Otto Bock Acro ComforT 5055 Instructions For Use Manual page 8

6.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der europäischen Richtlinie
93/42/EWG für Medizinprodukte. Aufgrund der Klassifizierungskriterien
nach Anhang IX dieser Richtlinie wurde das Produkt in die Klasse I einge­
stuft. Die Konformitätserklärung wurde deshalb vom Hersteller in alleiniger
Verantwortung gemäß Anhang VII der Richtlinie erstellt.
1 Foreword
INFORMATION
Last update: 2014-05-08
► Please read this document carefully.
► Follow the safety instructions.
These instructions for use provide important information on applying the
5055 Acro ComforT shoulder support.
2 Application
2.1 Intended Use
The support is intended exclusively for treating the upper limbs and
exclusively for contact with intact skin.
The support must be used according to the indication.
2.2 Indications
• Irritation in the shoulder region
• Degeneration of the rotator cuff
• Tendomyopathy in the shoulder region
• Shoulder instability
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 dis­
eases/injuries, inflammation, prominent, swollen scars, reddening and
hyperthermia in the relevant area; pronounced varicose veins, especially with
impaired blood return, lymph drainage disorders and unclear soft tissue
swelling distal to the support; sensory and circulatory disorders in the area
of the forearm and hand, e.g. associated with diabetic neuropathy.
8 | Ottobock
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