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Product features: UrgoK2 Compression System 8 cm, ankle circumference 25 - 32 cm, 6 pieces Characteristics: UrgoK2 is a two-component compression system consisting of a short-stretch bandage and a long-stretch bandage. The exclusive PresSureSystem technology, based on pressure indicators, facilitates application with correct stretch and overlap according to the selected set. This product is a medical device. Please read the instructions in the package leaflet carefully and familiarize yourself thoroughly with the functions and use of the product before use. The advantages of UrgoK2 at a glance: Comfortable to wear during the day and at night for improved patient adherence. Easy wearing of shoes. Good ankle mobility. Easy, quick and precise application thanks to the PresSure system: Therapeutic pressure is achieved from the very first application. High compression pressure at the ankle (approx. 40 mmHg). High stiffness index: Continuous compression thanks to a strong working pressure and a moderate resting pressure, creating a massage effect that supports venous return and edema reduction. The compression system can remain in place for up to seven days. Indications: Treatment of venous lower leg ulcers and/or edema of the lower extremities in adults when strong compression pressure is recommended. Contraindications: Moderate or severe arterial disease, especially with a current ankle-brachial pressure index (ABI) < 0.8. Patients with phlegmatia coerulea dolens or septic phlebitis. Edema in congestive heart failure. Epifascial arterial bypass. Known hypersensitivity to any of the ingredients—especially latex—for URGO K2. Precautions: This medical device must be applied by a person trained in the application of compression bandages. Read the instructions for use carefully. For single use only: do not wash, as this may impair the performance of the medical device. Do not sterilize. Do not use in direct contact with a wound. In the case of an arterial bypass, heart failure, peripheral neuropathy (for example in the case of diabetes), infected dermatitis in the ulcer area or acute cellulitis (erysipelas), the compression system may only be used after referral to a specialist and under close medical supervision. In cases of an ABI of 1.3, suspected medial sclerosis or a history of revascularization, a comprehensive vascular assessment is recommended before starting compression therapy. In the case of an infected lower leg ulcer, the infection should be treated in combination with compression therapy. The effectiveness of URGO K2 (or URGO K2 Latex Free) has been tested and validated for the combined use of KTech and KPress (or KPress Latex Free). Follow the application instructions to achieve the recommended therapeutic pressure. The PresSure system was specifically designed to facilitate the application of the bandages. If additional material is used to fix the bandage, this must be done with care to avoid a reaction to this foreign material. This compression system should be worn continuously day and night, as directed by a doctor, until the next appointment. If discomfort, pain or skin reactions occur when using the product, the patient should consult their doctor. Any serious incident related to the product must be reported to the manufacturer and the relevant national authority. Reporting of side effects: If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Germany, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine. Distribution in Germany: Urgo Medical GmbH Justus-von-Liebig-Straße 16 66280 Sulzbach Germany This leaflet was last revised in December 2022. Source: www.urgo.de As of August 2023
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