Stryker AIM SafeLight Mode D'emploi page 11

1
Cleaning was validated using ENZOL® Enzymatic Detergent at 1 oz/gal. of tap water at 35 °C.
2
Cleaning was validated using a 50 mL syringe.
3
Cleaning was validated using an M16 soft-bristle brush.
4
Cleaning was validated using reverse osmosis/deionized (RO/DI) water.
5
Cleaning was validated using Prolystica® 2x Neutral Detergent at 1/8 oz/gal. of tap water at 35 °C.
6
Disinfection was validated using CIDEX® OPA at 25 °C with a soaking time of 12 minutes.
7
Disinfection was validated using deionized water.
8
Double wrapping the device during sterilization was validated with Kimberly-Clark® KC600 KIMGUARD®
sterilization wrap.
9
For United States users: when sterilizing the device, use only sterilization wraps and sterilization trays that
have been cleared by the FDA to use with the selected sterilization cycle.
Instructions for Reprocessing
Point of Use
• Remove the scope adapter from the cable to optimize the cleaning and
sterilization process. Reprocess the adapter according to instructions in the
SafeLight Scope Adapter user manual (P10238).
• Wipe excess soil from the device using disposable paper towels.
• If an automated reprocessing method will be used, rinse any hard-to-reach areas
in the device with 50 mL of sterile distilled water immediately after use.
Containment and Transportation
• Reprocess the device as soon as reasonably practical following use.
Note: cleaning was validated with a 30 minute wait time.
• Transport the device in a tray to avoid damage. Follow the facility's internal
procedures for the transportation of contaminated surgical instruments and
devices.
Cleaning
Manual Cleaning
Note: for necessary materials and equipment, see the Materials and Equipment
table.
1. Soak
• Prepare an enzymatic detergent according to the manufacturer instructions.
• Fully immerse the device in the detergent. Use a syringe to inject 50 mL of the
detergent into any mated services and crevices to remove loose debris.
• Soak the device in the detergent for 10 minutes.
2. Brush
• Thoroughly brush the exterior of the device with a soft-bristle brush for
90 seconds, focusing on any mated surfaces and crevices.
• Use a syringe to inject 50 mL of the detergent into any mated surfaces and
crevices 5 times.
EN-7