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
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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
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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.

Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
18 The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be to the dealer or the manufacturer for
recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose them
together with house-hold garbage. At the end of their life hand the batteries over to
the applicable collection points for the recycling of waste batteries. For more detailed
information about recycling of this product or battery, please contact your local Civic
Office, or the shop where you purchased the product.
19 If leakage or foul odor is detected, ensure that there’s no fire around.
20 The packaging is to be disposed of according to local or hospital’s regulations;
otherwise, it may cause environmental contamination. Place the packaging at the
place which is inaccessible to children.
21 This equipment is not intended for home usage.
22 Do not service or maintain the monitor or any accessory which is in use with the patient.
23 The appliance coupler or mains plug is used as isolation means from supply mains.
Position the monitor in a location where the operator can easily access the
disconnection device.
24 Assembly of the monitor and modifications during actual service life shall be
evaluated based on the requirements of IEC60601-1.
25 The monitors are MR Unsafe. The monitors are not intended for use in an MRI
environment.
26 Only recommended batteries can be used for the monitor.
27 Additional multiple socket-outlets or extension cords can’t be connected to the
system.
28 Only items that have been specified as part of the system or specified as being
compatible with the system can be connected to the system.
29 Connecting any accessory (such as external printer) or other device (such as the
computer) to this monitor makes a medical system. In that case, additional safety
measures should be taken during installation of the system, and the system shall
provide:
a) Within the patient environment, a level of safety comparable to that provided by
medical electrical equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety standards.
30 The medical electrical equipment needs to be installed and put into service according
to the EMC Information provided in this user manual.

Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
31 Portable and mobile RF communications equipment can affect medical electrical
equipment; refer to the recommended separation distances provided in this user
manual.
32 Using accessories other than those specified may result in increased electromagnetic
emission or decreased electromagnetic immunity of the monitoring equipment.
33 The monitor should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, you must check that normal operation is
possible in the necessary configuration before you start monitoring patients.
34 Do not touch accessible parts of medical or non-medical electrical equipment in the
patient environment and the patient simultaneously, such as USB connector, VGA
connector or other signal input/output connectors.
35 SHOCK HAZARD - Don't connect electrical equipment, which has not been supplied
as a part of the system, to the multiple portable socket-outlet supplying the system.
36 SHOCK HAZARD - Don't connect electrical equipment, which has been supplied as a
part of the system, directly to the wall outlet when the non-medical equipment is
intended to be supplied by a multiple portable socket-outlet with an isolation
transformer.
37 Operation of the equipment exceeding specified physiological signal or the
operational specification may cause inaccurate results.
38 The equipment can provide protective means to prevent the patient from being
burned when used with HF SURGICAL EQUIPMENT. The equipment can protect
against the effects of the discharge of a defibrillator. Use only EDAN-approved
accessories.
39 When the monitor is used with HF surgical equipment, the transducer and the cables
must be avoided from conductive connection to the HF equipment. This is to protect
against burns to the patient.
40 To protect the monitor from damage during defibrillation, for accurate measurement
information and to protect against noise and other interference, use only accessories
specified by EDAN.
41 No modification of this equipment is allowed without authorization of the manufacturer.
If this equipment is modified, appropriate inspection and testing must be conducted to
ensure continued safe operation.
42 Clinical decision making based on the output of the device is left to the discretion of
the provider.
43 The monitor is equipped with wireless AP/Wi-Fi to receive RF electromagnetic energy.
Therefore, any other equipment complying with CISPR radiation requirements may
also interfere with the wireless communication and make it interrupted.

Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
44 Wireless LAN equipment contains an intentional RF radiator that has the potential of
interfering with other medical equipment, including patient implanted devices. Be sure
to perform the electromagnetic compatibility test before installation and any time new
medical equipment is added to the Wireless LAN coverage area.
45 If the protective grounding (protective earth) system is doubtful, the monitor must be
supplied by internal power only.
46 Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the monitor, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
47 The monitor is suitable for use in the presence of electrosurgery. When the monitor is
used with HF surgical equipment, user (doctor or nurse) should be cautious about
patient safety.
48 Make sure networking function is used in a secure network environment.
CAUTION
1 Electromagnetic Interference - Ensure that the environment in which the patient
monitor is installed is not subject to any sources of strong electromagnetic
interference, such as radio transmitters, mobile telephones, microwaves, etc.
2 Keep the environment clean. Avoid vibration. Keep it far away from corrosive
medicine, dust area, high temperature and humid environment.
3 Do not immerse transducers in liquid. When using solutions, use sterile wipes to
avoid pouring fluids directly on the transducer.
4 Do not use autoclave or gas to sterilize the monitor, recorder or any accessories.
5 The device and reusable accessories may be sent back to the manufacturer for
recycling or proper disposal after their useful lives.
6 Disposable devices are intended for single use only. They should not be reused as
performance could degrade or contamination could occur.
7 Remove a battery whose life cycle has expired from the monitor immediately.
8 To ensure patient safety, use only parts and accessories manufactured or
recommended by EDAN.
9 Before connecting the monitor to the AC power, make sure the voltage and the power
frequency are consistent with the requirements indicated on the device label or in this
user manual.
10 Protect the device against mechanical damage resulting from falls, impacts, and
vibration.
11 Do not touch the touch screen with a sharp object.

