IMS Giotto Image 3D y 3DL Quality Control Manual

IMAGE 3D-3DL
Calibration Procedure and

Quality Control Manual
Quality Control Procedures
for Radiologic Technologists
MANUAL CODE: M 172 T

Rev. 1.1
S.r.l. - Bologna - Italy

Via SAGITTARIO, 5 40037 - Pontecchio Marconi - Bologna - ITALY - Tel. (051) 84.68.51 - Fax (051) 84.68.56
E - MAIL: Export Dept.: imscomm@imsitaly.com - Technical Dept.: imstech@imsitaly.com
2
Many thanks for having selected our GIOTTO IMAGE 3D/3DL mammography unit.
I.M.S. is known across the world for its quality, high-tech radiology units.
The following manuals will help you to familiarize yourself with the GIOTTO IMAGE 3D/3DL unit, supplying
you with all the necessary information for correct use and providing advice on maintenance and safekeeping
of the unit.
All rights of this publication are reserved for I.M.S. Any reproduction or dissemination, whether complete or
partial, that has not been duly authorized in writing, is absolutely forbidden.
This manual cannot be reproduced, transmitted, transcribed, archived in a retrieval system or translated into
other languages without prior written approval by I.M.S.
The buyer may reproduce copies for his/her/its internal use.
I.M.S. s.r.l. reserves the right to change at any time and without prior notice the technical and aesthetic
characteristics of the products mentioned here - the said characteristics are, therefore.
This manual is structured to supply essential information for the performance of Quality Control Tests on the
unit: GIOTTO IMAGE 3D/3DL
It is an essential part of the supply, and must therefore be kept together with the machine’s other technical
documentation for the life time of the machine.
The subjects dealt with are exclusively aimed at specialist users.
Before carrying out any operation, ensure that you have read and understood the contents of this manual.
The Manufacturer declines all liability for damage of any kind, caused by incorrect use, negligence,
superficial interpretation or failure to observe the safety conditions indicated in this manual.
CONFORMITY OF THE EQUIPMENT

This machine is certified as fixed installation medical-electrical equipment and was built in conformity with the
applicable provisions of directive 93/42/EEC concerning medical devices and of Law Decree No.46 of
24.02.97 “Implementation of Directive 93/42/EEC concerning medical devices”, amended by “Law Decree
No.95 of 25.02.98.
CE Certificate No.: 7505 0459
CLASSIFICATION OF THE EQUIPMENT
I.M.S. s.r.l.
Via SAGITTARIO, 5
40037 - Pontecchio Marconi
Bologna - ITALY
Tel. (051) 846851
Fax (051) 846856
E - MAIL:
Export Dept.: imscomm@imsitaly.com
Technical Dept.: imstech@imsitaly.com
3
Introduction ..........................................................................................................................5
List of Common Abbreviations .............................................................................................6
List of Quality Control Tests.................................................................................................7
List of Phantom Test Device ................................................................................................8
Test Frequencies .................................................................................................................9
Calibration Procedures ......................................................................................................10
Long Calibration .............................................................................................................10
Defects Calibration .........................................................................................................12
Fast Calibrations ............................................................................................................14
Dose Calibration.............................................................................................................18
Daily Check........................................................................................................................20
Automatic Exposure Control system (AEC) .......................................................................22
Phantom Image Quality Test (ACR Mammography Accreditation Phantom).....................26
Signal to Noise Ratio (SNR) and Contrast to Noise Ratio (CNR) ......................................29
AEC Reproducibility ...........................................................................................................32
Flat Field Homogeneity ......................................................................................................34
Artefacts Evaluation ...........................................................................................................35
Detector Response function and Noise level evaluation ....................................................37
kVp Accuracy and Reproducibility .....................................................................................40
Tube Output.......................................................................................................................42
Exposure Time...................................................................................................................44
Mean Glandular Dose (MGD) ............................................................................................45
QC Tests Forms ................................................................................................................48
Daily Check History............................................................................................................52
Appendix A: Detector Defective Elements Evaluation .......................................................53
Appendix B: Dance Factor for MGD calculation for PMMA plates .....................................54
Appendix C: Half-Value Layer (HVL) for MGD calculation .................................................56
Appendix D: Summary of Tests Results for Giotto 3D-3DL W/Rh-Ag configuration ..........57
Appendix E: Procedure for Noise Evaluation and Analysis................................................60
Reference ..........................................................................................................................66
4
Introduction
This manual is designed to be used as a complete Quality Control (QC) manual for the IMS Giotto
Image Full-Field Digital Mammography system.
All the tests have been taken from the European Guidelines for Quality Assurance in Breast
Cancer Screening And Diagnosis Fourth Edition.
The QC tests have been organized by recommended order of performance. Performing tests in a
specific order is sometimes important for digital mammography. For example, it is best to perform
the Flat Field uniformity and artefact tests before performing the phantom and dosimetry tests,
since the latter tests may leave a latent imprint of the phantom or dosimeter on the image receptor.
Hence we recommend performing the QC test in the order listed in this manual. We also
recommend covering the digital detector with a lead or steel sheet in tests where images are not
needed and the Automatic Exposure Control (AEC) system is not being tested.
Before performing these tests it is necessary that the unit is completely calibrated, and a
description of the complete procedure for calibration is dedicated Detector Calibrations Procedure
section.
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List of Common Abbreviations
AEC - Automatic Exposure Control
AWS - Acquisition Work station
FFDM - Full Field Digital Mammography
CNR - Contrast-to-Noise Ratio
kV - KiloVolt
HVL - Half-Value-Layer
mAs - milliAmpere-second
MGD - Mean Glandular Dose
MP - Medical Physicist
PMMA - Poly Methyl Methacrylate
RWS - Review Work Station
ROI - Region of Interest
SNR - Signal-to-Noise-Ratio
T - Technologist
W/Rh - Tungsten/Rhodium
W/Ag - Tungsten/Silver
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List of Quality Control Tests
Automatic Exposure Control system (AEC)
Phantom Image Quality Test (ACR)
Signal-to-Noise Ratio (SNR) and Contrast-to-Noise Ratio (CNR)
AEC Reproducibility
Flat-Field Homogeneity
Artefacts Evaluation
Detector Response Function and Noise evaluation
kVp Accuracy and Reproducibility
Tube Output
Exposure time
Mean Glandular Dose (MGD)
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List of Phantom Test Device
PMMA plates covering the whole imaging area, and covering a total thickness range from
20 to70 mm (including 5mm for the standard test block of 45mm PMMA);
2 PMMA blocks 20mm of thickness each one of dimension 150x145mm and their dedicated
metal support;
Image Quality phantom (ACR phantom);
Aluminium sheet of high purity (>99.9%) and 0.2mm thickness;
Dose meter;
Tube voltage meter;
Exposure timer;
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Test Frequencies
Test Frequency Equipment
Daily Check Daily 40mmPMMA;
Automatic Exposure Control (AEC) Six Months PMMA plates thickness range
from 20 to70 mm (including
45mm) ;
Phantom for Image Quality Daily ACR M.A.P. (RMI-156 or
Nuclear Associates 18-220);
Signal-to-Noise Ratio (SNR) and Contrast-to- Six Months PMMA plates thickness range
Noise Ratio (CNR) from 20 to70 mm (including
45mm); 0.2mmAl sheet;
AEC Reproducibility Six Months 40mmPMMA;
Flat Field Homogeneity Six Months 40mmPMMA;
Artefacts Evaluation Six Months 40mmPMMA;
Response function and Noise evaluation Six Months 40mmPMMA; Dose meter
kVp Accuracy and Reproducibility Yearly kV meter;
Tube Output Yearly Dose meter
Exposure time Yearly 40mmPMMA

