ConvaTec Flexi Seal PROTECT PLUS - Page 7

Flexi-Seal™ PROTECT PLUS Fecal Management System | 7
F. Administration of medication (dosage needs to be controlled by physician) using 2 syringes (1 for flushing
with water, 1 for administering medication)
1. Fill a syringe with 10ml of water, attach the syringe to the blue connector and ush the irrigation line with
10ml of water.
2. Prepare a new syringe with prescribed medication. Position the cinch clamp loosely on the catheter at the
black indicator line. Connect the syringe to the connector in the blue irrigation/medication housing (“IRRIG./R”
Figure 7-1a) and administer medication. Clinicians should take extra care to use the connector in the blue
irrigation/medication housing only when delivering medication. Do not administer medication through the
white ination port (marked “≤45ml” Figure 7-1b) as this would lead to over ination of the retention balloon
and the patient would not receive medication as intended.
3. To ensure delivery of medication into the rectum ll the syringe used for water ushing with 50ml of water and
immediately ush the irrigation line. Tighten the cinch clamp on the catheter to ensure no ow through the
catheter (ensure the second notch is engaged; squeeze tightly using forenger and thumb of both hands to
ensure a good seal). Allow the medication to dwell in the rectum for the desired amount of time as dictated
by the prescribing physician.
4. Remove the cinch clamp. Fill the syringe used for water ushing with 10ml of water and ush the irrigation
line. Dispose both syringes per institutional policy.
G. Sampling
To collect a sample from the catheter, open the dark blue sample port cap. Press the tip of a Luer-slip syringe or
catheter syringe through the slit inside of the sampling port to access the interior of the catheter. Withdraw the
syringe plunger to collect the sample. Withdraw the syringe and close the dark blue sampling port cap.
H. Removal of the device and deflation of the balloon
To remove the catheter from the rectum, the retention balloon must rst be deated. Remove the white cap from
the ination port. Attach a Luer syringe to the white ination port (marked “≤45ml”) and slowly withdraw all uid
from the retention balloon. (Figure 2-1b).
Disconnect the Luer syringe and discard. Grasp the catheter as close to the patient as possible and slowly
remove from the anus. Dispose of the device in accordance with institutional protocol for disposal of medical
waste. If the balloon is difcult or impossible to deate, cut the ination lumen and drain out the water in the
balloon. On no account should the device be removed from a patient with the balloon still inated.
General guidelines
The device may be changed as needed to perform normal patient assessment.
The device is not intended for use for more than 29 consecutive days.
MRI Safety Information
Non-clinical testing has demonstrated that the Flexi-Seal™ PROTECT PLUS is MR Conditional. A patient
with this device can be safely scanned in an MR system meeting the following conditions:
• Static magnetic eld of 1.5 T or 3.0 T
• Maximum spatial eld gradient of 2,000 gauss/cm (20 T/m)
• Maximum MR system reported, whole body averaged specic absorption rate (SAR) of 4 W/kg (First Level
Controlled Operating Mode)
The presence of this device may produce an image artifact.
©2023 ConvaTec Inc.
™ indicates trademarks of ConvaTec Inc. ConvaTec, the ConvaTec Logo, Flexi-Seal, the Flexi-Seal Logo are
registered trademarks of ConvaTec Inc. in the U.S.
M R