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Clean dry cloth or filtered
pressurized air (≤40 psi)
Non-enzymatic
detergent
5
Automated washer-
disinfector
S S t t e e r r i i l l i i z z a a t t i i o o n n
Sterilization system
Sterilization wrap
6,7
Sterilization tray
7
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
Double wrapping the device during sterilization was validated with Kimberly-Clark® KC600 KIMGUARD® sterilization wrap.
7
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.
4.5
Instructions for Reprocessing
4.5.1
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.
4.5.2
Containment and Transportation
•
Reprocess the device as soon as reasonably practical following use.
•
Transport the device in a tray to avoid damage. Follow the facility's internal procedures
for the transportation of contaminated surgical instruments and devices.
4.5.3
Preparation for Cleaning
N N o o t t e e : : F F o o r r n n e e c c e e s s s s a a r r y y m m a a t t e e r r i i a a l l s s a a n n d d e e q q u u i i p p m m e e n n t t , , s s e e e e t t h h e e M M a a t t e e r r i i a a l l s s a a n n d d E E q q u u i i p p m m e e n n t t
t t a a b b l l e e . .
1.
Prepare an enzymatic detergent according to the manufacturer's recommendations
(one ounce per gallon of tap water at 35–40 °C).
2.
Wipe the entire device with the detergent, using a clean cloth.
3.
Immerse the device in the detergent. Using a syringe, inject any inside regions of the
device with 50 mL of the detergent to ensure all parts of the device are reached.
4.
Soak the device in the detergent for a minimum of 15 minutes.
To assist with drying
Used in cleaning solution to remove surgical debris
To perform automated cleaning and (optional) thermal
disinfection
•
Steam (Autoclave)
•
Steris®/Amsco® V-PRO® 1, V-PRO 1 Plus, or V-PRO
maX
•
Sterrad 100S, 200, NX®, or 100NX®
To maintain sterile barrier
Optional. Must be compatible with sterilization method.
EN- 9
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