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EDAN SE 3 Service Manual PDF
EDAN SE 3 Service Manual PDF
EDAN SE 3 Service Manual PDF
SE-3 3-
Statement
Edan Instruments, Inc. (hereinafter called EDAN) makes no warranty of any kind with regard to
this material, including, but not limited to the implied warranties of merchantability and fitness
for a particular purpose. EDAN assumes no responsibility for any error that may appear in this
document, or for incidental or consequential damage in connection with the furnishing,
performance or use of this material.
All information contained in this publication is believed to be correct. EDAN shall not be liable
for errors contained herein nor for incidental or consequential damages in connection with the
furnishing, performance, or use of this material. This publication may refer to information and
protected by copyrights or patents and does not convey any license under the patent rights of
this company, nor the rights of others. This company does not assume any liability arising out of
any infringements of patents or other rights of third parties.
The electrical installation of the relevant room complies with national standards, and
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-
Using This Label Guide
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.
-II-
Table of Contents
3.3 Lead................................................................................................................................. 7
5.3 Troubleshooting............................................................................................................. 23
7.1 Clean.............................................................................................................................. 34
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SE-3 3-Channel Electrocardiograph Service Manual
Chapter 1 General
♦ Automatic mode, manual mode, rhythm mode and USB print mode optional
♦ Hint information for lead off, lack of paper and low battery capacity etc.
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SE-3 3-Channel Electrocardiograph Service Manual
Power Supply
1) Mains Supply:
Rated input voltage: 100V~115V/220V~240V
Rated frequency: 50Hz/60Hz
Rated input power: 35VA
2) Built-in Rechargeable Lithium Battery Pack:
Rated voltage: 14.8V
3) Power Consumption: 35VA
4) Fuse Specification:
T200mA 250V Ø5×20 (for 220V~240V)
T400mA 250V Ø5×20 (for 100V~115V)
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SE-3 3-Channel Electrocardiograph Service Manual
Record Paper
USB Interface
Recorder
RS232 Socket
Figure 2-1 Main Unit (320×240 dot single color LCD Screen)
There are sockets including the patient cable socket, RS232 socket, external input/output
socket and USB interface at the right side of the main unit as Figure 2-1 shows.
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SE-3 3-Channel Electrocardiograph Service Manual
2) RS232 Socket
WARNING :
RS232 interface is 1500V AC isolated intensity and the maximum voltage applied
should not exceed +15V DC.
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4) USB Interface
Fuse Label
Label
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SE-3 3-Channel Electrocardiograph Service Manual
Chapter 3 Principle
The heart is a power organ of the body blood circulation. Before the systole or diastole, a cardiac
impulse happens in the heart muscle, and a faint bioelectric current signal is thus generated. The
bioelectric current signal is transmitted through the whole body, and the electric 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 electric potential distribution on the body
skin surface. The electric potential difference is sampled by the electrodes, and is amplified and
processed by the electrocardiograph, and at last it is recorded on the paper. From it the doctor can
detect if the heart has a disease. The Electrocardiograph is just a kind of medical electrical
equipment intended for producing cardiograms for diagnostic purposes with 10 associated
electrodes at certain specific locations on the body. They only record the heart's electrical activity.
They do not produce any electricity of their own. The test does not hurt and has no known side
effects. It does not require any preparation (except for possibly shaving chest hair to get a better
recording). The recording itself takes only a few seconds.
There has been more than one hundred years since the electrocardiograph was applied in clinical
diagnosis. It is an important measure in clinical diagnosis of heart-disease. This instrument has
been equipped in almost every hospital and clinic.
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SE-3 3-Channel Electrocardiograph Service Manual
3.3 Lead
It is important to remember that the 12-lead ECG provides spatial information about the
heart's electrical activity in 3 approximately orthogonal directions:
Right Left
Superior Inferior
Anterior Posterior
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SE-3 3-Channel Electrocardiograph Service Manual
Each of the 12 leads 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)
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This module is a 12-channel ECG signal sampling and processing module. It can realize the
amplification and pre-processing of patient ECG signal in every channel, and the detection of
lead situations, as well as sending data to ARM9 MCU. This module is connected to ARM9MCU
through UART port.
The standard 12-lead electrocardiograph has 10 lead cables, including 9 lead signal input and 1
Right Foot electrode as the float ground. The ECG signals pass through the defibrillator
protection circuit, buffering circuit (U1~U3), and enter the difference amplifier circuit. And then
they continue to pass through the pacemaker pulse restraining, high-pass filter, low-pass filter,
channel switch, second level amplification, and are sent to the A/D sampling port of
MSP430F147.
