Rechtliche Hinweise; Ce-Konformität; Intended Use - Ottobock 6005 Dorso Direxa Basic Instrucciones De Uso

7 Rechtliche Hinweise

Alle rechtlichen Bedingungen unterliegen dem jeweiligen Landesrecht des Verwenderlandes und
können dementsprechend variieren.
7.1 Haftung
Der Hersteller haftet, wenn das Produkt gemäß den Beschreibungen und Anweisungen in diesem
Dokument verwendet wird. Für Schäden, die durch Nichtbeachtung dieses Dokuments, insbe­
sondere durch unsachgemäße Verwendung oder unerlaubte Veränderung des Produkts verur­
sacht werden, haftet der Hersteller nicht.
7.2 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: 2020-05-12
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 product or in case of prob­
►
lems.
Report each serious incident in connection with the product, in particular 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 fitting and application of the 6005
Dorso Direxa Basic lumbar orthosis.

2 Intended use

2.1 Indications for use
The orthosis is intended exclusively for orthotic fittings of the back and exclusively for contact
with intact skin.
The orthosis must be used in accordance with the indications.
2.2 Indications
• Lower back pain
• Sciatica
• Muscular imbalances of the lower thoracic spine and/or lumbar spine
• Degenerative changes of the lower thoracic spine and/or lumbar spine
Indications must be determined by the physician.
2.3 Contraindications
2.3.1 Absolute Contraindications
Not known.
2.3.2 Relative Contraindications
The following conditions require consultation with a physician: skin diseases/injuries, inflamma­
tion, raised scars with swelling, reddening, and warming in the area where the support is fitted,
tumours, lymphatic congestion – including unclear soft tissue swelling distal to the support, and
dysaesthesia in the trunk.
6
English