Safety - Teufel LimbLogic M Gebrauchsanweisung

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LimbLogic M
DE

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
proper function, possible wear and tear
and potential damage by an orthopedic
technician at regular intervals.
• If the prosthesis or any of its compo-
nents have been subject to dispropor-
tionate 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 following 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 com-
EN-4
ponents to fabricate a prosthetic limb,
User Manual
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 compo-
nents 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 com-
ponents 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 ac-
cidental loosening or twisting with
suitable Threadlocking fluid.
• Safety related regulations for
individual components (e.g. specific