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Biatain Silicone Ag Absorbent polyurethane foam with silver and silicone adhesive layer. Class III medical device. Description Antibacterial, absorbent, multi-layered dressing composed of an absorbent polyurethane foam layer, two polyurethane film layers (one external and one internal), and a final layer in contact with the wound and skin made of a delicate, perforated silicone adhesive. The absorbent antibacterial layer, covered in perforated silicone, is made of Biatain polyurethane foam, a multi-layered, hydrophilic, vertically honeycombed foam that releases silver ions into the wound bed in a continuous and controlled manner, ensuring antibacterial action for up to seven days. The release of silver ions (intelligent release of the Alphasan complex) is unique and patented. The silver-based compound is evenly distributed within the polyurethane foam. Thanks to the special 3D vertical honeycomb technology, it absorbs and prevents the release of exudate even under compression, thus creating the ideal moist environment for wound healing and preventing maceration of the periwound skin. The polyurethane foam is positioned seamlessly at the same level as the wound, avoiding any pressure marks on the periwound skin. When in contact with exudate, the foam optimally conforms to the wound bed, reducing dead spaces where bacteria can nest. The external polyurethane film layer, in direct contact with the foam layer, creates a barrier against exogenous bacteria and external contaminants and ensures high breathability. It also ensures optimal fluid management thanks to its high permeability. The internal polyurethane film layer, which 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 a moist environment. The external silicone adhesive layer, in contact with the wound and skin, is perforated (with patented Coloplast technology) along the entire surface, both of the foam and the edge. The silicone adhesive layer is gentle and does not cause trauma to the wound during dressing changes and application. Perforations in the polyurethane foam allow exudate to pass through to the absorbent layer of the dressing and also ensure a secure fit. Perforations at the edges ensure adequate breathability and moisture evaporation from the skin. Acute and chronic skin wounds with a high bacterial load, which delays the healing process, and moderate to highly exuding wounds. The dressing can be used prophylactically or on infected ulcers under medical supervision. Average wear time (medium to highly exuding wounds and ulcers): 3-4 days. Maximum wear time: 7 days. Contraindications and incompatibilities Do not use Biatain Silicone Ag in individuals with known hypersensitivity to silver and its derivatives. In case of allergic reactions, please contact Coloplast for information on the ingredients. Biatain dressings and secondary dressings must be removed before radiation treatment (X-rays, ultrasound, diathermy, and microwaves). Do not use Biatain dressings with oxidizing solutions such as hypochlorite and hydrogen peroxide. Composition External and internal polyurethane film, polyurethane foam, perforated silicone adhesive layer. The foam contains a silver-based compound, AlphaSan complex, an ionic smart release silver complex that releases silver when it comes into contact with sodium ions present in the wound exudate. Antibacterial activity Biatain Silicone Ag is effective against microorganisms commonly present in lesions for up to 7 days. Skin flora bacteria, such as: Acinetobacter, Coag. neg. S. epidermidis, E. Cloacae, E. Coli, E. Faecalis, E. Faecium, Hemolytic streptococci, gr. A, P. Aeruginosa, P. Mirabilis, P. Vulgaris and S. Aureus. Tissue bacteria such as: Anaerobic Streptococcus, B. Fragilis, C. Perfringens. Resistant bacteria including MRSA and VRE. Chemical-physical characteristics Product Silver content mg/cm² Absorption g/m2, 1 h Absorption g/m2, 24 h Absorption under compression g/m2, 24 h Permeability (MVTR) g/m2, 24 h Fluid Handling (FHC) g/m2, 24 h Polyurethane Foam Dressing with Silver and Silicone Adhesive Layer 0.95 4,780 5,600 2,500 9,200 14,800 Sterilization Biatain Silicone Ag is sterilized with ethylene oxide. Each package is marked with the batch number and expiration date. Validity 2 years from date of manufacture, unless otherwise indicated on the packaging. Codes Product Commercial Code Size (cm) CND Code ISO code GMDN Code Polyurethane foam dressing with silver and silicone adhesive layer 39636 7.5x7.5 M04040802 09.21.12.003 48124 Polyurethane foam dressing with silver and silicone adhesive layer 39637 10x10 M04040802 09.21.12.003 48124 Polyurethane foam dressing with silver and silicone adhesive layer 39638 12.5x12.5 M04040802 09.21.12.003 48124 Polyurethane foam dressing with silver and silicone adhesive layer 39639 15X15 M04040802 09.21.12.003 48124 Polyurethane foam dressing with silver and silicone adhesive layer 39640 17.5x17.5 M04040802 09.21.12.006 48124 Packaging Unit of use 1 dressing in a single pack. Order unit 39636 39637 39638 39639 39640 5 units of use 135 x 147 mm 5 units of use 165 x 177 mm 5 units of use 166 x 177 mm 5 units of use 220 x 227 mm 5 units of use 226 x 227 mm Packaging 39636 39637 39638 39639 39640 32 Order Units 48 Order Units 48 Order Units 24 Order Units 24 Order Units Barcodes: present on the order unit and on the packaging. Product storage Products must be stored at room temperature (25°C). Disposal The product does not contain any ecotoxic components and therefore does not require special disposal procedures. Do not dispose of in the environment as it is not biodegradable. Code 39636/39637/39638/39639/39640
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