01.54.19998 SE-1 Single Channel Electrocardiograph Service Manual-V1.2

EDAN INSTRUMENTS, INC.
SE-1
Electrocardiograph
Manual Ver: 1.2

Release Date: Mar. 2010
Part Number: 01.54.19998-12
P/N: 01.54.19998-12
Copyright
© Copyright EDAN INSTRUMENTS, INC. 2005-2010. 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.
Using This Label Guide
I
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.
Revision History
Date ECR# Version Description

2005/03 1.0 1st edition
Updated the power supply
2010/03 ECR-SE-9066 1.2 information of the main board,
modified battery specifications
II
Table of Contents
Chapter 1 Warranty and Service.......................................................................................................1
Chapter 2 Safety Guidance............................................................................................................4
2.1 List of Symbols.......................................................................................................................4

2.2 Safety Information..................................................................................................................5
2.3 Warnings and Cautions............................................................................................................6
2.3.1 Safety Warnings................................................................................................................7
2.3.2 Battery Care Warnings......................................................................................................8
2.3.3 General Cautions..............................................................................................................9
2.3.4 Cleaning and Disinfection Cautions...............................................................................10
Chapter 3 Operating Principle....................................................................................................11
3.1 Basic Theory of ECG Operation...........................................................................................11

3.2 Composition of ECG.............................................................................................................11
3.3 Lead.......................................................................................................................................12
3.4 Description of Hardware Design Principle...........................................................................14
3.4.1 Description of Signal Sample Module............................................................................16
3.4.2 Description of Main Control Part...................................................................................17
3.4.3 Description of Power Control Part.................................................................................18
Chapter 4 Functional Verification...............................................................................................19
4.1 System Tests..........................................................................................................................19

4.2 Application System Tests......................................................................................................19
4.3 Safety Tests...........................................................................................................................21
Chapter 5 Troubleshooting..........................................................................................................22
Chapter 6 Modules’ Malfunction Verification...........................................................................25
Chapter 7 Disassembling the Main Unit.....................................................................................27
7.1 Disassembly Steps.................................................................................................................27

7.2 Internal Boards and Interfaces..............................................................................................31
Chapter 8 Cleaning, Care and Maintenance..............................................................................35
8.1 Cleaning................................................................................................................................35
8.1.1 Cleaning the Main Unit and the Patient Cable...............................................................35
8.1.2 Cleaning the Reusable Electrodes..................................................................................35
8.1.3 Cleaning the Print Head..................................................................................................35
8.2 Disinfection...........................................................................................................................36
8.3 Care and Maintenance...........................................................................................................36
8.3.1 Recharge and Replacement of Battery...........................................................................36
III
8.3.2 Recorder Paper...............................................................................................................37
8.3.3 Maintenance of Main Unit, Patient Cable and Reusable Electrodes..............................38
Chapter 9 Renewal Parts.................................................................................................................40
IV
SE-1 Electrocardiograph Service Manual
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 original serial number label or 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
-1-
below:
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
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 end-user will return the defective parts to
EDAN on time. We will, at this option, dispatch the replacement one(s) with confirmed
shipping invoice.
NOTES:
(1) Both Return Material Authorization Form and Declaration Form are offered
by EDAN service department once the SCF is confirmed by service
engineer.
(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
-2-
instructions are included. The RMA number should be indicated on the outside of the
shipping container.
NOTE: EDAN should not have any obligation to the end-user or 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 hand.
 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: +86-755-26898321, 26899221
FAX: +86-755-26882223, 26898330
E-mail: support@edan.com.cn
-3-
Chapter 2 Safety Guidance

2.1 List of Symbols
External output
External input
Equipment or part of CF type with defibrillation proof
Caution
Consult Instructions for Use
Potential equalization
Mains supply
On (mains supply)
Off (mains supply)
Battery indicator
Battery recharging indicator
-4-
Recycle
Part Number
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.
It indicates that the device should be sent to the special

agencies according to local regulations for separate collection
after its useful life.
2.2 Safety Information
Standard:
IEC 60601-1: 1988+A1+A2, EN 60601-1:1990+A1+A2, IEC/EN60601-1-2: 2001+A1,

