EDAN iM3 Bedienungsanleitung

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


I
About this Manual
P/N: 01.54.457703
MPN: 01.54.457703011
Release Date: August 2017
© Copyright EDAN INSTRUMENTS, INC. 2017. All rights reserved.
Statement
This manual will help you understand the operation and maintenance of the product better. It is
reminded that the product shall be used strictly complying with this manual. User‘s operation
failing to comply with this manual may result in malfunction or accident for which EDAN
INSTRUMENTS, INC. (hereinafter called EDAN) cannot be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any
materials contained in this manual shall not be photocopied, reproduced or translated into other
languages.
Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information are contained in this manual, the user shall
not disclose such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
EDAN only considers itself responsible for any effect on safety, reliability and performance of
the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by EDAN, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.

II
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal
injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.

III
Table of Contents
Chapter 1 Intended Use and Safety Guidance ................................................................................1
1.1 Intended Use/Indications for Use...........................................................................................1
1.2 Safety Guidance.....................................................................................................................1
1.3 Explanation of Symbols on the Monitor................................................................................6
Chapter 2 Installation........................................................................................................................9
2.1 Initial Inspection.....................................................................................................................9
2.2 Mounting the Monitor............................................................................................................9
2.3 Connecting the Power Cable..................................................................................................9
2.4 Checking the Monitor ............................................................................................................9
2.5 Connecting Sensor to Patient...............................................................................................10
2.6 Checking the Recorder.........................................................................................................10
2.7 Setting Date and Time..........................................................................................................10
2.8 Handing Over the Monitor...................................................................................................10
Chapter 3 Basic Operation..............................................................................................................11
3.1 Overview..............................................................................................................................11
3.1.1 Front View.................................................................................................................11
3.1.2 Rear View..................................................................................................................13
3.1.3 Side View..................................................................................................................15
3.2 Operating and Navigating....................................................................................................16
3.2.1 Using Keys................................................................................................................19
3.3 Operating Mode ...................................................................................................................21
3.3.1 Demo Mode...............................................................................................................21
3.3.2 Standby Mode ...........................................................................................................21
3.3.3 Night Mode ...............................................................................................................22
3.3.4 Other Modes..............................................................................................................22
3.4 Changing Monitor Settings..................................................................................................22
3.4.1 Adjusting Screen Brightness.....................................................................................22
3.4.2 Adjusting Volume......................................................................................................23
3.5 Checking Your Monitor Information ...................................................................................23
3.6 Networked Monitoring.........................................................................................................23
3.7 Common Settings.................................................................................................................24
3.8 Disabling the Touch Screen..................................................................................................24
3.9 Using the Barcode Scanner..................................................................................................24
3.10 Using Keyboard and Mouse...............................................................................................24
Chapter 4Alarms.............................................................................................................................25
4.1 Alarm Category....................................................................................................................25
4.1.1 PhysiologicalAlarms ................................................................................................25
4.1.2 Technical Alarms.......................................................................................................25
4.1.3 Prompts .....................................................................................................................25

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

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

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

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

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