Gima 1212G ECG User guide

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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 function

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.

III

Responsibility of the company

The company supplies qualified products to user in accordance with enterprise



standard.

The company installs and debugs the equipment and trains the physicians by



contract.

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.



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.

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 ......................................................................................................... 5

Chapter3 Warranty Regulation ..................................................................................................... 8

Chapter4 Working Principle and Structural Characteristics .......................................................... 9

4.1 Brief Description and Block Diagram of the Working Principle .................................. 9

4.2 Name of each part and its function ............................................................................. 10

Chapter 5 Operation Precautions ................................................................................................ 15

5.1 Precautions before use ................................................................................................ 15

5.2 Precautions during operating ...................................................................................... 15

5.3 Precautions after use ................................................................................................... 15

Chapter 6 Preparations before Operation .................................................................................... 16

6.1 Recording paper.......................................................................................................... 16

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

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

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

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

7.1 Main Interface ............................................................................................................ 20

7.2 Sampling ................................................................................................

7.3 Case management ....................................................................................................... 23

7.4 Latest case .................................................................................................................. 26

7.5 System setup ............................................................................................................... 28

7.6 Print setup ................................................................................................................... 34

.................... 20

7.7 Lead placement ........................................................................................................... 34

7.8 About .......................................................................................................................... 34

Chapter 8 Troubleshooting ......................................................................................................... 35

8.1 Auto shutdown ........................................................................................................... 35

8.2 AC interference .......................................................................................................... 35

8.3 EMG interference ....................................................................................................... 35

8.4 Baseline drift .............................................................................................................. 36

8.5 Troubleshooting list .................................................................................................... 36

Chapter 9 Maintenance ............................................................................................................... 37

9.1 Battery ........................................................................................................................ 37

9.2 Recording paper.......................................................................................................... 38

9.3 Maintenance after use ................................................................................................. 38

9.4 Lead cables and electrodes ......................................................................................... 39

9.5 Silicone rubber roller .................................................................................................. 39

9.6 Cleaning of thermal print head ................................................................................... 39

9.7 Fuse replacement ........................................................................................................ 40

9.8 Disposal of product scrap ........................................................................................... 40

9.9 Others ......................................................................................................................... 40

Chapter 10 Packing List and Accessories ................................................................................... 41

10.1 Accompanying accessories ....................................................................................... 41

10.2 Notes ........................................................................................................................ 41

Appendix I ECG Automated Measurement&Interpretation Guide ............................................. 42

Appendix II EMC Guidance and Manufacturer Declaration

....................................................... 70

Chapter1 Overview

1.1 Overview

This product is such a kind of electrocardiograph, which samples 12 leads ECG signals

simultaneously and prints out the ECG waveform with thermal printing system. Its functions are

as follows: recording and displaying ECG waveform in auto/manual mode; measuring and

diagnosing ECG waveform parameters automatically; electrode-off and paper lack prompt;

optional interface languages(Chinese/English,etc.); built-in lithium battery, powered either by

AC or DC; arbitrarily select the rhythm lead to observe abnormal heart rhythm conveniently;

case database management, etc.

1.2 Intended Use

This product is suitable for hospitals, scientific research, wards, ambulances and carrying out

medical consultations. It is used by medical institutions to record human ECG signals, collect

and extract the ECG waveform of the human body.

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: 14.8 V, 5200 mAh rechargeable lithium battery

Transportation and Storage: a). Environment temperature: -20 ℃～+55 ℃

b). Relative humidity: ≤95% c). Atmospheric pressure: 500 hPa～1060 hPa

1.3.2 Input way: Floating and defibrillation protection

1.3.3 Lead: Standard 12 leads

1.3.4 Patient leakage current: <10µA

1.3.5 Input impedance: ≥2.5 MΩ

1.3.6 Frequency response:

Test Input frequency and waveform Relative output response

1.0 0.67Hz~40Hz, Sine wave ±10%a

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

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

0.5 150 Hz ~ 500 Hz, Sine wave

+10 %, -100 %

1.5 ≤1Hz,200ms, Triangle wave

relative to 10Hz b relative to 200 ms

+0 %, -10 %

1.3.7 Time constant: ≥3.2s

1.3.8 CMRR: >105 dB

1.3.9 Filter: AC Filter(50Hz/60 Hz), EMG Filter, Low-pass Filter, DFT Filter

1.3.10 Recording way: Thermal printing system

1.3.11 Specification of recording paper:210 mm(W)×20 m(L) high-speed thermal paper

1.3.12 Time base selection(paper speed):

12.5 mm/s, 25 mm/s, 50 mm/s, error: ±5%

1.3.13 Gain control(sensitivity): 5, 10, 20 mm/mV, accuracy is ±2%;

Standard sensitivity:10 mm/mV±0.2 mm/mV

1.3.14 Auto record: record setup according to auto record format and mode, automatically

change leads, automatically measure and analyze.

1.3.15 Rhythm record: record setup according to rhythm record format and mode, automatically

measure and analyze.

1.3.16 Manual record: record according to manual record format.

1.3.17 Measurement parameters: HR, 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 function 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 Pacing detection channel: II

1.3.26 Pacing signal sampling frequency: 32kHz

1.3.27 Accuracy of input signal: The overall system error, ±5%.

1.3.28 Amplitude quantization: ≤5µV/LSB

1.3.29 Interchannel time deviation: <100 µs

1.3.30 Fuse specification: 2pcs φ5×20mm AC delay insurance: T3.15AH250V

1.3.31 Size: 340 mm(L)×320 mm(W)×86mm(H)

1.3.32 Net Weight: 5 kg

1.4 Main Characteristics

1.4.1 Display with 1280*800 dots 10.1 inch high resolution color LCD, operate either by touch

screen or function buttons, which is convenient and quick

1.4.2 Sync collection for 12-lead ECG, support for 12-lead and Cabrera-lead waveform display,

adopt digital signal processing technology and get high-quality ECG waveform via power

frequency filter (50/60Hz), baseline filter and EMG filter (25Hz/35Hz) of ECG signal.

1.4.3 Display of 3/6/12-lead ECG on one screen, and HR value, print mode, sensitivity, paper

speed, filter state, clock, battery level, background gridlines, measured data and interpretation

information, etc. Prompting function for lead-off and overload, system working state.

1.4.4 The device can be powered either by AC or DC(can adapt to 50/60Hz AC frequency), with

built-in rechargeable lithium battery and charging circuit, perfect battery overcurrent and

overvoltage protection circuit.

1.4.5 In optimal DC state, up to 10-hour standby time, continuous print more than 3-hour, record

up to 1000 ECG waveform(commonly, it is 3s case), which meets the requirements of visiting a

patient at home and body examination.

14.6 Built-in thermal printer, support for automatic M*N, M*N+1, M*N+2, M*N+3, rhythm M

manual and other printing modes and formats.. The printed content contains time, paper

line,

speed, sensitivity, calibration signal, name of lead, filter state and patient’s information.

Information including printed waveform length, output measurement parameter, diagnostic

conclusion, superposition QRS waveform, histogram, trend chart and interval list, can be set, and

with time print function and auto arrhythmia print function, which meets different requirements.

1.4.7 With the functions of auto-measurement and auto-interpretation for routine ECG

parameters, provide measurement results and auto-diagnosis conclusion for HR, PR Interval, P

Duration, QRS Duration, T Duration, QT/QTc Interval, P/QRS/T Axis, R(V5), S(V1),

R(V5)+S(V1) amplitude, Cornell index, etc. which reduces the doctor’s burden.

1.4.8 The built-in large-capacity memory can store at least 4000 medical records, making it easy

for doctors to review medical records and statistical information.

1.4.9 Multi-language(Chinese, English) interface and report. Full touch screen with buttons

operation, built-in virtual keyboard, support Chinese and English input methods.

1.4.10 With functions of LAN, USB cable transmission. Automatically upload cases, download

reports and print them.

1.4.11 Support external USB standard keyboard, mouse, scanner, printer.

1.4.12 Historical medical records can be reviewed, inquired, modified, transmitted, printed, lead

correction, exported to other electronic file formats (dat, pdf, xml, bmp, jpeg, png etc.)

