Gima 300G VET ECG User guide

I

II

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

III

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.



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.

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.

IV

V

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 ....................................................................................... 11

5.1 Precautions before use ....................................................................................... 11

5.2 Precautions during operating ............................................................................. 12

5.3 Precautions after use .......................................................................................... 12

Chapter 6 Preparations before Operation .......................................................................... 13

6.1 Installation of recording paper ........................................................................... 13

6.2 Power supply connection.................................................................................... 13

6.3 Lead cable connection ........................................................................................ 14

6.4 Electrode installation .......................................................................................... 14

Chapter 7 Operation Instructions and Parameter Setting ................................................... 16

7.1 Main Interface .................................................................................................... 16

7.2 Sample interface ................................................................................................

7.3 Case information input interface ........................................................................ 19

7.4 Case management .............................................................................................. 19

7.5 Query .................................................................................................................. 20

7.6 Review ................................................................................................................ 21

7.7 Date and time setup ........................................................................................... 22

7.8 System setup ...................................................................................................... 22

7.9 Sample setup ...................................................................................................... 23

7.10 Analysis setup ................................................................................................... 24

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VI

7.11 Print setup ........................................................................................................ 24

7.12 Lead placement ................................................................................................ 26

7.13 About ................................................................................................................ 26

Chapter 8 Troubleshooting ................................................................................................. 27

8.1 Auto shutdown ................................................................................................... 27

8.2 AC interference ................................................................................................... 27

8.3 EMG interference ............................................................................................... 27

8.4 Baseline drift ....................................................................................................... 28

8.5 Troubleshooting list ............................................................................................ 28

Chapter 9 Maintenance ...................................................................................................... 30

9.1 Battery ................................................................................................................ 30

9.2 Recording paper ................................................................................................. 31

9.3 Maintenance after use ........................................................................................ 31

9.4 Lead cables and electrodes ................................................................................. 32

9.5 Silicone rubber roller .......................................................................................... 32

9.6 Cleaning of thermal print head ........................................................................... 32

9.7 Disposal of product scrap ................................................................................... 32

9.8 Others ................................................................................................................. 32

Chapter 10 Packing List and Accessories ............................................................................. 34

10.1 Accompanying accessories ............................................................................... 34

10.2 Notes ................................................................................................................ 34

Appendix I ECG Automated Measurement&Interpretation Guide ...................................... 35

1. Preface .................................................................................................................. 35

2. Automated measurement parameters and Automated interpretation items ...... 35

3. Algorithm description ........................................................................................... 37

4. Data sources and data preprocessing ................................................................... 47

5. Process and Result of Verification ........................................................................ 51

Appendix II EMC Guidance and Manufacturer6 Declaration ............................................... 61

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; 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

rhythm; 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: ≤150 VA

Battery: 7.4 V, 3500 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: 7 leads

1.3.4 Patient leakage current: <10µA

1.3.5 Input impedance: ≥2.5 MΩ

1.3.6 Frequency response:

Rated input

amplitude

1.0 0.67Hz~40Hz, Sine wave ±10%a

0.5 40Hz~100Hz, Sine wave +10 %, -30 %a

Input frequency and waveform Relative output response

1

0.25 100Hz~150Hz, Sine wave +10 %, -30 %a

0.5 150 Hz ~ 500 Hz, Sine wave

1.5 ≤1Hz,200ms, Triangle wave

a

relative to 10Hz b relative to 200 ms

+10 %, -100 %

+0 %, -10 %

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: 80 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, 20mm/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, PR Interval, P Duration, QRS Duration, T Duration, QT/

QTc Interval, P/QRS/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 The minimum detection signal: 10 Hz, 20 µV(peak-peak value) deflected sinusoidal signal

can be detected

1.3.25 Accuracy of input signal: ±5%.

1.3.26 Amplitude quantization: ≤5µV/LSB

1.3.27 Dimension: 315 mm(L)×215 mm(W)×77 mm(H)

1.3.28 Net Weight: 1.6 kg

1.3.29 Interchannel time deviation: <100 µs

1.4 Main Characteristics

1.4.1 High resolution thermal-array output system(8 dots/mm), no adjustment required.

Frequency Response is up to 150Hz.

1.4.2 Record clear and exact three channels ECG waveform and remarks in real-time and

continuously. The remark includes: lead sign, sensitivity, paper speed, filter state, etc.

a

b

2

1.4.3 In auto mode, recording can be completed with one-button operation, which improves

work efficiency.

1.4.4 Under the best DC condition, the device can stand by for 10 hours, or print for at least 3

hours, or print 260 pieces ECG.

1.4.5 At least 1,000 pieces of medical records can be stored in the device, which facilitates

doctors to review and information statistics.

1.4.6 Beautiful and smooth appearance.

1.4.7 Degree of protection against ingress of liquid: IPX0

1.4.8 Use digital signal processing technology to conduct AC filter, baseline filter and EMG filter

on ECG signals, in order to get high-quality ECGs.

1.4.9 With auto-measurement, auto-analysis functions of regular ECG parameters, which

reduces doctor’s workload and improves working efficiency.

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:embedded software

Software specification: none

Software version: V1.9.11

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.

3

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 replacing the fuse or 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.

Warning：Do not operate the instrument on parts of human body with wounds,and do not

perform measurements on parts with wounds on the surface.

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

4

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.

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

IEC60601-1-2 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.
 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.

 The use of ACCESSORIES other than those specified by the MANUFACTURER of the device

or system, may result in increased EMISSIONS or decreased IMMUNITY of the ME

EQUIPMENT or ME SYSTEM.

 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

5

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.

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.

7

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 DC voltage

and supplied to the DC-DC power 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 A/D conversion (with sampling accuracy of

24 bits) 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

optoelectronic coupler.

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 optoelectronic coupler 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.

8

Control system

Signal acquisition

system

Display system

Button system

Printing system

Power module

4

（2）Principle block diagram is shown in Figure 4-1.

