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HD11 XE Getting Started
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Transducer Care and Maintenance
Safety Considerations When Using Disinfectants and Gels
Observe the following warnings and cautions when using disinfectants and gels.
More specific warnings and cautions are included within the various procedures in
this section and on the labels of the cleaning or disinfection solutions.
ARNINGS
• Disinfectants listed in “Disinfectants Compatibility Table” on page 178 are rec-
ommended because of their chemical compatibility with product materials, not
their biological effectiveness. For the biological effectiveness of a disinfectant, see
the guidelines and recommendations of the disinfectant manufacturer, the U.S.
Food and Drug Administration, and the U.S. Centers for Disease Control.
• The level of disinfection required for a device is dictated by the type of tissue
it will contact during use. Ensure the disinfectant type is appropriate for the
type of transducer and the transducer application. For information on the lev-
els of disinfection requirements, see Table 8-1. Also, see the disinfectant label
instructions and the recommendations of the Association for Professionals in
Infection Control, the U.S. Food and Drug Administration, and the U.S. Cen-
ters for Disease Control.
• Some transducers cannot be sterilized. For intraoperative procedures,
high-level disinfections and the use of a sterile transducer cover and gel (as
described in the instructions provided with the transducer cover) is an
accepted method of infection control. See the FDA Guidance document
“Information for Manufacturers Seeking Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers,” September 30, 1997. The guidance
document is located on the following Web site:
www.fda.gov/cdrh/ode/ulstran.pdf
For information on ordering transducer covers, contact CIVCO (see “HD11
XE System Supplies, Peripherals, and Accessories” on page 259).
• The use of protective transducer covers and coupling gel is recommended for
clinical applications of all intracavity transducers (including transesophageal).
Use a sterile protective transducer cover with sterile ultrasound transmission
gel during intraoperative and biopsy examinations.
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