Bauerfeind SecuTec Lumbo Bedienungsanleitung Seite 4

Legen Sie die Velourtasche vor sich. Das Einnähetikett zeigt
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die Seite die nach oben (up) zeigen muss. Drehen Sie nun die
Verlourtasche, so dass die Öffnung zu Ihnen zeigt. Legen Sie
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den CFK-Rahmen in die Tasche ein und schließen Sie diese.
Legen Sie das Gestrickteil mit dem Einnähetikett oben rechts
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vor sich hin. Befestigen Sie je zwei doppelseitige Mikroklettpunkte
auf den Velourstreifen des Gestrickteils. Die Abstände müssen
dabei so gewählt werden, dass die Velourtasche mit dem Rahmen
und das Gestrickteil gut verbunden werden können. Kletten
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Sie die Velourtaschen mit dem Überbrückungsrahmen und dem
Gestrickteil zusammen.
Kletten Sie die Bauchpelotte auf die vor sich liegende rechte
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Verschlusshälfte.
Üben Sie das An- und Ablegen der Orthese mit dem Patienten.
Stand der Information: 2023-09
1 Hinweis auf Gefahr von Personenschäden (Verletzungs-, Gesundheits- und
Unfallrisiko) ggf. Sachschaden (Schäden am Produkt)
2 Fachpersonal ist jede Person, die nach den für Sie geltenden staatlichen
Regelungen zur Anpassung und Einweisung in den Gebrauch von Bandagen
und Orthesen befugt ist.
3
Orthese = orthopädisches Hilfsmittel zur Stabilisierung, Entlastung,
Ruhigstellung, Führung oder Korrektur von Gliedmaßen oder Rumpf
en english
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 and observe these instructions for use carefully. If you have
any questions, please contact your doctor or medical retailer.
Intended purpose
SecuTec Lumbo is a medical device. It is an orthosis 3 for lordosis
reduction and relief of the lumbar spine with a bridging frame.
Indications
• Most severe lumbosciatica with muscular deficiencies in cases
of significant intervertebral disk protrusions / herniated disks
• Most severe (pseudo) radicular lumbar syndrome
• Spondylolysis / spondylolisthesis, grades I – III
• Moderate to severe lumbar deformity in cases of facet
syndrome / osteoarthritis
• Lumbar spinal canal stenosis
• Moderate to severe degeneration / muscular insufficiency
• Vertebral fractures (lumbar spine) with vertebral body damage
• Condition following herniation, e. g. post-operative
• Condition following discectomy
Risks of using this product
Caution 1
• SecuTec Lumbo must only be worn in accordance with the
specifications contained in these instructions and used for the
areas of application (places of use) listed.
• SecuTec Lumbo is a prescribed product that should be applied
under a physician's guidance.
• To ensure the best possible fit, the SecuTec Lumbo must be
individually adapted by a trained specialist 2 to optimally suit the
patient's requirements (adaptation of the bridging frame).
• Only a trained specialist may carry out the (initial) fitting of the
orthosis and provide instruction.
• Use in combination with other products, e. g. as part of
compression treatment (compression stockings), must be
discussed beforehand with your physician.
• The SecuTec Lumbo is to be worn under your T-shirt or
undershirt.
• If you notice any negative changes or an increase in symptoms
while using the product, stop any further use and contact your
physician.
• Incorrect use of the support will cancel any product liability.
• Do not allow the product to come into contact with ointments,
lotions or substances containing grease or acids.
• Side effects involving the body as a whole have not been
reported to date. Correct fitting is assumed. Do not put the
SecuTec Lumbo on too tightly as this could lead to local pressure
symptoms. In rare cases, constriction of blood vessels and
nerves may occur.
• If you would like to use your Bauerfeind product due to acute
symptoms / injuries, make sure to obtain and follow the advice
of a medical professional before first using the product.
Restrictions may exist given the specific indication which the
specialist retailer can clarify. In particular, the ability to operate
vehicles, other means of transport or machinery may be limited.
In case of doubt, we recommend temporarily refraining from the
activities mentioned above.
• Caution: When loosening the straps or tensioning and
fastening systems, or when removing the product or adjusting
configured limitations of movement, there is not sufficient
support / sufficient protection of the body part requiring
treatment. In this case, particularly avoid placing any strain on
this body part.
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
Hypersensitivity reactions harmful to health have not been
reported to date. In the following conditions such aids should only
be put on and applied 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 movement disorders, e. g. in the case of
diabetes mellitus
• 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)
Application instructions
A – Knitted fabric portion
B – Fastening with finger pocket
C – Tensioning straps
D – Pocket with bridging frame
E – Abdominal pad
Fitting
The SecuTec Lumbo must be adapted by a trained specialist
before the first fitting.
Position the orthosis centrally, at waist height, so that the
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lower back is covered. To ensure optimal effectiveness, the
orthosis should be positioned as low as possible without pressing
uncomfortably against the groin area while the patient is sitting
upright. Then slide your fingers from the sides into the finger
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pockets provided on the fastening and steadily pull the fastening
forward.
Then press the left half of the fastening onto your stomach and
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position the right half of the fastening on top of the left half so that
it can be fastened to it on the left-hand side. When fastening the
two halves, pull your fingers out of the left-hand finger pocket first
and then out of the right-hand one. Then take hold of the two
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tensioning straps and pull them forward, steadily and at the same
time, until the desired level of tension (stabilization) is achieved.
Then fasten the two tensioning straps close together on the
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large fastening. + Now fasten the two upper tensioning
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straps.
