Siemens Healthcare MAMMOMAT Revelation User manual

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MAMMOMAT Revelation
Operator Manual – Tomosynthesis Quality Control
Manual
VC20

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Table of contents
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1 Introduction 4
1.1 Required frequency of QC tests 4
1.2 Annually - Medical Physicist (MP) 5
1.3 Weekly - Radiologic Technologist (T) 5
2 Test 1: Average Glandular Dose 6
2.1 Objective 6
2.2 Equipment required 6
2.3 Procedure 6
2.4 Performance criteria/corrective action 7
2.5 Test 1 Test Report 7
3 Test 2: a. Geometric accuracy in X and Y direction / b. Z-resolution 9
3.1 Objective 9
3.2 Equipment required 9
3.3 Procedure 9
3.4 Performance criteria/corrective action 12
3.5 Test 2a. Test Report X and Y accuracy 13
3.6 Test 2b. Test Report Z-resolution 13
3.6.1 Measurement result 13
4 Test 3: Radiation 󹪝eld 16
4.1 Objective 16
4.2 Equipment required 16
4.3 Procedure 16
4.4 Performance criteria/corrective action 17
4.5 Test 3 Test Report 17
5 Test 4: System Imaging Quality 18
5.1 Objective 18
5.2 Equipment required 18
5.3 Procedure 18
5.4 Performance criteria/corrective action 20
5.5 Test 4 Test Report 21
6 Test 5: Artifact detection 22
6.1 Objective 22
6.2 Equipment required 22
6.3 Procedure 22
6.4 Performance criteria/corrective action 23
6.5 Test 5 Test Report 23
7 Changes in this version 24
Index 25

1 Introduction
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1 Introduction
The purposes of this QC-manual (QC=quality control) is how to perform and interpret
the equipment function tests and the possible corrective actions if needed. The objective
of QC is to detect, identify and correct equipment-related problems before they may
in󹪞uence the clinical images. The tests described in this manual should be performed as
described below to ensure that system behavior ful󹪝lls the performance requirements
and does not degrade over time.
Focus of QC-testing is always to ensure reproducible system performance with use of
known and given settings.
Before conducting quality control tests for tomosynthesis, make sure that the quality
control tests in FFDM mode have been performed without errors.
1.1 Required frequency of QC tests
The following table speci󹪝es when the di󹪜erent tests are to be performed and by whom:
Test Annually Weekly
1. Average Glandular Dose MP
2. Geometric accuracy in X and Y
direction and Z-resolution
(MP)
3. Radiation 󹪝eld MP
4. System Imaging Quality MP T
- only the test with tube head
at 0°
5. Artifact detection MP
MP = Medical Physicist
(MP) = Medical Physicist, optional test only
T = Technologist
If not otherwise speci󹪝ed, measurements are performed with the tube head in
0° position.
All tests shall be performed in tomo-only mode, see Operator Manual Tomosynthesis,
section Creating a 2D + 3D exposure.

1 Introduction
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1.2 Annually - Medical Physicist (MP)
These tests may be performed by the MP. The tests include comparisons to values
measured during the MEE tests to ensure that performance has not degraded. The MP is
also responsible for reviewing the results of the testing which is performed periodically
by the radiologic technologist.
1.3 Weekly - Radiologic Technologist (T)
These tests shall be performed on a weekly basis, not to exceed 7 days. If the 7th day falls
on a day when the system won't be used (e.g. due to national holiday), then the tests
shall be done during the next working day.
Weekly tests do not need to be conducted prior to the 󹪝rst patient examination on the
day of the test.

2 Test 1: Average Glandular Dose
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2 Test 1: Average Glandular Dose
2.1 Objective
Compliance with max. Average Glandular Dose values based on PMMA using FFDM dose
table by Dance, DR.
(D.R. Dance et al.: Additional factors for the estimation of mean glandular
breast dose using the UK mammography dosimetry protocol. Phys. Med. Biol. 45,
3225-3240 (2000))
2.2 Equipment required
•PMMA plates, 15 cm x 15 cm with a thickness of 20 mm, 40 mm, 60 mm
•Tomo Compression Plate 25 cm x 36 cm
2.3 Procedure
1Create a new patient record in the local database.
Fill in:
Last Name: Test_One
First Name: AGD (Average Glandular Dose)
Patient ID: Day+time when the test is performed
(Example: 200707071030)
DOB: 05 05 1955
Sex: Other
2Select the procedure QC-processed Tomo.
3Select the AEC exposure technique
Advanced settings:
OPCOMP: On
Auto Decompression: O󹪜
AEC Segmentation: O󹪜
Dose level: Normal
Check Stationary Tomo.

