EDAN M3 User manual

I
About this Manual
P/N: 01.54.109395-16
Release Date: January 2012
© Copyright EDAN INSTRUMENTS, INC. 2008-2012. 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 ....................................................................................................7
2.1 Opening the Package and Checking.......................................................................................7
2.2 Connecting the Power Cable..................................................................................................7
2.3 Powering on the Monitor .......................................................................................................7
2.4 Connecting Sensor to Patient .................................................................................................8
2.5 Checking the Recorder...........................................................................................................8
Chapter 3 Introduction......................................................................................................................9
3.1 General Information...............................................................................................................9
3.2 Screen Display .....................................................................................................................10
3.2.1 General Display Mode ..............................................................................................10
3.2.2 Double-Parameter Mode ...........................................................................................14
3.2.3 Single Parameter Mode.............................................................................................16
3.3 Button Functions ..................................................................................................................18
3.4 Interfaces ..............................................................................................................................20
3.5 Built-in Rechargeable Battery..............................................................................................23
Chapter 4 System Menu ..................................................................................................................25
4.1 Patient Setup.........................................................................................................................25
4.2 Default Setup........................................................................................................................26
4.3 System Setup........................................................................................................................26
4.4 Selection...............................................................................................................................28
4.5 Deleting Data .......................................................................................................................33
4.6 Version..................................................................................................................................33
4.7 Time Setup ...........................................................................................................................33

IV
4.8 NIBP Setup...........................................................................................................................34
4.9 TEMP Setup .........................................................................................................................35
4.10 Alarm Setup........................................................................................................................35
4.11 Maintain .............................................................................................................................36
4.12 Data Storing .......................................................................................................................42
4.13 Sleep Mode.........................................................................................................................46
Chapter 5 Alarm...............................................................................................................................47
5.1 Alarm Modes........................................................................................................................47
5.1.1 Alarm Level...............................................................................................................47
5.1.2 Alarm Modes.............................................................................................................47
5.1.3 Alarm Setup...............................................................................................................49
5.2 Alarm Cause .........................................................................................................................50
5.3 Silence..................................................................................................................................50
5.4 Parameter Alarm...................................................................................................................51
5.5 When an Alarm Occurs ........................................................................................................51
5.6 Testing Alarms......................................................................................................................51
Chapter 6 Trend and Recording .....................................................................................................52
6.1 General Information on Recording ......................................................................................52
6.2 Recorder Operations.............................................................................................................52
Chapter 7 Maintenance/ Cleaning..................................................................................................54
7.1 System Check.......................................................................................................................54
7.2 General Cleaning..................................................................................................................54
7.3 Sterilization ..........................................................................................................................55
7.4 Disinfection..........................................................................................................................56
7.5 Replacement of Fuse............................................................................................................56
7.6 Cleaning Battery and Battery Compartment Cover .............................................................57
Chapter 8 SpO2Monitoring (Optional) .........................................................................................58
8.1 What is SpO2Monitoring.....................................................................................................58
8.2 Precautions during SpO2/Pulse Monitoring .........................................................................59
8.3 Monitoring Procedure ..........................................................................................................59
8.4 Limitations of Measurement ................................................................................................60
8.5 Alarm Setup Menu ...............................................................................................................60
8.6 Alarm Description ................................................................................................................62
8.7 Maintenance and Cleaning...................................................................................................63
Chapter 9 NIBP Monitoring (Optional) .........................................................................................65
9.1 Overview..............................................................................................................................65

