EDAN SE-3 Series User manual

I
About this Manual
P/N: 01.54.20094-16
Release Date: July 2011
© Copyright EDAN INSTRUMENTS, INC. 2005-2011. 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 Warranty and Service..................................................................................................1
Chapter 2 Safety Guidance ...........................................................................................................4
2.1 List of Symbols....................................................................................................................... 4
2.2 Safety Information.................................................................................................................. 6
2.3 Warnings and Cautions ........................................................................................................... 7
2.3.1 Safety Warnings ............................................................................................................... 8
2.3.2 Lithium Battery Care Warnings ....................................................................................... 9
2.3.3 General Cautions............................................................................................................ 10
2.3.4 Cleaning and Disinfection Cautions............................................................................... 12
Chapter 3 Operating Principle ...................................................................................................13
3.1 Basic Theory of ECG Operation...........................................................................................13
3.2 Composition of ECG ............................................................................................................ 13
3.3 Lead ...................................................................................................................................... 14
3.4 Description of Hardware Design Principle........................................................................... 16
3.4.1 ECG Board Description .................................................................................................18
3.4.2 Description of Main Control Part................................................................................... 19
3.4.3 Description of Power Control Part................................................................................. 20
Chapter 4 Functional Verification..............................................................................................21
4.1 System Tests ......................................................................................................................... 21
4.2 Application System Tests...................................................................................................... 21
4.3 Safety Tests ........................................................................................................................... 23
Chapter 5 Modules’ Malfunction Verification...........................................................................24
5.1 Verifying the Main Board ..................................................................................................... 24
5.2 Verifying the ECG Board...................................................................................................... 25
Chapter 6 Electrocardiograph Servicing...................................................................................27
6.1 Disassembly Steps ................................................................................................................ 27
6.2 Internal Boards and Interfaces.............................................................................................. 34
6.3 Troubleshooting .................................................................................................................... 42
Chapter 7 Cleaning, Care and Maintenance.............................................................................46
7.1 Cleaning................................................................................................................................ 46
7.1.1 Cleaning the Main Unit and the Patient Cable...............................................................46
7.1.2 Cleaning the Electrodes.................................................................................................. 46
7.1.3 Cleaning the Print Head ................................................................................................. 46

IV
7.2 Disinfection .......................................................................................................................... 47
7.3 Care and Maintenance .......................................................................................................... 47
7.3.1 Recharge and Replacement of Battery ........................................................................... 47
7.3.2 Recorder Paper............................................................................................................... 48
7.3.3 Maintenance of Main Unit, Patient Cable and Electrodes ............................................. 49
Chapter 8 Renewal Parts.............................................................................................................51

SE-3 Electrocardiograph Service Manual Warranty and Service
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Chapter 1 Warranty and Service
Standard Service
EDAN provides a one-year-warranty for the warranted products (accessories are included). The
warranty period begins on the date the products are shipped to customers. If a customer promptly
notifies EDAN of customer’s warranty claim hereunder, EDAN will either repair, adjust or
replace (with new or exchange replacement parts) EDAN’s products. EDAN warrants that any
service it provides to customers will be performed by trained individuals in a workmanlike
manner.
Limitation of Warranty
Direct, indirect or final damage and delay caused by the following situations for which EDAN is
not responsible may void the warranty:
Groupware is dismounted, stretched or redebugged.
Unauthorized modification or misuse.
Damage caused by operating beyond the environmental specifications for the medical
product.
Change or remove the original serial number label or the manufacturer symbol.
Improper use.
Service Procedure
(1) Fill in the Service Claim Form (SCF).
Fill in the SCF with detailed information including: Model Name, Serial Number (SN) and
Problem Phenomena.
EDAN should not have any obligation to take over the case without this information. The
form can be downloaded at: http://www.edan.com.cn or obtained from EDAN’s service
department.
(2) Send EDAN the SCF and Select a Solution.
Once the service department receives the fully filled SCF, EDAN’s engineer will offer a
solution in three working days. EDAN will follow out the case based on the two conditions
below:

