PROFESSIONAL MEDICAL PRODUC TS

CARDIOPOCKET ECG - 3 CHANNELS

User manual

ATTENTION: The operators must carefully read

and completely understand the present manual
before using the product.

ECG90A (GIMA 33232)

CONTEC MEDICAL SYSTEMS CO., LTD
No.112 Qinhuang West Street, Economic & Technical
Development Zone, Qinhuangdao, Hebei Province, 0123
PEOPLE’S REPUBLIC OF CHINA
Made in China
1060hPa 95% +55˚C

Prolinx GmbH, Brehmstr. 56, 40239 %

M33232-GB-Rev.3-12.24

Duesseldorf Germany
500hPa 0% -20˚C
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
 Preface
Please read the User Manual carefully before using this product. The operating
procedures specified in this User Manual should be followed strictly.This manual describes in
detail the operation steps which must be noted, the procedures which may result in
abnormality, and possible damage to the product or users. Refer to following chapters for
details. Failed to follow the User Manual may cause measuring abnormality, device damage or
personal injury. The manufacturer is NOT responsible for the safety, reliability and performance
issues of such results due to user’s negligence of this user manual for using, maintenance or
storage. The free service s and repairs do not cover such faults either.
The content in this user manual complies with real product. For software upgrade and
some modifications, the content in this user manual is subject to change without prior notice,
and we sincerely apologize for that.
Attentions
Before using this product, the safety and effectiveness described in the following shall be
considered:
 Type of protection against electric shock: class I (AC power supply), internal powered
equipment (power supplied by battery)
 Degree of protection against electric shock: type CF, defibrillation-proof applied part
 Working mode: continuous running equipment
 Enclosure protection class: IPX0
 Measurement results shall be described by professional doctor combined with clinical
symptoms.
 The using reliability depends on whether the operation guide and maintenance
instructions in this user manual is followed.
 Service life: 5 years
 Date of manufacture: see the label
 Contraindications: none
Warning: To ensure the device safety and effectiveness, please use the company
recommended accessories. The maintenance and repair of the device should be done by

professional personal specified by the company. It is forbidden to refit the device.

Responsibility of the operator

 The device must be operated by a professionally trained medical staff, and kept by a
special person.
 The operator should read the User Manual carefully before use, and strictly follow the
operating procedure described in the User Manual.
 The safety requirements have been fully considered in product designing, but the
operator can not ignore the observation of the patient and device.
 The operator is responsible for providing the information of product use to the company.
Responsibility of the company
 The company supplies qualified products to user in accordance with enterprise standard.
 The company installs and debugs the equipment and trains the physicians by contract.
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 The company performs device repair in warranty period (a year) and maintenance
service after warranty period.
 The company responds timely to the user's request.
The user manual is written by Contec Medical Systems Co., Ltd. All rights reserved.

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 Statement
Our company owns all rights to this unpublished work and intends to maintain it as confidential
information. This user manual is used only for reference of operation, maintenance, or repair of
our device. No part of this can be disseminated to others. And our company takes no
responsibilities for any consequences and liabilities caused by using this user manual for other
purposes.
This document contains proprietary information, which is protected by copyright. All rights
reserved. Photocopy, reproduction or translation of any part in the manual without our
company's written permission is prohibited.
All information contained in this user manual is believed to be correct. Our company shall not
be liable for incidental and consequential damages in connection with the furnishing,
performance, or use of this material. This user manual may refer to information and protected
by copyrights or patents and does not convey any license under the patent rights of our
company, nor the rights of others.Our company does not assume any liability for arising out of
any infringements of patents or other rights of the third parties.
Our company owns the final explanation right to this user manual, and reserves the right
to change the content of this user manual without prior notice, and the rights to change
product technology and specification.

III
 Contents
Chapter1 Overview ....................................................................................................................... 1

1.1 Overview ......................................................................................................................... 1

1.2 Intended use ................................................................................................................... 1

1.3 Main technical specifications .......................................................................................... 1

1.4 Main Characteristics ........................................................................................................ 2

1.5 Software overview .......................................................................................................... 3

Chapter2 Safety Precautions ......................................................................................................... 4

Chapter3 Warranty ....................................................................................................................... 7

Chapter4 Working Principle and Structural Characteristics........................................................... 8

4.1 Working principle and its block diagram ......................................................................... 8

4.2 Name of each part and its function ................................................................................. 9

Chapter 5 Operation Precautions................................................................................................ 14

5.1 Precautions before use.................................................................................................. 14

5.2 Precautions during operating ........................................................................................ 14

5.3 Precautions after use .................................................................................................... 14

Chapter 6 Preparations before Operation ................................................................................... 15

6.1 Installation of recording paper ...................................................................................... 15

6.2 Power supply connection .............................................................................................. 16

6.3 Lead cable connection................................................................................................... 16

6.4 Electrode installation .................................................................................................... 16

Chapter 7 Operation Instructions and Parameter Setting ........................................................... 20

7.1 Main Menu.................................................................................................................... 20

7.2 Sample Interface ........................................................................................................... 20

7.3 System Settings ............................................................................................................. 23

7.4 Sample Setting .............................................................................................................. 25

7.5 Print Setting .................................................................................................................. 26

7.6 Analyse Setting .............................................................................................................. 27

7.7 Time Setting .................................................................................................................. 28

7.8 Archive Management .................................................................................................... 29

7.9 About ............................................................................................................................ 30

7.10 USB Port ...................................................................................................................... 31

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 7.11 SD Card........................................................................................................................ 31

Chapter 8 Troubleshooting ......................................................................................................... 33

8.1 Auto shutdown.............................................................................................................. 33

8.2 AC interference ............................................................................................................. 33

8.3 EMG interference .......................................................................................................... 33

8.4 Baseline drift ................................................................................................................. 34

8.5 Troubleshooting list ....................................................................................................... 34

Chapter 9 Maintenance .............................................................................................................. 36

9.1 Battery .......................................................................................................................... 36

9.2 Recording paper ............................................................................................................ 37

9.3 Maintenance after use .................................................................................................. 37

9.4 Lead cables and electrodes ........................................................................................... 37

9.5 Silicone rubber roller ..................................................................................................... 38

9.6 Cleaning of thermal print head ..................................................................................... 38

9.7 Disposal of product scrap .............................................................................................. 38

9.8 Others ........................................................................................................................... 38

Chapter 10 Packing List and Accessories ..................................................................................... 39

10.1 Accompanying accessories .......................................................................................... 39

10.2 Notes ........................................................................................................................... 39

Appendix I ECG Automated Measurement&Interpretation Guide .............................................. 40

Appendix II EMC Guidance and Manufacturer Declaration ......................................................... 71

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 Chapter1 Overview

1.1 Overview
This product is a kind of electrocardiograph, which is able to sample 12 leads ECG signals
simultaneously and print out the ECG waveform with thermal printing system. Its functions are
as follows: recording and displaying ECG waveform in auto/manual mode; measuring ECG
waveform parameters automatically, and automatic analysis and diagnosis; prompt for
electrode-off and out of paper; optional interface languages(Chinese/English, etc.); built-in
lithium battery, powered either by AC or DC; arbitrarily select the rhythm lead to conveniently
observe abnormal heart rate; case database management, etc.
1.2 Intended use
This product is suitable for hospital, scientific research, wards, ambulances and carrying
out medical consultations. It can be used by medical institutions to record human ECG signals,
collect and extract the ECG waveform.
1.3 Main technical specifications
1.3.1 Environment conditions
Operation:
a). Environment temperature: 5℃~40℃
b). Relative humidity: 25%~95%(no condensation)
c). Atmospheric pressure: 700 hPa~1060 hPa
d). Power supply:
Voltage: 100-240 V～
Frequency: 50 Hz, 60 Hz
Input power: ≤50 VA
Battery: 7.4 V, 2000 mAh rechargeable lithium battery
Transportation and Storage:
a). Environment temperature: -20 ℃～+55 ℃
b). Relative humidity: ≤95%
c). Atmospheric pressure: 500 hPa～1060 hPa
1.3.2 Input way: Floating and defibrillation protection
1.3.3 Lead: Standard 12 leads
1.3.4 Patient leakage current: <10µA
1.3.5 Input impedance: ≥2.5 MΩ
1.3.6 Frequency response:
Rated input
Input frequency and waveform Relative output response
amplitude
1.0 0.67Hz~40Hz, Sine wave ±10%a
0.5 40Hz~100Hz, Sine wave +10 %, -30 %a
0.25 100Hz~150Hz, Sine wave +10 %, -30 %a
0.5 150 Hz ~ 500 Hz, Sine wave +10 %, -100 %a
1.5 ≤1Hz,200ms, Triangle wave +0 %, -10 %b
a relative to 10Hz b relative to 200 ms

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1.3.7 Time constant: ≥3.2s
1.3.8 CMRR: >105 dB
1.3.9 Filter: power frequency(AC50/60 Hz), myoelectricity(25 Hz/35 Hz (-3 dB)), baseline drift
filter
1.3.10 Recording way: Thermal printing system
1.3.11 Specification of recording paper: 50 mm(W)×20 m(L) high-speed thermal paper
1.3.12 Time base selection(paper speed):
12.5 mm/s, 25 mm/s, 50 mm/s, error: ±5%
1.3.13 Gain control(sensitivity): 5, 10, 20 mm/mV, accuracy is ±2%; Standard sensitivity: 10
mm/mV±0.2 mm/mV
1.3.14 Auto record: record setup according to auto record format and mode, automatically
change leads, automatically measure and analyze.
1.3.15 Rhythm record: record setup according to rhythm record format and mode,
automatically measure and analyze.
1.3.16 Manual record: record according to manual record format.
1.3.17 Measurement parameters: HR, P-R interval, P Duration, QRS Duration, T Duration, Q-T
interval, Q-Tc, P Axis, QRS Axis, T Axis, R(V5) amplitude, S(V1) amplitude, R(V5)+S(V1) amplitude
1.3.18 Product safety type: Class I type CF defibrillation-proof applied part
1.3.19 Polarization resistance voltage: ±610 mV
1.3.20 Noise level: ≤12 µVp-p
1.3.21 ECG signal input sampling frequency: 32 kHz
1.3.22 Waveform data processing sampling frequency: 1 kHz
1.3.23 Sampling precision: 24-bit
1.3.24 Pacing detection channel: standard II
1.3.25 The minimum detection signal: 10 Hz, 20 µV(peak-peak value) deflected sinusoidal signal
can be detected
1.3.26 Dimension: 207 mm(L)×96 mm(W)×62 mm(H)
1.3.27 Net Weight: 0.5 kg
1.3.28 Accuracy of input signal: ±5 %
1.3.29 Amplitude quantization: ≤5µV/LSB
1.3.30 Interchannel time deviation: <100 µs
1.3.31 Fuse specification: 2 AC delay insurance: T2A 250V
1.4 Main Characteristics
1.4.1 Display with 320×240 dots, high-resolution color LCD, operate either by touch screen or
function buttons, which is convenient and quick.
1.4.2 Sync collection for 12-lead ECG, use digital signal processing technology to conduct AC
filter, baseline filter and EMG filter on ECG signals, in order to get high-quality ECGs.
1.4.3 Display of 3/6/12-lead ECG on one screen, and print mode, sensitivity, paper speed, filter
state and other information, which facilitates comparative diagnosis.
1.4.4 The device can be powered either by AC or DC(can adapt to 50/60Hz AC frequency), with
built-in rechargeable lithium battery and charging circuit, perfect battery overcurrent and
overvoltage protection circuit.
1.4.5 Multiple print mode and format, including 1×12, 1×12+1(rhythm lead), 2×6, 2×6+1
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(rhythm lead), 3×4, manual and store modes. Printed waveform length is adjustable, which
satisfies various application requirements.
1.4.6 Rhythm leads can be arbitrarily selected to facilitate the observation of abnormal heart
rate.
1.4.7 Clinical information such as patient’s name, gender, age and weight can be input.
1.4.8 Optional large-capacity memory can store 1,000 medical records, making it easy for doctor
to review medical records and statistical information.
1.4.9 Multi-language (Chinese, English, Russian, etc.) interface and report.
1.5 Software overview
The ECG analysis program shows the results after analyzing the form of the
electrocardiogram, providing auxiliary reference for doctors to make diagnosis. The analysis
result cannot be used as the only standard for diagnosis. A comprehensive evaluation should be
made by professional electrocardiogram technicians and physicians according to clinical
experience and other test results.
The device is intended for use on all patient populations, which is decided by the clinical
doctor. The analysis program only provides ECG analysis for patients above 3 years old
(including 3 years).
Name of software: ECG90A embedded software
Software specification: none
Software version: Vx.x.x
Version naming rules: V<major version number>.<minor version number>.<revision version
number>
The version of the software can be obtained in “About”.
Involved algorithm:
Name: ECG algorithm
Type: mature algorithm
Use: to convert ECG signals of human body into intuitive waveform images and then analyzing.
Clinical function: Electrocardiogram is an important method for clinical diagnosis of
cardiovascular disease. How to use computer to quickly, automatically and accurately analyze
ECG has been a hot topic for scholars at home and abroad. The ECG algorithm is the key to the
analysis and diagnosis of ECG signals, and its accuracy and reliability determine the
effectiveness of diagnosis and treatment of patients with heart disease.

