Release 1.1: Advanced Instrumentations, Inc

Electrocardiograph
ECG-12 Series
ADVANCED INSTRUMENTATIONS, INC.
Release 1.1
About this Manual
P/N: 01.54.455124-11
Release Date: Sept. 2010
Statement
This manual will help you understand the operation and maintenance of the product
better. It is reminded that the product shall be used strictly complying with this manual.
User’s operation failing to comply with this manual may result in malfunction or accident
for which the manufacturer cannot be held liable.
The manufacturer owns the copyrights of this manual. Without prior written consent of the
manufacturer, 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 the manufacturer.
The manufacturer holds the rights to modify, update, and ultimately explain this manual.
Product Information
Product Name: ECG-12 Series Electrocardiograph
Model: ECG-12, ECG-12 Plus
Responsibility of the Manufacturer

The manufacturer 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 the manufacturer, and
The electrical installation of the relevant room complies with national standards, and
I
The instrument is used in accordance with the instructions for use.
Upon request, the manufacturer may provide, with compensation, necessary circuit
diagrams, and other information to help qualified technician to maintain and repair some
parts, which the manufacturer may define as user serviceable.
Terms Used in this Manual

This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in
personal injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment,
produce inaccurate data, or invalidate a procedure.
NOTE: A NOTE provides useful information regarding a function or a procedure.
II
Table of Contents
Chapter 1 Safety Guidance........................................................................................ 1

1.1 List of Symbols................................................................................................. 1
1.2 Warnings and Cautions.................................................................................... 3
1.2.1 Safety Warnings ..................................................................................... 3
1.2.2 Battery Care Warnings............................................................................ 5
1.2.3 General Cautions.................................................................................... 5
1.2.4 Cleaning & Disinfection Cautions............................................................ 7
1.2.5 Preparation Warnings (for ECG-12 Plus Exercise ECG) ........................ 7
Chapter 2 Overview.................................................................................................... 9
2.1 Technical Specifications ................................................................................... 9
2.2 System Test Interface .................................................................................... 10
Chapter 3 Operating Principle................................................................................. 21
3.1 Basic Theory of ECG Operation..................................................................... 21
3.2 Composition of ECG ...................................................................................... 21
3.3 Lead............................................................................................................... 23
3.4 Description of Hardware Design Principle...................................................... 25
3.4.1 Main Board Description ........................................................................ 26
3.4.2 ECG Board Description ........................................................................ 28
3.4.3 PS900D Power Supply Module Description.......................................... 29
3.4.4 Key Board Description .......................................................................... 29
Chapter 4 Functional Verification ........................................................................... 31
4.1 System Tests.................................................................................................. 31
4.2 Application System Tests ............................................................................... 31
4.3 Safety Tests ................................................................................................... 33
Chapter 5 Troubleshooting...................................................................................... 34
Chapter 6 Modules’ Malfunction Verification ......................................................... 38
6.1 Verifying the Main Board................................................................................ 38
6.2 Verifying the ECG Board................................................................................ 40
6.3 Verifying the Key Board ................................................................................. 41
Chapter 7 Electrocardiograph Servicing................................................................ 44
7.1 Disassembly Procedures ............................................................................... 44
7.2 Internal Boards and Interfaces ....................................................................... 49
Chapter 8 Cleaning, Care and Maintenance........................................................... 59
8.1 Cleaning......................................................................................................... 59
8.1.1 Cleaning the Main Unit and the Patient Cable ...................................... 59
8.1.2 Cleaning the Reusable Electrodes........................................................ 59
8.1.3 Cleaning the Print Head........................................................................ 59
III
8.2 Disinfection .................................................................................................... 60
8.3 Care and Maintenance................................................................................... 60
8.3.1 Recharge and Replacement of Battery................................................. 60
8.3.2 Recorder Paper .................................................................................... 61
8.3.3 Maintenance of Main Unit, Patient Cable and Reusable Electrodes..... 62
Chapter 9 Renewable Parts ..................................................................................... 65
Chapter 10 After-Sales Service ............................................................................... 66
IV
ECG-12 Series Electrocardiograph Service Manual Safety Guidance
Chapter 1 Safety Guidance

This chapter describes important issues related to safely servicing the electrocardiograph.
The service provider must read and understand all the information presented in this
manual before servicing a unit.
1.1 List of Symbols
External output
External input
Equipment or part of CF type with defibrillator proof
Caution
Consult Instructions for Use
Potential equalization
Mains supply
USB port
Battery indicator
Battery recharging indicator
-1-
Delete key
Enter key
Esc key/Reset key
Shift key
Fn key
Power On/Off key
COPY key
MODE key
SLEEP/WAKE UP key
START/STOP key
Tab key/Feed paper key
UP/DOWN/LEFT/RIGHT Arrow key
Recycle
-2-
Part Number
Serial Number
Date of Manufacture
Federal (US) law restricts this device to sale by or on

Rx only (U.S.)
the order of a physician.
It indicates that the device should be sent to the special

agencies according to local regulations for separate
collection after its useful life.
1.2 Warnings and Cautions

In order to service the system safely and effectively, and avoid the possibility of injury,
please read the user manual and this service manual in detail and be sure to be
familiar with proper service methods. The following precautions must be paid more
attention to during the service procedure.
Notes:
1 This device is not intended for home use.
2 The pictures and interfaces in this manual are for reference only.
1.2.1 Safety Warnings
WARNING
1 The service provider must read and understand all the information presented in the
user manual and this service manual before installing or servicing a unit.
2 Only qualified service engineers can install this equipment, and only service
engineers authorized by the manufacturer can open the shell.
-3-
WARNING
3 This device is not intended for treatment or monitoring.
4 EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of

flammable anesthetic mixtures with oxygen or other flammable agents.
5 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.
6 If the integrity of the external protective conductor is in doubt, the equipment should
be powered by a built-in rechargeable battery.
7 Do not use this equipment in the presence of high static electricity or high voltage
equipment which may generate sparks.
8 This equipment is not designed for internal use or direct cardiac application.
9 Only the patient cable and other accessories supplied by the manufacturer can be
used. Or else, the performance and electric shock protection can not be guaranteed.
10 In order to avoid being burnt, please keep the electrodes far away from the radio knife
while using electrosurgical equipment.
11 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.
12 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.
13 The potential equalization bar can be connected to that of other equipment when
necessary. Make sure that all these devices are connected to the potential
equalization terminal.
14 The equipment is protected against malfunctions caused by electrosurgery according

