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Gima 1200G ECG, Руководство пользователя

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Gima 1200G ECG Скачать руководство пользователя страница 63

 

 

57 

 

Note: 

The  heart  abnormalities  such  as  posterior  myocardial  ischemia,  early  posterior  MI  and  old 
posterior MI are not included in the database. These abnormalities and other heart disorders not 
contained  in  above  sheet  won’t  be  regarded  as  the  judgment  object  for  the  verification  of 
automated interpretation accuracy. 

4.6 Data preprocessing 
4.6.1 CTS preprocessing 

The  16  cases  (CAL05000,  CAL10000,  CAL15000,  CAL20000,  CAL20002,  CAL20100, 

CAL20110, CAL20160, CAL20200, CAL20210, CAL20260, CAL20500, CAL30000, ANE20000, 
ANE20001, ANE20002) from CTS-ECG shall be processed for voltage conversion and frequency 
conversion for resampling as the applicable format in the system. Then cases will be imported to the 
device. After that, the verification of automated measurement parameters will be carried on. 

4.6.2 CSE preprocessing 

The  cases  (MA_0001~MA0125,  D_0001~D_1220)  from  the  CSE  shall  be  processed  for 

voltage  conversion  and  frequency  conversion  for  resampling  as  the  applicable  format  in  the 
system. Then cases will be imported to  the device. After that, the case  of MA_0001~MA0125 
shall be used for the following verification of automated measurement parameters, and the case 

Содержание 1200G ECG

Страница 1: ... MEDICAL SYSTEMS CO LTD No 112 Qinhuang West Street Economic Technical Development Zone Qinhuangdao Hebei Province PEOPLE S REPUBLIC OF CHINA Made in China ECG1200G 33224 Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 20537 Hamburg Germany 0123 95 0 1060 hPa 500 hPa 55 C 20 C ...

Страница 2: ... supply internal powered equipment power supplied by battery Ø Degree of protection against electric shock type CF defibrillation proof function applied part Ø Working mode continuous running equipment Ø Enclosure protection class IPX0 Ø Measurement results shall be described by professional doctor combined with clinical symptoms Ø The using reliability depends on whether the operation guide and m...

Страница 3: ... 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 Ø The company responds timely to the user s request The user manual is written by Contec Medical Systems Co Ltd All rights reserved ...

Страница 4: ...pany 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 c...

Страница 5: ...recautions 14 5 1 Precautions before use 14 5 2 Precautions during operating 14 5 3 Precautions after use 14 Chapter 6 Preparations before Operation 15 6 1 Installation of recording paper 15 6 2 Power supply connection 16 6 3 Lead cable connection 16 6 4 Electrode installation 17 Chapter 7 Operation Instructions and Parameter Setting 20 7 1 Main Interface 20 7 2 Sampling interface 21 7 3 Case info...

Страница 6: ...ct scrap 40 9 9 Others 40 Chapter 10 Packing List and Accessories 41 10 1 Accompanying accessories 41 10 2 Notes 41 Appendix I ECG Automated Measurement Interpretation Guide 42 1 Preface 42 2 Automated measurement parameters and Automated interpretation items 42 3 Algorithm description 44 3 5 Interpretations judgment based on parameters 50 4 Data sources and data preprocessing 54 4 5 Data coverage...

Страница 7: ... by medical institutions to record human ECG signals collect and extract the ECG waveform 1 3 Main technical specifications 1 3 1 Environment conditions Operation a Environment temperature 5 40 b Relative humidity 25 95 no condensation c Atmospheric pressure 700 hPa 1060 hPa d Power supply Voltage 100 240 V Frequency 50 Hz 60 Hz Input power 150 VA Battery 14 8 V 3500 mAh rechargeable lithium batte...

