Orthosoft Inc. R20S21A Manual Do Utilizador
SmartKnee Surgical Technique
33 of 58
Before every surgery the user must verify that all instruments have been sterilized.
5.1.1 Instruments Sterilization / Cleaning methods
Section 5.1.3 lists the instruments supplied by Zimmer CAS and describes the sterilization methods
recommended for each instrument. Re-usable 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, re-usable instruments require
manual cleaning steps as follows. All multi-components instruments should be disassembled and pre-soaked
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
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 5 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 as
required with a medical grade surgical lubricant. The above instructions that are instrument type dependent
are indicated in Section 5.1.3 as applicable to each instrument.
recommended for each instrument. Re-usable 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, re-usable instruments require
manual cleaning steps as follows. All multi-components instruments should be disassembled and pre-soaked
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
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 5 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 as
required with a medical grade surgical lubricant. The above instructions that are instrument type dependent
are indicated in Section 5.1.3 as applicable to each instrument.
5.1.2 Sterilization Parameters
The following parameters are given for reference. Refer to the package insert included in each instrument
package for more details or updates.
package for more details or updates.
Steam Sterilization (Autoclave)
Cycle type
Temperature
Time
Pre-Vacuum
132°C (270°F)
4 minutes
Indicated 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 as prescribed in the European Union.
according to local requirements as prescribed in the European Union.
5.1.3 Master Instrumentation kit
Additional specific cleaning instructions as defined in the text are indicated as applicable to each
instrument as follows:
instrument as follows:
A. Requires disassembly.
B. Requires water jet to flush difficult to access areas.
C. Screw/unscrew components while flushing the area
D. Requires a minimum of 10 minutes ultrasonic cleaning cycle in an enzymatic solution.
E. Screws/mechanisms should be checked and lubricated as required.