Otto Bock 50K13N Genu Arexa, Инструкция по эксплуатации

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7.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der europäischen Richtlinie 93/42/EWG für Medizinpro­
dukte. Aufgrund der Klassifizierungskriterien nach Anhang IX dieser Richtlinie wurde das Produkt
in die Klasse I eingestuft. Die Konformitätserklärung wurde deshalb vom Hersteller in alleiniger
Verantwortung gemäß Anhang VII der Richtlinie erstellt.
7.3 Lokale Rechtliche Hinweise
Rechtliche Hinweise, die
ausschließlich
in einzelnen Ländern zur Anwendung kommen, befin­
den sich unter diesem Kapitel in der Amtssprache des jeweiligen Verwenderlandes.
1 Foreword English
INFORMATION
Last update: 2017-04-26
► Please read this document carefully before using the product.
►
Follow the safety instructions to avoid injuries and damage to the product.
► Instruct the user in the proper and safe use of the product.
► Please keep this document in a safe place.
These instructions for use provide important information on the fitting and application of the
50K13N Genu Arexa knee joint brace.
2 Product description
Item Component (see fig. 1) Item Component (see fig. 1)
1 Strap guide loop 5 Technogel® condyle pad
2 Pad button 6 Pad retainer
3 Clip rivet 7 Extension stop (square grip)
4 Tibia pad 8 Flexion stop (round grip)
3 Intended use
3.1 Indications for use
The brace is intended
exclusively
for orthotic fittings of the lower limbs and
exclusively
for con­
tact with intact skin.
The brace must be used in accordance with the indications.
3.2 Indications
• After ruptures of the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL),
collateral ligament injuries (MCL, LCL) or after capsular ligament surgery
• Conservative, pre-operative and post-operative joint stabilisation (e.g. after meniscal fixation
or meniscus replacement) with limited range of motion
• Conservative therapy of chronic complex knee joint instability
The indication must be determined by the physician.
3.3 Contraindications
3.3.1 Absolute Contraindications
None known.
3.3.2 Relative Contraindications
The following indications require consultation with a physician: skin diseases/injuries; inflamma­
tion; prominent, swollen scars; reddening and hyperthermia of the treated limb; pronounced vari­