IEC/EN60601-2-25
-5-
Classification:
Anti-electric-shock type: Class І with internal power supply

Anti-electric-shock degree: Type CF
Degree of protection against harmful Ordinary equipment (Sealed equipment without
ingress of water: 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
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
25% ~ 93% 25% ~ 80%
Relative Humidity:
Non-Condensing Non-Condensing
Atmospheric
700hPa ~ 1060hPa 860hPa ~ 1060hPa
Pressure:
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.
Notes:
1. This device is not intended for home use.
2. The pictures and interfaces in this manual are for reference only.
-6-
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.
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.
12. Do not touch the patient, bed, table or the equipment while using the ECG
together with a defibrillator.
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
-7-
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.
17. The potential equalization conductor can be connected to that of other

equipment when necessary, to make sure that all these devices are connected
to the potential equalization bus bar of the electrical installation.
2.3.2 Battery Care Warnings
WARNING :
1. Improper operation may cause the 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.
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.
-8-
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.
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 circuit-
breaking characteristics.
d) Verify 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.
-9-
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 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.
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.
- 10 -
Chapter 3 Operating Principle
This chapter describes the basic theory and the internal circuit structure of SE-1 to let the service
provider understand the operating principle.
3.1 Basic Theory of ECG Operation
The heart is the 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 the y-axis indicates voltage. When the printing speed is 25mm/s and the sensitivity is
10mm/mV, one small grid on the x-axis represents 0.04s, and one small grid on the y-axis
represents 0.1mV.
This diagram illustrates ECG waves and intervals as well as standard time and voltage measures
on the ECG paper.
- 11 -
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
- 12 -
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
- 13 -
V2: Fourth intercostal space at the left border of the sternum

V3: Fifth rib between V2 and V4
V4: Fifth intercostal space on the left midclavicular line
V5: Left anterior axillary line at the horizontal level of V4
V6: Left midaxillary line at the horizontal level of V5
Figure 3-3 Standard Chest and Limb Leads
3.4 Description of Hardware Design Principle
The SE-1 electrocardiograph consists of the following functional blocks:

1) Key panel for user input;
2) Signal sample module including the signal acquisition, digital filter and amplifier;
3) MCU, peripheral module and RS232 communication ports;
4) Thermal printer module;
5) LCD display module;
6) Power supply module.
- 14 -
Figure 3-4 SE-1 Block Diagram
- 15 -
3.4.1 Description of Signal Sample Module
Figure 3-5 Block Diagram of the Signal Sample Module
This module is a sampling and processing module of single-channel ECG signal. It can amplify
and preprocess ECG signal in one channel, detect lead situations, and send data to MCU. This
module is connected to MCU through the SPI port.
The standard 12-lead electrocardiograph has 10 lead wires. 9 lead wires input ECG signals and
one right foot lead wire provides the float ground. The ECG signals pass through the defibrillator
protection circuit, the buffering circuit, and enter the difference amplifier circuit. Then they
continue to pass through the pacemaker pulse restraining, high-pass filter, low-pass filter, channel
switch, second level amplification, and gain control circuit.
Because the ECG system must meet the safety requirement of the photo-electricity isolation, the
serial signals will be sent to the photo-electricity component.
- 16 -
3.4.2 Description of Main Control Part

The main control part includes MCU and interface circuit.
The interface circuit consists of RS232 interface, USB interface, printer interface, LCD interface,
key panel interface, power interface, etc.
128K PS2 Port SPI to Applied RS232

