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Pro-CT mk II

Last update 20.01.2020

PRO-PROJECT HENRYK KARTASZYŃSKI


Kwiatowa 43A Street, 22-105 Okszow, Poland
tel.: +48 668 453 266; fax: +48 82 545 24 40

www.pro-project.pl
e-mail: contact@pro-project.pl
Pro-CT mk II

CE – Marking

• This product bears CE-Marking “CE” in accordance with the Council Directive
93/42/EEC about Medical Devices, and fulfils essential requirements of Annex 1 of the
Directive.
The product is a class I device without a measuring function (MDD).

General information

• This user manual is an integral part of the product and should always be kept near the
device. Observance of the manual is a prerequisite for proper performance and correct
operation of the device.
• General warranty period: 1 years and can be indefinitelly extended if the product is
registered in a Pro-Control.online account with a valid subscription.
Even if your product is not supported by the software, in terms of auto-analysis, you
may use your PCO subscription to extend its warranty. Number of products you want
to cover with extended warranty cannot be greater than the limit of supported equipment
of your subscription. So, 1 with the ECO subscription, 3 with BASIC and unlimited
with PRO.
• This technical documentation is in conformity with the device specifications and all
applicable safety standards valid on the day of printing.
All rights are reserved for devices, techniques and names appearing in the manual.

Safety instructions

• Dispose of packaging material according to the applicable waste disposal regulations


and keep it out of the reach of children.
• The product is a medical device. Only a person with sufficient knowledge and skill may
use the device.
• Before using the device, the operator must ascertain that it is in correct working order
and operating condition.
• The operator must be trained in the use of the device.

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Disclaimer
• Operator safety, specific measuring accuracy and interference-free operation can be
guaranteed only if original devices and parts are used. Safe operation and proper device
performance are not guaranteed if accessories or consumables from other manufacturers
are used.
• Pro-Project cannot be held liable for any damage resulting from the use of accessories
or consumables from other manufacturers
• Pro-Project considers itself responsible for safety, reliability and performance of the
device only if assembly, extension, readjustment, modification or repair is carried out
by Pro-Project or by persons/companies authorized by Pro-Project, and only if the
device is used in compliance with the technical documentation.

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Pro-CT mk II
The Pro-CT mk II phantom may be used for carrying out acceptance and constancy tests of
computed tomography systems according to IEC 61223-3-5 and the AAPM (American Association
of Physicists in Medicine) guidelines.
This phantom consists of several test modules placed inside of the cylindrical container that can be
mounted either directly on a holder of the CT table or on an adjustable stand. It allows for accurate
alignment for measurements on and off the table.
Markings on the phantom and leveling aids
provide further facilitation of the positioning process.

The phantom can be used to do the following tests:


• Geometric distortion
• CT number (HU) measurement
• Noise / Uniformity
• Artefacts
• MTF
• SSP, LSF, PSF
• CNR
• Spatial resolution
• Spatial resolution in Z dimension
• Contrast resolution
• Low contrast resolution
• Slice profile
• Alignment
• Linearity
• Beamwidth

Technical data (can be modified to customer specifications):


• Main module contains PMMA section with array of holes 2mm in diameter, 10mm deep
placed in 10mm intervals
• Outside diameter 220mm
• Optional external beam hardening rings:
o 380mm outside diameter

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o 350mm outside diameter


o 300 – 380mm outside oval diameter o 450 – 550mm outside oval diameter
• Positioning stand for on and off table measurements
• Carrying case


Low contrast module


• diameter: 200mm 

• thickness 30mm 

• made of PMMA
• contains three groups of low-contrast objects. In each group, there are rods of the same
density, 20 mm in height and with diameters: 1, 2, 3, 4, 5, 7, 9, 11, 13, 15mm. Contrast
difference between groups and surrounding material is 0.3, 0.6 and 1% 

• optional subslice targets having a nominal 1.0% contrast
and z-axis lengths of 3, 5, and 7
mm. For each of these lengths, there are objects of 3, 5, 7 and 9 mm in diameter (04-311)
• optional stacked 25 mm diameter contrast-to-noise discs made of aluminum, PTFE, POM-
C (delrin), PE-300
and air suspended in PMMA (04-312)

