Teufel Easy-Slipper neo, Руководство пользователя

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Donning Aids User Manual
EN-6
components to fabricate a prosthetic
limb, the following aspects have to be
considered:
• Use components only according to
their intended purpose.
• If components with different weight
limits are combined, the weight limit
of the weakest component applies to
the whole prosthesis.
• If components for different activity
levels are combined, the activity level
of the component with the lowest
activity level applies to the whole
prosthesis.
• Using individual, certified compon-
ents with the CE-marking does not
release technicians from their duty
to check component combinations
within their means for fitness for
purpose, proper assembly and safety.
• Should there be evidence that a
certain combination of components is
not as safe as required, the compon-
ents must not be combined.
• The prosthesis has to be configured
and assembled according to the reco-
gnized technical rules of the trade.
• The locking torque specifications
given for the modular component
have to be met. A suitable tool (i.e. a
torque wrench) has to be used to set
the locking torque accordingly.
• Before the prothesis is handed over
to the user, all modular components
have to be secured against accidental
loosening or twisting with suitable
Threadlocking fluid.
• Safety related regulations for
individual components (e.g.
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, adaptation, appli-
cation and/or faulty inspection of this
product may cause health damage.
• The prosthesis and its functional
components must be checked for pro-
per function, possible wear and tear
and potential damage by an orthope-
dic technician at regular intervals.
• If the prosthesis or any of its compo-
nents have been subject to dispro-
portionate 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
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 fol-
lowing consequences:
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.
• When using modular prosthetic