Product Description; Indications For Use - Ossur MIAMI LSO Gebrauchsanweisung

ENGLISH
Medical Device

PRODUCT DESCRIPTION

Miami LSO is a semi-rigid lumbar belt available in Standard (8"/20 cm)
and Slim (6"/15 cm) heights. Panels can be added for increased rigidity
based on the desired degree of motion restriction.
Product overview (Fig. 1)
a. Belt Compression System
b. Compression System Handles
c. Overlap Closures
d. Össur Fit Tool (sold separately)
e. Adjustable Belt
f. Belt Ends
g. Anterior Panel
h. Standard Posterior Panel
i. Posterior Panel without Lateral Support
j. Posterior Panel with Lateral Support
k. Hook and Loop Strip
l. Belt Extension x2 (sold separately)

INDICATIONS FOR USE

Conditions that require gross immobilization of the lumbar region of the
spine, this may include Stable, non-displaced spinal fractures (L1-L5),
Spinal stenosis, Herniated discs, Degenerative spinal pathologies,
Spondylolisthesis, Spondylolysis.
CONTRAINDICATIONS
Unstable, displaced fractures.
INTENDED USE
The device is intended to provide compression and gross immobilization
of the lower back.
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.
• This product has been designed and tested based on single patient
usage and is not recommended for multiple patient use.
• If any problems occur with the use of this product, immediately
contact your healthcare professional.
• This product is a supportive brace only and is not intended or
guaranteed to prevent spinal injury.
• This product should be applied by a licensed healthcare practitioner
and as directed by a physician or other qualified medical authority.
• The patient should be instructed how to tighten and loosen the
compression system while at home. Do not over tighten the
compression system to the point where it causes discomfort or
difficulty breathing.
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