Service Manual EKG EDAN SE-3 PDF

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. Users 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.
I
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.
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.................................................................................................................. 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
III
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
IV
SE-3 Electrocardiograph Service Manual Warranty and Service
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 customers warranty claim hereunder, EDAN will either repair, adjust or
replace (with new or exchange replacement parts) EDANs 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 EDANs service
department.
(2) Send EDAN the SCF and Select a Solution.
Once the service department receives the fully filled SCF, EDANs engineer will offer a
solution in three working days. EDAN will follow out the case based on the two conditions
below:
-1-
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.
-2-
NOTE: EDAN should not have any obligation to the end-user or the customer
who returns the goods without the notification by EDANs 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 Edans 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-
SE-3 Electrocardiograph Service Manual Safety Guidance
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
-4-
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
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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.
Federal (U.S.) law restricts this device to sale by or on the

Rx only (U.S.)
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 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
-6-
presence of flammable gas: of flammable gas
Working mode: Continuous operation

EMC: Group , Class A
Environment:
Transport & Storage Working

Temperature: -20 C ~ +55 C 5 C ~ 40 C
25% ~ 93% 25% ~ 80%

Relative Humidity:
Non-Condensing Non-Condensing
Atmospheric
700hPa ~ 1060hPa 860hPa ~ 1060hPa
Pressure:
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 520 / T200mA 250V 520
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.
-7-
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.
-8-
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.
-9-
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 C and 40 C during operation, and it should be kept between -20 C and
55 C 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.
- 10 -
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 A,
SFC 1000A.
g) Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC

100A, SFC 500A.
h) Test the patient leakage current according to IEC/EN 60601-1: Limit: NC a.c.
10A, d.c. 10A; SFC a.c. 50A, d.c. 50A.
i) Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC a.c.
10A, d.c. 10A; SFC a.c. 50A, d.c. 50A.
j) Test the patient leakage current under single fault condition with mains voltage on
the applied part according to IEC/EN 60601-1: Limit: 50A (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.
- 11 -
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.
- 12 -
SE-3 Electrocardiograph Service Manual Operating Principle
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.
- 13 -
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
- 14 -
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
- 15 -
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 Chest Electrode of the Standard Limb Leads
3.4 Description of Hardware Design Principle
SE-3 consists of the following functional blocks:

1) Key panel for user input;
2) Front end module including the signal acquisition, digital filter and amplifier;
3) Main board: ARM9 and peripheral module;
4) Thermal printer module;
5) LCD display module;
6) Power supply module.
- 16 -
Figure 3-4 SE-3 Block Diagram
- 17 -
3.4.1 ECG Board Description
Figure 3-5 Block Diagram of the ECG Board Circuit
This module is a sampling and processing module of 12-channel ECG signals. It can amplify and
preprocess ECG signals in every channel, detect lead situations, and send data to ARM9 MCU.
This module is connected to ARM9 MCU through the UART port.
The electrocardiograph has 10 lead cables. Nine lead cables input ECG signals and one right foot
lead cable provides the float ground. The ECG signals pass through the defibrillator protection
circuit, the buffering circuit (U1~U3), 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 enter the A/D sampling port.
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.
- 18 -
3.4.2 Description of Main Control Part

The main control part is SE-3 main board, which is divided into two parts (the ARM9 circuit and
the interface circuit).
The ARM9 circuit consists of MCU S3C2410, SDRAM, NAND FLASH, NOR FLASH, LAN
controller, CPLD etc. The main frequency is 203MHz.
The interface circuit consists of the RS232 interface, LAN interface, USB interface, printer
interface, LCD interface, key panel interface etc. It also provides power supply to the device.
Figure 3-6 Block Diagram of the ARM9 Circuit

