What is the G-EYE® colonoscope?
The G-EYE® colonoscope is constructed of a 510(k) cleared standard colonoscope, which is remanufactured by SMART Medical to install the G-EYE® balloon on its bending section. The installed balloon is reusable and reprocessable, and following installation forms part of the remanufactured device. Following balloon installation, SMART assumes full and sole responsibility of the remanufactured G-EYE® colonoscope.
Is the G-EYE® colonoscope based on a specific brand/model of endoscope?
The G-EYE® balloon can be installed on a selected number of brands and models of 510(k) cleared colonoscopes. Please contact your local SMART representative for more information.
How can the G-EYE® colonoscope be reprocessed?
The G-EYE® balloon is reusable and is reprocessed as part of the G-EYE® colonoscope reprocessing. The G-EYE® colonoscope is reprocessed by common endoscope reprocessing techniques, according to the Reprocessing IFU document provided by SMART.
What is the durability of the G-EYE® balloon?
The G-EYE® balloon was successfully tested for long-term repeated cycles of operation, and should be replaced once a year (or earlier during routine service).
What is the warranty rendered for the G-EYE® balloon?
The G-EYE® balloon is included in the warranty of the G-EYE® colonoscope.
How can I be sure there is no leak in the G-EYE® balloon?
During G-EYE® colonoscopy the integrity of the G-EYE® balloon and underlying colonoscope is monitored in real-time by the SPARKC inflation & control system, which would give an audiovisual alert in case of leak. After each procedure, leak testing is performed on the G-EYE® colonoscope (balloon and underlying colonoscope) by the SPARKC.
How do you inflate and deflate the G-EYE® balloon and how quick is it?
The SPARKC inflation & control system inflates and deflates the G-EYE® balloon by press of a remote-panel button or foot pedal. Inflation/deflation typically takes few seconds.
How do I know the G-EYE® is functioning properly?
The G-EYE® inflation & control system, the SPARKC, has a startup sequence that ensures full integrity of the entire system once switched on and monitors full system integrity until it will be switched off at the end of the procedure.
Can the G-EYE® build pressure that may risk the patient?
The G-EYE® is designed and built in a way that it cannot generate pressure exceeding a defined safety level. There are redundant mechanisms in the design of the G-EYE® system preventing pressures exceeding beyond safe predefined levels.
What if I do not want to use the G-EYE® balloon during a certain procedure or at a time during a procedure?
Following initialization sequence of the SPARKC, the G-EYE® balloon is in a deflated state, allowing advancement of the colonoscope in the colon by the standard technique. Following inflation, the G-EYE® balloon can be instantly deflated at any time during the procedure, upon physician’s choice, by pressing on the foot pedal or inflate/deflate button on the SPARKC’s remote panel. The balloon can be re-inflated again at any time, by consecutive press on the foot pedal or remote panel button.
When during colonoscopy do you inflate the G-EYE® balloon?
After reaching the cecum and prior to starting the withdrawal would be a good moment to inflate the G-EYE® balloon.
Does the G-EYE® require a special technique for colonoscopy?
The G-EYE® colonoscope is used similarly to standard colonoscopes, no special technique is required.
Is the G-EYE® made for beginners or experts?
The G-EYE® is designed to assist in maintaining colonoscope’s view-field and positioning. Any user will benefit from this effect.
For which procedures is the G-EYE® indicated?
The G-EYE® is intended for use in colonoscopy.
How does the G-EYE® balloon change or impact the colonoscope properties?
There is only minimal effect to the endoscope properties when the G-EYE® balloon is deflated, and it can be instantly inflated upon need.
What happens if the G-EYE® balloon passes through a narrow lumen, flexure or stricture?
The SPARKC inflation & control system will automatically and dynamically adjust the G-EYE® balloon diameter and maintain the predefined pressure level, based on proprietary algorithms.
What is the material the G-EYE® balloon is made of?
The G-EYE® balloon material is biocompatible and Latex-free, and is SMART’s proprietary trade secret.
Is the G-EYE® a patented technology?
Yes, the G-EYE® technology is protected under numerous granted patents in global key markets including the USA.
What are the known risks for the G-EYE® colonoscopy?
The known risks for the G-EYE® are similar to the known risks of flexible endoscopy procedures. Please refer to the G-EYE® Operation IFU for detailed information, known risks and warnings.
Where can I buy the G-EYE®?
Please contact us through this website and we will let you know the relevant SMART representative for your region.