contrast detail curve
TRANSCRIPT
Rev1709 - © 2017 Artinis Medical Systems
By Roeland van der Burght, Marianne Floor, Martin Thijssen1 and Remko Bijkerk2
Artinis Medical Systems Einsteinweg 17 6662 PW Elst
The Netherlands www.artinis.com
Tel: + 31 481 350 980;
1,2 Dept. of Radiology, Radboud University Nijmegen, the Netherlands
Contrast Detail CurveAlpha = 0.0001, a priori diff of means = 0]
Dia
mete
r (m
m)
8.0
6.3
5.0
4.0
3.2
2.5
2.0
1.6
1.3
1.0
0.8
0.6
0.5
0.4
0.3
0.3 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 3.2 4.05.0 6.3 8.0
Depth (mm)
0.5 mAs
0.71 mAs
1.4 mAs
2.0 mAs
IQFInv ScoresAlpha = 0.0001, a priori diff of means = 0]
0
1
2
3
4
5
6
7
IQF
Inv
0.5 mAs
0.71 mAs
1.4 mAs
2.0 mAs
Total Detected (%)Alpha = 0.0001, a priori diff of means = 0]
0
10
20
30
40
50
60
70
80
%
0.5 mAs
0.71 mAs
1.4 mAs
2.0 mAs
CDQuality ScoresAlpha = 0.0001, a priori diff of means = 0]
0
10
20
30
40
50
60
70
CD
Qualit
y
0.5 mAs
0.71 mAs
1.4 mAs
2.0 mAs
Contrast Detail CurveAlpha = 0.0001, a priori diff of means = 0]
Dia
mete
r (m
m)
8.0
6.3
5.0
4.0
3.2
2.5
2.0
1.6
1.3
1.0
0.8
0.6
0.5
0.4
0.3
0.3 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 3.2 4.05.0 6.3 8.0
Depth (mm)
0.5 mAs
0.71 mAs
1.4 mAs
2.0 mAs
IQFInv ScoresAlpha = 0.0001, a priori diff of means = 0]
0
1
2
3
4
5
6
7
IQF
Inv
0.5 mAs
0.71 mAs
1.4 mAs
2.0 mAs
Total Detected (%)Alpha = 0.0001, a priori diff of means = 0]
0
10
20
30
40
50
60
70
80
%
0.5 mAs
0.71 mAs
1.4 mAs
2.0 mAs
CDQuality ScoresAlpha = 0.0001, a priori diff of means = 0]
0
10
20
30
40
50
60
70
CD
Qualit
y
0.5 mAs
0.71 mAs
1.4 mAs
2.0 mAs
Contrast Detail CurveAlpha = 0.0001, a priori diff of means = 0]
Dia
mete
r (m
m)
8.0
6.3
5.0
4.0
3.2
2.5
2.0
1.6
1.3
1.0
0.8
0.6
0.5
0.4
0.3
0.3 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 3.2 4.05.0 6.3 8.0
Depth (mm)
Totals for 0.71 mAs
0.71 mAs 4
0.71 mAs 5
0.71 mAs 6
0.71 mAs 7
0.71 mAs 2
0.71 mAs 3
Contrast Detail Score DiagramAlpha = 0.0001, a priori diff of means = 0]
Dia
mete
r (m
m)
8.0
6.3
5.0
4.0
3.2
2.5
2.0
1.6
1.3
1.0
0.8
0.6
0.5
0.4
0.3
0.3 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 3.2 4.05.0 6.3 8.0
Depth (mm)
Contrast Detail CurveAlpha = 0.0001, a priori diff of means = 0]
Dia
mete
r (m
m)
8.0
6.3
5.0
4.0
3.2
2.5
2.0
1.6
1.3
1.0
0.8
0.6
0.5
0.4
0.3
0.3 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 3.2 4.05.0 6.3 8.0
Depth (mm)
Totals for 0.71 mAs
0.71 mAs 4
0.71 mAs 5
0.71 mAs 6
0.71 mAs 7
0.71 mAs 2
0.71 mAs 3
Contrast Detail Score DiagramAlpha = 0.0001, a priori diff of means = 0]
Dia
mete
r (m
m)
8.0
6.3
5.0
4.0
3.2
2.5
2.0
1.6
1.3
1.0
0.8
0.6
0.5
0.4
0.3
0.3 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 3.2 4.05.0 6.3 8.0
Depth (mm)
Contents
1. Introduction .................................................................................................. 1 2. Description of the phantom ................................................................................ 1 3. Directions for use of the phantom ........................................................................ 3 4. Phantom handling ........................................................................................... 3 5. Evaluation of the phantom image ........................................................................ 3
5.1. Correction scheme .................................................................................... 4 5.2. Correction examples .................................................................................. 4 5.3. Presentation of the results .......................................................................... 5
5.3.1. By using formula’s ............................................................................... 5 5.3.2. The Contrast-Detail curve ..................................................................... 7
6. CDRAD Analyser .............................................................................................. 8 6.1. Introduction ............................................................................................ 8 6.2. Resolving the phantom position .................................................................... 8 6.3. Resolving the centre position of the 225 contrast-detail combinations ..................... 8 6.4. Determination of the Phantom version (drill pattern) .......................................... 9 6.5. Determination of the background signal .......................................................... 9 6.6. Determination of the spot signal ................................................................... 9 6.7. True/False allocation ................................................................................ 10 6.8. Computation of the Contrast Detail curve ....................................................... 10 6.9. Multivariable contrast detail curve ................................................................ 11 6.10. IQFInv and Total detected ....................................................................... 12
7. CDRAD Phantom exposure ................................................................................. 12 8. Group analysis ............................................................................................... 13
8.1. Introduction ........................................................................................... 13 8.2. Defining Groups ....................................................................................... 13 8.3. Adding DICOM files to a Group ..................................................................... 14 8.4. Group results .......................................................................................... 18
8.4.1. Computation of the Overall Contrast Detail curve ....................................... 18 8.4.2. The IQFInv group result ....................................................................... 18
9. Comparing different Groups of images ................................................................. 19 10. CDRAD Analyser commands ............................................................................ 20
10.1. Program Menu ...................................................................................... 20 10.2. Right mouse button ............................................................................... 25 10.3. Toolbar .............................................................................................. 25
11. Instructions and problem solving ..................................................................... 26 12. System requirements and installation ............................................................... 27
12.1. System requirements, operating system and file types..................................... 27 12.2. Installation and the use of the USB Key ....................................................... 27
13. CDRAD Analyser versions ............................................................................... 28 13.1. Improvements implemented in version 1.1 ................................................... 28 13.2. Improvements implemented in version 2.1 ................................................... 28
14. Literature ................................................................................................. 28 Index ................................................................................................................ 29 Appendices ......................................................................................................... 30
A1. Score form of the CDRAD phantom .................................................................... 31 A2. Evaluation form of the CDRAD phantom .............................................................. 32
Software License Agreement ................................................................................... 37 15. Warranty Policy Artinis Medical Systems. ........................................................... 39
1
1. Introduction
Most definitions of image quality in radiology are based on characterizing the psychical properties
of the imaging chain. However, medical diagnosis is not made by the image alone also the
perception by the observer is crucit should be monitored.
A test of the observer’s perception is possible with so called Contrast-Detail (CD) phantoms. With a
CD-phantom it is possible to quantify the visibility of details at various contrasts, as observed by the
radiologist. The CDRAD 2.0 phantom can be used within the entire range of diagnostic imaging
systems, such as fluoroscopy and digital subtraction angiography.
