EDAN iM8 User manual

I
About this Manual
P/N: 01.54.456009-10
Release Date: April 2013
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 cannot 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.
Upon request, the manufacturer may provide, with compensation, necessary circuit diagrams, and
other information to help qualified technician to maintain and repair some parts, which the
manufacturer may define as user serviceable.

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...........................................................................................................................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 Explanation of Symbols on the Monitor .....................................................................5
Chapter 2 Installation of Monitor ....................................................................................................7
2.1 Opening the Package and Checking.......................................................................................7
2.2 Connecting the Power Cable..................................................................................................7
2.3 Powering on the Monitor .......................................................................................................8
2.4 Connecting Patient Sensors....................................................................................................8
2.5 Checking the Recorder...........................................................................................................8
Chapter 3 Introduction......................................................................................................................9
3.1 General Information...............................................................................................................9
3.2 Screen Display .....................................................................................................................12
3.3 Button Functions ..................................................................................................................16
3.4 Interfaces ..............................................................................................................................18
3.5 Built-in Rechargeable Battery..............................................................................................20
3.5.1 Battery Safety Information........................................................................................20
3.5.2 Battery Status on the Main Screen ............................................................................20
3.5.3 Checking Battery Performance .................................................................................21
3.5.4 Replacing the Battery................................................................................................21
3.5.5 Recycling the Battery................................................................................................21
3.5.6 Maintaining the Battery.............................................................................................21
Chapter 4 System Menu..................................................................................................................22
4.1 Patient Setup.........................................................................................................................23
4.2 Default Setup........................................................................................................................24
4.3 Mark Event...........................................................................................................................25

IV
4.4 Face Select ...........................................................................................................................26
4.5 Time Setup ...........................................................................................................................27
4.6 Record Setup ........................................................................................................................28
4.7 Module Setup .......................................................................................................................29
4.8 Tracing Waveforms Selection ..............................................................................................29
4.9 Monitor Version ...................................................................................................................30
4.10 Alarm Volume ....................................................................................................................30
4.11 Key Volume........................................................................................................................31
4.12 Drug Calculation ................................................................................................................31
4.13 Waveform Demonstration ..................................................................................................32
4.14 Maintenance .......................................................................................................................32
4.15 Data Storing .......................................................................................................................34
Chapter 5 Face Select.......................................................................................................................39
5.1 Selecting Operating Screen..................................................................................................39
5.2 Standard Screen....................................................................................................................39
5.3 Trend Screen.........................................................................................................................39
5.4 oxyCRG Screen....................................................................................................................40
5.5 Large Font Screen ................................................................................................................40
Chapter 6 Alarm...............................................................................................................................44
6.1 Alarm Modes........................................................................................................................44
6.1.1 Alarm Level...............................................................................................................44
6.1.2 Alarm Modes.............................................................................................................44
6.1.3 Alarm Setup...............................................................................................................47
6.2 Alarm Cause.........................................................................................................................49
6.3 Silence..................................................................................................................................49
6.4 Parameter Alarm...................................................................................................................50
6.5 When an Alarm Occurs ........................................................................................................50
6.6 Testing Alarms......................................................................................................................51
6.7 Adjustable Range of Alarm Limits.......................................................................................51
Chapter 7 Freeze ..............................................................................................................................54
7.1 General .................................................................................................................................54
7.2 Entering/Exiting Freeze Status.............................................................................................54
7.3 FROZEN Menu....................................................................................................................54
7.4 Reviewing Frozen Waveform...............................................................................................55

V
Chapter 8 Recording (Optional).....................................................................................................56
8.1 General Information on Recording ......................................................................................56
8.2 Recording Type ....................................................................................................................56
8.3 Recording Startup.................................................................................................................58
8.4 Recorder Operations and Status Messages ..........................................................................59
Chapter 9 Trend and Event.............................................................................................................61
9.1 Trend Graph .........................................................................................................................61
9.2 Trend Table...........................................................................................................................62
9.3 NIBP Recall..........................................................................................................................64
9.4 Alarm Event Recall ..............................................................................................................65
Chapter 10 Drug Calculation and Titration Table (Optional).....................................................68
10.1 Drug Calculation ................................................................................................................68
10.2 Titration Table ....................................................................................................................70
Chapter 11 Maintenance/Cleaning.................................................................................................72
11.1 System Check.....................................................................................................................72
11.2 General Cleaning................................................................................................................72
11.3 Disinfection ........................................................................................................................73
11.4 Replacement of Fuse ..........................................................................................................74
11.5 Cleaning Battery and Battery Compartment Cover ...........................................................74
Chapter 12 ECG/RESP Monitoring ...............................................................................................75
12.1 What Is ECG Monitoring ...................................................................................................75
12.2 Precautions During ECG Monitoring.................................................................................75
12.3 Monitoring Procedure ........................................................................................................76
12.3.1 Preparation ..............................................................................................................76
12.3.2 Placing Electrodes for ECG Monitoring.................................................................77
12.4 ECG Screen Hot Keys........................................................................................................81
12.5 ECG Menu .........................................................................................................................82
12.5.1 ECG SETUP............................................................................................................82
12.6 ECG Alarm Information.....................................................................................................86
12.7 ST Segment Monitoring.....................................................................................................88
12.8 Arr. Monitoring ..................................................................................................................91
12.9 Measuring RESP ................................................................................................................96
12.9.1 How to Measure RESP............................................................................................97
12.9.2 Setting Up RESP Measurement ..............................................................................97

