Se-601c Manual de Servicio Ingles V1.4

EDAN INSTRUMENTS, INC.
Manual Ver: V1.0

Release Date: Jan. 2009
Part Number: MS1R-110350-V1.0
P/N: MS1R-110350-V1.0
Copyright
© Copyright EDAN INSTRUMENTS, INC. 2009. All rights reserved.
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.
No part of this document may be photocopied, reproduced or translated to another language

without prior written consent of EDAN.
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 company does not assume any liability
arising out of any infringements of patents or other rights of third parties.
The information contained in this document is subject to change without notice.
Product Information
Product Name: Electrocardiograph
Model: SE-601A, SE-601B, SE-601C
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.
NOTE: This device is not intended for home use.
I
WARNING : This device is not intended for treatment.
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

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 ECO# Version Description
2009.01 V1.0 1st edition
II
Table of Contents
Chapter 1 Warranty and Service............................................................1
Chapter 2 Safety Information.................................................................4
2.1 List of Symbols............................................................................................................. 4
2.2 Warning and Caution................................................................................................... 6
Chapter 3 Overview ................................................................................9
3.1 Environment and Power Supply Requirements ...................................................... 9
3.2 System Diagnostics Window ................................................................................... 10
Chapter 4 Work Theory Introduction...................................................16
4.1 Basic Theory of ECG Operation.............................................................................. 16
4.2 Composition of ECG ................................................................................................. 16
4.3 Lead and Electrode ................................................................................................... 18
4.4 Hardware Design Principle Description ................................................................. 19
4.4.1 Mainboard description .................................................................................... 20
4.4.2 ECG Board Description .................................................................................. 21
4.4.3 PS900G Power Supply Module Description ............................................... 22
4.4.4 Key Board Description.................................................................................... 23
Chapter 5 Functional Verification ........................................................24
5.1 System Tests .............................................................................................................. 24
5.2 Application System Tests.......................................................................................... 24
5.3 Safety Tests ................................................................................................................ 26
Chapter 6 Troubleshooting ..................................................................27
Chapter 7 Modules’ Malfunction Verification......................................31
7.1 Verifying the Main Board .......................................................................................... 31
7.2 Verifying the ECG Board .......................................................................................... 33
7.3 Verifying the Keyboard.............................................................................................. 35
Chapter 8 Disassembling the Monitor.................................................36
8.1 Disassembly Procedures.......................................................................................... 36
8.2 Internal Boards and Interfaces ................................................................................ 42
Chapter 9 Field Replaceable Parts ......................................................49
Chapter 10 Cleaning .............................................................................50
10.1 Cleaning .................................................................................................................... 50
10.1.1 Cleaning the Main Unit and Patient Cable ................................................ 50
10.1.2 Clean the Electrodes .................................................................................... 50
10.1.3 Clean the Print Head .................................................................................... 50
10.2 Disinfection ............................................................................................................... 51
Chapter 11 Maintenance.......................................................................52
11.1 Recharge and Replacement of Battery ................................................................ 52
11.2 Recording Paper ...................................................................................................... 53
III
11.3 Maintenance of Main Unit, Patient Cable & Electrodes..................................... 53
IV
SE-601 series 6-Channel 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 customer promptly
notifies EDAN of customer’s warranty claim hereunder, EDAN will either repair, adjust or replace
(with new or exchange replacement parts) the EDAN’s product. 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 are
not responsible may void the warranty:
² Groupware is dismounted, stretched or re-debugged.

² Unauthorized modification or misuse.
² Damage caused by operating beyond the environmental specifications for the medical product.
² Change or remove original serial number label or Manufacturer symbol.
² Improper use.
Service Procedure
(1) Fill in 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 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 following two conditions:
Within Warranty:
There are two options:
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i) After receiving the Return Material Authorization (RMA) form from EDAN service
department, the customer sends EDAN the defective parts and informs 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 replace one(s) with 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 engineer.
(2) 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
customer.
Out of Warranty:
After receiving the RMA from service department, customer sends defective parts to EDAN in
advance. We will analyze the problems and discuss with 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 confirmed address.
NOTE: Customer is responsible for any freight & insurance charge for the
returned product.
(3) Obtain RMA Form.
Before the shipment of the materials, customer must obtain a RMA form from our service
department, in which the RMA number, description of returning parts and shipping instruction
are included. The RMA number should be indicated on the outside of the shipping container.
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NOTE: EDAN should not have any obligation to end-user or customer who
returns the goods without the notification by EDAN’s service
department. The sender takes the whole responsibility of accounted fee.
(4) Send the Parts to EDAN.
Follow these recommended instructions:
² Disassemble the parts with anti-static facility. Do not touch the parts with naked hand.
² Pack the parts safely before returning.
² Put the RMA number on the parcel.
² Describe the returned parts. The total value on the invoice should be less than USD100, and
note on the invoice as “sample, no commercial value”.
² Confirm the invoice with EDAN before shipment.
² 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
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Chapter 2 Safety Information
2.1 List of Symbols
External output
External input
Equipment or part of CF type with defibrillator proof
Attention – general warning (see accompanying document)
Potential equalization
Mains supply
USB port
Battery indicator
Battery recharging indicator
Delete key
Enter key
Esc key
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Space key
Shift key
Fn key
Power On/Off key
MODE key
RESET key
1mV/COPY key
START/STOP key
Recycle
Part Number
Serial Number
Date of Manufacture
Manufacturer
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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 and that this unit was put on
the market after 13 August 2005
Federal (U.S.) Law restricts this device to sale by or on the

