Gima ECG90A User Manual
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Gima ECG90A User Manual

Gima ECG90A User Manual

Cardiopocket ecg-3 channels
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PROFESSIONAL MEDICAL PRODUC TS
CARDIOPOCKET ECG - 3 CHANNELS
User manual
ATTENTION: The operators must carefully read
and completely understand the present manual
before using the product.
ECG90A (GIMA 33232)
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
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
1060hPa
%
0%
500hPa
0123
95%
+55˚C
-20˚C

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  • Page 1 CARDIOPOCKET ECG - 3 CHANNELS User manual ATTENTION: The operators must carefully read and completely understand the present manual before using the product. ECG90A (GIMA 33232) CONTEC MEDICAL SYSTEMS CO., LTD No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei Province, 0123 PEOPLE’S REPUBLIC OF CHINA...
  • 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 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  • Page 4 Statement Our company owns all rights to this unpublished work and intends to maintain it as confidential information.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 .................
  • Page 6 7.11 SD Card ........................31 Chapter 8 Troubleshooting ......................33 8.1 Auto shutdown ......................33 8.2 AC interference ......................33 8.3 EMG interference ......................33 8.4 Baseline drift ......................... 34 8.5 Troubleshooting list....................... 34 Chapter 9 Maintenance ....................... 36 9.1 Battery .......................... 36 9.2 Recording paper ......................

  • 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: 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: 50 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

    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: ECG90A embedded software Software specification: none Software version: Vx.x.x Version naming rules: V<major version number>.<minor version number>.<revision version...

  • 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 2.15 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 YY 0505 standard may cause harmful interference to the device or prevent the device from performing its intended function or degrade its performance.
  • Page 12 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 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 Principle of power supply After the AC power supply enters the switching power supply, it is converted to 12V DC voltage and supplied to the main 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 15: Name Of Each Part And Its Function

    4.2 Name of each part and its function 4.2.1 Front view Figure 4-2 Front view Note Do not put heavy objects on the screen or hit against it, otherwise the screen will be  damaged. If the device is not in use, cover it to prevent liquid spills on the screen. ...
  • Page 16 Figure 4-3 Side view Equipotential terminal: Connect with the potential equalization conductor. Lead cable interface: Connect with lead cables. USB interface: Communicate 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.
  • Page 17 4.2.3 Buttons Figure 4-5 Schematic diagram of buttons 1. Functional button: Menu/Confirm It is the menu button under sampling interface, and confirm button under the menu interface. 2. Functional button: ON/OFF/Change displayed leads/Confirm Long press it to turn on/off the device. In menu interface, short press it to confirm the setting. In sampling interface, short press it to change the number of displayed leads.
  • Page 18 Lead cable socket PATIENT Standby, charging state Caution: read instructions (warnings) carefully. Serial number Manufacturer Date of manufacture Lot number Atmospheric pressure limit Temperature limit Humidity limit For indoor use only Polarity of d.c. power connector Direct current WEEE disposal This way up Fragile, handle with care...
  • Page 19 Keep in a cool, dry place Stacking limit by number Follow instructions for use SD card port General warning lable Medical Device compliant with Directive 93/42/EEC The device poses unacceptable risks to the patient, medical staff or other persons within the MR environment The device is prescription device, the federal law restricts this device Rx Only to sale by or on the order of a physician...

  • 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 50 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, press the paper compartment cover, it is automatically bounced, take out the paper axis, insert it into the recording paper as shown in the figure.

  • Page 22: Power Supply Connection

    6.2 Power supply connection 6.2.1 AC Connect the provided three-core power cord with power adapter, insert one end of power adapter 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 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: 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...
  • Page 24 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 Black Green Chest 1 Chest 2...
  • Page 25 detected, the screen will display corresponding lead code on the top left corner, as shown in Figure 7-2. Note In the lead-off prompt area, red font represents lead-off, yellow font represent  overload. When the connection between lead cable and patient/the device is not reliable, and ...

