COOK Medical Entuit Gastrostomy BR Mode D'emploi page 2

ENGLISH
ENTUIT ® GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFit
CONNECTION
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 with ENFit® Connection
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.
The device is intended to connect to the following enteral devices:
• Enteral giving sets with ENFit connector for feeding administration
• Syringes with ENFit connector for feeding / medication administration
• Inflation syringe with Luer connector for balloon inflation and deflation
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 incorporates ENFit connectors which are designed to reduce the likelihood of tubing
misconnections; however, the potential to misconnect this device with medical devices of other
healthcare applications still exists.
• This device contains small parts that are a potential choking hazard.
• Do not attempt to force non-enteral connectors to this device.
• Do not overtighten ENFit connectors. Full engagement of connector is achieved once resistance is
felt, typically after half to one full turn of the connector, as illustrated below.
• Clean device/connectors with ONLY mild soap and water
• 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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Nominal gap is expected. Do not force to fully seat.