Rx only (U.S.)
order of a physician
2.2 Warning and Caution
Warning and Caution messages must be observed. To avoid the possibility of injury, observe the
following precautions during the operation of the instrument.
WARNING :
Z Only qualified service engineers can install this equipment. And only service engineers
authorized by the manufacturer can open the shell.
Z EXPLOSION HAZARD-Do not use the electrocardiograph in the presence of

flammable anesthetic mixture with oxygen or other flammable agents.
Z 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.
Z If the integrity of external protective conductor in installation or arrangement is in doubt,

the equipment should be operated by using the built-in rechargeable battery.
Z 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
configurations shall comply with the valid version of the standard IEC/EN 60601-1-1.
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Therefore anybody, who connects additional equipment to the signal input connector
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.
Z The summation of leakage current should never exceed leakage current limits while
several other units are used at the same time.
Z Improper operation may cause the battery to be hot, ignited or exploded, and it may
lead to the declination of battery’s capacity. It is necessary to read the user manual
carefully and pay more attention to warning messages.
Z Only qualified service engineer authorized by the manufacturer can open the battery
compartment and replace the battery, and the battery of same model and specification
provided by manufacturer should be used.
Z Danger of explosion -- Do not reverse the anode and cathode when connecting the
battery.
Z If using electrode gel with reusable electrodes during defibrillation, ECG recovery will
take longer than 10 seconds. EDAN recommends the use of disposable electrodes at
all times.
Z Do not heat or splash the battery or throw it into fire or water.
Z 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.
Z 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.
Z Only when the device is off can the battery be Installed or removed.
CAUTION :
Z 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.
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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 0.1
ohm.
f) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500
uA, SFC 1000uA.
g) Test the patient leakage current according to IEC/EN 60601-1: Limit: 10 uA
(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 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.
Z Ruptured fuse must only be replaced with that of the same type and rating as the
original.
Z The device and reusable accessories could be sent back to the manufacturer for
recycling or proper disposal after their useful lives.
Z Federal (U.S.) law restricts this device to sale by or on the order of a physician.
Z Turn off the power before cleaning and disinfection. If mains supply used, the power
cord should also be drugged out of the outlet, and prevent the detergent from seeping
into the equipment.
Z Do not immerse the unit or patient cable into liquid under any circumstances.
Z Do not clean the unit and accessories with abrasive fabric and avoid scratching the
electrodes.
Z Any remainder of detergent should be removed from the unit and patient cable after
cleaning.
Z Do not use chloric disinfectant such as chloride and sodium hypochlorite etc.
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Chapter 3 Overview
The service manual is a reference for periodic preventive maintenance and corrective service
procedures for the SE-601 series (SE-601A/B/C) 6-channel Electrocardiograph.
WARNING : When performing a service procedure, follow the instructions exactly as

presented in this manual. Failure to do so could damage the monitor,
invalidate the product warranty, and lead to serious personal injury.
This guide provides troubleshooting information, assembly procedures, and instructions for
functional testing and performance verification. It is intended for use only by technically qualified
service personnel.
3.1 Environment and Power Supply Requirements
The environment requirements are listed in the following table.
Transport and Storage Working

Temperature: -20 ºC ~+55 ºC 5 ºC ~40 ºC
25%~93% 25%~80%
Relative Humidity:
(non-condensing) (non-condensing)
Atmospheric Pressure: 700hPa~1060hPa 860hPa~1060hPa
1) Mains Supply:
Rated input voltage: 100V~240V
Rated frequency: 50Hz/60Hz
Rated input power: 70VA
2) Built-in Rechargeable Lithium Battery Pack:
Rated voltage: 14.8V; Rated capacity = 2200mAh
3) Power Consumption: 70VA

