CONTEC MEDICAL SYSTEMS ECG300GT Manual
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CONTEC MEDICAL SYSTEMS ECG300GT Manual

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Please read the User Manual carefully before using this product. The operating
procedures specified in this User Manual should be followed strictly.This manual describes
in detail the operation steps which must be noted, the procedures which may result in
abnormality, and possible damage to the product or users. Refer to following chapters for details.
Failed to follow the User Manual may cause measuring abnormality, device damage or personal
injury. The manufacturer is NOT responsible for the safety, reliability and performance issues of
such results due to user's negligence of this user manual for using, maintenance or storage. The
free service s and repairs do not cover such faults either.
The content in this user manual complies with real product. For software upgrade and some
modifications, the content in this user manual is subject to change without prior notice, and we
sincerely apologize for that.
Attentions
Before using this product, the safety and effectiveness described in the following shall
be considered:
Type of protection against electric shock: class I (AC power supply), internal powered
equipment (power supplied by battery)
Degree of protection against electric shock: type CF, defibrillation-proof applied part
Working mode: continuous running equipment
Enclosure protection class: IPX0
Measurement results shall be described by professional doctor combined with clinical
symptoms.
The using reliability depends on whether the operation guide and maintenance instructions
in this user manual is followed.
Service life: 5 years
Date of manufacture: see the label
Contraindications: none
Warning: To ensure the device safety and effectiveness, please use the company
recommended accessories. The maintenance and repair of the device should be done by
professional personal specified by the company. It is forbidden to refit the device.
Responsibility of the operator
The device must be operated by a professionally trained medical staff, and kept by a
special person.
The operator should read the User Manual carefully before use, and strictly follow the
operating procedure described in the User Manual.
The safety requirements have been fully considered in product designing, but the operator
can not ignore the observation of the patient and device.
The operator is responsible for providing the information of product use to the company.
Preface
.
I

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Summary of Contents for CONTEC MEDICAL SYSTEMS ECG300GT

  • Page 1 Preface Please read the User Manual carefully before using this product. The operating procedures specified in this User Manual should be followed strictly.This manual describes in detail the operation steps which must be noted, the procedures which may result in abnormality, and possible damage to the product or users.
  • Page 2 The company performs device repair in warranty period (a year) and maintenance service  after warranty period. The company responds timely to the user's request.  The user manual is written by Contec Medical Systems Co., Ltd. All rights reserved.
  • Page 3 Statement Our company owns all rights to this unpublished work and intends to maintain it as confidential information. This user manual is used only for reference of operation, maintenance, or repair of our device. No part of this can be disseminated to others. And our company takes no responsibilities for any consequences and liabilities caused by using this user manual for other purposes.

  • Page 4: Table Of Contents

    Contents Chapter1 Overview........................1 1.1 Overview......................... 1 1.2 Intended use......................1 1.3 Main technical specifications.................. 1 1.4 Main Characteristics....................2 1.5 Software overview....................3 Chapter2 Safety Precautions....................4 Chapter3 Warranty........................7 Chapter4 Working Principle and Structural Characteristics............8 4.1 Working principle and its block diagram..............8 4.2 Name of each part and its function................9 Chapter 5 Operation Precautions...................
  • Page 5 7.10 Analysis parameters setup................... 29 7.11 Print setup......................29 7.12 Lead placement....................31 7.13 About........................31 Chapter 8 Troubleshooting....................32 8.1 Auto shutdown...................... 32 8.2 AC interference..................... 32 8.3 EMG interference....................32 8.4 Baseline drift......................33 8.5 Troubleshooting list....................33 Chapter 9 Maintenance......................34 9.1 Battery........................

  • Page 6: Chapter1 Overview

    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;...

  • Page 7: Main Characteristics

    150 Hz ~ 500 Hz, Sine wave +10 %, -100 % ≤1Hz,200ms, Triangle wave +0 %, -10 % relative to 10Hz relative to 200 ms 1.3.7 Time constant: ≥3.2s 1.3.8 CMRR: >105 dB 1.3.9 Filter: power frequency(AC50/60 Hz), myoelectricity(25 Hz/35 Hz (-3 dB)), baseline drift filter 1.3.10 Recording way: Thermal printing system 1.3.11 Specification of recording paper: 80 mm(W)×20 m(L) high-speed thermal paper...

