GIMA 1200G ECG 12 Channel With Monitor User Manual

1200G ECG 12 Channel With Monitor

PROFESSIONAL MEDICAL PRODUCTS1200G ECG 12 CHANNEL WITH MONITOR

ECG1200G (33224)CONTEC MEDICAL SYSTEMS CO., LTD No. 112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei Province, PEOPLE’S REPUBLIC OF CHINA Made in China Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537, Hamburg, Germany

0123

55°C

1060 hPa

95%

-20°C

500 hPa

M33224-GB-Rev.0-05.21

PrefacePlease 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. AttentionsBefore using this product, the safety and effectiveness described in the following shall be considered: Ø Type of protection against electric shock: class I (AC power supply), internal poweredequipment (power supplied by battery) Ø Degree of protection against electric shock: type CF, defibrillation-proof function appliedpart Ø Working mode: continuous running equipment Ø Enclosure protection class: IPX0 Ø Measurement results shall be described by professional doctor combined with clinicalsymptoms. Ø The using reliability depends on whether the operation guide and maintenance instructionsin this user manual is followed. Ø Service life: 5 years Ø Date of manufacture: see the label Ø Contraindications: noneWarning: To ensure the device safety and effectiveness, please use the companyrecommended accessories. The maintenance and repair of the device should be done byprofessional personal specified by the company. It is forbidden to refit the device.Responsibility of the operator Ø The device must be operated by a professionally trained medical staff, and kept by aspecial person. Ø The operator should read the User Manual carefully before use, and strictly follow theoperating procedure described in the User Manual. Ø The safety requirements have been fully considered in product designing, but the operatorcan not ignore the observation of the patient and device. Ø The operator is responsible for providing the information of product use to the company.I

Responsibility of the company Ø The company supplies qualified products to user in accordance with enterprise standard. Ø The company installs and debugs the equipment and trains the physicians by contract. Ø The company performs device repair in warranty period (a year) and maintenance serviceafter warranty period. Ø The company responds timely to the user’s request.The user manual is written by Contec Medical Systems Co., Ltd. All rights reserved.II

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

ContentsChapter1 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………………………………………………………………………………………….3Chapter2 Safety Precautions …………………………………………………………………………………………..4 Chapter3 Warranty ………………………………………………………………………………………………………..7 Chapter4 Working Principle and Structural Characteristics ………………………………………………84.1 Working principle and its block diagram………………………………………………………….8 4.2 Name of each part and its function…………………………………………………………………..9 Chapter 5 Operation Precautions …………………………………………………………………………………..14 5.1 Precautions before use…………………………………………………………………………………..14 5.2 Precautions during operating …………………………………………………………………………14 5.3 Precautions after use……………………………………………………………………………………..14 Chapter 6 Preparations before Operation ……………………………………………………………………….15 6.1 Installation of recording paper……………………………………………………………………….15 6.2 Power supply connection ………………………………………………………………………………16 6.3 Lead cable connection…………………………………………………………………………………..16 6.4 Electrode installation …………………………………………………………………………………….17 Chapter 7 Operation Instructions and Parameter Setting …………………………………………………20 7.1 Main Interface………………………………………………………………………………………………20 7.2 Sampling interface………………………………………………………………………………………..21 7.3 Case information input interface ……………………………………………………………………24 7.4 Case management…………………………………………………………………………………………25 7.5 Date and time setup ………………………………………………………………………………………28 7.6 System setup ………………………………………………………………………………………………..28 7.7 Sampling setup……………………………………………………………………………………………..30 7.8 Print setup ……………………………………………………………………………………………………30 7.9 Lead placement…………………………………………………………………………………………….32 7.10 About…………………………………………………………………………………………………………33IV

Chapter 8 Troubleshooting……………………………………………………………………………………………34 8.1 Auto shutdown……………………………………………………………………………………………..34 8.2 AC interference…………………………………………………………………………………………….34 8.3 EMG interference …………………………………………………………………………………………34 8.4 Baseline drift………………………………………………………………………………………………..35 8.5 Troubleshooting list………………………………………………………………………………………35Chapter 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 ………………………………………………………………………………………….39 9.8 Disposal of product scrap………………………………………………………………………………40 9.9 Others ………………………………………………………………………………………………………….40Chapter 10 Packing List and Accessories ………………………………………………………………………41 10.1 Accompanying accessories ………………………………………………………………………….41 10.2 Notes………………………………………………………………………………………………………….41Appendix I ECG Automated Measurement&Interpretation Guide…………………………………..42 1. Preface …………………………………………………………………………………………………………..42 2. Automated measurement parameters and Automated interpretation items ………….42 3. Algorithm description …………………………………………………………………………………….44 3.5 Interpretations judgment based on parameters ………………………………………………..50 4. Data sources and data preprocessing………………………………………………………………..54 4.5 Data coverage of verification for automated interpretation ………………………………565. Process and Result of Verification …………………………………………………………………………….58 5.1 Verification of measurement function ……………………………………………………………58Appendix II EMC Guidance and Manufacturer Declaration……………………………………………67V

Chapter1 Overview

1.1 Overview

This product is a kind of electrocardiograph, which is able to sample 12 leads ECG signals simultaneously and print out the ECG waveform with thermal printing system. Its functions are as follows: recording and displaying ECG waveform in auto/manual mode; measuring ECG waveform parameters automatically, and automatic analysis and diagnosis; prompt for electrode-off and out of paper; optional interface languages(Chinese/English, etc.); built-in lithium battery, powered either by AC or DC; arbitrarily select the rhythm lead to conveniently observe abnormal heart rate; case database management, etc.

1.2 Intended use

This product is suitable for hospital, scientific research, wards, ambulances and carrying out medical consultations. It can be used by medical institutions to record human ECG signals, collect and extract the ECG waveform.

1.3 Main technical specifications

1.3.1 Environment conditions

Operation: a). Environment temperature: 5~40

b). Relative humidity: 25%~95%(no condensation)

c). Atmospheric pressure: 700 hPa~1060 hPa

d). Power supply: Voltage: 100-240 V

Frequency: 50 Hz, 60 Hz Input power: 150 VA

Battery: 14.8 V, 3500 mAh rechargeable lithium battery

Transportation and Storage: a). Environment temperature: -20 +55 b). Relative humidity: 95%

c). Atmospheric pressure: 500 hPa1060 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 M

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 %a

1.5

1Hz,200ms, Triangle wave

+0 %, -10 %b

a relative to 10Hz b relative to 200 ms

1.3.7 Time constant: 3.2s 1.3.8 CMRR: >105 dB 1.3.9 Filter: AC Filter(50Hz/60 Hz), EMG Filter(25 Hz/35 Hz (-3 dB)), 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, P-R interval, P Duration, QRS Duration, T Duration, Q-T interval, Q-Tc, P Axis, QRS Axis, T Axis, R(V5) amplitude, S(V1) amplitude, R(V5)+S(V1) amplitude 1.3.18 Product safety type: Class I type CF defibrillation-proof 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: standard II 1.3.26 Accuracy of input signal: The overall system error, ±5%. 1.3.27 Amplitude quantization: 5µV/LSB 1.3.28 Interchannel time deviation: <100 µs 1.3.29 Fuse specification: 2pcs 5×20mm AC delay insurance: T1.6AL250V 1.3.30 Dimension: 340 mm(L)×320 mm(W)×85mm(H) 1.3.31 Net Weight: 3.2 kg1.4 Main Characteristics1.4.1 Display with 800*600 dots, 8″ high-resolution color LCD, operate either by touch screen or function buttons, which is convenient and quick. 1.4.2 Sync collection for 12-lead ECG, use digital signal processing technology to conduct AC filter, baseline filter and EMG filter on ECG signals, in order to get high-quality ECGs. 1.4.3 Display of 3/6/12-lead ECG on one screen, and print mode, sensitivity, paper speed, filter state and other information, which facilitates comparative diagnosis. 1.4.4 The device can be powered either by AC or DC(can adapt to 50/60Hz AC frequency), with built-in rechargeable lithium battery and charging circuit, perfect battery overcurrent and2

overvoltage protection circuit. 1.4.5 Multiple print mode and format, including, automatic 12×1, 6×2+1(rhythm lead), 6×2, 3×4+2 (rhythm lead), rhythm 12, rhythm 10, rhythm 8, rhythm 6 and manual. Trend graph and histogram of RR interval can be printed. Printed waveform length is adjustable. With timed print function to satisfy various application requirements. 1.4.6 Rhythm leads can be arbitrarily selected to facilitate the observation of abnormal heart rate. 1.4.7 Clinical information such as patient’s name, gender, age, sampling mode and department can be input. 1.4.8 The built-in large-capacity memory, making it easy for doctor to review medical records and statistical information. 1.4.9 Multi-language (Chinese, English, Turkish, Portuguese, German, Russian, Kazakhstan, etc.) interface and report. 1.5 Software overview Name of software: ECG1200G embedded software Software specification: none Software version: V1.6.1 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: to convert ECG signals of human body into intuitive waveform images and then analyzing. Clinical function: Electrocardiogram is an important method for clinical diagnosis of cardiovascular disease. How to use computer to quickly, automatically and accurately analyze ECG has been a hot topic for scholars at home and abroad. The ECG algorithm is the key to the analysis and diagnosis of ECG signals, and its accuracy and reliability determine the effectiveness of diagnosis and treatment of patients with heart disease.3