1.5 Software Overview

Name of software: native embedded software

Software specification: none

Software version: V1.1.1

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: by processing and analyzing the static ECG data, measurement parameters such as HR of

ECG and automatic interpretation items are obtained.

Clinical function: provide measurement parameters such as HR of ECG and automatic

interpretation items to assist the physician in diagnosing cardiovascular disease. Automatic

measurement parameters and interpretation results are for the reference of the physician only,

and can not be used as the sole basis for clinical diagnosis. The diagnosis needs to be combined

with the clinical.

Chapter2 Safety Precautions

2.1 Ensure that the device is placed on a flat level worktable. Avoid too 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.

2.3 A perfect power system and grounding is need in room.

Warning：To avoid the risk of electric shock,this equipment must only be connected to

a power supply network with a protective ground

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 design of this device has mature consideration of security, but operator should never

neglect attention to device state and patient’s observation. Cut off the power or take off the

electrode when necessary to ensure patient's security.

2.6 Please turn off the device and pull out power supply plug before replacing the fuse or

cleaning and disinfection. Don't rub the screen with edge tools or sharp materials.

2.7 Keep the device from water, don't use or store it in the place with the 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 electrode

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 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, away from

。

emission sources such as mobile phones.

2.14 When other devices are connected with this ECG instrument, they must be Type I devices

which accord with IEC60601-1. Because the total amount of leakage current may hurt patients,

the monitoring of leakage current is carried out and taken charge by connect devices.

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.

In addition to transducers and cables sold by the manufacturer of the device or



system as spare parts for internal components, use of accessories and cables outside of the

regulations may result in reduced muscle-building emitted by device or system and

interference immunity.

Effect from radiated electromagnetic waves:



The use of a mobile phone may affect the operation of the device. When installing medical

electrical equipment, be sure to remind people around the device to turn off mobile phones and

small radios.

Effect from shock and conduction electromagnetic waves:



High frequency noise from other equipment can enter the device through the AC socket. Please

identify the source of noise, if possible, stop using the equipment. If the equipment can not be

deactivated, use noise cancellation equipment or take other measures to reduce the impact.

Effect from static electricity:



Static electricity in a dry environment(indoor) may affect the operation of the device, especially

in winter. Before using the device, humidify the indoor air or discharge the static electricity from

the cable and ECG record personnel.

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, pull the AC power plug and use the internal power supply.

2.16 Notes concerning ECG waveform measurement and analysis

2.16.1 P wave and Q wave identify are not always reliable with intensive EMG or AC

interference. Neither are the ST segment and T wave with baseline drift.

2.16.2 Winding and unclear end position of S wave and T wave may cause error in

measurement.

2.16.3 When R wave is uninspected caused by some leads off or QRS wave low voltage, the

heart rate measurement may deviate greatly from the correct.

2.16.4 In case of QRS low voltage, ECG axis calculation and border-point identify of QRS wave

are not always reliable.

2.16.5 Occasionally, frequent ventricular premature complexes may be identified as dominant

beat.

2.16.6 Merging of versatile arrhythmia may result in unreliable measurement because of the

difficulty in distinguishing P wave in such situation.

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.

Chapter3 Warranty Regulation

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's 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 calling in, etc to

carry out warranty promise.

3.3 Even in warranty period , the following repairs are charged in principle.

3.3.1 Faults or injuries caused by misuse not according to user manual and operation notes.

3.3.2 Faults or injuries caused by dropping accidentally when moving after purchasing.

3.3.3 Faults or injuries caused by repair, reconstruction, decomposition, etc not in 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 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.

DC-DC conversion

Battery

Display unit

Thermal print

head

Switching power

supply

DC-DC conversion

Acquisition unit

Control unit

Motor

AC100~240V

50/60Hz

+24V

+14.8V

Charging

+5V

+12V

+14.8V

Chapter4 Working Principle and Structural Characteristics

4.1 Brief Description and Block Diagram of the Working Principle

4.1.1 The power supply unit

（1）Principle of power supply

The switching power supply provides +24V working voltage for the thermal print head, provides

constant voltage current limiting charging for the rechargeable lithium battery in the device

through the DC-DC circuit, and generates +5V and +12V voltage through the power conversion

to supply power to the corresponding modules. At the same time, the lithium battery in the

device can independently complete working requirements of each module in the device through

the buck-boost circuit. （2）Principle block diagram is shown in Figure4-1.

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 and data processing part with sampling

accuracy of 24 bits. 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, completes 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.

Figure4-1 Block diagram of power principle

Note: The principle block diagram and component list are only available to service

Control system

Signal acquisition

system

Display system

Button system

Printing system

Power module

1 3

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 from the button system to complete the interrupt

processing. In addition, the lead-off signal, paper out detection, battery voltage management, and

automatic power-off are also managed by the CPU system. The liquid crystal controller receives

data and commands from the CPU system to complete the display of the control state of the

device. （2）Principle block diagram is shown in Figure4-2.

Figure 4-2 Block diagram of control unit

4.2 Name of each part and its function

4.2.1 Front view

Figure 4-3 Front view

1. Paper compartment cover

Keep the paper compartment closed, hold the printing paper

2. Display screen

Display patient ECG and related information

3. Button area

Control the operations of the device

4. Toggle switch

Press down the toggle switch to open 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.

4.2.2 Side view

Figure 4-4-1 Side view 1

5. Lead cable interface

Connect with lead cables.

6. USB interface

Communicate with the computer. The ECG data and analysis results can be transmitted to a

computer, by using the computer, many functions can be achieved, such as archiving, managing,

and analyzing ECG data, facilitating clinical research, organizing teaching and training as well as

program upgrade, export of cases and connect to external printers, etc.

7. Network interface

Connect with the LAN, then perform case analysis and remote control by expert in the LAN

8. Upgrade interface

A USB interface used for program upgrading

9. Equipotential terminal

Connect with the potential equalization conductor

4 5 7

10. Hook

A hook for power cable, to prevent unintended falling of the power cable

11. Input socket

Connect with the AC power cable.

12. Fuse

Built-in fuse tube, T3.15AH250V. It can avoid the damage to human body caused by large

voltage and large current generated by grid pollution.

13. Battery compartment Built-in rechargeable lithium battery

4.2.3 Buttons

Figure 4-4-2 Side view 2

Figure 4-5 Bottom view

Figure 4-6 Schematic diagram of buttons

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

CA 100-240V

Corrente alternata

2. SEN

Used to adjust the sensitivity manually.

3. SPEED

Used to set the ECG recording speed.

4. PRINT

Used to print the sampled ECG waveform or end the printing.

5. START/STOP

Used to start/stop the sampling.

6. 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.

7. Power status indicator

When green means AC power supply,it is no battery in the machine or the battery is full;Other

colors indicate that the battery is being charged.

8. Startup indicator

The indicator lights in green after the device is turned on.

4.2.4 Meaning of symbols

Equipotential point, the equipotential point of this device is combined with the protective earth.

Caution: read instructions (warnings) carefully

PAZIENTE

Type CF applied part

USB interface

Network interface

Drop cable socket

Serial number

Manufacturer

Date of manufacture

Lot number

Atmospheric pressure limit

Temperature limit

Humidity limit

Follow instructions for use

Fragile, handle with care

Keep in a cool, dry place

Imported by

Product code

Authorized representative in the European community

WEEE disposal.

Medical Device complies with Directive 93/42/EEC

General warning sign NOTE: Background color: yellow Triangle band: Black

Keep away from sunlight

Chapter 5 Operation Precautions

5.1 Precautions before use

5.1.1 For safe and effective use, please read the user manual carefully before operation.

5.1.2 Check to ensure that the device is in good condition.

5.1.3 The device shall be placed on a flat surface,and moves gently to avoid strong vibration or

shock.

5.1.4 Check to ensure that the lead cables are correctly connected, and the device grounding is

correct.

5.1.5 The AC frequency and voltage should comply with the requirements, and enough current

capacity should be guaranteed.

5.1.6 When using the battery for power supply, check to ensure that the battery voltage and

battery status is 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.