Sensitometric / contrast module


• diameter: 200 mm 

• thickness: 30 mm 

• contains 9 sensitometric samples shaped like rods (ø25 mm): PTFE, PE-300, POM-C, ABS,
PA-6, PET, air, plastic water equivalent and PMMA – modules body
• optional insert with 3 Ti rods 5mm in diameter (04-315)


Geometry module
• diameter: 200 mm 

• thickness: 30 mm 

• contains two pairs of aluminium wire ramps whose slope angle tangent is equal to 0.5. 

• middles of ramps intersect on the same plane allowing very precise evaluation of the slice
location 


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• contains four air rods (ø5 mm) placed in vertexes of a square (sides 100 mm long). The rods
are placed on the vertical and horizontal axes of the module. This makes it possible to
precisely evaluate the correctness of shape and geometry imaging. 

• contains 8 rods from the air in the vertices of the regular octagon close to the outer perimeter
of the phantom for evaluating symmetry and circular geometry
• optional eight spheres to evaluate the scanner’s imaging of subslice spherical volumes,
diameters: 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0 and 10.0 mm (04-313) 


Spatial / high contrast resolution module


• diameter: 200 mm
• thickness: 30 mm
• contains 13 concentrically placed high contrast elements for spatial resolution evaluation
from 1 to 13 LP/cm
• two tungsten carbide beads ø0.28 mm for MTF and SSP calculation
• Linear Spread Function (LSF) PTFE / PMMA interface
• Point Spread Function (PSF) - 0.25 mm stainless steel wire in air 

• optional, additional concentrically placed high contrast elements for spatial resolution
evaluation from 14 to 30 LP/cm (04-314)

Water filled module


• diameter: 200 mm
• thickness: 35mm
• screws for easy fill up and empty procedures

Product features:
• complies with:
o IEC 61223-3-5
o IEC 61223-2-6
o AAPM guidelines o ACR guidelines
• CE certified
• the Manual provides detailed guidelines for carrying out each test, results assessment
and registration

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Procedures for carrying out tests with the Pro-CT mk II

Put about 10-14kg counterweight on the stand


before mounting the phantom on it.

Case is about 4kg. Adding, for example,


two 5l water containers into it will be enough.

This is an example. Be sure to comply with your local regulations.

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Artefacts (Homogenous module)

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Procedure:
1. place phantom module on a stand on a CT table
2. level the phantom so the horizontal light markers go through the upper edge of the stand
– this marks the half of the module
3. scanning plane should be placed on the middle of the module
4. start the scan
5. make visual evaluation of the image

Recommendations:
• there should be no significant artefacts or distortions visible.

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Noise level (Homogenous module)

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Procedure:
1. place phantom module on a stand on a CT table
2. level the phantom so the horizontal light markers go through the upper edge of the stand
– this marks the half of the module
3. scanning plane should be placed on the middle of the module
4. start the scan
5. measure a standard deviation of HU in 500mm2 ROI (Region Of Interest) in centre of
module image
Note! Reference value should be evaluated by performing a series (about 5) of measurements
for completely functional CT scanner (right after installation). They should be repeated after
each modifications or repairs of the device.

Recommendations:
• standard deviation in ROI shouldn’t differ more than ± 20% from reference values.

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Homogeneity (Homogenous module)

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Procedure:
1. place phantom module on a stand on a CT table
2. level the phantom so the horizontal light markers go through the upper edge of the stand
– this marks the half of the module
3. scanning plane should be placed on the middle of the module
4. start the scan
5. measure a mean value of HU in 500mm2 ROIs (Region Of Interest): in centre of the
module and in four places near its border

Note! Reference value should be evaluated by performing a series (about 5) of


measurements for completely functional CT scanner (right after installation). They
should be repeated after each modifications or repairs of the device.

Recommendations:
• difference in HU value between the centre and sides should be constant in time – differ
less than ± 4 HU from reference values.

