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4.7
Sterilization
4.7.1
STERRAD
®
Instructions For Use | 7 - Feb - 2023 | Version: B
Sterilization Process 100S, NX, 100NX
NOTICE! STERRAD
sterilization may result in cosmetic device changes that do
®
not usually affect the device function.
NOTICE! The product must be completely dry before it can be sterilized in the
STERRAD
sterilizer. Loads containing moisture may cause a cycle cancellation.
®
The STERRAD
Sterilization Systems, manufactured by Advanced Sterilization
®
Products (ASP), use low-temperature, hydrogen peroxide gas plasma technolo-
gy for terminal sterilization of properly cleaned, rinsed, and dried reusable medical
devices.
Refer to the STERRAD
®
tions for use of any STERRAD
www.sterradsterilityguide.com or contact ASP customer service.
Use only legally marketed reprocessing trays
sterilization. Observe the instructions for use of the tray.
1. Make sure that manual or automated cleaning and disinfection is complete.
2. Place the camera head in the reprocessing tray.
3. Place a STERRAD
®
4. Seal the tray.
5. Double-wrap the tray with 2 single layers of legally marketed sterilization
wrap.
6. STERRAD
100S and STERRAD
®
shelf of the sterilization chamber. The bottom shelf must be empty.
STERRAD
NX: Load the wrapped tray on the bottom shelf of the sterilization
®
chamber. The top shelf must be removed.
Position the tray so that the sterilization medium can act thoroughly on all ar-
eas. Do not allow any item to touch the wall of the sterilizer.
7. Start the sterilization cycle in accordance with the manufacturer's instructions
and instructions for use for the sterilizer.
STERRAD
sterilization was validated for the following cycles:
®
STERRAD
100S Short Cycle (top shelf only)
®
STERRAD
NX Standard Cycle (bottom shelf only)
®
STERRAD
100NX Standard Cycle (top shelf only)
®
8. Remove the reprocessed product from the sterilizer.
Ensure that products remain sterile after reprocessing.
1
for sterilization validation the camera head was placed in a standard reprocessing tray (OM-1002-SY)
that was double-wrapped in polypropylene wrap (Kimguard
Kimberly Clark, PC 68248)
Sterilization Systems User Guide for detailed instruc-
unit, ASP's STERRAD
®
that are approved for STERRAD
1
indicator strip in the tray.
100NX: Load the wrapped tray on the top
®
4 Reprocessing
4.7 Sterilization
Sterility Guide (SSG) at
®
KC400 Sterilization Wrap,
®
Page 58 of 62
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