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Biatain Silicone Adhesive polyurethane foam. Product manufactured without natural rubber latex. Contains no phthalates. Description The new Biatain Silicone is a multi-layered absorbent dressing composed of two absorbent layers, two polyurethane film layers, one outer and one inner, and a pressure-sensitive adhesive (PSA) that holds the two absorbent layers together. The last layer, in contact with the lesion and the skin, is made of delicate perforated adhesive silicone. The first absorbent layer, covered in perforated silicone, is made of Biatain polyurethane foam, a multi-layered, hydrophilic foam with a vertical honeycomb structure. Thanks to the special 3D vertical alveolar technology, it absorbs and prevents the release of exudate even under compression, thus creating the ideal moist environment for the wound healing process, and avoiding maceration of the periwound skin. The polyurethane foam is positioned without steps at the same level as the wound, avoiding any pressure marks on the periwound skin. In contact with the exudate, the foam conforms optimally to the wound bed, reducing dead spaces where bacteria can nest. The second absorbent layer, above the first, in contact with the external polyurethane film, is a hydrocapillary superabsorbent pad made of polyethylene, cellulose fibres (CMC) and SAP (Super Absorbent Particles in sodium polyacrylate polymers). The instant absorption of excess exudate passing through the first layer of polyurethane foam gives the super-absorbent pad a hydrocapillary effect: fluids are absorbed vertically and distributed both vertically and horizontally. In fact, the cellulose and SAP polymers in contact with the exudate change phase, gelling. The gel that forms helps maintain the optimal moist environment for wound healing and ensures a high level of retention even under compression. The two absorbent layers are held together by PSA, Pressure Sensitive Adhesive, which prevents delamination of the absorbent layers when they come into contact with moisture following the absorption of exudate. The external polyurethane film layer, in direct contact with the superabsorbent layer, creates a barrier against exogenous bacteria and external pollutants and ensures high breathability. It also guarantees optimal fluid management thanks to its high permeability. The internal polyurethane film layer that adheres to the polyurethane foam on one side and the silicone on the other, creates an intermediate layer that prevents the foam from delaminating in humid environments. The external adhesive silicone layer in contact with the wound and the skin is perforated (with patented Coloplast technology) along the entire surface of both the foam and the edge. The silicone adhesive layer is gentle and does not cause trauma to the wound during dressing changes and application. The perforation in the polyurethane foam allows the passage of exudate towards the absorbent layer of the dressing and also ensures secure adhesion of the dressing. The perforations on the edges ensure adequate breathability and the evaporation of moisture from the skin. Directions Acute and chronic skin lesions of medium to high exudate. Biatain Silicone helps prevent post-operative blistering. Average dwell time (medium to highly exuding wounds and ulcers): 3-4 days. Maximum time on site: 7 days. Contraindications and incompatibilities In case of allergic reactions, please contact Coloplast for information on the ingredients. Biatain dressings and secondary dressings must be removed prior to radiation treatment (X-ray, ultrasound, diathermy and microwave). Do not use Biatain dressings with oxidizing solutions such as hypochlorite and hydrogen peroxide. Composition External and internal polyurethane film, polyurethane foam, cellulose fibers (CMC), sodium polyacrylate, polyethylene, adhesive (PSA), perforated silicone adhesive layer. ProductAbsorption g/m 2 , 1 hourAbsorption g/m 2 , 24 hoursAbsorption under compression g/m 2 , 24 hoursPermeability (MVTR) g/m 2 , 24 hoursFluid Handling (FHC) g/m 2 , 24 hours Super-absorbent polyurethane foam dressing with silicone adhesive layer 13860 9100 10460 7400 16500 Sterilization Biatain Silicone is sterilized with ethylene oxide. The batch number and expiry date appear on each package. Validity 3 years from date of manufacture, unless otherwise indicated on the packaging. Codes TypeCommercial CodeSize (cm)CND CodeISO codeGMDN Code Super-absorbent polyurethane foam dressing with silicone adhesive 33434 7.5x7.5 M04040602 09.21.12.003 44970 Super-absorbent polyurethane foam dressing with silicone adhesive 33435 10x10 M04040602 09.21.12.003 44970 Super-absorbent polyurethane foam dressing with silicone adhesive 33436 12.5x12.5 M04040602 09.21.12.003 44970 Super-absorbent polyurethane foam dressing with silicone adhesive 33437 15x15 M04040602 09.21.12.003 44970 Super-absorbent polyurethane foam dressing with silicone adhesive 33438 17.5x17.5 M04040602 09.21.12.006 44970 Super-absorbent polyurethane foam dressing with silicone adhesive 33400 10x20 M04040602 09.21.12.003 44970 Super-absorbent polyurethane foam dressing with silicone adhesive 33401 10x30 M04040602 09.21.12.006 44970 Super-absorbent polyurethane foam dressing with silicone adhesive 33404 15x19 Sacred M04040602 09.21.12.012 44970 Super-absorbent polyurethane foam dressing with silicone adhesive 33405 25x25 Sacred M04040602 09.21.12.012 44970 Super-absorbent polyurethane foam dressing with silicone adhesive 33406 18x18 Heel M04040602 09.21.12.012 44970 Super-absorbent polyurethane foam dressing with silicone adhesive 33408 14x19.5 Multisite M04040602 09.21.12.012 44970 Packaging Unit of use1 dressing in single pack 33434 10 units of use 135 x 147 mm 33435 10 units of use 165 x 177 mm 33436 10 units of use 166 x 177 mm 33437 5 units of use 220 x 227 mm 33438 5 units of use 226 x 227 mm 33400 5 units of use 150 x 250 mm 33401 5 units of use 350 x 150 mm 33404 5 units of use 200 x 250 mm 33405 5 units of use 300 x 300 mm 33406 5 units of use 230 x 250 mm 33408 5 units of use 190 x 250 mm Indications on Primary Packaging (Unit of Use) Single-use product, CE marking, manufacturers name, production batch code, expiry date, manufacturing without natural rubber latex, microbiological status (sterility by irradiation), handling information, instructions for use. Product storage Products must be stored at room temperature (25°C). Disposal The product does not contain ecotoxic components and therefore does not require special disposal protocols. Do not dispose of in the environment as it is not biodegradable
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