Teufel Single Axis Fuß Gebrauchsanweisung Seite 12

ES
FR
EN
Single Axis Foot
DE
b) temporary or permanent health
deterioration of a patient, user or
other persons
c) a serious public health threat.
• When using modular prosthetic
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 components
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 components must
not be combined.
• The prosthesis has to be configured
and assembled according to the recog-
nized 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.
EN-4
User Manual
• 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. specific combination
possibilities, maintenance intervals etc.)
must be followed.
• If different components (from one or
from several manufacturers) are combi-
ned: Only use components which meet
the requirements of DIN EN ISO 10328
and the Medical Devices Act.
• In the event of damage to a prosthesis
which combines components from
different manufacturers, every manu-
facturer can only be held liable for the
failure of those components produced
by them. Beyond that, manufacturers
can only be held liable if their compo-
nents are proven to have caused dama-
ge to or failure of components which
were produced by other manufacturers.
• This product is intended for use
on one person. It may not be
reused on on another person.