EDAN INSTRUMENTS SE-3 User manual

EDAN INSTRUMENTS, INC.
Manual Ver: V1.7
Release Date: Aug. 2008
Part Number: MS1R-20055-V1.7
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Copyright
Copyright EDAN INSTRUMENTS, INC. 2008.All rights reserved.
Statement
Edan Instruments, Inc. (hereinafter called EDAN) makes no warrantyofanykind with regard to
this material, including,but not limited to the implied warranties of merchantabilityand fitness
for aparticular purpose. EDAN assumes noresponsibilityforanyerrorthat mayappear in this
document, or for incidental or consequential damageinconnection with the furnishing,
performance or use of this material.
No part of this document maybephotocopied,reproduced or translated to another language
without prior written consent of EDAN.
All information contained in this publication is believed to be correct. EDAN shall not be liable
for errors contained herein nor for incidental orconsequential damages inconnection with the
furnishing,performance,or use of this material. This publication mayrefer to information and
protected bycopyrights or patents and does not conveyanylicense under the patent rights of
this company,nor the rights of others. This companydoes not assume anyliabilityarisingout of
anyinfringements of patents or other rights of third parties.
The information contained in this document is subject to changewithout notice.
Responsibility of the Manufacturer
EDAN onlyconsiders itself responsible for anyeffect on safety,reliabilityand performance of
the equipment if:
Assemblyoperations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized byEDAN, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
NOTE:This device is not intended for home use.
WARNING :This device is not intended for treatment.
Upon request, EDAN mayprovide, with compensation, necessarycircuitdiagrams, and other
information to help qualified technician to maintain and repair some parts, which EDAN may
define as user serviceable.

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Using This Label Guide
This guide is designed togive keyconcepts on safetyprecautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal
injuryor 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 regardinga function or a procedure.

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Table of Contents
1 SAFETYGUIDANCE ..............................................................................................................1
1.1 SAFETY INFORMATION..........................................................................................................1
1.2WARNINGS AND CAUTIONS...................................................................................................1
1.2.1 Safety Warnings..........................................................................................................2
1.2.2 BatteryCare Warnings...............................................................................................3
1.2.3 General Cautions........................................................................................................4
1.2.4 Cleaning & Disinfection Cautions.............................................................................5
2 INTRODUCTION......................................................................................................................6
2.1 FUNCTION FEATURES...........................................................................................................6
2.2 LISTOF SYMBOLS.................................................................................................................7
3 GENERAL INFORMATION..................................................................................................10
3.1TOP PANEL..........................................................................................................................10
3.1.1 LCD Screen...............................................................................................................10
3.1.1.1 LCD Screen (320×240 dot single color)................................................................11
3.1.1.2 LCD Screen (192×64 dot single color)..................................................................12
3.1.2 Control Panel and Keys...........................................................................................12
3.2 PATIENT CABLE SOCKETAND SIGNAL INTERFACE.............................................................15
3.3 MAINS CONNECTION AND SWITCH.....................................................................................18
3.4 BOTTOM PANEL ..................................................................................................................18
4 OPERATION PREPARATIONS...........................................................................................20
4.1 POWER AND EARTHING ......................................................................................................20
4.2 LOADING/REPLACING RECORD PAPER..............................................................................21
4.3 PATIENT CABLE CONNECTION............................................................................................22
4.4 ELECTRODES CONNECTIONS.............................................................................................23
4.5 INSPECTION BEFORE POWER ON.......................................................................................25
5 OPERATION INSTRUCTIONS............................................................................................27
5.1 SWITCHING ON...................................................................................................................27
5.2AUTO MODE......................................................................................................................27
5.3 MANUALMODE ................................................................................................................28
5.4 RHYTHMMODE ................................................................................................................28
5.5 USBPRT MODE .................................................................................................................29
5.6 ECG RECALL OPERATION..................................................................................................29
5.6.1 ECG Recall................................................................................................................29
5.6.2 ECG Copy..................................................................................................................32
5.7 USING THE MENU SYSTEM.................................................................................................33