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HU values (Sensitometric module)

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Procedure:
1. place phantom module on a stand on a CT table
2. level the phantom so the horizontal light markers go through the upper edge of the stand
– this marks the half of the module
3. scanning plane should be placed on the middle of the module
4. start the scan
5. measure a mean value of HU in ROIs (Region Of Interest) placed in centre of each
sensitometric sample and body of the module

Note! Reference value should be evaluated by performing a series (about 5) of


measurements for completely functional CT scanner (right after installation). They should
be repeated after each modifications or repairs of the device.
Recommendations:
• difference in mean HU values for each sensitometric sample and module body should
be constant in time – differ less than ± 4 HU from reference values.

Pro-CT mk II materials

Electron Density Relative


Material Gravity Sample HU
[10^23e/cm^3] Electron Density

Air 0.00 -1020 0,004 0,001

Water 1,00 -5 3,343 1,0

PTFE 2,16 941 6,243 1,868

LDPE 0,93 -87 3,160 0,945

POM-C 1,41 320 4,557 1,363

ABS 1,05 -39 3,400 1,017

PA-6 1,13 61 3,730 1,116

PET 1,36 247 3,160 0,945

PMMA 1,18 106 3,833 1,147

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Spatial resolution (High contrast modules)

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Procedure:
1. place phantom module on a stand on a CT table
2. level the phantom so the horizontal light markers go through the upper edge of the stand
– this marks the half of the module
3. scanning plane should be placed on the middle of the module
4. start the scan
5. evaluate the number of distinguishable high contrast patterns.
6. optional, additional Z high contrast resolution (aluminum/polymer) - 5.0, 8.3, 10.0,
12.5, 16.7, 20.0 LP/cm (04-421)

Note! Reference value should be evaluated by performing a series (about 5) of


measurements for completely functional CT scanner (right after installation). They
should be repeated after each modifications or repairs of the device.

Recommendations:
• number of distinguishable high contrast objects should not differ from reference values.

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Low contrast resolution (Low contrast module)

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Procedure:
1. place phantom module on a stand on a CT table
2. level the phantom so the horizontal light markers go through the upper edge of the stand
– this marks the half of the module
3. scanning plane should be placed on the middle of the module
4. start the scan
5. evaluate the number of distinguishable low contrast objects in each group.

Note! Reference value should be evaluated by performing a series (about 5) of


measurements for completely functional CT scanner (right after installation). They
should be repeated after each modifications or repairs of the device.
Diameters of rods are: 1, 2, 3, 4, 5, 7, 9, 11, 13, 15mm
Least visible group is 0.3%, second - 0.6% and the best visible 1%.

Recommendations:
• number of distinguishable low contrast objects in each group should not differ from
reference values.

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FWHM measurement (Geometry module)

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Procedure:
1. place phantom module on a stand on a CT table
2. level the phantom so the horizontal light markers go through the upper edge of the stand
– this marks the half of the module
3. scanning plane should be placed on the middle of the module (positioning in this case
is very important)
4. start the scan

To calculate FWHM (Full Width at Half Maximum) for wire ramps maximal HU values for
background and ramps must be evaluated. To find the ramp maximum restrict the window to 1
or lowest selectable value. Move the window centre to the point when ramp image almost
disappears. This level value is maximum for the ramp. Background can be evaluated using
ROI tool – mean value of HU near ramps.
Net HU peak = maximal HU value for ramps – background
Half peak net = Net HU peak / 2
HU Value at half maximum = Half peak net + background

5. set window centre to calculated HU value and window width to 1


6. measure ramp length to get FWHM

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Image geometry (Geometry module)

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Procedure:
1. place phantom module on a stand on a CT table
2. level the phantom so the horizontal light markers go through the upper edge of the stand
– this marks the half of the module
3. scanning plane should be placed on the middle of the module (positioning in this case
is very important)
4. start the scan
5. measure distances between four rods in horizontal, vertical and diagonal directions.
Rods are placed in vertexes of square 10x10cm rotated 450. Diameter of each rod is
5mm.

