Flexi-Seal Signal Fecal Management System Kit - Charcoal Filtered

The Flexi-Seal SIGNAL Fecal Management System (FMS) is a specialized solution designed for bedridden or immobilized patients with liquid or semi-liquid stool. This temporary containment system helps safely manage fecal incontinence while protecting patients’ skin and wounds from contamination. It provides an easy-to-use, hygienic alternative to traditional incontinence methods, supporting infection control and overall patient comfort.

• Soft Silicone Catheter with Retention Balloon: Ensures secure placement while safely diverting fecal matter.
• SIGNAL™ Indicator: Provides visual cues to help prevent overfilling of the retention balloon.
• Blue Finger Pocket: Patented design simplifies catheter insertion for caregivers.
• Odour Barrier: Runs the length of the catheter to minimize unpleasant odors.
• Charcoal-Filtered Collection Bags: Includes three bags that release excess gas while reducing aerosolized contaminants, helping limit the spread of C. difficile.
• Complete Kit Contents: Comes with one soft silicone catheter, one syringe, and three filtered collection bags.
• Safe and Hygienic: Designed to contain fecal matter effectively, reducing the risk of skin breakdown and environmental contamination.
• Cap Closure for Collection Bags: Enhances hygiene and prevents spills.

• Dual-Port Design: Comes with white and blue Ports.
  • White Port: Used for inflating the retention balloon to the correct volume.
  • Blue Port: Marked “IRRIG./Rx,” it allows for irrigation or medication administration if prescribed.

The Flexi-Seal SIGNAL Fecal Management System contains:

• (1) Soft catheter tube assembly
• (1) Luer-Lock Syringe
• (3) Collection bags with filter
• (1) Cinch clamp

Indications:

For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications.

Contraindications:

1. This product is not intended for use:
   • For more than 29 consecutive days
   • For pediatric patients (patients under 18 years of age) as its use has not been tested in this population
2. The Flexi-Seal SIGNAL Fecal Management System should not be used on individuals who:
   • Have suspected or confirmed rectal mucosal impairment, i.e. severe proctitis, ischemic proctitis, mucosal ulcerations
   • Have had rectal surgery within the last year
   • Have any rectal or anal injury
   • Have hemorrhoids of significant size and/or symptoms
   • Have a rectal or anal stricture or stenosis
   • Have a suspected or confirmed rectal/ anal tumor
   • Have any in-dwelling rectal or anal device (e.g. thermometer) or delivery mechanism (e.g. suppositories or enemas) in place
   • Are sensitive to or who have had an allergic reaction to any component within the system

Warnings:

• Clinicians should be aware that there are very limited clinical data on the use of in-dwelling fecal management systems after 14 days continued use.
• There is a potential risk of misconnections with connectors from other healthcare applications, such as intravenous equipment, breathing and driving gas systems, urethral/urinary, limb cuff inflation neuraxial devices and other enteral and gastric applications.
• Not following these instructions for use may increase the likelihood of an adverse event.
• Patients should be monitored daily for and a physician notified immediately if any of the following occur - Rectal pain - Rectal bleeding - Abdominal symptoms such as distension/pain
• Over inflation of the retention balloon has the potential to increase the risk of adverse events. Never inflate the retention balloon with more than 45ml of water.

General Guidelines:

• The device may be changed as needed to perform normal patient assessment.
• The device is not intended for use for more than 29 consecutive days.
• If the product packaging or content are visibly damaged, do not use.