EDAN INSTRUMENTS IT20EDAN Telemetry Transmitter User Manual MFM CMS

EDAN INSTRUMENTS, INC. Telemetry Transmitter MFM CMS

Exhibit 08 Users Manual

About this Manual P/N: 01.54.456527 MPN: 01.54.456527011 Release Date: January 2015 © Copyright EDAN INSTRUMENTS, INC. 2014-2015. All rights reserved. Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages. Materials protected by the copyright law, including but not limited to confidential information such as technical information and patent information are contained in this manual, the user shall not disclose such information to any irrelevant third party. The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectual properties of EDAN. EDAN holds the rights to modify, update, and ultimately explain this manual. Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety, reliability and performance of the equipment if: Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by EDAN, and The electrical installation of the relevant room complies with national standards, and The instrument is used in accordance with the instructions for use. Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other information to help qualified technician to maintain and repair some parts, which EDAN may I
define as user serviceable. Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure. II
Table of Contents Chapter 1 Intended Use and Safety Guidance ............................................................................ 1 1.1 Intended Use/Indications for Use ........................................................................................ 1 1.2 Safety Guidance .................................................................................................................. 1 1.3 Explanation of Symbols on the Telemetry transmitter ........................................................ 6 Chapter 2 Overview ....................................................................................................................... 8 2.1 System Introduction ............................................................................................................ 8 2.2 Display Screen of Telemetry Transmitter............................................................................ 8 2.2.1 Default Interface........................................................................................................ 8 2.2.2 Main Interface ........................................................................................................... 9 2.2.3 Setting Interface ...................................................................................................... 12 2.3 Appearance of Telemetry Transmitter ............................................................................... 12 2.3.1 Front View ............................................................................................................... 12 2.3.2 Rear View ................................................................................................................ 14 2.3.3 Left Side View ......................................................................................................... 15 2.3.4 Right Side View ...................................................................................................... 15 2.3.5 Top View ................................................................................................................. 16 2.3.6 Bottom View ........................................................................................................... 16 2.4 Configuration .................................................................................................................... 16 2.5 Display Screens of the MFM-CMS................................................................................... 17 2.5.1 Overview ................................................................................................................. 17 2.5.2 Main Screen ............................................................................................................ 17 2.5.3 Auxiliary Screen ...................................................................................................... 20 2.5.4 Large Font Display .................................................................................................. 22 2.5.5 Layout of Patient Sectors ........................................................................................ 23 Chapter 3 Installation of Telemetry Monitoring System .......................................................... 24 3.1 Initial Inspection................................................................................................................ 24 3.2 Installation Environment ................................................................................................... 24 3.3 Power Supply Requirement............................................................................................... 24 3.4 Wireless Network .............................................................................................................. 25 3.5 Installation Method ........................................................................................................... 25 3.6 Checking the Printer .......................................................................................................... 26 3.7 Checking the Telemetry Monitoring System .................................................................... 26 3.8 Setting Date and Time ....................................................................................................... 26 III
3.9 Handing Over the Central Monitoring Systerm ................................................................ 27 Chapter 4 Basic Operations ........................................................................................................ 29 4.1 Basic Operations for Telemetry Transmitter ..................................................................... 29 4.1.1 Battery Installing and Replacing ............................................................................. 29 4.1.2 Switching On ........................................................................................................... 30 4.1.3 Switching Off .......................................................................................................... 30 4.1.4 Open/ Close Screen ................................................................................................. 30 4.1.5 Leather Cover Wearing ........................................................................................... 31 4.1.6 Nurse Call ............................................................................................................... 31 4.2 Basic Operations for MFM-CMS ..................................................................................... 31 4.2.1 Mouse Operation ..................................................................................................... 31 4.2.2 Switching on/off the MFM-CMS ............................................................................ 32 Chapter 5 Patient Management .................................................................................................. 34 5.1 Admitting a Patient ............................................................................................................ 34 5.2 Changing Patient Information ........................................................................................... 34 5.3 Switching Patient sector .................................................................................................... 35 5.4 Discharging a Patient ........................................................................................................ 35 5.5 Transferring a Patient ........................................................................................................ 35 5.6 Monitoring Statistics ......................................................................................................... 35 5.7 Nurse Call / Patient Call .................................................................................................... 36 Chapter 6 Patient Sector ............................................................................................................. 37 6.1 Overview ........................................................................................................................... 37 6.2 Networked Monitoring Display ........................................................................................ 37 6.3 Menu in the Patient Sector ................................................................................................ 39 6.4 Parameter/ Waveform Setup .............................................................................................. 39 6.4.1 Setting Waveforms .................................................................................................. 39 6.4.2 Setting Parameters ................................................................................................... 40 6.5 Freeze ................................................................................................................................ 40 6.6 Real-Time Printing ............................................................................................................ 40 6.7 Alarm Reset ....................................................................................................................... 41 Chapter 7 Viewing Single Bed ..................................................................................................... 42 7.1 Display of Single Bed ....................................................................................................... 42 7.2 Hiding/Showing Multi-Lead Waveform ........................................................................... 43 7.3 Short Trend Review .......................................................................................................... 43 7.4 OxyCRG ............................................................................................................................ 44 IV
7.5 Freeze ................................................................................................................................ 44 Chapter 8 Setting Telemetry Transmitters via MFM-CMS .............................................................. 45 8.1 Changing Patient Information ........................................................................................... 45 8.2 Setting Parameters ............................................................................................................. 45 8.2.1 Parameters Alarm Setting ........................................................................................ 46 8.2.2 Physiological Parameter Attribute and Configuration ............................................ 46 Chapter 9 Review ......................................................................................................................... 47 9.1 Patient List ........................................................................................................................ 47 9.1.1 Patient Review ........................................................................................................ 47 9.1.2 History Patient Review ........................................................................................... 47 9.1.3 Backup Patient Review ........................................................................................... 48 9.2 Wave Review ..................................................................................................................... 48 9.2.1 Reviewing Normal Waveforms ............................................................................... 48 9.2.2 Reviewing Compressed Waveforms ....................................................................... 48 9.2.3 Setting Wave Speed ................................................................................................. 49 9.2.4 Refreshing Waveform ............................................................................................. 49 9.2.5 Selecting Waveform ................................................................................................ 49 9.2.6 Print ......................................................................................................................... 49 9.3 Alarm Review.................................................................................................................... 49 9.3.1 Locking and Unlocking Alarm Information ............................................................ 49 9.3.2 Printing Alarm Information ..................................................................................... 50 9.3.3 Sequencing the Alarm List ...................................................................................... 50 9.3.4 Annotating Alarm .................................................................................................... 50 9.3.5 Filtering Alarm Events ............................................................................................ 50 9.4 Trend Review .................................................................................................................... 51 9.4.1 Setting Resolution ................................................................................................... 51 9.4.2 Viewing Parameters selectively .............................................................................. 51 9.4.3 Refreshing Data ....................................................................................................... 51 9.4.4 Printing Trend Review ............................................................................................ 51 9.4.5 Selecting Trend Table, Trend Graph ....................................................................... 51 Chapter 10 System Setup ............................................................................................................. 52 10.1 Common Setup ................................................................................................................ 52 10.1.1 Color Setup ........................................................................................................... 52 10.1.2 Display Setup ........................................................................................................ 52 10.1.3 Telemetry Module Switch Setup ........................................................................... 52 V
10.1.4 Help ....................................................................................................................... 53 10.2 User Maintain .................................................................................................................. 53 10.2.1 Telemetry Transmitter Batch Settings ................................................................... 53 10.2.2 Telemetry Alarm Latch Setup ............................................................................... 53 10.2.3 Date/Time Setup .................................................................................................... 54 10.2.4 MFM-CMS System Alarm Setup .......................................................................... 54 10.2.5 Changing Language .............................................................................................. 54 10.2.6 HL7 ....................................................................................................................... 54 10.2.7 Database Maintain ................................................................................................. 55 10.2.8 Other Setups .......................................................................................................... 55 10.2.9 User Password Setting........................................................................................... 55 10.2.10 About ................................................................................................................... 55 Chapter 11 Alarm Management ................................................................................................. 56 11.1 Overview ......................................................................................................................... 56 11.1.1 Physiological Alarms............................................................................................. 56 11.1.2 Technical Alarms ................................................................................................... 56 11.1.3 Prompts.................................................................................................................. 57 11.2 Alarm Levels ................................................................................................................... 57 11.3 Parameters Alarm Setting ................................................................................................ 57 11.4 Alarm Mute ..................................................................................................................... 57 11.5 Audio Pause ..................................................................................................................... 58 11.6 Alarm Prompt/Response .................................................................................................. 58 11.7 Testing Alarms ................................................................................................................. 59 11.8 Alarms for Networking Status ......................................................................................... 60 Chapter 12 Alarm Information ................................................................................................... 61 12.1 Physiological Alarm Information .................................................................................... 61 12.2 Technical Alarm Information .......................................................................................... 63 12.3 Prompts ........................................................................................................................... 66 12.4 Adjustable Range of Alarm Limits .................................................................................. 66 Chapter 13 Printing ..................................................................................................................... 68 13.1 Printing Report with a Printer ......................................................................................... 68 13.2 Printing Preview/ Printing Settings ................................................................................. 68 13.2.1 Printing Preview .................................................................................................... 68 13.2.2 Printing Settings .................................................................................................... 68 13.3 Exporting the PDF File ................................................................................................... 68 VI
Chapter 14 Database Management ............................................................................................ 70 14.1 Database Backup ............................................................................................................. 70 14.2 Reviewing Backup Database........................................................................................... 70 Chapter 15 Monitoring ECG ...................................................................................................... 71 15.1 Overview ......................................................................................................................... 71 15.2 ECG Safety Information ................................................................................................. 71 15.3 ECG Display ................................................................................................................... 72 15.3.1 ECG Display on Telemetry Transmitter Screen .................................................... 72 15.3.2 ECG Display on MFM-CMS ................................................................................ 73 15.4 Selecting Calculation Lead ............................................................................................. 73 15.5 Changing Size of ECG Waveform .................................................................................. 74 15.6 Changing ECG Filter Settings ......................................................................................... 74 15.7 ECG Alarm Settings ........................................................................................................ 74 15.8 Monitoring Procedure ..................................................................................................... 75 15.8.1 Preparation ............................................................................................................ 75 15.8.2 Connecting ECG Cables ....................................................................................... 75 15.9 Installing Electrodes ........................................................................................................ 75 15.9.1 Electrode Placement for 3-lead ............................................................................. 76 15.9.2 Electrode Placement for 5-lead ............................................................................. 76 15.10 Setting Alarm Source .................................................................................................... 78 15.11 Smart Lead Off .............................................................................................................. 78 15.12 Setting Pace Status ........................................................................................................ 79 15.13 ECG Calibration ............................................................................................................ 79 15.14 ECG Waveform Settings ............................................................................................... 79 15.15 ST Segment Monitoring ................................................................................................ 80 15.15.1 Open/ Close ST Analysis .................................................................................... 80 15.15.2 ST Display ........................................................................................................... 80 15.15.3 ST Alarm Settings ............................................................................................... 80 15.15.4 About ST Measurement Points ............................................................................ 80 15.16 Arr. Monitoring ............................................................................................................. 81 15.16.1 Arrhythmia Analysis ........................................................................................... 81 15.16.2 ARR Analysis Menu ............................................................................................ 82 Chapter 16 Monitoring RESP ..................................................................................................... 84 16.1 Overview ......................................................................................................................... 84 16.2 RESP Safety Information ................................................................................................ 84 VII
16.3 Electrode Placement for Monitoring RESP .................................................................... 84 16.4 Cardiac Overlay .............................................................................................................. 85 16.5 Chest Expansion .............................................................................................................. 85 16.6 Abdominal Breathing ...................................................................................................... 85 16.7 Selecting RESP Lead ...................................................................................................... 85 16.8 Changing the Apnea Time ............................................................................................... 85 16.9 Changing the Size and Speed of the Respiration Waveform .......................................... 86 16.10 RESP Alarm Settings .................................................................................................... 86 Chapter 17 Monitoring SpO2 ...................................................................................................... 87 17.1 Overview ......................................................................................................................... 87 17.2 SpO2 Safety Information ................................................................................................. 87 17.3 Measuring SpO2 .............................................................................................................. 88 17.4 Measurement Procedure .................................................................................................. 88 17.5 Assessing the Validity of a SpO2 Reading ....................................................................... 89 17.6 SpO2 Alarm Delay ........................................................................................................... 90 17.7 Setting Sensitivity ........................................................................................................... 90 17.8 SpO2 Alarm Settings ....................................................................................................... 90 Chapter 18 Monitoring PR .......................................................................................................... 91 18.1 Overview ......................................................................................................................... 91 18.2 Selecting the Active Alarm Source ................................................................................. 91 18.3 PR Alarm Settings ........................................................................................................... 91 Chapter 19 Using Battery ............................................................................................................... 92 19.1 Battery Status on Screen ................................................................................................. 92 19.2 Replacing the Battery ...................................................................................................... 94 19.3 Recycling the Battery ...................................................................................................... 94 Chapter 20 Safety ......................................................................................................................... 95 20.1 Control and Safety Index ................................................................................................ 95 20.2 Characteristics ................................................................................................................. 95 Chapter 21 Care and Cleaning ................................................................................................... 96 21.1 General Points ................................................................................................................. 96 21.2 Cleaning .......................................................................................................................... 96 21.2.1 Cleaning the Telemetry Transmitter ...................................................................... 97 21.2.2 Cleaning the Reusable Accessories ....................................................................... 97 21.3 Disinfection ..................................................................................................................... 98 21.3.1 Disinfecting the Telemetry Transmitter................................................................. 98 VIII
