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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 palmar stay.
Slip on the splint, making sure that the thumb is correctly positioned in the opening.
Position the ulnar head in the hole of the silicone insert.
If additional pressure is required, add the removable strap.
Attach the strap onto the self-fastening surface on the inside of the splint, then
wrap the strap around the wrist.
Removal: To remove the splint, pull simultaneously the knit and the stay.
Care
Product can be washed in accordance with the instructions shown on this 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
30°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 STABILISIERUNG DES HANDGELENKS
Beschreibung/Zweckbestimmung
Bei diesem Produkt handelt es sich um eine Handgelenksorthese zur Stabilisierung
des Gelenks.
Das Produkt ist ausschließlich für die Behandlung der aufgeführten Indikationen
und für Patienten vorgesehen, deren Körpermaße der Größentabelle entsprechen.
Zusammensetzung
Polyamid - Polyester - Baumwolle - Elastan - Polyurethan - Aluminium - Silikon.
Eigenschaften/Wirkweise
Stabilisierung des Handgelenks durch eine feste volare Schiene, die anatomisch
geformt und anpassbar ist.
Das anatomische Gestrick gewährleistet die Propriozeption.
Komfortzone auf der Ebene des Ulnarknöchels (Silikonpelotte).
Abnehmbarer Riemen zur Einstellung der Druckstärke.
Indikationen
Distorsion des Handgelenks.
Tendomyopathien des Handgelenks.
Postoperative/posttraumatische Restschmerzen und/oder -ödeme.
Arthrose des Handgelenks.
Gegenanzeigen
Verwenden Sie das Produkt nicht bei einer unsicheren Diagnose.
Das Produkt nicht direkt auf geschädigter Haut anwenden.
Das Produkt bei einer bekannten Allergie gegen einen der Bestandteile nicht
anwenden.
Vorsichtsmaßnahmen
Vor jeder Verwendung die Unversehrtheit des Produkts überprüfen.
Das Produkt nicht verwenden, wenn es beschädigt ist.
Die für den Patienten geeignete Größe anhand der Größentabelle auswählen.
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 30°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 : 2016
Conserver cette notice
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WRIST STABILISING SPLINT
Description/Destination
This device is a wrist splint 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
Polyamide - polyester - cotton - elastane - polyurethane - aluminium - silicone.
Properties/Mode of action
Stabilisation of the wrist via a rigid, malleable and anatomical palmar stay.
Anatomically-shaped knit ensuring proprioception.
Comfort zone at the ulnar head (silicone pad).
Removable strap to adjust compression level.
Indications
Wrist sprain.
Wrist tendinopathies.
Post-operative, post-traumatic residual pain and/or edema.
Wrist osteoarthritis.
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 healthcare professional supervises the first application.
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 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…).
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.
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VALIDATION
