Biatain Silicone Ag

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

Description
Antibacterial, absorbent, multilayer dressing, composed of an absorbent layer in polyurethane foam, two layers of polyurethane film, one external and one internal and a last layer, in contact with the lesion and the skin, in delicate perforated adhesive silicone. The antibacterial, absorbent layer, covered in perforated silicone, is made up of Biatain polyurethane foam, multi-layered, hydrophilic, with a vertical alveolar structure, which releases silver ions on the wound bed in a continuous and controlled manner, to guarantee the 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 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 lesion, avoiding any pressure marks on the periwound skin. In contact with the exudate, the foam conforms optimally to the wound bed, reducing the dead spaces where bacteria can lodge. The external polyurethane film layer, in direct contact with the foam 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 to the silicone on the other, creates an intermediate layer that prevents delamination of the foam in the presence of a humid environment. The external layer of adhesive silicone, in contact with the lesion and the skin, is perforated (with patented Coloplast technology) along the entire surface, both of the foam and of the edge. The silicone adhesive layer is delicate and does not cause trauma to injury during dressing changes and application. The matching perforation of the polyurethane foam allows the exudate to pass through the absorbent layer of the dressing and also ensures a secure adhesion of the dressing. Perforation on the edges ensures adequate transpiration and evaporation of moisture from the skin.

Indications
Acute and chronic skin lesions with high bacterial load, which delays the healing process, from medium to highly exuding. The dressing can be used for prophylactic purposes or on an infected ulcer under medical supervision. Average time of permanence (medium to highly exuding wounds and ulcers): 3-4 days. Maximum time on site: 7 days.

Contraindications and incompatibility
Do not use Biatain Silicone Ag in subjects with ascertained hypersensitivity to silver and its derivatives. In case of allergic reactions, please contact Coloplast for information on the components. Biatain dressings and secondary dressings must be removed prior to radioactive treatment (X-ray, ultrasound treatment, 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, perforated silicone adhesive layer. The foam contains a silver compound, AlphaSan complex, an “intelligent release” ion complex of silver that releases silver when it comes into contact with sodium ions present in the exudate of the lesion.

Antibacterial activity
Biatain Silicone Ag is effective against microorganisms commonly present in lesions for up to 7 days. Bacteria of the skin flora, 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 eVRE.

Physico-chemical characteristics
Permeability (MVTR) g / m2, 24 h4.780 9.200

Product	Silver contentmg / cm²	Absorption g / m2, 1 h	Absorption g / m2, 24h	Absorption under compression g / m2, 24 h	Fluid Management (FHC) g / m2, 24 h
Polyurethane foam dressing with silver and silicone adhesive layer	0.95	5,600	2,500	14,800

Sterilization
Biatain Silicone Ag is sterilized with ethylene oxide. The lot number and the expiry date appear on each package.

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

Codes
Code GMDN7,5x7,5 09.21.12.00339637M040408024812412,5x12,509.21.12.00339639M040408024812417,5x17,509.21.12.006

Product	Commercial Code	Measure (cm)	CND code	ISO code
Polyurethane foam dressing with silver and silicone adhesive layer	39636	M04040802	48124
Polyurethane foam dressing with silver and silicone adhesive layer	10x10	09.21.12.003
Polyurethane foam dressing with silver-extracted silicone adhesive	39638	M04040802	48124
Polyurethane foam dressing with silver and silicone adhesive layer	15X15	09.21.12.003
Polyurethane foam dressing with silver-extracted silicone adhesive	39640	M04040802	48124

Packaging


5 usage units 135 x 147 mm
5 use units 165 x 177 mm
5 usage units 166 x 177 mm
5 use units 220 x 227 mm
5 usage units 226 x 227mm

32 Ordering units
48 Order units
48 Order units
24 Order units
24Order unit

Usage unit	1 single pack dressing.
Order unit 39636 39637 39638 39639 39640
Packing 39636 39637 39638 39639 39640

Barcodes: present on the order unit and on the packaging.

Product storage
The products must be stored at room temperature (25 ° C).

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

Cod. 39636/39637/39638/39639/39640