I I t t e e m m
Clean cloth or filtered
pressurized air (≤40 psi)
Non-enzymatic detergent
5
Automated washer
D D i i s s i i n n f f e e c c t t i i o o n n
Water basin
Disinfecting solution
Tap water
Reverse osmosis/
deionized water
4
Clean cloth or filtered
pressurized air (≤40 psi)
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
Sterilization tray
9
1
Cleaning was validated using ENZOL® Enzymatic Detergent at 1 oz/gal. at 35 °C.
2
Cleaning was validated using a 50 mL syringe.
3
Recommend to clean with 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 at 35 °C.
6
Disinfection was validated using CIDEX® Activated at 25 °C with a soaking time of 45 minutes.
7
Steris System 1, System 1 Plus, and System 1 Express are not intended for use in the U.S.
8
Sterilization was validated using 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.
EN
34
D D e e s s c c r r i i p p t t i i o o n n
To assist with drying
Used in cleaning solution to remove surgical debris
For using the automated cleaning procedure
Large enough to accommodate camera head without
excessive bending of cable
6
≥ 2.4% glutaraldehyde
To prepare disinfecting solution
To rinse the device
To assist with drying
7
· Sterrad 100S, 200, NX®, or 100NX
· Steris/Amsco® V-PRO® 1, V-PRO 1 Plus, or V-PRO maX
· Steris System 1®, System 1E®, System 1 Plus, or
System 1 Express
· Ethylene Oxide (EO)
8,9
To maintain sterile barrier
Optional. Must be compatible with sterilization method.
P29924F