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3.9 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...).
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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.
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Note the instructions of the clinical personnel that indicated the use of the osseointegrated
implant system.
3.10 Information on the use of a mobile device with the cockpit app
CAUTION
Improper use of the mobile device
Falling due to altered damping behaviour as a result of unexpected switching into a MyMode.
►
Use the instructions for use (user) to instruct the patient on the proper handling of the
mobile device with the Cockpit app.
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
app is installed.
►
Do not make any independent changes to the software/firmware of the mobile device that
are not included in the update function of the software/firmware.
CAUTION
Improper mode switching with the mobile device
Falling due to unexpected product behaviour because of changed damping behaviour.
►
Ensure that the patient stands securely during all switching processes.
►
Inform the patient that the changed damping characteristics have to be verified after switch
ing, and feedback from the acoustic signal emitter and the mobile device display must be
observed.
►
Switching back to basic mode is mandatory once the activities in the MyMode have been
completed.
Summary of Contents for C-Leg 3C88-3
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