Maintenance; Legal Information; Technical Data - Ottobock Prosedo 3R31 Gebrauchsanweisung

9 Maintenance

CAUTION
Failure to follow the maintenance instructions
Risk of injuries due to changes in or loss of functionality and damage to the product
► Observe the maintenance instructions.
► CAUTION! For trial fittings, inspect the prosthesis several times according to the trial period
and use.
► CAUTION! For all maintenance and before each use, inspect the plastic components of the
product for deformation, damage and cracks.
► NOTICE! Do not lubricate and grease the prosthetic joint.
► NOTICE! Repair work must be performed exclusively by manufacturer service.
► The prosthetic components should be inspected after the first 30 days of use.
► Arrange regular maintenance intervals with the patient depending on the level of use.
► Following an individual period for the patient to get accustomed to the prosthesis, check the
settings of the prosthetic joint and adapt them to the patient's requirements again as needed.
► Inspect the entire prosthesis for wear during normal consultations.
► Conduct annual safety inspections.
► 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.
10 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.

11 Legal Information

11.1 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.
11.2 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.

12 Technical data

For the technical data, see Figure
1
h Proximal system height
s-prox
32
on page 23.
Abbreviations in the technical data
2
h Distal system height
s-dist
Ottobock | 47