EDAN M8 Series User manual

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文件名称(Document Name)：iM8 M8 系列 说明书_英文 中性
文件编号(Number)：01.54.456009
版本(Version)：1.5
产品型号(Product Model)：iM8;iM8A;iM8B;M8;M8A;M8B
项目编码(Project Code)：2705I000
签批信息(Signature):
作者(Originator) : 陈 艳娟 (chenyanjuan) 2018-09-21 10:51:26
审核人(Reviewers) : 史 洪华 (shihonghua) 2018-09-25 09:43:23
审核人(Reviewers) : 韩 吉灯 (hanjideng) 2018-09-25 10:07:12
审核人(Reviewers) : 韦 华彪 (weihuabiao) 2018-09-25 16:26:06
审核人(Reviewers) : 王 敏 (wangmin) 2018-09-25 09:21:33
审核人(Reviewers) : 明 镭 (minglei) 2018-09-26 13:31:31
批准人(Approvers) : 夏 欢欢 (xiahuanhuan) 2018-09-29 15:24:05
批准人(Approvers) : 陈 浩杰 (chenhaojie) 2018-09-29 21:50:28
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: 01.54.456009
MPN: 01.54.456009015
Release Date: September, 2018
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 the
manufacturer can not be held liable.
The manufacturer owns the copyrights of this manual. Without prior written consent of the
manufacturer, 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 the manufacturer.
The manufacturer holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
The manufacturer 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 the manufacturer, 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.............................................................................................2
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.....................................................................9
Chapter 2 Installation of Monitor ..................................................................................................12
2.1 Opening the Package and Checking.....................................................................................12
2.2 Connecting the Power Cable................................................................................................12
2.3 Powering on the Monitor .....................................................................................................13
2.4 Connecting Patient Sensors..................................................................................................13
2.5 Checking the Recorder.........................................................................................................13
Chapter 3 Introduction....................................................................................................................14
3.1 General Information.............................................................................................................14
3.2 Screen Display .....................................................................................................................17
3.3 Button Functions..................................................................................................................21
3.4 Interfaces..............................................................................................................................22
3.5 Built-in Rechargeable Battery..............................................................................................24
3.5.1 Battery Safety Information........................................................................................24
3.5.2 Battery Status on the Main Screen............................................................................24
3.5.3 Checking Battery Performance .................................................................................25
3.5.4 Replacing the Battery................................................................................................25
3.5.5 Recycling the Battery................................................................................................26
3.5.6 Maintaining the Battery.............................................................................................26
3.5.7 Battery Alarm Information........................................................................................26
Chapter 4 System Menu ..................................................................................................................27
4.1 Patient Setup ........................................................................................................................28
4.2 Default Setup........................................................................................................................29
4.3 Mark Event...........................................................................................................................30
4.4 Face Select ...........................................................................................................................31
4.5 Time Setup ...........................................................................................................................32
4.6 Record Setup........................................................................................................................32

IV
4.7 Module Setup.......................................................................................................................34
4.8 Tracing Waveforms Selection ..............................................................................................34
4.9 Monitor Version ...................................................................................................................34
4.10 Alarm Volume ....................................................................................................................35
4.11 Key Volume........................................................................................................................35
4.12 Drug Calculation................................................................................................................35
4.13 Waveform Demonstration..................................................................................................35
4.14 Maintenance.......................................................................................................................36
4.15 Data Storing .......................................................................................................................39
4.16 Wireless Network with Router (Optional) .........................................................................42
Chapter 5 Face Select.......................................................................................................................44
5.1 Selecting Operating Screen..................................................................................................44
5.2 Standard Screen....................................................................................................................44
5.3 Trend Screen ........................................................................................................................44
5.4 oxyCRG Screen....................................................................................................................45
5.5 Large Font Screen ................................................................................................................45
Chapter 6Alarms.............................................................................................................................48
6.1 Alarm Modes........................................................................................................................48
6.1.1 Alarm Level...............................................................................................................48
6.1.2 Alarm Modes.............................................................................................................48
6.1.3 Alarm Setup...............................................................................................................50
6.2 Alarm Cause.........................................................................................................................52
6.3 Audio Alarm Paused.............................................................................................................52
6.4 Audio Alarm Off ..................................................................................................................53
6.5 Alarm Reset..........................................................................................................................53
6.6 Parameter Alarm...................................................................................................................53
6.7 When an Alarm Occurs........................................................................................................54
6.8 Testing Alarms......................................................................................................................54
Chapter 7Alarm Information.........................................................................................................55
7.1 PhysiologicalAlarm Information.........................................................................................55
7.2 Technical Alarm Information ...............................................................................................59
7.3 Prompts ................................................................................................................................66
7.4 Adjustable Range of Alarm Limits.......................................................................................67
Chapter 8 Freeze ..............................................................................................................................70
8.1 General.................................................................................................................................70
8.2 Entering/Exiting Freeze Status.............................................................................................70
8.3 FROZEN Menu....................................................................................................................70
8.4 Reviewing Frozen Waveform...............................................................................................71
Chapter 9 Recording (Optional).....................................................................................................72

