8
sondere durch unsachgemäße Verwendung oder unerlaubte Veränderung des Produkts verur
sacht werden, haftet der Hersteller nicht.
9.2 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.
1 Product description
English
INFORMATION
Last update: 2019-04-08
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Please read this document carefully before using the product.
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Follow the safety instructions to avoid injuries and damage to the product.
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Instruct the user in the proper and safe use of the product.
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Please keep this document in a safe place.
INFORMATION
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The patient must be fitted with the liner no later than the date printed on the inside of the
packaging or on the label (MHD/BBD).
1.1 Function
The 6Y200 liner connects the residual limb to the Varos 5A60 prosthetic socket. For this purpose,
the liner is equipped with a textile outer layer and a magnetic cap, which improve the adhesion of
the liner in the socket.
1.2 Combination possibilities
This prosthetic component is compatible with Ottobock's system of modular connectors. Func
tionality with components of other manufacturers that have compatible modular connectors has
not been tested.
Limited combination options for Ottobock components
The liner can only be combined with the 5A60=* Varos transfemoral socket (main product).
2 Intended use
2.1 Indications for use
The product is to be used solely for lower limb prosthetic fittings.
2.2 Service life
The product is a wear part, which means it is subject to normal wear and tear.
2.3 Indications
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The information can be found in the instructions for use for the main product
2.4 Contraindications
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The information can be found in the instructions for use for the main product
