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Quality Control ManualMAMMOMAT Novation DR

The original version of this operator manual was written in the Ger-man language.

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This document ist the confidential property of Siemens AG MedicalSolutions.No part of it may be transmitted, reproduced, published, or used byother persons without the permission of Siemens AG MedicalSolutions.

MAMMOMAT Novation DR

SPB7-250.623.02.04.02

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Table of Contents

MAMMOMAT Novation DR 1SPB7-250.623.02.04.02

Table of Contents

List of tables

List of figures

List of common abbreviations

IntroductionMammography Equipment Evaluation (MEE) - Medical physicist (MP)................................. 13Annually or every six months - Medical physicist (MP) ......................................................... 13Weekly - Technologist (T) ...................................................................................................... 13When needed - Technologist (T)............................................................................................ 13Recommended frequency of QC tests.................................................................................. 14Important notes ..................................................................................................................... 15Recommended corrective action........................................................................................... 15Documents required.............................................................................................................. 15Equipment required ............................................................................................................... 16

Startup and loginStarting the system from the off state .................................................................................. 17Starting the system from standby mode............................................................................... 17

Performing an examinationProcedure .............................................................................................................................. 18

PrerequisitesObjective ............................................................................................................................... 20Equipment required ............................................................................................................... 20Procedure .............................................................................................................................. 20Performance criteria and corrective action ............................................................................ 20

Test 1: Clinical settingsObjective ............................................................................................................................... 21Procedure .............................................................................................................................. 21

Test 2: Mechanical inspection and follow-upObjective ............................................................................................................................... 22Equipment required ............................................................................................................... 22Procedure .............................................................................................................................. 22Performance criteria and corrective action ............................................................................ 24

Test 3: CompressionObjective ............................................................................................................................... 25Equipment required ............................................................................................................... 25Procedure .............................................................................................................................. 25Performance criteria and corrective action ............................................................................ 26

Table of Contents

2 Quality Control ManualSPB7-250.623.02.04.02

Test 4: Chest wall missed tissueObjective................................................................................................................................ 27Equipment required ............................................................................................................... 27Procedure .............................................................................................................................. 27Performance criteria and corrective action ............................................................................ 28

Test 5: Compression plate alignmentObjective................................................................................................................................ 29Equipment required ............................................................................................................... 29Procedure .............................................................................................................................. 29Performance criteria and corrective action ............................................................................ 30

Test 6: Collimator assessmentObjective................................................................................................................................ 31Equipment required ............................................................................................................... 31Optional equipment ............................................................................................................... 31Procedure .............................................................................................................................. 31Performance criteria and corrective action ............................................................................ 36

Test 7: Tube voltage measurement and reproducibilityObjective................................................................................................................................ 37Equipment required ............................................................................................................... 37Procedure .............................................................................................................................. 37Calculations............................................................................................................................ 38Performance criteria and corrective action ............................................................................ 39

Test 8: Artifact detectionObjective................................................................................................................................ 40Equipment required ............................................................................................................... 40Procedure .............................................................................................................................. 40Performance criteria and corrective action ............................................................................ 40

Test 9: AEC: Safety testObjective................................................................................................................................ 41Equipment required ............................................................................................................... 41Procedure .............................................................................................................................. 41Performance criteria and corrective action ............................................................................ 42

Test 10: AEC: Reproducibility of automatic exposure controlObjective................................................................................................................................ 43Equipment required ............................................................................................................... 43Procedure .............................................................................................................................. 43Performance criteria and corrective action ............................................................................ 44

Test 11: AEC: Long-term reproducibility of automatic exposure controlObjective................................................................................................................................ 45Equipment required ............................................................................................................... 45Procedure .............................................................................................................................. 45Performance criteria and corrective action ............................................................................ 46

Table of Contents


Test 12: AEC: Tracking testObjective ............................................................................................................................... 47Equipment required ............................................................................................................... 47Procedure .............................................................................................................................. 47Performance criteria and corrective action ............................................................................ 48

Test 13: Linearity and noise evaluationObjective ............................................................................................................................... 49Equipment required ............................................................................................................... 49Procedure .............................................................................................................................. 49Performance criteria and corrective action ............................................................................ 51

Test 14: Detector uniformityObjective ............................................................................................................................... 52Equipment required ............................................................................................................... 52Procedure .............................................................................................................................. 52Performance criteria and corrective action ............................................................................ 53

Test 15: Phantom image qualityObjective ............................................................................................................................... 54Equipment required ............................................................................................................... 54Procedure .............................................................................................................................. 54Analysis ................................................................................................................................. 56Performance criteria and corrective action ............................................................................ 56

Test 16: Phantom image quality – Maximum resolutionObjective ............................................................................................................................... 57Equipment required ............................................................................................................... 57Procedure .............................................................................................................................. 57Performance criteria and corrective action ............................................................................ 58

Test 17: Mean glandular doseObjective ............................................................................................................................... 59Equipment required ............................................................................................................... 59Requirements ........................................................................................................................ 59Procedure .............................................................................................................................. 59Performance criteria and corrective action ............................................................................ 60

Test 18: Ghost image evaluationObjective ............................................................................................................................... 61Equipment required ............................................................................................................... 61Requirements ........................................................................................................................ 61Procedure .............................................................................................................................. 61Performance criteria and corrective action ............................................................................ 63

Test 19: AWS monitor checkObjective ............................................................................................................................... 64Equipment required ............................................................................................................... 64Procedure .............................................................................................................................. 64Performance criteria and corrective action ............................................................................ 66

Table of Contents


Test 20: Printer checkObjective................................................................................................................................ 67Equipment required ............................................................................................................... 67Procedure .............................................................................................................................. 67Performance criteria and corrective action ............................................................................ 67

Appendix 1 – Test formsTest form Test 1: Clinical settings..........................................................................71Test form Test 2: Mechanical inspection and follow-up ........................................73

Mechanical inspection and follow-up..................................................................................... 74

Test form Test 3: Compression .............................................................................75Compression.......................................................................................................................... 76

Test form Test 4: Chest wall missed tissue...........................................................77Chest wall missed tissue....................................................................................................... 77

Test form Test 5: Compression plate alignment....................................................79Compression plate overlap .................................................................................................... 79

Test form Test 6: Collimator assessment ..............................................................81

Test form Test 7: Tube voltage measurement and reproducibility ........................85Tube voltage and reproducibility ............................................................................................ 86

Test form Test 8: Artifact detection.......................................................................87Clinically relevant artifacts ..................................................................................................... 87

Test form Test 9: AEC: Safety test ........................................................................89AEC: Safety test .................................................................................................................... 89

Test form Test 10: AEC: Reproducibility of automatic exposure control ...............91AEC: Reproducibility of automatic exposure control ............................................................. 92

Test form Test 11: AEC: Long-term reproducibility of automatic exposure control ....................................................................................................................93

AEC: Long-term reproducibility of automatic exposure control ............................................. 93

Test form Test 12: AEC: Tracking test ...................................................................95Object thickness and tube voltage compensation................................................................. 95

Test form Test 13: Linearity and noise evaluation .................................................97Linearity ................................................................................................................................. 98Noise evaluation .................................................................................................................... 99

Test form Test 14: Detector uniformity ...............................................................101Detector uniformity.............................................................................................................. 102Results from ROI statistics.................................................................................................. 102

Test form Test 15: Phantom image quality ..........................................................103Contrast resolution .............................................................................................................. 103

