Otto Bock 50R230 Smartspine TLSO, Инструкция по эксплуатации

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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
English
INFORMATION
Date of last update: 2020-03-04
► 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
50R230 Smartspine TLSO thoracolumbosacral brace.
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
• Thoracic spine pain (mechanical)
• Thoracic kyphosis (hunchback) (without fused vertebrae, mechanical)
• Scheuermann's disease
• Compression fractures of the thoracic spine (with no neurological deficits)
• Severe degeneration of the thoracic and/or lumbar spine
• Stable traumatic fractures of the vertebral bodies in the thoracic and/or lumbar spine
• Severe degeneration of the intervertebral discs in the thoracic and/or lumbar spine
• Facet syndrome of the thoracic spine
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 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,
tumors, lymphatic congestion – including unclear soft tissue swelling distal to the support, and
dysesthesia in the trunk.
2.4 Mechanism of Action
The brace supports muscular stabilization of the thoracic spine and straightens it actively. It pro­
motes sensorimotor function, helps alleviate pain and relieves the thoracic spine through active