The G-EYE® can be based on any brand name colonoscope. Based on our regulatory approval in the country of use we can convert PENTAX, OLYMPUS and FUJIFILM colonoscopes to G-EYE®
The G-EYE® balloon will fit into your current reprocessing regimen, as it does not require dedicated detergents, chemicals or Automated Endoscope Reprocessing (AER). Always refer to the detailed reprocessing manual for reprocessing instructions of the G-EYE® colonoscope.
We have had several different and external expert laboratories verifying our compliance with applicable standards and guidelines for reprocessing.
The G-EYE® balloon was developed and manufactured under a Quality Management System as mandatory for medical devices and it has been tested for numerous uses and reprocessing cycles and was found to be very durable. The G-EYE® balloon should be replaced yearly. Refer to the instruction for use for additional details.
The repair exchange of the G-EYE® balloon is about a similar effort of changing the bending rubber on the distal deflection part of the colonoscope, which is simply the most common and minor repair on a colonoscope.
The G-EYE® balloon comes as an integral part of the underlying colonoscope and you may therefore conclude that is no more sensitive than the colonoscope itself. What is good for your colonoscope will be good for the G-EYE® balloon.
The G-EYE® balloon is typically provided with the same warranty as the underlying colonoscope.
During the endoscopic procedure the technical integrity of the entire endoscope and the G-EYE® balloon is permanently monitored by the SPARKC control unit, which would give an aural and optical alert in case of any leak to the system. SPARKC is also available in the reprocessing room.
Upon activation, SPARKC, the G-EYE® control unit, will insufflate and deflate the G-EYE® balloon in seconds. Activation is done via a simple ON/OFF foot or hand switch provided with the system.
The G-EYE® control unit called SPARKC has a startup sequence that ensures full integrity of the entire system once switched on and monitors full system integrity until it is switched off at the end of the procedure.
The G-EYE® will fit seamlessly into your personal method to perform colonoscopies.
The G-EYE® is designed to smoothen colon topography and straighten haustral folds. Any user will benefit from this effect.
Every colonic procedure may benefit from the features of the G-EYE®, may it be for the reduced slippage, optic centrilization, or stabilization during intervention.
The G-EYE® control unit called SPARKC will automatically and dynamically adjust the G-EYE® balloon based on proprietary algorithms built into the system.
The G-EYE® balloon material is a SMART proprietary trade secret and it is free of Latex.
The number of granted and submitted patents around the G-EYE® and its technology is well over one hundred and continues to grow all around the globe and in key markets.
The contraindications for the G-EYE® – if any – depend on the underlying colonoscope and the regulatory approval as applicable in the country of use. Please refer to the instructions for use as appropriate for your G-EYE® product.
The NaviAid™ AB is intended to perform on-demand deep small bowel enteroscopy, either upper or lower.
According to clinical studies, the NaviAid™ AB enables advancement of up to 350cm in the jejunum and 150cm in the ileum. Please find the article referred to here: https://www.giejournal.org/article/S0016-5107(15)02397-4/fulltext
Any Gastroscope or Colonoscope having a tool channel equal or larger than 3.7mm can be used, each for its intended purpose and based on its regulatory approval.
The NaviAid™ AB can be taken out at any time during the procedure. Once use of any other accessory is concluded, the NaviAid™ AB can be inserted again to continue advancement or perform Controlled Withdrawal™.
Risks involved in using the NaviAid™ AB are no different than those incurred in endoscopy in general.