Integra Omni-Tract Instrucciones De Uso página 7

Indications for Use Statement:
A table mounted retractor system used to provide constant absolute exposure of the acetabulum during Anterior Hip Replacement surgery.
Caution:
Excessive and prolonged periods of retraction can cause tissue necrosis,
and compression neuropathy. Be sure to release retractors every 20 minutes.
Do not force the sterile field post clamp handle beyond the 180 degree stop when locking onto
a supporting Omni-Tract component. Forcing the handle past the 180 degree stop while locked
onto a component will cause damage to the clamp. The clamp is fully locked when the handle
is turned 180 degrees.
Do not clamp the ratcheting mechansim on the retaining ring at the end of the bar.
Do not force handle past the stop point.
Following cleaning, pre-sterilization, perform maintenance, and check
mechanical function. Be sure to check device integrity before sterilization.
Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
Device Disposal:
The Omni-Tract devices have been deemed environmentally non-hazardous and require no special
handling and/or treatment during setup, assembly/disassembly and during normal use, and are
safe for disposal in landfills. At end of life, device recycling and/or disposal should be performed in
compliance with your facility disposal protocol.
Integra, the Integra logo and Omni-Tract are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.
©2020 Integra LifeSciences Corporation. All Rights Reserved. 40-9010 Rev AAA 2020-09 774002-2
Symbols used on labeling
Manufacturer
Integra LifeSciences Corporation
4900 Charlemar Drive, Cincinnati, Ohio 45227 USA
800-367-8657 outside USA
integralife.com
EU Representative
Integra LifeSciences Services
Immeuble Sequoia 2
97 allée Alexandre Borodine
Parc Technologique de la Porte des Alpes
69800 Saint Priest–France
Telephone: 33 (0) 4 37 47 59 10
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EN – ENGLISH
Caution
Manufacturer
Catalog number
Authorized representative in the European community
Lot number
Consult instructions for use
CE-mark and identification number of Notified Body. The
product meets the essential requirements of the Medical
Device Directive 93/42/EEC
651-287-4300 USA 651-287-4400 fax
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