Vital Signs Monitor User Manual Intended Use and Safety Guidance
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CAUTION
12 A ventilated environment is required for monitor installation. Do not block up the
ventilation grille at the back of the device.
13 The device must be connected to the ground to avoid signal interference.
14 To protect eyes from damage, don't look directly at supplementary light for long time.
15 Poor connection might be caused by frequently plugging and unplugging the power
cord. Check the power cord regularly and replace it in time.
NOTE:
1 Position the device in a location where the operator can easily see the screen and
access the operating controls.
2 The monitor can only be used on one patient at a time.
3 If the monitor gets damp or liquid pours on the monitor, please contact the service
personnel of EDAN.
4 This monitor is not a device for treatment purposes.
5 The pictures and interfaces in this manual are for reference only.
6 Regular preventive maintenance should be carried out every two years. You are
responsible for any requirements specific to your country.
7 When there's measurement beyond range, invalid measurement or no measurement
value, it will display -?-.
8 In normal use, the operator shall stand in front of the monitor.
1.3 Explanation of Symbols on the Monitor
1
DEFIBRILLATION-PROOF TYPE BF APPLIED PART
2
TYPE BF APPLIED PART
3
Caution
4
MR Unsafe - Keep away from magnetic resonance
imaging (MRI) equipment
5
Equipotentiality
6 Power Supply switch

Vital Signs Monitor User Manual Intended Use and Safety Guidance
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7 Serial number
8
Network port
9 USB (Universal Serial Bus) Connection
10 CE marking
11
AUTHORISED REPRESENTATIVE IN THE
EUROPEAN COMMUNITY
12 Date of manufacture
13
Manufacturer
14 Part Number
15
General symbol for recovery/recyclable
16
Disposal method
17
Operating instructions
18
Refer to instruction manual/booklet
(Background: Blue; Symbol: White)
19
Warning
(Background: Yellow; Symbol & outline: black)
20
Ingress Protection IPX1 (Protected against vertically
falling water drops)
21
Caution: Federal (U.S.) Law restricts this device to sale by
or on the order of a physician.
22
Non-ionizing electromagnetic radiation
23 Alternating Current

Vital Signs Monitor User Manual Intended Use and Safety Guidance
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24
Output/ Nurse call
25 Chargeable battery
26 Battery check
27 Contains FCC ID
Federal Communications Commission:
Contains FCC ID: SMQ9113EDAN, or
Contains FCC ID: 2AMWOFSC-BT836B
28
Conforms to AAMI Std. ES60601-1,IEC Std. 80601-2-30,
IEC Std. 60601-2-49, ISO Std. 80601-2-56, ISO Std.
80601-2-61
Certified to CSA Std. C22.2 No. 60601-1, No 80601-2-30,
No 60601-2-49, No 80601-2-56, No 80601-2-61
29
This way up
30 Fragile, handle with care
31
Keep dry
32
Stacking limit by number
33
Handle with care
34 Do not step on
35 Use-by date
NOTE:
The user manual is printed in black and white.