Exposure timer;
Mean Glandular Dose (MGD) Six Months PMMA plates thickness range
from 20 to70 mm (including
45mm);
Dose meter;
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Calibration Procedures
In this section is described the complete procedure for the calibration of the detector: subtraction
correction of the dark frame, the gain and offset correction, and the defect pixels correction.
Is described also the procedure to make the filter and grid calibration, the magnification platform
calibration and the biopsy calibration.
Long Calibration
Required Equipment:
• Dedicated support;
• 2 blocks of PMMA of thickness of 20mm each one of dimension 150x145mm.
Frequency:
At acceptance and then at least every year.
Procedure:
1. Turn on the X-ray Generator;
2. ensure that the machine is NOT in modality M2 (Giotto Image 3D/3DL);
3. ensure that machine is in “Service Mode” (5 clicks on the off button at machine powerup)
for MD/SD/SDL (Giotto Image MD/SD/SDL);
4. ensure that the automatic x-ray cable is connected (X34 connector for Giotto Image
3D/3DL);
5. close the RAFFAELLO application;
6. open the GMD Service application from Start->Programs->RAFFAELLO->GMD Service;
7. click on “Service Procedure”, and enter the service password: “giottomdsrv”;
8. ensure that the Acquisition Service is active;
9. remove the anti-scatter grid;
10. place the dedicated support under the collimator as shown in figures;
11. place the small square PMMA blocks of 4cm of thickness into the dedicated support,
downstream the x-ray tube as shown in picture;
12. ensure that the detector is in IDLE Mode;

13. click the button “Calibration”;
10
14. ensure that the procedure has been started correctly. If the calibration procedure does not
start check for possible problems in Troubleshooting section.
Troubleshooting
If the Calibration procedure do not start:
• Check the service mode for Giotto Image 3D/3DL: it shall NOT be “M2”.
• Restart the Giotto MD/SD/SDL in “Service Mode” (pressing 5 times on the OFF button after
power-up).
• Check if the Acquisition Service Status is “Idle mode”: select the Test Acquisition option in
GMD Service and then check the Acquisition Service Status in the bottom part of the
dialog; if not, click on the “Stop Study” button and then wait until Acquisition Service Status
becomes “Idle mode”.
• Check if the Automatic X-ray cable is connected.
11
Defects Calibration
Required Equipment:
• 2 blocks of PMMA of thickness of 20mm each one of dimension 150x145mm.
Frequency:
At acceptance and then at least every six months. This calibration has to be repeated also if some
new defective pixels are discovered on the detector.
Procedure:
1. If the Long Calibration has been done just now, skip the following steps and go directly to
step 13;
2. turn on the X-ray Generator;
4. ensure that machine is in “Service Mode” (5 clicks on the off button at machine power-up)
3D/3DL);
7. open the GMDService application from Start->Programs->RAFFAELLO->GMD Service;
11. the dedicated support under the collimator as shown in figure;
12. place the small square PMMA blocks of 4cm of thickness into the dedicated support,
downstream the x-ray tube as shown in picture;

14. click the button “Defects Calibration”;
12
15. ensure that the procedure has been started correctly;
16. when the Defect Calibration procedure has finished, remove the PMMA blocks and the
dedicated support.
Troubleshooting
power-up).
13
Fast Calibrations
Required Equipment:
• 2 blocks of PMMA of thickness of 20mm each covering the whole imaging area.
Frequency:
At acceptance and then at least every six months.
Procedure:
1. If the Long or Defects Calibration has been done just now, skip the following steps and go
directly to step 10;
2. turn on the X-ray Generator;
3D/3DL);
10. install the plastic cover of x-ray tube;
11. insert the anti-scatter grid;
12. place the PMMA plates of 4cm on the image plane to cover all the active area of the
detector as shown in picture;

14. click the button “Fast Calibration”;
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15. select the first Large focal spot calibration and then press Continue;

17. when the Fast calibration procedure has finished, repeat the procedure for the other filter (if
present);
18. remove the PMMA plates and the anti-scatter grid;
19. if the magnification device is not present, skip to step 24;
20. place the magnification platform and place on it the PMMA plates as shown in picture;
15
1. click the button “Fast Calibration” and select small focus type;

3. when the procedure has finished, remove the PMMA plates and the magnification platform;
4. place the PMMA plates of 4cm on the image plane to cover all the active area of the
detector (the grid has not to be installed);
5. click the button “Fast Calibration” and select Biopsy calibration;
6. ensure that the procedure has been started correctly.
16
Troubleshooting
power-up).
17
Dose Calibration
The dose calibration needs about 15 minutes to be completed and it will require 2 steps: 1 for large
focal spot and 1 for small focal spot.
For every step the software will let you acquire 4 images. The 4th image is optional: you have to
acquire it only if you have a dose-meter.
The first three images are useful to optimize the processing applied on biopsy and spots images,
the fourth image is useful to compensate the tube dose drop off, stabilizing the automatic exposure
control and improving the automatic calculation of the Average Glandular Dose done by the Giotto
(the AGD compensation is done only on Giotto Image 3D/3DL machines).
Required Equipment:
Dose-meter (optional).
Frequency:
At acceptance and then at least every six months. The dose calibration has also to be repeated
when the tube or detector have been changed.
Procedure:
1. Turn on the X-ray Generator;
3D/3DL);
11. click the button “Dose Calibration”;
12. select the “Large Focal Spot” option;

14. After these 3 images the software asks you if you want to acquire a 4th image with the
dose-meter. If you have the dose-meter, read carefully into the message dialog what is the
anode/filter combination you have to set in the dose-meter and then click yes, otherwise
click no; if you choose not to make this image, the software will ask you if you want to
delete the previous dosimeter value. if the x-ray tube was changed, then click yes;
15. place the dose-meter on the detector surface in the centre of the detector at 6cm from the
chest wall (see the picture below);
18
16. after having acquired the fourth image with the dose-meter, the software will ask to insert
the dose value (in uGy) read from the dose-meter; if you insert 0, the previous inserted
dose-meter value will be deleted and then the default values will be used instead;
17. if the magnification device is not present, the Dose Calibration has finished, otherwise go
on with the
18. insert the magnification platform (if present, otherwise ;
20. click the button “Dose Calibration”;
21. select the “Small Focal Spot” option;
23. After these 3 images the software asks you if you want to acquire a 4th image with the
dose-meter. If you have the dose-meter, read carefully into the message dialog what is the
anode/filter combination you have to set in the dose-meter and then click yes, otherwise
click no; if you choose not to make this image, the software will ask you if you want to
delete the previous dosimeter value. if the x-ray tube was changed, then click yes;
24. place the dose-meter on the detector surface in the centre of the detector at 6cm from the
chest wall (see the picture below); be careful: the dose-meter has to be positioned on the
detector under the magnification platform;
25. after having acquired the fourth image with the dose-meter, the software will ask to insert
the dose value (in uGy) read from the dose-meter; if you insert 0, the previous inserted
dose-meter value will be deleted and then the default values will be used instead.
Troubleshooting
power-up).
19
Daily Check
Objective:
This test is normally performed every day by the radiologic technologist . It is indicated as a very
basic test to be done at every maintenance session. This test allows the facility to verify that the
performance of each of the digital imaging system is good enough for a clinical examination.
It include the following tests:
• Flat Field (GAIN LUT)
• SNR uniformity
• Digital detector efficiency
Frequency:
Daily
Procedure:
1. Open RAFFAELLO (acquisition software) and click on the “DAILY TEST” button.
2. Place 40mm of PMMA at the image plane to cover the active area of the detector. The
PMMA should be clean and free of scratches.
3. Check that no error messages are displayed on the GIOTTO control.
4. Wait until compare “Press Continue to Start the Selected Check” (F. 2) and make the xray
exposure as suggested by GIOTTO (note that kV, mAs and time are preset by GIOTTO).
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5. An image will appear on the AWS monitor; this image should be completely flat. Some
number will appear on the AWS monitor allowing you to check if the image taken is good
enough
Next to each number there is an automatic evaluation criteria: OK, BAD.

