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Legal Information - Ottobock 3S80 Gebrauchsanweisung

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  • DEUTSCH, seite 5
As part of the safety inspections, inspect the prosthetic knee joint for
wear and proper functionality. Special attention should be paid to move­
ment resistance, bearings and abnormal noises. Full flexion and exten­
sion must be ensured at all times. Readjust as required.
Direct the patient to observe the following maintenance instructions:
Check the entire prosthesis for damage after each use.
In case of changes in or loss of functionality and damage, do not contin­
ue using the prosthesis and have it checked by qualified personnel.
Comply with the maintenance intervals.
Cleaning
CAUTION
Use of unsuitable cleaning agents or disinfectants
Impairment of functionality and damage due to incorrect cleaning agents or
disinfectants
► Only clean the product with the approved cleaning agents.
► Only disinfect the product with the approved disinfectants.
► Observe the instructions for cleaning and care.
► Inform the patient.
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

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. The manufacturer is not liable for damage
caused by component combinations that were not authorised by the manu­
facturer.
9.2 CE Conformity
This device meets the requirements of the 93 / 42 / EEC guidelines for med­
ical devices. This device has been classified as a class I device according to
Ottobock | 29

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3s80 - 1 sport

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