EDAN M3A User manual

I
About this Manual
P/N: 01.54.112593
MPN: 01.54.112593024
Release Date: March, 2019
© Copyright EDAN INSTRUMENTS, INC. 2009-2019. 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) can not 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
1.2.1 Environment................................................................................................................1
1.2.2 Power Source Requirements.......................................................................................1
1.2.3 Grounding the Monitor ...............................................................................................1
1.2.4 Equipotential Grounding.............................................................................................2
1.2.5 Condensation...............................................................................................................2
1.2.6 Safety Precautions.......................................................................................................2
1.2.7 Protecting Personal Information .................................................................................8
1.2.8 Explanation of Symbols on the Monitor.....................................................................9
Chapter 2 Installation of Monitor ..................................................................................................11
2.1 Opening the Package and Checking.....................................................................................11
2.2 Connecting the Power Cable................................................................................................11
2.3 Powering on the Monitor .....................................................................................................11
2.4 Connecting Sensor to Patient...............................................................................................12
Chapter 3 Introduction....................................................................................................................13
3.1 General Information.............................................................................................................13
3.2 Screen Display .....................................................................................................................15
3.2.1 All Parameters Display..............................................................................................15
3.2.2 Optional Displays......................................................................................................19
3.3 Button Functions..................................................................................................................20
3.4 Interfaces..............................................................................................................................22
3.5 Built-in Rechargeable Battery..............................................................................................24
3.5.1 Battery Safety Information........................................................................................24
3.5.2 Battery Status on the Main Screen............................................................................25
3.5.3 Checking Battery Performance .................................................................................26
3.5.4 Replacing the Battery................................................................................................26
3.5.5 Recycling the Battery................................................................................................26
3.5.6 Maintaining the Battery.............................................................................................26
3.5.7 Battery Alarm Information........................................................................................26
Chapter 4 System Menu ..................................................................................................................27
4.1 Patient Setup ........................................................................................................................27
4.2 NIBP Setup...........................................................................................................................27
4.3 SpO2Setup...........................................................................................................................27
4.4 TEMP Setup.........................................................................................................................27
4.5 Alarm Setup..........................................................................................................................27
4.6 Data Management ................................................................................................................27
4.7 Recorder...............................................................................................................................28

IV
4.8 System Setup........................................................................................................................28
4.8.1 General Setup............................................................................................................28
4.8.2 General Alarm Setup.................................................................................................28
4.8.3 Time & Date Setup....................................................................................................28
4.8.4 Default Configuration ...............................................................................................29
4.9 Maintenance.........................................................................................................................29
4.10 Standby Mode ....................................................................................................................33
Chapter 5Alarm...............................................................................................................................34
5.1 Alarm Modes........................................................................................................................34
5.1.1 Alarm Level...............................................................................................................34
5.1.2 Alarm Modes.............................................................................................................34
5.1.3 Alarm Setup...............................................................................................................36
5.2 Alarm Cause.........................................................................................................................36
5.3 Audio Alarm Paused.............................................................................................................37
5.4 Audio Alarm Off ..................................................................................................................37
5.5 Alarm Reset..........................................................................................................................38
5.6 Parameter Alarm...................................................................................................................38
5.7 When an Alarm Occurs........................................................................................................39
5.8 Testing Alarms......................................................................................................................39
Chapter 6 Trend and Recording.....................................................................................................40
6.1 Trend List.............................................................................................................................40
6.2 Trend Graph .........................................................................................................................40
6.3 Recording.............................................................................................................................41
6.3.1 Recorder Operations..................................................................................................41
6.3.2 Outputing the Monitoring Data.................................................................................42
6.3.3 Recorder Alarm Information.....................................................................................42
Chapter 7 Maintenance and Cleaning............................................................................................43
7.1 Inspecting.............................................................................................................................43
7.2 Maintenance Task and Test Schedule...................................................................................43
7.3 General Cleaning..................................................................................................................44
7.3.1 Cleaning the Monitor ................................................................................................44
7.3.2 Cleaning the Reusable Accessories...........................................................................44
7.3.3 Cleaning the Dust-proof Filter Assembly .................................................................45
7.4 Disinfection..........................................................................................................................46
7.4.1 Disinfecting the Monitor...........................................................................................47
7.4.2 Disinfecting the Reusable Accessories .....................................................................48
7.5 Replacement of Fuse............................................................................................................48
7.6 Cleaning Battery and Battery Compartment Cover .............................................................49
Chapter 8 SpO2Monitoring (Optional) .........................................................................................50
8.1 Safety Information ...............................................................................................................50
8.2 Measuring SpO2...................................................................................................................51