If all of them are OK the machine can be used clinically.
If one or more are BAD, repeat the examination and if some numbers are still not OK call service.
The image produced by the machine may not to be good enough for clinical use.
Troubleshooting
If the system fails the test:
• Replace the PMMA plates.
• Clean the detector surface.
• Clean or check the status of the mirror (dust may be present).
• Wait 1 hour until the system is thermally stable.
• Repeat the Daily Check.
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Objective:
This test is designed to check the performance of the Automatic Exposure Control (AEC) system
incorporated in the mammography unit and to ensure that the system chooses the correct
technique factors and exposure parameters in the Automatic Mode.
Required Test Equipment:
• PMMA plates covering the whole imaging area, and have a total thickness range from 20
to70 mm (including 5mm for the standard test block of 45mm PMMA).
Frequency:
Every six months and after any maintenance;
Procedure:
1. Open RAFFAELLO (acquisition software) and open a new study called “AEC TEST”, give it
a patient ID number and insert a birth date and click on Start Acquisition;
2. Place a 20mm PMMA plate on the image plane to cover the active area of the detector as
shown in the picture. Ensure the grid and compression paddle are in place;
22
Measure condition for AEC Test. Here with 40mm of PMMA.
3. Compress the PMMA plates until the maximum force. The Acquisition Work Service
become active (the x-ray button will become green) and “READY” will appear on the
display;
4. Select the Automatic Exposure mode (“AUTO” on the display), select the R-CC (Right-
Cranio-Caudal) view and make an exposure;
Control panel for the AEC Test

5. Repeat the procedure in the same manner for each PMMA thickness;
6. Close the study.
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Data Interpretation and Analysis
7. Expand on RAFFAELLO the last study and select the raw images;
8. Right-click on the series and select “Export DICOM Files”, and export the raw images in a
directory;
9. Open IMS Quality Control Program;
10. Click on “Select Output Dir” and select the directory where to put the analysis results files;
11. Click on “AEC” button and with the dialog window select all the images exported;
12. If the test is performed with success it should appear the window “Processing Successful”;
13. On the selected directory for the results it has been created the “AEC.txt” file with the
analysis results; Open the file and read the data inside;
14. Record these values on the data forms (Chart 1);
24
Performance Criteria
The kV, Target/Filter combination have to be the same as the reference value listed in the following
table; the value of SNR must to be within ± 10% of the reference value listed in the table.
If the system fails the test the source of the problem must be identified, and corrective action taken
by a qualified service engineer and successfully retested by a medical physicist before any further
clinical examinations are performed on the system.
Reference Values Table

mm Anode/Filter kV SNR
20 Mo/Mo 27 55 ± 5
30 Mo/Rh 29 55 ± 5
40 Mo/Rh 30 55 ± 5
45 Mo/Rh 30 55 ± 5
50 Mo/Rh 31 55 ± 5
60 Mo/Rh 32 55 ± 5
70 Mo/Rh 33 55 ± 5
20 W/Rh 24 60 ± 5
30 W/Rh 26 60 ± 5
40 W/Rh 28 60 ± 5
45 W/Rh 30 60 ± 5
50 W/Rh 30 60 ± 5
60 W/Rh 31 60 ± 5
70 W/Rh 32 60 ± 5
20 W/Rh 24 65 ± 6
30 W/Ag 25 65 ± 6
40 W/Ag 26 65 ± 6
45 W/Ag 27 65 ± 6
50 W/Ag 28 65 ± 6
60 W/Ag 30 65 ± 6
70 W/Ag 31 65 ± 6
Troubleshooting
• Check for consistency of the PMMA thickness.
• Check if there is a foreign object in the image.
• Check for consistency of the thickness indicator.
• Check the consistency of the x-ray field collimation looking in the image if there is a cut
white area at the chest wall side or performing the Artefact Test.
• Check for consistency between the nominal and the actual kV values.
25
Phantom Image Quality Test (ACR Mammography
Accreditation Phantom)
Objective:
This test is designed to ensure that the image quality is adequate and has not degraded over time.
• ACR Mammography Accreditation Phantom (RMI-156 or Nuclear Associates 18-220). Use
the same phantom each time.
Frequency:
Daily (Technologist)
Procedure:
1. Open RAFFAELLO (acquisition software) and open a new study called “ACR TEST”, give it
a patient ID number and insert a birth date;
2. Place the ACR phantom on the image plane centred laterally along the chest wall of the
phantom aligned with the chest wall edge of the image receptor, as shown in the picture,
and compress it;
Measurement set-up for the Phantom Image Quality Test with ACR phantom
3. Select the AUTOMATIC Exposure mode and R-CC view and make an exposure;
4. Close the study;

6. Open the raw images and examine the image at acquisition size (1:1 button) and optimize
the window level setting (W/L button). It can be useful to take advantage of the zoom and
invert function.
26
7. Determine how many fibres, specks and masses can be visualized. Always count the
number of visible objects from the largest object of a given type downward. Examine the
image carefully for artefacts, including grid lines or other equipment-induced artefacts;
Potentially Visible Objects in the accreditation phantom

The resulting phantom score should be at least 4 fibres, 3 speck groups, and 3 masses with each
display method. If phantom image scores on your system are less than this, the test fails.
Accreditation Phantom Object Required
Fibres ≥4
Speck groups ≥3
Masses ≥3
The ACR Phantom is an ideal phantom for assessing the presence of artefacts that might mimic or
reduce the visibility of suspicious findings. Examine the phantom image using the same window
width and level settings that give good visibility of fibres, specks, and masses.
If artefacts are present or if any object score fails, contact your service engineer. Significant
artefacts or other problems must be corrected by qualified service engineer and successfully
retested by a medical physicist before any further clinical examinations are performed on the
system.
Troubleshooting
• Check for consistency of the exposure parameter selected.
• Check if there is a foreign object inside the AEC area looking the image or performing the
Artefacts Evaluation Test.
27
Image obtained with ACR phantom
28
Signal to Noise Ratio (SNR) and Contrast to Noise Ratio (CNR)
Objective:
This test is designed to check the consistency of the contrast-to-noise ratio (CNR) and the signal-
to-noise ratio (SNR) over time.

• PMMA plates covering the whole imaging area, and covering a total thickness range
from 20 to70 mm (including 5mm for the standard test block of 45mm PMMA).
• Aluminium sheets of high purity (99.9%) 0.2mm thickness.

Frequency:
Procedure:
1. Open RAFFAELLO (acquisition software) and open a new study called “CNR TEST”, give it
2. Place 20 mm of PMMA on the image plane to cover the active area of the detector and
place the Al object on the right side as shown in the picture below. Ensure that the grid and
compression paddle are in place;
3. Compress the PMMA plates;
0.2 mm of Al
Measurements set-up, for the SNR and CNR Test. Shown here with 40mm of
PMMA.
4. Select the Manual Exposure mode and make an exposure with the same parameters
(Target-Filter combination, kV, and mAs) used in the previous test;
29
Control panel set-up for the SNR and CNR Test for 45mm of PMMA
5. Repeat the procedure in the same manner used previously for each PMMA thickness;
6. Close the study;

directory;
11. Click on “CNR” button and with the dialog window select all the images exported and wait
that the window “Processing Successful”;
12. On the selected directory for the results it has been created the “CNR.txt” file with the
14. The Signal-to-Noise Ratio and the Contrast-to-Noise Ratio are calculated using the
formulas below:
AverageCounts Average Counts (PMMA) - Average Counts (Al)

SNR = CNR =
σ σ (PMMA)2 + σ (Al)2
2
The measured SNR and CNR values must be within ± 20% of the established operating level. If
the measured SNR and CNR values are not within this range, the system fails the SNR and CNR
test.
If the system fails the test, the source of the problem must be identified, and corrective action taken
30
mm kV Anode/Filter SNR CNR
20 27 Mo/Mo 55 ± 5 10 ± 1
30 29 Mo/Rh 55 ± 5 9±1
40 30 Mo/Rh 55 ± 5 8±1
45 30 Mo/Rh 55 ± 5 7±1
50 31 Mo/Rh 55 ± 5 7±1
60 32 Mo/Rh 55 ± 5 6±1
70 33 Mo/Rh 55 ± 5 5±1
20 24 W/Rh 60 ± 5 11 ± 1
30 26 W/Rh 60 ± 5 10 ± 1
40 28 W/Rh 60 ± 5 9±1
45 30 W/Rh 60 ± 5 9±1
50 30 W/Rh 60 ± 5 8±1
60 31 W/Rh 60 ± 5 8±1
70 32 W/Rh 60 ± 5 7±1
20 24 W/Rh 65 ± 6 12 ± 1
30 25 W/Ag 65 ± 6 11 ± 1
40 26 W/Ag 65 ± 6 10 ± 1
45 27 W/Ag 65 ± 6 9±1
50 28 W/Ag 65 ± 6 9±1
60 30 W/Ag 65 ± 6 8±1
70 31 W/Ag 65 ± 6 8±1
Troubleshooting
• Check if there is a foreign object in the analyzed area.
• Check for consistency of the exposure parameter used.
31
AEC Reproducibility
Objective:
This test is designed to check the reproducibility of the AEC parameters.

