EDAN iM3 User manual

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--Signatures related to this document and performed in EDAN Agile PLM.
文件名称(Document Name)：iM3 说明书_英文
文件编号(Number)：01.54.457703
版本(Version)：1.1
产品型号(Product Model)：iM3
项目编码(Project Code)：00004I002
签批信息(Signature):
作者(Originator) : 陈 艳娟 (chenyanjuan) 2017-08-23 10:53:00
审核人(Reviewers) : 程 亮 (chengliang) 2017-08-24 13:01:47
审核人(Reviewers) : 史 洪华 (shihonghua) 2017-08-23 11:16:51
审核人(Reviewers) : 韦 华彪 (weihuabiao) 2017-08-23 11:19:01
审核人(Reviewers) : 陈 良款 (chenliangkuan) 2017-08-23 13:23:34
批准人(Approvers) : 夏 欢欢 (xiahuanhuan) 2017-08-29 18:57:24
批准人(Approvers) : 陈 浩杰 (chenhaojie) 2017-08-29 16:16:36
版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)

I
About this Manual
P/N: 01.54.457703
MPN: 01.54.457703011
Release Date: August 2017
© Copyright EDAN INSTRUMENTS, INC. 2017. 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) cannot 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.

II
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.

III
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 Monitor................................................................................6
Chapter 2 Installation........................................................................................................................9
2.1 Initial Inspection.....................................................................................................................9
2.2 Mounting the Monitor............................................................................................................9
2.3 Connecting the Power Cable..................................................................................................9
2.4 Checking the Monitor ............................................................................................................9
2.5 Connecting Sensor to Patient...............................................................................................10
2.6 Checking the Recorder.........................................................................................................10
2.7 Setting Date and Time..........................................................................................................10
2.8 Handing Over the Monitor...................................................................................................10
Chapter 3 Basic Operation..............................................................................................................11
3.1 Overview..............................................................................................................................11
3.1.1 Front View.................................................................................................................11
3.1.2 Rear View..................................................................................................................13
3.1.3 Side View..................................................................................................................15
3.2 Operating and Navigating....................................................................................................16
3.2.1 Using Keys................................................................................................................19
3.3 Operating Mode ...................................................................................................................21
3.3.1 Demo Mode...............................................................................................................21
3.3.2 Standby Mode ...........................................................................................................21
3.3.3 Night Mode ...............................................................................................................22
3.3.4 Other Modes..............................................................................................................22
3.4 Changing Monitor Settings..................................................................................................22
3.4.1 Adjusting Screen Brightness.....................................................................................22
3.4.2 Adjusting Volume......................................................................................................23
3.5 Checking Your Monitor Information ...................................................................................23
3.6 Networked Monitoring.........................................................................................................23
3.7 Common Settings.................................................................................................................24
3.8 Disabling the Touch Screen..................................................................................................24
3.9 Using the Barcode Scanner..................................................................................................24
3.10 Using Keyboard and Mouse...............................................................................................24
Chapter 4Alarms.............................................................................................................................25
4.1 Alarm Category....................................................................................................................25
4.1.1 PhysiologicalAlarms ................................................................................................25
4.1.2 Technical Alarms.......................................................................................................25
4.1.3 Prompts .....................................................................................................................25

IV
4.2 Selecting Alarm Tone Type..................................................................................................25
4.3 Alarm Levels........................................................................................................................26
4.4 Controlling Alarm ................................................................................................................27
4.4.1 Setting Parameter Alarm...........................................................................................27
4.4.2 Audio Alarm Paused..................................................................................................28
4.4.3 Audio Alarm off ........................................................................................................29
4.4.4 Alarm Reset...............................................................................................................29
4.5 Latching Alarms...................................................................................................................30
4.6 Alarm of SpO2Sensor Off....................................................................................................30
4.7 Network Disconnected Alarms ............................................................................................30
4.8 Delete All Alarm Events ......................................................................................................30
4.9 Testing Alarms......................................................................................................................31
Chapter 5Alarm Information.........................................................................................................32
5.1 PhysiologicalAlarm Information.........................................................................................32
5.2 Technical Alarm Information ...............................................................................................33
5.3 Prompts ................................................................................................................................40
5.4 Adjustable Range of Alarm Limits.......................................................................................41
Chapter 6 Managing Patients .........................................................................................................43
6.1 Monitor Mode ......................................................................................................................43
6.1.1 Admitting a Patient....................................................................................................43
6.1.2 Quick Admit..............................................................................................................44
6.1.3 Editing Patient Information.......................................................................................44
6.2 Round Mode.........................................................................................................................44
6.2.1 Patient Management..................................................................................................44
6.2.2 Choose Patient for Measurement..............................................................................46
6.2.3 Round Record ...........................................................................................................46
6.3 Spot-checking Mode ............................................................................................................47
6.3.1 Admit Patient.............................................................................................................47
6.3.2 Modify Patient Information.......................................................................................47
6.4 Inquire for Patient Information via Network .......................................................................47
6.5 Central Monitoring System..................................................................................................48
Chapter 7 User Interface.................................................................................................................49
7.1 Setting Interface Style..........................................................................................................49
7.2 Selecting Display Parameters...............................................................................................49
7.3 Changing Parameter and Waveform Colors.........................................................................49
7.4 User Configuration...............................................................................................................49
7.5 Default Configuration ..........................................................................................................50
Chapter 8 Monitoring SpO2............................................................................................................51
8.1 Overview..............................................................................................................................51
8.2 SpO2Safety Information......................................................................................................51