SE-3 Electrocardiograph Service Manual Warranty and Service
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Within Warranty:
There are two options:
i) After receiving the Return Material Authorization (RMA) form from EDAN service
department, the customer sends EDAN the defective parts and informs about the shipment
tracking number. Then we will dispatch new part(s) to your confirmed address with the
confirmed shipping invoice.
ii) The customer signs the Declaration Form and sends it back by email or fax. This form is
legally certificated to make sure the customer or the end-user will return the defective parts to
EDAN on time. We will, at this option, dispatch the replacement one(s) with the confirmed
shipping invoice.
NOTE:
(1) Both Return Material Authorization Form and Declaration Form are offered
by EDAN service department once the SCF is confirmed by service
engineers.
(2) The customer is responsible for freight & insurance charges when the
equipment is shipped to EDAN for service, including custom charges. EDAN
is responsible for the freight, insurance & custom charges from EDAN to the
customer.
Out of Warranty:
After receiving the RMA form from the service department, the customer sends defective
parts to EDAN in advance. We will analyze the problems and discuss with the customer about
either repairing or replacing the part(s). Once the maintenance fee is invoiced and paid, we
will make sure to dispatch good part(s) to the confirmed address.
NOTE: The customer is responsible for any freight & insurance charge for the
returned product.
(3) Obtain the RMA Form.
Before the shipment of the materials, the customer must obtain an RMA form from our
service department, in which the RMA number, description of returning parts and shipping
instructions are included. The RMA number should be indicated on the outside of the
shipping container.

SE-3 Electrocardiograph Service Manual Warranty and Service
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NOTE: EDAN should not have any obligation to the end-user or the customer
who returns the goods without the notification by EDAN’s service
department. The sender takes full responsibility for the accounted fee.
(4) Send the Parts to EDAN.
Follow these recommended instructions:
Please disassemble the parts with anti-static facility, do not touch the parts with naked hands.
Please pack the parts safely before return.
Please put the RMA number on the parcel.
Please describe the returned parts as ‘sample of *****’ and put the total value on the invoice,
and note on the invoice as ‘sample, no commercial value’.
Please confirm the invoice with Edan before shipment.
Please send back the parts after Edan’s confirmation.
Contact Information
If you have any question about maintenance, technical specifications or malfunctions of devices,
do not hesitate to contact us.
EDAN Instruments, Inc.
TEL: [phone]
FAX: [phone]
E-mail: [email protected]

SE-3 Electrocardiograph Service Manual Safety Guidance
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Chapter 2 Safety Guidance
This chapter describes important issues related to safely servicing SE-3. The service provider
must read and understand all the information presented in this manual before servicing a unit.
2.1 List of Symbols
External output
External input
Equipment or part of CF type with defibrillator proof
Caution
Consult Instructions for Use
Potential equalization
Mains supply
On (mains supply)
Off (mains supply)
Battery indicator
Battery recharging indicator

SE-3 Electrocardiograph Service Manual Safety Guidance
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Sensitivity switch key
Recall key
1mV calibration key & Copy key
Mode/RST switch key
Lead switch key
Print/Stop key
ON/OFF key
Menu key
Up arrow/Down arrow key
Left arrow/ Right arrow key
Recycle
Part Number

SE-3 Electrocardiograph Service Manual Safety Guidance
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Serial Number
Date of Manufacture
Manufacturer
Authorized Representative in the European Community
The symbol indicates that the device complies with the
European Council Directive 93/42/EEC concerning medical
devices.
The symbol indicates that the device should be sent to the
special agencies according to local regulations for separate
collection after its useful life.
Rx only (U.S.) Federal (U.S.) law restricts this device to sale by or on the
order of a physician
2.2 Safety Information
Safety Standard:
IEC/EN 60601-1+A1+A2, IEC/EN 60601-1-2+A1, IEC/EN60601-2-25,
ANSI/AAMI EC-11
Classification:
Anti-electric-shock type: Class Іwith internal power supply
Anti-electric-shock degree: Type CF
Degree of protection against harmful
ingress of water:
Ordinary equipment (Sealed equipment without
liquid proof)
Disinfection/sterilization method: Refer to the user manual for details
Degree of safety of application in the Equipment not suitable for use in the presence

