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Legal Information; Technical Data - Ottobock Pheon 3R62 KD Gebrauchsanweisung

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  • DEUTSCH, seite 10
► As part of the safety inspections, inspect the prosthetic joint for wear and proper functionality.
Special attention should be paid to movement resistance, bearings and abnormal noises. Full
flexion and extension must be ensured at all times. Readjust as required.
► Check the initial tension settings (EBS unit, extension assist) to make sure they are free of
play. Increase the initial tension if needed.
Replacing the stops
► Check the stops shown in Fig. 
is inspected.
► Check the serial number according to the steps (  –  ).
► CAUTION! If the serial number is smaller than shown in the illustration, only have the stops
replaced by the manufacturer's technical service.
► If the serial number is equal to or greater than shown in the illustration, replace the stops
according to the subsequent steps (  –  ).
► CAUTION! If the control measurement in the illustration is exceeded, do not use the product.
Contact the manufacturer's technical service.
9 Disposal
This product may not be disposed of with regular domestic waste in all jurisdictions. Disposal that
is not in accordance with the regulations of the country where the product is used may have a det­
rimental impact on health and the environment. Please observe the information provided by the
responsible authorities in the country of use regarding return, collection and disposal procedures.

10 Legal information

10.1 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.
10.2 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 out­
lined in Annex IX of the directive. The declaration of conformity was therefore created by the man­
ufacturer with sole responsibility according to Annex VII of the directive.

11 Technical data

For the technical data, see Figure 
   
h
Proximal system height
s-prox
1 Remarques sur le document
INFORMATION
Date de la dernière mise à jour : 2017-03-22
Veuillez lire attentivement l'intégralité de ce document avant d'utiliser le produit.
Respectez les consignes de sécurité afin d'éviter toute blessure et endommagement du pro­
duit.
Apprenez à l'utilisateur à bien utiliser son produit et informez-le des consignes de sécurité.
Conservez ce document.
32
12
on page 13 for wear and integrity every time the prosthesis
13
on page 14.
Abbreviations in the technical data
   
h
Distal system height
s-dist
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