Ce-Konformität; Intended Use; Contraindications - Ottobock 50P20 Manu Arexa Gebrauchsanweisung

7.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der europäischen Richtlinie
93/42/EWG für Medizinprodukte. Aufgrund der Klassifizierungskriteri­
en 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.
1 Foreword
INFORMATION
Last update: 2018-12-07
► 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 50P20 Manu Arexa and 50P21 Manu Arexa
Pollex wrist braces.

2 Intended use

2.1 Indications for use
The brace is intended exclusively for orthotic fittings of the upper
limbs and exclusively for contact with intact skin.
The brace must be used in accordance with the indications.
2.2 Indications
• Sprains of the wrist joint or the thumb saddle joint
• Rheumatoid arthritis
• Wrist drop due to paresis or paralysis of the radial nerve
50P20 Manu Arexa additional indications
• Tendinopathy of the wrist joint
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• Ligament injury, ligament strain in the wrist
• Wrist instability
• Impingement syndrome
• Irritation in the wrist area
• Carpal tunnel syndrome
50P21 Manu Arexa Pollex additional indications
• Fractures of the distal forearm or carpal bone
English
• Ligament rupture (partial rupture)
• Partial arthrodesis
• Preoperative/postoperative/posttraumatic conditions that require
immobilization of the wrist
• Irritation in the wrist and thumb areas
• Night positioning
The indication must be determined by the physician.

2.3 Contraindications

2.3.1 Absolute Contraindications
None known.
2.3.2 Relative Contraindications
The following indications require consultation with a physician: skin
diseases/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 device; sensory and circulato­
ry disorders in the area of the forearm and hand, e.g. associated with
diabetic neuropathy.
2.4 Mechanism of Action
The brace stabilizes the wrist.