The system uses ARM9 (S3C2410) (U1) as the control MCU, and the peripheral equipment is
connected to the MCU ports. The MCU controls the peripheral equipment in several kinds of
ways. The system expands 64M external SDRAM (U10, U11), 8M NOR FLASH (U12, U13),
64M FLASH (U3), LAN Controller (U15) and CPLD (U14).
The interface circuit integrates all sockets for USB, Ethernet, input/output, RS232 and thermal
printer. The main control circuits include the paper detection circuit (U25), the motor driving
circuit (U22, U23, U56) and the heat time control circuit (U14, the CPLD). The external analog
input is connected to MCU by U28.
The thermal recorder has the step motor and the transmission frame of its own. The paper
detection is carried out by using a photoelectric diode.
The key panel uses membrane keys, and the key panel control component uses 34 matrixes.
There are 12 keys in total.
SE-3 (19264 LCD screen) adopts 8 bit bus interface. The main board uses 8 GPIO to simulate 8
bit buses to control the reading and writing of the LCD screen.
SE-3 (320240 LCD screen) adopts the standard FSTN interface. Because ARM9 has the FSTN
interface of its own, it can be driven directly after connected.
- 19 -
3.4.3 Description of Power Control Part
The AC voltage passes the linear transformer and is transformed into 20V AC voltage. One part is
provided to charge the battery, and the other part passes DC/DC to provide +8V for the thermal
print head, +5V for the electric machine, and +5V for the main board and the ECG board.
Figure 3-7 Block Diagram of the Power Supply Module Circuit
- 20 -
SE-3 Electrocardiograph Service Manual Functional Verification
Chapter 4 Functional Verification

This chapter describes the procedure of a complete functional test to support recommended
preventive maintenance schedules.
Functional verification does not require opening the device case.
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 Requirement
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.
- 21 -
3. Lead Off Tests

In the AUTO mode, when the lead cables are 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 cable.
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 the current time,
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 the 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 printing mode of the
electrocardiograph is set to AUTO, the speed is set to 25mm/s, AC FILTER and EMG FILTER
are set to off, LOWPASS FILTER is set to 150Hz and all the options on the record setting
interface are on. Install the recorder paper and press the PRINT/STOP key to begin to print ECG
reports. 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 ECG reports. 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 be 20mm.
3) The ECG report includes date and time, ID, name, sex, age, sensitivity, paper speed, filter, lead,
1mV calibration mark, ECG waveform, heart rate etc. 1mV calibration mark and lead names are
printed before ECG waves in the ECG reports. The printed characters and waveforms 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.
- 22 -
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 A, SFC 1000A.
3) Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC 100A, SFC
500A.
4) Test the patient leakage current according to IEC/EN 60601-1: Limit: NC a.c. 10A, d.c. 10A;
SFC a.c. 50A, d.c. 50A.
5) Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC a.c. 10A, d.c.
10A; SFC a.c. 50A, d.c. 50A.
6) Test the patient leakage current under single fault condition with mains voltage on the applied
part according to IEC/EN 60601-1: Limit: 50A (CF).
- 23 -
SE-3 Electrocardiograph Service Manual Modules Malfunction Verification
Chapter 5 Modules Malfunction Verification

When a module is suspected of malfunction, the verification methods are described in this
chapter.
5.1 Verifying the Main Board
To verify the main board,
1) Open the main unit following the procedures described in Section 6.1, Disassembly Steps.
2) Switch on the device.
3) Measure the voltage to earth of the test points listed below by using a multimeter.
Item Test point Reference result
T3 18V~24V
T5 +5V0.25V
T7 +5V0.25V
T2 18V~24V
T6 +5V0.25V
T4 +8V0.5V
- 24 -
T3 T5 T7
T2 T6 T4
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.
5.2 Verifying the ECG Board
To verify the ECG board,
1) Make sure that the malfunction of ECG measurement is not caused by other defects, such as
defective connection, inoperative electrodes or main board, etc.
2) Open the main unit following the procedures described in Section 6.1, Disassembly Steps.
- 25 -
3) Switch on the device.
4) Measure the voltage to earth of the test points listed below by using a multimeter.
Item Test Point Reference Result
-VCC -7.5V
+VCC 7.5V
+5V 5.0V0.15V
+3.3V 3.3V0.1V
GND 0V
+2.5V 2.5V0.05V
-VCC +VCC +2.5V
+5V
+3.3V
GND
5) Compare the measurement results with the reference results in the list. If any one of the results
exceeds the reference range, the ECG board defection is confirmed. Replacement of the ECG
board is recommended.
- 26 -
SE-3 Electrocardiograph Service Manual Electrocardiograph Servicing
Chapter 6 Electrocardiograph Servicing

