AMT MINI ONE BALLOON BUTTON Instructions For Use Manual page 7

CAUTION: Prior to placement, please inspect all contents of the kit for damage. If the package is damaged or sterile barrier
is breached, do not use the product.
1. Select the correct MiniONE
NOTE: When replacing a device, stoma length should be periodically measured to ensure the correct
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MiniONE Balloon Button size is being used. If patient size/weight has changed since device was placed,
fit is too tight or loose, or it has been over six months since the device was last measured, it is recom-
mended that you speak to your healthcare professional to ensure device length does not need changed.
2. Prior to placing the MiniONE
using a Luer slip syringe with distilled or sterile water to the recommended fill volume. The recommended
fill-volume can be found on Table 1 or printed above the balloon inflation port of the device. Remove the
syringe and verify balloon integrity by gently squeezing the balloon to check for leaks. Visually inspect the
balloon to verify symmetry. Verify that sizing information is appropriate for measured length. Reinsert the
syringe and deflate all of the water from the balloon after inspection.
3. Lubricate the tip of the tube with water soluble lubricant. Do not use mineral
oil or petroleum jelly. Insert optional introducer into the feed port if in-
creased stiffness is desired during placement.
4. Gently guide the tube through the stoma and into the stomach until the
external flange is flush to the skin.
5. Remove Introducer (if used in step 3).
6. Inflate balloon with distilled or sterile water according to the fill volume in
the chart in Table 1.
7. Gently lift the tabs and check for signs of gastric leakage.
NOTE: If leakage is observed, increase balloon volume in increments of 0.5-1 ml. Do not exceed maximum fill volume.
Fr Size
12 F
14 F
16 F
18 F
20 F
24 F
1. Ensure the feeding set clamp is closed and attach the feeding set to the button by lining up the dark line on the feeding set con-
nector with the dark line on the button. Fully press the feeding set connector into the button. Turn 3/4 to the right (clock-wise) to
lock the feeding set in place.
2. Attach a large diameter catheter / screw tip syringe with 5ml of water into the feeding set. Open the feeding set clamp. Aspi rate for
contents. Spontaneous return of gastric contents should occur.
3. After air and/or gastric contents are observed, flush the device with water.
WARNING: NEVER INJECT AIR INTO THE MINIONE
WARNING: NEVER CONNECT THE EXTENSION SET TO THE BALLOON INFLATION PORT.
4. When placement is confirmed, gastric decompression or feeding channeling can begin.
WARNING: THIS DEVICE HAS THE POTENTIAL TO MISCONNECT WITH SMALL BORE CONNECTORS OF OTHER
HEALTHCARE APPLICATIONS. ONLY USE THIS DEVICE TO CONNECT TO COMPATIBLE ENTERAL DEVICES. DO NOT USE
FOR NON-ENTERAL APPLICATIONS.
WARNING: IF USING A LEGACY-STYLE (NON-ENFIT
NECT TO THE FOLLOWING SYSTEMS: BREATHING, CONES AND SOCKETS OF ANESTHETIC AND RESPIRATORY EQUIP-
MENT, INTRAVENOUS, LIMB CUFF, NEURAXIAL CONNECTORS, NIPPLES OF RESPIRATORY THERAPY EQUIPMENT,
URINARY, AND TEMPERATURE SENSOR CONNECTORS OF RESPIRATORY HUMIDIFYING EQUIPMENT.
1. Inspect contents for damage. If damaged, do not use. Obtain another package.
2. The feeding set may be used for syringe, gravity or pump feeding or decompression.
3. Ensure the feeding set clamp is closed and attach the feeding set to the button by lining up the dark line on the feeding set con-
nector with the dark line on the button. Fully press the feeding set connector into the button. Turn 3/4 to the right (clock-wise) to
lock the feeding set in place.
4. Attach the opposite end of the feeding set to the connector being used. If using a bolus or luer connector, firmly insert the connect-
or while using a slight rotation into the feeding set to lock in place. If using a rotating connector, firmly rotate the connector clock-
wise into the feeding 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 CONNECT-
OR. IMPROPER USE CAN LEAD TO CRACKING, LEAKAGE, OR OTHER FAILURE.
WARNING: ENSURE DEVICE IS CONNECTED TO AN ENTERAL PORT ONLY AND NOT TO AN IV SET.
WARNING: IF FEEDING SET IS NOT PROPERLY PLACED AND LOCKED, LEAKAGE MAY OCCUR. WHEN TWISTING THE
CONNECTOR HOLD THE BUTTON IN PLACE TO AVOID ROTATION WHILE PLACING THE FEEDING SET. NEVER INSERT
FEEDING SET CONNECTOR INTO A BALLOON INFLATION PORT; THIS MAY CAUSE THE INTERNAL BALLOON TO DEFLATE.
5. When feeding is complete, flush with 5-10ml water. Close the clamp to prevent leakage while removing the feeding set. Remove
the feeding set by holding the button in place, grasp the feeding connector, twist 3/4 turn to the left (counter clock-wise) to unlock,
and gently remove the feeding set from the button. Snap button plug in place to keep lumen clean.
6. The feeding set should be cleansed with soap and water and thoroughly rinsed. Store in a clean, dry place. Never use a dishwash-
er for cleaning.
DEVICE PLACEMENT PROCEDURE
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Balloon Button size for placement.
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Balloon Button, inflate balloon through the balloon inflation port (see Fig 4)
Table 1: Balloon Inflation Volumes
Minimum Fill Volume Recommended Fill Volume Maximum Fill Volume
2 ml
3 ml
4 ml
6 ml
7 ml
7 ml
PLACEMENT VERIFICATION
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FEEDING SET INSTRUCTIONS FOR USE
4
2.5 ml
4 ml
6 ml
8 ml
10 ml
10 ml
BALLOON BUTTON.
®
) EXTENSION SET, THIS DEVICE HAS THE POTENTIAL TO MISCON-
3
5
3 ml
5 ml
8 ml
10 ml
15 ml
15 ml
7