3 Application
3.1 Indications for use
The product is intended solely for orthotic fittings of the lower limbs.
3.2 Indications
•
Leg paresis or flaccid paralysis, e.g. due to polio, traumatic paresis including paraplegia.
•
Physical prerequisites such as muscle status, mobility grade and axis deviations that guaran
tee proper control of the orthosis are crucial.
•
The patient must fulfil the physical and mental requirements for the perception of audible sig
nals.
Indications must be determined by the physician.
3.3 Contraindications
3.3.1 Orthosis construction with spring element
•
Flexion contracture in the knee joint in excess of 10°
•
Varus malposition in excess of 10° or valgus malposition in excess of 10°
•
Ankle arthrodesis: passive range of motion less than 2°
•
Body weight over 125 kg / 275 lbs with use of the carbon spring element (17CF2=1)
•
Body weight over 100 kg / 220 lbs with use of the glass fibre spring element (17CF2=4)
•
Body weight less than approx. 45 kg / 100 lbs
3.3.2 Orthosis construction with Sensor Ankle
•
Body weight over 85 kg / 187 lbs when using the Sensor Ankle (17LA3=16-T), for unilateral
fitting
•
Body weight over 120 kg / 265 lbs when using the Sensor Ankle (17LA3=16-T), for bilateral
fitting
•
Body weight over 110 kg / 243 lbs when using the Sensor Ankle (17LA3=20-T), for unilateral
fitting
•
Flexion contracture in the knee joint in excess of 10°
•
Varus malposition in excess of 10° or valgus malposition in excess of 10°
•
Ankle arthrodesis: passive range of motion less than 2°
3.4 Qualification
3.4.1 Qualification of the orthopaedic technician
Fitting a patient with the product may only be carried out by orthopaedic technicians who have
been authorised by Ottobock after completion of a corresponding training course.
The adjustment software may only be used by users who have participated in the relevant product
training. Additional product training courses may become necessary to qualify for software
updates.
3.4.2 Qualifications of the therapist or nursing staff
The therapists or nursing staff must be trained in handling the product. Training must be carried
out by the authorised orthopaedic technician.
3.5 Use/Field of Application
The product is an orthopaedic device that makes it possible or easier for the user to stand and
walk, and may also fulfil other medical requirements. If the activity level of the user increases in
the course of use, adjustments are required. Changes will also have to be made if the user's
physical condition worsens and more support from the product is needed.
Compliance with the daily duration of use and accompanying therapeutic measures is required.
In general, major discomfort should not be experienced when wearing the product. The affected
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