Chapter 6 Preparations before Operation

6.1 Recording paper

6.1.1 The following thermal recording paper can be applied to the device: Roll paper: 210 mm(W)×20 m(L), 210 mm(W)×30 m(L)（optional）, 216 mm(W)×20 m(L) （optional）;Folding paper: 210×140-20M（optional）

Note:

1.The recording paper should be aligned with the slot of the paper compartment cover. It is

recommended to leave 2cm paper outside.

2.This instrument uses roll paper up to meet:50mm(outer diameter)×16.5mm(inner

diameter)×210mm(long),please use thermal recording paper that meets the requirements

to achieve the best results.

6.1.2 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 machine is used in conjunction with other medical equipment, use the supplied potential equalization wire to connect the equipotential terminal of the device to the equipotential terminal of the connected equipment to prevent leakage current and protect the device.

6.2.2 Battery

The device has a built-in rechargeable lithium battery, which does not need to be re-installed by the 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 purpose 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.

6.4.1 Chest electrodes

As shown in Figure 6-1:

Figure 6-1 Installation of chest electrode

The chest electrodes should be installed to the following parts: C1（Vl）: the fourth intercostal space at the right sternal margin C2（V2）: the fourth intercostal space at the left sternal margin C3（V3）: between C2 and C4 C4（V4）: the intersection between midclavicular line and the fifth intercostal space C5（V5）: left anterior axillary line on the same plane as C4 C6（V6）: left midaxillary line on the same plane as C4 Clean the chest skin where the electrodes to be installed with alcohol, and apply some conductive pastes to these skin (about 25 mm-diameter range) and the edge of the chest electrode suction cup. Squeeze the suction cup to install the chest electrode at the positions of Cl-C6.

Note: The conductive paste coating should be separated from each other, and the chest

electrodes should not touch each other to avoid short circuit.

Note: Please use qualified conductive paste to avoid damaging the skin.

6.4.2 Limb electrodes

The limb electrodes should be placed on the soft skin of both hands and feet. Before connecting,

clean the skin of the electrode installation area with alcohol, and then apply a small amount of

conductive paste on the cleaned skin. The electrode connection of the limbs is shown in Figure

6-2.

Electrode position

European standard

American standard

Mark

Color

Mark

Color

Right arm

Red

White

Left arm

Yellow

Black

Left leg

Green

Red

Right leg

N/RF

Black

Green

Chest 1

Red

Chest 2

Yellow

Chest 3

Green

Chest 4

Brown

Blue

Chest 5

Black

Orange

Chest 6

Purple

6.4.3 Colors of lead cables

As shown in Table 6-1:

Figure 6-2 Installation of limb electrode

Table 6-1 Colors of lead cables

6.4.4 Lead method and system

As shown in Figure 6-3:

Note

 It is recommended to install the lead cables after turning off the device.  Apply appropriate amount of conductive paste on the electrode when installing

the electrode.  If the ECG waveform does not appear for a long time, check if the electrode is

in good contact with the skin.

Figure 6-3 Lead system

6.4.5 Lead-off and overload indication

The device can check the connection status of the lead at any time. If lead-off or overload is

detected, the screen will display corresponding prompts.

Note

 A red lead icon displayed in the status bar under the sampling interface

represents lead-off. A yellow lead icon represents 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.

Chapter 7 Operation Instructions and Parameter Setting

7.1 Main Interface

The main interface shows the following information:

 Status bar

 Battery: the current battery status (refer to 9.1)  Time: the system time

 Functional panel

 Gather: to input the case information, then enter the sampling interface to realize

waveform sampling, display and report printing.  Archive: to enter the case management interface, in this interface, user can query, modify, delete and export case information or review the case to view and print the diagnosis report.  Last: to quickly modify and review the latest collected case and view its diagnosis report.  System Setup: to making setting to the system, sampling, print, network, service and time, etc.

 Print Setup: to set the print mode, print style and print content, etc.  Placement: to view the lead placement schematic diagram.  About: to view the software version, software establish time, wired network address,

wireless network address and used space.

Click the functional module on the screen to quickly set the corresponding function.

7.2 Sampling

Click “Gather” on the main interface or press the START/STOP button to enter the case information input interface.

7.2.1 Input case information

In the case information input interface, input the patient’s information by typing or selecting, or obtain patient information via the ID card reader, or click “Get” to extract patient information from stored cases to avoid repeat operation.

 Case data

 Name: 0~18 chars  Sex: Male, Female  Section: 0~16 chars  Age: 0~150  Operator: 0~16 chars  Bed ID: 0~16 chars  Room ID: 0~16 chars  Accession Number: 0~16 chars  Custom 1: 0~24 chars  Content of custom 1: 0~24 chars  Custom 2: 0~24 chars  Content of custom 2: 0~24 chars  Custom 3: 0~24 chars  Content of custom 3: 0~24 chars

 Source: select from clinic, hospital, emergency, checkup, community  Pace: Whether the patient has a pacemaker.

 Operation field

 Get: obtain the case list in case management. Search a patient's information in the

list, select the case item, and information of this patient will be automatically added to

the edit box in case information input interface. Custom content can be set according to

your needs.  Gather: refer to 7.2.2

In the case information input interface, click any edit box to pop up the keyboard. Click the

Chinese】” key to switch between Chinese and English, click the “ ” key to switch

“【

between numeric keys, lowercase letters and uppercase letters. The “

space key, click it to enter a space; the “

character. Click the “ENT” key to confirm the entry and exit the interface.

According to the input limitation, after clicking the “ENT”, the maximum allowable characters

will be displayed in the edit box.

After entering the patient information, click “Gather” to enter the case sampling interface.

7.2.2 Case sampling

The sampling interface provides several lead display mode, including 3-lead, 6-lead and 12-lead.

The following figure uses 12-lead as an example:

” is the backspace key, click it to delete the last input

” is the

Figure 7-1 Sampling interface

 Status bar

 HR: current sampled heart rate value

Display content

Explanation

Process…

It is printing.

Waiting…

It is finishing printing.

No Paper.

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

s system and printing

sub-system.

Communication failure between this system and sampling

sub-system.

Low Power!

Low power, it cannot start printing.

connected to the external printer.

reaching the required time period.

 Lead-off and overload: In demo mode, it displays “Demo Mode”. In sampling mode, it displays the detected lead status. A red lead icon represents lead-off. A yellow lead icon represents overload.  System status indication:

Print Timeout

ECG Timeout

No USB device

Gather Time Less

 Display field

 The screen displays sampled 12-lead ECG waveform, by long pressing the screen

waveform, you can switch between 3-lead, 6-lead and 12-lead. You can slide up and

down to view each lead.

 Operation field

Control the print display mode of the device through the corresponding operation settings.

 Patient: If patient information is not entered before sampling, click this key to pop

up the case information input dialogue box to input information.  Lead: You can choose to display one, some or all of the leads in the waveform

display area in the pop-up dialog box.  Speed: use the SPEED button to switch the speed between 12.5 mm/s, 25 mm/s, 50

mm/s and other options.  Gain: use the SEN button to switch the gain between 5 mm/mV, 10 mm/mV, 20

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

function.  Print mode: in print setup, when the data type is set to “After Print”, use the MODE

button to switch the print mode between Manual, Auto M×N, Auto M×N+1, Auto

M×N+2, Auto M×N+3 and Rhythm M. Refer to the print mode in Section 7.5.3 for the

value of M and N.

 Print/End print: use the PRINT button to start or end the printing operation.

 Auto mode: After starting to print, the system automatically prints and stores

the real-time ECG waveform. The length is determined by the relevant settings

in the print setup. Based on the settings, the automatic analysis data and

Communication failure between thi

No external printer connected, user should restart printing after

The sampling time is not enough, the print shall be started after

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 occurs during sampling process, the printed waveform will be

marked with “*”.  If lead overload occurs during sampling process, the printed waveform will

be marked with “+”.

 End sampling: After the device starts sampling, use the START/STOP button to

end the sampling, and back to the main interface.

7.3 Case management

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

Figure 7-2 Case management interface

This interface shows all the cases stored in the device. User can search the required case by the

query function; modify case information and view stored waveform in the “Review”; and delete

cases via delete function.