Страница 8: ...p 1 3 21 ECG signal input sampling frequency 32 kHz 1 3 22 Waveform data processing sampling frequency 1 kHz 1 3 23 Sampling precision 24 bit 1 3 24 The minimum detection signal 10 Hz 20 µV peak peak value deflected sinusoidal signal can be detected 1 3 25 Pacing detection channel standard II 1 3 26 Accuracy of input signal The overall system error 5 1 3 27 Amplitude quantization 5µV LSB 1 3 28 In...

Страница 9: ...h Turkish Portuguese German Russian Kazakhstan etc interface and report 1 5 Software overview Name of software ECG1200G embedded software Software specification none Software version V1 6 1 Version naming rules V major version number minor version number revision version number The version of the software can be obtained in About Involved algorithm Name ECG algorithm Type mature algorithm Use to c...

Страница 10: ... use the device in the place with flammable anesthetic gases or other flammable chemicals otherwise there is a danger of explosion or fire 2 9 Do not use the device in medical hyperbaric oxygen chamber otherwise there is a danger of explosion or fire 2 10 This device is not intended to act directly on the human heart If this device is used with cardiac defibrillator or other electric stimulating d...

Страница 11: ... the device When installing medical electrical equipment be sure to remind people around the device to turn off mobile phones and small radios n Effect from shock and conduction electromagnetic waves High frequency noise from other equipment can enter the device through the AC socket Please identify the source of noise if possible stop using the equipment If the equipment can not be deactivated us...

Страница 12: ...omatic analysis function that automatically analyzes the obtained ECG waveform without reflecting all the patient s status The results of the analysis may sometimes not comply with the doctor s diagnosis Therefore the final conclusion needs to be comprehensively analyzed by doctors in combination with analysis results patient clinical characterization and other test results ...

Страница 13: ...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 14: ...ce personnel designated by our company 4 1 2 Signal acquisition unit The signal acquisition unit uses a floating setting which is a signal acquisition and processing system including analog circuit part and A D conversion with sampling accuracy of 24 bits and data processing part The analog circuit consists of signal following amplification anti aliasing low pass filtering lead off detection and o...

Страница 15: ...d analysis The CPU system also receives an interrupt signal and button code from the button system to complete the interrupt processing In addition the lead off signal paper out detection battery voltage management and automatic power off are also managed by the CPU system The liquid crystal controller receives data and commands from the CPU system to complete the display of the control state of t...

Страница 16: ...permanent damage to the buttons 4 2 2 Side view Figure 4 4 Side view 4 Lead cable interface Connect with lead cables 5 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 6 Network interfa...

Страница 17: ... USB interface Operator must not touch the USB interface and patient at the same time 4 2 3 Buttons Figure 4 6 Schematic diagram of buttons 1 Startup indicator It lights in green after turning on the device 2 Power status indicator Green indicates that the AC power supply is used At this time there is no battery in the device or the battery is full Red and green two colors indicate that the batter...

Страница 18: ...e MODE button to select the print mode 11 PRINT Print the sampled ECG waveform or end the printing 12 Switch button of input method Under the inputting state use this button to switch between numbers lowercase capital and symbols 13 Setting button of acquisition system Collect ECG waveform and set the display mode 4 2 4 Symbols AC Alternating current OFF Alternating current OFF ON Alternating curr...

Страница 19: ...aste cannot be disposed of as unsorted municipal waste and must be recycled separately This way up Fragile handle with care Keep away from rain Stacking limit by number Refer to instruction manual booklet This item is compliant with Medical Device Directive 93 42 EEC of June 14 1993 a directive of the European Economic Community Catalogue number Authorized representative in the European Community ...

Страница 20: ...ding 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 Pr...

Страница 21: ...ed downwards and then install it to proper position in the paper compartment Figure 6 1 Installation of recording paper 2 Pull out the recording paper from the slot of the paper compartment cover and close the cover Note Ø When opening the paper compartment cover it is not allowed to open one side separately otherwise the operation of the device will be affected Ø The recording paper should be ali...

Страница 22: ... device 6 2 2 Battery The device has a built in rechargeable lithium battery which does not need to be re installed by user Check the battery s power and status before use Note Connect one end of the potential equalization wire to the equipotential terminal of the device and connect the other end to the ground to enhance the reliability of the grounding Do not use other pipes as ground wire otherw...

