Zoektermen
(1) High-level disinfection and the use of a sterile gel and a transducer cover, as described in the instructions provided with the transducer cover, is an accepted method of infection control for ultrasound transducers. See the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," updated September 9, 2008, at the following website.
All imaging transducers are rated at a minimum IPX7 in accordance with IEC 60529, “Degrees of Protection Provided by Enclosures (IP code).” This rating indicates that the device is protected against the effects of immersion. Continuous wave (non-imaging) transducers are rated IPX1. This rating indicates that the device is protected against the effects of vertically falling water. For all TEE transducers, the control module is rated IPX1, while the endoscope is rated IPX7, in accordance with IEC 60529.
These warnings and cautions must be observed during all cleaning, disinfection, and sterilization procedures.
WARNINGS
CAUTIONS