V
9.1 General Information on Recording ......................................................................................72
9.2 Recording Type....................................................................................................................72
9.3 Recording Startup.................................................................................................................74
9.4 Recorder Operations and Status Messages ..........................................................................75
9.5 Recorder Alarm Information................................................................................................76
Chapter 10 Trend and Event...........................................................................................................77
10.1 Trend Graph .......................................................................................................................77
10.2 Trend Table.........................................................................................................................78
10.3 NIBP Recall........................................................................................................................80
10.4 Alarm Event Recall............................................................................................................81
Chapter11DrugCalculationandTitrationTable(Optional).................................................................83
11.1 Drug Calculation................................................................................................................83
11.2 Titration Table ....................................................................................................................85
Chapter 12 Maintenance/Cleaning.................................................................................................87
12.1 Inspecting...........................................................................................................................87
12.2 Maintenance Task and Test Schedule.................................................................................87
12.3 Care and Cleaning..............................................................................................................88
12.3.1 General Points.........................................................................................................88
12.3.2 Cleaning ..................................................................................................................88
12.3.3 Disinfection.............................................................................................................92
12.3.4 Cleaning and Disinfecting OtherAccessories.........................................................94
12.4 Replacement of Fuse..........................................................................................................94
12.5 Cleaning Battery and Battery Compartment Cover ...........................................................94
Chapter 13 Monitoring ECG/RESP...............................................................................................95
13.1 Overview............................................................................................................................95
13.2 ECG Safety Information ....................................................................................................95
13.3 Monitoring Procedure ........................................................................................................97
13.3.1 Preparation ..............................................................................................................97
13.3.2 Placing Electrodes for ECG Monitoring.................................................................98
13.4 ECG Screen Hot Keys......................................................................................................102
13.5 ECG Menu .......................................................................................................................103
13.5.1 ECG SETUP .........................................................................................................103
13.6 ST Segment Monitoring (Optional) .................................................................................107
13.7 Arr. Monitoring (Optional)...............................................................................................111
13.8 Measuring RESP..............................................................................................................115
13.8.1 How to Measure RESP .........................................................................................116
13.8.2 Setting up RESP Measurement .............................................................................116
13.8.3 Installing Electrode for RESP Measurement ........................................................117
13.8.4 RESP SETUP........................................................................................................117

