CLEANING, DECONTAMINATION AND STERILIZATION
17
If the lift out tray (REF 89-8510-459-48) is not being used, load the equipment into the automated washer in a wire basket. Make
sure to orient the equipment vertically to assist in drainage. Load the equipment carefully to prevent movement that may inhibit
proper cleaning and always avoid contact between multiple components.
The components should be positioned on the lift out tray following the diagrams printed on the lift out tray. Do not overload
the lift out tray.
AUTOMATED CLEANING AND DISINFECTION
Put medical devices in the automated washer. Avoid all contact between the devices (movement may damage devices and may
jeopardize the cleaning operation).
Put implements so that holes are aimed downwards to allow proper water drainage.
Start the automated washer.
Automated cleaning and disinfection procedure
STEP DESCRIPTION
STEP INSTRUCTION
ACCESSORIES
DURATION
Automated washer
Place entire device into the
automated washer, placing
implements so that holes are
aligned downward.
−
Automated washer
− Disassembled device
−
Washer cleaning solution
− Washer neutralizing
solution
Minimum total cycle time: 51
minutes when including all
steps below.
Validated automated washer cycle
Step
Minimum time
Recommended temperature
Pre-Wash
2:00 minutes
Water temperature 20°C (68°F)
Cleaning
5:00 minutes
Water temperature 55°C (131°F)
Neutralizing
2:00 minutes
Water temperature 20°C (68°F)
Rinse I
2:00 minutes
Water temperature 20°C (68°F)
Rinse II (Final)
5:00 minutes
Water temperature 93°C (200°F)
Drying
35:00 minutes
Chamber temperature 99°C (210°F)
Only washing parameters shown above have been validated for cleaning effectiveness.
However, the performance of
Zimmer
® UNIVERSAL Power System is not affected in case lower temperature and/or shorter dwell
time are used.
INSPECTION
Inspect each part of the devices to make sure all soil is removed.
If necessary, repeat the cleaning process.
STERILIZATION
The referenced steam sterilization cycle parameters listed below have been validated and provide a sterile result by steam
sterilization according to ANSI/AAMI/ISO 17665-1:2006, Sterilization of Health Care Products. Part 1: Moist Heat. The steam
sterilization process for these products has been validated to provide a sterility assurance level (SAL) of 10-6 or better when
using the sterilization cases (REF 89-8510-459-41 or REF 89-8510-459-42 or REF 89-8510-459-43 or REF 89-8510-459-45 or REF
89-8510-459-46). Use of these UNIVERSAL sterilization cases is strongly recommended.
Please note that the processes described in this chapter are the only ones covered by our warranty conditions. Any other
sterilization processes must not be used, with the risk to induce a premature wear and a deterioration of the device.
The steam sterilization procedure must be carried out in a qualified autoclave.
The components should be positioned in the cases following the diagrams printed on the cases. Do not overload the cases.
CAUTIONS
:
•
For pneumatic handpiece:
Remove all washing caps (REF 89-8510-455-50, REF 89-8510-555-00) on hoses and on handpiece
air inlet before the sterilization process.
•
Do not subject any cap to the sterilization process.
ENGLISH
Summary of Contents for Universal Power System
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