EDAN iM3 User manual

I
About this Manual
P/N: 01.54.457703
MPN: 01.54.457703020
Release Date: September 2020
© Copyright EDAN INSTRUMENTS, INC. 2017-2020. 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...................................................................................................11
2.9 FCC Statement .....................................................................................................................11
2.10 FCC RF Radiation Exposure Statement............................................................................. 11
Chapter 3 Basic Operation..............................................................................................................12
3.1 System Components.............................................................................................................12
3.1.1 Front View.................................................................................................................12
3.1.2 Rear View..................................................................................................................14
3.1.3 Side View ..................................................................................................................16
3.2 Operating and Navigating ....................................................................................................17
3.2.1 Using Keys................................................................................................................20
3.3 Work Modes .........................................................................................................................22
3.4 Operating Modes..................................................................................................................22
3.4.1 Demo Mode...............................................................................................................22
3.4.2 Standby Mode ...........................................................................................................22
3.4.3 Night Mode ...............................................................................................................23
3.5 Changing Monitor Settings ..................................................................................................24
3.5.1 Adjusting Screen Brightness .....................................................................................24
3.5.2 Adjusting Volume......................................................................................................24
3.6 Checking Your Monitor Information....................................................................................24
3.7 Device Settings.....................................................................................................................24
3.8 Disabling the Touch Screen..................................................................................................25
3.9 Using the Barcode Scanner ..................................................................................................25
3.10 Using Mouse ......................................................................................................................25
Chapter 4 Monitor Mode.................................................................................................................26
4.1 Admitting a Patient...............................................................................................................26
4.1.1 Patient Category ........................................................................................................27
4.2 Quick Admit.........................................................................................................................27
4.3 Admit by Barcode ................................................................................................................27
4.4 Editing Patient Information..................................................................................................28
4.5 Monitoring Data Review......................................................................................................28
4.5.1 Trend Graph Review .................................................................................................28
4.5.2 Trend Table Review ..................................................................................................28
4.5.3 NIBP Review.............................................................................................................29
4.5.4 Alarm Review............................................................................................................29
4.5.5 Technical Alarm Checking ........................................................................................30
4.5.6 Event Marking...........................................................................................................30

IV
Chapter 5 Ward Round Mode.........................................................................................................31
5.1 Patient Information Item Management ................................................................................31
5.2 Patient Management.............................................................................................................31
5.2.1 Create New Patient....................................................................................................31
5.2.2 Import Patient............................................................................................................32
5.2.3 Delete Patient ............................................................................................................33
5.3 Choose Patient for Measurement .........................................................................................34
5.4 Ward Round Record .............................................................................................................34
5.4.1 Data Update...............................................................................................................34
5.4.2 Ward Round Record Confirmation ...........................................................................35
5.5 Operator Information & Custom Parameters .......................................................................35
5.6 Ward Round Record Review................................................................................................36
Chapter 6 Spot-checking Mode.......................................................................................................37
6.1 Admit Patient........................................................................................................................37
6.2 Modify Patient Information..................................................................................................37
6.3 Spot-checking Data Review.................................................................................................37
6.4 Spot-checking Data Trend Table ..........................................................................................38
Chapter 7 Networking .....................................................................................................................39
7.1 Cybersecurity Measures .......................................................................................................39
7.1.1 Personal Information Safety......................................................................................39
7.1.2 Network Security ......................................................................................................40
7.2 Wi-Fi ....................................................................................................................................42
7.3 Network Disconnected Alarms ............................................................................................43
7.4 e-link Function .....................................................................................................................44
7.5 Connecting the Monitor to MFM-CMS ...............................................................................45
7.6 Connecting the Monitor to CMS-LITE................................................................................45
7.7 Gateway Communication.....................................................................................................46
7.8 HL7 Communication............................................................................................................46
7.9 Inquire for Patient Information via Network (ADT)............................................................46
7.10 Uploading Data to Network Server....................................................................................47
7.10.1 Continue to Upload from Breakpoint......................................................................47
Chapter 8 Alarms .............................................................................................................................48
8.1 Alarm Category ....................................................................................................................48
8.1.1 Physiological Alarms ................................................................................................48
8.1.2 Technical Alarms.......................................................................................................48
8.1.3 Prompts .....................................................................................................................48
8.2 Alarm Levels ........................................................................................................................48
8.3 Controlling Alarm ................................................................................................................50
8.3.1 Setting Parameter Alarm ...........................................................................................50
8.3.2 Audio Alarm Paused..................................................................................................51
8.3.3 Audio Alarm off ........................................................................................................51
8.3.4 Alarm Reset...............................................................................................................52
8.4 Latching Alarms ...................................................................................................................52
8.5 Alarm of SpO2Sensor Off....................................................................................................52
8.6 Delete All Alarm Events.......................................................................................................53
8.7 Testing Alarms......................................................................................................................53
8.8 Alert Setup............................................................................................................................53
8.9 Nurse Call.............................................................................................................................54
Chapter 9 Alarm Information.........................................................................................................55
9.1 Physiological Alarm Information.........................................................................................55

