ConvaTec Flexi Seal PROTECT PLUS - En English

Flexi-Seal™ PROTECT PLUS Fecal Management System | 3
1 Catheter Irrigation and Medication Port
2 Balloon Ination Port with 2-Dome Fill
Indicator and Cap
3 Sampling Port
4 Catheter
5 Position Indicator Line
6 Low-Pressure Retention Balloon with
Finger Pocket
7 Self-Closing Connector
8 Hanging Strap
9 Luer-Lock Syringe
10 Collection Bag
11 Cinch Clamp
12 4 ConvaTec Diamonds™ Gelling and
Odor Control Sachets
1 2
3
4
5
6
7
8
9
10
11
12
SL2187VB
GELLING AND ODOUR CONTROL SACHETS
convatec.com
The Flexi-Seal™ PROTECT PLUS Fecal Management System contains (Figure 1):
1
privacy bag
with filter
1
self-closing
soft catheter
tube assembly 1
Luer-
Lock
syringe 1
cinch
clamp
4
ConvaTec Diamonds™
gelling and odor
control sachets
English
en
The soft catheter is inserted into the rectum for fecal management to contain and divert fecal waste to protect
the patient’s skin and keep the bedding clean. There is a low-pressure retention balloon at the distal end and a
connector for attaching the collection bag at the other end. There is a recess under the balloon for the clinician’s
nger allowing the device to be positioned digitally. A blue and a white port are attached to the side of the catheter.
The white port, marked “≤45ml” is used to inate the retention balloon after the device has been inserted into
the patient’s rectum. (Figure 2-1b). This white ination port is equipped with two ll indicating domes (PROTECT
indicator domes), green color (i.e., the dome closest to the catheter tubing) and red color (i.e., the dome furthest
from the catheter tubing). The green ll indication dome provides a visual and tactile indication as to when the
low-pressure retention balloon is lled to its optimal volume. A red-dome ll indicator provides a visual and tactile
indication when the balloon over-ination occurs. A white cap is provided to close off the white ination port after
the balloon ination. The Luer-Lock connector in the blue housing, marked “IRRIG. /Rx” is used to ush the device
if needed and administer medication, if prescribed. (Figure 2-1a). A dark blue sampling port is also present if stool
samples are required to be taken by the clinician.
Intended Clinical Benefit
As determined by the available data, the clinical benets of the Flexi-Seal™ FMS family of products include:
• Containment and diversion of faecal matter
• The enablement of being able to administer medication
Claims
In addition to the safety and performance claims relating to the safe use of the device, performance claims made
for the device include:
• A product shelf life of 5 years
• The collection bag shall have 1 litre volume capacity.
• The Collection Bag shall have volume graduation marking ranging from 100 ml to 1,000 ml with an accuracy of
± 15%.
Indications for use
The 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.