.jpg)
MonoStereo Visualization System
Product Introduction
Product Briefing
MonoStereo Visualization System designed to have the stereo visualization from monoscopic image during the Minimally Invasive Surgery (MIS). It provides real-time display and adjustable 3D effects to minimally invasive surgery.
Since 2D rigid and flexible endoscope are both emerging tools for MIS and interventions, unfortunately, depth perception is lost in 2D endoscopic capturing and display. It makes surgical and interventional tasks harder and difficult to recognize the tissues lesions.
The system works well with all HD 2D endoscope systems, not only keep 2D features as room-in, room-out and rotation, but also see 3D effects with depth perception and adjustable 3D disparity.
Value Proposition
MonoStereo ® 3D system updates and integrates the 2D endoscope systems into 3D to provide surgeons depth perception which lack in traditional MIS surgery.
Key Features
Keep 2D, See 3D
The beauty of Monostereo is based on algorithm. There is no need to change current instruments and endoscope system and lens, but have a 3D vision for surgery.
Keep 2D, See 3D. With Monostereo 3D endoscopic visualization system, hospitals do not have to throw the existing 2D endoscopic system away and replace them with the expensive 3D systems. The 3D visualization with the system allows novice surgeon to have a better understanding of the anatomical structures during the surgery. It also allows the experienced surgeon to get a quick help in a case of complex anatomy or a situation at risk of complications.
Adjustable 3D effect
Surgeons will have the 3D vision with adjustable 3D perception for the surgeries.
Connect & work with most of 2D endoscopic system
Another distinctive advantage of MonoStereo, 2D to 3D system, accommodates both rigid and flexible endoscopes. In addition to that, this system allows the view angle to remain the same as in original 2D system and surgeons can adjust the depth perceptions to him or her best vision.
MonoStereo® 3D Endoscopic Visualization System could work well with any kind of current endoscope devices. In addition, the 2D-to-3D MonoStereo system accommodates both rigid and flexible endoscopes, allows the view angle to remain the same as in the original 2D system, and each surgeon can adjust the depth of perceptions to his/her best vision.An easy installation of the MonoStereo system along with a pre-existing 2D endoscope system allows the surgeon to use it easily, without changing the endoscope, camera, monitor or the workflow during the surgery. This system would also allow the surgeons to use endoscopes with different angulated optical lens (0°-30°-45°-70°) during the intervention. Therefore, the ease of implementation of the 3D system makes it suitable for experienced as well as a novice surgeon, and it does not obstruct any step in the surgical workflow.
Easily switch between 2D/3D mode
Another thoughtful design in MonoStereo is give control to all surgeons who may switch from 2D to 3D mode easily throughout the surgical procedure as their eyes get fatigued during long time operation. Moreover, the 3D system can easily connect to all kinds of endoscopes, cameras and light sources.
Validation
MonoStereo® 3D system also completed the clinical evaluation in Taiwanese Hospital to evaluate the performance in different clinical specialties. For more than 50 cases, the operation can be done by watching the converted stereo images without any serious adverse event happened. The experiments show the safety and low risks in the surgeries.
It was verified by more than 50 different IRB operations in endoscopy. After doing standard GS, upper GI navigation and the initial steps of gastric ESD, ENT.....the perceived value and high satisfaction among surgeons.
Overall experience of the surgeries with the system, the new system is useful in perceiving 3D of the surgical anatomy and helps during the surgery. Moreover, the system was easy to use without disturbing the workflow of the operation room .
Commercially Available
To validate the performance of MonoStereo®, the system already got the international IEC 60601-1 Medical electrical equipment: General requirements for basic safety and essential performance, IEC 62366 Medical devices -- Part 1: Application of usability engineering to medical devices form the third body validation.
To meet the high quality of the medical device, MonoStereo has been certified by the international Quality Management System- ISO 13485, the Taiwan Good Manufacturing Practice (GMP) and received the approvals of CE, Taiwan TFDA, Japan FDA, Philippine FDA, Australia TGA, Malaysia, Indonesia, with many others such as FDA 510(k), Thailand etc. in the approving process.
As result of such, we believe MonoStereo is an image evolution; it leads MIS a new vision and serves surgeons with great satisfaction and confidence.
Taiwan FDA Class II
CE MARK Class I
Australia TGA
Japanese PMDA
Philippines FDA
Malaysia MDA
Indonesia MOH
Thailand FDA
- Others: India Class I,
- Applying : FDA 510(k), Brazil, Korea…
Next Step
MedicalTek Co., Ltd. (MDTK) is devoted to advance medical imaging of minimally invasive surgery (MIS). The MonoStereo® 3D endoscope visualization system provides an ultimate solution to the lack of depth perception issue in conventional 2D endoscope systems, enabling a quick and effective 3D visualization. To ensure continuous innovation and quality improvement, we partner with international MIS experts, global IRCAD institutes and Show Chwan Health Care System for R&D and collaborate with world–class companies in IT, IC design, semiconductor and display for manufacturing.
MedicalTek strives to excellence in ingenuity and quality and is committed to continue delivering reliable and user friendly solutions to the health and medical industries.