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.
The main control part includes ARM9 Board and Interface Circuit Board.
ARM9 Board consists of MCU S3C2410, SDRAM, NAND FLASH, NOR FLASH, LAN
controller, and CPLD etc. The main frequency is 203MHz.
The interface Circuit Board consists of RS232 interface, LAN interface, USB interface, printer
interface, LCD interface, and keyboard interface etc. It also provides power supply to the device.
The system uses ARM9 (S3C2410) (U1) as the control MCU, and the peripheral equipments are
connected to the MCU ports. The MCU controls the peripheral equipments by several kinds of
methods. The system expands 64M external SDRAM (U6, U7), 64M FLASH (U2), LAN
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SE-3 3-Channel Electrocardiograph Service Manual
220VAC voltage passes linear transformer and is transformed into 20VAC voltage. One part is
provided to charge the battery, and another part passes DC/DC to provide +8V for thermal
prinhead, +5V for electric machine, +5V for core board and +5V for ECG board.
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SE-3 3-Channel Electrocardiograph Service Manual
Chapter 4 Tests
1. Equipment Requirement
Equipment Model
ECG emulator FLUKE MPS450
4. Keys tests
Press every key on the keyboard to test if they work as the descriptions in the user manual.
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system will be shifted to the main interface automatically. And then enter the corresponding
interfaces of the System Setup window to set the current time and change some menu options and
exit.
Turn off the electrocardiograph, and turn on it five seconds later. When the electrocardiograph is
ready for examination and recording, observe if the time displayed on the LCD screen is the
current time. And enter the corresponding interfaces of the System Setup window to see if these
menus keep the changed options. Then restore these menus to the default values and turn off the
electrocardiograph. Five seconds later, turn on the electrocardiograph again. When the
electrocardiograph is ready for examination and recording, observe if the menus are still the
default options.
7. Recording tests
1) Set the following values:
The heart rate output of ECG emulator is 80bpm, the work mode of electrocardiograph is auto,
the speed is 25mm/s, the AC Filter is off, the Lowpass Filter is 150Hz and all the options in the
Record Setting menu are on. Install the recording paper and press PRINT/STOP key to begin to
record. Examine whether the recording content are integrated and consistent with the information
displayed on the LCD screen.
2) Make the ECG detector output the sine wave with 2mV and 10Hz. Press PRINT/STOP key to
begin to record. Examine whether the recording content are integrated and consistent with the
information displayed on the LCD screen. The amplitude of ECG waveform of Lead I should not
be less than 25mm.
3) The ECG record includes: Date and time, ID, Name, Sex, Age, Sensitivity, Paper speed, filter,
Lead, 1mV calibration mark, ECG waveform, Heart Rate etc. Meanwhile, before recording ECG
wave, 1mV Calibration mark and lead names will be recorded. Recorded characters and
waveforms are clear.
4) Open the casing of recorder and remove paper, the hint information of “Paper?” should be
displayed. Install the paper again and close the casing of recorder, the hint information of
“Paper?” should disappear.
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SE-3 3-Channel Electrocardiograph Service Manual
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 uA, SFC 1000uA.
3) Test the patient leakage current according to IEC/EN 60601-1: Limit: 10 uA (CF).
4) Test the patient leakage current under single fault condition with mains voltage on the applied
part according to IEC/EN 60601-1: Limit: 50uA (CF).
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SE-3 3-Channel Electrocardiograph Service Manual
Remove the crosshead screws ① (M3×10) in the four corners of the bottom of electrocardiograph.
Open the upper unit ③ and remove the cables between the upper and lower unit, and then
separate the upper unit from the lower. In the following pictures, ② is the lower unit, and ④ is
the recorder casing.
3. Disassembly steps of the upper unit (Configuration A--192×64 dot single color LCD
screen)
The upper unit of the electrocardiograph (192×64 dot single color LCD screen) includes the
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lower casing of the displaying box, filmy switch panel, LCD screen, rotation base etc.
The disassembly steps:
Remove the cables between LCD screen ⑩, filmy switch panel ⑨ and transfer board
②.→Remove the five crosshead panhead screws ① (M3×6), and dismantle the transfer 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 (11) and filmy switch panel ⑨ are sticked to the upper unit ③, and can be torn off.
Note: The LCD screen should be protected from being damaged when disassembling it.
