Hi everyone,
I'm developing a wearable ECG device and given that I'm new to IEC60601, I'm having some insecurities regarding the electrical safety.
My device has the following characteristics: - Battery powered device (compliant with IEC 62133-2:2017) - Applied parts: the whole wearable device. I assume it is a type BF applied part. - Patient connections: 2 electrodes / snaps for ECG circuit - Accessible parts: SD card socket (where an SD card is inserted) and P3A port (used for charging) - Accessories: Medical-grande charger (compliant with IEC60601-1 with 2 MOPP) with a P3A output.
I'm complying with the separation between the patient connection and all the other parts (clause 8.5.2.1) through the ADuM4401, which gives me 2 MOPP.
My question is: Given that the device can only be charged via my medical-grande charger via the P3A port (which isn't something common), do I need to add any more separation in my circuit? Namely at the charging part.
I'm developing a wearable ECG device and given that I'm new to IEC60601, I'm having some insecurities regarding the electrical safety.
My device has the following characteristics: - Battery powered device (compliant with IEC 62133-2:2017) - Applied parts: the whole wearable device. I assume it is a type BF applied part. - Patient connections: 2 electrodes / snaps for ECG circuit - Accessible parts: SD card socket (where an SD card is inserted) and P3A port (used for charging) - Accessories: Medical-grande charger (compliant with IEC60601-1 with 2 MOPP) with a P3A output.
I'm complying with the separation between the patient connection and all the other parts (clause 8.5.2.1) through the ADuM4401, which gives me 2 MOPP.
My question is: Given that the device can only be charged via my medical-grande charger via the P3A port (which isn't something common), do I need to add any more separation in my circuit? Namely at the charging part.
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