Integra LifeSciences Kirschner Wires - Manual (Page 2)

Symbols
Integra, the Integra logo and Miltex are registered trademarks of Integra
LifeSciences Corporation or its subsidiaries in the United States and/or other countries.
© 2012 Integra LifeSciences Corporation. All Rights Reserved.
SURGKWIREDFU Rev. A 06/12
Cleaning Instructions:
Products are delivered in a non-sterile condition and must be cleaned,
disinfected and sterilized prior to use. For cleaning, disinfecting, and
sterilization, the implant must be removed from its packaging. A suitable
cleaning, disinfection and sterilization process must be applied by the user.
Only pH-neutral cleaning agents should be used. The preparation reference of
the respective cleaning and disinfection agent manufacturer must be considered.
After following decontamination recommendations, reusable instruments are
ready for sterilization.
Sterilization Instructions:
Non-sterile implants must be sterilized by the user prior to use. The implants
must be sterilized using a process that has been validated by the health care
provider – reference ISO 11134, “Sterilization of health care products –
requirements for validation and routine control – Industrial moist heat
sterilization” and AAMI TIR 12, “Designing, testing and labeling reusable medical
devices for reprocessing in health care facilities: a guide for device
manufacturers.”
Personnel should follow accepted guidelines as recommended in ANSI/AAMI
ST79 “Comprehensive guide to steam sterilization and sterility assurance in
health care facilities” and ISO 17664 “Sterilization of medical devices –
Information to be provided by the manufacturer for the processing of
resterilzable medical devices.”
The implants can be sterilized using the following steam sterilization cycle:
• Pre-vacuum steam sterilization, wrapped items
• 275°F (134° C) for 4 minutes, with a minimum dry time of 15 minutes
AAMI standards recommend that sterilizer manufacturer’s written instructions
for cycle parameters should also be followed. Medical device manufacturer’s
exposure times to sterilization temperature may need to be longer than minimum
indicated by sterilizer manufacturer but must never be shorter. It is the
responsibility of the user to establish whether sterilizer meets these
minimum recommendations.
Returned Goods Policy
Products must be returned in unopened packages with manufacturer’s seals
intact to be accepted for replacement or credit unless returned due to a
complaint of product defect. Determination of a product defect will be made by
Integra. Products will not be accepted for replacement if they have been in the
possession of the customer for more than 90 days.
Repairs and Maintenance
Should your instruments require repair or maintenance, contact Integra Miltex
for return authorization and address. Instruments returned to Integra Miltex for
repair must have a statement testifying that each instrument has been
thoroughly cleaned and sterilized. Failure to supply evidence of cleaning and
disinfection will result in a cleaning charge and delayed processing of your
instrument repair.
Product Information Disclosure
Integra and its subsidiaries (“integra”) and manufacturer exclude all warranties,
except Integra’s applicable standard warranty whether expressed or implied,
including but not limited to, any implied warranties of merchantability or fitness
for a particular purpose. Neither Integra nor manufacturer shall be liable for any
incidental or consequential loss, damage, or expense, directly or indirectly aris-
ing from use of this product. Neither Integra nor manufacturer assume nor autho-
rize any person to assume for them any other or additional liability or responsibil-
ity in connection with these products.
ENGLISH
Integra York PA, Inc. i 589 Davies Drive, York, PA 17402 USA
866-854-8300 USA i 717-840-2763 outside USA i 717-840-9347 fax
integralife.com/integra-miltex
Manufacturer 1
Catalog number
Lot number
Caution: see warnings or precautions
Federal (USA) law restricts this device to sale by or
on the order of a physician or practitioner
Consult instructions for use and website address
1
Company responsible for a device marketed under its own name regardless of
whether “manufactured for” or “manufactured by” the company.
Integra
®
Miltex
®
Kirschner Wires
Directions for Use