EasyManua.ls Logo

Philips HD11 XE - Acoustic Coupling Medium; Cleaning, Disinfecting, and Sterilizing Transducers; Table 8-1 Levels of Disinfection Requirements

Philips HD11 XE
278 pages
To Next Page IconTo Next Page
To Next Page IconTo Next Page
To Previous Page IconTo Previous Page
To Previous Page IconTo Previous Page
Loading...
8
HD11 XE Getting Started
4535 612 62651
161
Transducer Care and Maintenance
Acoustic Coupling Medium
For proper transmission of the acoustic beam, use the ultrasound transmission
gel supplied by or recommended by Philips, or another glycol, glycerol, or
water-based acoustic coupling medium.
CAUTION
Do not use mineral oil, oil-based couplants, gels with lotions or emollients of any
kind, or other unapproved materials because they might damage the transducer.
Cleaning, Disinfecting, and Sterilizing Transducers
This section provides information and instructions for cleaning, disinfecting, and
sterilizing transducers, cables, and connectors.
Choosing a Disinfectant
To choose an appropriate disinfectant, you first must determine the required level
of disinfection, based on the device classification (Table 8-1).
Table 8-1 Levels of Disinfection Requirements
Classification Definition Level of Disinfection
Critical Device enters otherwise sterile
tissue (for example, intraoperative
applications)
Sterilization
a
a. High-level disinfection and the use of a sterile gel and a sterile 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 Diag-
nostic Ultrasound Systems and Transducers,” September 30, 1997. For more
information, see the following Web site: www.fda.gov/cdrh/ode/ulstran.pdf
Semi-critical Device contacts mucous
membranes (for example,
intracavity applications)
High
Noncritical Device contacts intact skin Intermediate or low

Table of Contents

Related product manuals