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Philips iE33 - Electrical Safety and TEE Transducers; Leakage Current and TEE Transducers; Reducing Risks of Using TEE Transducers

Philips iE33
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Electrical Safety and TEE Transducers
The ultrasound system and its transducers comply with common medical device
electrical safety standards.
For electrical safety information about TEE transducers, see "Leakage Current
and TEE Transducers" on page 246 and "Reducing Risks of Using TEE Transducers"
on page 246.
For safety information on electrosurgical units, pacemakers, defibrillators, and
related topics, see "Electrical Safety" on page 28.
Leakage Current and TEE Transducers
For the TEE transducers discussed in this document, the insertion tube and tip
are Type BF , as described in IEC 60601-1. There are no exposed conductive
surfaces distal to the transducer handle. Within the flexible shaft, all active circuits
and conductors are surrounded by a chassis-grounded shield that runs the length
of the transducer.
If the outer layer of the shaft is punctured or cracked, a patient’s esophagus
could be exposed to chassis leakage current. This leakage current is not hazardous
provided that the ground connector (third wire) in the ultrasound system power
cable is intact and connected to a properly grounded wall outlet. Even if the
ground connector breaks, leakage current is in compliance with the limits noted
in IEC 60601-1.
Leakage hazards are further reduced when the ultrasound system is plugged into
an isolated power outlet, which is standard in most operating rooms.
Reducing Risks of Using TEE Transducers
To reduce the possibility of electrical risks associated with use of TEE transducers,
follow these recommendations:
Visually and tactually inspect a TEE transducer for bumps, cracks, and cuts
before each TEE exam. A small bump on the shaft surface could indicate
iE33 User Manual
246
4535 616 23901
Transesophageal Transducers
10

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