4 of 64
•
Non-sterile components of the system should be thoroughly
inspected during cleaning and prior to surgery for
possible damage.
GENERAL CLEANING INSTRUCTIONS
FOR REUSABLE INSTRUMENTS
Microsurgical instruments should be separated from other
instruments prior to cleaning.
Disassemble instruments, as appropriate. Prepare an enzy-
matic cleaning solution per the manufacturer’s instructions.
Soak soiled instrument for 5 minutes. Use a soft bristle
brush to remove all traces of blood and debris, paying
close attention to threads, crevices, seams, and any hard
to reach areas. Brush delicate features of the instruments
with care to avoid bending or breaking of such features. If
the instrument has sliding mechanisms or hinged joints,
actuate the area to free any trapped blood and debris. If
the instrument is cannulated, insert a soft nylon brush, or
pipe cleaner, to remove debris. Using a syringe filled with
enzymatic cleaning solution, flush internal areas that cannot
be accessed with a brush.
Rinse the instrument thoroughly with warm tap water. Rinse
all lumens, internal areas, sliding mechanisms, and hinged
joints, actuating sliding mechanisms and hinged joints
while rinsing. Ultrasonically clean instrument for 10 minutes
in neutral pH detergent, prepared in accordance with the
manufacturer’s instructions. Rinse the instrument thoroughly
with warm tap water. Rinse all lumens, internal areas, sliding
mechanisms, and hinged joints. Actuate sliding mechanisms
and hinged joints while rinsing. Dry immediately after final
rinse. Dry internal areas with filtered compressed air, if
available. Lubricate moving parts with a water-soluble
lubricant, if applicable. Inspect all instruments prior to steril-
ization or storage to ensure instruments are suitable for use.
STERILIZATION
Sterile Instruments
The retraction port and clamp are disposable instruments
and are intended for single use. The contents of the package
are sterile unless the package is damaged or opened, or
if the expiration date on the package label has passed.
Ensure that the packaging is not damaged prior to use.
Non-sterile Instruments
All PIPELINE instruments and components except the
retraction port, clamp, and incision template are reusable
instruments that must be sterilized before use. The incision
template is a disposable instrument that must be sterilized
before use.
RECOMMENDATIONS FOR STEAM STERILIZATION:
Cycle: Pre-Vacuum
Temperature: 270°F (132°C)
Exposure Time:
6 min.
To ensure effective sterilization, it is critical that the steam
sterilizer be properly maintained, calibrated, and validated
for applicable load configurations. A facility may choose
to use a different steam sterilization cycle than the cycle
suggested, if the facility has properly validated the cycle for
the instrument(s) being sterilized.
Only legally marketed, FDA cleared sterilization wrap,
pouches, or DePuy Synthes Reusable Sterilization
Containers should be used by the end-user for packaging
terminally sterilized devices. The manufacturer's instructions
for use for the sterilization wrap, pouches, or DePuy Synthes
Reusable Sterilization Containers are to be followed. The
use of DePuy Synthes Reusable Sterilization Containers
are limited to use in the United States only, and are not
approved for use outside of the United States.
For further information related to the use of this instrument,
please contact your DePuy Spine representative, or
distributor.
LIMITED WARRANTY AND DISCLAIMER
PRODUCTS FROM DEPUY SYNTHES PRODUCTS, INC. ARE
SOLD WITH A LIMITED WARRANTY TO THE ORIGINAL
PURCHASER AGAINST DEFECTS IN WORKMANSHIP
AND MATERIALS. ANY OTHER EXPRESS OR IMPLIED
WARRANTIES, INCLUDING WARRANTIES OF MERCHANT-
ABILITY OR FITNESS, ARE HEREBY DISCLAIMED.
IF MORE THAN TWO YEARS HAVE ELAPSED BETWEEN
THE DATE OF ISSUE/REVISION OF THIS INSERT
AND THE DATE OF CONSULTATION, CONTACT
DEPUY SYNTHES SPINE FOR CURRENT INFORMATION
AT +1-800-365-6633 OR AT +1-508-880-8100.
Содержание DePuy Synthes PIPELINE Access System
Страница 63: ...63 of 64 ...
