Philips Lumify - Transducer Care Methods

Transducer Care Methods Transducer Care
Lumify Ultrasound System 131
Philips Healthcare 4535 618 58571_A/795 * MAY 2016
WARNING
Transducer covers may contain natural rubber latex. Those covers may cause allergic
reactions in some individuals.
For information on allergic reactions to latex-containing medical devices, see “FDA Medical
Alert on Latex” on page 35.
Transducer Care Methods
Transducer care methods are based on the use of the transducer.
Care Methods by Transducer Use
Transducer Use Example Classification Care Method
Contacts intact skin Curved, linear, and sector
transducers
Noncritical Low-level disinfection (see “Low-level
Disinfecting of Transducers” on page
135)
Contacts mucous
membranes
Endocavity and
transesophageal (TEE)
transducers
Semi-critical High-level disinfection (see “High-level
Disinfecting of Transducers” on page
137)
1
Enters otherwise
sterile tissue
Intraoperative and
laparoscopic transducers
Critical Sterilization
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:
www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/UCM070911.pdf