Sterilization - Integra Padgett S Guide De L'utilisateur

Sterilization

The Electric Slimline Dermatome Models S and S6 are provided NON-STERILE and must be
sterilized prior to use. The sterilization cycle parameters outlined below have been validated
for the Electric Slimline Dermatome Models S and S6.
Steam Sterilization:
Cycle
Conditions
Wrapped Pre-Vacuum
Wrapped Gravity
Wrapped Pre-Vacuum
- UK Cycle
Wrapped Pre-Vacuum
- French Cycle
NOTE: Ensure sufficient cooling time after the sterilization process to allow the dermatome
temperature to equilibrate to ambient room temperature.
100% Ethylene Oxide Sterilization: Precondition the chamber to the specified exposure
temperature and 55% relative humidity for a minimum of 1 hour. The 100% Ethylene Oxide gas
concentration is 725 mg/L.
Cycle
Conditions
Wrapped
Wrapped
Note: It is the sole responsibility of the end user to validate alternate sterilization
methods and cycles that do not comply with the validated sterilization methods
and cycles specified within this manual.
Exposure
Temperature
132°C (270°F)
132°C (270°F)
134°C -0/+3°C
(274° F - 0/+ 5° F)
134°C -0/+3°C
(274° F - 0/+ 5° F)
Exposure
Temperature
37°C (99°F)
55°C (131°F)
Exposure Time
4 minutes
15 minutes
3 minutes
18 minutes
Exposure Time Aeration Time
12 hrs. min at
8 hours
51-59°C
12 hrs. min at
180 minutes
51-59°C
Dry Time
20 minutes
20 minutes
15 minutes
15 minutes
18