Sterile incise film with antimicrobial

Surgical-site infections are an important health care problem and may result in significantly more post-surgical complications, lengthier hospital stays and increased mortality.

Incision films are a surgeon’s best allies for reducing microbial proliferation and minimising the incidence of trans- and post-operative infections, which have always been a serious problem for the patient’s health and an important cost-driver for the health care industry.

SoFilmPlus has a two-way design. An acrylic-based adhesive with anti-allergenic and biocompatible properties provides perfect adhesion to the skin, while active silver ions provide antimicrobial protection during the operation. It is easy to apply, extremely flexible and adapts well to more complexly-shaped parts of the body. All films are transparent and antireflective to allow the surgeon a perfectly clear view of the operating field.

Intended use
SoFilmPlus is intended for covering and protecting the surgical area to maintain sterility, and to be applied on the skin for skin protection.

Product description
SoFilmPlus is a transparent incise film enhanced with active silver ions for a continuous antimicrobial effect during the entire duration of the intervention. SoFilmPlus consists of a polyurethane film single coated with a pressure- and temperature-sensitive adhesive and supplied with a 120 grams release liner and a 5cm wide transparent finger lift. SoFilmPlus is resistant to water, body fluids, detergents and alcohol. SoFilmPlus is individually wrapped, pouched and sterilised by EO.

Certification
SoFilmPlus is a medical device and a CE mark is placed on the products’ packaging. A certificate of the manufacturer that the product meets all of the requirements of the Medical Devices Directive (MDD 93/42/EEC) is available upon request.

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Product nameProduct code Dimensions
SoFIlmPlus 25x20306001GGZSME 25cm (A) x 20cm (B) | 2x 5cm FL | folded | sterile | antimicrobial
SoFilmPlus 50x35306003GGZSME 50cm (A) x 35cm (B) | 2x 5cm FL | folded | sterile | antimicrobial
SoFilmPlus 50x45306004GGZSME 50cm (A) x 45cm (B) | 2x 5cm FL | folded | sterile | antimicrobial
SoFilmPlus 65x45306005GGZSME 65cm (A) x 45cm (B) | 2x 5cm FL | folded | sterile | antimicrobial
SoFilmPlus 65x60306006GGZSME 65cm (A) x 60cm (B) | 2x 5cm FL | folded | sterile | antimicrobial
SoFilmPlus 65x85306011GGZSME 65cm (A) x 85cm (B) | 2x 5cm FL | folded | sterile | antimicrobial
SoFilmPlus 95x65306007GGZSME 95cm (A) x 65cm (B) | 2x 5cm FL | folded | sterile | antimicrobial

Custom dimensions and versions are available on request.

Primary packaging containing the product
SoFilmPlus is packed in a medical grade sterile barrier pouch to prevent recontamination of the product after sterilization. It provides an effective microbial barrier The pouch maintains sterility during storage and transport.

Secondary packaging (inner box)
10 pouches are packed in a carton inner box used to facilitate proper storage and internal transport to the user.

Transport packaging (outer box)
Either 3 or 6 inner boxes are packed in a carton outer box for external transporting of sterile goods in their primary and secondary packaging.


Somed

Eurotape B.V.
Oostergracht 2 / NL-3763 LZ Soest
The Netherlands