External (Analog Part
RAM Input/Output)
Power
management,
RTC MCU
Charge, Control
Thermal Printer
192*64 12-Key Membrane
LCD Key Panel
Buzzer
Figure 3-6 Block Diagram of MCU Board Circuit
The system uses U25 as the control MCU. The peripheral equipment is connected to the MCU
ports. The MCU controls the peripheral equipment in several ways. U26 is a chip of power
voltage monitor and program watchdog. The system expands 128k external RAM (U18, U27,
U28). MCU can get system real time by RTC through port T, and an ECG wave is displayed on
the 192*64 dot LCD screen through port T too.
The thermal printer communicates with MCU through SPI. The printer control circuit includes
the thermal protecting circuit (U32B), paper detecting circuit (U32A), heat time control circuit
(U41) and motor driving circuit (U34).
The key panel circuit is made up of 12 membrane keys. It is connected to the main board with a
9-line electrical outlet which forms a 3*4 matrix key panel.
The LCD screen is a standard STN black and white screen, which is connected to the connecting
board of the upper and lower casings with a 20-pin flat socket.
The key panel wire, the LCD socket wire and the LED wire compose a 40-pin socket, which is
connected to the main board by a cable.
The analog input signal passes through a buffer circuit (U36B, U36A) firstly. Then it is sampled
by the MCU AD port. The analog output signal is realized by processing the PWM signal
generated by MCU with a low-pass filter (U40A).
- 17 -
3.4.3 Description of Power Control Part

The power supply voltage passes through the linear transformer and is transformed into 16.8V
AC voltage. This voltage passes through a full-bridge rectifier circuit (B11,C79, C80) and is
transformed into approximate 21V DC voltage. Then three DC/DC circuits convert it into 3-
channel voltages: +8V, +5V, and +11V.
The lithium battery charge circuit is made up of U52, Q6, and U51.
U56 is used as a power switch-off component.
Figure 3-7 Circuit Block Diagram of Power Supply
- 18 -
Chapter 4 Functional Verification

This chapter describes the procedures of a complete functional test to support recommended
preventive maintenance schedules.
The following functional tests should be performed at least every 24 months by a qualified person
who has adequate training, knowledge, and practical experience to perform these tests.
Functional verification does not require opening the shell.
WARNING : Only qualified service personnel should perform a full functional

checkout procedure.
Whenever the electrocardiograph is serviced or problems are suspected, the manufacturer
recommends a functional test.
4.1 System Tests
1. Unit Appearance and Assembly Examinations

1) Clean appearance, firm assembly, no remainder in the unit when it is shaken.
2) Keys feel good when pressed.
3) Labels are complete and correct.
4) Standard configuration is complete. Sockets are installed firmly.
5) The vibration test should be done before the following tests are performed.
2. Switching On the Electrocardiograph
After turned on, the electrocardiograph runs well and the LCD screen displays well.
4.2 Application System Tests
1. Equipment Requirements
Equipment Model
ECG simulator FLUKE MPS450
ECG detector NMI EGC-1C
2. LCD Screen Tests

Observe whether some characters are missing, or there are bright spots and dark shadows on the
LCD screen. Observe whether the waveforms, fonts and symbols displayed on the LCD screen
are normal.
- 19 -
3. Lead Off Tests

In the auto mode, when a lead wire is pulled out from or inserted into the ECG simulator in
sequence, the electrocardiograph will accurately identify the disconnection or the connection of
the corresponding lead.
4. Key Tests
Press every key on the key panel to test whether they work as described in the user manual.
5. System Setup Tests

Press the MEMU key to open the system setup interface. Set DEFAULT SETTING to
RESTORE. Then set the current examination time.
Turn off the electrocardiograph, and turn it on five seconds later. When the electrocardiograph is
ready for examination, observe whether the time displayed on the LCD screen is correct, and
open the system setup interface to see whether the items keep the default options. Then change
some items and exit. Turn off the electrocardiograph. Five seconds later, turn on the
electrocardiograph again. When the electrocardiograph is ready for examination, observe whether
the items keep the changed options.
6. Heart Rate Display Tests

