Sterilization - Integra Padgett C Manual De Operación

STERILIZATION

The Model C Air Dermatome is provided NON–STERILE and must be sterilized prior to use. The
sterilization cycle parameters outlined below have been validated for the Model C Dermatome.
Steam Sterilization:
Cycle
Conditions
Wrapped Pre-
Vacuum Settings
Wrapped Gravity
Settings
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
Sterrad Sterilization: Dermatome to be processed on STERRAD
consists of the following steps:
Vacuum
1st Injection Stage
1st Diffusion Stage
1st Gas Plasma Stage
2nd Injection Stage
2nd Diffusion Stage
2nd Gas Plasma Stage
Vent
Total Cycle Time = ~55 minutes
It is the user's responsibility to validate any sterilization parameters that are not provided directly by
the manufacturer.
Exposure
Temperature
132°C (270°F)
132°C (270°F)
Exposure
Temperature
37°C (99°F)
55°C (131°F)
Exposure Time
4 minutes
15 minutes
Exposure Time
8 hours
180 minutes
100S unit (short cycle) which
®
Dry Time
20 minutes
20 minutes
Aeration Time
12 hrs. min at
51-59°C
12 hrs. min at
51-59°C
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