4
Intended use
An effective device used in channeling irrigation fluid from a fluid source to a bowel management
device. For use in patients of all ages.
Indications for Use
The Bowel Management Irrigation Set is intended to allow connection between a compatible bowel
management device and the delivery tubing of an irrigation/enema bag system.
Contraindications
At this time there are no contraindications for use of the Irrigation Sets.
Clinical Benefits
Clinical benefits to be expected when using the Irrigation Set include but are not limited to:
Provides connection between irrigation/enema bags and bowel management device.
Allows for channeling of irrigation fluid to support daily continence.
Performance Characteristics
Performance characteristics of the Irrigation Set include but are not limited to:
Provides secure attachment to bowel management device.
Safety port cover and clamp provide additional leakage protection.
WARNING: This device has the potential to misconnect with small bore connectors of other
healthcare applications. Only use device to connect to cecostomy devices.
Note:
This device is intended to be used by qualified professionals and lay users.
1. Inspect contents for damage. If damaged, do not use. Obtain another package.
2. The irrigation set may be used for gravity irrigation/enema.
3. Ensure the clamp is closed and attach the irrigation set (
Fig A
) to the MiniACE® button by lining
up the dark line on the irrigation set connector with the dark line of the interlock on the MiniA-
CE® button. Fully press the irrigation set connector into the MiniACE® button. Turn 3/4 to the
right (clock-wise) to lock the irrigation set in place (
Fig B
).
4. Attach the opposite end of the irrigation set to the connector being used. If using a bolus or luer
connector, firmly insert the connector while using a slight rotation into the irrigation set to lock in
place. If using a rotating connector, firmly rotate the connector clockwise into the irrigation set
while avoiding excessive force to lock in place. Once connected, open the clamp to allow flow.
WARNING: Only tighten by hand. Never use excessive force or a tool to tighten a rotating
connector. Improper use can lead to cracking, leakage, or other failure.
WARNING: Ensure device is connected to a cecostomy port only and NOT to an IV set.
IRRIGATION SET INSTRUCTIONS
INSTRUCTIONS FOR USE
ENGLISH
INDICATIONS, CONTRAINDICATIONS
CLINICAL BENEFITS, PERFORMANCE CHARACTERISTICS