Страница 23: ... between C2 and C4 C4 V4 the intersection between midclavicular line and the fifth intercostal space C5 V5 left anterior axillary line on the same plane as C4 C6 V6 left midaxillary line on the same plane as C4 Clean the chest skin where the electrodes to be installed with alcohol and apply some conductive pastes to these skin about 25 mm diameter range and the edge of the chest electrode suction ...

Страница 24: ...L Red Right leg N RF Black RL Green Chest 1 Cl Red Vl Red Chest 2 C2 Yellow V2 Yellow Chest 3 C3 Green V3 Green Chest 4 C4 Brown V4 Blue Chest 5 C5 Black V5 Orange Chest 6 C6 Purple V6 Purple Note n It is recommended to install the lead cables after turning off the device n Apply appropriate amount of conductive paste on the electrode when installing the electrode n If the ECG waveform does not ap...

Страница 25: ...e If lead off or overload is detected the screen will display corresponding lead code on the top left corner as shown in Figure 7 2 Note Ø In the lead off prompt area red font represents lead off yellow font represent overload Ø When the connection between lead cable and patient the device is not reliable and the ECG signal can not correctly transmitted the device displays lead off ...

Страница 26: ...CG recording can be noted 2 Memory usage It directly shows the capacity of memory space according to actual usage The green part represents the memory usage the white part represents the remaining memory space 3 Total number of cases stored in memory 4 Input method indication Current input method is marked by green color Use button to switch input methods ...

Страница 27: ...etting to set the print mode print style and print content etc to view software version and other information Quick switch use the buttons on the keyboard to switch between each functional module after selecting press button to enter its setting Quick setup Click the functional module on the screen to quickly set the corresponding function 7 Friendly tips 7 2 Sampling interface Click on the main i...

Страница 28: ...nclude standard 12 lead additional 6 lead and standard 12 lead additional 6 lead 4 System status indication Display content Explanation Process It is printing Waiting It is finishing printing No Paper Lack of paper user should restart printing after loading paper Print Timeout Communication failure between this system and printing sub system ECG Timeout Communication failure between this system an...

Страница 29: ...uto mode After starting to print the system automatically prints and stores the real time 12 lead ECG waveform The length is determined by the relevant settings in the print setup Based on the settings the automatic analysis data and conclusions are printed and the system automatically ends printing 2 Manual mode After starting to print user need to switch the lead to print the waveform of differe...

Страница 30: ...er the System Setup initial password is 888888 After selecting a edit box pressing button could pop up a soft keyboard shown as below Click CN or EN to switch between Chinese and English Clicking Caps can switch between numbers lowercase letters capital letters and symbols Space is the space key press it to enter a space Backspace is the backspace key press it to delete the last character entered ...

Страница 31: ...the last character entered According to the limitation of the content the selected input method is displayed in green when switching input method and the restricted input method is grayed out and unavailable 7 4 Case management In the main interface click to enter the case management interface as shown below Figure 7 6 The above interface shows all medical records stored in the device User can sea...

Страница 32: ... format of report 2 aECG case data that conform to the HL7 standard 3 DAT case data self defined format Query see 7 4 1 7 4 1 Query Click Query in the Adv opr setting to enter the query interface shown below Input query conditions and click Select to obtain expected results After clicking Clear the system will clear all query conditions that entered Figure 7 7 Cond And and Cond Or indicate the mat...

Страница 33: ... displays the case information User is allowed to modify patient information after clicking Save the information will be changed Please note that the modification is irreversible Figure 7 8 Make sure the input information is correct click Review to enter the review interface which is similar with the sampling interface Figure 7 9 ...

Страница 34: ...ewed waveform and the printed waveform will be marked with 4 If lead overload occurs during sampling process the reviewed waveform and the printed waveform will be marked with 7 5 Date and time setup In the main interface click to enter the following interface to set date and time Figure 7 10 In current interface user can switch the items via buttons and adjust the content of the item by buttons I...

