Isolation requirements for Wireless ECG device

#1
Hi Beloved Engineers,

I have a question regarding IEC60601-1 requirement for Wireless ECG device.
-> This device will be internally powered. (Li-Po rechargeable battery)
-> Device will be connected to PC wirelessly (Bluetooth)
-> Also recharged Wirelessly (qi 2.0).
-> Defibrillator protected with transient suppression diodes

Which clearly means device will never be connected to mains supply in its entire life cycle..
So do I really need MOOP (Means of operator protection) and MOPP (Means of patient protection)
rough block diagram is attached.

Thanks in advance.

Winston
 

Attachments

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Benjamin Weber

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#2
You maybe also need means of protection (operator and patient) for secondary circuits. For operator protection I see a good chance, that the voltage and stored energy in the battery will be below the limits of cl. 8.4.2 c). But for patient protection there is no scuh thing as "safety extra voltage" at all in 60601. You have to make sure, that the leakage and patient auxiliary current limits are not exceeded. And therefor MOPP should be implemented.
 
#3
Thanks Benjamin,

Can you please look at attached block diagram and tell me if that isolation is enough for MOPP ?
Or do I need isolation between defib protection and ADC input ? Apologies if this question is noob.

Thanks,

Winston
 

Attachments

#4
Hi Winston,
The only isolation barrier I see is between the battery terminals and the enclosure (2MOOP for 3.3Vdc), that should be ensured by the plastic enclosure.
However, you have to check that the auxiliary leakage currents between the different connections to the patient, and also between the patient connections and the other parts (enclosure) remain below the limits in both normal and SF conditions. Normally this should be the case thanks to the high input impedance of the ECG amplifier. But still you have to check it by putting in fault the relevant components and barriers.

Regards

Souheil
 
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