Test form Test 16: Phantom image quality – Maximum resolution .....................105Resolution............................................................................................................................ 105

Test form Test 17: Mean glandular dose .............................................................107Mean glandular dose ........................................................................................................... 109

Test form Test 18: Ghost image evaluation .........................................................111Ghost image evaluation ....................................................................................................... 112

Table of Contents


Test form Test 19: AWS monitor check .............................................................. 113AWS monitor check and viewing conditions ....................................................................... 113

Test form Test 20: Printer check ......................................................................... 115

Appendix 2 – Test forms for installation

Test form Test 1: Clinical settings ....................................................................... 121

Test form Test 2: Mechanical inspection and follow-up ...................................... 123Mechanical inspection and follow-up................................................................................... 124

Test form Test 3: Compression ........................................................................... 125Compression ....................................................................................................................... 126

Test form Test 4: Chest wall missed tissue ........................................................ 127Chest wall missed tissue..................................................................................................... 127

Test form Test 5: Compression plate alignment ................................................. 129Compression plate overlap .................................................................................................. 129

Test form Test 6: Collimator assessment............................................................ 131

Test form Test 8: Artifact detection..................................................................... 135Clinically relevant artifacts ................................................................................................... 135

Test form Test 11: AEC: Long-term reproducibility of automatic exposure control.................................................................................................................. 137

AEC: Long-term reproducibility of automatic exposure control ........................................... 137

Test form Test 12: AEC: Tracking test................................................................. 139Object thickness and tube voltage compensation............................................................... 139

Test form Test 13: Linearity and noise evaluation ............................................... 141Linearity ............................................................................................................................... 142Noise evaluation .................................................................................................................. 143

Test form Test 14: Detector uniformity ............................................................... 145Detector uniformity ............................................................................................................. 146Results from ROI statistics.................................................................................................. 146

Test form Test 15: Phantom image quality.......................................................... 147Contrast resolution .............................................................................................................. 147

Test form Test 16: Phantom image quality – Maximum resolution ..................... 149Resolution............................................................................................................................ 149

Test form Test 17: Mean glandular dose............................................................. 151Mean glandular dose ........................................................................................................... 153

Test form Test 18: Ghost image evaluation......................................................... 155Ghost image evaluation ....................................................................................................... 156

Test form Test 19: AWS monitor check .............................................................. 157AWS monitor check and viewing conditions ....................................................................... 157

Test form Test 20: Printer check ......................................................................... 159

Table of Contents


Tables


List of tables

Table 1 Frequency of tests .................................................................................... 14Table 2 Object score criteria.................................................................................. 56

Tables


Figures


List of figures

Figure 1 Patient registration symbol...................................................................... 18

Figure 2 Patient Registration window ................................................................... 18

Figure 3 Examination task card ............................................................................. 19

Figure 4 Error indicator lamp symbol..................................................................... 23

Figure 5 Placing the coin ....................................................................................... 27

Figure 6 Admissible compression plate overlap.................................................... 30

Figure 7 Position of the DXR................................................................................. 32

Figure 8 X-ray image of the DXR........................................................................... 33

Figure 9 Placing the coins ..................................................................................... 34

Figure 10 Light field luminance measurement........................................................ 35

Figure 11 Mounting the magnification table............................................................ 35

Figure 12 Adjusting the magnification table ............................................................ 36

Figure 13 Positioning the phantom and dose sensor .............................................. 49

Figure 14 ROIs on the detector............................................................................... 53

Figure 15 Positioning the PMMA phantom ............................................................. 54

Figure 16 Potentially visible objects in the ACR phantom....................................... 55

Figure 17 Placing the resolution phantom............................................................... 57

Figure 18 Positioning the PMMA phantom and the dosimeter............................... 60

Figure 19 Second exposure..................................................................................... 62

Figure 20 Third exposure after 180 seconds........................................................... 63

Figure 21 Arrangement of squares.......................................................................... 64

Figure 22 Arrangement of resolution bar pattern .................................................... 65

Figures


Abbreviations


List of common abbreviations

AEC Automatic Exposure Control

AEC D Button AEC Detail Mode Button

AEC H Button AEC Low Dose Button

AWS Acquisition Workstation

CNR Contrast-to-Noise Ratio

FD Flat Detector

FFDM Full-Field Digital Mammography

HVL Half Value Layer

mAs Milliampere/second

MEE Mammography Equipment Evaluation

Mo/Mo Molybdenum/Molybdenum

Mo/Rh Molybdenum/Rhodium

MP Medical Physicist

PMMA Polymethylmethacrylate

ROI Region Of Interest

SID Source-Image Distance

SMPTE Society of Motion Picture and Television Engineers

SNR Signal-to-Noise Ratio

SP Special Systems

T Technologist = user

W/Rh Tungsten/Rhodium

Abbreviations


For notes

Introduction


Introduction

Mammography Equipment Evaluation (MEE) - Medical physicist (MP)

The MEE tests of the MAMMOMAT Novation DR should be performed whenever a new MAMMOMAT Novation DR system has been installed and whenever changes that might affect system performance have been made to an existing system. For ex-ample, the MEE tests should be performed if the system has been disassembled and reassembled or if major components have been changed or repaired.

The MEE tests of the MAMMOMAT Novation DR involve the performance of all QC procedures in this Quality Control Manual, ensuring that minimum image quality cri-teria are met before the system is used on patients. For each part of the MEE tests, action levels that must be met are specified. The values determined during the MEE tests are to be used as baseline values and then referred to during future tests to de-termine if equipment performance is stable or not.

The Quality Control Manual is based on the EUREF: Digital Addendum to the Europe-an Protocol, Version 1.0.

Annually or every six months - Medical physicist (MP)These tests may be performed by the MP. The tests include comparisons to values measuring during the MEE tests. This is to ensure that system performance has not degraded.

Weekly - Technologist (T)These tests shall be performed on a weekly basis. They should always be carried out on the same working day of the week before patients are examined with the MAM-MOMAT Novation DR system.

When needed - Technologist (T)These tests shall be performed whenever there is suspicion of artifacts or incorrect settings to determine if patients can be examined.

Introduction

14 Quality control manualSPB7-250.623.02.04.02

Recommended frequency of QC testsSince some tests have already been performed in the factory when a new system is installed, not all MEE tests but only those tests listed in Appendix 2 need to be per-formed.

Table 1-1 describes when the different tests are to be performed and by whom.

Table 1 Frequency of tests

For the qualification of the printer please follow the printer manufacturer's recom-mendations.

Test MEE Annually Every six months

Weekly

1. Clinical settings MP MP

2. Mechanical inspection and follow-up MP MP

3. Compression MP MP

4. Chest wall missed tissue MP

5. Compression plate alignment MP MP

6. Collimator assessment MP MP

7. Tube voltage measurement and reproducibility MP MP

8. Artifact detection MP T

9. AEC: Safety test MP MP

10. AEC: Reproducibility of automatic exposure control MP MP

11. AEC: Long-term reproducibility of automatic exposure control

MP T

12. AEC: Tracking test MP MP

13. Linearity and noise evaluation MP MP

14. Detector uniformity MP T

15. Phantom image quality MP MP

16. Phantom image quality – Maximum resolution MP MP T

17. Mean glandular dose MP MP

18. Ghost image evaluation MP MP

19. AWS monitor check MP MP

20. Printer check MP MP

Introduction


Important notesBefore performing any quality control tests, make sure you are thoroughly familiar with the Operator Manual for MAMMOMAT Novation DR.

