EDAN M3 User manual

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文件名称(Document Name)：M3 说明书_英文
文件编号(Number)：01.54.109395
版本(Version)：2.5
产品型号(Product Model)：M3
项目编码(Project Code)：2077I000
签批信息(Signature):
作者(Originator) : 吴 孝萍 (wuxiaoping) 2019-01-16 15:28:45
审核人(Reviewers) : 史 洪华 (shihonghua) 2019-01-16 15:46:10
审核人(Reviewers) : 韦 华彪 (weihuabiao) 2019-01-16 15:53:18
审核人(Reviewers) : 王 敏 (wangmin) 2019-01-16 15:45:06
审核人(Reviewers) : 陈 艳娟 (chenyanjuan) 2019-01-16 16:30:27
审核人(Reviewers) : 王 红春 (wanghongchun) 2019-01-16 16:52:54
审核人(Reviewers) : 刘 自成 (liuzicheng) 2019-01-16 15:45:52
批准人(Approvers) : 夏 欢欢 (xiahuanhuan) 2019-01-16 17:33:59
批准人(Approvers) : 陈 浩杰 (chenhaojie) 2019-01-16 17:17:19
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: 01.54.109395
MPN: 01.54.109395025
Release Date: January 2019
© Copyright EDAN INSTRUMENTS, INC. 2008-2019. 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
1.2.1 Environment................................................................................................................1
1.2.2 Power Source Requirements.......................................................................................1
1.2.3 Grounding the Monitor ...............................................................................................1
1.2.4 Equipotential Grounding.............................................................................................1
1.2.5 Condensation...............................................................................................................2
1.2.6 Safety Precautions.......................................................................................................2
1.2.7 Protecting Personal Information .................................................................................7
1.2.8 Explanation of Symbols on the Monitor.....................................................................8
Chapter 2 Installation of Monitor ..................................................................................................11
2.1 Opening the Package and Checking.....................................................................................11
2.2 Connecting the Power Cable................................................................................................11
2.3 Powering on the Monitor .....................................................................................................11
2.4 Connecting Sensor to Patient...............................................................................................12
2.5 Checking the Recorder.........................................................................................................12
Chapter 3 Introduction....................................................................................................................13
3.1 General Information.............................................................................................................13
3.2 Screen Display .....................................................................................................................14
3.2.1 General Display Mode ..............................................................................................14
3.2.2 Double-Parameter Mode...........................................................................................19
3.2.3 Single Parameter Mode.............................................................................................20
3.3 Button Functions..................................................................................................................21
3.4 Interfaces..............................................................................................................................23
3.5 Built-in Rechargeable Battery..............................................................................................26
3.5.1 Battery Safety Information........................................................................................26
3.5.2 Battery Status on the Main Screen............................................................................27
3.5.3 Checking Battery Performance .................................................................................27
3.5.4 Replacing the Battery................................................................................................28
3.5.5 Recycling the Battery................................................................................................28
3.5.6 Maintaining the Battery.............................................................................................28
3.5.7 Battery Alarm Information........................................................................................28
Chapter 4 System Menu ..................................................................................................................29
4.1 Patient Setup ........................................................................................................................29
4.2 Default Setup........................................................................................................................29
4.3 System Setup........................................................................................................................29
4.4 Selection...............................................................................................................................30
4.5 Deleting Data .......................................................................................................................30

