USB charging and NIBP device

#1
My question may have been at least partly answered in other posts already, but I would like to be 100% sure.

We are designing a NIBP device. The only applicable part (BF) is the cuff itself.

The device will have an accessible USB connector used both for data transmission and charging.
It will be possible to charge it when in use, using a dedicated mains / 5V adapter connected to the USB connector. As part of the risks management it is however anticipated that the user may use another adapter, even it the documentation will forbid it.

As the applicable part has no PATIENT CONNECTION as per 60601-1 definition, and considering chapter 8 of the standard do we still need a galvanic isolation between the USB connector and the rest of the device?

If so, can the isolation be provided by the mains / 5V adapter or is it mandatory to place the isolation in the device itself, after the connector?

Thanks for your views
 
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#2
If it's home use you might have to delineate between the user being both "operator" and "patient" at the same time, for example pressing the start button is operator (hence no isolation from USB/internal voltages required), while the cuff measurement is patient (isolation required, but inherent, but obviously OK, air filled tube).

I would be comfortable with this but if you are getting the device tested by a lab they may not see it that way. You should discuss this up front before deciding the test lab.
 
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