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 Chapter2 Safety Precautions
2.1 Ensure that the device is placed on a flat level worktable. Avoid strong vibration or impact
when moving it.
2.2 When working with AC power, the power cord must be 3-core, the frequency and voltage
value of the AC power source must match the identification on the manual and have sufficient
capacity. When the provided three-core power cord cannot be used, please use the built-in DC
power supply or replace the three-core power cord that meets the standard requirements.
2.3 A perfect power supply system and grounding are necessary in the room.
Warning: To avoid the risk of electric shock, the device must be connected a power supply
with protective grounding.
2.4 If there are any questions for the integrality of protective grounding cable or the reliability
of protective grounding cable connection can not be guaranteed, the device must be run with
built-in DC power supply.
2.5 The safety requirements have been fully considered in product designing, but the operator
can not ignore the observation of the patient and device. Cut off the power or take off the
electrode when necessary to ensure patient's safety.
2.6 Please turn off the device and unplug the power cord before cleaning and disinfection. Don't
rub the screen with sharp materials.
2.7 Keep the device from water, don't use or store it in places with high air pressure, humidity
or temperature over the standard, bad ventilation, or too much dust.
2.8 Do not use the device in the place with flammable anesthetic gases or other flammable
chemicals, otherwise there is a danger of explosion or fire.
2.9 Do not use the device in medical hyperbaric oxygen chamber, otherwise there is a danger of
explosion or fire.
2.10 This device is not intended to act directly on the human heart. If this device is used with
cardiac defibrillator or other electric stimulating devices at the same time, single-use electrodes
and ECG lead cables with defibrillation-proof function should be selected. It is better not to use
this device with other electric stimulating devices at the same time. If it is necessary, there must
be professional technician guiding on the scene, and the selected accessories should be
designated by our company.
2.11 When the electrocardiograph is used together with a high-frequency electrosurgical knife,
the ECG electrode should be kept away from the contact of the electrosurgical knife to prevent
burns and burning of the electrode wires caused by high-frequency sparks.
2.12 When the electrocardiograph is used together with a defibrillator, the operator should
avoid contact with the patient or the sickbed. The defibrillation electrode should not directly
touch the ECG electrode to prevent sparks from burning the device and the patient.
2.13 Please do not use the electrocardiograph in the environment that is interfered by
high-power device such as high-voltage cables, X-rays, ultrasonic machines and electrizer, keep
the device away from emission sources such as mobile phones.
2.14 If other equipment is connected with this ECG device, it must be a Class I device that
complies with IEC60601-1. Because the total leakage current may hurt patient, the monitoring
of leakage current is carried out and taken charge by the connected equipment.

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2.15 Notes related to EMC
The device complies with the safety standards for medical electrical equipment or system
electromagnetic compatibility in IEC60601-1-2. Electromagnetic environments exceeding the YY
0505 standard may cause harmful interference to the device or prevent the device from
performing its intended function or degrade its performance. Therefore, if there is a
phenomenon that does not match its function during use, be sure to confirm and eliminate
adverse effects before continuing to use it. Corresponding precautions for this situation are
given in this manual.
1. The device or system should not be used near or stacked with other devices. If it must
be used near or stacked with other devices, it should be observed and verified that
the device is working normally under the configuration it is using.
2. Use of accessories other than those specified by the manufacturer of the device or
system may result in increased emissions of the device or system and reduced
immunity.
 Effect from radiated electromagnetic waves:
The use of a mobile phone may affect the operation of the device. When installing medical
electrical equipment, be sure to remind people around the device to turn off mobile phones
and small radios.
 Effect from shock and conduction electromagnetic waves:
High frequency noise from other equipment can enter the device through the AC socket.
Please identify the source of noise, if possible, stop using the equipment. If the equipment can
not be deactivated, use noise cancellation equipment or take other measures to reduce the
impact.
 Effect from static electricity:
Static electricity in a dry environment(indoor) may affect the operation of the device,
especially in winter. Before using the device, humidify the indoor air or discharge the static
electricity from the cable and operator.
 Effect from thunder and lightning:
If there is thunder and lightning nearby, it may cause a voltage surge in the device. If you
are concerned about danger, disconnect the AC power and use the internal power supply.
2.16 Notes concerning ECG waveform measurement and analysis
2.16.1 The identification of P wave and Q wave is not always reliable with intensive EMG or AC
interference. Neither are the ST segment and T wave with baseline drift.
2.16.2 Winding and unclear end position of S wave and T wave may cause error in
measurement.
2.16.3 When R wave is uninspected caused by some leads off or QRS wave low voltage, the
heart rate measurement may deviate greatly from the correct.
2.16.4 In case of QRS low voltage, ECG axis calculation and border-point identify of QRS wave
are not always reliable.
2.16.5 Occasionally, frequent ventricular premature complexes may be identified as dominant
beat.
2.16.6 Merging of versatile arrhythmia may result in unreliable measurement because of the
difficulty in distinguishing P wave in such situation.

5
2.16.7 The device has an automatic analysis function that automatically analyzes the obtained
ECG waveform without reflecting all the patient’s status. The results of the analysis may
sometimes not comply with the doctor’s diagnosis. Therefore, the final conclusion needs to be
comprehensively analyzed by doctors in combination with analysis results, patient clinical
characterization and other test results.

6
 Chapter3 Warranty
3.1 In normal use, under strict observance of user manual and operation notes, in case of failure,
please contact with our customer service department. Our company has the sales record and
customer archives for each device. The customer has one year free warranty service from the
date of shipping according to the following conditions. To supply all-around and quick
maintenance service for you, please mail the maintenance card to us in time.
3.2 Our company may adopt such ways as guidance, express to company or door-to-door
service, etc. to carry out warranty promise.
3.3 Even in warranty period, the following repairs are charged.
3.3.1 Faults or injuries caused by misuse that not according to user manual and operation notes.
3.3.2 Faults or injuries caused by dropping accidentally after purchase.
3.3.3 Faults or injuries caused by repair, reconstruction, decomposition, etc. not by our
company.
3.3.4 Faults or injuries caused by improper storage or force majeure after purchase.
3.3.5 Faults or injuries caused by using improper thermal recording paper.
3.4 The warranty period for accessories and fray parts is half a year. Power cable, recording
paper, operation manual and packing material are excluded.
3.5 Our company is not responsible for the faults of other connected devices caused by the
faults of this device directly or indirectly.
3.6 The warranty will be canceled if we find the protection label has been destroyed.
3.7 For charged maintenance beyond warranty period, our company advises to continue using
"Maintenance contract regulation". Please refer to our customer service department for details.

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 Chapter4 Working Principle and Structural Characteristics

4.1 Working principle and its block diagram

4.1.1 The power supply unit
Principle of power supply
After the AC power supply enters the switching power supply, it is converted to 12V DC
voltage and supplied to the main unit, it also provides constant voltage current limiting charging
for the rechargeable lithium battery in the device through the DC-DC circuit, and generates +5V
and +8.5V voltage through the power conversion to supply power to the corresponding
modules. At the same time, the lithium battery in the device can independently satisfy working
requirements of each module in the device through the buck-boost circuit.
Note: The principle block diagram and component list are only available to service
stations or maintenance personnel designated by our company.
4.1.2 Signal acquisition unit
The signal acquisition unit uses a floating setting, which is a signal acquisition and
processing system, including analog circuit part and 24-bit A/D conversion and data processing
part. The analog circuit consists of signal following, amplification, anti-aliasing low-pass filtering,
lead-off detection and overload detection. CPU system is responsible for coordinating the work
of each circuit such as the A/D converter, the lead-off detection circuit and the overload
detection circuit, in order to achieve signal acquisition, processing, and lead-off detection.
Control information and A/D conversion and data acquisition between the floating circuit and
the solid circuit are transmitted through the signal isolation circuit.
4.1.3 Control unit
（1）Principle of control unit
The control system consists of printing system, button system, liquid crystal display system,
and signal acquisition system. The ECG signal sent from the signal acquisition system through the
high-speed isolation circuit is received by the CPU system, after digital filtering, gain adjustment
and motor drive, it is sent to the printing system to print the ECG waveform. After the printing is
completed, the CPU system processes waveform measurement and analysis. The CPU system also
receives an interrupt signal and button code from the button system to complete the interrupt
processing. In addition, the lead-off signal, paper out detection, battery voltage management, and
automatic power-off are also managed by the CPU system. The liquid crystal controller receives
data and commands from the CPU system to complete the display of the control state of the
device.
（2）Principle block diagram is shown in Figure4-1.
Signal acquisition
Button system
system

Control system

Printing system Display system

Power module

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 Figure 4-1 Block diagram of control unit

4.2 Name of each part and its function

4.2.1 Front view

Figure 4-2 Front view

Note
 Do not put heavy objects on the screen or hit against it, otherwise the screen will be
damaged.
 If the device is not in use, cover it to prevent liquid spills on the screen.
 Do not use sharp stuff to operate the buttons, otherwise it may case permanent
damage to the buttons.
4.2.2 Side view

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 Figure 4-3 Side view
Equipotential terminal: Connect with the potential equalization conductor.
Lead cable interface: Connect with lead cables.
USB interface: Communicate with the computer. The ECG data can be transmitted to a computer,
by using the computer, many functions can be achieved, such as archiving, managing, and
analyzing ECG data, which facilitates clinical research, organization teaching and training.
Note
Lead cables must be disconnected from patient before connecting with a computer via the
USB interface.
Operator must not touch the USB interface and patient at the same time.

