in die Klasse I eingestuft. Die Konformitätserklärung wurde deshalb vom Hersteller in alleiniger
Verantwortung gemäß Anhang VII der Richtlinie erstellt.
1 Foreword
INFORMATION
Last update: 2019-11-20
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Please read this document carefully before using the product.
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Follow the safety instructions to avoid injuries and damage to the product.
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Instruct the user in the proper and safe use of the product.
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Please keep this document in a safe place.
These instructions for use provide important information on the fitting and application of the 8165
Genu Neurexa knee 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
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Paresis of leg muscles resulting in hyperextension of the knee
Caused for example by:
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Stroke
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Intervertebral disc prolapse in the lumbar spine
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Peripheral nerve damage
2.3 Contraindications
2.3.1 Absolute Contraindications
Not known.
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 distant to the body area to which
the medical device will be applied; sensory and circulatory disorders in the leg area.
2.4 Effects
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Supports and stabilises the knee joint
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Improves proprioception
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Supports sensorimotor function
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Prevents hyperextension
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Promotes the reduction of oedemas and haematomas
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Can relieve pain
3 Safety
3.1 Explanation of warning symbols
Warning regarding possible risks of accident or injury.
CAUTION
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English