V
9.2 Technical Alarm Information ...............................................................................................56
9.3 Prompts ................................................................................................................................64
9.4 Adjustable Range of Alarm Limits.......................................................................................65
9.5 Known Issues and Directions...............................................................................................67
Chapter 10 User Interface...............................................................................................................68
10.1 Setting Interface Style ........................................................................................................68
10.2 Selecting Display Parameters.............................................................................................68
10.3 Changing Parameter and Waveform Colors.......................................................................68
10.4 User Configuration.............................................................................................................68
10.5 Default Configuration ........................................................................................................69
Chapter 11 Monitoring SpO2..........................................................................................................70
11.1 Overview ............................................................................................................................70
11.2 SpO2Safety Information ....................................................................................................70
11.3 Measuring SpO2.................................................................................................................71
11.4 Measurement Limitations...................................................................................................73
11.5 Assessing the Validity of a SpO2Reading..........................................................................74
11.6 SpO2Alarm Delay..............................................................................................................75
11.7 Perfusion Index (PI)* .........................................................................................................75
11.8 Setting Pitch Tone ..............................................................................................................75
11.9 Setting Sensitivity ..............................................................................................................76
11.10 Measuring SpO2and NIBP Simultaneously.....................................................................76
11.11 SatSeconds Alarm Management*.....................................................................................76
11.11.1 Describing SatSeconds ..........................................................................................76
11.11.2 SatSeconds “Safety Net” .......................................................................................78
11.11.3 Setting SatSeconds Duration .................................................................................78
Chapter 12 Monitoring PR..............................................................................................................79
12.1 Overview ............................................................................................................................79
12.2 PR Source...........................................................................................................................79
12.3 Setting PR Volume .............................................................................................................79
Chapter 13 Monitoring NIBP .........................................................................................................80
13.1 Overview ............................................................................................................................80
13.2 NIBP Safety Information ...................................................................................................80
13.3 Measurement Limitations...................................................................................................81
13.4 Measurement Methods.......................................................................................................82
13.5 Measurement Procedures ...................................................................................................82
13.5.1 Operation Prompts ..................................................................................................84
13.5.2 Correcting the Measurement if Limb is not at Heart Level ....................................85
13.6 NIBP Multi-Review Window.............................................................................................85
13.7 Resetting NIBP...................................................................................................................85
13.8 Calibrating NIBP................................................................................................................86
13.9 Leakage Test.......................................................................................................................86
13.10 Setting Inflation Value......................................................................................................87
13.11 Measuring PR...................................................................................................................87
13.12 NIBP Auto Recording ......................................................................................................87
Chapter 14 Monitoring TEMP........................................................................................................88
14.1 Quick TEMP with T2A Module.........................................................................................88
14.1.1 Introduction.............................................................................................................88
14.1.2 Measuring Procedure ..............................................................................................89
14.1.3 TEMP Setup for T2A Module .................................................................................90
14.2 Quick TEMP with F3000 Module......................................................................................90