• 40mmPMMA plates covering the whole imaging area.
Frequency:
Procedure:
1. Open RAFFAELLO (acquisition software) and open a new study called “AEC
REPRODUCIBILITY TEST”, give it a patient ID number and insert a birth date;
2. Place a 40mm PMMA plate on the image plane to cover the active area of the detector;
3. Compress the PMMA plates until the Acquisition Work Service become active (the x-ray
button will become green) and “READY” will appear on the display;
4. Select the Automatic Exposure mode (“AUTO” on the display), select the R-CC (Right-
Cranio-Caudal) view and make an exposure;
5. Repeat the procedure 8 times;
32
directory;
10. Click on “Reproducibility” button and with the dialog window select all the images exported
and wait that the window “Processing Successful”;
11. On the selected directory for the results it has been created the “Reproducibility.txt” file with
the analysis results; Open the file and read the data inside;
The value of the percentage variation of the mAs and of the SNR must be within the EC protocol
limits (Dev% <5%). If the value of the percentage variation of the mAs and of the SNR is not within
this limit, the system fails the AEC Reproducibility Test.
If the system fails the test. The source of the problem must be identified, and corrective action
taken by a qualified service engineer and successfully retested by a medical physicist before any
further clinical examinations are performed on the system.
Troubleshooting
33
Flat-Field Homogeneity
Objective:
This test is designed to ensure that digital images are free from significant non-uniformities caused
by detector sensitivity differences or improper gain correction.
• 40mm PMMA plates covering the whole imaging area.
Frequency:
Procedure:
1. Open RAFFAELLO (acquisition software) and open a new study called “HOMOGENEITY
TEST”, give it a patient ID number and insert a birth date;
2. Place 40 mm of PMMA on the image plane to cover the active area of the detector. Ensure
the grid and compression paddle are in place;
3. Compress the PMMA plates until the Acquisition Work Service becomes active (Green light
on x-ray button);
4. Select the Automatic Exposure mode, select the R-CC view and make an exposure;
directory;
9. Click on “Homogeneity” button and with the dialog window select the image exported and
wait that the window “Processing Successful”;
10. On the selected directory for the results it has been created the “Homogeneity.txt” file with
the analysis results; Open the file and read the data inside;
The maximum deviation in ROI signal has to be <15% from the average of the 5 ROI signals, and
the maximum deviation in SNR value has to be <15% from the average of the 5 SNR values for
Giotto 3D, and has to be <25% for Giotto 3DL.
If the value of maximum deviation from the average are not within these limits, the system fails the
Homogeneity Test.
34
Objective:
This test is designed to ensure that digital images are free from big artefacts caused by the
presence of something on the detector surface or on the anti-scatter grid, and also free from
significant non-uniformities caused by detector sensitivity differences or improper gain correction.
• 40mm PMMA plates covering the whole imaging area.
Frequency:
Procedure:
1. Open RAFFAELLO (acquisition software) and open a new study called “ARTEFACTS
2. Remove the compressor paddle;
3. Place 40 mm of PMMA on the image plane to cover the active area of the detector. Ensure
the grid is in place;
4. Select the Manual Exposure mode, select the R-CC view and make an exposure with the
same parameters obtained in AEC test for 40mm of PMMA;
5. Repeat the procedure 6 times changing the position of PMMA plates for every image
acquired.
directory;
10. Click on “Calculate Flat-Field” button and with the dialog window select the analysis
parameters showed in the next picture;
35
11. Wait that the window “Processing Successful”;
12. On the selected directory for the results it has been created the “FlatFieldAnalyzer.txt” file
with the analysis results; Open the file and read the data inside;
13. At the end of file read the deviating pixel results for the images merge.
No deviating pixel have to be over threshold for the merge image results.
If the value of maximum deviation from the average for merge is not within this limits, the system
fails the Artefact Test.
Troubleshooting
If the system fails the test check the source of the problem in terms of:
• Presence of an object on the filter (large object very blurred, not present performing an
image with other filter)
• Presence of an object on the mirror (large object very blurred, present for both filter)
• Presence of an object on the grid (little object not very blurred)
• Presence of an object on detector surface (little object not very blurred)
• Presence of an object on PMMA surfaces (little object not very blurred)
• Presence of an object during calibration (black every time present)
• Wrong collimation
If the problem is recognized as “Presence of an object during calibration” is necessary to

recalibrate the detector after having recognized the position of the artefact and clean it.
36
Detector Response function and Noise level evaluation
Objective:
This test is designed to asses the degree of linearity of the detector response function and quantity
of noise in flat field images. Noise performance is evaluated by determining linearity of ROI
variance against detector exposure level.
• 2 PMMA plates each with a thickness of 20mm;
• Aluminium or lead plate covering all the detector surface;
Frequency:
Every six months and after detector or x-ray tube replacement;
Procedure:
1. Place the support for PMMA block for long calibration into the cover of the x-ray tube.
2. Place the small square PMMA blocks of 40mm of thickness (used for the long calibration)
into the dedicated support, downstream the x-ray tube.
3. Turn Off the HV generator
4. Digit the sequence for service mode M1 for acquiring images without grid;
1 2 3 4 5 6
5. Remove the compression paddle and the anti-scatter grid.
6. Turn On the Unit;
7. Open RAFFAELLO (acquisition software) and open a new study called “LINEARITY TEST”,
give it a patient ID number and insert a birth date;
8. Select the Manual Exposure mode and make 10 images at 28kV with the W/Rh target/filter
combination or at 26kV with the W/Ag target/filter combination and with mAs in range of 4-
160mAs.
9. Close the study;
10. Place the Aluminium or lead plate covering all the detector surface to protect them;
11. Turn Off the x-ray generator;
37
12. Digit the sequence for service mode M2 for use the unit without acquiring images;
M2
2 4 6
1 3 5
13. Turn On the x-ray generator;
14. In the same conditions used for the acquisition of the images, make 8 exposures and for
each one register with a dose-meter, the value of Entrance Surface Air KERMA (ESAK)
positioning the probe of dose-meter at 60mm from the chest wall edge and laterally
centred.

directory;
20. Click on “Linearity” button and with the dialog window select the image exported and wait
that the dialog window “Insert the ESAK (uGy) for image ……..”;
21. Insert the ESAK value read for each mAs used;
22. On the selected directory for the results it has been created the “Linearity.txt” file with the
The value of the square of correlation coefficient (R2) must to be >0.99 for all the interpolation.
The value of the mean pixel value offset (q value for ROI Average Vs ESAK) must to be 0±5.
The value of the variance value offset (q value for s2 Vs ESAK) must to be <10.
If the value of the square of the correlation coefficient does not meet the action limit specified
above, the system fails the Detector Response function test.
If the value of mean pixel value offset does not meet the action limit specified above, the system
fails the Detector Response function test.
38
Reference Graphs
Detector Response Function y = 3.84x - 1.77

R2 = 1
1750
1500
1250
Average Counts
1000
750
500
250
0
0 50 100 150 200 250 300 350 400 450
ESAK [ΗGy]
Noise Evaluation y = 0.33x + 6.55

R2 = 0.9991
200
150
Variance (ℵ2)
100
50
0
0 50 100 150 200 250 300 350 400 450
ESAK [ℵGy]
Linearity Test Results