VI
12.9.3 Installing Electrode for RESP Measurement ..........................................................97
12.9.4 RESP SETUP ..........................................................................................................98
12.9.5 RESP Alarm Message ...........................................................................................100
12.10 Maintenance and Cleaning.............................................................................................101
Chapter 13 SpO2Monitoring........................................................................................................102
13.1 What is SpO2Monitoring.................................................................................................102
13.2 Precautions during SpO2/Pulse Monitoring .....................................................................103
13.3 Monitoring Procedure ......................................................................................................103
13.4 SpO2SETUP ....................................................................................................................104
13.5 Alarm Description ............................................................................................................106
13.6 Maintenance and Cleaning...............................................................................................107
Chapter 14 NIBPMonitoring........................................................................................................108
14.1 Overview..........................................................................................................................108
14.2 NIBP Safety Information .................................................................................................108
14.3 Measurement Procedures .................................................................................................109
14.4 NIBP SETUP.................................................................................................................... 112
14.5 Resetting NIBP.................................................................................................................113
14.6 Calibrating NIBP..............................................................................................................113
14.7 Leak Test ..........................................................................................................................113
14.8 NIBP Alarm Message and Prompt Message ....................................................................114
14.9 Maintenance and Cleaning...............................................................................................117
Chapter 15 TEMP Monitoring......................................................................................................119
15.1 TEMP Monitoring ............................................................................................................119
15.2 TEMP SETUP ..................................................................................................................119
15.3 TEMP Alarm Message .....................................................................................................120
15.4 Care and Cleaning............................................................................................................121
Chapter 16 IBPMonitoring (Optional)........................................................................................123
16.1 Introduction......................................................................................................................123
16.2 Precautions during IBP Monitoring .................................................................................123
16.3 Monitoring Procedure ......................................................................................................124
16.4 IBP Menu .........................................................................................................................125
16.5 Alarm Information............................................................................................................131
16.6 Maintenance and Cleaning...............................................................................................133
Chapter 17 CO2Measuring (Optional)........................................................................................134

VII
17.1 General .............................................................................................................................134
17.2 Monitoring Procedure ......................................................................................................135
17.3 CO2SETUP......................................................................................................................140
17.4 Alarm Information and Prompt ........................................................................................143
17.5 Maintenance and Cleaning...............................................................................................144
Chapter 18Accessories and Ordering Information....................................................................145
Chapter 19 Warranty and Service................................................................................................149
19.1 Warranty ...........................................................................................................................149
19.2 Contact Information .........................................................................................................149
Appendix I Specifications..............................................................................................................150
A1.1 Classification...................................................................................................................150
A1.2 Specifications ..................................................................................................................150
A1.2.1 Size and Weight....................................................................................................150
A1.2.2 Environment.........................................................................................................150
A1.2.3 Display .................................................................................................................151
A1.2.4 Battery ..................................................................................................................151
A1.2.5 Recorder (Optional)..............................................................................................152
A1.2.6 Recall....................................................................................................................153
A1.2.7 ECG......................................................................................................................153
A1.2.8 RESP ....................................................................................................................156
A1.2.9 NIBP.....................................................................................................................157
A1.2.10 SpO2...................................................................................................................158
A1.2.11 TEMP .................................................................................................................159
A1.2.12 IBP (Optional) ....................................................................................................160
A1.2.13 CO2(Optional) ...................................................................................................160
Appendix II EMC Information.....................................................................................................164
A2.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS ..............................164
A2.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS ...............................164
A2.3 Electromagnetic Immunity - for EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING................................................................................................................166
A2.4 Recommended Separation Distances ..............................................................................167
Appendix III Default Settings.......................................................................................................168
A3.1 Patient Information Default Settings...............................................................................168
A3.2 Alarm Default Settings ....................................................................................................168

VII
A3.3 ECG Default Settings ......................................................................................................168
A3.4 RESP ...............................................................................................................................170
A3.5 SpO2................................................................................................................................170
A3.6 PR....................................................................................................................................170
A3.7 NIBP................................................................................................................................171
A3.8 TEMP ..............................................................................................................................171
A3.9 IBP...................................................................................................................................172
A3.10 CO2................................................................................................................................172

Patient Monitor User Manual Intended Use and Safety Guidance
- 1 -
Chapter 1 Intended Use and Safety Guidance
1.1 Intended Use
This monitor is intended to be used for monitoring, storing, reviewing, recording, and generating
alarms for multiple physiological parameters including ECG, respiration (RESP), temperature
(TEMP), oxygen saturation of arterial blood (SpO2), non-invasive blood pressure (NIBP),
invasive blood pressure (IBP) and carbon dioxide (CO2) of adults, pediatrics and neonates in
hospital environments.
This monitor is suitable for use in hospital environments including wards, OR, PACU, ICU and
neonate intensive care room.
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 5℃and 40℃.
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
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.