4) Fuse Specification: T1AL250VP Ø5×20
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3.2 System Diagnostics Window
This System Diagnostics Window is password protected and only the manufacturer authorized
technician can access it.
(1) Entering the System Diagnostics Window
In the System Setup window, press Shift+F2 on the keyboard to pop up the Enter Password
interface. (See Figure 3-1) After entering the right password and pressing Enter key, the System
Diagnostics window will appear. (See Figure 3-2)
In the System Diagnostics Window, press / / / function key
and Tab key to move the cursor to a certain sub-item, and then press Enter key to get onto the test
interface of the sub-item.
Figure 3-1 Enter Password interface
System
Diagnostics
Window
Sub-item
Figure 3-2 System Diagnostics window
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(2) Display Test

and Tab key to move the cursor to the Display Test item, and then press Enter key to pop up the
Display Test Selection interface. (See Figure 3-3) The user can select Pixel Verification or Gray
Scale Test Patterns.
Figure 3-3 Display Test Selection interface

When the user selects Pixel Verification Test and press Enter key to confirm, Pixel Verification Test
interface appears. (See Figure 3-4)
Press / key to move the color bar across the screen, and the user can inspect
whether the LCD screen is intact and displays well.
Press F1 to display a full screen, and then press F1 to shift the color of the full screen from white to
green, red and blue.
Press ESC key to exit the interface.
Figure 3-4 Pixel Verification Test interface

When the user selects Gray Scale Test Patterns and press Enter key to confirm, Gray Scale Test
Patterns interface 1 appears. (See Figure 3-5)
Press any key to enter the Gray Scale Test Patterns interface 2. (See Figure 3-6)
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Figure 3-5 Gray Scale Test Patterns interface1
Figure 3-6 Gray Scale Test Patterns interface2

(3) Keyboard Test
and Tab key to move the cursor to the Keyboard Test item, and then press Enter key to get onto
the Keyboard Test interface.
When you press a key on the keyboard of the device, this key will be displayed in the corresponding
position on the Keyboard Test interface.
Note: When you press the Power ON/OFF key, the device will be turned off.
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Figure 3-7 Keyboard Test interface

(4) Recorder Test
and Tab key to move the cursor to the Recorder Test item, and then press Enter key to get onto the
Recorder Test interface.
On this interface, press the START/STOP key to begin to record the triangle waveform in effective
paper width. The status of print head can be estimated from this triangle wave. Press START/STOP
key again to stop record. Press ESC key to exit the interface.
Note: During the course of recording, the user should not press the ESC key to exit.
Figure 3-8Writer Test interface

(5) FS Test
and Tab key to move the cursor to the FS Test item, and then press Enter key to get onto the File
System interface.
This interface displays the numbers of files, the total space, the space of used and the percent of
used space.
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Figure 3-9 File System interface
(6) Battery Test

and Tab key to move the cursor to the Battery Test item, and then press Enter key to get onto the
Battery Test interface.
This interface displays the capacity of the battery, whether AC power is used and whether battery is
being charged.
Figure 3-10 Battery Test interface

(7) UART Test
and Tab key to move the cursor to the UART Test item, and then press Enter key to get onto the
UART Test interface.
On this interface, pressing the START/STOP key can make the system send and receive signals.
When the signal received is always the same to the signal sent, which is displayed on the screen, the
user can make sure that the system UART is good.
Press START/STOP key again to stop test. Press ESC key to exit the interface.
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Note: During the course of testing, the user should not press the ESC key to exit.
Figure 3-11 UART Test interface

(7) Statistic Info
and Tab key to move the cursor to the Statistic Info item, and then press Enter key to get onto the
Statistic Info interface.
Statistic Info includes numbers of auto record, manual record and rhythm record, and the total time
of recording and work of the device.
Figure 3-12 Statistic Info interface
Note: The Net Test function and External Test function are reserved.
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Chapter 4 Work Theory Introduction
4.1 Basic Theory of ECG Operation
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 an amplified record 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.
4.2 Composition of ECG
The standard 12-lead electrocardiogram is a representation of the heart's electrical activity recorded
from electrodes on the body surface. The normal ECG wave consists of P wave, QRS complex, ST
segment, T wave and U wave. In the following figure, the x-axis is time and y-axis is voltage. When
the recording speed is 25mm/s and the sensitivity is 10mm/mV, one little grid in x-axis represents
0.04 second, and one little grid in y-axis represents 0.1mV.
This diagram illustrates ECG waves and intervals as well as standard time and voltage measures on
the ECG paper.
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Figure 4-1 Composition of ECG

