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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

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.............................................................................................16

Chapter 7 Operation Instructions and Parameter Setting.......................................................19

7.1 Main Interface....................................................................................................... 19

7.2 Sampling interface.................................................................................................20

7.3 Case information input interface........................................................................... 22

7.4 Case management..................................................................................................23

7.5 Query.....................................................................................................................24
7.6 Review...................................................................................................................25

7.7 Date and time setup...............................................................................................26

7.8 System setup..........................................................................................................27

7.9 Sampling setup...................................................................................................... 28

Содержание ECG300GT

Страница 1: ...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 main...

Страница 2: ... The company installs and debugs the equipment and trains the physicians by contract The company performs device repair in warranty period a year and maintenance service after warranty period The company responds timely to the user s request The user manual is written by Contec Medical Systems Co Ltd All rights reserved ...

Страница 3: ...mpany 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 ...

Страница 4: ... 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 16 Chapter 7 Operation Instructions and Parameter Setting 19 7 1 Main Interface 19 7 2 Sampling interface 20...

Страница 5: ... cables and electrodes 36 9 5 Silicone rubber roller 36 9 6 Cleaning of thermal print head 36 9 7 Disposal of product scrap 36 9 8 Others 36 Chapter 10 Packing List and Accessories 38 10 1 Accompanying accessories 38 10 2 Notes 38 Appendix I ECG Automated Measurement Interpretation Guide 39 1 Preface 39 2 Automated measurement parameters and Automated interpretation items 39 3 Algorithm descriptio...

Страница 6: ...nd 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 V...

Страница 7: ... 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 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 T...

Страница 8: ... A comprehensive evaluation should be made by professional electrocardiogram technicians and physicians according to clinical experience and other test results 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 S...

Страница 9: ... 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 defibril...

Страница 10: ...tic waves High frequency noise from other equipment can enter the device through the AC socket Please identify the source of noise if possible stop using the equipment If the equipment can not be deactivated use noise cancellation equipment or take other measures to reduce the impact Effect from static electricity Static electricity in a dry environment indoor may affect the operation of the devic...

Страница 11: ...veform 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 ...

Страница 12: ...o 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 an...

Страница 13: ...ass 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 ...

Страница 14: ...isplay screen Display patient s ECG and related information 3 Button area Control the operations of the device and enter information 4 Cover switch To open or close the paper compartment cover Note Do not put heavy objects on the screen or hit against it otherwise the screen will be damaged If the device is not in use cover it to prevent liquid spills on the screen Do not use sharp stuff to operat...

Страница 15: ...linical research organization teaching and training as well as program upgrade case import and export and connection with external printer Note 1 Lead cables must be disconnected from patient before connecting with a computer via the USB interface 2 Operator must not touch the USB interface and patient at the same time 4 2 3 Rear view Figure 4 4 Rear view 7 Equipotential terminal Connect with the ...

Страница 16: ...printing 7 Direction button Up button 8 Direction button Right button 9 SET System menu and confirm 10 Direction button Down button 11 Direction button Left button 12 FILTER Set the filter mode 13 SPEED Change the ECG recording speed 14 SEN Adjust the sensitivity manually 15 ON OFF When the device is turned on short press this button it will prompt whether to shut down the device long press this b...

Страница 17: ...itation 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 This item is compliant with Medical Device Directive 93 42EEC of June 14 1993 a directive of the European Economic Community Refer to instruction manual booklet Catalogue number ...

Страница 18: ...d 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 ...

Страница 19: ...uding 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 P...

Страница 20: ...de with grids should be faced downwards and then install it to proper position in the paper cabinet Figure 6 1 Installation of recording paper 2 Close the paper cabinet cover it would be better to leave 2cm paper outside the exit of paper cabinet Note The recording paper should be aligned with the slot of the paper cabinet cover It is recommended to leave 2cm paper outside 6 1 3 If the recording p...

Страница 21: ...the grounding Do not use other pipes as ground wire otherwise the patient may be in danger of electric shock 6 3 Lead cable connection Connect the lead cable to the lead cable interface on the device and fasten it to the device with the fixing knobs at both sides of the lead cable in order to prevent bad connection and affecting the detection Note The lead cable interface can not be used for other...

Страница 22: ...d not touch each other to avoid short circuit 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 Figure 6 4 Installation of limb electrodes ...

Страница 23: ...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 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 de...

Страница 24: ...ly 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 to perform system setting to perform sampling setting to set the parameters used in automatic analysis to set the print mode print style and print content etc ...

Страница 25: ...uses 12 lead as an example End sampling After the device starts sampling use the button to end the sampling and back to the main interface Switch lead When the device does not simultaneously display 12 leads use the and buttons to switch displayed waveform Switch lead display style use the and buttons to switch the display style between 3 lead 6 lead and 12 lead Lead off information In demo mode i...

Страница 26: ...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 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 ...