  • Page 8: Software Overview

    The device is intended for use on all patient populations, which is decided by the clinical doctor. The analysis program only provides ECG analysis for patients above 3 years old (including 3 years). Name of software: ECG300GT embedded software Software specification: none Software version: V1.9.10 Version naming rules: V<major version number>.<minor version number>.<revision version...

  • Page 9: Chapter2 Safety Precautions

    Chapter2 Safety Precautions 2.1 Ensure that the device is placed on a flat level worktable. Avoid strong vibration or impact when moving it. 2.2 When working with AC power, the power cord must be 3-core, the frequency and voltage value of the AC power source must match the identification on the manual and have sufficient capacity.
  • Page 10 leakage current is carried out and taken charge by the connected equipment. 2.15 Notes related to EMC The device complies with the safety standards for medical electrical equipment or system electromagnetic compatibility in IEC60601-1-2. Electromagnetic environments exceeding the IEC60601-1-2 standard may cause harmful interference to the device or prevent the device from performing its intended function or degrade its performance.
  • Page 11 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.

  • Page 12: Chapter3 Warranty

    Chapter3 Warranty 3.1 In normal use, under strict observance of user manual and operation notes, in case of failure, please contact with our customer service department. Our company has the sales record and customer archives for each device. The customer has one year free warranty service from the date of shipping according to the following conditions.

  • Page 13: Chapter4 Working Principle And Structural Characteristics

    Chapter4 Working Principle and Structural Characteristics 4.1 Working principle and its block diagram 4.1.1 The power supply unit Principle of power supply After the AC power supply enters the switching power supply, it is converted to DC voltage and supplied to the DC-DC power unit, it also provides constant voltage current limiting charging for the rechargeable lithium battery in the device through the DC-DC circuit, and generates +5V and +8.5V voltage through the power conversion to supply power to the corresponding modules.

  • Page 14: Name Of Each Part And Its Function

    （2）Principle block diagram is shown in Figure 4-1. Figure 4-1 Block diagram of control unit 4.2 Name of each part and its function 4.2.1 Front view Figure 4-2 Front view 1. Paper compartment cover Keep the paper compartment closed, hold the printing paper 2.
  • Page 15 4.2.2 Side view Figure 4-3 Side view 5. Lead cable interface Connect with lead cables. 6. USB interface Communicate with the computer. The ECG data and analysis result can be transmitted to a computer, by using the computer, many functions can be achieved, such as archiving, managing, and analyzing ECG data, which facilitates clinical research, organization teaching and training, as well as program upgrade, case import and export, and connection with external printer.
  • Page 16 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.
  • Page 17 USB interface Lead cable socket PATIENT Serial number Manufacturer Date of manufacture Batch code Latex free Atmospheric pressure limitation Temperature limitation Humidity limitation This way up Fragile, handle with care Keep away from rain Stacking limit by number General warning label NOTE: Background col our:yellow Triangular band:Black...
  • Page 18 Authorized representative in the European Community 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.

  • Page 19: Chapter 5 Operation Precautions

    Chapter 5 Operation Precautions 5.1 Precautions before use 5.1.1 For safe and effective use, please read the user manual carefully before operation. 5.1.2 Check to ensure that the device is in good condition. 5.1.3 The device shall be placed on a flat surface, and moves gently to avoid strong vibration or shock.

  • Page 20: Chapter 6 Preparations Before Operation

    Chapter 6 Preparations before Operation 6.1 Installation of recording paper 6.1.1 The device adopts high-speed recording paper, its specification is 80 mm(W)×20 m(L). 6.1.2 The installation method of recording paper is described as below: 1. As shown in Figure 6-1, open the paper cabinet cover, take out the paper axis, insert it into the roll paper as shown in the figure.

  • Page 21: Power Supply Connection

    6.2 Power supply connection 6.2.1 AC Insert one end of the provided three-core power cord into the device’s input socket, and insert the other end into a three-core power socket that meets the requirements. Ensure that the connection is secure and reliable, and the device is automatically grounded. When the device is used in conjunction with other medical equipment, use the supplied potential equalization wire to connect the equipotential terminal of the device to the equipotential terminal of the connected equipment to prevent leakage current and protect the device.
  • Page 22 The chest electrodes should be installed to the following parts: C1（Vl）: the fourth intercostal space at the right sternal margin C2（V2）: the fourth intercostal space at the left sternal margin C3（V3）: between C2 and C4 C4（V4）: the intersection between midclavicular line and the fifth intercostal space C5（V5）: left anterior axillary line on the same plane as C4 C6（V6）: left midaxillary line on the same plane as C4 Clean the chest skin where the electrodes to be installed with alcohol, and apply some...
  • Page 23 Chest 5 Black Orange Chest 6 Purple Purple Note It is recommended to install the lead cables after turning off the device.  Apply appropriate amount of conductive paste on the electrode when installing the  electrode. If the ECG waveform does not appear for a long time, check if the electrode is in ...

