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Annexe F Sensitivity Test and ECG Waveform Distortion
F.1 Sensitivity Test
Testing device: Calibration Device for Electric Cardiac Monitor
Testing method:
1.
Connect the tested electrocardiograph with the calibrator through
patient cable, and set the sensitivity of electrocardiograph at
10mm/mV. The calibrator outputs a sine wave signal with a peak
value of 1mV and a frequency of 10Hz to the tested
electrocardiograph.
2.
Adjust the sensitivity of the electrocardiograph, and adjust the peak-
peak value of the calibrator according to the set sensitivity, input a
sine wave signal with the frequency of 10Hz to make the peak value
of the waveform display theoretically be 10mm, and confirm the
peak-peak value displayed by lead I of the electrocardiograph.
3.
According to the methods in steps 1 and 2 above, change the leads of
the electrocardiograph in turn, and connect the output signal of the
calibrator to the corresponding lead of the electrocardiograph to
complete the test of all channels. Select the test results with the
largest relative deviation from the test results of each test point as
the verification result of this item.
Acceptance criteria: The measured calibration voltage is within 5%.
Test cycle: Test the sensitivity once a year according to the above method.
F.2 ECG Waveform Distortion Test
The function of the electrocardiograph will not be affected by pacemaker,
which can be verified by the following methods:
1.
Superimpose the pulse wave with peak value of 200mV, rise time of
less than 100μs, pulse width of 1ms, repetition rate of 100 times /
min and sine wave signal with peak valley value of 1mV and
frequency of 40Hz, input them to the electrocardiograph, and the
time taken for the recorded sine wave signal to return to 70% of the
initial value (which should be 10mm when the peak valley value is
1mV and the sensitivity is 10mm/mV) should not be more than 50ms.
In the above test, the maximum baseline drift accumulated in 10s is
less than 10mm. In the case of pulse and without pulse, the
Test
F-1
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