The test parameters used and the test results obtained can be entered in the en-closed test form tables (Appendix).

Recommended corrective actionIf the result of a test described in this manual fails to meet the action level specified, the problem must be determined and corrected before further examinations are per-formed with the system. The result shall be reported to a service engineer and appro-priate corrective action shall be taken to address the problem.

If a result meets the action level, but there is a clear degradation compared to the re-sult obtained during the previous test, the system may continue to be used, but the degradation shall be reported to a service engineer. It is recommended that corrective action be taken within 30 days.

More detailed information can be found at the end of each test description.

Documents required• MAMMOMAT Novation DR Operator Manual

• syngo MammoReport Quality Control Manual (optional - for systems that use a softcopy reporting station)

Introduction


Equipment requiredThe test equipment listed below must always display a valid calibration stamp. Ensure compliance with the described measurement and calibration intervals.

• Mammography line pair phantom (2 to 10 lp/mm)

• PMMA phantom that attaches to the collimator (40 mm thick)*

• Three PMMA phantoms 100 x 100 mm, (each 20 mm thick)*

• PMMA phantom 100 x 100 mm, (10 mm thick)*

• Lint-free, non-woven cotton or gauze (100% cotton)

• Water or lukewarm diluted aqueous solution of household dishwashing liquid

• Illuminance meter

• Densitometer

• Non-invasive digital kV meter

• Dosimeter, calibrated at the anode/filter combinations used

• Film or CR cassette, 24 x 30 cm or larger

• Magnification table (optional)

• Compression plate simulator**

• 2 mm steel plate (FD object table size)*

• 2 mm steel plate (3 x 10 cm)*

• Six sheets of 99.9% pure aluminum, (0.1 mm thick)

• Six coins

• Timer (stop watch)

• Ruler with millimeter scale

• RMI-156 phantom (ACR phantom)

• Foam rubber or other compressible phantom

• Compression plate 24 x 30 cm ***

• Unfors DXR+ X-ray ruler (optional)

* Provided with every system.

** Provided with every system. Allows exposures to be performed without compression plate attached.

*** If not available, you may also use a different plate (except spot compression plate) that is suitable for Opcomp operation

Startup and login


Startup and loginThe MAMMOMAT Novation DR system can be started either from the off state (i.e. from being completely shut down) or from standby mode.

Starting the system from the off state

CAUTION!Incorrect operation can lead to image quality losses.

Allow the MAMMOMAT Novation DR to warm up for at least 60 min-utes to ensure optimal results during the image quality test or calibra-tion.

1. Switch the main power switch in the room on.

2. Wait approx. 5 minutes.

3. Press the On button on the control console to enable the MAMMOMAT Novation

DR.The internal monitoring system automatically performs a functional test of the MAMMOMAT Novation DR.

4. Wait until “DR” is displayed on the control console.

5. Switch on the workstation and the monitor at the acquisition workstation.

6. Log in at the workstation.

7. Allow the MAMMOMAT Novation DR to warm up for at least 60 minutes to obtain optimum image quality.

Starting the system from standby mode1. Press the On button on the control console to enable the

MAMMOMAT Novation DR.

2. Wait until “DR” is displayed on the control console.

3. Switch on the workstation and the monitor at the acquisition workstation, if they are switched off. The workstation boots up.

4. To ensure optimum image quality, allow the MAMMOMAT Novation DR to warm up for at least 5 minutes. The internal monitoring system automatically performs a functional test of the MAMMOMAT Novation DR."dr" is displayed on the film density display on the control panel to indicate that the communication with the MAMMOMAT Novation DR system is functioning.

5. Log in at the workstation.

NOTE!NOTE!The room must be equipped with a dimmer switch to dim the light in the room when necessary.

Performing an examination


Performing an examinationProcedure

1. Log in observing the safety information in the Startup and login section.

Figure 1 Patient registration symbol

2. Click the button shown.The Patient Registration window opens.

Figure 2 Patient Registration window

Performing an examination


3. Enter the required examination data.

4. Click the Exam button.This will take you back to the Examination task card.

Figure 3 Examination task card

5. Select the Procedure required for your examination from the selection list (1). The projection sequence preset for the procedure is displayed in the PAO selec-tion list.

6. The projection views (2) to be performed are displayed as buttons on the Images subtask card according to their sequence.

7. The exposure is release by double-clicking the first projection view on the Imag-es subtask card.

8. Position the swivel arm of the MAMMOMAT according to the first required pro-jection view.

9. Position the phantom on the object table according to the view selected at the acquisition workstation.

10. Release the exposure. To do this, keep both exposure release buttons on the control console pressed until the acoustic signal has sounded and stopped.Radiation is released and the first image is acquired.At the end of the exposure the acquired image is displayed in the image area.

NOTE!NOTE!The radiation indicator may light up only when the exposure release button is pressed. Observe radiation protective measures.

1

2

Prerequisites


Prerequisites

ObjectiveTo determine if the detector is damaged or dusty and has been calibrated.

Equipment requireda) Lint-free, non-woven cotton or gauze (100% cotton)

b) Water or lukewarm diluted aqueous solution of household dishwashing liquid

Procedure1. Wipe the detector surface with a wet lint-free non-woven cotton cloth or cotton

pad (100% cotton). For moistening, use water or a lukewarm diluted aqueous so-lution of household dishwashing liquid.

NOTE!NOTE!Do not spray the unit! The cleaning fluid must under no circumstances penetrate into the unit.

2. Calibrate the detector according to the chapter Calibrating the detector in the MAMMOMAT Novation DR Operator Manual. When doing so, use the main an-ode/filter combination typically used in clinical practice (see Test 1: Clinical set-tings).

Performance criteria and corrective actionThere must be no visible damage.

No artifacts must be visible on the calibration images.

Test 1: Clinical settings


Test 1: Clinical settings

Objective To determine the main settings typically used in clinical practice.

Procedure 1. Determine the main exposure technique used and record it in the Test form, page

71.

2. Determine the main anode/filter combination used and record it in the Test form, page 71.

NOTE!NOTE!This anode/filter combination must be used to perform the detector gain calibration.

3. Determine the current Opdose settings and record them in the Test form, page 71.Using the service software, you can read under "Configuration / Miscellaneous / Panel programming“ the maximum value for the compression height that can be used before the system switches to the next higher Opdose program. The set-tings for each Opdose program are displayed upon actuation of the correspond-ing button at the control console.

Test 2: Mechanical inspection and follow-up



ObjectiveMEE:

• To ensure that the system is mechanically intact and all displays on the con-trol panel and stand are functioning properly.

Annual test:

• To ensure that the system is mechanically intact and all displays on the con-trol panel and stand are functioning properly.

• To look for trends in the results of all non-annual tests.

Equipment requiredMEE:

a) Compression plate 24 x 30

Annual test:

a) Test reports of the daily tests

b) Compression plate 24 x 30

Procedure1. Check that there is no visible damage to the cables. Record the result in the Test

form, page 73.

2. Check that the control panel lights up, indicating that the power is switched on. Record the result in the Test form, page 73.



3. Turn the swivel arm 180° so that the tube head is straight upside down. Lower the system as close to the floor as possible. Check that the error indicator lamp (see Figure 4) is lit. Raise the system again, turn the swivel arm back and check that the lamp goes out. Record the result in the Test form, page 73.