Set the heart rate output from the ECG simulator to different values, and the error of heart rate
values displayed on the LCD screen of the electrocardiograph should be within ±1bpm.
7. Recording Tests
1) Set the following values:
The heart rate output from the ECG simulator is 80bpm, the working mode of the
electrocardiograph is auto, the speed is 25mm/s, FILTER SETTING is set to OFF, LOWPASS
FILTER is set to 150Hz, the other recording settings are restored to the default values. Install the
recorder paper and press the PRINT/STOP key to begin to print an ECG report. Examine
whether the printed contents are integrated and consistent with the information displayed on the
LCD screen.
2) Make the ECG detector output sine waves with the amplitude of 2mV and the frequency of
10Hz. Press the PRINT/STOP key to begin to print an ECG report. Examine whether the printed
contents are integrated and consistent with the information displayed on the LCD screen. The
amplitude of the ECG waveform of lead I should not be less than 20mm.
3) The ECG report includes the date and time, ID, name, sex, age, sensitivity, paper speed, filter,
lead, 1mV calibration mark, ECG waveform, heart rate etc. 1mV calibration marks and lead
names are printed before ECG waves in the ECG reports. The printed characters and waveforms
- 20 -
are clear.
4) Open the recorder casing and remove the recorder paper, and then the hint information
PAPER? should be displayed. Install the recorder paper again and close the recorder casing, and
then the hint information PAPER? should disappear.
4.3 Safety Tests
1) Test the protection earth resistance according to IEC/EN 60601-1: Limit: 0.1 ohm.
2) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500 μA, SFC 1000μA.
3) Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC 100μA, SFC
500μA.
4) 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.
5) Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC a.c. 10μA, d.c.
6) 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).
- 21 -
Chapter 5 Troubleshooting
WARNING : Replace parts, components, or accessories only with parts supplied or
approved by the manufacturer. The use of any other parts can lead to
inferior device performance and will void the product warranty.
This troubleshooting guide introduces the suitable actions for correcting the problems, replacing
the accessories or calling the service personnel. It can also help you describe the fault symptoms
more exactly when calling for service, which greatly makes the service fast and efficient.
1. Troubles of the Main Unit
Fault Symptoms Possible Causes Correction Action
① Fuse failure ① Replace the fuse

When the mains supply is ② Main board failure ② Replace the main board
used, you can not turn on the ③ Key panel failure ③ Replace the key panel
electrocardiograph. ④ Failure of the power ④ Replace the power connecting
connecting board board
When the battery is used, you ① Battery failure ① Replace the battery
can not turn on the ② Main board failure ② Replace the main board
electrocardiograph. ③ Key panel failure ③ Replace the key panel
① Strong interference of
the mains supply ① Inspect the power supply and
The electrocardiograph fails to ② Main board failure earthing system
function. ③ Power supply or the ② Replace the main board
plug-in unit on the main ③ Replace or repair plug-in unit
board failure
① Open the electrocardiograph
① The power supply or
Fuse is burned when you turn and check which board short-
other components short-
on the electrocardiograph. circuits. Replace the short
circuit.
circuited board
Fuse is burned when the device
① This component short-
connects to a certain ① Replace this component.
circuits.
component.
- 22 -
2. Display Troubles
Some characters displayed on

① LCD screen failure ① Replace the LCD screen
the LCD screen are missing.
① The brightness of the
① Adjust the variable resistor
main board is not adjusted
The LCD screen is dark. VR1 on the main board
well.
② Replace the LCD screen
② LCD screen failure
3. Operation Troubles
1 Key panel failure 1 Replace the key panel

Key failure
2 Main board failure 2 Replace the main board
No key beep or key beep is

① Buzzer failure ① Replace the buzzer
raucous
① The recorder paper runs
① Install the recorder paper
out.
② Replace the print head
The electrocardiograph can ② Print head failure
③ Replace the main board
not print reports. ③ Main board failure
④ Replace or repair the
④ Recorder connection
recorder connection cord
cable failure
① Dirty print head ① Clean the print head
The printed report is illegible
② Print head failure. ② Replace the print head
Some characters or
① The print head is dirty. ① Clean the print head
waveforms printed are
② Print head failure ② Replace the print head
missing.
① There is a stain on the
detecting position of the ① Clean the print head
Fail to detect paper print head. ② Replace the print head
② Print head failure ③ Replace the main board
③ Main board failure
- 23 -
4. Parameter Troubles
① Reconnect the electrode

