Ce-Konformität; Explanation Of Symbols - Otto Bock 8360 Manual

8 CE-Konformität
Das Produkt erfüllt die Anforderungen der Richtlinie 93 / 42 / EWG für Me-
dizinprodukte. Aufgrund der Klassifizierungskriterien für Medizinprodukte
nach Anhang IX der Richtlinie wurde das Produkt in die Klasse I eingestuft.
Die Konformitätserklärung wurde deshalb von Otto Bock in alleiniger Ver-
antwortung gemäß Anhang VII der Richtlinie erstellt.

Explanation of Symbols

Warnings regarding possible risks of accident or injury.
CAUTION
Warnings regarding possible technical damage.
NOTICE
Additional information on the fitting / use.
INFORMATION
INFORMATION
Please read these instructions for use carefully and pay special
attention to the safety information!
1 Function
Stabilises the patella laterally and has a pain-relieving effect. This is a small
support with a important functions. Easy to use when moving around and
taking part in sports. Can be used on both the right and the left knee. User-
friendly support which is anatomically designed. A material which drains
away moisture and keeps the skin dry.
2 Indications
• Patellofemoral pain syndrome (e.g. chondromalacia, chondropathia
patellae, moderate arthrosis of the patellofemoral joint)
• Patellofemoral maltracking
• Stabilization after patellar luxations/subluxations
• Stabilization after lateral release operation
2.1 Contraindications
2.1.1 Absolute Contraindications
None.
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