For mammography the CDMAM 3.4 phantom has been developed as a specific tool.
The CDRAD phantom has been adapted from the Burger phantom1. With the phantom, the "threshold
contrast" as a function of object diameter can be determined, and plotted in a Contrast-Detail
curve. The phantom has been designed by the project team:
Quality Assurance in Radiology
Department of Radiology
University Medical Center Nijmegen
P.O.BOX 9101
NL-6500 HB NIJMEGEN
The Netherlands
1988 - 1992
The use of digital systems makes it possible to automatically evaluate the images made from the
CDRAD phantom. This enhances the use of this phantom as the time consuming task of manual
evaluation is reduced significantly. By using the knowledge of different academic institutes 2,3 the
CDRAD Analyser program was developed.
In this manual, a description of the CDRAD-phantom is given in chapter 2, directions for use are
presented in chapter 3 and the evaluation of the X-ray image is discussed in chapter 4. Chapter 5-12
describe the CDRAD Analyser software. Some literature is given in Chapter 13.
2. Description of the phantom
The CDRAD phantom consists of a Plexiglas tablet (square 265 x 265 mm) with a thickness of 10 mm.
The tablet contains cylindrical holes of exact diameter and depth (tolerances: 0.03 mm). In the
tablet a grid (line pattern) has been engraved, which was treated with led-containing paint. The X-
ray image will show 225 squares arranged in 15 columns and 15 rows. In each square either one or
two spots are present, being the images of the holes. The first three rows show only one spot, while
the other rows have two identical spots in each square, one in the middle and one in a randomly
chosen corner, to allow verification of the detection of each object. Easily recognisable patterns
have been avoided. Figure 2.1 shows a schematic representation of the phantom.
Within a row the hole-diameter is constant, with exponentially increasing depth, and within a
column the hole-depth is constant, with exponentially increasing diameter (Table 1).
2
Figure 2.1. Schematic representation of the CDRAD-phantom
Column Depth [mm] Row Diameter [mm]
1 0.3 1 0.3
2 0.4 2 0.4
3 0.5 3 0.5
4 0.6 4 0.6
5 0.8 5 0.8
6 1 6 1
7 1.3 7 1.3
8 1.6 8 1.6
9 2 9 2
10 2.5 10 2.5
11 3.2 11 3.2
12 4 12 4
13 5 13 5
14 6.3 14 6.3
15 8 15 8
Table 1. Depth and diameter of the holes within the phantom
3
3. Directions for use of the phantom
To make an X-ray image, the CDRAD-phantom should be positioned on the patient table over the
cassette and automatic exposure control (AEC), in combination with one or more Plexiglas plates to
fit the average patient thickness and examinations for that X-ray machine. A loaded cassette should
be put in the table. Choices have to be made with regard to the exposure technique:
- Tube potential
- Focal spot size
- With or without grid
- Manual or automatic exposure
The density of the image has to be checked after the film has been processed. In a series of CD-
images, all images should approximately have the same densities in a reference-position on the film
(approximately 1.5 OD).
Possible measurements with the phantom are:
- Comparison of image quality with various film-screen combinations.
- Determination of the optimum background density, by variation of this density.
- Determination of optimum exposure technique, e.g. by variation of tube potential.
- Comparison of image quality at various object thicknesses, by variation of the amount of
Plexiglas at a fixed density.
- Influence of filtering by variation of the added filter thickness
For different simulated patient thicknesses different Plexiglas thickness should be added, preferably
symmetrical over and under the phantom.
4. Phantom handling
Store and use the phantom and its belongings at room temperature (15o-25o) and at normal humidity
protected for fluid and moisture, dust, etc. preferable in the delivered case. Handle all products
with care. PMMA scratches easily which might give that the phantom or plates is useless for
evaluation. Clean the materials with non-aggressive general cleaner. The phantom cannot be used
in MRI systems or in the neighbourhood of other magnetic materials.
Send back to manufacturer
5. Evaluation of the phantom image
For best results the X-ray image of the CDRAD-phantom needs to be evaluated by at least 3
experienced observers. To increase statistics three independent images made at the same settings
can be evaluated. The "Score form CDRAD-phantom" (see Appendix 1) can be used for this purpose.
The image should be evaluated in the area where the holes are just visible, by indication of the
location where the non-central holes are seen. At least 3 fields, covering at least one non-visible
choice, must be observed in each column or row, in order to comply with the suggested correction
4
scheme, which is described in paragraph 5.1.
The indicated positions of the eccentric holes have to be compared to the true hole-positions in the
phantom, for which the "Evaluation form CDRAD-phantom" can be used (see Appendix 2). To
evaluate the observations certain rules have to be applied, taking into account the 4 nearest
neighbours (defined by a common vertice) of the field under examination. The evaluation of a
particular field will always refer to the original observations for the nearest neighbours. Examples
of the correction scheme are discussed in paragraph 5.2.
5.1. Correction scheme
In the correction scheme, there are three possibilities for each observation:
- T: the eccentric hole was indicated at the true position
- F: the eccentric hole was indicated at a false position
- N: the eccentric hole was not indicated at all
The two main rules within the correction scheme are:
1. A True needs 2 or more correctly indicated nearest neighbours to remain a True.
2. A False or Not indicated hole will be considered as True when it has 3 or 4 correctly indicated
nearest neighbours.
Exceptions on the two main rules are:
1. A True which has only 2 nearest neighbours (at the edges of the phantom) needs only 1 correctly
indicated nearest neighbour to remain True.
2. A False or Not indicated hole which has only 2 nearest neighbours will be regarded True if both
nearest neighbours are correctly indicated.
5.2. Correction examples
Six examples of the correction scheme are discussed below.
T T T T
N T* T T
N F* T T
N N N T
Example 1: The common situation. T* remains T because of its 2 correctly indicated nearest
neighbours. F* remains F because it has only 2 correctly indicated nearest neighbours.
T T T T
N T* F* T
N N T* T
N N N T
Example 2: F* is considered T because it has more than 2 correctly indicated nearest
neighbours. Both T*'s however have only 1 correctly identified nearest neighbour, and thus are
considered to be F's.
5
T* T T T
N N T T
N N N T
N N N N
Example 3: T* remains T because it has 1 out of 2 correctly indicated nearest neighbours.
F* T T T
T* T T T
N N T T
N N N T
Example 4: F* will be considered as a T because of its 2 out of 2 correctly indicated nearest
neighbours. T* will be considered as an F because it has only 1 correctly indicated nearest
neighbour.
F* T* T T
N N T T
N T* N T
N N N N
Example 5: F* remains an F, because it has only 1 out of 2 correctly indicated nearest
neighbours. Both T*'s are considered as F's because they have none respectively 1 correctly
indicated nearest neighbour.
T* F* T T
T T T T
N T T T
N N T T
Example 6: T* remains T because it has 1 out of 2 correctly indicated nearest neighbours. F*
will be considered as a T because of 3 correctly indicated nearest neighbours.
5.3. Presentation of the results
5.3.1. By using formula’s
The curve through the threshold fields is called the Contrast-Detail curve4. The image quality can be
expressed in a figure by calculation of the ratio of correctly identified hole-positions to the total
number of squares (formula 1).
100%x squares of number Total
nsobservatio Correct = ratio nobservatio Correct (1)
Another method to quantify image quality is called the Image Quality Figure (IQF)-method 5,6, which
6
is defined in formula 2.
DC = IQF thi,i
1
1=i
5
(2)
where Di,th denotes the threshold (th) diameter in contrast-column Ci. Summation over all contrast-
columns yields the IQF.