Страница 35: ... it is set to None the system will not prompt for low power AC filter 50Hz 60Hz To set the parameters of AC filter EMG filter 25Hz 30Hz 35Hz 40 Hz 45Hz To set the parameters of EMG filter DFT Filter 0 05Hz 0 5Hz 1Hz 0 15Hz 0 25Hz 0 32Hz 0 67Hz 0 01Hz To set the parameters of Baseline filter Low pass Filter OFF 75Hz 100Hz 150Hz To set the parameters of low pass filter Language English Chinese etc T...

Страница 36: ...CG Background Grid Show Not Show Set to use the background grid or not Premature 0 100 The system will use the input value as a standard of judging premature beat Pause Time 1200 3000 The system will use the input value as a standard of judging beat pause Tachycardia 0 250 The system will use the input value as a standard of judging tachycardia Bradycardia 0 99 The system will use the input value ...

Страница 37: ...ich can be chosen by user as demand Period Off per 1 min per 2 min per 3 min per 5 min per 10 min per 20 min per 30 min per 60 min During the ECG acquisition process the system will automatically activate the printing operation according to the selected time interval When the printing mode is manual mode the printing will output Auto 12 1 format otherwise it will output according to the current se...

Страница 38: ...button or after clicking Rhythm 1 I II III aVR aVL aVF V1 V2 V3 V 4 V5 V6 Set the rhythm lead that used for printing under rhythm mode Rhythm 2 I II III aVR aVL aVF V1 V2 V3 V 4 V5 V6 Set the Auto 3 4 2 mode that used for printing under rhythm mode Conclusion title Conclusions by default Set the printed conclusion title Physician Physician Specialist Set doctor s signature in printed report 7 9 Le...

Страница 39: ...t of Std 12 and Add 6 Click Return to exit 7 10 About In the main interface click to view the information about the device which including the following content 1 App Version the version number of current software 2 Firm Info click it see the firmware information of the device 3 Return click it to exit the interface ...

Страница 40: ...ther the patient is touching the wall or metal parts of the bed Ø Whether the patient touches other people Ø Whether there is high power electric equipment working nearby Such as X ray 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 Ø Whether the room is comfortable Ø Whether the patient is nervous...

Страница 41: ...is not connected reliably 2 Lead cables are not connected reliably 3 There is AC interference 4 Patient is nervous and can not keep quiet 1 Check the power cord and lead cables 2 Let the patient prepare 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...

Страница 42: ...r 2 Patient movement 1 Charge the battery 2 Keep patient still Unclear waveform 1 Low battery 2 The printer head surface is dirty 3 The thermal paper problem 1 Charge the battery 2 Cut off the power clean the printer head with alcohol air dry 3 Replace the thermal print paper with specified one ...

Страница 43: ...ote When charging the battery the displayed status of battery level switches between icon f to icon c 9 1 2 The device can continuously print for 3 hours or work for more than 10 hours in standby mode when battery is completely charged When the device is powered by battery a battery icon will be displayed on the LCD screen showing the battery capacity in 5 modes When the battery capacity is too lo...

Страница 44: ...y even increase the wear of the device and shorten the service life of important parts such as the thermal print head For information on how to purchase such recording paper please contact your dealer or the company Please be careful 9 2 1 When using recording paper it is absolutely not allowed to use recording paper with wax on the surface or in grayish black color Otherwise the wax will stick to...

Страница 45: ...e of the electrode may oxidize and discolor due to corrosion and other factors which may affect the signal acquisition In this case the electrode must be replaced 9 5 Silicone rubber roller The silicone rubber roller should be smooth and free of stains otherwise it will affect the ECG recording effect In order to remove the stains on the roller please use a clean soft cloth damped with a small amo...

