System for assisted
inspection of stents
In-line Inspection | Process Development | QA | R&D

Optical Stent Inspection

Outstanding solution for in-line inspection

Be fast,feel safe
The Q six has been designed as
a comprehensive solution forsimplifying and streamlining
stent assessment and approval.
High-resolution imaging and
3D optical measurement allow
for complete surface inspectionof the stent structure, reducing
errors, quality control costs, andinspection time, making thetask of acceptance faster, easierand more reliable.

2

Assisted concept

Qualitydecisions
The proprietary SensoINSPECT software of theQ six was designed for versatility. The manualmode is designed for flexibility in R&D andProcess Development, while the assisted modeis the optimal solution for fast in-line inspection.
Dimensional pass/fail data and classified defectinformation 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 automaticallytransfer the Stent Inspection Results to theProduction ERP. Easy implementation of the Q six
within QA and production environments isfacilitated by the SensoINSPECT assisted approach.

High performance

Immediate
results
The Q six is able to simultaneously acquire andanalyze 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.

3Outer surface view

Inner surface view

Complete surface inspection

Unroll yourview

Never before seen, high-quality
unrolled images of the outer andinner surfaces and the sidewalls ofstents. Quality of edges can be also
assessed from these images.

4Sidewalls view5X

10X
20X

Astonishinghigh-resolution imaging

Observe thesmallest details

High NA optical design, premium CF60-2 Nikon
objectives, a multi-million pixel imaging array and aunique combination of light sources provide extremely
sharp views of the complete stent surface with
unprecedented real color, resolution and contrast.

A wide-variety of
sharp possibilities
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.

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Accuratedimensional analysis

Simultaneousacquisition& analysis

CD

Extremely highinspection rate

Critical Dimensions
SensoINSPECT algorithms use sub-pixel
resolution to detect the width of the strut. CriticalDimensions can be determined throughout
the entire stent structure (CD Full analysis) or inpreviously defined areas of interest in the Stent
Model Database (CD Regions analysis).

Average: 146.3 μm
Std Dev: 1.3 μm
Reliability: 110.1
In/Out: IN

Dimensional analysis results are obtained with arepeatability 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 theaccepted tolerance range allowing immediate
decision-making.

Edges
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 (EdgesFull analysis) or in individual areas of interest(Edges Regions analysis).

Sidewalls
SensoINSPECT obtains immediate readings ofthe real size of stent sidewalls by measuring
them at every position along the length of thestruts displayed in the unrolled section (without
applying any geometric correction).

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Defect detection and classification

Train your system
Pitting

Crack

ScoremarkScratch8

Reduce time spent on tedious visualinspections with the Q six. SensoINSPECT
detects and classifies surface defects
based on a customer-defined defectlibrary and displays the position of eachdefect on a high-resolution unrolled
image. Classification algorithms are easily
trained from representative defect images
stored in the library.

ACCEPT

Assisted decisions

REJECT

Accept or reject
your stent

C. Dim.
Edges

8 SECTIONSSIDEWALLS

12345678C. Dim.
INNER
SURFACE

Edges

8 SECTIONS

1231 C. Dim.
OUTER
SURFACE

456781Edges

13 Defects
8 SECTIONS

123245678Operators using the Q six in the assistedmode easily undertake accurate and reliable
decisions for acceptance. If necessary, theoperator can immediately navigate backto any position on the surface to review
dimensional results, observe potential defects
in more detail using higher magnification
objectives or even perform additional analysis
using 3D modes. Stent Inspection Results willbe transferred to the Production ERP, making
the inspection process traceable.

Report and savestent inspection
results9

3DmodesOvercoming thelimits of 2D Imaging

Non-contact optical 3D profiling using
Sensofar’s proven Vertical Scanning
Interferometry (VSI) technology.

Surface topography

0.96 μm

10

Verify the depth of scoremarks
or scratches of your stents. 3D
Topography of a defect can beobtained in seconds with a lateral
resolution of 0.5 µm and a verticalresolution of 1nm.

Mapping thethickness of coatings
Check the performance of your process
and coating uniformity. Thickness of
optically transparent coatings is mapped
all across the width of the struts witha lateral resolution of 0.5 microns anda vertical resolution of 2 nm in just afew seconds. The minimum value ofthe thickness that can be measured isapproximately 2 microns.

Surface roughness
Check the quality of your electropolishing process. Standard surface
texture parameters are measured
according to ISO 25178. The operator
can select areas of measurement at
the outer surface of the stent andfiltering parameters.

