Medical Device - Teufel DynaCox evolution Gebrauchsanweisung

Medical Device

The DynaCox evolution
is a medical device.
Safety
• Before this device is used, the orthosis
has to be individually adapted to the
patient by an experienced orthopedic
technician and the patient has to be
trained in the orthosis' use according to
the doctor' s instructions.
• Incorrect selection, adaptation, appli-
cation, and/or failure to monitor the
correct fit of this product may cause
health damage.
• Check orthosis for damage (such as
loose connections, fasteners, belts,
etc.) each time it is put on.
• Do not remove the textile label from
textile products.
• In case you suspect any performance
malfunctions (e.g. an apparent reducti-
on or lack of effect), immediately call on
your doctor or orthopedic technician.
• All serious incidents that occur in
connection with this product have to
be reported to the Wilhelm Julius Teufel
GmbH and the competent authority
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
DynaCox® evolution
b) temporary or permanent health
deterioration of a patient, user or other
persons
c) a serious public health threat.
• Never wear the orthosis on broken skin.
• The orthosis must be checked for proper
function, correct fit and potential dama-
ge by a doctor or orthopedic technician
at regular intervals. The timing of these
intervals has to be defined individually
for each patient.
• Should the product have been subject to
disproportionate stress, it must be checked
for potential damage by an orthopedic
technician before further use.
• Harmful pressure caused by the ortho-
sis may cause skin injuries or disrupt
blood flow and must be avoided.
• This product is intended for use
on one person. It may not be
reused on on another person.
The DynaCox evolution hip orthosis
is designed to be adjusted for either
the right or the left hip joint, but not
for bilateral use. Due to the required
individual adaptation the orthosis
is not suitable for reuse by other
persons!
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User Manual
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