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.
Prevacuum Steam Sterilization Parameters
Preconditioning Pulses: 3
Temperature: 132°C (270°F)
Exposure Time: 4 minutes
Dry Time: 30 minutes
Sterilization Configuration: Cleared (i.e. FDA, etc.)
Sterilization Wrap (2 layer 1-ply or 1 layer 2-ply)
Sterilization for outside United States Market
Prevacuum Steam Sterilization Parameters
Preconditioning Pulses: 3
Temperature: 132°C (270°F) - 135°C (275°F)
Exposure Time: 3-18 minutes
Dry Time: 30 minutes
Sterilization Configuration: Cleared
Sterilization Wrap (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.
Ratchet Instructions
Ergonomic ring handle devices allow for use with or without the locking ratchet.
Leaving the Ratchet Lever in the neutral position allows the ratchet to engage
(see above left).
Movement down, toward the front ring handle, releases the ratchet momentarily
(see below left). Movement of the Ratchet Lever to the upper position defeats the
ratchet (see below right).
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