V
8.3 Measurement Limitations ....................................................................................................52
8.4 Assessing the Validity of a SpO2Reading............................................................................53
8.5 SpO2Alarm Delays..............................................................................................................53
8.6 PI (Perfusion Index)*...........................................................................................................54
8.7 SpO2Setup...........................................................................................................................54
8.8 Alarm....................................................................................................................................54
8.8.1 Adjustable Range of Alarm Limits............................................................................54
8.8.2 Alarm Information and Prompts ...............................................................................55
Chapter 9 NIBP Monitoring (Optional).........................................................................................57
9.1 Introduction..........................................................................................................................57
9.2 NIBP Safety Information .....................................................................................................57
9.3 Measurement Limitations ....................................................................................................58
9.4 NIBP Monitoring..................................................................................................................59
9.4.1 Operation Prompts ....................................................................................................60
9.4.2 Correcting the Measurement if Limb is not at Heart Level ......................................61
9.5 NIBP Setup...........................................................................................................................61
9.6 Alarm....................................................................................................................................61
9.6.1 Adjustable Range of Alarm Limits............................................................................61
9.6.2 Alarm Information and Prompts ...............................................................................62
Chapter 10 TEMP Monitoring (Optional).....................................................................................65
10.1 TEMP Monitoring with T2 Module...................................................................................65
10.1.1 Introduction.............................................................................................................65
10.1.2 Measuring Procedure ..............................................................................................66
10.1.3 TEMP Setup............................................................................................................67
10.1.4 Alarm.......................................................................................................................67
10.2 TEMP Monitoring with TH Module..................................................................................69
10.2.1 Introduction.............................................................................................................69
10.2.2 Measuring Procedure ..............................................................................................70
10.2.3 TEMP Setup............................................................................................................72
10.2.4 Alarm.......................................................................................................................72
10.2.5 Replacing the Battery..............................................................................................73
10.3 TEMP Monitoring with F3000 Module .............................................................................74
10.3.1 General Information................................................................................................74
10.3.2 Safety Information ..................................................................................................74
10.3.3 Probe Covers —Applying & Removing .................................................................75
10.3.4 Changing Isolation Chambers and Probes ..............................................................75
10.3.5 Measuring Mode .....................................................................................................76
10.3.6 Measuring Procedure ..............................................................................................77
10.3.7 TEMP Setup for F3000 Module..............................................................................79
10.3.8 Alarm.......................................................................................................................79
Chapter 11 Other Functions............................................................................................................82

VI
11.1 Nurse Call...........................................................................................................................82
11.2 Network..............................................................................................................................82
11.3 Central Monitoring System................................................................................................82
Chapter 12 Accessories ....................................................................................................................83
12.1 SpO2Accessories ...............................................................................................................83
12.2 NIBPAccessories...............................................................................................................84
12.3 TEMPAccessories .............................................................................................................85
12.4 Other Accessories...............................................................................................................86
Chapter 13 Warranty and Service..................................................................................................87
13.1 Warranty.............................................................................................................................87
13.2 Contact Information...........................................................................................................87
Appendix I Specifications................................................................................................................88
A1.1 Classification.....................................................................................................................88
A1.2 Specifications....................................................................................................................88
A1.2.1 Size and Weight......................................................................................................88
A1.2.2 Function Configuration..........................................................................................88
A1.2.3 Environment...........................................................................................................88
A1.2.4 Display ...................................................................................................................89
A1.2.5 Battery....................................................................................................................90
A1.2.6 Recorder.................................................................................................................90
A1.2.7 Data Storage...........................................................................................................90
A1.2.8 NIBP.......................................................................................................................90
A1.2.9 SpO2.......................................................................................................................92
A1.2.10 PR.........................................................................................................................92
A1.2.11 TEMP ...................................................................................................................93
AppendixⅡEMC Information - Guidance and Manufacture’s Declaration ...........................95
A2.1 Electromagnetic Emissions...............................................................................................95
A2.2 Electromagnetic Immunity................................................................................................95
A2.3 Electromagnetic Immunity................................................................................................97
A2.4 Recommended Separation Distances..............................................................................100
Appendix III Abbreviation............................................................................................................101

