Application Instructions - Bauerfeind SofTec Lumbo Guia Del Usuario

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Dear Customer,
thank you for choosing a Bauerfeind product.
We work to improve the medical effectiveness of our products every day –
because your health is very important to us. Please read through these
instructions for use carefully. If you have any questions, please contact
your doctor or medical retailer.
Intended purpose
SofTec Lumbo is a medical device. It is an orthosis for immobilizing the
lumbar spine with mobilization function in 3 stages.
Stage 1 (Immobilization phase):
Securing the spine after surgery or at the start of non-surgical treatment
by using a shell.
Stage 2 (Mobilization phase):
To allow for mobilization over the course of recovery, the shell is removed
and replaced by CFRP rods (carbon fiber reinforced plastic rods) in the
knitted fabric.
Stage 3 (Activity phase):
With increasing activity, the CFRP rods are replaced by corset stays,
thereby reducing the external supportive effect.
SofTec Lumbo must be individually adapted to the patient by a
trained orthopaedic technician in order to gain the maximum effect
and optimal wear comfort from this orthosis. If the product is not
used properly any claim for warranty will expire.
Indications
• Spondylolysis / spondylolisthesis, grades II – III
• Extremely severe lumbosciatica with muscular deficiencies in cases of
significant intervertebral disk protrusions/herniation
• Most severe (pseudo) radicular lumbar syndrome
• Degenerative facet syndrome
• Condition after herniation, e. g. post-operative care
• Condition after discectomy
• Condition after spondylodesis / kyphoplasty (one or more levels)
• Lumbar spinal canal stenosis
• Vertebral fractures (lumbar spine) with vertebral body damage
• Tumors (metastases)
• Severe degeneration / muscular insufficiency
Risks of using this product
Important information
• SofTec Lumbo is a prescribed product that should be worn under a
physician´s guidance.
SofTec Lumbo should only be worn in accordance with the instructions
contained in these usage directions and for the listed areas of
application.
• SofTec Lumbo is intended for single use by the patient.
• The plastic shell and rods of SofTec Lumbo may only be modified
by trained specialists. Failure to comply with this requirement may
adversely affect product performance, thereby cancelling any product
liability.
• If the knitted sections of SofTec Lumbo are subsequently modified, the
proper functioning of the support can no longer be guaranteed.
• Should you notice any unusual changes (e. g. increased symptoms),
please contact your doctor without delay.
• Please consult your doctor before using SofTec Lumbo in combination
with other products.
• Do not allow the product to come into contact with ointments, lotions or
substances containing grease or acids.
• SofTec Lumbo can readily be disposed of with domestic refuse.
• Side effects, with the assumption of correct fit involving the body as a
whole have not been reported to date. Any supports or orthoses applied
externally to the body can, if tightened excessively, signs of localized
pressure, rarely, constrict the underlying blood vessels or nerves.
Contains natural rubber latex (elastodiene), which can cause skin
irritation in persons with an allergy. Take off the orthose if you
notice any allergic reaction.
Contraindications
Hypersensitive reactions harmful to health have not been reported to
date. In the following conditions such supports or orthoses should only be
fitted and worn after consultation with your doctor:
• Skin disorders / injuries to relevant parts of the body, particularly if
inflammation is present. Likewise, any raised scars with swelling,
redness and excessive heat build-up.
• Impaired sensation.
• Severe restriction in the performance of heart and lungs (risk of
elevated blood pressure if the aid is worn during severe physical
exertion).

Application instructions

Fitting and removing SofTec Lumbo
Despite its special design, SofTec Lumbo is always fitted and removed in
the same way at all stages.
Fitting:
• After it has been individually adjusted by the orthopaedic technician, the
shell must sit loosely on the iliac crests (Fig. 2). When fitting the orthosis
without the shell, ensure that the support is correctly positioned. If
necessary, practice correct fitting with the orthopaedic technician.
• Place the support around the trunk so that the reinforcements visible on
the outer knitted section are positioned parallel to the spine (Fig. 3).
• Place your fingers in the specially provided loops on the two halves of
the light grey fastener and pull evenly forward (Fig. 5).
• Press the left half of the fastener against your stomach and place the
right half above it to secure the Velcro fastening. If the optional pressure
pad for the abdominal wall is used, ensure that this is posi-tioned
correctly (this pressure pad should be centrally positioned beneath the
fastening).
• When securing the Velcro fastening, remove your fingers from the left
loop first, followed by the right loop (Fig. 6).
• Take hold of the two LPT (Low Power Tension) straps in both hands
and pull evenly forward (Fig. 7). Secure both LPT straps onto the large
fastening (Fig. 8).
With the "long" version, always fasten the lower straps first and then
secure the upper straps on top.
• When the support is first fitted, the optimal, individual fit must be
checked, and if necessary corrected, by a trained fitter. Practice fitting
the support correctly.
Removal:
• Undo the Velcro fastenings of the LPT straps on the outer knitted section
and pull back the straps to loosen the support and fasten the ends of the
straps to the retracted sections.
• Open the large light grey fastener.
• Remove the support and reclose the light grey fastener.
Product care
Never expose the orthosis to direct heat
(e. g. heater, sunlight, etc.)!
• SofTec Lumbo can be washed separately by hand at 30 °C (86 °F) using
a mild detergent. Ensure that the plastic shell is removed beforehand.
Proceed as follows:
• Undo the Velcro fastenings of the two thin elastic straps. Pull the straps
out of the holes and remove.
• Undo the two Velcro fastenings between the outer and inner knitted
sections located at the center of the back.
• Remove the plastic shell from the support.
• The shell can easily be washed with a sponge, using a pH-neutral soap
or shampoo. Do not dry using direct heat (dryer, heater). Either rub dry
with a cloth or air dry.
• Removal of the CFR or corset rods is not necessary.
• If the rods are to be removed from the outer knitted section, turn back
the fasteners at the top (red section) and push out the rods (Fig. 9).
• To avoid damage and to preserve their long-term adhesive strength, we
recommend closing the Velcro fastenings before washing (including the
small Velcro dots between the inner and outer knitted sections).
• After washing, perform the above sequence in reverse. When re-
inserting the CFR rods, check the markings for correct orientation
(top / bottom and left / right). Also check the correct positioning of the
knitted sections containing the shell. Fasten identically coloured Velcro
dots to each other (the sewn-in labels are always at the top, the shell is
marked towards the top).
This product has been examined by our own quality control system.
However, should you have any complaint, please contact your retailer or
our customer service department.
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