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EDAN INSTRUMENTS
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IT20EDAN
Users manual
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EDAN INSTRUMENTS IT20EDAN 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

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 perform ance 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 th is 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 T ransmitter ............................................................................... 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 T op 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 W aveforms .................................................................................................. 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 W aveform ........................................................................... 43
7.3 Short Trend Review .......................................................................................................... 43
7.4 OxyCRG ............................................................................................................................ 44
IV
7.5 Freeze ................................................................................................................................ 44
Chapter 8 Setting T elemetry T ransmitters 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 W a ve Review ..................................................................................................................... 48
9.2.1 Reviewing Normal W a vefor ms ............................................................................... 48
9.2.2 Reviewing Compressed Waveforms ....................................................................... 48
9.2.3 Setting Wave Speed ................................................................................................. 49
9.2.4 Refreshing W aveform ............................................................................................. 49
9.2.5 Selecting W aveform ................................................................................................ 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 T elemetry 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 Alar m 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 T echnical 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 T esting 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 T e lemetry 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 W a rranty ........................................................................................................................ 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

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, t he pac ing impul se analy sis funct ion must be swit ched ON. Ot herwi se, 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 asy stol e.
9 Do not come into contact with the patient, table, or the telemetry transmitter during
defibrillation.
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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 el ect r ode an d gr ound .
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 audi ble alar m sy stem for pa tient moni tor ing. 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, an y
other equipment co mplying with CI SPR radi ation r equir ement s may a lso i nter fere w ith
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
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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 elec tr ic shoc k protec tio n cannot be g uaran teed, a nd th e p atien t 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 W ireless LAN equipment contains an intentional RF radiator that has the potential of
interfering w it h other m edic al eq ui p men t, i ncl u di ng patient implanted devices. Be sure
to perform the electromagnetic compatibility test, as described in the W ireless LAN
System Installation, before installation and any time new medical equipment is added
to the Wireless LAN coverage area.
21 W hen 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 w it h ho u s e-hol d g ar bag e. At the end of their l i fe h and 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
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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 ma y 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 transmit ter should not be used adj a cent t o or s t acke d wi th other eq uipment .
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 trans mitter and modifications during actual serv ic e 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 ex tension 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
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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 transfor mer.
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, mobi l e telep hon es , 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 tr ansd ucer s in liq uid. When u sing sol utions , us e st er ile w ipes to av oid
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 an d 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
Ingress Protection: IPX7 (protected against ingress of water with
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 tim e. 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
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
AUTHORISED REPRESENTATIVE IN THE EUROPEAN
Caution: Federal (U.S.) Law restricts this device to sale by or on the
Picture freeze
CE marking
COMMUNITY
Date of manufacture
MANUFACTURER
Part Number
General symbol for recovery/recyclable
Disposal method
order of a physician.
- 7 -
Telemetry Transmitter User Manual Overview
70
SpO
2 %
99
HR bpm
RR rpm
14
ST II 0.10
PR bpm
70
PACE
Icon
Bed No.
Networking Icon
Battery Status
Wireless signal Icon
Information
Parameter Pulse Bar Graph

Chapter 2 Overview

2.1 System Introduction

Telemetry monitoring system can realize an integrated monitoring for multiple mobile patients or bed patients via wirel ess network. It is eas y 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

2.2.1 Default Interface

follow:
Area
V alue Area
Figure 2-1 ECG + SpO2 + RESP Default Interface（ST on）
- 8 -
Telemetry Transmitter User Manual Overview
60
HR bpm
II
PACE Icon
Bed No.
Networking Icon
Battery Status
Wireless Signal Icon
SpO2 %
99
血氧波
60
HR bpm
Bed No.
Networking Icon
Battery Status
Wireless Signal Icon