IV
4.6 Version..................................................................................................................................31
4.7 Time Setup ...........................................................................................................................31
4.8 NIBP Setup...........................................................................................................................31
4.9 TEMP Setup.........................................................................................................................31
4.10 Alarm Setup........................................................................................................................31
4.11 Maintain .............................................................................................................................31
4.12 Data Store...........................................................................................................................35
4.13 Sleep Mode ........................................................................................................................36
Chapter 5Alarm...............................................................................................................................38
5.1 Alarm Modes........................................................................................................................38
5.1.1 Alarm Level...............................................................................................................38
5.1.2 Alarm Modes.............................................................................................................38
5.1.3 Alarm Setup...............................................................................................................40
5.2 Alarm Cause.........................................................................................................................40
5.3 Audio Alarm Paused.............................................................................................................41
5.4 Audio Alarm Off ..................................................................................................................41
5.5 Alarm Reset..........................................................................................................................42
5.6 Parameter Alarm...................................................................................................................42
5.7 When an Alarm Occurs........................................................................................................43
5.8 Testing Alarms......................................................................................................................43
Chapter 6 Trend and Recording.....................................................................................................44
6.1 General Information on Recording ......................................................................................44
6.2 Recorder Operations.............................................................................................................44
6.3 Recorder Alarm Information................................................................................................45
Chapter 7 Maintenance/Cleaning...................................................................................................46
7.1 Inspecting.............................................................................................................................46
7.2 Maintenance Task and Test Schedule...................................................................................46
7.3 General Cleaning..................................................................................................................47
7.3.1 Cleaning the Monitor ................................................................................................47
7.3.2 Cleaning the Reusable Accessories...........................................................................47
7.3.3 Cleaning the Dust-proof Filter Assembly .................................................................48
7.4 Disinfection..........................................................................................................................49
7.4.1 Disinfecting the Monitor...........................................................................................50
7.4.2 Disinfecting the Reusable Accessories .....................................................................50
7.5 Replacement of Fuse............................................................................................................51
7.6 Cleaning Battery and Battery Compartment Cover .............................................................51
Chapter 8 SpO2Monitoring (Optional) .........................................................................................52
8.1 Overview..............................................................................................................................52
8.2 SpO2Safety Information......................................................................................................52
8.3 Measuring SpO2...................................................................................................................53
8.4 Measurement Limitations ....................................................................................................54

V
8.5 Assessing the Validity of a SpO2Reading............................................................................55
8.6 SpO2Alarm Delay................................................................................................................56
8.7 Perfusion Index (PI)*...........................................................................................................56
8.8 SatSeconds Alarm Management* ........................................................................................56
8.8.1 Describing SatSeconds..............................................................................................56
8.8.2 SatSeconds “Safety Net”...........................................................................................58
8.8.3 Setting SatSeconds Duration.....................................................................................58
8.9 Alarm....................................................................................................................................58
8.9.1 Adjustable Range of Alarm Limits............................................................................58
8.9.2 Alarm Information and Prompts ...............................................................................58
Chapter 9 NIBP Monitoring (Optional).........................................................................................61
9.1 Overview..............................................................................................................................61
9.2 NIBP Safety Information .....................................................................................................61
9.3 Measurement Limitations ....................................................................................................62
9.4 NIBP Monitoring..................................................................................................................63
9.4.1 Operation Prompts ....................................................................................................64
9.4.2 Correcting the Measurement if Limb is not at Heart Level ......................................65
9.5 NIBP Setup...........................................................................................................................65
9.6 Alarm....................................................................................................................................65
9.6.1 Adjustable Range of Alarm Limits............................................................................65
9.6.2 Alarm Information and Prompts ...............................................................................66
Chapter 10 TEMP Monitoring (Optional).....................................................................................69
10.1 TEMP Monitoring with T2 Module...................................................................................69
10.1.1 Introduction.............................................................................................................69
10.1.2 Measuring Procedure ..............................................................................................70
10.1.3 TEMP Setup for T2 Module....................................................................................71
10.1.4 Alarm.......................................................................................................................71
10.2 TEMP Monitoring with TH Module..................................................................................73
10.2.1 Introduction.............................................................................................................73
10.2.2 Measuring Procedure ..............................................................................................74
10.2.3 Alarm.......................................................................................................................76
10.2.4 Replacing the Battery..............................................................................................77
10.3 TEMP Monitoring with F3000 Module .............................................................................77
10.3.1 General Information................................................................................................77
10.3.2 Safety Information ..................................................................................................78
10.3.3 Probe Covers —Applying & Removing .................................................................79
10.3.4 Changing Isolation Chambers and Probes ..............................................................79
10.3.5 Measuring Mode .....................................................................................................80
10.3.6 Measuring Procedure ..............................................................................................80
10.3.7 TEMP Setup for F3000 Module..............................................................................82
10.3.8 Alarm.......................................................................................................................82

