Patient Circuits / Patient Connection / Applied Parts - Medical Device Definitions

W

william_N

#1
Hi all, I have a confusing problem about understanding patient circuits/patient connection/applied parts?
for example: a non-invasive sphygmomanometer. applied part is obvious.
but what is patient connection? what is patient circuits?

Thanks
 
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Peter Selvey

Staff member
Super Moderator
#2
Re: Patient circuits/Patient connection/Applied parts

An applied part is a part of the equipment which needs to contact the patient in normal use. Issues associated with applied parts include electric shock, burns (thermal) and biocompatiblity.

A patient connection is a part of the applied part through which current can flow, so it is purely an electrical issue. Also it is possible that a single applied part (such as an ECG) can have multiple patient connections (e.g. RA, LA, LL, etc).

A patient circuit was a defined term in the 2nd edition, but this has been left undefined in the 3rd, and only appears twice and one time seems to be a mistake and the other in the rationale. The idea was to capture the electrical circuits that extend into the medical device, such as an ECG circuit. It's still a good concept, but not one that needs to be written into the standard (you don't have to have a patient circuit, in other words).
 
W

william_N

#3
Re: Patient circuits/Patient connection/Applied parts

hi, peter, thanks for your reply. Is mean that if a device has a patient connection it has applied part definitely, however, if has applied part maybe have a patient connection?
 

Peter Selvey

Staff member
Super Moderator
#4
Re: Patient Circuits / Patient Connection / Applied Parts - Medical Device Definition

Yes, it is possible to have an applied part where there is no possibility for current to flow (e.g. NIBP with air filled tubing to the cuff).

Normally if there are circuits inside an insulated probe (e.g. temp probe, SpO2 probe) it is still considered to be a patient connection through capacitive coupling.

Also, if the probe insulation is not really designed for safety (e.g. many SpO2 probes) then the internal circuit could be considered the actual patient connection.
 
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