Integra cusa excel User Manual page 118

Sterilize the Handpiece
With Manifold tubing Attached
– Cycles that include the CUSA EXcel Manifold
Tubing contained five BIs in each of three CUSA EXcel handpiece
assemblies for a total of 15 BIs per run. The locations were the following:
• In the center of the manifold suction tubing (spore strip or dot)
• In the center of the manifold irrigation tubing (spore strip or dot)
• In the center of an unattached tip (spore suture)
• In the center of an unattached flue tubing with tip cleaner inserted into
the flue (spore suture)
• Under the front o-ring of the handpiece (spore suture).
Acceptance Criteria
In order for the CUSA EXcel handpiece to be considered validated, none
of the biological indicators demonstrated growth of the indicator
organism. A 6-log reduction at the half cycle exposure time indicates that
a full cycle (twice the half cycle exposure time) will produce sufficient
-6
lethality to effect at least a 12-log reduction and provide a 10 sterility
assurance level (SAL).
Packaging
Wrapped: Sterilizer case double wrapped in hospital CSR material.
Flash: Sterilizer case unwrapped.
10-4 CUSA Excel Ultrasonic Surgical Aspirator System User's Guide