Figure 4-1 Block diagram of control unit

4.2 Name of each part and its function

4.2.1 Front view

1

2

3

Figure 4-2 Front view

1. Paper compartment cover

Keep the paper compartment closed, hold the printing paper

2. Display screen

Display patient’s ECG and related information

3. Button area

Control the operations of the device, and enter information.

4. Cover switch

To open or close the paper compartment cover.

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.

9

4.2.2 Side view

6

5

Figure 4-3 Side view

5. Lead cable interface

Connect with lead cables.

6. USB interface

Communicate with the computer. The ECG data and analysis result 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, as

well as program upgrade, case export and connection with external printer.

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.

4.2.3 Rear view

Figure 4-4 Rear view

7. Equipotential terminal

Connect with the potential equalization conductor.

8. Input socket

Connect with AC power cord.

4.2.4 Buttons

10

municipal waste and must be recycled separately.

Figure 4-5 Schematic diagram of buttons

1. Startup indicator

It lights in green after turning on the device.

2. Power status indicator

Green indicates that the AC power supply is used. At this time, there is no battery in the device

or the battery is full. Red and green two colors indicate that the battery is being charged.

3. MENU

Menu button

4. MODE

When the device in sampling interface, use MODE button to select the print mode.

5. 1mV

Calibration button

6. PRINT

Print the sampled ECG waveform or end the printing.

7. Direction button

Up button

8. Direction button

Right button

9. SET

System menu and confirm.

10. Direction button

Down button

11. Direction button

Left button

12. FILTER

Set the filter mode.

13. SPEED

Change the ECG recording speed

14. SEN

Adjust the sensitivity manually.

15. ON/OFF

When the device is turned on, short press this button, it will prompt whether to shut down the

device, long press this button to turn off the device.

Waste disposal symbol. This symbol indicates that electrical and

electronic equipment waste cannot be disposed of as unsorted

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.

11

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.

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Chapter 6 Preparations before Operation

6.1 Installation of recording paper

6.1.1 The device adopts high-speed recording paper, its specification is 80 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, open the paper cabinet cover, take out the paper axis, insert it into

the roll 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 cabinet.

Figure 6-1 Installation of recording paper

2. Close the paper cabinet cover, it would be better to leave 2cm paper outside the exit of

paper cabinet.

Note: The recording paper should be aligned with the slot of the paper cabinet cover. 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.

6.2 Power supply connection

6.2.1 AC

Insert one end of the provided three-core power cord 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.

13

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, it will seriously affect the ECG recording. 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.

Following is the configuration per American standard when using five leadwires:

Figure 6-2 Leads Placement

■ RA (right arm) lead: on the right foreleg.

■ LA (left arm) lead: on the left foreleg.

■ RL (right leg) lead: on the right hind leg.

■ LL (left leg) lead: on the left hind leg.

■ V (precordial) lead: exploring lead.

Note: The exploring lead is used for diagnostic purposes as needed. Otherwise, it may be

14

left unplugged.

The chart below shows the label used to identify each leadwire. Included also is its

associated color code per American (AHA) and European (IEC) standards.

American Standard European Standard

Label Color Label Color

RA White R Red

LA Black L Yellow

LL Red F Green

RL Green N Black

V Brown C White

6.4.1 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.

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

“+”.

15

Total：1

New

Archive

Figure

Date And Time

Analysis Setup

System Setup

Print Setup

Sample Setup

About

title

gather

Time

Chapter 7 Operation Instructions and Parameter Setting

7.1 Main Interface

As shown in below figure:

 Status bar

 Storage space usage: display the usage condition of current storage space

 Current case amount: display the total number of current case

 Battery power (refer to 9.1): display current power status of the device

 Time (on bottom right corner of the screen): display current time of the system

 Function buttons

 New: to enter the sampling interface, finish waveform acquisition, display and report

printing, generally, the device will automatically enter this interface after powering on

 Archive: to enter the case management interface, in this interface, user can query,

modify or delete case information

 Figure: to view the placement of leads

 Date And Time: to set time and date

 System Setup: to perform system setting

 Sample Setup: to perform sampling setting

 Analysis Setup: to set the parameters used in automatic analysis

 Print Setup: to set the print mode, print style and print content, etc.

 About: to display software version No., creation time and firmware information, etc.

7.2 Sample interface

Click “New” on the main interface or press the

interface.

Note: If “Info Input” is set to “Before” in Sample Setup, the case information needs

button to enter the sampling

to be entered before acquisition (refer to 7.3).

16

Instant Heart rate

Return

Instant Waveform

Print

Lead-off Information Status

Speed FilterGain

Lead

Print Mode

The sampling interface provides several lead display modes, including 3-lead, 6-lead and

12-lead. The following figure uses 12-lead as an example:

End sampling: After the device starts sampling, use the

button to end the

sampling, and back to the main interface.

Switch lead: When the device does not simultaneously display 12 leads, use the

and

buttons to switch displayed waveform.

Switch lead display style: use the

and buttons to switch the display style

between 3-lead, 6-lead and 12-lead.

Lead-off information: In demo mode, it displays “DEMO ECG”. In sampling mode, it

displays the detected lead status.

Print mode: use the

button to switch the print mode between Manual, Auto

4×3, Auto 3×4+1, Auto 3×4, Auto 2×6+1, Auto 2×6, Auto 3-2+1, Auto 3-2, Auto 1×12+1, Auto

1×12, Rhythm 4, Rhythm 3 and Rhythm 2.

Gain (sensitivity): use the

button to switch the gain between 5 mm/mV, 10

mm/mV and 20 mm/mV. The overall gain (sensitivity) can be checked by calibration function.

Speed: use the

button to switch the speed between 12.5 mm/s, 25 mm/s and

50 mm/s.

Filter: use the

AC+EMG, AC+DFT, EMG+DFT and AC+EMG+DFT.

button to switch the filter between no filter, AC, EMG, DFT,

In which, AC AC filter

EMG EMG filter

DFT Baseline filter

17

Display content

Explanation

Process…

It is printing.

Waiting…

It is finishing printing.

No Paper.

Lack of paper, user should restart printing after loading paper.

