Sterilize the Handpiece
Sterilizing Handpieces and
Accessories
CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide 10-3
Sterilize the Handpiece
Sterilizing with Steam
Sterilizing the handpiece with steam depends on the following factors:
•Temperature
•Exposure time
• Population and resistance of resident bioburden
• The method of removing air from the autoclave (high vacuum versus
gravity displacement).
Use the validated steam sterilization cycle parameters in these
instructions. If you deviate from this recommended method of
processing, it is your responsibility to validate the deviations.
For sterilizing the handpiece with steam, do not exceed 138° C (280° F).
Validation of Steam Sterilization Parameters
A steam sterilization study was conducted according to AAMI TIR
No. 12-1994–Designing, Testing, and Labeling Reusable Medical Devices
for Reprocessing in Health Care Facilities: A Guide for Device
Manufacturers.
Challenge
A minimum of 1 x 10
6
bacillus stearothermophilus on a spore strip/disk
carrier and a braided nylon suture carrier. (D
121°C
= 1.5 and 1.6 minutes).
Placement of Biological Indicators (BIs)
Without Manifold Tubing Attached – Cycles that do not include the CUSA EXcel
Manifold Tubing contained three BIs (spore sutures) in each of three
CUSA EXcel handpieces for a total of nine BIs per run. The locations were
in the center of an unattached tip, in the center of an unattached flue
tubing with tip cleaner inserted into the flue, and under the front o-ring of
the handpiece.
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