Figure 4-4 Bottom view

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4.2.3 Buttons

Figure 4-5 Schematic diagram of buttons

1. Functional button: Menu/Confirm
It is the menu button under sampling interface, and confirm button under the menu interface.
2. Functional button: ON/OFF/Change displayed leads/Confirm
Long press it to turn on/off the device. In menu interface, short press it to confirm the setting.
In sampling interface, short press it to change the number of displayed leads.
3. Functional button: Return/Print
It performs return function in menu interface, and print function in sampling interface.
4. Direction button: LEFT
Move to left.
5. Direction button: UP
Move upwards.
6. Direction button: DOWN
Move downwards.
7. Direction button: RIGHT
Move to right.
4.2.4 Symbols

Quick setup of filter

No SD card

With SD card

Equipotential point

Defibrillation-proof type CF applied part

USB interface

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PATIENT Lead cable socket

Standby, charging state

Caution: read instructions (warnings) carefully

Serial number

Manufacturer

Date of manufacture

Lot number

Not made with natural rubber latex

Atmospheric pressure limit

Temperature limit

Humidity limit

For indoor use only

Polarity of d.c. power connector

Direct current

WEEE disposal

12
 This way up

Fragile, handle with care

Keep in a cool, dry place

Keep away from sunlight

Stacking limit by number

Follow instructions for use

SD card port

General warninging lable

Medical Device compliant with Directive 93/42/EEC

The device poses unacceptable risks to the patient, medical staff or

other persons within the MR environment

The device is prescription device, the federal law restricts this

Rx Only device to sale by or on the order of a physician

Product code

Authorized representative in the European Community

Imported by

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 Chapter 5 Operation Precautions

5.1 Precautions before use

5.1.1 For safe and effective use, please read the user manual carefully before operation.
5.1.2 Check to ensure that the device is in good condition.
5.1.3 The device shall be placed on a flat surface, and moves gently to avoid strong vibration or
shock.
5.1.4 Check to ensure that the lead cables are correctly connected, and the device grounding is
correct.
5.1.5 The AC frequency and voltage should comply with the requirements, and enough current
capacity should be guaranteed.
5.1.6 When using the battery for power supply, check to ensure that the battery voltage and
battery status are in good condition, and the battery has enough power.
5.1.7 When the device is used together with other equipment, all devices and equipment
should be equipotential grounded in order to protect the user and operator.
5.1.8 Install the device where easily grounded in the room. Do not allow the patient and
patient-connected lead cables and electrodes to come into contact with other conductor parts,
including the earth or a hospital bed.
5.1.9 Clean the lead cable with neutral solvent. Do not use alcohol-based cleaners or gemicides.
5.1.10 Ensure that the device is running within the normal ambient temperature range of 5℃ to
40℃. If the device is stored at a higher or lower temperature, leave it in the operating
environment for approximately 10 minutes before use in order to ensure the normal work.
5.2 Precautions during operating
5.2.1 The printing can be started after the ECG waveform is stable.
5.2.2 During using, the doctor should observe the patient carefully and cannot leave the
operating site. If necessary, turn off the power or remove the electrode to ensure patient safety.
5.2.3 The patient and the device can only be connected via lead cables through the electrodes,
in order to avoid patient touches other parts of device or conductors.
5.2.4 Patient can not move during operating.
5.2.5 Maintenance or repair to the device or accessory is not allowed during using.
5.3 Precautions after use
5.3.1 Set the states of all functions to initial states.
5.3.2 Cut off the power, gently remove the electrodes and limb clips, then remove the lead
cables, do not pull with force.
5.3.3 Clean the device and all accessories, and store them for the next use.

14
 Chapter 6 Preparations before Operation

6.1 Installation of recording paper

6.1.1 The device adopts high-speed recording paper, its specification is 50 mm(W)×20 m(L).
6.1.2 The installation method of recording paper is described as below:
1. As shown in Figure 6-1, press the paper compartment cover, it is automatically bounced, take
out the paper axis, insert it into the recording paper as shown in the figure. The paper side with
grids should be faced downwards, and then install it to proper position in the paper
compartment, and press the rubber roller on the recording paper.

Figure 6-1 Installation of recording paper

2. Pull out the recording paper from the paper exit, and close the cover.
Note
 When the paper compartment cover is open, press it again to lock it, no need other
operations.
 The recording paper should be aligned with the paper exit. It is recommended to leave
2cm paper outside.
6.1.3 If the recording paper runs out during recording, the device will stop printing
automatically, and the screen will display a prompt of lack of paper, as shown in Figure 6-2.

Figure 6-2 Lack of paper prompt

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6.2 Power supply connection
6.2.1 AC
Connect the provided three-core power cord with power adapter, insert one end of power
adapter into the device’s input socket, and insert the other end into a three-core power socket
that meets the requirements. Ensure that the connection is secure and reliable, and the device
is automatically grounded.
When the device is used in conjunction with other medical equipment, use the supplied
potential equalization wire to connect the equipotential terminal of the device to the
equipotential terminal of the connected equipment to prevent leakage current and protect the
device.
6.2.2 Battery
The device has a built-in rechargeable lithium battery, which does not need to be
re-installed by user. Check the battery's power and status before use.
Note: Connect one end of the potential equalization wire to the equipotential terminal of

the device, and connect the other end to the ground to enhance the reliability of the

grounding. Do not use other pipes as ground wire, otherwise, the patient may be in danger of

electric shock.

6.3 Lead cable connection

Connect the lead cable to the lead cable interface on the device, and fasten it to the device
with the fixing knobs at both sides of the lead cable in order to prevent bad connection and
affecting the detection.
Note: The lead cable interface can not be used for other purposes except as the input
interface of ECG signals.

6.4 Electrode installation

Proper installation of the electrodes is an important part of accurately recording the
electrocardiogram. Make sure the electrodes are in good contact. Old and new electrodes or
reusable electrodes and disposable electrodes cannot be used at the same time. If different
types of electrodes are used together, some electrodes are subject to a large bias potential due
to the polarization, which results in a longer polarization time and a longer recovery time after
defibrillation. Squeezed spherical electrodes are commonly used in ECG recording and diagnosis,
and especially cause this polarization voltage. Therefore, the ECG recording will be seriously
affected. The electrode or lead plug must not touch other object surfaces or conductors, such as
metal beds. Please replace them all when updating the electrodes.
Warning: Do not test on part with wounds.

16
6.4.1 Chest electrodes
As shown in Figure 6-3:

Figure 6-3 Installation of chest electrode

The chest electrodes should be installed to the following parts:
C1（Vl）: the fourth intercostal space at the right sternal margin
C2（V2）: the fourth intercostal space at the left sternal margin
C3（V3）: between C2 and C4
C4（V4）: the intersection between midclavicular line and the fifth intercostal space
C5（V5）: left anterior axillary line on the same plane as C4
C6（V6）: left midaxillary line on the same plane as C4
Clean the chest skin where the electrodes to be installed with alcohol, and apply some
conductive pastes to these skin (about 25 mm-diameter range) and the edge of the chest
electrode suction cup. Squeeze the suction ball to install the chest electrode at the positions of
Cl-C6.
Note: The conductive paste coating should be separated from each other, and the chest
electrodes should not touch each other to avoid short circuit.

6.4.2 Limb electrodes

The limb electrodes should be placed on the soft skin of both hands and feet. Before
connecting, clean the skin of the electrode installation area with alcohol, and then apply a small
amount of conductive paste on the cleaned skin. The electrode connection of the limbs is
shown in Figure 6-4.

Figure 6-4 Installation of limb electrodes

17
6.4.3 Colors of lead cables
As shown in Table 6-1:
Table 6-1 Colors of lead cables
European standard American standard
Electrode position
Mark Color Mark Color
Right arm R Red RA White
Left arm L Yellow LA Black
Left leg F Green LL Red
Right leg N/RF Black RL Green
Chest 1 Cl Red Vl Red
Chest 2 C2 Yellow V2 Yellow
Chest 3 C3 Green V3 Green
Chest 4 C4 Brown V4 Blue
Chest 5 C5 Black V5 Orange
Chest 6 C6 Purple V6 Purple
Note
 It is recommended to install the lead cables after turning off the device.
 Apply appropriate amount of conductive paste on the electrode when installing the
electrode.
 If the ECG waveform does not appear for a long time, check if the electrode is in good
contact with the skin.
6.4.4 Lead method and system
As shown in Figure 6-5:

Figure 6-5 Lead system

18
6.4.5 Lead-off and overload indication
The device can check the connection status of the lead at any time. If lead-off or overload
is detected, the screen will display corresponding lead code on the top left corner, as shown in
Figure 7-2.
Note
 In the lead-off prompt area, red font represents lead-off, yellow font represent
overload.
 When the connection between lead cable and patient/the device is not reliable, and
the ECG signal can not correctly transmitted, the device displays lead-off.
 In the printed report, lead-off is marked with “*”, and lead overload is marked with “+”.

19
 Chapter 7 Operation Instructions and Parameter Setting

7.1 Main Menu

Selected unselected

Fig. 7-1
【Operating instructions】
1. Enter corresponding setting interface by touch screen.
2.Use "Up""Down""Left""Right" to move the focus to the wanted submenu and press confirm

key or touch to enter corresponding interface.

3.Click or press return key to return the sample interface.

7.2 Sample Interface

The interface is shown as Fig.7-2.
【Function introduction】
This interface shows waveform. You can modify gain, speed, print mode, waveform display
mode (3-lead, 6-lead, 12-lead), in addition print, set filter quickly, check sate of SD-card.
Operating instructions are as follows:
filter quick setup
Lead information State of USB
HR Tim State of SD
e
State of Battery

Wave area

Buttons

Fig. 7-2
20
【Operating instructions】

1. Enter "Filter Setting" interface as Fig.7-3.

Selected state

Fig. 7-3
(1) You can select AC, EMG or DFT. In two frequency selections of AC or EMG, you can only
select one.

(2) Click or [Confirm] key on the panel to save the current settings.
(3) Click or [Confirm] key on the panel to exit without save.

2. Click this icon to check the state of SD card, as Fig.7-4.

Fig. 7-4

Click or press confirm key to exit this interface.

3. Click this icon or the menu key to enter the main menu, as Fig.7-5.

Fig. 7-5

21
4. Click this icon or press "UP" and "DOWN" key on the panel to switch speed.
5. Click this icon or press "UP" and "DOWN" key on the panel to switch gain.

6. Click this icon or press "UP" and "DOWN" key on the panel to switch print mode.

7. Click this icon or press "PRINT" key on the panel to print.

Attention:
Please ensure that there is paper in the paper carriage, otherwise the prompt of paper-lack will
appear, as Fig.7-6:

Fig. 7-6

Click and load paper, then print is enabled.

8. Wave display mode switch: glide left and right in the wave area on the screen or press
[confirm] key to switch wave display mode as Fig.7-7, Fig.7-8).

Fig. 7-7

22
 Fig. 7-8
9. Lead switch: glide up and down in the wave area on the screen to switch leads.
7.3 System Settings
The interface is showed as Fig.7-9, Fig.7-10
【Function introduction】
System settings includes backlight, power alarm, key voice, language, case store, information
input, USB-mode, calibrate, etc..

Fig. 7-9

Fig. 7-10
【Operating instructions】
You can touch the corresponding button to enter into the setting interface, where you can
select the item you want or move the focus on the wanted item, then press [Confirm] or [Right]
key to call up the setting menu to set. As Fig.7-11

23
 Fig. 7-11

1. Click or press [UP] [DOWN] to turn page up and down.

2. Click to save the current settings and exit this interface into the main menu, click
to exit without save.
3. BackLight: select "OFF" and confirm it, the back light will close and device will enter the
power-save mode. Then press any a key on the panel to open the back light.
4. Power alarm: when it is enabled, system can alarm every 10s when the charge of battery is
less than 5% without AC power source.
5. Key voice: when it is enabled, key can make sound after device is started. Otherwise it is the
silence mode.
6. Language: can select Chinese or English.
7. Infor input: when it is enabled, you have to enter the interface "Set Patient" as Fig.7-12
before print or save.

Fig. 7-12
(1) switch setting information by [UP] [DOWN] on the panel.
(2) select the item you want to set, then touch the keyboard on the screen or press [Confirm] on
the panel and move focus to the keyboard to set current information. Click to delete
the input. Click to confirm your setting .

(3) click to save the setting and print. Click to print without save.
Attention: (a) you can click directly or press [LEFT] [RIGHT] to set sex without keyboard.
(b) the length of name is no more than 7.
(c) age <200.
(d) weight(kg)<200
8. USB-mode
(1) this item is disabled when USB is not connected as Fig.7-10.
(2) this item is enabled when USB is connected. "Store" or "Sync" can be selected.