Print Timeout.

Communication failure between this system and printing sub-system.

ECG Timeout

Communication failure between this system and sampling sub-system.

Low Power

Low power, it cannot start printing.

please print again after connecting a USB printer.

printing under rhythm mode

Show Speed

[12.5mm/s]/[25mm/s]/[50mm/s]

Set the speed of displayed ECG.

Display calibration signal: after pressing button,1 mV signal will occur on the

screen once.

Note: The calibration is an automatic process, user does not need to press any button.

Print/End print: use the

Auto mode: After starting to print, the system automatically prints and stores the real-time

12-lead ECG waveform. The length is determined by the relevant settings in the print setup.

Based on the settings, the automatic analysis data and conclusions are printed, and the system

automatically ends printing.

Manual mode: After starting to print, user need to switch the lead to print the waveform

of different leads, that is, the ECG printed in the manual mode is asynchronous, and the data is

not saved. User need to press the PRINT button again when the print needs to be terminated.

If lead-off appears during acquisition, the waveform printed will be marked with “*”.

If lead overload appears during acquisition, the waveform printed will be marked with “+”.

During printing, the display content of print status are including:

Print Failed

Note: You can not print until ECG waveforms are displayed on the screen.

In current interface, press

of each setting item and its description are shown in the following table:

Item Options Description

AC filter

EMG filter

DFT Filter

Rhythm Lead

When it was set to use a USB printer, no such printer was connected,

[ON]/[OFF]

[ON]/[OFF]

[ON]/[OFF]

Any lead among the 12 leads

button to start or end the printing operation.

to enter quick setup interface. The optional content

Turn on or off the AC filter.

Turn on or off the EMG filter.

Turn on or off the Baseline filter.

Set the rhythm lead that used for

Show Style [3 Leads]/[6Leads]/[12Leads] Set the display method of ECG.

Show Gain [5mm/mV]/[10mm/mV]/[20mm/m

V]

Click "OK" to apply new setup and return to sampling interface; while click"Cancel" not to

18

Set the gain of displayed ECG.

Start

Cancel

ID

Name

Sex

Date And Time

Age

Height

Weight

/

SYS/DIA

Pace

Physician

mmHg

cm kg

Total：1 Current：1 / 1

Date And Time ID Name Sex TimeLen

Case list

Adv-opr

丨<

Review Delete

Return

<< >>

>丨

Sampling Time 001 Patient Name Sex TimeLen

apply and directly return to sampling interface.

7.3 Case information input interface

Due to the difference of Info Input (refer to 7.9), user could choose to input case

information (including ID, name, etc.) before or after the sampling, or not input the case

information, the dialogue box is shown as below:

After selecting a edit box, pressing

Clicking “Caps” can switch between numbers, lowercase letters, capital letters and symbols.

“Space” is the space key, press it to enter a space; “Backspace” is the backspace key, press it to

delete the last character entered. Click “OK” to confirm the entry and exit the interface.

The keyboard may have input restrictions according to the limitation of content. The

restricted keys will be grayed out and unavailable.

7.4 Case management

In the main interface, click “Archive” to enter the case management interface, as shown

below:

The above interface shows all medical records stored in the device. User can search

19

button could pop up a soft keyboard.

Select Close

ID

Name

Cond.And

Select Conditions

Clear

Cond.or

Sex

Weight

SYS/DIA

Physician

/

kg

Age

Height

cm

necessary cases by the query function in the interface (refer to 7.5), modify any case

information and review the case waveform stored by “Review” (refer to 7.6), and delete the

case by “Delete”.

The Adv-opr includes the following contents:

 List All: list all cases
 Query: refer to 7.5
 Delete All: delete all cases (caution, it is unrecoverable).
 Export: connect the U disk through the USB port, to export the cases in the device

into the specified folder in the U disk.

 Return: return to the case management interface.

modify or delete case information by edit function, and review stored case information

(refer to 7.6).

Click

Click

Click

Click

7.5 Query

Select “Adv-opr” in the case management interface to enter its sub-menu, then select

“Query” to enter its setting interface. Input query conditions and click “Select” to obtain

expected results. After clicking “Clear”, the system will clear all query conditions that entered.

to jump to the first page of case list.

to jump to the last page of case list.

to jump to the previous page.

to jump to the next page.

“Cond.And” and “Cond.Or” indicate the matching mode of the query conditions. You can

choose one of the two. If you select “Cond.And”, the displayed query results will satisfy all the

input conditions at the same time; if you select “Cond.Or”, the displayed query results only

need to meet any of the conditions entered.

Suggestion: When there are many cases, it would be better to input accurate query

conditions and choose “Cond.And” to quickly find the case.

20

Review Close

ID

Name

Sex

Sampling Time

Age

Height

Weight

/

SYS/DIA

Pace

Physician

mmHg

cm kg

Save

Sampling Time

Return

Review Waveform

Print

Review time / Sampling

time length

Status

Speed

<<

Gain

Print Mode

>>

Diagnose

7.6 Review

In the case management interface, select a case to be reviewed, click “Review” to enter

the following dialog box, which displays the case information. User is allowed to modify patient

information, after clicking “Save”, the information will be changed. Please note that the

modification is irreversible.

Make sure the input information is correct, click “Review” to enter the review interface,

which is similar with the sampling interface.

In current interface, user could adjust the time period of displayed waveform by

buttons, each pressing could move the waveform to corresponding direction for 1s, and

the speed and gain can be changed (refer to 7.2).

marked with “*”.

be marked with “+”.

In this interface, if lead-off appears during acquisition, the waveform reviewed will be

In this interface, if lead overload appears during acquisition, the waveform reviewed will

21

and

Item

Options

Description

current case

mode.

rhythm mode

ECG.

ECG.

ECG.

Item

Options

Description

used..

In this interface, user can use button to change the print mode.

In this interface, user can use

If lead-off appears during acquisition, the waveform printed will be marked with “*”.

If lead overload appears during acquisition, the waveform printed will be marked with “+”.