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5.7.1 Entering and Exiting the Menu...............................................................................33
5.7.2 Moving in the Sub-menus .......................................................................................33
5.7.3 Parameter Modification............................................................................................33
5.7.4 Switching between the Setup Windows (onlyfor 320×240 dot single color LCD
Screen)...................................................................................................................................34
5.8 SETTINGS (320 240DOTSINGLE COLOR LCD SCREEN).................................................34
5.8.1 LOGIN Settings.........................................................................................................34
5.8.2 RECORD Settings....................................................................................................35
5.8.2.1 Lead Settings.........................................................................................................35
5.8.2.2 Sample Mode Settings.........................................................................................36
5.8.2.3 Recording Settings................................................................................................36
5.8.2.4 Measurement and Interpretation.........................................................................37
5.8.2.5 Parameter Options................................................................................................38
5.8.3 GENERAL Settings..................................................................................................39
5.8.3.1 Filter Settings.........................................................................................................39
5.8.3.2 External Input/Output Settings............................................................................40
5.8.3.3 KeyBeep & QRS Beep Settings.........................................................................40
5.8.3.4 IPSettings..............................................................................................................40
5.8.3.5 Save Option Settings............................................................................................40
5.8.3.6 Transfer Settings...................................................................................................41
5.8.3.7 Parameter Options................................................................................................42
5.8.4 SYSTEM Settings.....................................................................................................42
5.8.4.1 DisplayMode Settings..........................................................................................43
5.8.4.2 Parameter Options................................................................................................45
5.8.5 Settings (192 64 dot single color).........................................................................45
5.9AUTO MODE RECORD........................................................................................................47
5.10 RHYTHMMODE RECORD................................................................................................49
5.11 USBPRT MODE RECORD.................................................................................................51
5.12 SWITCH OFF.....................................................................................................................52
6 HINT INFORMATION............................................................................................................53
7 TECHNICAL SPECIFICATIONS.........................................................................................54
8 CLEAN, CARE AND MAINTENANCE...............................................................................57
8.1 CLEAN.................................................................................................................................57
8.1.1 Clean the Main Unit and Patient Cable.................................................................57
8.1.2 Clean the Electrodes................................................................................................57
8.1.3 Clean the Print Head................................................................................................57
8.2 DISINFECTION.....................................................................................................................58
8.3 CARE AND MAINTENANCE ..................................................................................................58
8.3.1 Recharge and Replacement ofBattery.................................................................58

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8.3.2 Record Paper............................................................................................................59
8.3.3 Maintenance ofMain Unit, Patient Cable & Electrodes .....................................59
9ACCESSORIES......................................................................................................................62
10 WARRANTY& SERVICE POLICY...................................................................................63
11 EMC INFORMATION - GUIDANCE AND MANUFACTURE S DECLARATION ......65
11.1 ELECTROMAGNETIC EMISSIONS -FOR ALL EQUIPMENTAND SYSTEMS...................65
11.2 ELECTROMAGNETIC IMMUNITY -FOR ALL EQUIPMENTAND SYSTEMS.....................65
11.3 ELECTROMAGNETIC IMMUNITY -FOR EQUIPMENTAND SYSTEMSTHATARE NOT
LIFE-SUPPORTING..............................................................................................................66
11.4 RECOMMENDED SEPARATION DISTANCES.......................................................................67