  • Page 26: Chapter 7 Operation Instructions And Parameter Setting

    Chapter 7 Operation Instructions and Parameter Setting 7.1 Main Menu unselected Selected Fig. 7-1 【Operating instructions】 1. Enter corresponding setting interface by touch screen. 2.Use "Up""Down""Left""Right" to move the focus to the wanted submenu and press confirm key or touch to enter corresponding interface.
  • Page 27 【Operating instructions】 Enter "Filter Setting" interface as Fig.7-3. Selected state Fig. 7-3 (1) You can select AC, EMG or DFT. In two frequency selections of AC or EMG, you can only select one. (2) Click or [Confirm] key on the panel to save the current settings. (3) Click or [Confirm] key on the panel to exit without save.
  • Page 28 Click this icon or press "UP" and "DOWN" key on the panel to switch gain. Click this icon or press "UP" and "DOWN" key on the panel to switch print mode. Click this icon or press "PRINT" key on the panel to print. Attention: Please ensure that there is paper in the paper carriage, otherwise the prompt of paper-lack will appear, as Fig.7-6:...

  • Page 29: System Settings

    9. Lead switch: glide up and down in the wave area on the screen to switch leads. 7.3 System Settings The interface is showed as Fig.7-9, Fig.7-10 【Function introduction】 System settings includes backlight, power alarm, key voice, language, case store, information input, USB-mode, calibrate, etc..
  • Page 30 1. Click or press [UP] [DOWN] to turn page up and down. 2. Click to save the current settings and exit this interface into the main menu, click to exit without save. 3. BackLight: select "OFF" and confirm it, the back light will close and device will enter the power-save mode.

  • Page 31: Sample Setting

    9. Screen Calibrate Click "Carlibrate" to call up the dialog box as Fig.7-13 Fig. 7-13 Click "Yes" to enter the calibration interface as Fig.7-14. Fig. 7-14 Please operate according to the prompt. If calibration is successful, the prompt "Calibrate OK!" will appear.

  • Page 32: Print Setting

    The operation is same as system setting. Filter setting can be performed by clicking on the screen. 7.5 Print Setting The interface is shown as Fig.7-16 and7-17. Fig. 7-16 Fig. 7-17 【Function introduction】 Print setting, prepared for print, includes print mode, auto strip, gain set, speed set, report print set (QRS-temp, case information, parameters, conclusion) 【Operating instructions】...

  • Page 33: Analyse Setting

    Store: in this mode case can be saved but can't be printed. The interface is shown s Fig.7-18 Fig. 7-18 Click "Start", system starts to save case. In the process of that, the interface is shown as Fig.7-19. Fig.7-19 2. Other settings are same as system setting. Auto strip: The automatic print length of each strip can be set to 3s, 6s, 10s, 12s, 15s and 20s.

  • Page 34: Time Setting

    【Function introduction】 Here you can set the items about analyse. 【Operating instructions】 (1) Rhythm lead: click button to call up the interface as Fig.7-21 Fig. 7-21 Please select the lead you wanted by clicking on the keyboard or pressing keys on the panel. (2) Pause Time : click corresponding button to call up the interface as Fig.7-22.

  • Page 35: Archive Management

    【Function introduction】 Data and time settings. 【Operating instructions】 Select the wanted item, and click to set. 7.8 Archive Management As Fig.7-24 and 7-25 Fig. 7-24 Fig. 7-25 【Function introduction】 Here you can look over all of the stored case, and can replay or delete them. 【Operating instructions】...

  • Page 36: About

    Fig.7-26. Fig. 7-26 : Return "Archive" interface from "Replay" interface. : Click this button to replay waves statically, as Fig.7-27. Fig. 7-27 You can glide screen left and right to check the waves of different times, and glide screen up and down to check the waves of different leads.

  • Page 37: Usb Port

    7.10 USB Port 【Function introduction】 USB works in store (MASS) or synchronization (HID) mode. In MASS mode, SD card can be read by PC. In HID mode, you can sample real-time case by synchro analyse software. 7.11 SD Card 【Function introduction】 SD card is used to store case and upgrade process.
  • Page 38 (4) if there is no enough memory in SD card to store this case, the prompt as Fig.7-32 will appear. Fig. 7-32 Click "Yes", and system will exit print, then clean up SD card and print again. If you need SD card, please show us before purchase, and use the SD card specified by our company.

