Mepilex Ag 20 x 50 cm sterile/ BOX-2

GENERAL DESCRIPTION:
Mepilex® Ag 20 x 50 cm. Antimicrobial soft silicone foam dressing, sterile, box of 2

PRODUCT DESCRIPTION INCLUDING TECHNICAL SPECIFICATIONS:
Mepilex Ag consists of a SafetacR wound contact layer, a flexible absorbent pad of grey polyurethane foam containing silver sulphate and coloured by activated carbon and a breathable and water proof film.
SafetacR is a proprietary adhesive technology developed by Molnlycke that minimises pain to patients and trauma to intact skin or wounds. Mepilex Ag is a highly conformable dressing that absorbs exudate and maintains a moist wound environment.
Mepilex Ag contains silver sulphate that releases silver ions to create an effective bacterial barrier and inactivates a wide range of wound related pathogens (bacteria and fungi), shown in vitro. By reducing the number of microorganisms, Mepilex Ag may also reduce odour.
Mepilex Ag has also been shown to inactivate wound related pathogens, up to 7 days in vitro.

Dressing material content: polyurethane, silicone, silver sulphate which equals to 1.2 mg/cm2 silver

PACKAGING:
Packaging and labelling:
Primary packaging: Unit of use.
One Mepilex Ag 20 x 50 cm in an individual sterilised peel pack.

Secondary packaging: Protected unit.
Box of 2 Mepilex Ag s 20 x 50 cm in an individual sterilised peel pack/s.


Indications for use
Mepilex Ag is an antimicrobial soft silicone foam dressing that is designed for the management of low to moderately exuding leg and foot ulcers, pressure ulcers and partial thickness burns.
Mepilex Ag may be used on infected wounds as part of a treatment regimen under supervision of a qualified health care professional. Mepilex Ag can be used under compression bandaging.

Precautions
Do not use Mepilex Ag on patient and/or user with known hypersensitivity to the ingoing materials/components of the product.
Clinicians/healthcare professionals should be aware that there are very limited data on prolonged and repeated use of silver containing dressings, particularly in children and neonates.
Frequent or prolonged use of this product may result in transient or permanent discoloration of skin.
Do not reuse. If reused performance of the product may deteriorate, cross contamination may occur.
Sterile. Do not use if sterile barrier is damaged or opened prior to use. Do not re-sterilise.

Instructions for use
Mepilex Ag should be used by or under the supervision of a qualified health care professional.
Note that local hygiene procedures should be followed prior to and following the dressing change.

1.Cleanse the wound with saline solution or water according to standard clinical practice.
2.Dry the surrounding skin thoroughly.
3.Select appropriate dressing size. For best clinical outcomes, ensure that the product covers the wound bed and overlaps the wound edges.
4.Cut to appropriate size (if needed). Remove the release films and apply the adherent side to the wound. Do not stretch.
5.When necessary, fixate Mepilex Ag with a bandage or other fixation.
Each Mepilex Ag dressing may be left in place for 7 days depending on the condition of the wound and surrounding skin, or as indicated by accepted clinical practice. A change in dressing regimen can result in an initial increased level of exudates, which temporarily may require an increased change frequency.
Mepilex Ag is intended for short-term use up to 4 weeks. For long-term use, a clinical assessment by a physician is recommended. In case of clinical infection Mepilex Ag does not replace the need for systemic or other adequate infection treatment.
The interaction of Mepilex Ag together with cleansing agents, oxidising agents such as hypochlorite solutions/hydrogen peroxide and topical treatments has not been demonstrated.
Prior to commencing radiation therapy, remove Mepilex Ag if product is present in the treatment area. A new dressing can be applied following treatment. Avoid contact with electrodes or conductive gels during electronic measurements,
e.g. electrocardiograms (ECG) and electroencephalograms (EEG).

Special storage conditions and handling conditions
Mepilex Ag should be stored in dry conditions below 25°C/77°F and protected from direct sunlight. Note that any colour variances in Mepilex Ag do not affect product performance or safety. Disposal should be handled according to local environmental procedures.

Other information
For EU-customers, for further information on the safety and clinical performance of Mepilex Ag please refer to the ‘Summary of Safety and Clinical Performance for Mepilex Ag’. You can access the document on molnlycke.com. In the future the document will also be published in the European Database on Medical Devices, EUDAMED.

ENVIRONMENTAL CONDITIONS:
Storage conditions:
Temperature: Below 25°C
Humidity: No limitations
Protect from direct sunlight

WEIGHT AND VOLUME:
Estimated weight 0.288 kg
Estimated volume 0.004 m3

SHELF LIFE: 3 years