Troubleshooting
• Check the consistency of the tube output linearity calculating the value of the square of
correlation coefficient for the Dose over mAs. The tube response must be linear with a
R2>0.999.
• Check the consistency of the measure condition and the internal calibration configuration of
the instrument.
• Check the calibration certificate date of the dose meter.
39
Objective:
This test is designed to assure that the actual peak kilovoltage (kVp) delivered by the X-ray system
is both accurate and reproducible. The reproducibility tests procedure is described in the 4th
edition of the "European protocol for the quality control of the physical and technical aspects of
mammography screening (2b.2.1.3.3 and 2b.2.1.3.4)" and it is suggested that you use it. The
accuracy test the following procedure should be applied.
• Test device capable of measuring kVp to an accuracy of ± 1 kVp and a precision of 0.5 kVp
within the mammographic kVp range;
• Lead or steel sheet large enough to cover the entire digital detector.
Frequency:
Every six months.
Procedure:
M2
2 4 6
1 3 5
3. Remove the anti-scatter grid and compressor paddle;
5. Place the Aluminium or lead plate covering all the detector surface to protect them;
6. Place the probe of the kVp meter at 6cm from chest wall laterally centred, and set the kV
meter for the correct measurement configuration (W/Rh 50µm and 50ms of delay time for
kV measurement).
7. Select the Manual Exposure mode and make an exposure for each value of kVp value
(from 22 to 35kVp) using the W/Rh target/filter combination and 10 mAs.
8. After completing this measurement, select the Manual Exposure mode again and make 10
exposures using the W/Rh target/filter combination at 28kV and 10 mAs.
40
9. Record the values of kVp read on the data forms (Chart 7);
10. Compare the kVp value measured with the value of the present nominal kVp.
11. To determinate kVp accuracy, compute the standard deviation of the kVp values for each
kVp setting and then calculate the coefficient of variation by dividing the standard deviation
by the mean kVp value measured.
The accuracy action limit is ± 1kVp and the short term reproducibility action limit is ± 0.5 kVp
compared to the average.
If the nominal kVp value differs by more than 1kV value measured with kVp meter, the system fails
the Accuracy test.
If the variation from the average value is bigger than 0.5 kVp, the system fails the short term
reproducibility test.
If the system fails these tests the source of the problem must be identified, and corrective action
taken by a qualified service engineer and successfully retested by a medical physicist before any
further clinical examinations are performed on the system.
Troubleshooting
the instrument.
• Check the calibration certificate date of the kV meter.
• Check in the internal setting of the instrument the kV measurements delay time. It is
suggested a minimum value of 50ms.
41
Tube Output
Objective:
This test is designed to evaluate the efficiency of the x-ray tube.
• Dose meter
Frequency:
At acceptance, every six months and after x-ray tube replacement.
Procedure:
M2
2 4 6
1 3 5
4. Place the probe of dose meter at 6cm from chest wall laterally centred.
5. Ensure the grid and compression paddle are NOT in place;
6. Place the Aluminium plate covering all the detector surface to protect them;
7. Select the Manual Exposure mode and make an exposure with 28kVp with configuration
W/Rh LF and 20 mAs.
8. Record the value of dose read on the data forms (Chart8);
The values of tube output must to be within the limit values reported in the following reference
table.
If the values of tube output are not within these limits the system fails this test.
If the system fails this test, the source of the problem must be identified, and corrective action
(TUBE REPLACEMENT) taken by a qualified service engineer before any further clinical
examinations are performed on the system.
42
Nominal values and measure condition

Focus LF
Filter Rh
kV 28
mAs 20
Compressor Paddle NO
Anti-scatter Grid NO
Focus-Probe Distance (mm) 630
6cm from chest-wall side
Probe position
and laterally centred
Reference value for installation

ESAK Fluence Exposure Time HVL Efficiency
kV
(mGy) (mGy/s) (ms) (mm Al) (uGy/mAs)
28 ± 0.5 1.1 ± 0.1 7.8 ± 0.1 140 ± 10 0.51 ± 0.01 55 ± 5
Reference value for periodic control

ESAK Fluence Exposure Time HVL Efficiency
kV
(mGy) (mGy/s) (ms) (mm Al) (uGy/mAs)
28 ± 0.5 > 0.7 > 5.4 140 ± 10 0.51 ± 0.01 >35
Troubleshooting
the instrument.
• Check the exposure time performing the Exposure Time Test
43
Exposure Time
Objective:
This test is designed to evaluate the exposure time in clinical condition.
• Exposure timer
Frequency:
Yearly and when tube output problems are suspected.
Procedure:
1. Place on the grid surface 45mm of PMMA.
2. Place the exposure timer at 6cm from chest wall laterally centred following the
manufacturer's manual.
3. Open RAFFAELLO (acquisition software) and open a new study called “EXPOSURE TIME
4. Select the Manual Exposure mode and make an exposure in the with the same
configuration (Target-Filter combination, kV and mAs) obtained in the AEC system test for
45mm.
5. Record the Exposure time values on the data forms (Chart1);
The values of the exposure time values must to be within the limiting values reported in the
following reference table.
If the system fails the test, the source of the problem must be identified, and corrective action taken
by a qualified service engineer before any further clinical examinations are performed on the
system.
Exposure Time
Acceptable Achievable
>1s 0.5s
Troubleshooting
• Check for consistency of the exposure parameters selected.
44
Objective:
This test is designed to evaluate the Mean Glandular Dose for each PMMA thickness, in clinical
condition.
• PMMA plates covering the whole imaging area, and covering a total thickness range from
20 to70 mm (including 5mm for the standard test block of 45mm PMMA);
• Dose meter.
Frequency:
Six Months;
Procedure:
1. Place on the grid surface 20mm of PMMA.
2. Place the probe of dose meter at 6cm from chest wall laterally centred as shown in picture;
Ensure the compression paddle is in place;
Measure condition for MGD Test

3. Open RAFFAELLO (acquisition software) and open a new study called “MGD TEST”, give it
4. Select the Manual Exposure mode and make an exposure in the with the same
configuration (Target-Filter combination, kV and mAs) obtained in the AEC system test for
20mm.
45
5. Place on the grid surface 30mm of PMMA, select the Manual Exposure mode and make an
exposure in the with the same configuration (Target-Filter combination, kV and mAs)
obtained in the AEC system test for 3cm.
6. Repeat the procedure for all PMMA thickness.
7. Record the Exposures values and the value of Entrance dose read on the data forms
(Chart 9);

8. Expand on RAFFAELLO the AEC Test study and select the raw images;
directory;
12. Click on “MGD” button and with the dialog window to select the image exported and wait
that the dialog window “Insert the ESAK (mGy) for image ……..”;
13. Insert the ESAK value read for each mm PMMA used and the HVL value obtained for each
beams and finally wait the window “Processing Successful”; If the dose meter is not able to
give the HVL don’t insert any value, and the default value will be used for the MGD
calculation;
14. On the selected directory for the results it has been created the “MGD.txt” file with the
The Mean Glandular Dose is calculated with the following formula:
MGD = ESAK ⋅ g ⋅ c ⋅ s
Where g, c and s are the Dance factor (Dance 2000; Dance 2009).
The Dance factors are chosen to calculate the Mean Glandular Dose for a breast equivalent to
each PMMA thickness and are reported in the appendix A.
A detailed description of the calculation of the MGD can be found in the reference articles or in
European Guidelines for Quality Assurance in Breast Cancer Screening And Diagnosis Fourth
Edition.
The calculated MGD value must be within the EC protocol limits. If the calculated MGD value is not
within these limits, the system fails the MGD Test.
If the system fails the test. The source of the problem must be identified, and corrective action
taken by a qualified service engineer before any further clinical examinations are performed on the
system.
46
Troubleshooting
• Check for consistency of the exposure parameters used.
the instrument.
• Check the calibration certificate date of the kV meter.

