Testing my ECG device as per IEC 60601-2-25

subbash

Involved In Discussions
#1
Dear Peter,

I want to test my ECG device as per IEC 60601-2-25. I have gone through the document.

I wanted a clarification regarding the recovery time test. \

Test mentions we feed a signal on lead III for 1 minute duration. Post 1 minute, we switch to lead II and should monitor if baseline switches back to previous position within 2 seconds.

I need clarification about how to monitor the time. 2 seconds is a very little time. Request your inputs to perform this test.

Thanks in advance.
 
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Peter Selvey

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#2
For 12 lead ECGs, most modern systems sample all leads continuously and apply filtering in software, so lead switching is just for the display only and does not affect the baseline. In this case I don't even bother doing the test (formally that is, of course a spot check is always worth it).

If you do use hardware lead switching then there may be long duration transients caused by the 0.05Hz high pass filter. To overcome this you need a baseline reset function in the software or hardware.

If you don't have this function, the test will fail. The 0.05Hz filter takes about 10s to settle down, which is >> 2s.

Upshot: It's not really critical how accurate the 2s period is, it's all about the design.
 

subbash

Involved In Discussions
#3
Dear Peter,

Thank you for your time in addressing my query.

I have some more doubts related to the measurement parameters. Currently our ECG report only contains details about H-R, RR, PR, QRS Duration, QRS Axis, QT/QTc. But for the below mentioned test they ask for some measurements to be used for evaluating results.

1. In the Filters test,

Standard says: to compare the peak noise measured in ST segment.

Clarification required: Does the standard require us to print the ST segment detail on the report for comparison...?

2. In the Frequency Response Test:

Standard says: To verify peak amplitudes of R, S waves and ST amplitude , Ringing noise before and after the main deflection (QS, R, RS). Slope of ST segment.

Clarification Required: Do we need to display all these values of R,S, ST amplitudes on ECG report and for checking Ringing noise before and after main deflection (QS, R, RS). How do we calculate the St segment slope.

3. Amplitude and Absolute interval and wave duration measurements:
Do we have to display all the measurements of amplitude and wave duration on the graph.

Based on my research, there are SECG, MECG, CMRR devices from Whaleteq. Any suggestions regarding this devices...?

In our current software version we are filtering from 0.05 to 40 Hz. Hence Line frequency components are not processed.

For CMRR test, it requires Line frequency filter to be switched switched off. So do we need to add the feature to turn the switch on/off the filter.

Thanks and Regards,
Subbash
 
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