P wave: the sequential activation (depolarization) of the right and left atria
QRS complex: right and left ventricular depolarization (normally the ventricles are
activated simultaneously)
ST-T wave: ventricular repolarization
U wave: origin for this wave is not clear - but probably represents "after-depolarizations"
in the ventricles.
PR interval: time interval from onset of atria depolarization (P wave) to onset of
ventricular depolarization (QRS complex)
QRS duration: duration of ventricular muscle depolarization
QT interval: duration of ventricular depolarization and repolarization
RR interval: duration of ventricular cardiac cycle (an indicator of ventricular rate)
PP interval: duration of atria cycle (an indicator or atria rate)
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4.3 Lead and Electrode
Figure 4-2 Standard electrodes

RA: Right arm
LA: Left arm
LL: Left Leg
RL: Right Leg
V1: Fourth intercostals space at right border of sternum
V2: Fourth intercostals space at left border of sternum
V3: Fifth rib between V2 and V4
V4: Fifth intercostals space on left mid-clavicular line
V5: Left anterior axillary line at the horizontal level of V4
V6: Left mid-axillary line at the horizontal level of V4
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4.4 Hardware Design Principle Description
The 6-channel electrocardiograph consists of the following functional blocks:

1) PS900G Power supply board.
2) Thermal Printer module
3) Main board
4) ECG board
5) LCD Display module
6) Key board
7) Lithium battery
Figure 4-3 Working Theory Diagram
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4.4.1 Mainboard description
Mainboard includes Core CPU，SDRAM，FLASH，Buffer Chip and Ethernet Driver Chip.

Power supply, Printing interface, Audio interface, STN screen interface, TFT screen interface, USB
interface, RS232-Serial port, analog input and output.
Figure 4-4 Mainboard Diagram
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4.4.2 ECG Board Description
Figure4-5 ECG Board Diagram

The standard 12-lead electrocardiograph has 10 lead cables. 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 is sent to the A/D sampling port of ADC.
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4.4.3 PS900G Power Supply Module Description
Figure 4-6 PS900G Power Supply Module Diagram

PS900G power supply module is shown in the figure above. This module provides +12V, +5V and
+8.1V voltage for the whole system and device, and also provides recharging circuit for battery.
The hardware of the device can control the switch of DC/DC module to turn on the device.
When the software of the device detects the signal of turnoff, it will save necessary data and then
control the system to turn off the device.
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4.4.4 Key Board Description
Key board is shown in the figure below. When a key is pressed down, the interrupt logic of key
matrix emits an interrupt signal. After CPU detects the interrupt signal, it will read the keys by line
scan and sequence scan, and send values to the main control board through the serial port.
Figure 4-7 Key board diagram
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Chapter 5 Functional Verification
This section 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 Check.
5.1 System Tests
1. Unit appearance and assembly examinations

1) Clean appearance, firm assembly, no remainder in the unit when shaking it.
2) Keys feel well when pressing.
3) Labels are full and correct.
4) Standard configurations are full; Sockets are installed firmly.
5) Vibration test should be done before the following tests are performed.
2. Switch on
After turned on, the electrocardiograph runs well and LCD screen displays well.
5.2 Application System Tests
1. Equipment Requirement
Equipment Model
ECG emulator FLUKE MPS450
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. On the Display Setup interface of the System Setup window, adjusting the value of the
Brightness item can change the screen brightness.
3. Lead off tests
In the AUTO mode, when pulling out and inserting the lead cables according to the sequence of the
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lead cables inserted into the ECG emulator, the electrocardiograph will accurately identify the
disconnection and connection of the corresponding lead cables.
When pulling out several lead cables simultaneously, the electrocardiograph will give the hint
information of lead off circularly.
4. Keys tests
Press every key on the keyboard to test if they work as described in the user manual.
5. Menu setup and store capability tests

Enter the More Setup interface of System Setup window, and set the Default as Yes, and then the
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 it on five seconds later. When the electrocardiograph is
ready for examination and recording, observe whether the time displayed on the LCD screen is the
current time, and enter the corresponding interfaces of the System Setup window to see whether
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 whether the menus are still the
default options.
6. Heart rate display tests