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4Place a 20 mm thick PMMA plate on the object table, as shown in the following 󹪝gure.
(1)
(2)
(3)
Placement of PMMA plate
(1) Detector
(2) PMMA plate
(3) Chest wall side
5Perform compression.
6Perform a Tomo scan with the speci󹪝ed kV value and thickness (see table) and note
the displayed value for mAs and AGD.
Please note that the AGD values are computed automatically by the system.
7Repeat steps 4 through 6 for PMMA plates with a thickness of 40 mm and 60 mm.
8End the examination.
2.4 Performance criteria/corrective action
If the test results fall outside of the action limits, the source of the problem shall
be identi󹪝ed and corrective actions shall be taken before any further mammographic
tomosynthesis images are acquired using the image acquisition system.
If the source of the problem is a major component, the medical physicist must evaluate
the equipment.
The requirements pertaining to the evaluation are described in FDA regulations and in
subsequently issued guidance.
The issue should be addressed and documented by a Siemens customer
support engineer.
2.5 Test 1 Test Report
PMMA
thickness
[mm]
Voltage
[kV]
Tube load
[mAs]
Average Glan‐
dular Dose
AGDTomo [mGy]
Maximum value
[mGy]
AGDTomo ≤ Maximum value
Passed Failed
20 26 1.1 ☐ ☐
40 28 2.2 ☐ ☐

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PMMA
thickness
[mm]
Voltage
[kV]
Tube load
[mAs]
Average Glan‐
dular Dose
AGDTomo [mGy]
Maximum value
[mGy]
AGDTomo ≤ Maximum value
Passed Failed
60 30 4.7 ☐ ☐
Please note that the test is performed with normal dose settings according to
manufacturer. In case your individual clinical setting di󹪜er from the manufacturer
setting you can calculate your clinical glandular dose by multiply the measured dose
with your individual dose level (in %) divided by 100.

3 Test 2: a. Geometric accuracy in X and Y direction / b. Z-
resolution
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3 Test 2: a. Geometric accuracy
in X and Y direction / b. Z-
resolution
3.1 Objective
This optional test checks the geometric accuracy and the Z-resolution of the
Tomosynthesis algorithm. It need to be performed in case of a major change of the
Tomosynthesis reconstruction algorithm only.
3.2 Equipment required
•PMMA plate, 20 mm thick, 15 cm x 15 cm
•ACR phantom
•Tomo Compression Plate 25 cm x 36 cm
3.3 Procedure
1Create a new patient record in the local database.
Fill in:
Last Name: Test_Two
First Name: Geometry
Patient ID: Day+time when the test is performed
(Example: 200707071030)
DOB: 05 05 1955
Sex: Other
2Select the procedure QC-processed Tomo.
3Select the AEC exposure technique
Advanced settings:
OPCOMP: O󹪜
compress with 90 N minimum
Auto Decompression: O󹪜
AEC Segmentation: O󹪜
Dose level: Normal
4Select as RPG “Standard_Phantom”

3 Test 2: a. Geometric accuracy in X and Y direction / b. Z-
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5Position the ACR phantom centrally at a distance of 5 mm from the chest wall side,
as shown in the following 󹪝gure. Than place a 20 mm thick PMMA plate centrally on
top of the ACR phantom.
Measure the outer dimensions X and Y of the phantom and note the values in the test
report ( Page 13 Test 2a. Test Report X and Y accuracy).
Y
X
~ 5 mm
ACR phantom
with insert
15 cm x 15 cm
PMM A
right
Chestwall
Stand side
left
20 mm PMMA
ACR phantom
Positioning of PMMA plate and ACR phantom with insert
Measurement setup: The ACR phantom (wax insert up) is placed directly on
the image receptor support device and the PMMA plate is placed on top of the
ACR phantom.
De󹪝nition:
•X = horizontal (width)
•Y = vertical (length)
•Z = depth
6Perform compression ≥ 90N to secure the phantom and PMMA in position.
7Perform a regular Tomo scan using the clinical kV appropriate for this PMMA thickness
(e.g. 30 kV).
After the reconstruction, scroll through the slices and select the slice, where the
objects (Fibers, Specks, Masses) are best visible.
Measure X and Y using the distance line (Tools > Distance) and record the values in
the test report ( Page 13 Test 2a. Test Report X and Y accuracy) (reconstructed).

