8
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 Effects
The ankle foot orthosis provides lifting of the foot and limits plantar flexion.
3 Safety
3.1 Explanation of warning symbols
WARNING
Warning regarding possible serious risks of accident or injury.
CAUTION
Warning regarding possible risks of accident or injury.
NOTICE
Warning regarding possible technical damage.
3.2 General safety instructions
CAUTION
Reuse on other persons and improper cleaning
Skin irritation, formation of eczema or infections due to contamination with germs
►
The product may be used by one person only.
►
Clean the product regularly.
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