Otto Bock 28U50 Malleo Neurexa Pro Instructions For Use Manual page 8

► Please read this document carefully before using the product.
► Follow the safety instructions to avoid injuries and damage to the product.
Instruct the user in the proper and safe use of the product.
►
► Please keep this document in a safe place.
These instructions for use contain important information for fitting and setting up your 28U50 Mal­
leo Neurexa Pro 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
• Dorsal flexor weakness, (e.g. after stroke, traumatic brain injury, in multiple sclerosis, neur­
omuscular atrophy, or peroneal paralysis)
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
• Leg ulcers
• Moderate to severe foot deformities
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 Further Usage Restrictions
The orthosis must not be used for the prevention of contractures (shortening) etc.
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.
2.5 Service Life
The manufacturer has determined a maximal service life of one year for the product.
2.6 Effects
The ankle foot orthosis provides lifting of the foot and limits plantar flexion.
3 Safety
3.1 Explanation of warning symbols
Warning regarding possible serious risks of accident or injury.
WARNING
Warning regarding possible risks of accident or injury.
CAUTION
Warning regarding possible technical damage.
NOTICE
8