SE-3 Electrocardiograph Service Manual Safety Guidance
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presence of flammable gas: of flammable gas
Working mode: Continuous operation
EMC: Group І, Class A
Environment:
Transport & Storage Working
Temperature: -20 ºC ~ +55 ºC 5 ºC ~ 40 ºC
Relative Humidity:
25% ~ 93%
Non-Condensing
25% ~ 80%
Non-Condensing
Atmospheric
Pressure: 700hPa ~ 1060hPa 860hPa ~ 1060hPa
Power Supply Specifications:
1) Mains Supply:
Operating Voltage: 100V-115V~ / 220V-240V~
Operating Frequency: 50Hz/60Hz
Input Power: 35VA
2) Built-in Rechargeable Lithium Battery Pack:
Rated voltage: 14.8V; Rated capacity: 2200mAh
3) Power Consumption: 35VA (max)
4) Fuse Specification: T400mA 250V Ø5×20 / T200mA 250V Ø5×20
2.3 Warnings and Cautions
In order to service the system safely and effectively, and avoid the possibility of injury, please
read the user manual and this service manual in detail and be sure to be familiar with proper
service methods. The following precautions must be paid more attention to during the service
procedure.
Note:
1. This device is not intended for home use.
2. The pictures and interfaces in this manual are for reference only.

SE-3 Electrocardiograph Service Manual Safety Guidance
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2.3.1 Safety Warnings
WARNING
1. The service provider must read and understand all the information presented in the
user manual and this service manual before installing or servicing a unit.
2. Only qualified service engineers can install this equipment, and only service engineers
authorized by the manufacturer can open the shell.
3. Only qualified installation or service engineers can shift the mains supply shift switch
(100V-115V/220V-240V) according to local mains supply specifications.
4. This device is not intended for treatment or monitoring.
5. EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of
flammable anesthetic mixtures with oxygen or other flammable agents.
6. SHOCK HAZARD - The power receptacle must be a hospital grade grounded outlet.
Never try to adapt the three-prong plug to fit a two-slot outlet.
7. If the integrity of the external protective conductor is in doubt, the equipment should be
operated by using the built-in rechargeable battery.
8. Do not use this equipment in the presence of high static electricity or high voltage
equipment which may generate sparks.
9. 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.
10.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.
11.Electrodes with defibrillator protection should be used during defibrillation. To avoid a
polarization or DC offset voltage, use non-polarizing electrodes (which will not form a
DC offset voltage when subjected to a DC current) such as silver/silver-chloride types
if there is a situation where there is a likelihood that a defibrillation procedure will be
necessary.
12.Do not touch the patient, bed, table or the equipment while using the ECG together
with a defibrillator.

SE-3 Electrocardiograph Service Manual Safety Guidance
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WARNING
13.In order to avoid being burned, please keep the electrodes far away from the radio
knife while using electrosurgical equipment.
14.If reusable electrodes with electrode gel are used during defibrillation, ECG recovery
will take more than 10 seconds. The manufacturer recommends the use of disposable
electrodes at all times.
15.Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing
equipment and IEC/EN 60601-1 for medical equipment). Furthermore all configuration
shall comply with the valid version of the standard IEC/EN 60601-1-1. Therefore
anybody, who connects additional equipment to the signal input or output connector to
configure a medical system, must make sure that it complies with the requirements of
the valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult our
technical service department or your local distributor.
16.The summation of leakage current should never exceed leakage current limits while
several other units are used at the same time; otherwise, electric shock may happen.
17.The potential equalization conductor can be connected to that of other equipment
when necessary. Make sure that all these devices are connected to the potential
equalization bus bar of the electrical installation.
18.We recommend that the electrocardiograph should be working on AC power supply at
least 8 hours per month to avoid DATE&TIME missing.
2.3.2 Lithium Battery Care Warnings
WARNING
1. Improper operation may cause lithium battery (hereinafter called battery) to be hot,
ignited or exploded, and it may lead to the declination of the battery capacity. It is
necessary to read the user manual carefully and pay more attention to warning
messages.
2. Only qualified service engineers authorized by the manufacturer can open the battery
compartment and replace the battery. The battery of the same model and specification
provided by the manufacturer should be used.

