Medical Device; Safety - Teufel 26.300.000.01 Gebrauchsanweisung

Medical Device

The Screw Valve Kit
is a medical device.

Safety

• Before this component is
used, both the component
and the prosthesis it is used
for have to be individually
adapted to the user.
• Before the component is
used, the user has to be
trained in the component's
use by an experienced
orthopedic technician.
• Incorrect selection, adaptati-
on, application and/or faulty
inspection of this product
may cause health damage.
• The prosthesis and its
functional components
must be checked for proper
function, possible wear and
tear and potential damage
by an orthopedic technician
at regular intervals.
Screw Valve Kit User Manual
• If the prosthesis or any of
its components have been
subject to disproportionate
stress (e.g. due to a fall), they
must be checked for potential
damage by an orthopedic
technician before further use.
• All serious incidents that
occur in connection with this
product have to be reported
to the Wilhelm Julius Teufel
GmbH and the competent au-
thority of the member state
in which you are established.
A „serious incident" is any
incident that caused, may
have caused, or may cause,
directly or indirectly, one of
the following consequences:
a) death of a patient, user,
or other persons
b) temporary or permanent
severe health deterioration
of a patient, user or other
persons
c) a serious public health
threat.
• When using modular
prosthetic components to
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