VI
14.2.1 Introduction.............................................................................................................90
14.2.2 Probe Covers —Applying & Removing .................................................................92
14.2.3 Changing Isolation Chambers and Probes ..............................................................92
14.2.4 Measuring Mode .....................................................................................................93
14.2.5 Measuring Procedure ..............................................................................................94
14.2.6 TEMP Setup for F3000 Module..............................................................................95
14.3 Infrared TEMP with TH Module........................................................................................96
14.3.1 Introduction.............................................................................................................96
14.3.2 Measuring Procedure ..............................................................................................97
14.3.3 Replacing the Battery..............................................................................................99
Chapter 15 Warning-Score System...............................................................................................101
15.1 Warning-Score Interface ..................................................................................................101
15.2 Warning-Score Method ....................................................................................................101
15.3 Warning-Score Criteria ....................................................................................................102
15.4 Warning-Score Result ......................................................................................................103
15.5 Warning-Score Trend Table..............................................................................................104
Chapter 16 Storing Data in the Storage Device ...........................................................................105
16.1 Setting Storage Mode (For Monitor Mode Only) ............................................................105
16.2 Selecting a Storage Device...............................................................................................105
16.3 Reviewing Data Stored in the Storage Device.................................................................106
16.4 Deleting Data Stored in the Storage Device.....................................................................106
16.5 Exporting Data Stored in the Internal Storage Device.....................................................107
16.6 Ejecting a Removable Device ..........................................................................................107
16.7 Recording Data by Recorder............................................................................................108
16.8 Formatting the Internal Storage Device ...........................................................................108
Chapter 17 Recording....................................................................................................................109
17.1 Performance of the Recorder ...........................................................................................109
17.2 Starting and Stopping Recording .....................................................................................109
17.3 Recorder Operations and Status Messages ...................................................................... 111
17.3.1 Record Paper Requirement ................................................................................... 111
17.3.2 Proper Operation ................................................................................................... 111
17.3.3 Paper Out............................................................................................................... 111
17.3.4 Replacing Paper .................................................................................................... 111
17.3.5 Removing Paper Jam.............................................................................................112
Chapter 18 Using Battery.............................................................................................................. 113
18.1 Battery Safety Information...............................................................................................113
18.2 Battery Power Indicator ...................................................................................................114
18.3 Battery Status on the Main Screen ...................................................................................114
18.4 Checking Battery Performance ........................................................................................114
18.5 Replacing the Battery.......................................................................................................115
18.6 Recycling the Battery.......................................................................................................115
18.7 Maintaining the Battery....................................................................................................115
Chapter 19 Care and Cleaning ..................................................................................................... 117
19.1 Safety Instructions............................................................................................................117
19.2 General Points ..................................................................................................................117
19.3 Cleaning ...........................................................................................................................118
19.3.1 Cleaning the Monitor ............................................................................................118
19.3.2 Cleaning the Reusable Accessories.......................................................................119
19.4 Disinfection......................................................................................................................120
19.4.1 Disinfecting the Monitor.......................................................................................121

VII
19.4.2 Disinfecting the Reusable Accessories..................................................................122
19.5 Cleaning and Disinfecting Other Accessories..................................................................123
19.6 After Reprocessing ...........................................................................................................123
19.7 Storage and Transport ......................................................................................................123
Chapter 20 Maintenance ...............................................................................................................124
20.1 Inspecting .........................................................................................................................124
20.2 Maintenance Task and Test Schedule...............................................................................125
Chapter 21 Warranty and Service ................................................................................................126
21.1 Warranty ...........................................................................................................................126
21.2 Contact Information .........................................................................................................126
Chapter 22 Accessories ..................................................................................................................127
22.1 SpO2Accessories .............................................................................................................127
22.2 NIBP Accessories.............................................................................................................128
22.3 TEMP Accessories ...........................................................................................................129
22.4 Other Accessories.............................................................................................................130
A Product Specification .................................................................................................................132
A.1 Classification.....................................................................................................................132
A.2 Physical Specifications......................................................................................................132
A.2.1 Size and Weight......................................................................................................132
A.2.2 Environment Specification.....................................................................................132
A.2.3 Display ...................................................................................................................133
A.2.4 Battery Specification ..............................................................................................133
A.2.5 Recorder .................................................................................................................134
A.2.6 Data Management ..................................................................................................134
A.3 NIBP..................................................................................................................................135
A.4 SpO2..................................................................................................................................138
A.5 PR......................................................................................................................................139
A.6 TEMP ................................................................................................................................140
A.7 Adjustable Range of Alert Limits......................................................................................142
A.8 Wi-Fi..................................................................................................................................143
A.9 e-link..................................................................................................................................143
A.10 Interfaces .........................................................................................................................144
A.10.1 Nurse Call.............................................................................................................144
A.10.2 USB Interfaces .....................................................................................................144
A.10.3 OTG Interfaces.....................................................................................................144
A.10.4 Wired Network Interface......................................................................................144
B EMC Information.......................................................................................................................145
B.1 Electromagnetic Emissions ...............................................................................................145
B.2 Electromagnetic Immunity ................................................................................................145
B.3 Electromagnetic Immunity ................................................................................................147
B.4 Recommended Separation Distances ................................................................................149
C Default Settings...........................................................................................................................151
C.1 Patient Information Default Settings .................................................................................151
C.2 Alarm Default Settings ......................................................................................................151
C.3 SpO2 Default Settings ........................................................................................................151
C.4 PR Default Settings ...........................................................................................................152
C.5 NIBP Default Settings .......................................................................................................152
C.6 TEMP Default Settings......................................................................................................153
D Abbreviations..............................................................................................................................154