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1 SafetyGuidance
1.1 SafetyInformation
The designof SE-3 3-channel electrocardiograph complies with international standard IEC/EN
60601-1 Medical Electrical Equipment: General Requirements forSafetyandIEC/EN
60601-2-25 Particular Requirements for the Safetyof Electrocardiographs etc. The
classification of this equipment is Class І,type CF,whichmeansahigher degree of protection
against electric shock and the patient connection is fullyisolated and defibrillation protected.
This equipment is not explosion-proof. Do not use it in the presence of flammable anesthetics.
This equipment is designedfor continuous operation and is ‘ordinary’(i.e. notdrip or
splash-proof).
Classification:
1) Anti-electric-shock type:Class Іwith internal power supply
2) Anti-electric-shock degree: CF
3) Degree of protection against harmful
ingress of water: Ordinaryequipment (Sealed equipment without liquid proof)
4) Disinfection/sterilization method: Refer to the user manual for details
5) Degree of safetyofapplication in the
presence of flammable gas: Equipment not suitable for use in the presence of flammable gas
6) WorkingMode: Continuous operation
7) EMC: Group І
1.2 Warnings and Cautions
Inorder to use the electrocardiograph safelyand effectively,avoidingpossible dangers caused
byimproper operations, please read throughthe user manual and be sure to be familiar with all
functions of the equipment and proper operation procedures before use.
Please paymore attention to the followingwarningand caution information.

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1.2.1 SafetyWarnings
WARNING :
1. The electrocardiograph is provided for the use ofqualified physicians or
personnel professionallytrained. And theyshould be familiar with the contents
ofthis user manual before operation.
2. Onlyqualified service engineers can install this equipment. And onlyservice
engineers authorized byEDAN can open the shell.
3. Onlyqualified installation or service engineerscan shift the mains shift switch
(100V~115V/220V~240V) according to local mains supply.
4. The results given bythe equipment shouldbe examined with respect to the
overall clinical condition of the patient. And it can not substitute for regular
checking.
WARNING :
5. EXPLOSION HAZARD-Do not use the electrocardiograph in the presenceof
flammable anesthetic mixture with oxygen orother flammable agents.
6. SHOCK HAZARD-The power receptaclemust be ahospitalgrade grounded
outlet. Never tryto adapt the three-prong plug to fit a two-slot outlet.
7. If the integrityof external protectiveconductor in installation or arrangement is
in doubt, the equipment should be operated from the built-in rechargeable
battery.
8. Do not use this equipment in the presence ofhigh static electricityor high
voltage equipment which maygenerate sparks.
9. This equipment is not designed for direct cardiac application.
WARNING :
10. Onlypatient cable and other accessories supplied byEDAN can be used. Or
else, the performance and electric shock protection can not be guaranteed.
11. Be sure that all electrodes havebeen connected to the patient correctlybefore
operation.
12. Ensure that the conductivepartsofelectrodes and associated connectors,
including neutral electrode, do not come in contact with earth oranyother

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conducting objects.
13. Electrodes with defibrillator protection should be used while defibrillating.
14. There is no danger for patients with pacemaker.However,ifapacemaker is
used, the resultsgivenbythe equipment maybe invalid, or losethe clinical
significance.
15. Do not touch the patient, bed, table and the equipment while using defibrillator
or pacemaker simultaneously.
16. In order to avoid burning, please keep the electrode far awayfrom the radio
knife while using electrosurgical equipment simultaneously.
17. Alwaysuse electrode gel with reusable electrodes during defibrillation as ECG
recovery will be greater than 10 seconds. EDAN recommends the useof
disposable electrodes at all times.
WARNING :
18. Accessoryequipment connected to the analog and digital interfaces mustbe
certified according to the respectiveIEC/EN standards (e.g. IEC/EN 60950 for
dataprocessing equipment and IEC/EN 60601-1 for medical equipment).
Furthermore all configurations shall complywith the valid version ofthe
standard IEC/EN 60601-1-1. Therefore anybody,who connectsadditional
equipment to the signal input connector or output connector to configure a
medical system, mustmake sure that it complies with the requirementsof the
valid version of the system standard IEC/EN 60601-1-1. Ifin doubt, consult our
technical service department or your local distributor.
19. The summation ofleakage current should never exceed leakage current limits
while several other units are used at the same time.
20. The potentialequalization conductor can be connected to that of other
equipment when necessary,to make surethat all theseequipment are
connected with the potential equalization busbar ofthe electrical installation.
1.2.2 BatteryCare Warnings
WARNING :
21. Improper operation maycause the batteryto be hot, ignited or exploded, and it
maylead to the declination ofbattery’s capacity. It is necessaryto read the user

