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Effets secondaires indésirables
Ce dispositif peut entraîner des réactions cutanées (rougeurs,
démangeaisons, brûlures, cloques...) voire des plaies de sévérités variables.
Risque possible de thrombose veineuse.
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
Enfiler l'orthèse sur le pied.
Tirer sur les lacets pour fermer l'orthèse, sans trop serrer afin de ne pas
provoquer de garrot. (A)
Croiser une première fois les sangles sur le cou-de-pied, puis les croiser
une seconde fois au niveau de la naissance du mollet et venir attacher les
embouts auto-agrippants sur les côtés de la chevillère. (B-C).
En cas d'inconfort au niveau des malléoles, il est possible de modifier le
positionnement de l'armature en la glissant au-dessus ou en dessous du
point de couture qui se trouve en bas du cache armature.
Maintenance/Entretien
Produit lavable selon les conditions présentes sur cette notice et
l'étiquetage. Veiller à retirer les armatures latérales avant tout lavage.
A replacer à l'endroit initial avant la prochaine utilisation. 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.
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Premier marquage CE : 2013
Conserver cette notice.
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STABILISING ANKLE BRACE
Description/Destination
This device is an ankle brace providing joint stabilisation.
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, neoprene, elastane.
Rigid components: stainless steel.
Properties/Mode of action
Rigid side reinforcements to ensure ankle stability. ❶
Straps that optimise the action of the reinforcements. ❷
Fast, easy lace fastening. ❸
Bilateral product.
Indications
Moderate to severe ankle sprain.
Chronic ankle instability.
Ankle pain/oedema.
Sport activities resumption.
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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.
History of venous or lymphatic disorders.
Precautions
Verify the product's integrity before every use.
Do not use the product if it is damaged.
Choose the appropriate size to fit the patient, referring to the size chart.
It is recommended that a healthcare professional supervises the first
application.
Strictly comply with your healthcare professional's prescription and
recommendations for use.
Check the condition of the affected limb daily (with particular attention for
patients with sensory deficit).
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 healthcare 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...).
Do not wear the product in a medical imaging machine.
Do not wear the product when driving a vehicle.
The systematic use of a long sock is recommended when wearing the device.
It is recommended to adequately tighten the device to achieve support/
immobilisation without restricting blood circulation.
If the product comes into contact with water, make sure to remove the
lateral stays. Dry out the fabric part and wipe the stays thoroughly using
a dry cloth.
Undesirable side-effect
This device can cause skin reactions (redness, itching, burns, blisters,etc.) or
wounds of various degrees of severity.
Possible risk of venous thrombosis.
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
Slip the brace over the foot.
Pull the laces to close the brace, without tightening excessively to avoid any
tourniquet effect. (A)
Cross the straps over the top of the foot once, then cross them a second
time at the base of calf before attaching the self-fastening tabs to the sides
of the ankle brace. (B-C)
In the event of discomfort in the ankle bone area, the position of the frame
can be modified, by sliding it above or below the stitch located at the bottom
of the frame cover.
Care/maintenance
Product can be washed in accordance with the instructions shown on this
leaflet and on the label. Make sure to remove the lateral stays before washing.
Replace in the original location before next use. 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
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