Gima ECG90A - Page 65

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5.1.3 Verification results
5.1.3.1 Accuracy of amplitude measurements
Calibration and analytical ECGs shall be used to measure the amplitude value, the
summary as follows:
Amplitude
Mean difference (uV)
Standard deviation (uV)
P-wave
-1.70
5.72
Q-wave
7.51
18.07
R-wave
-18.05
21.70
S-wave
7.77
18.58
ST-segment
0.15
4.24
T-wave
-5.81
8.03
Note: In amplitude measurement, for large-amplitude ECG, such as CAL30000, it is necessary to
adjust to 0.5 times the gain before testing.
5.1.3.2 Accuracy of absolute interval and wave duration measurements
Calibration and analytical ECGs shall be used to measure the global interval and wave
duration (including Q-wave ,R-wave ,S-wave), the summary as follows:
Interval&Duration
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-interval
3.65
9.68
QRS-duration
-1.69
6.11
QT-interval
-2.32
20.69
5.1.3.4 Stability of measurements against NOISE
The test is carrying on according to MA-series data (008, 011, 013, 014, 015, 021, 026, 027, 042,
061) in CSE database.
Global measurement
parameters
Type of added
NOISE
Disclosed differences
Mean (ms)
Standard deviation (ms)
P-duration
High frequency
-5.65
12.33
P-duration
Line frequency
-0.25.
12.71
P-duration
Base-line
-4.90
33.15
QRS-duration
High frequency
-0.95
5.13
QRS-duration
Line frequency
1.35
4.71
QRS-duration
Base-line
-1.55
7.68