SE-3 Electrocardiograph Service Manual Safety Guidance
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WARNING
3. Danger of explosion -- Do not reverse the anode and the cathode when installing the
battery.
4. Do not heat or splash the battery or throw it into fire or water.
5. 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.
6. Remove the battery from the electrocardiograph when the electrocardiograph is not
used for a long time.
7. If the battery is stored alone and not used for a long time, we recommend that the
battery should be charged at least once every 6 months to prevent overdischarge.
2.3.3 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 equipment 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, mobile phones etc. Attention: large medical
electrical equipment such as electrosurgical equipment, radiological equipment and
magnetic resonance imaging equipment is likely to bring electromagnetic interference.
4. Before use, the equipment, the patient cable and electrodes should be checked.
Replacement should be taken if there is any evident defectiveness or aging symptom
which may impair the safety or the performance.
5. The following safety checks should be performed at least every 24 months by a
qualified person who has adequate training, knowledge, and practical experience to
perform these tests.

SE-3 Electrocardiograph Service Manual Safety Guidance
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CAUTION
a) Inspect the equipment and accessories for mechanical and functional damage.
b) Inspect the safety related labels for legibility.
c) Inspect the fuse to verify compliance with the rated current and breaking
characteristics.
d) Verify that the device functions properly as described in the instructions for use.
e) Test the protection earth resistance according to IEC/EN 60601-1: Limit 0.1 ohm.
f) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500 μA,
SFC 1000μA.
g) Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC
100μA, SFC 500μA.
h) Test the patient leakage current according to IEC/EN 60601-1: Limit: NC a.c.
10μA, d.c. 10μA; SFC a.c. 50μA, d.c. 50μA.
i) Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC a.c.
10μA, d.c. 10μA; SFC a.c. 50μA, d.c. 50μA.
j) Test the patient leakage current under single fault condition with mains voltage on
the applied part according to IEC/EN 60601-1: Limit: 50μA (CF).
The data should be recorded in an equipment log. If the device is not functioning
properly or fails any of the above tests, the device has to be repaired.
6. Ruptured fuses must only be replaced with those of the same type and rating as the
original.
7. The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be returned to the dealer or the manufacturer
for recycling or proper disposal. Batteries are hazardous waste. Do not dispose 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 the battery, please contact your
local Civic Office, or the shop where you purchased the product.
8. Federal (U.S.) law restricts this device to sale by or on the order of a physician.

SE-3 Electrocardiograph Service Manual Safety Guidance
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2.3.4 Cleaning and Disinfection Cautions
CAUTION
1. Turn off the power before cleaning and disinfection. If the mains supply is used, the
power cord should be dragged out of the outlet. Prevent the detergent from seeping
into the equipment during cleaning.
2. Do not immerse the unit or the patient cable into liquid under any circumstances.
3. Do not clean the unit and accessories with abrasive fabric and avoid scratching the
electrodes.
4. Any remainder of detergent should be removed from the unit and the patient cable
after cleaning.
5. Do not use chloric disinfectant such as chloride, sodium hypochlorite etc.

