Stryker 0242000112 Manual De Instrucciones página 9

Automated Cleaning
3 Cleaning validation was
performed with ENZOL®.
4 Cleaning validation was
performed with Renuzyme
Plus® and Tec Wash III®.
Maintenance
Inspection and Testing
Packaging for
Sterilization
Sterilization
1 . Prepare an enzymatic detergent according to the manufacturer's instructions.
2 . Perform pre-cleaning by flushing with an enzymatic detergent and using a soft
bristled brush to scrub the tray, focusing on the hard-to-clean areas.
3 . Rinse the tray with distilled or demineralized water until no visible detergent
is present.
4 . Clean the tray in a validated automated washer using the "INSTRUMENTS" cycle
and detergents intended for use in automated cleaning. Effective automated
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cleaning can be achieved using the following sequential parameters:
• Cold water wash (minimum of 35 seconds at 27°C / 80°F)
• Hot water wash (minimum of 2 minutes at 60°C / 140°F)
• Cold water wash (minimum of 45 seconds at 27°C / 80°F)
• Hot water wash (minimum of 2 minutes at 60°C / 140°F)
• Thermal rinse (minimum of 1 minute at 82.2°C / 180°F)
• Dry (minimum of 6 minutes at 82.2°C / 180°F)
• No routine maintenance is required for the sterilization tray.
• The sterilization tray should be replaced after one year.
• Inspect the tray after each cleaning cycle to ensure proper functionality and
safety.
• Inspect all components for cleanliness. Place a pipe cleaner down any crevice,
and then inspect the pipe cleaner for blood or debris. If blood or debris is
present, repeat the above cleaning procedure.
• Inspect the tray for dents and cracks. If a problem is observed or suspected, the
tray should be replaced.
• Steam sterilize the cleaned tray with no more than two layers of sterilization
wrap.
Warning: Sterilization is not a substitute for cleaning. The tray and
instruments must be thoroughly cleaned prior to sterilization.
Warning: The tray and instruments are only validated for steam sterilization.
Do not use any other sterilization methods.
Warning: The following autoclave processes have been validated; however,
the sterility assurance level for any given sterilization cycle is dependent on
the actual conditions selected by the user and the correct calibration of the
user's sterilization equipment and instrumentation. Because these factors are
not within the control of T.A.G. Medical Products Corporation Ltd., the user is
responsible for the sterility assurance level.
Warning: The adequacy of any sterilization procedure must be tested. It is
critical that appropriate process parameters be validated for each facility's
sterilization equipment and product/load configuration by persons who
have training and expertise in sterilization processes to substantiate the
process and its reliability and reproducibility.
• Prepare the device(s) and the sterilization tray as indicated in the "Sterilization
Tray Setup" section below.
• Sterilize the device(s) inside the tray according to the parameters indicated
below.
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