• Check the position of the probe.
Reference Value
ESAK [mGy] MGD Acceptable Achievable
mm kV Anode/Filter Results
measured [mGy] MGD [mGy] MGD [mGy]
20 27 Mo/Mo 2.16 0.81 1.0 0.6 OK
30 29 Mo/Rh 2.86 0.95 1.5 1.0 OK
40 30 Mo/Rh 5.18 1.38 2.0 1.6 OK
45 30 Mo/Rh 7.19 1.72 2.5 2.0 OK
50 31 Mo/Rh 9.25 2.06 3.0 2.4 OK
60 32 Mo/Rh 15.59 2.99 4.5 3.6 OK
70 33 Mo/Rh 24.72 4.04 6.5 5.1 OK
ESAK [mGy] Acceptable Achievable

mm kV Anode/Filter MGD [mGy] Results
measured MGD [mGy] MGD [mGy]
20 24 W/Rh 1.32 0.65 1.0 0.6 OK
30 26 W/Rh 2.19 0.82 1.5 1.0 OK
40 28 W/Rh 3.71 1.16 2.0 1.6 OK
45 30 W/Rh 4.64 1.38 2.5 2.0 OK
50 30 W/Rh 5.93 1.60 3.0 2.4 OK
60 31 W/Rh 9.87 2.31 4.5 3.6 OK
70 32 W/Rh 15.46 3.06 6.5 5.1 OK
ESAK [mGy] Acceptable Achievable

mm kV Anode/Filter MGD [mGy] Results
measured MGD [mGy] MGD [mGy]
20 24 W/Rh 1.33 0.63 1.0 0.6 OK
30 25 W/Ag 2.40 0.91 1.5 1.0 OK
40 26 W/Ag 3.56 1.14 2.0 1.6 OK
45 27 W/Ag 4.16 1.26 2.5 2.0 OK
50 28 W/Ag 5.11 1.46 3.0 2.4 OK
60 30 W/Ag 7.85 2.04 4.5 3.6 OK
70 31 W/Ag 12.17 2.73 6.5 5.1 OK
47
QC Tests Forms
Machine Model:_____________
Machine S.N. : ____-____-____
Tube Manufacturer : ______________Tube Type: _____Tube S.N. :_______________
Detector ID: ____________________Detector S.N. :___________________________
Grid Type:_________
QC Test: Pass/Fail
Automatic Exposure Control (AEC)
Phantom Image Quality Test (ACR Phantom)
Signal-to-Noise Ratio (SNR) and Contrast-to-Noise Ratio (CNR)
AEC Reproducibility
Flat Field Homogeneity
Phantom Image Quality (ACR)
Response function and Noise evaluation
Tube Output
Exposure Time
48
mm mm Giotto Anode/Filter kV mAs Exposure Time SNR
20
30
40
45
50
60
70
Chart 1. AEC system
Phantom Image Quality Test (ACR)

Accreditation Phantom Object Obtained Required
Fiber ≥4
Speck groups ≥3
Masses ≥3
Chart 2. ACR Test
Signal to Noise Ratio (SNR) and Contrast to Noise Ratio (CNR)

Standard
Standard Average
Average Deviation
mm mm kV mAs Anode/Filter deviation ROI SNR CNR
ROI (Al) ROI
ROI (Al) (PMMA)
(PMMA)
20 20
30 30
40 40
45 45
50 50
60 60
70 70
Chart 3. SNR and CNR Test
AEC Reproducibility
Anode mAs SNR
mm Exp. Mode mm read kV mAs Dev.% Dev.%
/Filter results Average Dev. Std. SNR results
40
40
40
40
40
40
40
40
Average/Max values mAs % Average/Max values SNR %
Chart 4. AEC Reproducibility Test
49
Flat Field Homogeneity
Deviation Deviation
ROI ROI Average from average SNR from average
values (%) values (%)
ROI 1:
ROI 2:
ROI 3:
ROI 4:
ROI 5:
Avg. values / max. deviations
Results:
Chart 5. Flat Field Homogeneity Test
Response function and Noise evaluation

2 2
kV mAs Anode/Filter ESAK [µ
µGy] Average ROI σ ROI SNR ROI SNR ROI σ ROI
ROI average Vs ESAK interpolation line

2
m q R Limit Result
2
R >0.99
2
SNR Vs ESAK interpolation line
2
m q R Limit Result
2
R >0.99
2
σ Vs ESAK interpolation line
2
m q R Limit Result
2
R >0.99
Chart 6. Detector response function and Noise evaluation Test
50
Accuracy Reproducibility
kVp Measured Results kVp Measured Results Dose (mGy) Dose results
22 28
23 28
24 28
25 28
26 28
27 28
28 28
29 28
30 28
31 28
32 Average: Average:
33 Variability: Variability:
34 Accuracy limit: < ± 1 kV
35 Reproducibility limit: < ± 0.5 kV and < ± 0.05 mGy with respect to the average
Chart 7. kVp Accuracy and short term Reproducibility Test
Tube Output
Large Focus W/Rh No Paddle
Efficiency (mGy/mAs) at Fluence (mGy/s) at HVL
kV
630mm 630mm (mmAl)
28
Chart 8. Tube Output Test
ESAK
MGD Acceptable Achievable
mm cm Giotto kV mAs Anode/Filter measured
[mGy] MGD [mGy] MGD [mGy]
[mGy]
20 1.0 0.6
30 1.5 1.0
40 2.0 1.6
45 2.5 2.0
50 3.0 2.4
60 4.5 3.6
70 6.5 5.1
MGD= ESAK⋅ g ⋅ c ⋅ s
mm ESAK (mGy) HVL (mmAl) g c s
20
30
40
45
50
60
70
Chart 9. Mean Glandular Dose (MGD) Test
51
Daily Check History
Uniformity SNR
Data
Deviation Average
52
Appendix A: Detector Defective Elements Evaluation
This section of the manual provides detailed procedures for the acquisition of the Defectives Map,
and for the analysis of the uncorrected elements in the digital detector.
Frequency:
At acceptance and when image quality problems are suspected.
1. Open RAFFAELLO (Image Acquisition Software)
2. Open New Study
3. Insert First and second name and a patient ID, a birth date and click on Start Acquisition
4. When the detector state is ready click Ctrl+Alt+D.
5. It should appears the defective pixel map.
6. Close the study.
7. Right click on the image in the study list and export in DICOM format.

Check in DefectsReport.txt file in D:\ProgramFiles\IMS\Acquisition\Images\Calibration.
Legend for the interpretation of the DefectsReport.txt:
• CDL = Correctable Defective Lines
• CDC = Correctable Defective Columns
• SDP = Single Defective Pixel
• CC = Correctable Clusters
• UDL = Uncorrectable Defective Lines
• UDC = Uncorrectable Defective Columns
• UCC = Uncorrectable Defective Clusters
Performance Criteria:
Correctable Defective Lines/Columns:
Max 10 lines or columns (2 half-columns made 1 column);
Are not accepted two defective Lines/Columns close together. It is necessary to have three good
lines/columns between two defective lines/columns.
Are excluding all pixels of two lines at the upper and lower boards, and 150 x 150 pixel at left-top
that are black for the High Voltage Contact.
Single Defective Pixel: < 2500 pixels (3D); < 5000 pixels (3DL)
Correctable Clusters: < 100 cluster (3D); <150 clusters (3DL) (max 8 pixels)
Is not accepted no one uncorrectable element.
53
Appendix B: Dance Factor for MGD calculation for PMMA
plates
The factor g, corresponds to a glandularity of 50%, and is derived from the values calculated and is
shown below for a range of HVL. The c-factor corrects for the difference in composition of typical
breasts from 50% glandularity and is given here for typical breasts in the age range 50 to 64. Note
that the c and g-factors applied are those for the corresponding thickness of typical breast rather
than the thickness of PMMA block used. Where necessary interpolation may be made for different
values of HVL. The factor s shown in the second table corrects for any difference due to the choice
of X-ray spectrum.
g-factor
mm HVL (mm Al)
PMMA Breast 0.25 0.30 0.35 0.40 0.45 0.50 0.55 0.60
20 21 0.329 0.378 0.421 0.460 0.496 0.529 0.559 0.585
30 32 0.222 0.261 0.294 0.326 0.357 0.388 0.419 0.448
40 45 0.155 0.183 0.208 0.232 0.258 0.285 0.311 0.339
45 53 0.130 0.155 0.177 0.198 0.220 0.245 0.272 0.295
50 60 0.112 0.135 0.154 0.172 0.192 0.214 0.236 0.261
60 75 0.088 0.106 0.121 0.136 0.152 0.166 0.189 0.210
70 90 / 0.086 0.098 0.111 0.123 0.136 0.154 0.172
80 103 / 0.074 0.085 0.096 0.106 0.117 0.133 0.149
c-factor
mm HVL (mm Al)
PMMA Breast 0.25 0.30 0.35 0.40 0.45 0.50 0.55
20 21 0.889 0.895 0.903 0.908 0.912 0.917 0.921
30 32 0.940 0.943 0.945 0.946 0.949 0.952 0.953
40 45 1.043 1.041 1.040 1.039 1.037 1.035 1.034
45 53 1.109 1.105 1.102 1.099 1.096 1.091 1.088
50 60 1.164 1.160 1.151 1.150 1.144 1.139 1.134
60 75 1.254 1.245 1.235 1.231 1.225 1.217 1.207
70 90 1.299 1.292 1.282 1.275 1.270 1.260 1.249
80 103 1.307 1.299 1.292 1.287 1.283 1.273 1.262
s-factor
Target/Filter s-factor
Mo/Mo 1.000
Mo/Rh 1.017
W/Rh 1.042
W/Ag 1.063
Note: To chose the correct Dance factor for the MGD calculation, see the Half-Value Layer
value in Appendix B.
54
g-factor for PMMA plates
0.7
20mmPMMA 30mmPMMA 40mmPMMA 45mmPMMA
0.6
0.5
g-factor
0.4
0.3
0.2
0.1
0
0.25 0.3 0.35 0.4 0.45 0.5 0.55 0.6 0.65
HVL [mmAl]
c-factor for PMMA plates

