Die Konformitätserklärung wurde deshalb vom Hersteller in alleiniger Verant
wortung gemäß Anhang VII der Richtlinie erstellt.
1 Foreword
INFORMATION
Date of the last update: 2012-08-15
► Please read this document carefully.
► Follow the safety instructions.
These instructions for use provide important information on the fitting and
application of the 50S5 Malleo Sensa ankle support.
2 Application
2.1 Intended Use
The support is intended exclusively for orthotic fittings of the ankle and
exclusively for contact with intact skin.
The support must be used according to the indications and following the
instructions of a physician.
2.2 Indications
•
Post-operative and post-traumatic irritation
•
Joint effusion and swelling accompanying arthrosis and arthritis
•
Tendomyopathy
•
Ligament weakness
•
Feeling of instability
The indications must be determined by the physician.
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, inflammation, 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 support /
orthosis will be applied; sensory and circulatory disorders in the body region
being treated and in the area of the foot.
English
Ottobock | 7