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manual carefullyand paymore attention to warning messages.
22. Onlyqualified service engineer authorized byEDAN can open the battery
compartment and replace the battery.And the batteryof same model and
specification provided bymanufacturer should be used.
23. Danger ofexplosion -- Do not reverse the anode and cathode when connecting
the battery.
24. Do not heat or splash the batteryor throwit into fire or water.
25. When leakage or foul smell found, stop using the batteryimmediately.Ifyour
skin or cloth comes into contactwith the leakage liquid, cleanse it with clean
water at once. If the leakage liquid splashesinto your eyes, do not wipe them.
Irrigate them with clean water first and go to see a doctor immediately.
26. When the battery’suseful lifeis over,contactthe manufacturer or local
distributor for disposal or dispose the batteryaccording to local regulations.
1.2.3 General Cautions
CAUTION :
1. Avoid liquid splashand excessivetemperature. The temperaturemust be kept
between 5 and 40 while working. And it should be kept between -20 and
55 during transportation & storage.
2. Do not usethe equipment industyenvironment with bad ventilation or inthe
presence of corrosive.
3. Be sure that there is no intense electromagnetic interference source around the
equipment, suchas radio transmitter ormobile phone etc. Attention: large
medical electrical equipment such as electrosurgical equipment, radiological
equipment and magnetic resonance imaging equipment etc. are likelyto bring
electromagnetic interference.
CAUTION :
4. Before use, the equipment, patient cable and electrodes etc. should be
checked. Replacement should be taken ifthere is anyevident defectiveness or
aging symptom which mayimpair the safetyor performance.
5. The following safetychecks should be performed at least every24 months bya
qualified person who has adequate training, knowledge, and practical experience to

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perform these tests.
a) Inspectthe equipment and accessoriesformechanical and functional
damage.
b) Inspect the safetyrelevant labels for legibility.
c) Inspectthe fuse to verifycompliancewith rated current and breaking
characteristics.
d) Verifythe device functions properlyas described in the instructions for
use.
e) Testthe protection earth resistanceaccording to IEC/EN 60601-1: Limit
0.2 ohm.
f)Testthe earth leakage current according to IEC/EN 60601-1: Limit: NC
500 uA, SFC 1000uA.
g) Testthe patient leakage current according to IEC/EN 60601-1: Limit: 10
uA(CF).
h) Testthe patient leakage current undersingle fault condition with mains
voltage on the applied part according to IEC/EN 60601-1: Limit: 50uA
(CF).
The data should be recorded inan equipment log. If the device is not
functioning properlyor fails anyofthe abovetests, the device has to be
repaired.
6. Ruptured fuse mustonlybe replaced with the same type and rating as the
original.
7. When the effective lifetime of the equipment and accessories isover, collect and
classifythem, and dispose them according to local regulations.
8. Federal (US) lawrestricts this device to sale byor on the order of a physician.
1.2.4 Cleaning & Disinfection Cautions
CAUTION :
9. Turn offthe power before cleaning and disinfection. Ifmains supply used, the
power cord should be drugged out of the outlet also. And prevent the detergent
from seeping into the equipment.
10.Do not immerse the unit or patient cable into liquid under anycircumstances.
11. Do not clean the unit and accessories with abrasivefabric and avoid scratching
the electrodes.
12. Anyremainder ofdetergent should be removed from the unit and patient cable
after cleaning.
13. Do not use chloric disinfectant such as chloride and sodium hypochlorite etc.