24
9. Screen Calibrate
Click "Carlibrate" to call up the dialog box as Fig.7-13

Fig. 7-13
Click "Yes" to enter the calibration interface as Fig.7-14.

Fig. 7-14
Please operate according to the prompt. If calibration is successful, the prompt "Calibrate OK!"
will appear. If failed, "Calibrate fail, please again"will appear.
7.4 Sample Setting
The interface is shown as Fig.7-15.

Fig. 7-15
【Function introduction】
Sample settings include AC filter, EMG filter, DFT, Demo and Pace mode.
25
【Operating instructions】
The operation is same as system setting.

Filter setting can be performed by clicking on the screen.

7.5 Print Setting
The interface is shown as Fig.7-16 and7-17.

Fig. 7-16

Fig. 7-17
【Function introduction】
Print setting, prepared for print, includes print mode, auto strip, gain set, speed set, report print
set (QRS-temp, case information, parameters, conclusion)
【Operating instructions】
1. Print mode
1x12, 1x12+1, 2x6, 2x6+1, 3x4, manual, store modes including. The operating instruction of
each mode is shown as following:
1x12+1、2x6+1: rhythm lead print, rhythm lead can be set in analyse setting.
1x12、2x6、3x4: automatical print
Manual: in manual mode you can print waveform according to your need without save.

26
Store: in this mode case can be saved but can't be printed. The interface is shown s Fig.7-18

Fig. 7-18
Click "Start", system starts to save case. In the process of that, the interface is shown as
Fig.7-19.

Fig.7-19
2. Other settings are same as system setting.
Auto strip:
The automatic print length of each strip can be set to 3s, 6s, 10s, 12s, 15s and 20s. If it is set to
3s or 6s, the auto analysis function is unable to use due to the sampling time is too short.
Attention: "Auto strip" is defaulted as 3s and can't be changed when there is no SD card.
7.6 Analyse Setting
The interface is shown as Fig.7-20.

27
 Fig. 7-20
【Function introduction】
Here you can set the items about analyse.
【Operating instructions】
(1) Rhythm lead: click button to call up the interface as Fig.7-21

Fig. 7-21
Please select the lead you wanted by clicking on the keyboard or pressing keys on the panel.
(2) Pause Time : click corresponding button to call up the interface as Fig.7-22.

Fig. 7-22
Input number according to your need. Its operation is same as above.
(3) Operating instructions of other items are same as (2).
7.7 Time Setting
The interface is shown as Fig.7-23

28
 Fig. 7-23
【Function introduction】
Data and time settings.
【Operating instructions】

Select the wanted item, and click or to set.

7.8 Archive Management

As Fig.7-24 and 7-25

Fig. 7-24

Fig. 7-25

29
【Function introduction】
Here you can look over all of the stored case, and can replay or delete them.
【Operating instructions】
Click the case directly or press [UP] [DOWN] to examine the case you want.

Gray shows the current page is the first, otherwise it can be clicked to turn the page up.

Gray shows the current page is the last, otherwise it can be clicked to turn the page

down.

Replay:click or press [Confirm] on the panel to replay waves. Its interface is as

Fig.7-26.

Fig. 7-26

: Return "Archive" interface from "Replay" interface.

: Click this button to replay waves statically, as Fig.7-27.

Fig. 7-27
You can glide screen left and right to check the waves of different times, and glide screen up and
down to check the waves of different leads.
Current case print and print setting can be performed. The operations are same as sample
interface.
7.9 About
As Fig.7-28:
30
 Fig. 7-28
7.10 USB Port
【Function introduction】
USB works in store (MASS) or synchronization (HID) mode. In MASS mode, SD card can be read
by PC. In HID mode, you can sample real-time case by synchro analyse software.
7.11 SD Card
【Function introduction】
SD card is used to store case and upgrade process. In the process of use, SD card may appear
some problems, for those, there are different prompts to instruct users to operation.
(1) when the case is being printed in the 1x12、1x12+1、2x6、2x6+1、3x4 mode, if there is no SD
card, the dialog box as Fig.7-29 will appear to prompt users the case can't be stored if print
continues.

Fig. 7-29
Click "Yes", print will continue but the case will not be stored. Click "No", print will be canceled,
you can insert SD card then continue to print.
(2) If you select "Only store" mode, when there is no SD card or SD card operating error, the
prompt as Fig.7-30 will appear to prompt users that store is disabled because of SD card error..

Fig. 7-30

31
Here click "OK" and insert SD card again, then continue to store case.
(3) when system enters Archive Management, the prompt as Fig.7-31 appears, please insert SD
card again.

Fig. 7-31
(4) if there is no enough memory in SD card to store this case, the prompt as Fig.7-32 will
appear.

Fig. 7-32
Click "Yes", and system will exit print, then clean up SD card and print again.
If you need SD card, please show us before purchase, and use the SD card specified by our
company.

32
 Chapter 8 Troubleshooting

8.1 Auto shutdown

 The battery is almost running out, which causes overdischarge protection circuit action.
 The voltage of AC power supply is too high, which causes overvoltage protection circuit
action.
8.2 AC interference

 Whether the device is grounded reliably?

 Whether the electrode or lead cable is connected correctly?
 Whether the electrodes and skin are daubed with enough conductive paste?.
 Whether the metal bed is grounded reliably?
 Whether the patient is touching the wall or metal parts of the bed?
 Whether the patient touches other people?
 Whether there is high power electric equipment working nearby? Such as X-ray machine
or ultrasonic device, etc.
Note: If the interference can not be removed after taking above measures, please use a
AC filter.

8.3 EMG interference

 Whether the room is comfortable?

 Whether the patient is nervous?
 Whether the bed space is narrow?
 Whether patient speaks during recording?
 Whether the limb electrode is too tight?
Note: If the interference can not be removed after taking above measures, please use a

EMG filter. The ECG waveform recorded at this time will be slightly attenuated.

33
8.4 Baseline drift

 Whether the electrode installation is stable?

 Whether the connection of lead cables or electrodes is reliable?
 Whether the electrodes and patient skin are cleaned and are daubed with enough
conductive paste?
 Whether it is caused by patient's movement or breathing?
 Whether the electrodes or leads are in bad connection?
Note: If the interference can not be removed after taking above measures, please use a
baseline filter.

8.5 Troubleshooting list

Phenomenon Cause of failure Solutions

1. Grounding cable is not 1. Check the power cord and

connected reliably. lead cables.
Too large
2. Lead cables are not connected 2. Let the patient prepare for
interference,
reliably. the measurement.
disorderly
3. There is AC interference.
waveform
4. Patient is nervous and can not
keep quiet.
1. AC interference is large. 1. Improve the environment.
2. Patient nervous, and EMG 2. If the bed is made of steel,
interference is large. replace it.
Baseline burr
3. The power cable and lead
cables are not parallel or too
close to each other.
1. Bad electrode conductivity. 1. Use alcohol of high quality.
2. Low battery. 2. Clean electrode slice and the
Not regular 3. Bad connection between skin under the electrode with
waveform, large electrodes and patient skin. alcohol.
up-and-down, 4. Loose connection between lead 3. Charge the battery.
beeline figure cables and the device's plug.
5. Bad connection between
electrodes and lead cables.

34
 1. Low power. 1. Charge the battery.
Baseline draft 2. Patient movement. 2. Keep patient still.

1. Low battery. 1. Charge the battery.

2. The printer head surface is dirty. 2. Cut off the power, clean the
3. The thermal paper problem. printer head with alcohol, air
Unclear waveform
dry.
3. Replace the thermal print
paper with specified one.

35
 Chapter 9 Maintenance

9.1 Battery
9.1.1 The device is designed with built-in full-sealed and maintenance-free rechargeable lithium
battery, also equipped with perfect auto-charging-discharging monitor system. When the device
is connected to AC power supply, the battery will be charged automatically. Battery status will
be displayed on right edge of LCD screen in powering on state, as shown in Table 9-1. After
absolutely discharged, the battery needs 3.5 hours to charge to 90%, and 4 hours to charge to
full capacity.
Table 9-1 Battery status display
No. Icon Description
a The battery status is unknown.
Cycled display
b It is charging.
from g to c
Using battery, and battery is full, or using AC power supply, and
c
the battery is completely charged.
d Using battery, and battery level is 3/4 of battery full

e Using battery, and battery level is 1/2 of battery full

f Using battery, and battery level is 1/4 of battery full

Using battery, and the battery is low. It is recommended to
g
charge the battery before use or adopt AC power supply.
Note: When charging the battery, the displayed status of battery level switches between icon
g to icon c.
9.1.2 The device can continuously print for 1.5 hours or work for more than 4 hours in standby
mode when battery is completely charged. When the battery capacity is too low for the device
to operate, the device will turn off automatically to avoid permanent damage to the battery.
Note: The above data is obtained by printing demo waveform under the test environment of
temperature 25℃, speed 25mm/s and gain 10mm/mV. In actual use, the operation time may be
shorten due to operation condition and environment.
9.1.3 The battery should be recharged in time after discharged completely. If not used for long
period, the battery should be recharged every 3 months, which can extend the life of the
battery.
9.1.4 When the battery can not be recharged or works no more than 10 minutes after fully
charged, please replace the battery.
Note
 Do not try to dismantle the sealed battery without permission.The replacement of
battery shall be carried out by professional maintenance personal authorized by our
company, and the same model of rechargeable battery provided by our company
should be used.
 Do not touch the positive and negative terminals of the battery directly with wire,
otherwise there is a danger of fire.

36
 Do not use the battery near fire sources or in environments where the temperature
exceeds 60°C. Do not heat the battery or throw it into fire, water and avoid splashed by
water.
 Do not puncture, hammer or strike the battery or destroy it by other ways, otherwise it
will cause battery overheat, smoke, deform or burn dangers.
 Keep away from the battery when it appears leakage or emitting unpleasant smell. If
the battery electrolyte leaks onto the skin or clothes, clean with water immediately. If
the electrolyte accidentally enters your eyes, do not rub your eyes, immediately clean
with water and see a doctor.
 If the battery reaches its service life, or battery smell, deform, discolor or distorted
appears, please stop using the battery and dispose it in accordance with local
regulations.
9.2 Recording paper
In order to ensure the quality of the ECG waveform, please use the high-speed thermal
recording paper supplied or specified by the company. If you use unspecified recording paper,
the recorded ECG waveform may be blurred, faded, and the paper feeding may not be smooth.
This may even increase the wear of the device and shorten the service life of important parts
such as the thermal print head. For information on how to purchase such recording paper,
please contact your dealer or the company. Please be careful!
9.2.1 When using recording paper, it is absolutely not allowed to use recording paper with wax
on the surface or in grayish/black color. Otherwise, the wax will stick to the heating part of the
print head, resulting in abnormal work or damage of the print head.
9.2.2 High temperature, humidity and sunlight may cause the recording paper to change color.
Please keep the recording paper in a dry and cool place.
9.2.3 Please do not place the recording paper under fluorescent light for a long time, otherwise
it will affect the recording effect.
9.2.4 Please do not to put the recording paper together with the PVC plastic, otherwise the
color of recording paper will change.
9.2.5 Please use the recording paper with specified dimension. Recording paper that does not
meet the requirements may damage the thermal print head or silicone rubber roller.
9.3 Maintenance after use
9.3.1 Turn off the device.
9.3.2 Unplug the power cord and lead cables. Hold the header of plug to disconnect, and do not
pull the cable with force directly.
9.3.3Clean the device and accessories, cover them up to against dust.
9.3.4 Store the device in a cool and dry place, avoid strong vibration when moving.
9.3.5 When cleaning the device, do not immerse it in the cleaner. Power supply must be cut off
before cleaning. Use neutral detergents for cleaning. Do not use any detergent or disinfectant
containing alcohol.
9.4 Lead cables and electrodes
9.4.1 The connectivity of the lead cable can be detected by the multimeter. Check whether each
wire of the lead cable is in good contact according to the following table. The resistance of each

