Integra CUSA Clarity System - Sterilizing the System

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CUSA® Clarity System Service and Maintenance Manual Page 45 of 117 0645403-2-EN
Note
Make sure to keep the connector dry.
Note
Make sure to keep the handpiece cable connector dry.
• If the footswitch is contaminated with blood or fluid:
o Immerse the footswitch in warm water containing detergent or disinfectant.
o Rinse the footswitch with clean water.
• Allow the footswitch to drain aer rinsing.
Cleaning the Handpiece, EUT, and Torque Base:
The handpiece, tips, and torque base may be cleaned by either manually cleaning or autowash cycle process prior to sterilization.
Item Initially Sterile Reusable/Requires
Sterilization by the User
Validated Number of
Sterilizations Cycles
Sterilization Method
Handpiece No Yes 200 Steam
Torque Base No Yes 200 Steam
Torque Wrench Yes No Single Use Not Applicable
CUSA Quick Connect
Cartridge and Tubing Set
Yes No Single Use Not Applicable
Single Use Tip Pack (all items) Yes No Single Use - One time
prior to use
Steam
EUT Tip Pack (all items) No Tip: Yes 5 (EUT tip only) Steam
All other items: No (not
reusable; but require
sterilization prior to use)
Flue, stylet and
nosecone - one time
prior to use
6.3.2 Sterilizing the System
Sterilize the CUSA® Clarity system components and accessories with steam. Some of the CUSA Clarity system accessories are sterile, single-use items.
Other accessories are reusable. Table 6-2 describes the sterilization requirements for the handpiece and accessories.
• Manually Cleaning the Handpiece, Tips and Torque Base
o Use the provided cleaning brush to clean out the internal channels of both the handpiece and tip. Continue to pass the brush
through the tip and handpiece until it comes out clean.
o Clean the exterior of the handpiece and tip with a lint free cloth soaked with warm water and a non-alkaline detergent.
o Manually clean the junction with a so cloth where the tip aaches.
o Rinse the entire handpiece, tip thoroughly with water, and dry with a so cloth.
• Autowash Cycle:
o Before autowashing, thoroughly clean the internal channels of the handpiece and other components with the cleaning brush
Continue to pass the brush through the tip and handpiece until it comes out clean.
o In a Steelco DS50 DRS or equivalent washer/disinfector, perform a prewash cycle of 5 minutes, then clean using a 1% solution of
alkaline detergent (neodisher® MediClean forte or equivalent, final pH between 10.0-11.5) for 10 minutes at 60°C (140°F), disinfect for
10 minutes at 93°C (199.4°F), and dry for 20 minutes.
Table 6-2 Sterilization Requirements
WARNING
Single-use devices are for single patient use only. Do not reprocess or re-use.