In current interface, press

of each setting item and its description are shown in the following table:

[Auto 4×3]/[Auto 3×4]/[Auto 2×6], and

Print Mode

Rhythm Lead Any lead among the 12 leads

Show Style

Show Gain

Show Speed

Click "OK" to apply new setup and return to review interface; while click"Cancel" not to

apply and directly return to review interface.

7.7 Date and time setup

In the main interface, click “Date And Time” to set date and time.

other print modes that applicable for

[3 Leads]/[6Leads]/[12Leads]

[5mm/mV]/[10mm/mV]/[20mm/mV]

[12.5mm/s]/[25mm/s]/[50mm/s]

button to print.

to enter quick setup interface. The optional content

The system takes the

selected option as print

Set the rhythm lead that

used for printing under

Set the display method of

Set the gain of displayed

Set the speed of displayed

content of the item by

7.8 System setup

descriptions are as followings:

In current interface, user can switch the items via

and buttons.

Select “System Setup” in main menu to enter its setting interface, the options and their

[None]/[30Seconds]/[1

ScreenSaver

Minute]/[2 Minutes] /[5

Minutes]/[10 Minutes], etc.

22

and buttons, and adjust the

If there is no operation after reaching the

set time, screen saver will be active. If it is

set to “None”, this function will not be

always keep on.

Minutes]/[60 Minutes], etc.

always keep on.

device uses in low power.

[60Hz/25Hz]/[60Hz/35Hz]

filter.

Language

[English]/[Chinese], etc.

To set the default language of system.

sound.

the system will run in

, the system will

run in sampling mode.

restore to the default options.

Item

Options

Description

[OFF]/[ON]

Turn on or off the EMG filter.

[OFF]/[ON]

Turn on or off the Baseline filter.

to input the case information

before or after sampling, or not input

0mm/mV]

mm/s]

-opr

Lead]

[30Seconds]/[1 Minute]/[2

Back-light

Auto Off

Low Power [None]/[Only once]/[Always]

Filter Freq

K-B Sound [ON]/[OFF]

Demo Mode [ON]/[OFF]

Default ————

7.9 Sample setup

Select “Sample Setup” in main menu to enter its setting interface, the options and their

descriptions are as followings:

Minutes] /[5 Minutes]/[10

Minutes]/[Always On], etc.

[None]/[1 Minute]/[3

Minutes]/[5 Minutes]/[10

Minutes]/[15 Minutes]/[30

[50Hz/35Hz]/[50Hz/25Hz]/

If there is no operation after reaching the

set time, screen backlight will turn off. If it

is set to “Always On”, the backlight will

If there is no operation after reaching the

set time, the system will automatically turn

off. If it is set to “None”, the system will

It determines the alarm method that the

To set the parameters of AC filter and EMG

If it is selected, the button makes sound

while pressing, otherwise, there will be no

If it is selected,

Demo mode; otherwise

Select “Default”, the system settings will

AC Filter

EMG Filter

DFT Filter

Info Input [Before]/[After]/[None]

Show Style

Show Gain [5mm/mV]/[10mm/mV]/[2

Show Speed [12.5mm/s]/[25mm/s]/[50

Adv

Sort Lead

[OFF]/[ON] Turn on or off the AC filter.

[3 Leads]/[6 Leads]/[12

Leads]

[Routine Lead] / [Cabrera

Set

Set the display method of ECG.

Set the gain of displayed ECG.

Set the speed of displayed ECG.

Set the arrangement mode of the lead

23

nd Grid

Be used to set whether with

background grid.

Filter

[150Hz]], etc.

filter.

[1Hz], etc.

Hospital

————

Fill in the hospital name in the report.

“Default”, the system settings

will restore to the default options.

V5]/[V6]

heartbeat sound.

as the criterion of premature beat.

as the criterion of asystole.

as the criterion of tachycardia.

Print Mode

[Manual]/[Auto

The system takes the selected

Backgrou

Low-pass

DFT Freq

Default ————

7.10 Analysis setup

Select “Analysis Setup” in main menu to enter its setting interface, the options and their

descriptions are as followings:

The setup here will affect real-time analysis during sampling, case review and diagnosis

prompt of print report.

Item Options Description

Rhythm Lead

Heartbeat Sound [OFF]/[ON]

Premature (%) ————

[Show]/[Not Show]

[OFF]/[75Hz]/[100Hz]]/

[0.05Hz]/[0.15Hz]/[0.25Hz]/

[0.32Hz]/[0.50Hz]/[0.67Hz]/

[I]/[II]/[III]/[aVR]/[aVL]/[a

VF]/[V1]/[V2]/[V3]/[V4]/[

Set the parameters of the low-pass

Set the parameters of the DFT filter.

Select

Set the rhythm lead, be used to print

under rhythm mode.

Be used to set whether it has

The system will take the input value

Pause Time (ms) ————

Tachycardia (bpm) ————

Bradycardia (bpm) ————

Default ————

7.11 Print setup

Select “Print Setup” in main menu to enter its setting interface, the options and their

descriptions are as followings:

Item Options Description

The system will take the input value

The system will take the input value

The system will take the input value

as the criterion of bradycardia.

Select “Default”, the system settings

will restore to the default options.

24

etc.

means the system will

adjust gain automatically to fit

print gain.

The system takes the selected

set to

, the system will take

length for printing each

[Not print], etc.

When “Print Mode” is set to

will print the average QRS

waveform in selected format.

[Not print]

by user as demand.

[Off]/[per 1 min]/[per 2

in]/[per 5

the ECG acquisition

process, the system will

operation according to the

will output according to the

4×3]/[Auto 3×4+1]/[Auto

3×4]/[Auto 2×6+1]/[Auto

2×6]/[Auto 3-2+1]/[Auto

3-2]/[Auto 1×12+1]/[Auto

1×12]/[Rhythm

4]/[Rhythm 3][/Rhythm 2],

Lead Gain [Smart]/[Current] The system will take the selected

[3 sec]/[4 sec]/[5 sec]/[6

Auto Strip

Rhythm Strip

sec]/[8 sec]/[10 sec]/[15

sec]/[20 sec]/[25 sec], etc.

