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Connector) device.
3. Perform a digital rectal exam to evaluate suitability for insertion of device.
C. Insertion of the device and inflation of the balloon using a Luer syringe
1. Remove the white cap from the inflation port. Using the Luer syringe provided, remove the air that is in
the balloon by attaching the Luer syringe to the white inflation port (marked "≤45ml") and withdrawing the
plunger. Remove the supplied Luer syringe and fill it with 45ml of water or saline and connect the Luer syringe
to the white inflation port of the catheter. Insert a lubricated gloved finger into the blue finger pocket for
digital guidance during device insertion (the finger pocket is located above the position indicator line). (Figure
4) Coat the balloon end of the catheter with lubricant. Grasp the catheter and gently insert the balloon end
through the anal sphincter until the balloon is beyond the external orifice and well inside the rectal vault. The
finger may be removed or remain in place in the rectum during initial balloon inflation.
2. Inflate the balloon with up to 45ml of fluid by slowly depressing the Luer syringe plunger. With the insertion
finger removed, the green indication dome will indicate once the balloon has reached the optimal fill level for
the anatomy. (Figure 5). Stop inflation once the green dome has signaled optimal fill. Under no circumstances
should the balloon be inflated with more than 45ml of fluid. If the green indication dome indicates at less
than 30ml of fluid, withdraw the fluid and reposition the balloon in the rectal vault. After repositioning, fill the
balloon as described above. Do not fill with more than 45ml of fluid. If the red indication dome starts to inflate,
assess the patient's position, fully deflate the balloon and repeat the balloon inflation process. Stop inflation
once green dome has signaled optimal fill.
3. Remove the Luer syringe from the inflation port, and gently pull on the soft catheter to check that the balloon
is securely in the rectum and that it is positioned against the rectal floor. (Figure 6). Close the cap on the white
inflation port to avoid misconnection issues.
4. Position the length of the flexible catheter along patient's leg avoiding kinks and obstruction. Take note of the
position indicator line relative to the patient's anus. Regularly observe changes in the location of the position
indicator line to determine movement of the retention balloon in the patient's rectum. This may indicate the
need for the balloon or device to be re-positioned. In the event of expulsion of the device, deflate the balloon
fully; rinse the balloon end of the catheter and reinsert following the instructions for 'Insertion of Device'. A
rectal exam should be conducted prior to re-insertion to verify that no stool is present. If expulsion continues
for more than three episodes, discontinuation of the device should be considered.
5. Hang the bag by the bead strap on the bedside at a position lower than that of the patient. Add insertion
date of the fecal management system onto the supplied date formatted adhesive label and affix label onto
flat region of the hanging strap.
D. Irrigation of the device using a purple ENFit™ syringe
To irrigate the device, fill a purple ENFit™ syringe with water at room temperature, remove the purple ENFit™
cap and attach the purple ENFit™ syringe to the purple ENFit™ connector in the blue irrigation/medication
housing (marked "IRRIG./Rx" Figure 7-1a) and slowly depress the plunger. Close the cap on the purple
ENFit™ connector to avoid misconnection issues. Do not irrigate through the white inflation port (marked
"≤45ml" Figure 7-1b) as this would lead to over inflation of the retention balloon and the device would not be
irrigated as intended. Repeat the irrigation procedure as often as necessary to maintain proper functioning
of the device. Flushing the device as described above is an optional procedure for use only when needed to
maintain the unobstructed flow of stool into the collection bag. If repeated flushing with water does not return
the flow of stool through the catheter, the device should be inspected to ascertain that there is no external
obstruction (i.e. pressure from a body part, piece of equipment, or resolution of diarrhea). If no source of
obstruction of the device is detected, use of the device should be discontinued.
E. Maintenance of the device
Change the collection bag as needed per Step A.4. After removal of the bag from the catheter, close the bag with
the provided cap. To remove the collection bag, push the catheter connector into the bag connector and then
twist anti-clockwise to disengage. See correct method of holding the collection bag without trapping the bag
against the bag connector in figure 3. Gently pull the catheter connector from the collection bag. Use the thumb
to push the back of the cap into the bag connector which is to be held in place from the rear of the collection bag
using the middle and index fingers. Use thumb to press around the cap to ensure full bag closure. Discard used
bags per institutional protocol for disposal of medical waste. Observe the device frequently for obstructions from
kinks, solid fecal particles or external pressure.
F. Administration of medication (dosage needs to be controlled by physician) using 2 purple ENFit™
syringes (1 for flushing with water, 1 for administering medication)
1. Fill a purple ENFit™ syringe with 10ml of water, remove the purple ENFit™ cap, attach the purple ENFit™
syringe and flush the irrigation line with 10ml of water.
6 | Flexi-Seal™ PROTECT PLUS Fecal Management System
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