Biatain Silicone Ag

Absorbent polyurethane foam with silver and silicone adhesive layer.
Class III medical device.

Description
Antibacterial, absorbent, multilayered, consisting of an absorbent layer of polyurethane foam, two layers of polyurethane film, one external and one internal and one last layer, in contact with injury and skin, in delicate silicone perforated adhesive. The antibacterial, absorbent layer, covered in perforated silicone, consists of the Biatain polyurethane foam, multi-layered, hydrophilic, vertical alveolar structure, which releases silver ions on the lesion bed continuously and controlled, to ensure antibacterial action until the seventh day. The release of silver ions (intelligent release of the Alphasan complex) is unique and patented. The silver-based compound is homogeneously distributed within the polyurethane foam. Thanks to the special 3D vertical alveolar technology it absorbs and avoids the release of the exudate even under compression, thus creating the ideal humid environment for the healing process of the injury, and avoiding the maceration of the perilesional skin. Polyurethane foam is positioned without steps at the same level of injury avoiding any pressure marks on the perilesional skin. In contact with the exudate the foam conforms optimally to the lesion bed reducing the dead spaces where bacteria can nest. The external polyurethane film layer, in direct contact with the foam layer, creates a barrier to external exogenous bacteria and pollutants and ensures high breathability. It also ensures optimal fluid management thanks to its high permeability. The layer in internal polyurethane film that adheres to the polyurethane foam on one side and to the silicone on the other, creates an intermediate layer that prevents the delamination of the foam in the presence of humid environment. The external adhesive silicone layer, in contact with the lesion and the skin, is perforated (with Coloplast patented technology) throughout the surface, both foam and edge. The silicone adhesive layer is delicate and does not cause injury during changes and application of the dressing. The perforation at the polyurethane foam allows the passage of the exudate towards the absorbent layer of the dressing and also guarantees a safe adherence to the dressing. Drilling on the edges ensures adequate breathability and moisture evaporation from the skin.

Indications
Acute and chronic skin lesions with high bacterial charge, which delays the healing process, from medium to highly exudatory. Medication can be used for prophylactic purposes or on infected ulcer under medical control. Average stay time (average injuries and ulcers to highly exudatory): 3-4 days. Maximum time on site: 7 days.

Contraindications and incompatibility
Do not use Biatain Silicone Ag in subjects with hypersensitivity ascertained towards silver and its derivatives. In case of allergic reactions, please contact Coloplast for information on components. Biatain medications and secondary medicines must be removed before radioactive treatment (X-rays, ultrasound treatment, diathermia and microwave). Do not use Biatain medications with oxidizing solutions such as hypochlorite and oxygenated water.

Composition
Polyurethane film, polyurethane foam, perforated Silicone adhesive layer. The foam contains a silver-based compound, AlphaSan complex, an ionic complex with “smart release” of silver that releases silver when it comes into contact with the sodium ions present in the exudate of the injury.

Antibacterial activity
Biatain Silicone Ag is effective against microorganisms commonly present in lesions up to 7 days 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. Tissutali batteries: Streptococco Anaerobico, B. Fragilis, C. Perfringens. Resistant batteries including MRSA and VRE.

Chemical-physical characteristics

Product	Content of silver 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 management (FHC) g/m2, 24 h
Polyurethane foam medicine 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. On each package the lot number appears, and the expiry date.

Validity
2 years from the date of production, unless otherwise indicated in the package.

Codes

Product	Commercial code	Size (cm)	Code CND	ISO code	GMDN code
Polyurethane foam medicine with silver and silicone adhesive layer	39636	7,5x7,5	MANUFACTURE FROM MATERIALS OF ANY HEADING	09.21.12.003	48124
Polyurethane foam medicine with silver and silicone adhesive layer	39637	10x10	MANUFACTURE FROM MATERIALS OF ANY HEADING	09.21.12.003	48124
Polyurethane foam medicine with silver and silicone adhesive layer	39638	12,5x12,5	MANUFACTURE FROM MATERIALS OF ANY HEADING	09.21.12.003	48124
Polyurethane foam medicine with silver and silicone adhesive layer	39639	15	MANUFACTURE FROM MATERIALS OF ANY HEADING	09.21.12.003	48124
Polyurethane foam medicine with silver and silicone adhesive layer	39640	17,5x17,5	MANUFACTURE FROM MATERIALS OF ANY HEADING	09.21.12.006	48124

Packaging

Units of use	1 single package dressing.
Ordering units 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
Imballo 39636 39637 39638 39639 39640	32 Ordering units 48 Order units 48 Order units 24 Order units 24 Order units

Barcodes: present on the order unit and packaging.

Product preservation
Products must be kept at room temperature (25°C).

Disposal
The product does not contain ecotoxic components therefore it does not need special disposal protocols. Do not disperse in the environment as it is not biodegradable.

Cod.39636/39637/39638/39639/39640