Figure 4 Error indicator lamp symbol

4. Check that motorized movements are performed smoothly and properly. Record the result in the Test form, page 73.

5. Check that the height adjustment and rotation of the swivel arm system are dis-abled when the displayed compression force is ≥ 3 kp. Record the result in the Test form, page 73.

6. Perform a functional check of the EMERGENCY STOP button. Note that with the button depressed all motorized movements must be disabled. Record the result in the Test form, page 73.

7. Check that manual compression/decompression functions properly. Record the result in the Test form, page 73.

8. Check that the decompression button on the control console functions correctly. Record the result in the Test form, page 73.

9. There must be no sharp edges or cracks that could create sharp edges on the compression plates, the detector, etc. which could injure the patient. Record the result in the Test form, page 73.

10. The edges of the radiation shield must be clearly defined so that operating staff is aware of the outline. Record the result in the Test form, page 73.

11. The focal spot position must be clearly marked by the red dot on the tube assem-bly. Record the result in the Test form, page 73.

12. Motorized vertical movement must be possible even with the patient leaning against the breast support platform (without compression applied). Record the result in the Test form, page 73.

13. All foot switches must function properly. Record the result in the Test form, page 73.

14. All attachments must latch securely and their locks must function effectively. Record the result in the Test form, page 73.



Performance criteria and corrective action

Annual test: Follow-up checks

The daily test charts must be inspected. Look for trends, deviations, etc.

If these charts indicate a decrease in image quality over time, the physicist should compare these results with the tests he/she has performed himself/herself. If a level has degraded over time but is still within the action levels specified in this document, the system may continue to be used, but the degradation must be reported to a Sie-mens customer service engineer. In addition, it is recommended that the system be recalibrated.

If any of the specified performance criteria is not fulfilled, the cause of the prob-lem must be identified and the problem must be corrected by a Siemens cus-tomer service engineer. The criterion must then be successfully retested by the MP before further examinations are performed with the system.

Test 3: Compression


Test 3: Compression

ObjectiveTo ensure that the compression device functions properly

Equipment requireda) Foam rubber or other compressible phantom


c) PMMA phantom (2 x 20 mm plexi PMMA)

Procedure1. Create a new patient record in the local database.

Fill in: Last Name: Test_ThreeFirst Name: CompressionPatient ID: Day+time when the test is performed

(Example: 200411281350)DOB: 05 05 1955Sex: Other

2. Choose the "FD QC Raw" procedure.

3. Select Opdose program 3 on the control panel.

4. Place the foam rubber on the FD object table.

5. Mount the compression plate.

6. Run the compression plate against the FD object table and compress the phan-tom beyond the Opcomp threshold until compression stops. Record the value shown on the display of the stand base in the Test form, page 75.

7. Wait 1 minute and then record the displayed value in the Test form, page 75.

8. Activate automatic decompression on the control panel and make an exposure.

9. Check that the compression plate moves up at the end of the exposure and record the result in the Test form, page 75.

10. Remove the foam rubber and place the PMMA phantom (40 mm) on the object table.

11. Compress with a force of approx. 7 kp.

12. Deactivate automatic decompression on the control panel and make an expo-sure.

Test 3: Compression


13. Check that the compression plate does not move up at the end of the exposure and record the result in the Test form, page 75.

14. Read the displayed thickness off the image and record it in the Test form, page 75.

15. Close the patient by clicking the Close patient button.

Performance criteria and corrective action

Annual test: Follow-up checks

The maximum adjustable force must be 19 - 21 kp.The adjustable force must not vary by more than 2 kp within one minute.Activation and deactivation of automatic decompression must function properly.The compression height must be displayed in the image with an accuracy of ± 3 mm.


Test 4: Chest wall missed tissue



ObjectiveTo ensure that the chest wall dead space is within a tolerance range of max. 5 mm.

Equipment requireda) Coin

b) Compression plate simulator


Fill in: Last Name: Test_FourFirst Name: Chest Wall Missed TissuePatient ID: Day+time when the test is performed



3. Place the coin on the FD object table so that its edge is exactly tangent to the chest wall edge of the FD object table. See Figure 5.

Figure 5 Placing the coin

4. Mount the compression plate simulator.

5. Make an exposure with 28 kV, 50 mAs, Mo/Mo.

6. Using the measuring tool of the AWS, measure the diameter of the coin and the distance from the rear coin edge to the front detector edge. Record the values in the Test form, page 77.


< 5

mm

Detector

CoinChest wall edge

Carbonfibercover



Performance criteria and corrective actionThe distance should be less than or equal to 5 mm.


Test 5: Compression plate alignment



ObjectiveTo ensure that the position of the chest wall side of each compression plate allows for complete imaging of chest wall tissues.

Equipment requireda) All compression plates delivered with the unit

b) Ruler

c) PMMA phantom 2 x 20 mm


Fill in: Last Name: Test_FiveFirst Name: Compression Plate AlignmentPatient ID: Day+time when the test is performed


2. Mount a compression plate.

3. Measure the overlapping distance from the chest wall edge of the compression plate to the edge of the object table on the chest wall side.The distance must be measured in the middle of the compression plate.

4. Add to the measured value the value a from Test 4: Chest wall missed tissue and record it in the Test form, page 79.

5. Place the PMMA phantom (40 mm) centrally on the detector, flush with the front edge.

6. Compress to approx. 7 kp.


8. Check if the chest wall edge of the compression plate is visible in the image.

9. Repeat steps 2 through 6 for the remaining compression plates.



Figure 6 Admissible compression plate overlapα: Value for the dead space determined in Test 4: Chest wall missed tissue


Performance criteria and corrective actionThe compression plate overlap shall be less than or equal to 6.5 mm. Also, the chest wall edge of the compression plate must not be visible on the image receptor.


<6.5mm

a

Test 6: Collimator assessment



ObjectiveTo ensure that the collimator does not allow significant radiation beyond the edges of the image detector.

Equipment requiredThe test can be performed in two different ways:

a) With X-ray ruler:

• Unfors DXR+ X-ray ruler

• Compression plate simulator


b) With film or CR cassette This variant requires a film processor for the X-ray film.

• Six coins

• Ruler

• Film or CR cassette

• Compression plate simulator


Optional equipmenta) Magnification table


Fill in: Last Name: Test_SixFirst Name: Collimator AssessmentPatient ID: Day+time when the test is performed



3. Make sure that the compression plate simulator is mounted.

4. Swivel the X-ray tube into the 0° position.

With X-ray ruler (steps 5 - 11)

5. Place the DXR according to Figure 7 position 1 (arrow labeled "X-ray" on the DXR must point to the center of the detector)



Figure 7 Position of the DXR

6. Activate the light field. Align the red line on the DXR with the edge of the light field. Enter the value 0 in the "Value light field“ column in the Test form, page 81.


8. View the display on the DXR and record the value next to the last visible digit on the scale in the "Value radiation field“ column in the Test form, page 81 (last digit shows the edge of the radiation field).

9. View the image on the workstation. Change the window levels until the scale in the DXR is visible, see Figure 8. Record the last visible number at the end of the active area in the "Value detector field“ column in the Test form, page 81 (scale indicates the edge of the active detector area).



Figure 8 X-ray image of the DXR

10. Repeat steps 5 to 9 on all four edges of the detector Figure 7 Position 2 to 4.

11. Repeat steps 5 to 10 with W/Rh.

With film or CR cassette (steps 12 - 20)

12. Place a film or CR cassette (24 x 30 or larger) on top of the FD-object table and turn it so that the mid-points of the light field edges are within the film/cassette dimensions; see Figure 9.