For calculation purposes two extra rules apply:
1. A completely invisible column will result in a Di,th of 10.00 mm (for a hole depth between 0.3 and
8 mm).
2. A completely visible column will result in a Di,th of 0.3 mm (for a hole depth between 0.3 and 8
mm).
Image quality increases with an increasing number of correctly identified hole-positions. In this case
the IQF will become smaller because the values of diameter and depth of the threshold-holes are
smaller.
If another approach, giving an increasing figure for increasing image quality, is required formula 3
should be used.
thii DC = IQFinv
i,
10015
1
(3)
Figure 5.1. Contrast detail lines of monitor image (--●---) and the hard copy image (---▲---) of
the same DSA (Digital Subtraction Angiography) equipment
7
5.3.2. The Contrast-Detail curve
The results can be presented in a graph, in which the hole-depth is plotted against the hole-
diameter. The curve through the threshold fields is called the Contrast-Detail curve 4-6.
For comparison of the imaging performance of different systems, phantom images are made under
identical conditions and evaluated by the same observer and at the same time. The better system
will produce an image in which smaller contrasts and details are visible: producing a shift of the CD-
curve to the lower left part of the image (Figure 5.1).
Comparison of the performance of several observers is also possible. The better performing
observer produces a CD-curve more to the lower left part of the image.
8
6. CDRAD Analyser
6.1. Introduction
The CDRAD Analyser analyses the images and applies a statistical method in order to determine
whether a certain contrast-detail combination is detected or not. This statistical method uses the
average pixel signal value and standard deviation of both the image of the contrast-detail
combination under evaluation and its background pixels. In order to correctly determine these two
variables it is necessary to correctly locate the positions of all the 225 different contrast-detail
combinations of the phantom image.
The program first determines the position of the contrast-detail combinations. Subsequently, by
using a statistical method, it is determined whether a contrast-detail combination can be
significantly detected or not. After this the program shows the results to the user. This chapter
describes how these steps are performed. The evaluation of a single CDRAD image can be divided
into seven steps:
1. Resolving of the position of the phantom
2. Resolving of the centre of the 225 contrast-detail combinations of the phantom
3. Determination of the phantom drill pattern type
4. Determination of the background signal
5. Determination of the relevant contrast-detail signal
6. True/False allocation
7. Computation of the Contrast detail curve
Please read this chapter carefully as it provides the necessary background information for a correct
use of the program.
6.2. Resolving the phantom position
For automatic detection of the phantom position the program determines the four corners of the
surrounding grid. First, it assumes that only the phantom is illuminated. This results in an almost
black background. The program uses this information in order to determine the phantom edges.
Subsequently, the phantom outline is determined by a search algorithm, which detects for all four
sides the first lead engraved outline. Once these lines are determined, the four phantom corners
and phantom position are known.
If the program is not able to detect the four phantom corners automatically the user has to indicate
the four phantom corners manually (see paragraph 10.1).
6.3. Resolving the centre position of the 225 contrast-detail
combinations
The CDRAD phantom consists of a Plexiglas tablet (square 265 x 265 mm). In the tablet a line
pattern has been engraved, which was treated with lead-containing paint. The X-ray image will
show 225 squares arranged in 15 columns and 15 rows. In each square either one or two spots are
present, being the projections of the relevant contrast-detail combination. The position of the
central spot (contrast-detail combination) in each of the 225 squares is accurately determined. This
is needed in order to determine the pixel values of the images of both the centre and the second
(corner) contrast-detail combination. The algorithm first determines the centre of the relevant
square and then the centre of the central spot.
9
The following algorithm is used for this purpose:
- Step 1: The four phantom corners are used in order to determine the approximate centre of
each separate square.
- Step 2: By using this centre the four sides of the square under evaluation are determined.
Subsequently the new centre is calculated by using the middle of all four sides of the square
under evaluation.
- Step 3: The X-ray image is the projection of the phantom on the detector plate, which gives a
deviation between the projection of engraved lines (on the surface of the phantom) and the
image of the contrast-detail combination under evaluation. This deviation depends on the
source-bucky distance of the relevant phantom image. Therefore a projection correction is
executed on the centre found in step 2.
6.4. Determination of the Phantom version (drill pattern)
For an accurate evaluation of the phantom it is of importance to take into account the projection of
the second (corner) spot. This provides the underlying statistics with additional information, thus
enhancing the result of the analysis.
During manual evaluation one tends to memorize the positions of the corner spots. To avoid this
Artinis delivers four different versions (drill patterns) of the CDRAD phantom. These versions differ
in the location of the second spot. The CDRAD Analyser program is able to automatically determine
the version of the phantom under evaluation. However it is also possible to manually prescribe one
of the five drill patterns (see paragraph 8.1). The latter is advised for images where only some spots
in the right upper corner are visible.
For the automatic determination the program uses that part of the phantom where the spots are
best depicted (e.g. depth 8 mm and diameter 4 mm). Once the drill pattern of the phantom is
known the position of the second spot is calculated by using the specific version information.
The used version of the phantom has to be either:
- Drill pattern 1 (most common used)
- Mirrored Drill pattern 1 (no longer available)
- Drill pattern 2
- Drill pattern 3
- Drill pattern 4
For other versions of the phantom the software will not work.
6.5. Determination of the background signal
The background signal is calculated using the red areas of Figure 6.1. As can be seen from Figure
6.1 the location of the two background areas depends on the location of the second spot (the white
areas). The white and red areas form always a square. This method diminishes the influence of the
heel effect; it is the same for both the spot signal as for the background signal. From these red
areas the average value μbackground and the standard deviation σbackground are calculated.
6.6. Determination of the spot signal
Paragraph 6.3 describes how the centre of the central spot is determined. For spots which have a
nominal diameter of less than 3 pixels, an area of 3 x 3 pixels is taken in order to determine the
spot signal. For the other spots all the pixels within the real spot diameter are taken. From both the
pixels of the central spot and the second spot the average value μsignal and the standard deviation
σsignal are calculated.
10
Figure 6.1. Determination of the background signal. White areas are the signal spots, the red
areas are used for background signal determination.
6.7. True/False allocation
After the mentioned steps are performed for each square within the phantom the information from
Table 2 is available.
Using the Welch Satterthwhaite method (Student t-test with Welch correction) the program
determines if the contrast-detail combination in a certain square is positively seen.
Signal Background
Average value μsignal μbackground
Standard deviation σsignal σbackground
Number of observations nsignal nbackground
Table 2. Information for statistic tests
Two statistical values can be adjusted by the user:
- Alpha level of significance (Alpha)
- A priori difference of means (APD)
The program tests if the average signal level in a certain square is greater than the average
background level plus an “a priory difference of means”. All squares where a significant difference
between the signal and the background is found are marked with a red dot. The level of significance
is defined by Alpha.
The APD is set relatively to the image depth. For example if images with an image depth of 16 bits
are compared with images with an image depth of 12 bits, an APD of 16 for the 16 bits images is the
same as an APD of 1 for the 12 bits images.
6.8. Computation of the Contrast Detail curve
The program comes up with the Contrast Detail diagram showing a red dot in all squares where the
11
contrast-detail combination under evaluation was detected (Figure 6.2). Within the same figure the
CD curve (classic IQF score curve) is shown.
Figure 6.2. Detected Contrast-Detail combinations with classic IQF score curve
The results are presented in a graph, in which the hole-depth is plotted against the hole-diameter.