VI
Chapter 11 Other Functions............................................................................................................85
11.1 Nurse Call...........................................................................................................................85
11.2 Network..............................................................................................................................85
11.3 Central Monitoring System................................................................................................85
Chapter 12 Accessories ....................................................................................................................86
Chapter 13 Warranty and Service..................................................................................................90
13.1 Warranty.............................................................................................................................90
13.2 Contact Information...........................................................................................................90
Appendix A Specifications...............................................................................................................91
A.1 Classification.......................................................................................................................91
A.2 Specifications......................................................................................................................91
A.2.1 Size and Weight........................................................................................................91
A.2.2 Function Configuration............................................................................................91
A.2.3 Environment.............................................................................................................91
A.2.4 Display .....................................................................................................................92
A.2.5 Battery......................................................................................................................92
A.2.6 Recorder...................................................................................................................93
A.2.7 Data Storage.............................................................................................................93
A.2.8 NIBP.........................................................................................................................93
A.2.9 SpO2.........................................................................................................................94
A.2.10 PR...........................................................................................................................96
A.2.11 TEMP .....................................................................................................................96
Appendix B EMC Information - Guidance and Manufacture’s Declaration.............................99
B.1 Electromagnetic Emissions .................................................................................................99
B.2 Electromagnetic Immunity..................................................................................................99
B.3 Electromagnetic Immunity................................................................................................101
B.4 Recommended Separation Distances ................................................................................103
Appendix C Abbreviation..............................................................................................................105

M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
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Chapter 1 Intended Use and Safety Guidance
1.1 Intended Use/Indications for Use
The monitor is intended to be used by qualified physicians or personnel professionally trained
and it is for monitoring adults, pediatrics and neonates in hospital environments.
This monitor is used to monitor vital signals for patients and is suitable for use in hospital
environments including out-patient department, wards and NICU.
Monitored parameters include: NIBP, SpO2, pulse rate, Quick TEMP/Infrared TEMP.
1.2 Safety Guidance
1.2.1 Environment
Follow the instructions below to ensure completely safe electrical installation. The environment
where the monitor will be used should be reasonably free from vibration, dust, corrosive or
explosive gases, extremes of temperature, humidity, and so on. For a cabinet mounted installation,
allow sufficient room at the front for operation and sufficient room at the rear for servicing with
the cabinet access door open.
The monitor operates within specifications at ambient temperatures between 0 C ~+40 C.
Ambient temperatures that exceed these limits could affect the accuracy of the instrument and
cause damage to the modules and circuits. Allow at least 2 inches (5 cm) clearance around the
instrument for proper air circulation.
1.2.2 Power Source Requirements
Refer to Appendix A .
1.2.3 Grounding the Monitor
To protect the patient and hospital personnel, the cabinet of the monitor must be grounded.
Accordingly, the monitor is equipped with a 3-wire cable which grounds the instrument to the
power line ground (protective earth) when plugged into an appropriate 3-wire receptacle. If a
3-wire receptacle is not available, consult the hospital electrician.
Connect the grounding wire to the equipotential grounding terminal on the mains system. If it is
not evident from the instrument specifications whether a particular instrument combination is
hazardous or not, for example due to summation of leakage currents, the user should consult the
manufacturers concerned or an expert in the field, to ensure that the necessary safety of all
instruments concerned will not be impaired by the proposed combination.
1.2.4 Equipotential Grounding
Protection class 1 instruments are already included in the protective grounding (protective earth)
system of the room by way of grounding contacts in the power plug. For internal examinations on
the heart or the brain, the Monitor must have a separate connection to the equipotential grounding
system. One end of the equipotential grounding cable (potential equalization conductor) is
connected to the equipotential grounding terminal on the rear panel of the instrument and the
other end to one point of the equipotential grounding system. The equipotential grounding system