13. Press the light field button. Place four coins on the film / the CR cassette as mark-ers on the mid-point of each light field edge. The edges of the coins must be tan-gent to the outer light field edges. See Figure 9. Place two additional coins for orientation!

End of active area

Edge of light field

X-ray scale

Last visible number



Figure 9 Placing the coins


15. Develop the film or CR cassette and mark it with the anode/filter combination used.

16. Using a ruler, measure the distance e on the developed film / the CR cassette for each coin, see Figure 9, and record the value in the "Value light field“ column in the Test form, page 81. Also measure the distance f and record the value in the "Value radiation field“ column in the Test form, page 81.

17. Measure for each coin the distance g on the monitor of the acquisition worksta-tion see Figure 9, and record the value in the "Value detector field“ column in the Test form, page 81.

a

b

g

f

e

Film cassetteLight field

Radiation field

Image receptor area / detector



18. Repeat steps 12 - 17 with W/Rh.


20. Perform the calculation according to the test form and check the values.

21. Use an illuminance meter to measure the light intensity of the radiation field on the object table in the four areas specified in Figure 10. Record the result in the Test form, page 81.

Figure 10 Light field luminance measurement

Test with magnification table (optional equipment)

22. Mount the magnification table by placing the table forks into the slots (see Posi-tion 1, Figure 11) on both sides of the FD object table and slide it in.

Figure 11 Mounting the magnification table

Light field

1 2

34

1



23. Slide the magnification carbon fiber top into the lower compartment for magnifi-cation factor 1.5 (see Figure 12).

Figure 12 Adjusting the magnification table

24. Create a new patient record in the local database.Fill in: Last Name: Test_Six_Mag

First Name: Collimator AssessmentPatient ID: Day+time when the test is performed


25. Repeat the test from step 2 using one of the two procedures (X-ray ruler/film or CR cassette). Step 21 is inapplicable.

Performance criteria and corrective action• The total radiation field/light field misalignment (sum of misalignments on op-

posite sides) shall not exceed 2% of the SID (13 mm).

• The radiation field shall not extend beyond any edge of the image receptor by more than 2% of the SID (13 mm). Note that this value is a maximum overlap for individual sides and no summing of opposite sides shall be made in this case.

• The mean value of the light intensity shall be more or equal to 160 lux.

If any of these tests fail, the cause must be identified and the problem must be corrected before further examinations are performed with the system. The result must be reported to a service engineer. In addition, appropriate cor-rective action shall be taken to address the problem. After the problem has been corrected, a medical physicist or technologist must conduct the test again to confirm that the problem has indeed been corrected.

Magnification factor 1.5

Test 7: Tube voltage measurement and reproducibility



ObjectiveCheck that the accuracy of the displayed tube voltage value complies with the speci-fications.

Equipment requireda) Calibrated, non-invasive digital kV meter


c) 2 mm steel plate (object table size)


Fill in: Last Name: Test_SevenFirst Name: Tube VoltagePatient ID: Day+time when the test is performed



3. Ensure that the Mammomat system was switched on at least 15 minutes before the test is performed.


5. Place the 2 mm steel plate on the detector.

NOTE!NOTE!The 2 mm steel plate must cover the detector during the entire length of the test. Otherwise, detector saturation or ghosting will occur.



6. Place the kV sensor on top of the steel plate, 40 mm from the chest wall side and centered.

7. Take four successive exposures with the following setting: 28 kV, 50 mAs and Mo/Mo.Enter the kV value for the tube voltage measured with the kV meter into the Test form, page 85.

8. Take four exposures with the following settings: 24/27/30/33 kV, each exposure with 50mAs and Mo/Mo.Enter the kV value for the tube voltage measured with the kV meter into the Test form, page 85.


NOTE!NOTE!Note that these measurements must be performed consecutively and must be completed within an hour.

Calculations1. Check that the accuracy of the measured kV values for the different kV settings

is within ± 1.0 kV of the corresponding nominal value.

2. Calculate the mean value for the tube voltage at 28 kV:

kVi = Measured value from measurement i

3. Check that the measured kV value is within ± 0.5 kV of the kV-mean value:

(kVmean– 0.5 kV) ≤ kVmeas ≤ (kVmean+ 0.5 kV)

kVmeankV1 kV2 kV3 kV4+ + +

4---------------------------------------------------------------------------=



Performance criteria and corrective actionAccuracy: The measured tube voltage value shall not deviate by more

than ± 1.0 kV from the selected nominal value.

Reproducibility: The measured tube voltage value shall not deviate by more than ± 0.5 kV from the mean value.


Test 8: Artifact detection


Test 8: Artifact detectionObjective

To determine if the detector is dusty or damaged or shows other artifacts.

Equipment requireda) PMMA phantom that mounts to the collimator (40 mm)



Fill in: Last Name: Test_EightFirst Name: Artifact_DetectionPatient ID: Day+time when the test is performed




4. Attach the PMMA phantom (40 mm) to the collimator.

5. Make an exposure with 28 kV, 90 mAs. Use the anode/filter combination that was used in the system calibration, see Test 1: Clinical settings

6. Check the image for clinically relevant artifacts; if necessary, send the image to the viewing station for evaluation.

Performance criteria and corrective actionThere should be no clinically relevant artifacts visible in the image.


Test 9: AEC: Safety test



ObjectiveTo check that the AEC safety cut-off functions properly.

Equipment requireda) 2 mm steel plate (object table size)



Fill in: Last Name: Test_NineFirst Name: AEC: SafetyPatient ID: Day+time when the test is performed




4. Place the 2 mm steel plate on the breast support surface.

NOTE!NOTE!The 2 mm steel plate must cover the detector during the entire length of the test. Otherwise, detector saturation or ghosting will occur.

5. Select the AEC exposure H button, 28 kV, Mo/Mo.

6. Take an exposure.

7. Check that the exposure is interrupted.

8. Record the error number displayed on the control panel in the Test form, page 89.




Performance criteria and corrective actionThe AEC safety cut-off must function properly. The AEC- exposure must be interrupt-ed.Error 504, 578 or 579 must be displayed on the control panel.


Test 10: AEC: Reproducibility of automatic exposure control



ObjectiveTo measure the AEC image stability (reproducibility)

Equipment requireda) PMMA phantom 2 x 20 mm and 1 x 10 mm



Fill in: Last Name: Test_TenFirst Name: AEC: Short-term ReproPatient ID: Day+time when the test is performed




4. Place the PMMA phantom (50 mm) on the detector so that all three sensor areas are covered.

5. Using the markings on the compression plate, check that the PMMA phantom covers all three AEC regions.

6. Select the Opdose program for 50 mm on the control panel (default: program 3, see Test 1: Clinical settings) and record the set parameters in the Test form, page 91.

7. Make an exposure and record the mAs value displayed on the console in the Test form, page 91.

8. Select a ROI (region of interest) of approx. 10 x 10 mm for postprocessing with Tools > Rectangle and position it within the AEC region used (the AEC region can be displayed by selecting Tools > AEC Region) and record the displayed mean value in the Test form, page 91.



9. Repeat steps 7 and 8 until you have made 5 exposures.


11. Calculate the mean value of the displayed mean pixel values and the mAs values displayed on the console and record them in the relevant column in the Test form, page 91.

12. Calculate the deviation of each value from the calculated mean value:

and record the maximum deviation in the relevant column in the Test form, page 91.

