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EKG6012

5.2.1.2 Customized database

Initial case data

ecg format as 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 parameter

Start

Содержание EKG6012

Страница 1: ...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...

Страница 2: ...ins 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 man...

Страница 3: ...company 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 connectio...

Страница 4: ...pply unit 8 4 1 2 Signal acquisition unit 8 4 1 3 Control unit 8 4 2 Name of each part and its function 9 4 2 1 Front view 9 4 2 2 Side view 10 4 2 3 Buttons 10 4 2 4 Symbols 11 Chapter 5 Operation Pr...

Страница 5: ...y 23 7 4 2 Review 24 7 5 Date and time setup 25 7 6 System setup 25 7 7 Sampling setup 26 7 8 Print setup 27 7 9 Lead placement 28 7 10 About 29 Chapter 8 Troubleshooting 31 8 1 Auto shutdown 31 8 2 A...

Страница 6: ...tion after intervals determination 45 3 5 Interpretations judgment based on parameters 47 4 Data sources and data preprocessing 51 4 1 Data sources 51 4 2 CTS introduction 51 4 3 CSE introduction 52 4...

Страница 7: ...duration measurements 58 5 1 3 3 Accuracy of interval measurements on biological ECGs 58 5 1 3 4 Stability of measurements against NOISE 58 5 2 Verification of interpretation function 59 5 2 1 Verifi...

Страница 8: ...ards ambulances and 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 E...

Страница 9: ...rding to manual record format 1 3 17 Measurement parameters HR P R interval P Duration QRS Duration T Duration Q T interval Q Tc P Axis QRS Axis T Axis R V5 amplitude S V1 amplitude R V5 S V1 amplitud...

Страница 10: ...ace and report 1 5 Software overview The ECG analysis program shows the results after analyzing the form of the electrocardiogram providing auxiliary reference for doctors to make diagnosis The analys...

Страница 11: ...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 hum...

Страница 12: ...ter 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 mea...

Страница 13: ...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 resu...

Страница 14: ...g to 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 compa...

Страница 15: ...low pass 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 overlo...

Страница 16: ...ompartment cover Keep the paper compartment closed hold the printing paper 2 Display screen Display patient s ECG and related information 3 Button area Control the operations of the device and enter i...

Страница 17: ...ter 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 Note Lead cables must...

Страница 18: ...on to select the print mode 6 Setting button of acquisition system Collect ECG waveform and set the display mode 7 ON OFF When the device is turned on short press this button it will prompt whether to...

Страница 19: ...EKG6012 12 Latex free Atmospheric pressure limitation Temperature limitation Humidity limitation This way up Fragile handle with care Keep away from rain Stacking limit by number...

Страница 20: ...g 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 temperat...

Страница 21: ...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...

Страница 22: ...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 conn...

Страница 23: ...t electrode at the positions of Cl C6 Note The conductive paste coating should be separated from each other and the chest electrodes should not touch each other to avoid short circuit 6 4 2 Limb elect...

Страница 24: ...act with the skin 6 4 4 Lead method and system As shown in Figure 6 5 Figure 6 5 Lead system 6 4 5 Lead off and overload indication The device can check the connection status of the lead at any time I...

Страница 25: ...ty 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 Battery level re...

Страница 26: ...tting Quick setup Click the functional module on the screen to quickly set the corresponding function 7 2 Sampling interface Click on the main interface or press the button to enter the sampling inter...

Страница 27: ...e gain between 5 mm mV 10 mm mV and 20 mm mV The calibration voltage signal and overall gain sensitivity can be checked by calibration function 3 Filter click the screen to switch the filter between n...

Страница 28: ...er selecting a edit box pressing button could pop up a soft keyboard shown as below Clicking Caps can switch between numbers lowercase letters capital letters and symbols Space is the space key press...

Страница 29: ...ll medical records stored in the device User can search necessary cases by the query function in the interface refer to 7 4 1 modify or delete case information by edit function and review stored case...

Страница 30: ...matching mode of the query conditions You can choose one of the two If you select Cond And the displayed query results will satisfy all the input conditions at the same time if you select Cond Or the...

Страница 31: ...e Make sure the input information is correct click Review to enter the review interface which is similar with the sampling interface Figure 7 9 Click to enter the diagnosis interface shown as below do...

Страница 32: ...adjust the content of the item by buttons It can also be changed through the touch screen function which is convenient and quick 7 6 System setup In the main interface click to enter the system setup...

Страница 33: ...e system will always keep on Low Power None Only once Always It determines the alarm method that the device uses in low power Filter Freq 50Hz 35Hz 50Hz 25Hz 60Hz 25Hz 60Hz 35Hz To set the parameters...

Страница 34: ...ethod of ECG Show Gain 5mm mV 10mm mV 20mm mV Set the gain of displayed ECG Show Speed 12 5mm s 25mm s 50mm s Set the speed of displayed ECG during printing the auto mode and rhythm mode does not supp...