M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
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assumes the safety function of the protective grounding conductor if ever there is a break in the
protective grounding system. Examinations in or on the heart (or brain) should only be carried out
in medically used rooms incorporating an equipotential grounding system. Check each time
before use that the instrument is in perfect working order. The cable connecting the patient to the
instrument must be free of electrolyte.
WARNING
If the protective grounding (protective earth) system is doubtful, the monitor must be
supplied by internal power only.
1.2.5 Condensation
Make sure that during operation, the instrument is free of condensation. Condensation can form
when equipment is moved from one building to another, thus being exposed to moisture and
differences in temperature.
1.2.6 Safety Precautions
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the instrument.
WARNING
1 If liquid is inadvertently splashed on the equipment or its accessories, it may enter the
conduit or inside the monitor. At this moment, contact local Customer Service Center.
2 The monitor is intended to be used by qualified physicians or personnel
professionally trained. And they should be familiar with the contents of this user
manual before operation.
3 Only qualified service engineers can install this equipment. And only service
engineers authorized by EDAN can open the shell.
4 EXPLOSION HAZARD-Do not use the monitor in a flammable atmosphere where
concentrations of flammable anesthetics or other materials may occur.
5 SHOCK HAZARD-To avoid the RISK of electric shock, this equipment must only be
connected to a SUPPLY MAINS with protective earth.
6 Do not attempt to connect or disconnect a power cord with wet hands. Make certain
that your hands are clean and dry before touching a power cord.
7 The recommended battery can only be used for this monitor. Do not connect battery
directly to an electric outlet or cigarette lighter charger.
8 Do not unplug the battery when monitoring.
9 Always keep the battery away from fire.
10 Clinical decision making based on the output of the device is left to the discretion of
the provider.

M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
11 Do not solder the leading wire and the battery terminal directly.
12 Make sure the monitor is used in the appointed range of voltage so that the effect of
power supply can be ignored.
13 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 system standard IEC/EN60601-1. Everybody
who connects additional equipment to the signal input connector or signal output
connector configures a medical system, and is therefore responsible that the system
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.
14 The simultaneous use of cardiac pacemaker and other patient-connected equipment
may cause safety hazard.
15 If liquid leaking from the battery gets into your eyes, onto your skin or clothes, do not
rub your eyes. Wash them well with clean water and go to see a doctor immediately.
16 Stop using the battery if abnormal heat, odor, discoloration, deformation or abnormal
condition is detected during use, charge, or storage. Keep it away from the monitor.
17 Do not use a battery with serious scratch or deformation.
18 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 or
sterilized accessory is intact. Do not use it if its casing is damaged.
19 The user should check the monitor and accessories before use.
20 Please set the alarm according to the individual status of patient to avoid delaying
treatment. Ensure there will be alarm audio prompt when alarming.
21 Devices connecting with monitor should be equipotential.
22 The monitor is equipped with a wireless AP/Wi-Fi via network interface to receive RF
electromagnetic energy. Therefore, any other equipment complies with CISPR
radiation requirements may also interfere with the wireless communication and make
it interrupted.
23 Please disinfect timely to prevent cross infection between patients.
24 When the monitor and electrosurgical device are used together, the user (physician
or nurse) should guarantee the safety of patient.
25 This monitor is not a device for treatment purposes.
26 Do not touch the patient, bed or instrument during defibrillation.
27 Do not service or maintain the monitor or any accessory which is in use with the patient.
28 During monitoring, if the power supply is off and there is no battery for standby, the
monitor will be off. All last settings used will be recovered when the power is restored.

M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
29 If leakage or foul odor is detected, ensure that there’s no fire around.
30 Only NIBP and SpO2applied parts of the monitor are defibrillation-proof. When a
defibrillator is applied, keep other accessories away from the patient. Otherwise, it
may result in damaging the monitor or harming the patient.
31 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.
32 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 before installation and any time
new medical equipment is added to the Wireless LAN coverage area.
33 The equipment can provide protective means to prevent the patient from being
burned when used with HF SURGICAL EQUIPMENT. Use only EDAN-approved
accessories.
34 Without any external memory, 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.
35 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.
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 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.
38 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.
39 Connecting any accessory (such as external printer) or other device (such as the
computer) to this patient 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
40 Additional multiple socket-outlet or extension cord can’t be connected to the system.
41 Setting alarm limits to extreme values may cause the alarm system to become
ineffective. It is recommended to use the default settings.

M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
42 The medical electrical equipment needs to be installed and put into service according
to the EMC Information provided in this user manual.
43 Portable and mobile RF communications equipment can affect medical electrical
equipment; refer to the recommended separation distances provided in Appendix A2
EMC Information.
44 Operation of the equipment exceeding specified physiological signal or the
operational specification may cause inaccurate results.
45 The use of patient cable and other accessories not supplied by the manufacturer may
result in increased emissions or decreased immunity of the equipment.
46 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.
47 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.
48 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.
49 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.
50 Only recommended batteries can be used for the monitor.
51 If several items of medical equipment are interconnected, pay attention to the sum of
the leakage currents, otherwise it may cause shock hazard. Consult your service
personnel.
52 The device must be connected to the ground to avoid signal interference.
53 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.
54 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.
55 Make sure networking function is used in a secure network environment.