V
8.3 Measuring SpO2...................................................................................................................52
8.4 Measurement Limitations ....................................................................................................53
8.5 Assessing the Validity of a SpO2Reading............................................................................54
8.6 SpO2Alarm Delay................................................................................................................54
8.7 Perfusion Index (PI)*...........................................................................................................55
8.8 Setting Pitch Tone ................................................................................................................55
8.9 Setting Sensitivity ................................................................................................................55
8.10 NIBP/SpO2Simul Measurement Setting ...........................................................................55
8.11 SatSeconds Alarm Management*.......................................................................................56
8.11.1 Describing SatSeconds............................................................................................56
8.11.2 SatSeconds ―Safety Net‖.........................................................................................57
8.11.3 Setting SatSeconds Duration...................................................................................57
Chapter 9 Monitoring PR................................................................................................................58
9.1 Overview..............................................................................................................................58
9.2 PR Source.............................................................................................................................58
9.3 Setting PR Volume...............................................................................................................58
Chapter 10 Monitoring NIBP .........................................................................................................59
10.1 Overview............................................................................................................................59
10.2 NIBP Safety Information ...................................................................................................59
10.3 Measurement Limitations ..................................................................................................60
10.4 Measurement Methods.......................................................................................................61
10.5 Measurement Procedures...................................................................................................61
10.5.1 Operation Prompts ..................................................................................................63
10.5.2 Correcting the Measurement if Limb is not at Heart Level ....................................64
10.6 NIBP Multi-Review Window.............................................................................................64
10.7 Resetting NIBP ..................................................................................................................64
10.8 Calibrating NIBP................................................................................................................65
10.9 Leakage Test.......................................................................................................................65
10.10 Setting Inflation Value......................................................................................................66
10.11 Measuring PR...................................................................................................................66
10.12 NIBPAuto Recording ......................................................................................................66
Chapter 11 Monitoring TEMP........................................................................................................67
11.1 Quick TEMP with T2A Module.........................................................................................67
11.1.1 Introduction.............................................................................................................67
11.1.2 Measuring Procedure...............................................................................................68
11.1.3 TEMP Setup for T2AModule .................................................................................69
11.2 Quick TEMP with F3000 Module......................................................................................69
11.2.1 Introduction.............................................................................................................69
11.2.2 Probe Covers —Applying & Removing .................................................................71
11.2.3 Changing Isolation Chambers and Probes ..............................................................71