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Chapter 2 Installation
NOTE:
The monitor installations and settings must be configured by the authorized hospital
personnel.
2.1 Initial Inspection
Before unpacking, check the packaging and ensure that there are no signs of mishandling or
damage. If the shipping cartons are damaged, contact the carrier for compensation and package
them again.
Open the package carefully and remove the monitor and accessories. Check that the contents are
complete and that the correct options and accessories have been delivered.
If you have any question, please contact your local supplier.
2.2 Mounting the Monitor
If all situations are normal, please place the monitor on a flat, level surface, on a trolley or mount
on a wall. About how to install the trolley or wall mount for the monitor, please refer to Trolley
Installation Guide or Wall Mounting Bracket Assembly Instruction.
WARNING
1 The wall mounting bracket can be fixed only on a concrete wall.
2 The safe loads of the wall mounting bracket and the trolley are 7.5 kg and 11 kg
respectively. Exceeding the safe load may cause bracket to fail and the device to fall.
2.3 Connecting the Power Cable
Connection procedure of the AC power line is listed below:
1Make sure the AC power supply complies with the following specifications: 100 V-240 V~,
50 Hz/60 Hz.
2Connect the power cord provided with the monitor. Connect the power cord to connector of
the monitor. Connect the other end of the power cord to a grounded power outlet.
NOTE:
1 Connect the power cable to the socket specialized for hospital use.
2 Only use the power cable supplied by EDAN.
2.4 Checking the Monitor
Make sure there is no damage on the measurement accessories and cables. Then turn on the
monitor, check whether the monitor can start normally. Make sure all alarm lamps light up and
the alarm sound is heard when turning on the monitor. Please refer to chapter Testing Alarms.

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WARNING
If any sign of damage is detected, or the monitor displays some error messages, do not
use it on any patient. Contact customer service center immediately.
NOTE:
1 Check all the functions of the monitor and make sure that the monitor is in good
status.
2 If rechargeable batteries are provided, charge them after using the device every time,
to ensure the electric power is enough.
3 After long-time continuous running, please restart the monitor to ensure the monitor’s
steady performance and long lifespan.
2.5 Connecting Sensor to Patient
Connect all the necessary patient sensors between the monitor and the patient.
NOTE:
For information on correct connection, refer to related chapters.
2.6 Checking the Recorder
If your monitor is equipped with a recorder, open the recorder’s door to check if paper is properly
installed in the slot. If no paper exists, refer to Chapter Recording for details.
2.7 Setting Date and Time
To set the date and time:
1. Select Menu > System Setup > Date/Time.
2. Adjust the date display format based on the user’s habit.
3. Set the correct time of year, month, day, hour, min and sec. Display Second can be set to On
or Off as needed.
4. Set Sync Time: default selection is Off.
CMS, is used for time synchronization with MFM-CMS.
NTP (Network Time Protocol), is used for time synchronization with the server with
NTP function in hospital. Then, set the Time Zone of the monitor and NTP Server IP.
NOTE:
1 If the system is not used for a longer period of time, its system time may be
inaccurate. In this case, readjust the system time after powering on.
2 If the system time cannot be saved and resumes the default value after restart,
contact the service department of EDAN to replace the button cell in main board.
WARNING
Changing date and time will affect the storage of trend data.

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2.8 Handing Over the Monitor
If you are handing over the monitor to the end-users directly after configuration, make sure that it
is in normal working status and let user know the status.
The users must be adequately trained to use the monitor before monitoring a patient. To achieve
this, they should have access to, and read, the following documentation delivered with the
monitor:
User Manual (this book) - for full operating instructions.
Quick Reference Card - for quick reminders during use.
2.9 FCC Statement
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates and can radiate
radio frequency energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the interference by one or more of the
following measures:
1. Reorient or relocate the receiving antenna.
2. Increase the separation between the equipment and receiver.
3. Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
4. Consult the dealer or an experienced radio/TV technician for help.
This device complies with Part 15 of FCC Rules.
Operation is subject to the following two conditions:
1. This device may not cause harmful interference, and
2. This device must accept any interference received, including interference that may cause
undesired operation.
NOTE:
The manufacturer is not responsible for any radio or TV interference caused by
unauthorized modifications to this equipment. Such modifications could void the user’s
authority to operate this equipment.
2.10 FCC RF Radiation Exposure Statement
This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled
environment. This equipment should be installed and operated with a minimum distance of 20
centimeters between the radiator and your body.

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Chapter 3 Basic Operation
This user manual describes all features and options. Your monitor may not have all of them; they
are not all available in all geographies. Your monitor is highly configurable. What you see on the
screen, how the menus appear and so forth, depend on the way it has been tailored for your
hospital and may not be exactly as shown here.
You may frequently use the follow functions:
SpO2monitoring (Refer to Monitoring SpO2for more information.)
PR monitoring (Refer to Monitoring PR for more information.)
NIBP monitoring (Refer to Monitoring NIBP for more information.)
TEMP monitoring (Refer to Monitoring TEMP for more information.)
Alarm (Refer to Alarms for more information.)
3.1 System Components
3.1.1 Front View
Recorder Quick TEMP Module
NIBP
Interface
SpO2
Interface