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
- 1 -
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.

M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance
- 2 -
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
- 3 -
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.