[10 sec]/[15 sec]/[20

sec]/[25 sec]/[30 sec], etc.

option as the default print mode.

item as the gain mode of printing.

“Smart”

paper height. “Current” indicates

that the system will use the gain

of waveform on the screen as the

time as the time for printing each

strip.

When “Print Mode” is

“Rhythm”

the selected time as the time

waveform.

Average QRS

Auto-Diagnosis

Period

[4×3+Mark]/[4×3]/

[3×4+Mark]/[3×4]/

[2×6+Mark]/[2×6]/

[All]/[Only Data]/

[Only Conclusion]/

min]/[per 3 m

min]/[per 10 min]/[per 20

min]/[per 30 min]/[per 60

min], etc.

25

“Auto” or “Rhythm”, the system

The diagnosis contains data and

conclusion, which can be chosen

During

automatically activate the printing

selected time interval. When the

print mode is set to “Manual”, it

will output 3-lead, otherwise, it

current setting mode.

the case after pressing “PRINT”.

Print ST

Vector

vector.

Depth

the waveform as required.

options.

Print-Save [Print and Save]/[Save no

Print]/[Print no Save]

Print

Adv-opr

Default ————

Note 1: The settings of auto strip, rhythm strip, average QRS, auto diagnosis and periodic

print are only optional in auto mode and rhythm mode.

Note 2: If printing time is less than 8s, no analysis, the sampling and printing time are the

same; if the printing time is equal to or greater than 8s, the sampling and analysis time keeps

the same with print time.

7.12 Lead placement

Select “Figure” in main menu to check the sketch map of lead placement (also refer to

6.4).

Press any button to exit this interface.

7.13 About

Select “About” in main menu to view the information about the device, it contains the

following contents:

 Version: version No. of current program
 Build: creation time of current program.
 FirmInfo: select it to check the firmware information of the device.

Device

Print

[Inside]/[Outside A4]

[Not Print]/[Print]

[1]/[2]/[3]/[4]

When sampling the case, the user

can select whether print / save

The user can select to use the

internal thermal paper or outside

USB printer to print.

Be used to set whether to print ST

The user can select the depth of

Select “Default”, the system

settings will restore to the default

26

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.

27

1. Grounding cable is not

keep quiet.

close to each other.

Not regular
waveform, large

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

Too large
interference,
disorderly
waveform

Baseline burr

up-and-down,
beeline figure

connected reliably.

2. Lead cables are not connected
reliably.

3. There is AC interference.

4. Patient is nervous and can not

1. AC interference is large.

2. Patient nervous, and EMG
interference is large.

1. Bad electrode conductivity.

2. Low battery.

3. Bad connection between
electrodes and patient skin.

4. Loose connection between lead
cables and the device's plug.

5. Bad connection between
electrodes and lead cables.

28

1. Check the power cord and
lead cables.

2. Let the patient prepare for
the measurement.

1. Improve the environment.

2. If the bed is made of steel,
replace it.

3. The power cable and lead
cables are not parallel or too

1. Use alcohol of high quality.

2. Clean electrode slice and the
skin under the electrode with
alcohol.

3. Charge the battery.

Baseline draft

Unclear
waveform

1. Low power.

2. Patient movement.

1. Low battery.

2. The printer head surface is
dirty.

3. The thermal paper problem.

1. Charge the battery.

2. Keep patient still.

1. Charge the battery.

2. Cut off the power, clean the
printer head with alcohol, air
dry.

3. Replace the thermal print
paper with specified one.

29

The battery status is unknown, generally it appears within 1 min after
turning on.

Using AC power supply, and the battery is full or no battery in the
device

Using battery, and the battery is low. It is recommended to charge the
battery before use or adopt AC power supply.

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 5 hours to charge to 90%, and 5.5 hours to

charge to full capacity.

Table 9-1 Battery status display

No. Icon Description

a

b

c

d

e

f

g

Note: When charging the battery, the displayed status of battery level switches between icon

f to icon c.

9.1.2 The device can print for 3 hours or work for more than 10 hours in standby mode when

battery is completely charged. When the device is powered by battery, a battery icon will be

displayed on the LCD screen, showing the battery capacity in 5 modes. 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

Using battery, and battery is full

Using battery, and battery level is 3/4 of battery full

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

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

30

should be used.

 Do not touch the positive and negative terminals of the battery directly with wire,

otherwise there is a danger of fire.

 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 Press

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

button to shutdown the device.

31

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 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.

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

32

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).

33

Name

Quantity

Electrocardiograph

1 pc

Limb electrodes (limb clip)

1 set

ECG lead cable

1 pc

Potential equalization wire

1 pc

Power cord

1 pc

User manual

1 pc

Recording paper

1 pc

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

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.

34

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

No.

Item

2

Sinus mode Bradycardia

3

Sinus mode Tachycardia

5

Right atrium Hypertrophy

6

Dual atrium Hypertrophy

8

Cardiac electric axis normal

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

2.2 Interpretation items

1 No abnormal

4 Left atrium Hypertrophy

7 QRS low voltage

35

9

Left axis deviation

10

Right axis deviation

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

36

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

and diagnosis

to above description

Application site

hospitals

sensitivity and specificity.

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

Population Teenagers and adults, age range: 12-87

Accuracy

Others

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 accuracy of this function is reflected by the balance performance of

This function does not generate any alarm when using, so it should be

operated by professional or trained personal.

37

Start

End

The workflow is shown as below:

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

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.

38

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

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.

39

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 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

40

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

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

41

RR

QT

PI

180 )3 S),S(S arctan(2.0

IIIII

××+×

4 QRS-duration Se⑤ - Qs

5 T-duration Te⑦ - Ts⑥

6 QT Te⑦ - Qs

7 QTc

Electric axis formula:

⑧

P electric axis:

S

: voltage sum from the beginning point to the end

III

point of P-wave on lead III

S

: voltage sum from the beginning point to the end

I

8

P/QRS/T electric

axis

point of P-wave on lead I

QRS electric axis:

S

: voltage sum from the beginning point to the end

III

point of QRS-complex on lead III

S

: voltage sum from the beginning point to the end

I

point of QRS-complex on lead I

T electric axis:

S

: voltage sum from the beginning point to the end

III

point of T-wave on lead III

S

: voltage sum from the beginning point to the end

I

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



42

No.

