Leakage Current Testing for Intraoperative Transducers
Philips transducers approved for intraoperative use are labeled on the transducer
connector as Type CF in accordance with the IEC 60601-1. Type CF
classification indicates that the degree of protection from electrical shock afforded
by the transducer is suitable for all patient applications, including direct cardiac
and intraoperative applications.
Leakage current tests should be performed by a technically qualified person any
time that the transducer is dropped or if cracks or cuts are found on the
transducer.
Normal leakage current testing frequency should be based on the procedures
established by the hospital for operating-room-based equipment.
Regularly perform the electrical safety check to ensure that IEC 60601-1 Type
CF leakage limits are not exceeded. You can perform this procedure with any
commercially available safety analyzer that is designed for hospital use.
WARNING
Only a technically qualified person should perform the leakage current test
procedure.
Test 1 tests the current leakage, using a Dynatech Nevada 232 Safety/ECG
Analyzer. This procedure shows one example of a current leakage test (source
and sink). The procedure for your safety analyzer may be very different.
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Intraoperative Transducers