to the clause 36.202.101 in the standard IEC 60601-2-25.
-4-
15 If the wireless AP technology is used, in order to maintain compliance with the FCC
RF exposure guidelines, the wireless AP should be installed and operated with a
minimum distance of 20cm between the radiator and the human body. Use the
supplied antenna only. There should be no shield in or around the room where the
wireless AP is used.
1.2.2 Battery Care Warnings
WARNING
1 Improper operation may cause the battery to be hot, ignited or exploded, and it may
lead to the decrease of the battery capacity. It is necessary to read the user manual
carefully and pay more attention to warning messages.
2 Only qualified service engineers authorized by the manufacturer can open the battery
compartment and replace the battery, and batteries of the same model and
specification should be used.
3 DANGER OF EXPLOSION -- Do not reverse the anode and the cathode when
installing the battery.
4 Do not heat or splash the battery or throw it into fire or water.
5 When leakage or foul smell is found, stop using the battery immediately. If your skin
or cloth comes into contact with the leakage liquid, cleanse it with clean water at once.
If the leakage liquid splashes into your eyes, do not wipe them. Irrigate them with
clean water first and go to see a doctor immediately.
6 Only when the device is off can the battery be installed or removed.
1.2.3 General Cautions
CAUTION
1 Federal (U.S.) law restricts this device to sale by or on the order of a physician.
2 Avoid liquid splash and excessive temperature. The temperature must be kept
between 5 ºC and 40 ºC during operation, and it should be kept between -20 ºC and
55 ºC during transportation and storage.
-5-
CAUTION
3 Do not use the equipment in a dusty environment with bad ventilation or in the
presence of corrosive.
4 Make sure that there is no intense electromagnetic interference source around the
equipment, such as radio transmitters or mobile phones etc. Attention: large medical
electrical equipment such as electrosurgical equipment, radiological equipment and
magnetic resonance imaging equipment etc. is likely to bring electromagnetic
interference.
5 Before use, the equipment, patient cable and electrodes etc. should be checked.
Replacement should be taken if there is any evident defectiveness or aging symptom
which may impair the safety or the performance.
6 The following safety checks should be performed at least every 24 months by a
qualified person who has adequate training, knowledge, and practical experience to
perform these tests.
a) Inspect the equipment and accessories for mechanical and functional damage.
b) Inspect the safety related labels for legibility.
c) Inspect the fuse to verify compliance with the rated current and circuit-breaking
characteristics.
d) Verify 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 µA,
SFC 1000µA.
g) Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC
100µA, SFC 500µA.
h) Test the patient leakage current according to IEC/EN 60601-1: Limit: NC a.c.
10µA, d.c. 10µA; SFC a.c. 50µA, d.c. 50µA.
i) Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC a.c.
j) Test the patient leakage current under single fault condition with mains voltage
on the applied part according to IEC/EN 60601-1: Limit: 50µA (CF).
The data should be recorded in an equipment log. If the device is not functioning
properly or fails any of the above tests, the device has to be repaired.
7 Ruptured fuse must only be replaced with that of the same type and rating as the
original.
-6-
8 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 battery, please contact your
local Civic Office, or the shop where you purchased the product.
1.2.4 Cleaning & Disinfection Cautions
CAUTION
1 Turn off the power before cleaning and disinfection. If the mains supply is used, the
power cord should be dragged out of the outlet. Prevent the detergent from seeping
into the equipment.
2 Do not immerse the unit or the patient cable into liquid under any circumstances.
3 Do not clean the unit and accessories with abrasive fabric and avoid scratching the
electrodes.
4 Any remainder of detergent should be removed from the unit and the patient cable
after cleaning.
5 Do not use chloric disinfectant such as chloride, sodium hypochlorite etc.
1.2.5 Preparation Warnings (for ECG-12 Plus Exercise ECG)
WARNING
1 Ensure that the main unit and the treadmill/ergometer are effectively grounded.
2 Test the emergency stop switch of the treadmill before using the system.
3 Turn off the system power and disconnect the power cord from the wall outlet after
using the system.
4 Keep the treadmill/ergometer on a horizontal place and make sure it’s stably working.
5 Make sure that the power cable of the treadmill/ergometer is grounded. Don’t use
other electrical equipment with the same power supply line.
6 Keep the power cable far away from the running treadmill area and the heat surface.
-7-
WARNING
7 Examine the treadmill/ergometer carefully before using it.
8 Do not use the treadmill/ergometer in the open air.
9 The patient undergoing the stress exercise test should wear suitable clothes and
shoes.
10 Keep hands, hair, jewelry and loose clothing away from moving parts of the treadmill.
11 Children are prohibited from approaching the treadmill/ergometer alone.
12 Don’t insert anything into the treadmill, or place anything on its surface.
13 Press down the emergency stop switch to stop the treadmill immediately an
emergency happens.
-8-
ECG-12 Series Electrocardiograph Service Manual Overview
Chapter 2 Overview
The service manual is a reference for periodic preventive maintenance and corrective
service procedures for the ECG-12 Series Electrocardiograph.
WARNING
When performing a service procedure, follow the instructions in this manual exactly.
Failure to do so could damage the device, invalidate the product warranty, and lead to
serious personal injury.
This guide provides troubleshooting information, disassembly procedures, and

instructions for functional testing and performance verification. It is intended to be used
by technically qualified service personnel only.
2.1 Technical Specifications
Safety Standards:
IEC 60601-1: 1988+A1+A2, EN 60601-1:1990+A1+A2, IEC/EN60601-1-2: 2001+A1,

IEC/EN60601-2-25, ANSI/AAMI EC11, IEC/EN 60601-2-51
Classifications:
Anti-electric-shock type: Class І with internal power supply

Anti-electric-shock degree: Type CF
Degree of protection against harmful Ordinary equipment (Sealed equipment
ingress of water: without liquid proof)
Disinfection/sterilization method: Refer to the user manual for details
Degree of safety of application in the Equipment not suitable for use in the
presence of flammable gas: presence of flammable gas
Working mode: Continuous operation

