Optical Stent MeasurementSensofar Medical Q Six

The Q six has been designed as a comprehensive solution for simplifying and streamlining stent assessment and approval. High-resolution imaging and 3D optical measurement allow for complete surface inspection of the stent structure, reducing errors, quality control costs, and inspection time, making the task of acceptance faster, easier and more reliable.

Description

The proprietary SensoINSPECT software of the Q six was designed for versatility. The manual mode is designed for flexibility in R&D and Process Development, while the assisted mode is the optimal solution for fast in-line inspection. Dimensional pass/fail data and classified defect information can be gathered in a short time,
enabling the operator to make a fast and reliable decision to either accept or reject the stent. After this decision is made, the system will automatically transfer the Stent Inspection Results to the Production ERP. Easy implementation of the Q six within QA and production environments is facilitated by the SensoINSPECT assisted approach.

The Q six is able to simultaneously acquire and analyze images of the outer and inner surfaces as well as the sidewalls of the stent structure at a rate ranging from 5 mm2/s to 20 mm2/s. SensoINSPECT is compliant with 21CFR Part 11 requirements.

The Q six is able to achieve complete surface inspection with Never before seen, high-quality unrolled images of the outer and inner surfaces and the sidewalls of stents. Quality of edges can be also assessed from these images. High NA optical design, premium CF60-2 Nikon objectives, a multi-million pixel imaging array and a unique combination of light sources provide extremely sharp views of the complete stent surface with unprecedented real color, resolution and contrast. Autolight and autofocus features quickly and easily provide
sharp, clear images in multiple formats: Live, Screenshot, Extended Focus Field of View (EFOV), Unrolled Field of View (UFOV) and Unrolled Section.

SensoINSPECT algorithms use sub-pixel resolution to detect the width of the strut. Critical Dimensions can be determined throughout the entire stent structure (CD Full analysis) or in previously defined areas of interest in the Stent Model Database (CD Regions analysis). Dimensional analysis results are obtained with a repeatability of +/- 1% rms and +/- 3% PV. This information is superimposed onto the unrolled images with a green/red flag that indicates whether the dimensions are in or out of the accepted tolerance range allowing immediate decision-making.SensoINSPECT software simultaneously identifies the edges of struts in unrolled images and uses dimensional analysis to provide an accurate assessment of the shape (roundness / sharpness) of these edges. This kind of analysis can be also carried out throughout the complete stent structure (Edges Full analysis) or in individual areas of interest (Edges Regions analysis).SensoINSPECT obtains immediate readings of the real size of stent sidewalls by measuring them at every position along the length of the struts displayed in the unrolled section (without applying any geometric correction).

3D Modes for:

Surface Topography
Mapping the thickness of coatings
Surface Roughness Characterization

The Q six includes a high-accuracy positioning stage. The roller stage is a modular component of the Q six. Individual stents are manually loaded on the roller stage in the inspection position. All motion is motorized under complete software control, including X/Z translation and 360° rotation. The user can navigate through manual control or create a completely automatic recipe to scan the stent surfaces. Position accuracy of the stage is within 1 μm at any point on the surface of the stent.

The unique combination of three independent light sources (Epi white, Back green and Side white) offers the best illumination settings for each kind of imaging conditions. The cold light provided by LED technology does not affect stent materials and coatings. Long LED lifetime reduces maintenance costs for the Q six.

Mandrel fixtures are available as a customized solution for positioning stents with low stiffness. These mandrels are based on transparent thin-walled glass tubes. Mandrels do not affect the quality of the images or the results of the dimensional analysis.

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