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Owner's Guide
Instructions
Sterilization
Manufacturer Contact
Date issued: June 2024
The instructions provided above have been validated by the manufacturer of the medical device as being capable of preparing a medical device for reuse . It
remains the responsibility of the processor to ensure that the processing, as actually performed using equipment, materials and personnel in the processing
facility, achieves the desired result . This requires verification and/or validation and routine monitoring of the process .
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Do not sterilize the base unit or accessories . Only the handpiece sheath and ultrasonic inserts are
intended to be sterilized .
Pre-Vacuum: Place cleaned and dried BioSonic Inserts and Sheaths in an FDA-cleared sterilizer pouch .
Sterilize the pouched BioSonic inserts and sheaths via a pre-vac steam sterilizing cycle at 132°C for 4
minutes with a 30-minute drying time, or alternatively 134°C for 3 minutes with a 30-minute drying
time .
Do not use cold sterilization, chemical disinfection, or other methods of sterilization, including
chemical vapor and dry heat, since these methods may severely damage the insert and will void the
warranty .
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