Otto Bock AxonSkin Silicone 8S511 Series Instructions For Use Manual page 5

6.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der Richtlinie 93/42/EWG für Medizinprodukte. Aufgrund
der Klassifizierungskriterien für Medizinprodukte nach Anhang IX der Richtlinie wurde das Pro­
dukt in die Klasse I eingestuft. Die Konformitätserklärung wurde deshalb vom Hersteller in alleini­
ger Verantwortung gemäß Anhang VII der Richtlinie erstellt.
1 Product description
INFORMATION
Last update: 2015-12-15
► 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.
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 Application
2.1 Indications for use
The product may only be used as part of a prosthesis for the upper extremity (Michelangelo Hand
with Axon-Bus system).
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)
Allowable relative humidity: max. 80%
Cleaning agents: warm water and soap
Unallowable environmental conditions
Mechanical vibrations or impacts, touching of sharp-edged or pointed objects
Contact with acids, unallowable cleaning agents, abrasive media (e.g. sand), damp soil, dust, dirt, highly
staining materials (e.g. printing ink, new textiles), solvents (e.g. thinner, acetone, petrol), fire, embers and
unallowable heat (> +60 °C / > +140 °F)
Reference Number
8E500=* Michelangelo Hand
English
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