Integra Cadence Total Ankle System, Manual

Page: 7 / 84

5
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 Standard
Refer-
ence
Number
Sterilized
using
irradiation
Indicates a medical
device that has
been sterilized using
irradiation.
ISO 15223-1
Medical
Devices –
Symbols
to be
used with
medical
device
labels,
labelling
and
information
to be
supplied
5.2.4
Batch code
Indicates the
manufacturer’s batch
code so that the batch
or lot can be
identified.
5.1.5
Catalogue
Number
Indicates the
manufacturer’s
catalogue number so
that the medical
device can be
identified.
5.1.6
Manufacturer
Indicates the medical
device manufacturer,
as defined in EU
Directives 90/385/
EEC, 93/42/EEC and
98/79/EC.
5.1.1
Authorized
representative
in the
European
Community
Indicates the
authorized
representative in the
European Community
5.1.2
Do not use
if package is
damaged
Indicates a medical
device that should not
be used if the package
has been damaged or
opened.
5.2.8