  • Page 24: Chapter 7 Operation Instructions And Parameter Setting

    Chapter 7 Operation Instructions and Parameter Setting 7.1 Main Interface As shown in below figure: Power status: refer to 9.1 Functional buttons: to enter the sampling interface, generally, the device will automatically enter this interface after powering on to enter the case management interface, in this interface, user can query, modify or delete case information to view the placement of leads to set time and date...

  • Page 25: Sampling Interface

    to view the information about our company, software version. 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, case information should be input before formal sampling.
  • Page 26 Rhythm 2. Gain (sensitivity): use the button to switch the gain between 5 mm/mV, 10 mm/mV and 20 mm/mV. The overall gain (sensitivity) can be checked by calibration function. Speed: use the button to switch the speed between 12.5 mm/s, 25 mm/s and 50 mm/s.

  • Page 27: Case Information Input Interface

    In current interface, press to enter quick setup interface, shown as below: Click "OK" to apply new setup and return to sampling interface; while click"Cancel" not to apply and directly return to sampling interface. The optional content of each setting item and its description are shown in the following table: Item Options...

  • Page 28: Case Management

    After selecting a edit box, pressing button could pop up a soft keyboard shown as below. 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.

  • Page 29: Query

    The above interface shows all medical records stored in the device. User can search necessary cases by the query function in the interface (refer to 7.5), modify or delete case information by edit function, and review stored case information (refer to 7.6). Click to jump to the first page of case list.

  • Page 30: Review

    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. 7.6 Review In the case management interface, select a case to be reviewed, click “Review” to enter the following dialog box, which displays the case information.

  • Page 31: Date And Time Setup

    In this interface, user can use button to change the print mode. In this interface, user can use button to print. In current interface, press to enter quick setup interface, shown as below: Click "OK" to apply new setup and return to review interface; while click"Cancel" not to apply and directly return to review interface.

  • Page 32: System Setup

    In current interface, user can switch the items via buttons, and adjust the content of the item by buttons. 7.8 System setup In the main interface, click to enter the system setup interface, as shown below: After clicking “Default”, the system will restore all settings to default. The optional content of each setting item and its description are shown in the following table: Item Options...

  • Page 33: Sampling Setup

    [None]/[Only It determines the alarm method that the device Low Power once]/[Always] uses in low power. [50Hz/35Hz]/[50Hz/25 Hz]/ Filter Freq To set the parameters of AC filter and EMG filter. [60Hz/25Hz]/[60Hz/35 Language [English]/[Chinese], etc. To set the default language of system. If it is selected, the button makes sound while K-B Sound on/off...

  • Page 34: Analysis Parameters Setup

    7.10 Analysis parameters setup In the main interface, click to enter the analysis parameters setup interface, as shown below: The setup here will affect real-time analysis during sampling, case review and diagnosis prompt of print report. After clicking “Default”, the system will restore all settings to default. The optional content of each setting item and its description are shown in the following table: Item Description...
  • Page 35 In print setup interface, click “Adv-opr” to enter advanced setup interface: Type Item Options Description General Print [Auto 4×3]/[Auto The system takes the selected option setup Mode 3×4+1]/[Auto 3×4]/[Auto as default print mode. 2×6+1]/[Auto 2×6]/[Auto 3-2+1]/[Auto 3-2][Rhythm 4]/[Rhythm 3][/Rhythm 2]/[Manual] Lead [Smart]/[Current] The option selected will be used as...

  • Page 36: Lead Placement

    2Min]/[per3Min]/[per5Min]/ the system will automatically [per10Min]/[per20Min]/[per activate the printing operation 30Min]/[per 60 Min]/[Off] according to the selected time interval. When the printing mode is manual mode, the printing will output “Auto 3×4+1” format, otherwise, it will output according to the current setting mode. Advanc Print-Sa [Print and Save]/[Print no...