This chapter describes the electrocardiograph servicing, including disassembly steps, internal
boards and troubleshooting.
6.1 Disassembly Steps
1. Main Unit
2. Disassembly Steps of the Main Unit
Remove the crosshead screws (M310) on the bottom of the electrocardiograph. Open the
upper unit and remove the cables between the upper and lower units, and then separate the
upper unit from the lower unit. In the following pictures, is the lower unit, 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;
520.
WARNING
Ruptured fuses must only be replaced with those of the same type and rating as the
original.
- 28 -
Figure 6-1 Lower Unit
3. Disassembly Steps of the Upper Unit (19264 Dot Single Color LCD Screen)
Note: You should take care not to damage the LCD screen when disassembling it.
The upper unit of the electrocardiograph (19264 dot single color LCD screen) includes the
lower casing of the displaying box, filmy switch panel, LCD screen, rotation base etc.
The disassembly steps:
Remove the cables among the LCD screen , key panel and transfer board . Remove
the five crosshead panhead screws (M36), and dismantle the transfer board Remove
the four crosshead panhead screws (M38), and dismantle the upper casing of the displaying
box to show the LCD screen and the rotation base 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 (M320) to dismantle the lower casing of the
displaying box Remove the four crosshead sunk screws (M36) to dismantle the
rotation base .
The label and the key panel are stuck to the upper unit , and can be torn off.
- 29 -
4. Disassembly Steps of the Upper Unit (320240 Dot Single Color LCD Screen)
Note: You should take care not to damage the LCD screen when disassembling it.
The LCD screen (320240 dot single color LCD screen) is embedded in the upper casing of the
displaying box, while the LCD screen (19264 dot single color LCD screen) is fixed in the lower
casing of the displaying box by using screws.
The following picture shows: crosshead panhead screws M36, the transfer board, the
upper unit, the rotation base, crosshead panhead screws M38, the lower casing of the
displaying box, crosshead sunk screws M36, crosshead sunk screws M320, the LCD
screen, the filmy switch panel, the upper casing of the displaying box, the label,
the protection screen.
- 30 -
5. Disassembly Steps of the Lower Unit
Remove the cables between two parts before disassembly. Remove the screws on the ECG board
and dismantle the ECG board. Remove the main board which is embedded in the groove of
the lower unit. Remove the two crosshead panhead screws (M26) and dismantle the print
head . Remove the four crosshead sunk screws (M36) and dismantle the print bracket .
Remove crosshead panhead screws (M38) and dismantle the transformer . is the power
transition board.
- 31 -
- 32 -
Remove the screws on the main board.
- 33 -
Net Chip
(Optional)
6.2 Internal Boards and Interfaces
1. ECG Board -- Receiving and Processing ECG Signals
- 34 -
P2-- Socket connected to the main board
Pin Description Pin Description
1 Digital signal (output) 2 GND
3 RxD (input) 4 TxD (output)
5 +5V
- 35 -
2. SE-3 Main Board -- Integrating Power Supply, Input/Output Interfaces and ARM9
Circuit
- 36 -
J7-- connected to the transformer.
Pin Description
1, 2 16.8V AC INPUT
J8 -- connected to the printer
Pin Description
6, 7, 25, 26 +8V
2 +5V
15 +3.3V
24 N.C
5, 10, 11, 19, 20, 21, 22 GND
27, 28, 29, 30 Motor driving signal
Others Signal port of thermal print head
J9 -- connected to BP3 of the connecting board (Only for the ECG with narrow screen)
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 indication signal
Others N.C
J10 -- connected to BP3 of the connecting board (Only for the ECG with wide screen)
Pin Description
1 ~ 9, 13, 14 LCD control signal
11, 21, 27, 34, 35 GND
- 37 -
10, 40 +3.3V
20 LCD backlight
Others N.C
J15 -- connected to J2 of the ECG-12 board/J4 of the DE12 board
Pin Description
1 Enable
2 GND
3, 4 UART Signal
5 +5V
- 38 -
J11 -- connected to the Li-ion Battery
Pin Description
1 Battery supply
2 Battery detecting
3 GND
- 39 -
3. ARM9 Circuit -- LCD display control, data process, ECG analysis
4. Connecting Board
P1 BP2 BP3
BP1 -- connected to the LCD display
Pin Description
2 +5V
1, 20 GND
3~19 LCD control signal
- 40 -
BP2-- connected to key panel
Pin Description
1 ON/OFF
2 GND
Others Key panel array signal
BP3-- connected to J9 of the main board (Only for the ECG with narrow screen)
Pin Description
4, 40 +5V
3, 22, 27, 34, 35 GND
5 ~ 21 LCD control signal
36 ~ 39 LED indication signal
Others N.C
BP3-- connected to J10 of the main board (Only for the ECG with wide screen)
Pin Description
1 ~ 9, 13, 14 LCD control signal
11, 21, 27, 34, 35 GND
10, 40 +3.3V
20 LCD Backlight
Others N.C
- 41 -
6.3 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 section describes some of the most common symptoms and provides possible causes and
solutions to help you solve potential problems.
When you encounter a problem, address the issue in the following order:
1. Review the troubleshooting section to see whether your issue is addressed.
2. Contact your local distributor.
3. Contact EDAN service department.
EDAN service department can assist with product troubleshooting and provide technical
expertise to help with any issues with SE-3.
The troubleshooting section is for service engineers reference.

