Patient Information - Ottobock Genium Gebrauchsanweisung

Intended Use Intended Use
1.10 Patient information
WARNING
Danger of accidents when driving a motor vehicle. The ability of leg prosthesis wearers to operate a motor
vehicle is determined on a case-by-case basis. Criteria include the type of fitting (amputation height, unilateral or
bilateral, residual limb conditions, design of the prosthesis) and the individual abilities of the leg prosthesis wearer.
All persons are required to observe their country's national and state driving laws when operating motor vehicles.
For insurance purposes, drivers should have their driving ability examined and approved by an authorised test
centre. In general, Ottobock recommends that vehicles should be professionally retrofitted to meet each user's
individual needs (e. g. automatic transmission). Risk-free driving must be ensured even when the leg prosthesis is
not functioning.
CAUTION
Electromagnetic interference. The knee joint can malfunction when near high-voltage power lines, transmitters,
transformers, computer tomography equipment or other sources of strong electromagnetic radiation (such as secu-
rity systems for goods in department stores or body scanners in airports). This can cause the patient to fall.
Avoid proximity to strong sources of magnetic and electric interference (e.g. transformer stations, transmitters). If
this cannot be avoided, ensure at least that you are able to walk or stand steadily (e.g. by using a handrail or the
support of another person).
CAUTION
Thermal overloading. Extended exposure to high temperatures can lead to defects and result in malfunctions of the
knee joint with a loss of functionality due to structural failure. This can cause the patient to fall.
Avoid areas with extremely high temperatures (see Section 9.7 "Technical Information").
CAUTION
Mechanical overloading. External mechanical impact or stress such as shocks and vibrations can lead to:
• Short circuits in the electronics and battery, resulting in malfunction of the knee joint;
• Defects of the battery and the hydraulic unit, resulting in leaks;
• Loss of functionality due to structural failure.
This can cause the patient to fall and/or result in skin irritation.
Do not subject the system components to mechanical vibrations or impacts.
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
Penetration of dirt and humidity. Penetration of dirt and humidity into the system components can lead to:
• Short circuits in the electronics and battery, resulting in malfunction of the knee joint;
• Hydraulic unit defects with an associated leakage of fluid or a loss of functionality due to structural failure. This
can cause the patient to fall and/or result in skin irritation.
• Ensure that neither solid particles, foreign bodies nor liquids can penetrate the system components.
• The knee joint and the AXON tube adapter are protected against splashed water from all directions.
• The knee joint and the AXON tube adapter are not protected against submersion, jets of water and steam.
• If water has penetrated electronic system components, remove the cosmetic cover and allow the components to
dry. The knee joint must then be sent to an authorised Ottobock Service Centre for inspection. In this case, the
contact person is your prosthetist.
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