Manual Cleaning - Stryker 0233–050–064 Manual De Instrucciones

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
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 7,8
Sterilization tray 8
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 Steris System 1 is not intended for use in the United States.
7 Double wrapping the device during sterilization was validated with Kimberly-Clark® KC600 KIMGUARD® sterilization
wrap.
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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 any adapters from the cable to optimize the cleaning and sterilization process.
• 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.
N N o o t t e e : : C C l l e e a a n n i i n n g g w w a a s s v v a a l l i i d d a a t t e e d d w w i i t t h h a a 3 3 0 0 m m i i n n u u t t e e w w a a i i t t t t i i m m e e . .
• 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 Cleaning
4.5.3.1

Manual 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 . .
Used in cleaning solution to remove surgical debris
For using the automated cleaning procedure
To perform thermal disinfection
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• Steam (Autoclave)
• Steris®/Amsco® V-PRO® 1, V-PRO 1 Plus, or V-PRO
maX
• Steris System 1®
• Sterrad 100S, NX®, or 100NX
• Ethylene Oxide (EO)
To maintain sterile barrier
Optional. Must be compatible with sterilization method.
EN- 9