Medical Product; Safety - Teufel Return-to-Walk Step-On 100 User Manual

Medical Product

The Return-to-Walk Step-On
100 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:
Return-to-Walk Step-On 100
a) 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 pro-
per function, correct fit and potential
damage by a doctor or orthopedic tech-
nician 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 another person.
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