AMT MINI ONE BALLOON BUTTON Instructions For Use Manual page 9

1. Deflate the balloon by attaching the Luer slip tip syringe into the balloon inflation port (Fig. 4) to withdraw the water.
2. Once the balloon is fully deflated, gently remove the device from the stoma site.
3. Replace as necessary following the MiniONE
NOTE: Spontaneous closure of the stoma may occur as early as 24 hours after removal. Insert new device if enteral feeding by this
route is still intended.
WARNING: DO NOT CUT OFF THE INTERNAL BOLSTER OR TUBING, OR ALLOW TO PASS THROUGH THE INTESTINAL
TRACT.
NOTE: The device can be disposed of by following local disposal guidelines, facility protocol or through conventional waste.
Long-term device performance and functionality are dependent on proper device usage per the instructions and varying usage and
environmental factors. While it is expected that you will use your feeding device without any issues, unexpected device problems can
sometimes occur. The following section covers a number of performance or functionality related items and how to help prevent these
types of occurrences.
Anti-reflux valve leakage or blockage: Leakage/blockage of the anti-reflux valve typically occurs due to residue (feed, medication,
gastric contents, etc) becoming stuck in the valve area, preventing the valve from fully closing. Make sure device is flushed after each
use. Leakage can also be caused due to excessive pressure in stomach (see DECOMPRESSION section). The valve can also
become inverted in rare cases. Insert extension set into port to reset valve if this occurs. Avoid excessive pressure during channeling
through the device, as this can cause a tear to occur in the valve over time.
Leaking of balloon volume: If balloon is deflating, fully deflate the balloon and remove from stoma. Once removed, inflate balloon
with recommended fill-volume. Check balloon for leakage by gently massaging tubing and balloon. If no leakage is noted, deflate the
balloon, re-insert balloon back into stoma, and re-inflate the balloon to desired fill-volume. Do not exceed maximum fill volume. Only
access the balloon inflation port for balloon inflation and deflation. Other uses can result in balloon leakage or device failure. NOTE:
The balloon is made of a semi-permeable material and can lose a small amount of fill-volume over time depending on environment and
usage conditions.
A tear has formed: Tears can occur due to contact with a sharp or abrasive object, excessive force, or excessive pressure. Due to the
soft, comfortable nature of the material the device is made from, small tears can quickly lead to large tears or device failure. If a tear is
noticed on the device, consider replacing device and check for any sources of tension, force, or sharpness that may be leading to the
tears occurring.
Tubing has reduced flow or has become clogged: Tubing can become blocked due to not properly flushing after each use, use of
thick or improperly crushed medications, use of thick feeds/formulas, gastric reflux, and/or fungus growth. If clogged, refer to the
PROPER FLUSHING GUIDELINES section for instructions on how to unclog the device. If clog cannot be removed, device may need
to be replaced.
Foul smell coming from the device: Foul smells can occur due to not properly flushing the device after each use, infection, or other
growth forming inside of the device. If a foul smell is noted coming from the device, device should be flushed and stoma site should be
gently cleaned with soap and warm water. If foul smell does not go away, it is recommended that you contact your healthcare
professional.
Balloon inflation valve leakage: Leakage from this valve typically occurs due to residue in the fill-valve. Always use a clean syringe
when inflating the balloon and only inflate water through the valve. Leakage can also occur due to valve becoming stuck if syringe is
inserted too hard into valve. Insert the syringe into the balloon inflation port if leakage is occurring to attempt to reset valve. Several
attempts may be necessary before valve resets.
Device has become discolored: The device can become discolored over days to months of use. This is normal depending on the
types of feeds and medications being used with the device.
Balloon is misshaped: Be sure to inflate and inspect balloon prior to placement to check balloon symmetry. Balloons becoming
misshaped typically occur due to excessive force or tension on the device (pulling device out of stoma while balloon is inflated). This
can occur if the device is too short for the patient's stoma site. Additionally, a device that is placed too close to the pylorus can result in
a misshaped balloon and blockage of the pylorus. Balloons can be gently massaged with fingers back into symmetry if not excessively
misshaped. Device should be replaced if balloon is found excessively misshaped.
Balloon will not inflate or deflate: Inflation and deflation problems typically occur due to residue blocking the fill-lumen. Always use a
clean syringe when inflating the balloon. In some rare occurrences, fungus can grow inside of the tubing and block the fill-lumen.
Fungus growth can occur depending on patient environment and feeds/medications being channeled through the device. If balloon will
not deflate, contact your healthcare professional for removal. If deflation problem is the result of fungal growth, eliminati ng source of
fungal growth or anti-fungal medication may be required.
Interlock failure or cracked: The interlock has been designed to withstand extreme forces without detaching or cracking. However,
the strength of the bond and material can reduce over prolonged use depending on medications and feeds used through the device.
Excessive forces over an extended period of use can also reduce bond / material strength. The device should be replaced if interlock is
found cracked, leaking, or separating from the device.
Device fit is too tight or too loose: Balloon fit can be adjusted by changing the balloon inflation volume within the balloon inflation
range in Table 1. If balloon fit is too loose, increase balloon fill-volume above recommended but not above max fill-volume. If balloon fit
is too tight, decrease fill-volume below recommended but not below min fill-volume. If device does not properly fit with the fill-volume
range, a new device length will be needed.
Balloon failure: Early balloon failure can occur due to a number of patient or envirornmental factors, including but not limited to:
gastric pH, diet, certain medications, improper balloon fill volume, placement of device, improperly channeling food/medicati on into
balloon port, trauma, contact with a sharp or abrasive material, incorrect stoma length measurement, and overall care of the device.
Plug will not stay closed: Ensure that the plug is being firmly and fully pressed into the interlock connector. If the plug is not staying
closed, check the plug and feed-port area for any excess residue build-up. Clean excess residue build-up with cloth and warm water.
Thank you for choosing AMT. For additional help and information regarding the use of our device, feel free to contact AMT with the
contact information on the back of the instructions for use. We are happy to hear your thoughts and help with your concerns and
questions.
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Balloon Button directions for use.
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BALLOON BUTTON
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