EMC: Group І, Class A
Environment Requirements:
Transport and Storage Working
-20ºC (-4ºF) ~ +55ºC +5ºC (+41ºF) ~ +40ºC

Temperature:
(+131ºF) (+104ºF)
-9-
25%~93% 25%~80%
Relative Humidity:
Non-Condensing Non-Condensing
Atmospheric
700hPa ~1060hPa 860hPa ~1060hPa
Pressure:
Power Supply Specifications:

1) Mains Supply:
Operating Voltage: 100V-240V~
Operating Frequency: 50Hz/60Hz
Input Power: 70VA
2) Built-in Rechargeable Lithium Battery Pack:
ECG-12 Plus: Rated voltage: 14.8V; Rated capacity: 4400mAh
ECG-12 : Rated voltage: 14.8V; Rated capacity: 2200mAh
3) Power Consumption: 70VA
4) Fuse Specification: T1AL250VP Ø5×20
2.2 System Test Interface
The System Test interface is password protected and only technicians authorized by the
manufacturer can open it. The password is 006363.
1. Opening the System Test Interface
When the System Setup interface is displayed, press F2 on the keyboard to display the
Service Password interface (Figure 2-1). After you enter the correct password and press
Enter, the System Test interface (Figure 2-2) appears.
On the System Test interface, press Tab or Shift + Tab, or the Up, Down, Left or Right
arrow to move the cursor to a certain sub-item, and then press Enter to open the test
interface related to the sub-item.
Figure 2-1 Service Password Interface
- 10 -
Sub-item
Figure 2-2 System Test Interface
2. Display Test
arrow to move the cursor to the Display item, and then press Enter to display the
Display interface (Figure 2-3). Press the Up or Down arrow to select Pixel Verification
Test or Gray Scale Test Patterns.
Figure 2-3 Display Interface
Select Pixel Verification Test and press Enter, and then the Pixel Verification Test
interface (Figure 2-4) appears.
- 11 -
Figure 2-4 Pixel Verification Test Interface
Press the Left or Right arrow to move the color bars across the screen, and you 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
among white, green, red and blue.
Press the ESC key to exit the Pixel Verification Test interface.
- 12 -
Select Gray Scale Test Patterns and press Enter, and then the Gray Scale Test
Patterns interface1 (Figure 2-5) appears.
Figure 2-5 Gray Scale Test Patterns Interface1
Press any key to open the Gray Scale Test Patterns interface2 (Figure 2-6).
Figure 2-6 Gray Scale Test Patterns Interface2
Press ESC to exit the interface.
- 13 -
3. Touch Test (Only for ECG-12 Plus)

arrow to move the cursor to the Touch Screen item, and then press Enter to open the
Touch Screen interface.
On this interface, when you touch a key on the touch screen, this key will be displayed in
the blank field on the top of the interface.
Figure 2-7 Touch Screen Interface
4. Keyboard Test
arrow to move the cursor to the Keyboard item, and then press Enter to open the
Keyboard interface.
When you press a key on the keyboard of the device, this key will be displayed in the
corresponding position on the Keyboard interface.
Note: When you press the key, the device will be turned off.
- 14 -
Figure 2-8 Keyboard Interface
5. File System Test

arrow to move the cursor to the File System item, and then press Enter to open the File
System interface.
This interface displays the number of files, the total space, the used space and the use
ratio.
- 15 -
Figure 2-9 File System Interface
6. Battery Test
arrow to move the cursor to the Battery item, and then press Enter to display the Battery
interface.
This interface displays the battery capacity (including 033%, 066% and 100%), whether
AC power is used and whether the battery is being charged.
- 16 -
Figure 2-10 Battery Interface
7. UART Test
arrow to move the cursor to the UART item, and then press Enter to open the UART
interface.
On this interface, pressing the START/STOP key can make the system send and receive
characters. If the character received is always the same as the character sent, which is
displayed on the screen, it indicates that the system’s UART works well.
Press START/STOP again to stop testing. Press ESC to exit the interface.
Note: During the testing course, you should not press the ESC key to exit.
- 17 -
Figure 2-11 UART Interface

8. Recorder Test
arrow to move the cursor to the Recorder item, and then press Enter to display the
Recorder interface.
On this interface, press the START/STOP key to begin to print the triangle waves in
effective paper width. The status of the print head can be estimated from the triangle
waves. Press START/STOP again to stop printing.
Note: During the printing course, you should not press the ESC key to exit.
- 18 -
Figure 2-12 Recorder Interface
9. Statistics
arrow to move the cursor to the Statistics item, and then press Enter to open the
Statistics interface.
Statistic information includes the numbers of the auto records, manual records and
rhythm records, and the total recording and working time of the device.
- 19 -
Figure 2-13 Statistics Interface
- 20 -
ECG-12 Series Electrocardiograph Service Manual Operating Principle
Chapter 3 Operating Principle
This chapter describes the basic theory and the internal circuit structure of the
electrocardiograph to let the service provider understand the operating principle.
3.1 Basic Theory of ECG Operation
The heart is a power organ of the blood circulation. Before the systole or the diastole, a
cardiac impulse happens in the heart muscle, and a faint bioelectric signal is thus
generated. The bioelectric signal is transmitted through the whole body, and the potential
difference is generated on the different skin surfaces because of the different distances
from the heart.
The cardiogram is a record of the amplification of the potential distribution on the body
skin surface. The potential difference is sampled by the electrodes, and amplified and
processed by the electrocardiograph. Then it is recorded on the paper. The cardiogram
recorded by the electrocardiograph can help doctors to analyze and diagnose heart
disease. The intended use of the electrocardiograph is to acquire ECG signals from adult
and pediatric patients through body surface ECG electrodes. The electrocardiograph only
records the heart's electrical activity, and does not produce any electricity of its own. The
test does not hurt and has no known side effects. It does not require any preparations
except possibly shaving chest hair to get a better recording. The recording itself takes
only a few seconds.
It is more than one hundred years since the electrocardiograph was applied in clinical
diagnosis. The electrocardiograph is an important measurement in clinical diagnosis of
heart disease, and is equipped in almost every hospital and clinic.
3.2 Composition of ECG
The standard 12-lead electrocardiogram is a representation of the heart's electrical