① The electrode is not
again or clean the electrode
connected well.
area on body surface with
② Defective connection
No ECG waveform alcohol
between the patient cable
② Reconnect the patient cable
and the unit
to the unit
③ Main board failure
① The electrode is not again or clean the electrode
ECG waveform is abnormal connected well. area on body surface with
or disturbed. ② Patient cable failure alcohol
③ Main board failure ② Replace the patient cable
① Waveform measuring ① Reconnect the patient cable
Heart rate is not accurate.
failure to the unit
① The electrode is not again or clean the electrode
ECG waveform has burrs. connected well. area on body surface with
② Main board failure alcohol
② Replace the main board
- 24 -
Chapter 6 Modules’ Malfunction Verification

When a module is suspected of malfunction, the verification methods are described in this
chapter.
To verify the main board,
1) Open the main unit following the procedures described in Chapter 7, “Disassembling the
Main Unit”.
2) Switch on the device.
3) Measure the voltage to earth of the test points listed below by using a multimeter.
Note: The voltages of test points ②~⑤ are based on test point ① (GND). The voltages of
test points ⑦~⑩ are based on test point ⑥ (FGND).
Item Test point Reference result
① TP17 GND
② TPVCC +5V±0.25V
③ TPV11 +11V±0.5 V
④ TPV5 +5V±0.25V
⑤ TPV8 +8V±0.5V
⑥ TP16 FGND
⑦ TP11 +5V±0.25V
⑧ TP9 -5V±0.25V
⑨ TP10 +9.5V±0.5V
⑩ TP8 -9.5V±0.5V
- 25 -
⑦TP11 ⑧TP9 ⑨TP10
⑩TP8 ⑥TP16 ①TP17 ②TPVCC ③TPV11 ④TPV5 ⑤TPV8
4) Compare the measurement results with the reference results in the list. If any one of the
results exceeds the reference range, the main board defection is confirmed. Replacement of
the main board is recommended.
- 26 -
Chapter 7 Disassembling the Main Unit
7.1 Disassembly Steps
1. Main Unit
2. Disassembly Steps of the Main Unit
Remove the crosshead screws ① (M3×10) on the bottom of the electrocardiograph. Open the
recorder casing. Open the upper unit ③ and remove the c ables between the upper and lower
units, and then separate the upper unit from the lower unit. In the following pictures, ② is the
lower unit, ④ is the recorder casing.
- 27 -
There are two fuses of the same specifications installed on the bottom of the main unit. The
specifications are shown on the fuse label: AC220V-240V: T200mA; AC100V-115V: T400mA;
Φ5×20.
WARNING : Ruptured fuses must only be replaced with those of the same type
and rating as the original.
3. Disassembly Steps of the Upper Unit

The upper unit of the electrocardiograph includes the lower casing of the displaying box, key
panel, LCD screen, rotation base etc.
The disassembly steps:
Remove the cables among the LCD screen ⑩, key panel ⑨ and connecting board of the upper
and lower casings ②. → Remove the five crosshead panhead screws ① (M3×6), and dismantle
the connecting board ② → Remove the four crosshead panhead screws ⑤ (M3×8), and
dismantle the upper casing of the displaying box to show the LCD screen ⑩ and rotation base ④
fixed on the lower casing of the displaying box. → Remove the screws used to fix the LCD
screen and dismantle the LCD screen. → Remove the two crosshead sunk screws ⑧ (M3×20) to
dismantle the lower casing of the displaying box ⑥ → Remove the four crosshead sunk screws
⑦ (M3×6) to dismantle the rotation base ④.
The label and key panel ⑨ are stuck to the upper unit ③, and can be torn off.
- 28 -
Note: You should take care not to damage the LCD screen when disassembling the
upper unit.
4. Disassembly Steps of the Lower Unit
Remove the cables between two parts before disassembly. Remove the screws on the main board
⑨ and dismantle the board. → Remove the power connecting board ⑧ which is embedded in the
groove of the lower unit. → Remove the two crosshead panhead screws ⑥ (M2×6) and dismantle
the print head ⑦. → Remove the four crosshead sunk screws ⑤ (M3×6) and dismantle the print
bracket ④. → Remove crosshead panhead screws ③ (M3×8) and dismantle the transformer ②.
① is the lower casing of SE-1.
- 29 -
- 30 -
7.2 Internal Boards and Interfaces
1. Main Board
① J7 -- connected to the transformer
Pin Description
1, 2 16.8V AC INPUT
- 31 -
② J5 -- connected to the printer
Pin Description
6, 7, 25, 26 +8V
2, 15 +5V
4, 5, 24 NC
10, 11, 17, 21, 22 GND
27, 28, 29, 30 Motor driving signal
Others Signal port of the thermal print head
③ J12 -- connected to BP3 of the connecting board of the upper and lower casings
Pin Description
4, 40 +5V
3, 22, 27, 34, 35 GND
5~21 LCD control signal
25, 26, 28~33 Key panel signal
36~39 LED indicator signal
others NC
- 32 -
④ J8 -- connected to the lithium battery
Pin Description
1 Battery supply
2 Battery detecting
3 GND
2. Connecting Board of the Upper and Lower Casings
- 33 -
①BP1 ②BP2 ③BP3