3 Test 2: a. Geometric accuracy in X and Y direction / b. Z-
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8To judge the Z-resolution scroll to the slice where the specks of the ACR phantom are
best visible, then scroll down 2 slices.
In each one of the slices mentioned in the following, zoom into the area with
the largest specks and measure the following mean pixel values, see 󹪝gure
( Page 11 Object group 7 (largest specks)) for details:
S(z-2) = the average of the maximum pixel values of each of the 6 specks and
S(bg-2) = mean value of the background (between the specks)
Record the two values S(z-2) and S(bg-2) in the test report ( Page 13 Test 2b. Test
Report Z-resolution).
Object group 7 (largest specks)
(1) Measure the maximum value (Tools > Circle) of each of the single specks
and calculate the mean value of these 6 maximum values. This gives S(z) for
this slice.
(2) 6 largest specks
(3) Measure the mean pixel value inside each of the 5 background regions being
located between the specks, and than calculate the global mean value among
the results from the 5 background regions. This gives the value S(bg) for
this slice.
To facilitate the measurement of the Z-resolution we propose to set all ROI's around
the specks and for the background regions in one slice 󹪝rst, then select all ROI's (via
left mouse click and keeping the CTRL-button pressed). After that make a right mouse
click and select "copy" from the appearing context menu. You can insert the same
ROI's in any other slice of the Z-resolution measurement via right click in the slices and
selecting "paste" from the appearing context menu.
Please note: It may occur that, the ability to di󹪜erentiate between the specks and
background may be limited visually (e.g. 2 slices above or below the reference slice).
If this occurs, the corresponding ASF value should be set to zero on the test report
( ( Page 13 Test 2b. Test Report Z-resolution) e.g. ASF(-2) = 0 and / or ASF(2) =
0). This indicates that the di󹪜erentiation was not resolved visually (which in turn, is
indicative of a good Z-resolution).
Scroll up one slice and measure the following pixel values:

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S(z-1) = the average of the maximum pixel values of each of the 6 specks and S(bg-1)
= mean value of the background (between the specks). Record the two values S(z-1)
and S(bg-1) in the test report ( Page 13 Test 2b. Test Report Z-resolution).
Scroll up one slice (slice where the specks are best visible) and measure the following
pixel values:
S(z0) = the average of the maximum pixel values of each of the 6 specks and
S(bg0) = mean value of the background (between the specks). Record the two values
S(z0) and S(bg0) in the test report ( Page 13 Test 2b. Test Report Z-resolution).
As S(z0) is a self-determined reference slice, please make sure to verify the specks max
pixel value is ( >) greater than the corresponding slices specks max pixel value (e.g.
S(z +/-1) & S(z +/-2)) used in the evaluation. Overlook of this veri󹪝cation can result in
Z-resolution failure.
Scroll up one slice and measure the following pixel values:
S(z1) = the average of the maximum pixel values of each of the 6 specks and
S(bg1) = mean value of the background (between the specks). Record the two values
of S(z1) and S(bg1) in the test report ( Page 13 Test 2b. Test Report Z-resolution).
Scroll up one slice and measure the following pixel values:
S(z2) = the average of the maximum pixel values of each of the 6 specks and
S(bg2) = mean value of the background (between the specks).
Record the two values S(z2) and S(bg2) in the test report ( Page 13 Test 2b. Test
Report Z-resolution).
9End the examination.
10 Complete the test reports ( Page 13 Test 2a. Test Report X and Y accuracy) and
( Page 13 Test 2b. Test Report Z-resolution) by calculating all derived values and
evaluate the results for X and Y accuracy as well as for the Z-resolution (the formulas
to calculate the geometric accuracy are given in the test report ( Page 13 Test 2a.
Test Report X and Y accuracy), formulas for the Z-resolution are given in the test
report ( Page 13 Test 2b. Test Report Z-resolution).
3.4 Performance criteria/corrective action
The values of X and Y must be measurable with an accuracy of ± 2%.
If the test results fall outside of the allowed tolerance, the source of the problem shall be
identi󹪝ed and corrective actions shall be taken within thirty days of the test date.
If the source of the problem is a major component, the medical physicist must evaluate
the equipment.
The requirements pertaining to the evaluation are described in FDA regulations and in
subsequently issued guidance.
The issue should be addressed and documented by a Siemens customer
support engineer.