4. Disassembly steps of the upper unit (Configuration B--320×240 dot single color LCD
screen)
The difference between disassembling Configuration A and B is that the LCD screen of
Configuration B is embedded in the upper casing of the displaying box, while the LCD screen of
Configuration A is fixed in the lower casing of the displaying box by screws.
The following picture shows: ① crosshead panhead screws M3×6, ② transfer board, ③ the
upper unit, ④ rotation base, ⑤ crosshead panhead screws M3×8, ⑥ the lower casing of the
displaying box, ⑦crosshead sunk screws M3×6, ⑧crosshead sunk screws M3×20, ⑨ LCD
screen, ⑩ filmy switch panel, (11) the upper casing of the displaying box, (12) label, (13)
protection screen.
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SE-3 3-Channel Electrocardiograph Service Manual
Remove the cables between two parts before disassembly. Remove the transfer board of power
supply ⑨ which is embedded in the groove of the lower unit→ Remove screws to dismantle the
interface board ⑧ and ECG board ⑦→Remove crosshead panhead screws ⑥ (M3×8) and
dismantle the transformer ⑤→Remove the two crosshead panhead screws ④ (M2×6) and
dismantle the print-head ③→Remove the four crosshead sunk screws ② (M3×6) and dismantle
the print bracket ①.
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5 +5V
② ③ ④
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① CON11-- Socket connected to ECG board. Please refer to P2 socket of ECG board for pin
information.
Pin Description
1 Draw to GND
2, 15 +5V
3 Paper Detection
16 Temperature Detection
4, 5, 24 NC
6, 7, 25, 26 +8V
8 Data Output
9 Clock Output
12, 13, 14, 17, 18, 23 Control Signal Input (valid in low electrical level)
Pin Description
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SE-3 3-Channel Electrocardiograph Service Manual
H: DISPLAY ON
10, 40 +3V
14 Restoration Signal
Pin Description
1, 2, 23, 24 NC
3, 22, 27, 34, 35 GND
4 +5V
5, 6 Analog Signal Input
7, 8, 11, 12, 21 Control Signal of LCD Screen
9 Restoration Signal
10, 13~20 Data Signal of LCD Screen
25, 26, 28~33 Control Signal of Filmy Switch Panel
36 Mains Supply Indicator Signals (Analog Signal)
37, 39 Battery Recharging Indicator Signals (Analog Signal)
38 Battery Indicator Signals (Analog Signal)
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5.3 Troubleshooting
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① strong interference of
electric networks ① Inspect Power supply and
② ARM9 board failure earthing system
Out of work
③ Power supply or ② Change ARM9 board
plug-in unit on the master ③ Change or repair plug-in unit
control board failure
① The power supply or
Fuse is burned when turning on ① open the electrocardiograph
other component is
the electrocardiograph. for further examination
short-circuited.
Fuse is burned when
① This component is
connecting a certain ① Change this component
short-circuited.
component.
2. Display troubles
3. Transmission troubles
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4. Operation troubles
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5. Parameter troubles
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CAUTION :
Before use, the equipment, patient cable and electrodes should be checked. Replace it if
there is any evident defectiveness or aging which may impair the safety or performance.
And be sure that the equipment is in proper working condition.
WARNING :
If the integrity of external protective conductor in installation or arrangement is in doubt,
the equipment should be operated from the built-in rechargeable battery.
Power Supply
The electrocardiograph can be powered either by mains supply or the built-in rechargeable
lithium battery pack.
1. Mains supply
The mains connection socket is on the left of the unit. If mains supply used, connect the power
cord to the socket first, and then connect the plug of the cord to the hospital grade outlet.
Rated input voltage: 100V~115V or 220V~240V
Rated frequency: 50Hz/60Hz
Rated input power: 35VA
Make sure the mains supply meets the above requirements before power on. And then press the
mains power switch to power on the unit. Then the mains supply indicator lamp ( ) will be lit.
If the built-in rechargeable battery is weak when mains supply used, it will be recharged
automatically at the same time. And both the mains supply indicator lamp ( ) and the battery
recharging indicator lamp ( ) will be lit.
The battery symbol will be displayed on the LCD screen. Because of the consumption
during storage and transport, the capacity of battery may not be full. If the symbol and the
hint information “BAT WEAK” are displayed, which means the battery capacity is weak, please
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SE-3 3-Channel Electrocardiograph Service Manual
WARNING :
Two kinds of paper can be used as ECG record paper. One is Rolled thermal paper with 80mm
width, and the other is folded thermal paper with 80mm width.