Chapter2 Safety Precautions2.1 Ensure that the device is placed on a flat level worktable. Avoid strong vibration or impact when moving it. 2.2 When working with AC power, the power cord must be 3-core, the frequency and voltage value of the AC power source must match the identification on the manual and have sufficient capacity. When the provided three-core power cord cannot be used, please use the built-in DC power supply or replace the three-core power cord that meets the standard requirements. 2.3 A perfect power supply system and grounding are necessary in the room.Warning: To avoid the risk of electric shock, the device must be connected a power supply with protective grounding. 2.4 If there are any questions for the integrality of protective grounding cable or the reliability of protective grounding cable connection can not be guaranteed, the device must be run with built-in DC power supply. 2.5 The safety requirements have been fully considered in product designing, but the operator can not ignore the observation of the patient and device. Cut off the power or take off the electrode when necessary to ensure patient’s safety. 2.6 Please turn off the device and unplug the power cord before replacing the fuse or cleaning and disinfection. Don’t rub the screen with sharp materials. 2.7 Keep the device from water, don’t use or store it in places with high air pressure, humidity or temperature over the standard, bad ventilation, or too much dust. 2.8 Do not use the device in the place with flammable anesthetic gases or other flammable chemicals, otherwise there is a danger of explosion or fire. 2.9 Do not use the device in medical hyperbaric oxygen chamber, otherwise there is a danger of explosion or fire. 2.10 This device is not intended to act directly on the human heart. If this device is used with cardiac defibrillator or other electric stimulating devices at the same time, single-use electrodes and ECG lead cables with defibrillation-proof function should be selected. It is better not to use this device with other electric stimulating devices at the same time. If it is necessary, there must be professional technician guiding on the scene, and the selected accessories should be designated by our company.WarningDo 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, keep the device away from emission sources such as mobile phones.4

2.14 If other equipment is connected with this ECG device, it must be a Class I device that complies with IEC60601-1. Because the total leakage current may hurt patient, the monitoring of leakage current is carried out and taken charge by the connected equipment. 2.15 Notes related to EMCThe 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. n The device or system should not be used near or stacked with other devices. If it must beused near or stacked with other devices, it should be observed and verified that the device is working normally under the configuration it is using. n Use of accessories, transducers, and cables other than those specified by the manufacturer of the device or system as spare parts for internal components may result in increased emissions of the device or system and reduced immunity. n 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. n 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. n Effect from static electricity: Static electricity in a dry environment(indoor) may affect the operation of the device, especially in winter. Before using the device, humidify the indoor air or discharge the static electricity from the cable and operator. n Effect from thunder and lightning: If there is thunder and lightning nearby, it may cause a voltage surge in the device. If you are concerned about danger, disconnect the AC power and use the internal power supply. 2.16 Notes concerning ECG waveform measurement and analysis 2.16.1 The identification of P wave and Q wave is not always reliable with intensive EMG or AC interference. Neither are the ST segment and T wave with baseline drift. 2.16.2 Winding and unclear end position of S wave and T wave may cause error in measurement. 2.16.3 When R wave is uninspected caused by some leads off or QRS wave low voltage, the heart rate measurement may deviate greatly from the correct. 2.16.4 In case of QRS low voltage, ECG axis calculation and border-point identify of QRS wave are not always reliable. 2.16.5 Occasionally, frequent ventricular premature complexes may be identified as dominant beat.5

2.16.6 Merging of versatile arrhythmia may result in unreliable measurement because of the difficulty in distinguishing P wave in such situation. 2.16.7 The device has an automatic analysis function that automatically analyzes the obtained ECG waveform without reflecting all the patient’s status. The results of the analysis may sometimes not comply with the doctor’s diagnosis. Therefore, the final conclusion needs to be comprehensively analyzed by doctors in combination with analysis results, patient clinical characterization and other test results.6

Chapter3 Warranty3.1 In normal use, under strict observance of user manual and operation notes, in case of failure, please contact with our customer service department. Our company has the sales record and customer archives for each device. The customer has one year free warranty service from the date of shipping according to the following conditions. To supply all-around and quick maintenance service for you, please mail the maintenance card to us in time. 3.2 Our company may adopt such ways as guidance, express to company or door-to-door service, etc. to carry out warranty promise. 3.3 Even in warranty period, the following repairs are charged. 3.3.1 Faults or injuries caused by misuse that not according to user manual and operation notes. 3.3.2 Faults or injuries caused by dropping accidentally after purchase. 3.3.3 Faults or injuries caused by repair, reconstruction, decomposition, etc. not by our company. 3.3.4 Faults or injuries caused by improper storage or force majeure after purchase. 3.3.5 Faults or injuries caused by using improper thermal recording paper. 3.4 The warranty period for accessories and fray parts is half a year. Power cable, recording paper, operation manual and packing material are excluded. 3.5 Our company is not responsible for the faults of other connected devices caused by the faults of this device directly or indirectly. 3.6 The warranty will be canceled if we find the protection label has been destroyed. 3.7 For charged maintenance beyond warranty period, our company advises to continue using “Maintenance contract regulation”. Please refer to our customer service department for details.7

Chapter4 Working Principle and Structural Characteristics

4.1 Working principle and its block diagram

4.1.1 The power supply unit1Principle 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 satisfy working requirements of each module in the device through the buck-boost circuit. 2Principle block diagram is shown in Figure4-1.

+24V

DC- DC conver si on

Ther mal pr i nt head

Di spl ay uni t

Char gi ng +14.8V

+14.8V

Bat t er y +5V

Acqui si t i on uni t Cont r ol uni t

Swi t chi ng power suppl y

DC- DC conver si on

+14.8V +12V

Mot or

AC100~240V 50/60Hz

Figure4-1 Block diagram of power principle

Note: The principle block diagram and component list are only available to service stations or maintenance personnel designated by our company.

4.1.2 Signal acquisition unitThe signal acquisition unit uses a floating setting, which is a signal acquisition and processing system, including analog circuit part and A/D conversion (with sampling accuracy of 24 bits) and data processing part. The analog circuit consists of signal following, amplification, anti-aliasing low-pass filtering, lead-off detection and overload detection. CPU system is responsible for coordinating the work of each circuit such as the A/D converter, the lead-off detection circuit and the overload detection circuit, in order to achieve signal acquisition, processing, and lead-off detection. Control information and A/D conversion and data acquisition between the floating circuit and the solid circuit are transmitted through the optoelectronic

coupler.4.1.3 Control unit 1Principle of control unitThe control system consists of printing system, button system, liquid crystal display system, and signal acquisition system. The ECG signal sent from the signal acquisition system through the high-speed optoelectronic coupler is received by the CPU system, after digital filtering, gain adjustment and motor drive, it is sent to the printing system to print the ECG waveform. After the printing is completed, the CPU system processes waveform measurement and analysis. The CPU system also receives an interrupt signal and button code from the button system to complete the interrupt processing. In addition, the lead-off signal, paper out detection, battery voltage management, and automatic power-off are also managed by the CPU system. The liquid crystal controller receives data and commands from the CPU system to complete the display of the control state of the device. 2Principle block diagram is shown in Figure4-2.

But t on syst em Pr i nt i ng syst em

Cont r ol syst em

Si gnal acqui si t i on syst emDi spl ay syst em

Power modul e

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 9

1. Paper compartment cover Keep the paper compartment closed, hold the printing paper2. Display screen Display patient’s ECG and related information3. Button area Control the operations of the device, and enter information. NoteØ Do not put heavy objects on the screen or hit against it, otherwise the screen will be damaged.Ø If the device is not in use, cover it to prevent liquid spills on the screen. Ø Do not use sharp stuff to operate the buttons, otherwise it may case permanentdamage to the buttons. 4.2.2 Side viewFigure 4-4 Side view 4. Lead cable interfaceConnect with lead cables. 5. USB interfaceCommunicate with the computer. The ECG data can be transmitted to a computer, by using the computer, many functions can be achieved, such as archiving, managing, and analyzing ECG data, which facilitates clinical research, organization teaching and training. 6. Network interfaceConnect with the LAN, then perform case analysis and remote control by expert in the LAN. 7. Mains power switchA control button connecting with AC power. 8. Input socketConnect with the AC power cord. 9. Equipotential terminalConnect with the potential equalization conductor.10

Figure 4-5 Bottom view 10. Battery compartmentBuilt-in rechargeable lithium battery. 11. FuseBuilt-in fuse tube, T1.6A L250V. It can avoid the damage to human body caused by large voltage and large current generated by grid pollution.Note Lead cables must be disconnected from patient before connecting with a computer via the USB interface. Operator must not touch the USB interface and patient at the same time. 4.2.3 ButtonsFigure 4-6 Schematic diagram of buttons 1. Startup indicator It lights in green after turning on the device. 2. Power status indicator Green indicates that the AC power supply is used. At this time, there is no battery in the device or the battery is full. Red and green two colors indicate that the battery is being charged. 3. Number buttons Input patient’s information, hospital name, bed number and other information, both Chinese and11

English are supported.

