Integra Omni-Tract Instrucciones De Uso página 9

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The strap clamp holders are also useful securing femur elevating retractors. Before placing the retractor, position the OmniAccess frame interior to the
level of the surgical field so that the final position of the levering retractor is above the frame arm. Attach the strap clamp and secure the retractor as
described in steps 14 and 15.
Indications for Use Statement:
A table mounted retractor system used to provide constant absolute exposure of the acetabulum during total hip arthroplasty and revision and procedures.
Caution:
Excessive and prolonged periods of retraction can cause tissue necrosis,
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.
Federal law restricts this device to sale by or on the order of a licensed
healthcare practitioner.
Cleaning and Sterilization:
Your Omni-Tract system is provided to you in a non-sterile condition. Please
reference instrument cleaning, sterilization and care instructions.
(Omni-Tract document 40-9015)
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, Omni-Tract and Wishbone are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.
OmniAccess is a trademark of Integra LifeSciences Corporation or its subsidiaries. ©2020 Integra LifeSciences Corporation. All Rights Reserved. 40-6126 Rev AAA 2020-09 0773956-2
Anterolateral Set-up Posterolateral Set-up
Symbols used on labeling
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
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
651-287-4300 USA 651-287-4400 fax
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