VI
Chapter 14 Monitoring SpO2........................................................................................................120
14.1 Overview..........................................................................................................................120
14.2 SpO2Safety Information..................................................................................................120
14.3 Monitoring Procedure ......................................................................................................121
14.4 Measurement Limitations ................................................................................................122
14.5 Assessing the Validity of a SpO2Reading........................................................................123
14.6 SpO2Alarm Delays..........................................................................................................123
14.7 Perfusion Index (PI).........................................................................................................124
14.8 SpO2SETUP....................................................................................................................124
Chapter 15 Monitoring NIBP .......................................................................................................126
15.1 Overview..........................................................................................................................126
15.2 NIBP Safety Information .................................................................................................126
15.3 Measurement Limitations ................................................................................................127
15.4 Measurement Methods.....................................................................................................128
15.5 Measurement Procedures.................................................................................................128
15.6 NIBP SETUP....................................................................................................................131
15.7 Resetting NIBP ................................................................................................................132
15.8 Calibrating NIBP..............................................................................................................132
15.9 Leak Test..........................................................................................................................132
Chapter 16 Monitoring TEMP......................................................................................................134
16.1 TEMP Monitoring............................................................................................................134
16.2 TEMP SETUP..................................................................................................................134
Chapter 17 Monitoring IBP (Optional)........................................................................................136
17.1 Introduction......................................................................................................................136
17.2 IBP Safety Information ....................................................................................................136
17.3 Monitoring Procedure ......................................................................................................137
17.4 IBP Menu .........................................................................................................................138
Chapter 18 Monitoring CO2(Optional).......................................................................................145
18.1 General.............................................................................................................................145
18.2 Monitoring Procedure ......................................................................................................146
18.2.1 Zeroing the sensor.................................................................................................147
18.2.2 Sidestream CO2Module........................................................................................147
18.2.3 Mainstream CO2Module ......................................................................................150
18.3 CO2SETUP......................................................................................................................152
18.4 Setting CO2Corrections...................................................................................................155
Chapter 19 Accessories ..................................................................................................................157
Chapter 20 Warranty and Service................................................................................................164
20.1 Warranty...........................................................................................................................164
20.2 Contact Information.........................................................................................................164

VII
Appendix I Specifications..............................................................................................................165
A1.1 Classification...................................................................................................................165
A1.2 Specifications..................................................................................................................165
A1.2.1 Physical Specifications.........................................................................................165
A1.2.2 Environment.........................................................................................................166
A1.2.3 Function Configuration........................................................................................167
A1.2.4 Display .................................................................................................................167
A1.2.5 Battery..................................................................................................................167
A1.2.6 Recorder (Optional)..............................................................................................168
A1.2.7 Recall....................................................................................................................168
A1.2.8 ECG......................................................................................................................169
A1.2.9 RESP ....................................................................................................................172
A1.2.10 NIBP...................................................................................................................173
A1.2.11 SpO2....................................................................................................................174
A1.2.12 PR.......................................................................................................................175
A1.2.13 TEMP .................................................................................................................175
A1.2.14 IBP (Optional)....................................................................................................176
A1.2.15 CO2(Optional) ...................................................................................................176
A1.2.16 Interfaces............................................................................................................182
Appendix II EMC Information.....................................................................................................183
A2.1 Electromagnetic Emissions.............................................................................................183
A2.2 Electromagnetic Immunity..............................................................................................183
A2.3 Electromagnetic Immunity..............................................................................................185
A2.4 Recommended Separation Distances..............................................................................188
Appendix III Default Settings.......................................................................................................189
A3.1 Patient Information Default Settings...............................................................................189
A3.2 Alarm Default Settings....................................................................................................189
A3.3 ECG Default Settings......................................................................................................189
A3.4 RESP ...............................................................................................................................191
A3.5 SpO2................................................................................................................................191
A3.6 PR....................................................................................................................................191
A3.7 NIBP................................................................................................................................192
A3.8 TEMP ..............................................................................................................................192
A3.9 IBP...................................................................................................................................192
A3.10 CO2................................................................................................................................193
Appendix IVAbbreviations...........................................................................................................194

Patient Monitor User Manual Intended Use and Safety Guidance
- 1 -
Chapter 1 Intended Use and Safety Guidance
1.1 Intended Use/Indications for Use
iM8 Series: The Patient Monitor (hereinafter called monitor) is intended to be used for
continuous monitoring of ECG, RESP, SpO2, NIBP (Non-invasive Blood Pressure), dual-TEMP,
dual-IBP and CO2.
M8 Series: The Patient Monitor (hereinafter called monitor) is intended to be used for continuous
monitoring of ECG, RESP, SpO2, NIBP (Non-invasive Blood Pressure), dual-TEMP, dual-IBP
and CO2.
The monitor is intended to be used only under regular supervision of clinical personnel. It is
applicable to adult, pediatric, and neonatal usage in a hospital environment and during patient
transport inside a healthcare facility.
The monitor is equipped with alarms that indicate system faults (such as loose or defective
electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
1.2 Safety Guidance
1.2.1 Environment
Follow the instructions below to ensure a 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 and 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 (5cms) clearance around the
instrument for proper air circulation.
1.2.2 Power Source Requirements
Refer to Appendix Ⅰ .
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 in the main 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