activity recorded from electrodes on the body surface. A normal ECG wave consists of a
P wave, a QRS complex, an ST segment, a T wave and a U wave. In the following figure,
the x-axis indicates time and the y-axis indicates voltage. When the printing speed is
25mm/s and the gain is 10mm/mV, one small grid on the x-axis represents 0.04 seconds,
and one small grid on the y-axis represents 0.1mV.
This diagram illustrates ECG waves and intervals as well as standard time and voltage
- 21 -
measures on the ECG paper.
Figure 3-1 Composition of ECG
P wave: the sequential activation (depolarization) of the right and left atria
QRS complex: the right and left ventricular depolarization (normally the ventricles are
activated simultaneously)
ST-T wave: the ventricular repolarization
U wave: the origin of this wave is not clear - but probably represents
"after-depolarization" in the ventricles
PR interval: the interval from the onset of the atrial depolarization (P wave) to the
onset of the ventricular depolarization (QRS complex)
QRS duration: the duration of the ventricular muscle depolarization
QT interval: the duration of the ventricular depolarization and repolarization
RR interval: the duration of the ventricular cardiac cycle (an indicator of the ventricular
rate)
PP interval: the duration of the atrial cycle (an indicator of the atrial rate)
- 22 -
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
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)
- 23 -
Figure 3-2 Standard Limb Leads
RA: Right arm

LA: Left arm
LL: Left leg
V1: Fourth intercostal space at the right border of the sternum
V2: Fourth intercostal space at the left border of the sternum
V3: Fifth rib between V2 and V4
V4: Fifth intercostal space on the left midclavicular line
V5: Left anterior axillary line at the horizontal level of V4
V6: Left midaxillary line at the horizontal level of V5
- 24 -
Figure 3-3 Standard Chest and Limb Leads
3.4 Description of Hardware Design Principle
The ECG-12 Series Electrocardiograph consists of the following functional blocks:

1) PS900D power supply board
2) Lithium battery
3) Main board
4) Key board
5) LCD display module
6) ECG board
7) Thermal printer module
- 25 -
Figure 3-4 Block Diagram of the Electrocardiograph
3.4.1 Main Board Description
The main board includes Core CPU, SDRAM, FLASH, buffer chip, Ethernet driver chip,
power supply, printing interface, audio interface, TFT screen interface, USB interface,
RS232-Serial port, analog input and output.
- 26 -
Figure 3-5 Main Board Diagram
- 27 -
3.4.2 ECG Board Description
Figure 3-6 ECG Board Diagram
- 28 -
The electrocardiograph has 10 lead cables. The ECG signals pass through the
defibrillator protection circuit, the buffering circuit, and enter the difference amplifier circuit.
Then they continue to pass through the pacemaker pulse restraining, high-pass filter,
low-pass filter, channel switch, second level amplification, and enter the A/D sampling
port of ADC.
3.4.3 PS900D Power Supply Module Description
Figure 3-7 PS900D Power Supply Module Diagram
PS900D power supply module is shown in the above figure. This module provides +12V
and +5V voltages for the main board, and also provides recharging circuit for the 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.
3.4.4 Key Board Description
The 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 (ATmega161) detects the interrupt
signal, it reads the key by row scan and column scan, and sends values to the main
board through the serial port.
- 29 -
Figure 3-8 Key Board Diagram
- 30 -
ECG-12 Series Electrocardiograph Service Manual Functional Verification
Chapter 4 Functional Verification
This chapter describes the procedure of a complete functional test to support

recommended preventive maintenance schedules.
The following functional tests should be performed at least every 24 months by a
Functional verification does not require opening the device case.
WARNING
Only qualified service personnel should perform a full functional checkout procedure.
Whenever the electrocardiograph is serviced or problems are suspected, the

manufacturer recommends a functional test.
4.1 System Tests
1. Unit Appearance and Assembly Examinations

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

Observe whether some characters are missing, or there are bright spots and dark
- 31 -
shadows on the LCD screen. Observe whether the waveforms, fonts and symbols
displayed on the LCD screen are normal. On the Display Setup interface, press the Up
or Down arrow to adjust the Brightness progress bar, and the brightness of the LCD
screen changes.
3. Lead Off Tests

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

When the System Setup interface is displayed, press Tab or Shift + Tab, or the Up,
Down, Left or Right arrow to move the cursor to Maintenance, and then press Enter to
open the System Maintenance interface. Press Tab or Shift + Tab to move the cursor to
the Load Factory Settings button on the System Maintenance interface, and then
press Enter to load the factory settings from the ECG. Press Enter to confirm and return
to the System Setup interface. Press Tab or Shift + Tab, or the Up, Down, Left or Right
arrow to move the cursor to Date&Time, and then press Enter to open the Date&Time
Setup interface. Set the current time, and then press Enter to confirm.
Turn off the electrocardiograph, and turn it on five seconds later. When the
electrocardiograph is ready for examination, observe whether the time displayed on the
LCD screen is the current time, and open the sub-interfaces of the System Setup
interface to see whether these items keep the default options. Then change some items
and exit. Turn off the electrocardiograph. Five seconds later, turn on the
electrocardiograph again. When the electrocardiograph is ready for examination, observe
whether the items keep the changed options.
6. Heart Rate Display Tests

