Description
Medical Device compliant with EEC Directive 93/42.
Sterilized by ethylene oxide using a process validated according to EN 550:1994, ISO 11135:1994 and ISO 109937:1995 for EtO residues.
Highly conformable dressing made of transparent and breathable film with a soft silicone contact layer with selective micro-adherence.
Mepitel Film is suitable for the management of a wide range of superficial wounds:
- first and second stage pressure ulcers;
- superficial burns;
- traumatic wounds and superficial skin lesions;
- protection of surgical wounds.
It can also be used as:
- secondary fixing dressing;
- in combination with gels and creams;
- under plasters and fixing devices to create a Landing Zone, so that the product works as a protector for the skin, even fragile ones.

Mepitel Film provides flexible, transparent protection for wounds and intact skin. It acts as a barrier against fluid penetration and external and bacterial contamination, conforming to the skin's irregular surface.
It maintains the ideal moist environment for wound healing; the dressing's permeability allows excess moisture to escape. Thanks to Safetac technology, it conforms perfectly to the dressing area without the need for additional pressure to secure it. The Safetac contact layer also ensures atraumatic removal. The dressing leaves no residue and does not increase its adhesion strength over time.
Latex free.

Safetac® is a proprietary soft silicone technology exclusive to Mölnlycke Health Care, which minimizes patient pain and wound trauma:
- does not adhere to moist surfaces, such as open wounds, but to the dry edges of the wound;
- it adapts to the irregular surface of the skin to create a larger contact area, which allows for a better distribution of the force required for removal, preventing skin stripping;
- seals the edges of the wound, preventing exudate from spreading to the periwound skin, minimising the risk of maceration;
- leaves no residue either on the wound bed or on the periwound skin.

Technical features :

Polyurethane film thickness	20 mcm
Polyurethane film grammage	20 g/m 2
Thickness of the protective polyethylene film	100 mcm
Weight of the protective polyethylene film	100 g/ 2
Contact layer	free of polyacrylates

It has successfully passed biocompatibility tests:
- Non-cytotoxic (applied standard EN 10993 - 5: 2009)
- Non-sensitizing (applied standard EN 10993 – 10: 2010)
- Non-irritating (applied standard EN 10993 – 10: 2010)
- Non-toxic (applied standard EN 10993 - 5: 2009)

Components
1) Silicone paper support frame.
2) Transparent and breathable polyurethane film.
3) Soft silicone wound contact layer (Safetac® Technology).
4) Protective film made of polyethylene film.

How to use
Cleanse the wound and surrounding skin. Allow the surrounding skin to dry. Open the package and remove the protective paper (printed with the Safetac® logo). Correct removal of the film allows for a sterile application. Position and smooth the dressing over the treatment area to ensure a good seal. Mepitel Film can be repositioned as long as the paper frame is in place. Remove the white paper frame. Do not stretch the dressing during application. To achieve a secure fit, Mepitel Film should cover the dry surrounding skin by at least 1-2 cm for smaller sizes (up to 10.5 x 12 cm) and at least 5 cm for larger sizes. Mepitel Film can be removed and repositioned without causing skin stripping or pain.

Warnings
Mepitel Film should not be used as primary fixation of intravascular catheters, ports, cannulas or other vital devices.
It is not a contact dressing and does not allow exudate to pass vertically from the wound to the secondary dressing.
If multiple dressings are used in overlapping layers, permeability may decrease, preventing proper evaporation of excess moisture.
In case of infected wounds, use under medical supervision is recommended.
If you experience clinical signs of infection, consult your healthcare professional.
If the product is reused, its performance may deteriorate and cross-contamination may occur.
Sterile product: do not use if the package is damaged.

Conservation
Store at room temperature away from extremes of humidity, dust, pollutants, etc.
The minimum durability date refers to the product correctly stored in intact packaging.
Shelf life in intact packaging: 36 months.

Format

Company int. code	Dimensions	No. of pieces
296170	6x7 cm	10
296500	10.5x12 cm	10
296700	10.5x25 cm	10
296900	15.5x20 cm	10