M3A 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
This monitor is intended to be used for monitoring, storing, reviewing, recording, and generating
alarms for SpO2 (oxygen saturation of arterial blood), NIBP (non-invasive blood pressure) and
TEMP (quick temperature or infrared ear temperature) of adults, pediatrics and neonates in
hospital environments.
This monitor is used to monitor vital signals for patients and is suitable for use in hospital
environments including out-patient department, wards and NICU.
Monitored paramenters include: NIBP, SpO2, pulse rate, Quick TEMP/Infrared TEMP.
1.2 Safety Guidance
1.2.1 Environment
Follow the instructions below to ensure completely safe electrical installation. The environment
where the monitor will be used should be reasonably free from vibration, dust, corrosive or
explosive gases, extremes of temperature, humidity, and so on. For a cabinet mounted installation,
allow sufficient room at the front for operation and sufficient room at the rear for servicing with
the cabinet access door open.
The monitor operates within specifications at ambient temperatures between 0 C and +40 C.
Ambient temperatures that exceed these limits could affect the accuracy of the instrument and
cause damage to the modules and circuits. Allow at least 2 inches (5 cm) clearance around the
instrument for proper air circulation.
1.2.2 Power Source Requirements
Refer to Appendix Ⅰ .
1.2.3 Grounding the Monitor
To protect the patient and hospital personnel, the cabinet of the monitor must be grounded.
Accordingly, the monitor is equipped with a 3-wire cable which grounds the instrument to the
power line ground (protective earth) when plugged into an appropriate 3-wire receptacle. If a
3-wire receptacle is not available, consult the hospital electrician.
Connect the grounding wire to the equipotential grounding terminal on the mains system. If it is
not evident from the instrument specifications whether a particular instrument combination is
hazardous or not, for example due to summation of leakage currents, the user should consult the
manufacturers concerned or an expert in the field, to ensure that the necessary safety of all
instruments concerned will not be impaired by the proposed combination.

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1.2.4 Equipotential Grounding
Protection class 1 instruments are already included in the protective grounding (protective earth)
system of the room by way of grounding contacts in the power plug. For internal examinations on
the heart or the brain, the Monitor must have a separate connection to the equipotential grounding
system. One end of the equipotential grounding cable (potential equalization conductor) is
connected to the equipotential grounding terminal on the rear panel of the instrument and the
other end to one point of the equipotential grounding system. The equipotential grounding system
assumes the safety function of the protective grounding conductor if ever there is a break in the
protective grounding system. Examinations in or on the heart (or brain) should only be carried out
in medically used rooms incorporating an equipotential grounding system. Check each time
before use that the instrument is in perfect working order. The cable connecting the patient to the
instrument must be free of electrolyte.
WARNING
If the protective grounding (protective earth) system is doubtful, the monitor must be
supplied by internal power only.
1.2.5 Condensation
Make sure that during operation, the instrument is free of condensation. Condensation can form
when equipment is moved from one building to another, thus being exposed to moisture and
differences in temperature.
1.2.6 Safety Precautions
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the instrument.
WARNING
1 Before using the device, the equipment, patient cable and electrodes etc. should be
checked. Replacement shall be taken if there is any evident defect or signs of aging
which may impair the safety or performance.
2 If liquid is inadvertently splashed on the equipment or its accessories, it may enter the
conduit or inside the monitor. At this moment, contact local Customer Service Center.
3 The monitor is intended to be used by qualified physicians or personnel professionally
trained. And they should be familiar with the contents of this user manual before
operation.
4 Only qualified service personnel can install this equipment. And only service
personnel authorized by EDAN can open the shell.
5 The device must be connected to the ground to avoid signal interference.