① BP1-- connected to the LCD display
Pin Description
2 +5V
1, 20 GND
② BP2 -- connected to the key panel
Pin Description
1 ON/OFF
2 GND
others Key panel array signal
③ BP3 -- connected to J12 of the main board
Pin Description
4, 40 +5V
3, 22, 27, 34, 35 GND
25, 26, 28~33 Key panel signal
36~39 LED indicator signal
others NC
- 34 -
Chapter 8 Cleaning, Care and Maintenance
This chapter describes common maintenance of SE-1. These procedures are intended to maintain
the quality of SE-1.
8.1 Cleaning
CAUTION :
Turn off the power before cleaning and disinfection. The mains supply must be
switched off if it is used.
8.1.1 Cleaning the Main Unit and the Patient Cable
The surfaces of the main unit and the patient cable can be wiped with a clean soft cloth
damped in soapy water or non-caustic neutral detergent. After that, remove detergent
remainder with a clean dry cloth.
8.1.2 Cleaning the Reusable Electrodes

Remove the remainder gel from the electrodes with a clean soft cloth first. Take suction
bulbs and metal cups of chest electrodes apart, and take clamps and metal parts of limb
electrodes apart. Clean them in warm water and make sure that there is no remainder gel.
Dry the electrodes with a clean dry cloth or air dry naturally.
8.1.3 Cleaning the Print Head
Dirty and soiled thermal print head will deteriorate the printing definition. So it should be
cleaned at least once a month regularly.
Open the recorder casing and remove the paper. Wipe the print head gently with a clean soft
cloth damped in 75% alcohol. For stubborn stains, soak them with a little alcohol first and
wipe them off with a clean soft cloth. After air dries, load the recorder paper and shut the
recorder casing.
- 35 -
CAUTION :
1. Prevent the detergent from seeping into the main unit while cleaning. Do not
immerse the unit or the patient cable into liquid under any circumstances.
2. Do not clean the unit and accessories with abrasive fabric and avoid scratching
the electrodes.
8.2 Disinfection
To avoid permanent damage to the equipment, disinfection can be performed only when it is
considered as necessary according to your hospital’s regulations.
Before disinfection, clean the equipment first. Then wipe the surfaces of the unit and the
patient cable with hospital standard disinfectant.
CAUTION :
Do not use chloric disinfectant such as chloride, sodium hypochlorite etc.
8.3 Care and Maintenance
8.3.1 Recharge and Replacement of Battery
1) Capacity Identification
The current capacity of the rechargeable battery can be identified according to the battery
symbol in the last row of the LCD screen.
: Capacity is full
: Capacity is not full but enough
: Capacity is limited, and recharge should be taken into account.
: Capacity is low, and the hint BATTERY WEAK will be displayed on the LCD screen.
The battery should be recharged immediately.
2) Recharge
SE-1 is equipped with recharge control circuit together with the built-in rechargeable lithium
- 36 -
battery. When the unit is connected to the mains supply, the battery will be recharged
automatically. Then the battery recharging indicator ( ) and the mains supply indicator (
) will be lit at the same time. During the recharging course, the symbol flashes in the
last row of the LCD screen. When the battery capacity is full, the symbol stops flashing,
and the battery recharging indicator lamp ( ) is black. When SE-1 is turned off, the
battery recharging indicator lamp ( ) is still lit because the equipment can not monitor
the recharge status, so you need to turn on the device to verify the recharge status.
Because of the capacity consumption during the storage and transport course, the battery
capacity is not full when it is used for the first time. Battery recharge should be considered
before the first use. If you do not use the equipment for a long time, please take out the
battery, and charge it once every three months.
3) Replacement
When the useful life of the battery is over, or foul smell and leakage are found, please
