Integra Cadence Total Ankle System Manuel page 7

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.
Title of
Symbol Meaning of Symbol
Symbol
Indicates a medical
Sterilized
device that has
using
been sterilized using
irradiation
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 defined in EU
Manufacturer
Directives 90/385/
EEC, 93/42/EEC and
98/79/EC.
Authorized
Indicates the
representative
authorized
in the
representative in the
European
European Community
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.
Refer-
Standard ence
Number
5.2.4
5.1.5
ISO 15223-1
Medical
Devices –
5.1.6
Symbols
to be
used with
medical
device
labels,
labelling
5.1.1
and
information
to be
supplied
5.1.2
5.2.8
5