Notes On The Safety Modes; Instructions For Use With An Osseointegrated Implant System; Information On The Use Of A Mobile Device With The Cockpit App - Otto Bock Genium X3 Instructions For Use Manual

Safety

4.9 Notes on the safety modes

CAUTION
Using the product in safety mode
Falling due to unexpected product behaviour because of changed damping behaviour.
► The warnings/error signals (see page 55) have to be observed.
► Particular caution is necessary when using a bicycle without a freewheel (with a fixed gear).
CAUTION
Safety mode cannot be activated due to malfunction caused by water penetration or mechanical damage
Falling due to unexpected product behaviour because of changed damping behaviour.
► Using the product when it is defective is prohibited.
► The product must be inspected by an authorised Ottobock Service Centre.
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 55) 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

Only valid for the products 3B5-2/3B5-2=ST
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 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
Improper use of the setting parameters in the MyModes
Falling due to unexpected product behaviour because of changed damping behaviour.
► Instruct the patient regarding the functionality and adjustment options for all parameters of the MyModes.
24 Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge­
nium X3 3B5-2/3B5-2=ST