Instructions For Use With An Osseointegrated Implant System; Information On The Use Of A Mobile Device With The Cockpit App - Otto Bock C-Leg 3C98-3 Instructions For Use Manual

CAUTION
Safety mode cannot be deactivated
Falling due to unexpected product behaviour because of changed damping behaviour.
► If safety mode cannot be deactivated by recharging the battery, a permanent error has occurred.
► Using the product when it is defective is prohibited.
► The product must be inspected by an authorised Ottobock Service Centre.
CAUTION
Safety signal occurs (ongoing vibration)
Falling due to unexpected product behaviour because of changed damping behaviour.
► The warnings/error signals (see Page 42) have to be observed.
► After the safety signal has been emitted, further use of the product is prohibited.
► The product must be inspected by an authorised Ottobock Service Centre.

4.10 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 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 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.

4.11 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.
► Use the instructions for use (user) to instruct the patient on proper use of the device with the cockpit app.
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 the patient stands securely during all switching processes.
► Inform the patient that the changed damping characteristics have to be verified after switching, and feedback
from the acoustic signal emitter and the device display must be observed.
► Switching back to basic mode is mandatory once the activities in MyMode have been completed.
NOTICE
Destruction of the device due to falling or penetration of water
Malfunction of the device.
► Note the instructions for use for the device.
► If it should no longer be possible to switch back from a MyMode to basic mode, the component can only be
switched back to basic mode by using a movement pattern (see Page 35) or by connecting/disconnecting the
inductive battery charger.
C-Leg 3C98-3/3C88-3
Safety
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