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• Moveable parts should have smooth movement
without excessive play.
• Locking mechanisms should fasten securely and
close easily.
• Long, thin instruments should be free of bending
and distortion.
PACKAGING
• For instruments that are provided in sets,
instrument trays may be used for containment
during sterilization.
• Package trays/instruments with a barrier wrap
material in accordance with local procedures,
using standardized wrapping techniques such as
those described in ANSI/AAMI ST46-1993.
STERILIZATION
Trays
Place DePuy Mitek instrument in the appropriate
location within the DePuy Mitek sterilization tray.
If a specific location is not identified for an instru-
ment, it may be placed in the general purpose area
(pin-mat) ensuring that the sterilant has adequate
access to all surfaces including difficult to reach
areas, lumens, etc.
• Use a validated, properly maintained and
calibrated steam sterilizer.
• Effective steam sterilization can be achieved
using the following cycles:
Cycle Type
Prevacuum
Prevacuum
STORAGE
Store sterile packaged instruments in accordance
with local procedures.
WARRANTY INFORMATION
DePuy Mitek products are guaranteed to be free
from defects in material and workmanship for
the warranty period for a particular product, if
applicable, beginning from the date of purchase.
All components related to the EXPRESSEW II
and EXPRESSEW III Flexible Suture Passers are
covered by warranty for a period of one year from
the original purchase date.
Disclaimer of Warranty
and Limitation of Remedy.
This warranty is restricted to repair or replacement
by DePuy Mitek, at its option, of the product found
to be defective during the warranty period. Damage
inflicted to the product by the user may void the
warranty. This includes, but is not limited to, any
attempted repairs by unauthorized service pro-
viders, using a sterilization method not approved
by DePuy Mitek, and using the product in a way
that is not intended. All warranties apply to the
original buyer and are not transferable. In no event
shall DePuy Mitek be liable for any anticipated
profits, consequential damage, or loss of time
incurred by the buyer with the purchase or use of
any product.
Temperature
132 - 134° C
134 - 137° C
6
Minimum
Exposure Time
4 minutes
3 minutes
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