Description

The Peristeen Plus Transanal Irrigation (TAI) System with Balloon Catheter is an innovative medical device designed to enhance bowel management for individuals experiencing neurogenic bowel dysfunction, chronic constipation, or faecal incontinence. By introducing water into the bowels through a rectal catheter while seated on the toilet, this system effectively flushes out stool, helping to prevent faecal incontinence and constipation for up to two days.

Key Features

• Target Audience: Suitable for both children (ages 2 and up) and adults, the system can be used independently or with assistance, provided users receive proper instructions from a healthcare professional.
• Balloon Catheter: The catheter features an inflatable balloon that creates a seal in the rectum, ensuring effective water retention during irrigation.
• Ease of Use: Designed for individuals with poor manual dexterity, the system is lightweight, portable, and easy to store, making it convenient for use at home or while traveling.

System Components

• Control Unit
• Balloon Catheters: Includes two catheters with sizes in regular and small. Features such as a smooth, flexible design, large finger grip, turquoise insertion dot, and twist-and-lock connection enhance usability. These catheters are single-use only.
• Water Bag: Equipped with a screw top and temperature indicator.
• Additional Accessories: Includes straps, a tube, and an optional toiletry bag.

Usage Guidelines

• Training: Proper training and instructions from a healthcare professional are required before first use.
• Water Temperature: Utilizes clean tap water at body temperature (93-104°F) for comfort and effectiveness.
• Procedure Duration: Typically takes 30-45 minutes.
• Disposal: Used catheters should be disposed of with household waste.

Contraindications

The system is contraindicated for individuals with conditions such as:

• Known anal or colorectal stenosis
• Active or recurrent colorectal cancer
• Recent abdomino-perineal surgery
• Severe autonomic dysreflexia
• Pregnancy (if not previously used)

Safety Information

• Risks: Bowel perforation is a rare but serious complication that requires immediate medical attention.
• Precautions: Users must thoroughly read the label and instructions, including contraindications, warnings, and precautions.
• Medical Oversight: The device is restricted to sale by or on the order of a physician.

Benefits

The Peristeen Plus TAI system offers a safe and effective alternative to medication-based or invasive surgical bowel management methods. Clinical studies have shown its benefits in improving quality of life and reducing involuntary bowel leakage for both adults and children with neurogenic bowel dysfunction. By promoting user independence and confidence, it empowers individuals to manage their bowel movements effectively.