  • Page 37: Chapter 8 Troubleshooting

    Chapter 8 Troubleshooting 8.1 Auto shutdown The battery is almost running out, which causes overdischarge protection circuit action.  The voltage of AC power supply is too high, which causes overvoltage protection circuit  action. 8.2 AC interference Whether the device is grounded reliably? ...

  • Page 38: Baseline Drift

    8.4 Baseline drift Whether the electrode installation is stable?  Whether the connection of lead cables or electrodes is reliable?  Whether the electrodes and patient skin are cleaned and are daubed with enough  conductive paste? Whether it is caused by patient's movement or breathing? ...

  • Page 39: Chapter 9 Maintenance

    Chapter 9 Maintenance 9.1 Battery 9.1.1 The device is designed with built-in full-sealed and maintenance-free rechargeable lithium battery, also equipped with perfect auto-charging-discharging monitor system. When the device is connected to AC power supply, the battery will be charged automatically. Battery status will be displayed on right edge of LCD screen in powering on state, as shown in Table 9-1.

  • Page 40: Recording Paper

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

  • Page 41: Lead Cables And Electrodes

    before cleaning. Use neutral detergents for cleaning. Do not use any detergent or disinfectant containing alcohol. 9.4 Lead cables and electrodes 9.4.1 The connectivity of the lead cable can be detected by the multimeter. Check whether each wire of the lead cable is in good contact according to the following table. The resistance of each wire from the electrode plug to the corresponding pin in the lead cable plug should be less than 10Ω.
  • Page 42 9.8.2 The device associated circuit schematics and critical parts list are only available to authorized service station or maintenance personnel, who is responsible for maintenance of the device. 9.8.3 The device belongs to measuring instrument. User should send the device to national designated inspection institution for inspection according to the requirements of the national metrological verification procedure.

  • Page 43: Chapter 10 Packing List And Accessories

    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)

  • Page 44: Appendix I Ecg Automated Measurement&Interpretation Guide

    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.
  • Page 45 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...

  • Page 46: Algorithm Description

    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...
  • Page 47 The workflow is shown as below: Start ECG waveform sampling Recognize all R points by slope method Waveform superposition taking R point as center Determine the positions of each wave Calculate the amplitudes of each wave Get measurement parameter, interpretation item 3.1 Find the cardiac impulse location 1) Data preprocessing, obtain the absolute value trend of slope for each lead;...
  • Page 48 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.
  • Page 49 5) Change the searching range of 30ms-100ms to 100ms-350ms in step 1, repeat step 1-4. 6) If the found P-wave is still narrow, it means that P-wave doesn’t exist. 4. Find T-wave 1) Peak of T-wave: search the max value within 30ms-300ms after the end of QRS-complex, save it as the peak of T-wave.
  • Page 50 points forms a sub-wave. Determine whether each sub-wave is a recognizable minimum wave (see the definition below). If it is a recognizable minimum wave, first identify its direction. If it is above the QRS baseline, it is R wave, if it is below the baseline, it is Q wave or S wave. Find the extreme value of this wave, and the difference between the extreme value and the baseline is the amplitude of Q/R/S wave.
  • Page 51 T-duration - Ts ⑦ ⑥ - Qs ⑦   Electric axis formula: arctan(2.0     ⑧ P electric axis: : voltage sum from the beginning point to the end point of P-wave on lead III : voltage sum from the beginning point to the end P/QRS/T electric point of P-wave on lead I axis...
  • Page 52 3.5 Interpretations judgment based on parameters Item Rule of interpretation No any abnormal are detected No abnormal 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-wave≥110ms, or P-wave displays Left atrium Hypertrophy...
  • Page 53 lead V5 >2.5mV, R amplitude of lead aVL >1.2mV, hypertrophy R amplitude of lead aVF >2mV, R amplitude of lead V5 minus S amplitude of lead V1 >4mV (male) or 3.5mV (female). R amplitude of lead aVR >0.5mV, R amplitude of lead V1 >1mV, R amplitude of lead V1 minus S Right ventricular amplitude of lead V5 >1.2mV, R amplitude of lead...
  • Page 54 Acute myocardial infarction change of leads I, aVL, Possible acute anterolateral V4, V5, V6. Old myocardial infarction change of leads I, aVL, Old anterolateral MI V4, V5, V6 Early myocardial infarction change of leads I, aVL, Early high lateral MI no change of leads II, III, aVF, V4, V5, V6.
  • Page 55 ST depression, mild high Mild ST-segment depression of leads I, aVL, and no lateral myocardial change of leads II, III, aVF, V4, V5, V6. ischemia ST depression, mild Mild ST-segment depression of leads II, III, aVF, and inferior myocardial no change of leads I, aVL. ischemia ST depression, mild Mild ST-segment depression of leads I, II, III, aVL,...

