Legal Information - Ottobock 3R80 Gebrauchsanweisung

INFORMATION
► Clean the product after contact with liquids or if it gets dirty.
► For disinfection, only use disinfectants that do not affect the materials of the product. For
further information, please consult the manufacturer.
► Observe the cleaning instructions for all prosthetic components.
1) Clean the product with a damp cloth and soap.
2) Rinse the product with clean, fresh water.
3) Dry the product with a soft cloth.
4) NOTICE! Do not store the product while moist.
Allow to air dry in order to remove residual moisture.
7 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 following maintenance instructions.
► 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.
► The prosthetic components should be inspected after the first 30 days of use.
► 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.
8 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.

9 Legal Information

9.1 Liability
The manufacturer recommends using the device only under the specified conditions and for the
intended purposes. The device must be maintained according to the Instructions for Use. The
device must only be operated with tested modular components in accordance with the MOBIS
Mobility System. The manufacturer is not liable for damage caused by component combinations
that were not authorised by the manufacturer.
9.2 CE Conformity
This device meets the requirements of the 93 / 42 / EEC guidelines for medical devices. This
device has been classified as a class I device according to the classification criteria outlined in
appendix IX of the guidelines. The declaration of conformity was therefore created by the manu­
facturer with sole responsibility according to appendix VII of the guidelines.
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