGain
Accuracy
5000V/360J 5 %
Baseline recovery time Auto discharge; fast recovery.
<5 s (after defibrillation)
Defibrillation proof Meets IEC 60601-2-27, AAMI EC-13
P/N: 0152-20-39887 (2.1)
HR measurement/alarm
range
15 to 300 bpm
HR resolution 1 bpm
HR accuracy ±1 bpm or ±1%, whichever is greater.
ST analysisPacer Detection Analyzing leads: 2 leads simultaneously.
Monitoring range: -2.0 to +2.0mVAmplitude: ±10 to ±700mV
Duration: 0.1 to 2ms
Rise time: 10 to 100µs
ANSI/AAMI EC13：2002 标准符合性
Tall T-Wave Rejection When tested in accordance with the ANSI/AAMI EC13-2002
Section 4.1.2.1 c), the heart rate meter will reject all T-waves
with amplitudes less than 1.2 mV, 100 ms QRS, a T wave
duration of 180ms and a Q-T interval of 350 ms.
Heart Rate Averaging
The average Heart Rate is computed in line with the ANSI/AAMI
EC13-2002 Section 4.1.2.1 d) as follows:
The average heart rate is calculated on the basis of the mean
RR-interval of the last 16 beats, unless the heart rate calculated
using the last 4 beats is less than or equal to 48, then this rate is
used.
The displayed Heart Rate is updated once per second.
Heart Rate Meter
Accuracy and Response to
Irregular Rhythm
When tested in accordance with the ANSI/AAMI EC13-2002
Section 4.1.2.1 e), the indicated heart rate after a 20 second
stabilization period is:
Figure 3a (Ventricular Bigeminy) – 80±1 bpm
Figure 3b (Slow Alternating Ventricular Bigeminy) – 60±1 bpm
Figure 3c (Rapid Alternating Ventricular Bigeminy) –120±1 bpm
Figure 3d (Bi-directional Systoles) – 90±1 bpm
Response time to heart rate
changes
Meets the requirement of ANSI/AAMI EC13-2002: Section
Less than 11 sec for a step increase from 80 to 120 BPM
Less than 11 sec for a step decrease from 80 to 40 BPM
Response time of
tachycardia alarm
18-13
When tested in accordance with ANSI/AAMI EC13-2002 Section
4.1.2.1 g, the response time is as follows.
Figure 4ah – range:
4ad – range:
Figure 4bh – range:
4bd – range:
4.30 to 5.34 s, average: 4.75 s
3.94 to 5.92 s, average: 4.69 s
4.28 to 5.18 s, average: 4.78 s
3.57 to 8.22 s, average: 4.83 s
P/N: 0152-20-39887 (2.1)
3.09 to 4.11 s, average: 3.64 s
3.20 to 4.52 s, average: 4.09 s
Measurement range – 2.0 to +2.0 mV
– 0.8 to +0.8mV:
Beyond this range:
A.9 SpO2 Specifications
SpO2 range 0 to100%
SpO2 resolution 1%
SpO2 accuracy ± 2 70 to 100% (Adult/Pediatric)
± 3 70 to 100% (Nenoate)
0~69% not defined
SpO2 alarm limit
high limit：(low limit +1) to 100
low limit：50 to (high limit -1)
Pulse rate range 18 to 300 bpm
Pulse accuracy ±3%
Wavelength Red light to 660 nm
Ultra-red light to 905 nm
Numeric updata rate Every 1seconds for continuius Spo2 reading
PR alarm limit
high limit (low limit +2) to 300
low limit：20 to (high limit-2)
The maximum optical
output power of SpO2
sensors
Less than 18 mw.
Mindray SpO2 Specificat
A.10 Arrhythmia and ST Analysis Specifications
Arrhythmia
Arrhythmia analysis ASYSTOLE; VFIB/VTAC; PVC; COUPLET; VT>2;
BIGEMINY; TRIGEMINY; TACHY; R ON T; BRAD;
P/N: 0152-20-39887 (2.1)
MISSED BEATS, VRT, PNC; PNP.