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3.5 Test 2a. Test Report X and Y accuracy
Test object: _______________
Measured values of phan‐
tom
Lower limit
(X * 0.98 and Y * 0.98)
Upper limit
(X * 1.02 and Y * 1.02)
X [mm]
Y [mm]
X (reconstructed)
[mm]
Y (reconstructed)
[mm]
Passed
(X and Y within the limits of
table above)
Failed
(X and Y outside the limits
of table above)
☐ ☐
3.6 Test 2b. Test Report Z-resolution
Maximum Background Calculate:
S(z0) = S(bg0) = S(z0) - S(bg0) =
3.6.1 Measurement result
Values for slice z-2 Enter the maximum value of
each the 6 specks
Background
Speck 1
Speck 2
Speck 3
Speck 4
Speck 5
Speck 6
Calculate the mean value of the
measured specks values above
and enter it here →
This is the value S(z-2) =
Values for slice z-1 Enter the maximum value of
each the 6 specks
Background
Speck 1
Speck 2
Speck 3
Speck 4

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Values for slice z-1 Enter the maximum value of
each the 6 specks
Background
Speck 5
Speck 6
Calculate the mean value of the
measured specks values above
and enter it here →
This is the value S(z-1) =
Values for slice z0Enter the maximum value of
each the 6 specks
Background
Speck 1
Speck 2
Speck 3
Speck 4
Speck 5
Speck 6
Calculate the mean value of the
measured specks values above
and enter it here →
This is the value S(z0) =
Values for slice z+1 Enter the maximum value of
each the 6 specks
Background
Speck 1
Speck 2
Speck 3
Speck 4
Speck 5
Speck 6
Calculate the mean value of the
measured specks values above
and enter it here →
This is the value S(z+1) =
Values for slice z+2 Enter the maximum value of
each the 6 specks
Background
Speck 1
Speck 2
Speck 3
Speck 4
Speck 5

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Values for slice z+2 Enter the maximum value of
each the 6 specks
Background
Speck 6
Calculate the mean value of the
measured specks values above
and enter it here →
This is the value S(z+2) =
Insert average S(zx) values in the following table:
i = Maximum
S(zi)
Background
S(bgi)
Calculate:
S(zi) - S(bgi)
Calculate:
ASF(i) = [ S(zi) - S(bgi) ] / [ S(z0) - S(bg0) ]
-2 ASF(-2) =
-1 ASF(-1) =
0 ASF(0) = 1
1 ASF(1) =
2 ASF(2) =
↓
Calculate: Limit Passed: ≤ Limit Failed: > Limit
[ ASF(-1) + ASF(1) ] / 2 = 0.9 ☐ ☐
[ ASF(-2) + ASF(2) ] / 2 = 0.6 ☐ ☐

4 Test 3: Radiation 󹪝eld
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4 Test 3: Radiation field
4.1 Objective
To check if edges of collimator or paddle are visible in the projections.
4.2 Equipment required
•Collimator mountable 40 mm PMMA phantom
•Tomo Compression Plate 25 cm x 36 cm
4.3 Procedure
1Create a new patient record in the local database.
Fill in:
Last Name: Test_Three
First Name: Radiation 󹪝eld
Patient ID: Day+time when the test is performed
(Example: 200707071030)
DOB: 05 05 1955
Sex: Other
2Select the procedure QC-processed Tomo.
3Select the AEC exposure technique
28 kV
Anode/󹪝lter W/Rh
Advanced settings:
OPCOMP: On
Auto Decompression: O󹪜
AEC Segmentation: O󹪜
Dose level: Normal
4Select as RPG “Standard_Proj”.
5Mount the 40 mm PMMA phantom on the collimator.
6Mount the compression plate and lower it all the way.
7Perform a Tomo scan.