Performance criteria and corrective actionThe maximum deviation from the calculated mean value must be ≤ 5%.


ValueMean value---------------------------------------- 1–⎝ ⎠⎛ ⎞ 100%⋅

Test 11: AEC: Long-term reproducibility of automatic exposure control



ObjectiveTo measure the AEC image stability (long-term reproducibility)




Fill in: Last Name: Test_ElevenFirst Name: AEC: Long-term ReproPatient ID: Day+time when the test is performed





5. Using the markings on the compression plate, check that the PMMA phantom covers all three AEC regions.

6. Select the Opdose program for 50 mm on the control panel (default: program 3, see Test 1: Clinical settings) and record the set parameters in the Test form, page 93.

7. Make an exposure and record the mAs value displayed on the console in the Test form, page 93.

8. Select a ROI (region of interest) of approx. 10 x 10 mm for postprocessing with Tools > Rectangle and position it within the AEC region used (the AEC region can be displayed by selecting Tools > AEC Region) and record the displayed mean pixel value in the Test form, page 93.




Performance criteria and corrective actionThe mean pixel value must not deviate by more than ± 10% from the baseline value determined during the acceptance test.

NOTE!NOTE!Since this test must be performed weekly, copies of the test form must be made in time.


Test 12: AEC: Tracking test



ObjectiveTo measure the AEC image stability for different object thicknesses




Fill in: Last Name: Test_TwelveFirst Name: AEC: TrackingPatient ID: Day+time when the test is performed





5. Compress and, using the markings on the compression plate, check that the PMMA phantom covers all three AEC regions.

6. Make an exposure with Opdose and record the set parameters in the Test form, page 95.

7. Select a ROI (region of interest) of approx. 10 x 10 mm for postprocessing with Tools > Rectangle and position it within the AEC region used (the AEC region can be displayed by selecting Tools > AEC Region) and record the displayed mean pixel value in the Test form, page 95.

8. Repeat steps 3 - 7 for the PMMA thicknesses 30, 40, 50, 60 and 70 mm.


10. Calculate the mean value of the displayed mean pixel values and record it in the relevant column in the Test form, page 95.

11. Calculate the deviation of each value from the calculated mean value:

and record the maximum deviation in the relevant column in the Test form, page 95.

ValueMean value---------------------------------------- 1–⎝ ⎠⎛ ⎞ 100%⋅



Performance criteria and corrective actionThe maximum deviation from the calculated mean value must be ≤ 15%.


Test 13: Linearity and noise evaluation



ObjectiveTo measure the linearity and system noise


b) Dosimeter

c) Compression plate 24 x 30


Fill in: Last Name: Test_ThirteenFirst Name: Linearity and Noise EvaluationPatient ID: Day+time when the test is performed





5. Place the dose sensor near AEC position 1 (front marking on the compression plate) as shown in Figure 13, and fix it in place.

Figure 13 Positioning the phantom and dose sensor

6. Make an exposure with 28 kV, 5 mAs and the anode/filter combination used in the system calibration. Record the measured air kerma in the Test form, page 97.

Dose sensor

ROI

PMMA

20 mm



7. Choose Tools > Rectangle and select a ROI (region of interest) of approx. 10 x 10 mm that is at a distance of 20 mm from the chest wall side and centered on the left and right. Record the displayed mean pixel value in the Test form, page 97.

8. Calculate d2, K2 and K•d and record the values in the Test form, page 97.

9. Repeat steps 6 to 8 with the mAs values specified in table Test form, page 97.

10. Calculate the mean values of d, K, d2, K2 and K•d and record them in the Test form, page 97.

11. Calculate the offset of the pixel value according to the following formula:

and record the result in the Test form, page 97.

12. Calculate the square of the correlation coefficient according to the following for-mula:

and record the result in the Test form, page 97.

13. Make an exposure with 28 kV, Mo/Mo and AEC H. Record the mAs value dis-played on the console and the measured air kerma in the Test form, page 97.

14. Select a ROI (region of interest) of approx. 10 x 10 mm for postprocessing with Tools > Rectangle and position it within the AEC region used (the AEC region can be displayed by selecting Tools > AEC Region) and record the displayed mean pixel value and the displayed standard deviation in the Test form, page 97.

15. Repeat steps 13 and 14 with W/Rh.

16. Calculate the SNR values according to the following formula:

and record them in the Test form, page 97.


doffsetK2( )mean dmean• Kmean K d•( )mean•–

K2( )mean Kmean( )2–

------------------------------------------------------------------------------------------------------------------------------=

R2 K d•( )mean Kmean dmean•–( )2

K2( )mean Kmean( )2–( ) d2( )mean dmean( )2

–( )•----------------------------------------------------------------------------------------------------------------------------------------------------=

SNRd doffset–

s dard deviationtan-----------------------------------------------------------------=



Performance criteria and corrective actionThe linear correlation coefficient R2 must be at least 0.99.The SNR value must be at least 40.


Test 14: Detector uniformity



ObjectiveTo measure the uniformity of the detector response across its entire surface.

Equipment requireda) PMMA phantom that mounts to the collimator (40 mm)



Fill in: Last Name: Test_FourteenFirst Name: Detector UniformityPatient ID: Day+time when the test is performed



3. Attach the PMMA phantom (40 mm) to the collimator.


5. Make an exposure with 28 kV, AEC "H" mode and the anode/filter combination that was used in the system calibration.

6. Select a ROI (region of interest) of approx. 10 x 10 mm for postprocessing with Tools > Rectangle.

7. Measure the pixel value within each of the five regions located approx. 20 mm from the edges. Also refer to Figure 14. To do this, move the ROI to the relevant position and record the displayed mean value in the Test form, page 101.



Figure 14 ROIs on the detector


Performance criteria and corrective actionThe displayed mean pixel value inside each of the five ROI regions must not deviate by more than 5% from the calculated mean value.


Test 15: Phantom image quality



ObjectiveTo ensure adequate image quality.

Equipment requireda) RMI-156 phantom



Fill in: Last Name: Test_FifteenFirst Name: Phantom Image QualityPatient ID: Day+time when the test is performed



3. Position the RMI-156 phantom centrally on the FD object table so that the wax insert points to the X-ray tube, see Figure 15. The phantom must be flush with the front edge of the object table, without a visible gap.

Figure 15 Positioning the PMMA phantom

4. Mount the compression plate and compress.

5. Select the clinically used setting by selecting the Opdose program corresponding to the phantom thickness on the control console. AEC sensor 2 must be selected at the AWS.



6. Make an exposure and record the mAs and kV values displayed on the control panel as well as the set anode/filter combination in the Test form, page 103.

7. Examine the image and determine how many fibers, specks and masses can be identified. In doing so, change the gray value and magnification to achieve optimal results. Always count the number of visible objects from the largest object of a given type downward. Record the results in the Test form, page 103.

8. If a problem occurs when you are viewing the image at the AWS, send the image to the reporting station or the printer and then check it.


Figure 16 Potentially visible objects in the ACR phantom

XXX XXX

Fibers

Specks (Microcalcifications)

Masses



Analysis• Count each fiber as one point if the full length of the fiber is visible. Count a

fiber as 0.5 points if not the entire but at least half the fiber is visible. • When examining the specks, the zoom and invert function may be useful.

Each speck group shall be counted as one point. A full speck group is counted as such if four or more specks are visible in the group in the proper locations. Count a speck group as 0.5 points if two or three specks of the group are vis-ible.

