Legal Information; Technical Data - Ottobock 4R101 Instrucciones De Uso

► Inspect the entire prosthesis for wear during normal consultations.
► Conduct annual safety inspections.
8 Disposal
This product may not be disposed of with regular domestic waste in all juris­
dictions. Disposal that is not in accordance with the regulations of the coun­
try 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 accord­
ance 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 unauthor­
ised 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 war­
ranty 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 manufac­
turer within the warranty period.
Further information on the warranty terms and conditions can be obtained
from the competent manufacturer distribution company.

10 Technical data

Reference number
Weight [g]
System height [mm]
14
4R101
205
25