Note: When using folded thermal paper, the Paper Roller is unnecessary, and it can be
taken out.
When there is no record paper loaded or it reaches the end of record paper, warning message
“Paper?” will be given on the screen. Under this circumstance, record paper should be loaded or
replaced immediately.
Paper Roller
Groove
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SE-3 3-Channel Electrocardiograph Service Manual
4) Place the paper and roller gently in the recorder with the roller pin on the roller’s left
side facing to the groove;
5) Pull about 2cm of paper out, and put down the recorder casing;
6) Secure the casing by pressing it firmly.
Loading/Replacing Process for Folded thermal paper:
1) Place fingers under the flange of the recorder casing, pull upwards directly to release
the casing;
2) Remove residual paper in the Paper Tray if necessary;
3) Take off the wrapper of folded thermal paper, and then put it in the Paper Tray with the
paper’s grid side facing the thermal print head while put the free end of paper upright;
4) Pull about 2cm of paper out, and put down the recorder casing;
5) Secure the casing by pressing it firmly.
WARNING : The performance and electric shock protection can be guaranteed only
if original EDAN patient cable and electrodes are used.
Patient cable includes two parts, main cable and lead wires with associated connectors, which
can be distinguished from the color and identifier on the connectors.
Main Cable
Lead Wires
Screw
Electrode Connectors
Connector
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SE-3 3-Channel Electrocardiograph Service Manual
Chest Electrode:
Suction Bulb
Limb Electrode:
Electrode
Reed
Clamp
The identifier and color code of electrodes used complies with IEC/EN requirements. In order
to avoid incorrect connections, the electrode identifier and color code is specified in Table 4-1.
Moreover the equivalent code according to American requirements is given in Table 4-1 too.
Table 4-1 Electrodes and their identifier and color code
European American
Electrodes Identifier Color code Identifier Color code
Right arm R Red RA White
Left arm L Yellow LA Black
Right leg N or RF Black RL Green
Left leg F Green LL Red
Chest 1 C1 Red V1 Red
Chest 2 C2 Yellow V2 Yellow
Chest 3 C3 Green V3 Green
Chest 4 C4 Brown V4 Blue
Chest 5 C5 Black V5 Orange
Chest 6 C6 Violet V6 Violet
As the following figure shows, the chest electrodes’ position on body surface is
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SE-3 3-Channel Electrocardiograph Service Manual
C1
C4
C2
C6
C3
C5
The contacting resistance between the patient and the electrode will affect the quality of ECG
greatly. In order to get a high-quality ECG, the skin/electrode resistance must be minimized
while connecting electrodes.
WARNING : Be sure that all electrodes have been connected to the patient
correctly before operation.
then the electrode is adsorbed on chest. Attach all chest electrodes in the same way.
In order to avoid safety hazards and get good ECG record, the following inspection procedure
is recommended before power on and operation.
1) Environment:
♦ Check and make sure that there is no electromagnetic interference source around the
equipment, especially large medical electrical equipment such as electrosurgical
equipment, radiological equipment and magnetic resonance imaging equipment etc.
Switch off these devices when necessary.
♦ Keep the examination room warm to avoid muscle action voltages in ECG signal
caused by cold.
2) Power Supply:
♦ If mains power used, please check whether the power cord has been connected to the
unit well. And the grounded three-phase outlet should be used.
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♦ Recharge the battery first when the battery capacity is weak before use.
3) Patient Cable:
♦ Check whether the patient cable has been connected to the unit firmly, and keep it far
away from the power cord.
4) Electrodes:
♦ Check whether all electrodes have been connected to lead wires of patient cable
correctly according to the identifier and color.
♦ Ensure that the chest electrodes haven’t contacted with each other.
5) Recorder Paper:
♦ Ensure that there is enough recorder paper loaded correctly.
6) Patient:
♦ The patient should not contact with conducting object such as earth, and metal part of
bed etc.
♦ Ensure the patient is warm and relaxed, and breathe calmly.
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Chapter 7 Cleaning
7.1 Clean
CAUTION :
Turn off the power before cleaning and disinfection. Mains supply must be switch off
if it has been in use.
The surface of the main unit and 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.
Remove the remainder gel from the electrodes with a clean soft cloth first. Take the suction
bulb and mental cup of chest electrodes apart, and take the clamp and the metal part of the
limb electrodes apart. Clean them in warm water and be sure there is no remainder gel. Dry
the electrodes with a clean dry cloth or air dry naturally.
