3 Intended use
3.1 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.
3.2 Indications
With pain syndromes of the lumbar spine caused by:
•
Lumbar spinal canal stenosis
•
Lumbar facet joint syndrome
•
Lumbar radicular syndrome (anterior thigh pain, lumboischialgia)
•
Lumbar instability (spondylolisthesis, spondylolysis)
•
Lumbar spondylarthrosis
•
Intervertebral disc prolapse and protrusion in the lumbar spine area
•
General degenerative changes with reduced intervertebral disc height
The indication must be determined by the physician.
3.3 Contraindications
3.3.1 Absolute Contraindications
None known.
3.3.2 Relative Contraindications
Report to and discuss with the physician any of the following accompanying symptoms: contrac
tures of the spine, restricted chest breathing ability, skin diseases/injuries, inflammation, raised
scars with swelling, reddening and warming in the area where the brace is fitted, lymphatic con
gestion – including unclear swelling of soft tissue distal to the device, and dysaesthesia in the
legs.
3.4 Mechanism of Action
The three-point principle and the spring mechanism result in an effective and statistically signifi
cant reduction of the muscle-force-induced compression of the movement segments and the
small vertebral joints in the lumbar spine region. Spine deformation occurs in both the sagittal
and the frontal planes. This applies for moderate as well as maximum loads. The brace effectively,
significantly and systematically reduces the load on the lumbar spine.
4 Safety
4.1 Explanation of warning symbols
Warning regarding possible risks of accident or injury.
CAUTION
Warning regarding possible technical damage.
NOTICE
4.2 General safety instructions
CAUTION
Excessive strain on load-bearing components
Injuries due to changes in or loss of functionality
Only use the product for the defined area of application.
►
If the product has been exposed to extreme strain (e.g. due to falling), take any necessary
►
measures (e.g. repair, replacement, inspection by the manufacturer's customer service,
etc.).
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