EDAN M3A User manual

I
About this Manual
P/N: 01.54.112593-13
Release Date: April 2012
© Copyright EDAN INSTRUMENTS, INC. 2010-2012. 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.
Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other
information to help qualified technician to maintain and repair some parts, which EDAN may
define as user serviceable.

II
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal
injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.

III
Table of Contents
Chapter 1 Intended Use and Safety Guidance ................................................................................1
1.1 Intended Use...........................................................................................................................1
1.2 Safety Guidance .....................................................................................................................1
1.2.1 Environment................................................................................................................1
1.2.2 Power Source Requirements .......................................................................................1
1.2.3 Grounding the Monitor ...............................................................................................1
1.2.4 Equipotential Grounding.............................................................................................2
1.2.5 Condensation...............................................................................................................2
1.2.6 Safety Precautions.......................................................................................................2
1.2.7 Explanation of Symbols on the Monitor .....................................................................5
Chapter 2 Installation of Monitor ....................................................................................................8
2.1 Opening the Package and Checking.......................................................................................8
2.2 Connecting the Power Cable..................................................................................................8
2.3 Powering on the Monitor .......................................................................................................8
2.4 Connecting Sensor to Patient .................................................................................................9
Chapter 3 Introduction....................................................................................................................10
3.1 General Information .............................................................................................................10
3.2 Screen Display .....................................................................................................................11
3.2.1 All Parameters Display..............................................................................................11
3.2.2 Optional Displays......................................................................................................16
3.3 Button Functions ..................................................................................................................18
3.4 Interfaces ..............................................................................................................................20
3.5 Built-in Rechargeable Battery..............................................................................................22
Chapter 4 System Menu ..................................................................................................................24
4.1 Patient Setup.........................................................................................................................24
4.2 NIBP Setup...........................................................................................................................24
4.3 SpO2Setup ...........................................................................................................................25
4.4 TEMP Setup .........................................................................................................................25
4.5 Alarm Setup..........................................................................................................................25
4.6 Data Management ................................................................................................................25
4.7 Recorder ...............................................................................................................................26
4.8 System Setup........................................................................................................................26
4.8.1 General Setup............................................................................................................26
4.8.2 General Alarm Setup.................................................................................................27
4.8.3 Time & Date Setup....................................................................................................27
4.8.4 Default Configuration ...............................................................................................28
4.9 Maintenance .........................................................................................................................28

IV
4.10 Standby Mode ....................................................................................................................33
Chapter 5 Alarm...............................................................................................................................35
5.1 Alarm Modes........................................................................................................................35
5.1.1 Alarm Level...............................................................................................................35
5.1.2 Alarm Modes.............................................................................................................35
5.1.3 Alarm Setup...............................................................................................................37
5.2 Alarm Cause.........................................................................................................................38
5.3 Silence..................................................................................................................................38
5.4 Parameter Alarm...................................................................................................................39
5.5 When an Alarm Occurs ........................................................................................................39
5.6 Testing Alarms......................................................................................................................39
Chapter 6 Trend ...............................................................................................................................40
6.1 Trend List .............................................................................................................................40
6.2 Trend Graph .........................................................................................................................41
Chapter 7 Recording........................................................................................................................43
7.1 Recorder ...............................................................................................................................43
7.1.1 Performance of the Recorder ....................................................................................43
7.1.2 Operations .................................................................................................................43
7.2 Outputing the Monitoring Data............................................................................................44
Chapter 8 Maintenance and Cleaning............................................................................................45
8.1 System Check.......................................................................................................................45
8.2 General Cleaning..................................................................................................................45
8.3 Sterilization ..........................................................................................................................47
8.4 Disinfection..........................................................................................................................47
8.5 Replacement of Fuse ............................................................................................................48
8.6 Cleaning Battery and Battery Compartment Cover .............................................................48
Chapter 9 SpO2Monitoring (Optional) .........................................................................................49
9.1 What is SpO2Monitoring.....................................................................................................49
9.2 Precautions During SpO2/PR Monitoring ............................................................................50
9.3 Monitoring Procedure ..........................................................................................................51
9.4 Limitations of Measurement ................................................................................................51
9.5 SpO2Setup Menu.................................................................................................................52
9.5.1 SpO2Setup ................................................................................................................52
9.5.2 Alarm Setup Menu ....................................................................................................52
9.6 Alarm Description ................................................................................................................53
9.7 Maintenance and Cleaning...................................................................................................55
Chapter 10 NIBP Monitoring (Optional) .......................................................................................56
10.1 Introduction........................................................................................................................56
10.2 NIBP Monitoring................................................................................................................57