contact the manufacturer or the local distributor for replacement.
WARNING :
1. 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 must be used.
2. Danger of explosion -- Do not reverse the anode and the cathode when
installing the battery.
3. When the battery’s useful life is over, contact the manufacturer or the local
distributor for disposal or dispose of the battery according to local regulations.
8.3.2 Recorder Paper
Note: The recorder paper provided by the manufacturer should be used. Other paper
may shorten the life of the thermal print head. The deteriorated print head may
lead to illegible ECG reports and block the advance of the paper.
Storage Requirements:
♦ Recorder paper should be stored in a dry, dark and cool area, avoiding excessive
temperature, humidity and sunshine.
♦ Do not put the recorder paper under fluorescence for a long time.
- 37 -
♦ Make sure that there is no polyvinyl chloride or other chemicals in the storage
environment, which will lead to color change of the paper.
♦ Do not overlap the recorder paper for a long time, or else the ECG reports may trans-
print each other.
8.3.3 Maintenance of Main Unit, Patient Cable and Reusable
Electrodes
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.
 Inspect the equipment and accessories for mechanical and functional damage.
 Inspect the safety related labels for legibility.
 Inspect the fuse to verify compliance with the rated current and circuit-breaking
characteristics.
 Verify that the device functions properly as described in the instructions for use.
 Test the protection earth resistance according to IEC/EN 60601-1: Limit: 0.1 ohm.
 Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500μA, SFC
1000μA.
 Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC 100μA, SFC
500μA.
 Test the patient leakage current according to IEC/EN 60601-1: Limit: NC a.c. 10μA, d.c.
 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.
 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 leakage current should never exceed the limit. The data should be recorded in an
- 38 -
equipment log. If the device is not functioning properly or fails any of the above tests, the
device has to be repaired.
WARNING : Failure on the part of the responsible individual hospital or

institution employing this equipment to implement a satisfactory maintenance
schedule may cause undue equipment failures and possible health hazards.
1) Main Unit
♦ Avoid excessive temperature, sunshine, humidity and dirt.
♦ Put the dustproof coat on the main unit after use and prevent shaking it violently when
moving it to another place.
♦ Prevent any liquid from seeping into the equipment; otherwise the safety and the
performance of the electrocardiograph can not be guaranteed.
2) Patient Cable
♦ Integrity of the patient cable, including the main cable and lead wires, should be
checked regularly. Make sure that it is conductible.
♦ Do not drag or twist the patient cable with excessive stress while using it. Hold the
connector plug instead of the cable when connecting or disconnecting the patient cable.
♦ Align the patient cable to avoid twisting, knotting or crooking at a closed angle while
using it.
♦ Store the lead wires in a big wheel to prevent any people from stumbling.
♦ Once damage or aging of the patient cable is found, replace it with a new one
immediately.
3) Reusable Electrodes
♦ Electrodes must be cleansed after use and make sure there is no remainder gel on them.
♦ Keep suction bulbs of chest electrodes away from sunshine and excessive temperature.
♦ After long-term use, the surfaces of electrodes will be oxidized because of erosion and
other causes. By this time, electrodes should be replaced to achieve high-quality ECG
records.
CAUTION :
- 39 -
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.
- 40 -
Chapter 9 Renewal Parts
The following list is intended as a guide for ordering parts of SE-1.
Part Number Description
01.57.040163 European style chest electrode
01.57.040162 European style limb electrode
01.57.107402 European style patient cable