21.3.2 Disinfecting the Reusable Accessories.................................................................. 98 Chapter 22 Maintenance ........................................................................................................... 100 22.1 Inspecting ...................................................................................................................... 100 22.2 Maintenance Task and Test Schedule ............................................................................ 100 Chapter 23 Warranty and Service ............................................................................................ 101 23.1 Warranty ........................................................................................................................ 101 23.2 Contact information ...................................................................................................... 101 Chapter 24 Accessories .............................................................................................................. 102 24.1 ECG Accessories ........................................................................................................... 102 24.2 SpO2 Accessories .......................................................................................................... 103 24.3 Other Accessories .......................................................................................................... 104 A Product Specifications ............................................................................................................ 105 A.1 Classification of Telemetry Transmitter ......................................................................... 105 A.2 Specifications of Telemetry Transmitter ........................................................................ 105 A.2.1 Physical Specifications ......................................................................................... 105 A.2.2 Environmental Specifications .............................................................................. 105 A.2.3 Display Specifications .......................................................................................... 106 A.2.4 Battery .................................................................................................................. 106 A.3 Data Storage ................................................................................................................... 107 A.4 Specifications of MFM-CMS ......................................................................................... 107 A.4.1 Recommended Hardware Configuration .............................................................. 107 A.4.2 Software Performance .......................................................................................... 109 A.5 ECG ................................................................................................................................ 109 A.6 RESP .............................................................................................................................. 114 A.7 SpO2 ............................................................................................................................... 115 A.8 Wi-Fi............................................................................................................................... 116 B EMC Information ................................................................................................................... 117 B.1 Electromagnetic Emissions ............................................................................................ 117 B.2 Electromagnetic Immunity ............................................................................................. 117 B.3 Electromagnetic Immunity ............................................................................................. 119 B.4 Recommended Separation Distances ............................................................................. 120 C Default Settings ....................................................................................................................... 122 C.1 Patient Information Default Settings .............................................................................. 122 C.2 Alarm Default Settings (MFM-CMS) ............................................................................ 122 C.3 ECG Default Settings ..................................................................................................... 122 IX
C.4 RESP Default Settings .................................................................................................... 123 C.5 SpO2 Default Settings ..................................................................................................... 124 C.6 PR Default Settings ........................................................................................................ 124 D Abbreviation ........................................................................................................................... 125 X
Telemetry Transmitter User Manual Intended Use and Safety Guidance Chapter 1 Intended Use and Safety Guidance 1.1 Intended Use/Indications for Use Telemetry transmitter (hereinafter called iT20) must work with central monitoring system (hereinafter called MFM-CMS) manufactured by EDAN. Telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept., Respiratory Dept.). It is intended to be used for adults and pediatrics. The monitored physiological parameters include: ECG, respiration (RESP), oxygen saturation of arterial blood (SpO2) and pulse rate (PR). 1.2 Safety Guidance Federal (U.S.) law restricts this device to sale by or on the order of a physician. WARNING 1 Before using the device, the equipment, patient cable and electrodes etc. should be checked. Replacement shall be taken if there is any evident defect or signs of aging which may impair the safety or performance. 2 The electrodes expired are forbidden to be used. 3 Medical technical equipment such as telemetry monitoring system must only be used by persons who have received adequate training in the use of such equipment and who are capable of applying it properly. The user should have access to, and fully read user manual (this book) before use. Harm to patient may occur if users’ operating is not in accordance with user manual. 4 It is prohibited that the operator touches battery and patient simultaneously. 5 Do not use the device with electrosurgical unit simultaneously. 6 EXPLOSION HAZARD-Do not use the device in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur. 7 SHOCK HAZARD-To avoid the RISK of electric shock, MFM-CMS must only be connected to a SUPPLY MAINS with protective earth. Never adapt the three-prong plug from the MFM-CMS to fit a two-slot outlet. 8 Under simultaneous use of cardiac pacemaker and other patient-connected equipment, the pacing impulse analysis function must be switched ON. Otherwise, the pacing impulse may be counted as regular QRS complexes, which could prevent an asystole event from being detected or could lead to false alarm of asystole. 9 Do not come into contact with the patient, table, or the telemetry transmitter during defibrillation. - 1 -
Telemetry Transmitter User Manual Intended Use and Safety Guidance WARNING 10 Extreme care must be exercised when applying medical electrical equipment. Many parts of the human/machine circuit are conductive, such as the patient, connectors, electrodes, transducers. It is very important that these conductive parts do not come into contact with other grounded, conductive parts when connected to the isolated patient input of the device. Such contact would bridge the patient's isolation and cancel the protection provided by the isolated input. In particular, there must be no contact of the neutral electrode and ground. 11 Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the telemetry transmitter comply with the relevant EMC requirements. X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. 12 Route all cables away from patient’s throat to avoid possible strangulation. 13 Two batteries must be used as power supply. 14 Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in a hazard to the patient. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. 15 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards. Furthermore all configurations shall comply with the valid version of the standard IEC/EN 60601-1. Therefore anybody, who connects additional equipment to the signal input or output connector to configure a medical system, must make sure that it complies with the requirements of the valid version of the system standard IEC/EN60601-1. If in doubt, consult our technical service department or your local distributor. 16 Telemetry transmitter is connected to MFM-CMS via wireless network. Therefore, any other equipment complying with CISPR radiation requirements may also interfere with the wireless communication and make it interrupted. 17 Telemetry transmitter will sent technical alarm information of low battery power to MFM-CMS informing user of changing battery when battery power is 0-level. Meanwhile, telemetry transmitter gives out a periodic sound of “du-du-du” whose interval is 10 seconds till shutdown. After shutdown, module configuration and patient information can be saved. User should restart the device after changing battery. 18 Clinical decision making based on the output of the device is left to the discretion of the provider. WARNING - 2 -
Telemetry Transmitter User Manual Intended Use and Safety Guidance 19 Only use patient cable and other accessories supplied by EDAN. Or else, the performance and electric shock protection cannot be guaranteed, and the patient may be injured. Prior to use, check if the casing of a disposable or sterilized accessory is intact. Do not use it if its casing is damaged. 20 Wireless LAN equipment contains an intentional RF radiator that has the potential of interfering with other medical equipment, including patient implanted devices. Be sure to perform the electromagnetic compatibility test, as described in the Wireless LAN System Installation, before installation and any time new medical equipment is added to the Wireless LAN coverage area. 21 When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients. 22 If multiple instruments are connected to a patient, the sum of the leakage currents must not exceed the limits; or it may result in shock hazard. 23 During monitoring, if the power supply is off and there is no battery for standby, the telemetry transmitter will be off. Last settings used will be recovered when the power is restored. 24 When leakage or foul odor is detected，stop using and keep away from fire immediately. 25 The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose them together with house-hold garbage. At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries. Inappropriate disposals of waste may contaminate the environment. For more detailed information about recycling of this product or battery, please contact your local Civic Office, or the shop where you purchased the product. 26 The packaging is to be disposed of according to local or hospital’s regulations; otherwise, it may cause environmental contamination. Place the packaging at the place which is inaccessible to children. 27 After defibrillation, the ECG display recovers within 10 seconds if the correct electrodes are used and applied based on the manufacturers’ instructions. 28 When deploying wireless network, hospital should make sure that clinicians have acknowledged and familiarized the coverage of wireless network signal. Patients’ activity must be within that range. 29 This equipment is not intended for home usage. 30 Do not service or maintain the telemetry transmitter or any accessories during patient monitoring. WARNING - 3 -
Telemetry Transmitter User Manual Intended Use and Safety Guidance 31 The 30-meter indoor barrier-free distance of distinct vision is the coverage of wireless network connecting telemetry transmitter and MFM-CMS. Telemetry transmitter is 30 meters (distinct vision) from wireless AP. 32 Nurse call is the only one function the patient can safely use. Other functions are all prohibited for patient to operate. 33 The patient should wear the telemetry transmitter by leather cover, and leather cover. 34 Operation of the equipment exceeding the measurement range may cause inaccurate results. 35 Portable and mobile RF communications equipment can affect medical electrical equipment; Refer to the recommended separation distances provided in Appendix B EMC Information. 36 Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of telemetry transmitter. 37 Telemetry transmitter should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, you must check that normal operation is possible in the necessary configuration before you start monitoring patients. 38 Assembly of the telemetry transmitter and modifications during actual service life shall be evaluated based on the requirements of IEC60601-1. 39 Connecting any accessory (such as external printer) or other device (such as the computer) to telemetry transmitter makes a medical system. In that case, additional safety measures should be taken during installation of the system, and the system shall provide: a) Within the patient environment, a level of safety comparable to that provided by medical electrical equipment complying with IEC/EN 60601-1, and b) Outside the patient environment, the level of safety appropriate for non-medical electrical equipment complying with other IEC or ISO safety standards. 40 All the accessories connected to system must be installed outside the patient vicinity, if they do not meet the requirement of IEC/EN 60601-1. 41 Additional multiple socket-outlet or extension cord can’t be connected to the system. 42 Only items that have been specified as part of the system or specified as being compatible with the system can be connected to the system. 43 The appliance coupler or mains plug is used as isolation means from supply mains. Position the MFM-CMS in a location where the operator can easily access the disconnection device. 44 Do not touch accessible parts of non-medical electrical equipment in the patient environment and the patient simultaneously. WARNING - 4 -
Telemetry Transmitter User Manual Intended Use and Safety Guidance 45 SHOCK HAZARD - Don't connect non-medical electrical equipment, which has been supplied as a part of the system, directly to the wall outlet when the non-medical equipment is intended to be supplied by a multiple portable socket-outlet with an isolation transformer. 46 The telemetry transmitter is intended for use by trained healthcare professionals in hospital environments. 47 SHOCK HAZARD - Don't connect electrical equipment, which has not been supplied as a part of the system, to the multiple portable socket-outlet supplying the system. CAUTION 1 Electromagnetic Interference - Ensure that the environment in which the system is installed is not subject to any sources of strong electromagnetic interference, such as radio transmitters, mobile telephones, etc. 2 Keep the environment clean. Avoid vibration. Keep it far away from corrosive medicine, dust area, high temperature and humid environment. 3 Do not immerse transducers in liquid. When using solutions, use sterile wipes to avoid pouring fluids directly on the transducer. 4 Do not sterilize telemetry transmitter or any accessories. 5 The device and reusable accessories could be sent back to the manufacturer for recycling or proper disposal after their useful lives. 6 Remove a battery from the telemetry transmitter immediately if battery life cycle has expired or it is not used for a long time. 7 Disposable devices are intended for single use only. They should not be reused as performance could degrade or contamination could occur. 8 Avoid liquid splash on the device. 9 To ensure patient safety, use only parts and accessories manufactured or recommended by EDAN. 10 Before connecting the system to the AC power, make sure the voltage and the power frequency are consistent with the requirements indicated on the device label or in this user manual. 11 Protect the device against mechanical damage resulting from gravitation, collision, powerful vibration and so on. 12 Do not touch the touch screen with a sharp object. 13 A drafty environment for system installation is required. NOTE： - 5 -
Telemetry Transmitter User Manual Intended Use and Safety Guidance 1 Position the device in a proper location that is stable and not easy to fall or shake. 2 The telemetry transmitter can only be used on one patient at a time. 3 If the telemetry transmitter gets damp or liquid pours on it, please contact the service personnel of EDAN. 4 This telemetry transmitter is not a device for treatment purposes. 5 The pictures and interfaces in this manual are for reference only. 6 Regular preventive maintenance should be carried out every two years. You are responsible for any requirements specific to your country. 1.3 Explanation of Symbols on the Telemetry transmitter DEFIBRILLATION-PROOF TYPE CF APPLIED PART Caution Operating instructions Operating instructions Background color---blue Symbol color---white The user manual is printed in black and white. Non- ionizing electromagnetic radiation Ingress Protection: IPX7 (protected against ingress of water with harmful effects: temporary immersion) General warning sign Background color---yellow Symbol and outline color---black The user manual is printed in black and white. Power Supply switch SERIAL NUMBER Trend - 6 -
Telemetry Transmitter User Manual Intended Use and Safety Guidance Picture freeze CE marking AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY Date of manufacture MANUFACTURER Part Number General symbol for recovery/recyclable Disposal method Caution: Federal (U.S.) Law restricts this device to sale by or on the order of a physician. - 7 -
Telemetry Transmitter User Manual Overview Chapter 2 Overview 2.1 System Introduction Telemetry monitoring system can realize an integrated monitoring for multiple mobile patients or bed patients via wireless network. It is easy for extending and net deploying. Among the system, telemetry transmitter owns small size, light weight and long battery life and works with MFM-CMS to form an integrated monitoring solution. The detailed operation instructions of MFM-CMS refer to Central Monitoring System User Manual 2.2 Display Screen of Telemetry Transmitter The display screen of telemetry transmitter is associated with the parameters’ configuration customer bought. 2.2.1 Default Interface The default interface has two parts: Information Area and Parameter Value Area. Under parameters on, the symbol ？will be displayed in parameter value area if measuring is not implemented or the measured value is invalid. The default interface with three parameters on is as follow: 70 SpO2 %99HR bpmRR rpm14ST II 0.10PR bpm70PACE IconBed No. Networking Icon Battery StatusWireless signal Icon Figure 2-1 ECG + SpO2 + RESP Default Interface（ST on） Information Area Parameter Value Area Pulse Bar Graph - 8 -
Telemetry Transmitter User Manual Overview 2.2.2 Main Interface Main interface has two kinds: Value - Waveform Main Interface and Trend Graph Main Interface.  Value - Waveform Main Interface 1. ECG Interface: includes information area, ECG value of calculated lead and corresponding wave. 60HR bpmIIPACE IconBed No. Networking Icon Battery StatusWireless Signal Icon Figure 2-2 ECG Interface（ST off） 2. SpO2 Interface: includes information area, SpO2 value, PR value and PLETH wave. SpO2 %99血氧波60HR bpmBed No. Networking Icon Battery StatusWireless Signal Icon Figure 2-3 SpO2 & PR Interface - 9 -
Telemetry Transmitter User Manual Overview 3. ECG&SpO2 Interface: includes information area, ECG value of calculated lead, SpO2 value and ECG wave. 60 SpO2 %99HR bpmIIST II 0.10PACE IconBed No. Networking Icon Battery StatusWireless Signal Icon Figure 2-4 ECG & SpO2 Interface（ST on） 4. ECG&RESP Interface: includes information area, ECG value of calculated lead, RR value and ECG wave. 60 RR rpm14HR bpmIIST II 0.10PACE IconBed No. Networking Icon Battery StatusWireless Signal Icon Figure 2-5 ECG & RESP Interface（ST ON） - 10 -
Telemetry Transmitter User Manual Overview 5. ECG&SpO2&RESP Interface: includes information area, ECG value of calculated lead, SpO2 value, PR value and RR value. It’s actually the same with default interface. 70SpO2 %99HR bpmRR rpm14ST II 0.10PR bpm70PACE IconBed No.Networking Icon Battery StatusWireless signal Icon Figure 2-6 ECG & SpO2 & PR & RESP Interface（ST ON）  Trend Graph Main Interface Trend Graph Main Interface can be displayed when parameters are on. It includes current patient’s data only, not the history patient’s. According to the parameters customer chosen, trend graph main interface has four kinds: ECG Trend Graph Main Interface, SpO2 Trend Graph Main Interface, PR Trend Graph Main Interface and RESP Trend Graph Main Interface. Networking IconBed No.Wireless signal Icon Battery StatusminXXX0xx-90 -60 -30xx Figure 2-7 Trend Graph Main Interface Parameter name and unit Parameter scale value - 11 -
Telemetry Transmitter User Manual Overview 2.2.3 Setting Interface Setting interface includes password inputting interface and function setting interface that will be displayed after confirm password. Under non-0-level of battery condition, when screen is in the setting interface, the screen can keep opened till 0 level of battery. In setting interface, there are functions: choosing demo mode, choosing language of telemetry transmitter, checking network configuration, upgrading operation and checking related information of telemetry transmitter. WARNING 1. The functions in setting interface, such as checking network configuration and upgrading operation, are for service personnel only. 2. Demo Mode is for demonstration purposes only. You must not change into Demo Mode during monitoring. In Demo Mode, all stored trend information is deleted from the telemetry transmitter’s memory. NOTE: Multiple languages are applicable to main interface. Setting interface supports English only. 2.3 Appearance of Telemetry Transmitter 2.3.1 Front View Front View 1 2 3 4 5 - 12 -
Telemetry Transmitter User Manual Overview Terms explanation  Main Interface, Default Interface and Setting Interface: refer to 2.2 Display Screen of Telemetry Transmitter.  Control focus: means the position cursor chosen by shifting key.  Focus acceptance: means user accept the position where the control focus is. It is triggered by function acceptance key. 1 Power supply switch  Under telemetry transmitter off: Keep pressing at least for 2 seconds to turn on and the green light on power supply switch will occur.  Under telemetry transmitter on: When power is in 0 level or screen is open, keep pressing at least for 3 seconds to turn off.  When screen is open, press it to close screen. Under telemetry transmitter on, when screen is closed with non-0-level of battery, press is to open screen. (If screen is closed with 0 level of battery, pressing it cannot open screen, and the screen will keep closed till shutdown). 2 Shifting  In main interface, press it to display between Value - Waveform Main Interface and Trend Graph Main Interface.  In setting interface, press it to switch control focus.  When input password or choose language: ① press shifting to switch control focus; ② press function acceptance to accept focus; ③ press shifting to choose password or language.  In ECG leads connection sketch interface (refer to 4.1.2 Switching On), press it to make the sketch disappear. - 13 -
Telemetry Transmitter User Manual Overview 3 Function acceptance  In main interface, press it to return to default interface.  In setting interface, after control focus is switched to an icon, press function acceptance to accept this function.  When input password or choose language: ① press shifting to switch control focus; ② press function acceptance to accept focus; ③ press shifting to choose password or language; ④ press function acceptance to exit focus acceptance. 1+3 Function group key (press power supply switch and function acceptance simultaneously at least for 1second)  In main interface or in default interface, press it to display password window.  In DEMO mode, press it to exit demo mode. 4 Display screen 5 Speaker 2.3.2 Rear View Rear View Manufacturer’s information is listed on this side. Detailed information please refers to the actual machine. - 14 -
