Gima ECG90A Manuel D'utilisation page 65

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
P-wave
Q-wave
R-wave
S-wave
ST-segment
T-wave
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
P-duration
PQ-interval
QRS-duration
QT-interval
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
P-duration
PR-interval
QRS-duration
QT-interval
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
P-duration
P-duration
P-duration
QRS-duration
QRS-duration
QRS-duration
Mean difference (uV)
-1.70
7.51
-18.05
7.77
0.15
-5.81
Mean difference (ms)
-5.70
-2.58
-0.23
-6.70
Mean difference (ms)
0.99
3.65
-1.69
-2.32
Type of added
NOISE
High frequency
Line frequency
Base-line
High frequency
Line frequency
Base-line
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Standard deviation (uV)
Standard deviation (ms)
Standard deviation (ms)
Disclosed differences
Mean (ms) Standard deviation (ms)
-5.65
-0.25.
-4.90
-0.95
1.35
-1.55
5.72
18.07
21.70
18.58
4.24
8.03
1.88
1.94
3.26
4.37
13.46
9.68
6.11
20.69
12.33
12.71
33.15
5.13
4.71
7.68