EKG6012
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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> voltage of R-wave and R’-wave, and/or Q-duration>40ms.
For leads V1, V2, voltage of Q-wave <-0.08mV and Q-duration>10ms.
ST elevation:
For leads I, II, III, avR, avL, avF, V4, V5, V6, the voltage of ST segment at 60ms
point >0.1mV, and for leads V1, V2, V3, the voltage at 60ms point >0.3mV.
ST slope elevation:
Voltage of ST segment at 20ms point>=voltage of J point, voltage at 40ms point >= the one
at 20ms, voltage at 60ms point >= the one at 40ms, with change of ST elevation.
4. Data sources and data preprocessing
4.1 Data sources
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 electrocardiograph
, the CSE measurement database,
CSE diagnostic database, CTS calibration database and customized data shall be used to evaluate
the function of automated measurements and automated interpretations.
Verification
Database
Database items
Automated
measurement
CTS database
CAL05000 CAL10000 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 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
their effectiveness in a series of official tests. 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
electrocardiograph Clause 50.101.1
, 13 data (CAL05000, CAL10000, CAL15000, CAL20000,
CAL20002, CAL20100, CAL20110, CAL20160, CAL20200, CAL20210, CAL20260,
CAL20500, CAL30000) are used in the automated parameters verification for this test.
Summary of Contents for EKG6012
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