Ce-Konformität; Intended Use; Safety Instructions - Ottobock 8E51 Gebrauchsanweisung

Das Öffnen und Reparieren dieses Produkts darf nur von autorisiertem Ottobock Fachpersonal
durchgeführt werden.
11 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 von Ottobock in alleini-
ger Verantwortung gemäß Anhang VII der Richtlinie erstellt.
Date of the last update: 2014-11-26
• Please read this document carefully.
• Follow the safety instructions and the precautions specified in this accompanying document.
• If assistance is required during the start-up, use or maintenance of the product, as well as
in the event of unexpected operating behaviour or circumstances, contact the manufacturer
(see manufacturer's address on the back of this accompanying document).

1 Intended use

1.1 Medical Purpose
The Electrohand 2000 is to be exclusively used for the prosthetic fitting of amputations or mal-
formation of the upper limb.
1.2 Trademarks
All product names mentioned in this accompanying document are subject without restriction to
the respective applicable trademark laws and are the property of the respective owners.
All brands, trade names or company names may be registered trademarks and are the property
of the respective owners. Should trademarks used in this accompanying document fail to be
explicitly identified as such, this does not justify the conclusion that the denotation in question is
free of third-party rights.
1.3 Application
The Electrohand 2000 may be used for unilateral or bilateral amputees or in case of dysmelia.
1.4 Application conditions
The Electrohand 2000 has been developed for everyday use and must not be used for unusual
activities such as extreme sports (free climbing, paragliding, etc.).
The Electrohand 2000 is designed exclusively for use on one patient. Use of the product by other
persons is not approved by the manufacturer.
1.5 Prosthetist qualifications
The fitting of a patient with the Electrohand 2000 may only be carried out by prosthetists who have
been trained and certified by Ottobock for the use of MyoBock components.
2 Safetyinstructions
Failure to follow the safety instructions given below can lead to damage to or malfunction of the
product. Follow the safety instructions and the precautions specified in this accompanying docu-
ment.
8 | Ottobock
English
8E51