Bauerfeind LumboLoc Forte XT User manual

Lumbar orthosis
LumboLoc® Forte XT
Rev. 5 – 2019-03_110 250
Material
Polyamide (PA)
Polyurethane (PUR)
Elastodiene (ED)
Viscose (CV)
Polyethylene,
medium density (PE-MD)
Spring Steel Strip C75
Polyoxymethylene (POM)
Ethylene Propylene Diene
M-Class Rubber (EPDM)
Spring Steel Wire
Cotton (CO)
Polyester (PES)
Polypropylene (PP)
Polyethylene (PE)
Copolyester
Elastane (EL)
USA
Bauerfeind USA, Inc.
1230 Peachtree St NE
Suite 1000
Atlanta, GA 30309
P [phone]
P [phone]
F [phone]
E [email protected]
BAUERFEIND AG
Triebeser Straße 16
07937 Zeulenroda-Triebes
Germany
P [phone]
F [phone]
E [email protected]
BAUERFEIND.COM
30°C
86°F All instructions for use:
www.bauerfeind.com/downloads

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en english
These instructions for use can also be downloaded from: www.bauerfeind.com/downloads
Dear Customer,
thank you for placing your trust in a Bauerfeind-product. The LumboLoc Forte XT you have purchased is a
high-quality medical product.
Read the instructions carefully and in full, as they contain important information on the use, indications,
contraindications, set-up, care and disposal of the LumboLoc Forte XT. Please keep these instructions in case
you need them again in the future. Consult your physician or medical retailer with any questions you may have.
Intended use
LumboLoc Forte XT is a stabilizing orthosis for optimal spinal column statics and relief of the lumbar spine.
Relief of the lumbar spine is achieved with the aid of a back pad that can be adjusted to the correct anatomical
position. The abdominal pad supports the upright posture of the spine and thus also provides relief. The
function strap permits individual adjustment ofthe force exerted to the desired location and intensity, and
supports the eect of the pad. LumboLoc Forte XT can be adapted to suit individual requirements by removing
the corset stays and/ or inserting back pads.
Indications / Areas of Application
– Degeneration/ muscular insuciency of the spine (severe)
– Spondylolysis / spondylolisthesis
– Lumbar syndrome
– Discectomy
Risks of using this product
Caution*
• LumboLoc Forte XT must only be worn in accordance with the specifcations contained in these instructions
and used for the areas of application (places of use) listed. To guarantee the best possible fit of the
LumboLoc Forte XT, it is essential to check whether the product is adequately shaped and whether it needs
to be anatomically reshaped by a specialist1. Only a specialist may carry out the (initial) fitting of the orthosis
and provide instruction.
• The sewn-in label of the LumboLoc Forte XT, which contains information on the product name, size,
manufacturer, washing instructions and CE mark, is located on the upper edge of the knitted part.
• LumboLoc Forte XT must be applied over a T-shirt or undershirt.
• Use in combination with other products, e.g. as part of compression treatment (compression stockings), must
be discussed beforehand with your physician.
• If you notice any unusual changes (e.g. increased symptoms), please contact your physician without delay.
• No product liability is accepted in the event of improper use. Avoid the use of ointments, lotions or any
substances including grease or acids.
• Do not make any alterations to the product. Failure to comply with this requirement may adversely aect
product performance, thereby voiding any product liability.
• Side eects involving the body as a whole have not been reported to date.
• Correct fitting is assumed. Do not put LumboLoc Forte XT on too tightly as this could lead to local pressure
symptoms. In rare cases, constriction of blood vessels and nerves may occur. If this happens, loosen the
straps of the LumboLoc Forte XT and, if neccesary, check the size of your LumboLoc Forte XT.
Contains natural rubber latex (Elastodiene) which can cause skin irritation in persons with an allergy. Take
o the support if you notice any allergic reaction.
Contraindications
Hypersensitivity reactions harmful to health have not been reported to date.
