Legal Information - Ottobock 3R60 Gebrauchsanweisung

Please check the knee joint for wear and proper function at least once a year and make adjust-
ments if necessary. Special attention should be paid to the flexion and extension resistances,
bearings, and abnormal noises. Full flexion and extension must be guaranteed.
This component has been tested according to ISO 10328 standard for three million
load cycles. Depending on the amputee's activity this corresponds to a duration of
use of three to five years.
We recommend carrying out regular yearly safety checks.

5 Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary
accordingly.
5.1 Liability
The manufacturer will only assume liability if the product is used in accordance with the descrip-
tions and instructions provided in this document. The manufacturer will not assume liability for
damage caused by disregard of this document, particularly due to improper use or unauthorised
modification of the product.
5.2 CE conformity
This product meets the requirements of the European Directive 93 / 42 / EEC for medical devices.
This product has been classified as a class I device according to the classification criteria outlined
in Annex IX of the directive. The declaration of conformity was therefore created by the manufac-
turer with sole responsibility according to Annex VII of the directive.
INFORMATION
Date de la dernière mise à jour: 2017-07-10
f Veuillez lire attentivement l'intégralité de ce document avant d'utiliser le produit.
f Respectez les consignes de sécurité afin d'éviter toute blessure et endommagement du
produit.
f Apprenez à l'utilisateur à bien utiliser son produit et informez-le des consignes de sécurité.
f Conservez ce document.
1 Pièces détachées (ill. 1)
(1) Clé de réglage 710H10=2×3
(2) Butée 4Z59=5.5×6
(3) Plaque signalétique 4G444=3R60-N
(4) Capotage 4G375
(5) Ancre à couler 4G70 avec
4 boulons à tête bombée 501T1=M5×16 (a)
4 écrous à deux trous 502R1=M5×16 (b)
2 tiges filetées 506G3=M8×12-V (c)
1 tige filetée 506G3=M8×10 (d)
24 | Ottobock 3R60, 3R60=ST, 3R60=KD, 3R60=HD
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