  • Page 56: Data Sources And Data Preprocessing

    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.
  • Page 57 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.
  • Page 58 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.
  • Page 59 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.

  • Page 60: Process And Result Of Verification

    system. Then cases will be imported to the device. After that, the case of MA_0001~MA0125 shall be used for the following verification of automated measurement parameters, and the case of D_0001~D_1220 shall be used for the following verification of automated interpretation. 4.6.3 Customized data preprocessing The customized initial case files shall be processed for voltage conversion and frequency conversion for resampling as the applicable format in the system.
  • Page 61 5.1.2 Verification and Process for CSE measurement database Import the converted case files into the device, add appropriate database records, then waveform for all case files can be reviewed in the device, therefore the automated measurement parameters can be obtained. Eliminate the cases existing obvious error for the diagnostic parameters (P-wave location is wrong) from the CSE database.
  • Page 62 Flow diagram of CSE measurement database verification process Start Read expert diagnostic marks Eliminate obvious unfit cases Read initial case of DCD file Frequency conversion Voltage conversion Get ECG data file parameters Automated measurement Compare automated measurement parameter and expert diagnostic mark Conclude mean value of comparison Eliminate the four largest deviations from the mean Recalculate the mean value and variation of comparison result...
  • Page 63 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...
  • Page 64 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.
  • Page 65 5.2.1.2 Customized database Start Initial case data ecg format as system required Import to device Expert diagnosis Draw ECG waveform Identify QRS-complex QRS-complex superposition Auto measurement Conclude automated interpretation items Start comparing Summarize the global statistical results of comparison for each case...
  • Page 66 5.2.2 Verification results Positive ECGs Sensitivit Specific Item predictive number ity % value % No abnormal 92.01 79.16 97.38 Sinus mode Bradycardia 96.68 99.73 98.64 Sinus mode Tachycardia 97.44 96.49 96.90 Left atrium Hypertrophy 51.09 99.89 81.82 Right atrium Hypertrophy 42.64 99.66 50.00...
  • Page 67 Acute apical MI 78.12 78.66 53.85 Old apical MI 79.63 89.94 80.00 Early anterolateral MI 77.51 79.94 83.33 Possible acute anterolateral MI 28.57 99.77 33.33 Old anterolateral MI 70.00 93.60 50.00 Early high lateral MI 79.65 95.78 80.42 Possible acute high lateral MI 81.60 99.94 85.71...
  • Page 68 ST depression, high lateral 90.06 99.31 57.14 myocardial ischemia ST depression, inferior myocardial 89.88 99.13 40.08 ischemia ST depression, inferolateral 91.39 99.16 50.47 myocardial ischemia Sensitivity: probability that a "True sample" would be determined as certain "Item" by automated interpretation function; Specificity: probability that a "True unfit sample"...

  • Page 69: Appendix Ii Emc Guidance And Manufacturer Declaration

    Appendix II EMC Guidance and Manufacturer Declaration Table 1: Guidance and manufacturer’s declaration –electromagnetic emission The Infrared Thermometer is intended for use in the electromagnetic environment specified below. The purchaser or the user of the device should assure that it is used in such environment.
  • Page 70 Table 3: Guidance and manufacturer’s declaration – electromagnetic immunity The Infrared Thermometer is intended for use in the electromagnetic environment specified below. The customer the user of the Infrared Thermometer should assure that it is used in such environment. Immunity test IEC 60601 test level Compliance level 0,15 MHz –...
  • Page 71 communicatio Pulse LTE Band ns equipment) 704– 787 modulation b) 13,17 217 Hz 800/900, Pulse – TETRA 800, modulation b) iDEN 820, 18 Hz CDMA 850, LTE Band 5 GSM 1800; 1720 CDMA 1845 1900; Pulse 1 700 – GSM 1900; modulation b) 1 990 DECT;...
  • Page 72 Warning Don’t near active HF SURGICAL EQUIPMENT and the RF shielded room of an  ME SYSTEM for magnetic resonance imaging, where the intensity of EM DISTURBANCES is high. Use of this equipment adjacent to or stacked with other equipment should be avoided ...

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