Set the heart rate output from the ECG simulator to different values, and the error of heart
rate values displayed on the LCD screen of the electrocardiograph should be within
±1bpm.
7. Recording Tests
1) Set the following values:
The heart rate output from the ECG simulator is 80bpm, the working mode of the
- 32 -
electrocardiograph is auto, the speed is 25mm/s, the gain is 10mm/mV, the AC filter is off,
the Lowpass filter is 150Hz and all the items in the Auto Record Info frame on the Setup
2 sub-interface of the Record Info Setup interface are selected. Install the recorder
paper and press the START/STOP key to begin to print an ECG report. Examine whether
the printed contents are integrated and consistent with the information displayed on the
LCD screen.
2) Make the ECG detector output sine waves with the amplitude of 2mV and the
frequency of 10Hz. Press the START/STOP key to begin to print ECG reports. Examine
whether the printed contents are integrated and consistent with the information displayed
on the LCD screen.
3) The ECG report includes the date and time, ID, name, sex, age, gain, paper speed,
filter, lead, 1mV calibration mark, ECG waveform, heart rate etc. The 1mV calibration
mark and lead names are printed before ECG waves in the ECG reports. The printed
characters and waveforms are clear.
4) Open the recorder casing and remove the recorder paper, and then the hint
information No Paper should be displayed. Install the recorder paper again and close the
recorder casing, and then the hint information No Paper should disappear.
4.3 Safety Tests
1) Test the protection earth resistance according to IEC/EN 60601-1: Limit: 0.1 ohm.
2) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500 µA, SFC
1000µA.
3) Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC 100µA,
SFC 500µA.
4) Test the patient leakage current according to IEC/EN 60601-1: Limit: NC a.c. 10µA, d.c.
10µA; SFC a.c. 50µA, d.c. 50µA.
5) Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC a.c. 10µA,
d.c. 10µA; SFC a.c. 50µA, d.c. 50µA.
6) Test the patient leakage current under single fault condition with mains voltage on the
applied part according to IEC/EN 60601-1: Limit: 50µA (CF).
- 33 -
ECG-12 Series Electrocardiograph Service Manual Troubleshooting
Chapter 5 Troubleshooting
WARNING
Replace parts, components, or accessories only with parts supplied or approved by the
manufacturer. The use of any other parts can lead to inferior device performance and will
void the product warranty.
This troubleshooting guide introduces the suitable actions for correcting the problems,
replacing the accessories or calling the service personnel. It can also help you describe
the fault symptoms more exactly when calling for service, which greatly makes the
service fast and efficient.
1. System Troubles
Conditions Possible Causes Actions
Fuse failure Replace the fuse

When the mains supply is Power board or main Replace the power board or
used, you can not turn on board failure. the main board
the electrocardiograph. Silicone keyboard Replace the silicone
failure keyboard
Battery failure Replace the battery
When the battery is used, Main board or power Replace the main board or
you can not turn on the board failure the power board
electrocardiograph. Silicone keyboard Replace the silicone
failure keyboard
Strong interference of
Inspect the power supply
electric networks
and grounded system.
The electrocardiograph fails Main board failure
Replace the main board
to function. The plug-in unit on the
Replace or repair the
main board or the power
plug-in unit
supply failure
Fuse is burned when you The power supply or Open the
turn on the other components electrocardiograph for further
electrocardiograph. short-circuit. examination
Fuse is burned when the
This component
device connects to a certain Replace this component.
short-circuits.
component.
- 34 -
2. Display Troubles
Some characters displayed

on the LCD screen are LCD screen failure. Replace the LCD screen
missing.
The brightness of the Adjust the brightness of the

LCD screen is not LCD screen on the Display
The LCD screen is dark.
adjusted well. Setup interface.
LCD screen failure Replace the LCD screen
3. Transmission Troubles
Examine whether the

transmission settings are
correct. (The first three
Fail to transmit ECG data
Setup error sections of Local IP and
through the net port
Connection cable Remote IP must be set the
failure same as the first three
Fail to copy data from the
Port failure sections of the IP of the PC.)
electrocardiograph to the U
U disk failure Replace the connection
disk
cable
Replace the port
Replace the U disk
4. Operation Troubles
① The key board is

① Replace the key board
Key failure damaged
② Replace the main board
② Main board failure
No key beep or key beep is

① Speaker failure ① Replace the speaker
raucous
- 35 -
The recorder paper

Install the recorder paper
runs out.
Replace the print head
The electrocardiograph can Print head failure
Replace the main board
not print reports. Main board failure
Replace or repair the
Recorder related
recorder related cable
cable failure
① The rubber roller of
the recorder casing has

① Clean the rubber roller
The printed report is stain.
illegible
② The elasticity of the ② Replace the spring
spring of the recorder

frame is not good.
The rubber roller of
Some characters or the recorder casing has ① Replace the rubber roller
waveforms printed are a stain.
missing. ② Replace the print head
② Print head failure.
① There is a stain on ① Clean the stain on the
the detecting position of detecting position of the

the printing bracket. printing bracket
Fail to detect paper
② Reflective ② Replace the reflective
photosensor failure photosensor
③ Main board failure ③ Replace the main board
5. Parameter Troubles
Defective connection Attach the electrodes to

between the patient and the patient again or clean
the electrodes the electrode area on body
No ECG waveform Defective connection surface with alcohol
between the patient cable Connect the patient cable
and the unit to the unit
ECG board failure Replace the ECG board
- 36 -
① Attach the electrodes to

① Defective connection
the patient again or clean
between the patient and the electrode area on body
ECG waveform is the electrodes surface with alcohol
abnormal or disturbed
② Patient cable failure ② Replace the patient
cable
③ ECG board failure
③ Replace the ECG board
① Waveform measuring
Heart rate is not accurate ① Adjust connections
failure
① Attach the electrodes to
the patient again or clean

① Defective connection the electrode area on body
surface with alcohol
between the patient and
the electrodes ② Replace the ECG board
② ECG board failure Look for devices that

could be causing electrical
Electrical interference
ECG waveform has burrs interference, and then
from another device
unplug the devices. Or run
(microwave oven, cellular
the electrocardiograph on
phone, wireless device,
the battery power.
etc.)
An improperly-grounded Lay the lead wires
electrical device near the alongside the limbs and
away from any electrical
electrocardiograph
devices. Turn on the AC
filter on the Filter Setup
interface
- 37 -
ECG-12 Series Electrocardiograph Service Manual Modules’ Malfunction Verification
Chapter 6 Modules’ Malfunction Verification

When a module is suspected of malfunction, the verification methods are described in
this chapter.
6.1 Verifying the Main Board
To verify the main board,
1) Open the main unit following the procedures described in Chapter 7,

“Electrocardiograph Servicing”.
2) Switch on the device.
3) Measure the voltage to earth of the test points listed below by using a multimeter.
Item Test point Reference result
TP14 +3.3V±0.15V
TP6 +1.8V±0.09V
TP7 +2V±0.1V
GND
TP13 +3.3V±0.15V
TP11 +5V±0.25V
TP10 +5V±0.25V
TP9 +12V±0.6V
- 38 -
TP14 TP6 TP7 GND TP13 TP11 TP10 TP9
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.
- 39 -
6.2 Verifying the ECG Board
To verify the ECG board,
1) Make sure that the malfunction of ECG measurement is not caused by other defects,
such as defective connection, inoperative electrodes or main board, etc.

