CareFusion V. Mueller RH4701-001 Manual Del Usuario página 4

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.
All devices with concave surfaces shall be configured so that
water pooling does not occur.
Prevacuum Steam Sterilization Parameters
Preconditioning Pulses: 3
Temperature: 132°C (270°F)
Exposure Time: 4 minutes
Dry Time: 30 minutes
Sterilization Configuration: Wrapped
(2 layer 1-ply or 1 layer 2-ply)
Sterilization for outside United States market.
Prevacuum Steam Sterilization Parameters
Minimum Preconditioning Pulses: 3
Minimum Temperature: 132°C (270°F)
Minimum Exposure Time: 3 minutes
Minimum Dry Time: 30 minutes
Sterilization Configuration: Wrapped
(2 layer 1-ply or 1 layer 2-ply)
Gravity Steam Sterilization Parameters
Temperature: 132°C (270°F)
Exposure Time: 15 minutes
Dry Time 30 minutes
Sterilization Configuration: Wrapped
(2 layer 1-ply or 1 layer 2-ply)
Gravity Steam Sterilization Parameters
Temperature: 121°C (250°F)
Exposure Time: 30 minutes
Dry Time 30 minutes
Sterilization Configuration: Wrapped
(2 layer 1-ply or 1 layer 2-ply)
EO Sterilization Parameters
Sterilizer Cycle: 100% Ethylene Oxide (EO)
Preconditioning Time: 30 minutes
EO Gas Concentration: 725 mg/L
Temperature: 55°C (130°F)
Humidity: 50-80%
Exposure Time: 60 minutes
Aeration: 8 hours @ 43°C (110°F)
Sterilization Configuration:
Wrapped (2 layer 1-ply or 1 layer 2-ply)
Storage
After sterilization, devices must remain in sterilization packaging
and be stored in a clean, dry environment.
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