Sterilization Recommendations - Zimmer Air Dermatome II Bedienungsanleitung

STERILIZATION RECOMMENDATIONS

Steam sterilization is safe and effective and is the only recommended method for the dermatome. There are no
contraindications for sterilizing the Zimmer Air Dermatome II and accessories.
Ethylene oxide sterilization is not recommended because reliable outgassing times are difficult to determine for
lubricated powered instruments.
• Place cleaned instruments in an instrument tray or fully perforated autoclave case. The Zimmer Dermatome II
Autoclave Case (REF 00-8851-003-00) is recommended. (See Fig. 14.)
• Insure depth gauge control lever is on 0.002 in (0.05 mm).
• Do not kink the hose when closing the case lid.
• If the Zimmer Dermatome II Autoclave Case is used, the instruments are to be wrapped, two double thicknesses
of #140 thread count wrappers, or equivalent. If sterilization wraps are used, they must be free of detergent
residues. Foam sheets should not be reused. They may have trapped impurities from the steam supply, and
subsequently may form deposits on the instruments. Textiles that have been scorched by overheating also
may form deposits on instruments. Exposure times are the same for wrapped or unwrapped instruments.
• Follow instructions in RECOMMENDED STEAM STERILIZATION PARAMETERS.
• Do not immerse in liquid to cool. Cool by exposure to room temperature or cover with a cold, sterile towel.
RECOMMENDED STEAM STERILIZATION PARAMETERS
Cycle Type
,
1 3 Prevacuum/ Pulsating
Vacuum
,
2 3 Prevacuum/Pulsating
Vacuum
,
3 4
Prevacuum/Pulsating
Vacuum
5 Prevacuum/Pulsating
Vacuum
Gravity/Gravity
Displacement
1. Minimum validated steam sterilization time required to achieve a 10 -
2. Minimum validated steam sterilization temperature required to achieve a 10 -
3. Local or national specifications should be followed where steam sterilization requirements are stricter or more
conservative than those listed in this table.
4. Disinfection /steam sterilization parameters recommended by the World Health Organization (WHO) for reprocessing
instruments where there is concern regarding TSE/CJD contamination.
5. For universal Instrument Cases without defined load configurations.
6. AAMI/AORN steam sterilization cycles with longer times than those listed are also acceptable.
7. Medical grade steam sterilization compatible wrap equivalent to four thicknesses of 140-thread-count muslin.
8. Rigid sterilization container that complies with ANSI/AAMI ST46.
9. Flash (unwrapped) sterilization by exposure at 132°C/270°F should only be used as an emergency
procedure. Instruments must be cleaned and disassembled.
10. Drying times vary according to load size and should be increased for larger loads.
Note: The Sterilizer Manufacturer's instructions for operation and load configuration should be followed
explicitly.
Flash sterilization (10-minute exposure in a gravity displacement sterilizer in an open tray at 270° F [132° C]) is not
recommended for the Zimmer Air Dermatome II as this method may not provide sterility throughout the instrument.
Minimum
Temperature
134°C
273°F
132°C
270°F
134°C
273°F
132°C
270°F
Not recommended due to excessively long sterilization cycles which are not practical.
6
Minimum Exposure Time
7,8 9
Wrapped Unwrapped
3 min
4 min
18 min
8 min
6 sterility assurance level (SAL).
6
sterility assurance level.
10
3,10
Minimum Dry
Time
3 min
4 min
8 minutes
8 min
8 min