Страница 27: ...G filter DFT Filter ON OFF Turn on or off the Baseline filter Rhythm Lead Any lead among the 12 leads Set the rhythm lead that used for printing under rhythm mode Show Style 3 Leads 6Leads 12Leads Set the display method of ECG Show Gain 5mm mV 10mm mV 20mm m V Set the gain of displayed ECG Show Speed 12 5mm s 25mm s 50mm s Set the speed of displayed ECG 7 3 Case information input interface Due to ...

Страница 28: ...ess 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 The keyboard may have input restrictions according to the limitation of content The restricted keys will be grayed out and unavailable as shown below 7 4 Case management In the main interface click to enter the case management interface as shown ...

Страница 29: ...interface click Adv opr to enter the following interface Advanced options Click Query to enter the query interface shown below Input query conditions and click Query to obtain expected results After clicking Clear the system will clear all query conditions that entered Matching mode Query condition Clear input conditions Return to case management Query by current condition Cond And and Cond Or ind...

Страница 30: ...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 Make sure the input information is correct click Review to enter the review interface which is similar with the sampling interface In current interface user could adjust the time period of displayed waveform by and buttons each pre...

Страница 31: ... in the following table Item Options Description Print Mode Auto 4 3 Auto 3 4 Auto 2 6 and other print modes that applicable for current case The system takes the selected option as print mode Rhythm Lead Any lead among the 12 leads Set the rhythm lead that used for printing under rhythm mode Show Style 3 Leads 6Leads 12Leads Set the display method of ECG Show Gain 5mm mV 10mm mV 20mm mV Set the g...

Страница 32: ...econds 1 Minute 2 Minutes 5 Minutes 10 Minutes If there is no operation after reaching the set time screen saver will be active If it is set to None this function will not be used Back light 30Seconds 1 Minute 2 Minutes 5 Minutes 10 Minutes Always On 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 Auto ...

Страница 33: ...n the main interface click to enter the sampling 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 Description AC Filter ON OFF Turn on or off the AC filter EMG Filter ON OFF Turn on or off the EMG filter DFT Filter ON OFF Turn on or off th...

Страница 34: ...llowing table Item Description Rhythm Lead Set the rhythm lead that used for printing under rhythm mode Heartbeat Sound To turn on or off the heartbeat sound Premature The system will use the input value as a standard of judging premature beat Pause Time The system will use the input value as a standard of judging beat pause Tachycardia The system will use the input value as a standard of judging ...

Страница 35: ...t of printing Auto Strip 3 sec 4 sec 5 sec 6 sec 8 sec 10 sec 15 sec 20 sec 25 sec 30 sec The system takes the selected option as the print time length of each strip Rhythm Strip 10 sec 15 sec 20 sec 25 sec 30 sec When Print Mode is set to Rhythm 2 Rhythm 3 or Rhythm 4 the system takes the selected option as the print time length of each waveform Average QRS 2 6 2 6 Mark 3 4 3 4 Mark 4 3 4 3 Mark ...

Страница 36: ...The settings of auto strip rhythm strip average QRS auto diagnosis and periodic print 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 7 12 Lead placement In the main interface click to view the sch...

Страница 37: ...ther the patient is touching the wall or metal parts of the bed Whether the patient touches other people Whether there is high power electric equipment working nearby Such as X ray machine or ultrasonic device etc Note If the interference can not be removed after taking above measures please use a AC filter 8 3 EMG interference Whether the room is comfortable Whether the patient is nervous Whether...

Страница 38: ...pare for the measurement Baseline burr 1 AC interference is large 2 Patient nervous and EMG interference is large 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 Not regular waveform large up and down beeline figure 1 Bad electrode conductivity 2 Low battery 3 Bad connection between electrodes and pati...

Страница 39: ...e battery the displayed status of battery level switches between icon f to icon c 9 1 2 The device can 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 d...

Страница 40: ...ice 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 w...

Страница 41: ...ffect 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 pa...

Страница 42: ...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 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 ...

Страница 43: ...uctions 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 otherwis...

Страница 44: ... 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 ...

Страница 45: ...2 Possible acute forepart anteroseptal MI 23 Old anteroseptal MI 24 Early anterior MI 25 Possible acute anterior MI 26 Old anterior MI 27 Early extensive anterior MI 28 Possible acute extensive anterior MI 29 Old extensive anterior MI 30 Early apical MI 31 Acute apical MI 32 Old apical MI 33 Early anterolateral MI 34 Possible acute anterolateral MI 35 Old anterolateral MI 36 Early high lateral MI ...

Страница 46: ...surement Interpretation function is shown as below Application and diagnosis To detect the abnormal of heart of human body examination items refer to above description Population Teenagers and adults age range 12 87 Application site hospitals Accuracy The accuracy of this function is reflected by the balance performance of sensitivity and specificity Others This function does not generate any alar...

Страница 47: ...g 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 100m...

Страница 48: ...essed 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...

Страница 49: ...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 th...

Страница 50: ...e 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...

Страница 51: ...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 9 R V5 Height voltage value of R wave on lead V5 10 S V1 Height voltage value of S wave on lead V1 Note RR ...