  • Page 39: 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 40: 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 41 1. Low power. 1. Charge the battery. Baseline draft 2. Patient movement. 2. Keep patient still. 1. Low battery. 1. Charge the battery. 2. The printer head surface is dirty. 2. Cut off the power, clean the 3. The thermal paper problem. printer head with alcohol, air Unclear waveform dry.

  • Page 42: 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 43: Recording Paper

    exceeds 60°C. Do not heat the battery or throw it into fire, water and avoid splashed by water. Do not puncture, hammer or strike the battery or destroy it by other ways, otherwise  it will cause battery overheat, smoke, deform or burn dangers. Keep away from the battery when it appears leakage or emitting unpleasant smell.

  • Page 44: Silicone Rubber Roller

    10Ω. The integrity of the lead cable must be checked regularly. Any lead wire damage will cause a false waveform of the corresponding lead or all leads on the ECG. The lead cable can be cleaned with neutral solvent. Do not use the detergent or germicide containing alcohol (Please do not immerse the lead cables in liquid for cleaning).

  • Page 45: 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 46: 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 47 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 48 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...
  • Page 49 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 50 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 51 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 52 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.
  • Page 53  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 QRS electric axis:...
  • Page 54 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, Left atrium Hypertrophy...
  • Page 55 lead I and lead aVL are rS type, lead II, III and aVF are qR type, and Q-wave of lead II and III <20ms. R amplitude of lead I >1.5mV, R amplitude of lead V5 >2.5mV, R amplitude of lead aVL >1.2mV, R amplitude of lead Left ventricular hypertrophy aVF >2mV, R amplitude of lead V5 minus S...
  • Page 56 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 57 V3, and no change of leads V4, V5. myocardial ischemia Mild ST-segment depression of leads V3, V4, ST depression, mild anterior 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.
  • Page 58 Note: Early myocardial infarction: normal Q-wave, ST elevation or ST slope elevation Acute myocardial infarction: abnormal Q-wave, ST elevation or ST slope elevation Old myocardial infarction: abnormal Q-wave, no ST elevation. Abnormal Q-wave: For leads I, II, III, avR, avL, avF, V3, V4, V5, V6, voltage of Q-wave <-0.3mV, or 4 times of negative wave of Q-wave>...
  • Page 59 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.
  • Page 60 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.
  • Page 61 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 62 4.6.3 Customized data preprocessing The customized initial case files shall be processed for voltage conversion and frequency conversion for resampling as the applicable format in the system. Then cases will be imported to the device. After that, the verification of automated interpretation will be carried on. 5.
  • Page 63 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 64 Start Read expert diagnostic marks Eliminate obvious unfit cases Read initial case of DCD file Frequency conversion Voltage conversion Get ECG data file Automated measurement parameters 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 Summarize the comparison results...
  • Page 65 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 66 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...
  • Page 67 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 parameter Conclude automated interpretation items Start comparing Summarize the global statistical results of comparison for each case...
  • Page 68 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 69 Old extensive anterior MI 90.91 88.05 37.04 Early apical MI 88.32 87.21 88.54 Acute apical MI 78.12 78.66 53.85 Old apical MI 79.63 89.94 80.00 Early anterolateral MI 77.51 79.94 83.33 Possible acute anterolateral MI 28.57 99.77 33.33 Old anterolateral MI 70.00 93.60 50.00...
  • Page 70 ischemia ST depression, anterolateral 87.42 98.97 59.09 myocardial ischemia 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;...

  • Page 71: Appendix Ii Emc Guidance And Manufacturer Declaration

    Appendix II EMC Guidance and Manufacturer Declaration Warning The use of ACCESSORIES other than those specified by the MANUFACTURER of  the device or system, may result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM. ①...
  • Page 72 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. IEC60601 test Compliance Electromagnetic Immunity test level level environment-guidance Electrostatic ±6kV contact ±6kV contact Floors should be wood,...
  • Page 73 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 IEC60601 Compliance Electromagnetic environment -guidance test test level level 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...
  • Page 74 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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