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Clarification regarding tests in IEC 60601-2-25

subbash

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#1
I am new to testing the ECG device as per IEC 60601-2-25 standard. I want to test a battery operated ECG device, which can work in 6 lead or 12 lead mode.

I have gone through the IEC60601-2-25 document and have few aspects that needs clarification.

1. In the indication of Inoperable ECG test. The standard says that when the saturation point is reached, we need to check that the amplitude of the signal (10 Hz, 1 mV) that is fed is reduced to less than 0.5 mV.

Clarification required: Observing the reduction in amplitude when saturation point is reached is it the only requirement or do we need to have any indicator.


2. On the ECG report we are only printing Heart rate, RR,PR interval, QRS, QT/QTc duration, QRS Axis. But there are some tests which require measurements related to amplitude and ST segment details. The standard does not mention if we have to print on the ECG record.

Clarification required: If we have to print the details on the report.

3. Recovery Time test: Is this test applicable to an ECG device which have a lead switch function only..?



Request you to provide me some suggestions and share your experience in qualifying the ECG device as per IEC60601-2-25 standard

Please also share your experience about the testing device if you have used such as Whaleteq's SECG, MECG, CMRR devices.

Thanks and Regards,
Subbash
 
Last edited:
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#2
I think,
1. An indication is required in the ECG report to identify the device was in inoperable (saturation or overloaded)
this Indication should visible on the report (like some instruction "device inoperable", or indicated by the absence of a visible trace in the report.

2. The standard states like "if measurements are provided" so it's not mandatory to provide the measurements. (if it's related with 201.12.1.101.1 Automated measurements on ECG)

3. The Recovery Time test will be applicable for the device, but no impact due to this test as the modern ECG devices process all leads together and mostly no hardware lead switch used, (this test will have an impact if the filter required reinitialization after the lead switching)
 
#3
I think,
1. An indication is required in the ECG report to identify the device was in inoperable (saturation or overloaded)
this Indication should visible on the report (like some instruction "device inoperable", or indicated by the absence of a visible trace in the report.

2. The standard states like "if measurements are provided" so it's not mandatory to provide the measurements. (if it's related with 201.12.1.101.1 Automated measurements on ECG)

3. The Recovery Time test will be applicable for the device, but no impact due to this test as the modern ECG devices process all leads together and mostly no hardware lead switch used, (this test will have an impact if the filter required reinitialization after the lead switching)
With reference to point 3, can you please elaborate what exactly you mean by filter reinitialization ?
 
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