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Dear customer,
please read through these instructions for use carefully.
If you have any questions, please contact your doctor or medical retailer.
Intended purpose
The OrthoPrax LSO 631 is a medical device.
It is an orthosis that provides relief and functional
mobilization of the lumbar spine by reducing
lordosis.
Indications
• Severe lumbar deformity in case of facet
syndrome / osteoarthritis
• Post-traumatic treatment of non-severe vertebral
fractures
• Sprains
• Excessive strain on the spine caused by
abdominal compression
• Spondylolisthesis, grade II, with recurring
lumbosciatica
• Collapsed superior end plates in the lumbar spine
• Spinal canal decompression
Risks of using this product
• Please closely observe the specifications in these
instructions for use and the instructions given by
the specialist.
• OrthoPrax LSO 631 unload must only be worn in
accordance with the specifications contained in
these instructions and used for the indications
listed (part of the body this product is used for).
To guarantee the best possible fit, it is essential to
check whether the product is adequately shaped
and whether it needs to be anatomically reshaped
by a specialist. Only a specialist may carry out
the (initial) fitting of the product and provide
instructions.
• The OrthoPrax LSO 631 must be applied over a
T-shirt or undershirt.
• The use in combination with other products, e. g.
as part of compression treatment (compression
pantyhose), must be discussed beforehand with
your physician.
• If you notice any unusual changes or your
symptoms get worse, please contact your
physician without delay.
• No product liability is accepted in the event of
improper use.
• Do not allow the product to come into contact
with ointments, lotions, or substances containing
grease or acids.
• Do not make any alterations to the product.
Failure to comply with this requirement may
adversely affect product performance, thereby
voiding any product liability.
• Side effects involving the body as a whole have
not been reported to date. Correct usage / fitting
is assumed. Do not fit the OrthoPrax LSO 631
too tightly, as this could lead to local pressure
symptoms. In rare cases, constriction of blood
vessels and nerves may occur. In this case, loosen
the straps and, if necessary, check the size of
your product.
Contraindications
Hypersensitive reactions harmful to health have not
been reported to date. In the following conditions
such aids should only be fitted and applied after
consultation with your medical provider:
• Skin disorders / injuries in the relevant part of
the body, particularly if inflammation is present.
Likewise, any raised scans with swelling, redness
and excessive heat build-up.
• Severe restriction of the performance of the heart
and lungs (risk of a rise in blood pressure if the
aid is worn during intense physical exertion)
• Impaired lymphatic drainage and soft tissue
swelling of unknown origin
• Pacemaker (follow physician's instructions)
• Ostomy (follow physician's instructions)
• Chronic inflammation of organs in the abdominal
area
* A specialist is any person who is authorized, according to their state's regulations,
to fit supports and orthoses and provide instructions on how to use them.
Application instructions
Putting on and taking off the OrthoPrax LSO 631
1. While standing upright, position the orthosis so
that the back section is directly centered above
the waist on your spine. For orientation, the
bottom edge of the orthosis can be positioned on
a level with the base of the buttocks.
2. Keeping the rear stabilizing element centered on
your back, pull the sides of the support around
your abdomen.
3. Tighten the front fastening and close it over the
abdomen. Make sure that the rear stabilizing
element is centered on your spine. Adjust it as
required.
4. Insert your thumbs into the compression strap
loops and pull them away from your body until
you have created the desired compression. Then
attach the loops on the abdominal fastening.
5. As required, this compression level can be
adjusted over the course of the day.
Reinigungshinweise
Wash the product by hand. Never expose your prod-
uct to direct heat / cold. Also observe the washing
symbols in the instructions for use.
General information for specialists
Instruct the patient how to put on the orthosis
correctly.
Adjusting the size:
1. Determine the size by measuring the waist and
comparing with the size chart.
2. On the inside of the pelvic support, the corre-
sponding sizes are marked and labeled. Fasten
the strap at the correct marking and cut off the
excess material using scissors.
Notes on reuse
This product is intended to be fitted to one patient
only.
Warranty
The statutory regulations of the country of
purchase apply. Please first contact the retailer
from whom you obtained the product directly in the
event of a potential claim under the warranty. The
product must be cleaned before submitting it in
case of warranty claims. Warranty may be limited
or excluded if the instructions on how to handle
and care for the OrthoPrax LSO 631 have not been
observed.
Warranty is excluded if:
• The product was not used according to the
indication
• The instructions given by the specialist were not
observed
• The product was modified arbitrarily
Duty to report
Due to regional legal regulations, you are required
to immediately report any serious incident involving
the use of this medical device to both the manu-
facturer and the responsible authority. Our contact
details can be found on the back of this brochure.
Disposal
Once you have finished using the product, please
dispose of it according to local specifications.
Material content
Polyester (PES), PU foam, Polypropylene (PP),
nylon, XPE foam
– Medical Device
– DataMatrix Unique Device Identifier UDI
EN
2021-10
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