Cleaning Instructions

52 | iASSIST 2-Pod Version Surgical Technique
5.1 Sterilization Parameters
Steam Sterilization (Autoclave)
Cycle Type Temperature
1
Exposure Time
1
Minimum Dry Time
2
Minimum Cool Time
3
Pre-Vacuum 132 °C (270 °F) 4 minutes
40 minutes
30 minutes
1
Both the given cycle temperature and time can be increased to 134°C + 3°C (273.2°F + 5.4°F) and 18 minutes
according to local requirements outside of the United States such as in the European Union.
2
Drying times vary according to load size and should be increased for larger loads.
3
Cooling times vary according to the type of sterilizer used, device design, temperature and humidity of ambient
environment, and type of packaging used. Cooling process should comply with ANSI/AAMI ST79.
The methodology, “Combination Cleaning and Disinfection Instructions”, described in the Reprocessing Manual,
available at http://www.zimmerbiomet.com, is also applicable.
Warning: The washer/disinfector manufacturer’s
instructions should be strictly adhered to. Use
only cleaning agents recommended for the
specic type of automated washer/ disinfector.
A washer/disinfector with approved ecacy
(e.g. CE mark, FDA approval, and validation
according to ISO 15883) should be used.
Warning: Before every surgery the user must:
1. Verify that all instruments have been sterilized.
2. Verify that the instruments are in good
condition to perform the operation. If any signs
of fatigue or deterioration are noticed, do not
use the iAssist Knee System and contact the
technical support.
Step Description
1 2 minutes prewash with cold tap water
2 20 seconds enzyme spray with hot tap
water
3 1 minute enzyme soak
4 15 seconds cold tap water rinse (X2)
5 2 minutes detergent wash with hot tap
water (64-66°C/146-150 °F)
6 15 seconds hot tap water rinse
7 2 minutes thermal rinse (80-93 °C/176-
200°F)
8 10 seconds puried water rinse with op-
tional lubricant (64-66°C/146-150 °F)
9 7 to 30 minutes hot air drying
(116°C/240°F)
Table 5.1 Typical US Automated Washer/
Disinfector Cycle for Surgical Instruments
Table 5.2 Typical European Automated Washer/
Disinfector Cycle for Surgical Instruments
Step Description
1 5 minutes prewash with cold tap water
2 10 minutes alkaline cleaning agent wash
at 55°C
3 2 minutes rinse with neutralizer
4 1 minute rinse with cold tap water
5 Disinfection at 93°C with hot puried
water until A0 3000 is reached (approx.
10 minutes)
6 40 minutes hot air drying at 110°C