Item Test Point Reference Result
5V 5.0V±0.15V
V- ≤-5.9V
2.5V 2.5V±0.085V
-2.5V -2.5V±0.05V
3.3V 3.3V±0.1V
V+ ≤5.9V
- 40 -
V- -2.5V ⑥ V+ 5V 2.5V
3.3 V
the results exceeds the reference range, the ECG board defection is confirmed.
Replacement of the ECG board is recommended.
6.3 Verifying the Key Board
To verify the key board,

Item Test point Reference result
T3V3 3.3±0.1V
T+5V 5±0.5V
GND
- 41 -
③ GND
② T+5V
① T3V3
ECG-12 Plus Key Board
- 42 -
① T3V3
② T+5V
③ GND
ECG-12 Key Board
the results exceeds the reference range, the key board defection is confirmed.
Replacement of the key board is recommended.
- 43 -
ECG-12 Series Electrocardiograph Service Manual Electrocardiograph Servicing
Chapter 7 Electrocardiograph Servicing
7.1 Disassembly Procedures
1. Main Unit
2. Disassembly Procedures of the Main Unit
Remove the eight pan head screws on the lower unit to open the device. But the upper
unit and the lower unit can not be separated because there are signal cables between
them. Therefore you should be careful to avoid destroying the signal cables when
disassembling the device. Remove these signal cables that can be dismantled directly
and move them out of the lower unit to uncover the hidden signal cables. Then dismantle
these hidden signal cables to separate the upper and lower units.
1) Disassembly Procedures of the Upper Unit (ECG-12 )
Remove the six pan head screws to separate the front component from the rear
component of the LCD screen. Three sunk screws are used to fix the recorder
casing .
- 44 -
2) Disassembly Procedures of the Upper Unit Components (ECG-12 )

Dismantle the upper unit in the following sequence: key board → silicone keyboard
→ upper casing of recorder → rotation axis → press-plate of slide bar → slide bar
→ slide block .
In the following figure, is a tapping screw which is used to fix the upper casing of the
recorder, and is a pan head screw which is used to fix the rotation axis. The working
surface of is on the back of the upper casing .
- 45 -
3) Disassembly Procedures of the Rear Components of LCD Screen (ECG-12 )
The transition board ② and the LCD screen ④ are fixed on the rear casing of the LCD
unit ①. There are two cables connected to the transition board, and you should pull out
the cables before disassembly.
4) Disassembly Procedures of the Upper Unit (ECG-12 Plus)
Firstly, remove the six groups of stoppers in the screw holes ③ and the tapping screws
②, and pull out the cables between the front component of the LCD screen ④ and the
upper unit ①. Then dismantle the front component of the LCD screen ④ from the upper
unit ①. Take care of the cable sockets when inserting or pulling out cables. The recorder
casing ⑤ is fixed on the upper unit with three sunk screws ⑥.
- 46 -
5) Disassembly Procedures of the Upper Unit Components (ECG-12 Plus)

Make sure that there is no cable between each component of the upper unit before
disassembly. Dismantle the screws which are used to fix the key board and the upper
recorder casing . Then the two parts and the silicone keyboard can be moved out.
Dismantle the screws securing the left rotation axis , the right rotation axis and the
rear component of the LCD screen. Then the rear component of the LCD screen can be
moved out. The display switch board , display switch bar , switch cover and rotation
axis inlay can be dismantled after their corresponding screws are removed.
6) Disassembly Procedures of the Front Component (ECG-12 Plus)

Remove the related cables, dismantle the inverter and the transition board of the LCD
- 47 -
screen , remove the four groups of pan head screws and the fixing column . Then
the LCD screen, the fixing frame and the touch screen can be moved out. After
removing the hexagon nut and the gaskets , the LCD screen can be dismantled.
In the following figure, sponge chip is used to protect the LCD screen and the touch
screen. are the indicators.
7) Disassembly Procedures of the Lower Unit (ECG-12 Plus/ECG-12 )

In the following figure, is the lower unit, and is a pan head screw securing the upper
and the lower unit. Remove all the related cables that can be moved out directly, and
dismantle the unit in the following sequence: ECG board → power supply socket
components (including gasket and grounded bar ) → the remainder cables → main
board → paper tray component of the recorder → PS900D power supply board →
recorder frame plate .
- 48 -
7.2 Internal Boards and Interfaces
1. ECG Board -- Receiving and Processing ECG Signals
- 49 -
J4-- connected to main board J3
Pin Description
2 GND
5 DVcc+5V
3, 4 Data transmitting
2. PS900D Power Supply Board -- Providing Power Supply
- 50 -
P2 -- connected to the transition board of the power supply
② P3 -- connected to main board J1
Pin Description
1, 5, 6, 9 GND
2 Turn on
3 Recharging Lock
4 Turnoff detecting
7 Mains supply
8 Turn off by software
10 Recharge voltage detecting
- 51 -
P1 -- connected to main board J12, power output
Pin Description
4, 5, 6 GND
1 +12V
2 +5V
6 -12V
3 Battery Voltage
3. Key Board - Input Interface
ECG-12 Plus Key Board
J2 -- connected to LCD screen①
Pin Description
9, 10, 11, 12, 17, 20 GND
- 52 -
5, 7 Vcc+5V
6, 8 DVcc+12V
19 Mains supply
1, 2, 3, 4 LCD screen power supply
13 Background light switch control
14 Background brightness control
15 Provide power supply for battery indicator circuit
16, 18 Provide power supply for recharging indicator circuit
J1 -- connected to main board
Pin Description
11, 13 GND
7, 9 Key_+5V
15, 17 DVcc+12V
10 Mains supply
1, 2, 3, 4 LCD screen power supply
14 Battery voltage detecting
16 Turn on
18 Turnoff detecting
22 Recharging Lock
- 53 -
ECG-12 Key Board
J1 -- connected to main board
Pin Description
4, 11, 19, 25, 28, 30 GND
10, 12 Key_+5V
27, 29 DVcc+12V
21 AC+
16 Battery voltage detecting
24 Recharging Lock
1, 2, 3, 6, 7, 8, 9, 14 LCD screen power supply
J2 -- connected to LCD screen
Pin Description
4, 11, 13 GND
19 Mains supply
12, 14, 15, 17 DVcc+12V
- 54 -
16, 18 Provide power supply for recharging circuit
20 Provide power supply for battery recharging