Страница 46: ...ser should treat the scrapped products and materials properly according to the laws and regulations and try to support the classification and recycling work 9 9 Others 9 9 1 Do not open the device enclosure to avoid electric shock danger 9 9 2 The device associated circuit schematics and critical parts list are only available to authorized service station or maintenance personnel who is responsibl...

Страница 47: ...ctions on the package when opening the package 10 2 2 After unpacking please check the accessories and accompanying documents in accordance with the packing list then start inspecting the device 10 2 3 If the packaging content does not meet the requirement or the device does not work properly please contact our company immediately 10 2 4 Please use the accessories provided by our company otherwise...

Страница 48: ...ccuracy 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 1 HR bpm 2 P...

Страница 49: ...ute 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 37 Possible a...

Страница 50: ...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 51: ...nt location is less than 150ms then give up the location Otherwise take the 1 4 of threshold value as a reference find the beginning of qrs complex within 100ms before the current location When the value is less than the threshold value it may be the end of qrs complex Take the 1 4 of threshold value as a reference find the end of qrs complex If the found qrs complex is wide this qrs complex shall...

Страница 52: ...S complex P wave and T wave as the followings 4 Read the next data of qrs complex repeat step 2 and step 3 until the analyzing of all qrs complex are finished 2 Find QRS complex 1 Calculate the threshold value of S wave search the minimal value within 200ms after the peak of R wave take the value that equals to minimal value plus 0 4 as the threshold value for finding the end of S wave 2 Find the ...

Страница 53: ...e QRS complex It is depends on the number of leads containing equipotential segments If there are more leads containing equipotential segments the slope value will be smaller after superposition so it is difficult to meet the threshold condition and only a small part of the equipotential segments is counted to the start and end points of the QRS complex On the contrary if there are less leads cont...

Страница 54: ...inimum wave The minimum wave can be recognized by the algorithm according to the requirement of IEC60601 2 51 2003 Medical electrical equipment Part 2 51 Particular requirements for safety including essential performance of recording and analysing single channel and multichannel electrocardiographs Annex GG Clause GG 5 Definition of waveforms measurement of minimum waves The wave that meet the fol...

Страница 55: ...int to the end point of QRS complex on lead III SI voltage sum from the beginning point to the end point of QRS complex on lead I T electric axis SIII voltage sum from the beginning point to the end point of T wave on lead III SI voltage sum from the beginning point to the end point of T wave on lead I 9 R V5 Height voltage value of R wave on lead V5 10 S V1 Height voltage value of S wave on lead ...

Страница 56: ...V and P wave duration 110ms 7 QRS low voltage Voltage of I aVF limb leads 0 5mV and voltage of V1 V6 chest leads 0 8mV 8 Cardiac electric axis normal QRS axis between 30 to 90 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 ...

Страница 57: ...21 Early anteroseptal MI Early myocardial infarction change of leads V1 V2 V3 no change of leads V4 V5 22 Possible acute forepart anteroseptal MI Acute myocardial infarction change of leads V1 V2 V3 no change of leads V4 V5 23 Old anteroseptal MI Old myocardial infarction change of leads V1 V2 V3 no change of leads V4 V5 24 Early anterior MI Early myocardial infarction change of leads V3 V4 V5 no ...

Страница 58: ... leads I aVL no change of leads II III aVF V4 V5 V6 38 Old high lateral MI Old myocardial infarction change of leads I aVL no change of leads II III aVF V4 V5 V6 39 Early inferior MI Early myocardial infarction change of leads II III aVF no change of leads I aVL 40 Possible acute inferior MI Acute myocardial infarction change of leads II III aVF no change of leads I aVL 41 Old inferior MI Old myoc...

Страница 59: ...change of leads V4 V5 54 ST depression anterior myocardial ischemia Severe ST segment depression of leads V3 V4 V5 and no change of leads V1 V2 V6 55 ST depression extensive anterior myocardial ischemia Severe ST segment depression of leads V1 V2 V3 V4 V5 56 ST depression apical myocardial ischemia Severe ST segment depression of leads V4 V5 and no change of leads V1 V2 V3 57 ST depression anterol...