Dirty and soiled thermal print head will deteriorate the record 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 stain, soak it with a little alcohol first and wipe it
off with a clean soft cloth. After air dried, load the record paper and shut the casing of the
recorder.
CAUTION :
Prevent the detergent from seeping into the main unit while cleaning. Do not
immerse the unit or patient cable into liquid under any circumstances.
CAUTION :
Do not clean the unit and accessories with abrasive fabric and avoid scratching the
electrodes.
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7.2 Disinfection
To avoid permanent damage to the equipment, disinfection can be performed only when it has
been considered as necessary according to your hospital’s regulations.
Before disinfection clean the equipment first. Then wipe the surface of the unit and patient
cable with hospital standard disinfectant.
CAUTION :
Do not use chloric disinfectant such as chloride and sodium hypochlorite etc.
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SE-3 3-Channel Electrocardiograph Service Manual
Chapter 8 Maintenance
1) Capacity Identification
Current capacity of the rechargeable battery can be identified according to the battery
symbol in the top right corner on LCD screen.
: Full capacity
will be lit at the same time. During the course of recharging, the symbol “ ” will flash in
the top right corner of LCD screen. When the capacity of battery is full, the symbol “ ”
will stop flashing, and the battery recharge indicator lamp ( ) will usually be black. But
if SE-3 is power off, the lamp will still lit just because the equipment will not monitor the
recharge status; so you need to power on the device to verify the status.
Because of the capacity consumption during storage and transport, the capacity of battery is
not full while using at the first time. Battery recharge should be considered before first
usage.
3) Replacement
When the useful life of battery is over, or foul smell and leakage has been found, please
contact with manufacturer or local distributor for replacement of battery.
WARNING :
♦ Only qualified service engineer authorized by EDAN can open the battery
compartment and replace the battery. And the battery of same model and
specification provided by manufacturer must be used.
♦ Danger of explosion -- Do not reverse the anode and cathode when
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SE-3 3-Channel Electrocardiograph Service Manual
Note: Record paper provided by manufacturer should be used. Other paper may
shorten thermal print head’s life. And the deteriorated print head may lead to
illegible ECG record and block the advance of paper etc.
Storage requirements:
♦ Record paper should be stored in dry, dark and cool area, avoiding excessive
temperature, humidity and sunshine.
♦ Do not put the paper under fluorescence for long time.
♦ Be 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 long time, or else the ECG record may trans-print
each other.
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 relevant labels for legibility.
c) Inspect the fuse to verify compliance with rated current and 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 0.2ohm.
f) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500uA, SFC
1000uA.
g) Test the patient leakage current according to IEC/EN 60601-1: Limit: 10uA (CF).
h) Test the patient leakage current under single fault condition with mains voltage on the
applied part according to IEC/EN 60601-1: Limit: 50uA (CF).
The leakage current should never exceed the limit. The data should be recorded in an
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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 the use
of this equipment to implement a satisfactory maintenance schedule may cause undue
equipment failure and possible health hazards.
1) Main Unit
♦ Avoid excessive temperature, sunshine, humidity and dirt.
♦ Put on the dustproof coat after use and prevent from shaking violently when moving it
to another place.
♦ Prevent any liquid from seeping into the equipment, for it will affect the safety and
performance of electrocardiograph.
2) Patient Cable
♦ Integrity of patient cable, including main cable and lead wires, should be checked
regularly. And be sure that it is conductible.
♦ Do not drag or twist the patient cable with excessive stress while using. Hold the
connector plugs instead of the cable when connect or disconnect the patient cable.
♦ Align the patient cable to avoid twisting, knotting or crooking in closed angle while
using.
♦ Store the lead wires in bigger wheel to prevent any people from stumbling.
♦ Once damage or aging of the cable patient has been found, replace it with a new one
immediately.
3) Electrodes
♦ Electrodes must be cleansed after use and be sure there is no remainder gel on them.
♦ Keep the suction bulb of chest electrode from sunshine and excessive temperature.
♦ After long-term use, the surface of electrodes will be oxidized because of erosion and
other causes. By this time, electrodes should be replaced to achieve high-quality ECG.
CAUTION :
The equipment should be sent to the special agencies according to local regulation for
separate collection after its useful life.
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3) IEC/EN 60601-2-25,
4) ANSI/AAMI EC-11.
Dimensions 288mm×210mm×70mm
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Accuracy: ±1BPM
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AC Filter: On/Off
LOWPASS Filter:150Hz/100Hz/75Hz
CMRR ≥110dB
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EDAN INSTRUMENTS, INC.
EC REPRESENTATIVE