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2 Introduction
SE-3 is 3-channel electrocardiographs with 12 leads gatheredsimultaneously,visual displayof
operation menu, ECG parameters as well as electrocardiogram.
3-channelECG can beviewed onthe LCD(liquid crystal display)screen of SE-3
simultaneously.And it can be recorded byhigh-qualitythermal recorder.
Auto, manual, rhythm, USB print and off mode can be chosen conveniently.
Either mains supplyor built-in rechargeable Lithium batterycan be used as power.
With a highresolution thermal printer, 32-bit processor andhuge capacitymemorizer, SE-3 has
advanced performance and highreliability.And the compact size makes it suitable for clinic,
hospital and ambulance use.
Configurations:Main unit and accessories (power cord, earth wire, patient cable, electrodes
and thermal record paper)
Intended use: The intended use of electrocardiograph is to acquire ECG signals from adult and
pediatric patients through bodysurface ECG electrodes. The electrocardiograph
is onlyintended to be used in hospitals or healthcare facilities bydoctors and
trained healthcare professionals. The cardiogramrecordedbythe
electrocardiograph can help users to analyze and diagnoseheart disease.
However the ECG with measurements and interpretive statements is offered to
clinician on an advisorybasis only
WARNING :This equipment is intended for use in adult and pediatric patients
only.
WARNING :This equipment is not designed for direct cardiac application.
WARNING :The results given by the equipment should be examined with respect
to the overall clinical condition ofthe patient.And it can not substitute
for regular checking.
2.1 Function Features
♦Low weight and compactsize
♦Touch keyfor easyoperation
♦High resolution thermal recorder, recordingfrequencyresponse ≤150Hz

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♦12-lead gathered and amplified simultaneously, 3-channel built-in recorder
♦Auto mode, manual mode, rhythm mode, USB print mode and off mode optional
♦Measurement function and interpretation function optional
♦LOGIN/PRINT/GENERAL/SYSTEM menu forparameters setting (Onlyfor the device
with 320×240 dot single color LCD Screen)
♦Built-in rechargeable Libatterywith highcapacity
♦Hint information for leadoff, lack of paper and low batterycapacityetc.
♦Automatic adjustment of baseline for optimal recording
♦Standard input/output interface and RS232 communication interface for linking to
special network and settingup ECG database
2.2 List of Symbols
External output
External input
Equipment or part of CF type with defibrillator proof
Attention –general warning(see accompanyingdocument)
Potential equalization
Mains supply
On (mains supply)

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Off (mains supply)
Batteryindicator
Batteryrechargingindicator
Sensitivityswitch key
Recall key
1mVcalibration key& Copykey
Mode/RSTswitch key
Lead switch key
Print/Stop key
ON/OFF key
Menu key
Up Arrow/Down Arrowkey
Left Arrow/ RightArrow key

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Recycle
Part Number
Serial Number
Date of Manufacture
Manufacturer
Authorized Representative in the European Community
This item is compliant with Medical Device Directive
93/42/EEC of June 14, 1993, adirective ofthe European
Economic Community.
Itindicates that the equipment should be sent to the
special agencies accordingto local regulation for separate
collection after its useful life.
It indicates that the equipment is put on the market after
13 August 2005.
Rx only Federal (US) law restricts this device to sale byoron the
order of a physician

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3 General Information
3.1 Top Panel
Figure 3-1 Main Unit (320 240 dot single colorLCD Screen)
Product Information:
1) Trademark
2) Trade Name
Smart ECG
3) Model
SE-3 (3-channel electrocardiograph)
4) Classification Symbol
Equipment of CF typewith defibrillator proof
3.1.1 LCD Screen
The LCD Screen has two specifications: 320×240dot single color LCDScreen or 192×64 dot
single color LCD Screen.
LCD Screen
Patient Cable Socket
Smart ECG SE
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3
RecordPaper
RS232 Socket
Recorder
Control Panel
External Input/Output
Socket
USB Interface

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3.1.1.1 LCD Screen (320 240 dot single color)
ID: 210605-1812 Female Age 30 AUTO 11:01:43
60
RLF
C1 C2C3
C4 C5 C6
10mm/mV
25mm/s
AC ON
EMGOFF
Main Interface(320 240 dot single colorLCD screen)
Normally, the contents displayed on the LCD screen include:
Top Row (describingfrom left to right):
♦Patient ID(created automaticallyaccordingto current date and time)
♦Sex(Male/Female) and Age
♦Record mode(AUTO,MANUAL, RHYTHM, USBPRTor OFF)
♦Current time and batterycapacity(onlywhen the built-in batteryis used)
Right Row (describingfrom top to bottom):
♦Heart rate (Actual heart rate)
♦Electrodes and electrode status (Black backgroundshows the status of LeadOFF)
♦Sensitivity(×2.5mm/mV, ×5mm/mV, ×10mm/mV, ×20mm/mV,AGCwhile in
manual mode and auto sensitivitysymbol while in auto mode)
♦Record speed (5mm/s, 6.25mm/s, 10mm/s, 12.5mm/s, 25mm/s, 50mm/s)
♦AC FILTER (AC ON,AC OFF)
♦EMG FILTER (EMG OFF, EMG25Hz, EMG35Hz, EMG45Hz)
♦Hint information (Paper?, Printing, Sampling, Bat Weak etc.)

