EDAN SE-2003 User manual

I
About this Manual
P/N: 01.54.455144-13
Release Date: April 2014
© Copyright EDAN INSTRUMENTS, INC. 2010-2014. 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 ofContents
1 Safety Guidance...........................................................................................................................1
1.1 Intended Use........................................................................................................................... 1
1.2 Warnings and Cautions .......................................................................................................... 1
1.2.1 Safety Warnings.............................................................................................................. 2
1.2.2 Alkaline Battery Care Warnings ..................................................................................... 3
1.2.3 General Cautions............................................................................................................. 3
1.3 List of Symbols ...................................................................................................................... 4
2 Introduction.................................................................................................................................5
2.1 Appearance............................................................................................................................. 6
2.2 Lead Input/USB Socket.......................................................................................................... 7
2.3 Control Key............................................................................................................................ 7
2.4 Data Storage ........................................................................................................................... 7
2.4.1 Capacity Requirements ................................................................................................... 8
2.4.2 SD Card Loading and Unloading.................................................................................... 8
2.5 Battery Loading...................................................................................................................... 9
2.6 Features .................................................................................................................................. 9
3 Operation Preparations............................................................................................................11
3.1 Requested Materials ............................................................................................................. 11
3.2 Connecting the Patient Cable to the Recorder and Electrodes............................................. 11
3.2.1 Connecting the Patient Cable to the Recorder .............................................................. 11
3.2.2 Connecting the Patient Cable to Electrodes .................................................................. 11
3.3 Preparing the Patient ............................................................................................................ 15
3.3.1 Instructing the Patient ................................................................................................... 15
3.3.2 Preparing the Skin......................................................................................................... 15
3.4 Attaching the Electrodes to the Patient ................................................................................ 16
3.4.1 Electrode Placement...................................................................................................... 16
3.4.2 Attaching the Electrodes ............................................................................................... 19
4 Recorder Preparation...............................................................................................................20
4.1 Menu Setting ........................................................................................................................ 20
4.2 System Setting...................................................................................................................... 20
4.2.1 Channels........................................................................................................................ 21
4.2.2 Gain............................................................................................................................... 21
4.2.3 Recording time.............................................................................................................. 21
4.3 Advanced Setting ................................................................................................................. 21
4.3.1 ECG Preview................................................................................................................. 21
4.3.2 Patient ID Writing......................................................................................................... 22
4.3.3 ECG Display ................................................................................................................. 22

IV
4.3.4 LCD Contrast ................................................................................................................ 22
4.3.5 Data Protection.............................................................................................................. 22
4.3.6 Languages ..................................................................................................................... 23
4.3.7 Font ............................................................................................................................... 23
4.3.8 Check WP Switch ......................................................................................................... 23
4.3.9 Pole-fall Sound.............................................................................................................. 23
4.3.10 Battery Type................................................................................................................ 24
4.3.11 Date and Time............................................................................................................. 24
4.3.12 Exit .............................................................................................................................. 24
4.4 Screen Description ............................................................................................................... 25
4.4.1 Start-up Picture.............................................................................................................. 25
4.4.2 Low Battery Message 1................................................................................................. 25
4.4.3 Low Battery Message 2................................................................................................. 25
4.4.4 Inserting SD Card Message........................................................................................... 26
4.4.5 Read-write Errors of SD Card Message........................................................................ 26
4.4.6 Write-protect of SD Card Message............................................................................... 27
4.4.7 Data Protection Message............................................................................................... 27
4.4.8 No Patient Cable Message ............................................................................................ 27
4.4.9 Automatic Shutdown Message...................................................................................... 28
4.4.10 Shutdown Message...................................................................................................... 28
5 Recording...................................................................................................................................29
5.1 Overview .............................................................................................................................. 29
5.2 Start Recording..................................................................................................................... 29
5.2.1 Start Recording.............................................................................................................. 30
5.2.2 Input Patient ID............................................................................................................. 30
5.2.3 ECG Preview................................................................................................................. 31
5.2.4 Confirmation ................................................................................................................. 31
5.3 Recording Status .................................................................................................................. 32
5.3.1 Information Display ...................................................................................................... 32
5.3.2 ECG Display ................................................................................................................. 33
5.4 Stopping Recording.............................................................................................................. 33
5.5 Data Transmission................................................................................................................ 34
5.5.1 Transmit by SD Card .................................................................................................... 34
5.5.2 USB Connection............................................................................................................ 34
6 Cleaning, Care and Maintenance ............................................................................................36
6.1 Cleaning the Patient Cable ................................................................................................... 36
6.2 Care and Maintenance.......................................................................................................... 36
6.2.1 Visual Inspection........................................................................................................... 36
6.2.2 Maintenance of the Recorder and the Patient Cable ..................................................... 37