37
wire from the electrode plug to the corresponding pin in the lead cable plug should be less than
10Ω. The integrity of the lead cable must be checked regularly. Any lead wire damage will cause
a false waveform of the corresponding lead or all leads on the ECG. The lead cable can be
cleaned with neutral solvent. Do not use the detergent or germicide containing alcohol (Please
do not immerse the lead cables in liquid for cleaning).
Note: The resistance of lead cable with defibrillation-proof protection function is about 10KΩ.
Table 9-2 Lead cable mark and pin position table

Mark L R C1 C2 C3 C4 C5 C6 F N

Pin position 10 9 12 1 2 3 4 5 11 14
9.4.2 Bending or knotting will shorten the service life of the lead cable. When using it, please
straighten the lead cable first.
9.4.3 The electrode should be well stored. After long time use, the surface of the electrode may
oxidize and discolor due to corrosion and other factors, which may affect the signal acquisition.
In this case, the electrode must be replaced.
9.5 Silicone rubber roller
The silicone rubber roller should be smooth and free of stains, otherwise it will affect the ECG
recording effect. In order to remove the stains on the roller, please use a clean soft cloth
damped with a small amount of alcohol to wipe it along the longitudinal direction, and scroll
the roller in the paper conveying direction while wiping until it is clean.
9.6 Cleaning of thermal print head
Dirt and dust on the surface of the TPH can affect the clarity of the waveform. To clean the
print head surface, open the paper compartment cover after turning off the device, use a clean
and soft cloth dampened with alcohol to wipe the surface gently. For the residual stains on print
head, moist it with a little alcohol first, then wipe with a soft cloth. Never use hard objects to
scratch the surface, otherwise the print head will be damaged. Wait until the alcohol has
evaporated, then close the paper compartment cover. The print head should be cleaned at least
once a month during normal use.
9.7 Disposal of product scrap
The disposal of packaging materials, waste battery and end-of-life device should obey the
local laws and regulations, and user should treat the scrapped products and materials properly
according to the laws and regulations, and try to support the classification and recycling work.
9.8 Others
9.8.1 Do not open the device enclosure to avoid electric shock danger.
9.8.2 The device associated circuit schematics and critical parts list are only available to
authorized service station or maintenance personnel, who is responsible for maintenance of the
device.
9.8.3 The device belongs to measuring instrument. User should send the device to national
designated inspection institution for inspection according to the requirements of the national
metrological verification procedure. The device shall be inspected at least once per year, and all
the accessories should be inspected and maintained regularly (at least once every six months).

38
 Chapter 10 Packing List and Accessories

10.1 Accompanying accessories

When the device is shipped from the factory, the intact packaging should contain the
following contents, as shown in Table 10-1:
Table 10-1 Packing list and accessories
Name Quantity
Electrocardiograph 1 pc
Chest electrodes (suction cup/electrode 1 set (6 pcs)
slice)
Limb electrodes (limb clip) 1 set (4 pcs)
ECG lead cable 1 pc
Potential equalization wire 1 pc
Power cord 1pc
Power adapter 1pc
User manual 1 pc
Recording paper 1 pc
10.2 Notes
10.2.1 Please follow the instructions on the package when opening the package.
10.2.2 After unpacking, please check the accessories and accompanying documents in
accordance with the packing list, then start inspecting the device.
10.2.3 If the packaging content does not meet the requirement or the device does not work
properly, please contact our company immediately.
10.2.4 Please use the accessories provided by our company, otherwise the performance and
safety of the device may be affected. If accessories provided by other company need to be used,
please first consult the after-sales service of our company, or we will not responsible for any
caused damages.
10.2.5 The package shall be kept properly for future use in regular maintenance or device repair.

39
 Appendix I ECG Automated Measurement&Interpretation Guide

1. Preface
The appendix describes the functions of ECG automated measurement and automated
interpretation. It explains the specific implementation method, algorithm and formulas related
to these two functions, as well as the content output by the automated measurement and
automated interpretation.
According to the requirement of IEC60601-2-51:2003 Medical electrical equipment - Part
2-51: Particular requirements for safety, including essential performance, of recording and
analysing single channel and multichannel electrocardiographs, Clause 50 Accuracy of operating
data, the appendix gives a description of verification process and results of the performance for
automated measurement and automated interpretation.
2. Automated measurement parameters and Automated interpretation items
The output measurement parameter, interpretation item and others that require
explanation are as follows:
2.1 Measurement parameters
No. Parameter Unit
1 HR bpm
2 PR-interval ms
3 P-duration ms
4 QRS-duration ms
5 T-duration ms
6 QT/QTc ms
7 P/QRS/T electric axis deg
8 R(V5)/S(V1) mV
9 R(V5)+S(V1) mV
2.2 Interpretation items

No. Item
1 No abnormal
2 Sinus mode Bradycardia
3 Sinus mode Tachycardia
4 Left atrium Hypertrophy
5 Right atrium Hypertrophy
6 Dual atrium Hypertrophy
7 QRS low voltage
8 Cardiac electric axis normal
9 Left axis deviation
10 Right axis deviation

40
11 Completeness Right Bundle branch block
12 Completeness Left Bundle branch block
13 No Completeness Right Bundle branch block
14 No Completeness Left Bundle branch block
15 V1 shows RSR' type
16 Left anterior fascicular block
17 Left posterior fascicular block
18 Left ventricular hypertrophy
19 Right ventricular hypertrophy
20 I atrioventricular block
21 Early anteroseptal MI
22 Possible acute forepart anteroseptal MI
23 Old anteroseptal MI
24 Early anterior MI
25 Possible acute anterior MI
26 Old anterior MI
27 Early extensive anterior MI
28 Possible acute extensive anterior MI
29 Old extensive anterior MI
30 Early apical MI
31 Acute apical MI
32 Old apical MI
33 Early anterolateral MI
34 Possible acute anterolateral MI
35 Old anterolateral MI
36 Early high lateral MI
37 Possible acute high lateral MI
38 Old high lateral MI
39 Early inferior MI
40 Possible acute inferior MI
41 Old inferior MI
42 Early inferolateral MI
43 Possible acute inferolateral MI

41
 44 Old inferolateral MI
45 ST depression, mild anteroseptal myocardial ischemia
46 ST depression, mild anterior myocardial ischemia
47 ST depression, mild extensive anterior myocardial ischemia
48 ST depression, mild apical myocardial ischemia
49 ST depression, mild anterolateral myocardial ischemia
50 ST depression, mild high lateral myocardial ischemia
51 ST depression, mild inferior myocardial ischemia
52 ST depression, mild inferolateral myocardial ischemia
53 ST depression, anteroseptal myocardial ischemia
54 ST depression, anterior myocardial ischemia
55 ST depression, extensive anterior myocardial ischemia
56 ST depression, apical myocardial ischemia
57 ST depression, anterolateral myocardial ischemia
58 ST depression, high lateral myocardial ischemia
59 ST depression, inferior myocardial ischemia
60 ST depression, inferolateral myocardial ischemia
2.3 Intended use
The intended use of the Automated Measurement&Interpretation function is shown as
below:
Application To detect the abnormal of heart of human body, examination items refer
and diagnosis to above description
Population Teenagers and adults, age range: 12-87
Application site hospitals
The accuracy of this function is reflected by the balance performance of
Accuracy
sensitivity and specificity.
This function does not generate any alarm when using, so it should be
Others
operated by professional or trained personal.
3. Algorithm description
This section describes the algorithm, formulas and judgment conditions for interpretation
items related to functions of ECG automated measurement and automated interpretation.
The 12-lead sync ECG waveform passes through the filter (AC, EMG, DFT (if has, and open))
into the module of automated measurement and automated interpretation.
The module of automated measurement and automated interpretation mainly includes
process of find the cardiac impulse location, find the beginning/end for each wave, amplitude
calculation, parameters calculation, and interpretations judgment based on known parameters.
The workflow is shown as below:
42
 Start