Страница 52: ...0 degree 9 Left axis deviation QRS axis between 90 to 30 degree 10 Right axis deviation QRS axis between 120 to 180 degree 11 Completeness Right Bundle branch block QRS duration 120ms R wave of lead V1 or aVR is wide width of R wave 80ms 12 Completeness Left Bundle branch block QRS duration 120ms R wave of lead V5 or V6 is wide 13 No Completeness Right Bundle branch block QRS duration 120ms R wave...

Страница 53: ...f leads V4 V5 24 Early anterior MI Early myocardial infarction change of leads V3 V4 V5 no change of leads V1 V2 V6 25 Possible acute anterior MI Acute myocardial infarction change of leads V3 V4 V5 no change of leads V1 V2 V6 26 Old anterior MI Old myocardial infarction change of leads V3 V4 V5 no change of leads V1 V2 V6 27 Early extensive anterior MI Early myocardial infarction change of leads ...

Страница 54: ...rior MI Old myocardial infarction change of leads II III aVF no change of leads I aVL 42 Early inferolateral MI Early myocardial infarction change of leads I II III aVL aVF 43 Possible acute inferolateral MI Acute myocardial infarction change of leads I II III aVL aVF 44 Old inferolateral MI Old myocardial infarction change of leads I II III aVL aVF 45 ST depression mild anteroseptal myocardial is...

Страница 55: ...ST segment depression of leads V4 V5 and no change of leads V1 V2 V3 57 ST depression anterolateral myocardial ischemia Severe ST segment depression of leads I aVL V4 V5 V6 58 ST depression high lateral myocardial ischemia Severe ST segment depression of leads I aVL and no change of leads II III aVF V4 V5 V6 59 ST depression inferior myocardial ischemia Severe ST segment depression of leads II III...

Страница 56: ...d data 000001 000549 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 ...

Страница 57: ...phy 53 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 data Description Total recording number 549 Race Yellow race Coverage of age gender Aged from 17 to 87 average age 57 23 standard deviation 21 32 326 male average age 55 54 standard deviation 19 81 223 female ...

Страница 58: ...stic 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 diagno...

Страница 59: ...00 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...

Страница 60: ...he 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 verif...

Страница 61: ...ostic 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 Medi...

Страница 62: ...ge conversion Read initial case of DCD file Get ECG data file Automated measurement parameters Conclude mean value of comparison Compare automated measurement parameter and expert diagnostic mark Summarize the comparison results Recalculate the mean value and variation of comparison result Start End Eliminate the four largest deviations from the mean ...

Страница 63: ...e 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 de...

Страница 64: ...ine 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 pr...

Страница 65: ...system required Import to device Draw ECG waveform Identify QRS complex Start comparing Conclude automated interpretation items Summarize the global statistical results of comparison for each case End QRS complex superposition Expert diagnosis Auto measurement Start ...

Страница 66: ...Bundle branch block 41 96 86 89 83 82 35 14 No Completeness Left Bundle branch block 47 94 68 89 83 89 66 15 V1 shows RSR type 13 90 32 91 14 65 12 16 Left anterior fascicular block 26 91 43 93 25 71 11 17 Left posterior fascicular block 18 89 29 97 37 52 63 18 Left ventricular hypertrophy 236 41 37 92 65 70 36 19 Right ventricular hypertrophy 108 39 75 93 47 65 39 20 I atrioventricular block 13 9...

Страница 67: ...ischemia 7 75 36 99 55 46 67 46 ST depression mild anterior myocardial ischemia 5 81 24 99 94 33 33 47 ST depression mild extensive anterior myocardial ischemia 13 79 83 99 13 53 59 48 ST depression mild apical myocardial ischemia 17 76 97 99 14 43 13 49 ST depression mild anterolateral myocardial ischemia 25 77 54 99 08 37 64 50 ST depression mild high lateral myocardial ischemia 21 80 64 99 14 4...

Страница 68: ...l myocardial ischemia 6 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 ...

Страница 69: ...urchaser or the user of the Infrared Thermometer should assure that it is used in such environment Immunity test IEC60601 test level Compliance level Electrostatic discharge ESD IEC 61000 4 2 8kV contact 15 kV air 8kV contact 15kV air Electrical fast transient burst IEC 61000 4 4 2kV for power supply lines 1 kV for input output line 2kV for power supply lines Not Applicable Surge IEC 61000 4 5 1 k...

Страница 70: ... 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 Infrared Thermometer is used exceeds the applicable RF compliance level above the Infrared Thermometer should be observed to verify ...

Страница 71: ...IPMENT or ME SYSTEM may be reduced to 1 m The 1 m test distance is permitted by IEC 61000 4 3 a For some services only the uplink frequencies are included b The carrier shall be modulated using a 50 duty cycle square wave signal c As an alternative to FM modulation 50 pulse modulation at 18 Hz may be used because while it does not represent actual modulation it would be worst case The MANUFACTURER...

Страница 72: ...ing peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the device including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result Active medical devices are subject to special EMC precautions and they must be installed and used in accordance with these guidelines Note The EMISS...

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