Set the heart rate output from the ECG emulator to different values, and the error of Heart Rate
values displayed on the LCD screen of electrocardiograph should be within ±1bpm. When the heart
rate output from the ECG emulator is 240bpm, the electrocardiograph will give the hint information
of Heart Rate exceeding the limit and make an alarm sound.
7. Recording tests
1) Set the following values:
The heart rate output from 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 items on the
Record Info setup interface of the System Setup window are on. Install the recording paper and
press START/STOP key to begin to record. Examine whether the recording content is 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 START/STOP key to
begin to record. Examine whether the recording content is integrated and consistent with the
information displayed on the LCD screen. The amplitude of ECG waveform of Lead II is 20±1mm.
3) The ECG record includes: Date and time, ID, Name, Sex, Age, Sensitivity, Paper speed, filter,
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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 “No Paper” should be
displayed. Install the paper again and close the casing of recorder, the hint information of “No
Paper” should disappear.
5.3 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 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).
-26-
Chapter 6 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.
The section includes several tables:

This troubleshooting guide introduces the suitable actions for correcting the problems or replacing
the accessory or calling the service personnel. It can also help the user to have more exact
descriptions of the fault symptoms when calling for service, which greatly makes the service fast
and efficient.
1. System troubles
Condition Possible causes Actions
① Fuse failure.
① Change fuse.
Can not turn on the ② Power board or Main
② Change power board or Main
electrocardiograph with mains board failure.
board.
supply. ③ Silica gel keyboard
③ Change silica gel keyboard.
failure.
① Battery failure.
Can not turn on the ① Change battery.
② Main board failure.
electrocardiograph with ② Change Main board.
③ Silica gel keyboard
battery. ③ Change silica gel keyboard.
failure.
① Some keys are plunged
into the Silica gel
Can not turn into the system ①loosen these keys
keyboard
②Restart the electrocardiograph
② software fails to
function
① Strong interference of
electric networks. ① Inspect Power supply and
The electrocardiograph fails to ② Main board failure. grounded system.
function ③ Power supply or ② Change Main 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.
-27-
Fuse is burned when

① This component is
connecting a certain ① Change this component.
short-circuited.
component.
2. Display troubles
① LCD screen failure.

① Change LCD screen.
②The LCD related cable
Some characters displayed on ② Check that the LCD related
is disconnected.
the LCD screen are missing. cable is well connected
③The LCD related cable
③ Change LCD related cable
is damaged
① Adjust the brightness of LCD
① The brightness of LCD
screen on the Display Setup
LCD screen is dark. screen is not adjusted well.
interface.
② LCD screen failure.
② Change LCD screen.
3. Transmission troubles
①Examine whether the

Transmission Setups are correct.
Fail to transmit by net port or ①Setup error. (The first three numbers of
serial port ②related cable failure. Local IP and Remote IP must be
③Port failure. set the same.)
Fail to copy to or from U disk ④IC failure. ②Change related cable
③Change port
④Change IC
4. Operation troubles
① Key board is damaged ① Change key board

② Main board failure ② Change Main board
③ The Key board related ③ Check that the Key board
Key failure
cable is disconnected related cable is well connected
④Key boa rd related cable ④ Change Key board related
is damaged cable
No Key Beep or Key Beep is
① Buzzer failure ① Change buzzer
raucous(only for SE-601A)
-28-
No Key Beep or Key Beep is

① Speaker failure ①Speaker buzzer
raucous (only for SE-601B/C)
① recorder is out of paper
② Print head failure ① Install paper for recorder
③ Main board failure ② Change print head
④ Recorder related cable ③ Change Main board
failure ④ Change or repair recorder c
Can not print
⑤ Dirty paper mark related cable
sensor ⑤ Clean the paper mark sensor
⑥ The paper mark sensor ⑥ Pull the recording paper
is covered by the black slowly
mark of recording paper
① Rubber roller of the
recording case has stains.
① Clean rubber roller.
Recording is illegible ② The elasticity of the
② Change spring
spring of the recording
frame is not good.
① Rubber roller of the
Some characters or waveform ① Clean rubber roller.
recording case has stain.
recorded are missing. ② Change print head.
② Print head failure.
① There is a stain on the ① Clean the stain on the
detecting position of the detecting position of the
Error for detecting paper print head. print-head.
② Print head failure. ② Change print head.
③ Main board failure. ③ Change main board.
5. Parameter troubles
① Install electrode clamp