M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
6 EXPLOSION HAZARD-Do not use the monitor in a flammable atmosphere where
anesthetics or other flammable materials may accumulate.
7 Do not attempt to connect or disconnect a power cord with wet hands. Make certain
that your hands are clean and dry before touching a power cord.
8 SHOCK HAZARD- the power receptacle must be a three-wire grounded outlet. A
hospital grade outlet is required. Never adapt the three-prong plug of the monitor to fit
a two-slot outlet.
9 Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards. Furthermore all configurations shall
comply with the valid version of the system standard IEC/EN60601-1. Everybody who
connects additional equipment to the signal input connector or signal output
connector configures a medical system, and is therefore responsible that the system
complies with the requirements of the valid version of the system standard
IEC/EN60601-1. If in doubt, consult our technical service department or your local
distributor.
10 Use the battery only in this monitor. Do not connect battery directly to an electric outlet
or cigarette lighter charger.
11 Make sure the monitor is used in the appointed range of voltage, the effect of power
supply can be ignored.
12 Do not solder the leading wire and the battery terminal directly.
13 If liquid leaking from the battery gets into your eyes, onto your skin or clothes, do not
rub your eyes. Wash them well with clean water and go to see a doctor immediately.
14 Always keep the battery away from fire.
15 Stop using the battery if abnormal heat, odor, discoloration, deformation or abnormal
condition is detected during use, charge, or storage. Keep it away from the monitor.
16 Do not use a battery with serious scratch or deformation.
17 Only patient cable and other accessories supplied by EDAN can be used. Or else, the
performance and electric shock protection can not be guaranteed, and the patient
may be injured.
18 Please set the alarm according to the individual condition of patient to avoid delaying
treatment. Ensure there will be an alarm audio prompt when an alarm occurs.
19 Devices connecting with the monitor should be equipotential.
20 This monitor is not a device for treatment purposes.
21 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.

M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
22 The simultaneous use of cardiac pacemaker and other patient-connected equipment
may cause safety hazard.
23 Only NIBP and SpO2applied parts of the monitor are defibrillation-proof. When a
defibrillator is applied, keep other accessories away from the patient. Otherwise, it
may result in damaging the monitor or harming the patient.
24 Do not touch the patient, table or instrument during defibrillation.
25 During monitoring, if the power supply is off and there is no battery for standby, the
monitor will be off. All last settings used will be recovered when the power is restored.
26 The equipment can provide protective means to prevent the patient from being
burned when used with HF SURGICAL EQUIPMENT. Use only EDAN-approved
accessories.
27 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.
28 Do not service or maintain the monitor or any accessory which is in use with the
patient.
29 Additional multiple socket-outlet or extension cord can’t be connected to the system.
30 Measured data (including trend data, review data and so on) are saved in dataflash
either when the monitor is turned off or when the monitor is powered down in the
process of monitoring.
31 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.
32 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.
33 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.
34 All the accessories connected to system must be installed outside the patient vicinity,
if they do not meet the requirement of IEC/EN 60601-1.
35 Using accessories other than those specified may result in increased electromagnetic
emission or decreased electromagnetic immunity of the monitoring equipment.

M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
36 The medical electrical equipment needs to be installed and put into service according
to the EMC Information provided in this user manual.
37 If device conflict occurs when monitor is connected to gateway, please modify the IP
address of the conflicted monitor.
38 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.
39 Please disinfect timely to prevent cross infection between patients.
40 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.
41 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.
42 Portable and mobile radio frequency (RF) communications equipment can affect
medical electrical equipment, please refer to the recommended separation distances
provided in Appendix A2 EMC Information.
43 Setting alarm limits to extreme values may cause the alarm system to become
ineffective. It is recommended to use the default settings.
44 The monitors are intended for use by trained healthcare professionals in hospital
environments.
45 Operation of the equipment exceeding specified physiological signal or the
operational specification may cause inaccurate results.
46 SHOCK HAZARD-To avoid the RISK of electric shock, this equipment must only be
connected to a SUPPLY MAINS with protective earth.
47 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.
48 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.