Telemetry Transmitter User Manual Overview 2.3.3 Left Side View Left Side View 2.3.4 Right Side View Right Side View Nurse call key: press it to display calling nurse information on MFM-CMS. Nurse call key - 15 -
Telemetry Transmitter User Manual Overview 2.3.5 Top View Top View 1 ECG cable connector 2 SpO2 sensor connector 2.3.6 Bottom View Refer to 4.1.1 Battery Installing and Replacing Battery Installing and Replacing. 2.4 Configuration The configuration of telemetry transmitter is listed below: Function Configuration ECG SPO2 PR RESP ECG √ × × ○ ECG & SPO2 √ ○ ○ ○ “√” means the parameter standardly configured is on by default after telemetry transmitter switches on. Changing status should be operated on MFM-CMS. The parameter status last used will be recovered when the device is switched on again. “○” means the parameter standardly configured is off by default after telemetry transmitter switches on. Changing status should be operated on MFM-CMS. The parameter status last used will be recovered when the device is switched on again. “×” means the parameter is not configured. NOTE: The parameters only standardly configured are applicable. 1 2 - 16 -
Telemetry Transmitter User Manual Overview 2.5 Display Screens of the MFM-CMS 2.5.1 Overview The MFM-CMS can display the monitoring data using a single display or using dual displays. The main screen and the auxiliary screen are the main operation screens. The main screen and auxiliary screen on a single display are different from those on dual displays. The patient sectors can be displayed in two modes: the general display mode with waveforms and physiological parameter values displaying on the screen and the large font display mode with only parameter values displaying on the screen. The number of patient sectors which you can simultaneously view on the main screen and the size of the patient sectors are depended on the layout of the patient sectors. 2.5.2 Main Screen If a single display is used, the MFM-CMS system will enter the main screen for the single display (shown as Figure 8) after the system starts up. If dual displays are used, it will enter the main screen for dual displays (shown as Figure 9). xxxxxxxx xx xx xx60 99xxxxxxxx xx xx xx60 99xxxxxxxx xx xx xx60 99xxxxxxxx xx xx xx60 99xxxxxxxx xx xx xx60 99xxxxxxxx xx xx xx60 99xxxxxxxx xx xx xx60 99132xxxx Figure 2-8 Main Screen on a Single Display 1: System information area 2: Patient sectors 3: Quick control area - 17 -
Telemetry Transmitter User Manual Overview Figure 2-9 Main Screen on Dual Displays 2.5.2.1 System Information Area The following information will be displayed in this area:  The hospital and department information.  Alarm sound pause indicator and alarm mute indicator .  When connecting with the telemetry transmitters: nurse call indicator and patient call indicator .  Alarm information and prompts of the MFM-CMS. If more than one piece of message occurs, they will be displayed circularly. For MFM-CMS system alarms and prompts, please refer to Appendix II of MFM-CMS Central Monitoring System User Manual.  The system time. 2.5.2.2 Patient Sectors A patient is monitored by a telemetry transmitter. This telemetry transmitter will occupy a patient sector when it is connected to the MFM-CMS; meanwhile, the monitoring data will be displayed in this patient sector. The MFM-CMS supports 64 telemetry transmitters connected to the system; therefore, a total of 64 patient sectors are available in the MFM-CMS. The layout of patient sectors may cause some patient sectors temporarily invisible (refer to 2.5.5 Layout of Patient Sectors). The patient sector has three types of state:  Network Disconnected: The black background with the white font Disconnected in a patient sector indicates no patient is admitted or assigned to this patient sector, or the patient assigned to this sector has been discharged.  Improper Offline: If the system is connected with telemetry transmitter, patient information, the name of telemetry transmitter, and the message Telemetry No Signal with yellow background are displayed in the patient sector and accompany with medium level alarm sound. Improper Offline indicates the patient in this sector has been admitted but is offline. - 18 -
Telemetry Transmitter User Manual Overview  Networked Monitoring: Display of patient information, waveforms, trend data and alarm information indicates the patient in this sector has been admitted and is properly networked and under observation. Refer to Chapter 6 for more information about the patient sectors in networked monitoring state. 2.5.2.3 Quick Control Area Function Buttons The quick control area contains the following function buttons: Button Button Label Function Main Screen Click on it to return to the main screen. Audio Pause Click on this symbol to make the alarm pause and the symbol appears in place of the symbol . And click on the symbol to disable the pause function and the symbol appears in place of the symbol . When the alarm sound pauses, the symbol as well as the related prompt will be displayed in the system information area. Review Click on it to enter the review interface, including patient information review, waveform review, alarm review, trend review. System Setup Click on it to enter the system setup menu. Shut Down Click on it to shut down the MFM-CMS and the operating system. Admission Click on it to open the patient admission window. System Volume Adjustor Click on it, and the volume adjustor icon appears. Select the Mute check box, and then enter the password ABC in the text box on the pop-up window; the entire system become mute, and the symbol appears. To disable the silence function, tick the Mute check box again and the symbol appears. Additionally, the user can drag - 19 -
Telemetry Transmitter User Manual Overview the volume adjustor to your desired volume. NOTE: MFM-CMS will keep mute as soon as mute check box is ticked. If a new alarm occurs, the system won’t break mute status and keep mute until mute check box is ticked again. Please use it with caution. Networked State The networked state window has 64 panes (shown as Figure 2-10) representing the 64 telemetry transmitters that can be supported and connected to the MFM-CMS. The pane only displays the telemetry transmitter’s number. You can access the single bed interface by clicking on the pane. 123……4 Figure 2-10 Networked State The pane has the several types of state:  Blank: Network disconnected (refer to Section 2.5.2.2 Patient Sectors).  With grey background and white bed number: Improper offline (refer to Section 2.5.2.2 Patient Sectors).  With green background: Networked monitoring (refer to Section 2.5.2.2 Patient Sectors); without physiological alarm.  With yellow background: Networked monitoring (refer to Section 2.5.2.2 Patient Sectors); with medium or low level physiological alarm.  With red background: Networked monitoring (refer to Section 2.5.2.2 Patient Sectors); with high level physiological alarm. 2.5.3 Auxiliary Screen If the patient sector is in the state either of improper offline or networked monitoring, you can access the auxiliary screen by clicking the waveform area or parameter area on the patient sector. The auxiliary screen on a single display is shown as Figure 2-11, and the one on dual displays is shown as Figure 2-12. - 20 -
Telemetry Transmitter User Manual Overview 32415xxx xx xx xx xx60 99xxxxxx xx xx xx xx60 99xxxxxx xx xx xx xx60 99xxxxxx xx xx xx xx60 99xxxxxx xx xx xx xx60 99xxxxxx xx xx xx xx60 99xxxxxx xx xx xx xx60 99xxxxxx xx xx xx xx60 99xxx Figure 2-11 Auxiliary Screen on a Single Display 1: System information area 2: Patient sectors 3: Switch and setup area for sub-window 4: Sub-window of auxiliary screen 5: Quick control area 2131354 Figure 2-12 Auxiliary Screen on Dual Displays 1: System information area 2: Patient sectors 3: Quick control area 3: Switch and setup area for sub-window 4: Sub-window of auxiliary screen The auxiliary screen contains a group of sub-windows including Single Bed View, Patient Mgmt, Wave Review, Alarm Review, Trend Review and Parameter/Waveform Setup. The sub-window of Single Bed View will be displayed by default when you access the auxiliary screen. In the switch and setup area for the sub-window, you can:  Click a tag to switch the current sub-window to another sub-window.  Click to scroll leftward and click to scroll rightward in the tag bar. - 21 -
Telemetry Transmitter User Manual Overview  Click to open the drop-down list in which you can set the tags to show/hide.  Click to exit the auxiliary screen and enter the main screen.  Drag a tag to adjust its location.  Click or to switch between full screen display mode and half screen display mode for the auxiliary screen when using a single display. 2.5.4 Large Font Display Choose Display the window in large font from the menu in the patient sector (refer to Section 6.3 Menu in the Patient Sector), and this sector will be displayed in the large font display mode shown as Figure 2-13. Choose Display the window in large font again, and the sector will be displayed in the general display mode. In the large font display mode, parameter values are displayed in the patient sector, but no waveform is shown. xxxxxxxx xx xx xx60 99xxxxxxxx xx xx xx60 99xxxxxxxx xx xx xx60 99xxxxxxxx xx xx xx60 99xxxxxxxx xx xx xx60 99xxxxxxxx xx xx xx60 9923145678xxxxxxxx xx xx xx60 9960 99 36.5 40xx xx xx xx xx xx xx xx Figure 2-13 Viewing One Patient Sector in Large Font Display Mode 1: Large font display mode 2-8: General Display Mode Choose Display all windows in large font from the menu in the patient sector, and all sectors will be displayed in the large font display mode shown as Figure 2-14 Choose Display all windows in large font again, and all sectors will be displayed in the general display mode. - 22 -
Telemetry Transmitter User Manual Overview 60 99 36.5 40xx xx xx xx xx xx xx xx60 99 36.5 40xx xx xx xx xx xx xx xx60 99 36.5 40xx xx xx xx xx xx xx xx60 99 36.5 40xx xx xx xx xx xx xx xx60 99 36.5 40xx xx xx xx xx xx xx xx60 99 36.5 40xx xx xx xx xx xx xx xx60 99 36.5 40xx xx xx xx xx xx xx xx60 99 36.5 40xx xx xx xx xx xx xx xx Figure 2-14 Viewing All Patient Sectors in Large Font Display Mode 2.5.5 Layout of Patient Sectors The number of patients you can view on the screen and the size of each patient sector depend on the layout of the patient sectors. If 64 telemetry transmitters are connected to the MFM-CMS and the number of patient sectors displayed on the main screen is set to 32, the screen will only display 32 patient sectors and the other 32 sectors are invisible. You may:  Switch between the visible and invisible patient sectors (refer to Section 5.3 Switching Patient sector).  Click bed number to view the 64 patient sectors in the networked state window (refer to Section 2.5.2.3 Quick Control Area). Refer to Section 10.1.2 Display Setup for more information about setting the layout of the patient sectors. - 23 -
Telemetry Transmitter User Manual Installation of telemetry monitoring system Chapter 3 Installation of Telemetry Monitoring System NOTE: 1. The entire system must be specified by the personnel authorized by EDAN. 2. To ensure that the system works properly, please read the user manual and follow the steps before using. 3.1 Initial Inspection Before unpacking, check the packaging and ensure that there are no signs of mishandling or damage. If the shipping cartons are damaged, contact the carrier for compensation and package them again. Open the package carefully and remove telemetry transmitter, MFM-CMS and accessories. Check that the contents are complete and that the correct options and accessories have been delivered. If you have any question, please contact your local supplier. 3.2 Installation Environment System working environment should be in consistent with the requirements in this user manual (refer to A.2.2 Environmental Specifications). System working should avoid noise, shock environment and the environment where the concentrations of flammable anesthetics or other explosive materials may occur. The surrounding of device should have enough space (at least 5 cm) to maintain and transfer heat. NOTE: 1. Please keep the system away from radio transmitters and high power electrical and mechanical device for those could affect monitoring. 2. Wireless transmission is applicable to the system. It’s normal that irregular waveform due to outside interference may occur. If you have any question on Electromagnetic environment, please contact service personnel. 3.3 Power Supply Requirement Power supply should be in consistent with the requirements in this user manual (refer to A.2.4 Battery). NOTE: 1 Connect the power cable of MFM-CMS to the socket specialized for hospital use. 2 Only use the power cable supplied by EDAN. - 24 -
Telemetry Transmitter User Manual Installation of telemetry monitoring system 3.4 Wireless Network Telemetry translator and MFM-CMS construct wireless network through AP. The qualified engineers specified by EDAN are responsible for installing wireless network and performance tests. For details, please refer to Patient Monitor Wireless Network Installation Guide. NOTE: 1. Be aware that some network-based functions may be limited for telemetry transmitter on wireless networks in comparison with those on wired networks. 2. The obstacle may interfere with data transmission and even cause data loss. 3. When telemetry transmitter has been connected to a wireless network, to make the change of the Bed No. effective, you need to disconnect the wireless connection and then connect it again or reboot telemetry transmitter. 3.5 Installation Method The personnel specified by EDAN are responsible for system installation, which includes surrounding verification, MFM-CMS installation, wireless device installation and telemetry transmitter installation, etc. WARNING 1. When the system is required to connected with other electric devices, and those electric devices are not approved to be safe for connection with the system, such as current leakage may cause electronic shock, please contact specialists in hospital or our service personnel. 2. Upgrade operation is only for personnel authorized by EDAN. 3. Plugging three-pin into two-pin adaptor is prohibited. 4. To change installation environment or move system to another site, please contact our service personnel. 5. The medical electrical equipment needs to be installed and put into service according to the EMC Information provided in this user manual. CAUTION 1. To avoid unpredictable results from sudden power interruption, please provide UPS (Uninterruptible power supplies) for the system. 2. Keeping battery bin dry is required. - 25 -
Telemetry Transmitter User Manual Installation of telemetry monitoring system NOTE: Crossover Ethernet cable is connected with computer and parallel Ethernet cable is connected with HUB. 3.6 Checking the Printer If an external printer is required, please confirm the printer is powered on and paper is properly installed in the slot. If it is not powered on or no paper exists, please power the printer on according to power requirements in MFM-CMS Central Monitoring System User Manual and put appropriate paper. WARNING External device connected with system, such as printer or speaker, should be in accordance with power requirements for system. 3.7 Checking the Telemetry Monitoring System Make sure there is no damage on the measurement accessories and cables. Then turn on the telemetry and MFM-CMS, check whether the system can start normally. Make sure battery for telemetry transmitter has enough power, MFM-CMS can alarm normally and the alarm sound is heard. WARNING If any signs of damage are detected, or screen displays error messages, do not use it on any patient. Contact service center immediately. NOTE: 1 Check all functions applicable and make sure that the system is in good status. 2 If telemetry transmitter is in low battery power status (0 level), replace battery to ensure the electric power is enough. 3.8 Setting Date and Time Setting and displaying date and time is applicable to MFM-CMS only. The user can set the correct date and time and their desired format. There are three kinds of date format: yyyy-MM-dd, dd-MM-yyyy, MM-dd-yyyy, two kinds of time format: HH-mm-ss (24 hours) and hh-mm-ss tt (12 hours), and three date separator: /, - and. To change the date and time setup, please select Main Screen > System Setup > Common Setup > Date /Time Setup, and select the desired settings from the right menu. The time and date displayed on the main screen will also change after change the date and time setup and their format. - 26 -
Telemetry Transmitter User Manual Installation of telemetry monitoring system WARNING During patient monitoring, a change in date and time will influence the storage of trend data. NOTE: 1 The user must restart MFM-CMS to make the change effective. 2 If the system is not used for a longer period of time, its system time may be inaccurate. In this case, reset the system time after powering on. 3 If the system time cannot be saved and resumes the default value after restart, contact the service department of EDAN. 3.9 Handing Over the Central Monitoring Systerm If you are handing over system to the end-users directly after installation and configuration, make sure that it is in the monitoring mode. The users must be adequately trained to use the system before monitoring a patient. To achieve this, they should have access to, and read, the following documentation delivered with system:  User Manual (this book) - for full operating instructions.  Quick Reference Card - for quick reminders during use. 3.10 FCC Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: 1. Reorient or relocate the receiving antenna. 2. Increase the separation between the equipment and receiver. 3. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. 4. Consult the dealer or an experienced radio/TV technician for help. This device complies with Part 15 of FCC Rules. Operation is subject to the following two conditions: - 27 -
Telemetry Transmitter User Manual Installation of telemetry monitoring system 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation. NOTE: The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. Such modifications could void the user’s authority to operate this equipment. - 28 -
Telemetry Transmitter User Manual Basic Operations Chapter 4 Basic Operations The general functions for telemetry transmitter are operated on MFM-CMS, which include chapter 5 patient management, chapter 6 patient sector, chapter 7 viewing single bed, chapter 8 setting telemetry transmitter via MFM-CMS, chapter 9 review, chapter 10 system setup, chapter 11 alarm management, chapter 12 alarm information, chapter 13 printing, and chapter 14 database management. The following introduction is about the basic operations for telemetry transmitter and MFM-CMS. 4.1 Basic Operations for Telemetry Transmitter 4.1.1 Battery Installing and Replacing Bottom View Installing: As pictured above, move the battery compartment latch right to open battery door. Install two AA alkaline batteries following “+” or “-” indication, and then press the door to close correctly with “ka-ka” sound. Replacing: Method is the same with installing. Under the condition that telemetry transmitter continuously works at least for 15 minutes and moreover it has a good Wi-Fi communication (typical network environment with no interference), the telemetry transmitter can keep power on up to 20 seconds after taking batteries out. Battery compartment latch Green bar occurs under locked status. Red bar occurs under unlocked status. - 29 -
Telemetry Transmitter User Manual Basic Operations WARNING It is prohibited for patient to install or replace battery. 4.1.2 Switching On Under switch off condition, keep pressing power supply switch at least for 2 seconds to turn on. Then the green light on power supply switch will occur. At the same time, the following self-tests will be carried out:  Read parameters configuration. Refer to 2.4 Configuration for configuration information;  Check ECG accessory compatibility. When accessory is not compatible, the screen will display “Check the ECG accessories”; When compatible and ECG module is active, telemetry transmitter will check ECG leads connection. The screen will enter into main interface under condition of correct leads connection. Under leads off or wrong connection, the screen will display ECG leads connection sketch in which wrong leads position and correct leads position will be indicated. ECG leads connection sketch will disappear in these conditions, leads connection restoring normally, pressing shifting key or over 60 seconds.  Read automatically ECG leads type (3-lead or 5-lead) and ECG leads style (AHA or IEC). NOTE: During switch on, user should confirm the green light on power supply switch occurs and screen displays normally. Nurse call and patient call sounds should also be tested normally. Refer to 5.7 Nurse Call / Patient Call for more nurse call and patient call information. 4.1.3 Switching Off Under telemetry transmitter on: When power is in 0 level or screen is open, keep pressing at least for 3 seconds to turn off.. 4.1.4 Open/ Close Screen  Under telemetry transmitter on, when screen is closed with non-0-level of battery, press is to open screen. The screen will be back to the interface last used after opening again.  Under screen open condition, do one of the following method to close: 1. Press power supply switch; 2. Without any actions in 15 seconds, screen will close automatically. After closing, monitoring and net connection keep working normally. - 30 -
Telemetry Transmitter User Manual Basic Operations 4.1.5 Leather Cover Wearing Telemetry transmitter supports leather cover to wear, as pictured below: WARNING To avoid infection or other severe results, leather cover must not touch injured skin. 4.1.6 Nurse Call Press nurse call key on the right side. Information about nurse call will be sent to MFM-CMS on which a nurse call symbol will be displayed to tell nurse patient’s calling. (Refer to 5.7 Nurse Call / Patient Call) 4.2 Basic Operations for MFM-CMS 4.2.1 Mouse Operation Usually, we use the following terms to describe mouse operation: Left-key: 1. Click: move mouse to the target, then quickly press left-key once and release it. 2. Double-click: move mouse to the target, then quickly press left-key twice and release it. 3. Drag: move mouse to the target, press left-key and move to the destination and then release it. Right-key: Nurse Call Key Lock Button - 31 -
Telemetry Transmitter User Manual Basic Operations 1. Click: move mouse to the target, then quickly press right-key once and release it. 2. Double-click: move mouse to the target, then quickly press right-key twice and release it. 4.2.2 Switching on/off the MFM-CMS  Starting monitoring NOTE: Before starting the system, please verify that the dongle has been installed. Otherwise, you may fail to access the system. When all of its components are correctly connected, press the power button on the front panel of the device. The power indicator on the front panel lights up and the device performs hardware self-test. If the device works normally, the main screen appears. If the device detects abnormity during self-test, it beeps to show alarm and displays error information on the screen. In this case, you should record the error information, shut down the device and contact technical representative of EDAN. After the system self-test is completed, you will access the MFM-CMS system interface and the system will also finish the environment self-test automatically. Meanwhile, the system will sound Do-Do-Do, a test sound. The user should set the volume system and confirm that the volume of the system can be heard clearly. CAUTION 1 Ensure that the sound equipment is always in a state of activation. 2 The audio adapter and network adapter should be correctly installed, or you may not access the MFM-CMS. NOTE: Ensure that the MFM-CMS system can give the test sound after startup.  Shutting down the System It is important to shut down the system properly. Follow this simple procedure to properly shut down your system. This prevents inadvertent errors from occurring during system shut down. The MFM-CMS can work continuously for a long time. You do not need to shut it down in order to achieve a longer working life. You should follow the procedure to shut down the MFM-CMS. Method 1: Select Shut Down on the main menu and enter the password ABC. Confirm the password by clicking OK, and the MFM-CMS as well as the operating system will be shut down. - 32 -
Telemetry Transmitter User Manual Basic Operations Method 2: Select System Setup > User Maintain, and enter the password ABC; select Other Setup.  Select Shut Down: the MFM-CMS as well as the operating system will be shut down.  Select Return to Windows: you will exit from MFM-CMS, but the operating system will not be shut down. WARNING 1 Shut down the system by strictly observing the shutdown procedure to avoid serious result. 2 Although UPS is an optional configuration of this system, if you really force to turn off the UPS, it results in system failure and hence affects the operation of next time. 3 If power cut-off occurs, turn off the system before the UPS exhausts its electricity. CAUTION Hospitals without a stable power source should use a UPS to provide power to the MFM-CMS. The UPS must not be turned off. When there is a power failure, the system should be shut down by following the specified shutdown procedure before the UPS is exhausted. If the system has a sudden power failure, system failure may occur and consequently the system may not work correctly next time or even has a serious result. NOTE: If you forget the password, please contact the technical representative of EDAN. - 33 -