The curve through the threshold fields is called the Contrast-Detail curve 4, 5, 6. For the calculation
of the Contrast-Detail curve a model based interpolation scheme 7 to fit a curve through the data is
used. The curve is fitted through the data by using a least square procedure for each depth
independently. A threshold at 50% detected contrast-detail combination is used for computing
contrast detail curves.
6.9. Multivariable contrast detail curve
Figure 6.3 shows the contrast detail curve in a simple model. The model shows that the contrast
and the detail are detectable to a certain level. The detection is limited by the contrast (the C-
line), by the detail (D-line) and by the combination of both (CD-line).
The transition between the high-score and low-score region is not as sharp as in the model,
especially not when comparing many files (see Figure 8.11). Instead the classic used IQF score curve
as shown in Figure 6.2, we developed a multivariable CD-curve, which takes into account the slopes
of the transitions.
The multivariable CD-curve is defined as
where
- f(x,y) is the CD-curve
12
- a is the location of the C-line
- b is the location of the D-line
- c is the intercept of the CD-line of the y-axis
- f,g,h are the slopes of the transitions from high to low for the C-, D- and CD-line
- α is the angle of the CD-line with the x-axis
Switch between the classic IQF score curve and the multivariable curve in the settings (paragraph
10.1 and Figure 10.2).
Figure 6.3. Left: Theoretical boundaries of the contrast detail curve. The C-line is the boundary
defining the minimal detectable contrast, the D-line is the boundary defining the minimal
detectable detail. Right: Multivariable contrast detial curve in CDRAD Analyser, compare with
Figure 6.2
6.10. IQFInv and Total detected
Besides the Contrast Detail Curve, also the IQFInv and the Total detected (%) are calculated over
the group. The IQFInv is calculated according to formula 3, using the contrast values determined by
the contrast detail curve as input values. The Total detected (%) is as the correct observated ratio
and calculated as in formula 1.
7. CDRAD Phantom exposure
For a correct use of the program the CDRAD image has to fulfill the following criteria:
When taking the image the CDRAD phantom has to be placed with its engraved line pattern and
textures placed faced upward as seen from the X-ray tube. This means that the textures have to be
readable when looking from the X-ray tube position to the phantom (View Position: AP). See step 3
in paragraph 6.3.
- The source to bucky distance must be at least 30 cm.
- For automatic detection of the phantom outline during exposure only the phantom should be
illuminated. This results in an almost black background.
13
- The position of the phantom has to be such that the objects with the largest details (diameter of
8 mm) are on the top side of the image.
- Place the middle of phantom under the middle of the x-ray source.
- The phantom should not be rotated more than plus or minus 5 degrees from the above described
position.
- The exposure within a cell of the CDRAD matrix should not deviate too much.
- The used version of the phantom has to be either:
o Drill pattern 1
o Mirrored Drill pattern 1
o Drill pattern 2
o Drill pattern 3
o Drill pattern 4
For other versions of the phantom the software works inaccurately.
8. Group analysis
8.1. Introduction
As for optimal quality control it is of importance to use more than one image. This will reduce the
influence of noise on the results. The CDRAD Analyser allows to merge the results of more images
into one so-called Group result. In order to do so CDRAD images have to be allocated to a certain
Group. This chapter describes how Groups are defined and how CDRAD Images can be allocated to a
certain Group.
8.2. Defining Groups
A group can be defined (Figure 8.1) by either:
- a right mouse click on the Project name
- a right mouse click on one of the already existing Groups
Rename the group by a right mouse click of the related Group and select “rename”. Remove a
Group by selection of “remove”.
Figure 8.1. Defining groups (left) and defining, renaming and removing groups (right)
14
8.3. Adding DICOM files to a Group
Once a Group has been defined CDRAD DICOM files can be added (Figure 8.2). DICOM files have the
extinction “.DCM”. DICOM files can be added by either:
- a right mouse click on the related Group.
- a right mouse click on one of the already available DICOM files in a Group.
- Add quickly images by dragging and dropping from a Windows folder to a group (Figure 8.3).
Already added DICOM files can be removed or renamed (Figure 8.2).
The program accepts DICOM format Monochrome 1 and 2, bitmap, jpeg and tiff files. Monochrome 2
files are inverted by the program.
BE AWARE THAT DIFFERENT FILE FORMATS HAVE DIFFERENT CONTRAST DETAIL QUALITY
PROPERTIES.
Figure 8.2. Adding DICOM files to a group
Use only one type of files per group! Add more files to the group to get better results. Small
detection deviations or bad pixels will be averaged out by using many pictures. Make new
groups to compare different settings, file types or systems in one project.
If you have problems to open a file, check the following:
- Is the file a DICOM file? The extension should be “.DCM”.
- Is the file compressed? Compressed files have to be decompressed before they can be analysed.
Use a decompressing program to decompress the files.
Note: DICOM files can be dragged from one Group to another Group.
Once a DICOM file has been added, the screen of Figure 8.4 will appear.
15
Figure 8.3. Drag and drop files to a group
Figure 8.4. Display of a single not analysed CDRAD image.
16
Figure 8.5. Analysed CDRAD image with the Contrast Detail Diagram
After the red exclamation mark in the toolbar is activated the active CDRAD image will be
analysed. Use Menu Analysis Batch run to analyse all images in the group. On the screen the
following (Figure 8.5) will be displayed. Move the cursor over the image to show the related depth
and diameter.
The properties of an image file can be viewed by right mouse clicking at a file and selecting
“properties” (Figure 8.6).
Figure 8.6. Image file properties – file properties
The pixel size of the file is shown at the second tab of this window (Figure 8.7). This window gives
the ability to use manual defined pixel size. In the case manual marking of the grid is necessary, it
is often due to the projection and the pixel size has to be adjusted.
17
Figure 8.7. Image file properties - pixel size
The third tab is for gray scale interpretation (Figure 8.7). Files with an inverted gray scale can be
analysed by selection of “reverse gray scale interpretation”.
Figure 8.8. Image file properties - gray scale interpretation
Often the properties of all files in a group have to be adjusted in the same way. Right click at the
group and select properties (Figure 8.9). The set pixel size of the group is shown at the second tab
of this window (Figure 6.10). This window gives the ability to use manual defined pixel size. We
advise to analyse first one file and take the settings of this file to the group. After setting the
properties of the group, the grids of the next files might be automatically detected without the
need for manual grid marking.
18
Figure 8.9. Selection of group properties. Figure 8.10. Group properties, pixel size
Adjust the gray scale interpretation per group by the second tab.
8.4. Group results
After all relevant DICOM files have been added to a Group and have been analysed, the Group
results can be displayed. Double click with the left mouse click on the Group Totals of the related
Group.
8.4.1. Computation of the Overall Contrast Detail curve
The program comes up with a Contrast Detail diagram showing darker and lighter red dots in all
squares where at least one contrast-detail combination was detected (Figure 8.11). The CD curves
are presented in a graph, the contrast detail curve, in which the hole-depth is plotted against the
hole-diameter. The curve through the threshold fields is called the Contrast-Detail curve 1,4,5. For
the calculation of the overall Group Contrast-detail curve a model based interpolation scheme 7 to
fit a curve through the data is used. The curve is fitted through the data by using a least square
procedure for each Depth independently. A threshold at 50% detected contrast-detail combination is
used for computing contrast-detail curves.
8.4.2. The IQFInv group result
The IQFInv are given in the table in the left window for each image and over all images of the
group. The group IQFInv score is determined over the group threshold diameters, first by a curve fit
through the group data by using a least square procedure for each depth independently. A threshold
at 50% detected contrast-detail combination is used for computing contrast detail curves and for
determination of the IQFInv group result. Also the percentage of detected dots is shown in this table
per image and for the group.