4. Backspace

Change entered information, long pressing it could clear the title.

5. 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.

6. Direction buttons

Including up, down, left, right and OK buttons, quick and convenient

7. SPEED

Change the ECG recording speed

8. SEN

Adjust the sensitivity manually.

9. FILTER

Set the filter mode.

10. MODE

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

11. PRINT

Print the sampled ECG waveform or end the printing.

12. Switch button of input method

Under the inputting state, use this button to switch between numbers, lowercase, capital and

symbols.

13. Setting button of acquisition system

Collect ECG waveform and set the display mode.

4.2.4 Symbols

Alternating current

OFF

Alternating current–OFF

Alternating current–ON

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

Caution! Refer to the accompanying document.

Type CF equipment, with defibrillation-proof function

USB interface

PATIENTFUSE T1.6AL250V5×20

Lead cable socket Fuse specification Serial number

ManufacturerDate of manufacture Batch codeLatex free Atmospheric pressure limitationTemperature limitationHumidity limitation For indoor use onlyPolarity of d.c. power connector Waste disposal symbol. This symbol indicates that electrical and electronic equipment waste cannot be disposed of as unsorted municipal waste and must be recycled separately. This way upFragile, handle with careKeep away from rainStacking limit by numberRefer to instruction manual/booklet This item is compliant with Medical Device Directive 93/42/EEC of June 14,1993,a directive of the European Economic Community.Catalogue numberAuthorized representative in the European Community General warning sign NOTEBackground col our: yellow Triangular band: Black13

Chapter 5 Operation Precautions5.1 Precautions before use 5.1.1 For safe and effective use, please read the user manual carefully before operation. 5.1.2 Check to ensure that the device is in good condition. 5.1.3 The device shall be placed on a flat surface, and moves gently to avoid strong vibration or shock. 5.1.4 Check to ensure that the lead cables are correctly connected, and the device grounding is correct. 5.1.5 The AC frequency and voltage should comply with the requirements, and enough current capacity should be guaranteed. 5.1.6 When using the battery for power supply, check to ensure that the battery voltage and battery status are in good condition, and the battery has enough power. 5.1.7 When the device is used together with other equipment, all devices and equipment should be equipotential grounded in order to protect the user and operator. 5.1.8 Install the device where easily grounded in the room. Do not allow the patient and patient-connected lead cables and electrodes to come into contact with other conductor parts, including the earth or a hospital bed. 5.1.9 Clean the lead cable with neutral solvent. Do not use alcohol-based cleaners or gemicides. 5.1.10 Ensure that the device is running within the normal ambient temperature range of 5 to 40. If the device is stored at a higher or lower temperature, leave it in the operating environment for approximately 10 minutes before use in order to ensure the normal work. 5.2 Precautions during operating 5.2.1 The printing can be started after the ECG waveform is stable. 5.2.2 During using, the doctor should observe the patient carefully and cannot leave the operating site. If necessary, turn off the power or remove the electrode to ensure patient safety. 5.2.3 The patient and the device can only be connected via lead cables through the electrodes, in order to avoid patient touches other parts of device or conductors. 5.2.4 Patient can not move during operating. 5.2.5 Maintenance or repair to the device or accessory is not allowed during using. 5.3 Precautions after use 5.3.1 Set the states of all functions to initial states. 5.3.2 Cut off the power, gently remove the electrodes and limb clips, then remove the lead cables, do not pull with force. 5.3.3 Clean the device and all accessories, and store them for the next use.14

Chapter 6 Preparations before Operation6.1 Installation of recording paper 6.1.1 The device adopts high-speed recording paper, its specification is 210 mm(W)×20 m(L). 6.1.2 The installation method of recording paper is described as below: 1. As shown in Figure 6-1, use both hands to lift both sides of the paper compartment cover at the same time to open it. Take out the roller, insert it into the roll paper as shown in the figure. The paper side with grids should be faced downwards, and then install it to proper position in the paper compartment.Figure 6-1 Installation of recording paper 2. Pull out the recording paper from the slot of the paper compartment cover, and close the cover.Note Ø When opening the paper compartment cover, it is not allowed to open one sideseparately, otherwise the operation of the device will be affected. Ø The recording paper should be aligned with the slot of the paper compartment cover.It is recommended to leave 2cm paper outside. 6.1.3 If the recording paper runs out during recording, the device will stop printing automatically, and the screen will display a prompt of lack of paper, as shown in Figure 6-2.15

Figure 6-2 Lack of paper prompt 6.2 Power supply connection 6.2.1 ACInsert one end of the provided three-core power cord into the device’s input socket, and insert the other end into a three-core power socket that meets the requirements. Ensure that the connection is secure and reliable, and the device is automatically grounded.When the device is used in conjunction with other medical equipment, use the supplied potential equalization wire to connect the equipotential terminal of the device to the equipotential terminal of the connected equipment to prevent leakage current and protect the device. 6.2.2 BatteryThe device has a built-in rechargeable lithium battery, which does not need to be re-installed by user. Check the battery’s power and status before use.Note: Connect one end of the potential equalization wire to the equipotential terminal of the device, and connect the other end to the ground to enhance the reliability of the grounding. Do not use other pipes as ground wire, otherwise, the patient may be in danger of electric shock. 6.3 Lead cable connectionConnect the lead cable to the lead cable interface on the device, and fasten it to the device with the fixing knobs at both sides of the lead cable in order to prevent bad connection and affecting the detection.Note: The lead cable interface can not be used for other purposes except as the input interface of ECG signals.16

6.4 Electrode installation Proper installation of the electrodes is an important part of accurately recording theelectrocardiogram. 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 6-3:Figure 6-3 Installation of chest electrode The chest electrodes should be installed to the following parts: C1Vl: the fourth intercostal space at the right sternal margin C2V2: the fourth intercostal space at the left sternal margin C3V3: between C2 and C4 C4V4: the intersection between midclavicular line and the fifth intercostal space C5V5: left anterior axillary line on the same plane as C4 C6V6: left midaxillary line on the same plane as C4 Clean the chest skin where the electrodes to be installed with alcohol, and apply some conductive pastes to these skin (about 25 mm-diameter range) and the edge of the chest electrode suction cup. Squeeze the suction ball to install the chest electrode at the positions of Cl-C6. Note: The conductive paste coating should be separated from each other, and the chest electrodes should not touch each other to avoid short circuit. 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 6-4.17

Figure 6-4 Installation of limb electrodes

6.4.3 Colors of lead cables As shown in Table 6-1:

Table 6-1 Colors of lead cables

Electrode position

European standard

Mark

Color

American standard

Mark

Color

Right arm

Red

White

Left arm Left leg Right leg

L F N/RF

Yellow Green Black

Black

Red

Green

Chest 1

Chest 2

Chest 3

Chest 4

Chest 5

Chest 6

Red Yellow Green Brown Black Purple

Red

Yellow

Green

Blue

Orange

Purple

Note n It is recommended to install the lead cables after turning off the device. n Apply appropriate amount of conductive paste on the electrode when installing theelectrode. n If the ECG waveform does not appear for a long time, check if the electrode is ingood contact with the skin.

6.4.4 Lead method and system As shown in Figure 6-5:Figure 6-5 Lead system 6.4.5 Lead-off and overload indicationThe device can check the connection status of the lead at any time. If lead-off or overload is detected, the screen will display corresponding lead code on the top left corner, as shown in Figure 7-2.Note Ø In the lead-off prompt area, red font represents lead-off, yellow font representoverload. Ø When the connection between lead cable and patient/the device is not reliable, andthe ECG signal can not correctly transmitted, the device displays lead-off.19

Chapter 7 Operation Instructions and Parameter Setting7.1 Main Interface

Status bar 1. Time

Figure 7-1

System time can be set in

, so the detail time of ECG recording can be noted.

2. Memory usage

It directly shows the capacity of memory space according to actual usage. The green part

represents the memory usage, the white part represents the remaining memory space.

3. Total number of cases stored in memory

4. Input method indication

Current input method is marked by green color. Use

button to switch input methods.

5. Battery level (refer to 9.1) Menus 6.Functional panel:to enter the sampling interface to collect and display waveform, and print report.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.

to view the placement of leads

to set time and date

to perform system setting

to perform sampling setting

to set the print mode, print style and print content, etc.

to view software version and other information

Quick switch: use the

buttons on the keyboard to switch between each

functional module, after selecting, press

button to enter its setting.

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

7.Friendly tips.

7.2 Sampling interface

Click

on the main interface or press the

button to enter the sampling interface.

