Otto Bock 1C63 Triton Low Profile Instructions For Use Manual page 18

7 Maintenance instructions
• Foot assembly should be inspected after 30 days (4 weeks) of use.
• Inspection of the entire prosthesis for wear during normal consultations.
• Footshell may require replacement if wear is excessive.
8 Legal information
All legal conditions are subject to the respective national laws of the country of use and may vary
accordingly.
8.1 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.
8.2 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
Explanation of the warning symbol
ISO 22675 – "P" – "m" kg*
* Body mass limit not be exceeded!
)
For specific conditions and limitations of use see
manufacturer's written instructions on intended use!
INFORMATION
This component has been tested according to ISO 22675 standard for two million load cycles.
Depending on the amputee's activity this corresponds to a duration of use of two to three years.
We recommend carrying out regular yearly safety checks.
18
:
In the standard mentioned on the left, test levels
)
(P) are assigned to certain maximal body masses
(m in kg). In some cases, which are marked with
, no test level is assigned to the product-related
maximal body mass.
In these cases, the test loads have been adapted
adequately on the basis of the specified test level.