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Equipment Inventory and Cleaning/Sterilization Methods
The "iASSIST Knee Master Instruments Kit" section
lists the instruments supplied by Zimmer CAS and
describes the sterilization methods recommended
for each instrument. Reusable instruments must be
cleaned after use prior to sterilization. They should
not be sterilized in the protective bag or packaging
supplied with them. All sterilizations should be
performed using standard and regularly maintained
equipment.
For cleaning, reusable instruments require manual
cleaning steps as follows: all multi-components
instruments should be disassembled and presoaked
in an enzyme solution followed by scrubbing with a
soft bristle brush to remove all visible soil. Use a water
jet to flush difficult to access areas and closely mated
surfaces. For threaded interfaces, screw/unscrew
Sterilization Parameters
Steam Sterilization (Autoclave)
Cycle Type
Temperature
Pre-Vacuum
132 °C (270 °F)
Both the given cycle temperature and time can be increased to 134°C + 3°C (273.2°F + 5.4°F) and 18 minutes
1
according to local requirements outside of the United States such as in the European Union.
Drying times vary according to load size and should be increased for larger loads.
2
Cooling times vary according to the type of sterilizer used, device design, temperature and humidity of ambient
3
environment, and type of packaging used. Cooling process should comply with ANSI/AAMI ST79.
Exposure Time
1
1
4 minutes
iASSIST 2-Pod Version Surgical Technique
43 |
components while flushing the areas. Ultrasound
cleaning (Sonication) in an enzyme solution is
recommended thereafter in all cases to complete
the cleaning steps, with minimum cycle times of five
minutes and, for those instruments with difficult to
access areas, cycle times of at least 10 minutes.
Following these steps, in all cases a thorough rinse is
required thereafter. Screws and other mechanisms
should be checked and lubricated with a medical
grade surgical lubricant normally after each
cleaning as determined upon inspection. The above
instructions that are instrument type dependent are
indicated in the "iASSIST Knee Master Instruments
Kit" section as applicable to each instrument.
Warning: Before every surgery, the user must verify
that all instruments have been sterilized.
Minimum Dry Time
2
30 minutes
Minimum Cool Time
3
30 minutes
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