M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
49 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.
50 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.
51 Route all cables carefully to avoid possible entanglement, apnea, or electrical
interference.
52 For the device mounted over the patient, sufficient precautionary measures should be
taken to prevent it from falling on the patient.
53 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.
CAUTION
1 Electromagnetic Interference –Ensure the environment in which the monitor is
installed is not subject to any sources of strong electromagnetic interference, such as
radio transmitters, mobile telephones, microwaves, etc.
2 Federal law (U.S.) restricts this device to sale by or on the order of a physician.
3 Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine, dust
area, high-temperature and humid environment.
4 The monitor is designed for continuous operation and is “ordinary” (i.e. not drip or
splash-proof).
5 The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be returned 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.
6 Do not immerse transducers in liquid. When using solutions, use sterile wipes to avoid
pouring fluids directly on the transducer.
7 Disposable devices are intended for single use only. They should not be reused as
performance could degrade or contamination could occur.

M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance
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CAUTION
8 If the monitor gets damp, put it in dry circumstance to dry it until it can work normally.
If liquid pours on the monitor, please contact the service personnel authorized by
EDAN.
9 Avoid liquid splash and excessive temperature. The working temperature must be
kept between 0 C and +40 C, and it is recommended to be kept between +10 C
and +40 C when the monitor is equipped with TEMP module. The temperature
should be kept between -20 C and +55 C during transportation and storage, and it is
recommended to be kept between -20 C and +50 C when the monitor is equipped
with TH module.
10 Remove a battery whose life cycle has expired from the monitor immediately.
11 A potential hazard may exist if different alarm presets are used for the same or similar
equipment in any single area.
12 Assembly of the monitor and modifications during actual service life shall be
evaluated based on the requirements of IEC60601-1.
13 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 The monitor can only be used on one patient at a time.
2 Position the device in a location where the operator can easily see the screen and
access the operating controls.
3 This equipment is not intended for home usage.
4 If the device is discolored or damaged, then discontinue use of the device.
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 The materials with which the patient or any other person can come into contact
conform to the standard of EN ISO 10993-1: 2013.
8 When there's measurement beyond range, invalid measurement or no measurement
value, it will display “---”.
9 To protect eyes from damage, don't look directly at supplementary light for long time.
10 Make sure networking function is used in a secure network environment.
11 In normal use, the operator shall stand in front of the monitor.

M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance
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1.2.7 Protecting Personal Information
Protecting personal health information is a major component of security strategy. To protect the
personal information and ensure the proper device performance, the user should take necessary
precautions in accordance with local laws and regulations and institution’s policies. EDAN
recommends health care organizations or medical institutions to implement a comprehensive and
multifaceted strategy to protect the information and systems from internal and external security
threats.
To ensure the patients’ safety and protect their personal health information, the user should
implement security practices or measures that include:
1. Physical safeguards - physical safety measures to ensure that unauthorized personnel do not
have access to the monitor.
2. Operational safeguards - safety measures during operation.
3. Administrative safeguards - safety measures in management.
4. Technical safeguards - safety measures in technical field.
CAUTION
1 The access/operation of the monitor is restricted to authorized personnel only. Assign
only staff with a specific role the right to use the monitor.
2 Ensure that all device components maintaining personal information (other than
removable media) are physically secure.
3 Ensure that the data are deleted after the patient is discharged. (Refer to Section 4.6
Data Management).
4 Ensure that the monitor is connected only to the device authorized/approved by
EDAN. Users should operate all EDAN deployed and supported monitors within
EDAN authorized specifications, including EDAN approved software, software
configuration, security configuration, etc.
5 Protect all the passwords to prevent unauthorized changes. Only the manufacturer’s
service personnel are allowed to modify the Factory Maintain settings.
6 Anti-virus measures such as USB device virus scanning should be carried out prior to
using USB flash drive.
7 When the monitor is returned for maintenance, disposed of, or removed from the
medical institution for other reasons, it is necessary to ensure that all patient data are
removed from the monitor. (Refer to Section 4.6 Data Management).
8 Please protect the privacy for the information and the data displayed on the screen,
and for the information and the data stored in the monitor.
9 Firewalls and/or other security devices should be in place between the medical
system and any externally accessible systems. It’s recommended to use Windows
defender firewall or any other firewall that can defend against Dos and DDos attacks,
and keep it up to date.
10 Dos and DDos protection of the router or switch must be turned on for defensing
against attacks.

