Otto Bock 1K10 Instructions For Use Manual page 12

5.2.3 Dynamic Trial Fitting
• Adapt the setup of the prosthesis in the frontal plane and the sagittal
plane (e.g. by making angle or slide adjustments) so that correct heel
contact and optimal roll-over are ensured.
TT fittings:Make sure that physiological knee movement is achieved
•
after the heel makes impact and the leg begins to bear weight.
6 Cleaning and Care
1) Clean the product with a damp, soft cloth.
2) Dry the product with a soft cloth.
3) Allow to air dry in order to remove residual moisture.
7 Maintenance
• The prosthesis components should be inspected after the first 30 days of
use.
• Inspect the entire prosthesis for wear during normal consultations.
• Conduct quarterly 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 and collection processes.
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 disregard of 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.
12 | Ottobock