Qualifications; Qualifications Of The Prosthetist; Qualifications Of The Therapist Or Nursing Staff; Function - Ottobock Genium Gebrauchsanweisung

Intended Use Intended Use
1.4 Qualifications
1.4.1 Qualifications of the Prosthetist
Only prosthetists who have been authorised by Ottobock after completing a corresponding training course may fit
patients with the 3B1/3B1=ST Knee Joint.
1.4.2 Qualifications of the Therapist or Nursing Staff
The therapists or nursing staff must be trained in handling the 3B1/3B1=ST Knee Joint (and accessories) by the
authorised prosthetist.
1.5 Function
The 3B1 / 3B1=ST Knee Joint is an electronic knee joint system with hydraulic stance and swing phase control. It
is controlled by a microprocessor-based hydraulic unit that dynamically adapts the system in real time. The control
mechanism is realised by a sensor system. The sensors collect measurements every 0.01 seconds (corresponds to
100 Hz). Through the evaluation of the measurements, the 3B1 / 3B1=ST Knee Joint recognises the current movement
phase of the wearer.
1.6 Safety Instructions
INFORMATION
Advise your patient of the information in this section.
CAUTION
Non-observance of safety instructions. Failure to observe the safety instructions and precautions described in this
accompanying document can lead to faulty control or malfunction of the product and may result in risk of injury for
the patient as well as destruction of the product.
1.7 Scope of Delivery
1 3B1/3B1=ST Genium - Bionic Prosthetic System
1 4X350 Remote Control
1 757L16-3 Power Supply
1 4E60 Inductive Charger
1 Installation Ring for 4X259 Inductive Charger
1 4H99 Flexion Stop
1 4H100 Flexion Stop
1 S3B1-53 Bit - Torx-Profil TX10, 1/4"
1.8 Recommended Accessories
1 2R20 AXON Tube Adapter/2R21 AXON Tube Adapter with Torsion
1 4X1=* X-Soft
1.9 General Safety Instructions
CAUTION
Alignment and adjustment errors. When fitting and adjusting the prosthesis, errors can occur, which can cause
malfunctions of the knee joint including loss of function due to structural failure. This can cause the patient to fall.
• Participation in an Ottobock product training course for the 3B1/3B1=ST Knee Joint is mandatory before the
first fitting. Additional product training courses may become necessary to qualify for product 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.
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