ECG waveform sampling

Recognize all R points by slope method

Waveform superposition taking R point as center

Determine the positions of each wave

Calculate the amplitudes of each wave

Get measurement parameter, interpretation item

End

3.1 Find the cardiac impulse location

1) Data preprocessing, obtain the absolute value trend of slope for each lead; then
superimpose each absolute value, obtain the superimposed graph of absolute value of slope.
2) Smoothing filter the superimposed graph on average of width 80ms, obtain the
analytical data source DDD.
3) Find the cardiac impulse location, give an initial threshold for searching, orderly scan the
data in the analytical data source DDD, then compare it with the threshold value:
When the value is greater than the threshold, it may be the beginning of qrs-complex. If
the distance from the previous qrs-complex to the current location is less than 150ms,
then give up the location.
Otherwise, take the 1/4 of threshold value as a reference, find the beginning of
qrs-complex within 100ms before the current location.
When the value is less than the threshold value, it may be the end of qrs-complex. Take
the 1/4 of threshold value as a reference, find the end of qrs-complex.
If the found qrs-complex is wide, this qrs-complex shall be excluded. Otherwise, save the
found qrs-complex.
4) Locate: after found the qrs-complex, search the max value point between the beginning
point and end point in the ecg original data, mark the point as cardiac impulse location.
5) Dynamically threshold adjustment: after found the cardiac impulse location, use the
value at the cardiac impulse location for the dynamically adaptive adjustment of the threshold
43
value. Define the threshold value as 1/3 of the average of the nearest three cardiac impulses.
6) After found the cardiac impulse location, compute the RR-interval and accumulate it
with the previous RR-intervals, then count the number of accumulated RR-intervals.
7) Continue searching until the end of data, and calculate the global average value for
RR-intervals at the same time.
3.2 Find the beginning/end for each wave
The beginning/end of qrs-complex has been approached in above cardiac impulse
locating process, but it is mainly in order to assist to find the cardiac impulse location; in
addition, the location is searched based on the slope threshold value, which is imprecise. Here,
according to the found cardiac impulse location, the beginning/end of qrs-complex will be
sought accurately. Name the cardiac impulse location as the peak of R-wave.
1. Read data
1) Read one data of qrs-complex: take the peak of R-wave as reference, locate directly to the
original ecg file, read a piece of data containing the qrs-complex.
2) Preprocessing: superimpose the absolute value of slope for 12-lead signals.
3) Use the preprocessed data to carry on the searching of QRS-complex, P-wave and T-wave as
the followings.
4) Read the next data of qrs-complex, repeat step 2 and step 3 until the analyzing of all
qrs-complex are finished.
2. Find QRS-complex
1) Calculate the threshold value of S-wave: search the minimal value within 200ms after the
peak of R-wave, take the value that equals to minimal value plus 0.4, as the threshold value for
finding the end of S-wave.
2) Find the beginning of Q-wave: take 0.5 as the threshold vale, search forwardly starting from
R-wave, a point that less than the threshold value, within 0ms-200ms before the peak of R-wave,
which is the beginning of Q-wave.
3) Find the end of S-wave: search backwardly starting from R-wave, a point that less than the
threshold value of the end of S-wave, within 0ms-200ms after the peak of R-wave, which is the
end of S-wave.
3. Find P-wave
1) Peak of P-wave: search the max value within 30ms-100ms before the beginning of Q-wave,
temporarily mark the point as the peak of P-wave.
2) Find the end of P-wave: search the minimal value between the peak of P-wave and the
beginning of Q-wave, the minimal value plus 0.05 is the threshold value, use the threshold value
to find the end of P-wave.
3) Find the beginning of P-wave: search the minimal value within 150ms before the peak of
P-wave, the minimal value plus 0.06 is the threshold value, use the threshold value to find the
beginning of P-wave.
4) If the found P-wave is narrow, research the P-wave according to the following steps.
5) Change the searching range of 30ms-100ms to 100ms-350ms in step 1, repeat step 1-4.
6) If the found P-wave is still narrow, it means that P-wave doesn’t exist.
4. Find T-wave
1) Peak of T-wave: search the max value within 30ms-300ms after the end of QRS-complex, save
44
it as the peak of T-wave.
2) Threshold value of the beginning of T-wave: search the minimal value within 0ms-100ms
after the end of QRS-complex, the minimal value plus 1/10 of the peak value of T-wave is the
threshold for finding the beginning of T-wave.
3) Threshold value of the end of T-wave: search the minimal value within 200ms after the peak
of T-wave, the minimal value plus 1/10 of the peak value of T-wave is the threshold for finding
the end of T-wave.
4) Find the beginning of T-wave: in the range between the minimal value in step2 and the peak
of T-wave, find a point that less than the threshold value of the beginning of T-wave, the point is
the beginning of T-wave.
5) Find the end of T-wave: in the range between the minimal value in step3 and the peak of
T-wave, find a point that less than the threshold value of the end of T-wave, the point is the end
of T-wave.
5. Explanation of equipotential segment
In searching the QRS-complex, this algorithm adopts the analysis method of superposition of
the slopes for all leads, therefore, the equipotential segments before and after the QRS-complex
are partly included in the start and end points of the QRS-complex. It is depends on the number
of leads containing equipotential segments. If there are more leads containing equipotential
segments, the slope value will be smaller after superposition, so it is difficult to meet the
threshold condition, and only a small part of the equipotential segments is counted to the start
and end points of the QRS-complex. On the contrary, if there are less leads containing
equipotential segments, a large part of the equipotential segments will be counted to the start
and end points of the QRS-complex. Anyway, the equipotential segments before and after the
QRS-complex are partly included in the QRS-complex duration.
3.3 Amplitude measurement
After finding the position of each wave, i.e. the start and end points of P wave, QRS
complex and T wave, use the following method to measure P, Q, R, S, ST and T waves of each
lead.
1. P-wave
Calculate the average value of the data 20ms before the start point of P wave, and use this
average value as the baseline of P wave. Find the max value between the start point and end
point of P wave, the difference between the max value and the baseline would be the
amplitude of P wave.
2. Q/R/S wave
Calculate the average value of the data 10-30ms before the start point of QRS complex, and use
this average value as the baseline of QRS complex. Search boundary points that exceeding the
baseline from the start point of Q wave to the end point of S wave. Each adjacent two boundary
points forms a sub-wave. Determine whether each sub-wave is a recognizable minimum wave
(see the definition below). If it is a recognizable minimum wave, first identify its direction. If it is
above the QRS baseline, it is R wave, if it is below the baseline, it is Q wave or S wave. Find the
extreme value of this wave, and the difference between the extreme value and the baseline is
the amplitude of Q/R/S wave.
Note: If there is only one downward wave, its amplitude should be respectively recorded in the
45
amplitude of Q wave and S wave.
3. ST segment
Take above baseline of QRS complex as the ST baseline. Calculate the differences between the
ST baseline and the points at 40ms and 60ms after the end point of QRS complex, and calculate
the average value of these two differences, the average value is the amplitude of ST segment.
4. T-wave
Calculate the average value of the data 20-50ms after the end point of T wave, and
average this value with the QRS baseline in 2, then use the result as the baseline of T wave. Find
the max value between the start point and end point of T wave, the difference between the
max value and the baseline would be the amplitude of T wave.
5. Recognition of minimum wave
The minimum wave can be recognized by the algorithm according to the requirement of
IEC60601-2-51:2003 Medical electrical equipment - Part 2-51: Particular requirements for safety,
including essential performance, of recording and analysing single channel and multichannel
electrocardiographs, Annex GG, Clause GG.5 Definition of waveforms, measurement of
minimum waves. The wave that meet the following conditions is the minimum wave that can be
recognized by the algorithm.
1）The signal part under consideration shows clearly two opposite slopes with at least
one turning point in between;
2）The signal part under consideration deviates at least 30μV from the reference level
for a duration of at least 6ms;
3）The minimum observable duration of wave under consideration is 12ms and
amplitude ≥30μV.
3.4 Calculation after intervals determination
The following parameters are determined according to the requirement of
IEC60601-2-51:2003 Medical electrical equipment - Part 2-51: Particular requirements for safety,
including essential performance, of recording and analysing single channel and multichannel
electrocardiographs, Annex GG Definitions and rules for the measurement of
ELECTROCARDIOGRAMS.
No. Parameter Calculation

1 HR 60 / RR

2 PR-interval Qs - Ps③

3 P-duration Pe④ - Ps③

4 QRS-duration Se⑤ - Qs

5 T-duration Te⑦ - Ts⑥

6 QT Te⑦ - Qs

QT
7 QTc 

RR
46
 Electric axis formula:

arctan(2.0 ×(SIII +SI ),SI × 3 ) × 180

PI
⑧

P electric axis:

SIII: voltage sum from the beginning point to the end

point of P-wave on lead III

SI : voltage sum from the beginning point to the end

P/QRS/T electric point of P-wave on lead I

8
axis QRS electric axis:

SIII : voltage sum from the beginning point to the end

point of QRS-complex on lead III

SI : voltage sum from the beginning point to the end

point of QRS-complex on lead I

T electric axis:

SIII : voltage sum from the beginning point to the end

point of T-wave on lead III

SI : voltage sum from the beginning point to the end

point of T-wave on lead I

9 R(V5) Height (voltage value) of R-wave on lead V5

10 S(V1) Height (voltage value) of S-wave on lead V1

Note:
① RR: RR-interval
② Qs: beginning of the Q-wave
③ Ps: beginning of the P-wave
④ Pe: end of the P-wave
⑤ Se: end of the S-wave
⑥ Ts: beginning of the T-wave
⑦ Te: end of the T-wave
⑧ PI: 3.1415926
3.5 Interpretations judgment based on parameters

No. Item Rule of interpretation

1 No abnormal No any abnormal are detected

47
 Sinus P-wave, PR-interval between
2 Sinus mode Bradycardia
110ms-210ms, HR≤*/min, general *=50
Sinus P-wave, PR-interval between
3 Sinus mode Tachycardia
110ms-210ms, HR≥ */min, general *=100
P-wave of leads I, II, aVL shall meet the
conditions: width increase of P-wave≥110ms,
4 Left atrium Hypertrophy
or P-wave displays in double-peak type, value
of peak to peak ≥40ms
For leads I, II, aVF, amplitude of P-wave
5 Right atrium Hypertrophy
≥0.25mV, or P-wave is sharp
For leads I, II, aVF, amplitude of P-wave
6 Dual atrium Hypertrophy
≥0.25mV and P-wave duration >110ms
Voltage of I-aVF limb leads ＜0.5mV, and
7 QRS low voltage
voltage of V1-V6 chest leads ＜0.8mV
8 Cardiac electric axis normal QRS-axis between 30 to 90 degree
9 Left axis deviation QRS-axis between -90 to-30 degree
10 Right axis deviation QRS-axis between 120 to 180 degree

Completeness Right Bundle branch QRS-duration>120ms, R-wave of lead V1 or

11
block aVR is wide (width of R-wave>80ms)

Completeness Left Bundle branch QRS-duration>120ms, R-wave of lead V5 or

12
block V6 is wide

No Completeness Right Bundle QRS-duration<120ms, R-wave of lead V1 or

13
branch block aVR is wide (width of R-wave>80ms)

No Completeness Left Bundle QRS-duration<120ms, R-wave of lead V15 or

14
branch block V6 is wide (width of R-wave>80ms)
15 V1 shows RSR' type QRS-complex of lead V1 is RSR' type
QRS-duration<110ms, QRS-axis <-30 degree,
lead I and lead aVL are qR type, and Q-wave
16 Left anterior fascicular block
duration<20ms, lead II, III and aVF are rS
type.
QRS-duration<110ms, QRS-axis >90 degree,
lead I and lead aVL are rS type, lead II, III and
17 Left posterior fascicular block
aVF are qR type, and Q-wave of lead II and III
<20ms.

48
 R amplitude of lead I >1.5mV, R amplitude of
lead V5 >2.5mV, R amplitude of lead
18 Left ventricular hypertrophy aVL >1.2mV, R amplitude of lead aVF >2mV, R
amplitude of lead V5 minus S amplitude of
lead V1 >4mV (male) or 3.5mV (female).
R amplitude of lead aVR >0.5mV, R amplitude
of lead V1 >1mV, R amplitude of lead V1
minus S amplitude of lead V5 >1.2mV, R
19 Right ventricular hypertrophy
amplitude of lead V1 is larger than S
amplitude, R amplitude of lead V5 is smaller
than S amplitude.
20 I atrioventricular block PQ interval >210ms
Early myocardial infarction change of leads
21 Early anteroseptal MI
V1, V2, V3, no change of leads V4, V5.

Possible acute forepart Acute myocardial infarction change of leads

22
anteroseptal MI V1, V2, V3, no change of leads V4, V5.
Old myocardial infarction change of leads V1,
23 Old anteroseptal MI
V2, V3, no change of leads V4, V5.
Early myocardial infarction change of leads
24 Early anterior MI
V3, V4, V5, no change of leads V1, V2, V6.
Acute myocardial infarction change of leads
25 Possible acute anterior MI
V3, V4, V5, no change of leads V1, V2, V6.
Old myocardial infarction change of leads V3,
26 Old anterior MI
V4, V5, no change of leads V1, V2, V6.
Early myocardial infarction change of leads
27 Early extensive anterior MI
V1, V2, V3, V4, V5.

Possible acute extensive anterior Acute myocardial infarction change of leads

28
MI V1, V2, V3, V4, V5.
Old myocardial infarction change of leads V1,
29 Old extensive anterior MI
V2, V3, V4, V5.
Early myocardial infarction change of leads
30 Early apical MI
V4, V5, no change of leads V1, V2, V3.
Acute myocardial infarction change of leads
31 Acute apical MI
V4, V5, no change of leads V1, V2, V3.

49
 Old myocardial infarction change of leads V4,
32 Old apical MI
V5, no change of leads V1, V2, V3.
Early myocardial infarction change of leads I,
33 Early anterolateral MI
aVL, V4, V5, V6
Acute myocardial infarction change of leads I,
34 Possible acute anterolateral MI
aVL, V4, V5, V6.
Old myocardial infarction change of leads I,
35 Old anterolateral MI
aVL, V4, V5, V6
Early myocardial infarction change of leads I,
36 Early high lateral MI
aVL, no change of leads II, III, aVF, V4, V5, V6.
Acute myocardial infarction change of leads I,
37 Possible acute high lateral MI
aVL, no change of leads II, III, aVF, V4, V5, V6.
Old myocardial infarction change of leads I,
38 Old high lateral MI
aVL, no change of leads II, III, aVF, V4, V5, V6.
Early myocardial infarction change of leads II,
39 Early inferior MI
III, aVF, no change of leads I, aVL.
Acute myocardial infarction change of leads
40 Possible acute inferior MI
II, III, aVF, no change of leads I, aVL.
Old myocardial infarction change of leads II,
41 Old inferior MI
III, aVF, no change of leads I, aVL.
Early myocardial infarction change of leads I,
42 Early inferolateral MI
II, III, aVL, aVF.
Acute myocardial infarction change of leads I,
43 Possible acute inferolateral MI
II, III, aVL, aVF.
Old myocardial infarction change of leads I,
44 Old inferolateral MI
II, III, aVL, aVF.

ST depression, mild anteroseptal Mild ST-segment depression of leads V1, V2,

45
myocardial ischemia V3, and no change of leads V4, V5.

ST depression, mild anterior Mild ST-segment depression of leads V3, V4,

46
myocardial ischemia V5, and no change of leads V1, V2, V6.

ST depression, mild extensive Mild ST-segment depression of leads V1, V2,

47
anterior myocardial ischemia V3, V4, V5.

ST depression, mild apical Mild ST-segment depression of leads V4, V5,

48
myocardial ischemia and no change of leads V1, V2, V3.