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8Check if edges of the collimator or the compression plate are visible in the projection
views. To do this, look at the 󹪝rst, the middle (13th) and the last projection view.
Use the magni󹪝cation tool, select the acquired image size and adapt the window
values. If there are problems regarding the viewing conditions, send the image to the
reporting station for further evaluation.
The following e󹪜ects are inherent and not caused by the collimator or compression
paddle. It will not compromise normal operation.
- At the right stand side corner of the image, there is a white square of about 11 mm
x 11 mm, which is the high voltage contact of the detector.
- On all edges except the chest wall side there can be slight shadows of up to ~10 mm,
which are part of the normal tube tolerances.
9End the examination.
4.4 Performance criteria/corrective action
The projection image must not show any edges of the collimator or compression plate.
In case of visible edges of the collimator or the compression plate, the source of the
problem shall be identi󹪝ed and corrective actions shall be taken within thirty days of the
test date.
If the source of the problem is a major component, the medical physicist must evaluate
the equipment.
The requirements pertaining to the evaluation are described in FDA regulations and in
subsequently issued guidance.
The issue should be addressed and documented by a Siemens customer
support engineer.
4.5 Test 3 Test Report
Tomo Compression Plate 25 cm x 36 cm
Passed Failed
Edges of collimator or compression plate
not visible
☐ ☐

5 Test 4: System Imaging Quality
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5 Test 4: System Imaging Quality
5.1 Objective
To ensure adequate image quality and monitor imaging performance.
5.2 Equipment required
•ACR phantom (RMI 156)
•Tomo Compression Plate 25 cm x 36 cm or 20 cm x 26 cm or 24 cm x 30 cm low edge
5.3 Procedure
1Create a new patient record in the local database.
Fill in:
Last Name: Test_Four
First Name: PhantomIQ
Patient ID: Day+time when the test is performed
(Example: 200707071030)
DOB: 05 05 1955
Sex: Other
2Select the procedure QC-processed Tomo.
3Select the AEC exposure technique
28 kV
AEC settings:
OPCOMP: On
Auto Decompression: O󹪜
AEC Segmentation: O󹪜
Dose level: Normal
4Select as RPG “Standard_Phantom”

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5Position the phantom on the object table as shown in the following 󹪝gure.
(1)
(2)
(3)
Position of the phantom
(1) Breast support
(2) ACR phantom with insert (RMI 156)
(3) Chest wall side
6Select as RPG “Standard_Phantom”
7Mount the compression plate and perform compression.
8Perform a Tomo scan (Combo mode deactivated).
9After reconstruction, scroll through the slices and select the slice where the objects
(Fibers, Specks, Masses) are best visible. Check the slice images. To evaluate the
image, use the magni󹪝cation tool, zoom or grayscale inversion and adapt the
window values, if helpful. If the viewing conditions are considered to be poor when
the image is reviewed on the AWS, send the image to the reporting station for
further examination.
If necessary, the evaluation can be performed across multiple slices.
10 Determine how many 󹪝bers, specks (microcalci󹪝cations) and masses can
be identi󹪝ed.
•Select the object class (masses, specks group, 󹪝bers), see 󹪝gure ( Page 20 ACR
phantom (RMI 156))
•Start with the evaluation of the most clearly visible object of the selected
object class.
•Count the number of visible objects of a class.
–A 󹪝ber is considered to be visible if its location and orientation are correct and
at least half its length is visible.
–A group of specks is considered to be visible if its location and orientation are
correct and at least four of the specks are visible.
–Masses are considered to be visible if their location and they appear
generally circular.
•Record the result in the test report ( Page 21 Test 4 Test Report).
•Record the displayed kV, mAs and AGD in the test report ( Page 21 Test 4
Test Report).

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Step 11 is required for the Medical Physicist only, in addition to 0° phantom imaging,
see table ( Page 4 Required frequency of QC tests).
11 Repeat steps 4 through 10 with a 90° tube head angulation (please make sure that
Auto Decompression is O󹪜 to avoid drop and damage of phantom).
12 End the examination.
5.4 Performance criteria/corrective action
ACR phantom (RMI 156)
(1) Fibers
(2) Speck groups
(3) Masses
Number of objects that need to be visible:
•Fibers ≥ 4
•Speck groups ≥ 3
•Masses ≥ 3
Please note that the AGD shall not exceed 3 mGy.
If the required minimum number of objects cannot be detected, we encourage testing
with a second ACR phantom. This QC-test has shown that results can vary between
individual ACR phantoms and/or the manufacturers of ACR phantoms.
If the test results still fall outside of the action limits, the source of the problem shall
be identi󹪝ed and corrective actions shall be taken before any further mammographic
tomosynthesis images are acquired using the image acquisition system.
If the source of the problem is a major component, the medical physicist must evaluate
the equipment.
The requirements pertaining to the evaluation are described in FDA regulations and in
subsequently issued guidance.
The issue should be addressed and documented by a Siemens customer
support engineer.