Pulse oximeters ISO 80601-2-61, is 0% okay for probe fault?

#1
Per 80601-2-61 section 201.13.101 , a visual indication of pulse oximeter probe faults is required. The example given is a "blank" display.

Is it acceptable to use 0% instead?

Anyone commenting on their experience getting a pulse ox through 510 k) would be greatly appreciated!
 
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#2
#3
Thats a good point, I think blank would probably be best.

For arguments sake: if we risk-analyzed displaying 0% and determined the risk of misinterpretation was low (feasible for our device class/risk profile), do you think that would fly during 510k?

We are already in works to change it from 0% to blank, so this is an academic question to gain some insight.
 
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