50
 ST depression, mild anterolateral Mild ST-segment depression of leads I, aVL,
49
myocardial ischemia V4, V5, V6.

ST depression, mild high lateral Mild ST-segment depression of leads I, aVL,

50
myocardial ischemia and no change of leads II, III, aVF, V4, V5, V6.

ST depression, mild inferior Mild ST-segment depression of leads II, III,

51
myocardial ischemia aVF, and no change of leads I, aVL.

ST depression, mild inferolateral Mild ST-segment depression of leads I, II, III,

52
myocardial ischemia aVL, aVF.

ST depression, anteroseptal Severe ST-segment depression of leads V1,

53
myocardial ischemia V2, V3, and no change of leads V4, V5.

ST depression, anterior myocardial Severe ST-segment depression of leads V3,

54
ischemia V4, V5, and no change of leads V1, V2, V6.

ST depression, extensive anterior Severe ST-segment depression of leads V1,

55
myocardial ischemia V2, V3, V4, V5.

ST depression, apical myocardial Severe ST-segment depression of leads V4,

56
ischemia V5, and no change of leads V1, V2, V3.

ST depression, anterolateral Severe ST-segment depression of leads I, aVL,

57
myocardial ischemia V4, V5, V6.

ST depression, high lateral Severe ST-segment depression of leads I, aVL,

58
myocardial ischemia and no change of leads II, III, aVF, V4, V5, V6.

ST depression, inferior myocardial Severe ST-segment depression of leads II, III,

59
ischemia aVF, and no change of leads I, aVL.

ST depression, inferolateral Severe ST-segment depression of leads I, II,

60
myocardial ischemia III, aVL, aVF.

Note:
Early myocardial infarction: normal Q-wave, ST elevation or ST slope elevation
Acute myocardial infarction: abnormal Q-wave, ST elevation or ST slope elevation
Old myocardial infarction: abnormal Q-wave, no ST elevation.
Abnormal Q-wave:
For leads I, II, III, avR, avL, avF, V3, V4, V5, V6, voltage of Q-wave <-0.3mV, or 4 times of
negative wave of Q-wave> voltage of R-wave and R’-wave, and/or Q-duration>40ms.
For leads V1, V2, voltage of Q-wave <-0.08mV and Q-duration>10ms.
ST elevation:
For leads I, II, III, avR, avL, avF, V4, V5, V6, the voltage of ST segment at 60ms point >0.1mV,
and for leads V1, V2, V3, the voltage at 60ms point >0.3mV.

51
 ST slope elevation:
Voltage of ST segment at 20ms point>=voltage of J point, voltage at 40ms point >= the one at
20ms, voltage at 60ms point >= the one at 40ms, with change of ST elevation.
4. Data sources and data preprocessing

4.1 Data sources

According to the requirement of IEC60601-2-51:2003 Medical electrical equipment - Part
2-51: Particular requirements for safety, including essential performance, of recording and
analysing single channel and multichannel electrocardiograph, the CSE measurement database,
CSE diagnostic database, CTS calibration database and customized data shall be used to
evaluate the function of automated measurements and automated interpretations.
Verification Database Database items
Automated CTS database CAL05000 CAL10000 CAL15000 CAL20000
measuremen CAL20002 CAL20100 CAL20110 CAL20160
t CAL20200 CAL20210 CAL20260 CAL20500
CAL30000 ANE20000 ANE20001 ANE20002
CSE measurement MA_0001～MA0125
database
Automated CSE diagnostic database D_0001～D_1220
interpretatio Customized data 000001～000549
n
4.2 CTS introduction
The CTS computerized ECG conformance testing project was launched in 1989 by the
European Union. This project laid the foundation for computerized ECG conformance testing
service. Currently, about 20 types of waveform have been designed derived from the test
signals having an infinite length, these signals are part of the CTS-ECG test database, and have
proven their effectiveness in a series of official tests. According to the requirement of
IEC60601-2-51:2003 Medical electrical equipment - Part 2-51: Particular requirements for safety,
including essential performance, of recording and analysing single channel and multichannel
electrocardiograph Clause 50.101.1, 13 data (CAL05000, CAL10000, CAL15000, CAL20000,
CAL20002, CAL20100, CAL20110, CAL20160, CAL20200, CAL20210, CAL20260, CAL20500,
CAL30000) are used in the automated parameters verification for this test.
4.3 CSE introduction
The EU CSE (Common Standards for Quantitative Electrocardiography) ECG database
contains 3-lead measurement database of collection1 and collection2, 12-lead measurement
database of collection3 and collection4, and a diagnostic database of collection5. In which, the
12-lead measurement database contains 250 groups of interference data; Diagnostic database
contains 1220 cases of short-term ECG recording. The primary development purpose of using
12-lead or 15-lead is to evaluate the performance of the automatic ECG analyzer. In addition to
the normal data, the database also includes clinically confirmed ECGs of variety cases, such as
left ventricular hypertrophy, right ventricular hypertrophy, every part of myocardial infarction
and ventricular hypertrophy accompanying myocardial infarction. The database has made a

52
great contribution to the study of electrocardiology, which is, the CSE group published a report
on the recommended standard for general ECG measurements based on the investigation and
study of the database, which has been widely recognized by the world.
CSE database diagnostic items:
Item Number
Normal 382
Left ventricular hypertrophy 183
Right ventricular hypertrophy 55
Biventricular hypertrophy 53
Anterior myocardial infarction 170
Inferior myocardial infarction 273
Complex myocardial infraction 104
Synthetical accuracy 1220
4.4 Customized data

4.4.1 Data description

Customized
Description
data
Total recording
549
number
Race Yellow race
Aged from 17 to 87, average age 57.23, standard deviation 21.32;
Coverage of
326 male, average age 55.54, standard deviation 19.81;
age, gender
223 female, average age 59.70, standard deviation 22.63.
12-lead ECG data (I, Ⅱ, Ⅲ, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6),
Sampling data sampling frequency of each channel: 1kHz, amplitude quantization:
2.4μV/LSB.
The interpretation conclusion of customized data is determined by the
physician diagnostic results of cardiac catheterization and ultrasonic
examination, and the ECG judgment result in physical examination, the
details as blow:
1) Normal ECG
Determined by the diagnostic result that judged as normal in cardiac
catheterization and ultrasonic examination, and the result that judged as
normal in physical examination.
Remark
2) Atrium hypertrophy
Determined by the diagnostic results of ultrasonic examination.
3) Myocardial infarction and myocardial ischemia
Determined by the physician diagnostic results of cardiac catheterization.
4) Tachycardia, bradycardia, low voltage, axis
Determined by the diagnostic results of ultrasonic examination.
5)Conduction block
Determined by the physician diagnostic results of cardiac catheterization.
53
 The standard of normal population in the customized database: physical
examination is normal, no heart disease or other diseases that may affect
cardiac functions or shape.
4.5 Data coverage of verification for automated interpretation
Analyzing the content of CSE diagnostic database and customized data, the overall
condition and coverage of statistical samples are shown as below:

54
Note:
The heart abnormalities such as posterior myocardial ischemia, early posterior MI and old
posterior MI are not included in the database. These abnormalities and other heart disorders
not contained in above sheet won’t be regarded as the judgment object for the verification of
automated interpretation accuracy.
4.6 Data preprocessing

4.6.1 CTS preprocessing

The 16 cases (CAL05000, CAL10000, CAL15000, CAL20000, CAL20002, CAL20100,
CAL20110, CAL20160, CAL20200, CAL20210, CAL20260, CAL20500, CAL30000, ANE20000,
ANE20001, ANE20002) from CTS-ECG shall be processed for voltage conversion and frequency
conversion for resampling as the applicable format in the system. Then cases will be imported
to the device. After that, the verification of automated measurement parameters will
4.6.2 CSE preprocessing
The cases (MA_0001~MA0125, D_0001~D_1220) from the CSE shall be processed for
voltage conversion and frequency conversion for resampling as the applicable format in the
system. Then cases will be imported to the device. After that, the case of MA_0001~MA0125
shall be used for the following verification of automated measurement parameters, and the
case of D_0001~D_1220 shall be used for the following verification of automated
interpretation.
4.6.3 Customized data preprocessing
The customized initial case files shall be processed for voltage conversion and frequency
conversion for resampling as the applicable format in the system. Then cases will be imported
to the device. After that, the verification of automated interpretation will be carried on.
5. Process and Result of Verification

5.1 Verification of measurement function

5.1.1 Verification and Process for CTS measurement database
The cases (CAL05000, CAL10000, CAL15000, CAL20000, CAL20002, CAL20100, CAL20110,

55
CAL20160, CAL20200, CAL20210, CAL20260, CAL20500, CAL30000, ANE20000, ANE20001,
ANE20002) imported to the device shall be used to verify the automated measurement
parameters.

Start

CTS preprocessing

Import preprocessing data to device

ECG automated measurement parameter

Calculate the difference of measurement and reference

Calculate mean differences

Eliminate the largest two deviations from the mean

Recalculate mean difference and standard deviation

End

5.1.2 Verification and Process for CSE measurement database

Import the converted case files into the device, add appropriate database records, then
waveform for all case files can be reviewed in the device, therefore the automated
measurement parameters can be obtained.
Eliminate the cases existing obvious error for the diagnostic parameters (P-wave location is
wrong) from the CSE database.
Make a comparison between the ECG analytical parameters (the beginning/end of P-wave,
QRS-complex and T-wave) and the diagnostic parameters (the beginning/end of P-wave,
QRS-complex and T-wave) provided by CSE database. Draw the two groups of waveform and
mark the location of the beginning/end of P-wave, QRS-complex and T-wave corresponding to

56
each case. The picture provides a visualized comparison, so the mean and standard deviation of
the differences can be calculated. According to the requirement of IEC60601-2-51:2003 Medical
electrical equipment - Part 2-51: Particular requirements for safety, including essential
performance, of recording and analysing single channel and multichannel electrocardiograph,
the four largest deviations from the mean shall be eliminated before recalculation of mean and
standard deviation of the differences.
Flow diagram of CSE measurement database verification process

57
 Start

Read expert diagnostic marks

Eliminate obvious unfit cases

Read initial case of DCD file

Frequency conversion

Voltage conversion

Get ECG data file

Automated measurement parameters

Compare automated measurement parameter and expert diagnostic mark

Conclude mean value of comparison

Eliminate the four largest deviations from the mean

Recalculate the mean value and variation of comparison result

Summarize the comparison results

End

58
5.1.3 Verification results

5.1.3.1 Accuracy of amplitude measurements

Calibration and analytical ECGs shall be used to measure the amplitude value, the
summary as follows:
Amplitude Mean difference (uV) Standard deviation (uV)
P-wave -1.70 5.72
Q-wave 7.51 18.07
R-wave -18.05 21.70
S-wave 7.77 18.58
ST-segment 0.15 4.24
T-wave -5.81 8.03
Note: In amplitude measurement, for large-amplitude ECG, such as CAL30000, it is necessary to
adjust to 0.5 times the gain before testing.
5.1.3.2 Accuracy of absolute interval and wave duration measurements
Calibration and analytical ECGs shall be used to measure the global interval and wave
duration (including Q-wave ,R-wave ,S-wave), the summary as follows:
Interval&Duration Mean difference (ms) Standard deviation (ms)
P-duration -5.70 1.88
PQ-interval -2.58 1.94
QRS-duration -0.23 3.26
QT-interval -6.70 4.37

5.1.3.3 Accuracy of interval measurements on biological ECGs

CSE database shall be used to evaluate the accuracy of interval measurements on
biological ECGs, the summary as follows:
Interval&Duration Mean difference (ms) Standard deviation (ms)
P-duration 0.99 13.46
PR-interval 3.65 9.68
QRS-duration -1.69 6.11
QT-interval -2.32 20.69

5.1.3.4 Stability of measurements against NOISE

The test is carrying on according to MA-series data (008, 011, 013, 014, 015, 021, 026, 027, 042,
061) in CSE database.
Global Type of added Disclosed differences
measurement NOISE Mean (ms) Standard deviation (ms)
parameters
P-duration High frequency -5.65 12.33
P-duration Line frequency -0.25. 12.71
P-duration Base-line -4.90 33.15
QRS-duration High frequency -0.95 5.13
QRS-duration Line frequency 1.35 4.71

59
 QRS-duration Base-line -1.55 7.68
QT-interval High frequency -14.55 6.51
QT-interval Line frequency -8.55 20.73
QT-interval Base-line 36.20 64.47
The biological ECGs are fed into the device in form of digital signals, then the
measurement value can be obtained by calculation.
Test condition:
a) without NOISE
b)with 25uV high frequency
c) with 50uV peak to valley 50Hz/60Hz sinusoidal line frequency NOISE
d) with 1mV peak to valley 0.3Hz sinusoidal base-line NOISE
For each NOISE level above, the differences of measurements between the NOISE-free ECGs and
the ECGs with NOISE shall be determined. The two largest deviations from the mean shall be
estimated before calculation of mean and standard deviation of differences.