V
7 Accessories.................................................................................................................................39
8 Warranty and Service Policy ...................................................................................................40
8.1 Warranty............................................................................................................................... 40
8.2 Contact Information ............................................................................................................. 40
Appendix 1 Technical Specifications..........................................................................................41
A1.1 Safety Specifications ......................................................................................................... 41
A1.2 Environment Specifications .............................................................................................. 41
A1.3 Physical Specifications...................................................................................................... 42
A1.4 Battery Specifications ....................................................................................................... 42
A1.5 Performance Specifications............................................................................................... 42
Appendix 2 EMC Information....................................................................................................43

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1 Safety Guidance
This chapter provides important safety information related to the use of SE-2003/SE-2012 Holter
System Recorder.
1.1 Intended Use
The SE-2003/SE-2012 Holter System (including analysis software and recorder) is intended to
record, analyze, display, edit and generate report of ambulatory ECG. It is mainly used for (but
not limited to) the following indications:
1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
2. Evaluation of patients for ST segment changes.
3. Evaluation of drug response in patients taking anti-arrhythmic medications.
4. Evaluation of patients with pacemakers.
The Holter system is intended to be used in hospitals and clinics by trained personnel
under the direction of doctors. The analysis results are offered to doctors on an advisory
basis only. The Holter system is intended for adult, paediatric patients and infants weighing
less than 10 kg.
WARNING
1. This recorder is not designed for internal use or direct cardiac application.
2. This recorder is not intended for treatment.
3. The results given by the recorder should be examined based on the overall clinical
condition of the patient, and they can not substitute for regular checking.
1.2 Warnings and Cautions
Consideration of Safety and Efficiency
♦The dependability of the recorder depends on the proper operation in accordance with
operation and maintenance guidance given in the manual.
♦The lifetime of the recorder mainly depends on the components validity, which is 5 years
under normal conditions. If components validity exceeds the time limit, the possibility of
aging failure will increase and it may lead to operational failure.
♦The measure result provided by the recorder is just a reference for physician. The final
diagnosis is made by physician.

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In order to use the recorder safely and effectively, and avoid possible dangers caused by improper
operation, please read through the user manual and be sure to be familiar with all functions of the
equipment and proper operation procedures before use.
Please pay more attention to the following warning and caution information.
1.2.1 Safety Warnings
WARNING
1. The recorder is intended to be used by qualified physicians or personnel
professionally trained. They should be familiar with the contents of this user manual
before operation.
2. Only qualified service engineers can install this recorder, and only service engineers
authorized by the manufacturer can open the shell.
3. EXPLOSION HAZARD - Do not use the recorder in the presence of flammable
anesthetic mixtures with oxygen or other flammable agents.
4. Do not use this recorder in the presence of high static electricity or high voltage
equipment which may generate sparks.
5. Prevent any liquid from seeping into the recorder; otherwise the safety and the
performance of the recorder can not be guaranteed.
6. Only the patient cable and other accessories supplied by the manufacturer can be
used. Or else, the performance and electric shock protection can not be guaranteed.
7. Make sure that all electrodes are connected to the patient correctly before operation.
8. Ensure that the conductive parts of electrodes and associated connectors, including
neutral electrodes, do not come in contact with earth or any other conducting objects.
9. The disposable electrodes can only be used for one time.
10.The use of equipment that applies high frequency voltages to the patient (including
electrosurgical equipment and some respiration transducers) is not supported and
may produce undesired results. Disconnect the patient data cable from the recorder,
or detach the leads from the patient prior to performing any procedure that uses high
frequency surgical equipment.
11.If multiple instruments are connected to a patient, the sum of the leakage currents
may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard.
Consult your service personnel.

