Ce-Konformität; Instructions For Use - Ottobock 8360 Genu Carezza Instrucciones De Uso

6.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der europäischen Richtlinie
93/42/EWG für Medizinprodukte. Aufgrund der Klassifizierungskriterien
nach Anhang IX dieser Richtlinie wurde das Produkt in die Klasse I einge­
stuft. Die Konformitätserklärung wurde deshalb vom Hersteller in alleiniger
Verantwortung gemäß Anhang VII der Richtlinie erstellt.
1 Foreword
INFORMATION
Last update: 2015-02-27
► Please read this document carefully before using the product.
► Follow the safety instructions to avoid injuries and damage to the prod­
uct.
► 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 8360 Genu Carezza patella stabilizer knee support.
2 Application
2.1 Indications for use
The support is intended exclusively for fittings of the lower limbs and exclu­
sively for contact with intact skin.
The support must be used according to the indication.
2.2 Indications
• Patellofemoral pain syndrome (e.g. chondromalacia patellae, chon­
dropathia patellae, retropatellar osteoarthritis)
• Patellofemoral maltracking
• Following patellar dislocation/subluxation
• After lateral release operations
The indication must be determined by the physician.
2.3 Contraindications
2.3.1 Absolute Contraindications
None known.
2.3.2 Relative Contraindications
The following indications require consultation with a physician: skin dis­
eases/injuries, inflammation, prominent scars that are swollen, reddening
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