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 for monitoring, storing, recording, and reviewing of, and to
generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The
monitor is intended for use by trained healthcare professionals in hospital environments.
Monitored parameters include: NIBP, SpO2, PR (pulse rate), Quick TEMP/Infrared TEMP.
The monitor is not intended for MRI environments. TEMP module is not intended for neonates.
1.2 Safety Guidance
Federal (U.S.) law restricts this device to sale by or on the order of a physician.
WARNING
1 To ensure that the monitor works properly, please read the user manual and follow
the steps before using the monitor.
2 Before using the device, the equipment, patient cable and sensors etc. should be
checked. Replacement should be taken if there is any evident defect or signs of aging
which may impair the safety or performance.
3 Medical technical equipment such as these monitor/monitoring systems must only be
used by persons who have received adequate training in the use of such equipment
and who are capable of applying it properly.
4 EXPLOSION HAZARD-Do not use the device 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. Never adapt the three-prong
plug from the monitor to fit a two-slot outlet.
6 Do not come into contact with the patient, table, or the monitor during defibrillation.
7 The simultaneous use of cardiac pacemaker and other patient-connected equipment
may cause safety hazard.
8 Extreme care must be exercised when applying medical electrical equipment. Many
parts of the human/machine circuit are conductive, such as the patient, connectors,
transducers. It is very important that these conductive parts do not come into contact
with other grounded, conductive parts when connected to the isolated patient input of
the device. Such contact would bridge the patient's isolation and cancel the protection
provided by the isolated input. In particular, there must be no contact of the neutral
electrode and ground.

Vital Signs Monitor User Manual Intended Use and Safety Guidance
- 2 -
WARNING
9 Magnetic and electrical fields are capable of interfering with the proper performance
of the device. For this reason make sure that all external devices operated in the
vicinity of the monitor comply with the relevant EMC requirements. X-ray equipment
or MRI devices are a possible source of interference as they may emit higher levels of
electromagnetic radiation.
10 Route all cables carefully to avoid possible entanglement, apnea, or electrical
interference. For the device mounted over the patient, sufficient precautionary
measures should be taken to prevent it from falling on the patient.
11 Devices connecting with monitor should be equipotential.
12 Do not rely exclusively on the auditory alarm system for patient monitoring.
Adjustment of alarm volume to a low level or off during patient monitoring may result
in a hazard to the patient. Remember that the most reliable method of patient
monitoring combines close personal surveillance with correct operation of monitoring
equipment.
13 Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing
equipment and IEC/EN 60601-1 for medical equipment). Furthermore all
configurations shall comply with the valid version of the standard IEC/EN 60601-1.
Therefore anybody, who connects additional equipment to the signal input or output
connector to configure a medical system, must make sure that it complies with the
requirements of the valid version of the system standard IEC/EN 60601-1. If in doubt,
consult our technical service department or your local distributor.
14 Only patient cable and other accessories supplied by EDAN can be used. The
performance and electric shock protection cannot be guaranteed, and the patient may
be injured otherwise. Prior to use, check if the casing of a disposable accessory is
intact. Do not use it if its casing is damaged.
15 When interfacing with other equipment, a test for leakage current must be performed
by qualified biomedical engineering personnel before using with patients.
16 If several items of medical equipment are interconnected, pay attention to the sum of
the leakage currents, otherwise it may cause shock hazard. Consult your service
personnel.
17 In monitor mode, when monitoring is in process, if the power supply is off and there is
no battery for standby, the monitor will be off. The settings configured by the user can
be stored, and settings not configured by user keep no change. That is, the last
settings used will be recovered when the power is restored. In round or spot-checking
mode, the patient type will be restored to adult by default, and the monitor is in status
with no patients, and other settings processing after power off are the same with that
in monitor mode.