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

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  Post Number #1  
Old 17th July 2018, 05:02 PM
thirdplanet

 
 
Total Posts: 9
Question Pulse oximeters ISO 80601-2-61, is 0% okay for probe fault?

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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  Post Number #2  
Old 18th July 2018, 11:14 AM
yodon

 
 
Total Posts: 1,169
Re: Pulse oximeters ISO 80601-2-61, is 0% okay for probe fault?

Take a look at this recent recall: Draeger Medical Systems, Inc. Jaundice Meter JM-103 and Jaundice Meter JM-105 Recalled Due to Misinterpretation of Display Messages for Out of Range Values

The display showed -0- or --- when the sensor reading exceeded a threshold value. Users misinterpreted this as being ok and the results were not good.

How will your users interpret 0%? Assuming they interpret it incorrectly (i.e., not as you intended), what's the likelihood of harm?
  Post Number #3  
Old 18th July 2018, 01:33 PM
thirdplanet

 
 
Total Posts: 9
Re: Pulse oximeters ISO 80601-2-61, is 0% okay for probe fault?

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.
  Post Number #4  
Old 19th July 2018, 12:02 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,371
Re: Pulse oximeters ISO 80601-2-61, is 0% okay for probe fault?

0% could also mean a dead man finger ... Just take care
  Post Number #5  
Old 19th July 2018, 10:10 AM
yodon

 
 
Total Posts: 1,169
Re: Pulse oximeters ISO 80601-2-61, is 0% okay for probe fault?

Quote:
In Reply to Parent Post by thirdplanet View Post

Thats a good point, I think blank would probably be best.
This is the whole idea behind usability engineering. What Draeger thought was clearly not what the users thought. Without getting user feedback, you're just guessing.
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