M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance
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NOTE:
Log files generated by the monitor are used for system troubleshooting and do not
contain protected medical data.
1.2.8 Explanation of Symbols on the Monitor
1
DEFIBRILLATION-PROOF TYPE BF APPLIED PART
2
TYPE BF APPLIED PART
3
TYPE CF APPLIED PART
4
Warning
(Background: yellow; Symbol and outline: black)
5
Operating instructions
6
Refer to User Manual
(Background: blue; Symbol: white)
7
Part Number
8
Equipotential grounding
9
Power Supply switch
10
Write and read data into and from store
11
SERIAL NUMBER
12
CE marking
13
AUTHORISED REPRESENTATIVE IN THE
EUROPEAN COMMUNITY

M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance
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14
Date of manufacture
15
MANUFACTURER
16
General symbol for recovery/recyclable
17
Disposal method
18
Caution: Federal law (U.S.) restricts this device to sale by
or on the order of a physician.
19
Ingress Protection IPX1 (Protected against vertically
falling water drops)
20
Caution
21
This way up
22
Fragile
23
Keep away from rain
24
Stacking limit by number
25
Handle with care
26
Do not step on
27
Conforms to UL Std. 60601-1, IEC Std. 60601-2-30, IEC
Std. 60601-2-49
Certified to CSA Std. C22.2 No 601.1, CSA Std. C22.2
No 60601-2-30, CSA Std. C22.2 No 60601-2-49
NOTE:
The user manual is printed in black and white.

M3A Vital Signs Monitor User Manual Installation of Monitor
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Chapter 2 Installation of Monitor
NOTE:
To ensure that the monitor works properly, please read Chapter 1 Intended Use and
Safety Guidance, and follow the steps before using the monitor.
2.1 Opening the Package and Checking
Visually examine the package prior to unpacking. If any signs of mishandling or damage are
detected, contact the carrier to claim for damage. Open the package and take out the monitor and
accessories carefully. Keep the package for possible future transportation or storage. Check the
components according to the packing list.
Check for any mechanical damage.
Check all the cables, modules and accessories.
If there is any problem, contact the manufacturer or local representative immediately.
2.2 Connecting the Power Cable
Connection procedure of the AC power line:
Make sure the AC power supply complies with the following specification: 100 V-240 V ~,
50 Hz/60 Hz.
Connect 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:
Connect the power line to the jack special for hospital usage.
Connect to the ground line if necessary. Refer to section 1.2 Safety Guidance for details.
NOTE:
When the battery is provided, after the monitor is transported or stored, the battery must
be recharged. Switching on AC power supply can recharge the battery no matter if the
monitor is powered on.
2.3 Powering on the Monitor
Press the ON/OFF button on the front panel to power on the monitor, all the seven-segment
displays are bright, and LOGO information is displayed on the screen.
WARNING
Do not use it on any patient if any sign of damage is detected, or the monitor displays
some error messages. Contact biomedical engineer in the hospital or Customer Service
Center immediately.

M3A Vital Signs Monitor User Manual Installation of Monitor
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NOTE:
1 During POST, make sure all the seven segments are bright, which indicates the seven
segments function well.
2 Check all the functions of the monitor and make sure that the monitor is in good
condition.
3 If rechargeable batteries are provided, recharge them after using the monitor every
time to ensure the electric power is enough.
4 After long-time continuous running, please restart the monitor to ensure the monitor’s
steady performance and long lifespan.
5 If the system is not used for a longer period of time, its system time may be inaccurate.
In this case, reset the system time after powering on.
6 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.
2.4 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.

M3A Vital Signs Monitor User Manual Introduction
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Chapter 3 Introduction
3.1 General Information
The monitor integrates the function of parameter measurement modules, display and output to
compose a compact, portable device. Its built-in replaceable battery provides convenience for
patient movement.
You may frequently use the following functions:
SpO2monitoring (Refer to Chapter Monitoring SpO2for details)
TEMP monitoring (Refer to Chapter Monitoring TEMP for details)
NIBP monitoring (Refer to Chapter Monitoring NIBP for details)
Alarm (Refer to Chapter Alarms for details)
The monitor is a user-friendly device with operations conducted by a few buttons on the front
panel. Refer to section 3.3 Button Functions for more details.
M3A with the T2 TEMP Module