1. Fully Automatic Inspection System
- Stents are used in the heart and other critical areas of blood flow. A failure in the function of the Stent could be very harmful. Till date, dimensional inspection is typically done by a human operator, utilizing a profile projector.
- The problems associated with the manual inspection are numerous. Human error makes visual inspection of products less than completely effective. Human eye tends to tire more quickly when required to constantly refocus on objects that move in and out of focus. Manual inspections are labor-intensive and from a practical standpoint, open to human error. Moreover, the "Pass/Fail" criteria of the profile projector typically employed in manual inspection, does not generally provide any numeric dimensional data that would otherwise be useful for process control.
- StentSpect delivers fully automated inspection process to erect all possible errors occurred due to manual inspection.
2. Non-Contact measurement system
- StentSpect is a non-contact system, ideal for measuring soft, deformable and sensitive objects, particularly Stents.
- Non-contact system is valuable when dealing with dozens of features, laid out in patterns or multiple axes. So it can measure more points, see patterns at once and measure in three to four axes in a single setup. In contrast, the contact system has to go across the component part from point-to-point, which makes the process very slow.
- The StentSpect system abolishes all the errors occur due to manual contact measurements and purge variations due to operator skill.
- Non-contact system leads to no surface damage, such as scratches and dents; also the properties of soft materials, such as thickness, cannot be physically changed, like it can with a hand-held micrometer.
3. 21 CFR Part 11 Compliant
- Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.
- StentSpect is 21 CFR Part 11 compliant system, which proves its legitimacy as an international quality machine for electronic records.
4. Precision you required
- The StentSpect measures the stent for best possible parameter set, considering the defect as well as generates individual images for each and every measurement and polishing defect. The StentSpect works as an all-in one equipment, which not only offers dimensional measurement, but also reveals inspection and surface defect within a single system.
- The StentSpect inspects the stent of different sizes, design, material used, crack occurred, burr, pits, scratch, heat effect, welding hitch, inner/outer surface of stent and edge cutting precision. By combining computerized machine vision and advanced 2-dimensional image processing, the StentSpect precisely scrutinize almost all defect present in stent and also measure all dimensions as per the set parameters, that helps in achieving the exact precision required in stent production.
- The StentSpect is an indispensable tool in today's scenario where a development of medical devices (equipment) has no bound of anticipation in standard and quality as the human life for a moment or two depend on it.
5. Uniqueness
- The StentSpect offers immensely accurate, non-contact and moderate technique for stents measurements and inspections based on user selected criteria.
- The StentSpect was meant to be ahead of the present class of stent inspection machines in every aspect. The StentSpect is a decision support tool, which assists the inspection operator in the most crucial step of stent inspection processing - measuring the stent dimensions, and all the functions necessary for stent inspection, at inspection stage.
- It can automatically inspect numerous classes of clinically important & aesthetic defects, such as structural and surface defects on the Stent, during its manufacturing within short inspection time.
- The 'StentSpect' is a unique solution for the automatic or manual inspection of stents, which generates the most accurate & repeatable results that ensures unmatched quality & competence in stent invention, development and production.
6. Multiple choices available (Choose 'StentSpect' that suits you the best)
- The StentSpect offers a range of inspection machines, personalized for different inspection needs. Whether its for inspecting stent after Electropolishing,or for inspecting stent after Coating, or for inspecting stent after Crimping, right selection of stentspect machine can address all the inspection needs.
7. Easy to use Machine Design
- The StentSpect machines illustrate ideal design for an inspection machine. Every single module of machine is designed with precision micro details. Whether it is high resolution camera, rotary motor or axes! All the modules are synchronized to provide an operator, with an essential tool for error classification and disposition.
- The StentSpect machine embodies an elegantly designed outer look, signifying avant-garde factor. This ultra advanced machine is designed for the end user convenience, with innovative mechanisms.
8. Instantaneous Reports & Documentation
- The humans are best analyst of results and reports. The inspection and measurement results and images that drive Stents limpidness are stored as reports. In StentSpect these reports, numbering from dozens to hundreds are generated automatically, while the role of analyzing data is vital and are best left for human beings. These can help increase accuracy, efficiency, decreases testing time and avoid errors.
- In the StentSpect, Inspection related data is captured directly whilst inspection is taking place and comprehensive reports are generated through minimal data entry.
- The StentSpect innate software provides automatic report generation which comprises measurement recipes of measurement positions, number of scans and rotation degree. Machine also generates the image documentation contains all the images captured during inspection along with stitched image for them.
- Reports are customize and can include product name, machine name, inspection date and time, operator's name, operator's shift, inspection history, and application version, etc. Reports files can also easily be saved for the future use.
9. High Resolution Camera & Advanced Measurement Software
- Stent must be inspected for dimensional compliance and also for visual deficiency. This process has usually paneled trained operators with a variety of optical comparators and microscopes.
- Regardless of how well trained and dedicated, a person continually looking into a microscope has saccadic flashes, when vision is frozen. Often parts are being rotated under the microscope, while the person is looking from point to point. This problem has been a challenge not only for stent manufacturer, but also for other device producer that must perform such optical inspections.
- Apart from traditional microscope, the StentSpect is equipped with high resolution camera and advanced measurement software to provide high contrast and high quality optical images, amid complete measurement details that enables complete automatic inspection and measurement of stents without human error.
10. Improve your Productivity
- The StentSpect is a non-contact measurement system, which makes the process fast and save valuable time.
- The StentSpect is a fully automatic inspection system that measures the stent, taking into consideration the measured and set parameters. It finds out any surface defects, cracks, burr, heat effect, welding slipup and pits automatically to provide the optimal solution.
- Its innate software provides a unique & advanced decision support facility, for managing & effecient office productivity and keep track of production & operator efficiency. It generates multiform graphs & charts based on production information. It is now easier to manage most complex and comprehensive databank.
11. Service at a Glance
- We have developed an exceptional Service infrastructure to support you in a best possible way. Reveal structures can be taught in and the assessment parameters can be adjusted. We have set up our distributor networks around the different countries to attend customers with ease. Customer Service is augmented in overall product-service bundle and a watchful eye is maintained in sensing customer service requirements & fulfilling them in time.