Cook Medical G31925 - BALLOON, ESOPHGL, HERCULE, 3 STAGE, 10-11-12, EACH

Cook Medical G31925 - BALLOON, ESOPHGL, HERCULE, 3 STAGE, 10-11-12, EACH

Hercules 3 Stage Balloon

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. With extraordinary radial strength at the stricture site, Hercules sets a new standard for accurate 3 stage esophageal dilation. Our unique proprietary technology generates greater radial force at the same or lower pressures than its competitors. For your next dilation procedure, choose Hercules.

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.

Features and Benefits

• Rapid balloon deflation is achieved with the Express Evacuation Catheter and patent-pending Rapid Deflation Sleeve.
• Kink-resistant Nitinol catheter provides maneuverability.
• Flexible atraumatic tip for smooth access through especially tight strictures.
• Excellent through-the-balloon visualization permits view of dilation progress.
• Glow-in-the-dark size and inflation information on packaging and catheter tags for easy identification.
• Pre-lubricated balloon facilitates removal from the accessory channel.

Clinical Strength

With Hercules, our ultimate goal is to improve patient outcomes. Hercules exceptional dilating strength can deliver more effective dilation force to relieve your patients dysphagia and may improve longer-term luminal patency.

Rapid Deflation

Hercules is fast. Rapid deflation is achieved by simply applying negative pressure. Even if removal begins prior to complete deflation, Hercules can easily be withdrawn into the endoscope.

Engineered for Strength

Our exclusive PETFLEX technology makes Hercules both strong and stageable. This first-of-its-kind technology utilizes PET - a material with high tensile strength - to create an optimal combination of hardness, durability and staging accuracy. As a result, Hercules generates greater radial force on a stricture at the same or lower pressures than other stageable balloon dilators.

Intended Use

This device is used to endoscopically dilate strictures of the esophagus.

Contraindications

Contraindications to dilation include, but are not limited to: asymptomatic rings, webs, orstrictures; known or suspected perforation; severe inflammation or scarring near the dilation site.

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.

Instructions for Use

• Fill the 60 cc inflation device. Purge excess air and water from the syringe by tilting the syringe assembly so that air bubbles float toward the luer lock end, then pump the handle level until all excess air and water is purged from syringe and connected tubing to 40 cc.
  
  
• Maintain water level at the 40 cc line in the syringe as shown.
• Securely attach balloon inflation port to inflation device.
• Apply negative pressure.

• Remove protective sheath from balloon.
• Lubricate balloon completely. Do not pre-inflate balloon, prior to introduction into the endoscope. After visualization of the silver positioning indicator, advance balloon to the desired position.
• To advance the wire in the wire guided version, move the blue wire lock to the ON position.

• Increase pressure to the specified pressure levels shown on the catheter tag.
• For rapid deflation*, apply negative pressure. Remove balloon from scope after balloon is deflated.
  
  

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.