COOK Medical Entuit Gastrostomy BR Gebrauchsanweisung Seite 2

ENGLISH
ENTUIT® GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE
Instructions For Use:
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician
(or properly licensed practitioner).
Contents of package:
1 - Entuit® Gastrostomy BR Balloon Retention Feeding Tube
DEVICE DESCRIPTION
The feeding tube is a sterile device consisting of a silicone balloon, bi-lumen shaft, three-port funnel
and bolster that allows for proper retention during enteral feeding, medication administration and
decompression. The device contains one valve that allows for inflation and deflation of the silicone
balloon.
INTENDED USE/INDICATIONS FOR USE
The feeding tube is intended to provide gastric access for enteral feeding, medication administration
and decompression through an established gastrointestinal stoma tract.
The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult
and pediatric patients that require enteral feeding, medication administration or decompression
through an established gastrointestinal stoma tract.
CONTRAINDICATIONS
Device placement is contraindicated for patients with evidence of granulation tissue, infection,
and/or irritation in the stoma site.
WARNING
• Inspect package integrity before use. Do not use device if package is damaged or if the sterile
barrier has been compromised. Do not use if labeling is incomplete or illegible.
• Do not resterilize or reprocess this medical device as this may have an adverse effect on the
known characteristics of the structural integrity, performance and biocompatibility of the
device.
• For single patient use only. Do not reuse this medical device as this may increase the risk
of contamination leading to transmission of infectious diseases which has the potential of
resulting in patient injury, illness or death.
• FOR ENTERAL USE ONLY. The device is intended to connect to enteral giving sets for enteral
feeding and syringes for feeding, medication and inflation of balloon.
• This device has KNOWN misconnections with connectors found in the following medical
devices/healthcare applications:
- Intravascular devices
- Hypodermic applications
- Breathing systems and driving gas devices
- Urethral/urinary devices
- Limb cuff inflation devices
- Neuraxial devices
• Do NOT use this product in the vasculature.
• Once used, dispose of packaging and package contents in accordance with healthcare
institution guidelines and/or local government policy.
PRECAUTIONS
• This device should only be used for its intended purpose by or under the supervision of
trained healthcare professionals with a comprehensive understanding in clinical principles,
procedures and risks associated with percutaneous placement of enteral feeding devices. It
is recommended to adhere to the instructions for use provided with this device, the enteral
feeding instructions for the healthcare facility and instructions recommended by physicians.
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