130
Safety
• Before this component is used, it is
essential that both the component and
the prosthesis it is used for are individu
ally adapted to the user.
• Before the component is used the
patient 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 components
have been subject to disproportionate
stress (e.g. due to a fall), they must be
checked for potential damage by an
orthopedic technician before further use.
Additional Safety Instructions
• When using modular prosthetic compo
nents 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 activi
ty level applies to the whole prosthesis.
• Using individual, certified components
with the CEmarking does not release
technicians from their duty to check com
ponent combinations within their means
for fitness of purpose, proper assembly
and safety.
• Should there be evidence that a certain
combination of components is not as
safe as required, the components must
not be combined.
• The prosthesis has to be configured
according to the recognized 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.
• The relevant locking torques have either
been lasered directly onto the adapter,
or can be found in the according chart
at www.teufel international.com in the
downloads section of the website.
• If the locking torque has been lasered
directly onto the adapter, the following
aspects have to be considered:
• If different locking torques have to be
considered for different screws on the
adapter, the relevant torque is indicated
on each individual screw.
• If the same locking torque applies to
different screws on the adapter, the
relevant torque is only given once
on the adapter.
• Locking torques always apply to the
screw threads of the adapters. If two
adapters are connected with each other,
the relevant locking torque is the one
given for the adapter that has
a screw thread. Because of this, some
KnieAgil® Joints
User Manual
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Summary of Contents for KA.L30
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