Charles M. Rosen, MD, Associate Professor of Medicine, Division of Gastroenterology, Mt. Sinai Medical Center, Miami Beach, Florida, demonstrates the Hercules® 3 Stage Balloon Dilator
INSTRUCTIONS FOR USE (IFU):
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MORE INFO:
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INTENDED USE
This device is used to endoscopically dilate strictures of the esophagus.
PRODUCT DESCRIPTION
This balloon can be inflated to three distinct diameters, as indicated on package and catheter tag. This device is used in conjunction with an inflation device.
NOTES
Do not use this device for any purpose other than stated intended use. Store in a dry location, away from temperature extremes.
Use of this device restricted to a trained healthcare professional.
CONTRAINDICATIONS
Contraindications to dilation include, but are not limited to: asymptomatic rings, webs, or strictures; known or suspected perforation; severe inflammation or scarring near the dilation site.
WARNINGS
This device is designed for single use only. Attempts to reprocess, resterilize, and/or reuse may lead to device failure and/or transmission of disease.
If package is opened or damaged when received, do not use. Visually inspect with particular attention to kinks, bends and breaks. If an abnormality is detected that would prohibit proper working condition, do not use. Please notify Cook for return authorization.
During dilation, do not inflate balloon beyond the maximum indicated inflation pressure. The balloon must be inflated with water only.
Do not advance the balloon dilator if resistance is encountered. Assess the cause of resistance to determine if dilation should be reattempted.
POTENTIAL COMPLICATIONS
Potential complications associated with gastrointestinal endoscopy include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.
PRECAUTIONS
Refer to package label for minimum channel size required for this device.
Do not pre-inflate the balloon.