circuit
1, 2, 3, 6, 7, 8, 9, 10 LCD screen power supply
4. ECG-12 Main board
① ⑨
②
⑧
③ ⑦
J2 -- connected to the speaker
Pin Description
1 Signal port of audio
2 GND (When the device is turned on)
- 55 -
J28 -- connected to the Wide Screen key board
Pin Description
3, 4, 7, 8, 11, 14, 27, 29, GND

36
5, 6, 9, 10, 12, 13, 15, Signal port of LCD

16
1, 2 VDD+3V
23, 25 DVcc+5V
31, 33 DVcc+12V
26 Mains supply
32 Turn on
34 LCD Turnoff detecting
38 Recharging Lock
J25 -- connected to Narrow Screen key board
Pin Description
4, 11, 19, 22, 25, 28, 30 GND
1, 2, 3, 5, 6, 7, 8, 9 Signal port of LCD
10, 12, 27, 29 DVcc+5V
21 Mains supply
- 56 -
18 Turn on
14 Vee+20V
24 Recharging Lock
④ J11 -- connected to power supply board P3
Pin Description
1, 5, 6, 9 GND
2 Turn on
3 Recharging Lock
4 Turnoff detecting
7 Mains supply
⑤ J12 -- connected to power supply board P1
Pin Description
4, 5, 6 GND
1 +12V
2 +5V
3 Battery voltage
⑥ J23 -- connected to the step motor
Pin Description
1, 2, 3, 5 Signal port of step motor
⑦ J19 -- connected to the thermal print head
- 57 -
Pin Description
4, 5, 6 GND
7 DVcc+5V
1, 2, 3 VH+24V
others Signal port of thermal print head
⑧ J3 -- connected to ECG board J4
Pin Description
2 GND
5 DVcc+5V
⑨ J6 -- connected to the reflective photosensor
Pin Description
1 Cathode of light emitting diode
3 DVcc+5V
2 Paper detecting signal
- 58 -
ECG-12 Series Electrocardiograph Service Manual Cleaning, Care and Maintenance
Chapter 8 Cleaning, Care and Maintenance
8.1 Cleaning
CAUTION
Turn off the power before cleaning and disinfection. The mains supply must be switched
off if it is used.
8.1.1 Cleaning the Main Unit and the Patient Cable
The surfaces of the main unit and the patient cable can be wiped with a clean soft
cloth damped in soapy water or non-caustic neutral detergent. After that, remove
detergent remainder with a clean dry cloth.
8.1.2 Cleaning the Reusable Electrodes
Remove the remainder gel from the electrodes with a clean soft cloth first. Take
suction bulbs and metal cups of chest electrodes apart, and take clamps and metal
parts of limb electrodes apart. Clean them in warm water and make sure there is no
remainder gel. Dry the electrodes with a clean dry cloth or air dry naturally.
8.1.3 Cleaning the Print Head
Dirty and soiled thermal print head will deteriorate the printing definition. So it should
be cleaned at least once a month regularly.
Open the recorder casing and remove the paper. Wipe the print head gently with a
clean soft cloth damped in 75% alcohol. For stubborn stain, soak it with a little alcohol
first and wipe it off with a clean soft cloth. After air drying, load the recorder paper
and shut the recorder casing.
CAUTION
1 Prevent the detergent from seeping into the main unit while cleaning. Do not immerse
the unit or the patient cable into liquid under any circumstances.
2 Do not clean the unit and accessories with abrasive fabric and avoid scratching the
- 59 -
electrodes.
8.2 Disinfection
To avoid permanent damage to the equipment, disinfection can be performed only

when it is considered as necessary according to your hospital’s regulations.
Before disinfection, clean the equipment first. Then wipe the surfaces of the unit and
the patient cable with hospital standard disinfectant.
Note: Clean and disinfect the chest and limb electrodes after each use.
CAUTION
Do not use chloric disinfectant such as chloride, sodium hypochlorite etc.
8.3 Care and Maintenance
8.3.1 Recharge and Replacement of Battery
1) Capacity Identification
The current capacity of the rechargeable battery can be identified according to the
battery symbol in the top right corner of the LCD screen.
: Full capacity;
: 2/3 capacity;
: 1/3 capacity;
: Low capacity
2) Recharge
The ECG-12 Series Electrocardiograph is equipped with the recharge control circuit
together with the built-in rechargeable lithium battery. When the unit is connected to
the mains supply, the battery will be recharged automatically. Then the battery
recharging indicator ( ) and the mains supply indicator ( ) will be lit at the same
time. During the recharging course, the symbol flashes in the top right corner of
the LCD screen. After the battery is fully recharged, the symbol stops flashing, and
the battery recharging indicator ( ) is black.
Because of the capacity consumption during the storage and transport course, the
- 60 -
battery capacity is not full when it is used for the first time. Battery recharge should
be considered before the first 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, and the battery of the same model and
specification provided by the manufacturer must be used.
2. Danger of explosion -- Do not reverse the anode and the cathode when installing the
battery.
3. When the battery’s useful life is over, contact the manufacturer or the local distributor
for disposal or dispose of the battery according to local regulations.
8.3.2 Recorder Paper
Note: Recorder paper provided by the manufacturer should be used. Other paper may
shorten the life of the thermal print head. The deteriorated print head may lead
to illegible ECG reports and block the advance of the paper.
Storage Requirements:
♦ Recorder paper should be stored in a dry, dark and cool area, avoiding
excessive temperature, humidity and sunshine.
♦ Do not put the recorder paper under fluorescence for a long time.
♦ Make sure that there is no polyvinyl chloride or other chemicals in the storage
environment, which will lead to color change of the paper.
♦ Do not overlap the recorder paper for a long time, or else the ECG reports may
trans-print each other.
- 61 -
8.3.3 Maintenance of Main Unit, Patient Cable and Reusable
Electrodes
The following safety checks should be performed at least every 24 months by a