Note: There is input time of cases in the system setting, therefore, in default, case

information should be input before sampling. (refer to 7.3 for details)

The sampling interface provides several lead display modes, including 1-lead, 3-lead, 6-lead and 12-lead. The following figure uses 12-lead as an example:Status barDisplay field

Operation field

Figure 7-2

Status bar

1. HR: current sampled heart rate value

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

displays the detected lead status. A red lead icon represents lead-off. A yellow lead icon

represents overload.

3. Std 12: It shows the sampling method. Before sampling, the sampling method can be set in

patient information input dialog box, settings include standard 12-lead, additional 6-lead, and

standard 12-lead+additional 6-lead.

4. System status indication:

Display content

Explanation

Process…

It is printing.

Waiting…

It is finishing printing.

No Paper.

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

Print Timeout

Communication failure between this system and printing sub-system.

ECG Timeout

Communication failure between this system and sampling sub-system.

Low Power!

Low power, it cannot start printing.

No USB device

No external printer connected, user should restart printing after connected to the external printer.

Gather Time Less

The sampling time is not enough, the print shall be started after reaching the required time period.

Display field The screen displays sampled 12-lead ECG waveform, by double clicking the waveform,you can switch between 1-lead, 3-lead, 6-lead and 12-lead. Operation field Control the print display mode of the device through corresponding operation settings.

1. Speed: use the

button to switch the speed between 5 mm/s, 6.25 mm/s, 10 mm/s,

12.5 mm/s, 25 mm/s and 50 mm/s.

2. Gain (sensitivity): use the

button to switch the gain between 2.5 mm/mV, 5

mm/mV, 10 mm/mV, 20 mm/mV and 40 mm/mV. The overall gain (sensitivity) can be checked

by calibration function.

3. Filter: use the

button to switch the filter between NONE, AC, EMG, AC+EMG,

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

In which: AC EMG DFT

AC filter EMG filter Baseline filter

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

button

to switch the print mode between Manual, Auto 12×1, Auto 6×2+1, Auto 6×2+1_H, Auto 6×2,

Auto 6×2_H, Auto 3×4+1, Auto 3×4+2, Auto 1×12, Rhythm 12, Rhythm 10, Rhythm 8 and

Rhythm 6.

5. Print/End print: use the

button to start or end the printing operation.

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

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

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

automatically ends printing.

2)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.

3)If lead-off occurs during sampling process, the printed waveform will be marked with “*”.

4)If lead overload occurs during sampling process, the printed waveform will be marked with

“+”.

6. During sampling process, press the PRINT button and wait until the printing is competed, it

will pop up a dialog box, which includes “Delete check box”, “Review”, “OK” and prompts (If

lead-off or overload occurs during sampling process, there will be a prompt in this dialog box).

Clicking “Review” could enter the case management to view sampled cases; Select the delete

check box and click “OK” to delete the case.

7. End sampling: After the device starts sampling, use the

button to end the sampling,

and back to the main interface. 7.3 Case information input interfaceThe case information input dialog box is shown as below:

Figure 7-3 Select “Get” to obtain the latest 10 pieces of patient information. For the same patient information, selecting it could add to the edit box. Custom content can be set according to your needs. “*” represents required content, it can be set after inputting the password in “Servicing” under the System Setup (initial password is 888888).

After selecting a edit box, pressing

button could pop up a soft keyboard shown as

below. Click “CN” or “EN” to switch between Chinese and English. Clicking “Caps” can switch

between numbers, lowercase letters, capital letters and symbols. “Space” is the space key, press

it to enter a space; “Backspace” is the backspace key, press it to delete the last character entered.

Click “OK” to confirm the entry and exit the interface.

Figure 7-4 The keyboard may have input restrictions according to the limitation of content. The restricted keys will be grayed out and unavailable, as shown below:24

Figure 7-5 In addition, you can use the number buttons on the control panel for editing, and pressbutton to switch between numbers, lowercase letters, capital letters and symbols. Press button to delete the last character entered. According to the limitation of the content, the selected input method is displayed in green when switching input method, and the restricted input method is grayed out and unavailable. 7.4 Case management

In the main interface, click below:

to enter the case management interface, as shown

Figure 7-6 The above interface shows all medical records stored in the device. User can search25

necessary cases by the query function in the interface (refer to 7.4.1), modify or delete case information by edit function, and review stored case information (refer to 7.4.2).

Click

to jump to the first page of case list.

Click

to jump to the last page of case list.

Click

to jump to the previous page.

Click

to jump to the next page.

In the operation field, “Adv-opr” contains menus of “list ALL” “Query” “Export ECG” and

“Return”.

“Export ECG”: export the cases in the device to a U-disk via the USB interface. Export

path can be self-defined (symbols such as ” / : ? < > |” are excluded), the type of files is

shown as below:

1.JPEG, BMP: the format of report.

2.aECG: case data that conform to the HL7 standard

3.DAT: case data, self-defined format

“Query”: see 7.4.1

7.4.1 Query

Click “Query” in the “Adv-opr” setting to enter the query interface shown below. Input

query conditions and click “Select” to obtain expected results. After clicking “Clear”, the system

will clear all query conditions that entered.

Figure 7-7 “Cond.And” and “Cond.Or” indicate the matching mode of the query conditions. You can choose one of the two. If you select “Cond.And”, the displayed query results will satisfy all the input conditions at the same time; if you select “Cond.Or”, the displayed query results only need to meet any of the conditions entered. Suggestion: When there are many cases, it would be better to input accurate query conditions and choose “Cond.And” to quickly find the case.26

7.4.2 Review In the case management interface, select a case to be reviewed, click “Review” to enter thefollowing dialog box, which displays the case information. User is allowed to modify patient information, after clicking “Save”, the information will be changed. Please note that the modification is irreversible.Figure 7-8 Make sure the input information is correct, click “Review” to enter the review interface, which is similar with the sampling interfaceFigure 7-9 27

Status bar 1.It shows detailed examination time of the reviewed case. 2.The sampled time length of this case is displayed. Setting field 3.To analyze data information and get diagnosis result of the case.Note:

1.In this interface, user can use

button to change the print mode.

2.In this interface, user can use

button to print.

3.If lead-off occurs during sampling process, the reviewed waveform and the printed waveform

will be marked with “*”.

4.If lead overload occurs during sampling process, the reviewed waveform and the printed

waveform will be marked with “+”.

7.5 Date and time setup

In the main interface, click

to enter the following interface to set date and time.

Figure 7-10

In current interface, user can switch the items via

buttons, and adjust the content

of the item by

buttons. It can also be changed through the touch screen function,

which is convenient and quick.

7.6 System setup

In the main interface, click

to enter the system setup interface. The optional 28

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

Item Back-light

Light-degree

Auto Off

Low Power

AC filter EMG filter

DFT FilterLow-pass Filter Language Hospital Heartbeat SoundK-B Sound

Demo Mode

Sync

Mode

Sync

Sync setup

Host Sync Port

MAC

Addre

Default

Options[30Seconds]/[1Minute]/ [2Minutes]/[5Minutes]/ [10Minutes]/[Always On][10%degree]/[20% degree]/ [30%degree]/[40% degree]/ [50%degree]/[60% degree]/ [70%degree]/[80% degree]/ [90%degree]/[100%degree] [None]/[1Minute]/[3 Minutes]/[5Minutes]/[10 Minutes]/[15Minutes]/[30 Minutes]/[60 Minutes][None]/[Only once]/[Always][50Hz]/[60Hz] [25Hz]/[30Hz]/[35Hz]/[40 Hz]/[45Hz] [0.05Hz]/[0.5Hz]/[1Hz]/[0. 15Hz]/[0.25Hz]/[0.32Hz]/[ 0.67Hz]/[0.01Hz] [OFF]/[75Hz]/[100Hz] /[150Hz] [English]/[Chinese], etc 0-64 characters

Description If there is no operation after reaching the set time, screen backlight will turn off. If it is set to “Always On”, the backlight will always keep on.After setting light degree, the screen will display different backlight strength.If there is no operation after reaching the set time, the system will automatically turn off. If it is set to “None”, the system will always keep on. It determines the alarm method that the device uses in low power. If it is set to “None”, the system will not prompt for low power. To set the parameters of AC filter.To set the parameters of EMG filter.To set the parameters of Baseline filter.To set the parameters of low pass filter.To set the default language of system. To fill in the name of hospital in report.

ON/OFF

To turn on or off the heartbeat sound.

ON/OFF ON/OFF

Set to on, the button makes sound while pressing, set to off, there will be no sound. Set to on, the system will run in Demo mode; set to off, the system will run in sampling mode.

[USB]/[Wi-Fi]

Set the sync mode.

——–

Sync the IP address of host.

6000 by default

Set the sync serial port.

——–

It is updated automatically after connected.

All above settings will restore to default after clicking this button.

