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

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 46).
Do not continue using the product after the safety signal has been emitted.
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The product must be inspected by an authorised Ottobock Service Center. The O&P profes­
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sional is your contact.

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, death of bone tis­
sue or bone fracture, 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
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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
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implant system.
Note changes in your state of health that result in restrictions or doubt regarding the use of
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the osseointegrated connection.

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

CAUTION
Improper use of the mobile device
Falling due to changed damping behaviour as a result of unexpected switching to a MyMode.
Make sure you have been instructed in the proper use of the mobile device with the Cockpit
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app.
CAUTION
Improper use of the setting parameters in the MyModes
Falling due to unexpected behaviour of the product because of changed damping behaviour.
Ask the O&P professional and/or therapist to instruct you regarding the functionality and
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adjustment options for all parameters of the MyModes.
CAUTION
Independently applied changes or modifications made to the mobile device
Falling due to altered damping behaviour as a result of unexpected switching to a MyMode.
Do not make any independent changes to the hardware of the mobile device on which the
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app is installed.
Do not make any independent changes to the software/firmware of the mobile device that
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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.
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