• Count each mass as one point if a density difference is visible in the correct location and the full mass is visible against the background. Count each mass as 0.5 points if a density difference is visible in the correct location but the full mass is not visible, so that the mass does not have a circular appearance.

Performance criteria and corrective actionThe table below shows how many fibers, specks and masses shall be identifiable (in total there are: 6 fibers, 5 specks and 5 masses.

Table 2 Object score criteria


Phantom used Required

Fibers ≥ 5

RMI-156 phantom Specks (Microcalcifica-tions)

≥ 4

Masses ≥ 4

Test 16: Phantom image quality – Maximum resolution



ObjectiveTo ensure that the maximum resolution is at least 7/mm.

Equipment requireda) Mammography line pair phantom (2 to 10 lp/mm)

b) PMMA phantom 2 x 20 mm and 1 x 10 mm



Fill in: Last Name: Test_SixteenFirst Name: Maximum ResolutionPatient ID: Day+time when the test is performed




4. Select the Opdose program for 50 mm on the control panel (default: program 3, see Test 1: Clinical settings). AEC sensor 3 must be selected at the AWS.

5. Position the PMMA phantom (50 mm) centrally and flush with the front detector edge. Place the line pair phantom diagonally on the plexiglas phantom (see Figure 17). Using the markings on the compression plate, check that AEC sensor area 3 (rear marking) is not covered.

Figure 17 Placing the resolution phantom

45

PMMA



6. Make an exposure and record the mAs and kV values displayed on the control panel as well as the set anode/filter combination in the Test form, page 105.

7. Examine the image and determine the highest resolution of the line pairs at which the bars and gaps can be clearly differentiated. In doing so, change the gray value and magnification to achieve optimal results. Record the result in the Test form, page 105.

8. If a problem occurs when you are viewing the image at the AWS, send the image to the reporting station or the printer and then check it.


Performance criteria and corrective actionThe measured resolution must be at least 7 lp/mm.


Test 17: Mean glandular dose



ObjectiveTo measure the mean glandular dose to ensure that it does not exceed the admissible maximum value specified in the regulations for film-screen systems and FFDM sys-tems (FFDM: Full-Field Digital Mammography).

Equipment requireda) Dosimeter, calibrated at the mammography X-ray beam energies

b) PMMA phantom 2 x 20 mm and 1 x 10 mm


RequirementsThe HVL values determined for the system are required for this test. These values can be found in the system documentation that was handed over to the customer at the time of installation.


Fill in: Last Name: Test_SeventeenFirst Name: Mean Glandular DosePatient ID: Day+time when the test is performed




4. Position the PMMA phantom (50 mm) on the detector so that all three sensor ar-eas are covered, and place the dosimeter near AEC position 1 (chest wall side marking on the compression plate) at the same level as the top side of the PMMA phantom, see Figure 18. If necessary, raise the position of the dosimeter by plac-ing suitable objects such as additional PMMA phantoms underneath.



Figure 18 Positioning the PMMA phantom and the dosimeter

5. Make an exposure with 28 kV, Mo/Mo and AEC D and record the mAs displayed on the control panel as well as the measured air kerma (in mGy) in the Test form, page 107.

6. Repeat step 5 with Mo/Rh and W/Rh.


8. Calculate the mean glandular dose with the aid of the tables in the Test form, page 107.

Performance criteria and corrective actionThe calculated glandular dose must not exceed 2.5 mGy.


Dose sensor

PMMA

Test 18: Ghost image evaluation



ObjectiveTo measure ghosting

Equipment requireda) PMMA phantom that mounts to the collimator (40 mm thick)

b) 2 mm steel plate (object table size)

c) 2 mm steel plate (approx. 3 x 10 cm)

d) Compression plate simulator

e) Timer (stop watch)

f) Paper clips

Requirements• Prior to the test, a new gain calibration must be performed (see MAMMO-

MAT Novation DR Operator Manual); after that, wait at least 10 minutes. No exposures must be made during this time.


Fill in: Last Name: Test_EighteenFirst Name: GhostingPatient ID: Day+time when the test is performed



3. Cover the object table with the 2 mm steel plate.


5. Make an exposure with 23 kV, 2 mAs and Mo/Mo.

6. Remove the large 2 mm steel plate and position the 2 mm steel plate (3 x 10 cm) centrally against the front edge, see Figure 19. Mark the corners with paper clips.

NOTE!NOTE!The paper clips must remain in the same position during the following two exposures.



Figure 19 Second exposure

7. Make an exposure with 28 kV, 200 mAs and Mo/Mo.

8. Start the timer right after releasing the exposure.

9. Remove the 2 mm steel plate and mount the PMMA phantom (40 mm) to the collimator. Make sure the paper clips do not move.

10. After 180 seconds, make an exposure with 28 kV, 14 mAs and Mo/Mo.

11. Determine the offset. To do this, go to the first exposure (with 2 mAs) and select a ROI (region of interest) of approx. 10 x 10 mm for postprocessing with Tools > Rectangle. Position the ROI centrally approx. 20 mm from the front detector edge and record the displayed mean pixel value as offset in the Test form, page 111.

Steel plate

Paper clip



Figure 20 Third exposure after 180 seconds

12. Go to the third exposure (with 14 mAs) and select a ROI (region of interest) of approx. 10 x 10 mm for postprocessing with Tools > Rectangle. For each of the four positions shown in Figure 20, determine the pixel value within (PV1) and out-side (PV2) the previously covered area. To do this, move the ROI to the relevant position and record the displayed mean pixel value in the Test form, page 111.


14. Calculate the ghosting factor for each position according to the following formu-lar:

and record the calculated values in the Test form, page 111.

15. Calculate the mean value from the four ghosting factors and record it in the Test form, page 111.

Performance criteria and corrective actionThe mean ghosting factor must be less than 3 %.


Position 3Position 2

Position 4Position 1

Ghosting factorPV1 PV2–( )

PV1 PV2 2 Offset⋅( )–+( )-------------------------------------------------------------------------------------- 200%⋅=

Test 19: AWS monitor check



ObjectiveTo assess the quality of the acquisition workstation monitor.

Equipment requireda) SMPTE test pattern (included in syngo)

Procedure1. Clean the monitor.

a) The monitor surface should be cleaned with a soft tissue material, e.g. a cot-ton cloth or lens cleaning cloth.

b) To remove stubborn stains, moisten the cloth with water to enhance its clean-ing power.

3. Select the Viewing task card.

4. Open the Patient Browser and select Service images, technical images.

5. Open the SMPTE image in the Viewing task card. Make sure the SMPTE image covers the entire viewing area, i.e. the window must not be divided into four viewing areas.Check that the window center is set to 2048 and the window width to 4096. Se-lect Image > Acquisition Size to check that the image is displayed in acquisition size.

6. The gray scale is shown as a series of squares in the center of the SMPTE image, ranging from black (0%) to white (100%). The 0% and 100% squares each con-tain smaller squares within them that represent signal level steps of 5% and 95% respectively (see Figure 21). It should be possible to differentiate the inner square from the larger square that contains it. The 5% square is normally quite difficult to differentiate. If this is not possible, perform the test again with dimmed room light.

Figure 21 Arrangement of squares



If the 5% and 95% squares are not visible, the monitor brightness and contrast must be readjusted. To do this, press the menu button on the monitor and follow the in-structions on the screen.In general, monitor contrast should be set to 100(%). To obtain acceptable brightness values, first set a low brightness value and then slowly increase the brightness until the 5% square is visible in the 0% square of the SMPTE image. In general, a higher brightness is recommended. However, the setting should not be too high, causing black areas on the screen to become light gray. After changing the monitor settings, repeat the entire test to check the monitor image quality with these settings.