7.7 Sampling setup

In the main interface, click

to enter the sampling setup interface. The optional

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

Item AC Filter EMG Filter DFT Filter Show Style Sort LeadShow GainShow Speed Background Grid Premature Pause Time Tachycardia Bradycardia

Options ON/OFF ON/OFF ON/OFF [1leads]/[3leads]/[6leads]/ [12 leads] [Routine Lead]/[Cabrera Lead] [2.5mm/mV]/[5mm/mV]/[10 mm/mV]/[20mm/mV]/[40m m/mV] [5mm/s]/[6.25mm/s]/[10mm /s]/[12.5mm/s]/[25mm/s]/[50 mm/s]

Description Turn on or off the AC filter. Turn on or off the EMG filter. Turn on or off the Baseline filter. Set the display method of ECG. Set the arrangement of the leads.Set the gain of displayed ECG.Set the speed of displayed ECG.

[Show]/[Not Show]

Set to use the background grid or not.

0~100 1200~3000 0~250 0~99

The system will use the input value as a standard of judging premature beat. The system will use the input value as a standard of judging beat pause. The system will use the input value as a standard of judging tachycardia. The system will use the input value as a standard of judging bradycardia.

Default

All above settings will restore to default after clicking this button.

7.8 Print setup

In the main interface, click

to enter the print setup interface. The optional

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

Item Print Mode

Options [Auto 12×1]/[Auto 6×2+1]/[Auto 6×2+1_H]/[Auto 6×2]/[Auto 6×2_H]/[Auto 3×4+1]/[Auto 3×4+2]/[Auto

Description The system takes the selected option as default print mode.

Lead GainAuto StripRhythm StripAverage QRS Auto-Diagn osis PeriodPrint Device Print Depth Timing Marker Arrhythmia

1×12]/[Rhythm 12]/[Rhythm 10]/[Rhythm 8]/ [Rhythm 6] [Smart]/[Current][2.5 sec]/[3 sec]/[4 sec]/[5 sec]/[6 sec]/[8 sec]/[10 sec]/[15 sec]/[20 sec]/[25 sec] [10 sec]/[15 sec]/[20 sec]/[25 sec]/[30 sec][3×4 + Mark]/[3×4]/[Not Print] [All]/[Only Data]/[Only Conclusion]/[Not Print] [Off]/[per 1 min]/[per 2 min] /[per 3 min] /[per 5 min]/[per 10 min]/[per 20 min]/[per 30 min]/[per 60 min][Inside]/[Outside A4][1]/[2]/[3]/[4]ON/OFF ON/OFF

The option selected will be used as printing gain mode. “Smart” means the system will adjust gain automatically to fit paper height; “Current” means it will use screen waveform gain as that of printing. The system takes the selected option as the print time length of each strip.When “Print Mode” is set to “Rhythm 12” “Rhythm 10” “Rhythm 8” or “Rhythm 6”, the system takes the selected option as the print time length of each waveform. When “Print Mode” is set to “Auto” or “Rhythm”, the system uses the selected format to print the average QRS waveform. The diagnosis contains data and conclusion two parts, which can be chosen by user as demand. During the ECG acquisition process, the system will automatically activate the printing operation according to the selected time interval. When the printing mode is manual mode, the printing will output “Auto 12×1” format, otherwise, it will output according to the current setting mode. Choose to print out the ECG waveform by thermal printing system or USB external printer Set the waveform depth according to necessary. Set to display the time mark on the print paper or not Set to turn on or off the arrhythmia analysis

Note 1: The settings of auto strip, rhythm strip, average QRS, auto diagnosis and period are only optional in auto mode and rhythm mode.Note 2: If print time length is less than 8s, the sampling and analysis time will be 8s; if the print time length is equal to or greater than 8s, the sampling and analysis time keeps the same with print time.31

In the print setup interface, click “Adv-opr” to enter advanced setup interface. The optional

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

Item

Options

Description

Auto-Print ON/OFF

Set to open the automatic print or not

Data Type

[Begin Print]/[After Print]

Set to print the data before clicking the PRINT button, or after clicking

Rhythm 1

[I]/[II]/[III]/[aVR]/[aVL]/ [aVF]/[V1]/[V2]/[V3]/[V 4]/[V5]/[V6]

Set the rhythm lead that used for printing under rhythm mode

Rhythm 2

[I]/[II]/[III]/[aVR]/[aVL]/ [aVF]/[V1]/[V2]/[V3]/[V 4]/[V5]/[V6]

Set the “Auto 3*4+2” mode that used for printing under rhythm mode

Conclusion title

[Conclusions] by default

Set the printed conclusion title

Physician [Physician]/[Specialist] Set doctor’s signature in printed report

7.9 Lead placement

In the main interface, click European Standard is shown as below:

to view the schematic diagram of lead placement, the

Figure 7-11 32

The American Standard is shown as below:

Figure 7-12 Click “Std 12” to switch the schematic diagram of lead placement of “Std 12” and “Add 6”. Click “Return” to exit. 7.10 About

In the main interface, click

to view the information about the device, which

including the following content:

1. App Version: the version number of current software 2. Firm Info: click it see the firmware information of the device. 3. Return: click it to exit the interface.

Chapter 8 Troubleshooting8.1 Auto shutdown Ø The battery is almost running out, which causes overdischarge protection circuit action. Ø The voltage of AC power supply is too high, which causes overvoltage protection circuitaction. 8.2 AC interferenceØ Whether the device is grounded reliably? Ø Whether the electrode or lead cable is connected correctly? Ø Whether the electrodes and skin are daubed with enough conductive paste?. Ø Whether the metal bed is grounded reliably? Ø Whether the patient is touching the wall or metal parts of the bed? Ø Whether the patient touches other people? Ø Whether there is high power electric equipment working nearby? Such as X-ray machineor ultrasonic device, etc. Note: If the interference can not be removed after taking above measures, please use a AC filter. 8.3 EMG interferenceØ Whether the room is comfortable? Ø Whether the patient is nervous? Ø Whether the bed space is narrow? Ø Whether patient speaks during recording? Ø 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.34

8.4 Baseline drift

Ø Whether the electrode installation is stable? Ø Whether the connection of lead cables or electrodes is reliable? Ø Whether the electrodes and patient skin are cleaned and are daubed with enoughconductive paste? Ø Whether it is caused by patient’s movement or breathing? Ø Whether the electrodes or leads are in bad connection?Note: If the interference can not be removed after taking above measures, please use a

baseline filter. 8.5 Troubleshooting list

Phenomenon Too large interference, disorderly waveformBaseline burrNot regular waveform, large up-and-down, beeline figure

Cause of failure 1. Grounding cable is not connected reliably. 2. Lead cables are not connected reliably. 3. There is AC interference. 4. Patient is nervous and can not keep quiet.1. AC interference is large. 2. Patient nervous, and EMG interference is large.1.Bad electrode conductivity. 2. Low battery. 3. Bad connection between electrodes and patient skin. 4. Loose connection between lead cables and the

Solutions1. Check the power cord and lead cables. 2. Let the patient prepare for the measurement.1. Improve the environment. 2. If the bed is made of steel, replace it. 3. The power cable and lead cables are not parallel or too close to each other. 1. Use alcohol of high quality. 2. Clean electrode slice and the skin under the electrode with alcohol. 3. Charge the battery.

Baseline draft Unclear waveform

device’s plug. 5. Bad connection between electrodes and lead cables.

1. Low power. 2. Patient movement.1. Low battery. 2. The printer head surface is dirty. 3. The thermal paper problem.

1. Charge the battery. 2. Keep patient still. 1. Charge the battery. 2. Cut off the power, clean the printer head with alcohol, air dry. 3. Replace the thermal print paper with specified one.

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, turn the mains power switch to ON state, the battery will be

charged automatically. Battery status will be displayed on right edge of LCD screen in powering

on state, as shown in Table 9-1. After absolutely discharged, the battery needs 4.5 hours to

charge to 90%, and 5 hours to charge to full capacity.

Table 9-1 Battery status display

No.

Icon

Description

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

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

Using battery, and 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 before use or adopt AC power supply.

Note: When charging the battery, the displayed status of battery level switches between icon f to icon c. 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 charged, please replace the battery.NoteØ 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 company37

should be used. Ø Do not touch the positive and negative terminals of the battery directly with wire,otherwise there is a danger of fire. Ø Do not use the battery near fire sources or in environments where the temperatureexceeds 60°C. Do not heat the battery or throw it into fire, water and avoid splashed by water. Ø 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. Ø 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. Ø 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 paperIn 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

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 electrodes9.4.1 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 10. 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 10K.Table 9-2 Lead cable mark and pin position table

Mark

L R C1 C2 C3 C4 C5 C6 F N

Pin position

10 9 12 1 2 3 4 5 11 14

9.4.2 Bending or knotting will shorten the service life of the lead cable. When using it, please straighten the lead cable first. 9.4.3 The electrode should be well stored. After long time use, the surface of the electrode may oxidize and discolor due to corrosion and other factors, which may affect the signal acquisition. In this case, the electrode must be replaced.

