► Please contact the manufacturer if you have questions about the prod
uct or in case of problems.
► Report each serious incident in connection with the product, in particu
lar 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 50R54 Lumbo Direxa Stable lumbar brace.
2 Intended use
2.1 Indications for use
The brace is intended exclusively for orthotic fittings of the back and exclu
sively for contact with intact skin.
The brace must be used in accordance with the indications.
2.2 Indications
The indication must be determined by the physician.
•
Lower back pain
•
Lumbar spine syndrome
•
Sciatica
•
Myostatic insufficiency/muscular imbalance of the lumbar trunk muscles
•
Degenerative changes of the lumbar spine
•
Intervertebral disc protrusion L4-S1
•
Stabilization after discectomy L4-S1
•
Stabilization after spinal fusion L3-S1
•
Aftercare of traumatic or osteoporotic fractures L3-L5
•
Stabilization of the lumbar spine in case of osteoporosis L3-S1
•
Moderate irritation of the sacroiliac joint
•
Minor to moderate spondylolisthesis L3-L5
2.3 Contraindications
2.3.1 Absolute Contraindications
None known.
2.3.2 Relative Contraindications
The following conditions require consultation with a physician: skin dis
eases/injuries, inflammation, raised scars with swelling, reddening, and
warming in the area where the support is fitted, tumors, lymphatic conges
tion – including unclear soft tissue swelling distal to the support, and dyses
thesia in the trunk.
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