Otto Bock Genium 3B1-3 Instructions For Use Manual page 19

CAUTION
Errors during prosthesis alignment
> Falling due to unexpected product behaviour as the result of a malfunction.
> Falling due to breakage of load-bearing components.
► At maximum flexion, it is essential to maintain a minimum distance of 3 mm (1/8") between the hydraulic unit
and the socket.
► At maximum extension (reached under full load), it is essential to maintain a minimum distance of 5 mm (1/4")
between the sealing sleeve/top edge of the installed Protective Cover and the socket.
► If there is contact between the socket and the joint (hydraulic unit, frame) at maximum flexion, then the joint
must be fitted with a flexion stop (e.g. in the case of voluminous residual limbs).
If contact between the socket and joint (hydraulic unit, frame) occurs anyway at maximum flexion, the socket
has to lie flat on the frame (with the help of soft padding on the socket).
CAUTION
Insufficient insertion depth of the tube adapter
Falling due to breakage of load-bearing components.
► Insert the tube adapter at least 40mm to ensure operational safety.
► The patient must be seated for length adjustments.
CAUTION
Operator errors when using the adjustment software to adjust settings
Fall due to unexpected prosthesis behaviour.
► Do not charge the prosthesis battery during the adjustment process since the prosthesis is not functional
while the battery is being charged.
► During the adjustment process, the prosthesis must not remain unattended while connected to the software if
it is being worn by the patient.
► Observe the maximum range of the Bluetooth connection and note that obstacles may limit this range.
► During the data transfer (PC to prosthesis), the prosthesis wearer should sit or stand still, and the BionicLink
PC must not be removed from the computer.
► If you only want to make temporary changes to the settings while connected to the adjustment software, you
must reverse these changes before disconnecting the adjustment software.
You must also ensure the patient does not leave the range of the Bluetooth connection if settings have been
changed temporarily.
► Inform the patient immediately if the data connection is accidentally interrupted during the adjustment pro­
cess.
► The connection to the prosthesis must always be disconnected after adjustments have been completed.
► Successful participation on an Ottobock product training course is mandatory prior to initial use. Additional
product training courses may be required to qualify for software updates.
► It is very important to enter the correct foot size, prosthesis dimensions and body weight in order to achieve a
quality fitting. If the values are too high, the prosthesis may not switch to the swing phase. If the values are too
low, the prosthesis may trigger the swing phase at the wrong time.
► If the patient uses walking aids (e.g., crutches or walking canes) during the adjustment process, you will need
to readjust the settings when the patient no longer requires the respective aids.
► Use the online help function which is integrated into the software.
► Do not disclose your personal access data.
CAUTION
Safety mode flexion resistance set too low
Falling due to unexpected product behaviour as the result of switching into safety mode.
► Safety mode flexion resistance should be configured so that it is possible to stand safely without the knee joint
buckling.
Genium 3B1-3/3B1-3=ST
Safety
19