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State of the art technology

Designed with you in
The new generation of dedicated tools
for the inspection of medical devices

Advanced illumination control

Up. Down. Lateral.

The unique combination of three independent lightsources (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.

Customized mandrels option

Designed to fit your stents
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 ofthe dimensional analysis.

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mind

High-accuracy positioning stage
The roller stage is a modular component of the Q
six. Individual stents are manually loaded on theroller 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 stentsurfaces. Position accuracy of the stage is within 1µm at any point on the surface of the stent.

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Data
management
Development
Environment

QA
Environment

Production
Environment

QA
ERP

Production
ERP

Inspection
Results

Inspection
Results

Part 11compliantPart 11compliant

Q six
ChangeControl Update

ChangeControl Update

Development
S.I. Database

QA
S.I. Database

Production
S.I. DatabaseNon-compliant

In-control

Compliant

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Depending on the intended
use, the Q six can be
operated in three different
environments: Development,Quality Assurance (QA)and Production. Eachenvironment has its own
databases.

Data is organized in threedifferent categories:
1 System Databases
containing User data andSystem configuration files
2 Stent Inspection Databases
containing Stent Modeldata, Defect libraries andAcquisition, Analysis andReport recipes
3 Inspection Results

Validation
package
Sensofar Medical can provide
specialized support to QA/RA
departments in qualificationand validation processes. A
complete validation package
for the Q six is available as anoption.

Objectives
Imaging Objectives3D Objectives

Magnification

2.5X

5X

10X

20X

10XDI

20XDI

50XDI

NA

0.08

0.15

0.20

0.45

0.30

0.40

0.55

WD (mm)

8.80

23.50

37.00

4.50

7.40

4.70

3.40

Horizontal FOV (mm)

7.20

3.60

1.80

0.90

1.80

0.90

0.36

Spatial sampling (µm) 1

3.52

1.76

0.88

0.44

0.88

0.44

0.18

Optical resolution (µm) 2

1.95

0.97

0.73

0.32

0.48

0.36

0.26

Acquisition time (mm2/s)

205

1.25

0.31

Vertical resolution (nm)–31 Pixel size on the surface–

2 L&S: Line and Space, half of the diffractionlimit according to the Rayleigh criterion(values for green LED)1

3 Values obtained undervibration isolation conditions

System specifications
Stent material Metal (Stainless Steel, CoCr) and Nitinol
Stent OD 1 - 15 mm
Stent length Up to 100 mm (XL stage option 200 mm)
Measurement array Color 2044 x 1084 effective pixels
LED light sources white (EPI and side) and green (530 nm) (back)Imaging modes Live image, screenshot, unrolled FOV and unrolled section
Inspection capabilities Outer surface, inner surface, sidewalls, edges
CD measurement repeatability +/- 1% rms
CD measurement accuracy +/- 3% PV
Surface inspection Automatic defect detection and classification
3D modes Surface topography, Roughness, Thickness of coatings
Assisted concept Acceptance decision made by the operator
Computer iMac; 2560 x 1440 pixels resolution (27”)
Operating system Microsoft Windows 8, 64-bit
Electrical requirements Line Voltage 100-240 V AC; frequency 50/60 Hz single phase

unit: mm700

Dimensions

41340315SENSOFAR is a leading-edge technology
company that has the highest quality standards
within the field of surface metrology
Sensofar Medical provides state-of-the-art technology for theinspection of implantable medical devices and components as wellas leading-edge solutions for R&D worldwide, with each systemdesigned to incorporate the highest quality standards within the field.
The Sensofar Group headquarters are located in Barcelona, thetechnological heart of Spain. The Group is represented in over 20
countries through a global network partners and has its own officesin Asia, Germany and the United States.
HEADQUARTERS

SENSOFAR MEDICAL | BARCELONA (Spain) | T. +34 93 700 14 92 | info@sensofar.com
SALES OFFICESSENSOFAR ASIA | SHANGHAI - China | T. +86 21 61400058 | info.asia@sensofar.com
SENSOFAR USA | NEWINGTON (CT) - USA | T. +1 617 678 4185 | info.usa@sensofar.com

BR50-05B-EN

sensofar.com

SENSOFAR is a trademark of SENSOFAR MEDICAL, SL. All other brand, product and logo are marks of their respective owners.
Copyright © 2020 SENSOFAR MEDICAL. All rights reserved. The information in this publication is based on SENSOFAR’s internal research and knowledge at the time of printing and is subject to change without notice. Appearance of products may vary.