9.5 Silicone rubber roller

The silicone rubber roller should be smooth and free of stains, otherwise it will affect the ECG recording effect. In order to remove the stains on the roller, please use a clean soft cloth damped with a small amount of alcohol to wipe it along the longitudinal direction, and scroll the roller in the paper conveying direction while wiping until it is clean. 9.6 Cleaning of thermal print head

Dirt and dust on the surface of the TPH can affect the clarity of the waveform. To clean the print head surface, open the paper compartment cover after turning off the device, use a clean and soft cloth dampened with alcohol to wipe the surface gently. For the residual stains on print head, moist it with a little alcohol first, then wipe with a soft cloth. Never use hard objects to scratch the surface, otherwise the print head will be damaged. Wait until the alcohol has evaporated, then close the paper compartment cover. The print head should be cleaned at least once a month during normal use.

9.7 Fuse replacement

Use a cross screwdriver to remove the fuse holder in the direction of the arrow (counterclockwise), and replace the damaged fuse with a primary fuse provided or approved by our company. Screw the fuse holder in the opposite direction to fasten it. The replacement method is shown in Figure 9-1:

Note

Figure 9-1 Replacing the fuse

Ø 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.Ø Press the fuse holder downward and rotate it counterclockwise as shown in Figure 9-1. After removing the damaged fuse replacing a new one, press down the fuse holder and rotate it clockwise.

9.8 Disposal of product scrap The disposal of packaging materials, waste battery and end-of-life device should obey thelocal 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 regularly (at least once every six months).

Chapter 10 Packing List and Accessories

10.1 Accompanying accessories

When the device is shipped from the factory, the intact packaging should contain the

following contents, as shown in Table 10-1:

Table 10-1 Packing list and accessories

Name

Quantity

Electrocardiograph

1 pc

Chest electrodes (suction cup/electrode 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

1pc

User manual

1 pc

Recording paper

1 pc

10.2 Notes

10.2.1 Please follow the instructions on the package when opening the package. 10.2.2 After unpacking, please check the accessories and accompanying documents in accordance with the packing list, then start inspecting the device. 10.2.3 If the packaging content does not meet the requirement or the device does not work properly, please contact our company immediately. 10.2.4 Please use the accessories provided by our company, otherwise the performance and safety of the device may be affected. If accessories provided by other company need to be used, please first consult the after-sales service of our company, or we will not responsible for any caused damages. 10.2.5 The package shall be kept properly for future use in regular maintenance or device repair.

Appendix I ECG Automated Measurement&Interpretation Guide

1. Preface

The appendix describes the functions of ECG automated measurement and automated interpretation. It explains the specific implementation method, algorithm and formulas related to these two functions, as well as the content output by the automated measurement and automated interpretation.According to the requirement of IEC60601-2-51:2003 Medical electrical equipment – Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs, Clause 50 Accuracy of operating data, the appendix gives a description of verification process and results of the performance for automated measurement and automated interpretation. 2. Automated measurement parameters and Automated interpretation items

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

are as follows:

2.1 Measurement parameters

No.

Parameter

Unit

bpm

PR-interval

P-duration

QRS-duration

T-duration

QT/QTc

P/QRS/T electric axis

deg

R(V5)/S(V1)

R(V5)+S(V1)

2.2 Interpretation items

No.

Item

No abnormal

Sinus mode Bradycardia

Sinus mode Tachycardia

Left atrium Hypertrophy

Right atrium Hypertrophy

Dual atrium Hypertrophy

QRS low voltage

Cardiac electric axis normal

Left axis deviation

Right axis deviation

Completeness Right Bundle branch block

Completeness Left Bundle branch block

No Completeness Right Bundle branch block

No Completeness Left Bundle branch block

V1 shows RSR’ type

Left anterior fascicular block

Left posterior fascicular block

Left ventricular hypertrophy

Right ventricular hypertrophy

I atrioventricular block

Early anteroseptal MI

Possible acute forepart anteroseptal MI

Old anteroseptal MI

Early anterior MI

Possible acute anterior MI

Old anterior MI

Early extensive anterior MI

Possible acute extensive anterior MI

Old extensive anterior MI

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

Old inferior MI

Early inferolateral MI

Possible acute inferolateral MI

Old inferolateral MI

ST depression, mild anteroseptal myocardial ischemia

ST depression, mild anterior myocardial ischemia

ST depression, mild extensive 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, mild inferolateral 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, anterolateral myocardial ischemia

ST depression, high lateral myocardial ischemia

ST depression, inferior myocardial ischemia

ST depression, inferolateral myocardial ischemia

2.3 Intended use

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

below:

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

and diagnosis above description

Population Teenagers and adults, age range: 12-87

Application siteAccuracyOthers

hospitalsThe accuracy of this function is reflected by the balance performance of sensitivity and specificity. This function does not generate any alarm when using, so it should be operated by professional or trained personal.

3. Algorithm description

This section describes the algorithm, formulas and judgment conditions for interpretation items related to functions of ECG automated measurement and automated interpretation.The 12-lead sync ECG waveform passes through the filter (AC, EMG, DFT (if has, and open)) into the module of automated measurement and automated interpretation.The module of automated measurement and automated interpretation mainly includes process of find the cardiac impulse location, find the beginning/end for each wave, amplitude calculation, parameters calculation, and interpretations judgment based on known parameters.

The workflow is shown as below: StartECG waveform samplingRecognize all R points by slope methodWaveform superposition taking R point as centerDetermine the positions of each waveCalculate the amplitudes of each waveGet measurement parameter, interpretation itemEnd 3.1 Find the cardiac impulse location1) 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.45

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 waveThe 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 1-4.46

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 measurementAfter 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 wave47

(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, andaverage 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. 1The signal part under consideration shows clearly two opposite slopes with at least one turning point in between; 2The signal part under consideration deviates at least 30V from the reference level for a duration of at least 6ms; 3The minimum observable duration of wave under consideration is 12ms and amplitude 30V. 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

PR-interval

P-duration

QRS-duration

60 / RR Qs – Ps Pe – Ps Se – Qs

T-duration

Te – Ts Te – Qs

QTc

Electric axis formula:

arctan(2.0´(SIII +SI ),SI ´ 3 ) ´180 PI

P electric axis:

SIII: voltage sum from the beginning point to the end

point of P-wave on lead III

SI : voltage sum from the beginning point to the end

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

axis

QRS electric axis:

SIII : voltage sum from the beginning point to the end point of QRS-complex on lead III

SI : voltage sum from the beginning point to the end

point of QRS-complex on lead I

T electric axis:

SIII : voltage sum from the beginning point to the end point of T-wave on lead III

SI : voltage sum from the beginning point to the end point of T-wave on lead I

R(V5)

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

S(V1)

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

Note: RR: RR-interval Qs: beginning of the Q-wave Ps: beginning of the P-wave

Pe: end of the P-wave Se: end of the S-wave Ts: beginning of the T-wave Te: end of the T-wave PI: 3.14159263.5 Interpretations judgment based on parameters

No.

Item

No abnormal

Rule of interpretation No any abnormal are detected

Sinus P-wave, PR-interval between

Sinus mode Bradycardia

110ms-210ms, HR*/min, general *=50

Sinus P-wave, PR-interval between

Sinus mode Tachycardia

110ms-210ms, HR */min, general *=100

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

conditions: width increase of P-wave110ms,

Left atrium Hypertrophy

or P-wave displays in double-peak type,

value of peak to peak 40ms

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

Right atrium Hypertrophy

0.25mV, or P-wave is sharp

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

Dual atrium Hypertrophy

0.25mV and P-wave duration >110ms

Voltage of I-aVF limb leads 0.5mV,

QRS low voltage

and voltage of V1-V6 chest leads 0.8mV

Cardiac electric axis normal

QRS-axis between 30 to 90 degree

Left axis deviation

QRS-axis between -90 to-30 degree

Right axis deviation

QRS-axis between 120 to 180 degree

Completeness Right Bundle branch

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

block

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

Completeness Left Bundle branch 12block

QRS-duration>120ms, R-wave of lead V5 or V6 is wide

No Completeness Right Bundle 13

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

branch block

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

No Completeness Left Bundle

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

branch block

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

V1 shows RSR’ type

QRS-complex of lead V1 is RSR’ type

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

Left anterior fascicular block

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

Left posterior fascicular block

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

lead II and III <20ms.

R amplitude of lead I >1.5mV, R

amplitude of lead V5 >2.5mV, R amplitude

of lead aVL >1.2mV, R amplitude of lead

Left ventricular hypertrophy

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

Right ventricular hypertrophy

V5 >1.2mV, R amplitude of lead V1 is larger

than S amplitude, R amplitude of lead V5 is

smaller than S amplitude.

I atrioventricular block

PQ interval >210ms

Early myocardial infarction change of leads

Early anteroseptal MI

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

Possible acute forepart anteroseptal

Acute myocardial infarction change of

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

Old myocardial infarction change of

Old anteroseptal MI

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

Early myocardial infarction change of leads

Early anterior MI

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

Acute myocardial infarction change of leads

Possible acute anterior MI

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

Old myocardial infarction change of leads

Old anterior MI

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

Early myocardial infarction change of leads

Early extensive anterior MI

V1, V2, V3, V4, V5.

Possible acute extensive anterior Acute myocardial infarction change of leads

V1, V2, V3, V4, V5.

