Application; Indications For Use; Indications; Orthosis Construction With Spring Element - Otto Bock C-Brace Instructions For Use Manual

3 Application

3.1 Indications for use

The product is intended solely for orthotic fittings of the lower limbs.

3.2 Indications

3.2.1 Orthosis construction with spring element

• Unilateral or bilateral lower limb paresis or flaccid paralysis, e.g. due to polio, traumatic paresis including para­
plegia.
• Physical prerequisites such as muscle status, mobility grade and axis deviations that guarantee proper control
of the orthosis are crucial.
• The patient must fulfil the physical and mental requirements for the perception of audible signals.
Indications must be determined by the physician.

3.2.2 Orthosis construction with Sensor Ankle

• Unilateral or bilateral lower limb paresis or flaccid paralysis, e.g. due to polio, traumatic paresis including para­
plegia.
• Ankle arthrodesis
• Physical prerequisites such as muscle status, mobility grade and axis deviations that guarantee proper control
of the orthosis are crucial.
• The patient must fulfil the physical and mental requirements for the perception of audible signals.
Indications must be determined by the physician.

3.3 Contraindications

3.3.1 Orthosis construction with spring element
• Flexion contracture in the knee and hip 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 Spring Element (17CF2=HD)
• Body weight over 110 kg/242 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 45 kg/100 lbs
• Body height less than 150 cm/59.06 inch
3.3.2 Orthosis construction with Sensor Ankle
• Flexion contracture in the knee and hip joint in excess of 10°
• Varus malposition in excess of 10° or valgus malposition in excess of 10°
• Body weight over 85 kg/187 lbs with use of one ankle joint (lateral installation) (17LA3=16-T)
• Body weight over 120 kg/265 lbs with use of two ankle joints (lateral and medial installation) (17LA3=16-T)
• Body weight over 110 kg/243 lbs with use of one ankle joint (lateral installation) (17LA3=20-T)
• Body weight over 125 kg/275 lbs with use of two ankle joints (lateral and medial installation) (17LA3=20-T)
• Body height less than 150 cm/59.06 inch

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 and have
been certified for the application. 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 author­
ised orthopaedic technician.
C-Brace
Application
49