Sterilizing Transducers
Sterilization is required if the device is classified as a critical device, and is used without a sterile cover or if the sterile cover is breached.
WARNINGS:
Always use protective eyewear and gloves when cleaning, disinfecting, or sterilizing any equipment.
In neurosurgical applications, sterilized transducers should be used with a pyrogen-free transducer cover.
If a premixed solution is used, be sure to observe the solution expiration date.
Cautions:
Transducers must be cleaned after each use. Cleaning the transducer is an essential step before effective disinfection or sterilization. Be sure to follow the manufacturer's instructions when using disinfectants.
Sterilize transducers by using only liquid solutions. Using autoclave, gas (EtO), or other methods not approved by Philips Ultrasound will damage your transducer and void your warranty.
Do not allow sharp objects, such as scalpels and cauterizing knives, to touch transducers or cables.
When handling a transducer, do not bump the transducer on hard surfaces.
Ensure the solution strength and duration of contact are appropriate for sterilization. Be sure to follow the manufacturer's instructions.
To sterilize a transducer
1. Clean the transducer according to the General Cleaning Procedures for All Transducers.
2. Mix the sterilization solution compatible with your transducer (use the Find Compatible Disinfectants search tool to find compatible sterilization solutions) according to label instructions for solution strength. A disinfectant listed in the search results with the footnote "FDA 510(k) cleared" is recommended in the U.S.
3. Immerse the transducer in the sterilization solution (see figure 1).
Figure 1: Immersion Section
4. Follow the instructions on the sterilization label for the duration of transducer immersion required for sterilization.
5. Remove the transducer from the sterilization solution after the recommended sterilization time has elapsed.
6. Using the instructions on the sterilization label, rinse the transducer in sterile water up to the point of immersion, and then air dry or towel dry with a sterile cloth.
7. Examine the transducer for damage, such as cracks, splitting, fluid leaks, or sharp edges or projections. If damage is evident, discontinue use of the transducer, and contact your Philips Ultrasound representative.
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