Ce-Konformität; Indications For Use - Ottobock 50R30 Lumbo TriStep Gebrauchsanweisung

12.1 Haftung
Der Hersteller haftet, wenn das Produkt gemäß den Beschreibungen und Anweisungen in diesem
Dokument verwendet wird. Für Schäden, die durch Nichtbeachtung dieses Dokuments, insbeson-
dere durch unsachgemäße Verwendung oder unerlaubte Veränderung des Produkts verursacht
werden, haftet der Hersteller nicht.
12.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der europäischen Richtlinie 93/42/EWG für Medizinpro-
dukte. Aufgrund der Klassifizierungskriterien 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.
INFORMATION
Last update: 2015-09-30
• 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.

1 Indications for use

The 50R30 Lumbo TriStep lumbar spine bridging brace with mobilizing function is intended solely
for the orthotic fitting of the lumbar spine and is designed for contact with intact skin only.
2 Indications and effects
Post-operative stabilization of the lumbar spine (e.g. spondylodesis), post-operative correction of
lordosis of the lumbar spine (e.g. after intervertebral disk surgery), facet syndrome, lumbar spinal
canal stenosis, symptomatic stenoses of the lumbar intervertebral foramina, degenerative insta-
bility, spondylolysis, spondylolisthesis, herniated intervertebral disk, follow-up treatment of stable
vertebral body fractures of the lower lumbar spine without neurological damage.
The indication must be diagnosed by a physician.
The 50R30 Lumbo TriStep is a bridging brace with a mobilizing function. By allowing for the re-
moval of individual elements, the Lumbo TriStep enables systematic rehabilitation of the lumbar
spine in three steps.
In the first stage of therapy, stabilization and relief are achieved through correction of lordosis of
the lumbar spine.
In the second stage of therapy, the bridging element (5) is removed to make the bridging brace
become a lumbar spine support brace. At this point, physiological lordosis will be nearly restored.
In the third stage of therapy, the support element (4) is removed from the brace. The remaining
lumbar spine brace stabilizes and relieves the lumbar region.
3 Size selection
The brace is available in three sizes. Size selection is based on the pelvis circumference as follows:
50R30 Lumbo TriStep
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