Streifeneder ortho.production 3A20 Instrucciones De Uso página 9

Konformitätserklärung
„
Die Streifeneder ortho.production GmbH erklärt als Hersteller in alleiniger Verantwortung, dass
das Produkt den Anforderungen der Verordnung (EU) 2017/745 für Medizinprodukte (MDR)
entspricht.
GB Instructions for Use
Use
„
The 3A20 and 3A36 Polycentric Knee Joint (hereinafter referred to as „the product") are
approved for activity level 1 and 2 according to Streifeneder walky-system and for a maximum
body weight of up to 100 kg, including carried and supported loads, and are not suitable for
sporting activities like jumping, running, etc.
The approved maximum weight load of this product is limited and depends on the component
with the lowest weight limit used in the prosthetic construction, which determines the maximum
weight load of the entire construction.
The indication-appropriate use must be assessed by a prosthetic specialist.
The product may be fitted by a prosthetic specialist only.
This product is intended for single patient use only.
Please note that this product is tested and approved only in combination with other
Streifeneder components.
Useful Life
„
The maximum useful life of the product is limited to 60 months.
Intended Use
„
The product is exclusively intended for lower extremity prosthetic treatment.
Assembling
„
The properties of the product can only be optimally utilized with correct prosthetic
alignment. For correct assembly, the residual limb position must be taken into account
for aligning the socket connection.
Do not touch the joint mechanism when flexing the knee joint – risk of injury and
finger pinching!
Basic set-up
„
The arrangement of the knee joint axes ensures that the instantaneous centre of rotation (D) is
above the knee joint and behind the load line in the extended position (fig. 1). Thus the stance
phase safety is determined exclusively by the prosthesis alignment.
The prosthesis should be assembled in such a way that in the frontal view (fig. 2) the plumb line
runs from the centre of the socket through the adjustment core and the centre of the tube adapter.
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