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Product features: Bort Generation thumb splint Please read these instructions for use carefully. If you have any questions, please contact your doctor or the retailer from whom you obtained this medical device. Intended purpose: This medical device is an orthosis for immobilizing the base and carpometacarpal joints of the thumb. Indications: Postoperative, post-traumatic, rhizarthrosis, degenerative, inflammatory, e.g. arthritis, ulnar/radial ligament injury of the thumb. Contraindications: Peripheral arterial occlusive disease (PAOD), lymphatic drainage disorders, also unclear soft tissue swellings distant from the applied aid, sensory and circulatory disorders of the supplied body region, diseases of the skin in the supplied body part. Application risks/Important information: This medical device is a prescription product. Discuss its use and duration with your prescribing physician. The selection of the appropriate size and instruction will be provided by the healthcare professional from whom you received the medical device. Remove the medical device before radiological examinations. Do not close too tightly during longer periods of rest, e.g., while sleeping. If numbness occurs, loosen or, if necessary, remove the medical device. If symptoms persist, consult a doctor or specialist retailer. Use the medical device according to the indication. Use other products simultaneously only after consulting your doctor. Do not make any changes to the product. Do not wear on open wounds. Do not use if you are intolerant to any of the materials used. No reuse – this device is intended for the care of one patient. During the wearing period of the orthosis: do not apply creams or ointments locally to the area of the applied device – this can damage the material. Dressing instructions: Before putting it on, adjust the thumb strap and wrist closure to the largest possible circumferences and pull the Bort Generation thumb splint over the thumb and metacarpal. First close the thumb strap and then the cord – closure at the wrist, which can be adjusted to the individual width using Velcro patches. Close the bandage completely. Take off: To remove the bandage, please open the Velcro fasteners and slide off the thumb orthosis. Material composition: Polyamide (PA), elastane (EL), polyester (PES). Please refer to the sewn-in garment label for the exact material composition. Cleaning instructions: Hand wash. Do not dry clean. Do not bleach. Do not tumble dry. Do not iron. Do not use fabric softener. Air dry. Warranty: The legal regulations of the country in which you purchased the product apply to this product. Please contact your retailer if you suspect a warranty claim. Please clean the product before submitting a warranty claim. Failure to adequately follow the enclosed instructions for use may impair or void the warranty. The warranty is excluded in cases of improper use, failure to observe the application risks and instructions, and unauthorized modifications to the product. Product usage/lifespan: The lifespan of the medical device is determined by natural wear and tear when handled properly and in accordance with its intended use. Reporting obligation: If the use of this medical device leads to a serious deterioration in your health, please report this to your specialist retailer or to us as the manufacturer, as well as to the BfArM (Federal Institute for Drugs and Medical Devices). Our contact details can be found in these instructions for use. The contact details of the notified body in your country can be found at the following link: www.bort.com/md-eu-kontakt. Disposal: After use, the product must be disposed of in accordance with local regulations. Declaration of Conformity: We confirm that this product complies with the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council. The current declaration of conformity can be found at the following link: www.bort.com/konformitaet This patient information leaflet was last revised in November 2019. Source: Information from the package insert As of December 2021
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