1.4 50mmPMMA 60mmPMMA 70mmPMMA 80mmPMMA
1.3
1.2
c-factor
1.1
1.0
0.9
0.8
0.25 0.30 0.35 0.40 0.45 0.50 0.55 0.60 0.65
HVL [mmAl]
55
Appendix C: Half-Value Layer (HVL) for MGD calculation
HVL (mm Al)

kVp Mo/Mo Mo/Rh W/Rh W/Ag
22 0.27 0.32 0.40 0.39
23 0.28 0.34 0.43 0.42
24 0.30 0.36 0.45 0.45
25 0.31 0.37 0.47 0.48
26 0.33 0.39 0.49 0.51
27 0.34 0.40 0.50 0.53
28 0.35 0.41 0.51 0.55
29 0.36 0.42 0.52 0.57
30 0.37 0.43 0.53 0.58
31 0.38 0.44 0.53 0.59
32 0.39 0.45 0.54 0.60
33 0.40 0.45 0.55 0.61
34 0.41 0.46 0.56 0.62
35 0.41 0.46 0.57 0.63
HVL
0.65
0.60
0.55
0.50
Mo/Mo
mmAl
Mo/Rh
0.45
W/Rh
0.40 W/Ag
0.35
0.30
0.25
21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
kV
56
Appendix D: Summary of Tests Results for Giotto 3D-3DL
W/Rh-Ag configuration
Automatic Exposure Control System (AEC)
mm mm Anode/Filter kV SNR SNR Limits

20 20 W/Rh 24 63 65 ± 6
30 30 W/Ag 25 68 65 ± 6
40 40 W/Ag 26 67 65 ± 6
45 45 W/Ag 27 67 65 ± 6
50 50 W/Ag 28 68 65 ± 6
60 60 W/Ag 30 70 65 ± 6
70 70 W/Ag 31 71 65 ± 6
Phantom Image Quality (A.C.R. Mammography Accreditation Phantom)

Accreditation Phantom Object Number of visible object Limits
Fiber 5 ≥4
Speck Group 4 ≥3
Masse 4 ≥3
Signal-to-Noise Ratio (SNR) and Contrast-to-Noise-Ratio (CNR)
Standard
Standard Average
Average ROI Deviation CNR
mm mm kV Anode/Filter deviation ROI SNR CNR
(Al) ROI Limits
ROI (Al) (PMMA)
(PMMA)
20 20 24 W/Rh 326.0 5.3 395.1 5.7 67.0 12.1 12 ± 1
30 30 25 W/Ag 401.7 5.9 473.2 6.3 72.3 11.2 11 ± 1
40 40 26 W/Ag 438.6 6.3 508.7 6.6 73.5 10.4 10 ± 1
45 45 27 W/Ag 452.0 6.4 520.2 6.8 73.8 9.9 9±1
50 50 28 W/Ag 450.8 6.5 515.2 6.8 72.4 9.3 9±1
60 60 30 W/Ag 496.2 6.9 561.3 7.2 74.4 8.8 8±1
70 70 31 W/Ag 532.1 7.4 598.0 7.7 74.7 8.4 8±1
57
Detector Response Function and Noise evaluation
2
ESAK [µ
µGy] Average ROI σ ROI SNR ROI SNR ROI σ 2 ROI
4.2 17.0 2.8 5.8 8.4 35.0

6.8 26.9 3.0 8.8 9.1 80.5
9.3 37.3 3.1 11.6 9.9 142.1
11.9 47.9 3.2 14.4 10.7 216.1
14.7 58.8 3.3 17.0 11.4 304.5
19.9 80.7 3.5 21.9 13.0 504.0
25.6 103.2 3.7 26.5 14.5 733.6
53.6 216.6 4.6 44.7 22.5 2085.7
109.8 444.4 6.1 70.3 38.4 5164.6
ROI average counts Vs ESAK interpolation line

2
m q R Limit
2
3.9 0.37 0.999 R >0.99
SNR2 Vs ESAK interpolation line
2
m q R Limit
2
49.1 -408.4 0.999 R >0.99
σ2 Vs ESAK interpolation line
2
m q R Limit
2
0.30 6.41 0.999 R >0.99
Tube Output
LF – W/Rh No Paddle
kV Efficiency (mGy/mAs) at 630mm Limits
28 0.50 >0.35
Exposure Time
mm PMMA kV mAs Exposure Time (s) Achievable Acceptable

45 27 70 0.515 0.500 <1
58
mm ESAK [mGy] Acceptable MGD Achievable

kV Anode/Filter MGD [mGy]
PMMA measured [mGy] MGD [mGy]
20 24 W/Rh 1.30 0.63 1.0 0.6
30 25 W/Ag 2.14 0.84 1.5 1.0
40 26 W/Ag 3.47 1.15 2.0 1.6
45 27 W/Ag 4.10 1.29 2.5 2.0
50 28 W/Ag 4.94 1.45 3.0 2.4
60 30 W/Ag 7.49 1.98 4.5 3.6
70 31 W/Ag 11.81 2.69 6.5 5.1
mm ESAK [mGy]
HVL (mmAl) g c s
PMMA measured
20 1.30 0.45 0.498 0.908 1.042
30 2.14 0.48 0.375 0.948 1.063
40 3.47 0.51 0.288 1.037 1.063
45 4.10 0.52 0.258 1.094 1.063
50 4.94 0.54 0.232 1.140 1.063
60 7.49 0.57 0.195 1.214 1.063
70 11.81 0.58 0.164 1.254 1.063
MGD
7.0
6.0
MGD
5.0 Acceptable
Achievable
MGD [mGy]
4.0
3.0
2.0
1.0
0.0
20 30 40 50 60 70
PMMA thickness [mm]
59
Appendix E: Procedure for Noise Evaluation and Analysis
The task of this part of the manual is to give an operative procedure to evaluate if there is a
problem related to the noise of the system, and to understand if the source of the problem is only
the digital detector, or some components of the mammographic unit in general.
It is very important follow the instruction step by step to avoid mistakes related with the analysis
interpretations!
First Step: CGrabDiff Analysis.
1. Log in as Administrator using password: DIGITGIOTTO