1. Troubles of the Main Unit
Fault Symptoms Possible Causes Correction Actions
Fuse failure Change the fuse

Main board failure Change the main board
Key panel failure Change the key panel
When the mains supply is
Transformer failure Change the transformer
used, you can not turn on the
Power transition board Change the power transition
electrocardiograph.
failure board
Faulty mains supply Change the mains supply
shift switch shift switch
When the battery is used, you Battery failure Change the battery
can not turn on the Main board failure Change the main board
electrocardiograph. Key panel failure Change the key panel
Strong interference of Inspect the power supply and
electric networks earthing system
The electrocardiograph fails to
function.
Faulty power supply of Change or repair the power
the ARM9 circuit supply
- 42 -
The power supply or

Fuse is burned when you turn Open the electrocardiograph
other components
on the electrocardiograph. for further examination
short-circuit.
The set mains supply
Set the mains supply shift
shift switch does not
switch according to local mains
accord with local mains
Fuse is burned when it is supply specifications
supply specifications.
connected to the voltage Change the rectifier
Rectifier failure
network. Change the transformer
Transformer failure
Change the power transition
Power transition board
board
failure
2. Display Troubles
LCD screen failure

Faulty connecting wire
Change the LCD screen
of the upper and lower
Change the connecting wire
Some characters displayed on units
Change the transition board
the LCD screen are missing or Faulty transition board
of the upper and lower units
mistaken. of the upper and lower
Change the transition board
units
of the narrow screen
Faulty transition board
of the narrow screen
The brightness of the Adjust the adjustable
main board is not adjusted transformer VR1 on the main
The LCD screen is dark. well. board
LCD screen failure Change the LCD screen
LCD screen failure Change the LCD screen
After you turn on the machine,
Transition board failure Change the transition board
the LCD screen is white.
Program running failure Reload the program
- 43 -
3. Transmission Troubles
Setup and connection