19
Figure 8.11. Overall Group result
9. Comparing different Groups of images
After all relevant Groups have been made the results of the different Groups can be compared.
Double click with the left mouse click on the Project Totals will show the screen of Figure 9.1. The
left part shows the IQF for each group and the total detected scores (%). The right window shows
the contrast detail curves. Scroll down to show the IQFInv per group and the total detected scores
per group.
CD Curve for
Group Total
The darkest red dots show
the positions where in all
DICOM images the related
contrast detail object was
scored.
The lighter the red dots,
the less DICOM images have
a scored detail contrast
object.
White squares mean that in
none of the DICOM images
the detail contrast object
was scored.
One left mouse
click will
highlight the
related CD curve.
A double left
mouse click will
show the related
image. IQFInv values
for the
different
Images and for
the Group total
and total
detected dots
(%)
Double
click
with left
mouse
click for
Group
Totals
20
Figure 9.1. Overall Project result
10. CDRAD Analyser commands
10.1. Program Menu
On the Program Menu the following commands are available:
- FILE
- EDIT
- VIEW
- WINDOW
- HELP
FILE
New Project
Open Project
21
Save Project
Save Project as
Save Report saves results into a HTML file and the graphs to separated files
Export exports the results into a TXT or HTML format
Print (CTRL P) prints the active pane.
Print Preview
Print Setup
Exit
All are standard Windows command, except the command “Save Report”, which saves the
Projects results or the active Group or the active (single) Image into a HTML file. The graphs
are saved in separate files which are linked to the report. These files should be kept together
in the same directory.
The Export function exports the results of the active Group or active DICOM file into either a
TXT format or XML format. In the Score matrix of the exported results represent the
proportional number of detected contrast-detail combination (max = 1, min = 0).
EDIT
Copy copies the active screen to the clipboard; tables have to be selected first
Drag Mode holds the left mouse click in order to drag the CDRAD image
Mark Top Left to mark the top left corner of the phantom outline
Mark Top Right to mark the top right corner of the phantom outline
Mark Bottom Left to mark the bottom left corner of the phantom outline
Mark Bottom Right to mark the bottom right corner of the phantom outline
Remove All Marks removes all marks which were placed manually
Rotate90 degrees rotates the CDRAD image by 90 degrees, clockwise
Provided that the image has made according to the guidelines of chapter 6 the program will
automatically detect the four corners of the surrounding grid. However, the user is able to
manually indicate these corners. This is done using Mark Top Left, Mark Top Right, Mark
Bottom Left and Mark Bottom Right.
It is necessary that the user indicates all four corners when the phantom outline is not
correctly indicated by the software itself.
NOTE: When the phantom outline is indicated manually it is important that all four
corners are placed accurately and in accordance with the corners of the phantom itself.
This improves the result of the analysis program! For this purpose use the zoom in
function.
The phantom outline is depicted by a yellow line. Figure 10.1 shows a correct indicated
phantom outline. The command remove all marks removes all marks which were placed
manually. The program switches back to the automatically found phantom outline (if
available). Manually placed outlines will be saved within the project file.
If all files in a group need manual corner indication, set the corners of the first file and use
the group properties as described in paragraph 8.3 for automatic detection of the corners of
the next files.
22
Figure 10.1. Correctly indicated phantom outline
ANALYSIS
Analyse CDRAD image starts the actual phantom evaluation
Batch run evaluates all images within a project using the actual settings
Settings gives Figure 10.2
When the settings command is given the pop-up menu of Figure 10.2 appears. In this menu
the following parameters can be defined:
Alpha level of significance Defines the level of significance (default value is 1e-008)
A priori difference of means the program tests if the average signal level in a certain
square is greater than the average background level plus an
“a priory difference of means”. All squares where a
significant difference between the signal and the
background is found are marked with a red dot. The “a
priori difference of means” (APD) is set relatively to the
image depth (default value is 0).
Phantom type
Auto detect Automatically detects phantom version
Drill pattern 1 User defines phantom as having drill pattern 1
Mirror Drill pattern 1 User defines phantom as having mirrored drill pattern 1
Drill pattern 2 User defines phantom as having drill pattern 2
Drill pattern 3 User defines phantom as having drill pattern 3
Drill pattern 4 User defines phantom as having drill pattern 4
Source to Bucky distance (cm) The distance between the source and the bucky
Comments User defined comments for specific setting
Heel effect compensation Toggle for heel correction (leveling the heel effect)
Display classic IQF score curve Toggle between classic IQF score curve and the multivariable CD
curve interpolation (see paragraph 6.8).
23
Figure 10.2. Pop-up menu of settings window
The user can pre-define which phantom version was used. It is advised to prescribe the
phantom version for images where only the spots in the right upper corner are visible.
Remark: most phantoms are of type drill pattern 1.
The distance between the source and Bucky is used as a parameter within the algorithm
which defines the center of the individual contrast-detail combinations. Therefore this
parameter has to be provided to the program. A default value of 100 cm (39.4 inches) is used.
Remark: The source to Bucky distance should be at least 30 cm (12 inches).
The default values for the analysis parameters are:
Alpha level of significance e-008
A priori difference of means 0
Phantom type Auto detect
Source to Bucky distance (cm) 100
Remark: All settings on this tab influence the analysis result!
At the second tab (Figure 10.3) the following settings are available:
Use relative file paths The user can define relative or absolute file paths
Open DICOM file when added to Group When this toggle is switched on the DICOM file
opens automatically
24
Figure 10.3. Pop-up menu of Project setting.
VIEW Toolbar switches the toolbar on/off
Statusbar switches the statusbar on/off
Show Diagrams toggle between showing/ not showing the Contrast Detail diagram
Zoom in enlarges the current CDRAD image
Zoom out decreased the enlargement of the current CDRAD image
Window Level opens Figure 10.4. Set the levels of the images automatically (Press auto)
or manually (move the bars or change the numbers). To set the levels
optimal for a certain area, press “select area”, select an area in the image
and press “auto”.
Figure 10.4. Window level
WINDOW
Cascade
Tile Horizontal
Tile Vertical
Close All Documents Closes all active windows
A maximum of eight DICOM files can be opened at the same time. The Window commands are
related to the way the opened DICOM files are tiled.
25
HELP
Help topics
About CDRAD Analyser
10.2. Right mouse button
Right mouse clicking on the phantom picture gives the following commands:
- Zoom in
- Zoom out
- Copy
- Drag mode
- Mark Top Left
- Mark Top Right
- Mark Bottom Left
- Mark Bottom Right
Right mouse clicking at the results gives the options to
- Print the results.
- Copy the results
Right mouse clicking at the project gives the options to
- Add a group
- Change the settings
Right mouse clicking at a group gives the options to:
- Properties
- Rename
- Add group
- Add Dicom file
- Remove
Right mouse clicking at a file gives the options to:
- Properties
- Rename
- Open file (double clicking at the file opens also the file)
- Add Dicom file
- Remove
10.3. Toolbar
Figure 10.5 depicts the toolbar buttons and their functions. In this paragraph only the commands
not described in the previous paragraph are set out in detail.
Figure 10.5. The toolbar and its buttons
The buttons of the toolbars are described from left to right.
Open project: Opens a project.
26
Save: Saves the actual project
Rotate 90 degrees: Rotates the CDRAD image by 90 degrees, clockwise
Zoom In: Enlarges the current CDRAD image, useful for placing the corners
manually in a correct way.
Zoom out: Decreases the enlargement of the current image.
