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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
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Pro-CT mk II
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
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.
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Pro-CT mk II
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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Pro-CT mk II
• 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)
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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Pro-CT mk II
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Pro-CT mk II
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Pro-CT mk II
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Pro-CT mk II
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Pro-CT mk II
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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Pro-CT mk II
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Pro-CT mk II
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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Pro-CT mk II
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Pro-CT mk II
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
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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Pro-CT mk II
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Pro-CT mk II
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
Pro-CT mk II materials
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Pro-CT mk II
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Pro-CT mk II
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)
Recommendations:
• number of distinguishable high contrast objects should not differ from reference values.
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Pro-CT mk II
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Pro-CT mk II
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.
Recommendations:
• number of distinguishable low contrast objects in each group should not differ from
reference values.
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Pro-CT mk II
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Pro-CT mk II
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
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Pro-CT mk II
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Pro-CT mk II
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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Pro-CT mk II
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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Pro-CT mk II
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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Pro-CT mk II
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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Pro-CT mk II
Recommendations:
• measured distance should not be greater than 2mm
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Pro-CT mk II
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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: ……………………………………......…..………………………………………………
Reference values
1 2 3 4 5 Mean
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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Pro-CT mk II
SENSITOMETRIC MODULE
Unit: ……………………………………......…..………………………………………………
Reference values
Mean HU value in sample I
1 2 3 4 5 Mean
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Pro-CT mk II
Test results
Date
II
III
Difference IV
from
reference
V
values [|HU|]
≤ 4 HU VI
VII
VIII
IX
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Pro-CT mk II
Reference values
1 2 3 4 5 Mean
1 2 3 4 5 Mean
1 2 3 4 5 Mean
Test results
Date
Number of
low contrast
objects
II
≥ reference
value
III
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Pro-CT mk II
Reference values
1 2 3 4 5 Mean
Test results
Date
Number of high
contrast patterns
≥ reference value
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Pro-CT mk II
GEOMETRY MODULE
Unit: ……………………………………......…..………………………………………………
Test results
Date
Distance II
between
rods [mm]
III
IV
I
Rod
diameter II
[mm] III
IV
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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