Indications For Use; Field Of Application; Safety Instructions - Ottobock 3R95 Gebrauchsanweisung

2 Description

2.1 Indications for use

Attention!
Reuse on another patient
Fall due to loss of functionality as well as damage to the product
• Only use the product for a single patient.
The 3R95 und 3R95=1 Modular Lightweight Single-Axis Knee Joints with integrated miniaturised
hydraulic swing phase control are to be used exclusively for the exoprosthetic fitting of the lower limb.
Amputation level: knee disarticulation, transfemoral amputation.

2.2 Field of application

2.2.1 Application of 3R95
Field of application according to the Ottobock MOBIS Mobility System:
Recommended for mobility grades 3 and 4
(unrestricted outdoor walkers and unrestricted outdoor walkers with especially
rigorous demands).
Approved for a patient weight of up to 150 kg/330 lbs.
2.2.2 Application of 3R95=1
Field of application according to the Ottobock MOBIS Mobility System:
Recommended for mobility grades 3 and 4
(unrestricted outdoor walkers and unrestricted outdoor walkers with especially
rigorous demands).
Approved for a patient weight of up to 75 kg/165 lbs.
2.2.3 Application conditions
Primarily recommended for transfemoral amputees who can actively contribute to stance phase
stability and wish to have a harmonious swing phase control. The light weight and low structural
height are special advantages when fitting women and adolescents.
The 3R95 and 3R95=1 Modular Lightweight Joints have been developed for everyday use and
must not be used for unusual activities such as extreme sports (free climbing, paragliding, etc.).

2.3 Safety instructions

2.3.1 General safety instructions
• The 3R95 and 3R95=1 Modular Lightweight Knee Joints may not be used for bathing prostheses.
• Please follow all indicated torque values.
• Use the Patient Information section of this pamphlet to inform your patient about the function
and use of the modular lightweight knee joint.
2.3.2 Patient information
• The modular lightweight knee joint should not be subjected to intense smoke, dust, mechanical
vibrations, shocks or high temperatures.
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