SE-3 Electrocardiograph Service Manual Operating Principle
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Chapter 3 Operating Principle
This chapter describes the basic theory and the internal circuit structure of SE-3 to let the service
provider understand the operating principle.
3.1 Basic Theory of ECG Operation
The heart is a power organ of the blood circulation. Before the systole or the diastole, a cardiac
impulse happens in the heart muscle, and a faint bioelectric signal is thus generated. The
bioelectric signal is transmitted through the whole body, and the potential difference is generated
on the different skin surfaces because of the different distances from the heart.
The cardiogram is a record of the amplification of the potential distribution on the body skin
surface. The potential difference is sampled by the electrodes, and amplified and processed by the
electrocardiograph. Then it is recorded on the paper. The cardiogram recorded by the
electrocardiograph can help doctors to analyze and diagnose heart disease. The intended use of
the electrocardiograph is to acquire ECG signals from adult and pediatric patients through body
surface ECG electrodes. The electrocardiograph only records the heart's electrical activity, and
does not produce any electricity of its own. The test does not hurt and has no known side effects.
It does not require any preparations except possibly shaving chest hair to get a better recording.
The recording itself takes only a few seconds.
It is more than one hundred years since the electrocardiograph was applied in clinical diagnosis.
The electrocardiograph is an important measurement in clinical diagnosis of heart disease, and is
equipped in almost every hospital and clinic.
3.2 Composition of ECG
The standard 12-lead electrocardiogram is a representation of the heart's electrical activity
recorded from electrodes on the body surface. A normal ECG wave consists of a P wave, a QRS
complex, an ST segment, a T wave and a U wave. In the following figure, the x-axis indicates
time and y-axis indicates voltage. When the recording speed is 25mm/s and the sensitivity is
10mm/mV, one small grid on x-axis represents 0.04 seconds, and one small grid on y-axis
represents 0.1mV.
This diagram illustrates ECG waves and intervals as well as standard time and voltage measures
on the ECG paper.

SE-3 Electrocardiograph Service Manual Operating Principle
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Figure 3-1 Composition of ECG
P wave: the sequential activation (depolarization) of the right and left atria
QRS complex: the right and left ventricular depolarization (normally the ventricles are
activated simultaneously)
ST-T wave: the ventricular repolarization
U wave: the origin of this wave is not clear - but probably represents "after-depolarization" in
the ventricles.
PR interval: the interval from the onset of the atrial depolarization (P wave) to the onset of the
ventricular depolarization (QRS complex)
QRS duration: the duration of the ventricular muscle depolarization
QT interval: the duration of the ventricular depolarization and repolarization
RR interval: the duration of the ventricular cardiac cycle (an indicator of the ventricular rate)
PP interval: the duration of the atrial cycle (an indicator of the atrial rate)
3.3 Lead
The 12-lead ECG provides spatial information about the heart's electrical activity in three
approximately orthogonal directions.
Right Left
Superior Inferior
Anterior Posterior

SE-3 Electrocardiograph Service Manual Operating Principle
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Each lead represents a particular orientation in space, as indicated below (RA = Right Arm, LA =
Left Arm, LL = Left Leg):
Bipolar limb leads (frontal plane):
Lead I: RA (-) to LA (+) (right left, or lateral)
Lead II: RA (-) to LL (+) (superior inferior)
Lead III: LA (-) to LL (+) (superior inferior)
Augmented unipolar limb leads (frontal plane):
Lead aVR: RA (+) to [LA & LL] (-) (rightward)
Lead aVL: LA (+) to [RA & LL] (-) (leftward)
Lead aVF: LL (+) to [RA & LA] (-) (inferior)
Unipolar (+) chest leads (horizontal plane):
Leads V1, V2, V3: (posterior anterior)
Leads V4, V5, V6: (right left, or lateral)
Figure 3-2 Standard Limb Leads
RA: Right arm
LA: Left arm
LL: Left leg
V1: Fourth intercostal space at the right border of the sternum
V2: Fourth intercostal space at the left border of the sternum
V3: Fifth rib between V2 and V4