 Case information field

 Patient name  Sampling time

 Age  Section  Sex  Diagnosis result

 Operation field

 Query: refer to 7.3.1  Export: connect the device with a USB flash disk, and export the case into the

Archive folder in the USB flash disk.

 Delete: delete the selected case (be careful, unrecoverable) or all cases  Review: refer to 7.3.3  Close: exit the case management interface

7.3.1 Query

In the case management interface, click “Query” to pop up the search case interface.

Figure 7-3 Search case interface

 Case information field

 Accession Number: input the accession number of patient  Name: input patient’s name  Age: input patient age  Diagnose: input the diagnosis information of the case to be searched

 Operation field

 Search: input the query conditions in the search case interface, click “Search”, all

cases that meet the query conditions will be displayed.  Close: exit the search interface.

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

conditions to quickly find the case.

7.3.2 Export

In order that the case is not used or known by unauthorized individuals or entities, click "Export"

button in the case management interface to open the password input dialog box (initial password:

888888, which can be set in the system setup, see 7.5.1). After inputting the password, click

“OK” to pop up the case export dialog box:

Figure 7-4 Export interface

 Information field

 Choose: select export all cases or export current case  File type:

 Case report: PDF report and image report, PNG, JPEG and BMP are the

format of image report.

 aECG: case data that conform to the HL7 standard  DAT: case data, self-defined format

 Orientation: This item is only valid for case report, which determines the generated

report is displayed in horizontal or vertical.

 Directory: the storage path of exported case report or case data  Progress bar: indicates the progress rate of exporting

 Operation field

 OK: perform the export operation  Close: exit case export interface

7.3.3 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, and user can modify the patient

information, switch the lead that placed wrong during sampling, and enter the waveform

interface to review the sampling process.

Figure 7-5 Case information interface

 Case information field

 The items are the same wit the items in 7.2.1.

 Operation field

 SwitchChannel: If a lead is placed incorrectly during sampling process, click this

key to make a correction.  Review: review the waveform of the selected case, the review interface is similar

with the sampling interface.  Save: user can modify the patient information of the selected case, then click

“Save” button to save the modification.  Close: exit the interface.

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

similar with the sampling interface.

7.4 Latest case

In the main interface, click “Last” to open the latest sampled case, the interface is similar with the sampling interface, user can view waveform of this case and print its report conveniently. Case review interface is shown as below.

 Display field

 Filter mode: the filter mode adopted by this case is displayed in the top right corner

of the waveform display area.  If lead-off occurs during sampling process, the reviewed waveform will be marked

with “*”.  If lead overload occurs during sampling process, the reviewed waveform will be

marked with “+”.

 Operation field

 Report: displays data information and diagnosis result of the case, as shown in

Figure 7-7.

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

Figure 7-6 Case review interface

 If lead-off occurs during sampling process, the printed waveform will be

marked with “*”.  If lead overload occurs during sampling process, the printed waveform will

be marked with “+”.

Item

Options

Explanation

Default

[OFF]/[1 min]/

etc

If there is no operation after

, screen

always keep on.

After setting light degree, the

screen will display different

Figure 7-7 Diagnosis interface

7.5 System setup

The device related functions can be set in the system setup, which includes the following setting

items.

 System setup  Sample setup  Print setup  Network setup  Server setup  Time setup

7.5.1 System setup

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

Back-light

Light-degree 0%~100%

[2 min]/[5 min]/

[10 min]/[20 min]/

[30 min]/[60 min],

reaching the set time

backlight will turn off. If it is

set to “OFF”, the backlight will

[OFF]

50%

backlight strength.

[OFF]/[1 min]/

etc

If there is no operation after

system will always keep on.

The system prompts for low

is selected, the

prompt when battery is low.

[Chinese]/

[English], etc

Set up the system default

language.

Set to on, the system will run in

Demo mode; set to off, the

system will run in sampling

mode

on makes

there will be no sound

Windows

Style

Set the windows style of the

system

[Small]/[Medium]/

[Large]

nd Color

Set the background color of

system interfaces

application from U

disk]

Reset

[Factory Reset]

Restore to factory setup

————

disk]

program to U-disk

Print Test

————

Test the print function

————

ure

the CPU

Password

Within 6 chars

Input the password

[888888]

clicking this

button.

Item

Options

Explanation

Default

AC Filter Enable

[On]/[Off]

Turn on or turn off the AC

[On]

[2 min]/[5 min]/

Auto off

Low Power

Language

Demo Mode [On]/[Off]

K-B Sound [On]/[Off]

Wind

ows

Style

Font Size

Backgrou

Upgrade

[10 min]/[20 min]/

[30 min]/[60 min],

[None]/[Only once]/

[Always]

[style 1]/ [style 2]

[Dark]/ [Light]

[Upgrade

reaching the set time, the

system will automatically turn

off. If it is set to “OFF”, the

battery according to the setting.

If “None”

system will not make any

Set to on, the butt

sound while pressing, set to off,

Set the font size of the system [Small]

Upgrade the program ————

[OFF]

[Always]

[English]

[Off]

[style 1]

[Dark]

Default [Reset this page]

7.5.2 Sample setup

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

Log

Temperat

[Export log to U

————

Export the running log of the

Display current temperature of

All above settings will restore

to default after

————

Filter

Turn on or turn off the DFT Filter

Turn on or turn off the Low-pass Filter

Set the parameter of the AC Filter

z], etc

[0.05Hz]/[0.50Hz]/

etc

[75Hz]/[100Hz]]/[1 50Hz]], etc

Set the parameter of the Low-pass Filter

Set to use the background grid or not

[Cabrera Lead]

e arrangement of the

leads.

e Lead]

[8sec]/[10sec]/

[360sec], etc

Set the time length of save

the data before

after clicking

Heartbeat Sound

Turn on or tun off the heartbeat sound

premature beat.

Pause Time

ms)

The system will use the input

beat pause.

bpm)

tachycardia.

EMG Filter Enable [On]/[Off]

DFT Filter Enable [On]/[Off]

Low-pass Filter Enable [On]/[Off]

AC Filter [50Hz]/[60Hz]

[25Hz]/[30Hz]]/[35

EMG Filter

DFT Filter

Low-pass Filter

Background Grid [On]/[Off]

Sort Lead

Save Time

Hz]]/[40Hz]]/[45H

[1.00Hz]/[0.15Hz]/ [0.25Hz]/[0.32Hz]/ [0.67Hz]/[0.01Hz],

[Routine Lead]/

[15sec]/[20sec]/ [25sec]/[30sec]/ [40sec]/[50sec]/ [60sec]/[90sec]/ [120sec]/[180sec]/ [240sec]/[300sec]/

Turn on or turn off the EMG

Set the parameter of the EMG Filter

Set the parameter of the DFT Filter

Set th

data

[On]

[Off]

[50Hz]

[25Hz]

[0.50Hz ]

[75Hz]

[Off]

[Routin

[10sec]

Save Data Type

Premature(1-

99) Analys is Set

(1200-3000

Tachycardia (80-250

[Begin Data]/ [After Data]

[On]/[Off]

1-99

1200-3000

80-250

Set to save clicking the PRINT button, or

The system will use the input value as a standard of judging

value as a standard of judging

The system will use the input value as a standard of judging

[After Data]

[Off]

2000

100

The system will use the input

bradycardia.

clicking this

button.

Item

Options

Explanation

Default

Rhythm M], etc

the setting of strip number.

It represents the number of

channels.

support the running

speeds of 12.5mm/s.

V], etc

]/[30sec], etc

Print Width

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

Set the print width

[1]

[In-phase]

rows waveform

ity]

mediately or

allows the device to

take more sampling, but it

will re-timing.

Bradycardia (30-80 bpm)

Default [Reset this page]

7.5.3 Print setup

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

Print Mode

Strip Num 3-12

Speed

Gain

30-80

[Manual]/[Auto

M×N]/[AutoM×N

+1]/[AutoM×N+2

]/[AutoM×N+3]/[

[12.5mm/s]/[25m

m/s]/[50mm/s],etc

[5mm/mV]/[10m

m/mV]/[20mm/m

value as a standard of judging

All above settings will restore to default after

The system takes the selected

option as default print mode.