V
10.3 NIBP Setup Menu ..............................................................................................................61
10.3.1 NIBP Setup..............................................................................................................61
10.3.2 NIBP Alarm Setup...................................................................................................61
10.4 NIBP Alarm Message and Prompt Message ......................................................................63
10.5 Maintenance and Cleaning.................................................................................................66
Chapter 11 TEMP Monitoring (Optional) .....................................................................................68
11.1 TEMP Monitoring with T2 Module ...................................................................................68
11.1.1 Introduction .............................................................................................................68
11.1.2 Measuring Procedure...............................................................................................69
11.1.3 TEMP Setup Menu ..................................................................................................70
11.1.4 Alarm Message........................................................................................................71
11.1.5 Care and Cleaning ...................................................................................................73
11.2 TEMP Monitoring with TH Module ..................................................................................75
11.2.1 Introduction .............................................................................................................75
11.2.2 Measuring Procedure...............................................................................................76
11.2.3 TEMP Setup ............................................................................................................78
11.2.4 Alarm Message........................................................................................................78
11.2.5 Replacing the Battery..............................................................................................79
11.2.6 Maintenance and Cleaning......................................................................................80
Chapter 12 Accessories and Ordering Information ......................................................................81
Chapter 13 Warranty and Service..................................................................................................84
13.1 Warranty .............................................................................................................................84
13.2 Contact Information ...........................................................................................................84
AppendixüSpecifications ...............................................................................................................85
A1.1 Classification.....................................................................................................................85
A1.2 Specifications ....................................................................................................................85
A1.2.1 Size and Weight......................................................................................................85
A1.2.2 Environment ...........................................................................................................85
A1.2.3 Display ...................................................................................................................86
A1.2.4 Battery ....................................................................................................................87
A1.2.5 Recorder .................................................................................................................87
A1.2.6 Review....................................................................................................................88
A1.2.7 NIBP (Optional) .....................................................................................................88
A1.2.8 SpO2(Optional)......................................................................................................89
A1.2.9 TEMP (Optional)....................................................................................................90
AppendixýEMC Information - Guidance and Manufacture’s Declaration ...........................91
A2.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS ................................91
A2.2 Electromagnetic Immunity - For all EQUIPMENT and SYSTEMS ................................91

VI
A2.3 Electromagnetic Immunity - For EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING.........................................................................................................93
A2.4 Recommended Separation Distances ................................................................................94

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
The M3A Vital Signs Monitor (hereinafter called monitor) is intended to be used for non-invasive
continuous monitoring of SpO2(oxygen saturation of arterial blood), NIBP (non-invasive blood
pressure) and TEMP (temperature).
The monitor is intended to be used only under regular supervision of clinical personnel. It is
applicable to adult, pediatric, and neonatal usage in hospitals, hospital type facilities and
intra-hospital moves.
The monitor is equipped with alarms that indicate system faults (such as loose or defective
electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
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 +5ćand +40 .ć
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 (5cm) clearance around the
instrument for proper air circulation.
1.2.2 Power Source Requirements
Refer to Appendix ĉ .
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 detachable 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
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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 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.
2 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.
3 Only qualified service engineers can install this equipment. And only service engineers
authorized by EDAN can open the shell.
4EXPLOSION HAZARD-Do not use the monitor in a flammable atmosphere where
anesthetics or other flammable materials may accumulate.
5 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.

M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
6SHOCK 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.
7 Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards (e.g. IEC/EN60950 for data processing
equipment and IEC/EN60601-1 for medical equipment). Furthermore all
configurations shall comply with the valid version of the system standard
IEC/EN60601-1-1. 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/EN60601-1-1. If in doubt, consult our technical service
department or your local distributor.
8 Use the battery only in this monitor. Do not connect battery directly to an electric outlet
or cigarette lighter charger.
9 Do not unplug the battery when monitoring.
10 Make sure the monitor is used in the appointed range of voltage, the effect of power
supply can be ignored.
11 Do not solder the leading wire and the battery terminal directly.
12 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.
13 Always keep the battery away from fire.
14 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.
15 Do not use a battery with serious scar or deformation.
16 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.
17 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.
18 Devices connecting with the monitor should be equipotential.
19 When the monitor and electrosurgical device are used together, the user (physician or
nurse) should guarantee the safety of patient.
20 The monitor can provide protective means to prevent the patient from being burned
when used with HF SURGICAL EQUIPMENT.

M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
21 The simultaneous use of cardiac pacemaker and other patient-connected equipment
may cause safety hazard.
22 Please disinfect timely to prevent cross infection between patients.
23 This monitor is not a device for treatment purposes.
24 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.
25 Do not touch the patient, bed or instrument during defibrillation.
26 During monitoring, if the power supply is off and there is no battery for standby, the
monitor will be off, and only the patient information and alarm settings can be saved.
After reconnecting the power supply, the user should turn on the monitor for
monitoring.
CAUTION
1 Federal law (U.S.) restricts this device to sale by or on the order of a physician.
2Electromagnetic 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, etc.
3 The monitor is designed for continuous operation and is “ordinary” (i.e. not drip or
splash-proof).
4 Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine, dust
area, high-temperature and humid environment.
5 Do not immerse transducers in liquid. When using solutions, use sterile wipes to avoid
pouring fluids directly on the transducer.
6 Do not sterilize the monitor, recorder or any accessories.
7 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.
8 Remove a battery whose life cycle has expired from the monitor immediately.

