Instructions For Use - Otto Bock Smartspine LSO high Instructions For Use Manual

6.2 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.
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: 2020-03-10
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
50R232 Smartspine LSO high, 50R233 Smartspine LSO low and 50R235 Smartspine LSO stan­
dard lumbosacral braces.
2 Intended use
2.1 Indications for use
The brace is intended exclusively for orthotic fittings of the back and exclusively for contact with
intact skin.
The brace must be used in accordance with the indications.
2.2 Indications
50R232 Smartspine LSO high
• Stenosis of the lumbar spine
• Degeneration of the intervertebral discs in the lumbar spine
• Spondylolisthesis of the lumbar spine
• Facet syndrome of the lumbar spine
• Spondylolysis of the lumbar spine
• Stable vertebral body fractures of the lumbar spine (without neurological deficits)
• Postoperative stabilization after spinal fusion
• Low back/thoracic spine pain (mechanical)
• Compression fractures of the thoracic and lumbar spine (with no neurological deficits)
• Intervertebral disc prolapse in the thoracic and lumbar spine
50R233 Smartspine LSO low
• Stenosis of the lumbar spine
• Degeneration of the intervertebral discs in the lumbar spine
• Spondylolisthesis of the lumbar spine
• Facet syndrome of the lumbar spine
8
English