Description

The SenSura Mio 1 Piece Open is an advanced ostomy pouching system designed by Coloplast to provide comfort and discretion for individuals with a stoma. This 1-piece, drainable system integrates the adhesive barrier with the pouch, allowing for seamless changes when needed. Its design is particularly beneficial for those managing more frequent or liquid stoma output.

Key Features

• Flexible Baseplate Options: Available in flat and convex designs, including shallow convexity, to accommodate various stoma and body profiles. The cut-to-fit and pre-cut options ensure a tailored fit for a range of stoma sizes.

• BodyFit Technology®: The elastic adhesive adapts to body movements, ensuring a secure fit and enhancing comfort throughout daily activities.

• Full-Circle Filter: Equipped with a pre-filter to significantly reduce ballooning, enhancing discretion and comfort by protecting the carbon and membrane.

• Soft Textile Cover: The neutral-colored cover is soft against the skin, water-repellent, and low friction with clothing. It dries quickly and remains discreet under clothing.

• Inspection Window: Available on select models for easy stoma monitoring and accurate placement.

• EasiClose™ Closure: Features a hide-away outlet with a closure system for hygienic emptying and cleaning, using either a hook-and-loop or VELCRO® Brand fastener.

Material Composition

The pouch is constructed from high-quality materials including EVA/PVdC multilayer film, polypropylene, polyethylene, and polyester. These components ensure durability and reliability, while the soft textile cover enhances comfort.

Safety and Compliance

SenSura Mio 1 Piece Open is non-toxic and complies with European REACH regulations, containing no Substances of Very High Concern. It is evaluated under the European Union Medical Device Regulation (EU) 2017/745, ensuring it meets stringent safety standards. As a regulated medical device in the European Economic Area, its regulatory status may vary in other regions.

Usage and Maintenance

Users are advised to store the product at room temperature and dispose of it with household waste, adhering to local regulations. It is crucial to read the label and instructions for use to understand intended use, contraindications, warnings, and precautions.

Additional Options

The SenSura Mio range also includes pediatric options, such as the SenSura Mio Kids 1-Piece Open, designed with features suitable for children. This system is crafted to provide a secure fit, comfort, and discretion, supporting users in leading active and confident lives.