M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance
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CAUTION
9 Before use, the equipment, patient cable and sensor should be checked.
Replacement should be taken if there is any evident defectiveness or aging symptom
which may impair the safety or performance.
10 The disposable accessories can not be reused.
11 Avoid liquid splash and excessive temperature. The temperature must be kept
between +5 andć+40 while working. And it should be kept betweenć-20 andć
+55 during transportation and storage.ć
12 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.
13 Setting alarm limits to extreme values can render the alarm system useless.
14 A potential hazard may exist if different alarm presets are used for the same or similar
equipment in any single area.
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 The equipment is calibrated to display functional oxygen saturation.
4 This equipment is not intended for family usage.
5 If the device is discolored or damaged, then discontinue use of the device.
6 The pictures and interfaces in this manual are for reference only.
7 Regular preventive maintenance should be carried out every two years. You are
responsible for any requirements specific to your country.
1.2.7 Explanation of Symbols on the Monitor
This symbol indicates that the instrument is
IEC/EN60601-1 Type BF equipment. The unit displaying
this symbol contains an F-Type isolated (floating) patient
applied part providing a high degree of protection against
shock, and is suitable for use during defibrillation.

M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance
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This symbol indicates that the instrument is
IEC/EN60601-1 Type BF equipment. The unit displaying
this symbol contains an F-Type isolated (floating) patient
applied part providing a high degree of protection against
shock. It is not suitable for use during defibrillation.
This symbol indicates that the instrument is
IEC/EN60601-1 Type CF equipment. The unit displaying
this symbol contains an F-Type isolated (floating) patient
applied part providing a high degree of protection against
shock, and is not suitable for use during defibrillation.
CAUTION
Consult Instructions for Use
Equipotentiality
ON/OFF switch
It indicates the port has Nurse Call or serial port function.
Serial number
The symbol indicates that the device complies with the
European Council Directive 93/42/EEC concerning
medical devices.
Authorized representative in the European community
Date of manufacture
Manufacturer

M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance
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P/N Part Number
Recycle
The symbol indicates that the device should be sent to the
special agencies according to local regulations for separate
collection after its useful life.
Rx only Federal law (U.S.) restricts this device to sale by or on the
order of a physician.

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: 100V-240V ~,
50Hz/60Hz.
Apply the power line provided with the monitor. Plug the power line to input interface of the
monitor. Connect the other end of the power line to a grounded power output.
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
- 9 -
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 The interval between double presses of the ON/OFF button should be more than 1
second.
5 After continuous 7 days’ (168 hours’) runtime, please restart the monitor to ensure the
monitor’s steady performance and long lifespan.
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.
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
M3A with the TH TEMP module
Figure 3-1 M3A Vital Signs Monitor

M3A Vital Signs Monitor User Manual Introduction
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M3A Vital Signs Monitor can monitor:
SpO2: Oxygen saturation of arterial blood (SpO2);
Pulse Rate (PR);
SpO2PLETH (Plethysmogram);
NIBP: Systolic Pressure (SYS);
Diastolic Pressure (DIA);
Mean Pressure (MAP);
Pulse Rate (PR).
TEMP: Temperature.
The monitor provides extensive functions such as visual and audible alarms, storage for data,
SpO2/NIBP/TEMP measurements review, nurse call and so on.
3.2 Screen Display
The monitor is equipped with LCD. The patient parameters, waveforms, alarm messages, patient
ID, time, monitor status and other information can be reflected from the screen.
If the monitor has SpO2, NIBP and TEMP functions. As an option, the monitor can be configured
to single SpO2, single NIBP, NIBP+SpO2, NIBP+TEMP or NIBP+SpO2+TEMP.
The configuration is preset by the manufacturer, and it can not be changed by the user.
3.2.1 All Parameters Display
The screen is divided into three areas:
1 Parameter area ķ
2 Waveform/ NIBP Multi-Group Review/ Trend list/ Trend Graph ĸ
3 Information area Ĺĺ

M3A Vital Signs Monitor User Manual Introduction
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Figure 3-2 Main display
The NIBP multi-group Review and SpO2waveform area is displayed as follows:
Figure 3-3 NIBP Multi-group Review
Change the display on the screen to Trend list as follows:
ĺ
ķ
Ĺ
ĸ
Ĺ

M3A Vital Signs Monitor User Manual Introduction
- 13 -
Figure 3-4 Display trend list
Change the display on the screen to Trend graph as follows:
Figure 3-5 Display SpO2trend graph
The icons on the interface and their meanings are as follows:
Battery status indicator
Connected to mains power supply
Audio system off
Audio alarm pause
Parameter alarm off