Ce-Konformität; Lokale Rechtliche Hinweise - Ottobock 28U24 Walk On Reaction Instrucciones De Uso

6.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der europäischen Richtlinie 93/42/EWG für Medizinpro­
dukte. Aufgrund der Klassifizierungskriterien nach Anhang IX dieser Richtlinie wurde das Produkt
in die Klasse I eingestuft. Die Konformitätserklärung wurde deshalb vom Hersteller in alleiniger
Verantwortung gemäß Anhang VII der Richtlinie erstellt.

6.3 Lokale Rechtliche Hinweise

Rechtliche Hinweise, die ausschließlich in einzelnen Ländern zur Anwendung kommen, befin­
den sich unter diesem Kapitel in der Amtssprache des jeweiligen Verwenderlandes.
1 Foreword
INFORMATION
Last update: 2016-03-17
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 provide important information on the fitting and application of the
28U24 WalkOn Reaction and 28U25 WalkOn Reaction Plus ankle foot orthoses.
2 Application
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, with or without mild spasticity (e. g. post CVA, traumatic brain injury,
multiple sclerosis, neuromuscular atrophy, or peroneal paralysis)
• Minor impairment of plantarflexors
• Impairment of plantarflexors (only 28U25)
• Flexible foot deformities that can be corrected with the use of a foot orthotic or use of the
supination correction strap
• Minor impairment of knee extensors
• Impairment of knee extensors (only 28U25)
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
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