Bauerfeind LumboLoc Forte ES Manuals

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 [email protected] 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 orthosis1 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 specialist2. Only a specialist may 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 left. 2 Guide the left fastening inwards slightly below the abdomen. 3 Close the orthosis. 4 Take hold of the tension straps and pull them simultaneously forward and sideways until a level of stability is reached that is comfortable for you. 5 Fasten the left tension strap first. 6 Then fasten the right strap. The two straps can also be placed on top of each other. 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 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 Specialists2 • 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). Rev. 13 – 2019-05_108 953 Material Polyamid (PA) Polyurethan (PUR) Elastodien (ED) Viskose (CV) Federbandstahl C75, kunststoffummantelt Polyoxymethylen (POM) Federstahldraht Sorte A, verzinkt Polyester (PES) Polyethylen (PE) 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) 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) 1 2 3 4 5 6 A B B A C D LumboLoc® Forte ES – Extra Stability Lumbalorthese Lumbar orthosis Orthèse lombaire Ortesis lumbar All instructions for use: www.bauerfeind.com/downloads 30°C 86°F BAUERFEIND AG Triebeser Straße 16 07937 Zeulenroda-Triebes Germany P +49 (0) 36628 66-40 00 F +49 (0) 36628 66-44 99 E [email protected] BAUERFEIND.COM