In the following conditions such aids should only be fitted and worn after consultation with your physician:
• Skin disorders/ injuries in the relevant part of the body, particularly if inflammation is present; likewise, any
raised scars with swelling, redness and excessive heat build-up
• Impaired sensation and circulatory disorders in the arm/ hand (e.g. diabetes mellitus)
• Impaired lymph drainage, including soft tissue swellings of uncertain origin located away from where the
orthosis is worn
• Significant restriction of cardiopulmonary performance (risk of raised blood pressure if strenuous physical
exertion is undertaken while wearing a fitted LumboLoc Forte XT)
Application instructions
Fitting the LumboLoc Forte XT
AFastening with finger pockets, BTension straps,
CAbdominal pad, DBack pad
1Open the LumboLoc Forte XT. Slide your hands into the finger pockets on the fastening and position the
orthosis at waist height in the middle of the pelvis. The abdominal pad is located on the left. 2Guide the left
fastening inwards slightly below the abdomen. 3Close the orthosis. 4Take hold of the tension straps and
pull them simultaneously forward and sideways until a level of stability is reached that is comfortable for you.
5Fasten the left tension strap first. 6Then fasten the right strap. The two straps can also be placed on top
of each other.
Removing the LumboLoc Forte XT
Start by unfastening the tension straps. Then open the large fastening. Take o the LumboLoc Forte XT.
Cleaning instructions
Note: Never expose the LumboLoc Forte XT to direct heat (e.g. heaters, sunlight, in your car,etc.)! This may
damage the material, which can impair the eectiveness of the LumboLoc Forte XT.
Fasten all Velcro straps before washing to avoid damage. Wash the LumboLoc® Forte XT and the pads
separately by hand with a mild detergent.
Usage location
In accordance with the indications (back). See purpose.
Maintenance instructions
With correct handling and care, the product is practically maintenance-free.
Assembly and fitting instructions
The LumboLoc Forte XT is supplied in a standard size and ready for use. The pads are equipped with a Velcro
strap and can be variably positioned on the knitted part, making it possible to individually adjust the orthosis
to fit the patient‘s anatomy.
If required, the posterior panel can be customized through thermo molding. For best results, please use a
heat gun. The ideal molding temperature range is 170°C – 190 °C or 338 °F– 374°F.
Technical specifications / parameters, accessories
The LumboLoc Forte XT consists of a knitted fabric part as well as back and abdominal pads. Both pads are
already pre-assembled. No spare parts are available.
Notes on reuse
The LumboLoc Forte XT is intended for your treatment only. It has been adapted specifically for you. It is
therefore important that you do not pass the LumboLoc ForteXT on to other people.
Warranty
The legal provisions of the country in which the product was purchased apply. Country-specific warranty
regulations that govern the relationship between the retailer and the buyer also apply where relevant. If
you believe that a claim may be made under the warranty, please first contact the retailer from which you
purchased the product directly.
Please do not make any changes to the product yourself. This particularly applies to individual adjustments
made by specialists. Please follow our instructions for use and care. These are based on our experience
gained over many years and ensure the functionality of our medically eective products for a long time. Only
aids that function optimally can help you. Failure to follow the instructions may also restrict the warranty.
Disposal
You can dispose of the product in accordance with national legal requirements.
Version: 2017-08
Specialists
General notes
• Check the optimal and individual fit of the LumboLoc Forte XT after the first fitting. Make any corrections if
necessary.
• Practice the correct procedure for putting on the orthosis with the patient.
• The product must not be changed in any improper way. Failure to comply with this requirement may
adversely aect product performance, thereby voiding any product liability.
• The LumboLoc Forte XT is intended for the treatment of one patient only.
The corset stays are anatomically contoured, but they still need to be individually adjusted to suit the
patient‘s anatomy.
Shaping the stays
Carefully remove the stays on the outside of the orthosis from the insertion pockets and shape them to the
anatomy of the patient. Reinsert the stays into the pockets provided.
Positioning the pads
Unfasten the pads from the knitted section of the orthosis. Position the pads at the anatomically correct
points and refasten them.
 A specialist is any person who is authorized according to the state regulations for fitting and instruction in the use of
orthoses which are relevant to you.
* Note on the risk of personal injury (risk of injury, harm to health and accidents) or material damage (damage to the
product).