Страница 60: ...L10000 CAL15000 CAL20000 CAL20002 CAL20100 CAL20110 CAL20160 CAL20200 CAL20210 CAL20260 CAL20500 CAL30000 ANE20000 ANE20001 ANE20002 CSE measurement database MA_0001 MA0125 Automated interpretation CSE diagnostic database D_0001 D_1220 Customized 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...

Страница 61: ...widely recognized by the world CSE database diagnostic items Item Number Normal 382 Left ventricular hypertrophy 183 Right ventricular hypertrophy 55 Biventricular hypertrophy 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 numb...

Страница 62: ...oltage axis Determined by the diagnostic results of ultrasonic examination 5 Conduction block Determined by the physician diagnostic results of cardiac catheterization The standard of normal population in the customized database physical examination is normal no heart disease or other diseases that may affect cardiac functions or shape 4 5 Data coverage of verification for automated interpretation...

Страница 63: ...0 CAL20500 CAL30000 ANE20000 ANE20001 ANE20002 from CTS ECG shall be processed for voltage conversion and frequency conversion for resampling as the applicable format in the system Then cases will be imported to the device After that the verification of automated measurement parameters will be carried on 4 6 2 CSE preprocessing The cases MA_0001 MA0125 D_0001 D_1220 from the CSE shall be processed...

Страница 64: ...fication 5 1 Verification of measurement function 5 1 1 Verification and Process for CTS measurement database The cases CAL05000 CAL10000 CAL15000 CAL20000 CAL20002 CAL20100 CAL20110 CAL20160 CAL20200 CAL20210 CAL20260 CAL20500 CAL30000 ANE20000 ANE20001 ANE20002 imported to the device shall be used to verify the automated measurement parameters Start CTS preprocessing Import preprocessing data to...

Страница 65: ...end of P wave QRS complex and T wave provided by CSE database Draw the two groups of waveform and mark the location of the beginning end of P wave QRS complex and T wave corresponding to each case The picture provides a visualized comparison so the mean and standard deviation of the differences can be calculated According to the requirement of IEC60601 2 51 2003 Medical electrical equipment Part 2...

Страница 66: ...60 ...

Страница 67: ...ion Mean difference ms Standard deviation ms P duration 5 70 1 88 PQ interval 2 58 1 94 QRS duration 0 23 3 26 QT interval 6 70 4 37 5 1 3 3 Accuracy of interval measurements on biological ECGs CSE database shall be used to evaluate the accuracy of interval measurements on biological ECGs the summary as follows Interval Duration Mean difference ms Standard deviation ms P duration 0 99 13 46 PR int...

Страница 68: ...ith 25uV high frequency c with 50uV peak to valley 50Hz 60Hz sinusoidal line frequency NOISE d with 1mV peak to valley 0 3Hz sinusoidal base line NOISE For each NOISE level above the differences of measurements between the NOISE free ECGs and the ECGs with NOISE shall be determined The two largest deviations from the mean shall be estimated before calculation of mean and standard deviation of diff...

Страница 69: ...63 5 2 1 2 Customized database ...

Страница 70: ...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 71: ...schemia 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 47...

Страница 72: ... 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 73: ...bserve and verify that they can operate normally in the configurations l Basic performance Stability of working state Waveform noise and measurement error appeared during measuring are automatically eliminated 10s after removing the interference the working state of device are not changed it could collect and record data continuously and the waveform does not show obvious changes before and after ...

Страница 74: ...ly lines 1 kV for input output line 2kV for power supply lines 1 kV for input output line Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV lines to lines 2 kV lines to earth 1 kV lines to lines 2 kV lines to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage...

Страница 75: ...Hz 80MHz 3 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P d 1 2 P 80MHz 800MHz d 2 3 P 800MHz 2 5GHz Where P is the maximum output power rating of the transmitter in wat...

Страница 76: ...le and mobile RF communications equipment and the device The device is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the device as recommended below acco...

Страница 77: ...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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