VI
11.2.4 Measuring Mode .....................................................................................................72
11.2.5 Measuring Procedure...............................................................................................73
11.2.6 TEMP Setup for F3000 Module..............................................................................74
11.3 Infrared TEMP with TH Module........................................................................................75
11.3.1 Introduction.............................................................................................................75
11.3.2 Measuring Procedure...............................................................................................76
11.3.3 Replacing the Battery..............................................................................................78
Chapter 12 Review (in Monitor Mode)..........................................................................................80
12.1 Trend Graph Review..........................................................................................................80
12.1.1 Selecting Trend Graph of Specific Parameter.........................................................80
12.1.2 Adjusting Trend Scale.............................................................................................80
12.1.3 Setting Interval........................................................................................................80
12.1.4 Scrolling Left and Right the Screen........................................................................80
12.2 Trend Table Review ...........................................................................................................80
12.2.1 Setting Interval........................................................................................................81
12.2.2 Scrolling the Screen ................................................................................................81
12.3 NIBP Review......................................................................................................................81
12.3.1 Scrolling the Screen ................................................................................................81
12.4 Alarm Review.....................................................................................................................81
12.4.1 Scrolling the Screen ................................................................................................81
12.4.2 Selecting Alarm Event of Specific Parameter.........................................................82
12.4.3 Setting Time Index..................................................................................................82
12.5 Technical Alarm Checking.................................................................................................82
12.6 Event Marking....................................................................................................................82
Chapter 13 Review (in Round or Spot-checking Mode)...............................................................83
13.1 Round Record Management...............................................................................................83
13.2 Review Spot-checking Data...............................................................................................83
13.3 Spot-checking Data Trend Table........................................................................................84
Chapter 14 Recording......................................................................................................................85
14.1 Performance of the Recorder .............................................................................................85
14.2 Starting and Stopping Recording .......................................................................................86
14.3 Recorder Operations and Status Messages ........................................................................87
14.3.1 Record Paper Requirement .....................................................................................87
14.3.2 Proper Operation.....................................................................................................87
14.3.3 Paper Out.................................................................................................................87
14.3.4 Replacing Paper ......................................................................................................87
14.3.5 Removing Paper Jam...............................................................................................89
Chapter 15 Other Functions............................................................................................................90
15.1 Nurse Call ..........................................................................................................................90
15.2 Wi-Fi ..................................................................................................................................90

VII
15.3 E-link Function ..................................................................................................................91
15.4 Uploading Data to Network Server....................................................................................92
15.5 Storing Data in the Storage Device....................................................................................92
15.5.1 Data Stored in the Storage Device ..........................................................................92
15.5.2 Selecting a Storage Device......................................................................................93
15.5.3 Reviewing Data Stored in the Storage Device........................................................94
15.5.4 Deleting Data Stored in the Storage Device............................................................94
15.5.5 Exporting Data Stored in the Internal Storage Device............................................94
15.5.6 Ejecting a Removable Device.................................................................................95
15.5.7 Recording Data by Recorder...................................................................................95
15.5.8 Formatting the Internal Storage Device..................................................................95
15.6 Warning-Score System.......................................................................................................96
15.6.1 Warning-Score Interface .........................................................................................96
15.6.2 Warning-Score Method ...........................................................................................96
15.6.3 Warning-Score Criteria ...........................................................................................96
15.6.4 Warning-Score Result .............................................................................................98
15.6.5 Warning-Score Trend Table.....................................................................................99
15.7 Alert Setup..........................................................................................................................99
Chapter 16 Using Battery..............................................................................................................101
16.1 Battery Safety Information...............................................................................................101
16.2 Battery Power Indicator ...................................................................................................102
16.3 Battery Status on the Main Screen...................................................................................102
16.4 Checking Battery Performance ........................................................................................102
16.5 Replacing the Battery.......................................................................................................103
16.6 Recycling the Battery.......................................................................................................103
16.7 Maintaining the Battery....................................................................................................103
Chapter 17 Care and Cleaning .....................................................................................................104
17.1 General Points..................................................................................................................104
17.2 Cleaning ...........................................................................................................................104
17.2.1 Cleaning the Monitor ............................................................................................105
17.2.2 Cleaning the ReusableAccessories.......................................................................105
17.3 Disinfection......................................................................................................................106
17.3.1 Disinfecting the Monitor.......................................................................................106
17.3.2 Disinfecting the Reusable Accessories..................................................................107
17.4 Cleaning and Disinfecting OtherAccessories..................................................................108
Chapter 18 Maintenance ...............................................................................................................109
18.1 Inspecting.........................................................................................................................109
18.2 Maintenance Task and Test Schedule...............................................................................109
Chapter 19 Warranty and Service................................................................................................110
19.1 Warranty...........................................................................................................................110

