19 General Safety Instructions - Otto Bock Genium X3 Instructions For Use Manual

Intended Use
1.9 General Safety Instructions
CAUTION
Alignment and adjustment errors. When fitting and adjusting the prosthesis, errors can occur, which can
cause malfunctions of the knee joint including loss of function due to structural failure This may cause the pa-
tient to fall
• Participation in an Ottobock product training course for the knee joint is mandatory prior to the first fitting
Additional product training courses may become necessary to qualify for product updates
• Correctly entering the foot size, the prosthesis dimensions and the body weight are important criteria for the
quality of the fitting If the values are too high, the prosthesis may not trigger the swing phase If the values
are too low, the prosthesis may trigger the swing phase at the incorrect time
CAUTION
Use of unsuitable prosthetic components. If unsuitable prosthetic components are installed in the prosthe-
sis, malfunction of the joint and a loss of functionality due to structural failure may occur This may cause the
patient to fall
Only combine the knee joint with adapters and feet tested by Ottobock (see system overview, front)
Ensure that the waterproofness and corrosion resistance of every single prosthetic component is considered
individually
Ottobock assumes no liability if the knee joint is used with components other than those specified (see system
overview, front)
CAUTION
Manipulation of system components. Independent changes and / or modifications of system components
may lead to malfunction of the knee joint and a loss of functionality due to structural failure This may cause the
patient to fall
• Any changes or modifications to the knee joint may limit its use
• The knee joint may only be opened and repaired by authorised Ottobock technicians and the battery may
only be handled by Ottobock Service Centres (no independent battery replacement)
CAUTION
Improper use of the knee joint. Any kind of overloading or excessive strain as well as improper use can lead
to defects with subsequent malfunctions of the knee joint and a loss of functionality due to structural failure
This may cause the patient to fall
The patient must be instructed in how to handle the knee joint properly and be informed of the patient instruc-
tions below
CAUTION
Improper use of the remote control. Improper use may damage the remote control This can lead to malfunc-
tion of the remote control and result in unexpected actions of the knee joint This may cause the patient to fall
Instruct the patient in how to use the remote control correctly based on the patient information (646D564) Ad-
vise the patient of the following patient instructions
CAUTION
MyMode switching via remote control. When the remote control is used for MyMode switching, the damping
properties of the knee joint are changed In certain situations (eg under flexion load in cycling mode), this may
cause the patient to fall
Instruct the patient in how to use MyMode switching in MyModes based on the patient information (646D564)
Advise the patient of the following patient instructions
8 | Ottobock Genium X3 - Bionic Prosthetic System