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1.2.2 Alkaline Battery Care Warnings
WARNING
1. Do not heat or splash the battery or throw it into fire or water.
2. Do not destroy the battery; Do not pierce battery with a sharp object such as a needle;
Do not hit with a hammer, step on or throw or drop to cause strong shock; Do not
disassemble or modify the battery.
3. When leakage or foul smell is found, stop using the battery immediately. If your skin or
cloth comes into contact with the leakage liquid, cleanse it with clean water at once. If
the leakage liquid splashes into your eyes, do not wipe them. Irrigate them with clean
water first and go to see a doctor immediately.
4. Properly dispose of or recycle the depleted battery according to local regulations.
5. Remove the battery from the recorder when the recorder isn’t used for a long time.
1.2.3 General Cautions
CAUTION
1. Avoid liquid splash and excessive temperature. The temperature must be kept
between 5 ºC and 40 ºC during operation, and it should be kept between -20 ºC and
55 ºC during transportation and storage.
2. Do not use the recorder in a dusty environment with bad ventilation or in the presence
of corrosive.
3. Make sure that there is no intense electromagnetic interference source around the
equipment, such as radio transmitters or mobile phones etc. Attention: large medical
electrical equipment such as electrosurgical equipment, radiological equipment and
magnetic resonance imaging equipment etc. is likely to bring electromagnetic
interference.
4. The recorder 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 of them together with house-hold garbage. At the end of their lives 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.

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1.3 List of Symbols
Symbol Description
Type CF equipment
Caution
Consult Instructions for Use
Waste Electrical and Electronic Equipment (WEEE) It is the
responsibility of the end user to dispose of this equipment at a
designated collection point for recycling.
Year of Manufacture
Manufacturer
SN Serial Number
Insert SD card in the direction the arrow indicates.
The symbol indicates that the device complies with the European
Council Directive 93/42/EEC concerning medical devices.
Authorized Representative in the European Community
Federal (U.S.) law restricts this device to sale by or on the order of a
physician

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2 Introduction
The manual mainly describes how to operate and maintain SE-2003/SE-2012 Holter System
Recorder (thereafter referred as SE-2003/SE-2012). SE-2003/SE-2012 plus SE-2003/SE-2012
Holter Analysis System compose SE-2003/SE-2012 Holter System. For the operation of analysis
software, refer to software manual.
Ambulatory Electrocardiogram (Holter) detection technology is an effective tool to detect
cardiovascular without the inference of distance, time, environment, the restriction of body
position and activity. It can detect large amount of ECG information and is unique in capture of
transient myocardial ischemia and diagnosis of transient arrhythmia.
SE-2003/SE-2012 is powered by an AAA battery. SD card is used as storage media and LCD
screen is used to set parameters and check wave quality. With a normal AAA alkaline battery,
SE-2012 can continuously record non-compressed and full-disclosure 12-lead ECG data for 24～
48 hours or 3-channel ECG data for 24~96 hours . With a normal AAA alkaline battery, SE-2003
can continuously record non-compressed and full-disclosure 3-channel ECG data for 24~96 hours.
With a Li-Fe battery, SE-2003(7d) can continuously record non-compressed and full-disclosure
3-channel ECG data for 7 days. SE-2003/SE-2012 can detect and record pacemaker pulse
information.
NOTE: Long-time recording analysis should be supported by software with
corresponding functions.

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2.1 Appearance
Please find appearance of SE-2003/SE-2012 Holter System Recorder below:
Multifunctional
Socket
Confirmation Key
LCD Screen
Left-up Key
Right-down Key
SD Card Port
Battery
Cathode
Battery Cover

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2.2 Lead Input/USB Socket
SE-2003/SE-2012 is featured by a 26-pin lead input/USB multi-functional connector socket. It
serves as lead input socket when collecting records. After recording finishes, insert USB cable
into the socket and data could be read into analysis system through USB 2.0 high speed transfer.
By using the same socket, possibility of connection of lead and USB with recorder at the same
time is prevented and potential safety hazards are effectively avoided.
NOTE: Pay attention to the plug direction. Please insert the side with marker toward
recorder with appropriate force.
CAUTION
Do not sway plug during use. Plug may fall off and that will cause record failure and even
damages to socket.
2.3 Control Key
SE-2003/SE-2012 keyboard is composed of confirmation key, left-up key and right-down key.
Confirmation key is used to confirm choice operations and change cursor status in menu
operation mode.
Confirmation key serves as patient events key in monitoring process. If patients feel
uncomfortable or want to record time of symbolic meaning (start to do exercise, begin to sleep,
etc), press the key and the recorder will record the time.
Left-up key is used to move the cursor to left or move up in menu operation mode.
Right-down key is used to move the cursor to right or move down in menu operation mode.
For detailed functions of different buttons, please refer to parameter setting section.
2.4 Data Storage
SE-2003/SE-2012 stores ECG data in Secure Digital card (SD card) which will be analyzed by
Holter analysis software after finishing recording.