Страница 35: ...en Print Mode is set to Auto or Rhythm the system uses the selected format to print the average QRS waveform Auto Diag All Data Conclusion None The diagnosis contains data and conclusion two parts whi...

Страница 36: ...6012 29 European Standard is shown as below Figure 7 15 The American Standard is shown as below Figure 7 16 7 10 About In the main interface click to view the information about the device shown as bel...

Страница 37: ...EKG6012 30 Figure 7 17...

Страница 38: ...e daubed with enough conductive paste Whether the metal bed is grounded reliably Whether the patient is touching the wall or metal parts of the bed Whether the patient touches other people Whether the...

Страница 39: ...ce can not be removed after taking above measures please use a baseline filter 8 5 Troubleshooting list Phenomenon Cause of failure Solutions Too large interference disorderly waveform 1 Grounding cab...

Страница 40: ...ead cables 2 Clean electrode slice and the skin under the electrode with alcohol 3 Charge the battery Baseline draft 1 Low power 2 Patient movement 1 Charge the battery 2 Keep patient still Unclear wa...

Страница 41: ...c 9 1 2 The device can continuously print for 1 5 hours or work for more than 4 hours in standby mode when battery is completely charged When the device is powered by battery a battery icon will be di...

Страница 42: ...r 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 Oth...

Страница 43: ...e 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 roll...

Страница 44: ...e 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...

Страница 45: ...tructions 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...

Страница 46: ...rocardiographs 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 Aut...

Страница 47: ...1 Early anteroseptal MI 22 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 Possib...

Страница 48: ...hemia 2 3 Intended use The intended use of the Automated Measurement Interpretation function is shown as below Application and diagnosis To detect the abnormal of heart of human body examination items...

Страница 49: ...e 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 Otherwis...

Страница 50: ...read a piece of data containing the qrs complex 2 Preprocessing superimpose the absolute value of slope for 12 lead signals 3 Use the preprocessed data to carry on the searching of QRS complex P wave...

Страница 51: ...arching the QRS complex this algorithm adopts the analysis method of superposition of the slopes for all leads therefore the equipotential segments before and after the QRS complex are partly included...

Страница 52: ...nd the max value between the start point and end point of T wave the difference between the max value and the baseline would be the amplitude of T wave 5 Recognition of minimum wave The minimum wave c...

Страница 53: ...eginning point to the end point of P wave on lead I QRS electric axis SIII voltage sum from the beginning point to the end point of QRS complex on lead III SI voltage sum from the beginning point to t...

Страница 54: ...ophy For leads I II aVF amplitude of P wave 0 25mV or P wave is sharp 6 Dual atrium Hypertrophy For leads I II aVF amplitude of P wave 0 25mV and P wave duration 110ms 7 QRS low voltage Voltage of I a...

Страница 55: ...n S amplitude R amplitude of lead V5 is smaller than S amplitude 20 I atrioventricular block PQ interval 210ms 21 Early anteroseptal MI Early myocardial infarction change of leads V1 V2 V3 no change o...

Страница 56: ...ld 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...

Страница 57: ...rdial 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...

Страница 58: ...ated interpretations Verification Database Database items Automated measurement CTS database CAL05000 CAL10000 CAL15000 CAL20000 CAL20002 CAL20100 CAL20110 CAL20160 CAL20200 CAL20210 CAL20260 CAL20500...

Страница 59: ...report on the recommended standard for general ECG measurements based on the investigation and study of the database which has been widely recognized by the world CSE database diagnostic items Item N...

Страница 60: ...ation 4 Tachycardia bradycardia low voltage axis Determined by the diagnostic results of ultrasonic examination 5 Conduction block Determined by the physician diagnostic results of cardiac catheteriza...

Страница 61: ...5000 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 f...

Страница 62: ...t the 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 datab...

Страница 63: ...ng 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...

Страница 64: ...ase 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...

Страница 65: ...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...

Страница 66: ...e 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 b...

Страница 67: ...tem 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 QR...

Страница 68: ...No Completeness Right 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 b...

Страница 69: ...on mild anteroseptal myocardial 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 8...

Страница 70: ...inferolateral 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...

Страница 71: ...purchaser 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 con...

Страница 72: ...io AM and 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 shou...

Страница 73: ...3 28 870 930 1720 1 700 1 990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 1845 1970 2450 2 400 2 570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pul...

Страница 74: ...voided because it could result in improper operation If such use is necessary this equipment and the other equipment should be observed to verify that they are operating normally Use of accessories tr...

Страница 75: ...EKG6012 When the device is disturbed the data measured may fluctuate please measure repeatedly or in another environment to ensure its accuracy...

Страница 76: ...EKG6012...

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