Directions For Use - ConvaTec Flexi Seal Protect Plus Gebrauchsanweisung

8. If the catheter becomes blocked with feces, it can be rinsed with water using the irrigation port only (see Direction
for Use "Irrigation of the Device"). DO NOT use the white inflation port (marked "≤45ml") to irrigate. If obstruction
of the catheter is due to solid stool, use of the device should be discontinued.
9. Clinicians should take extra care to use the purple ENFit™ syringe to couple to the purple ENFit™ connector
in the blue irrigation/medication housing (marked "IRRIG./Rx" Figure 7-1a) only when irrigating and delivering
medication. DO NOT irrigate or administer medication through the white inflation port (marked "≤45ml" Figure
7-1b) which is closed off with a white cap.
10. Discontinue the use of the device if the patient's bowel control, consistency and frequency of stool begin to
return to normal.
11. If the patient is regularly and closely monitored, patients may be seated for short periods i.e. for up to 2 hours, as
part of daily nursing care. During this period of seating, regular monitoring should be made to ensure the tubing
is never blocked or kinked and to check for and avoid pressure damage to the anal/peri-anal region. Clinicians
should be alert that for some patients seating time needs to be reduced due to the possibility of pressure
damage to the anal/peri-anal region – Adjust balloon fill volume in case the red indication dome pops.
12. As with the use of any rectal device, the following adverse events could occur:
• Leakage of stool around the device
• Rectal/anal bleeding due to pressure necrosis or ulceration of rectal or anal mucosa
• Peri-anal skin breakdown
• Temporary loss of anal sphincter muscle tone
• Infection
• Bowel obstruction
• Perforation of the bowel
13. This device is for single use only and should not be re-used. Re-use may lead to increased risk of infection or
cross contamination. Physical properties of the device may no longer be optimal for intended use.
14. If there is no flow of stools in a 24hr period then the following actions should occur, irrigation (see section D.
irrigation of the device, in Directions for use) or removal of the device.
15. The collection bag should be coupled to the catheter in the correct orientation as shown in Fig. 3 . Reading
measurements of the collection bag is approximate only. The collection bag measuring scale has an accuracy of
+/-15% and is for indication purposes only.
16. Do not use if package is damaged. Do not use Diamonds™ sachets if sachets are significantly broken.
17. If during the use of this device or as a result of its use a serious incident has occurred, please report it to the
manufacturer and to your national authority "Circumstances in which the user should consult a health care
professional"
18. After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted
medical practice and applicable local laws and regulations.

Directions for use

A. Preparation of the device
1. In addition to the device system, gloves and lubricant will be required.
2. Unfold the length of the catheter to lay it flat on the bed, extending the collection bag toward the foot of the bed.
3. Insert 3 or 4 ConvaTec Diamonds™ sachets, one at a time, into the bag opening. Do not force the sachets,
if resistance is met then gently move the sachet sideways ensuring they are placed at the bottom of the bag.
(WARNING: DO NOT use the bag content for source of clinical information on stool color or consistency as it
is modified by the gelling agent. Do not open sachet.).
4. Securely attach the collection bag to the connector at the end of the catheter with the correct orientation
without trapping the bag against the bag connector (Figure 3). WARNING: trapping the bag against the bag
connector would prevent coupling to the catheter.
4.1 Follow the label shown on the catheter connector to couple the collection bag and catheter correctly.
4.2 Position the catheter connector at a 90 degree angle to the bag connector opening and gently insert the
catheter connector into the bag connector.
4.3 Locate the two pins on the collection bag connector and align them to the two corresponding slots on the
catheter connector.
4.4 Gently push the catheter connector into the bag connector and then twist clockwise to securely attach the
collection bag to the connector at the end of the catheter.
B. Preparation of the patient
1. Position the patient in left side lying position; if unable to tolerate, position the patient so access to the rectum
is possible.
2. Remove any in-dwelling or anal device prior to insertion of the Flexi-Seal™ PROTECT PLUS (with ENFit™
Flexi-Seal™ PROTECT PLUS Fecal Management System | 5