Use; Intended Use; Indication; Qualification - FIOR & GENTZ NEURO CLASSIC-SPRING Notice D'utilisation

Limitation of the Joint Function Due to Improper Dirt Removal
Inform the patient on how to properly remove dirt from the orthosis and the system joint.
Breakage of System Components Due to Predetermined Breaking Point at the System Stirrup
If you need to file the system stirrup, note all information provided in these instructions for use in order to
avoid predetermined breaking points. File the system stirrup along the laser lines.

3. Use

3.1 Intended Use

The FIOR & GENTZ system ankle joints are exclusively for use for orthotic fittings of the lower extremity. The
system joints provide motion control and are only allowed to be used for producing an AFO or a KAFO. Every
system joint influences the orthosis' function and thus also the function of the leg. Depending on the type of
orthotic fitting and the patient's individual physical abilities, driving a motor vehicle safely should be guaran-
teed. The system joint may only be used for one fitting and must not be reused.

3.2 Indication

The indication for the treatment with an orthosis for the lower extremity is a pathological gait. This can be
caused, for example, by central, peripheral, spinal or neuromuscular paralyses, structurally conditioned de-
formities/malfunctions or surgery.
The physical conditions of the patient such as muscle strength or activity level are decisive for the orthotic
treatment. A safe handling of the orthosis must be ensured. The orthotist or qualified/trained expert selects
the appropriate system joints for the orthosis.

3.3 Qualification

The system joint must only be handled by an orthotist or qualified/trained expert.

3.4 Application

All FIOR & GENTZ system joints were developed for everyday life activities such as standing and walking.
Extreme loads connected to activities like running, climbing and parachuting are excluded.
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NOTICE
NOTICE