Item

Rule of interpretation

No abnormal

Cardiac electric axis normal

Left axis deviation

Right axis deviation

branch block

block

branch block

branch block

V1 shows RSR' type

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

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

Sinus mode Bradycardia

Sinus mode Tachycardia

Left atrium Hypertrophy

Right atrium Hypertrophy

Dual atrium Hypertrophy

QRS low voltage

Completeness Right Bundle

Completeness Left Bundle branch

No Completeness Right Bundle

No Completeness Left Bundle

Left anterior fascicular block

No any abnormal are detected

Sinus P-wave, PR-interval between

110ms-210ms, HR≤*/min, general *=50

Sinus P-wave, PR-interval between

110ms-210ms, HR≥ */min, general *=100

P-wave of leads I, II, aVL shall meet the

conditions: width increase of P-wave≥110ms,

or P-wave displays in double-peak type,

value of peak to peak ≥40ms

For leads I, II, aVF, amplitude of P-wave

≥0.25mV, or P-wave is sharp

For leads I, II, aVF, amplitude of P-wave

≥0.25mV and P-wave duration >110ms

Voltage of I-aVF limb leads ＜0.5mV,

and voltage of V1-V6 chest leads ＜0.8mV

QRS-axis between 30 to 90 degree

QRS-axis between -90 to-30 degree

QRS-axis between 120 to 180 degree

QRS-duration>120ms, R-wave of lead

V1 or aVR is wide (width of R-wave>80ms)

QRS-duration>120ms, R-wave of lead

V5 or V6 is wide

QRS-duration<120ms, R-wave of lead

V1 or aVR is wide (width of R-wave>80ms)

QRS-duration<120ms, R-wave of lead V15 or

V6 is wide (width of R-wave>80ms)

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 duration<20ms, lead II, III and aVF

are rS type.

43

I atrioventricular block

anteroseptal MI

MI

Acute apical MI

QRS-duration<110ms, QRS-axis >90

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

Left posterior fascicular block

Left ventricular hypertrophy

Right ventricular hypertrophy

Early anteroseptal MI

Possible acute forepart

Old anteroseptal MI

Early anterior MI

Possible acute anterior MI

Old anterior MI

Early extensive anterior MI

Possible acute extensive anterior

Old extensive anterior MI

Early apical MI

degree, lead I and lead aVL are rS type, lead

II, III and aVF are qR type, and Q-wave of

lead II and III <20ms.

R amplitude of lead I >1.5mV, R

amplitude of lead V5 >2.5mV, R amplitude of

lead 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 amplitude of lead V1 is larger

than S amplitude, R amplitude of lead V5 is

smaller than S amplitude.

PQ interval >210ms

Early myocardial infarction change of leads

V1, V2, V3, no change of leads V4, V5.

Acute myocardial infarction change of

leads V1, V2, V3, no change of leads V4, V5.

Old myocardial infarction change of

leads V1, V2, V3, no change of leads V4, V5.

Early myocardial infarction change of leads

V3, V4, V5, no change of leads V1, V2, V6.

Acute myocardial infarction change of leads

V3, V4, V5, no change of leads V1, V2, V6.

Old myocardial infarction change of leads V3,

V4, V5, no change of leads V1, V2, V6.

Early myocardial infarction change of leads

V1, V2, V3, V4, V5.

Acute myocardial infarction change of leads

V1, V2, V3, V4, V5.

Old myocardial infarction change of leads V1,

V2, V3, V4, V5.

Early myocardial infarction change of leads

V4, V5, no change of leads V1, V2, V3.

Acute myocardial infarction change of leads

44

myocardial ischemia

myocardial ischemia

anterior myocardial ischemia

myocardial ischemia

ST depression, mild anterolateral

V4, V5, no change of leads V1, V2, V3.

32

33

34

35

36

37

38

39

40

41

42

43

44

ST depression, mild anteroseptal

45

46

47

48

49

Old apical MI

Early anterolateral MI

Possible acute anterolateral MI

Old anterolateral MI

Early high lateral MI

Possible acute high lateral MI

Old high lateral MI

Early inferior MI

Possible acute inferior MI

Old inferior MI

Early inferolateral MI

Possible acute inferolateral MI

Old inferolateral MI

ST depression, mild anterior

ST depression, mild extensive

ST depression, mild apical

Old myocardial infarction change of leads V4,

V5, no change of leads V1, V2, V3.

Early myocardial infarction change of leads I,

aVL, V4, V5, V6

Acute myocardial infarction change of leads

I, aVL, V4, V5, V6.

Old myocardial infarction change of leads I,

aVL, V4, V5, V6

Early myocardial infarction change of leads I,

aVL, no change of leads II, III, aVF, V4, V5, V6.

Acute myocardial infarction change of leads

I, aVL, no change of leads II, III, aVF, V4, V5,

V6.

Old myocardial infarction change of leads I,

aVL, no change of leads II, III, aVF, V4, V5, V6.

Early myocardial infarction change of leads II,

III, aVF, no change of leads I, aVL.

Acute myocardial infarction change of leads

II, III, aVF, no change of leads I, aVL.

Old myocardial infarction change of leads II,

III, aVF, no change of leads I, aVL.

Early myocardial infarction change of leads I,

II, III, aVL, aVF.

Acute myocardial infarction change of leads

I, II, III, aVL, aVF.

Old myocardial infarction change of leads I,

II, III, aVL, aVF.

Mild ST-segment depression of leads V1, V2,

V3, and no change of leads V4, V5.

Mild ST-segment depression of leads V3, V4,

V5, and no change of leads V1, V2, V6.

Mild ST-segment depression of leads V1, V2,

V3, V4, V5.

