CareFusion Snowden-Pencer Tebbetts Mode D'emploi page 5

Let devices drip dry for three (3) minutes before packaging for
sterilization.
Immediately proceed to recommended steam sterilization. Do
not store instrument prior to sterilization.
Packaging
Devices can be loaded into dedicated packaging systems.
Sterilization wrap material must be cleared for the applicable
sterilization modality by your country's regulatory body. Use
in accordance with packaging manufacturer's sterilization
instructions being sure to protect jaws and cutting edges from
damage.
Sterilization
All devices must be processed in the completely open position
(i.e. flushports, jaws, etc.) to allow sterilant contact of all
surfaces. Note that applicable device disassembly should not
require any mechanical tooling (i.e. screwdriver, pliers etc.)
unless otherwise indicated.
All devices with concave surfaces shall be configured so that
water pooling does not occur.
Sterilization for United States Market
STANDARD PREVACUUM STEAM STERILIZATION CYCLES
Prevacuum Steam Sterilization Cycle
(U.S. "FDA Compliant – WRAPPED")
• Conditioning Pulses: 3
• Exposure Temperature: 132°C (270°F)
• Exposure Time: 4 minutes
• Dry Time: 30 minutes
• Sterilization Configuration: FDA Cleared Sterilization
Wrap (2 layer-1 ply, or 1 layer -2 ply – examples:
cellulose, polypropylene, muslin)
Prevacuum Steam Sterilization Cycle – Immediate Use
Steam Sterilization (U.S. "FDA Compliant – WRAPPED")
• Conditioning Pulses: 3
• Exposure Temperature: 132°C (270°F)
• Exposure Time: 4 minutes
• Sterilization Configuration: FDA Cleared Sterilization
Wrap (2 layer-1 ply, or 1 layer -2 ply – examples:
cellulose, polypropylene, muslin)
Note: Devices must be used immediately and cannot be
stored for later use.
Immediate Use Steam Sterilization is not recommended
as a routine practice. Refer to ANSI/AAMI ST79 for
requirements on when to perform and how to control
immediate use steam sterilization.
Reference: ANSI/AAMI ST79: (current revision)
Comprehensive guide to steam sterilization and sterility
assurance in health care facilities.
STANDARD GRAVITY STEAM STERILIZATION CYCLES
Gravity Steam Sterilization Cycle
(U.S. "FDA Compliant – WRAPPED")
• Temperature: 132°C (270°F)
• Exposure Time: 15 minutes
• Dry Time: 45 minutes
• Sterilization Configuration: FDA Cleared Sterilization
Wrap (2 layer-1 ply, or 1 layer -2 ply – examples:
cellulose, polypropylene, muslin)
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