Bauerfeind LumboLoc Forte ES - Extra Stabilit Mode D'emploi

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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 ES 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 ES. 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
The LumboLoc Forte ES is a medical device. It is an orthosis 1 for optimal spinal column statics and
relief of the lumbar spine.
Indications
• Non-specific lower back pain (lumbago)
• Weak back / abdominal muscles (muscular insufficiency)
• Slight vertebral displacement (spondylolisthesis)
• Ligament / tendon / muscle irritation (ligamento-tendomyopathies)
Risks of using this product
Caution*
LumboLoc Forte ES must only be worn in accordance with the specifications 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 ES, it is essential to check whether the product is adequately
shaped and whether it needs to be anatomically reshaped by a specialist
carry out the (initial) fitting of the orthosis and provide instruction.
The sewn-in label of the LumboLoc Forte ES, 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 ES 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
affect product performance, thereby voiding any product liability.
Side effects involving the body as a whole have not been reported to date. Correct fitting is assumed.
Do not put LumboLoc Forte ES 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 ES and, if neccesary, check the size of your LumboLoc Forte ES.
Contains natural rubber latex (elastodiene), which can cause skin irritation in persons with an
allergy. Take off the orthesis 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 ES).
Application instructions
Fitting the LumboLoc Forte ES
A – Fastening with finger pockets, B – Tension straps,
C – Abdominal pad, D – Back pad
1
Open the LumboLoc Forte ES. 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
2
left. Guide the left fastening inwards slightly below the abdomen.
hold of the tension straps and pull them simultaneously forward and sideways until a level of
5
stability is reached that is comfortable for you. Fasten the left tension strap first.
6 Then fasten the right strap. The two straps can also be placed on top of each other.
A
Material
Polyamid (PA)
C Polyurethan (PUR)
Elastodien (ED)
Viskose (CV)
B
Federbandstahl C75,
kunststoffummantelt
Polyoxymethylen (POM)
Federstahldraht Sorte A,
verzinkt
Polyester (PES)
Polyethylen (PE)
Material
Polyamide (PA)
Polyurethane (PUR)
Elastodiene (ED)
Viscose (CV)
Spring Steel Strip C75,
coated
Polyoxymethylene (POM)
Spring Steel Wire Type A,
galvanized
Polyester (PES)
Polyethylene (PE)
2
30°C
86°F
4
6
Removing the LumboLoc Forte ES
Start by unfastening the tension straps. Then open the large fastening.
Take off the LumboLoc Forte ES.
Cleaning instructions
Note: Never expose the LumboLoc Forte ES to direct heat (e. g. heaters, sunlight, in your car, etc.)!
This may damage the material, which can impair the effectiveness of the LumboLoc Forte ES.
Fasten all Velcro straps before washing to avoid damage. Wash the LumboLoc Forte ES 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 ES is supplied in a standard size and ready for use.
The pads are equipped with a Velcro strip and can be variably positioned on the knitted part, making
it possible to individually adjust the orthosis to fit the patient's anatomy.
Technical specifications / parameters
The LumboLoc Forte ES 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 ES 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 ES on to other people.
Warranty
2 . Only a specialist may
Warranty is provided in accordance with the statutory provisions as well as the terms of supply and
contractual terms of Bauerfeind AG (AGB), as long as all the points mentioned above are observed.
If you have any complaints, please contact your medical retailer only.
Please note that only clean goods can be dealt with.
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 manufacturer and the responsible authority. Our
contact details can be found on the back of this brochure.
Disposal
You can dispose of the product in accordance with national legal requirements.
Version: 2019-05
Specialists
• Check the optimal and individual fit of the LumboLoc Forte ES 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 affect product performance, thereby voiding any product liability.
• The LumboLoc Forte ES 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.
1 Orthosis = orthopaedic appliance used to stabilize, relieve, immobilize, control or correct the limbs or the torso
2
A specialist is any person who is authorized according to the state regulations for fitting and instruction in the
use of orthopedic orthoses that 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).
3 4
Close the orthosis. Take
Material Pelotten
Polyethylen (PE)
Ethylen-Propylen-Dien-
Kautschuk (EPDM)
Polyurethan (PUR)
Polyamid (PA)
Baumwolle (CO)
Polyester (PES)
Elastan (EL)
Material Pads
Polyethylene (PE)
Ethylene Propylene Dien
M-Class Rubber
(EPDM-rubber)
Polyurethane (PUR)
Polyamide (PA)
Cotton (CO)
Polyester (PES)
Elastane (EL)
2
LumboLoc® Forte ES – Extra Stability
Lumbalorthese
Lumbar orthosis
Orthèse lombaire
Ortesis lumbar
www.bauerfeind.com/downloads
USA
Bauerfeind USA, Inc.
1230 Peachtree St NE
Suite 1000
Atlanta, GA 30309
P +1 800 423-3405
P +1 404 201-7800
F +1 404 201-7839
E info@bauerfeindusa.com
BAUERFEIND AG
Triebeser Straße 16
07937 Zeulenroda-Triebes
Germany
P +49 (0) 36628 66-40 00
F +49 (0) 36628 66-44 99
E info@bauerfeind.com
BAUERFEIND.COM
All instructions for use:
Rev. 13 – 2019-05_108 953