When disposing of or returning insert assemblies, products
may be a potential biohazard. Handle and dispose of in
accordance with accepted medical practice and all applicable
local, state, federal, or country laws and regulations.
Lubrication
• Before sterilizing, lubricate the insert assembly with
instrument milk or a steam permeable/water soluble
lubricant. A proper lubricant will leave a thin film and help
the insert assembly move smoothly during use and maintain
functionality over the lifetime of the insert assembly.
• Insert assemblies can be lubricated in either the assembled
or disassembled configuration. If the insert assemblies are
to be lubricated in the assembled configuration, perform
the steps listed in the assembly instructions below before
proceeding with lubrication.
• Apply lubricant according to the lubricant manufacturer's
instructions.
• Lubricant may be applied by an automatic cleaner if the
cleaner has an option to apply lubricant after the final rinse.
• Let insert assemblies drip dry for three minutes before
packaging for sterilization.
• Immediately proceed to recommended steam sterilization.
Do not store insert assembly prior to sterilization.
Sterilization
Sterilization – General Instructions
• These insert assemblies may be sterilized in either
the assembled or disassembled configuration. If the
insert assemblies are to be sterilized in the assembled
configuration but are currently disassembled, perform
the steps listed in the assembly instructions below before
proceeding with sterilization.
• All insert assemblies must be processed in the completely
open position (i.e. flush ports, jaws, etc.) to allow sterilant
contact of all surfaces.
• All insert assemblies shall be positioned so that water
pooling does not occur.
Packaging
For United States market: Use FDA-cleared sterilization wrap.
• Use in accordance with packaging manufacturer's
sterilization instructions while being sure to protect jaws and
cutting edges from damage.
• Insert assembly configuration must meet the requirements
of the packaging system.
• Sterilization wrap material must be cleared for the applicable
sterilization modality by your country's regulatory body.
Prevacuum Steam Sterilization Parameters
Sterilization Configuration: Wrapped
(2 layer 1-ply or 1 layer 2-ply)
Temperature: 132°C (270°F)
Exposure Time: 4 minutes
Minimum Dry Time: 30 minutes
Sterilization for outside United States market
Prevacuum Steam Sterilization Parameters
Sterilization Configuration: Wrapped
(2 layer 1-ply or 1 layer 2-ply)
Minimum Preconditioning Pulses: 3
Temperature: 132°C (270°F) - 135°C (275°F)
Exposure Time: 3-4 minutes
Minimum Dry Time: 30 minutes
8