Change window image level: Set the window level of the image. Opens Figure 10.4.
Drag mode: Hold the left mouse click in order to drag the CDRAD image.
Mark Top Left: Marks the corner in the top left of the CDRAD image.
Mark Top Right: Marks the corner in the top right of the CDRAD image.
Mark Bottom Left: Marks the corner in the bottom left of the CDRAD image.
Mark Bottom Right: Marks the corner in the bottom right of the CDRAD image
Remove All Marks: Removes all marks from the CDRAD image.
Analyse: Analyses the current image and shows the results.
Toggle Diagram View: toggle between showing/ not showing the Contrast Detail diagram.
Print: Prints the active pane.
Artinis Logo: The button gives basic information on the program and the
company.
11. Instructions and problem solving
When using the CDRAD Analyser program it is of importance to take notice of the following:
- When comparing images see to it that the same values for Alpha level of significance (Alpha) and
“A priori difference of means” (APD) are used. Different values will lead to results which cannot
be compared.
- When the program is used for quality control purposes see to it that the exposure conditions of
the images under evaluation are the equal.
- When comparing images of different x-ray machines: be aware of the fact that the “a priori
difference of means” depends on the number of bits stored per pixel (e.g. the same “a priori
difference of means” for an image with a 12 bit image depth means something else then for an
image with a 16 bit image depth!) It is advised that in such cases an “a priori difference of
means” of zero is used.
- The comparison of image sets in different file formats (DICOM to JPEG or 8 and 16 bits images by
example) will also show the differences of contrast detail quality properties of the different file
formats besides the differences between by example the systems under examination.
- Check how many images are needed in order to create a reliable result.
If the results are not as expected or the analysis did not work not as expected, check the following:
- Are the corners of the phantom right detected? Change the corners manually if necessary. Use
the zooming tools to see the details.
- Use only one type of files within one group.
- Are the settings right? Check the settings at the menu Analysis Settings.
- Is the picture rotated? Try to rotate the picture
- Was the phantom up-side-down? Check the numbers at the bottom and the left side of the
phantom at the picture. You should be able to read them.
- Is the gray scale inverted? Change the gray scale at the file properties
- Is the pixel size right detected? Check the file properties
- Are the file formats equal (DICOM, JPEG, 8 bits or 16 bits)?
- Is the file compressed? Compressed files have to be decompressed before they can be analysed.
Use a decompressing program to decompress the files.
- Does automatic grid detection give troubles? Analyse the first file and copy the file properties to
the group properties.
- Do you see no results? Show the results via the toolbar button (Toggle diagram view) and make
sure you have analysed (all) the file(s).
27
Remark: The shown picture might change during the analysis, however the analysis is always
applied to the original pixel values.
The program might give the following warnings:
WARNING ACTION
“Size of the indicated frame is not in expected range” Reset the corners to the right
positions.
“Unable to detect drill pattern. Please check current settings” Check the corner positions, the file
and the group properties and the
settings
“Please close one or more DICOM files” Close one or more files (use “menu,
window, close all documents”). It is
not possible to OPEN more than 8
files, but you can ADD as many as
you want
“This file is already present in the project” Take another file or rename the file
before adding it to CDRAD Analyser.
12. System requirements and installation
12.1. System requirements, operating system and file types
- The program runs on Microsoft Windows 7, 8 and 10 platforms.
- The user has to have administrator rights to run the program
- A CD player to install the program should be present.
- It accepts DICOM 3.0 files, Monochrome 1 and 2, bitmap, jpeg and tiff files.
- Note: the program inverts Monochrome 2 files.
- For a correct working of the program the USB Key should always stay connected.
12.2. Installation and the use of the USB Key
REMARK: Before upgrading version 1.x to version 2.1, it is strongly recommend to remove the
older version (1.x) from the PC and to restart the PC.
The program is delivered on a CD which installs itself automatically. In case this will not function,
e.g. because the auto-run function of the CD/DVD player was disabled: run manually “setup.exe” in
the root directory of the CD/DVD drive. The name of the program is CDRADAnalyser.exe. The
program is installed in the directory C:\Program Files\Artinis Medical Systems BV\Artinis CDRAD
Analyser 2.1.15
Connect the delivered USB key in one of your free USB ports AFTER the software has been
installed. If after starting the program the message “Rockey dongle not detected” (the USB key)
appears, either restart the computer and/or disconnect – connect the USB Key. By using a key lock
device you could secure the key to the analysis computer. It can be necessary to run first a driver
installation manually for the dongle. The standard drivers can be found in the folder “Utilities” in
the installation folder of CDRAD Analyser.
In case you suspect malfunction of the USB key you can return it to the premises of Artinis Medical
Systems, and in case the key is defect it shall be replaced by a new one, free of charge within the
28
warranty period, and for a small fee outside the warranty period. In case the key is lost we will
charge you for the amount of EUR 250,-. In the case a key is lost for the second time we will charge
the full price of the program.
On the CD you can also find some example images and a sample project using the sample images.
13. CDRAD Analyser versions
13.1. Improvements implemented in version 1.1
As a result of user feedback the following improvements have been implemented during the
transition of version 1.0 to version 1.1.
- 90 degrees rotate function
- Window Level function
- Drag mode
- Improved automatic grid detection
- Export to TXT or XML format
- Contrast Detail curve determination based on curve fitting
- Multi Image function (enabling the user to combine the results of more than one image
automatically)
- Project manner of working enabling you to compare different Groups of images
13.2. Improvements implemented in version 2.1
The following improvements have been implemented in version 2.1.
- Besides DICOM Monochrome 1 and 2, also bitmap, jpeg and tiff files can be analysed.
- Improved signal background determination, diminishing the effect of the heel effect on the
analyser results. This leads to a better analysis.
- Improved grid detection
- Microsoft Windows 7® and Microsoft Windows 8® compatible
- Ability to drag and drop files from a Windows Explorer into a group
- Option to toggle for heel correction (levelling the heel effect)
- New method for CD curve interpolation: multivariable CD-curve
- Image file properties can be viewed
- Ability to use manual defined pixel size and transfer them from one image to the other images in
the same group
- Ability to analyse images with inverted gray scale
- Total % of detected dots as new quality figure next to the IQFinverse number
- Window level function also on a selected area
- One additional zoom in level
- When moving the cursor over the image the related depth and diameter appear
14. Literature
1 Burger, G.C.E., Phantom Tests with X-rays, Philips Technical Review, Vol. 11 (10) 291-298,
1950.
2 Talsma, A., Kamman R.L., Digitale kwaliteitscontrole voor kwantitatieve beoordeling van
röntgenopnamen. Afdeling Radiologie, AZG, Groningen The Netherlands.
3 Talsma, A., Kamman R.L., Digitale kwaliteitscontrole voor kwantitatieve beoordeling van
29
röntgenopnamen, tijdschrift Klinische Fysica jaargang 1998.
