Medical Device Quality Control and Assurance

Balloon catheter inspection
The VHX Series 4K Digital Microscope realizes a deep depth of field with its newly developed high-resolution HR lens, 4K CMOS sensor, and depth composition. This depth of field makes it possible to fully focus the image of the entire target in inspections of three-dimensional balloon catheters. With conventional microscopes, only a part of the image could be brought into focus at a time.

Guide wire inspection
The VHX Series 4K Digital Microscope is equipped with a High Dynamic Range (HDR) function that expresses high color gradation with 65000 or more colors by capturing multiple images with different shutter speeds. This function enables observation with high definition and high contrast even of microscopic locations on guide wires, which could not be viewed until now.

HDR imaging of a guide wire using the VHX Series 4K Digital Microscope

Hydrophilic coating inspection
A hydrophilic coating is an important piece of technology that provides guide wires and similar objects with lubrication inside veins. However, with conventional microscopes, it is extremely difficult to observe and inspect targets with hydrophilic coatings due to the faint color tones.
With the VHX Series 4K Digital Microscope, hydrophilic coatings can be easily observed due to the HDR function and high-definition 4K images. The coating film thickness can also be measured with the VHX.

3D shape measurement and appearance inspection of a catheter surface
With conventional microscopes, it is not possible to obtain fully focused images on targets that have uneven surfaces, like catheters.
With the VHX Series, depth composition is performed to capture fully focused images, even at high magnifications.
During the depth composition process, 3D height data is automatically captured. This allows a single VHX unit to be used for visual inspection, 2D measurements, and 3D profile measurements of scratches and defects.

Medical needle tip observation
With conventional optical microscopes, it was only possible to bring a part of the image into focus at the high magnifications required for the observation of the outer appearance of medical needle tips.
The deep depth of field of the VHX Series 4K Digital Microscope makes it possible to quickly and easily obtain fully-focused images even in the high magnification observations of needle tips, which have three-dimensional shapes.
Also, the HDR function can quickly obtain an image with high color gradation by obtaining multiple images at varying shutter speeds, thereby enabling observation at high levels of definition and contrast.

Observation of tips of medical needles using the VHX Series 4K Digital Microscope

Medical needle tip shape inspection
Conventionally, in addition to microscopes, it was also necessary to use various measurement systems to measure medical needles, which took a large amount of time and effort due to the increased number of inspections.
With the VHX Series 4K Digital Microscope, 2D measurement can be performed directly from observation. Various tools can be used to easily and quickly perform different types of measurements such as angle and width measurements.
3D measurement is also possible, enabling the inspection of the detailed shapes of medical needle tips by displaying the 3D shape and measuring the profile. This one unit is all that is needed to perform visual inspections, take 2D and 3D measurements, and record numerical values for reporting.

2D measurement of medical needle tip using the VHX Series 4K Digital Microscope

Free-angle imaging of a stent using the VHX Series 4K Digital Microscope

Stent strut bend radius measurement
The VHX Series 4K Digital Microscope uses high-resolution 4K images to perform 2D measurements not previously possible with conventional microscopes. The stent strut bend radius can be measured non-destructively using the built-in measurement tools.
The glare and ring-reflection removal functions can be used to eliminate the reflections from the metal surface that is typically seen on the surface of stents. Furthermore, the HDR function can be used to obtain images with high color gradations, enabling inspection of defects such as strut fractures.

Bioabsorbable stent inspection
The VHX Series 4K Digital Microscope can accurately observe bioabsorbable stents by minimizing reflections. Subtle fractures and other such defects can also be detected by using high-resolution 4K images to perform appearance inspections at high magnifications.
Furthermore, 3D shape and profiles measurements can be obtained quickly, so defects in strut appearance can be accurately measured and analyzed.

Bioabsorbable stent 3D shape measurement using the VHX Series 4K Digital Microscope

Implant wire observation and measurement
Implant wires can be easily observed and inspected due to the large depth of field of the VHX Series.

Pacemaker component inspection
The VHX Series 4K Digital Microscope can be used to observe defects in pacemaker components such as fractures and cracks with clear, 4K images. Also, by combining the free-angle observation system and backlighting, side walls of holes can also be inspected quickly and easily.

Appearance inspection of pacemaker components using the VHX Series 4K Digital Microscope
In high-magnification observation, conventional microscopes can only observe a portion of the target due to their shallow depth of field.
With the VHX Series, real-time depth composition makes it possible to obtain fully-focused and clear images of the entire target instantaneously. Because such images are automatically obtained, users are freed of the hassle of adjusting focus, leading to rapid efficiency improvements.

Comparison of images captured with a conventional microscope and with the VHX Series 4K Digital Microscope

Pacemaker Component 3D Shape and Profile Measurement
Another advantage the VHX Series has over SEMs is the ability to create 3D images by obtaining height information. These 3D images enable 3D shapes and profiles to be obtained from high-magnification images.

3D measurement of pacemaker components using the VHX Series 4K Digital Microscope

Resin packaging appearance inspection
Packaging defects affect the protection, preservation, safety, and reliability of the products contained within. Packaging inspection is one of the final steps in quality assurance before the product is shipped.
By using polarizing illumination, the VHX Series 4K Digital Microscope can minimize reflections from films and package surfaces made of plastic, enabling accurate appearance inspections.

Observation with reflections reduced using the VHX Series 4K Digital Microscope

Plastic Packaging Magnified Observation and Measurement
High-magnification observation of packaging using materials made of plastic can be difficult because it is hard to focus the image.
The VHX Series 4K Digital Microscope can use its HDR function, which obtains images with high color gradation and high contrast while changing the shutter speed, to observe clear, high-magnification images. The ability to perform accurate measurement using HDR images with easy operations leads to drastic improvements to inspection accuracy and speed.

HDR imaging and 2D measurement using the VHX Series 4K Digital Microscope

Plastic packaging 3D shape inspection
The deep depth of field and clear HDR images of the VHX Series 4K Digital Microscope make it possible to obtain fully-focused high-magnification images even when the target has an uneven surface. Furthermore, 3D images can be created from these high-magnification images and can be used to visualize and measure 3D shapes, enabling a single VHX Series unit to quickly complete the entire series of tasks that an inspection requires.

HDR imaging and 3D shape measurement using the VHX Series 4K Digital Microscope