Telemetry Transmitter User Manual Patient Management Chapter 5 Patient Management The contents related to this chapter are all operated on MFM-CMS. 5.1 Admitting a Patient Once MFM-CMS starts up and telemetry transmitter is properly connected with MFM-CMS, the system will prompt the user to admit patients by displaying the number of pending patients at the information area. Click Admission in the quick control area to display a window of Pending patient list. Select the patients you want to admit from the left list in the window, and enter the patient information in the right area of the window. Click the Admission button at the bottom of the window to complete patient admission. After being admitted, a patient will occupy a patient sector. The MFM-CMS displays the real-time monitoring data which will also be stored in the database. For the telemetry transmitter that has been offline due to network problems and is networked with MFM-CMS later, you need not readmit the patient of this telemetry transmitter. This telemetry transmitter will be automatically online in the patient sector which it has occupied. WARNING For telemetry transmitters that have been networked with MFM-CMS for the first time, you have to complete patient admission by using the methods mentioned above, which enables the telemetry transmitters to be online and observed by MFM-CMS. Otherwise, the telemetry transmitters will not be online on MFM-CMS, and the monitoring data will not be saved by MFM-CMS. 5.2 Changing Patient Information You can change the patient information on MFM-CMS when you find the information incorrect. To modify the patient information, choose Single Bed View > Patient Mgmt, enter the correct information in the appropriate fields and click Update Monitor. In the patient management window, the user can modify the patient information, such as Serial No., Patient Name, Type, Gender, Bed No., Date of Birth and so on. After editing the information, click on the Update Monitor button to update the changes. The patient information can be printed when the user click on Print. NOTE: If you have changed the patient type via the MFM-CMS, the patient type on the telemetry transmitter will be changed accordingly. - 34 -
Telemetry Transmitter User Manual Patient Management 5.3 Switching Patient sector  For a disconnected patient sector (refer to Section 2.5.2.2 Patient Sectors), click anywhere in it and choose a patient to be assigned to this section from the patient list.  For a patient sector which is either improper offline or networked (refer to Section 2.5.2.2 Patient Sectors), select Show from the list on the patient sector (refer to Sector 6.3 Menu in the Patient Sector), and choose another telemetry transmitter from the patient list; the chosen telemetry transmitter will be displayed in this patient sector. 5.4 Discharging a Patient When the monitoring on a patient is completed, you need to discharge this patient by any of the following methods:  Choose Discharge from the menu in the patient sector (refer to Section 6.3 Menu in the Patient Sector).  Choose Patient Mgmt > Discharge on the auxiliary screen.  Discharge the patient via the Review window. Refer to Section 9.1.1 Patient Review. The operation of discharging a patient will cause the patient offline from the MFM-CMS, and there will be no patient admitted in the related patient sector. The discharged patient will be shown in the history patient list. Refer to Section 9.1.2 History Patient Review. 5.5 Transferring a Patient Select Patient Mgmt >Transfer on the auxiliary screen, and you will see a list of online patients. From this list, select a patient whose bed will be considered as the destination bed and click OK, and then the current patient will be transferred to the destination bed. NOTE: Transferring a patient to the destination bed will at the same time discharge the selected patient on the destination bed. 5.6 Monitoring Statistics The monitoring statistics of the selected patients will be shown in the patient management window. The monitoring statistics covers the total monitoring time for waveforms and trends, the number of alarm events. Click Analysis, the system will:  Analyze the number of high and low limit alarms for each physiological parameter and analyze the percentage of the limit alarms of the parameter in all limit alarms.  Analyze the number of arrhythmia events for each type of arrhythmia and analyze the percentage of a certain type of arrhythmia.  Analyze the average value, maximum/minimum value, and measure time of the maximum/minimum value for the trend values. - 35 -
Telemetry Transmitter User Manual Patient Management 5.7 Nurse Call / Patient Call For the telemetry transmitter connected to network, you can use the functions of nurse call and patient call. The MFM-CMS will response to the nurse call with a sound “du” once the patient presses the nurse call button on the telemetry transmitter.  The nurse call indicator will be displayed in the system information area on the main screen. You can cancel nurse call by clicking the indicator.  The nurse call symbol will appear in the patient sector and cover the waveforms. You can cancel nurse call by clicking the symbol.  The nurse call indicator will be displayed in the indicator area in the single bed window.  The nurse call tune will sound. Telemetry transmitter will give a sound “du-du-du” when patient call is triggered. Patient Call Symbol will also appear in the system information area on the main screen. You can perform or cancel the patient call via the MFM-CMS as follows:  Choose Call Patients from the menu in the patient sector (refer to Section 6.3 Menu in the Patient Sector) to trigger, and choose Cancel Patient Calling to cancel.  Select the tag Patient Mgmt of auxiliary screen and access the Patient Mgmt window. Click Call Patients in this window to trigger and click Cancel Patient Calling to cancel. After calling patients, you can also click Patient Call Symbol in the system information area on the main screen to cancel. - 36 -
Telemetry Transmitter User Manual Patient Sector Chapter 6 Patient Sector The contents related to this chapter are all operated on MFM-CMS. 6.1 Overview Refer to Section 2.5.2.2 Patient Sectors for information about the three types of state of the patient sector. Refer to Section 2.5.4 Large Font Display for information about the large font display mode in the patient sector. Refer to Section 2.5.2 Main Screen for information about the layout of patient sectors. When the patient sector is in the improper offline state or in the networked monitoring state, you can open a menu by clicking on the patient information area. Refer to Section 6.3 Menu in the Patient Sector for more information about the menu. When the patient sector is in the improper offline state or in the networked monitoring state, you can access the auxiliary screen by clicking on the waveform area or parameter area in the patient sector. When the patient sector is in the disconnected state, you can switch between patient sectors by clicking on the patient sector. Refer to Section 5.3 Switching Patient sector for more information. 6.2 Networked Monitoring Display The display of patient sector which is networked is shown as Figure 6-1. xxxxxxxxxxxx60 9936.5 40xx xx xx xxxx xx xx xx3124 5xxx xxx xxx Figure 6-1 Display of the Networked Patient Sector 1: Waveform area 2: Parameter area 3: Patient information area 4: Technical alarm/ Prompts/ indicator area 5: Physiological alarm area  Waveform area and parameter area: It displays some of real-time monitoring waveforms and parameter values. Refer to Section 6.4 Parameter / Waveform Setup.  Patient information area: It displays the bed number, device name and patient name.  Technical alarm/ Prompts/ Indicator area: It displays the technical alarm messages when a technical alarm occurs (refer to Section 11.1.2 Technical Alarms). Click on the technical alarm message, and the list for the current technical alarms will be displayed. When no technical alarms and no prompts occur, it displays the indicators (shown as Table 6-) - 37 -
Telemetry Transmitter User Manual Patient Sector indicating the state of the telemetry transmitters. Indicator Description Pace on Pace off Battery power of the telemeter transmitter: Level 4 Battery power of the telemeter transmitter: Level 3 Battery power of the telemeter transmitter: Level 2 Battery power of the telemeter transmitter: Level 1 Battery power of the telemeter transmitter: Level 0 Wi-Fi signal intensity of the telemeter transmitter: Level 4 Wi-Fi signal intensity of the telemeter transmitter: Level 3 Wi-Fi signal intensity of the telemeter transmitter: Level 2 Wi-Fi signal intensity of the telemeter transmitter: Level 1 Table 6-2 Telemetry Transmitters State Indicators  Physiological alarm area: It displays the physiological alarm messages (refer to Section 11.1.1 Physiological Alarms). Click on the physiological alarm message, and the list for the current physiological alarms will be displayed. CAUTION 1 Due to the delay of network transmission, the waveform viewed at the MFM-CMS has a delay of 5 seconds compared with the waveform generated at the corresponding telemetry transmitter. 2 Due to the operating system schedule, the waveform scan of the MFM-CMS might be suspended for about 20 milliseconds in very few occasions. After the suspension, waveform scan will go back to normal status. The quality of patient monitoring during the suspension will not be affected. - 38 -
Telemetry Transmitter User Manual Patient Sector 6.3 Menu in the Patient Sector When the patient sector is in the improper offline state or in the networked monitoring state, you can open a menu by clicking on the patient information area. The available items in this menu are:  Display the window in large font: Switch between the large font display mode and the general display mode for the current patient sector. Refer to Section 2.5.4 Large Font Display.  Display all windows in large font: Switch between the large font display mode and the general display mode for all patient sectors. Refer to Section 2.5.4 Large Font Display.  Parameter/Waveform Setup: Switch to the Parameter/Waveform Setup window on the auxiliary screen. Refer to Section 6.4 Parameter/ Waveform Setup.  Monitor Parameter Setup: Switch to telemetry transmitter Parameter Setup window on the auxiliary screen. Refer to Section 8.2 Setting Parameters.  Discharge: Discharge the patient in the current patient sector. Refer to Section 5.4 Discharging a Patient.  Freeze: Freeze/ unfreeze the waveform in the current patient sector. Refer to Section 6.5 Freeze.  Print: Print the monitoring data in the current patient sector. Refer to Section 6.6 Real-Time Printing.  Call Patients: Nurse calls patient. Refer to Section 5.7 Nurse Call / Patient Call.  Show: Switch between patient sectors. Refer to Section 5.3 Switching Patient sector.  Alarm Reset: Activate alarm reset function. Refer to Section 6.7 Alarm Reset. 6.4 Parameter/ Waveform Setup Due to the limited display space of the patient sector, the numbers of waveforms and parameters to be displayed depends on the numbers of telemetry transmitters displayed on patient sector which can be set by users (refer to 10.1.2 Display Setup). 6 waveforms and 4 parameters to be displayed on patient sector are the maximum. You can set the displayed waveforms and parameters by setting configuration in the Parameter/Waveform Setup window. You may access this window by either of the two methods below:  Choose Parameter/ Waveform Setup from the menu on the patient sector.  Click the tag Parameter/ Waveform Setup on the auxiliary screen. 6.4.1 Setting Waveforms Select or deselect the check box before a Wave Name to display or not display the waveform. Click Update Wave Setup to confirm the configuration. The patient sector will only display the selected waveforms. Choose Speed and set the desired sweep speed for the waveform. Click Update Wave Setup to - 39 -
Telemetry Transmitter User Manual Patient Sector confirm the configuration. The waveform will be displayed according to the speed you have set. NOTE: Waveform setting is applicable only when the relevant module switches on. 6.4.2 Setting Parameters  Adding a parameter to be displayed To add a new parameter to be displayed, select the desired parameter name in Available Params and click on Add to add it into Current Params, and then click on Refresh ParamGroup to update the parameters displayed on the patient section.  Removing a parameter displayed To remove a parameter displayed, select the parameter in the Current Params box, and click on Remove and Refresh ParamGroup.  Setting Parameter Order for Display To adjust the display position of the parameter, select the parameter name in the Current Params box, and click on Move UP or Move Down. To make the change valid, click on Refresh ParamGroup. NOTE: Due to the limited display space, the displayed waveforms and parameters of each patient sector will decrease as the displayed patient sectors increase. If you want more waveforms and parameters to be displayed in one patient sector, modify the display layout by reducing the patient sectors displayed on the main screen. 6.5 Freeze Choose Freeze from the menu in the patient sector, you can freeze the waveform displayed in this patient sector. And the item name Freeze is changed into Unfreeze. You can unfreeze the waveform by choosing Unfreeze. And then the item name will resume Freeze. The wave stops scanning during freeze. The freeze time and a timeline will also be displayed in the window. You can use the arrow buttons and beside the timeline or drag the pointer on the freeze wave to review more details. You can review a frozen waveform of 3-minute period in length. 6.6 Real-Time Printing To print real-time data from MFM-CMS, click Print from the menu in the patient sector or click the Print button in the single bed window. After you select Print, MFM-CMS starts to collect data for printing and the system will indicate Collecting Data… at the top of the main screen. After the system completes 11-second data collecting, a dialog box for printing setup will appear. The printout includes the 11-second waveform data starting from the time chosen as the beginning time for printing, data of all - 40 -
Telemetry Transmitter User Manual Patient Sector physiological parameters at the time you select Print and the latest NIBP measurement which is the nearest from the time finishing collecting. 6.7 Alarm Reset Choose Alarm Reset from the menu in the patient sector to activate the alarm reset function. During the alarm reset status, MFM-CMS will do the followings:  The audio alarm is turned off, and no alarms are sounding.  The visual alarm indications are still displayed.  Clear all the latched alarms. NOTE: If a new alarm occurs during the alarm reset period, the new alarm on MFM-CMS will recover normal. That is, the new alarm will be sounded and displayed. - 41 -
Telemetry Transmitter User Manual Viewing Single Bed Chapter 7 Viewing Single Bed The contents related to this chapter are all operated on MFM-CMS. 7.1 Display of Single Bed The Single Bed View sub-window (shown as Figure 7-1) will be displayed by default when you access the auxiliary screen. xxxxxxxxxxxx609936.540xx xxxx xxxx xxxx xx16825xxx xxx xxxxxxxxxxxxxxxxxxx479xxx3xxx Figure 7-1 Single Bed View Sub-Window 1: Patient information area 2: Toolbar 3: Indicator area 4: Technical alarm area/ Prompts area 5: Physiological alarm area 6: Short trend area 7: Waveform area 8: Parameter area 9: Scroll bar  Patient information area: It displays the bed No., patient name, gender, patient type, and telemetry transmitter name.  You can perform the following functions via the toolbar: – Freezing or unfreezing the waveforms displayed in the Single Bed View sub-window. – Real-time printing (refer to Section 6.6 Real-Time Printing). – Display setup: choosing the multi-lead waveform of ECG to be hided or shown (refer to Section 7.2 Hiding/Showing Multi-Lead Waveform); setting the short trend display to on or off; choosing the OxyCRG window to be opened or closed.  Indicator area: It displays indicators indicating the state of the telemetry transmitters (refer to Table 6-). Nurse Call indicator will also be displayed here once the patient presses the nurse call button on the telemetry device.  Technical alarm area/ Prompts area: It displays technical alarm messages consistent with the messages displayed in the patient sector. The mouse operation here of technical alarm is the - 42 -
Telemetry Transmitter User Manual Viewing Single Bed same as the one in patient sector (refer to Section 6.2 Networked Monitoring Display).  Physiological alarm area: It displays physiological alarm messages consistent with the messages displayed in the patient sector. The mouse operation here of physiological alarm is the same as the one in patient sector (refer to Section 6.2 Networked Monitoring Display).  Short trend area: When the short trend display is on, the short trend will be displayed in this area. When the short trend display is off, waveforms will be displayed in this area.  Waveform area: It displays all waveforms from the networked telemetry transmitter.  Parameter area: It displays all parameters from the networked telemetry transmitter.  Scroll bar: You can drag the scroll bar to view more waveforms and parameters in this window. 7.2 Hiding/Showing Multi-Lead Waveform Choose View Selection > Multi-lead on the toolbar in the Single Bed View sub-window. The waveform area can display multi-lead waveforms for ECG (shown as Figure 7-2). Choose View Selection > Multi-lead again, and the multi-lead waveform display for ECG will become unavailable. xxxxxxxxxxxxxxxxxxxxx Figure 7-2 Multi-Lead Waveforms for ECG 7.3 Short Trend Review After entering the single bed view interface, choose View Selection > Trend Screen on the toolbar and the short trend will be displayed on the left of the interface. Click short trend area and a dialog box of short trend settings will pop up. You can set the display mode of the short trend with the optional items in Param Select and Interval. You may select the desired parameters needed to be displayed from the drop-down list of Param Select. Also, you can set the interval of the short trend by choosing from 1h, 2h, 4h, 8h and 12h in the drop-down list of Interval. - 43 -
Telemetry Transmitter User Manual Viewing Single Bed 7.4 OxyCRG In the Single Bed View window, choose View Selection > OxyCRG on the toolbar, and the OxyCRG window will be open. You can switch the display between respiratory rate and respiratory waveform by clicking RR and RESP. You can also set the interval of the OxyCRG to 1 minute, 2 minutes or 4 minutes. 7.5 Freeze You can freeze the waveform displayed in this window by choosing Freeze on the toolbar and unfreeze the waveform by choosing Unfreeze. The display of freezing waveform in the Single Bed View sub-window is consistent with the one in the patient sector. Refer to Section 6.5 Freeze for more information. - 44 -
Telemetry Transmitter User Manual Setting Telemetry Transmitters via MFM-CMS Chapter 8 Setting Telemetry Transmitters via MFM-CMS The contents related to this chapter are all operated on MFM-CMS. 8.1 Changing Patient Information Refer to Section 5.2 Changing Patient Information for more information. 8.2 Setting Parameters You can open the parameter setup window by two methods: Method 1: Choose Monitor Parameter Setup in the patient sector. Method 2: Select the parameter area in the single bed interface, and click on the chosen parameter area. 123 45 Figure 8-1 The Layout of the Parameter Setup Window 1: Physiological parameter list; 2: Alarm display and configuration list; 3: Physiological parameter attribute and configuration; 4: Update Monitor button; 5: Button for closing the window The layout of the parameter setup window is shown as Figure 8-1. The physiological parameter list shows all the available physiological parameter module of the networked telemetry transmitter. Choose a parameter, the relevant alarm settings and parameter attribute will be respectively displayed in Area 2 and Area 3. You can configure the alarm settings (including alarm level, alarm switch, alarm upper and lower limits) and modify parameter attributes, after which you click Update Monitor to update the relevant settings of the telemetry transmitter. Clicking button 5 can close parameter setup window. - 45 -
Telemetry Transmitter User Manual Setting Telemetry Transmitters via MFM-CMS 8.2.1 Parameters Alarm Setting You can configure the alarm setting via the alarm display and configuration list on the parameter setup window. You can configure the alarm switch, alarm level, alarm upper and lower limits. The operation steps are shown as follows: 1. Choose a parameter from the physiological parameter list. 2. Configure the alarm settings in the alarm display and configuration list. 3. Click Update Monitor to bring the configuration into effect. WARNING 1 Prior to monitoring, make sure that the alarm limit settings are appropriate for your patient. 2 When the alarm is set to OFF, MFM-CMS won’t give an alarm even if an alarm occurs. In order to avoid endangering the patient’s life, the user should use this function cautiously. 3 Setting alarm limits to extreme values may cause the alarm system to become ineffective. It is recommended to use the default settings. 8.2.2 Physiological Parameter Attribute and Configuration For the telemetry transmitters, the MFM-CMS can display the parameter attributes of ECG, SpO2 and RESP whose settings can also be configured. You can configure the following items for the parameter ECG of the telemetry devices: lead type, Calc. lead, pace, alarm source, filter, ECG Gain, ST Analysis, ARR Analysis, Smart LeadOff, Hum Filter and electrode setup. You can configure the following items for the parameter SpO2 of the telemetry devices: Sensitivity and Alarm Source (when choose PR). You can configure the following items for the parameter RESP of the telemetry devices: RESP Lead, Apnea Time and ECG Gain. NOTE: Telemetry transmitter reads leads style automatically. Electrode setup is only applicable to ECG lead off alarms for telemetry transmitter. - 46 -
Telemetry Transmitter User Manual Review Chapter 9 Review The contents related to this chapter are all operated on MFM-CMS. Via the MFM-CMS, you can review the history data of patients, which includes the list containing all patients, patient management, trend, alarm and wave. By clicking on the review button in quick control area of main screen, you can enter the review interface. 9.1 Patient List Clicking review button in quick control area of main screen and you will access the review interface. It displays the Patient List by default. By respectively selecting the items from the drop-down list shown at the top left corner, you can review the list of patients who have been admitted by the MFM-CMS, the list of patients who have been discharged, and the list of patients saved in the backup database. You can select a patient from the list and click the Patient Mgmt tab to review detailed information of this patient. Also, you can double click the patient name in the list to open the patient management window. Choose Trend Review, Alarm Review and Wave Review, you can review relevant monitoring data of the patient. There is a query column and a small inverted triangular black indicator on the top right corner of review interface. To search a patient’s information, click the inverted triangular black indicator and choose one of items (such as MRN, patient’s first name, patient’s family name and doctor) from the drop-down list. Input patient’s information related with the items and click on Query. If the patient information is saved, the corresponding information is displayed on the screen. 9.1.1 Patient Review By default, the Patient List displays the patients who have been admitted by the MFM-CMS after entering the review interface. And also, the default items from the drop-down lists shown at the top left corner will be Online Database Source and Patient Review. Select a patient and click Discharge, and this patient will be discharged. The discharged patients will be transferred to the History Patient Review list. Refer to Section 9.1.2 History Patient Review for more information. 9.1.2 History Patient Review Respectively select Online Database Source and History Patient Review from the drop-down lists shown at the top left corner, and you can review the list of patients who have been discharged. To delete patients, please: Select a patient > click Delete > input password ABC in popup window > click OK to finish deleting. The patients deleted will be completely deleted from the MFM-CMS. - 47 -
Telemetry Transmitter User Manual Review CAUTION If you delete a patient from the History Patient Review list, his or her data will be completely removed from the system. 9.1.3 Backup Patient Review Select Offline Database Source from the drop-down list shown at the top left corner, and you can review the backup patient data. Refer to Section 0 Reviewing Backup Database for more information. 9.2 Wave Review The MFM-CMS can review the change process of the physiological waveform of one patient in the latest 96 hours. And the system can provide 96-hour waveform review. To use 96-hour waveform review, please click on Main Screen > Review > Wave Review or access the auxiliary screen and choose Wave Review. On this screen, you can:  Review normal waveforms or compressed waveforms  Set wave speed  Select waveform  Refresh waveform  Print 9.2.1 Reviewing Normal Waveforms Normal waveform review is available to all parameter waveforms. In the normal waveform review window, the waveform is displayed with the same altitude and speed of the real-time waveform. You can select Show parameters/Hide parameters. If you select Show parameters, the related parameter value will also be displayed accompanying the waveform you choose. In this window, waveforms can also be presented by automatically sliding forward. 9.2.2 Reviewing Compressed Waveforms Compressed waveform review is only available to ECG waveforms. In the compressed waveform review window, the altitude of the ECG waveform will be compressed so that you can review the waveform containing longer time of data. - 48 -