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Only the SD card specified by manufacturer can be used in SE-2003/SE-2012. If you need to add
or replace SD card, please contact manufacturer or dealer. Do not insert incompatible or unknown
SD card into SE-2003/SE-2012 recorder. That is to avoid unnecessary damages.
CAUTION
SD card is a light and precise device. Do not knock or bend it or insert articles into the
jacks. Keep the SD card in the recorder and it helps to prevent foreign matters from
falling into SD card slot.
2.4.1 Capacity Requirements
Capacity of SD card accompanied with recorder is 2G. If the SD card is not provided together
with recorder, please contact the manufacturer or distributor.
2.4.2 SD Card Loading and Unloading
SD card holder is push-push structure.
Load:
Face front of SD card with a cut angle toward back cover of recorder, slightly push it into SD
card slot until the end of SD card and card slot are at the same level. Release the finger and let SD
card automatically draw back 1 mm or so. It means SD card is in the right place.
Unload:
Use finger to push SD card inside until its end and card slot are at the same level. Release the
finger and SD card will automatically eject 5 mm or so. Use fingernail to catch the end of SD
card and slightly pull it out.
CAUTION
1. Do not load SD card with too much force. If you feel resistance, please check load
direction or check if any articles block in the slot.
2. The first step to unload SD card is to push card inside and then let it pop up
automatically. Never pull out the card by force before it pops up. It may cause
damage to recorder and SD card.

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2.5 Battery Loading
SE-2003/SE-2012 is powered by one AAA battery. Large capacity AAA alkaline battery is
recommended. Press mark on battery compartment on the back of recorder by thumb and
push outwards with force. The cover of battery compartment will open. Load one AAA battery
according to polarity indication inside battery compartment.
NOTE: There is battery type setting in the setting menu of SE-2003/SE-2012: alkaline
battery and Ni-MH battery. The purpose is to give more exact warning message
on battery under-voltage according to discharge performance of different battery
types. Please set the menu according to used battery type.
WARNING
1. Take out battery if the recorder is not to be used for a long time. Or else damage from
corrosion could result.
2. Do not throw off used or scrapped batteries. Observe operation instructions and local
laws for battery disposal.
2.6 Features
zRefined appearance: 68 x 53 x16 mm, 42g
zSE-2012 Holter System Recorder is able to create standard 12 leads or 3 channels
complete ECG data;
zEDAN’s unique multi-channel pacemaker detect circuit effectively prevents wrong
detection of pacemaker signal caused by all kinds of artifacts (such as movement,
polarized voltage and skin impedance) and missing detection caused by software
detecting only. The detection sensitivity can reach 10-4 second.
z128 X 64 graphic LCD plus a 3-key keyboard make it easy to set recording parameters
of the Holter System Recorder. Real time ECG waves display helps to check electrode
placement quality. During recording, you can switch to ECG display window at any time
to master ECG recording situation;
zMulti-languages menu, easy and friendly to operate;
zReal-time clock, real-time display of year, month and date; the recording time is actual
time, which prevents trouble and poor accuracy caused by recording manually.
zE-label: Support either registration in analysis software or entry of patient ID by recorder
keyboard. Basic information (patient ID, name, gender, age) of patients is written into
data package before making records. In this way recorders used by different patients will

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not be mixed up when reviewing data package. Numerous data are included in the
package like hospital, signal channel, sampling rate, event information, recording date
and time, so as to facilitate data management and exchange.
zLeads-off warning: Poor electrode connection will be warned by voice or icon.
zPower supply management, prompt of detection of battery under voltage; the power
supply will shut off automatically after long time idling (15 minutes after last keyboard
response) or 30 minutes after end of recording so as to save battery capacity and avoid
battery leakage.
zFlexible communication mode, support plug-and-play SD card as well as USB 2.0
high-speed direct communication. SD card helps to speed up patient turnaround and is
convenient to maintain so as to alleviate users’ burden; on the other hand, USB 2.0
high-speed communication mode is simple and easy.
zEvents button precisely records event time.
NOTE: Press Confirmation key to restart SE-2003/SE-2012 if it shuts off automatically.
There is no need to load battery again.