Removal
To take off the orthosis, start by undoing the four tensioning
straps. Loosely refasten the straps onto the two halves of the
fastening, then open the large fastening. Remove the orthosis,
then refasten the large fastening to avoid damage.
Cleaning instructions
Note: Never expose the SecuTec Lumbo to direct heat (e. g. heater,
sunlight, in your car etc.)! This may cause damage to the material,
which can impair the effectiveness of the SecuTec Lumbo.
The sewn-in label of the the SecuTec Lumbo, containing
information about the product name, size, manufacturer, washing
instructions and CE identification, is located on the inside of the
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knitted material.
Before washing, remove the bridging frame from the velour
pocket, unfasten the abdominal pad and close all Velcro
fastenings to avoid damage.
Wipe the bridging frame clean with a mild detergent. Wash the
knitted fabric portion and the abdominal pad separately by hand
with a mild detergent at 30 °C.
Allow the bridging frame, abdominal pad and knitted section to air
dry.
When reinserting the bridging frame into the velour pocket
provided, make sure that the two markings ("up" and "outward")
are correctly oriented.
Part of the body this product is used for
In accordance with the indications (lower back).
See Purpose.
Maintenance instructions
With correct handling and care, the product is practically mainte-
nance-free.
Assembly and fitting instructions
The SecuTec Lumbo is supplied in a standard size and ready for
use. The bridging frame must be individually adapted by a trained
specialist and positioned in the knitted section.
Technical specifications / parameters
The SecuTec Lumbo is a orthosis for the lower back. It consists of
a knitted section, a velour pocket for inserting the bridging frame,
an abdominal pad and six double-sided micro Velcro fastenings.
The velour pocket and bridging frame are available as spare parts
on request.
Information about re-use
The SecuTec Lumbo is intended for your treatment only. It has
been adapted specifically for you. For this reason, do not pass the
SecuTec Lumbo on to other people.
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
2 instructions on how to handle and care for the SecuTec Lumbo
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
Disclaimer
Do not diagnose yourself or decide on which medication to
take unless you are a medical specialist. Before first using our
medical product, please seek the advice of a physician or trained
specialist, as this is the only way to assess the effect of our
product on your body and determine the potential risks of using
this product due to your personal constitution. Follow the advice
of this specialist as well as all instructions in this document or its
online version, including any excerpts (as well as texts, images,
graphics etc.).
If you still have doubts after your consultation with the specialist,
please contact your physician or retailer, or contact us directly.
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
Once you have finished using the product, please dispose of it
according to local specifications.
Material content
Polyamide (PA), Polyurethane (PUR), Stainless steel, Viscose (CV),
Glass fiber (GF), Elastodiene (ED), Polyethylene (PE),
Polyoxymethylene (POM), Polyether foam,
Ethylene propylene diene monomer rubber (EPDM),
Polyester (PES), Carbon fiber (CF), Cotton (CO),
Polypropylene (PP), Elastane (EL), Copolyester (TPC-ES)
– Medical Device
– DataMatrix Unique Device Identifier UDI
Specialists 2
General notes
Check the optimal and individual fit of the SecuTec Lumbo after
the first fitting. Adapt the bridging frame (CFR frame) according
to the area of application (indications) and the anatomy of the
patient. 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 SecuTec Lumbo is intended for the treatment of one patient
only.
Part of the body this product is used for
In accordance with the indications (lower back).
See Purpose.
Set-up and assembly instructions
A – Knitted fabric portion
B – Fastening with finger pocket
C – Tensioning straps
D – Velour pocket for bridging frame (CFR frame)
E – Abdominal pad
F – Bridging frame (CFR frame)
G – Double-sided micro Velcro fastenings
Caution 1
Wear protective gloves to avoid burns when handling the hot-air
device.
To prevent damage to the material, please pay attention to
the following: Use round bending hooks only. Do not heat the
CFR frame at temperatures higher than 190 °C. The optimum
temperature for manipulating the frame is between 170 °C and
190 °C. Maintain a minimum distance between the hot-air device
and the CFR frame. Heat the CFR frame evenly and over the entire
surface (not just at certain points).
Bend the CFR frame in large arches only (no sharp bends). You
can immerse the CFR frame in cold water to speed up the cooling
process. This will not have any negative impact on the properties
of the material.
You can heat and reshape the material more than once. The
heating process does not visually alter the surface of the material.
In order to find out the appropriate time to bend the material, test
it during the heating process.
Heat the CFR frame with a hot-air device and shape it to
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produce the necessary bridging angle in accordance with the area
of application (indication) and to suit the patient's anatomy. Make
sure that the "up" marking on the frame is correctly oriented.
Check the fit of the orthosis on the patient in both a standing and
a sitting position after each modification.
Lay out the velour pocket in front of you. The sewn-in label
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indicates which side should face upward ("up"). Then turn the
velour pocket so that the opening is pointing toward you.
the CFR frame in the pocket and close it. Place the knitted
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section in front of you with the sewn-in label on the top right.
Secure each pair of double-sided micro Velcro fastenings onto the
velour strip on the knitted section. The fastenings must be spaced
out at distances that enable the velour pocket to be securely
connected to the frame and the knitted section. Fasten the
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velour pocket to the bridging frame and the knitted section.
Fasten the abdominal pad onto the right-hand half of the
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fastening in front of you.
Practice the process of putting on and taking off the orthosis with
the patient.
Version: 2023-09
1 Note on the risk of personal injury (risk of injury, harm to health and
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Place
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