4 Thijssen, M.A.O., Bepaling en bewaking van de beeldkwaliteit in de radiodiagnostiek,
Universiteitsdrukkerij KUN, 1993, paragraph 2.1
5 Thijssen, M.A.O., Thijssen, H.O.M., Merx, J.L., van Woensel, M.P.L.M.: Quality analysis of DSA
equipment: Neuroradiology (1988) 30: 561-568, Springer-Verlag
6 Thijssen, M.A.O., Thijssen, H.O.M., Merx, J.L., Lindeijer, J.M. and Bijkerk, K.R.: A definition
of image quality: the image quality figure. BIR Report 20: Optimization of Image Quality and
Patient Exposure in Diagnostic Radiology, London, 1989
7 Karssemeijer, N., Thijssen, M.A.O.: Determination of contrast-detail curves of mammography
systems by automated image analysis. Digital Mammography ’96. Proceedings of the 3rd
International Workshop on Digital Mammography, 155-160 (1996)
Index
A priori difference of means 10, 22, 23, 26 Alpha See - Alpha level of significance Alpha level of significance 10, 22, 23, 26 analysis 16, 22, 26 APD See A priori difference of means automatic grid detection 8, 12, 17, 21, 26 background signal 8, 9 batch run 16, 22 Burger phantom 1 classic IQF score curve 11, 22 Contrast Detail diagram 10, 18, 24 Contrast-Detail curve 5, 7, 11, 18 corner 8, 21, 26 correction scheme 4 depth 1, 11, 16 diameter 1, 11, 16 DICOM files 14 drill pattern 9, 22, 23, 27 export 21 exposure conditions 3, 12, 26 file
add 14 format 14 properties 16 remove 14 rename 14
gray scale interpretation 17, 18 grid 1, 8 group 13, 14
add 13 properties 17 remove 13 rename 13 results 18 totals 18
heel effect 9, 22, 28 Image Quality Figure (IQF) 5 IQF See Image Quality Figure IQFInv 6, 18, 19 multivariable Contrast-Detail curve 11, 22 Observer evaluation 3 patient thickness 3 phantom dimensions 1
phantom position 8, 13 Phantom type See drill pattern pixel size 16, 17 print 21 project 13, 14
new 21 open 21 save 21 save as 21 totals 19
report 21 rotate 13, 21, 26 settings 22 Source to Bucky distance 12, 22, 23 spot signal 10 statistics 8, 10 tolerances 1 total detected scores 18, 19 USB key 27 warning 27 window level 24, 26 zoom 24, 26
30
Appendices
Appendix 1. Score form of the CDRAD phantom
Appendix 2. Evaluation form of the CDRAD phantom
After some experience one tends to memorise the positions of the corner
spots. Therefore, to avoid this, four versions are available upon request.
Evaluation form Drill Pattern 1
Evaluation form Mirrored Drill Pattern 1 (no longer available)
Evaluation form Drill Pattern 2
Evaluation form Drill Pattern 3
Evaluation form Drill Pattern 4
31
A1. Score form of the CDRAD phantom
32
A2. Evaluation form of the CDRAD phantom
Drill pattern 1
33
Mirrored drill pattern 1
34
Drill pattern 2
35
Drill pattern 3
36
Drill pattern 4
37
Software License Agreement
LICENSE GRANT. Artinis Medical Systems BV ("Artinis") hereby grants to Licensee a nonexclusive license to install and use the Program and Manual as provided herein. The licensed Program and Manual are, and shall at all times remain, the property of Artinis and/or its licensors, and Licensee shall have no right, title, or interest therein, except as expressly set forth in this Agreement. DEFINITIONS. Affiliate. A person or legal entity which is controlled by, or controls, or is under common control with Licensee. Control means(i) beneficial ownership of at least fifty percent (50%) of the voting securities of a corporation or other business organization with voting securities, or (ii) a fifty percent (50%) or
greater interest in the profits or capital of a partnership or other business organization without voting securities. Distribution. The distribution on physical media and/or electronic distribution. Manual(s). The user guides and instructional material, if any, accompanying delivery of a Program as may be updated from time to time. Manuals may be delivered in hard copy and/or electronic format. Internal Operations. The use of a Program by employees of Licensee or an Affiliate for the purpose of performing services on behalf of the Licensee or Affiliate, or in the performance of services for Third Parties who engage Licensee or an Affiliate for such services. As used herein, "employees" includes student interns and consultants of Licensee or its Affiliates. License. Artinis Medical Systems B.V. grants to Licensee of a nonexclusive right to install and use a Program which may be installed and operated on a single designated computer.
Program. The computer software and security USB key delivered hereunder. Third Party. Any person or legal entity which is not an Affiliate. INSTALLATION AND USE. Specific rights, obligations, and restrictions apply to each License Option. By accepting the terms and conditions of the Agreement, Licensee also accepts the applicable rights and agrees to be bound by the applicable obligations and restrictions of the License Option purchased. The Programs may be installed on a backup computer (while the designated computer is disabled) or on a replacement computer. Replacements include both permanent and temporary use at the same or different site. Temporary use at a different site may include installation for use at home by Licensee's employees, provided Licensee permits such home use and Licensee otherwise complies with the terms of this Agreement and causes its employees to so comply, including full compliance with all applicable laws and regulations relating to import and export of technical data and computer software.
Licensee shall use the Programs only for Internal Operations. Licensee may not sell, license, sublicense, rent, or make the Programs available for use by any Third Parties. Licensee shall not provide access to the Programs via a Web application. Licensee shall not provide multi-user access to the Programs by calling the Programs as a server from other programs. Licensee may make backup copies of the Programs as necessary to support the use of the Programs in accordance with this Agreement. Licensee may not remove any copyright, trademark, proprietary rights, disclaimer or warning notice included on or embedded in any part of the Programs. All copies of Programs shall contain all copyright and proprietary notices as in the original. Artinis Medical Systems B.V. supplies its Programs and Manual in archival form on CD-ROM and by means of electronic distribution. Artinis provides the Licensee
with a personal security USB key (‘Key’)or other security device that specifies
38
the Programs licensed by Licensee. Licensee shall not attempt to access or use
Programs that Licensee is not currently licensed to use. Furthermore, Licensee shall not disclose the Key or allow it to be used except for installation of the Programs as provided herein. Licensee shall not decompile, disassemble or otherwise reverse engineer the Programs. Except as expressly provided by this Agreement, Licensee may not alter or modify the Programs without the consent of Artinis. All copies of the Programs and Manual, whether made by Licensee or otherwise, shall be subject to the terms of this Agreement. MAINTENANCE AND SUPPORT. During any paid Maintenance and Support subscription term, if applicable, Artinis shall: deliver subsequent releases of the Programs that are not charged for separately; exert reasonable efforts to both (a) provide, within a reasonable time, workarounds for any material programming errors in the current release of the Programs that are directly attributable to
Artinis, and (b) correct such errors in the next available release, provided Licensee provides Artinis with sufficient information to identify the problems. During this same paid Maintenance and Support subscription term, Licensee shall also be entitled to receive technical support by fax or electronic mail regarding the installation and/or use of the licensed Programs and their interaction with hardware, operating environments, and other software products. Artinis reserves the option to discontinue, in whole or in part, offering Maintenance and Support subscriptions for any Program or platform. TERMINATION. Artinis may terminate this license grant, by written notice to Licensee if Licensee breaches any material term of this license, including failure to pay any license fees due, and Licensee has not cured such breach within sixty (60) days of written notification. Licensee may terminate this license at any time, for any reason. Licensee shall not be entitled to any refund if this license is terminated, except for license fees paid for any Programs for which the Acceptance Period has not expired at the time of termination. Upon termination, Licensee shall promptly return all but archival copies of the Programs and Manual in Licensee's possession or control, or promptly provide
