ChoiceSpine Ambassador Instrucciones De Uso página 2

(Kimguard KC600 or equivalent) using various wrapping techniques per
ANSI/AAMI ST79.
This steam sterilization cycle is not considered by the FDA to be a standard
sterilization cycle. It is the end user's responsibility to use only sterilizers
and accessories (such as sterilization wraps or pouches, chemical or
biological indicators, and sterilization cassettes) that have been cleared by
the FDA for the sterilization cycle specifications (time and temperature).
Alternative sterilization methods or cycles may be used, but should be
validated according to hospital practices and procedures. The use of an
FDA cleared wrap is recommended to ensure devices remain sterile prior
to implantation.
Patient Education:
It is essential to provide preoperative instructions to the patient. S/he
should be made aware of the potential risks of the surgery and the implant
limitations. The patient should be instructed to limit postoperative activity,
as this will reduce the risk of bent, broken or loose implant components.
The patient must be made aware that implant components may bend,
break, or loosen even though restrictions in activity are followed.
Storage and Handling:
Implants should be stored in the implant sterilization case in clean, dry,
well-ventilated conditions away from floors, ceilings, and outside walls.
Store and transport sterile implants in such a way as to maintain sterility
and functional integrity. Do not use implants if the sterilization wrap is
opened, damaged or wet. Implants should remain covered until needed to
avoid contamination. Only those to be implanted should be handled.
Limitations and Restrictions:
Repeated sterilization according to these instructions has a minimal effect
on ChoiceSpine devices. Sterilization equipment varies in performance
characteristics and must be validated accordingly. The sterilizing facility is
responsible for the routine validation and monitoring of all equipment,
materials and personnel used in their facility to ensure the desired results
are achieved. These instructions have been validated as being capable of
sterilizing these ChoiceSpine implants. Any deviations from these
procedures must be evaluated for efficacy by the sterilizing facility.
Device Retrieval Efforts:
Should it become necessary to remove any or all of the Ambassador®
Anterior Cervical Plate components, please call ChoiceSpine at the number
below to receive instructions regarding data collection, including
histopathological, mechanical, and adverse event information.
Surgical Technique Manual:
The ChoiceSpine Ambassador Anterior Cervical Plate System Surgical
Technique Manual is available by contacting ChoiceSpine Customer Service.
Caution:
Federal Law (USA) restricts this device to sale by or on the order of a
physician.
Product Complaints:
Any dissatisfaction with the product quality, labeling, or performance
should be reported to ChoiceSpine immediately by the customer or health
care provider. Furthermore, ChoiceSpine should be notified immediately
of an implant malfunction by telephone, fax, or written correspondence.
When filing a complaint, the name, part number, and lot number of the
part should be provided along with the name and address of the person
filing the complaint.
Some components may not be currently available. Please contact your
ChoiceSpine representative for additional information.
The products discussed herein may be available under different
trademarks in different countries. All copyrights and pending and
registered trademarks are property of ChoiceSpine. For more information
on a specific product or trademark, please contact your local ChoiceSpine
representative.
Information:
See choicespine.com for more information.
See choicespine.com/patents/ for patent information.
For product complaints please contact:
ChoiceSpine, LLC
Quality/Regulatory Department
400 Erin Drive
Knoxville, TN 37919
Phone: 865-246-3333; Fax: 865-588-4045
For additional product information please contact:
ChoiceSpine, LLC
Customer Service Department
400 Erin Drive
Knoxville, TN 37919
Phone: 865-246-3333 or fax: 865-588-4045
customerservice@choicespine.com
MedPass SAS
95 bis Boulevard Pereire
75017 Paris France
MedPass.ar@medpass.org
Tel: +33 (0)1 42 12 28 84
Fax: +33 (0)1 42 12 28 83
Symbol Legend:
Symbol Definition
Do not reuse
Caution, consult instructions for use for
warnings and precautions
Consult instructions for use
Do not use if package is damaged
Lot number
Reference number
Serial Number
Sterilized by irradiation
Use by
Manufacturer
Date of Manufacture
Federal law (USA) restricts this device to
sale by or on the order of a physician
Non-Sterile
European Medical Devices
Authorized representative in the European
Community
IFUC-A002 Rev A 8/19