① Electrode clamp is not
again or clean electrode area
installed well on patient.
on body surface with alcohol.
No ECG waveform ② Patient cable is loose
② connect the patient cable
from the unit.
with the unit.
③ ECG board failure.
③ Change ECG board.
-29-
① Install electrode clamp

again or clean electrode area
ECG waveform is abnormal installed well on patient.
on body surface with alcohol
or disturbed ② Patient cable failure.
② Change patient cable
③ ECG board failure.
③ Change ECG board
① Waveform measuring
Heart rate is not accurate ① Adjust connections
failure
①Install electrode clamp again
or clean electrode area on body
ECG waveform has burrs installed well.
surface with alcohol
② ECG board failure
② Change ECG board
-30-
Chapter 7 Modules’ Malfunction Verification

When a module is suspected of malfunction, the method to verify it is described in this chapter.
7.1 Verifying the Main Board
To verify the main board,
1) Open the main unit using the procedures described in Chapter 8.
2) Switch on the monitor. (Powered by AC or battery.)
3) Using a multimeter, measure the voltage to earth of the test points listed below.
Item Test point Reference result
① T3 +22V±0.2V(for SE-601B)
+30V±0.2V(for SE-601C)
② T5 +3.3V±0.15V
③ T6 +12V±0.6V
④ T7 +8.3V±0.42V
⑤ T8 +5V±0.25V
⑥ T19 -9.28V±0.1V (for SE-601A)
⑦ T14 +2.0V±0.1V
⑧ T17 +8.1V±0.4V
⑨ GND
-31-
⑧ T17 ⑨ GND ⑥ T19
④ T7
⑤ T8 ③ T6 ①T3 ② T5 ⑦ T14
4) Compare the measurement results with the reference results in the list. If anyone of the results
exceeds the reference range, the main board defection is confirmed. Replacement of the main
board is recommended.
-32-
7.2 Verifying the ECG Board
To verify the ECG board,
1) Make sure the malfunction of ECG measurement is not caused by other defects, such as bad
connection, defective electrodes or main board, etc.
3) Switch on the monitor.
① 5V 5.0V±0.15V
② -5V 5.0V±0.15V
③ 2.5V 2.5V±0.085V
④ -2.5V -2.5V±0.05V
⑤ 3.3V 3.3V±0.1V
⑥ 1V596 1.596V±0.014V
⑦ 1V1 1.2V±0.4V
⑧ -1V1 1.2V±0.4V
⑨ GND
-33-
③ 2.5V ④ -2.5V
① 5V
② -5V
⑤ 3.3V ⑦ -1V1 ⑧ 1V1
⑥ 1V596 ⑨ GND
exceeds the reference range, the ECG board defection is confirmed. Replacement of the ECG
board is recommended.
-34-
7.3 Verifying the Keyboard
To verify the Keyboard,
2) Switch on the monitor.
① T3V3 3.3±0.1V
② T+5V 5±0.5V
③ GND
② T+5V
③ GND
① T3V3
exceeds the reference range, the keyboard defection is confirmed. Replacement of the keyboard is
recommended.
-35-
Chapter 8 Disassembling the Monitor
8.1 Disassembly Procedures
1. View of integral unit
2. Disassembly procedures of the integral unit
Remove the eight Machine Screws in the lower case assembled to open the device. But the upper
case assembly and lower case assembly can not be separated because there are signal connectors
between them. Therefore the user should be careful when disassembling the device, avoiding
destroying the signal connectors. Remove these signal connectors that can be dismantled directly
and move out the shield box in the lower case assembled to uncover the hidden signal connectors.
And then dismantle these hidden signal connectors to separate the upper and lower case as the
following figure shows.
Lower Case
M3X10 Machine Screw
Upper Case
-36-
1) Upper case disassembly
The Electrocardiograph upper case consists of Keyboard Assembly, Recorder Case and Upper Case.
And the disassembly sequence is: Keyboard Assembly > Recorder Case -> Upper Case.
Remove the fifteen tapping screws, and then the key board and the silica gel keyboard can be
dismantled from the Upper Case, pull out the axis of rotation between the recorder case and the
Upper Case, and then the Recorder Case can be dismantled from the Upper Case, as the following
figure shows.
Recorder Case
Axis of Rotation
Upper Case
Silica Gel Keyboard
Tapping Screws Keyboard
-37-
2) Recorder Case disassembly
Remove the two tapping screws and the two groups of Fixing Bar, and then the Recorder Rotation
Axis can be dismantled from Recorder Case, as the following figure shows.
Tapping Screws
Fixing Bar
Recorder Rotation Axis
-38-
3). Lower case disassembly