Telemetry Transmitter User Manual Review 9.2.3 Setting Wave Speed By clicking on the Sweep button, you can set the width of waveforms displayed in the waveform area. Available options are 6.25 mm/s, 12.5 mm/s, 25 mm/s and 50 mm/s. Changing wave speed will affect the time length of the waveform area. 9.2.4 Refreshing Waveform Waveform will not update automatically. Therefore, if you want to view up-to-date waveform, you have to refresh them manually. Clicking on the Refresh button will refresh the waveform. 9.2.5 Selecting Waveform Click on the Select Wave button, and a list of available waveforms will be shown. By default, all waveforms are selected. You can deselect a waveform by ticking its check box. NOTE: The 96-hour full disclosure waveform storage will occupy a lot of hard disc. Therefore, the user shall be cautious to add additional waveform to the selecting waveform setup. 9.2.6 Print To print the waveform displayed on the current screen, please select Print on the screen to print it by the laser printer. 9.3 Alarm Review Alarm table and waveform will be generated when the MFM-CMS makes physiological alarm notification. Alarm review helps the clinician observe the details of the monitoring information. Alarm information can be stored by the user and thus become important alarm event. An alarm strip in the alarm review is a 16-second waveform. NOTE: If telemetry transmitter or MFM-CMS switches off, the alarm information stored by MFM-CMS will not be deleted. A maximum of 720 alarm information can be stored. If the storage space is full and there are new alarms occur, the earliest alarm information will disappear. 9.3.1 Locking and Unlocking Alarm Information When the user thinks that an alarm is very important, he/she can save it by locking the alarm information with a symbol √ on the alarm review interface. The symbol √ will appear to its right on this interface when the alarm is locked. The locked alarm cannot be deleted automatically. You can click on the symbol √ to unlock the locked alarm, the symbol √ will disappear. - 49 -
Telemetry Transmitter User Manual Review 9.3.2 Printing Alarm Information If the user wants to print alarm table, he/ she can click on Print on the interface to print it by a laser printer. NOTE: 1 The important alarm events can be deleted but not automatically .The non-important alarm events can be automatically replaced by new alarm events when they have accumulated to a certain amount. 2 The alarm stripe displays the physiological waveform at 25mm/s when an alarm takes place. 9.3.3 Sequencing the Alarm List You can sequence all alarms ascendingly or descendingly by clicking on the heading of any column:  Alarm Time: Clicking on it will sequence all alarms ascendingly or descendingly by time.  Alarm Information: Clicking on it will sequence all alarms ascendingly or descendingly by parameter.  Alarm Level: Clicking on it will sequence all alarms ascendingly or descendingly by level. At the same time, one of the following symbols will appear on the bottom of the heading:  The symbol ▲ indicates ascending sequence, and  The symbol ▼ indicates descending sequence. 9.3.4 Annotating Alarm You can add notes to illuminate an alarm. To annotate an alarm, select a certain alarm stripe and you will see the title Alarm Note on the bottom of the alarm review interface. Move the cursor 1cm left to the title Alarm Note and a pop-up input box in which you can input detailed information for the alarm will appear. After you complete your notes, move the cursor out of the area of the input box, and MFM-CMS will automatically save the input information. NOTE: Input characters are limited to 256. 9.3.5 Filtering Alarm Events You can filter alarm events by selecting or clearing the check boxes before the items in the Alarm Level list and in the Param Select list. The Alarm Review window will only display the alarm events whose alarm level /levels has/have be selected and the alarm events of selected parameters. - 50 -
Telemetry Transmitter User Manual Review 9.4 Trend Review Choose Main Screen > Review > Trend Review or choose Trend Review on the auxiliary screen, and you will enter the trend review interface, through which you can store and review up to 240 hours of trend data. Change of trends can be observed through trend table and trend graph. On this interface, you can:  set the resolution  view parameters selectively  refresh the data  print  Time Setup, can set the starting and ending time for review. 9.4.1 Setting Resolution You can select a time period as the resolution for viewing the graph and table as required. Options are 1s, 5s, 1m, 5m, 15m, 30m and 60m. To change the resolution, select Resolution Setting on the interface and select the desired option from the list. 9.4.2 Viewing Parameters selectively In the parameter list of Param Select, you can select modules or parameters by ticking their check boxes as required. Only the selected parameters are displayed in the graph or table. When a parameter module is selected or unselected, all of its parameters will be selected or unselected accordingly. 9.4.3 Refreshing Data Trend data will not update automatically. Therefore, if you want to view up-to-date trend data, you have to refresh them manually. Click on the Refresh button to refresh the data to up-to date. After refreshing them, the status selected and order of parameters remain unchanged. 9.4.4 Printing Trend Review Clicking on Trend Review > Print > Print Trend Table/ Print Trend Graph, you can print the trend table or the trend graph. By default, the system will print the latest data. 9.4.5 Selecting Trend Table, Trend Graph Select Trend table to review the trend table only. Select Trend Graph to review the trend graph only. Select Trend Table, Trend Graph to review the trend table and trend graph at the same time. - 51 -
Telemetry Transmitter User Manual System Setup Chapter 10 System Setup The contents related to this chapter are all operated on MFM-CMS. The System Setup function is used to modify the display information at the patient section according to the real requirements. By using this function, you can observe the waveform, parameter, and the parameter list as your desire. There are Common Setup, User Maintain, and Factory Maintain to be set. 10.1 Common Setup It is mainly used to make some conventional monitoring settings, such as Param Unit Setup, Color Settings, Display Setup, Help and Telemetry Module Switch Setup. 10.1.1 Color Setup The user can change the display color of all parameters and the other information of the parameter is displayed as the same color. And the information includes waveform name, gain and filter, real-time value (upper limit and lower limit), review waveform and so on. To change the color of the parameter: 1. Please select Main Screen > System Setup > Common Setup > Color Setup. Click on the Param Select to choose desired parameter, then choose desired color from the left color area or input desired RGB values of red, green, blue directly. 2. After this, click on OK to confirm. After setting, the color displayed on Color Setup colomn is the successfully chosen color. The color on Initial Color colomn is set by default. To get the default color, choose desired parameter from Param Select and click Default Settings, and then click OK to confirm. 10.1.2 Display Setup The user can set the bed numbers to be viewed on the screen. To change the display to be viewed, please select Main Screen > System Setup > Common Setup > Display Setup and choose the desired bed number 3, 4, 6, 8, 10, 12, 14, 16, 32, 64 from the drop-down list of display bed. NOTE: Two screens are needed if you want to simultaneously display the information of 64 telemetry transmitters. 10.1.3 Telemetry Module Switch Setup You can configure the module switch setting of the telemetry transmitter via the MFM-CMS. Choose Main Screen > System Setup > Common Setup > Telemetry Module Switch Setup. From the Telemetry Device List on the left of the setup window, choose the telemetry transmitter - 52 -
Telemetry Transmitter User Manual System Setup for which you want to configure the module switch setting. On the right of the setup window, configure the setting as required. 10.1.4 Help Help information is available on this interface. 10.2 User Maintain To access the settings interface of user maintain, you have to input a user password. The default password is ABC. 10.2.1 Telemetry Transmitter Batch Settings You can configure the alarm limit, alarm switch and alarm level for a group of telemetry transmitters. You need to choose a patient type from Adult or Pediat before you configure the alarm settings in Templet of Alarm Limit Adjusting Range. Choose the telemetry transmitters needing to be configured in the right pane in which you may see a list of telemetry transmitters, and click Config. The configuration in the left templet pane will be applied to the chosen telemetry transmitters. Besides, from the right pane, you can choose a telemetry transmitter whose alarm settings will serve as the source of batch settings for other telemetry transmitters. Select one telemetry transmitter in the right pane and click Obtain Monitor Configuration to obtain its parameter alarm settings. The obtained configuration will be displayed in the left templet pane. Choose the telemetry transmitters needing to be configured in the right pane and click Config to complete batch settings. NOTE: 1 If the patient type set in Templet of Alarm Limit Adjusting Range is different from the one set on the telemetry transmitter to be configured, the system may fail to set the configuration for telemetry transmitter. 2 The prompt message Success only indicates success in setting the configuration for current activated parameters on the telemetry transmitter. 10.2.2 Telemetry Alarm Latch Setup You can configure the alarm latching setting of the telemetry transmitter via the MFM-CMS. Choose Main Screen > System Setup > User Maintain > Telemetry Alarm Latch Setup. From the Telemetry Device List on the left of the setup window, choose the telemetry transmitter for which you want to configure the latching setting. On the right of the setup window, configure the setting as required. The latching alarm setting of the telemetry transmitter is off by default. For telemetry transmitter which has been offline and then online and in which the patient is admitted again, the latching alarm configuration remains the same as the last configuration used by the telemetry transmitter. - 53 -
Telemetry Transmitter User Manual System Setup To clear the alarms latched, please choose Alarm Reset from the menu in the patient sector. Refer to 6.3 Menu in the Patient Sector for details. 10.2.3 Date/Time Setup To change date and time for MFM-CMS, please refer to 3.8 Setting Date and Time. 10.2.4 MFM-CMS System Alarm Setup You can configure the alarm setting for the MFM-CMS. You can set the duration for the audio pause to 1 minute, 2 minute or 3 minute. By click the Audio Pause button on the main screen, you can activate or deactivate the audio pause function. You can enable/disable alarm mute function by selecting/ deselecting the Alarm Mute check box. When Alarm Mute is not selected, the alarm Mute is disabled. When Alarm Mute is selected, the alarm mute function is enabled. The icon is displayed at the top area of the screen. You can set alarm sound intervals by choosing the desired intervals from the drop-down list of High Alarm Interval (s), Med Alarm Interval (s) and Low Alarm Interval(s). NOTE: Once a new alarm occurs, the system will neglect the existing settings of Alarm Mute and generate a new alarm. 10.2.5 Changing Language To change the display language, please select Main Screen > System Setup > User Maintain, and input the correct password. Select Language Setup and select the desired language from the drop-down list. NOTE: The user must restart MFM-CMS to make the change effective. 10.2.6 HL7 Users can set the interval for HL7 data to be sent and set the format of HL7 packing data sent by MFM-CMS. The interval can be set to 1 to 120 minutes. HL7 data is sent in the format of HL7 Lower Level Protocol by default. If the item XML is selected, the data sent by MFM-CMS will be packed in the XML format. NOTE: HL7 data is sent via the port 9100 by default. - 54 -
Telemetry Transmitter User Manual System Setup 10.2.7 Database Maintain Refer to Section 14.1 Database Backup for more information about database backup. 10.2.8 Other Setups On this interface, you can:  Set Hospital Info. and Department. The hospital information and department will be displayed at the top left corner on the main screen.  Choose to display or conceal the grid in the View window by selecting or clearing the check box of Display Grid on View.  Set Electrode Setup to AHA or IEC. Electrode setup is only applicable to ECG lead off alarms for telemetry transmitter.  Return to Windows.  Switch off the system. 10.2.9 User Password Setting To modify the password, enter the old password in the Old Password field and a new one in the New Password field, after which you have to Confirm new password to complete the modification. NOTE: If you forget the password, please contact the technical representative of EDAN. 10.2.10 About It offers information about the software compiled time and software version. - 55 -
Telemetry Transmitter User Manual Alarm Management Chapter 11 Alarm Management The contents related to this chapter are all operated on MFM-CMS. 11.1 Overview Alarms, triggered by a physiological sign that appears abnormal or by technical problems of the telemetry transmitter, are sent to the MFM-CMS by the telemetry transmitters and then indicated to the users by the MFM-CMS. Alarms coming from the telemetry transmitters are displayed in the patient sectors and in the single bed view window. The alarm and prompts coming from the MFM-CMS system are displayed in the system information area on the upper screen. WARNING A potential hazard can exist if different alarm presets are used for the same or similar equipment in any single area, e.g. an intensive care unit or cardiac operating room. NOTE: The alarm signal will be delayed for no more than 5 seconds. 11.1.1 Physiological Alarms If one or several physiological parameters of the currently monitored patient exceed the predefined alarm limit, the telemetry transmitter will give an alarm, and this type of alarm is called physiological alarms. It includes parameter alarm and arrhythmia alarm. About the detailed alarm information, please refer to the Section Chapter 12 Alarm Information. Physiological information alarm arouses the doctors’ attention by means of visual and audible methods specified in harmonized international standard. Visual method is realized basically by the way of lightening or flicking of the color light. Audible method is realized by the sound for different levels. Physiological alarms are implemented by alarm limits, which define a range in which a certain physiological parameter is considered to be in the normal status. When a parameter value is beyond the range, the system will consider it to be in an abnormal status and consequently give an alarm. 11.1.2 Technical Alarms If one or several technical status of the device is in abnormal status, the telemetry transmitter will send an alarm to MFM-CMS. And this type of alarm is called technical alarms. Technical alarms can’t be disabled. Technical alarms of telemetry transmitter refer to alarms other than physiological alarms, including hardware failure, communication error, lead off, etc. About the detailed alarm information, please refer to Section Chapter 12 Alarm Information. - 56 -
Telemetry Transmitter User Manual Alarm Management For these technical alarms, the system indicates by four different types of audible and visual prompts. When a group of technical alarms (for example, transducer falls off) produced by telemetry transmitters, a piece of alarm prompt information in scrolling mode will appear on the main screen of MFM-CMS. In addition, the MFM-CMS will sound corresponding alarm (high, medium or low level alarm). 11.1.3 Prompts Telemetry transmitter can send the character indication of monitoring process or other functions to MFM-CMS. This character, with black background, white font and with no alarm sound, is called prompts. The About the detailed alarm information, please refer to Section Chapter 12 Alarm Information. 11.2 Alarm Levels Alarm level reflects the severity of an alarm. The alarms from telemetry transmitters are divided into three groups regarding the alarm levels. 1. High level alarms A high level alarm intensively warns the operator of a high priority alarm condition which requires immediate operator response. Failure to respond to the cause of the alarm condition is likely to result in death or irreversible injury of the patient. 2. Medium level alarms A medium level alarm warns the operator of a medium priority alarm condition which requires prompt operator response. Failure to respond to the cause of the alarm condition is likely to result in reversible injury of the patient. 3. Low level alarms A low level alarm reminds the operator of a low priority alarm condition which requires response. And the response time for a low priority alarm condition can be greater than that for a medium priority alarm condition. Failure to respond to the cause of the alarm condition is likely to result in discomfort or reversible minor injury of the patient. 11.3 Parameters Alarm Setting Refer to 8.2.1 Parameters Alarm Setting for Information related to parameters alarm setting. 11.4 Alarm Mute For information about how to set alarm mute, refer to Section 10.2.4 MFM-CMS System Alarm Setup. Alarm mute means that when an alarm occurs, the system will not give an alarm sound but only maintain a visual prompt. - 57 -
Telemetry Transmitter User Manual Alarm Management NOTE: Once a new alarm occurs, the system will neglect the existing settings of Alarm Mute and generate a new alarm. 11.5 Audio Pause Audio Pause means that during a period of time, when an alarm occurs, the system will not give alarm announcement. The duration setting is introduced in Section 10.2.4 MFM-CMS System Alarm Setup. By click the Audio Pause button on the main screen, you can activate or deactivate the audio pause function. When the duration of alarm pause has lasted for the preset-time, the system will stop the status of alarm pause and resume normal alarm automatically. NOTE: Once a new alarm occurs, the system will neglect the existing settings of Alarm Voice Pause and generate a new alarm. 11.6 Alarm Prompt/Response Alarm information can be prompted by means of visual and audible methods. Because the alarm information is very important and timely response to the alarm information is highly required, the MFM-CMS provides the following methods to indicate to the user the occurrence of the alarm.  The alarm message will be displayed in the technical area or physiological area of the patient sector and of the single bed view window. High level alarm: displayed with red background Medium level alarm: displayed with yellow background Low level alarm: displayed with yellow background  An asterisk or more will be displayed before the physiological alarm message to indicate the alarm level. High level alarm: *** Medium level alarm: ** Low level alarm: *  For limit alarms of the parameter, the relevant parameter value and alarm limit value will be respectively displayed with the color alternating between the parameter color and the alarm color. When physiological alarm exceeds the alarm limit, the icons for parameters exceeding the alarm limits will be displayed in parameter value area. The icon is for high level alarm; Icon is for medium and low level alarm. - 58 -
Telemetry Transmitter User Manual Alarm Management  Alarm sound If the system mute, alarm mute or alarm pause setup is deactivated, the system will warn the user about the alarm with the alarm sound. The sound pressure range for audible alarm signals is from 45 dB to 85 dB. The alarm sound can be: High level alarm: sound "DO-DO-DO DO-DO DO-DO-DO DO-DO"; The adjustable range of alarm sound interval is from 6 to 15 seconds. Medium level alarm: sound "DO-DO-DO"; The adjustable range of alarm sound interval is from 6 to 30 seconds. Low level alarm: sound "DO- ". The adjustable range of alarm sound interval is from 15 to 30 seconds. WARNING 1 Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Please remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. 2 Ensure the volume is properly set up. When the sound pressure of audible alarm is below or equivalent to the ambient noise, it may be difficult for the operator to distinguish the audible alarm. 11.7 Testing Alarms When you switch the MFM-CMS on, a self-test is started. Refer to 4.2.2 Switching on/off the MFM-CMS. The physiological alarms, technical alarms and prompts from telemetry transmitter are displayed on MFM-CMS. Before monitoring, user should perform the measurement on yourself or use a simulator to check the follows:  System information area can normally display technical alarms and prompts of MFM-CMS system;  Patient sector and single bed view can normally display physiological alarms, technical alarms and prompts of telemetry transmitter;  Alarm sound can be heard clearly. The correct checking above indicates that the visible and audible alarm are functioning correctly. For further alarm tests, please adjust the alarm limits to check whether the alarm response is correct. - 59 -
Telemetry Transmitter User Manual Alarm Management 11.8 Alarms for Networking Status When telemetry transmitter is online or offline, the system will indicate it with a sound of “du”. If telemetry transmitter is offline without being discharged, the system will indicate it with medium level alarm sound whose interval is same with interval of medium level alarm sound for parameters alarm. - 60 -
Telemetry Transmitter User Manual Alarm Information Chapter 12 Alarm Information All alarm information will be displayed on MFM-CMS. WARNING During monitoring, the physiological alarms including ASYSTOLE, VFIB/VTAC, RESP APNEA and SpO2 No Pulse are preset to be on and cannot be turned off. 12.1 Physiological Alarm Information Message Cause Alarm level HR High HR measuring value is above the upper alarm limit. User-selectable HR Low HR measuring value is below the lower alarm limit. User-selectable ST-X High ST measuring value is above the upper alarm limit. (X stands for I, II, III, aVR, aVL, aVF, V) User-selectable ST-X Low ST measuring value is below the lower alarm limit.(X stands for I, II, III, aVR, aVL, aVF, V) User-selectable PVCs High PVCs measuring value is above the upper alarm limit. User-selectable ASYSTOLE No QRS is detected for 4 consecutive seconds High (user-unselectable) VFIB/VTAC 4 consecutive seconds' fibrillation wave occurs, or each RR interval for 5 consecutive ventricular beats is less than 600 ms. High (user-unselectable) VT>2 3 ≤ the number of consecutive PVCs < 5 User-selectable COUPLET 2 consecutive PVCs User-selectable BIGEMINY A dominant rhythm of N, V, N, V (N = supraventricular beat, V = ventricular beat) was detected. User-selectable TRIGEMINY A dominant rhythm of N, N, V, N, N,V User-selectable R ON T A type of single PVC under the condition that HR<100，R-R interval is less than 1/3 the average interval, followed by a compensating pause of 1.25X the average R-R interval (the next R wave advances onto the previous T wave). User-selectable PVC Single PVC detected in normal heartbeats. User-selectable TACHY Adult: RR interval for 5 consecutive QRS complex ≤ 0.5s. Pediatric: RR interval for 5 consecutive QRS complex ≤ 0.375s. User-selectable - 61 -
Telemetry Transmitter User Manual Alarm Information Message Cause Alarm level BRADY Adult: RR interval for 5 consecutive QRS complex ≥ 1.5s. Pediatric: RR interval for 5 consecutive QRS complex ≥ 1s. User-selectable MISSED BEATS If HR < 120 bpm, no beats are detected for 1.75 times average RR interval; or if HR ≥ 120 bpm, no beats are detected for one second. User-selectable IRR Consistently irregular heart rhythm User-selectable PNC (with pacemaker) PACE NOT CAPTURE: no QRS complex detected in 300ms after a pace pulse. User-selectable PNP (with pacemaker) PACER NOT PACED: no pace pulse detected in 1.75 times RR interval after a QRS complex. User-selectable VBRADY VENTRICULAR BRADYCARDIA: Each RR interval for 5 consecutive ventricular beats > 1000 ms. User-selectable VENT VENTRICULAR RHYTHM: Each RR interval for 5 consecutive ventricular beats ranges from 600 ms to 1000 ms. User-selectable RESP APNEA RESP cannot be measured within the set apnea alarm delay time. High (user-unselectable) RR High RR measuring value is above upper alarm limit. User-selectable RR Low RR measuring value is below lower alarm limit. User-selectable SpO2 High SpO2 measuring value is above upper alarm limit. User-selectable SpO2 Low SpO2 measuring value is below lower alarm limit. User-selectable SpO2 No Pulse The signal of the measurement site is too weak, so the telemetry transmitter can’t detect the pulse signal. High (user-unselectable) PR High PR measuring value is above upper alarm limit. User-selectable PR Low PR measuring value is below lower alarm limit. User-selectable - 62 -
Telemetry Transmitter User Manual Alarm Information 12.2 Technical Alarm Information NOTE: The ECG alarm information listed in the below table describes the lead names in America. For the corresponding lead names in Europe, please refer to the section Installing Electrodes. Message Cause Alarm Level Action Taken ECG Lead Off 1) The drive electrode or more than one ECG limb electrode falls off the skin; 2) ECG cables fall off the telemetry transmitter. Low Make sure that all electrodes, leads and patient cables are properly connected. ECG LL Lead Off ECG electrode LL falls off the skin or the ECG cable LL falls off the telemetry transmitter. Low Make sure that all electrodes, leads and patient cables are properly connected. ECG LA Lead Off ECG electrode LA falls off the skin or the ECG cable LA falls off the telemetry transmitter. Low Make sure that all electrodes, leads and patient cables are properly connected. ECG RA Lead Off ECG electrode RA falls off the skin or the ECG cable RA falls off the telemetry transmitter. Low Make sure that all electrodes, leads and patient cables are properly connected. ECG V Lead Off ECG electrode V falls off the skin or the ECG cable V falls off the telemetry transmitter. Low Make sure that all electrodes, leads and patient cables are properly connected. ECG Signal Exceeded ECG measuring signal is beyond measuring range. Low Check lead connection and patient condition ECG Noise ECG measuring signal is greatly interrupted. Low Check lead connection and patient condition - 63 -
