AMT MiniACE Manual Del Usuario página 5

WARNING: If irrigation set is not properly placed and locked, leakage may occur. When
twisting the connector hold the MiniACE® button in place to avoid rotation while placing the
irrigation set. Never insert irrigation set connector into a Balloon Inflation Port (Fig C); this
may cause the internal balloon to deflate or lead to balloon failure if improper contents are
inserted into the balloon. Refer to button Directions for Use.
5. When irrigation is complete, flush with 5-10ml water (if not using water for irrigation). Close the
clamp to prevent leakage while removing the irrigation set. Remove the irrigation set by holding
the button in place, grasp the irrigation connector, twist 3/4 turn to the left (counter clock-wise) to
unlock, and gently remove the irrigation set from the button (Fig B). Snap the MiniACE® button
plug in place to keep lumen clean.
6. The irrigation set should be cleansed with soap and water and thoroughly rinsed. Store in a
clean, dry place. Never use a dishwasher for cleaning.
WARNING: In case of fever, abdominal distention, infection, blockage, or tissue necrosis,
patients should see their physician immediately.
WARNING: Do not place any foreign objects into the irrigation port.
WARNING: If using a transition connector, ensure that it is not connected to an IV set prior
to use.
WARNING: When using a bolus style irrigation set, this device has the potential to miscon-
nect to breathing system, limb cuff, and neuraxial connectors.
Note: The ENFit® connection is intended to reduce misconnections with other non -enteral
healthcare applications.
Irrigation sets are meant to be periodically replaced for optimal performance and cleanliness. AMT
recommends that the irrigation set be changed at least every 2 weeks or as often as indicated by
your healthcare professional. Device performance and functionality can degrade over time
depending on usage and environmental conditions. Some factors that can lead to reduced longevity
include: intestinal pH, irrigation solution used, frequency of use, trauma to the device, and overall
irrigation set care.
Device should be replaced if leakage, cracks, tears, excessive residue build-up, mold, fungus, or
other signs of failure are noted. The device can be disposed of by following local disposal
guidelines or through conventional waste. Some usage types can wear down device components
quicker than others. If tubing is becoming hardened, replacement is recommended in near future to
avoid failure.
Note: Please contact AMT, our Authorized Representative (EC Rep), and/or the competent
authority of the member state in which you are established if a serious incident has occurred in
relation to the device.
DEVICE LONGEVITY
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