Otto Bock 50K13 Genu Arexa, Инструкция по эксплуатации

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sondere durch unsachgemäße Verwendung oder unerlaubte Veränderung des Produkts verur­
sacht werden, haftet der Hersteller nicht.
7.3 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.
1 Foreword English
INFORMATION
Last update: 2018-06-07
► 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
50K13 Genu Arexa knee joint orthosis.
2 Product description
see fig. 1
Item
Component Item Component
1 Strap guide loop 6 Pad retainer
2 Pad button 7 Extension stop (square grip)
3 Clip rivet 8 Flexion stop (round grip)
4 Tibia pad - Straps 1 through 5
5 Condyle pad - Strap 6
(CI version,
optional
ACL/PCL version)
3 Intended use
3.1 Indications for use
The orthosis is intended
exclusively
for orthotic fittings of the lower limbs and
exclusively
for
contact with intact skin.
The orthosis must be used in accordance with the indications.
3.2 Indications
• Conservative treatment of injuries (e.g. after distension, partial ruptures, ruptures) of the
anterior and/or posterior cruciate ligament and/or the medial and/or lateral collateral ligament
of the knee joint
• Functional follow-up treatment after ligament surgery of the anterior and/or posterior cruciate
ligament and/or the medial and/or lateral collateral ligament of the knee joint
• Conservative therapy of chronic complex knee joint instabilities
Indications must be determined by the physician.
3.3 Contraindications
3.3.1 Absolute Contraindications
Not known.