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We make fecal management our priority, so it doesn’t have to be yours.
We make fecal management our priority, so it doesn’t have to be yours.
Up to 30% of patients admitted to the ICU experience fecal incontinence1 (FI) during their hospital stay. A serious threat to patients, FI also poses a significant challenge to hospitals to tackle. Especially, FI leads to:
In addition to the prevailing condition that brought them to the ICU, patients could have an undignified experience if FI is not taken care of effectively. Hospitalized adults with fecal incontinence are 22 times more likely to develop pressure ulcers than patients without fecal incontinence2.
C. difficile is shed in feces and can be transferred to patients mainly via the hands of healthcare personnel who have touched a contaminated surface or item3. In the USA, 1 in 5 patients with a healthcare-associated C. difficile infection experiences a recurrence of the infection4.
FI negatively impacts the treatment outcome binding significant resources and leading to prolonged patient suffering. If FI is not managed effectively additional and non-reimbursable cost can skyrocket. C. difficile infections result in approximately 3 million cases of diarrhea and colitis in the United States each year5; incurring US$6.3 billion in excess medical cost annually6.
We make fecal management our priority, so it doesn’t have to be yours.
Flexi-Seal™ PROTECT PLUS Fecal Management System is an indwelling fecal management catheter intended for use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications. The device is intended for use in adult patients.
The new Flexi-Seal™ PROTECT PLUS is designed with understanding to provide a safe, effective and dignifying solution to fecal management.
Flexi-Seal™ which is designed to help improve outcomes of patients suffering from FI has been shown to reduce complications and costs associated with FI in the hospital setting2.
Product Overview
Delivers medication effectively via a secondary route. Available with ENFit™ or Luer connector.
The ENFit™ connector (or the Luer connector in the blue housing) helps to reduce the risk of balloon over inflation by avoiding misconnection of medication to the inflation port.
One-way valve design to prevent leaks or back flow during medication administration or irrigation.
Increased efficiency for Health Care Professionals by administering medication rectally.
Medication/Irrigation port - Overview
Medication/Irrigation Port ENFit™ Connection
Medication/Irrigation Port Luer Connection
Designed to facilitate stool sampling. The blue sample port includes a cap and can easily be identified.
It allows for safe and easy stool collection helping to minimize the risk of fecal exposure.
The colored sample port is designed to simplify work routine and reduce nurse effort.
Sampling Port
The green dome indicates once the balloon has reached the patient’s individual fill volume.
75% of patients require 40ml or less fill volume for ideal fit and reduced leakage7.
Liquid stool in contact with skin is a major risk driver for pressure ulcers with each estimated to cost 40,000 USD8.
The red dome indicates if the balloon is over-filled. Over inflation beyond the optimal fit for individual patient may lead to complications.
Over inflation can lead to severe rectal tissue damage that requires prolonged treatment & hospitalization9.
Two-fill indicating dome system – overview
Two-fill indicating dome system – see how it works
Designed to reduce the risk of leakage and cross-contamination during bag change.
The self-closing catheter and the Privacy™ collection bag create a closed system that helps to reduce the risk of C. difficile contamination.
For increased caregiver confidence.
Helps to reduce the risk of CDI with a mean cost per hospital stay in the USA of $24,40010.
Self-closing catheter – Overview
Self-closing catheter – How to connect to the PRIVACY™ bag
Designed to allow easy and accurate placement of the soft silicone retention balloon.
The unique finger pocket design helps to facilitate balloon insertion for caregivers and to protect patients.
Helps to apply the catheter faster which saves time and worries.
Blue finger pocket - See how it works
Soft, flexible retention balloon conforms to the sphincter anatomy. It creates an effective seal to minimize leakage and is designed to minimize the chance of tissue necrosis.
Compared with competitor products, Flexi-Seal™ PROTECT PLUS is designed to help reduce cross-contamination risk by avoiding splatter upon removal11.
Helps to reduce the risk of CDI with a mean cost per hospital stay in the USA of $24,400.1010.
Balloon insertion
Odor barrier runs the full length of the catheter, providing an end-to-end odor barrier12.
Improves patient and caregiver experience and increases quality of life by reducing odor in the treatment area.
Zeolite™ Silicone catheter
Including 4 ConvaTec Diamonds™ gelling and odor control sachets.
Designed to contain and lock in odor. Opaque bag only reveals waste through the clear fill indication panel to protect patient dignity.
Minimizes the spread of C. difficile spores by releasing air through the active charcoal filter. Captures 6 times more odor13 than charcoal-filtered collection bags. This filter also eliminates the need to manually release the excess gas from the collection bag14.
Helps to reduce the risk of CDI with a mean cost per hospital stay in the USA of $24,40010.
Privacy™ collection bag – Overview
Privacy™ collection bag – How to connect to the self-closing catheter
ConvaTec Diamonds™ are gelling and odor control sachets with active charcoal to reduce the risk of spillage and odor effectively.
For insertion into the bag during the preparation of the device.
4 ConvaTec Diamonds™ gelling and odor control sachets are pre-packed in Flexi-Seal™ Protect Plus kit & the replacement bags.
ConvaTec Diamonds™
The cinch clamp is intended for clamping the catheter during administration of medication. It is applied on the catheter at the black indicator line.
During the time of application, the cinch clamp prevents medication from back flow, so it can dwell in the rectum for the required amount of time.
Increased efficiency for Health Care Professionals by administering medication rectally.
Medication/Cinch clamp
The Luer syringe is intended for inflation of the balloon through the white inflation port (marked “≤45ml”).
It contains graduation marks up to 45 ml to indicate the maximum fill volume, thus helps caregivers to prevent over inflation.
Over inflation beyond the optimal fit for individual patient may lead to complications.
Over inflation can lead to severe rectal tissue damage that requires prolonged treatment & hospitalization.9
Luer syringe
(only available in Flexi-Seal™ Protect Plus ENFit™ versions)
The ENFit™ syringe is used for irrigation of the device and administration of medication through the irrigation/medication port housing (marked “IRRIG./Rx”).
The ENFit™ tip is designed to avoid any potential mix up with the inflation port, thus helping to reduce the risk of misconnections.
Increased efficiency for Health Care Professionals by administering medication rectally.
ENFit™ syringe
Designed to hang the collection bag on the bedside in a suitable and convenient position.
The bead strap can be locked at the desired length. Its swivelling functionality allows for easy movement of the bag.
Bead strap
Flexi-Seal™ PROTECT PLUS Instruction for use video (US version)
Flexi-Seal™ PROTECT PLUS Instruction for use video
Customer Testimonial:
Flexi-Seal™ PROTECT PLUS
Customer Testimonial: The Royal Liverpool Hospital, UK
In vitro test: Removal force Flexi-Seal™ SIGNAL™ FMS
Select documents to download, or click to open PDF.
Flexi-Seal™ PROTECT PLUS brochure
Fecal Managment Algorithm
Directions for use poster (ENFit™ connection)
Directions for use poster (Luer connection)
How we can best support you to achieve improved patient outcomes together