Recommendations:
• dimensions measured on the image shouldn’t differ from actual values more than
±1mm.

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Slice thickness (Geometry module)

Procedure:
1. place phantom module on a stand on a CT table
2. level the phantom so the horizontal light markers go through the upper edge of the stand
– this marks the half of the module

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3. scanning plane should be placed on the middle of the module (positioning in this case
is very important)
4. start the scan
5. measure length of ramp images using FWHM procedure. Divide the mean value by 2 to
get the slice thickness

Recommendations:
• measured slice thickness should not differ more than ±20% form actually set value.

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Alignment (Geometry module)

Procedure:
1. place phantom module on a stand on a CT table
2. level the phantom so the horizontal light markers go through the upper edge of the stand
– this marks the half of the module
3. scanning plane should be placed on the middle of the module (positioning in this case
is very important)

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4. start the scan


5. mark main axes of the module by drawing lines passing vertically and horizontally
through middles of four rods.
6. measure distances between middles of ramp images and module axes to get actual
position of slice.
Module contains two sets of opposing ramps which middles are passing through actual
axes of the module.

Recommendations:
• measured distance should not be greater than 2mm

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Pro-CT Mini

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Pro-Dent CT Mini

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Pro-Dent CT Mini

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Pro-Dent CT Mini

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Pro-Dent CT Mini

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TEST RESULTS
Pro-CT mk II

HOMOGENOUS MODULE
Unit: ……………………………………......…..………………………………………………

X-Ray device: …...…………………………........……………………………………………...

Reference values

HU standard deviation in centre ROI

1 2 3 4 5 Mean

Mean difference between centre and side ROIs

1 2 3 4 5 Mean

Test results

Date

Artefacts visible
[Yeas / No]
No

Mean value in
centre ROI [HU]

Difference from
the reference [%]
≤ 20%

Mean difference
between centre and
side ROIs [HU]

Difference from
the reference
[HU]
≤ 4 HU

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SENSITOMETRIC MODULE
Unit: ……………………………………......…..………………………………………………

X-Ray device: …...…………………………........……………………………………………...

Reference values
Mean HU value in sample I
1 2 3 4 5 Mean

Mean HU value in sample II


1 2 3 4 5 Mean

Mean HU value in sample III


1 2 3 4 5 Mean

Mean HU value in sample IV


1 2 3 4 5 Mean

Mean HU value in sample V


1 2 3 4 5 Mean

Mean HU value in sample VI


1 2 3 4 5 Mean

Mean HU value in sample VII


1 2 3 4 5 Mean

Mean HU value in sample VIII


1 2 3 4 5 Mean

Mean HU value in module’s body IX


1 2 3 4 5 Mean

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Test results

Date

II

III

Difference IV
from
reference
V
values [|HU|]

≤ 4 HU VI

VII

VIII

IX

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LOW CONTRAST MODULE


Unit: ……………………………………......…..………………………………………………

X-Ray device: …...…………………………........……………………………………………...

Reference values

Number of low contrast objects (group I)

1 2 3 4 5 Mean

Number of low contrast objects (group II)

1 2 3 4 5 Mean

Number of low contrast objects (group III)

1 2 3 4 5 Mean

Test results

Date

Number of
low contrast
objects
II
≥ reference
value

III

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SPATIAL RESOLUTION MODULE


Unit: ……………………………………......…..………………………………………………

X-Ray device: …...…………………………........……………………………………………...

Reference values

Number of distinguishable high contrast patterns

1 2 3 4 5 Mean

Test results

Date

Number of high
contrast patterns

≥ reference value

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GEOMETRY MODULE
Unit: ……………………………………......…..………………………………………………

X-Ray device: …...…………………………........……………………………………………...

Test results

Date

Distance II
between
rods [mm]
III

IV

I
Rod
diameter II
[mm] III

IV

Mean ramp length (D)


[mm]

Mean ramp thickness


(S) [mm]

Slice thickness
(D - S) * 0,5

Difference between
set-up and measured
value [%]
≤ 20%

Mean distance of
ramp middles from
module axes (Sd)
[mm]
≤ ±2mm

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