Integra Padgett B, User Manual

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Integra
®
Padgett
®
Electric Dermatome Models B and PI
Sterilization
The
Integra Padgett Electric Dermatome Models B and PI
are provided NON-STERILE and
must be sterilized prior to use. The sterilization cycle parameters outlined below have been
validated for the Integra Padgett Electric Dermatome Models B and PI.
Steam Sterilization:
Cycle
Conditions
Exposure
Temperature
Exposure Time Dry Time
Wrapped Pre-Vacuum 132°C (270°F) 4 minutes 40 minutes
Wrapped Gravity 132°C (270°F) 15 minutes 50 minutes
Wrapped
Pre-Vacuum-UK Cycle 134°C -0/+3°C
(274°F -0/+5°F)
3 minutes 50 minutes
Wrapped Pre-Vacuum
- French Cycle 134°C -0/+3°C
(274° F - 0/+ 5° F)
18 minutes 50 minutes
NOTE: Ensure sufficient cooling time after the sterilization process to allow the dermatome
temperature to equilibrate to ambient room temperature.
Never immerse instrument, even to cool. This will result in the unit being damaged and
needing repair.
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.
ETO Sterilization:
The Integra Padgett Electric Dermatome Models B and PI have been successfully validated for
ethylene oxide sterilization to the parameters specified below:
For Wrapped Configurations subjected to 100% Ethylene Oxide (EO) Sterilization, the
following parameters apply:
Precondition the chamber to the specified exposure temperature and 55% relative
humidity for a minimum of one (1) hour. The 100% Ethylene oxide concentration is
725 mg/L. Note the specified exposure temperatures and times, as well as Aeration times
as listed in Table 2 below: