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1. The MiniONE
Balloon Button should be replaced periodically for optimal performance. If in place for three months or longer,
frequent performance checks are recommended. Clogging and/or reduced flow are indications of diminished performance. Refer to
the TROUBLESHOOTING section for additional signs of reduced performance or failure.
2. Be sure the balloon is within the stomach and the MiniONE
distilled or sterile water into the feeding port to determine proper function of the valve.
3. The stoma area should be cleansed daily with a mild soap and water. The stoma site should be clean and dry at all times. The
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MiniONE
Balloon Button should be rotated daily for site hygiene.
Liquid medication is preferred when available. If solid medication is required, consult with your physician regarding whether it is safe
to crush the medication. If safe, medication should be crushed as fine as possible (into powder form) and dissolved into water before
channeling medication through device. Channeling solid medication through the tubing that is not properly crushed can lead to block-
age in the tubing. Never crush enteric coated medication or mix medication with formula. Flush device with water after channeling
medication.
Decompression can be performed if there is a need to check for residuals, or if the patient tends to retain air during feeding causing
bloating and discomfort. To decompress, connect the feeding set to the interlock connector and drain stomach contents into a con-
tainer. After decompression is complete, flush the feeding set with water and remove the feeding set from the device.
Proper flushing techniques and frequency can help prevent tubing blockage, clogs, and tubing failure. Follow these flushing guide-
lines to maintain optimal device flow conditions:
• Use room temperature water for tube flushing. The amount of water will depend on the patient's needs, clinical condition, and type
of tube, but the average volume ranges from 10 to 50 ml for adults, and 3 to 10 ml for infants. Hydration status also influences the
volume used for flushing feeding tubes. In many cases, increasing the flushing volume can avoid the need for supplemental intra-
venous fluid. However, individuals with renal failure and other fluid restrictions should receive the minimum flushing volume neces-
sary to maintain potency.
• Flush the feeding tube with water every 4-6 hours during continuous feeding, anytime the feeding is interrupted, before and after
every intermittent feeding, or at least every 8 hours if the tube is not being used.
• Flush the feeding tube before and after medication channeling and between medications. This will prevent the medication from
interacting with formula and potentially causing the tube to clog.
• Do not use excessive force to flush the tube. Excessive force can perforate the tube and can cause injury to the gastrointestinal
tract.
UNCLOGGING A DEVICE: First check to make sure that the tube is not kinked or clamped anywhere. If there is a visible clog in the
tubing, attempt to massage the device to break up the clog. Connect a syringe to an extension set and attach into the interlock
connector. Fill the syringe with warm water and gently push and pull the syringe plunger to free the clog. It make take several cycles
of pushing / pulling the plunger to clear the clog. If clog cannot be removed, contact your healthcare professional, as the tube may
need to be replaced.
CAUTION: Do not use excessive force or pressure to attempt to clear the clog. This can cause the tubing to rupture.
Non-clinical testing demonstrated that the MiniONE
safely in an MR system under the following conditions:
• Static magnetic field of 1.5-Tesla and 3-Tesla, only
• Maximum spatial gradient magnetic field of 1,000-gauss/cm (10-T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes
of scanning (i.e., per pulse sequence) in the Normal Operating Mode
Under the scan conditions defined, the MiniONE
15 minutes of continuous scanning (i.e., per pulse sequence).
In non-clinical testing, the image artifact caused by the MiniONE
when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.
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MiniONE
Balloon Button: Low-profile balloon feeding devices are meant to be periodically replaced for optimal performance,
functionality, and cleanliness.
Exact device longevity cannot be predicted. Device performance and functionality can degrade over time depending on usage and
environmental conditions. Typical device longevity will vary for each patient depending on a number of factors, with typical device
longevity ranging from 1-9 months. Some factors that can lead to reduced longevity include: gastric pH, diet of the patient,
medications, balloon fill volume, trauma to the device, contact with sharp or abrasive objects, incorrect stoma length measurement,
and overall tube care.
For optimal performance, it is recommended that MiniONE
indicated by your healthcare professional. Proactive replacement of the device will help ensure optimal functionality and will help
prevent unexpected device failure. If devices are failing or performance is degrading earlier than the typical range for device longevity, it
is recommended that you speak with your healthcare professional regarding eliminating common factors that can lead to early device
degradation. Also reference the TROUBLESHOOTING section for additional information regarding device performance issues.
NOTE: To help prevent unneeded hospital visits, it is recommended that a spare device is kept on hand at all times for replacement
in case device failure occurs prior to scheduled replacement.
Feeding Sets: Feeding sets are meant to be periodically replaced for optimal performance and cleanliness. AMT recommends that
the feeding 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: gastric pH, diet of the patient, medications, frequency of use, trauma to the device, and overall feeding set care.
Device should be replaced if leakage, cracks, tears, excessive residue build-up, mold, fungus, or other signs of failure are noted.
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.
PLACEMENT CARE INSTRUCTIONS
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Balloon Button rotates freely before the feedings begin. Inject
MEDICATION CHANNELING
DECOMPRESSION
PROPER FLUSHING GUIDELINES
MRI SAFETY INFORMATION
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Balloon Button is MR Conditional. A patient with this device can be scanned
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Balloon Button is expected to produce a maximum temperature rise of 1.6°C after
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Balloon Button extends approximately 20-mm from this device
DEVICE LONGEVITY
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Balloon Button device be changed at least every 3 months or as often as
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