Cleaning; Maintenance; Disposal; Legal Information - Ottobock 7E9 Instrucciones De Uso

7 Cleaning

NOTICE
Use of unsuitable cleaning agents
Damage to the product (e.g. bearings, seals and plastic components) due to substances con­
tained in the cleaning agent
► Do not use aggressive cleaning agents.

8 Maintenance

INFORMATION
Due to the use of control functions which are performed hydraulically, movement noises may
result when exoprosthetic hip joints are used. Such noises are normal and inevitable. They gen­
erally do not cause any problems.
If movement noises increase noticeably over the lifecycle of the hip joint, the prosthetic joint
should be inspected immediately by a prosthetist.
• After the prosthetic hip joint has been worn for several weeks, it should be inspected and any
necessary adjustments should be made. After an adaptation phase, prosthesis wearers usu­
ally appreciate a slightly higher extension damping in the stance phase.
• Conduct annual safety inspections.
• Check the prosthetic hip joint for wear and proper function once a year and make adjustments
if necessary. Special attention should be paid to movement resistance and abnormal noises.
Full flexion and extension must be ensured.
• Do not disassemble the prosthetic hip joint. Please send the complete prosthetic joint to the
manufacturer for repair in case of problems.

9 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 and collection processes.

10 Legal Information

10.1 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.

10.2 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.

11 Technical Data

Reference number
Proximal connection
7E9
Lamination Plate
35