心律失常报警 室速/室颤/室性节律固定为高级报警
其他全部心律失常种类均支持：
声光报警
用户可设置报警级别以及控制报警开关
报警事件回顾
可回顾指定的心律失常报警事件，包括波形以及所有其他所
有的参数数据。心律失常回顾波形长度 32 秒。
心律失常学习方式 自学习，手动触发学习。系统应提示学习状态。
ST
Pulse rate rangeST analysis 2Analyzing leads: 2 leads simultaneously.
ST 测量范围 Monitoring range: -2.0 to 300 bpm+2.0mV
ST 测量误差 测量误差：在-0.8mV～+0.8mV 范围内测量误差应为±
0.02mV 或±10%取大者，其他范围内不予定义。
Measurement Points Adjustable ST, PR, and J Points
Update period Updated every 16 valid beats
Wavelength
Red light to 660 nm
Ultra-red light to 910 nm
SpO2 accuracy (±1 SD) 70 to 100% ± 2 bpm (finger sensor, adult)
70 to 100% ± 4 bpm (ear sensor)
<70% not defined (all sensors)
Pulse accuracy ±3% ±1 bpm
P/N: 0152-20-39887 (2.1)
B. EMC
The system meets the requirements of IEC 60601-1-2:2001.
WARNING
z Use of accessories, transducers, and cables other than those specified
may result in increased emission and/or decreased immunity of the
system.
z Devices too close or stacked may interfere with each other. Do not put
devices too close or stack them together. Keep a close eye on the
system in case there are other devices around it.
z Devices even in compliance with CISPR transmitting requirements may
interfere with the system.
z If the input signal is lower than the specified threshold, measurements
may be inaccurate.
Guidance and declaration — electromagnetic emissions
The system is intended for use in the electromagnetic environment specified below.
The user of the system should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment — guidance
RF emissions
CISPR 11
Group 1 The system generates electromagnetic energy that
may interfere with operation of other electronic
devices nearby.
RF emissions
CISPR 11
Class B
Harmonic
Emissions
IEC61000-3-2
Class A
The system is suitable for use in all electrical
installations.
other than domestic and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
P/N: 0152-20-39887 (2.1)
Voltage
Fluctuations/Flicker
Emissions IEC
61000-3-3
Compliance
Pst ,Tdt (ms)
Dmax(%)
Dc (%)
P/N: 0152-20-39887 (2.1)
Guidance and declaration — electromagnetic immunity
The system is intended for use in the electromagnetic environment specified below.
The user of the system should assure that it is used in such an environment.
sImmunity test IEC 60601
Test level
Complianc
e level
Electromagnetic environment —
guidance
Electrostatic
Discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
Transient/burst
IEC 61000-4-4
±2 kV for power cord
±1 kV for I/O cables
Surge IEC
61000-4-5
±1 kV different mode
±2 kV common mode
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips,
Short
interruptions
and voltage
variation on
power supply
input lines IEC
61000-4-11
<5% UT
(>95% dip in UT) for 0.5 cycle
40% UT
(60% dip in UT) for 5 cycle
70% UT
(30% dip in UT) for 25 cycle
<5% UT
(>95% dip in UT) for 5 sec
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of our
product requires continued
operation during power mains
interruptions, it is recommended
that our product be powered from
an uninterruptible power supply or
a battery.
Power
frequency
(50/60 HZ)
magnetic field
IEC 61000-4-8
3 A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
Note: UT is the A.C. mains voltage prior to application of the test level.
P/N: 0152-20-39887 (2.1)
Guidance and declaration — electromagnetic immunity
The system is intended for use in the electromagnetic environment specified below.
The customer or the user of the system should assure that it is used in such an environment
Immunit
y test
IEC
60601
Test
level
Complian
ce level Electromagnetic environment — guidance
Conduce
d RF
IEC
61000-4
-6
3 Vrms
150kHz
to
80MHz
3 Vrms
Radiated
RF IEC
61000-4
-3
3 V/m
80MHz
to
2.5GHz
3V/m
Portable and mobile RF communications
equipment should be used no closer to any part
of the system, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
Pd 2.1=
Pd 2.1= 80 MHz to 800 MHz
Pd 3.2= 800 MHz to 2.5GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range b Interference may occur in the
vicinity of equipment marked with the following
symbol:
Note — At 80 MHz and 800 MHz, the higher frequency range applies.
