Stryker 1688-020-122 Manual Del Usuario página 9

Clean lint-free cloth or filtered
pressurized air (≤ 40 psi)
Automated washer
Disinfection
Water basin
Disinfecting solution
Lukewarm water
Reverse osmosis/
deionized water
Clean lint-free cloth or filtered
pressurized air (≤ 40 psi)
Sterilization
Sterilization system
Sterilization wrap
Sterilization tray
1
The following detergents were validated for cleaning efficacy according to the
manufacturer's instructions. Choose one of the detergents listed below or a substantially
equivalent detergent:
Detergent
ENZOL® Enzymatic
Detergent
Prolystica® 2X
Neutral Detergent
Neodisher®
MediClean Forte
2
Cleaning was validated with an M16 soft-bristle brush.
3
Rinsing the device during cleaning and disinfection was validated using reverse osmosis/
deionized (RO/DI) water at ≤30°C.
4
Disinfection was validated using CIDEX® Activated at 25 °C with a soaking time of
45 minutes.
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.
7
Stryker sterilization trays 0233-032-301, 0233-032-302, and 0233-410-002 are validated as
compatible with the 4K Coupler.
4
3
5, 6
6, 7
Type
Enzymatic
Non-enzymatic
Enzymatic
To assist with drying
For using the automated
cleaning procedure
Large enough to accomodate
the device
≥ 2.4% glutaraldehyde
To prepare disinfecting solution
To rinse the device
To assist with drying
• STERRAD® 100S, NX®, 100NX®,
NX ALLClear®, or 100NX
ALLClear
• STERIS/AMSCO® V-PRO® 1,
V-PRO 1 Plus, V-PRO maX,
V-PRO maX 2, or V-PRO 60
To maintain sterile barrier
Optional. Must be compatible
with sterilization method.
Minimum
Concentration
1 oz/gal.
1/8 oz/gal. (1 ml/L)
5/8 oz/gal. (5 ml/L)
Minimum Soak
Time
1 minute
5 minutes
5 minutes
EN-5