Description

The SenSura Mio 1 Piece Closed Bag by Coloplast is an innovative ostomy pouching system designed to meet the needs of individuals with a stoma. Tailored for those managing solid or semi-solid stoma output, it offers a blend of comfort, discretion, and secure fitting to accommodate various body shapes.

Key Features

BodyFit Technology®

The system incorporates BodyFit Technology® with an elastic adhesive that adapts to natural body movements. This ensures a secure fit, minimizing leakage and providing peace of mind. The adhesive is permanently attached to the pouch, allowing the entire appliance to be removed and replaced during changes.

Baseplate Options

Available in flat or convex baseplates, the SenSura Mio offers adaptability to different stoma types and body profiles. The baseplates come in a wide range of pre-cut or customizable hole sizes, enhancing the personalized fit.

Pouch Variants

Pouches are available in various sizes, including mini, standard, and maxi, with capacities up to 550ml. The color options—transparent, neutral grey, or black—enhance discretion under different clothing, and some variants include an inspection window for easy monitoring.

Material and Design

The pouch is crafted from a soft, neutral-grey textile fabric that is water-repellent and low-friction, ensuring comfort against the skin. It remains discreet under clothing and does not retain moisture after activities like showering or swimming.

Integrated Filter System

A full-circle integrated filter with a unique pre-filter is included to reduce ballooning by up to 61%. This feature helps neutralize odor and prevent gas buildup, enhancing user comfort.

Application and Removal

The pouch includes a removal ear for easy, residue-free removal. Application involves aligning the adhesive around the stoma and pressing firmly for a secure seal. Removal is simplified by gently pulling the removal ear and rolling the adhesive downwards.

Additional Features

• Some variants include an integrated closure system and belt loops for optional support belt use.
• The backing fabric is soft and water-repellent, providing comfort and easy drying.
• The product is not made with natural rubber latex, using materials such as EVA/PvDC multilayer film and polypropylene.

Safety and Compliance

The SenSura Mio 1 Piece Closed Bag is MR safe and evaluated under the European Union Medical Device Regulation. It is non-toxic, non-hazardous, and free from Substances of Very High Concern (SVHC) above regulatory thresholds.

Storage and Disposal

Store the pouch horizontally at room temperature, away from sunlight. Disposal should be with household waste unless local regulations dictate otherwise. Reuse or reprocessing is not recommended due to contamination risks.

Usage Recommendations

Change frequency should align with healthcare practitioner guidance. Users with adhesive tape allergies should take necessary precautions. Always follow the provided instructions for optimal results.

Packaging

The packaging is made of corrugated cardboard and includes essential information such as batch code and use-by date, ensuring users have access to all necessary product details.