Otto Bock 8S11 Series, Instructions For Use Manual

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Ottobock | 5
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 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: 2015-12-03
► 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 prosthetic glove is used as a protective glove for a prosthetic hand.
The PVC material is characterised by robustness and durability.
The appearance is based on a real hand in order to achieve a high degree of naturalness.
The fingernails
cannot
be painted.
The following prosthetic gloves are suitable for men:
•
8S4=*, 8S11=*
The following prosthetic gloves are suitable for women:
•
8S5=*, 8S12=*, 8S13=*
The following prosthetic gloves are suitable for children:
•
8S6=*, 8S20=*
2 Application
2.1 Indications for use
The product is to be used solely for upper limb prosthetic fittings.
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, 640F12 Special Cleaner
Unallowable environmental conditions
Mechanical vibrations or impacts, touching of sharp-edged or pointed objects