GE Vscan Air Manual page 329

Leakage current and dielectric strength tests
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Vscan Air User Manual
Direction GP092020-1EN Rev 18
The Vscan Air CL probe is completely sealed. All data
communication to and from the probe, and all energy transfer to
the probe is performed wirelessly. The probe does not have any
connectors, metal-parts, or live parts accessible to the operator
or the patient. The biocompatible probe handle plastic material
is fully encapsulating the internal electronics, and also serves as
dielectric protection against any live parts. The dielectric
strength was tested during product approval as well as testing
for IP67 compliance. Design in combination with the tightness
test performed on all manufactured units guarantees the safety
of the operator and/or patient. A hazardous electrical circuit
could only be created if two live parts were exposed to the
patient or the user in such a way that a closed electrical circuit
could be created. For the operator or patient to gain access to
one or two live parts, the plastic housing of the Vscan Air probe
would need to be cracked open, first in one location, then in a
second location. The two cracks would next need to be large
enough for the operator or patient to insert one left hand finger
and one right hand finger, both being live, to create a closed
loop. The likelihood of this to occur is not reasonably
foreseeable.
The Vscan Air probe is an internally powered ultrasound device
and it does not have any electrical closed loop during intended
patient or operator use, therefore no electrical hazard applies. It
is not possible to conduct standard high-voltage tests, leakage
current tests, dielectric strength tests without destroying the
product due to the isolated/enclosed design of the Vscan Air
probe. The Vscan Air risk assessment does not identify a
necessity of leakage current and dielectric tests to be performed
as routine tests.
System care and maintenance
6-5