ConvaTec Flexi Seal Protect Plus Gebrauchsanweisung Seite 3

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GELLING AND ODOUR CONTROL SACHETS
convatec.com
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The Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ Connector)
contains (Figure 1):
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Privacy bag Self-closing
with filter soft catheter
tube assembly
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
finger 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 inflate
the retention balloon after the device has been inserted into the patient's rectum. (Figure 2-1b). This white inflation
port is equipped with two fill 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 fill indication dome
provides a visual and tactile indication as to when the low-pressure retention balloon is filled to its optimal volume.
A red-dome fill indicator provides a visual and tactile indication when the balloon over-inflation occurs. A white cap
is provided to close off the white inflation port after the balloon inflation. The purple ENFit™ connector in the blue
housing, marked "IRRIG. /Rx" is used to flush 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 benefits 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 (with ENFit™ Connector) 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.
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Luer-
Lock
syringe
Flexi-Seal™ PROTECT PLUS Fecal Management System | 3
1 Catheter Irrigation and Medication Port – ENFit™
2 Balloon Inflation Port with 2-Dome Fill
Indicator and Cap – Luer
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 ENFit™ Syringe
11 Collection Bag
12 Cinch Clamp
13 4 ConvaTec Diamonds™ Gelling and Odor
Control Sachets
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Purple Cinch
ENFit™ clamp
syringe
ConvaTec Diamonds™
gelling and odor
control sachets