Product Specifications
Intended Use
The Vizballoons™ is indicated for use with a colonoscope to facilitate ease of insertion.
Notes
Do not use this device for any purpose other than the stated intended use.
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 Vizballoons for return authorization.
The Vizballoons should only be used by or under the supervision of physicians trained in endoscopic procedures. A thorough understanding of the technical principles, clinical applications, and risks associated with these procedures is necessary before using these devices.
The Vizballoons are designed for use with endoscopes having a minimum working channel size of 3.2 mm.
Storage
Store at controlled room temperature.
Potential Complications
Those associated with GI endoscopy and colonoscopy include, but are not limited to: perforation; hemorrhage; hematoma; septicemia/ infection; general complications of the intravenous sedation.
Warnings and Precautions
- Do not use the Vizballoons immediately after air insufflation of unsuccessful standard colonoscopy. Reschedule patient for Vizballoons airless colonoscopy on a separate day.
- Consult the medical literature relative to complications, hazards, and techniques prior to the performance of any endoscopic procedure.
- Endoscopic procedures should only be performed by persons having adequate training and familiarity with these techniques.
- If resistance is met during the procedure, do not advance the catheter without first determining the cause of resistance and taking remedial action.
- Do not exceed the recommended Vizballoons inflation volume.
- Do not inflate the Vizballoons prior to insertion into the endoscope.
- Deflate the Vizballoons prior to retro-flexion in the rectum or cecum.
- Do not reuse the Vizballoons or try to sterilize; it is for Single Use Only
Contraindications
Contraindications include but are not limited to those specific to colonoscopy.
Indications For Use
The Vizballoons are intended for use in ANY situation where one seeks to avoid intestinal and abdominal distention: (a) Redundant anatomy with previous inability to reach the end of a colon; (b) Tortuous and long anatomy when previous attempt took significant time and effort; (c) Patients with chronic pulmonary diseases when excessive IV sedation and abdominal distention are undesirable; patients with severe cardiac conditions when excessive abdominal distention could cause cardiac arrhythmia, and it is to be avoided by all means.
Preparation
Precaution: A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic procedures is necessary before using this product.
- Open the package and remove the Vizballoons from the pouch.
- Prior to use, carefully examine the Vizballoons to verify that the catheter and sterile package have not been damaged during shipment. Do not use if tip is frayed, catheter is kinked, or balloon material is damaged.
Vizballoons Brochure
Additional Information
See our Info & Downloads section for extended information
Vizballoon™ in Action
See Vizballoon™ products in action in our video section
Contact Info
Email: Contact Us
Web: VIzballoons.com