17
Sterilization
The
Model SB Slimline Dermatome
is provided NON-STERILE and must be sterilized
prior to use. The sterilization cycle parameters outlined below have been validated
for the Model SB Slimline Dermatome.
Steam Sterilization:
Cycle
Conditions
Exposure
Temperature
Exposure Time
Dry Time
Wrapped Pre-Vacuum
132°C (270°F)
4 minutes
20 minutes
Wrapped Gravity
132°C (270°F)
15 minutes
20 minutes
Unwrapped (Flash)
Pre-Vacuum
132°C (270°F)
4 minutes
N/A
Unwrapped (Flash)
Gravity
132°C (270°F)
15 minutes
N/A
NOTE:
Ensure sufficient cooling time after the sterilization process to allow the
dermatome temperature to equilibrate to ambient room temperature. This is
especially important when utilizing a flash sterilization cycle.
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
Exposure
Temperature
Exposure Time
Aeration Time
Wrapped
37°C (99°F)
8 hours
12 hrs. min at
51-59°C
Wrapped
55°C (131°F)
180 minutes
12 hrs. min at
51-59°C
Sterrad Sterilization:
Dermatome to be processed on STERRAD® 100S unit (short
cycle) which 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.
