Integra Omni-Tract Instrucciones De Uso página 7

Indications for Use Statement:
A table mounted retractor system used to provide stable retraction during invasive surgery through an anterior approach to temporarily
retract tissues and organs in order to provide unencumbered direct visualization of target tissues and organs including the spine.
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.
Locking SnapClamp on the retractor frame prior to placing the
blade shaft into the SnapClamp may cause damage to the SnapClamp.
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.
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 compli-
ance with your facility disposal protocol.
Integra, the Integra logo, Omni-Tract and Omni-Clamp are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.
SnapClamp is a trademark of Integra LifeSciences Corporation or its subsidiaries. ©2020 Integra LifeSciences Corporation. All Rights Reserved. 40-6116 Rev BAA 2020-09 0773869-2
Symbols used on labeling
Caution
Manufacturer
Catalog number
Lot number
Consult instructions for use
Caution: Federal (US) law restricts this device to sale by or on
the order of a licensed healthcare practitioner.
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
EC REP
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
7
EN – ENGLISH
651-287-4300 USA 651-287-4400 fax
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