Össur MIAMI TLSO 456, Instructions For Use Manual

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ENGLISH
Medical Device
PRODUCT DESCRIPTION
Miami TLSO 456 is a modular rigid thoraco-lumbo-sacral spine orthosis
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.
A pulley system is used to tighten the belt and belt panels to the patient.
Product Overview
(Fig. 1)
a. Chest Buckle
b. D-Ring
c. Overlap Closure/Belt End
d. Shoulder Straps
e. PTE
f. Belt
g. Strap Anchor
INDICATIONS FOR USE
Indications that require 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
Unstable, displaced fractures.
GENERAL SAFETY INSTRUCTIONS / WARNINGS AND PRECAUTIONS
Warning:
In cases of functional change or functional loss, the patient
should stop using the device and contact a healthcare professional.
Warning: If the device shows signs of damage or wear hindering its
normal functions, the patient should stop using the device and contact
a healthcare professional.
• Do not over tighten 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 or irritation, contact your healthcare provider for
further instructions and discontinue.
• These are supportive braces only and are not intended or guaranteed
to prevent spinal injury. They should be applied by a licensed
healthcare practitioner and as directed by a physician or other
qualified medical.
• Do not machine wash or place in a tumble dryer.
• Össur accepts no responsibility for any injury which might occur while
using the orthosis.
• The braces are not designed to be worn while bathing.
• The device is a non-invasive, adjustable brace for single patient use.