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9.2 NIBP Safety Information .....................................................................................................65
9.3 NIBP Monitoring..................................................................................................................66
9.4 NIBP Setup Menu ................................................................................................................69
9.4.1 NIBP Setup................................................................................................................69
9.4.2 NIBP Unit Setup........................................................................................................70
9.4.3 NIBP Alarm Setup.....................................................................................................71
9.5 NIBP Alarm Message and Prompt Message ........................................................................73
9.6 Maintenance and Cleaning...................................................................................................75
Chapter 10 TEMP Monitoring (Optional) .....................................................................................77
10.1 TEMP Monitoring with T2 Module ...................................................................................77
10.1.1 Introduction.............................................................................................................77
10.1.2 Measuring Procedure ..............................................................................................78
10.1.3 TEMP Setup Menu..................................................................................................79
10.1.4 TEMP Alarm Message ............................................................................................82
10.1.5 Care and Cleaning...................................................................................................84
10.2 TEMP Monitoring with TH Module ..................................................................................85
10.2.1 Introduction.............................................................................................................85
10.2.2 Measuring Procedure ..............................................................................................86
10.2.3 Alarm.......................................................................................................................88
10.2.4 Replacing the Battery..............................................................................................88
10.2.5 Maintenance and Cleaning......................................................................................89
Chapter 11 Other Functions............................................................................................................91
11.1 Nurse Call...........................................................................................................................91
11.2 Wireless Network ...............................................................................................................91
Chapter 12 Accessories and Ordering Information ......................................................................92
Chapter 13 Warranty and Service..................................................................................................95
13.1 Warranty .............................................................................................................................95
13.2 Contact Information ...........................................................................................................95
AppendixĉSpecifications ...............................................................................................................96
A1.1 Classification.....................................................................................................................96
A1.2 Specifications ....................................................................................................................96
A1.2.1 Size and Weight......................................................................................................96
A1.2.2 Environment ...........................................................................................................96
A1.2.3 Display ...................................................................................................................97
A1.2.4 Battery ....................................................................................................................98
A1.2.5 Recorder .................................................................................................................98

VI
A1.2.6 Review....................................................................................................................99
A1.2.7 NIBP (Optional) .....................................................................................................99
A1.2.8 SpO2(Optional)....................................................................................................100
A1.2.9 TEMP (Optional)..................................................................................................102
A1.2.10 Wirless Network.................................................................................................102
AppendixĊEMC Information - Guidance and Manufacture’s Declaration .........................104
A2.1 Electromagnetic Emissions - For all EQUIPMENT and SYSTEMS .............................104
A2.2 Electromagnetic Immunity - For all EQUIPMENT and SYSTEMS ..............................104
A2.3 Electromagnetic Immunity - For EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING................................................................................................................106
A2.4 Recommended Separation Distances ..............................................................................107

M3 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 Vital Signs Monitor (hereinafter called monitor) is intended to be used for non-invasive
continuous monitoring of SpO2(oxygen saturation of the 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 +5℃~+40 .℃
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
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 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.

M3 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.
4 EXPLOSION HAZARD-Do not use the monitor in a flammable atmosphere where
concentrations of flammable anesthetics or other materials may occur.
5 SHOCK HAZARD- the power receptacle must be a three-wire grounded outlet. A
hospital grade outlet is required. Never adapt the three-prong plug from the monitor
to fit a two-slot outlet.

M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
6 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.
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 The simultaneous use of cardiac pacemaker and other patient-connected equipment
may cause safety hazard.
9 Use the battery only in this monitor. Do not connect battery directly to an electric
outlet or cigarette lighter charger.
10 Do not unplug the battery when monitoring.
11 Make sure the monitor is used in the appointed range of voltage so that 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 scar 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 The user should check the monitor and accessories before use.
19 Please set the alarm according to the individual status of patient to avoid delaying
treatment. Ensure there will be alarm audio prompt when alarming.
20 Devices connecting with monitor should be equipotential.
21 The monitor is equipped with a wireless AP via network interface to receive RF
electromagnetic energy. Therefore, any other equipment complies with CISPR
radiation requirements may also interfere with the wireless communication and make
it interrupted.
22 Wireless LAN equipment contains an intentional RF radiator that has the potential of
interfering with other medical equipment, including patient implanted devices.

M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
23 When the monitor and electrosurgical device are used together, the user (physician
or nurse) should guarantee the safety of patient.
24 Please disinfect timely to prevent cross infection between patients.
25 This monitor is not a device for treatment purposes.
26 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.
27 Do not touch the patient, bed or instrument during defibrillation.
28 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.
2 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, 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.
8 Remove a battery whose life cycle has expired from the monitor immediately.
9 Avoid liquid splash and excessive temperature. The temperature must be kept
between +5 and℃+40 while working. And it should be kept between℃-20 and℃
+55 during transportation and storage.℃
10 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.