EDAN SE-2003 User manual

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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.

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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.

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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

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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

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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

SE-2003&SE-2012 Holter System Recorder User Manual
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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.

SE-2003&SE-2012 Holter System Recorder User Manual
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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.

SE-2003&SE-2012 Holter System Recorder User Manual
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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