Gima 1200G ECG User Manual
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Gima 1200G ECG User Manual

12 channel with monitor
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PROFESSIONAL MEDICAL PRODUCTS
1200G 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
55°C
1060 hPa
-20°C
500 hPa
0123
95%
0%

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  • Page 1 PROFESSIONAL MEDICAL PRODUCTS 1200G ECG 12 CHANNEL WITH MONITOR 0123 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) 55°C...
  • Page 2 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 3 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 service after warranty period.
  • Page 4 Statement Our company owns all rights to this unpublished work and intends to maintain it as confidential information.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 5: 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 ....................14 5.1 Precautions before use....................14...
  • Page 6 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 ....................35 Chapter 9 Maintenance.......................37 9.1 Battery ........................37 9.2 Recording paper ......................38 9.3 Maintenance after use....................38 9.4 Lead cables and electrodes..................39 9.5 Silicone rubber roller ....................39 9.6 Cleaning of thermal print head .................39 9.7 Fuse replacement .......................39...

  • Page 7: 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 and diagnosis;...

  • Page 8: Main Characteristics

    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%;...

  • Page 9: Software Overview

    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.

  • Page 10: 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 11 2.14 If other equipment is connected with this ECG device, it must be a Class I device that complies with IEC60601-1. Because the total leakage current may hurt patient, the monitoring of leakage current is carried out and taken charge by the connected equipment. 2.15 Notes related to EMC The device complies with the safety standards for medical electrical equipment or system electromagnetic compatibility in IEC60601-1-2.
  • Page 12 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.

  • Page 13: 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 14: 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 （1）Principle of power supply The switching power supply provides +24V working voltage for the thermal print head, provides constant voltage current limiting charging for the rechargeable lithium battery in the device through the DC-DC circuit, and generates +5V and +12V voltage through the power conversion to supply power to the corresponding modules.

  • Page 15: Name Of Each Part And Its Function

    coupler. 4.1.3 Control unit （1）Principle of control unit The control system consists of printing system, button system, liquid crystal display system, and signal acquisition system. The ECG signal sent from the signal acquisition system through the high-speed optoelectronic coupler is received by the CPU system, after digital filtering, gain adjustment and motor drive, it is sent to the printing system to print the ECG waveform.
  • Page 16 1. Paper compartment cover Keep the paper compartment closed, hold the printing paper 2. Display screen Display patient’s ECG and related information 3. Button area Control the operations of the device, and enter information. Note Ø Do not put heavy objects on the screen or hit against it, otherwise the screen will be damaged.
  • Page 17 Figure 4-5 Bottom view 10. Battery compartment Built-in rechargeable lithium battery. 11. Fuse Built-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.
  • Page 18 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.
  • Page 19 Manufacturer Date of manufacture Batch code Latex free Atmospheric pressure limitation Temperature limitation Humidity limitation For indoor use only Polarity 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.

  • Page 20: 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 21: 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 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.

  • Page 22: Power Supply Connection

    Figure 6-2 Lack of paper prompt 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.

  • Page 23: Electrode Installation

    6.4 Electrode installation Proper installation of the electrodes is an important part of accurately recording the electrocardiogram. Make sure the electrodes are in good contact. Old and new electrodes or reusable electrodes and disposable electrodes cannot be used at the same time. If different types of electrodes are used together, it will seriously affect the ECG recording.
  • Page 24 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 European standard American standard Electrode position Mark Color Mark Color Right arm White Left arm Yellow Black Left leg Green Right leg N/RF...
  • Page 25 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 indication The device can check the connection status of the lead at any time. If lead-off or overload is detected, the screen will display corresponding lead code on the top left corner, as shown in Figure 7-2.

  • Page 26: Chapter 7 Operation Instructions And Parameter Setting

    Chapter 7 Operation Instructions and Parameter Setting 7.1 Main Interface Figure 7-1 Status bar 1. Time 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.

  • Page 27: Sampling Interface

    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...
  • Page 28 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 bar Display 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.
  • Page 29 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.

  • Page 30: Case Information Input Interface

    and back to the main interface. 7.3 Case information input interface The 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.

  • Page 31: Case Management

    Figure 7-5 In addition, you can use the number buttons on the control panel for editing, and press button 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.
  • Page 32 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.
  • Page 33 7.4.2 Review In the case management interface, select a case to be reviewed, click “Review” to enter the following dialog box, which displays the case information. User is allowed to modify patient information, after clicking “Save”, the information will be changed. Please note that the modification is irreversible.

  • Page 34: Date And Time Setup

    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.
  • Page 35 content of each setting item and its description are shown in the following table: Item Options Description If there is no operation after reaching the [30Seconds]/[1Minute]/ set time, screen backlight will turn off. If it Back-light [2Minutes]/[5Minutes]/ is set to “Always On”, the backlight will [10Minutes]/[Always On] always keep on.