Old extensive anterior MI

Old myocardial infarction change of leads V1, V2, V3, V4, V5.

Early myocardial infarction change of leads

Early apical MI

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

Acute myocardial infarction change of leads

Acute apical MI

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

Old apical MI

Old myocardial infarction change of leads V4, V5, no change of leads V1, V2, V3.

Early myocardial infarction change of leads I,

Early anterolateral MI

aVL, V4, V5, V6

Acute myocardial infarction change of leads

Possible acute anterolateral MI

I, aVL, V4, V5, V6.

Old myocardial infarction change of leads I,

Old anterolateral MI

aVL, V4, V5, V6

Early myocardial infarction change of leads I,

Early high lateral MI

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

V6.

Acute myocardial infarction change of leads

Possible acute high lateral MI

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

V5, V6.

Old myocardial infarction change of leads I,

Old high lateral MI

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

V6.

Early myocardial infarction change of leads

Early inferior MI

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

Acute myocardial infarction change of leads

Possible acute inferior MI

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

Old myocardial infarction change of leads II,

Old inferior MI

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

Early myocardial infarction change of leads I,

Early inferolateral MI

II, III, aVL, aVF.

Acute myocardial infarction change of leads

Possible acute inferolateral MI

I, II, III, aVL, aVF.

Old myocardial infarction change of leads I,

Old inferolateral MI

II, III, aVL, aVF.

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

myocardial ischemia

V3, and no change of leads V4, V5.

ST depression, mild anterior

Mild ST-segment depression of leads V3, V4,

myocardial ischemia

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

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

anterior myocardial ischemia

V3, V4, V5.

ST depression, mild apical

Mild ST-segment depression of leads V4, V5,

myocardial ischemia

and no change of leads V1, V2, V3.

ST depression, mild anterolateral Mild ST-segment depression of leads I, aVL,

myocardial ischemia

V4, V5, V6.

Mild ST-segment depression of leads I, aVL,

ST depression, mild high lateral

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

myocardial ischemia

V6.

ST depression, mild inferior

Mild ST-segment depression of leads II, III,

myocardial ischemia

aVF, and no change of leads I, aVL.

ST depression, mild inferolateral

Mild ST-segment depression of leads I, II,

myocardial ischemia

III, aVL, aVF.

ST depression, anteroseptal

Severe ST-segment depression of leads V1,

myocardial ischemia

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

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

ischemia

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

ST depression, extensive anterior

Severe ST-segment depression of leads V1,

myocardial ischemia

V2, V3, V4, V5.

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

ischemia

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

ST depression, anterolateral

myocardial ischemia

Severe ST-segment depression of leads I, aVL, V4, V5, V6.

Severe ST-segment depression of leads I,

ST depression, high lateral

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

myocardial ischemia

V5, V6.

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

ischemia

aVF, and no change of leads I, aVL.

ST depression, inferolateral

Severe ST-segment depression of leads I, II,

myocardial ischemia

III, aVL, aVF.

Note: Early myocardial infarction: normal Q-wave, ST elevation or ST slope elevation Acute myocardial infarction: abnormal Q-wave, ST elevation or ST slope elevation Old myocardial infarction: abnormal Q-wave, no ST elevation. Abnormal Q-wave:53

For leads I, II, III, avR, avL, avF, V3, V4, V5, V6, voltage of Q-wave <-0.3mV, or 4 times of negative wave of Q-wave> voltage of R-wave and R’-wave, and/or Q-duration>40ms.For leads V1, V2, voltage of Q-wave <-0.08mV and Q-duration>10ms. ST elevation: For leads I, II, III, avR, avL, avF, V4, V5, V6, the voltage of ST segment at 60ms point >0.1mV, and for leads V1, V2, V3, the voltage at 60ms point >0.3mV. ST slope elevation: Voltage of ST segment at 20ms point>=voltage of J point, voltage at 40ms point >= the one at 20ms, voltage at 60ms point >= the one at 40ms, with change of ST elevation. 4. Data sources and data preprocessing

4.1 Data sources

According to the requirement of IEC60601-2-51:2003 Medical electrical equipment – Part

2-51: Particular requirements for safety, including essential performance, of recording and

analysing single channel and multichannel electrocardiograph, the CSE measurement database,

CSE diagnostic database, CTS calibration database and customized data shall be used to evaluate

the function of automated measurements and automated interpretations.

Verification Database

Database items

Automated CTS database

CAL05000 CAL10000 CAL15000 CAL20000

measurement

CAL20002 CAL20100 CAL20110 CAL20160

CAL20200 CAL20210 CAL20260 CAL20500

CAL30000 ANE20000 ANE20001 ANE20002

CSE measurement

MA_0001MA0125

database

Automated CSE diagnostic database D_0001D_1220

interpretation Customized data

000001000549

4.2 CTS introduction

The CTS computerized ECG conformance testing project was launched in 1989 by the

European Union. This project laid the foundation for computerized ECG conformance testing

service. Currently, about 20 types of waveform have been designed derived from the test signals

having an infinite length, these signals are part of the CTS-ECG test database, and have proven

their effectiveness in a series of official tests. According to the requirement of

IEC60601-2-51:2003 Medical electrical equipment – Part 2-51: Particular requirements for

safety, including essential performance, of recording and analysing single channel and

multichannel electrocardiograph Clause 50.101.1, 13 data (CAL05000, CAL10000, CAL15000,

CAL20000, CAL20002, CAL20100, CAL20110, CAL20160, CAL20200, CAL20210,

CAL20260, CAL20500, CAL30000) are used in the automated parameters verification for this

test.

4.3 CSE introduction

The EU CSE (Common Standards for Quantitative Electrocardiography) ECG database

contains 3-lead measurement database of collection1 and collection2, 12-lead measurement

database of collection3 and collection4, and a diagnostic database of collection5. In which, the

12-lead measurement database contains 250 groups of interference data; Diagnostic database contains 1220 cases of short-term ECG recording. The primary development purpose of using

12-lead or 15-lead is to evaluate the performance of the automatic ECG analyzer. In addition to

the normal data, the database also includes clinically confirmed ECGs of variety cases, such as left ventricular hypertrophy, right ventricular hypertrophy, every part of myocardial infarction and ventricular hypertrophy accompanying myocardial infarction. The database has made a great

contribution to the study of electrocardiology, which is, the CSE group published a report on the recommended standard for general ECG measurements based on the investigation and study of the database, which has been widely recognized by the world.

CSE database diagnostic items:

Item

Number

Normal

382

Left ventricular hypertrophy

183

Right ventricular hypertrophy

Biventricular hypertrophy

Anterior myocardial infarction

170

Inferior myocardial infarction

273

Complex myocardial infraction

104

Synthetical accuracy

1220

4.4 Customized data

4.4.1 Data description

Customized

Description

data

Total recording 549

number

Race

Yellow race

Coverage of

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

age, gender

326 male, average age 55.54, standard deviation 19.81;

Sampling data

223 female, average age 59.70, standard deviation 22.63. 12-lead ECG data (I, , , AVR, AVL, AVF, V1, V2, V3, V4, V5, V6),

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

2.4µV/LSB.

Remark The interpretation conclusion of customized data is determined by the

physician diagnostic results of cardiac catheterization and ultrasonic

examination, and the ECG judgment result in physical examination, the

details as blow:

1) Normal ECG

Determined by the diagnostic result that judged as normal in cardiac

catheterization and ultrasonic examination, and the result that judged as normal in physical examination. 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 cardiac functions or shape. 4.5 Data coverage of verification for automated interpretation Analyzing the content of CSE diagnostic database and customized data, the overall condition and coverage of statistical samples are shown as below:56

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 preprocessingThe 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 preprocessingThe 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 case57

of D_0001~D_1220 shall be used for the following verification of automated interpretation. 4.6.3 Customized data preprocessingThe 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.StartCTS preprocessingImport preprocessing data to deviceECG automated measurement parameterCalculate the difference of measurement and referenceCalculate mean differencesEliminate the largest two deviations from the meanRecalculate mean difference and standard deviationEnd58

5.1.2 Verification and Process for CSE measurement database Import the converted case files into the device, add appropriate database records, thenwaveform 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 process59

5.1.3 Verification results

5.1.3.1 Accuracy of amplitude measurements

Calibration and analytical ECGs shall be used to measure the amplitude value, the summary

as follows:

Amplitude

Mean difference (uV)

Standard deviation (uV)

P-wave

-1.70

5.72

Q-wave

7.51

18.07

R-wave

-18.05

21.70

S-wave

7.77

18.58

ST-segment

0.15

4.24

T-wave

-5.81

8.03

Note: In amplitude measurement, for large-amplitude ECG, such as CAL30000, it is

necessary to adjust to 0.5 times the gain before testing.