“M” is the strip number, its

value range is 3-12, refer to

Set the waveform speed

displayed on the screen. The

Auto mode and rhythm mode

do not

Set the gain of ECG

——— —

[Auto

M×N]

[12]

[25mm/s

]

[10mm/

mV]

Auto Strip

Phase Mode

Data Type

[2.5sec]/[3sec]/[4s

ec]/[5sec]/[6sec]/[

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

ec]/[20sec]/[25sec

[Continuity]/

[Print

Immediately/

[Print Cache]

The system takes the selected

option as the print time length

of each strip.

The display mode of multiple

Set to print im

after reviewing. “Print

immediately” does not allow

repeat sampling; “Print

cache”

[2.5sec]

[Continu

[Print

Cache]

l be

"Smart" means the system

means it will use screen

waveform gain as that of

printing.

or “Auto

print mode is “Rhythm M”

The secondary main lead

main lead when

print function when

ECG sampling process.

During the ECG acquisition

process, the system will

printing operation according

When the printing mode is

manual mode, the printing

format, otherwise, it will

output according to the

current setting mode.

system or USB external

The option selected wil

used as printing gain mode.

Lead Gain [Smart]/[Current]

[I]/[II]/[III]/[aVR]

Rhythm1

Rhythm

Arrhythmia [On]/[Off]

Rhythm2

Rhythm3

/[aVL]/[aVF]/[V1

]/[V2]/[V3]/[V4]/[

V5]/[V6]

[I]/[II]/[III]/[aVR]

/[aVL]/[aVF]/[V1

]/[V2]/[V3]/[V4]/

[V5]/[V6]

[I]/[II]/[III]/[aVR]

/[aVL]/[aVF]/[V1

]/[V2]/[V3]/[V4]/[

V5]/[V6]

will adjust gain automatically

to fit paper height; "Current"

The main lead when print

mode is “Auto M×N+1”,

“Auto M×N+2”

M×N+3”; the main lead when

when print mode is “Auto

M×N+2” or “Auto M×N+3”.

The third

print mode is “Auto M×N+3”.

Set to automatically active the

arrhythmia occurs during

[Smart]

[II]

[V1]

[V2]

[Off]

Period

Print Device

Printer

set

[OFF]/[per1min]

/[per 2 min]

/[per 5 min]

/[per 10 min]

/[per 20 min]

/[per 30 min]

/[per 60 min], etc

[Inside]

/[Outside A4]

automatically activate the

to the selected time interval.

will output “Auto 12×1”

Choose to print out the ECG

waveform by thermal printing

[OFF]

[Inside]

printer

[Folding Paper]

paper]

[Landscape]

Set the print direction of

external USB printer

]

the position of patient

information for thermal print

Set to print the background

grid or not

Print time

mark

not

or not

QRS

or not

Conclusion

Set to print the diagnosis

conclusion or not

printed diagnosis conclusion

Data

or not

the name of hospital

printed in the report

button.

Item

Options

Explanation

Default

All above settings will

restore to default after

clicking this button.

Content

Paper type

Orientation

Info Align [Right]/[Top]

Print Grid [On]/[Off]

MultiSignal [On]/[Off]

Average

Diagnosis

Minnesota

Code

Diagnosis

Hospital 0-64 chars

[Roll paper]/

[Portrait]/

[On]/[Off]

Set the thermal paper type

Set

Set to print the time mark or

Set to print the multiple signal

Set to print the average QRS

Set whether the Minnesota

code is displayed in the

Set to print the diagnosis data

Input

[Roll

[Portrait

[Right]

[Off]

[On]

[Off]

[On]

Blank

Default [Reset this page]

Note: The auto strip, average QRS, print diagnosis and period are only optional in auto

mode and rhythm mode.

7.5.5 Server setup

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

SYNC Mode [USB] Set the synchronous mode [USB]

Default [Reset this page]

All above settings will restore

to default after clicking this

———

—

————

Item

Options

Explanation

Default

This option is

unavailable if

“Net Time” is

selected.

Current date

off the

network time

corresponding to the time

zone

Port

0-64 chars

Set the server port

123

zone from the list

button.

7.5.4 Time setup

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

Adjustment Time

Net Time [On]/[Off]

Server 0-64 chars

Time

Server

Time Zone Time zone list

Default [Reset this page]

7.6 Print setup

In the main interface, click “Print Setup” to enter the print setup directly.

7.7 Lead placement

In the main interface, click “Placement” to view the schematic diagram of lead placement, or you

can refer to Section 6.4 for the connection of electrodes.

7.8 About

In the main interface, click “About” to view the information about the device, which including

the following content:

 AppVersion: the version number of current software  AppBuild: the creation time of current software  Wired Mac: the MAC address of wired LAN  Wi-Fi Mac: the MAC address of wireless LAN  Spaced Used: the percentage of the memory that used in the system

Adjust the current date and

time manually.

Turn on or turn

Input the server address

Select the corresponding time

All above settings will restore

to default after clicking this

and time

[On]

cn.ntp.org.cn

[East Eight]

————

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.

Phenomenon

Cause of failure

Solutions

1. Grounding cable is not

keep quiet.

1. Check the power cord and lead

1. AC interference is large.

1. Improve the environment.

2. If the bed is made of steel,

3. The power cable and lead

to each other.

Not regular

1. Bad electrode conductivity.

electrodes and lead cables.

1. Use alcohol of high quality.

1. Low power.

2. Patient movement.

1. Charge the battery.

2. Keep patient still.

1. Low battery. The printer head surface is

1. Charge the battery.

with specified one.

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

Too large interference, disorderly waveform

Baseline burr

waveform, large up-and-down, beeline figure

Baseline draft

Unclear waveform

connected reliably.

2. Lead cables are not connected reliably.

3. There is AC interference.

4. Patient is nervous and can not

2. Patient nervous, and EMG interference is large.

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

2. dirty.

3. The thermal paper problem.

cables.

2. Let the patient prepare for the measurement.

replace it.

cables are not parallel or too close

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

3. Charge the battery.

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

3. Replace the thermal print paper

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. After absolutely discharged, the

battery needs 3.5 hours to charge to 90%, and 5 hours to charge to full capacity.

Table 9 Battery status display

No. Icon Description

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

icon b to icon e.

9.1.2 The device can continuously 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

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

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

Using battery, and the battery is low. It is recommended to charge the

battery and use AC power supply; or the battery status is unknown, this

happens at the starting of turning on the device.

Charging the battery

Battery is charged to full

Battery overheat

charged, please replace the battery.

Note

 Do not try to dismantle the sealed battery without permission.The replacement

of battery shall be carried out by professional maintenance personal authorized by

our company, and the same model of rechargeable battery provided by our company

should be used.  Do not touch the positive and negative terminals of the battery directly with

wire, otherwise there is a danger of fire.  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 the power button to shutdown the device.

9.3.2 Unplug the power cord and lead cables. Hold the header of plug to disconnect, and do not

pull the cable with force directly.

9.3.3Clean the device and accessories, cover them up to against dust.

9.3.4 Store the device in a cool and dry place, avoid strong vibration when moving.

9.3.5 When cleaning the device, do not immerse it in the cleaner. Power supply must be cut off

before cleaning. Use neutral detergents for cleaning. Do not use any detergent or disinfectant

containing alcohol.

9.4 Lead cables and electrodes

9.4.1 The connectivity of the lead cable can be detected by the multimeter. Check whether each

wire of the lead cable is in good contact according to the following table. The resistance of each

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 function protection function

is about 10KΩ.

Table 10 Lead cable mark and pin position table

Mark L R C1 C2 C3 C4 C5 C6 F N

Pin position 10 9 12 1 2 3 4 5 11 14

9.4.2 Bending or knotting will shorten the service life of the lead cable. When using it, please

straighten the lead cable first.

9.4.3 The electrode should be well stored. After long time use, the surface of the electrode may

oxidize and discolor due to corrosion and other factors, which may affect the signal acquisition.

In this case, the electrode must be replaced.