01.57.110375 American style patient cable
02.02.20462 Power connecting board PCBA
02.02.20463 LCD connecting board PCBA
02.02.20464 Connecting board of the upper and lower casings PCBA
01.16.078175 LCD screen/192×64
01.55.111451 SE-1 membrane key panel
02.02.31818-01 SE-1 main board (without firmware loaded)
01.21.064114 Lithium battery pack
01.17.078173 Thermal print head
- 41 -
EDAN INSTRUMENTS, INC.
3/F - B, Nanshan Medical Equipment Park, Nanhai Rd 1019#, Shekou, Nanshan
Shenzhen, 518067 P.R. China
TEL: +86-755-2689 8326 FAX: +86-755-2689 8330
Email: info@edan.com.cn
EC REPRESENTATIVE
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, D-20537 Hamburg Germany
TEL: +49-40-2513175 FAX: +49-40-255726
E-mail: antonjin@yahoo.com.cn

01.54.19998 SE-1 Single Channel Electrocardiograph Service Manual-V1.2

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

01.54.19998 SE-1 Single Channel Electrocardiograph Service Manual-V1.2

Uploaded by

Copyright:

Available Formats

EDAN INSTRUMENTS, INC.

Manual Ver: 1.2

Responsibility of the Manufacturer

Using This Label Guide

NOTE: A NOTE provides useful information regarding a function or a procedure.

Date ECR# Version Description

Chapter 1 Warranty and Service.......................................................................................................1

Chapter 2 Safety Guidance............................................................................................................4

2.1 List of Symbols.......................................................................................................................4

Chapter 3 Operating Principle....................................................................................................11

3.1 Basic Theory of ECG Operation...........................................................................................11

Chapter 4 Functional Verification...............................................................................................19

4.1 System Tests..........................................................................................................................19

Chapter 6 Modules’ Malfunction Verification...........................................................................25

Chapter 7 Disassembling the Main Unit.....................................................................................27

7.1 Disassembly Steps.................................................................................................................27

Chapter 8 Cleaning, Care and Maintenance..............................................................................35

Chapter 9 Renewal Parts.................................................................................................................40

Chapter 1 Warranty and Service

 Groupware is dismounted, stretched or redebugged.

(1) Fill in the Service Claim Form (SCF).

(2) Send EDAN the SCF and Select a Solution.

There are two options:

(3) Obtain the RMA Form.

(4) Send the Parts to EDAN.

Follow these recommended instructions:

 Please pack the parts safely before return.

 Please put the RMA number on the parcel.

 Please confirm the invoice with Edan before shipment.

 Please send back the parts after Edan’s confirmation.

EDAN Instruments, Inc.

TEL: +86-755-26898321, 26899221

FAX: +86-755-26882223, 26898330

Chapter 2 Safety Guidance

Equipment or part of CF type with defibrillation proof

Consult Instructions for Use

Off (mains supply)

Battery recharging indicator

Authorized Representative in the European Community

The symbol indicates that the device complies with the

It indicates that the device should be sent to the special

2.2 Safety Information

IEC 60601-1: 1988+A1+A2, EN 60601-1:1990+A1+A2, IEC/EN60601-1-2: 2001+A1,

Anti-electric-shock type: Class І with internal power supply

Disinfection/sterilization method: Refer to the user manual for details

Working mode: Continuous operation

Transport & Storage Working

2.3 Warnings and Cautions

1. This device is not intended for home use.

2.3.1 Safety Warnings

4. This device is not intended for treatment.

5. EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of

6. SHOCK HAZARD - The power receptacle must be a hospital grade grounded

7. If the integrity of the external protective conductor is in doubt, the equipment

11. Electrodes with defibrillator protection should be used during defibrillation.

use of disposable electrodes at all times.

17. The potential equalization conductor can be connected to that of other

2.3.2 Battery Care Warnings

4. Do not heat or splash the battery or throw it into fire or water.

2.3.3 General Cautions

3. Make sure that there is no intense electromagnetic interference source around

5. The following safety checks should be performed at least every 24 months by

i) Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC