Information On Proximity To Certain Areas - Ottobock Genium 3B1-2 Gebrauchsanweisung

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 during the adjustment process with the adjustment software
Falling due to unexpected behaviour of the product.
► Participation in an Ottobock product training course is mandatory prior to using the product. Additional
product training courses may become necessary to qualify for software 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 switch to the swing phase. If the values
are too low, the prosthesis may trigger the swing phase at the wrong time.
► Always enter the weight in the specified unit.
► Ensure that the required dimensions are selected and entered correctly.
► If the patient uses walking aids (e.g. crutches or walking canes) during the adjustment process, readjustment
is required as soon as the patient stops using these walking aids.
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.

4.7 Information on Proximity to Certain Areas

CAUTION
Distance to HF communication devices is too small (e.g. mobile phones, Bluetooth devices, WiFi
devices)
Falling due to unexpected behaviour of the product caused by interference with internal data communication.
► Therefore, keeping the following minimum distances to these HF communication devices is recommended:
• Mobile phone GSM 850/GSM 900: 0.50 m
• Mobile phone GSM 1800/GSM 1900/UMTS: 0.35 m
• DECT cordless phones incl. base station: 0.18 m
• WiFi (routers, access points,...): 0.11 m
• Bluetooth devices (third-party products not approved by Ottobock): 0.11 m
CAUTION
Proximity to sources of strong magnetic or electrical interference (e.g. theft prevention systems, metal
detectors)
Falling due to unexpected behaviour of the product caused by interference with internal data communication.
► Ensure that the patient is not in the vicinity of sources of strong magnetic and electrical interference during tri­
al fitting (e.g. computer tomographs, magnetic resonance tomographs ...).
If this cannot be avoided, ensure at least that the patient is able to walk or stand securely (e.g. by using a
handrail or the support of another person).
CAUTION
Remaining in areas outside the allowable temperature range
Falling due to malfunction or the breakage of load-bearing product components.
► Ensure that the patient is not in areas outside the permissible temperature range (see Page 93) during trial fit­
ting.
Genium 3B1-2/3B1-2=ST
Safety
Ottobock | 61