► Have the prosthetic components inspected every 3 months.
► Inspect the entire prosthesis for wear during normal consulta
tions.
8 Disposal
This product may not be disposed of with regular domestic waste in
all jurisdictions. Disposal that is not in accordance with the regula
tions of the country where the product is used may have a detrimental
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.
9 Legal information
All legal conditions are subject to the respective national laws of the
country of use and may vary accordingly.
9.1 Liability
The manufacturer will only assume liability if the product is used in
accordance with the descriptions and instructions provided in this
document. The manufacturer will not assume liability for damage
caused by disregarding the information in this document, particularly
due to improper use or unauthorised modification of the product.
9.2 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 manufacturer with sole responsibility according to Annex VII of the
directive.
9.3 Warranty
The manufacturer warrants this device from the date of purchase. The
warranty covers defects that can be proven to be a direct result of
flaws in the material, production or construction and that are reported
to the manufacturer within the warranty period.
12
Further information on the warranty terms and conditions can be
obtained from the competent manufacturer distribution company.
10 Technical data
Reference number
Material
System height [mm]
Weight [g]
Max. body weight [kg]
Max. body height [cm]
Max. foot size [cm]
1 Description du produit
INFORMATION
Date de la dernière mise à jour : 2019-12-03
► 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 produit.
► Apprenez à l'utilisateur à bien utiliser son produit et informez-le
des consignes de sécurité.
► Conservez ce document.
1.1 Conception et fonctionnement
L'admission d'emboîture 5R9 se monte par collage et stratification sur
l'extrémité distale recouverte de mousse de l'emboîture de prothèse.
L'adaptateur d'emboîture 4R60 permet de relier les composants pro
thétiques distaux et se fixe sur l'admission d'emboîture 5R9.
1.2 Combinaisons possibles
Ce composant prothétique est compatible avec le système modulaire
Ottobock pour enfants. Le fonctionnement avec des composants
5R9
4R60
Plastic
Aluminium
30
33
125
45
45
145
21
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