Dorsalex® User Manual; Reimbursement Code; Medical Device; Safety - Teufel Dorsalex Gebrauchsanweisung

Reimbursement Code

DE
HMV-Nr.: 23.03.02.5011
(Dorsalex)
HMV-Nr.: 23.03.02.5012
(Dorsalex XL)
HMV-Nr.: 23.03.02.5013
(Dorsalex Plus)
HMV-Nr.: 23.03.02.5015
(Dorsalex Forte)
AT
Tarif Nr.: 34351 015

Medical Device

The Dorsalex (XL / Plus /
Forte) 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, application,
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 reduction
or lack of effect), immediately call on your
doctor or orthopedic technician.
• All serious incidents that occur in connec-
tion with this product have to be reported
Dorsalex®
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) the death of a patient, user, or other
persons
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 orthosis
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
another person.
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