Telemetry Transmitter User Manual Alarm Information Message Cause Alarm Level Action Taken RESP Cardiac Artifact No RESP waveform can be detected due to apnea or shallow breathing of the patient. High Check whether the patient is breathing normally. Take measures to help the patient breathe normally when necessary. If the patient is breathing normally, try to adjust the electrode position on the patient in order to reduce the interference of cardiogenic artifact. RESP Noise RR cannot be measured due to patient movement. Low Check whether the RESP leads are well connected. Keep the patient calm for better monitoring. RR Exceed RR measuring value is out of the measure range. Medium Check whether interference to the respiratory signal exists. And check whether the patient is breathing normally; breathing too rapidly or too slowly may endanger patient’s life. SpO2 Sensor Off SpO2 sensor may be disconnected from the patient or the telemetry transmitter. Low Make sure the sensor is well connected to the patient’s finger or other parts. SpO2 No Sensor SpO2 sensor was not connected well or connected to the telemetry transmitter, or the connection is loose. Low Make sure the telemetry transmitter and sensor are well connected and reconnect the sensor. - 64 -
Telemetry Transmitter User Manual Alarm Information Message Cause Alarm Level Action Taken SpO2 Low Perfusion The pulse signal is too weak or the perfusion of the measurement site is too low. The value displayed may not be correct. Low Reconnect the SpO2 sensor and change the measurement site. If problem exists, please notify biomedical engineer or manufacturer’s service staff. SpO2 Noisy Signal There is interference with SpO2 measurement signals and the waveform is abnormal. Low Check the condition of patient and avoid patient movement; make sure the cable is well connected. SpO2 Light Interference Ambient light around the sensor is too strong. Low Reduce interference of the ambient light and avoid sensor’s exposure to strong light. Battery Low Battery Low High Change the batteries or charge the batteries. No signal for telemetry transmitter Telemetry transmitter didn’t connect to MFM-CMS. Medium Check whether network connection, MFM-CMS and wireless AP are work normally, or contact supplier. Check the ECG accessories ECG cables have connected to patient, and the valid authorized information for ECG accessories cannot be detected. Medium Use the specified ECG accessories. - 65 -
Telemetry Transmitter User Manual Alarm Information 12.3 Prompts Message Cause ECG Arr Learning The QRS template building required for Arr. Analysis is in process. SpO2 Search Pulse SpO2 module is analyzing the patient signal and searching for the pulse to compute the saturation, when sensor is connected with patient. Weak Wi-Fi signal The status that iT20 Wi-Fi signal is lower than level 1, means Wi-Fi signal is weak. 12.4 Adjustable Range of Alarm Limits ECG alarm limits are listed as follows: unit (bpm) Patient Type ALM HI ALM LO HR ADU 300 15 PED 350 15 ST analysis alarm limits are listed as follows: unit (mV) ALM HI ALM LO ST 2.0 -2.0 PVCs alarm upper limits are listed as follows: ALM HI ALM LO PVCs 10 0 RESP alarm limits are listed as follows: unit (rpm) Patient Type ALM HI ALM LO RESP ADU 120 6 PED 150 6 - 66 -
Telemetry Transmitter User Manual Alarm Information SpO2 alarm limits are listed as follows (unit %): ALM HI ALM LO SpO2 100 20 PR alarm limits is listed as follows: unit (bpm) ALM HI ALM LO PR 300 30 - 67 -
Telemetry Transmitter User Manual Printing Chapter 13 Printing The contents related to this chapter are all operated on MFM-CMS. 13.1 Printing Report with a Printer MFM-CMS can output the reports by equipped with a laser printer. HP LaserJet Series printers are recommended. The laser printer working with the MFM-CMS is independent of the mainframe. The printer has its independent power supply. It is connected to the mainframe via a USB interface or a network (wired or wireless). The laser printer generates the following types of printing:  Waveform review printing  Alarm wave printing  Alarm table printing  Trend graph printing  Trend table printing  Printing for drug calculation, hemodynamic calculation, oxygenation calculation, renal function calculation and ventilation calculation  Patient information printing NOTE: MFM-CMS only supports printing on A4 paper. 13.2 Printing Preview/ Printing Settings 13.2.1 Printing Preview Before the reports are printed, you can preview them on the screen. You will access the preview interface after you select the function of printing. If a report consists of more than one page, you may select a certain page to preview by turning to the page you want. Besides, you can adjust the zoom setting by choosing a certain option from the drop-down list of the SIZE. 13.2.2 Printing Settings Click on Print on the preview interface, and in the Print setup menu select the printer, the print range and the number of copies in demand and then click on OK to confirm it. 13.3 Exporting the PDF File MFM-CMS can export the PDF file by installing a PDF printer software. The software PDFCreator is recommended. You can obtain the installation version of PDFCreator in the MFM-CMS installation disk. Also, you may download it from the website - 68 -
Telemetry Transmitter User Manual Printing http://www.pdfforge.org/pdfcreator. To export the PDF file, choose a PDF printer (for instance, PDFCreator) from the drop-down list when you select the printers, and then confirm it by clicking on OK. - 69 -
Telemetry Transmitter User Manual Database Management Chapter 14 Database Management The contents related to this chapter are all operated on MFM-CMS. MFM-CMS provides database backup and review, which allows you to conveniently manage and maintain data. 14.1 Database Backup To backup database, please select Main Screen > System Setup > User Maintain, and input the correct password. Select Database Maintain and click on the button Browse to choose a directory for backup file storage. Then click on Backup Database to start database backup. NOTE: 1 During database backup, MFM-CMS automatically stops its patient monitoring. 2 MFM-CMS will restart automatically after it completes database backup. 3 If the check box indicating “Empty local database after backup is completed” is ticked, MFM-CMS will empty the local database after database backup is completed. 14.2 Reviewing Backup Database MFM-CMS allows you to review the backup data at any time. To review backup data, select Main Screen > Review > Patient List, and select the directory for storing backup file from the drop-down list of Offline Database Source. For more information about review, refer to Chapter 9 Review. NOTE: 1 It takes about 3 to 10 seconds for MFM-CMS to load the backup data. 2 During reviewing backup data, discharging or deleting patients is unavailable. - 70 -
Telemetry Transmitter User Manual Monitoring ECG Chapter 15 Monitoring ECG 15.1 Overview The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the telemetry transmitter as a waveform and a numeric. This chapter also tells you about arrhythmia monitoring and ST monitoring. 15.2 ECG Safety Information WARNING 1 Only use the ECG leads supplied by the manufacturer when using telemetry transmitter for ECG monitoring. 2 When connecting the cables and electrodes, make sure no conductive part is in contact with the ground. Verify that all ECG electrodes, including neutral electrodes, are securely attached to the patient but not the conductive part or ground. 3 Check every day whether there is skin irritation resulted from the ECG electrodes. If yes, replace electrodes every 24 hours or change their sites. 4 Place the electrode carefully and ensure a good contact. 5 Check if the lead connection is correct before monitoring. If you unplug the ECG cable from the socket, the screen will display the error message “ECG LEAD OFF” and the audible alarm is activated. 6 If the ECG signal exceeds the measuring range, MFM-CMS will indicates it by a message “ECG Signal Exceeded”. 7 When using the telemetry transmitter with the defibrillator or other high-frequency equipment, please use defibrillator-proof ECG lead to avoid burn. 8 For patients with pacemakers, the pacing impulse analysis function must be switched ON. Otherwise, the pacing impulse may be counted as regular QRS complexes, which could prevent an asystole event from being detected or could lead to false alarm of asystole. 9 The electrodes should be made of the same metal materials. 10 ECG cables can be damaged when connected to a patient during defibrillation or using other high frequency equipment. Check cables for functionality before using them again. It is recommended to use the ECG cables which are defibrillator-proof. 11 ECG accessories are not suitable for DIRECT CARDIAC APPLICATION. (Refer to IEC60601-1 for more information about the definition of DIRECT CARDIAC APPLICATION.) 12 Line isolation monitor transients may resemble actual cardiac waveforms and thus inhibit heart rate alarms. Check lead wires for damage and ensure good skin contact prior to and during use. Always use fresh electrodes and follow proper skin preparation techniques. - 71 -
Telemetry Transmitter User Manual Monitoring ECG NOTE: 1 Interference from a non-grounded instrument near the patient and ESU interference can cause inaccuracy of the waveform. 2 IEC/EN60601-1-2 (protection against radiation is 3v/m) specifies that the electrical field density exceeding 1v/m may cause measurement error in various frequencies. It is accordingly suggested that do not use equipment generating electrical radiation near ECG/RESP monitoring devices. 3 If the pacemaker signals are beyond the claimed range, the heart rate may be calculated incorrectly. 4 In the default settings of MFM-CMS, the ECG waveforms are the first two waveforms from top in the waveform area. 5 For measurements in or near the heart we recommend connecting the telemetry transmitter to the potential equalization system. 6 For protecting environment, the used electrodes must be recycled or disposed of properly. 15.3 ECG Display 15.3.1 ECG Display on Telemetry Transmitter Screen The figure below is the interface with ECG opened. It is for reference only. The display on your telemetry transmitter depends on the configuration you have chosen.  Device Status Indicator: including bed number, network symbol, Wi-Fi signal intensity symbol, power symbol and PACE icon.  Waveform Display: supports 1 channel at most; If ECG is configured and open, the calculated lead waveform is displayed by default. The waveforms of different leads can be switched. If the configuration has SpO2 without ECG, Pleth waveform will be displayed.  Parameter Value;  Trend Graph ( via pressing shifting key to display in turn) I, II and III lead are optional for 3-lead. I, II, III, aVR, aVF, aVL, and V lead are optional for 5-lead. - 72 -
Telemetry Transmitter User Manual Monitoring ECG 60HR bpmIIPACE IconBed No.Networking Icon Battery StatusWireless Signal Icon Figure 15-1 15.3.2 ECG Display on MFM-CMS The figure below is ECG waveform for 5-lead. It is for reference only. The display on your MFM-CMS depends on the configuration you have chosen. 15.4 Selecting Calculation Lead Selecting calculation lead is operated on MFM-CMS. Enter the Parameter Setup Window (way to entering refers to 8.2 Setting Parameters) > Click ECG on the left physiological parameter list > Choose Calc. Lead > Click Update Monitor to confirm. I, II and III lead are optional for 3-lead. I, II, III, aVR, aVF, aVL, and V lead are optional for 5-lead. Normal QRS complex should be:  The normal QRS should be either completely above or below the baseline and it should not be biphasic. For paced patients, the QRS complexes should be at least twice the height of pace pulses.  The QRS should be tall and narrow.  The P-waves and the T-waves should be less than 0.2 mV. - 73 -
Telemetry Transmitter User Manual Monitoring ECG 15.5 Changing Size of ECG Waveform Changing size of ECG waveform is operated on MFM-CMS. Enter the Parameter Setup Window (way to entering refers to 8.2 Setting Parameters) > Click ECG on the left physiological parameter list > Choose ECG Gain > Click Update Monitor to confirm. X0.125 to make strength of ECG signal waveform of 1mV become 1.25mm; X0.25 to make strength of ECG signal waveform of 1mV become 2.5mm; X0.5 to make strength of ECG signal waveform of 1mV become 5mm; X1 to make strength of ECG signal waveform of 1mV become 10mm; X2 to make strength of ECG signal waveform of 1mV become 20mm; X4 to make strength of ECG signal waveform of 1mV become 40mm; Auto let the MFM-CMS choose the optimal adjustment factor for all the ECG waves. NOTE: The effect of ECG waveform gain is subject to the size of the waveform area. Whichever waveform gain is chosen, the ECG waveform has to be displayed within the waveform area. 15.6 Changing ECG Filter Settings Changing ECG filter settings is operated on MFM-CMS. Enter the Parameter Setup Window (way to entering refers to 8.2 Setting Parameters) > Click ECG on the left physiological parameter list > Choose Filter > Click Update Monitor to confirm. – Monitor: Use this mode under normal measurement conditions. – Surgery: The filter reduces interference to the signal. It should be used if the signal is distorted by high frequency or low frequency interference. High frequency interference usually results in large amplitude spikes making the ECG signal look irregular. Low frequency interference usually leads to a wandering or rough baseline. In the operating room, the Filter reduces artifacts. Under normal measurement conditions, selecting Surgery may suppress the QRS complexes too much and thus interfere with the clinical evaluation of the ECG displayed on the MFM-CMS. –Diagnosis: Use when diagnostic quality is required. The unfiltered ECG waveform is displayed so that changes such as R-wave notching or discrete elevation or depression of the ST segments are visible. 15.7 ECG Alarm Settings ECG alarm settings are operated on MFM-CMS. Use can open or close the ECG alarm. Refer to 8.2.1 Parameters Alarm Setting for more information. - 74 -
Telemetry Transmitter User Manual Monitoring ECG 15.8 Monitoring Procedure 15.8.1 Preparation The skin is a poor conductor of electricity; therefore preparation of the patient's skin is important to facilitate good electrode contact to skin.  Select sites with intact skin, without impairment of any kind.  Shave hair from sites, if necessary.  Wash sites thoroughly with soap and water. (Never use ether or pure alcohol, because this increases skin impedance).  Rub the skin briskly to increase capillary blood flow in the tissues and remove skin scurf and grease. 15.8.2 Connecting ECG Cables 1. Attach clip or snap to electrodes prior to placement. 2. Put the electrodes on the patient. Before attaching, apply some conductive jelly on the electrodes if the electrodes are not electrolyte self-supplied. 3. Connect the electrode lead to the patient's cable. 4. Plug the patient cable into the ECG connector. CAUTION To protect the telemetry transmitter from damage during defibrillation, for accurate ECG information and to protect against noise and other interference, use only ECG electrodes and cables specified by EDAN. 15.9 Installing Electrodes NOTE: The following table gives the corresponding lead names used in Europe and America respectively. (Lead names are represented by R, L, F, N, C, C1-C6 in Europe, whose corresponding lead names in America are RA, LA, LL, RL, V, V1-V6.) AHA (American Standard) IEC (Europe Standard) Electrode Labels Color Electrode Labels Color RA White R Red LA Black L Yellow LL Red F Green RL Green N Black V Brown C White - 75 -
Telemetry Transmitter User Manual Monitoring ECG AHA (American Standard) IEC (Europe Standard) V1 Brown/ Red C1 White/ Red V2 Brown/ Yellow C2 White/ Yellow V3 Brown/ Green C3 White/ Green V4 Brown/Blue C4 White/ Brown V5 Brown/Orange C5 White/ Black V6 Brown/Purple C6 White/ Purple 15.9.1 Electrode Placement for 3-lead Take the American standard for example, see the following figure: ■ RA placement - directly below the clavicle and near the right shoulder. ■ LA placement: directly below the clavicle and near the left shoulder. ■ LL placement - on the left hypogastrium. Electrode Placement for 3-lead 15.9.2 Electrode Placement for 5-lead Take the American standard for example; see the following figure: ■ RA placement: directly below the clavicle and near the right shoulder. ■ LA placement: directly below the clavicle and near the left shoulder. ■ RL placement: on the right hypogastrium. ■ LL placement: on the left hypogastrium. ■ V placement: on the chest, the position depends on your required lead selection. - 76 -
Telemetry Transmitter User Manual Monitoring ECG Electrode Placement for 5-lead NOTE: To ensure the patient safety, all leads must be attached to the patient. For 5-lead, attach the V electrode to one of the indicated positions as below: ■ V1 On the 4th intercostal space at the right sterna margin. ■ V2 On the 4th intercostal space at the left sterna margin. ■ V3 Midway between V2 and V4 electrodes. ■ V4 On the 5th intercostal space at the left clavicular line. ■ V5 On the left anterior axillary line, horizontal with V4 electrode. ■ V6 On the left middle axillary line, horizontal with V4 electrode. ■ V3R-V6R On the right side of the chest in positions corresponding to those on the left. ■ VE Over the xiphoid position. ■ V7 On the 5th intercostal space at the left posterior axillary line of back. ■ V7R On the 5th intercostal space at the right posterior axillary line of back. - 77 -
Telemetry Transmitter User Manual Monitoring ECG V-Electrode Placement for 5-lead 15.10 Setting Alarm Source Setting alarm source is operated on MFM-CMS. Enter the Parameter Setup Window (way to entering refers to 8.2 Setting Parameters) > Click ECG on the left physiological parameter list > Choose Alarm Source > Click Update Monitor to confirm. HR: the telemetry transmitter considers the HR as HR/PR alarm source; PR: the telemetry transmitter considers the PR as HR/PR alarm source; AUTO: If the Alarm Source is set to Auto, the telemetry transmitter will use the heart rate from the ECG measurement as the alarm source whenever the ECG measurement is switched on and at least one ECG lead can be measured without a technical condition. The telemetry transmitter will automatically switch to Pulse as the alarm source if: –a valid ECG lead can no longer be measured and –a pulse source is switched on and available. The telemetry transmitter then uses the pulse rate from the measurement currently active as system pulse. While PR is the alarm source, all arrhythmia and ECG HR alarms are switched off. If an ECG lead becomes available again, the telemetry transmitter automatically uses HR as alarm source. 15.11 Smart Lead Off Choosing smart lead off is operated on MFM-CMS. When Lead Type is 5 Leads and Smart LeadOff is set to On, if the selected ECG waveform cannot be measured because of lead-off or other reasons, it will automatically switch to another available lead channel via which a waveform can be measured. And the lead name above the display ECG waveform also automatically turns into the current one. - 78 -
Telemetry Transmitter User Manual Monitoring ECG To change the smart lead off setting, enter the Parameter Setup Window (way to entering refers to 8.2 Setting Parameters) > Click ECG on the left physiological parameter list > Choose Smart LeadOff > Click Update Monitor to confirm. 15.12 Setting Pace Status Setting pace status is operated on MFM-CMS. It is important to set the paced status correctly when you start monitoring ECG. To change the paced status in the ECG Setup menu, enter the Parameter Setup Window (way to entering refers to 8.2 Setting Parameters) > Click ECG on the left physiological parameter list > Choose Pace > Click Update Monitor to confirm. When Pace is set to On: - Pace Pulse Rejection is switched on. This means that pacemaker pulses are not counted as extra QRS complexes. - Paced symbol is displayed as | on the main screen. NOTE: 1 When monitoring a patient with a pacemaker, set Pace to On. If monitoring a patient without a pacemaker, set Pace to Off. 2 If Pace is set to On, the system will not perform some types of ARR analysis. WARNING Some pace pulses can be difficult to reject. When this happens, the pulses are counted as a QRS complex, and could result in an incorrect HR and failure to detect cardiac arrest or some arrhythmias. Keep pacemaker patients under close observation. 15.13 ECG Calibration ECG calibration is operated on MFM-CMS. This item is used to calibrate ECG waveform. To calibrate ECG, enter the Parameter Setup Window (way to entering refers to 8.2 Setting Parameters) > Click ECG on the left physiological parameter list > Click Calibration to calibrate ECG waveform. Then click Stop to end calibration. NOTE: The device can’t be monitored during ECG calibration. 15.14 ECG Waveform Settings ECG waveform setting is operated on MFM-CMS and is applicable to the wave on MFM-CMS. User can select an appropriate setting. The bigger the value is, the wider the waveform is. 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s are optional. Please refer to 6.4.1 Setting Waveforms for more information. - 79 -
Telemetry Transmitter User Manual Monitoring ECG 15.15 ST Segment Monitoring Telemetry transmitter performs ST segment analysis on normal and atrially paced beats and calculates ST segment elevations and depressions. This information can be displayed in the form of ST numerics on telemetry transmitter and MFM-CMS(refer to 15.15.2 ST Display). ST segment monitoring function is shut off by default. You can switch it to On when necessary. NOTE: 1 ST-segment analysis is intended for use with adult patients only and is not clinically validated for use with pediatric patients. 2 The ST algorithm has been tested for accuracy of the ST segment data. The significance of the ST segment changes need to be determined by a clinician. 15.15.1 Open/ Close ST Analysis Setting ST analysis is operated on MFM-CMS. To set ST, enter the Parameter Setup Window (way to entering refers to 8.2 Setting Parameters) > Click ECG on the left physiological parameter list > Choose ON or OFF from ST Analysis, or click ST on the left physiological parameter list to choose ON or OFF> Click Update Monitor to confirm. 15.15.2 ST Display The ST display on telemetry transmitter is as figure 2-4 or figure 2-5. The ST display on MFM-CMS is on the following areas: Area 1: ST value area on the right of Single Bed View Sub-Window; Area 2: parameter value area of patient sector (under the condition that ST should be set as the active parameter. Detailed operations refer to 6.4.2 Setting Parameters). 15.15.3 ST Alarm Settings ST alarm settings are operated on MFM-CMS. Please refer to 8.2.1 Parameters Alarm Setting for more alarm settings. ST value range is from 2.0 mV to -2.0 mV. The minimum alarm high limit shall be 0.2 mV higher than the maximum alarm low limit. 15.15.4 About ST Measurement Points The ST value for each beat complex is the vertical difference between the ISO point and the ST point, as shown in the diagram below. The isoelectric (ISO) point provides the baseline, and the ST point is at the midpoint of the ST segment. The J point is where the QRS complex changes its slope; as it is a fixed distance away from the ST point, it can be useful to help you position the ST point correctly. - 80 -
Telemetry Transmitter User Manual Monitoring ECG DEF POINT About ISO and ST measurement points: For telemetry transmitters, the location of ISO and ST measurement points is not adjustable. Its initial value for ST testing points is +84ms by default. ST analysis takes no account of abnormal QRS wave. 15.16 Arr. Monitoring 15.16.1 Arrhythmia Analysis The arrhythmia algorithm is used to monitor ECG of adult patients in clinics, and detect the changes of heart rate and ventricular rhythm, and also save arrhythmia events and generate alarming information. The arrhythmia analysis is not clinically validated for use with neonatal and pediatric patients. Arrhythmia algorithm can monitor paced and non-paced patients. Qualified personnel can use arrhythmia analysis to evaluate patient’s condition (such as heart rate, PVCs frequency, rhythm and ectopic beat) and decide the treatment. Besides detecting change of ECG, arrhythmia algorithm can also monitor patients and give proper alarm for arrhythmia. Telemetry transmitter can support up to 16 different arrhythmia analyses. ARR Types Occurring Condition ASYSTOLE No QRS is detected for 4 consecutive seconds VFIB/VTAC 4 consecutive seconds' fibrillation wave occurs, or each RR interval for 5 consecutive ventricular beats is less than 600 ms. VT>2 3 ≤ the number of consecutive PVCs < 5 COUPLET 2 consecutive PVCs BIGEMINY A dominant rhythm of N, V, N, V (N = supraventricular beat, V = ventricular beat) was detected. TRIGEMINY A dominant rhythm of N, N, V, N, N,V. R ON T A type of single PVC under the condition that HR<100，R-R interval is less than 1/3 the average interval, followed by a compensating pause of 1.25X the average R-R interval (the next R wave advances onto the previous T wave). - 81 -
