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Electrosurgical Device User Need: Cord Flexibility -> Requirement

pziemlewicz

Involved In Discussions
#1
Cord flexibility was identified as user need for electrosurgical device. I get it, but am having trouble translating that into a requirement that can be verified or validated. Maybe there's an electrical engineering standard I'm missing. Can someone provide suggested requirement wording?

Thank you!
 
Elsmar Forum Sponsor
#2
Perhaps a bit obscure and OTT, but the pacemaker standard (I think this is from EN 45502) has requirements for lead flexibility.
Sorry I can't quote at the moment as I am stuck at home without access to the standard.

The requirement is based on bend radius under specified load. If I remember correctly, take a sample of the lead and hold at a 45 degrees upward angle. Measure the internal radius of the 'droop'. A truly flexible lead will droop almost totally.
 

pziemlewicz

Involved In Discussions
#3
Perhaps a bit obscure and OTT, but the pacemaker standard (I think this is from EN 45502) has requirements for lead flexibility.
Sorry I can't quote at the moment as I am stuck at home without access to the standard.

The requirement is based on bend radius under specified load. If I remember correctly, take a sample of the lead and hold at a 45 degrees upward angle. Measure the internal radius of the 'droop'. A truly flexible lead will droop almost totally.
Thank you! This is very helpful.
 

yodon

Staff member
Super Moderator
#4
This sounds like straight-up usability (62366), IMO, and could be validated in a summative study. Obviously, before you get there, you'd do formative studies to ensure that the flexibility met their usability needs.
 

pziemlewicz

Involved In Discussions
#5
This sounds like straight-up usability (62366), IMO, and could be validated in a summative study. Obviously, before you get there, you'd do formative studies to ensure that the flexibility met their usability needs.
Yes. The formative studies suggested that we may want something more flexible than the current, and it will be evaluated as part of the summative. That said, I guess it's really the translation from user requirement to product requirement to product requirement where I'm struggling. If possible, I'd like to verify at a component level prior to summative study.
 
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