The biological ECGs are fed into the device in form of digital signals, then the
measurement value can be obtained by calculation.
Test condition:
a) without NOISE
b)with 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 differences.
5.2 Verification of interpretation function
5.2.1 Verification process
5.2.1.1 CSE diagnostic database
Frequency conversion
Voltage conversion
Read initial DCD files
Get ECG data files
Automated interpretation item
Compare automated interpretation with expert diagnosis
Summarize comparison results, draw conclusions
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