M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
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CAUTION
1 Federal law (U.S.) restricts this device to sale by or on the order of a physician.
2 Electromagnetic Interference –Ensure the environment in which the monitor is
installed is not subject to any sources of strong electromagnetic interference, such as
radio transmitters, mobile telephones, microwaves, etc.
3 The monitor is designed for continuous operation and is “ordinary” (i.e. not drip or
splash-proof).
4 Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine,
dust area, high-temperature and humid environment.
5 The monitor is suitable for use in the presence of electrosurgery. When the monitor is
used with HF surgical equipment, user (doctor or nurse) should be cautious about
patient safety.
6 Do not immerse transducers in liquid. When using solutions, use sterile wipes to
avoid pouring fluids directly on the transducer.
7 The device and reusable accessories may be sent back to the manufacturer for
recycling or proper disposal after their useful lives. Alternatively, they can be returned
to the dealer or the manufacturer for recycling or proper disposal.
8 Avoid liquid splash and excessive temperature. The working temperature must be
kept between 0 C and +40 C, and it is recommended to be kept between +10 C
and +40 C when the monitor is equipped with TEMP module. The temperature
should be kept between -20 C and +55 C during transportation and storage, and it
is recommended to be kept between -20 C and +50 C when the monitor is
equipped with TH module.
9 If the monitor gets damp, put it in dry circumstance to dry it until it can work normally. If
liquid pours on the monitor, please contact the service personnel authorized by EDAN.
10 Remove a battery whose life cycle has expired from the monitor immediately.
11 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.
12 A potential hazard can exist if different alarm presets are used for the same or similar
equipment in any single area.
13 Assembly of the monitor and modifications during actual service life shall be evaluated
based on the requirements of IEC60601-1.
14 Disposable devices are intended for single use only. They should not be reused as
performance could degrade or contamination could occur.
15 A ventilated environment is required for monitor installation. Do not block up the
ventilation grille at the back of the device.
16 Poor connection might be caused by frequently plugging and unplugging the power
cord. Check the power cord regularly and replace it in time.

M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
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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 This equipment is not intended for home usage.
4 If the device is discolored or damaged, then discontinue use of the device.
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 materials with which the patient or any other person can come into contact
conform to the standard of EN ISO 10993-1: 2013.
8 It is recommended to format the USB flash drive to the FAT file type via PC prior to
use.
9 To protect eyes from damage, don't look directly at supplementary light for long time.
10 When there's measurement beyond range, invalid measurement or no measurement
value, it will display ---.
11 In normal use, the operator shall stand in front of the monitor.
1.2.7 Protecting Personal Information
Protecting personal health information is a major component of security strategy. To protect the
personal information and ensure the proper device performance, the user should take necessary
precautions in accordance with local laws and regulations and institution’s policies. EDAN
recommends health care organizations or medical institutions to implement a comprehensive and
multifaceted strategy to protect the information and systems from internal and external security
threats.
To ensure the patients’ safety and protect their personal health information, the user should
implement security practices or measures that include:
1. Physical safeguards - physical safety measures to ensure that unauthorized personnel do not
have access to the monitor.
2. Operational safeguards - safety measures during operation.
3. Administrative safeguards - safety measures in management.
4. Technical safeguards - safety measures in technical field.
CAUTION
1 The access/operation of the monitor is restricted to authorized personnel only. Assign
only staff with a specific role the right to use the monitor.
2 Ensure that all device components maintaining personal information (other than
removable media) are physically secure.