Inspect the equipment and accessories for mechanical and functional damage.
Inspect the safety related labels for legibility.
Inspect the fuse to verify compliance with the rated current and circuit-breaking
characteristics.
Verify that the device functions properly as described in the instructions for use.
Test the protection earth resistance according to IEC/EN 60601-1: Limit: 0.1 ohm.
Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500µA,
SFC 1000µA.
Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC

100µA, SFC 500µA.
Test the patient leakage current according to IEC/EN 60601-1: Limit: NC a.c.
Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC a.c.
Test the patient leakage current under single fault condition with mains voltage on
the applied part according to IEC/EN 60601-1: Limit: 50µA (CF).
The leakage current should never exceed the limit. The data should be recorded in
an equipment log. If the device is not functioning properly or fails any of the above
tests, the device has to be repaired.
WARNING
Failure on the part of the responsible individual hospital or institution employing this
equipment to implement a satisfactory maintenance schedule may cause undue
- 62 -
equipment failures and possible health hazards.
1) Main Unit
♦ Avoid excessive temperature, sunshine, humidity and dirt.
♦ Put the dustproof coat on the main unit after use and prevent shaking it violently
when moving it to another place.
♦ Prevent any liquid from seeping into the equipment; otherwise the safety and the
performance of the electrocardiograph can not be guaranteed.
2) Patient Cable
♦ Integrity of the patient cable, including the main cable and lead wires, should be
checked regularly. Make sure that it is conductible.
♦ Do not drag or twist the patient cable with excessive stress while using it. Hold
the connector plug instead of the cable when connecting or disconnecting the
patient cable.
♦ Align the patient cable to avoid twisting, knotting or crooking 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) Reusable Electrodes
♦ Electrodes must be cleansed after use and make sure there is no remainder gel
on them.
♦ Keep suction bulbs of chest electrodes away from sunshine and excessive
temperature.
♦ After long-term use, the surfaces of electrodes will be oxidized because of
erosion and other causes. By this time, electrodes should be replaced to
achieve high-quality ECG records.
CAUTION
- 63 -
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.
- 64 -
ECG-12 Series Electrocardiograph Service Manual Renewable Parts
Chapter 9 Renewable Parts
The following list is intended as a guide for ordering parts for the ECG-12 Series
Electrocardiograph.
Part Number Description
European-style chest electrode connection bulb /

11.57.40103
G-BE32-24 1×6
11.57.40104 European-style limb electrode clamp/ C-RYGNB 1×4
12.02.32001 Power transition board PCBA
02.03.106862 12-channel ECG board PCBA
11.17.32455 Thermal print head /C216
02.03.111662 Narrow Screen main board
02.03.111663 Wide Screen main board
02.03.32005-01 Narrow Screen key board PCBA (debugged)
01.16.045051 TFT LCD screen/ G121SN01V.3
01.16.045050 Four-wire touch screen / AMT 9542
01.60.32377-01 Wide Screen silicone keyboard
02.03.32006-01 Wide Screen key board PCBA (debugged)
02.03.32428 PSD900D power board PCBA (debugged)
- 65 -
ECG-12 Series Electrocardiograph Service Manual After-Sales Service
Chapter 10 After-Sales Service
If you have any question about maintenance, technical specifications or malfunctions of

devices, contact the manufacturer.
- 66 -
Advanced Instrumentations, Inc.
6800 NW 77th Ct
Miami, FL 33166, USA
P (305) 477-6331 F (305) 477-5351

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Electrocardiograph

ADVANCED INSTRUMENTATIONS, INC.

Release Date: Sept. 2010

Model: ECG-12, ECG-12 Plus

Responsibility of the Manufacturer

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

Terms Used in this Manual

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

Chapter 1 Safety Guidance........................................................................................ 1

Chapter 1 Safety Guidance

1.1 List of Symbols

Equipment or part of CF type with defibrillator proof

Consult Instructions for Use

Battery recharging indicator

Esc key/Reset key

Power On/Off key

Tab key/Feed paper key

UP/DOWN/LEFT/RIGHT Arrow key

Federal (US) law restricts this device to sale by or on

It indicates that the device should be sent to the special

1.2 Warnings and Cautions

1 This device is not intended for home use.

1.2.1 Safety Warnings

3 This device is not intended for treatment or monitoring.

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

14 The equipment is protected against malfunctions caused by electrosurgery according

1.2.2 Battery Care Warnings

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

1.2.3 General Cautions

1.2.4 Cleaning & Disinfection Cautions

5 Do not use chloric disinfectant such as chloride, sodium hypochlorite etc.

1.2.5 Preparation Warnings (for ECG-12 Plus Exercise ECG)

7 Examine the treadmill/ergometer carefully before using it.

8 Do not use the treadmill/ergometer in the open air.

11 Children are prohibited from approaching the treadmill/ergometer alone.

This guide provides troubleshooting information, disassembly procedures, and

2.1 Technical Specifications

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

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

Working mode: Continuous operation

Transport and Storage Working

-20ºC (-4ºF) ~ +55ºC +5ºC (+41ºF) ~ +40ºC

Power Supply Specifications:

2.2 System Test Interface

Figure 2-1 Service Password Interface

Figure 2-2 System Test Interface

Figure 2-3 Display Interface

Figure 2-4 Pixel Verification Test Interface

Figure 2-5 Gray Scale Test Patterns Interface1

Figure 2-6 Gray Scale Test Patterns Interface2

Press ESC to exit the interface.

3. Touch Test (Only for ECG-12 Plus)

Figure 2-7 Touch Screen Interface

Figure 2-8 Keyboard Interface

5. File System Test

Figure 2-9 File System Interface

Figure 2-10 Battery Interface

Figure 2-11 UART Interface

Figure 2-12 Recorder Interface

Figure 2-13 Statistics Interface

Chapter 3 Operating Principle

3.1 Basic Theory of ECG Operation

3.2 Composition of ECG