VIII
19.2 Contact Information.........................................................................................................110
Chapter 20 Accessories .................................................................................................................. 111
20.1 SpO2Accessories .............................................................................................................111
20.2 NIBPAccessories.............................................................................................................112
20.3 TEMPAccessories ...........................................................................................................113
20.4 Other Accessories.............................................................................................................114
A Product Specification .................................................................................................................116
A.1 Classification.....................................................................................................................116
A.2 Physical Specifications......................................................................................................116
A.2.1 Size and Weight......................................................................................................116
A.2.2 Environment Specification.....................................................................................116
A.2.3 Display ...................................................................................................................117
A.2.4 Battery Specification..............................................................................................117
A.2.5 Recorder.................................................................................................................118
A.2.6 Data Storage...........................................................................................................118
A.3 NIBP..................................................................................................................................119
A.4 SpO2..................................................................................................................................122
A.5 TEMP ................................................................................................................................123
A.6 Adjustable Range of Alert Limits......................................................................................125
A.7 Wi-Fi..................................................................................................................................126
A.8 E-link.................................................................................................................................126
A.9 Interfaces...........................................................................................................................127
A.9.1 Nurse Call...............................................................................................................127
A.9.2 USB Interfaces .......................................................................................................127
A.9.3 OTG Interfaces.......................................................................................................127
A.9.4 Network Interface...................................................................................................127
B EMC Information.......................................................................................................................128
B.1 Electromagnetic Emissions ...............................................................................................128
B.2 Electromagnetic Immunity................................................................................................128
B.3 Electromagnetic Immunity................................................................................................130
B.4 Recommended Separation Distances ................................................................................132
C Default Settings...........................................................................................................................134
C.1 Patient Information Default Settings.................................................................................134
C.2 Alarm Default Settings......................................................................................................134
C.3 SpO2 Default Settings........................................................................................................134
C.4 PR Default Settings ...........................................................................................................135
C.5 NIBP Default Settings .......................................................................................................135
C.6 TEMP Default Settings......................................................................................................136
DAbbreviations..............................................................................................................................137

Vital Signs Monitor User Manual Intended Use and Safety Guidance
- 1 -
Chapter 1 Intended Use and Safety Guidance
1.1 Intended Use/Indications for Use
The monitor is intended to be used for monitoring, storing, recording, and reviewing of, and to
generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The
monitor is intended for use by trained healthcare professionals in hospital environments.
Monitored parameters include: NIBP, SpO2, PR (pulse rate), Quick TEMP/Infrared TEMP.
The monitor is not intended for MRI environments. TEMP module is not intended for neonates.
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 sensors etc. should be
checked. Replacement should be taken if there is any evident defect or signs of aging
which may impair the safety or performance.
2 Medical technical equipment such as these monitor/monitoring systems 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.
3 EXPLOSION HAZARD-Do not use the device in a flammable atmosphere where
concentrations of flammable anesthetics or other materials may occur.
4 SHOCK HAZARD-To avoid the RISK of electric shock, this equipment must only be
connected to a SUPPLY MAINS with protective earth. Never adapt the three-prong
plug from the monitor to fit a two-slot outlet.
5 Do not come into contact with the patient, table, or the monitor during defibrillation.
6 The simultaneous use of cardiac pacemaker and other patient-connected equipment
may cause safety hazard.
7 Extreme care must be exercised when applying medical electrical equipment. Many
parts of the human/machine circuit are conductive, such as the patient, connectors,
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.
8 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 monitor 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.

Vital Signs Monitor User Manual Intended Use and Safety Guidance
- 2 -
WARNING
9 Route all cables carefully to avoid possible entanglement, apnea, or electrical
interference. For the device mounted over the patient, sufficient precautionary
measures should be taken to prevent it from falling on the patient.
10 Devices connecting with monitor should be equipotential.
11 Do not rely exclusively on the auditory 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.
12 Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing
equipment and IEC/EN 60601-1 for medical equipment). 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/EN 60601-1. If in doubt,
consult our technical service department or your local distributor.
13 Only patient cable and other accessories supplied by EDAN can be used. The
performance and electric shock protection cannot be guaranteed, and the patient may
be injured otherwise. Prior to use, check if the casing of a disposable accessory is
intact. Do not use it if its casing is damaged.
14 When interfacing with other equipment, a test for leakage current must be performed
by qualified biomedical engineering personnel before using with patients.
15 If several medical equipments are connected to a patient, the sum of the leakage
currents shouldn‟t exceed the limits, otherwise it may cause shock hazard.
16 In monitor mode, when monitoring is in process, if the power supply is off and there is
no battery for standby, the monitor will be off. The settings configured by the user can
be stored, and settings not configured by user keep no change. That is, the last
settings used will be recovered when the power is restored. In round or spot-checking
mode, the patient type will be restored to adult by default, and the monitor is in status
with no patients, and other settings processing after power off are the same with that
in monitor mode.
17 If leakage or foul odor is detected, ensure that there‟s no fire around.
18 The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be 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. 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.