M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
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CAUTION
3 Ensure that the data are deleted after the patient is discharged. (Refer to Section 4.12
Data Store).
4 Ensure that the monitor is connected only to the device authorized/approved by
EDAN. Users should operate all EDAN deployed and supported monitors within
EDAN authorized specifications, including EDAN approved software, software
configuration, security configuration, etc.
5 Protect all the passwords to prevent unauthorized changes.
6 Anti-virus measures such as USB device virus scanning should be carried out prior to
using USB flash drive.
7 Firewalls and/or other security devices should be in place between the medical
system and any externally accessible systems. It’s recommended to use Windows
defender firewall or any other firewall that can defend against Dos and DDos attacks,
and keep it up to date.
8 When the monitor is returned for maintenance, disposed of, or removed from the
medical institution for other reasons, it is necessary to ensure that all patient data are
removed from the monitor. (Refer to Section 4.12 Data Store).
9 Please protect the privacy for the information and the data displayed on the screen,
and for the information and the data stored in the monitor.
10 When building the networking environment: 1) If a wireless router is used, please turn
on the MAC address filtering function of the wireless router and add the MAC address
of the monitor to the rule list. The wireless router only allows devices in the rule list to
access the wireless network. 2) It is suggested to build a VLAN, assign the LAN ports
where the approved switch port, monitor and MFM-CMS are into the same VLAN, and
isolate it from other VLANs.
NOTE:
Log files generated by the monitor are used for system troubleshooting and do not
contain protected medical data.
1.2.8 Explanation of Symbols on the Monitor
1
TYPE CF APPLIED PART
2
DEFIBRILLATION-PROOF TYPE BF APPLIED PART
3
TYPE BF APPLIED PART

M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
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4
Caution
5
Operating instructions
6
Part Number
7
Refer to User Manual
(Background: blue; Symbol: white)
8
Equipotential grounding
9
Power Supply switch
10
SERIAL NUMBER
11
CE marking
12
AUTHORISED REPRESENTATIVE IN THE EUROPEAN
COMMUNITY
13
Date of manufacture
14
MANUFACTURER
15
General symbol for recovery/recyclable
16
Disposal method
17
Caution: Federal (US) law restricts this device to sale by or on
the order of a physician.
18
Ingress Protection IPX1 (Protected against vertically falling
water drops)

M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
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19
Warning
(Background: yellow; Symbol and outline: black)
20
This Way Up
21
Fragile
22
Keep Away From Rain
23
Stacking Limit By Number
24
Handle with care
25
Do not step on
26
Conforms to UL Std. 60601-1, IEC Std. 60601-2-30, IEC Std.
60601-2-49
Certified to CSA Std. C22.2 No 601.1, CSA Std. C22.2 No
60601-2-30, CSA Std. C22.2 No 60601-2-49
NOTE:
The user manual is printed in black and white.

M3 Vital Signs Monitor User Manual Installation of Monitor
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Chapter 2 Installation of Monitor
NOTE:
To ensure that the monitor works properly, please read Chapter 1 Intended Use and
Safety Guidance, and follow the steps before using the monitor.
2.1 Opening the Package and Checking
Visually examine the package prior to unpacking. If any signs of mishandling or damage are
detected, contact the carrier to claim for damage. Open the package and take out the monitor and
accessories carefully. Keep the package for possible future transportation or storage. Check the
components according to the packing list.
Check for any mechanical damage.
Check all the cables, modules and accessories.
If there is any problem, contact the manufacturer or local representative immediately.
2.2 Connecting the Power Cable
Connection procedure of the AC power line:
Make sure the AC power supply complies with following specification: 100 V–240 V ~, 50
Hz/60 Hz.
Connect 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:
Connect the power line to the jack special for hospital usage.
Connect to the ground line if necessary. Refer to section 1.2 Safety Guidance for details.
NOTE:
When the battery configuration is provided, after the monitor is transported or stored, the
battery must be recharged. Switch on AC power supply can recharge the battery no
matter if the monitor is powered on.
2.3 Powering on the Monitor
Press the ON/OFF button on front panel to power on the monitor, LOGO information will be
displayed on the screen.
WARNING
Do not use it on any patient if any sign of damage is detected, or the monitor displays
some error messages. Contact biomedical engineer in the hospital or Customer Service
Center immediately.

M3 Vital Signs Monitor User Manual Installation of Monitor
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NOTE:
1 Check all the functions of the monitor and make sure that the monitor is in good
condition.
2 If rechargeable batteries are provided, recharge them after using the monitor 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.
4 If the system is not used for a longer period of time, its system time may be
inaccurate. In this case, reset the system time after powering on.
5 If the system time cannot be saved and resumes the default value after restart,
contact the service department of EDAN to replace the button cell in main board.
2.4 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.
2.5 Checking the Recorder
If your monitor is equipped with a recorder, open the recorder door to check if paper is properly
installed in the slot. If no paper is present, refer to Chapter 6 Trend and Recording for details.