9.5 Silicone rubber roller

The silicone rubber roller should be smooth and free of stains, otherwise it will affect the ECG

recording effect. In order to remove the stains on the roller, please use a clean soft cloth damped

with a small amount of alcohol to wipe it along the longitudinal direction, and scroll the roller in

the paper conveying direction while wiping until it is clean.

9.6 Cleaning of thermal print head

Dirt and dust on the surface of the TPH can affect the clarity of the waveform. To clean the print

head surface, open the paper compartment cover after turning off the device, use a clean and soft

cloth dampened with alcohol to wipe the surface gently. For the residual stains on print head,

moist it with a little alcohol first, then wipe with a soft cloth. Never use hard objects to scratch

the surface, otherwise the print head will be damaged. Wait until the alcohol has evaporated,

then close the paper compartment cover. The print head should be cleaned at least once a month

during normal use.

9.7 Fuse replacement

Unplug the power cord, pull out the fuse box and replace the fuse, the specification of fuse is

T3.15AH250V, as shown in Figure 9-1:

Figure 9-1 Replacing the fuse

Note

 If the fuse blows again after replacing a fuse of the same specification, the

device may exists other problems, please cut off the power supply and contact the

after-sales service of our company or designated service center.

9.8 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.

9.9 Others

9.9.1 Do not open the device enclosure to avoid electric shock danger.

9.9.2 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.

9.9.3 The device belongs to measuring instrument. User should send the device to national

designated inspection institution for inspection according to the requirements of the national

metrological verification procedure. The device shall be inspected at least once per year, and all

the accessories should be inspected and maintained at least once every six months.

Name

Quantity

Electrocardiograph

1 pc

Chest electrodes (suction cup/electrode slice)

1 set (6 pcs)

Limb electrodes (limb clip)

1 set (4 pcs)

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 11:

Table 11 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.

bpm

P-duration

T-duration

P/QRS/T electric axis

deg

R(V5)+S(V1)

No.

Item

No abnormal

Sinus mode Bradycardia

Left atrium Hypertrophy

Right atrium Hypertrophy

Dual atrium Hypertrophy

QRS low voltage

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.

The appendix also contains rhythm diagnosis function, which interprets the ECG database used

for rhythm diagnosis and accuracy verification results of rhythm diagnosis.

2. Automated measurement parameters and Automated interpretation items

The output measurement parameter, interpretation item and others that require explanation are as

follows:

2.1 Measurement parameters

No. Parameter Unit

2 PR-interval ms

2.2 Interpretation items

3 Sinus mode Tachycardia

8 Cardiac electric axis normal

4 QRS-duration ms

6 QT/QTc ms

8 R(V5)/S(V1) mV

Left axis deviation

Right axis deviation

Completeness Left Bundle branch block

No Completeness Right Bundle branch block

No Completeness Left Bundle branch block

V1 shows RSR' type

Left posterior fascicular block

Left ventricular hypertrophy

Right ventricular hypertrophy

I atrioventricular block

Possible acute forepart anteroseptal MI

Old anteroseptal MI

Early anterior MI

Possible acute anterior MI

Early extensive anterior MI

Possible acute extensive anterior MI

Old extensive anterior MI

Early apical MI

Old apical MI

Early anterolateral MI

Possible acute anterolateral MI

Old anterolateral MI

Possible acute high lateral MI

Old high lateral MI

Early inferior MI

Possible acute inferior MI

Early inferolateral MI

Possible acute inferolateral MI

Old inferolateral MI

11 Completeness Right Bundle branch block

16 Left anterior fascicular block

21 Early anteroseptal MI

26 Old anterior MI

31 Acute apical MI

36 Early high lateral MI

41 Old inferior MI

ST depression, mild anteroseptal myocardial ischemia

ST depression, mild anterior myocardial ischemia

ST depression, mild apical myocardial ischemia

ST depression, mild anterolateral myocardial ischemia

ST depression, mild high lateral myocardial ischemia

ST depression, mild inferior myocardial ischemia

ST depression, anteroseptal myocardial ischemia

ST depression, anterior myocardial ischemia

ST depression, extensive anterior myocardial ischemia

ST depression, apical myocardial ischemia

ST depression, high lateral myocardial ischemia

ST depression, inferior myocardial ischemia

ST depression, inferolateral myocardial ischemia

and diagnosis

above description

site

sensitivity and specificity.

47 ST depression, mild extensive anterior myocardial ischemia

52 ST depression, mild inferolateral myocardial ischemia

57 ST depression, anterolateral myocardial ischemia

2.3 Intended use

The intended use of the Automated Measurement&Interpretation function is shown as below:

Application

To detect the abnormal of heart of human body, examination items refer to

Population Teenagers and adults, age range: 12-87

Application

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 workflow is shown as below:

hospitals

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.

Start

End

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.

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.

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

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

4 QRS-duration Se⑤ - Qs

5 T-duration Te⑦ - Ts⑥

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

IIIII

××+×

6 QT Te⑦ - Qs

7 QTc

Electric axis formula:

⑧

P electric axis:

: voltage sum from the beginning point to the end

III

point of P-wave on lead III

: voltage sum from the beginning point to the end

axis

P/QRS/T electric

point of P-wave on lead I

QRS electric axis:

: voltage sum from the beginning point to the end

III

point of QRS-complex on lead III

: voltage sum from the beginning point to the end

point of QRS-complex on lead I

T electric axis:

: voltage sum from the beginning point to the end

III

point of T-wave on lead III

: voltage sum from the beginning point to the end

point of T-wave on lead I

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

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



No.

Item

Rule of interpretation

No abnormal

Sinus P-wave, PR-interval between

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

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

Cardiac electric axis normal

QRS-axis between 30 to 90 degree

Left axis deviation

Right axis deviation

QRS-axis between 120 to 180 degree

block

QRS-duration>120ms, R-wave of lead V5 or

branch block

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

V1 shows RSR' type

Note:

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

3.5 Interpretations judgment based on parameters

Sinus mode Bradycardia

Sinus mode Tachycardia

Left atrium Hypertrophy

Right atrium Hypertrophy

Dual atrium Hypertrophy

QRS low voltage

Completeness Right Bundle branch

Completeness Left Bundle branch

block

No Completeness Right Bundle

No Completeness Left Bundle

No any abnormal are detected

110ms-210ms, HR≤*/min, general *=50

Sinus P-wave, PR-interval between

110ms-210ms, HR≥ */min, general *=100

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

≥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 -90 to-30 degree

QRS-duration>120ms, R-wave of lead V1 or

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

V6 is wide

QRS-duration<120ms, R-wave of lead V1 or

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

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

QRS-complex of lead V1 is RSR' type

QRS-duration<110ms, QRS-axis <-30

R amplitude of lead I >1.5mV, R amplitude

I atrioventricular block

Acute myocardial infarction change of leads

Old myocardial infarction change of leads

Acute myocardial infarction change of leads

Old extensive anterior MI

Left anterior fascicular block

Left posterior fascicular block

Left ventricular hypertrophy

Right ventricular hypertrophy

Early anteroseptal MI

Possible acute forepart anteroseptal

Old anteroseptal MI

Early anterior MI

Possible acute anterior MI

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

Q-wave duration<20ms, lead II, III and aVF

are rS type.

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

lead I and lead aVL are rS type, lead II, III

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

and III <20ms.

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.

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 anterior MI

Early extensive anterior MI

Possible acute extensive anterior

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

Early 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 I,

Old myocardial infarction change of leads I,

Acute myocardial infarction change of leads

Early myocardial infarction change of leads

Old myocardial infarction change of leads II,

myocardial ischemia

Mild ST-segment depression of leads V1, V2,

ST depression, mild anterior

Early apical MI

Acute apical MI

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

Early myocardial infarction change of leads

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

Acute myocardial infarction change of leads

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

Old myocardial infarction change of leads

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

aVL, V4, V5, V6

Acute myocardial infarction change of leads

I, aVL, V4, V5, V6.

aVL, V4, V5, V6

Early myocardial infarction change of leads I,

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

V6.

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.

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 inferior MI

Early inferolateral MI

Possible acute inferolateral MI

Old inferolateral MI

ST depression, mild anteroseptal

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.

