Tomosynthesis

Detector Calibration
Procedures Manual

MANUAL CODE: M
Rev. 1.0
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.: [email protected] - Tecnical Dept.: [email protected]

Many thanks for having selected our GIOTTO TOMO Mammography and Tomosynthesis 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 TOMO 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 TOMO
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.: [email protected]
Technical Dept.: [email protected]
Calibration Procedures for Mammography Operating Modality .......4

Long Calibration ......................................................................................... 4

Defects Calibration ..................................................................................... 7
Fast Calibrations......................................................................................... 9
Dose Calibration ....................................................................................... 13

Calibration Procedures for Tomosynthesis Operating Modality ....15

Long Calibration ....................................................................................... 15

Defects Calibration ................................................................................... 18
Fast Calibrations....................................................................................... 20
Dose Calibration ....................................................................................... 23
Calibration Procedures for Mammography Operating Modality

In this section is described the complete procedure for the calibration of the detector: dark frame
subtraction correction, the gain and offset correction, and the defect pixels correction.

Is described also the procedure to perform calibration for the correction of the non-uniformity of the
filters and grid, the calibration for the magnification technique and for the biopsy. At the end the
dose calibration for the compensation of the tube efficiency decay and to correct the calculation of
the mean glandular dose.

Long Calibration
The Long Calibration needs about 1 hour an half to be completed and it will require the acquisition
of 160 images. The task of this calibration is the correction of the gain of every pixel to compensate
for the differences in the read out electronics of the detector, and for the x-ray beam geometry
(Heel-effect).

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;
3. ensure that the automatic x-ray cable is connected (X34 connector);
4. close the RAFFAELLO application if it is open;
5. open the GMDService application from Start->Programs->RAFFAELLO->GMD Service;
6. click on “Service Procedure”, and enter the service password: “giottomdsrv”;
7. ensure that the Acquisition Service is active;
8. remove the plastic cover of x-ray tube and place the dedicated support under the collimator
as shown in figure;
9. place the small square PMMA blocks of 4cm of thickness into the dedicated support,
downstream the x-ray tube as shown in picture;
10. ensure that no foreign object (collimator, dust or other sources of artefacts on the image) is
in field taking a Dark-Sub image (enabling only the Dark Frame correction).
11. stop the study and ensure that the detector is in IDLE Mode;
12. click the button “Calibration”;

13. 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: it shall NOT be “M2”.

• Check if the Acquisition Service Status is “Idle mode”: select the Test Acquisition option in
GMDService 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.
Defects Calibration
The Defects Calibration needs about 10 minutes to be completed and it will require the acquisition
of 10 images. The task of this calibration is the correction of the defects of the detector, in terms of
defective pixel and defective rows or columns.

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 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 11;
2. turn on the X-ray Generator;
3. ensure that the machine is NOT in modality M2;
4. ensure that the automatic x-ray cable is connected (X34 connector);
5. close the RAFFAELLO application if it is open;
6. open the GMDService 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 plastic cover of x-ray tube and place the dedicated support under the collimator
as shown in figure;
10. place the small square PMMA blocks of 4cm of thickness into the dedicated support,
downstream the x-ray tube as shown in picture;

11. ensure that the detector is in IDLE Mode;

12. click the button “Defect Calibration”;
 13. ensure that the procedure has been started correctly. If the calibration procedure does not
start check for possible problems in Troubleshooting section;
14. when the Defect Calibration procedure has finished, remove the PMMA blocks and the
dedicated support.

Troubleshooting
If the Calibration procedure do not start:

• Check the service mode: it shall NOT be “M2”.

• Check if the Acquisition Service Status is “Idle mode”: select the Test Acquisition option in
GMDService 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.
Fast Calibrations

The Fast Calibrations need about 10 minutes each one to be completed and they will
require the acquisition of 10 images each one. The task of this calibration is the correction
of the non-uniformity of the filters and grid.

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 9;
2. turn on the X-ray Generator;
3. ensure that the machine is NOT in modality M2;
4. ensure that the automatic x-ray cable is connected (X34 connector);
5. close the RAFFAELLO application if it is open;
6. open the GMDService 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. install the plastic cover of x-ray tube;
10. insert the anti-scatter grid;
11. place the PMMA plates of 4cm on the image plane to cover all the active area of the
detector as shown in picture;

12. ensure that the detector is in IDLE Mode;

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

15. ensure that the procedure has been started correctly. If the calibration procedure does not
start check for possible problems in Troubleshooting section;
16. when the Fast calibration procedure has finished, repeat the procedure for the other filter;
17. when the Fast calibration procedure for the second filter has finished, insert the
magnification platform and put the PMMA on it;
 18. select the first Small focal spot with magnification platform without grid and then press
Continue;
19. ensure that the procedure has been started correctly. If the calibration procedure does not
start check for possible problems in Troubleshooting section;
20. when the Small focal spot with magnification platform without grid procedure finished,
remove the magnification platform and put the PMMA on the breast support;

21. select the first Biopsy calibration without grid and without biopsy and then press Continue;
22. 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: it shall NOT be “M2”.

• Check if the Acquisition Service Status is “Idle mode”: select the Test Acquisition option in
GMDService 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.
Dose Calibration
The dose calibration needs about 5 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 dosemeter.
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 Mean Glandular Dose done by the unit.

