Description

The Peristeen Plus System Cone Catheter is an innovative transanal irrigation (TAI) device designed to assist individuals in managing challenging bowel symptoms. This system introduces water into the bowel using a rectal cone catheter, providing an effective solution for those with specific clinical needs, such as Low Anterior Resection Syndrome (LARS). Suitable for both adults and children, it offers flexibility in use, whether independently or with assistance.

Key Features

• Comfort and Design: The cone catheter features a rounded tip and two large water eyelets, ensuring effective irrigation. Its hydrophilic coating facilitates easier insertion, while the design allows for personal preference in grip, providing sound and tactile feedback for correct connection.

• Single-Use Convenience: Each catheter is intended for single use, promoting hygiene and effectiveness with every irrigation session.

• Expert Development: Developed with insights from colorectal surgeons and nurses, the catheter's shape, curvature, length, and flexibility are tailored for optimal performance.

System Components

The system, excluding the bag, includes:

• 1 control unit
• 2 cone catheters
• 1 water bag with screw top and temperature indicator
• 2 straps (1 pack)
• 1 tube
• 1 toiletry bag

A refill pack is available without the toiletry bag, enhancing convenience and adaptability.

Operation

The Peristeen Plus System operates using only water, eliminating the need for medication. The process is conducted while seated on the toilet, where water is introduced into the bowel via the rectal cone catheter, flushing out stool and emptying the lower bowel. The average irrigation time ranges from 30 to 45 minutes, and it can be performed independently or with assistance.

Materials

The system's components are crafted from high-quality materials, including:

• SEBS (Styrene-ethylene-butadiene-styrene)
• Polypropylene (PP)
• Polyethylene (PE)
• Acrylonitrile-butadiene-styrene (ABS)
• Polyvinyl chloride (PVC)
• Polyamide (PA)
• Polyester (PET)
• Stainless steel
• Silicone

Regulatory Information

Regulated as a medical device within the EEA, the Peristeen Plus System complies with the EU Medical Device Regulation (EU) 2017/745. It is considered non-toxic, with no Substances of Very High Concern (SVHC) above 0.1% w/w. Disposal should follow local regulations, and the device is not considered recyclable, allowing for disposal as regular household waste.

Storage and Maintenance

Store the system at room temperature unless otherwise stated on the packaging. Single-use catheters should be disposed of after each irrigation, and equipment should be dried before storage. Comprehensive instructions from a healthcare professional are essential, and users should always read the label and follow the directions for use.

Benefits

Regular use of the Peristeen Plus System can lead to predictable bowel movements, reducing the risk of skin irritation, urinary tract infections, and flatulence. Its portability and ease of storage make it a practical choice for effective bowel management.