Zimmer Meshgraft II, Instruction Manual, Page: 6 / 112

6
STERILIZATION RECOMMENDATIONS
Steam sterilization is safe and effective and is the only recommended method for the
Meshgraft
II Tissue Expansion
System. There are no contraindications for sterilizing the
Meshgraft
II Tissue Expansion System. Do not autoclave
Dermacarrier
II Skin Graft Carriers.
• Place cleaned instrument in an instrument tray or fully perforated autoclave case. The
Meshgraft
II Autoclave
Case (REF 00-2195-006-00) is recommended. An alternative sterilization case may be utilized when validated by
the end user.
• If the
Meshgraft
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
Minimum
Temperature
6
Minimum Exposure Time
3,10
Minimum Dry
Time
7,8
Wrapped
9
Unwrapped
1,3
Prevacuum/ Pulsating
Vacuum
134°C
273°F
3 min 3 min
8 minutes
2,3
Prevacuum/Pulsating
Vacuum
132°C
270°F
4 min 4 min
3,4
Prevacuum/Pulsating
Vacuum
134°C
273°F
18 min 18 min
5
Prevacuum/Pulsating
Vacuum
132°C
270°F
8 min 8 min
Gravity/Gravity
Displacement
Not recommended due to excessively long sterilization cycles which are not practical.
1. Minimum validated steam sterilization time required to achieve a 10
-6
sterility assurance level (SAL).
2. Minimum validated steam sterilization temperature required to achieve a 10
-6
sterility assurance level.
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. This device should 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
Meshgraft
II Tissue Expansion System as this method may not provide sterility throughout
the instrument.
MAINTENANCE
The
Meshgraft
II Tissue Expansion System requires lubrication only if “oil” is stamped on sideplate.
As needed, the ratchet handle should be lubricated by placing 1–2 drops of surgical instrument lubricant in the grooved
section of the ratchet. Turn the ratchet sections a few times to spread the oil evenly before autoclaving the instrument.