written certification of their destruction. EXPORT CONTROL. The Programs may be subject to U.S. export control laws. Notwithstanding any other term of this Agreement or third party agreement, Licensee's rights under this Agreement may not be exercised by Licensee or any Third Party in violation of such laws and regulations, nor may this Agreement be transferred to any party where doing so would result in such a violation. The terms of any limitation on the use, transfer or re-export of the Programs and Manual imposed by Artinis in any Destination Control Statement or other document for the purpose of export control shall prevail over any term in this Agreement. USE OF NAME AND TRADEMARKS. Licensee shall not use the name, trade names or trademarks of Artinis or any of its Affiliates in any advertising, promotional literature or any other material, whether in written, electronic, or other form, distributed to any Third Party, except in the form provided by Artinis, and then solely for purposes of identifying Artinis Programs. ASSIGNMENT. This license is nontransferable to a Third Party without Artinis
consent, which shall not be unreasonably withheld. This license may be transferred to an Affiliate provided that Artinis is notified in writing of the transfer and the Affiliate accepts these same terms and conditions. LIMITATION OF LIABILITY. ARTINIS MAKES NO WARRANTY, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OR MERCHANTABILITY OR FITNES FOR A PARTICULAR PURPOSE REGARDING THESE MATERIALS, AND MAKES SUCH MATERIALS AVAILABLE SOLELY ON AN “AS-IS” BASIS. IN NO EVENT SHALL ARTINIS BE LIABLE TO ANYONE FOR SPECIAL, COLLATERAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING OUT OF PURCHASE OR USE OF THESE MATERIALS. THE PROGRAMS SHOULD NOT BE RELIED ON AS THE SOLE BASIS TO SOLVE A PROBLEM WHOSE INCORRECT SOLUTION COULD RESULT IN INJURY TO PERSON OR PROPERTY. IF A PROGRAM IS EMPLOYED IN SUCH A MANNER, IT IS AT THE LICENSEE'S OWN RISK AND ARTINIS EXPLICITLY DISCLAIMS ALL LIABILITY FOR SUCH MISUSE TO THE EXTENT ALLOWED BY LAW. EXCEPT AS AFORESAID, (A) ANY OTHER LIABILITY OF ARTINIS (WHETHER IN RELATION TO BREACH OF CONTRACT, NEGLIGENCE OR OTHERWISE)
SHALL NOT IN TOTAL EXCEED THE AMOUNT PAID TO ARTINIS UNDER THIS AGREEMENT IN THE
39
TWELVE MONTH PERIOD PRECEDING THE CLAIM IN QUESTION, FOR THE PROGRAM WITH RESPECT
TO WHICH THE LIABILITY IN QUESTION ARISES, AS INSTALLED ON THE DESIGNATED COMPUTER(S) OR DESIGNATED SERVER(S) FOR WHICH USE OF THE PROGRAM IS LICENSED HEREUNDER; AND (B) ARTINIS SHALL HAVE NO LIABILITY FOR ANY INDIRECT OR CONSEQUENTIAL LOSS (WHETHER FORESEEABLE OR OTHERWISE AND INCLUDING LOSS OF PROFITS, LOSS OF BUSINESS, LOSS OF OPPORTUNITY, AND LOSS OF USE OF ANY COMPUTER HARDWARE OR SOFTWARE). LIMITED WARRANTY/LIMITATION OF REMEDIES. Artinis warrants that Artinis or its licensors has the right to grant the license rights hereunder. Artinis warrants that the physical media provided shall be free from defects in material and workmanship for a period of ninety (90) days from delivery, or it will be replaced by Artinis at no cost to Licensee. Artinis further warrants, for a period of one (1) year from delivery, that each copy of each Program will conform in all material respects to the description of such Program's operation in the Manual. In the event that the Program does not operate as warranted, Licensee's exclusive remedy and Artinis sole liability under this warranty shall be a) the correction or workaround by Artinis of major defects within a reasonable time, or b) should such correction or workaround prove neither satisfactory nor practical,
termination of the relevant license and refund of the initial license fee paid to Artinis for the Programs. Specific rules may apply to the Key provided. All requests for warranty assistance should be directed to Artinis Medical Systems BV, Einsteinweg 17, 6662 PW Elst, The Netherlands. EXCEPT AS EXPRESSLY PROVIDED BY THIS AGREEMENT (OR AS IMPLIED BY LAW WHERE THE LAW PROVIDES THAT THE PARTICULAR TERMS IMPLIED CANNOT BE EXCLUDED BY CONTRACT), ALL OTHER CONDITIONS, WARRANTIES, OR OTHER TERMS (INCLUDING ANY WITH REGARD TO INFRINGEMENT, MERCHANTABLE QUALITY, OR FITNESS FOR PURPOSE) ARE EXCLUDED. LICENSEE ACCEPTS RESPONSIBILITY FOR ITS USE OF THE PROGRAMS AND THE RESULTS OBTAINED THEREFROM. APLLICABLE LAW. Dutch Law shall apply to all our quotations, and contracts and the implementation thereof. All disputes arising between us and the client shall be settled by the authorized civil judge in Arnhem, the Netherlands, unless the cantonal judge is authorized.
15. Warranty Policy Artinis Medical Systems.
Product Warranty
The warranty of Artinis Medical Systems products is one year from date of delivery, except for
optical fibers, which are fully excluded from warranty. These warranties do not cover product
abuse, modification, and failure to adhere to product instructions, improper operations and/or
misuse. Artinis Medical Systems B.V. is not responsible for damage arising from failure to follow
instructions relating to the product’s intended use. Artinis Medical Systems B.V. is not responsible
for injury or loss caused by or associated with the installation and/or use of equipment in any
manner other than in strict conformance with the instructions set in this manual. Artinis Medical
Systems B.V. does not warrant damages or defects to unauthorized changes to one of the items or
shipping damage (other than original shipment from Artinis Medical Systems). The warranty is
voided if the serial number of the product is defaced, modified or missing. Software Products are
covered specifically for defective media or manuals only, and are provided as is. The software
license you acquired cannot under any circumstance by transferred back to Artinis Medical
Systems B.V. Artinis Medical Systems B.V. does not warrant or represent that third-party software
or hardware will function error-free when used in conjunction with its products.
Artinis Medical Systems devices are not intended to cure, treat, mitigate or prevent any disease.
Warranty Repair
In the event that any Artinis Medical Systems product becomes defective in material or
workmanship during the warranty period, Artinis Medical Systems B.V. will determine if the
product defect is covered under warranty. Artinis Medical Systems B.V., at its sole discretion,
may replace or repair the unit determined to be under warranty. The labor and material costs
associated with the repair of the product may be the responsibility of Artinis Medical Systems if
determined to be under warranty. You must receive pre-approval by Artinis Medical Systems for
40
the labor and material costs prior to repair or replacement of warranty products. You must
contact Artinis Medical Systems to obtain a Return Material Authorization (RMA) number. An RMA
number may be obtained by contacting Artinis Medical Systems B.V. online or by telephone.
Performance of any repair or replacement on product under warranty does not renew or extend
the warranty period. For repairs of products obtained via a reseller or distributor, contact the
reseller or distributor for warranty.
Non-Warranty Repair
You can return a product for repair that is not covered by warranty only if you have received a
preapproved RMA number from Artinis Medical Systems. Labor costs and freight charges
associated with non-warranty repair will be the sole responsibility of the customer. For any
product that is repaired outside of the warranty period, extra costs for labor and materials
specific for the needed repair will be offered by Artinis Medical Systems BV after receiving the
product and has to be approved by the customer before start of the repair. Repairs on products
out of warranty carry a half year warranty, but only for the repaired parts. The warranty becomes
effective the day that you receive the item after repair. For repairs of products obtained via a
reseller or distributor, contact the reseller or distributor for warranty.
Non-Defective Products
You are notified if, after examining and testing a returned product, Artinis Medical Systems
concludes that the product is not defective. The product is returned to you and you would be
responsible for the freight charges associated with the return.