Instructions For Use With An Osseointegrated Implant System; Information On The Use Of A Mobile Device With The Cockpit App - Ottobock Genium 3B1-3 Gebrauchsanweisung

CAUTION
Safety signal occurs (ongoing vibration)
Falling due to unexpected behaviour of the product because of changed damping behaviour.
► Observe the warnings/error signals (see Page 91).
► Do not continue using the product after the safety signal has been emitted.
► The product must be inspected by an authorised Ottobock Service Centre. In this case, the
contact person is your prosthetist.

4.9 Instructions for use with an osseointegrated implant system

WARNING
High mechanical loads due to normal or unusual situations, such as falling
> Overloading of the bone, which can lead to pain, loosening of the implant, necrosis or frac­
ture among other things.
> Damage or breakage of the implant system or its components (safety components...).
► Verify compliance with the fields of application, conditions of use and indications according
to the information of the manufacturers, both for the knee joint and for the implant system.
► Note the instructions of the clinical personnel that indicated the use of the osseointegrated
implant system.
► Note changes in your state of health that result in restrictions or doubt regarding the use of
the osseointegrated connection.

4.10 Information on the use of a mobile device with the cockpit app

CAUTION
Improper use of the device
Falling due to altered damping behaviour as a result of unexpected switching into MyMode.
► Make sure you have been instructed in the proper use of the device with the cockpit app.
CAUTION
Improper use of the setting parameters in the MyModes
Falling due to unexpected product behaviour because of changed damping behaviour.
► Get the O&P professional and/or therapist to instruct you regarding the functionality and
adjustment options for all parameters of the MyModes.
CAUTION
Independently applied changes or modifications made to the device
Falling due to altered damping behaviour as a result of unexpected switching into MyMode.
► Do not make any independent changes to the hardware of the device.
► Do not make any independent changes to the software/firmware of the device which are not
included in the update function of the software/firmware.
CAUTION
Improper mode switching with the device
Falling due to unexpected product behaviour because of changed damping behaviour.
Ensure that you stand securely during all switching processes.
►
► Verify the changed damping characteristics after switching and observe the feedback from
the acoustic signal emitter (beeper) and the display on the device.
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