Professional Documents
Culture Documents
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.
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
IV
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.
-3-
Safety Guidance
External input
Caution
Potential equalization
Mains supply
On (mains supply)
Battery indicator
-4-
Safety Guidance
Recall key
Print/Stop key
ON/OFF key
Menu key
Recycle
Part Number
-5-
Safety Guidance
Serial Number
Date of Manufacture
Manufacturer
Anti-electric-shock degree:
Type CF
Disinfection/sterilization method:
Safety Guidance
of flammable gas
Working mode:
Continuous operation
EMC:
Group , Class A
Environment:
Temperature:
Relative Humidity:
Atmospheric
Pressure:
Working
-20 C ~ +55 C
5 C ~ 40 C
25% ~ 93%
25% ~ 80%
Non-Condensing
Non-Condensing
700hPa ~ 1060hPa
860hPa ~ 1060hPa
-7-
Safety Guidance
-8-
Safety Guidance
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.
-9-
Safety Guidance
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.
- 10 -
Safety Guidance
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 -
Safety Guidance
- 12 -
Operating Principle
- 13 -
Operating Principle
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 -
Operating Principle
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)
Operating Principle
2)
Front end module including the signal acquisition, digital filter and amplifier;
3)
4)
5)
6)
- 16 -
Operating Principle
- 17 -
Operating Principle
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 -
Operating Principle
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 -
Operating Principle
- 20 -
Functional Verification
Model
ECG simulator
FLUKE MPS450
ECG detector
NMI EGC-1C
- 21 -
Functional Verification
Functional Verification
- 23 -
Test point
Reference result
T3
18V~24V
T5
+5V0.25V
T7
+5V0.25V
T2
18V~24V
T6
+5V0.25V
T4
+8V0.5V
- 24 -
T2
T5
T6
T7
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.
- 25 -
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 -
Electrocardiograph Servicing
- 27 -
Electrocardiograph Servicing
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 -
Electrocardiograph Servicing
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 .
and the key panel are stuck to the upper unit , and can be torn off.
The label
- 29 -
Electrocardiograph Servicing
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 -
Electrocardiograph Servicing
- 31 -
Electrocardiograph Servicing
- 32 -
Electrocardiograph Servicing
- 33 -
Electrocardiograph Servicing
Net
Chip
(Optional)
- 34 -
Electrocardiograph Servicing
Pin
Description
Pin
Description
GND
RxD (input)
TxD (output)
+5V
- 35 -
Electrocardiograph Servicing
2. SE-3 Main Board -- Integrating Power Supply, Input/Output Interfaces and ARM9
Circuit
- 36 -
Electrocardiograph Servicing
Description
1, 2
16.8V AC INPUT
Description
6, 7, 25, 26
+8V
+5V
15
+3.3V
24
N.C
GND
Others
J9 -- connected to BP3 of the connecting board (Only for the ECG with narrow screen)
Pin
Description
4, 40
+5V
GND
5 ~ 21
25, 26, 28 ~ 33
36~39
Others
N.C
J10 -- connected to BP3 of the connecting board (Only for the ECG with wide screen)
Pin
Description
1 ~ 9, 13, 14
GND
- 37 -
Electrocardiograph Servicing
10, 40
+3.3V
25, 26, 28 ~ 33
20
LCD backlight
36~39
Others
N.C
Description
Enable
GND
3, 4
UART Signal
+5V
- 38 -
Electrocardiograph Servicing
Description
Battery supply
Battery detecting
GND
- 39 -
Electrocardiograph Servicing
4. Connecting Board
P1
BP2
BP3
Description
+5V
1, 20
GND
3~19
- 40 -
Electrocardiograph Servicing
Description
ON/OFF
GND
Others
BP3-- connected to J9 of the main board (Only for the ECG with narrow screen)
Pin
Description
4, 40
+5V
GND
5 ~ 21
25, 26, 28 ~ 33
36 ~ 39
Others
N.C
BP3-- connected to J10 of the main board (Only for the ECG with wide screen)
Pin
Description
1 ~ 9, 13, 14
GND
10, 40
+3.3V
25, 26, 28 ~ 33
20
LCD Backlight
36~39
Others
N.C
- 41 -
Electrocardiograph Servicing
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
Fuse failure
Main board failure
Key panel failure
Transformer failure
Power transition board
failure
Faulty mains supply
shift switch
Battery failure
Main board failure
Key panel failure
Strong interference of
electric networks
Main board failure
Faulty power supply of
the ARM9 circuit
- 42 -
Correction Actions
Change the fuse
Change the main board
Change the key panel
Change the transformer
Change the power transition
board
Change the mains supply
shift switch
Change the battery
Change the main board
Change the key panel
Inspect the power supply and
earthing system
Change the main board
Change or repair the power
supply
Electrocardiograph Servicing
2. Display Troubles
Fault Symptoms
Possible Causes
- 43 -
Correction Actions
Electrocardiograph Servicing
3. Transmission Troubles
Fault Symptoms
Possible Causes
Setup and connection
error
Connection
cable
failure
Net port failure
The ECG system does
not support the U disk type
USB socket failure
Correction Actions
Reset and reconnect the
device
Change the connection cable
Change the net port
Only the U disk in FAT
format can be used
Change the USB socket
4. Operation Troubles
Fault Symptoms
Key failure
No key beep
Possible Causes
The key panel is
damaged
Main board failure
Faulty transition board
of the upper and lower
units
Buzzer failure
KEY BEEP is set to
Off
Main board failure
Correction Actions
Buzzer failure
- 44 -
Electrocardiograph Servicing
Some characters or
waveforms recorded are
missing.
5. Parameter Troubles
Fault Symptoms
Possible Causes
Correction Actions
Reconnect the electrode
clamp again or clean the
electrode area on body surface
with alcohol
Reconnect the patient cable
to the unit
Change the ECG board
Reconnect the electrode
clamp again or clean the
electrode area on body surface
with alcohol
Change the patient cable
Change the ECG board
No ECG waveform
Waveform measuring
failure
Adjust connections
- 45 -
- 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.
) 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
) 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 (
- 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.
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 -
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 -
Renewal Parts
Part number
Description
01.57.040163
01.57.040162-11
01.57.471016
01.57.471017-11
02.02.20462-11
02.02.106908-01
02.02.20465
01.16.078199
01.16.078175
01.55.111450-01
02.02.106867
02.02.106870
01.17.078197
- 51 -