First remove all the relevant cables that can be moved out directly, and dismantle the unit in the
following sequence, as shown in the following figure.
Display Screen Assembly → Main Board → Paper Tray Component of Recorder → Power Supply
Board→ ECG Board →Recorder Frame Plate→ Handle→ Power Supply Socket components
Display Screen Assembly
Main Board
Paper Tray Component of Recorder

Thermal Head
Recorder Frame Plate

Power Supply Socket components
Power Supply Board

Lower Case
Handle
ECG Board
-39-
4). Display screen disassembly for SE-601A

Remove the four cross recessed tapping screws to separate the LCD Screen and Display Screen
Frame, as shown in the following figure.
Cross Recessed Tapping Screw
LCD Screen
Display Screen Frame
5). Display screen disassembly for SE-601B

Remove the six cross recessed tapping screws to separate the LCD Screen and Display Screen
LCD Screen
-40-
6). Display screen disassembly for SE-601C

Remove the four cross recessed tapping screws to separate the LCD Screen and Display Screen
LCD Screen
-41-
8.2 Internal Boards and Interfaces
1. ECG board—receiving and processing ECG signals
1、J4-- connected to the main board J15.
Pin Description
2 GND
3, 4 Data transmitting
5 Vcc+5V
-42-
2. PS900G power supply board—providing power supply
1
2
1、J5-- connected to the transition board of power supply
2、J1-- connected to the lithium battery
Pin Description
1 Battery supply
2 Battery detecting
3 GND
3、J3-- connected to Mainboard J17 power output
Pin Description
1, 2 +12V
3, 4, 7, 10, 11 GND
5, 6 +5V
8, 9 8.1V
-43-
4、J1(power control board)-- connected to the Mainboard J13
Pin Description
1, 7, 9 GND
10 Turn on/off
5 Recharging Lock
3 Turnoff detecting
6 Mains supply
8 Battery measure
2 Turn off by software
4 Battery detecting
3. Keyboard PCB—Input interface
-44-
1、J6—connected to Mainboard
Pin Description
1 Vcc+ 5V
2, 3,10 GND
6 Turn on/off
7 Mains supply
8 Provide power supply for battery indicator circuit
9 Provide power supply for recharging indicator circuit
4. Mainboard
1 2 3 4 5 6
12 11 10 9
-45-
1、J7—connected to KEY board J6
Pin Description
1 Vcc+ 5V
2, 3,10 GND
6 Turn on/off
7 Mains supply
8 Provide power supply for battery indicator circuit
9 Provide power supply for recharging indicator circuit
2、J21—connected to SE-601B Screen
Pin Description
3 Vcc+5V
2 GND
1 Vcc+20V
others Signal port of LCD
3、J12—connected to SE-601C Screen
Pin Description
1,5,12,19,26,33 GND
28,29 Vdd+3V
4、J15—Connected to ECG board J4
Pin Description
2 GND
-46-
5 Vcc+5V
5、J13—Connected to power control board J1
Pin Description
1, 7, 9 GND
10 Turn on/off
5 Recharging Lock
3 Turnoff detecting
6 Mains supply
8 Battery measure
2 Turn off by software
4 Battery detecting
6、J17—Connected to Power supply board J3
Pin Description
1, 2 +12V
3, 4, 7, 10, 11 GND
5, 6 +5V
8, 9 8.1V
7、J16—connected to step motor
Pin Description
1,9,10 GND
2 Vcc+5V
3 Input port for paper detecting signal
4, 5, 6,7,8 Signal port of step motor
-47-
8、J11—connected to thermal print head
Pin Description
2,11,12,13,14,15,16,17,18,20, GND
1,24 Vdd+3V
3,4,5,28,29,30 VHH+8.1V
others Signal port of hermal print head
9、J19—connected to SE-601B Background brightness
Pin Description
1 Vcc+5V
2 GND
10、J18—connected to SE-601C Background brightness
Pin Description
1,2,3 Vcc+28V
4,5,6 GND
11、J24—connected to SE-601A Screen
Pin Description
1,20 GND
2 Vcc+5V
19 Background brightness control
12、J1—connected to Audio
Pin Description
1 Signal port of Audio
2 GND(MCU control)
-48-
Chapter 9 Field Replaceable Parts

The following list is intended as a guide for ordering parts for 6-Channel Electrocardiograph.
Part Number Description
M50R-078175 3.5 inch STN LCD
M50R-078182 5.7 inch STN LCD
MS1R-110325-A0 Silica gel keyboard
MS6R-110287 Keyboard PCB
M50R-078181 5.7 inch TFT LCD
M50R-078176 Thermal print-head

