Flexi-Seal Signal FMS Fecal Management System Kit is designed to safely contain and divert fecal waste, helping protect patient skin and maintain a clean care environment. The system features a soft, flexible catheter inserted into the rectum, which channels waste into a collection bag, minimizing the risk of skin breakdown and cross-contamination. Its low-pressure retention balloon ensures secure placement while maintaining patient comfort, making it ideal for effective fecal management in bedridden or incontinent patients.

Features:

• Soft, Flexible Catheter: Gently inserted into the rectum to divert fecal waste, helping protect skin integrity and maintain hygiene.
• Low-Pressure Retention Balloon: Inflates via the white “≤45 ml” port to securely hold the catheter in place while preventing leakage or discomfort.
• Visual and Tactile Inflation Indicator: The white inflation port provides both visual and tactile feedback to ensure optimal balloon filling and safe pressure levels.
• Clinician-Friendly Design: Includes a finger recess under the balloon to facilitate controlled digital positioning and secure placement during insertion.
• Secure Waste Collection: Features a connector for attaching a fecal collection bag, ensuring effective containment and reducing odor or contamination risks.
• 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.

• The product warranty is applicable as per the terms and conditions provided by the product manufacturer.

Please call us for specific details.

• No returns will be accepted after 30 days from the date of shipment.
• All returns are subject to a restocking fee as per manufacturers terms and conditions.
• All returns must have an RGA number (Returned Goods Authorization), unauthorized returns will not be accepted.
• We do not guarantee fulfillment of any desired purpose or product suitability to the user and this will not be considered as a valid reason for return.
• The products must be new, unused condition, not tampered with, in original packaging and returned at the customers expense in the original packaging.
• If your return is not due to any manufacturing defect then the original shipping cost will be deducted from the total refund.
• Hygiene, bath and toilet items cannot be returned once opened or used.
• Standard manufacturer terms and conditions apply for return policy of this product.

Please call us for specific details.