Mild ST-segment depression of leads V4, V5,

and no change of leads V1, V2, V3.

Mild ST-segment depression of leads I, aVL,

45

myocardial ischemia

myocardial ischemia

myocardial ischemia

myocardial ischemia

myocardial ischemia

ischemia

myocardial ischemia

ischemia

myocardial ischemia

ischemia

myocardial ischemia

V4, V5, V6.

ST depression, mild high lateral

50

51

52

53

54

55

56

57

58

59

60

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.

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.

ST depression, mild inferior

ST depression, mild inferolateral

ST depression, anteroseptal

ST depression, anterior myocardial

ST depression, extensive anterior

ST depression, apical myocardial

ST depression, anterolateral

ST depression, high lateral

myocardial ischemia

ST depression, inferior myocardial

ST depression, inferolateral

Mild ST-segment depression of leads I, aVL,

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

Mild ST-segment depression of leads II, III,

aVF, and no change of leads I, aVL.

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

aVL, aVF.

Severe ST-segment depression of leads V1,

V2, V3, and no change of leads V4, V5.

Severe ST-segment depression of leads V3,

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

Severe ST-segment depression of leads V1,

V2, V3, V4, V5.

Severe ST-segment depression of leads V4,

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

Severe ST-segment depression of leads I,

aVL, V4, V5, V6.

Severe ST-segment depression of leads I,

aVL, and no change of leads II, III, aVF, V4,

V5, V6.

Severe ST-segment depression of leads II, III,

aVF, and no change of leads I, aVL.

Severe ST-segment depression of leads I, II,

III, aVL, aVF.

46

Verification

Database

Database items

CAL30000 ANE20000 ANE20001 ANE20002

database

n

CSE diagnostic database

D_0001～D_1220

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.

CAL05000 CAL10000 CAL15000 CAL20000

Automated

measuremen

t

Automated

interpretatio

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

CTS database

CSE measurement

Customized data 000001～000549

CAL20002 CAL20100 CAL20110 CAL20160

CAL20200 CAL20210 CAL20260 CAL20500

MA_0001～MA0125

47

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

data

223 female, average age 59.70, standard deviation 22.63.

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:

4.4 Customized data

4.4.1 Data description

Customized

Description

Total recording

number

Race Yellow race

Coverage of

age, gender

Sampling data 12-lead ECG data (I, Ⅱ, Ⅲ, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6),

Remark The interpretation conclusion of customized data is determined by the

549

Aged from 17 to 87, average age 57.23, standard deviation 21.32;

326 male, average age 55.54, standard deviation 19.81;

sampling frequency of each channel: 1kHz, amplitude quantization:

2.4μV/LSB.

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.

2) Atrium hypertrophy

Determined by the diagnostic results of ultrasonic examination.

48

cardiac functions or shape.

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.

The standard of normal population in the customized database: physical

examination is normal, no heart disease or other diseases that may affect

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:

49

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 be carried on.

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.

50

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

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,

CAL20160, CAL20200, CAL20210, CAL20260, CAL20500, CAL30000, ANE20000, ANE20001,

ANE20002) imported to the device shall be used to verify the automated measurement

parameters.

5.1.2 Verification and Process for CSE measurement database

Import the converted case files into the device, add appropriate database records, then

51

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

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

52

Eliminate obvious unfit cases

Frequency conversion

Read expert diagnostic marks

Voltage conversion

Read initial case of DCD file

Get ECG data file

Automated measurement parameters

Conclude mean value of comparison

Compare automated measurement parameter and expert diagnostic mark

Summarize the comparison results

Recalculate the mean value and variation of comparison result

Start

End

Eliminate the four largest deviations from the mean

53

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

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

parameters

Disclosed differences

P-duration

High frequency

-5.65

12.33

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:

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:

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

measurement

Type of added

NOISE

Mean (ms) Standard deviation (ms)

54

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

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.

55

Frequency conversion

Voltage conversion

Read initial DCD files

Get ECG data files

Automated interpretation item

Start

Summarize comparison results, draw conclusions

End

5.2 Verification of interpretation function

5.2.1 Verification process

5.2.1.1 CSE diagnostic database

Compare automated interpretation with expert diagnosis

56

ecg format as system required

Import to device

Start comparing

case

Auto measurement parameter

Start

5.2.1.2 Customized database

Initial case data

Draw ECG waveform

Identify QRS-complex

QRS-complex superposition

Conclude automated interpretation items

Expert diagnosis

Summarize the global statistical results of comparison for each

End

57

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

block

block

branch block

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

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

5.2.2 Verification results

No. Item

ECGs

numbe

Sensitivit

y %

Specifici

ty %

Positive

predictive

11 Completeness Right Bundle branch

12 Completeness Left Bundle branch

13 No Completeness Right Bundle

14 No Completeness Left Bundle

22 Possible acute forepart

28 97.00 89.50 95.45

32 97.73 89.65 91.43

41 96.86 89.83 82.35

47 94.68 89.83 89.66

27 16.67 98.73 91.89

58

MI

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

myocardial ischemia

myocardial ischemia

anterior myocardial ischemia

myocardial ischemia

myocardial ischemia

myocardial ischemia

myocardial ischemia

myocardial ischemia

myocardial ischemia

ischemia

45 ST depression, mild anteroseptal

46 ST depression, mild anterior

47 ST depression, mild extensive

48 ST depression, mild apical

49 ST depression, mild anterolateral

50 ST depression, mild high lateral

51 ST depression, mild inferior

52 ST depression, mild inferolateral

53 ST depression, anteroseptal

54 ST depression, anterior myocardial

7 75.36 99.55 46.67

5 81.24 99.94 33.33

13 79.83 99.13 53.59

17 76.97 99.14 43.13

25 77.54 99.08 37.64

21 80.64 99.14 47.39

12 79.73 99.60 55.16

20 80.59 99.26 50.61

4 85.41 99.72 44.44

12 87.66 98.58 34.85

59

myocardial ischemia

ischemia

myocardial ischemia

myocardial ischemia

ischemia

myocardial ischemia

55 ST depression, extensive anterior

56 ST depression, apical myocardial

57 ST depression, anterolateral

58 ST depression, high lateral

59 ST depression, inferior myocardial

60 ST depression, inferolateral

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".

