Otto Bock 28U80 Malleo Neurexa Instructions For Use Manual page 9

► Report each serious incident in connection with the product, in particular a worsening of the
state of health, to the manufacturer and to the relevant authority in your country.
Please keep this document for your records.
►
These instructions for use provide important information on the fitting and application of the
28U80 Malleo Neurexa ankle-foot orthosis.
2 Intended use
2.1 Indications for use
The orthosis is intended exclusively for orthotic fittings of the lower limbs and exclusively for
contact with intact skin.
The orthosis must be used in accordance with the indications.
2.2 Indications
• Drop foot (minor impairment of the dorsiflexor muscles in the leg)
Caused for example by:
• Stroke
• Traumatic brain injury
• Multiple sclerosis
• Neuromuscular atrophy
• Peroneal nerve injury
Indications must be determined by the physician.
2.3 Contraindications
2.3.1 Absolute Contraindications
• Moderate to severe spasticity in the lower leg
• Moderate to severe oedema
• Moderate to severe foot deformities
• Leg ulcers
2.3.2 Relative Contraindications
The following indications require consultation with a physician: skin diseases/injuries, inflamma­
tion, prominent scars that are swollen, reddening and hyperthermia of the fitted limb/body area;
lymphatic flow disorders, including unclear soft tissue swelling distal to the body area to which
the medical device will be applied; sensory and circulatory disorders in the lower leg and the foot
area.
2.4 Service life
The manufacturer has determined a maximal service life of one year for the product.
2.5 Restrictions for use
The orthosis must not be used for sports activities that involve jumping, sudden movements or
rapid step sequences (e.g. basketball, badminton, riding sports). Sports activities should gener­
ally be discussed with the patient.
2.6 Effects
• Supports dorsiflexion
2.7 Options/spare parts (not included in the scope of delivery)
Item Designation
1 Lower leg strap
Article number
29U85
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