Stryker SERFAS - Page 19

CLEANING AND STERILIZATION
STERILIZATION:
The recommended sterilization parameters are only valid with sterilization equipment that is properly maintained and
calibrated. The Handpiece Cable can be sterilized using one of the following methods:
1. EtO Sterilization
2. Steam Sterilization
NOTE: Handpiece Cables can be sterilized and should be replaced if inspection indicates any damage.
1. Clean and prepare the Handpiece Cable as described in the Handpiece Cable Cleaning Section (pg 14).
2. Sterility has been validated using the following sterilization methods and parameters only. Do not use any other
sterilization method.
EtO Sterilization (100% EtO, wrapped)
Temperature: .............................................55ºC (131ºF)
Exposure Time: ............................................... 60 minutes
Aeration Time: .................................8 hours, 55ºC (131ºF)
Steam Sterilization
1. Pre-Vacuum, Wrapped:
Temperature: ........................... 132 – 135ºC (270 – 275ºF)
Exposure Time: ................................................. 4 minutes
Drying Time: .................................... 5 minutes (minimum)
2. Pre-Vacuum, Unwrapped:
Temperature: ........................... 132 – 135ºC (270 – 275ºF)
Exposure Time: ................................................. 4 minutes
Drying Time: .................................... 5 minutes (minimum)
3. Gravity, Wrapped:
Temperature: ........................ 121 – 123ºC (250 – 254ºF)
Exposure Time: ............................................... 30 minutes
Drying Time: ...................................................... 8 minutes
4. Gravity, Unwrapped:
Temperature: ........................... 132 – 135ºC (270 – 275°F)
Exposure Time: ............................................... 10 minutes
Drying Time: ...................................................... 8 minutes
CAUTION:
● Make sure the Handpiece Cable is thoroughly dry prior to use. Wet cables may damage the cable and other
system components.
● After sterilization, inspect the Handpiece Cable for any signs of damage, such as nicks or cuts. DO NOT reuse
any damaged cables.
● Ensure that cable connectors are properly attached to Probe and Generator prior to use.
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