Reset and reconnect the
Fail to transmit ECG data error
device
through the net port or the Connection cable
Change the connection cable
serial port failure
Change the net port
Net port failure
Fail to copy data between the The ECG system does Only the U disk in FAT
electrocardiograph and the U not support the U disk type format can be used
disk USB socket failure Change the USB socket
4. Operation Troubles
The key panel is

damaged Change the key panel
Key failure
Faulty transition board Change the transition board
of the upper and lower of the upper and lower units
units
Buzzer failure
Change the buzzer
KEY BEEP is set to
No key beep Set KEY BEEP to On
Off
Change the main board
Main board failure
Key beep is raucous Buzzer failure Change the buzzer
The recorder paper

Install the recorder paper
The electrocardiograph can runs out.
Change the print head
not print reports Print head failure
Change the main board
Main board failure
The paper roller or the Clean the paper roller or the

print head is dirty. print head
The printed report is illegible
Print head failure Change the print head
- 44 -
Some characters or
The print head is dirty. Clean the print head
waveforms recorded are
Print head failure Change the print head
missing.
There is a stain on the
detecting position of the Clean the print head
Fail to detect paper print head. Change the print head
Print head failure Change the main board
Main board failure
5. Parameter Troubles
Reconnect the electrode

The electrode clamp is
clamp again or clean the
not connected well.
electrode area on body surface
Defective connection
No ECG waveform with alcohol
between the patient cable
Reconnect the patient cable
and the unit
to the unit
ECG board failure
Change the ECG board
The electrode clamp is clamp again or clean the
ECG waveform is abnormal not connected well. electrode area on body surface
or disturbed Patient cable failure with alcohol
ECG board failure Change the patient cable
Waveform measuring
Heart rate is not accurate Adjust connections
failure
The electrode clamp is clamp again or clean the
ECG waveform has burrs not connected well. electrode area on body surface
ECG board failure with alcohol
- 45 -
SE-3 Electrocardiograph Service Manual Cleaning, Care and Maintenance
Chapter 7 Cleaning, Care and Maintenance
7.1 Cleaning
CAUTION
Turn off the power before cleaning and disinfection. The mains supply must be switched
off if it is in use.
7.1.1 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.
7.1.2 Cleaning the 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 there is no remainder gel. Dry the electrodes with a
clean dry cloth or air dry naturally.
7.1.3 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 recorder paper. Wipe the print head gently with a clean
soft cloth damped in 75% alcohol. For stubborn stain, soak it with a little alcohol first and wipe it
off with a clean soft cloth. After air dries, load the recorder paper and shut the recorder casing.
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.
- 46 -
7.2 Disinfection
To avoid permanent damage to the equipment, disinfection can be performed only when it is
considered as necessary according to your hospitals 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.
7.3 Care and Maintenance
7.3.1 Recharge and Replacement of Battery
1) Capacity Identification
The battery capacity of the rechargeable battery can be identified according to the battery
symbol in the top right corner of the LCD screen.
: Full capacity
: Capacity is limited, and recharge should be taken into account.