V3, and no change of leads V4, V5.

Mild ST-segment depression of leads V3, V4,

myocardial ischemia

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

anterior myocardial ischemia

myocardial ischemia

Mild ST-segment depression of leads I, aVL,

myocardial ischemia

Mild ST-segment depression of leads I, II,

myocardial ischemia

ischemia

Severe ST-segment depression of leads V3,

myocardial ischemia

ischemia

myocardial ischemia

Severe ST-segment depression of leads I,

ischemia

myocardial ischemia

Severe ST-segment depression of leads I, II,

ST depression, mild extensive

ST depression, mild apical

ST depression, mild anterolateral

ST depression, mild high lateral

myocardial ischemia

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

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,

V4, V5, V6.

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.

III, aVL, aVF.

Severe ST-segment depression of leads V1,

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

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.

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.

ST depression, high lateral

myocardial ischemia

ST depression, inferior myocardial

ST depression, inferolateral

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.

III, aVL, aVF.

Verification

Database

Database items

CAL30000 ANE20000 ANE20001 ANE20002

CSE diagnostic database

D_0001～D_1220

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.

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

measurement

Automated

interpretation

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

CTS database

CSE measurement

database

Customized data 000001～000549

CAL20002 CAL20100 CAL20110 CAL20160

CAL20200 CAL20210 CAL20260 CAL20500

MA_0001～MA0125

Item

Number

Normal

382

Left ventricular hypertrophy

183

Right ventricular hypertrophy

Biventricular hypertrophy

Anterior myocardial infarction

170

Inferior myocardial infarction

273

Complex myocardial infraction

104

Synthetical accuracy

1220

data

number

catheterization and ultrasonic examination, and the result that judged as

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 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

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;

223 female, average age 59.70, standard deviation 22.63.

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

cardiac functions or shape.

normal in physical examination.

2) Atrium hypertrophy

Determined by the diagnostic results of ultrasonic examination.

3) Myocardial infarction and myocardial ischemia

Determined by the physician diagnostic results of cardiac catheterization.

4) Tachycardia, bradycardia, low voltage, axis

Determined by the diagnostic results of ultrasonic examination.

5)Conduction block

Determined by the physician diagnostic results of cardiac catheterization.

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:

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.

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.

Start

CTS preprocessing

Import preprocessing data to device

ECG automated measurement parameter

Calculate the difference of measurement and reference

Calculate mean differences

Eliminate the largest two deviations from the mean

Recalculate mean difference and standard deviation

End

5.1.2 Verification and Process for CSE measurement database

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

for all case files can be reviewed in the device, therefore the automated measurement parameters

can be obtained.

Eliminate the cases existing obvious error for the diagnostic parameters (P-wave location is

wrong) from the CSE database.

Make a comparison between the ECG analytical parameters (the beginning/end of P-wave,

QRS-complex and T-wave) and the diagnostic parameters (the beginning/end of P-wave,

QRS-complex and T-wave) provided by CSE database. Draw the two groups of waveform and

mark the location of the beginning/end of P-wave, QRS-complex and T-wave corresponding to

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

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

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

-5.70

1.88

PQ-interval

-2.58

1.94

QRS-duration

-0.23

3.26

QT-interval

-6.70

4.37

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

NOISE

Disclosed differences

Mean (ms)

Standard deviation (ms)

P-duration

High frequency

-5.65

12.33

P-duration

Line frequency

-0.25.

12.71

P-duration

Base-line

-4.90

33.15

QRS-duration

High frequency

-0.95

5.13

QRS-duration

Line frequency

1.35

4.71

QRS-duration

Base-line

-1.55

7.68

QT-interval

High frequency

-14.55

6.51

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:

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

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.

5.2 Verification of interpretation function

5.2.1 Verification process

5.2.1.1 CSE diagnostic database

Frequency conversion

Voltage conversion

Read initial DCD files

Get ECG data files

Automated interpretation item

Compare automated interpretation with expert diagnosis

Start

Summarize comparison results, draw conclusions

End

Initial case data

ecg format as system required

Import to device

Start

5.2.1.2 Customized database

Draw ECG waveform

Expert diagnosis

value %

No abnormal

585

92.01

79.16

97.38

Sinus mode Bradycardia

191

96.68

99.73

98.64

Sinus mode Tachycardia

97.44

96.49

96.90

Left atrium Hypertrophy

51.09

99.89

81.82

Right atrium Hypertrophy

42.64

99.66

50.00

Dual atrium Hypertrophy

93.58

99.14

60.19

QRS low voltage

96.37

99.36

63.25

5.2.2 Verification results

No. Item

ECGs

number

Sensitivit

y %

Specific

ity %

Positive

predictive

Cardiac electric axis normal

733

98.36

89.13

98.79

Left axis deviation

168

98.65

89.40

98.18

Right axis deviation

107

98.23

88.99

94.90

block

branch block

V1 shows RSR' type

90.32

91.14

65.12

Left anterior fascicular block

91.43

93.25

71.11

Left posterior fascicular block

89.29

97.37

52.63

Left ventricular hypertrophy

236

41.37

92.65

70.36

Right ventricular hypertrophy

108

39.75

93.47

65.39

I atrioventricular block

94.58

91.67

80.64

Early anteroseptal MI

83.33

99.94

90.91

Old anteroseptal MI

92.00

98.90

86.47

Early anterior MI

93.90

88.22

71.96

Possible acute anterior MI

80.00

99.72

44.44

Old anterior MI

24.00

99.66

50.00

Early extensive anterior MI

79.67

99.43

41.18

Old extensive anterior MI

90.91

88.05

37.04

Early apical MI

88.32

87.21

88.54

Acute apical MI

78.12

78.66

53.85

Old apical MI

79.63

89.94

80.00

Early anterolateral MI

77.51

79.94

83.33

Possible acute anterolateral MI

28.57

99.77

33.33

Old anterolateral MI

70.00

93.60

50.00

Early high lateral MI

79.65

95.78

80.42

Possible acute high lateral MI

81.60

99.94

85.71

Old high lateral MI

81.82

99.66

60.00

11 Completeness Right Bundle branch

12 Completeness Left Bundle branch

13 No Completeness Right Bundle

14 No Completeness Left Bundle

22 Possible acute forepart anteroseptal

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

28 Possible acute extensive anterior

16 81.82 99.66 75.00

Early inferior MI

88.89

95.00

40.00

Possible acute inferior MI

76.00

99.60

61.11

Old inferior MI

101

96.07

99.24

93.44

Early inferolateral MI

98.77

96.82

75.94

Possible acute inferolateral MI

11.11

99.94

50.00

Old inferolateral MI

84.62

99.83

78.57

myocardial ischemia

anterior myocardial ischemia

myocardial ischemia

ischemia

myocardial ischemia

ischemia

myocardial ischemia

ischemia

ST depression, inferolateral

91.39

99.16

50.47

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

55 ST depression, extensive anterior

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

7 84.78 98.04 67.75

56 ST depression, apical myocardial

57 ST depression, anterolateral

58 ST depression, high lateral

59 ST depression, inferior myocardial

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

myocardial ischemia

Rhythm type

Number

Total

Male

Female

est

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".

6. Accuracy of rhythm diagnosis

6.1 ECG database used for rhythm diagnosis

The ECG database that used for testing the accuracy of rhythm diagnosis contains 3000 cases of

12-lead ECG, each case length is 10s. The data is measured by 12-lead ECG device of our

company. The true value of data is judged by a heart expert with more than 10 years of work

experience based on those 12-lead ECG waveform.

The number of cases with the following diagnosis types (the case diagnosis may contain one or

more types) is shown as below:

2003

313

338

112

230

140

147

232

ung

12 92

SD T

era

47.

Sinus rhythm

Sinus Tachycardia

Sinus Bradycardia

Arrhythmia

Ventricular premature beat

Ventricular premature beat (double)

Ventricular premature beat (bigeminy)

Ventricular premature beat (trigeminy)

Ventricular tachycardia

Atrial fibrillation

Other rhythm types that not included in the database: atrial flutter, ventricular fibrillation,

supraventricular rhythm, junctional rhythm, pacemaker rhythm, Ⅱ°/Ⅲ° atrioventricular block,

arrest and other ECG abnormal.

