Stryker 0700010000, Руководство пользователя

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Materials and Equipment
All materials and equipment required to reprocess the camera head shall be
supplied by the user unless otherwise noted
Item Description
All phases
Gloves, eye protection,
etc.
Wear protective equipment as required by the medical
facility and procedure.
Cleaning
Tray For safe transportation of device within the medical
facility. Not to be used for reprocessing the device unless
sterilized first.
Water basin Large enough to accommodate camera head without
excessive bending of cable
Enzymatic detergent
1
Used in cleaning solution to remove surgical debris
Tap water To prepare cleaning solutions
Syringe Minimum volume: 50 mL
Soft-bristed brush
2
To clean exterior of device
Reverse osmosis/
deionized water
3
To rinse device
Clean cloth or filtered
pressurized air
To assist with drying
Non-enzymatic
detergent
4
Used in cleaning solution to remove surgical debris
Automated washer For using the automated cleaning procedure
Disinfection
Washer disinfector To perform thermal disinfection
Sterilization
Sterilization system Steam (Autoclave)
Steris®/Amsco® V-PRO® maX, V-PRO 1 Plus, or V-PRO 1
Sterrad® 100S, 200, NX®, or 100NX®
Sterilization wrap
5,6
To maintain sterile barrier
Sterilization tray
6
Optional. Must be compatible with sterilization method.
1
Cleaning was validated using Enzol® Enzymatic Detergent at 1 oz/gal.
2
Cleaning was validated using an M16 brush.
3 Cleaning was validated using reverse osmosis/deionized (RO/DI) water.
4 Cleaning was validated using Prolystica® 2x Neutral Detergent at 1/8 oz/gal.
5 Sterilization was validated using Kimberly-Clark® KC600 KIMGUARD sterilization wrap.
6 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.