Vital Signs Monitor User Manual Intended Use and Safety Guidance
- 3 -
WARNING
19 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.
20 This equipment is not intended for home usage.
21 Do not service or maintain the monitor or any accessory which is in use with the patient.
22 The appliance coupler or mains plug is used as isolation means from supply mains.
Position the monitor in a location where the operator can easily access the
disconnection device.
23 Assembly of the monitor and modifications during actual service life shall be
evaluated based on the requirements of IEC60601-1.
24 The monitors are MR Unsafe. The monitors are not intended for use in an MRI
environment.
25 Only recommended batteries can be used for the monitor.
26 In monitor mode, without use of data store function, all data measured (including trend
data, review data, alarm events and so on) are cleared either when the monitor is
turned off or when the monitor is powered down in the process of monitoring.
27 Additional multiple socket-outlets or extension cords can‟t be connected to the
system.
28 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.
29 Connecting any accessory (such as external printer) or other device (such as the
computer) to this monitor 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.
30 The medical electrical equipment needs to be installed and put into service according
to the EMC Information provided in this user manual.
31 Portable and mobile RF communications equipment can affect medical electrical
equipment; refer to the recommended separation distances provided in this user
manual.
32 Using accessories other than those specified may result in increased electromagnetic
emission or decreased electromagnetic immunity of the monitoring equipment.

Vital Signs Monitor User Manual Intended Use and Safety Guidance
- 4 -
WARNING
33 The monitor 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.
34 Do not touch accessible parts of medical or non-medical electrical equipment in the
patient environment and the patient simultaneously, such as USB connector, VGA
connector or other signal input/output connectors.
35 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.
36 SHOCK HAZARD - Don't connect 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.
37 Operation of the equipment exceeding specified physiological signal or the
operational specification may cause inaccurate results.
38 The equipment can provide protective means to prevent the patient from being
burned when used with HF SURGICAL EQUIPMENT. The equipment can protect
against the effects of the discharge of a defibrillator. Use only EDAN-approved
accessories.
39 When the monitor is used with HF surgical equipment, the transducer and the cables
must be avoided from conductive connection to the HF equipment. This is to protect
against burns to the patient.
40 To protect the monitor from damage during defibrillation, for accurate measurement
information and to protect against noise and other interference, use only accessories
specified by EDAN.
41 No modification of this equipment is allowed without authorization of the manufacturer.
If this equipment is modified, appropriate inspection and testing must be conducted to
ensure continued safe operation.
42 Clinical decision making based on the output of the device is left to the discretion of
the provider.
43 The monitor is equipped with Wi-Fi to receive RF electromagnetic energy. Therefore,
any other equipment complying with CISPR radiation requirements may also interfere
with the wireless communication and make it interrupted.
44 If the earth protection system is not stable, use the batteries for power supply.

Vital Signs Monitor User Manual Intended Use and Safety Guidance
- 5 -
WARNING
45 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.
46 Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the monitor, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
47 When the monitor is used with HF surgical equipment, user (doctor or nurse) should
be cautious about patient safety.
48 If device conflict occurs when monitor is connected to gateway, please modify the IP
address of the conflicted monitor.
CAUTION
1 Electromagnetic Interference - Ensure that the environment in which the patient
monitor is installed is not subject to any sources of strong electromagnetic
interference, such as radio transmitters, mobile telephones, microwaves, 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 use autoclave or gas to sterilize the monitor, recorder or any accessories.
5 The device and reusable accessories may be sent back to the manufacturer for
recycling or proper disposal after their useful lives.
6 Disposable devices are intended for single use only. They should not be reused as
performance could degrade or contamination could occur.
7 Remove a battery whose life cycle has expired from the monitor immediately.
8 To ensure patient safety, use only parts and accessories manufactured or
recommended by EDAN.
9 Before connecting the monitor 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.
10 Protect the device against mechanical damage resulting from falls, impacts, and
vibration.

Vital Signs Monitor User Manual Intended Use and Safety Guidance
- 6 -
CAUTION
11 Do not touch the touch screen with a sharp object.
12 A ventilated environment is required for monitor installation. Do not block up the
ventilation grille at the back of the device.
13 The device must be connected to the ground to avoid signal interference.
14 To protect eyes from damage, don't look directly at supplementary LED for long time.
15 Poor connection might be caused by frequently plugging and unplugging the power
cord. Check the power cord regularly and replace it in time.
NOTE:
1 Position the device in a location where the operator can easily see the screen and
access the operating controls.
2 The monitor can only be used on one patient at a time.
3 If the monitor gets damp or liquid pours on the monitor, please contact the service
personnel of EDAN.
4 This monitor 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.
7 The monitor may not be compatible with all models of USB flash drives. Use the USB
flash drives that are recommended by EDAN.
1.3 Explanation of Symbols on the Monitor
1
DEFIBRILLATION-PROOF TYPE BF APPLIED PART
2
TYPE BF APPLIED PART
3
Caution
4
MR Unsafe - Keep away from magnetic resonance
imaging (MRI) equipment
5
Equipotential grounding

