Description
The new Biatain Silicone is a multi-layered absorbent dressing consisting of two absorbent layers, two layers of polyurethane film, one external and one internal, 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 in delicate perforated silicone adhesive.
The first absorbent layer, covered in perforated silicone, is made up of Biatain polyurethane foam, multi-layered, hydrophilic, with a vertical alveolar structure.
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 second absorbent layer, higher than the first, in contact with the external polyurethane film, is a hydrocapillary Superabsorbent pad made of polyethylene, cellulose fibers (CMC) and SAP (Super Absorbent Particles in sodium dipolyacrylate polymers).
The instant absorption of the excess exudate that passes through the first layer of polyurethane foam gives the dihydrocapillarity effect to the super absorbent pad: the 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 allows to maintain the optimal moist environment for the healing of the lesions and to guarantee 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 absorption of exudate.
The external polyurethane film layer, in direct contact with the super-absorbent 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 the foam from laminating in the presence of a humid environment.
The external adhesive silicone layer in contact with the lesion and the skin is perforated (with Coloplast patented technology) along the entire surface of both the foam and the edge.
The silicone adhesive layer is delicate and does not cause trauma to the injury during changes and dressing application.
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 secure adhesion of the dressing.
The perforation on the edges ensures adequate transpiration and the evaporation of moisture from the skin.

Indications
Medium to highly exuding acute and chronic skin lesions.
Biatain Silicone helps prevent post-operative blisters.
Average residence time (medium to highly exuding wounds and ulcers): 3-4 days.
Maximum time spent on site: 7 days.

Contraindications and incompatibility
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-rays, 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, cellulose fibers (CMC), sodium polyacrylate, polyethylene, adhesive (PSA), adhesive layer in perforated silicone.

10460

Product	Absorption g / m 2 , 1 hour	Absorption g / m 2 , 24 hours	Absorption under compression g / m 2 , 24 hours	Permeability (MVTR) g / m 2 , 24 hours	Fluid Management (FHC) g / m 2 , 24 hours
Superabsorbent Polyurethane Foam Dressing with silicone adhesive	13860	9100	7400	16500

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

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

Codes
M04040602 44970 44970 44970 44970 17.5x17.5 44970 10x30 44970 44970 44970 09.21.12.012

Guy	Commercial Code	Measure (cm)	CND code	ISO code	CodeGMDN
Super absorbent polyurethane foam dressing with silicone adhesive	33434	7.5x7.5	09.21.12.003
Superabsorbent Polyurethane Foam Dressing with silicone adhesive	33435	10x10	M04040602	09.21.12.003
Superabsorbent Polyurethane Foam Dressing with silicone adhesive	33436	12.5x12.5	M04040602	09.21.12.003
Superabsorbent Polyurethane Foam Dressing with silicone adhesive	33437	15x15	M04040602	09.21.12.003
Superabsorbent Polyurethane Foam Dressing with silicone adhesive	33438	M04040602	09.21.12.006	44970
Superabsorbent Polyurethane Foam Dressing with silicone adhesive	33400	10x20	M04040602	09.21.12.003
Superabsorbent Polyurethane Foam Dressing with silicone adhesive	33401	M04040602	09.21.12.006	44970
Superabsorbent Polyurethane Foam Dressing with silicone adhesive	33404	15x19 Sacred	M04040602	09.21.12.012
Superabsorbent Polyurethane Foam Dressing with silicone adhesive	33405	25x25 Sacred	M04040602	09.21.12.012
Superabsorbent Polyurethane Foam Dressing with silicone adhesive	33406	18x18 Heel	M04040602	09.21.12.012
Superabsorbent Polyurethane Foam Dressing with silicone adhesive	33408	14x19.5 Multisite	M04040602	44970

Packaging

Usage unit	1 dressing in single pack
33434	10 units of use 135x 147 mm
33435	10 usage units 165 x177 mm
33436	10 use units 166 x 177mm
33437	5 usage units 220 x 227mm
33438	5 usage units 226 x 227mm
33400	5 usage units 150 x 250mm
33401	5 usage units 350 x 150mm
33404	5 usage units 200 x 250mm
33405	5 usage units 300 x 300mm
33406	5 usage units 230 x 250mm
33408	5 usage units 190 x 250mm

Indications on Primary Packaging (Usage Unit)
Disposable product, CE mark, manufacturer indication, production lot code, expiry date, indication of manufacture without natural rubber latex, microbiological statistic (sterility by irradiation), handling information, instructions for use.

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.