10
Sterilization Parameters
The CUSA Clarity handpiece and components must be sterilized with steam.
Sterilization Tray Packaging
The handpiece and components can be packaged in the sterilization tray either:
•
Wrapped
—Sterilization tray double wrapped in hospital CSR material
•
Immediate-Use Steam Sterilization / Flash (Unwrapped)
— Sterilization tray unwrapped
The cycles below were validated for sterilizing the CUSA Clarity handpiece and components:
Packaging
Temperature
Type
Time
Dry Cycle
Wrapped
132˚C (269.6˚F)
Prevac
4 min
40 min
134˚C (273.2˚F)
Prevac
3 min
40 min
134˚C (273.2˚F)
Prevac
18 min
40 min
Immediate-Use Steam
Sterilization / Flash
(Unwrapped)
132˚C (269.6˚F)
Prevac
4 min
None
Sterilization Cycles for the 23 kHz and 36 kHz Handpiece and Components
CAUTION
Do not sterilize flues with temperatures in excess of 134ºC (273.2°F)
as this may damage the flue.
The CUSA Clarity handpieces and components can be effectively
sterilized with alternate cycles between the ranges of the validated
sterilization cycles outlined in the tables above. If an alternative
sterilization cycle is used, it is recommended that the reprocessor
ensures use of FDA cleared sterilizers and accessories for the alter-
native sterilization cycle.
The figure to the right illustrates the endpoints of the steam
sterilization cycles that have been validated to achieve effective
sterilization. Cycles that fall outside of the shaded gray area have
not been validated.
St
eriliz
ation T
emper
at
ur
e (°C
)
Sterilization Time (min)
3
3.5
4
18
132
133
134
135
136
137
