Biatain Silicone Ag

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

Description
Antibacterial, absorbent, multilayered dressing, composed of an absorbent layer in polyurethane foam, two layers in polyurethane film, one outer and one inner and one last layer, in contact with the lesion and the skin, in delicate perforated adhesive silicone. The antibacterial layer, absorbent, 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 lesion bed in a continuous and controlled manner, to ensure antibacterial action up to 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 inside 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 wet environment for the healing process of the lesion, and avoiding the maceration of the perileonic skin. The polyurethane foam is positioned without steps at the same level as the lesion avoiding any signs of pressure on the perilesional skin. In contact with the exudate the foam conforms optimally to the lesion bed by reducing dead spaces where bacteria can lurk. The outer polyurethane film layer, in direct contact with the foam layer, creates a barrier to exogenous bacteria and external pollutants and ensures high breathability. It also guarantees optimal fluid management due to its high permeability. The inner 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 delamination of the foam in the presence of a humid environment. The outer 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 the injury during changes and the application of the dressing. The perforation in correspondence of the polyurethane foam allows the passage of the exudate towards the absorbent layer of the dressing and also guarantees a safe adhesion of the dressing. The perforation on the edges ensures adequate perspiration and evaporation of moisture from the skin.

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

Contraindications and incompatibility
Do not use Biatain Silicone Ag in subjects with established hypersensitivity to silver and its derivatives. In case of allergic reactions, please contact Coloplast for information about the components. Biatain dressings and secondary dressings should be removed before radioactive treatment (X-ray, ultrasound treatment, diathermia and microwaves). Do not use Biatain dressings with oxidizing solutions such as hypochlorite and hydrogen peroxide.

Composition
Outer and inner polyurethane film, polyurethane foam, perforated silicone adhesive layer. The foam contains a silver-based compound, AlphaSan complex, an “intelligent release” ionic complex of silver that releases silver when it comes into contact with the sodium ions present in the exudate of the lesion.

Antibacterial activity
Biatain Silicone Ag is effective against microorganisms commonly found in lesions up to 7 gg. Bacteria of the skin flora, such as: Acinetobacter, Coag. Neg. S. epidermis, E. Clockwise, E. Coli, E. Faecalis, E. Faye, Hemolytic stress, sir. A, P. Aeruginosa, P. Wonderful, P. S. Vulgaris. Gold. 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 management (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. On each package appears the batch number, and the expiration date.

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

Codes

Product	Commercial Code	Measure (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 for use	1 dressing in single pack.
Order unit 39636 39637 39638 39639 39640	5 units of use 135x147mm 5 units of use 165x177mm 5 units of use 166x177mm 5 units of use 220x227mm 5 units of use 226x227mm
Packing 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
The products must be stored at room temperature (25 °C).

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

Cod.39636/39637/39638/39639/39640