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3 Operation Preparations
WARNING
Before use, the recorder, patient cable and electrodes should be checked. Replace them
if there is any evident defectiveness or aging which may impair the safety or the
performance, and make sure that the equipment is in proper working condition.
3.1 Requested Materials
1. Recorder, patient cables, leads, SD card;
2. An analysis system able to make electronic labeling registration or other specialized
software;
3. 10 (or 5, 7) disposable electrodes;
4. 1 AAA Alkaline battery or 1 fully charged Ni-MH rechargeable battery;
5. Patient log, pen;
6. Other supplementary materials like alcohol, medical adhesive plaster.
3.2 Connecting the Patient Cable to the Recorder and
Electrodes
WARNING
The performance and electric shock protection can be guaranteed only if the original
patient cable and electrodes of the manufacturer are used.
SE-2003/SE-2012 adopts optimized and incorporated lead structure, which can reduce potential
difference disturbance during monitoring process.
3.2.1 Connecting the Patient Cable to the Recorder
Connect the patient cable to the patient cable socket on the top side of the recorder.
3.2.2 Connecting the Patient Cable to Electrodes
Standard lead name and color code are marked on each electrode head of every lead.
Snap the electrodes to the lead wires according to the color identifiers.

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3.2.2.1 10 Electrodes 12 Leads
(AHA)
White RA ●Black LA ●Green RL ●Red LL
●Red V1 ●Yellow V2 ●Green V3 ●Blue V4 ●Orange V5 ●Purple V6
(IEC)
Red R ●Yellow L ●Black N ●Green F
●Red C1 ●Yellow C2 ●Green C3 ●Brown C4 ●Black C5 ●Purple C6
Table 3-1 Electrode Connectors and Their Identifiers and Color Codes
IEC AHA
Right arm/Right deltoid R Red RA White
Left arm/Left deltoid L Yellow LA Black
Right leg/Upper leg as
close to torso as possible N or RF Black RL Green
Left leg/Upper leg as
close to torso as possible F Green LL Red
Chest 1 C1 Red V1 Red
Chest 2 C2 Yellow V2 Yellow
Chest 3 C3 Green V3 Green
Chest 4 C4 Brown V4 Blue
Chest 5 C5 Black V5 Orange
Chest 6 C6 Purple V6 Purple

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3.2.2.2 5 Electrodes 3 Channels
(AHA)
1 Red (CH1+) ●2 Brown (CH2+) ●3 Orange (CH3+) ●4 White (COM-)
●5 Green (RL)
(IEC)
1 Green (CH1+) ●2 White (CH2+) ●3 Orange (CH3+) ●4 Red (COM-)
●5 Black (RL)
Table 3-2 Electrode Connectors and Their Identifiers and Color Codes
Electrode Code (IEC) Code (AHA)
Channel 1
Positive Electrode Green Red
Negative Electrode Red White
Channel 2
Positive Electrode White Brown
Negative Electrode Red White
Channel 3
Positive Electrode Orange Orange
Negative Electrode Red White
Neutral Electrode Black Green

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3.2.2.3 7 Electrodes 3 Channels
(AHA)
●1Red(CH1+) ●2 White (CH1-) ●3 Brown (CH2+)
●4Black(CH2-) ●5 Orange (CH3+) 6 Blue (CH3-) ●7 Green (RL)
(IEC)
1 Green (CH1+)●2 Red (CH1-) ●3 White (CH2+) ●4 Yellow (CH2-)
●5 Orange (CH3+) ●6 Blue (CH3-) ●7 Black (RL)
Table 3-3 Electrode Connectors and Their Identifiers and Color Codes
Electrode Code (IEC) Code (AHA)
Channel 1
Positive Electrode Green Red
Negative Electrode Red White
Channel 2
Positive Electrode White Brown
Negative Electrode Yellow Black
Channel 3
Positive Electrode Orange Orange
Negative Electrode Blue Blue
Neutral Electrode Black Green