Vital Signs Monitor User Manual Intended Use and Safety Guidance
- 7 -
6
Alternating Current
7
Power Supply switch
8
SERIAL NUMBER
9
Network port
10
USB (Universal Serial Bus) Connection
11
CE marking
12
AUTHORISED REPRESENTATIVE IN THE
EUROPEAN COMMUNITY
13
Date of manufacture
14
MANUFACTURER
15
Part Number
16
General symbol for recovery/recyclable
17
Disposal method
18
Operating instructions
19
Refer to User Manual
(Background: Blue; Symbol: White)

Vital Signs Monitor User Manual Intended Use and Safety Guidance
- 8 -
20
Warning
(Background: Yellow; Symbol & outline: black)
21
Ingress Protection IPX1 (Protected against vertically
falling water drops)
22
With respect to electrical shock, fire and mechanical
hazards only in accordance with UL 60601-1 and
CAN/CSA C22.2 No. 601.1, IEC 60601-2-30, IEC
60601-2-49
23
Caution: Federal (U.S.) Law restricts this device to sale
by or on the order of a physician.
24
Non-ionizing electromagnetic radiation
25
Output/ Nurse call
26
Chargeable battery
27
Battery check
NOTE:
The user manual is printed in black and white.

Vital Signs Monitor User Manual Installation
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Chapter 2 Installation
NOTE:
1 The monitor installations and settings must be configured by the authorized hospital
personnel.
2 To ensure that the monitor works properly, please read the user manual and follow
the steps before using the monitor.
2.1 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 the monitor 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.
2.2 Mounting the Monitor
If all situations are normal, please place the monitor on a flat, level surface, on a trolley or mount
on a wall. About how to install the trolley or wall mount for the monitor, please refer to Trolley
Installation Guide or Wall Mounting Bracket Assembly Instruction.
WARNING
1 The wall mounting bracket can be fixed only on a concrete wall.
2 The safe loads of the wall mounting bracket and the trolley are 7.5 kg and 11 kg
respectively. Exceeding the safe load may cause bracket to fail and the device to fall.
2.3 Connecting the Power Cable
Connection procedure of the AC power line is listed below:
1Make sure the AC power supply complies with the following specifications: 100 V-240 V~,
50 Hz/60 Hz.
2Connect the power cord provided with the monitor. Connect the power cord to connector of
the monitor. Connect the other end of the power cord to a grounded power outlet.
NOTE:
1 Connect the power cable to the socket specialized for hospital use.
2 Only use the power cable supplied by EDAN.
2.4 Checking the Monitor
Make sure there is no damage on the measurement accessories and cables. Then turn on the
monitor, check whether the monitor can start normally. Make sure all alarm lamps light up and
the alarm sound is heard when turning on the monitor. Please refer to chapter Testing Alarms.

Vital Signs Monitor User Manual Installation
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WARNING
If any sign of damage is detected, or the monitor displays some error messages, do not
use it on any patient. Contact customer service center immediately.
NOTE:
1 Check all the functions of the monitor and make sure that the monitor is in good
status.
2 If rechargeable batteries are provided, charge them after using the device every time,
to ensure the electric power is enough.
3 After long-time continuous running, please restart the monitor to ensure the monitor‟s
steady performance and long lifespan.
2.5 Connecting Sensor to Patient
Connect all the necessary patient sensors between the monitor and the patient.
NOTE:
For information on correct connection, refer to related chapters.
2.6 Checking the Recorder
If your monitor is equipped with a recorder, open the recorder‘s door to check if paper is properly
installed in the slot. If no paper exists, refer to Chapter Recording for details.
2.7 Setting Date and Time
To set the date and time:
1. Select Menu > System Setup > Date/Time.
2. Adjust the date display format based on the user‘s habit.
3. Set the correct time of year, month, day, hour, min and sec.
2.8 Handing Over the Monitor
If you are handing over the monitor to the end-users directly after configuration, make sure that it
is in normal working status and let user know the status.
The users must be adequately trained to use the monitor before monitoring a patient. To achieve
this, they should have access to, and read, the following documentation delivered with the
monitor:
User Manual (this book) - for full operating instructions.
Quick Reference Card - for quick reminders during use.