Leakage Current Testing For Intraoperative Transducers - Philips EPIQ 7 User Manual

Leakage Current Testing for Intraoperative Transducers

Intraoperative Transducers
Intraoperative transducers are classified as a Type CF isolated patient-applied part, as
described in IEC 60601-1. There are no exposed conductive surfaces on the transducer head. To
ensure safe operation of this transducer, read the cautions and warnings in the "Safety"
section, especially those that address electrosurgical units, pacemakers, and defibrillators.
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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