MS6R-110289 PS900G power board
MS6R-110290 PS900G power control board
MS6R-106796 ECG board
MS6R-110278 SE-601A main board
MS6R-110279 SE-601B main board
MS6R-110280 SE-601C main board
-49-
Chapter 10 Cleaning
10.1 Cleaning
CAUTION :
Turn off the power before cleaning and disinfection. Mains supply must be switched off
if it has been in use.
10.1.1 Cleaning the Main Unit and Patient Cable
The surfaces 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.
10.1.2 Clean the Electrodes
Remove the remainder gel from the electrodes with a clean soft cloth first. Take the suction
bulb and the 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.
10.1.3 Clean the Print Head
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.
-50-
CAUTION :
Do not clean the unit and accessories with abrasive fabric and avoid scratching the
electrodes.
10.2 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 surfaces of the unit and patient cable
with hospital standard disinfectant.
CAUTION :
Do not use chloric disinfectant such as chloride and sodium hypochlorite etc.
-51-
Chapter 11 Maintenance
11.1 Recharge and Replacement of Battery
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
: Capacity is limited, and hint information “BAT WEAK” will be displayed on LCD
screen. Recharge should be taken into account.
: Battery is weak, and hint information “BAT WEAK” will be displayed on LCD screen.
The battery should be recharged immediately.
2) Recharge
6-channel electrocardiograph is equipped with recharge control circuit together with built-in
rechargeable lithium battery. When connect with the mains supply, the battery will be
recharged automatically. And then the battery recharge indicator lamp ( ) and the mains
supply indicator lamp ( ) 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 be black.
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 the manufacturer 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
connecting the battery.
♦ When the battery’s useful life is over, contact the manufacturer or local
distributor for disposal or dispose the battery according to local regulations.
-52-
11.2 Recording Paper
Note: Recording 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:
♦ Recording 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 recording paper long time, or else the ECG record may trans-print each
other.
11.3 Maintenance of Main Unit, Patient Cable & 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 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 0.1ohm.
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
equipment log. If the device is not functioning properly or fails any of the above tests, the
device has to be repaired.
-53-
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 connecting or disconnecting the patient cable.
♦ Align the patient cable to avoid twisting, knotting or crooking in closed angle while using.
♦ Store the lead wires in a 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 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.
-54-
EDAN INSTRUMENTS, INC.
3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, shekou, Nanshan

Shenzhen, 518067 P.R. China
TEL:86-755-26882220 FAX: ＋86-755-26882223
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

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EDAN INSTRUMENTS, INC.

Manual Ver: V1.0

No part of this document may be photocopied, reproduced or translated to another language

The information contained in this document is subject to change without notice.

Model: SE-601A, SE-601B, SE-601C

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.

NOTE: This device is not intended for home use.

Using This Label Guide

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

Chapter 1 Warranty and Service

² Groupware is dismounted, stretched or re-debugged.

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

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

There are two options:

(3) Obtain RMA Form.

(4) Send the Parts to EDAN.

Follow these recommended instructions:

EDAN Instruments, Inc.

TEL: +86-755-26898321, 26899221

FAX: +86-755-26882223, 26898330

Chapter 2 Safety Information

2.1 List of Symbols

Equipment or part of CF type with defibrillator proof

Attention – general warning (see accompanying document)

Battery recharging indicator

Power On/Off key

Authorized Representative in the European Community

The symbol indicates that the device complies with the

The symbol indicates that the device should be sent to the

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

2.2 Warning and Caution

Z EXPLOSION HAZARD-Do not use the electrocardiograph in the presence of

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

Z If the integrity of external protective conductor in installation or arrangement is in doubt,

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

Z The following safety checks should be performed at least every 24 months by a

a) Inspect the equipment and accessories for mechanical and functional

WARNING : When performing a service procedure, follow the instructions exactly as

3.1 Environment and Power Supply Requirements

The environment requirements are listed in the following table.

Transport and Storage Working

Rated voltage: 14.8V; Rated capacity = 2200mAh

3) Power Consumption: 70VA

3.2 System Diagnostics Window

Figure 3-1 Enter Password interface

Figure 3-2 System Diagnostics window

(2) Display Test

Figure 3-3 Display Test Selection interface

Figure 3-4 Pixel Verification Test interface

Figure 3-5 Gray Scale Test Patterns interface1

Figure 3-6 Gray Scale Test Patterns interface2

Figure 3-7 Keyboard Test interface

Figure 3-8Writer Test interface

Figure 3-9 File System interface

(6) Battery Test

Figure 3-10 Battery Test interface