Thuasne LombaSkin, Manual

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“SECOND SKIN”* LUMBAR
SUPPORT BELT
The LombaSkin belt is breathable thanks to its
Combitex fabric. The edges of the fabric are seamless
to give it greater flexibility for wearing next to the skin,
with a “second skin” effect*.
Description/Destination
The device is intended only for the treatment
of the indications listed and for patients whose
measurements correspond to the sizing table.
Composition
Aerated and breathable Combitex fabric. ❶
Abdominal panels with self-fastening surface and
finger-loops. ❷
Conformable dorsal stays ❸
Texile components: polyamide - polyurethane -
polyester - elastan.
Non-textile components: brushed tempered steel -
polyoxymethylene - polypropylene.
Properties/Mode of action
The device relieves low back pain, supporting the
lumbar spine: compartmental lumbar unloading is
therefore achieved via increased intra-abdominal
pressure.
Indications
Non-specific low back pain (acute, subacute and
chronic phases).
Spinal stenosis.
Contraindications
Do not apply the product in direct contact with
broken skin.
Do not use in the event of known allergy to any of
the components.
Do not use on pregnant women.
Do not use in the event of a hiatus hernia.
Do not use in the event of bone cancer with spinal
metastases.
Do not use in the event of circulatory, pulmonary
or cardiovascular problems in patients for whom
an increase in arterial blood pressure is not
recommended.
Precautions
Verify the product’s integrity before every use.
Do not use the device if it is damaged.
Choose the appropriate size to fit the patient,
referring to the size chart.
Strictly comply with your healthcare professional’s
prescription and recommendations for use.
It is recommended that a healthcare professional
adjust the stays to the shape of the patient’s back
before the belt is worn for the first time.
Do not wear the product in a medical imaging
machine.
Do not wear the product while sleeping.
Consult a health professional if discomfort or pain
occurs.
The use of a medical device by a child, should
be done under the supervision of an adult or a
healthcare professional.
Undesirable side-effect
This device can cause skin reactions (redness, itching,
irritations…).
Any serious incidents occurring related to the device
should be reported to the manufacturer and to the
competent authority of the Member State in which
the user and/or patient is resident.
Instructions for use/Application
Position the belt around the waist, placing your hands
in the finger loops located on the abdominal panels. Ⓐ
The belt must be centred on the spine: the dorsal
stays should be positioned on either side of the spine.
The bottom of the belt must stop at the top of the
crease between the buttocks.
The Thuasne logo indicates which way up the belt
should be put on.
Pull the finger loops on the abdominal panels
simultaneously and evenly. Ⓑ
Fasten the belt, right side over left side, adjusting to
the desired compression. Ⓒ
The level of compression can be adjusted as required
throughout the day.
Care
Close the self-fastening tabs before washing.
Machine washable at 30°C (delicate programme).
Do not machine wash the device more than
10 times. Do not dry clean. Do not use detergents,
fabric softeners or aggressive products (products
containing chlorine). Do not tumble-dry. Do not iron.
Squeeze out excess water. Dry away from any direct
heat source (radiator, sun, etc.). Dry flat.
Storage
Store at room temperature, preferably in the original
packaging.
Disposal
Dispose of in accordance with local regulations.
* OC1806 In-house study report, 2019.
This medical device is a regulated health product with
CE marking
Keep this instruction leaflet
de
LWS-STABILISIERUNGSORTHESE
MIT „ZWEITE-HAUT-EFFEKT“*
Die LombaSkin-Bandage ist dank ihres Combitex-
Gewebes atmungsaktiv. Die Stoffränder weisen keine
Nähte auf, wodurch mehr Flexibilität durch direktes
Tragen auf der Haut mit einem sogenannten „Zweite-
Haut-Effekt“* gegeben ist.
Beschreibung/Zweckbestimmung
Das Produkt ist ausschließlich für die Behandlung
der aufgeführten Indikationen und für Patienten
vorgesehen, deren Körpermaße der Größentabelle
entsprechen.