Is insulation between F type applied part and other parts a must?

Roland chung

Trusted Information Resource
#1
Dear all,

There is a battery operated equipment. It is body-worn equipment and has a BF type applied part (esophageal catheter), plastic enclosure and a micro USB port which is intended for data transfer. The equipment does not employ isolation barrier between patient connection and internal circuits (including USB port).

But according to the clause 8.5.2.1, F type applied part shall be separated from all other parts by 1 MOPP for working voltage equal to maximum mains voltage and according to the clause 8.3 b), applied part that is intended to deliver electrophysiological signal from the patient shall be a type BF or type CF applied part.

The equipment now fails the standard clearly. Is there a way to fulfil the standard without redesign? I do not think such body-worn equipment could get an unintended mains voltage.

Any advices will be appreciated!

Roland
 
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Peter Selvey

Staff member
Super Moderator
#2
If the dataport is not intended for use when the patient is wearing the device, it should be OK.

In that case, when used on the patient the whole device is considered the applied part, so no F-Type isolation is necessary.
 

Roland chung

Trusted Information Resource
#3
Thank you for your input.

A warning 'DO NOT CONNECT THE PATIENT DURING DATA TRANSFER' is specified in the user manual.

Is it necessary to prevent from the misuse by design? For example, the equipment stop acquiring data when USB port is connected to the computer.
 
B

bassa

#4
Is it necessary to prevent from the misuse by design?
Not always, but i believe its the best way to go. (when you read the 60601, almost every option to prevent from a risk is by design, but if that is not possible, other alternatives are reached out)
(note that you can prevent from misuse, or remove the hazards that might arise when a product is misused)

Your risk assessment should point out if the risk is bearable, when it's not, the risk must be taken away somehow.

In your case, stopping data acquisition probably won't do, the connection is already made, stopping a digital process (i guess that is what you mean) won't change that.

Maybe a physical way to prevent connection to USB and applied part might be a better option?
or build in the neccesary mop.
 
Last edited by a moderator:

Peter Selvey

Staff member
Super Moderator
#5
As mentioned, for foreseeable misuse it's OK to use risk management.

It is worth to note that the standard has a lot of worst case assumptions in the F-type requirements, for example the patient being exposed to hypothetical low impedance source of mains voltage (not just leakage current, but solid contact with a bare mains part).

When considering foreseeable misuse, it's OK to pull apart these worst case assumptions and make an overall decision based on the true probability of harm, not the probability of misuse.
 
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