Rechtliche Hinweise; Ce-Konformität; Product Description; Intended Use - Ottobock 8S511 AxonSkin Silicone Instrucciones De Uso

6 Rechtliche Hinweise

6.1 Haftung
Der Hersteller haftet, wenn das Produkt gemäß den Beschreibungen und Anweisungen in diesem
Dokument verwendet wird. Für Schäden, die durch Nichtbeachtung dieses Dokuments, insbe­
sondere durch unsachgemäße Verwendung oder unerlaubte Veränderung des Produkts verur­
sacht werden, haftet der Hersteller nicht.
6.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der Verordnung (EU) 2017/745 über Medizinprodukte. Die
CE-Konformitätserklärung kann auf der Website des Herstellers heruntergeladen werden.

1 Product description

INFORMATION
Date of last update: 2020-10-02
Please read this document carefully before using the product and observe the safety
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notices.
Obtain instruction from the qualified personnel in the safe use of the product.
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Please contact the qualified personnel if you have questions about the product or in case of
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problems.
Report each serious incident in connection with the product, in particular a worsening of the
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state of health, to the manufacturer and to the relevant authority in your country.
Please keep this document for your records.
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The AxonSkin prosthetic glove is used as a protective glove for a prosthetic hand.
Designation
Prosthetic hand
The multi-layered silicone material maintains its high elasticity even at low temperatures, thereby
enabling constant functionality of the prosthetic hand.
8S511=* AxonSkin Silicone
The 8S511=* AxonSkin Silicone is designed for men.
Its appearance is based on a real hand in order to achieve a high degree of naturalness.
The prosthetic glove is coloured by hand, giving rise to possible variations in appearance, which
are not a product defect.
The fingernails cannot be painted.

2 Intended use

2.1 Indications for use
The product may only be used as part of an upper limb prosthesis with Michelangelo Hand.
2.2 Area of application
The product has been developed for use in everyday activities. It must not be used for activities
where it would be exposed to unallowable environmental conditions or strains (e.g. extreme
sports).
2.3 Environmental conditions
Allowable environmental conditions
Allowable operating temperature: -10 °C to +60 °C (+14 °F to +140 °F)
Allowable storage temperature: -20 °C to +40 °C (-4 °F to +104 °F)
Allowable transport temperature: -20 °C to +60 °C (-4 °F to +140 °F)
Reference Number
8E500=* Michelangelo Hand
English
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