Ce-Konformität; Intended Use - Ottobock Malleo Direxa Stirrup Instrucciones De Uso

Verwendung oder unerlaubte Veränderung des Produkts verursacht werden,
haftet der Hersteller nicht.
6.3 CE-Konformität
Das Produkt erfüllt die Anforderungen der Verordnung (EU) 2017/745 über
Medizinprodukte. Die CE-Konformitätserklärung kann auf der Website des
Herstellers heruntergeladen werden.
1 Foreword
INFORMATION
Date of last update: 2020-05-20
► Please read this document carefully before using the product and
observe the safety notices.
► Instruct the user in the safe use of the product.
► Please contact the manufacturer if you have questions about the prod­
uct or in case of problems.
► Report each serious incident in connection with the product, in particu­
lar a worsening of the state of health, to the manufacturer and to the
relevant authority in your country.
► Please keep this document for your records.
These instructions for use provide important information on the application of
the 50S9 Malleo Direxa Stirrup ankle brace.

2 Intended use

2.1 Indications for use
The product is intended exclusively for orthotic fittings of the lower limbs.
The brace must be used in accordance with the indications.
2.2 Indications
The indication must be determined by the physician.
• Functional treatment of ligament instability
• Post-operative treatment of ligament ruptures
• Ankle sprains
• Functional, conservative therapy of lateral ligament ruptures
2.3 Contraindications
2.3.1 Absolute Contraindications
None known.
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