AMT MINI ONE Bedienungsanleitung Seite 4

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MiniONE Balloon Button
ENGLISH
Low Profile Gastrostomy Feeding Tube
INSTRUCTIONS FOR USE
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Notice: Peel off ID sticker from tray and store for future use in patient chart or other convenient location.
The device is provided STERILE for single use. Please inspect all contents of the kit for damage. If damaged, do not use.
This device is intended to connect to compatible enteral devices only. Do not use for non-enteral applications.
INTENDED USE
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The MiniONE Balloon Button provides nutrition, medication, and decompression access into the stomach through a secured (initial
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placement) or formed (replacement) stoma. The MiniONE Balloon Button is intended to be used by clinicians and trained patients/
caregivers.
INDICATIONS FOR USE
The Low Profile Balloon Feeding Device is indicated for use in patients who require long term feeding, are unable to tolerate oral feed-
ing, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a
secured (initial placement) or formed (replacement) stoma. The Low Profile Balloon Feeding Device is intended for all age groups.
CONTRAINDICATIONS
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Contraindications for placement of the MiniONE Balloon Button include but are not limited to:
Initial Placement:
Colonic interposition • Ascites • Portal hypertension • Peritonitis • Uncorrected coagulopathy • Infection around stoma site • Uncertain-
ty as to gastrostomy tract direction and length (abdominal wall thickness)
Replacement:
Lack of adherence of the stomach to the abdominal wall • Lack of a well established gastrostomy site • Evidence of infection • Uncer-
tainty as to gastrostomy tract direction and length (abdominal wall thickness) • Presence of multiple stoma fistulous tracts
Notice:
• Please contact a professional health care giver or physician for explanation of the warnings, care, and use of the device.
• This device has been designed to provide feeding/medication/decompression access to the stomach. Other applications not
advised.
COMPLICATIONS
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Potential complications when using the MiniONE Balloon Button include but are not limited to:
Nausea, vomiting, abdominal bloating or diarrhea • Aspiration • Peristomal pain • Abscess, wound infection and skin breakdown •
Pressure necrosis • Hypergranulation tissue • Intraperitoneal leakage • Buried bumper syndrome • Peristomal leakage • Balloon failure
or dislodgement • Tube clog • Gastrointestinal bleeding and/or ulcerations • IIeus or gastroparesis • Bowel and gastric volvulus
WARNING: THIS DEVICE IS INTENDED FOR SINGLE USE. DO NOT REUSE, REPROCESS OR RE-STERILIZE THIS MEDICAL
DEVICE. DOING SO MAY COMPROMISE BIOCOMPATIBILITY CHARACTERISTICS, DEVICE PERFORMANCE AND/OR MATE-
RIAL INTEGRITY; ANY OF WHICH MAY RESULT IN POTENTIAL PATIENT INJURY, ILLNESS AND/OR DEATH.
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.
CLINICAL BENEFITS, PERFORMANCE CHARACTERISTICS
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Clinical Benefits to be expected when using the MiniONE Balloon Button include but are not limited to:
• Provides direct access to the stomach for feeding, decompression, and channeling medication
• Device may be placed either during an initial placement procedure or as a replacement device
• Balloon design aids in easy, at home replacement when necessary
• Soft, flexible bolster is easy to clean and less likely to create trauma to the stoma site
• Balloon design results in a larger gastric seal surface which may help to reduce leakage and granulation tissue
• Made from medical-grade silicone to reduce irritation and improve patient comfort
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Performance Characteristics of the MiniONE Balloon Button include but are not limited to:
• Low profile design sits flush against the skin
• Anti-leakage valve prevents backflow of stomach contents
• Balloon fill volume can be easily adjusted for a custom-fit
• Interlock allows safe and secure attachment of the extension set
• Unique "apple" shape balloon designed to reduce leakage and reduce the risk of accidental pull-outs from the stoma site
• Glow green feed port provides better visibility in the dark for easier nighttime feeds
DEVICE MATERIALS
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Materials in the MiniONE Balloon Button include: Medical-grade silicone (81%) • Medical-grade thermoplastic (16%) • Stainless steel
spring (2%) • Medical-grade silicone pad print ink (1%)
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