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
- 1 -
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
- 2 -
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.