Zimmer Biomet Electric Dermatome, Instruction Manual

Page: 8 / 22

RECOMMENDED STEAM STERILIZATION PARAMETERS
Cycle Type Minimum
Temperature Pressure
6
Minimum Exposure Time
7
Minimum
Dry Time
3,11
Wrapped
8,9
Unwrapped
10
Prevacuum/
Pulsating Vacuum
1,3
134°C
273°F 3bar
28.5 psi 3 min 3 min
8 minutes
Prevacuum/Pulsating
Vacuum
2,3
132°C
270°F 1.86bar
27 psi 4 min 4 min
Prevacuum/Pulsating
Vacuum
3,4
134°C
273°F 3bar
28.5 psi 18 min 18 min
Prevacuum/Pulsating
Vacuum
5
132°C
270°F 1.86bar
27 psi 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. Sea level. 7. AAMI/AORN steam sterilization cycles with longer times than those listed
are also acceptable. 8. Medical grade steam sterilization compatible wrap equivalent to four thicknesses
of 140-thread-count muslin. 9. Rigid sterilization container that complies with ANSI/AAMI ST46. 10.Flash
(unwrapped) sterilization by exposure at 132°C/270°F should only be used as an emergency procedure.
Instruments must be cleaned and disassembled. 11. Drying times vary according to load size and should
be increased for larger loads.
Note: The Sterilizer Manufacturerʼs 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 Electric Dermatome as this method may not provide sterility
throughout the instrument.