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Effets secondaires indésirables
Ce dispositif peut entraîner des réactions cutanées (rougeurs,
démangeaisons, brûlures, cloques...) voire des plaies de sévérités variables.
Tout incident grave survenu en lien avec le dispositif devrait faire l'objet
d'une notification au fabricant et à l'autorité compétente de l'État Membre
dans lequel l'utilisateur et/ou le patient est établi.
Mode d'emploi/Mise en place
Si nécessaire, conformer les baleines.
Ouvrir l'attelle et positionner le pouce et le poignet à l'intérieur du produit.
Ajuster le système de serrage (poignet puis pouce) pour fermer l'attelle.
Entretien
Produit lavable selon les conditions présentes sur cette notice et
l'étiquetage. Enlever la baleine avant lavage. A replacer à l'endroit initial
avant la prochaine utilisation. Fermer les auto-agrippants avant lavage.
Lavable en machine à 40°C (cycle délicat). Ne pas utiliser de détergents,
adoucissants ou de produits agressifs (produits chlorés...). Ne pas nettoyer
à sec. Ne pas utiliser de sèche-linge. Ne pas repasser. Essorer par pression.
Sécher à plat. Sécher loin d'une source directe de chaleur (radiateur, soleil...).
Stockage
Stocker à température ambiante, de préférence dans l'emballage d'origine.
Élimination
Éliminer conformément à la réglementation locale en vigueur.
Premier marquage CE : 2005
Conserver cette notice.
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WRIST AND THUMB IMMOBILISATION SPLINT
Description/Destination
This device is a wrist-thumb splint providing joint immobilisation.
The device is intended only for the treatment of the indications listed and for
patients whose measurements correspond to the sizing table.
Composition
Textile components: Polyamide - Polyester - Cotton - Elastane.
Rigid components: Polyoxymethylene - Aluminium.
Properties/Mode of action
Immobilisation of the wrist and thumb via 2 rigid, malleable and anatomical
palmar stays.
Aerated, foam lined fabric.
Dual strap system ensuring even compression.
Indications
Thumb sprain.
Wrist and/or thumb sprain.
Non surgical scaphoid fracture.
Non surgical wrist fracture.
Post-operative or post-traumatic wrist/thumb immobilisation.
Wrist and/or thumb tendinopathies.
De Quervain tenosynovitis.
Rheumatoid arthritis.
Lateral epicondylitis.
Conservative treatment of carpal tunnel syndrome.
Thumb/wrist osteoarthritis.
Neuro-muscular impairements (contracture, hand drop or spasticity...).
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Contraindications
Do not use the product if the diagnosis has not been confirmed.
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.
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.
It is recommended that a health care professional supervises the first
application.
It is recommended that an adult supervises the application and use of the
product by a child.
Strictly comply with your healthcare professional's prescription and
recommendations for use.
In the event of discomfort, significant hindrance, pain, variation in limb
volume, abnormal sensations or change in colour of the extremities, remove
the device and consult a health care professional.
For hygiene and performance reasons, do not re-use the product for
another patient.
Do not use the device in case of application of certain products on the skin
(creams, ointments, oils, gels, patches...).
It is recommended to adequately tighten the device to achieve support/
immobilisation without restricting blood circulation.
Undesirable side-effect
This device can cause skin reactions (redness, itching, burns, blisters...) or
wounds of various degrees of severity.
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
If necessary, shape the stays.
Open the splint et position the thumb and the wrist inside the product.
Adjust the tightening system (wrist then thumb) to close the splint.
Care/Maintenance
Product can be washed in accordance with the conditions shown on this
instruction leaflet and on the label. Remove stay before washing. Replace
in the original location before next use. Close the self-fastening tabs before
washing.
Machine washable at 40°C (delicate programme). Do not use detergents,
fabric softeners or aggressive products (products containing chlorine). Do
not dry clean. Do not tumble-dry. Do not iron. Squeeze out excess water. Dry
flat. Dry away from any direct heat source (radiator, sun, etc.).
Storage
Store at room temperature, preferably in the original packaging.
Disposal
Dispose of in accordance with local regulations.
Keep this instruction leaflet.
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ORTHESE ZUR RUHIGSTELLUNG VON
HANDGELENK UND DAUMEN
Beschreibung/Zweckbestimmung
Bei diesem Produkt handelt es sich um eine Handgelenk- und
Daumenorthese zur Immobilisation des Handgelenks und des Daumens.
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