2. Open the in the directory C:\WINDOWS the file AcquisitionService.ini and edit the field
SAVE_CGRABDIFF = 1.
3. Set the GMD Service in the advanced user following this procedure:
• Close the GMD Service if it is open;
• In START \ Run, type “regedit”, press enter;
• Select HKEY_LOCAL_MACHINE \ SOFTWARE \ 105 \ 104 \ 103;
• Open the file Enable and set the value at 1 and click OK;
• Open the GMD Service program, now the program is in advanced user and the CGD,
and NFT functions are available.
4. Open the GMD Service following the path: Start/Program/RAFFAELLO/GMDService.
5. Click on: Action/Open Control Dialog and click in STOP in the section Acquisition Service.
6. Click on: Start Console and the acquisition Console should open.
7. When appears the message “Not taking E0 because the HV is not On” or the message “Not
taking E0 because the detector is not in the correct state” click on Close in the Control
Dialog window and click on the button Test Acquisition; the detector state should “Idle
mode”.
8. Click on button Start Study to give the HV at the detector.
9. Observe that after few seconds in the acquisition console appears the message “waiting 50
seconds for the next E0”.
10. When the count down is finished the detector begins to acquire dark frames. After 20 dark
frames the detector generate the first CGrabDiff, that is the difference between two
consecutive Dark Frames, and it is an indicator of the only noise related to the electronic of
the detector.
11. Click Cancel button in the Acquisition Dialog window and following this path, File/Open/C:\,
open the CGrabDiff.dat image.
60
12. Click the button CGD and read the min, max and mean value of the Horizontal Ratio, and
read the number of the ROI over the threshold.
13. For Giotto image 3D the acceptance limits are:
• Mean value 0.13 ± 0.01
• Max number of ROI over threshold <10
• Max Horizontal Ratio value <= 0.17.
14. For Giotto image 3DL the acceptance limits are:
• Mean value 0.12 ± 0.01
• Max number of ROI over threshold <10
• Max Horizontal Ratio value <= 0.15.
15. After this analysis click on button NFT and with button browse load the CGrabDiff.dat
image.
16. Check the section Save NPS Hor and Save NPS Ver and click on Calculate button.
17. See the Noise Power Spectrum in the horizontal and vertical direction and in the profile
should not appear evident peaks.
Second Step: Image with grid analysis
1. Ensure that the anti-scatter grid is in place.

2. Put 4cm of PMMA on the grid.
3. Set the GMDService in the advanced user following this procedure:
• Close the GMDService if it is open;
• Open the file Enable and set the value at 1 and save;
• Open the GMDService program, now the program is in advanced user and the CGD,
4. Open the GMDService following the path: Start/Program/RAFFAELLO/GMDService
5. Click on the button Test Acquisition;.
6. Click on button Start Study to give the HV at the detector and wait the message “Detector
ready”.
7. Select the exposure parameter: Silver Filter, Large Focus, 26kV, 60mAs and make an
image.
8. Save the image in a directory with name NoiseGrid.dat.
9. Click on button NFT and with button browse load the NoiseGrid.dat image.
61
11. The software calculates the NPS profile in both direction using these analysis parameters:
3D 3DL
Pixel Width 0.085 0.085
ROI Dimension 256 256
ROI Number 16 16
Window Dimension 1024 1024
Column 795 1660
Row 375 760
Vedantham et al.
For each ROIs the software computes the Wiener Spectrum in both directions, using
the average of four rows and columns of the Fourier Space excluding the first two.
The final profile (128 points) is the average of all the 16 profiles (in both directions and one for
each ROI).
62
12. See the Noise Power Spectrum in the horizontal and vertical direction and in the Horizontal
NPS profile should appear only one evident peaks around the position of 3lp/mm, in the
vertical profile should not appear evident peaks.
Horizontal NPS with grid (type 4:1, 31lp/cm)
1.4E-05
1.2E-05
1.0E-05
8.0E-06
a.u.
6.0E-06
4.0E-06
2.0E-06
0.0E+00
0 1 2 3 4 5 6
lp/mm
Good Profile
Horizontal NPS with grid (type 4:1, 31lp/cm)
1.4E-05
1.2E-05
1.0E-05
8.0E-06
a.u.
6.0E-06
4.0E-06
2.0E-06
0.0E+00
0 1 2 3 4 5 6
lp/mm
Bad Profile! Noise Problem!!
63
Third Step: Image without grid analysis
1. Ensure that the anti-scatter grid is NOT in place.

2. Put 4cm of PMMA on the detector surface.
3. Set the GMD Service in the advanced user following this procedure:
• Close the GMD Service if it is open;
• Open the file Enable and set the value at 1 and save;
• Open the GMD Service program, now the program is in advanced user and the CGD,
4. Open the GMD Service following the path: Start/Program/RAFFAELLO/GMDService
5. Click on the button Test Acquisition;.
6. Click on button Start Study to give the HV at the detector and wait the message “Detector
ready”.
7. Select the exposure parameter: Silver Filter, Large Focus, 26kV, 40mAs and make an
image.
8. Save the image in a directory with name NoiseNoGrid.dat.
9. Click on button NFT and with button browse load the NoiseGrid.dat image.
11. See the Noise Power Spectrum in the horizontal and vertical direction and in the Horizontal
NPS profile should not appear evident peaks.
64
Horizontal NPS without grid
1.4E-05
1.2E-05
1.0E-05
8.0E-06
a.u.
6.0E-06
4.0E-06
2.0E-06
0.0E+00
0 1 2 3 4 5 6
lp/mm
.
Good Profile
Horizontal NPS without grid
1.4E-05
1.2E-05
1.0E-05
8.0E-06
a.u.
6.0E-06
4.0E-06
2.0E-06
0.0E+00
0 1 2 3 4 5 6
lp/mm
Bad Profile! Noise Problem!!
65
Reference
• European Guidelines for Quality Assurance in Breast Cancer Screening And Diagnosis Fourth
Edition.
• D.R. Dance et al., “Additional factors for the estimation of mean glandular dose using the UK
mammography protocol”, Phys. Med. Biol., 2000, Vol. 45, 3225-3240.
• D.R. Dance et al., “Further factors for the estimation of mean glandular dose using the United
Kingdom, European and IAEA breast dosimetry protocols”, Phys. Med. Biol., 2009, Vol. 54,
4361-4372.
• EUREF website: www.euref.org
• Vedantham et al. ”Full breast digital mammography with an amorphous silicon-based flat
panel detector: Physical characteristics of a clinical prototype” Med. Phys. 27 .3., March 2000.
66

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IMAGE 3D-3DL

Calibration Procedure and

MANUAL CODE: M 172 T

S.r.l. - Bologna - Italy

CONFORMITY OF THE EQUIPMENT

CE Certificate No.: 7505 0459

CLASSIFICATION OF THE EQUIPMENT

AWS - Acquisition Work station

FFDM - Full Field Digital Mammography

CNR - Contrast-to-Noise Ratio

MGD - Mean Glandular Dose

PMMA - Poly Methyl Methacrylate

RWS - Review Work Station

ROI - Region of Interest

Automatic Exposure Control system (AEC)

Phantom Image Quality Test (ACR)

Signal-to-Noise Ratio (SNR) and Contrast-to-Noise Ratio (CNR)

Detector Response Function and Noise evaluation

kVp Accuracy and Reproducibility

Mean Glandular Dose (MGD)

Image Quality phantom (ACR phantom);

Aluminium sheet of high purity (>99.9%) and 0.2mm thickness;

Tube voltage meter;

Daily Check Daily 40mmPMMA;

from 20 to70 mm (including

Phantom for Image Quality Daily ACR M.A.P. (RMI-156 or

Nuclear Associates 18-220);

Noise Ratio (CNR) from 20 to70 mm (including

45mm); 0.2mmAl sheet;

AEC Reproducibility Six Months 40mmPMMA;

Flat Field Homogeneity Six Months 40mmPMMA;

Artefacts Evaluation Six Months 40mmPMMA;

kVp Accuracy and Reproducibility Yearly kV meter;

Tube Output Yearly Dose meter

Exposure time Yearly 40mmPMMA

12. ensure that the detector is in IDLE Mode;

13. ensure that the detector is in IDLE Mode;

13. ensure that the detector is in IDLE Mode;

16. ensure that the procedure has been started correctly;

2. ensure that the procedure has been started correctly;

6. ensure that the procedure has been started correctly.

12. select the “Large Focal Spot” option;

3. Check that no error messages are displayed on the GIOTTO control.

Next to each number there is an automatic evaluation criteria: OK, BAD.

Control panel for the AEC Test

6. Close the study.

9. Open IMS Quality Control Program;

14. Record these values on the data forms (Chart 1);

Reference Values Table

4. Close the study;

8. Record these values on the data forms (Chart 2);

Potentially Visible Objects in the accreditation phantom

Accreditation Phantom Object Required

Required Test Equipment:

• Aluminium sheets of high purity (99.9%) 0.2mm thickness.

3. Compress the PMMA plates;

6. Close the study;

Data Interpretation and Analysis

9. Open IMS Quality Control Program;

Machine S.N. : --

Tube Manufacturer : ____________Tube Type: _Tube S.N. :_____________

Detector ID: Detector S.N. :_______