  • Page 36: Sampling Setup

    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 Options Description AC Filter ON/OFF Turn on or off the AC filter. EMG Filter ON/OFF Turn on or off the EMG filter.
  • Page 37 1×12]/[Rhythm 12]/[Rhythm 10]/[Rhythm 8]/ [Rhythm 6] Lead Gain [Smart]/[Current] 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. Auto Strip [2.5 sec]/[3 sec]/[4 sec]/[5 The system takes the selected option as the...

  • Page 38: Lead Placement

    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 [Begin Print]/[After Set to print the data before clicking the PRINT Data Type...

  • Page 39: About

    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.

  • Page 40: Chapter 8 Troubleshooting

    Chapter 8 Troubleshooting 8.1 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 circuit action. 8.2 AC interference Ø Whether the device is grounded reliably? Ø...

  • Page 41: Baseline Drift

    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 enough conductive paste? Ø Whether it is caused by patient's movement or breathing? Ø...
  • Page 42 device's plug. 5. Bad connection between electrodes and lead cables. 1. Low power. 1. Charge the battery. Baseline draft 2. Patient movement. 2. Keep patient still. 1. Charge the battery. 1. Low battery. 2. Cut off the power, clean 2. The printer head surface the printer head with Unclear waveform is dirty.

  • Page 43: 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, turn the mains power switch to ON state, the battery will be charged automatically.

  • Page 44: Recording Paper

    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 temperature exceeds 60°C.

  • Page 45: Lead Cables And Electrodes

    9.3.5 When cleaning the device, do not immerse it in the cleaner. Power supply must be cut off before cleaning. Use neutral detergents for cleaning. Do not use any detergent or disinfectant containing alcohol. 9.4 Lead cables and electrodes 9.4.1 The connectivity of the lead cable can be detected by the multimeter. Check whether each wire of the lead cable is in good contact according to the following table.

  • Page 46: Disposal Of Product Scrap

    Figure 9-1 Replacing the fuse Note ： If the fuse blows again after replacing a fuse of the same specification, the device may Ø exists other problems, please cut off the power supply and contact the after-sales service of our company or designated service center. Ø...

  • Page 47: 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 48: 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 49 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...

  • Page 50: 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 51 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 52 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 53 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.
  • Page 54 (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 55 ⑦ ⑥ T-duration - Ts ⑦ - Qs ‚  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 56: Interpretations Judgment Based On Parameters

    ④ Pe: end of the P-wave ⑤ Se: end of the S-wave ⑥ Ts: beginning of the T-wave ⑦ Te: end of the T-wave ⑧ PI: 3.1415926 3.5 Interpretations judgment based on parameters Item Rule of interpretation No any abnormal are detected No abnormal Sinus P-wave, PR-interval between Sinus mode Bradycardia...
  • Page 57 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...
  • Page 58 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 myocardial infarction change of leads Old apical MI V4, V5, no change of leads V1, V2, V3.
  • Page 59 V5, and no change of leads V1, V2, V6. myocardial ischemia Mild ST-segment depression of leads V1, V2, ST depression, mild extensive V3, V4, V5. anterior myocardial ischemia Mild ST-segment depression of leads V4, V5, ST depression, mild apical and no change of leads V1, V2, V3. myocardial ischemia Mild ST-segment depression of leads I, aVL, ST depression, mild anterolateral...

  • Page 60: Data Sources And Data Preprocessing

    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.
  • Page 61 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.

  • Page 62: Data Coverage Of Verification For Automated Interpretation

    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.
  • Page 63 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 64: Process And Result Of Verification

    of D_0001~D_1220 shall be used for the following verification of automated interpretation. 4.6.3 Customized data preprocessing The customized initial case files shall be processed for voltage conversion and frequency conversion for resampling as the applicable format in the system. Then cases will be imported to the device.
  • Page 65 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 67 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 68 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...
  • Page 69 5.2.1.2 Customized database...
  • Page 70 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 71 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 72 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 73: Appendix Ii Emc Guidance And Manufacturer Declaration

    Appendix II EMC Guidance and Manufacturer Declaration Warning 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.
  • Page 74 IEC 61000-3-2 voltage power supply network that supplies buildings used for domestic purposes. Voltage fluctuations/ flicker emission Applicable IEC 61000-3-3 Electromagnetic immunity 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.
  • Page 75 Power frequency 3A/m 3A/m Power frequency magnetic (50/60 fields should be at levels magnetic field characteristic of a typical IEC 61000-4-8 location typical commercial 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.
  • Page 76 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.
  • Page 77 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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