Telemetry Transmitter User Manual Monitoring ECG ARR Types Occurring Condition PVC Single PVC detected in normal heartbeats. TACHY Adult: RR interval for 5 consecutive QRS complex ≤ 0.5s. Pediatric: RR interval for 5 consecutive QRS complex ≤ 0.375s. BRADY Adult: RR interval for 5 consecutive QRS complex ≥ 1.5s. Pediatric: RR interval for 5 consecutive QRS complex ≥ 1s. MISSED BEATS If HR < 120 bpm, no beats are detected for 1.75 times average RR interval; or if HR ≥ 120 bpm, no beats are detected for one second. IRR Consistently irregular heart rhythm PNC PACE NOT CAPTURE: no QRS complex detected in 300ms after a pace pulse. PNP PACER NOT PACED: no pace pulse detected in 1.75 times RR interval after a QRS complex. VBRADY VENTRICULAR BRADYCARDIA: Each RR interval for 5 consecutive ventricular beats > 1000 ms. VENT VENTRICULAR RHYTHM: Each RR interval for 5 consecutive ventricular beats ranges from 600 ms to 1000 ms. 15.16.2 ARR Analysis Menu 15.16.2.1 Switching ARR Analysis On and Off Switching ARR on or off is operated on MFM-CMS. Enter the Parameter Setup Window (way to entering refers to 8.2 Setting Parameters) > Click ECG on the left physiological parameter list > Choose ARR Analysis, or click ECG ARR on the left physiological parameter list to choose ARR Analysis > Click Update Monitor to confirm. 15.16.2.2 PVCs Alarm Settings PVCs alarm settings are operated on MFM-CMS. Please refer to 8.2.1 Parameters Alarm Setting for more alarm settings. Select On in the menu to enable prompt message when an alarm occurs; select Off to disable the alarm function, and there will be a symbol beside PVCs. - 82 -
Telemetry Transmitter User Manual Monitoring ECG WARNING When the PVCs Alarm is set to OFF, MFM-CMS won’t give an alarm prompt even if an alarm occurs. In order to avoid endangering the patient’s life, the user should use this function cautiously. 15.16.2.3 ARR Relearning ARR relearning is operated on MFM-CMS. Enter the Parameter Setup Window (way to entering refers to 8.2 Setting Parameters) > Click ECG ARR on the left physiological parameter list > Click ECG Selflearn > Click Update Monitor to confirm. Pick this item to start a learning procedure, and ECG ARR LEARNING is displayed on the screen. The ECG ARR LEARNING will start in the following status:  Connecting leads;  Starting ARR learning manually;  Switching calculation leads. 15.16.2.4 ARR Alarm Settings ARR alarm settings are operated on MFM-CMS. Please refer to 8.2.1 Parameters Alarm Setting for more alarm settings. The users can switch on or off all arrhythmia alarms by ARR alarm settings. And some arrhythmia alarms can be individually switched on or off. They are: R-ON-T, VT>2, COUPLET, PVC, BIGEMINY, TRIGEMINY, TACHY, BRADY, MISSED BEATS, IRR, PNC, PNP, VBRADY and VENT. Some arrhythmia alarms are preset to be on and cannot be turned off. They are ASYSTOLE and VFIB/VTAC.- 83 -
Telemetry Transmitter User Manual Monitoring RESP Chapter 16 Monitoring RESP 16.1 Overview Telemetry transmitter measures respiration from the amount of thoracic impedance between two ECG electrodes. The change of impedance between the two electrodes, (due to the thoracic movement), produces a respiratory waveform on the screen. 16.2 RESP Safety Information WARNING 1 The respiration measurement does not recognize obstructive and mixed apneas - it only indicates an alarm when a pre-adjusted time has elapsed since the last detected breath. 2 If operating under conditions according to the EMC Standard EN 60601-1-2 (Radiated Immunity 3V/m), field strengths above 1V/m may cause erroneous measurements at various frequencies. Therefore it is recommended to avoid the use of electrically radiating equipment in close proximity to the respiration measurement unit. 3 Cardiogenic artifact in impedance respiration monitoring may make it difficult to detect breaths or may otherwise be counted as breaths. In some instances, the breath rate may also correspond to the heart rate making it difficult to determine if the signal is due to breathing or the cardiac cycle. Do not rely on RESP monitoring as the sole method for detecting cessation of breathing. Follow hospital guidelines and best clinical practices for apnea detection including monitoring additional parameters that indicate the patient’s oxygenation status, such as EtCO2 and SpO2. NOTE: The RESP monitoring is not recommended to be used on patients who are very active, as this can cause false alarms. 16.3 Electrode Placement for Monitoring RESP Correct patient skin preparation techniques for electrode placement are important for RESP measurement: you will find this information in the chapter on ECG. The RESP signal is always measured between two of the ECG electrodes. There is only one standard ECG lead for telemetry transmitter: II lead (RA and LL). - 84 -
Telemetry Transmitter User Manual Monitoring RESP Electrodes Placement for 5-lead 16.4 Cardiac Overlay Cardiac activity that affects the RESP waveform is called cardiac overlay. It happens when the RESP electrodes pick up impedance changes caused by the rhythmic blood flow. Correct electrode placement can help to reduce cardiac overlay: avoid the liver area and the ventricles of the heart in the line between the respiratory electrodes. 16.5 Chest Expansion Some patients, expand their chests laterally. In these cases it is best to place the two respiratory electrodes in the right midaxillary and left lateral chest areas at the patient’s maximum point of breathing movement to optimize the respiratory wave. 16.6 Abdominal Breathing Some patients with restricted chest movement breathe mainly abdominally. In these cases, you may need to place the left leg electrode on the left abdomen at the point of maximum abdominal expansion to optimize the respiratory wave. NOTE: Place the red and green electrodes diagonally to optimize the respiration waveform. Avoid the liver area and the ventricles of the heart in the line between the RESP electrodes so as to avoid cardiac overlay or artifacts from pulsating blood flow. 16.7 Selecting RESP Lead II lead is constant as the RESP lead. 16.8 Changing the Apnea Time Changing the apnea time is operated on MFM-CMS. - 85 -
Telemetry Transmitter User Manual Monitoring RESP The apnea alarm is a high priority red alarm used to detect apneas. The apnea alarm delay time defines the time period between the point where the telemetry transmitter cannot detect any respiration activity and the indication of the apnea alarm. Enter the Parameter Setup Window (way to entering refers to 8.2 Setting Parameters) > Click RESP on the left physiological parameter list > Click Apnea Time (10s, 15s, 20s, 25s, 30s, 35s and 40s are optional) > Click Update Monitor to confirm. NOTE: Apnea time means the time period with no apnea alarm. If the actual apnea time of patient is over that that period, MFM-CMS will give apnea alarm. Please use it cautiously. 16.9 Changing the Size and Speed of the Respiration Waveform RESP waveform setting is operated on MFM-CMS and is applicable to the waveform on MFM-CMS.  To changing the size of RESP waveform, enter the Parameter Setup Window (way to entering refers to 8.2 Setting Parameters) > Click RESP on the left physiological parameter list > Click Gain (X0.25, X0.5, X1, X2, X3, X4 and X5 are optional) > Click Update Monitor to confirm.  User can select an appropriate waveform speed. The bigger the value is, the wider the waveform is. 6.25mm/s, 12.5mm/s, 25mm/s are optional. Please refer to 6.4.1 Setting Waveforms for more information. 16.10 RESP Alarm Settings RESP alarm settings are operated on MFM-CMS. Use can open or close the RESP alarm. Please refer to 8.2.1 Parameters Alarm Setting for more alarm settings. - 86 -
Telemetry Transmitter User Manual Monitoring SpO2 Chapter 17 Monitoring SpO2 17.1 Overview SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. SpO2 Plethysmogram measurement is employed to determine the oxygen saturation of hemoglobin in the arterial blood. If, for example, 97% of the hemoglobin molecules in the red blood cells of the arterial blood combine with oxygen, then the blood has a SpO2 oxygen saturation of 97%. The SpO2 numeric on the telemetry transmitter will read 97%. The SpO2 numeric shows the percentage of hemoglobin molecules which have combined with oxygen molecules to form oxyhemoglobin. The SpO2/PLETH parameter can also provide a pulse rate signal and a plethysmogram wave. 17.2 SpO2 Safety Information WARNING 1 If the SpO2 sensor cannot work properly, please reconnect the sensor or change a new one. 2 Do not use the sterile supplied SpO2 sensors if the packaging or the sensor is damaged and return them to the vendor. 3 Prolonged and continuous monitoring may increase the risk of unexpected change of dermal condition such as abnormal sensitivity, rubescence, vesicle, repressive putrescence, and so on. It is especially important to check the sensor placement for the patients of poor perfusion or immature dermogram by light collimation and proper attaching strictly according to changes of the skin. More frequent examinations may be required for different patients. 4 Tissue damage may be caused by incorrect application or prolonged measurement duration using the sensor (more than 4 hours). Inspect the sensor periodically according to the sensor user manual. 5 Use only EDAN permitted sensors and extension cables with the oximeter. Other sensors or extension cables may cause improper telemetry transmitter performance and/or minor personal injury. NOTE: 1 Make sure the nail covers the light window. The wire should be on the backside of the hand. 2 SpO2 waveform is not proportional to the pulse volume. 3 Avoid placing the sensor on extremities with an arterial catheter, or intravascular venous infusion line. 4 Don’t use the functional tester or patient simulator to assess the SpO2 accuracy. - 87 -
Telemetry Transmitter User Manual Monitoring SpO2 5 The device is calibrated to display functional oxygen saturation. 6 The materials with which the patient or any other person can come into contact conform with the standard of EN ISO 10993-1: 2009. 7 SpO2 waveform is not proportional to the pulse volume. 8 When the SpO2 value is potentially incorrect, it will display “?”. 17.3 Measuring SpO2 1. Select the correct Type in the patient management window (Adult/ Pediat) and click Update Monitor to confirm, as this is used to optimize the calculation of the SpO2 and pulse numerics. 2. During measurement, ensure that the application site: – has a pulsatile flow, ideally with a good circulation perfusion. – has not changed in its thickness, causing an improper fit of the sensor. 17.4 Measurement Procedure 1. Switch on telemetry monitoring system. 2. Attach the sensor to the appropriate site of the patient finger. 3. Plug the connector of the sensor extension cable into the SpO2 socket on telemetry transmitter. Mounting of the Sensor WARNING Inspect the application site every two to three hours to ensure skin quality and correct optical alignment. If the skin quality changes, move the sensor to another site. Change the application site at least every four hours. NOTE: Injected dyes such as methylene blue or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements. Interference can be caused by:  High levels of ambient light or strobe lights or flashing lights (such as fire alarm lamps). - 88 -
Telemetry Transmitter User Manual Monitoring SpO2 (Hint: cover application site with opaque material.)  High-frequency electrical noise, including electro-surgical apparatus and defibrillators  Intravascular dye injections  Significant concentrations of dysfunctional hemoglobin, such as carboxyhemoglobin and methemoglobin  Excessive patient movement and vibration  Improper sensor application  Low perfusion or high signal attenuation  Venous pulsation  Placement of the sensor on an extremity that has a blood pressure cuff, arterial catheter, or intravascular line 17.5 Assessing the Validity of a SpO2 Reading You can check the quality of the pleth wave and the stability of the SpO2 values to assess whether the sensor functions properly and whether the SpO2 readings are valid. Always use these two indications simultaneously to assess the validity of a SpO2 reading. Generally, the quality of the SpO2 pleth wave reflects the quality of the light signals obtained by the sensor. A wave of poor quality manifests a decline of the signal validity. On the other hand, the stability of the SpO2 values also reflects the signal quality. Different from varying SpO2 readings caused by physiological factors, unstable SpO2 readings are resulted from the sensor’s receiving signals with interference. The problems mentioned above may be caused by patient movement, wrong sensor placement or sensor malfunction. To obtain valid SpO2 readings, try to limit patient movement, check the placement of the sensor, measure another site or replace the sensor. NOTE: 1. The SpO2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-oximeter measurements. The volunteer population in the studies composed of local healthy men and women from age 19 to 37, with various skin pigmentations. 2. The pulse rate accuracy is obtained by comparison to the pulse rate generated with an arterial oxygen simulator (also an electronic pulse simulator). - 89 -
Telemetry Transmitter User Manual Monitoring SpO2 17.6 SpO2 Alarm Delay There is a delay between a physiological event at the measurement site and the corresponding alarm at the MFM-CMS. This delay has two components: 1. The time between the occurrence of the physiological event and when this event is represented by the displayed numerical values. This delay depends on the algorithmic processing time and the sensitivity setting. The lower the sensitivity configured, the longer the time needed until the numerical values reflect the physiological event. 2. The time between the displayed numerical values exceeding an alarm limit and the alarm indication on the MFM-CMS. This delay is the combination of the configured alarm delay time plus the general system delay time. 17.7 Setting Sensitivity Setting sensitivity is operated on MFM-CMS. The different sensitivity indicates different refresh frequency. High indicates the refresh frequency of SpO2 value is the most frequent. To change the sensitivity, please: Enter the Parameter Setup Window (way to entering refers to 8.2 Setting Parameters) > Click SpO2 on the left physiological parameter list > Click Sensitivity (High, Med and Low are optional) > Click Update Monitor to confirm. 17.8 SpO2 Alarm Settings SpO2 alarm settings are operated on MFM-CMS. Use can open or close the ECG alarm. Please refer to 8.2.1 Parameters Alarm Setting for more alarm settings. - 90 -
Telemetry Transmitter User Manual Monitoring PR Chapter 18 Monitoring PR 18.1 Overview The pulse numeric counts the arterial pulsations that result from the mechanical activity of the heart in beats per minute (bpm). You can display a pulse from any measured SpO2 signal. 18.2 Selecting the Active Alarm Source In most cases, the HR and Pulse numerics are identical. In order to avoid simultaneous alarms on HR and Pulse, the telemetry transmitter uses either ECG or Pulse as its active alarm source. Selecting active alarm source is operated on MFM-CMS. Enter the Parameter Setup Window (way to entering refers to 8.2 Setting Parameters) > Click PR on the left physiological parameter list > Click Alarm Source (HR, PR and AUTO are optional) > Click Update Monitor to confirm.  HR: if you want HR to be the alarm source for HR/Pulse.  PR: if you select Pulse as the alarm source, ECG HR alarms are switched off.  AUTO: If the Alarm Source is set to Auto, the telemetry transmitter will use the heart rate from the ECG measurement as the alarm source whenever the ECG measurement is switched on and at least one ECG lead can be measured without a technical condition. The telemetry transmitter will automatically switch to Pulse as the alarm source if: –a valid ECG lead can no longer be measured and –a pulse source is switched on and available. The telemetry transmitter then uses the pulse rate from the measurement currently active as system pulse. While PR is the alarm source, all arrhythmia and ECG HR alarms are switched off. If an ECG lead becomes available again, the telemetry transmitter automatically uses HR as alarm source. NOTE: Pulse alarms are only generated when the active alarm source is set to PR, a pulse source is set as system pulse and pulse alarms are switched on. 18.3 PR Alarm Settings PR alarm settings are operated on MFM-CMS. Use can open or close the ECG alarm. Please refer to 8.2.1 Parameters Alarm Setting for more alarm settings. - 91 -
Telemetry Transmitter User Manual Using Battery Chapter 19 Using Battery Telemetry transmitter supports 2 sections of AA batteries which cannot be charged directly in battery bin. CAUTION Remove the batteries from the telemetry transmitter if they are not used for a longer period of time. 19.1 Battery Status on Screen The screen of telemetry transmitter as well as technical alarm/ indicator area in patient sector of MFM-CMS (refer to 6.2 Networked Monitoring Display) displays battery status. Higher the battery surplus’ level is, more power the battery has. The following is the definition about the battery level under the typical testing environment. Battery Level Power Surplus Level 0 near to using up Level 1 work continuously no less than 6 mins Level 2 work continuously no less than 20 hours Level3 work continuously no less than 40 hours Level 4 work continuously no less than 60 hours The typical testing environment includes: Temperature 25±2℃, SpO2 module unconnected, continuously testing ECG of 3-lead（pace off and RESP off）, typical network environment with no interference, screen closed and at least 5 mins of continuous work. In actual application, power surplus may be different with the table above due to batteries’ performance. Telemetry transmitter will sent technical alarm information of low battery power to MFM-CMS informing user of changing battery when battery power is 0-level. Meanwhile, telemetry transmitter gives out a periodic sound of “du-du-du” whose interval is 10 seconds till shutdown. - 92 -
Telemetry Transmitter User Manual Using Battery WARNING 1. Please use the specified battery and confirm its quality. 2. Before installing or replacing battery, be sure to read the user manual and safety precautions thoroughly. 3. The service life of the batteries depends on the service frequency and time. The service life of the batteries may shorten if they are used inappropriately. 4. Periodic checks on the battery performance are required. Change the batteries if necessary. 5. Do not place battery in the monitor with the (+) and (-) in the wrong way. 6. Do not connect the positive (+) and negative (-) terminals with metal objects, and do not put the batteries together with metal objects, which can result in short circuits. 7. Do not unplug the batteries when monitoring. 8. Do not heat or throw the batteries into a fire. 9. Do not use, leave the batteries close to fire or other places where temperature may be above 60°C. 10. Do not immerse, throw, or wet the batteries in water/seawater. 11. Do not destroy the batteries: do not pierce the batteries with a sharp object such as a needle; do not hit with a hammer, step on or throw or drop to cause strong shock; do not disassemble or modify the batteries. 12. Do not disassemble the battery. 13. Do not use with new and old batteries at the same time, or use with alkaline and nickel-metal hydride battery. 14. Do not solder the leading wire and the battery terminal directly. 15. If liquid leaking from the batteries gets into your eyes, do not rub your eyes. Wash them well with clean water and go to see a doctor immediately. If liquid leaks of the batteries splash onto your skin or clothes, wash well with fresh water immediately. 16. Keep away from fire immediately when leakage or foul odor is detected. 17. Stop using the batteries if abnormal heat, odor, discoloration, deformation or abnormal condition is detected during use, charge, or storage. Keep it away from the telemetry transmitter. 18. Do not use a battery with serious scar or deformation. 19. Use the batteries with similar performance, which can extend the service life of the batteries. If one of the two batteries is malfunctioning, it is recommended to change both of the two batteries. 20. Do not replace the batteries during monitoring patients - 93 -
Telemetry Transmitter User Manual Using Battery 19.2 Replacing the Battery To install or replace the battery, please refer to 4.1.1 Battery Installing and Replacing. 19.3 Recycling the Battery When the battery no longer holds a charge, it should be replaced. Remove the old battery from the battery bin and recycle it properly. WARNING Do not disassemble the battery, put it into fire or cause it to short circuit. It may ignite, explode or leak, causing personal injury. - 94 -
Telemetry Transmitter User Manual Safety Chapter 20 Safety 20.1 Control and Safety Index Windows XP/ Windows 7 workstation, printer, UPS (optional), Keyboard, display and mouse should accord with the corresponding safety requirements. They are not suitable for installing in the patients’ environment. 20.2 Characteristics The standard MFM-CMS includes the following characteristics:  Up to 240 hours of trend data storage and review  Storage of patients’ history data  96-hour full disclosure physiological waveforms  12-lead ECG display  12-hour short trend data  Printing report  Monitoring 64 patients simultaneously  Transfer waveforms, parameters, alarms, etc.- 95 -
Telemetry Transmitter User Manual Care and Cleaning Chapter 21 Care and Cleaning Use only the EDAN-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods. EDAN Instruments has validated the cleaning and disinfection instructions included in this User Manual. It is the responsibility of the healthcare professional to ensure that the instructions are followed so as to ensure adequate cleaning and disinfection 21.1 General Points Keep your device, cables and accessories free of dust and dirt. To prevent the device from damage, please follow the procedure:  Use only recommended cleaning substances and disinfectants listed in this manual. Others may cause damage (not covered by warranty), reduce product lifetime or cause safety hazards.  Always dilute according to the manufacturer’s instructions.  Unless otherwise specified, do not immerse any part of the equipment or any accessories in liquid.  Do not pour liquid onto the system.  Do not allow liquid to enter the case.  Never use abrasive material (such as steel wool or silver polish).  Inspect the telemetry transmitter and reusable accessories after they are cleaned and disinfected. CAUTION If you spill liquid on the equipment, battery, or accessories, or they are accidentally immersed in liquid, contact your service personnel or EDAN service engineer. 21.2 Cleaning If the device or accessory has been in contact with the patient, then cleaning and disinfection is required after every use. If there has been no patient contact and there is no visible contamination then daily cleaning and disinfection is appropriate. The validated cleaning agents for cleaning the telemetry transmitter and reusable accessories are:  Mild near neutral detergent  Ethanol (75%)  Isopropanol (70%) Cleaning agents should be applied and removed using a clean, soft, non-abrasive cloth or paper towel. - 96 -
Telemetry Transmitter User Manual Care and Cleaning 21.2.1 Cleaning the Telemetry Transmitter WARNING Before cleaning the device, make sure that the telemetry transmitter is switched off and take the battery out. To surface-clean the telemetry transmitter, follow these steps: 1. Switch off the telemetry transmitter and take the battery out. 2. Wipe the entire exterior surface, including the screen, of the equipment using a soft cloth dampened with the cleaning solution thoroughly until no visible contaminants remain.. 3. Wipe off the cleaning solution with a fresh cloth or towel, dampened with tap water after cleaning until no visible cleaning agent remains.. 4. Dry the telemetry transmitter in a ventilated and cool place. 21.2.2 Cleaning the Reusable Accessories 21.2.2.1 Cleaning the ECG Cable Assembly 1. Wipe the cable assembly with a soft cloth dampened with the cleaning solution until no visible contaminants remain. 2. Wipe off the cleaning solution with a fresh cloth or towel, dampened with tap water after cleaning until no visible cleaning agent remains.. 3. Wipe off with a dry cloth to remove residual moisture. 4. Leave the cable assembly to air dry. 21.2.2.2 Cleaning the SpO2 Sensor 1. Wipe the surfaces of the sensor and cable using a soft cloth dampened with the cleaning solution until no visible contaminants remain. 2. Wipe the patient contact area of the sensor with the cotton swab dampened with the cleaning solution. until no visible contaminants remain 3. Wipe off the cleaning solution with a fresh cloth or towel, dampened with tap water after cleaning until no visible cleaning agent remains. 4. Wipe off with a dry cloth to remove residual moisture. 5. Leave the sensor to air dry. 21.2.2.3 Cleaning Leather Cover 1. Wipe leather cover with a soft cloth dampened with the cleaning solution until no visible contaminants remain. 2. Wipe off the cleaning solution with a fresh cloth or towel, dampened with tap water after cleaning until no visible cleaning agent remains.. - 97 -
Telemetry Transmitter User Manual Care and Cleaning 3. Wipe off with a dry cloth to remove residual moisture. 4. Leave leather cover to air dry. 21.3 Disinfection For telemetry transmitter or accessories, low level disinfection is appropriate. Clean the telemetry transmitter and reusable accessories before they are disinfected. The validated disinfectants for cleaning the telemetry transmitter and reusable accessories are:  Ethanol (75%)  Isopropanol (70%) If Ethanol or Isopropanol is used for both cleaning and disinfecting, then a new cloth is required to be used for the disinfection step. WARNING The telemetry transmitter and reusable accessories shall be disinfected regularly to avoid patient cross infection. 21.3.1 Disinfecting the Telemetry Transmitter WARNING Before disinfecting the telemetry transmitter, make sure that the telemetry transmitter is switched off and take batteries out. To disinfect the telemetry transmitter, follow these steps: 1. Switch off the telemetry transmitter and take batteries out. 2. Wipe the display screen using a soft, clean cloth dampened with the disinfectant solution. 3. Wipe the exterior surface of the equipment using a soft cloth dampened with the disinfectant solution. 4. Wipe off the disinfectant solution with a dry cloth after disinfection if necessary. 5. Dry the telemetry transmitter for at least 30 minutes in a ventilated and cool place. 21.3.2 Disinfecting the Reusable Accessories 21.3.2.1 Disinfecting the ECG Cable Assembly 1. Wipe the cable assembly with a soft cloth dampened with the disinfectant solution. 2. Wipe off the disinfectant solution with a dry cloth after disinfection. 3. Leave the cable assembly to air dry for at least 30 minutes. - 98 -