2.2.2 Main Interface

Main interface has two kinds: Value - Waveform Main Interface and Trend Graph Main Interface. Value - Waveform Main Interface
wave.
Figure 2-2 ECG Interface（ST off）
2. SpO2 Interface: includes information area, SpO2 value, PR value and PLETH wave.
Figure 2-3 SpO 2 & PR Interface
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Telemetry Transmitter User Manual Overview
60
SpO
2
%
99
HR bpm
II
ST
II
0.10
PACE
Icon
Bed No.
Networking Icon
Battery Status
Wireless Signal Icon
60
RR rpm
14
HR bpm
II
ST
II
0.10
PACE
Icon
Bed No.
Networking Icon
Battery Status
Wireless Signal Icon
and ECG wave.
Figure 2-4 ECG & S pO2 Interface（ST on）
4. ECG&RESP Interface: includes information area, ECG value of calculated lead, RR value
and ECG wave.
Figure 2-5 ECG & RESP Interface（ST ON）
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Telemetry Transmitter User Manual Overview
70
SpO2 %
99
HR bpm
RR rpm
14
ST
II
0.
10
PR
bpm
70
PACE
Icon
Bed No
.
Networking Icon
Battery Status
Wireless signal Icon
Networking Icon
Bed No
.
Wireless signal Icon
Battery Status
min
XXX
0
xx
-90 -60 -30
xx
Parameter name
and unit
Parameter
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.
Figure 2-6 ECG & SpO2 & PR & RESP Interface（ST ON）
Trend Graph Main Interface
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.
scale value
Figure 2-7 Trend Graph Main Interface
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Telemetry Transmitter User Manual Overview
1

2.2.3 Setting Interface

Setting interface includes password inputting interface and function setting interfac e that will be displayed after confirm pass word. Under non-0-level of bat tery 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 transmi tter, 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

2
3
Front View
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Telemetry Transmitter User Manual Overview
n, keep pressing at least for 3
press shifting to
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 a cceptance: 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 ope 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 choose password or language.
In EC G leads connection sketch interface (refer to 4.1.2 Switching On), pr ess
it to make the sketch disappear.
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Telemetry Transmitter User Manual Overview
to exit focus
Function acceptance
3
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
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 pl ease refers to the actual machine.
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Telemetry Transmitter User Manual Overview
Nurse call key

2.3.3 Left Side View

2.3.4 Right Side View

Left Side View
Right Side View
Nurse call key: press it to display calling nurse information on MFM-CMS.
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Telemetry Transmitter User Manual Overview
1
2

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 b y 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 param eter standa rdly configured is off by default after telemetry transmitter
√ × × ○
√ ○ ○ ○
switches on. Changing status should be operated on MFM-CMS. T he 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.
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Telemetry Transmitter User Manual Overview
xx
x
xx
x
xx xx xx xx
60
99
xx
x
xx
x
xx
xx xx
xx
60
99
xx
x
xx
x
xx xx xx xx
60
99
xx
x
xx
x
xx
xx xx xx
60
99
xx
x
xx
x
xx xx xx xx
60
99
xx
x
xx
x
xx
xx xx
xx
60
99
xx
x
xx
x
xx xx
xx xx
60
99
1
3
2
xxxx

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 t he auxiliary screen are the main op eration screens. The main screen and auxiliary screen on a single display are different from those on dual displays.

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).
1: System information area 2: Patient sectors 3: Quick control area
Figure
2-8 Main Screen on a Single Display
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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.
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Telemetry Transmitter User Manual Overview
Button
Button Label
Function
Click on this symbol to make the alarm pause and the
to disable the pause function and the
Click on it to enter the review interface, including patient information review, waveform review, alarm review, trend
Click on it to shut down the MFM-CMS and the operating
System Volume
then enter the password
up window; the entire
appears. To
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:
Main Screen Click on it to return to the main screen.
symbol appears in place of the symbol . And click
Audio Pause
on the symbol symbol appears in place of the symbol . When the alarm sound pauses, the symbol as well as th e related
prompt will be displayed in the system information area.
Review
review.
System Setup Click on it to enter the system setup menu.
Shut Down
system.
Admission Click on it to open the patient admission window.
Click on it, and the volume adjustor icon appears.
Adjustor
Select the Mute check box, and ABC in the text box on the pop-
system become mute, and the symbol disable the silence function, tick the Mute ch eck box again
and the symbol appears. Additionally, the user can drag
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