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3.1.1.2 LCD Screen (192 64 dot single color)
Main Interface (192 64 dot single colorLCD screen)
Normally, the contents displayed on the LCD screen include: (descript from left to right)
First Row:
♦Record mode(AUTO,MANUAL, RHYTHM, USBPRTor OFF)
♦Hint information (Paper?, Printing, Sampling, Bat Weak etc.)
♦Sex(Male/Female) and Age
Second Row:
♦Current lead (І, П, Ш, aVR, aVL, aVF,V1, V2,V3, V4, V5, V6)
♦Sensitivity(×2.5mm/mV, ×5mm/mV, ×10mm/mV, ×20mm/mV,AGCwhile in
manual mode and auto sensitivitysymbol while in auto mode)
♦Heart rate (Actual heart rate)
♦Batterycapacity(Onlywhen the built-in batteryis used)
Third Row:
♦ECG wave
3.1.2 Control Panel and Keys
AUTOPaper? M35Y
I II III 10mm/mV♥60

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1) IndicatorLamp
Mains supplyindicator lamp: when mains supplyis used, the lamp will be light.
Batteryindicator lamp: when the built-in rechargeable Lithium batteryisused,
the lamp will be light.
Batteryrechargingindicator lamp: when the batteryis recharged, this lamp will
be light.
2) SENS (Sensitivity Switch Key)
The sensitivityswitchingorder: ×10 mm/mV→×20 mm/mV →AGC→×2.5 mm/mV→
×5 mm/mV.And AGC means auto gain control.
3) Recall Key
Press this keyto review the patient files saved in the recall window.
4) 1mV/COPYKey
Under MANUALmode, this keycan bepressed torecord a1mVcalibration pulse at any
time while recording.
Under AUTOmode, once the hint information “COPY”appears in the hint information
field on the LCD screen, this keycan be pressed to recall the electrocardiogram that
recorded last time.
5) MODE/RST(Mode Switch Key)
This keycan be pressedto select record mode betweenAUTO, MANUAL,RHYTHM,
USBPRTand OFF.The switchingorder of lead groups is listed in Table 3-1.
Recordingunder Manualmode, this keycan be pressed to reset the waveform quickly.

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WARNING :
When using the device with defibrillator,after the defibrillator discharge, the
MODE/RSTkeyshould be pressed to reset the waveform quickly.
Table 3-1 Lead Group Switching orderof Different Mode
Mode Switching Order(fromleft to right)
І/П/ШaVR/aVL/aVF V1/V2/V3 V4/V5/V6
AUTO(Standard)
AUTO(Cabrera) aVL/I/-aVR II/aVF/ IIIV1/V2/V3 V4/V5/V6
MANUAL
Inthis mode, needto press LeadSwitch Keyto change the lead ,the
lead switch order can be that of AUTO(Standard)or
AUTO(Cabrera), which is determined bysettings of lead sequence
and record format in the MENU
6) LEAD (Lead Switch Key)
Under MANUALmode, press the keyto switch the lead group.
For 192×64 dot single color LCD screen electrocardiograph, this keycan be pressed to
turn the pages in Recall window or Menu interface.
7) PRINT/STOPKey
Used to begin recordingand stop recording.
8) ON/OFFKey
When the unit has been powered on, press this keyto turn on it. Press again to turn off it.
9) MENU Key
Press this keyto enter menu settings.