Telemetry Transmitter User Manual Care and Cleaning 21.3.2.2 Disinfecting the SpO2 Sensor 1. Wipe the surfaces of the sensor and cable using a soft cloth dampened with the disinfection solution. 2. Wipe the patient contact area of the sensor with the cotton swab dampened with the disinfection solution. 3. Wipe off the disinfection solution with a dry cloth after disinfection. 4. Leave the sensor to air dry for at least 30 minutes. 21.3.2.4 Cleaning Leather Cover 1. Wipe leather cover with a soft cloth dampened with the disinfectant solution. 2. Wipe off the disinfectant solution with a dry cloth after disinfection. 3. Leave leather cover to air dry for at least 30 minutes. 21.3.2.4 Cleaning and Disinfecting Other Accessories For cleaning and disinfecting other accessories, refer to the instructions delivered with the accessories. If the accessories are not accompanied by instructions, refer to this manual for the methods of cleaning and disinfecting the telemetry transmitter. - 99 -
Telemetry Transmitter User Manual Maintenance Chapter 22 Maintenance WARNING 1 Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. 2 If you discover a problem with any of the equipment, contact your service personnel, or your authorized supplier. 22.1 Inspecting The overall check of the telemetry transmitter, including the safety check, should be performed only by qualified personnel every 24 months, and each time after fix up. The following items should be checked:  If the environment condition and power supply meet requirement.  If the power supply cord has damage and insulativity meets requirement.  If the device and accessories have damage.  Specified accessories.  If the alarm system can work properly.  If the printer can work properly and the paper meets the requirement.  Battery performance  If all monitoring functions are in good conditions.  If the grounding resistance and leakage current meet requirement. If any damage or abnormality is found, please don’t use the telemetry transmitter and contact local Customer Service Center. 22.2 Maintenance Task and Test Schedule Maintenance shall be carried out at least once every two years, or as specified by local laws. The following tasks are for EDAN-qualified service professionals only. Contact an EDAN-qualified service provider if your device needs a safety or performance test. Clean and disinfect equipment to decontaminate it before testing or maintaining it. Maintenance and Test Schedule Frequency Safety checks. Selected tests on the basis of IEC60601-1 At least once every two years, or as needed, after any repairs where the power supply is removed or replaced, or if the telemetry transmitter has been dropped. Check all monitoring functions and measuring functions At least once every two years, or as needed. - 100 -
Telemetry Transmitter User Manual Warranty and Service Chapter 23 Warranty and Service 23.1 Warranty EDAN warrants that EDAN’s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period. The warranty is void in cases of: a) damage caused by mishandling during shipping. b) subsequent damage caused by improper use or maintenance. c) damage caused by alteration or repair by anyone not authorized by EDAN. d) damage caused by accidents. e) replacement or removal of serial number label and manufacture label. If a product covered by this warranty is determined to be defective because of defective materials, components, or workmanship, and the warranty claim is made within the warranty period, EDAN will, at its discretion, repair or replace the defective part(s) free of charge. EDAN will not provide a substitute product for use when the defective product is being repaired. 23.2 Contact information If you have any question about maintenance, technical specifications or malfunctions of devices, contact your local distributor. Alternatively, you can send an email to EDAN service department at: support@edan.com.cn. - 101 -
Telemetry Transmitter User Manual Accessories Chapter 24 Accessories You can order accessories from EDAN supplies at www.edan.com.cn or consult your local EDAN representative for details. WARNING 1 Never reuse disposable transducers, sensors, accessories and their casing that are intended for single use; or only use them on a single patient. Reuse may compromise device functionality and system performance and cause a potential hazard. 2 Use only EDAN-approved accessories. Using non-EDAN-approved accessories may compromise device functionality and system performance and cause a potential hazard. It is not recommended to use accessories supplied by EDAN with patient monitors or telemetry transmitters by other manufacturers. 3 Do not use a sterilized accessory if its casing is damaged. NOTE: Transducers and sensors have a limited shelf life. Refer to the package labeling. The following cables may not all be available in all countries. Please check availability with your local EDAN supplier. 24.1 ECG Accessories Part Number Accessories 01.57.471397 3-lead, IEC, snap, adult, limb wires for telemetry transmitter 01.57.471398 3-lead, AHA, snap, adult, limb wires for telemetry transmitter 01.57.471399 3-lead, IEC, clip, adult, limb wires for telemetry transmitter 01.57.471400 3-lead, AHA, clip, adult, limb wires for telemetry transmitter 01.57.471401 5-lead, IEC, snap, adult, limb wires for telemetry transmitter 01.57.471402 5-lead, AHA, snap, adult, limb wires for telemetry transmitter 01.57.471403 5-lead, IEC, clip, adult, limb wires for telemetry transmitter 01.57.471404 5-lead, AHA, clip, adult, limb wires for telemetry transmitter 01.57.471276 ECG CONDUCTIVE ADHESIVE ELECTRODES, TYCO KENDALL MEDI TRACE 210, 10PCS/package 01.57.471056 Adult Disposable Adhesive Electrodes, TYCO H99SG,30PCS/ package, CE - 102 -
Telemetry Transmitter User Manual Accessories 01.57.471057 Children Disposable Adhesive Electrodes, TYCO H124SG, 50PCS/package,CE 01.57.471060 Adult Disposable Adhesive Electrodes, TYCO Medi-Trace 200, 100PCS/ package, FDA 24.2 SpO2 Accessories NOTE: The information about wavelength range can be especially useful to clinicians (for instance, when photodynamic therapy is performed). Part Number Accessories For EDAN Module 02.01.210120 EDAN SH1 Adult Reusable SpO2 Sensor (DB9) (Only compatible with EDAN SpO2 module and EDAN SpO2 Extension cable ), 1m (finger type, patient size>40kg) 02.01.210122 EDAN SH4 Adult Silicone Soft-tip SpO2 Sensor (DB9) (Immersion Disinfection) (Only compatible with EDAN SpO2 module and EDAN SpO2 Extension cable), 1m (finger type, patient size>50kg) 02.01.210121 EDAN SH5 pediatric Silicone Soft-tip SpO2 Sensor (DB9) (Only compatible with EDAN SpO2 module and EDAN SpO2 Extension cable), 1m (finger type, patient size: 10kg to 50kg) 01.57.471235 EDAN Adult Single-Patient SpO2 sensor SHD-A (forefinger, for patients over 30kg) 01.57.471236 EDAN Pediatrics Single-Patient SpO2 sensor SHD-P (forefinger, for patients between 10kg to 50kg) 01.57.471237 EDAN Infant Single-Patient SpO2 sensor SHD-I (big toe, for patients between 3kg to 20kg) 01.57.471405 SpO2 Extension cable for telemetry transmitter 01.57.040196 Adult Disposable SpO2 Sensor (DB9) 01.57.040197 Pediatric Disposable SpO2 Sensor (DB9) 01.57.040198 Infant Disposable SpO2 Sensor (DB9) - 103 -
Telemetry Transmitter User Manual Accessories 24.3 Other Accessories Part Number Accessories 01.56.465786 Elastic tape 01.56.465787 Leather Cover - 104 -
Telemetry Transmitter User Manual Product Specifications A Product Specifications NOTE: The performance of the equipment with ☆ mark was determined to be essential performance. A.1 Classification of Telemetry Transmitter Anti-electroshock type Internal powered equipment Anti-electroshock degree ECG (RESP) CF SpO2, CF Ingress Protection IPX7 Working system Continuous operation equipment Compliant with Standards IEC 60601-1: 2005/ EN 60601-1: 2006 IEC 60601-1-2: 2007/ EN 60601-1-2: 2007 IEC 60601-2-49: 2011 A.2 Specifications of Telemetry Transmitter A.2.1 Physical Specifications Product Dimension Max Weight Comments iT20 100mm±1mm *64mm±1mm *26mm±1mm <140g without battery and accessories A.2.2 Environmental Specifications Telemetry transmitter may not meet the performance specifications given here if stored or used outside the specified temperature and humidity ranges. When Telemetry transmitter and related products have differing environmental specifications, the effective range for the combined products is that range which is common to the specifications for all products. - 105 -
Telemetry Transmitter User Manual Product Specifications Main unit Temperature Working 0 °C ~ +40 °C Transport and Storage -20 °C ~ +55 °C Humidity Working 15% ~ 95% (non-condensing) Transport and Storage 15% ~ 95% (non-condensing) Altitude Working 860 hPa to 1060 hPa Transport and Storage 700 hPa to 1060 hPa A.2.3 Display Specifications Product Display iT20 (Telemetry Transmitter) Display screen: 1.46-inch color screen Resolution: 128 x128 A.2.4 Battery Battery Type 2 sections of AA batteries or rechargeable battery which cannot be charged directly in battery bin Batteries’ model: ( 2 *1.5 V ) AA IEC LR6 Power Supply Time ≥100 hrs. Temperature 25±2 °C for working environment, with fully new batteries, SpO2 module unconnected, continuously testing ECG of 3-lead（pace off and RESP off）, typical network environment with no interference, and screen closed ≥36 hrs. Temperature 25±2 °C for working environment, with fully new batteries, continuously testing SpO2, continuously testing ECG of 5-lead （pace off ）, typical network environment with no interference, and screen closed Support alarm of low battery - 106 -
Telemetry Transmitter User Manual Product Specifications A.3 Data Storage Telemetry Transmitter: Patient’s Information Bed number Trend 1.5 hrs., at 1 min. resolution Trend Display Trend Graph （HR, SpO2, RR, PR） MFM-CMS: Patient’s Information Department, MRN, Bed No, Last Name, First Name, Patient Type, Gender, BloodType, Date of Admission, Date of Birth, Height, weight, PACE, Doctor Trend 240 hrs., at 1 second. resolution Alarm review 720 sets A.4 Specifications of MFM-CMS A.4.1 Recommended Hardware Configuration The minimum requirements of hardware configuration for the MFM-CMS are shown as below. Components Requirements System Meet the IEC/EN control requirements for ITE device PC workstation CPU: Intel Core 2 Duo 2.0GHz or above Memory: 2G or above Hard disk: 320GB or above Display interface: 2 LAN port: 1 or above USB port: more than one OS: Windows XP (32 bit), Windows 7 Keyboard PS/2 or USB keyboard Mouse PS/2 or USB mouse - 107 -
Telemetry Transmitter User Manual Product Specifications Display Specifications: Dimensions (inch) Resolution (pixel) *17 (regular-screen) 1280X1024 *Recommended Quantity: For 1 to32 telemetry transmitters: one display For 33 to 64 telemetry transmitters: two displays Printer LaserJet UPS 1000 W Network device specifications Structure Ethernet 802.3 Device Network switch Transmission rate 10 M, 100 M Transmitted information Waveforms, parameters and alarms of all networked telemetry transmitters Compatible telemetry transmitters telemetry transmitters complying with EDAN network protocol Maximum number of networked telemetry transmitters 64 Speaker Built-in speaker is recommended. CAUTION Ensure that the computer hardware can meet the requirements of the software installation and running. Also, the video adapter, the audio adapter, the network adapter and their respective drivers should been installed well in the computer; otherwise, the software may not run normally. NOTE: 1 The hardware specifications require the use of PC that complies with IEC/EN requirements for ITE equipment. 2 The configuration mentioned above is for reference and not permanent. EDAN preserves the right to change and upgrade system settings. - 108 -
Telemetry Transmitter User Manual Product Specifications A.4.2 Software Performance Trend 240-hour trend review for each telemetry transmitter; 12-hour short trend dynamic display for each telemetry transmitter; Alarm events 720 pieces of parameter alarm events for each telemetry transmitter Alarm type Physiological Alarm Technical Alarm Alarm mode 3 levels of audible and visual alarms Nurse call records (from the telemetry transmitter are stored by MFM-CMS) Store 100 groups Patient call records (from the telemetry transmitter are stored by MFM-CMS) Store 100 groups Waveform storage and review 96-hour waveform for each telemetry transmitter A.5 ECG Complies with IEC 60601-2-27: 2011 Lead Mode  Automatic identification for leads  3-Lead: I, II, III  5-Lead: I, II, III, aVR, aVL, aVF, V Support Smart Lead Off Check (Telemetry transmitter) cannot choose calculation lead; (MFM-CMS) supports choosing calculation lead. Lead naming style AHA, IEC ☆ Display Sensitivity MFM-CMS: 1.25 mm/mV (×0.125), 2.5 mm/mV (×0.25), 5 mm/mV (×0.5), 10 mm/mV (×1), 20 mm/mV (×2), 40 mm/mV (×4), AUTO gain Telemetry Transmitter: AUTO gain - 109 -
Telemetry Transmitter User Manual Product Specifications ☆ Sweep MFM-CMS: 6.25 mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s Telemetry Transmitter: 12.5 mm/s ☆ Bandwidth (-3 dB) Diagnosis: 0.05 Hz to 150 Hz Monitor: 0.5 Hz to 40 Hz Surgery: 1 Hz to 20 Hz ☆ CMRR (Common Mode Rejection Ratio) Diagnosis: >95 dB Monitor: >105 dB Surgery: >105 dB Notch In diagnosis, monitor and surgery modes: 50 Hz/60Hz (Notch filter can be turned on or off manually) ☆ Differential Input Impedance >5 MΩ ☆ Input Signal Range ±10 mV PP ☆ Accuracy of Input Signal Reproduction The total error and frequency response comply with IEC 60601-2-27: 2011, Sect. 201.12.1.101.1. ☆ Electrode Offset Potential Tolerance ±500 mV Auxiliary Current (Leads off detection) Active electrode: <100 nA Reference electrode: <900 nA ☆ Recovery time after Defibrillation <5 s ☆ Leakage current of patient <10 μA ☆ Scale signal 1 mVPP, accuracy is ±5％ ☆ System noise <30 μVPP Multichannel Crosstalk Complied with IEC 60601-2-27: 2011, Sect. 201.12.1.101.5. Frequency and Impulse Response Complied with IEC 60601-2-27: 2011, Sect. 201.12.1.101.8. - 110 -
Telemetry Transmitter User Manual Product Specifications Pace Pulse Pulse indicator Pulse is marked if the requirements of ANSI/AAMI IEC 60601-2-27: 2011, Sect. 201.12.1.101.12 are met: Amplitude: ±2 mV to ±700 mV Width: 0.2 ms to 2.0 ms Ascending time: 10 μs to 100 μs And Amplitude: ±3 mV to ±700 mV Width: 0.1 ms to 2.0 ms Ascending time: 10 μs to 100 μs Pulse Rejection Pulse is rejected if the requirements of IEC 60601-2-27: 2011, Sect. 201.12.1.101.13 are met: Amplitude: ±2 mV to ±700 mV Width: 0.1 ms to 2.0 ms Ascending time: 10 μs to100 μs Baseline Reset Time < 3 s. Complied with IEC 60601-2-27: 2011, Sect. 201.12.1.101.11 Minimum input slew rate >2.5 V/S Heart Rate HR Calculation ☆ Range ADU: 15 bpm to 300 bpm PED: 15 bpm to 350 bpm ☆ Accuracy ±1% or ±1 bpm, whichever is greater ☆ Resolution 1 bpm Sensitivity ≥300 μV PP QRS QRS Detection Range Complied with IEC 60601-2-27: 2011, Sect. 201.12.1.101.15. - 111 -
Telemetry Transmitter User Manual Product Specifications PVC ☆ Range ADU: 0 to 300 PVCs/ min PED: 0 to 350 PVCs/ min ☆ Resolution 1 PVCs/min ST value ☆ Range -2.0 mV to +2.0 mV ☆ Accuracy -0.8 mV to +0.8 mV: ±0.02 mV or 10%, whichever is greater. Beyond this range: not specified. ☆ Resolution 0.01 mV HR Averaging Method Method 1 Heart rate is computed by excluding the minimum and maximum values from the 12 most recent RR intervals and averaging the residual 10 RR intervals. Method 2 If each of three consecutive RR intervals is greater than 1200ms, then the four most recent RR intervals are averaged to compute the HR. Range of Sinus and SV Rhythm Tachy Adult: RR interval for 5 consecutive QRS complex ≤ 0.5s. Pediatric: RR interval for 5 consecutive QRS complex ≤ 0.375s. Normal Adult: 0.5s < RR interval for 5 consecutive QRS complex < 1.5s. Pediatric: 0.375s < RR interval for 5 consecutive QRS complex < 1s. Brady Adult: RR interval for 5 consecutive QRS complex ≥ 1.5s. Pediatric: RR interval for 5 consecutive QRS complex ≥ 1s. Range of Ventricular Rhythm Ventricular Tachycardia The interval of 5 consecutive ventricular beats is less than 600 ms - 112 -
Telemetry Transmitter User Manual Product Specifications Ventricular Rhythm The interval of 5 consecutive ventricular beats ranges from 600 ms to 1000 ms Ventricular Bradycardia The interval of 5 consecutive ventricular beats is more than 1000 ms ☆ Maximum start-up alarm time for Tachycardia Ventricular Tachycardia 1 mV 206bpm Gain 1.0: 10 s Gain 0.5: 10 s Gain 2.0: 10 s Ventricular Tachycardia 2 mV 195bpm Gain 1.0: 10 s Gain 0.5: 10 s Gain 2.0: 10 s Response time of Heart Rate Meter to Change in HR HR range: 80 bpm to 120 bpm Within 11 seconds HR range: 80 bpm ~ 40 bpm Within 11 seconds Tall T-wave Rejection Complied with IEC 60601-2-27: 2011, Sect. 201.12.1.101.17 minimum recommended 1.2 mV T-Wave amplitude Accuracy of Heart Rate Meter and Response to Irregular Rhythm Complied with IEC 60601-2-27: 2011, Sect. 201.7.9.2.9.101 b) 4), the HR value after 20 seconds of stabilization is displayed as follows: Ventricular bigeminy: 80 bpm±1 bpm Slow alternating ventricular bigeminy: 60 bpm±1 bpm Rapid alternating ventricular bigeminy: 120 bpm±1 bpm Bidirectional systoles: 91 bpm±1 bpm Time to Alarm for Heart Rate alarm conditions Asystole alarm: ≤ 10 s HR low alarm: ≤ 10 s HR high alarm: ≤ 10 s Complied with IEC 60601-2-27: 2011, Sect. 208.6.6.2.103. - 113 -
Telemetry Transmitter User Manual Product Specifications Arrhythmia analyses ASYSTOLE VFIB/VTAC COUPLET VT>2 BIGEMINY TRIGEMINY VENT R on T PVC TACHY BRADY MISSED BEATS IRR VBRADY PNC PNP A.6 RESP Method Impedance RA-LL Measurement lead lead II Calculation Type Automatic Respiration excitation waveform Square Wave, 64 kHz(±10%), <500 μA ☆ Measuring Sensitivity Within baseline impedance range: 0.3 Ω ☆ Waveform bandwidth 0.2 Hz to 2.5 Hz (-3 dB) ☆ Baseline Impedance Range 200 Ω to 2500 Ω (leads cables 1 KΩ resistance) ☆ RR Measuring Range Adult 0 rpm to 120 rpm Ped 0 rpm to 150 rpm Resolution 1 rpm ☆ Accuracy Adult 6 to 120 rpm: ±2 rpm 0 to 5 rpm: not specified Ped 6 to 150 rpm: ±2 rpm 0 to 5 rpm: not specified ☆ Gain Selection (MFM-CMS) ×0.25, ×0.5, ×1, ×2, ×3, ×4, ×5 Sweep (MFM-CMS) 6.25 mm/s, 12.5 mm/s, 25 mm/s - 114 -
Telemetry Transmitter User Manual Product Specifications Apnea Alarm Time Setup 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s; default value is 20 s. ±3 seconds delayed is acceptable. A.7 SpO2 Complies with ISO 80601-2-61: 2011. ☆ Measuring Range 0 to 100 % ☆ Alarm Range 20 to 100 % ☆ Resolution 1 % ☆ Data update period 1 s ☆ Accuracy Adult /Pediatric ±2 % (70% to 100% SpO2) Undefined (0 to 69% SpO2) Pulse Rate ☆ Measuring Range 25 bpm to 300 bpm ☆ Adjustable Range of Alarm Limits 30 bpm to 300 bpm Resolution 1 bpm ☆ Accuracy ±2 bpm Sensor Red light 660±3 nm Infrared light 905±10 nm Emitted light energy < 15 mW Sweep (MFM-CMS) 6.25 mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s Alarm signal System delay less than 3 s Pause duration 60 s, 120 s, 180 s NOTE: Information about the wave length range can be especially useful to clinicians (for instance, when photodynamic therapy is performed). - 115 -
Telemetry Transmitter User Manual Product Specifications A.8 Wi-Fi IEEE 802.11b/g/n Frequency 2.4 GHz ISM band Modulation OFDM（BPSK，QPSK，16-QAM，64-QAM） CCK/DSSS（802.11b） Typical Transmit Power (±2 dBm) 17 dBm for 802.11b DSSS 17 dBm for 802.11b CCK 15 dBm for 802.11g/n OFDM - 116 -
Telemetry Transmitter User Manual EMC Information B EMC Information B.1 Electromagnetic Emissions Electromagnetic emission iT20 is intended for use in the electromagnetic environment specified below. The customer or the user of the iT20 should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 iT20 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emission CISPR 11 Class A iT20 is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions IEC/EN 61000-3-2 Not applicable Voltage fluctuations/ flicker emissions IEC/EN 61000-3-3 Not applicable B.2 Electromagnetic Immunity Electromagnetic immunity iT20 is intended for use in the electromagnetic environment specified below. The customer or the user of the iT20 should assure that it is used in such an environment. Immunity test IEC/EN 60601 test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC/EN 61000-4-2 ±6 kV contact ±8 kV air ±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/EN 61000-4-4 ±2 kV for power supply lines ±1 kV for input/output lines Not applicable Not applicable - 117 -
Telemetry Transmitter User Manual EMC Information Surge IEC/EN 61000-4-5 ±1 kV for line to line ±2 kV lines to earth Not applicable Not applicable Power frequency (50/60Hz) magnetic field IEC/EN 61000-4-8 3A/m 3A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC/EN 61000-4-11 <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec Not applicable Not applicable NOTE UT is the a.c. mains voltage prior to application of the test level. - 118 -
Telemetry Transmitter User Manual EMC Information B.3 Electromagnetic Immunity Electromagnetic immunity iT20 is intended for use in the electromagnetic environment specified below. The customer or the user of iT20 should assure that it is used in such an environment. Immunity test IEC/EN 60601 test level Compliance level Electromagnetic environment - guidance Conducted RF IEC/EN 61000-4-6 Radiated RF IEC/EN 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 Vrms 3 V/m Portable and mobile RF communications equipment should be used no closer to any part of iT20, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Pd2.1=150 kHz to 80 MHz Pd2.1= 80 MHz to 800 MHz Pd3.2= 800 MHz to 2.5 GHz 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 metres (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 - 119 -
Telemetry Transmitter User Manual EMC Information the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 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 iT20 is used exceeds the applicable RF compliance level above, iT20 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating iT20. b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m. B.4 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and iT20 iT20 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of iT20 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and iT20 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter(m) 150 kHz to 80 MHz Pd2.1= 80 MHz to 800 MHz Pd2.1= 800 MHz to 2.5 GHz Pd3.2= 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated 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. - 120 -
Telemetry Transmitter User Manual EMC Information NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. - 121 -
Telemetry Transmitter User Manual Default Settings C Default Settings This appendix documents the most important default settings of your telemetry transmitter as it is delivered from the factory. Note: If your telemetry transmitter has been ordered preconfigured to your requirements, the settings at delivery will be different from those listed here. C.1 Patient Information Default Settings Patient Information Settings Patient Type Adult Pace Off C.2 Alarm Default Settings (MFM-CMS) Alarm Settings Pause Time 120s Mute Off Alarm Latch Off C.3 ECG Default Settings ECG Settings ADU PED Alarm Switch On Alarm Level Medium Alarm High Limit 120 160 Alarm Low Limit 50 75 Pace Off Lead Type Distinguish automatically Calculation Lead Lead II Filter Mode Monitor Smart Lead Off Off ST Alarm Level Med. ST Analysis Off Alarm Switch Off Alarm Level Medium - 122 -
Telemetry Transmitter User Manual Default Settings X stands for I, II, III, aVR, aVL, aVF, V, V1, V2, V3, V4, V5 or V6. ARR Analysis ARR Analysis On PVCs Alarm Level Medium PVCs Alarm Switch Off ARR Alarm Settings Alarm Switch Alarm Level Alarm Record ASYSTOLE On High Off VFIB/VTAC On High Off R ON T On Medium Off VT > 2 On Medium Off COUPLET On Medium Off PVC On Medium Off BIGEMINY On Medium Off TRIGEMINY On Medium Off TACHY On Medium Off BRADY On Medium Off MISSEDBEATS On Medium Off IRR On Medium Off PNC On Medium Off PNP On Medium Off VBRADY On Medium Off VENT On Medium Off C.4 RESP Default Settings RESP Settings ADU PED Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit 30 30 Alarm Low Limit 8 8 Apnea Time 20s Sweep 12.5mm/s - 123 -
Telemetry Transmitter User Manual Default Settings C.5 SpO2 Default Settings SpO2 Settings ADU PED Alarm Switch On Alarm Level Medium Alarm High Limit 100 100 Alarm Low Limit 90 90 Sensitivity Meddium Sweep 12.5mm/s C.6 PR Default Settings PR Settings ADU PED PR Source SpO2 Alarm Switch On Alarm Level Medium Alarm High Limit 120 160 Alarm Low Limit 50 75 Alarm Source Auto - 124 -
Telemetry Transmitter User Manual Abbreviation D Abbreviation Abbr English Full Name/Description AC Alternating current Adu Adult CISPR International Special Committee on Radio Interference CMS Central monitoring system DC Direct current ECG Electrocardiogram EEC European Economic Community EMC Electromagnetic compatibility EMI Electromagnetic interference ESU Electrosurgical unit FCC Federal Communication Commission FDA Food and Drug Administration HR Heart rate ID Identification IEC International Electrotechnical Commission IEEE Institute of Electrical and Electronic Engineers LA Left arm LCD Liquid crystal display LED Light emitting diode LL Left leg MDD Medical Device Directive MRI Magnetic resonance imaging N/A Not applied oxyCRG Oxygen cardio-respirogram Ped Pediatric Pleth Plethysmogram PR Pulse rate PVC Premature ventricular complex R Right - 125 -
Telemetry Transmitter User Manual Abbreviation RA Right arm Resp Respiration RL Right leg RR Respiration Rate SpO2 Oxygen saturation of arterial blood USB Universal serial bus - 126 -

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