Intended Use; Medical Purpose; Area Of Application; Conditions Of Use - Ottobock Genium Gebrauchsanweisung

Explanation of symbols in the instructions for use
Warnings regarding directly impending risks of severe accident or injury.
DANGER
Warnings regarding possible risks of severe accident or injury.
WARNING
Warnings regarding possible risks of accident or injury.
CAUTION
Warnings regarding possible technical damage.
NOTICE
1 Intended Use
INFORMATION
Before using the 3B1/3B1=ST Knee Joint, please read these instructions for use thoroughly! Pay special attention
to the safety instructions and the precautions specified in this accompanying document.
The patient must be taught how to handle, care for and operate the prosthesis properly. See the following sections:
1.3 Conditions of Use, 1.5 Function, 1.6 Safety Instructions, 2.1 Charging the 3B1/3B1=ST Knee Joint, 6 MyMode
Motion Switching, 7 Remote Control, 9 Important Patient Information, 11 Liability
Only start up the product in accordance with the information contained in the accompanying documents supplied.
Instruct the patient in the proper use and care of the product. The product may not be transferred to the patient wit-
hout prior instruction.
1.1 Medical Purpose
The 3B1 / 3B1=ST Knee Joint is intended exclusively for exoprosthetic fittings of the lower limbs.
1.2 Area of application
The patient must meet the following requirements:
• The patient must fulfil the physical and mental requirements for perceiving audible signals and/or mechanical
vibrations.
• The skin on the residual limb must be completely healed.
• The knee rotation point-ground measurement must be at least 318 mm (if the 2R20 and 1E57 are used). The mi-
nimum distal system height (distance between the knee axis and the centre point of the lower pyramid receiver at
the AXON tube adapter) of the 3B1/3B1=ST Knee Joint with AXON tube adapter must be 310 mm if the 2R20 is
used and 344 mm if the 2R21 is used.
• Hip disarticulation and/or hemipelvectomy patients must be fitted with the 7E10=* Helix
INFORMATION
Advise your patient of the information in this section.
Area of application according to the MOBIS, the Ottobock mobility system:
Recommended for mobility grades 2, 3 and 4 (restricted outdoor walkers, unrestricted outdoor
walkers and unrestricted outdoor walkers with especially high requirements).
Approved for body weights of up to 150 kg with the 2R20, or up to 125 kg with the 2R21.
1.3 Conditions of Use
INFORMATION
Advise your patient of the information in this section.
The 3B1/3B1=ST Knee Joint was designed for everyday activities, but not for extreme sports such as free-clim-
bing, skydiving, paragliding etc. See Section 9.7 Technical Information for the permitted ambient conditions. The
3B1 / 3B1=ST Knee Joint is intended exclusively for fittings of amputees or dysmelia patients. Use of the product by
other persons is not approved by the manufacturer.
Genium - Bionic Prosthetic System Genium - Bionic Prosthetic System
Intended Use Intended Use
hip joint.
3D
Ottobock | 41 Ottobock | 41