Integra Cadence Total Ankle System Gebrauchsanweisung Seite 5

Sterility
The Cadence Total Ankle System prosthesis components are supplied sterile. The
metal components are sterilized by gamma radiation, and the polymer (UHMWPE)
components are sterilized by ethylene oxide (EO) gas.
If either the implant or the package appears to be damaged, or has been opened, or if
sterility is questioned for any reason, the implant should not be used. Re-sterilization of
this product is not recommended.
Inner packaging should be handled under sterile conditions (persons/instruments).
Do not re-sterilize this product.
Storage
All implants must be stored in a clean, dry environment and be protected from sunlight
and extremes in temperature.
Surgical Procedure
A Surgical Technique brochure is available which outlines the basic procedure for device
implantation and use of the specialized surgical instrumentation. It is the responsibility
of the surgeon to be familiar with the procedure before use of these products. Each
surgeon must evaluate the appropriateness of the surgical technique used based on
personal medical training and experience.
Meticulous preparation of the implant site and selection of the proper size implant
increase the potential for successful reconstruction. A complete set of instruments for
each type of implant is available to aid bone preparation and reduce the operative time.
It is suggested that the proper size implant be removed from its sterile package only
after the implant site has been prepared and properly sized.
Training
Surgeons may obtain training from a qualified instructor prior to implanting the
Cadence Total Ankle System to ensure thorough understanding of the implantation
techniques and the instrumentation.
PRODUCT INFORMATION DISCLOSURE
INTEGRA HAS EXERCISED REASONABLE CARE IN THE SELECTION OF MATERIALS AND
THE MANUFACTURE OF THESE PRODUCTS. INTEGRA EXCLUDES ALL WARRANTIES,
WHETHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
INTEGRA SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSS,
DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING FROM USE OF THIS
PRODUCT. INTEGRA NEITHER ASSUMES NOR AUTHORIZES ANY PERSON TO ASSUME
FOR IT ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION
WITH THESE PRODUCTS.
Symbol Title of Symbol Meaning of Symbol
Indicates a medical
Sterilized using device that has been
irradiation sterilized using
irradiation.
Indicates the
manufacturer's batch
Batch code
code so that the batch
or lot can be identified.
Indicates the
manufacturer's
Catalogue
catalogue number so
Number
that the medical device
can be identified.
Indicates the medical
device manufacturer, as
Manufacturer defined in EU Directives
90/385/EEC, 93/42/EEC
and 98/79/EC.
Authorized Indicates the
representative authorized
in the European representative in the
Community European Community
Indicates a medical
Do not use device that should not
if package is be used if the package
damaged has been damaged or
opened.
Indicates the date after
Use-by date
which the medical
(YYYY-MM-DD)
device is not to be used.
Consult Indicates the need for
instructions the user to consult the
for use instructions for use.
4
EN – ENGLISH
Reference
Standard
Number
5.2.4
5.1.5
5.1.6
ISO 15223-1
5.1.1
Medical Devices
– Symbols to be
used with medical
device labels,
labelling and
information to be
5.1.2
supplied
5.2.8
5.1.4
5.4.3