7 84.78 98.04 67.75

18 79.95 99.14 55.12

13 87.42 98.97 59.09

16 90.06 99.31 57.14

12 89.88 99.13 40.08

6 91.39 99.16 50.47

60

Guidance and manufacturer’s declaration –electromagnetic emission

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

IEC 61000-3-2

Guidance and manufacturer’s declaration-electromagnetic immunity

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.

test level

IEC 61000-4-2

± 15 kV air

±15kV air

±2kV for power supply

± 1 kV for input/output line

short interruptions

and voltage vatiations on power

<5%UT(>95%dip in UT) for

%UT(30%dip in UT) for

<5%UT(>95%dip in UT) for

5 sec

<5%UT(>95%dip in UT) for

40% UT(60%dip in UT) for 5

70%UT(30%dip in UT) for 25

<5%UT(>95%dip in UT) for 5

sec

IEC 61000-4-8

Guidance and manufacturer’s declaration – electromagnetic immunity

Appendix II EMC Guidance and Manufacturer6 Declaration

Table 1:

The device

RF emissions CISPR 11 Class A

Harmonic emissions

Class A

Voltage fluctuations/flicker emissions

IEC 61000-3-3

Table 2:

The device

Immunity test

Electrostatic discharge (ESD)

Electrical fast transient/burst

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage dips,

supply input lines

IEC 61000-4-11

Power frequency (50 / 60Hz)

magnetic field

Table 3:

Not applicable

IEC60601

±8kV contact

lines

±1 kV lines to lines

±2 kV lines to earth

0.5 cycle

40% UT(60%dip in UT) for 5

cycle

70

25 cycle

30 A/m 30A/m

61

Compliance level

±8kV contact

±2kV for power supply lines

Not Applicable

±1 kV lines to lines

±2 kV lines to earth

0.5 cycle

cycle

cycle

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.

IEC61000-4-3

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)

ones and land mobile radios, amateur radio, AM and FM radio broadcast and TV

ss the electromagnetic

environment due to fixed RF transmitters, an electromagnetic site survey should be

red. If the measured field strength in the location in which the device or system is

device should be observed to

ay be

necessary, such as adjusting the direction or location of the device.

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

tions for

ications

(MHz)

18 Hz

± 5 kHz

1 kHz sine

LTE Band

217 Hz

The device

Immunity test IEC 60601 test level Compliance level

3 V
Conducted RF
IEC61000-4-6

Radiated RF

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2

teleph
broadcast cannot be predicted theoretically with accuracy. To asse

conside
used exceeds the applicable RF compliance level above, the
verify normal operation. If abnormal performance is observed, additional measures m

Tab le 4 ：

Radiated

RF

IEC6100

0-4-3

(Test

specifica

ENCLOS

URE

PORT

IMMUNI

TY to

RF

wireless

commun

Test

Frequenc

y

385

450

710

745

780

0,15 MHz – 80 MHz

6 V in ISM bands between

0,15 MHz and 80 MHz

3 V/m 80 MHz- 2.7 GHz 3 V/m80 MHz- 2.7 GHz

Band a)

(MHz)

380

–390

380

–390

704 –

787

Service

a)

TETRA

400

GMRS

460,

FRS 460

13,

17

Modulation

b)

Pulse

modulation

b)

FM c)

deviation

Pulse

modulation

b)

3 V
0,15 MHz – 80 MHz
6 V in ISM bands between
0,15 MHz and 80 MHz

Modulation

b) (W)

1,8 0,3 27

2 0,3 28

0,2 0,3 9

62

Distance

(m)

IMMUNITY

TEST LEVEL

(V/m)

LTE Band

5

LTE Band

4, 25;

UMTS

LTE Band

7

217 Hz

5785

he

may be reduced to 1 m. The 1 m test distance is permitted by

IEC 61000-4-3.

equipme

nt)

810

870

930

1720

1845

1970

2450

800 –

960

1 700 –

1 990

2 400 –

2 570

GSM

800/900,

TETRA

800,

iDEN

820,

CDMA

850,

GSM

1800;

CDMA

1900;

GSM

1900;

DECT;

1, 3,

Bluetoot

h,

WLAN,

802.11

b/g/n,

RFID

2450,

Pulse

modulation

b)

18 Hz

Pulse

modulation

b)

217 Hz

Pulse

modulation

b)

217 Hz

2 0,3 28

2 0,3 28

2 0,3 28

5240

5500

NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between t

transmitting antenna and the

ME EQUIPMENT or ME SYSTEM

5 100 –

5 800

WLAN

802.11

a/n

Pulse

modulation

b)

63

0,2 0,3 9

, 50 % pulse modulation at 18 Hz may be used because

LEVELS that are appropriate for the

reduced minimum separation distance. Minimum separation distances for higher IMMUNITY

P

d

6

E =

IMMUNITY TEST LEVEL in V/m.

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

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

TEST LEVELS shall be calculated using the following equation:

Where P is the maximum power in W, d is the minimum separation distance in m, and E is the

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.

64

～

combined with the protective grounding.

Triangular band:Black

4.2.5 Symbols

AC Alternating current

Equipotential point, the equipotential point of this device is

Caution: read instructions (warnings) carefully

PATIENT

Defibrillation-proof type CF applied part

USB interface

Lead cable socket

Serial number

Manufacturer

Date of manufacture

Lot number

Latex free

Atmospheric pressure limit

Temperature limit

Humidity limit

This way up

Fragile, handle with care

Keep in a cool, dry place

Stacking limit by number

General warning label

NOTE:

Background col our:yellow

65

Medical Device compliant with Regulation (EU) 2017/745

Follow instructions for use

Product code

Authorized representative in the European Community

GIMA WARRANTY TERMS

The Gima 12-month standard B2B warranty applies.

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

66