5.1.3.2 Accuracy of absolute interval and wave duration measurements

Calibration and analytical ECGs shall be used to measure the global interval and wave

duration (including Q-wave ,R-wave ,S-wave), the summary as follows:

Interval&Duration

Mean difference (ms)

Standard deviation (ms)

P-duration

-5.70

1.88

PQ-interval

-2.58

1.94

QRS-duration

-0.23

3.26

QT-interval

-6.70

4.37

5.1.3.3 Accuracy of interval measurements on biological ECGs

CSE database shall be used to evaluate the accuracy of interval measurements on biological

ECGs, the summary as follows:

Interval&Duration

Mean difference (ms)

Standard deviation (ms)

P-duration

0.99

13.46

PR-interval

3.65

9.68

QRS-duration

-1.69

6.11

QT-interval

-2.32

20.69

5.1.3.4 Stability of measurements against NOISE

The test is carrying on according to MA-series data (008, 011, 013, 014, 015, 021, 026, 027,

042, 061) in CSE database.

Global measurement parameters

Type of added 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

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

5.2.1.2 Customized database 63

5.2.2 Verification results

ECGs Sensitivit

No.

Item

number y %

No abnormal

585

Sinus mode Bradycardia

191

Sinus mode Tachycardia

Left atrium Hypertrophy

Right atrium Hypertrophy

Dual atrium Hypertrophy

QRS low voltage

Cardiac electric axis normal

733

Left axis deviation

168

Right axis deviation

107

11 Completeness Right Bundle branch 28block

12 Completeness Left Bundle branch 32block

No Completeness Right Bundle

branch block

No Completeness Left Bundle

branch block

V1 shows RSR’ type

Left anterior fascicular block

Left posterior fascicular block

Left ventricular hypertrophy

236

Right ventricular hypertrophy

108

I atrioventricular block

Early anteroseptal MI

22 Possible acute forepart anteroseptal 27MI

Old anteroseptal MI

Early anterior MI

Possible acute anterior MI

Old anterior MI

Early extensive anterior MI

Possible acute extensive anterior

Old extensive anterior MI

Early apical MI

92.01 96.68 97.44 51.09 42.64 93.58 96.37 98.36 98.65 98.2397.0097.7396.8694.6890.32 91.43 89.29 41.37 39.75 94.58 83.3316.6792.00 93.90 80.00 24.00 79.6781.8290.91 88.32

Specific ity %79.16 99.73 96.49 99.89 99.66 99.14 99.36 89.13 89.40 88.9989.5089.6589.8389.8391.14 93.25 97.37 92.65 93.47 91.67 99.9498.7398.90 88.22 99.72 99.66 99.4399.6688.05 87.21

Positive predictive value %97.38 98.64 96.90 81.82 50.00 60.19 63.25 98.79 98.18 94.9095.4591.4382.3589.6665.12 71.11 52.63 70.36 65.39 80.64 90.9191.8986.47 71.96 44.44 50.00 41.1875.0037.04 88.54

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

Old inferior MI

101

Early inferolateral MI

Possible acute inferolateral MI

Old inferolateral MI

45 ST depression, mild anteroseptal 7myocardial ischemia

ST depression, mild anterior

myocardial ischemia

ST depression, mild extensive

anterior myocardial ischemia

ST depression, mild apical

myocardial ischemia

49 ST depression, mild anterolateral 25myocardial ischemia

ST depression, mild high lateral

myocardial ischemia

ST depression, mild inferior

myocardial ischemia

52 ST depression, mild inferolateral 20myocardial ischemia

ST depression, anteroseptal

myocardial ischemia

54 ST depression, anterior myocardial 12ischemia

55 ST depression, extensive anterior 7myocardial ischemia

56 ST depression, apical myocardial 18ischemia

ST depression, anterolateral

myocardial ischemia

78.12 79.63 77.51 28.57 70.00 79.65 81.60 81.82 88.89 76.00 96.07 98.77 11.11 84.62 75.3681.2479.8376.9777.5480.6479.7380.5985.4187.6684.7879.9587.42

78.66 89.94 79.94 99.77 93.60 95.78 99.94 99.66 95.00 99.60 99.24 96.82 99.94 99.83 99.5599.9499.1399.1499.0899.1499.6099.2699.7298.5898.0499.1498.97

53.85 80.00 83.33 33.33 50.00 80.42 85.71 60.00 40.00 61.11 93.44 75.94 50.00 78.57 46.6733.3353.5943.1337.6447.3955.1650.6144.4434.8567.7555.1259.09

ST depression, high lateral

myocardial ischemia

90.06

99.31

57.14

59 ST depression, inferior myocardial 12ischemia

89.88

99.13

40.08

ST depression, inferolateral

myocardial ischemia

91.39

99.16

50.47

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”.

Appendix II EMC Guidance and Manufacturer Declaration

Warning

l The use of ACCESSORIES, transducers and cables other than those specified, with

the exception of transducers and cables sold by the MANUFACTURER of the the

device as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM. The following cable types must be used to ensure that they comply with interference

radiation and immunity standards:

No.

Name

Cable length (m)

Power cord

1.7

ECG lead cable

3.4

Potential equalization conductor

3.0

l Active medical devices are subject to special EMC precautions and they must be installed and used in accordance with these guidelines.l Portable and mobile communication radiation equipment may affect the normal use the medical device.l The device should not be used when they are close to or stacked with other equipment, if necessary, please observe and verify that they can operate normally in the configurations.l Basic performance: Stability of working state: Waveform noise and measurement error appeared during measuring are automatically eliminated 10s after removing the interference, the working state of device are not changed, it could collect and record data continuously, and the waveform does not show obvious changes before and after the test.Electromagnetic emission

Guidance and manufacture’s declaration-electromagnetic emission

The device is tended for use in the electromagnetic environment specified below. The purchaser or the user of the device should assure that it is used in such an environment.

Emission test

Compliance

Electromagnetic environment-guidance

RF emissions CISPR 11

Group 1

The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11Harmonic emissions

Class B Class A

The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low

IEC 61000-3-2

Voltage fluctuations/

flicker emission

Applicable

IEC 61000-3-3

Electromagnetic immunity

voltage power supply network that supplies buildings used for domestic purposes.

Guidance and manufacture’s declaration-electromagnetic immunity

The device is intended for use in the environment specified below. Buyer or operator should

assure that it is used in such environment.

Immunity test

IEC60601 level

test Compliance level

Electromagnetic environment-guidance

Electrostatic

±6kV contact

±6kV contact Floors should be wood,

discharge (ESD)

±8kV air

concrete or ceramic tile. If

IEC 61000-4-2

floor is covered with

synthetic material, the

relative humidity should be

at least 30%.

Electrical

fast

transient/burst

IEC 61000-4-4

±2kV for power supply lines ± 1 kV for input/output line

Mains power quality should be that of a typical commercial or hospital environment.

±1 kV lines to ±1 kV lines to Mains power quality should

Surge

lines

be that of a typical

IEC 61000-4-5

±2 kV lines to ±2 kV lines to commercial or hospital

earth

environment.

Voltage dips, short interruptions and voltage vatiations on power supply input lines IEC 61000-4-11

<5%UT(>95%dip in UT) for 0.5 cycle 40% UT(60%dip in UT) for 5 cycle 70%UT(30%dip in UT) for 25 cycle <5%UT(>95%dip in UT) for 5 sec

<5%UT(>95%d ip in UT) for 0.5 cycle 40% UT(60%dip in UT) for 5 cycle 70%UT(30%dip in UT) for 25 cycle <5%UT(>95%d ip in UT) for 5 sec

Mains power quality should

be that of a typical

commercial or hospital

environment. If the user

requires

continued

operation during power

mains interruptions, it is

recommended that the

device be powered from an

uninterruptible

power

supply or a battery.

Power frequency

(50/60

Hz)

magnetic field

IEC 61000-4-8

3A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacture’s declaration-electromagnetic immunity

The device is intended for use in the environment specified below. Buyer or operator should

assure that it is used in such environment.

Immunity test

IEC60601 test level

Compliance level

Electromagnetic environment -guidance

Conducted RF IEC61000-4 -3

3 Vrms 150kHz 3 Vrms 80MHz

Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d=1.2Pd=1.2P 80MHz-800MHzd=2.3P 800MHz-2.5GHz

Radiated RF IEC61000-4 -3

3 V/m 80 MHz 3 V/m 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity ofequipment marked with the following symbol:

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

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is

affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device or system is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as adjusting the direction or location of the device. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended safety distanceRecommended separation distances between portable and mobile RF communications equipment and the device

The device is intended for use in the electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the device can help prevent

electromagnetic interference by maintaining a minimum distance between portable and

mobile RF communications equipment (transmitters) and the device as recommended below,

according to the maximum output power of the communications equipment.

Rated power of transmitter(W)

Separation distance according to power of transmitter (m)

150 k Hz 80 MHz d=1.2P

80 MHz 800 MHz d=1.2P

800 MHz 2.5 GHz d=2.3P

0.01

0.12

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

For transmitters rated at a maximum output power not listed above, the recommended separation distanced in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Disposal: The product must not be disposed of along with other domestic waste. The users must dispose of this equipment by bringing it to a specific recycling point for electric and electronic equipment.GIMA WARRANTY TERMS The Gima 12-month standard B2B warranty applies.

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2023-01-20

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