60
5.2 Verification of interpretation function
5.2.1 Verification process
5.2.1.1 CSE diagnostic database

Start

Read initial DCD files

Frequency conversion

Voltage conversion

Get ECG data files

Automated interpretation item

Compare automated interpretation with expert diagnosis

Summarize comparison results, draw conclusions

End

61
5.2.1.2 Customized database

Start

Initial case data

ecg format as system required

Import to device

Expert diagnosis
Draw ECG waveform

Identify QRS-complex

QRS-complex superposition

Auto measurement parameter

Conclude automated interpretation items

Start comparing

Summarize the global statistical results of comparison for

each case

End

62
5.2.2 Verification results

ECGs Positive
Sensitivit Specifici
No. Item numbe predictive
y% ty %
r value %
1 No abnormal 585 92.01 79.16 97.38
2 Sinus mode Bradycardia 191 96.68 99.73 98.64
3 Sinus mode Tachycardia 78 97.44 96.49 96.90
4 Left atrium Hypertrophy 51 51.09 99.89 81.82
5 Right atrium Hypertrophy 43 42.64 99.66 50.00
6 Dual atrium Hypertrophy 22 93.58 99.14 60.19
7 QRS low voltage 5 96.37 99.36 63.25
8 Cardiac electric axis normal 733 98.36 89.13 98.79
9 Left axis deviation 168 98.65 89.40 98.18
10 Right axis deviation 107 98.23 88.99 94.90
11 Completeness Right Bundle branch
28 97.00 89.50 95.45
block
12 Completeness Left Bundle branch
32 97.73 89.65 91.43
block
13 No Completeness Right Bundle
41 96.86 89.83 82.35
branch block
14 No Completeness Left Bundle
47 94.68 89.83 89.66
branch block
15 V1 shows RSR' type 13 90.32 91.14 65.12
16 Left anterior fascicular block 26 91.43 93.25 71.11
17 Left posterior fascicular block 18 89.29 97.37 52.63
18 Left ventricular hypertrophy 236 41.37 92.65 70.36
19 Right ventricular hypertrophy 108 39.75 93.47 65.39
20 I atrioventricular block 13 94.58 91.67 80.64
21 Early anteroseptal MI 10 83.33 99.94 90.91
22 Possible acute forepart
27 16.67 98.73 91.89
anteroseptal MI
23 Old anteroseptal MI 26 92.00 98.90 86.47
24 Early anterior MI 77 93.90 88.22 71.96
25 Possible acute anterior MI 10 80.00 99.72 44.44
26 Old anterior MI 13 24.00 99.66 50.00
27 Early extensive anterior MI 24 79.67 99.43 41.18
28 Possible acute extensive anterior
16 81.82 99.66 75.00
MI

63
29 Old extensive anterior MI 30 90.91 88.05 37.04
30 Early apical MI 15 88.32 87.21 88.54
31 Acute apical MI 21 78.12 78.66 53.85
32 Old apical MI 19 79.63 89.94 80.00
33 Early anterolateral MI 36 77.51 79.94 83.33
34 Possible acute anterolateral MI 9 28.57 99.77 33.33
35 Old anterolateral MI 14 70.00 93.60 50.00
36 Early high lateral MI 16 79.65 95.78 80.42
37 Possible acute high lateral MI 8 81.60 99.94 85.71
38 Old high lateral MI 23 81.82 99.66 60.00
39 Early inferior MI 31 88.89 95.00 40.00
40 Possible acute inferior MI 11 76.00 99.60 61.11
41 Old inferior MI 101 96.07 99.24 93.44
42 Early inferolateral MI 73 98.77 96.82 75.94
43 Possible acute inferolateral MI 29 11.11 99.94 50.00
44 Old inferolateral MI 28 84.62 99.83 78.57
45 ST depression, mild anteroseptal
7 75.36 99.55 46.67
myocardial ischemia
46 ST depression, mild anterior
5 81.24 99.94 33.33
myocardial ischemia
47 ST depression, mild extensive
13 79.83 99.13 53.59
anterior myocardial ischemia
48 ST depression, mild apical
17 76.97 99.14 43.13
myocardial ischemia
49 ST depression, mild anterolateral
25 77.54 99.08 37.64
myocardial ischemia
50 ST depression, mild high lateral
21 80.64 99.14 47.39
myocardial ischemia
51 ST depression, mild inferior
12 79.73 99.60 55.16
myocardial ischemia
52 ST depression, mild inferolateral
20 80.59 99.26 50.61
myocardial ischemia
53 ST depression, anteroseptal
4 85.41 99.72 44.44
myocardial ischemia
54 ST depression, anterior myocardial
12 87.66 98.58 34.85
ischemia
55 ST depression, extensive anterior
7 84.78 98.04 67.75
myocardial ischemia
56 ST depression, apical myocardial 18 79.95 99.14 55.12
64
 ischemia
57 ST depression, anterolateral
13 87.42 98.97 59.09
myocardial ischemia
58 ST depression, high lateral
16 90.06 99.31 57.14
myocardial ischemia
59 ST depression, inferior myocardial
12 89.88 99.13 40.08
ischemia
60 ST depression, inferolateral
6 91.39 99.16 50.47
myocardial ischemia
Sensitivity: probability that a "True sample" would be determined as certain "Item" by
automated interpretation function;
Specificity: probability that a "True unfit sample" would be determined as certain "Unfit
item" by automated interpretation function;
Positive predictive value: probability that a determined "Unfit item" is a "True unfit item".

65
 Appendix II EMC Guidance and Manufacturer Declaration

Table 1:
Guidance and manufacturer’s declaration –electromagnetic emission
The device is intended for use in the electromagnetic environment specified below. The
purchaser or the user of the device should assure that it is used in such environment.
Emission test Compliance
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class A
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations/flicker emissions
Not applicable
IEC 61000-3-3
Table 2:

Guidance and manufacturer’s declaration-electromagnetic immunity

The device is tended for use in the electromagnetic environment specified below. The
purchaser or the user of the device should assure that it is used in such an environment.
IEC60601
Immunity test Compliance level
test level
Electrostatic discharge (ESD) ±8kV contact ±8kV contact
IEC 61000-4-2 ± 15 kV air ±15kV air
Electrical fast transient/burst ±2kV for power supply lines ±2kV for power supply lines
IEC 61000-4-4 ± 1 kV for input/output line Not Applicable
Surge ±1 kV lines to lines ±1 kV lines to lines
IEC 61000-4-5 ±2 kV lines to earth ±2 kV lines to earth
<5%UT(>95%dip in UT) for <5%UT(>95%dip in UT) for
0.5 cycle 0.5 cycle
Voltage dips, short
40% UT(60%dip in UT) for 5 40% UT(60%dip in UT) for 5
interruptions and voltage
cycle cycle
vatiations on power supply
70%UT(30%dip in UT) for 70%UT(30%dip in UT) for 25
input lines
25 cycle cycle
IEC 61000-4-11
<5%UT(>95%dip in UT) for <5%UT(>95%dip in UT) for 5
5 sec sec
Power frequency (50 / 60Hz)
magnetic field 30 A/m 30A/m
IEC 61000-4-8
Table 3:
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is tended for use in the electromagnetic environment specified below. The
purchaser or the user of the device should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level

3V 3V
Conducted RF 0,15 MHz – 80 MHz 0,15 MHz – 80 MHz
IEC61000-4-6 6 V in ISM bands between 6 V in ISM bands between
0,15 MHz and 80 MHz 0,15 MHz and 80 MHz
 Radiated RF
3 V/m 80 MHz- 2.7 GHz 3 V/m80 MHz- 2.7 GHz
IEC61000-4-3
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the device or system is
used exceeds the applicable RF compliance level above, the device should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as adjusting the direction or location of the device.
Table 4：
Guidance and manufacturer’s declaration - electromagnetic Immunity
The [Code SI] is intended for use in the electromagnetic environment specified below. The customer or the
user of the [Code SI] should assure that it is used in such an environment
Test Immunity
Band a) Modulation Distance
Frequency Service a) Modulation b) Test level
(MHz) b) (W) (m)
(MHz) (V/m)
Pulse
380
385 TETRA 400 modulation b) 1,8 0,3 27
–390
18 Hz
FM c)
380 GMRS 460, ± 5 kHz
450 2 0,3 28
–390 FRS 460 deviation
1 kHz sine
710 Pulse
704 – LTE Band 13,
745 modulation b) 0,2 0,3 9
787 17
Radiated RF 780 217 Hz
IEC61000-4-3 810 GSM
(Test 800/900,
Pulse
specifications 800 – TETRA 800,
870 modulation b) 2 0,3 28
for ENCLOSURE 960 iDEN 820,
18 Hz
PORT CDMA 850,
IMMUNITY to 930 LTE Band 5
RF wireless GSM 1800;
communicatio 1720
CDMA 1900;
ns equipment) GSM 1900; Pulse
1845 1 700 –
DECT; modulation b) 2 0,3 28
1 990
LTE Band 1, 217 Hz
1970 3,
4, 25; UMTS
Bluetooth,
WLAN, Pulse
2 400 –
2450 802.11 b/g/n, modulation b) 2 0,3 28
2 570
RFID 2450, 217 Hz
LTE Band 7
5240 Pulse
5 100 – WLAN 802.11
5500 modulation b) 0,2 0,3 9
5 800 a/n
5785 217 Hz
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna
and the
ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC
61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does
not represent actual modulation, it would be worst case.
The MANUFACTURER should consider reducing the minimum separation distance, based on
RISK MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced
minimum separation distance. Minimum separation distances 6 for higher IMMUNITY TEST LEVELS shall be
calculated using the following equation: E= P
d
Where P is the maximum power in W, d is the minimum separation distance in m, and E is the
IMMUNITY TEST LEVEL in V/m.

Warning
 Don’t near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME
SYSTEM for magnetic resonance imaging, where the intensity of EM DISTURBANCES is
high.
 Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating
normally.
 Use of accessories, transducers and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.”
 Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the device including cables specified by the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
 Active medical devices are subject to special EMC precautions and they must be
installed and used in accordance with these guidelines.
Note：
 The EMISSIONS characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for
which CISPR 11 class B is normally required) this equipment might not offer adequate
protection to radio-frequency communication services. The user might need to take
mitigation measures, such as relocating or re-orienting the equipment.
 When the device is disturbed, the data measured may fluctuate, please measure
repeatedly or in another environment to ensure its accuracy.

Disposal: The product must not be disposed of along with other domestic waste.
The users must dispose of this equipment by bringing it to a specific recycling point for
electric and electronic equipment.

GIMA WARRANTY TERMS

The Gima 12-month standard B2B warranty applies