: Capacity is low, and hint information BAT WEAK will be displayed on the LCD screen.
The battery should be recharged immediately.
2) Recharge
SE-3 is equipped with the recharge control circuit together with the built-in rechargeable
lithium battery. When the unit is connected to the mains supply, the battery will be recharged
automatically. Then the battery recharging indicator lamp ( ) and the mains supply
indicator lamp ( ) will be lit at the same time. During the recharging course, the symbol
flashes in the top right corner of the LCD screen. When the battery capacity is full, the
symbol stops flashing, and the battery recharging indicator lamp ( ) is black. The
3-channel electrocardiograph can not be recharged when it is printing reports, and the
battery recharging indicator is black; when the 3-channel electrocardiograph is switched off,
the battery recharging indicator lamp ( ) will be black if the battery is fully recharged.
- 47 -
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.
Note: If the battery has not been used for more than two months, it should be
recharged before use.
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. Remove the battery from the electrocardiograph when the electrocardiograph is not
used for a long time.
4. 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.
7.3.2 Recorder Paper
Note: 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.
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 recorded paper for a long time, or else the ECG reports may
trans-print each other.
- 48 -
7.3.3 Maintenance of Main Unit, Patient Cable and 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.
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 500A, SFC
1000A.
g) Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC 100A,
SFC 500A.
h) Test the patient leakage current according to IEC/EN 60601-1: Limit: NC a.c. 10A, d.c.
10A; SFC a.c. 50A, d.c. 50A.
i) Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC a.c. 10A,
d.c. 10A; SFC a.c. 50A, d.c. 50A.
j) Test the patient leakage current under single fault condition with mains voltage on the
applied part according to IEC/EN 60601-1: Limit: 50A (CF).
The leakage current should never exceed the limit. 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.
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 or 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.
- 49 -
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 in 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) 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
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.
- 50 -
SE-3 Electrocardiograph Service Manual Renewal Parts
Chapter 8 Renewal Parts

The following list is intended as a guide for ordering parts of SE-3.
Part number Description
European-style chest electrode connection bulb / G-BE32-24

01.57.040163
16
01.57.040162-11 European-style limb electrode clamp / C-RYGNB 14
01.57.471016 European-style patient cable
01.57.471017-11 American-style patient cable
02.02.20462-11 Power transition board PCBA
02.02.106908-01 12-channel ECG board PCBA (without firmware)
02.02.20465 Key panel transfer board PCBA
01.16.078199 LCD screen / 320240
01.16.078175 LCD screen / 19264
01.55.111450-01 SE-3 membrane key panel
02.02.106867 SE-3 main board (narrow LCD, without firmware)
02.02.106870 SE-3 main board (wide LCD, without firmware)
01.17.078197 Thermal print head
- 51 -

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About this Manual

Release Date: July 2011

Copyright EDAN INSTRUMENTS, INC. 2005-2011. All rights reserved.

Responsibility of the Manufacturer

Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by

The instrument is used in accordance with the instructions for use.

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

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

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

Chapter 3 Operating Principle ................................................................................................... 13

3.1 Basic Theory of ECG Operation........................................................................................... 13

Chapter 4 Functional Verification .............................................................................................. 21

4.1 System Tests ......................................................................................................................... 21

Chapter 5 Modules Malfunction Verification........................................................................... 24

5.1 Verifying the Main Board ..................................................................................................... 24

Chapter 6 Electrocardiograph Servicing ................................................................................... 27

6.1 Disassembly Steps ................................................................................................................ 27

Chapter 7 Cleaning, Care and Maintenance ............................................................................. 46

Chapter 8 Renewal Parts............................................................................................................. 51

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 Edans confirmation.

EDAN Instruments, Inc.

TEL: +86-755-26898321, 26899221

FAX: +86-755-26882223, 26898330

Chapter 2 Safety Guidance

2.1 List of Symbols

Equipment or part of CF type with defibrillator proof

Consult Instructions for Use

Off (mains supply)

Battery recharging indicator

Sensitivity switch key

1mV calibration key & Copy key

Mode/RST switch key

Lead switch key

Up arrow/Down arrow key

Left arrow/ Right arrow key

Authorized Representative in the European Community

The symbol indicates that the device complies with the

Federal (U.S.) law restricts this device to sale by or on the

2.2 Safety Information

IEC/EN 60601-1+A1+A2, IEC/EN 60601-1-2+A1, IEC/EN60601-2-25,

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

presence of flammable gas: of flammable gas

Working mode: Continuous operation

Transport & Storage Working

25% ~ 93% 25% ~ 80%

Power Supply Specifications:

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 or monitoring.

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

11.Electrodes with defibrillator protection should be used during defibrillation. To avoid a