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.
Make a comparison between the ECG analytical parameters (the beginning/end of P-wave,
QRS-complex and T-wave) and the diagnostic 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 Medical
electrical equipment - Part 2-51: Particular requirements for safety, including essential
performance, of recording and analysing single channel and multichannel electrocardiograph, the
four largest deviations from the mean shall be eliminated before recalculation of mean and
standard deviation of the differences.
Flow diagram of CSE measurement database verification process
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