Note — These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the system is used
exceeds the applicable RF compliance level above, the system should be observed to verify
P/N: 0152-20-39887 (2.1)
normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the system.
b Over the frequency ranges 150kHz to 80MHz, field strengths should be less than 3V/m.
Recommended separation distances between portable and mobile RF
communication and the system
The system is intended for use in an electromagnetic environment in which radiated RF
disturbance are controlled. The customer or the user of the system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communication equipment (transmitters) and the system as recommended below,
according to the maximum output power of the communication equipment.
Separation Distance According to Frequency of Transmitter
M (Meters)
Rated Maximum
Output power of
Transmitter W
(Watts)
150kHz -80MHz
Pd 2.1=
80MHz to 800MHz
Pd 2.1=
800MHz to
2.5GHz
Pd 3.2=
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.34
10 3.69 3.69 7.38
100 11.67 11.67 23.34
For transmitters at a maximum output power not listed above, the recommended separation
distanced in meters (m) can be determined using the equation applicable to the frequency of
the transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
Note — At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
Note — These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
P/N: 0152-20-39887 (2.1)
C. Symbols and Abbreviations
C.1 Units
A ampere
Ah ampere hour
bpm beats per minute
℃ centigrade
cc cubic centimeter
cm centimeter
dB decibel
DS dyne. second
℉ fahrenheit
g gram
hr hour
hPa hundred pascal
Hz hertz
inch inch
k kilo
kg kilogram
kPa kilopascal
l litre
lb pound
m meter
mg milligrams
min minute
ml milliliter
mm millimeters
ms millisecond
mV millivolt
P/N: 0152-20-39887 (2.1)
mW milliwatt
nm nanometer
ppm part per million
s second
V volt
VA volt ampere
Ω ohm
µA microampere
µm micron
µV microvolt
W watt
C.2 Symbols
- minus
% percent
/ per; divide; or
^ power
+ plus
= equal to
< less than
> greater than
≤ less than or equal to
≥ greater than or equal to
± plus or minus
× multiply
© copyright
P/N: 0152-20-39887 (2.1)
C.3 Abbreviations
AAMI Association for Advancement of Medical Instrumentation
AC alternating current
ADT adult
AHA American Heart Association
ANSI American National Standard Institute
ARR arrhythmia
ART arterial
AUX Auxiliary output
aVF left foot augmented lead
aVL left arm augmented lead
aVR right arm augmented lead
CH channel
CISPR International Special Committee on Radio Interference
CMS central monitoring system
cmos Complementary Metal Oxide Semiconductor
CPU central processing unit
CVP central venous pressure
DC direct current
D, DIA diastolic
ECG electrocardiograph
EEC European Economic Community
EMC electromagnetic compatibility
err error
ES electrosurgical
ESU electrosurgical unit
EURO European
fpga Field Programmable Gate Array
Hb-CO Carbonmono-xide hemoglobin
HR heart rate
P/N: 0152-20-39887 (2.1)
HT height
IEC International Electrotechnical Commission
ID
IM
IS
——
ISO International organization for standardization
LA(L) left arm
LAP left atria pressure
LED light emitting diode
LL(F) left leg
Loop loop read-write test fail
M, MEAN mean pressure
MDD Medical Device Directive
MetHb methemoglobin
MII initialize MII registers fail
MRI magnetic resonance imaging
N/A not applied
O2 oxygen
P power
PA pulmonary artery
PD photodetector
PM Patient Monitor
PR pulse rate
PVCs ——
QRS interval of ventricular depolarization
(QRS complex)
RA(R) right arm
RAM random access memory
Reg test NE2000 registers fail
RL(N) right leg
ROM read-only memory
P/N: 0152-20-39887 (2.1)
SpO2 arterial oxygen saturation from pulse oximetry
S, SYS systolic pressure
TD temperature difference
TEMP temperature
TFT Thin-Film Technology
V(C) precordial lead(Chest)
VGA Video Graphics Array