Product Description; Indications For Use; Intended Use; General Safety Instructions - Össur MIAMI TLSO 464 Manual Del Usuario

ENGLISH

PRODUCT DESCRIPTION

Miami TLSO 464 is a reusable rigid thoraco-lumbo-sacral spine orthosis
implemented as a modular compression belt. The device is designed to
support and provide motion restriction to a patient's spine during
routine daily use.
The device is a non-invasive, adjustable brace for single patient use.
Device length can be adjusted to patient morphology requirements.
A pulley system is used to tighten the belt and belt panels to the patient.
List of parts (Fig. 1)
a. Yoke
b. Strut
c. Overlap closure/ belt end
d. Buckle
e. PTE
f. Belt
g. Pectoral disc
h. ATE

INDICATIONS FOR USE

Gross thoracic and lumbar spine immobilization in all three planes, in
which the following conditions may be present:
• Herniated disc
• Degenerative spinal pathologies
• Post-surgical stabilization
• Stable, non-displaced spinal fractures
• Spinal stenosis
• Spondylolisthesis
• Spondylolysis
CONTRAINDICATIONS
Do not use with unstable, displaced fractures.

INTENDED USE

Patients requiring a gross thoracic and lumbar spine immobilization in
all three planes. Sizing is appropriate for most adults; the product is non-
gender specific.

GENERAL SAFETY INSTRUCTIONS

Warning:
The Miami TLSO with anterior and posterior thoracic extensions is
a supportive brace only, and is not intended or guaranteed to prevent
spinal injury. It should be applied by a licensed healthcare practitioner
and as directed by a physician, or other qualified medical authority. Össur
accepts no responsibility for any injury that might occur while using the
orthosis.
Precaution:
Do not overtighten the compression system to the point where it causes
discomfort or difficulty breathing. For sitting, the patient may find it
desirable to slightly loosen the compression system.
If brace causes discomfort, irritation, or is damaged, contact your
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