Required Equipment:
Dosemeter (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;

2. ensure that the machine is NOT in modality M2;
3. ensure that the automatic x-ray cable is connected (X34 connector);
4. close the RAFFAELLO application if it is open;
5. open the GMDService application from Start->Programs->RAFFAELLO->GMD Service;
6. click on “Service Procedure”, and enter the service password: “giottomdsrv”;
7. ensure that the Acquisition Service is active;
8. remove the anti-scatter grid;
9. ensure that the detector is in IDLE Mode;
10. click the button “Dose Calibration”;

11. select the “Large Focal Spot” option;

12. ensure that the procedure has been started correctly;
13. After these 3 images the software asks you if you want to acquire a 4th image with the
dosemeter. If you have the dosemeter, read carefully into the message dialog what is the
 anode/filter combination you have to set in the dosemeter 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 xray tube was changed, then click yes;
14. place the dosemeter on the detector surface in the centre of the detector at 6cm from the
chest wall (see the picture below);

15. after having acquired the fourth image with the dosemeter, the software will ask to insert
the dose value (in uGy) read from the dosemeter; if you insert 0, the previous inserted
dosemeter value will be deleted and then the default values will be used instead;

Troubleshooting
If the Calibration procedure do not start:

• Check the service mode: it shall NOT be “M2”.

• Check if the Acquisition Service Status is “Idle mode”: select the Test Acquisition option in
GMDService 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.
Calibration Procedures for Tomosynthesis Operating Modality
In this section is described the complete procedure for the calibration of the detector in
Tomosynthesis operating modality; These calibrations are necessary to obtain a good correction
for the dark frame subtraction, the gain and offset correction, and the defect pixels correction.

Is described also the procedure to make the calibration for the correction of the non-uniformity of
the filters and the Dose calibration for a correct calculation of the Mean Glandular Dose.

Long Calibration
The Long Calibration needs about an half of hour to be completed and it will require the acquisition
of 75 images. The task of this calibration is the correction of the gain of every pixel to compensate
for the differences in the read out electronics of the detector, and for the x-ray beam geometry
(heel effect).

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;
3. ensure that the automatic x-ray cable is connected (X34 connector);
4. close the RAFFAELLO application if it is open;
5. open the GMDService application from Start->Programs->RAFFAELLO->GMD Service;
6. click on “Service Procedure”, and enter the service password: “giottomdsrv”;
7. ensure that the Acquisition Service is active;
8. remove the plastic cover of x-ray tube and place the dedicated support under the collimator
as shown in figure;
9. place the small square PMMA blocks of 4cm of thickness into the dedicated support,
downstream the x-ray tube as shown in picture;
 10. ensure that the detector is in IDLE Mode;
11. click the button “Calibration”;

12. 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: it shall NOT be “M2”.

• Check if the Acquisition Service Status is “Idle mode”: select the Test Acquisition option in
GMDService 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.
Defects Calibration
The Defects Calibration needs about 5 minutes to be completed and it will require the acquisition of
10 images. The task of this calibration is the correction of the defects of the detector, in terms of
defective pixel and defective rows or columns.

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 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 11;
2. turn on the X-ray Generator;
3. ensure that the machine is NOT in modality M2;
4. ensure that the automatic x-ray cable is connected (X34 connector);
5. close the RAFFAELLO application if it is open;
6. open the GMDService 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 plastic cover of x-ray tube and place the dedicated support under the collimator
as shown in figure;
10. place the small square PMMA blocks of 4cm of thickness into the dedicated support,
downstream the x-ray tube as shown in picture;

11. ensure that the detector is in IDLE Mode;

12. click the button “Defect Calibration”;
 13. 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: it shall NOT be “M2”.

• Check if the Acquisition Service Status is “Idle mode”: select the Test Acquisition option in
GMDService 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.
Fast Calibrations
The Fast Calibrations need about 5 minutes each one to be completed and they will require the
acquisition of 10 images each one. The task of this calibration is the correction of the non-
uniformity of the filters.

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 six months.

Procedure:

1. If the Long Calibration has been done just now, skip the following steps and go directly to
step 11;
2. turn on the X-ray Generator;
3. ensure that the machine is NOT in modality M2;
4. ensure that the automatic x-ray cable is connected (X34 connector);
5. close the RAFFAELLO application if it is open;
6. open the GMDService 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 plastic cover of x-ray tube and place the dedicated support under the collimator
as shown in figure;
10. place the small square PMMA blocks of 4cm of thickness into the dedicated support,
downstream the x-ray tube as shown in picture;

11. ensure that the detector is in IDLE Mode;

12. click the button “Fast Calibration”;
 13. Select the first filter and then press Continue;

14. ensure that the procedure has been started correctly;

15. when the Fast calibration procedure has finished, repeat the procedure for the other filter (if
present);

Troubleshooting
If the Calibration procedure do not start:

• Check the service mode: it shall NOT be “M2”.

• Check if the Acquisition Service Status is “Idle mode”: select the Test Acquisition option in
GMDService 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.
Dose Calibration
The dose calibration needs about 5 minutes to be completed. The software will let you acquire 3
images. These images are useful to optimize the reconstruction processing.

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;
2. ensure that the machine is NOT in modality M2;
3. ensure that the automatic x-ray cable is connected (X34 connector);
4. close the RAFFAELLO application if it is open;
5. open the GMDService application from Start->Programs->RAFFAELLO->GMD Service;
6. click on “Service Procedure”, and enter the service password: “giottomdsrv”;
7. ensure that the Acquisition Service is active;
8. ensure that the detector is in IDLE Mode;
9. ensure that no absorbing material is present in field;
10. click the button “Dose Calibration”;

11. 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: it shall NOT be “M2”.

• Check if the Acquisition Service Status is “Idle mode”: select the Test Acquisition option in
GMDService 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.