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Maintenance, Inspection, And Testing - Stryker Hip Arthroskopy Bedienungsanleitung

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Automated Cleaning:
1 . Prepare an enzymatic detergent
2 . Perform pre-cleaning by flushing an enzymatic detergent through the lumens
using a 5 ml syringe and needle and using a soft bristled brush to scrub the lumens,
crevices, and slots.
3 . Rinse the instruments with distilled or demineralized water until no visible
detergent is present.
4 . Place the instruments in the washer in a manner to facilitate draining.
5 . Clean in a validated automatic washer using the "INSTRUMENTS" cycle and
detergents
intended for use with automated cleaning. Effective automated
(4)
cleaning can be achieved using the following parameters:
5.1 Cold water wash (minimum of 35 seconds at 27°C / 80°F)
5.2 Hot water wash (minimum of 2 minutes at 60°C / 140°F)
5.3 Cold water wash (minimum of 45 seconds at 27°C / 80°F)
5.4 Hot water wash (minimum of 2 minutes at 60°C / 140°F)
5.5 Thermal rinse (minimum of 1 minute at 82.2°C / 180°F)
5.6 Drying (minimum of 6 minutes at 82.2°C / 180°F)
6 . Inspect the instruments after each cleaning cycle to ensure proper functionality
and safety:
6.1 If you suspect a problem, do not use the instrument.
6.2 Inspect all components for cleanliness: activate all moving parts to their
maximum positions while inspecting for blood or debris. Place a pipe cleaner
down any cannulation or crevice, and then inspect the pipe cleaner for blood
or debris. If blood or debris is present, repeat the above cleaning procedure.
(3) Validation was performed using ENZOL®.
(4) Validation was performed using Renuzyme Plus® and Tec Wash III®.
Disinfection:
Warnings:
Disinfection alone is not adequate to render the instruments sterile. Sterilization must
be performed before each procedure.
1. After cleaning, disinfection should be performed by immersion in 2.4% CIDEX®
equivalent) with a minimum immersion time of 45 minutes at 25°C/77°F following
the manufacturer's instructions.
2. Rinse with distilled or demineralized water, agitating for one minute; repeat rinse
twice.
3. Dry all instruments thoroughly before storage.
(5) Validation was performed using CIDEX®.

Maintenance, Inspection, and Testing:

Inspect the Instruments for damage, such as deformed shafts or tips. Ensure proper
functionality. If a problem is observed or suspected, contact your Stryker
representative for replacement or repair.
Packaging for Sterilization:
Use no more than two layers of sterilization wrap.
Sterilization:
Warnings:
• Sterilization is not a substitute for cleaning. Instruments must be thoroughly
cleaned prior to sterilization, or incomplete decontamination will result.
• The sterilization parameters provided for use with a sterilization tray might differ
from those provided for the instruments alone. When sterilizing the instruments
inside a tray, select the more stringent set of parameters.
• These devices were not validated for ethylene oxide (EO) or gas plasma sterilization
methods. Use only steam (autoclave) sterilization as outlined in these instructions,
or incomplete sterilization may result.
according to the manufacturer's instructions.
(3)
8
(or
(5)

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