The statistical information of ECG database that used for testing the accuracy of rhythm

diagnosis is shown as below:

ung

12 93

SD T

era

48.

You

nges

12 93

SD T

era

50. 7

0 7 0

value %

beat

beat (double)

beat (bigeminy)

beat (trigeminy)

6.2 Verification results of accuracy of rhythm diagnosis

The ECG obtained from the ECG database for rhythm diagnosis is input to the

electrocardiograph for testing in form of digital signals. The rhythm results analyzed by

electrocardiograph are compared with the true rhythm results of ECG, and the calculated

sensitivity, specificity and positive predictive value are shown as below:

Positive

predictive

Rhythm type ECGs number

Sensitivity % Specificity

Sinus rhythm

Arrhythmia

Tachycardia

Bradycardia

Ventricular tachycardia

Ventricular premature

Atrial fibrillation

Note:

Sensitivity: probability that a "True sample" would be determined as certain "Rhythm type" by

rhythm diagnosis function.

Specificity: probability that a "True unfit sample" would be determined as certain "Unfit rhythm

type" by rhythm diagnosis function.

Positive predictive value: probability that a determined "Unfit rhythm type" is a "True unfit

rhythm type".

3000 83.82 97.79 98.71

3000 75.89 98.86 72.03

3000 96.81 95.27 70.47

3000 99.11 99.44 95.71

3000 83.33 99.73 81.4

3000 81.3 98.3 79.91

3000 87.5 99.87 77.78

3000 93.57 99.55 90.97

3000 88.44 99.82 96.3

3000 50.86 98.55 74.68

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 intended for use in the electromagnetic environment specified below. The

purchaser or the user of this machine should assure that it is used in such 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)

70%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

70%UT(30%dip in UT) for

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

5 sec

60Hz)

IEC 61000-4-8

Appendix II EMC Guidance and Manufacturer Declaration

Table 1:

This machine

RF emissions CISPR 11 Class A

Harmonic emissions

Class A

Voltage fluctuations/flicker emissions

IEC 61000-3-3

Table 2:

This machine

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 /

magnetic field

Not applicable

IEC60601

±8kV contact

lines

±1 kV lines to lines

±2 kV lines to earth

for 0.5 cycle

40% UT(60%dip in UT) for

5 cycle

25 cycle

30 A/m 30A/m

Compliance level

±8kV contact

±2kV for power supply lines

Not Applicable

±1 kV lines to lines

±2 kV lines to earth

0.5 cycle

5 cycle

25 cycle

Guidance and manufacturer’s declaration – electromagnetic immunity

ified below. The

customer the user of this machine should assure that it is used in such environment.

IEC61000-4-3

ctromagnetic 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)

radio broadcast and TV

To assess the electromagnetic

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

is used exceeds the

should be observed to verify normal

operation. If abnormal performance is observed, additional measures may be necessary, such as

reorienting or relocating this machine.

Guidance and manufacturer’s declaration - electromagnetic Immunity

The [Code SI] is intended for use in the electromagnetic environment specified below. The customer

ions for

(MHz)

(V/m)

18 Hz

± 5 kHz

1 kHz sine

Table 3:

This machine is intended for use in the electromagnetic environment spec

Immunity test IEC 60601 test level Compliance level

Conducted RF

IEC61000-4-6

Radiated RF

3 V

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

3 V

0,15 MHz – 80 MHz

6 V in ISM bands between

0,15 MHz and 80 MHz

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

NOTE 2 These guidelines may not apply in all situations. Ele

telephones and land mobile radios, amateur radio, AM and FM

broadcast cannot be predicted theoretically with accuracy.

If the measured field strength in the location in which this machine

applicable RF compliance level above, this machine

Table 4 ：

or the user of the [Code SI] should assure that it is used in such an environment

Radiated

IEC6100

0-4-3

(Test

specificat

Test

Frequency

385

Band a)

(MHz)

380

–390

Service a)

TETRA

400

Modulation

Pulse

modulation

Modulation

b) (W)

1,8 0,3 27

Distance

(m)

IMMUNITY

TEST LEVEL

ENCLOS

URE

PORT

IMMUNI

TY to

450

710

745

380

–390

704 –

787

GMRS

460,

FRS 460

LTE

Band 13,

FM c)

deviation

Pulse

modulation

2 0,3 28

0,2 0,3 9

217 Hz

Band 5

4, 25;

Band 7

217 Hz

5785

ance between the transmitting

ced to 1 m. The 1 m test distance is permitted by

IEC 61000-4-3.

wireless

communi

cations

equipmen

780

810

870

930

1720

1845

1970

2450

800 –

960

1 700 –

1 990

2 400 –

2 570

17 b)

GSM

800/900,

TETRA

800,

iDEN

820,

CDMA

850,

LTE

GSM

1800;

CDMA

1900;

GSM

1900;

DECT;

LTE

Band 1, 3,

UMTS

Bluetooth

WLAN,

802.11

b/g/n,

RFID

2450,

LTE

Pulse

modulation

18 Hz

Pulse

modulation

217 Hz

Pulse

modulation

217 Hz

2 0,3 28

5240

5500

NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the dist

antenna and the

ME EQUIPMENT or ME SYSTEM may be redu

5 100 –

5 800

WLAN

802.11

a/n

Pulse

modulation

0,2 0,3 9

e modulation at 18 Hz may be used because

t are appropriate

for the reduced minimum separation distance. Minimum separation distances for higher

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, 50 % puls

while it does not represent actual modulation, it would be worst case.

The MANUFACTURER should consider reducing the minimum separation distance, based on

RISK MANAGEMENT, and using higher IMMUNITY TEST LEVELS tha

IMMUNITY 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.

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

Gima 1212G ECG User guide

Specifications and Main Features

Frequently Asked Questions

User Manual

Chapter1 Overview

1.1 Overview

1.2 Intended Use

1.3 Main Technical Specifications

1.4 Main Characteristics

1.5 Software Overview

Chapter2 Safety Precautions

Chapter3 Warranty Regulation

Chapter4 Working Principle and Structural Characteristics

4.1 Brief Description and Block Diagram of the Working Principle

4.1.1 The power supply unit

4.1.2 Signal acquisition unit

4.1.3 Control unit

4.2 Name of each part and its function

4.2.1 Front view

4.2.2 Side view

4.2.3 Buttons

4.2.4 Meaning of symbols

Chapter 5 Operation Precautions

5.1 Precautions before use

5.2 Precautions during operating

5.3 Precautions after use

Chapter 6 Preparations before Operation

6.1 Recording paper

6.2 Power supply connection

6.2.1 AC

6.2.2 Battery

6.3 Lead cable connection

6.4 Electrode installation

6.4.1 Chest electrodes

6.4.2 Limb electrodes

6.4.3 Colors of lead cables

6.4.4 Lead method and system

6.4.5 Lead-off and overload indication

Chapter 7 Operation Instructions and Parameter Setting

7.1 Main Interface

7.2 Sampling

7.2.1 Input case information

7.2.2 Case sampling

7.3 Case management

7.3.1 Query

7.3.2 Export

7.3.3 Review

7.4 Latest case

7.5 System setup

7.5.1 System setup

7.5.2 Sample setup

7.5.3 Print setup

7.5.5 Server setup

7.5.4 Time setup

7.6 Print setup

7.7 Lead placement

7.8 About

Chapter 8 Troubleshooting

8.1 Auto shutdown

8.2 AC interference

8.3 EMG interference

8.4 Baseline drift

8.5 Troubleshooting list

Chapter 9 Maintenance

9.1 Battery

9.2 Recording paper

9.3 Maintenance after use

9.4 Lead cables and electrodes

9.5 Silicone rubber roller

9.6 Cleaning of thermal print head

9.7 Fuse replacement

9.8 Disposal of product scrap

9.9 Others

Chapter 10 Packing List and Accessories

10.1 Accompanying accessories

10.2 Notes

Appendix I ECG Automated Measurement&Interpretation Guide

Appendix II EMC Guidance and Manufacturer Declaration