7. Visually check the monitor for streaking, flicker and shadows.

8. The spatial resolution (linearity) and aliasing (distortion) of the monitor are consid-ered to be within acceptable limits if the resolution bar pattern in the test image can be seen as patterns of white and black pairs. Inspect the 6 squares with al-ternating black and white, vertical and horizontal bars of different widths in each corner (see Figure 22) and in the center of the screen. You should be able to dif-ferentiate all the bars, from wide to narrow (6 pixels, 4 pixels and 2 pixels), both horizontally and vertically.

Figure 22 Arrangement of resolution bar pattern




Performance criteria and corrective action• The 5% and 95% squares must be visible.

• The resolution bar patterns in the four corners and in the center of the image (see Figure 22) must be visible.


Test 20: Printer check


Test 20: Printer checkThis test is required only if a laser camera is used.

ObjectiveTo assess the quality of the laser camera.

Equipment requireda) Calibrated densitometer

Procedure1. Log in as described under Startup and login.

2. Select the service patient in the Patient Browser.

3. Select the SMPTE image of the service patient and open it in the Viewing task card.

4. Send the image to a printer.

5. The printer must be configured for Min. Density = 20 and Max. Density = 350.Information on the Min. Density, Max. Density and LUT used can be found in the service menu.

6. Evaluate the printed SMPTE image by measuring the eleven density values from 0 to 100 % with the densitometer, and record the measured values in the Test form, page 115.

Performance criteria and corrective actionThe values for the different optical densities must be within the action limits specified in the Test form, page 115.


For the qualification of the printer please follow the printer manufacturer's rec-ommendations.

Test 20: Printer check


For notes

Appendix 1 to MAMMOMAT Novation DR Quality Control Manual


Appendix 1 – Test formsMAMMOMAT Novation DR



For notes



Test form Test 1: Clinical settings

NOTE!NOTE!Copy this Appendix, record the measured values on the copy and file it together with this QC manual.

Site: ________________________________________________

________________________________________________

Room: ________________________________________________

Type of test: ________________________________________________

Performed by: ________________________________________________

Date: ________________________________________________



Opdose setting used (enter only if setting deviates from the factory settings indicated in brackets):

Opdose AEC H AEC D Manual

Main exposure technique used

l l l l

Mo/Mo Mo/Rh W/Rh

Main anode/filter combination used l l l

Program Compression height range

Anode/filter combination

kV value AEC

1(0 ... 29 mm) (W/Rh) (27) (H)

2(30 ... 45 mm) (W/Rh) (27) (H)

3(45 ... 59 mm) (W/Rh) (28) (H)

4(≥ 60 mm) (W/Rh) (32) (H)

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 2: Mechanical inspection and follow-up


Site: ________________________________________________

________________________________________________

Room: ________________________________________________

Type of test: ________________________________________________

Performed by: ________________________________________________

Date: ________________________________________________



Mechanical inspection and follow-up

Test no.: Performance criteria

Passed Failed

1. Inspection of cables --- l l2. Control panel lights up --- l l3. LED indicates tube close to floor --- l l4. Test of motorized movements --- l l5. Movements disabled --- l l6. Emergency Stop button --- l l7. Manual compression buttons --- l l8. Decompression button --- l l9. No sharp edges --- l l10. Radiation shield --- l l11. Focal spot position --- l l12. Vertical movements --- l l13. Foot switches --- l l14. Attachments --- l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 3: Compression

NOTE!NOTE!Copy Appendix 1, record the measured values on the copy and file it together with this QC manual.

Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________



Compression

Test Display value (kp)

Criterion Passed Failed

Compression force 19 - 21 kp l lCompression force after 1 minute

Change ≤ ± 2 kp l l

Automatic decompression


On Decompression at the end of the exposure

l l

Off No decompression at the end of the exposure

l l

Compression height displayed

(mm)


40 ± 3 mm l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 4: Chest wall missed tissue


Chest wall missed tissue

Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________

Performance criteria Passed Failed

Coin diameter (d1):

Rear coin edgeto front detector edge dis-tance (d2)

Calculated chest wall missed tissue, α = d1 - d2: ≤ 5 mm l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 5: Compression plate alignment


Compression plate overlapPerformance criteria: Measured value + α ≤ 6.5 mm

Chest wall edge of compression plate not visible in the image

Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________

Compression plates Measured value+ α

Passed Failed

Low edge, 18 x 24 cmPart number: 10048516

l l

High edge, 18 x 24 cmPart number: 10048519

l l


l l


l l

High edge, 24x30 cm, Flex Part number: 10048517

l l


l l

High edge, 20 x 22 cm, Flex Part number: 10048521

l l

High edge, 20 x 24 cm Part number: 10390201

l l



High edge, 20 x 24 cm, FlexPart number: 10390202

l lDetail compression plate 9 x 9Part number: 10048513

l l

Perforated biopsy compression platePart number: 10046676

l l

Alphanumeric plate Part number: 10140380

l l

SpotPlus plate Part number: 10253164

l l

Axilla plate Part number: 10040381

l l

Compression plate 1.5Part number: 10048522

l l

Spot compression plate 1.5Part number: 10048524

l l


l l


l l

l l

l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 6: Collimator assessmentNOTE!NOTE!

Copy Appendix 1, record the measured values on the copy and file it together with this QC manual.

Collimator assessmentB is the deviation between radiation field and active detector area.

A is the deviation between radiation field and light field.

If B is positive, the X-ray field is larger than the detector area.

If B is negative, the X-ray field is smaller than the detector area.

If A is positive, the X-ray field is smaller than the light field.

If A is negative, the X-ray field is larger than the light field.

Site: ___________________________________________________

___________________________________________________

Room: ___________________________________________________

Type of test: ___________________________________________________

Performed by: ___________________________________________________

Date: ___________________________________________________



Distances measured with large focal spot

Distances measured with small focal spot (optional)

Position F/A combi-nation

Value light field VLF (mm)

Value X-ray field VSF (mm)

Value detector field VDF (mm)

A = VSF - VLF (mm)

B = VDF - VLF (mm)

Chest wall edge (pos. 1)

Mo/Mo

Right edge (pos. 2)

Nipple-side edge (pos. 3)

Left edge (pos. 4)


W/Rh

Right edge (pos. 2)


Left edge (pos. 4)





A = VSF - VLF (mm)

B = VDF - VLF (mm)


Mo/Mo

Right edge (pos. 2)


Left edge (pos. 4)


W/Rh

Right edge (pos. 2)


Left edge (pos. 4)



Light intensity measurement test

Value (lux)

Acceptance criteria Passed Failed

Area 1

Area 2

Area 3

Area 4

Mean value > 160 lux l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 7: Tube voltage measurement and re-producibility


Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________



Tube voltage and reproducibilityMo/Mo; 28 kV; 50 mAs

Mo/Mo; 50 mAs

Parameters kVmeas Performance criteria Passed Failed

1. Exposure (kVmean– 0.5 kV) ≤ kVmeas ≤ (kVmean+ 0.5 kV) l l2. Exposure (kVmean– 0.5 kV) ≤ kVmeas ≤ (kVmean+ 0.5 kV) l l3. Exposure (kVmean– 0.5 kV) ≤ kVmeas ≤ (kVmean+ 0.5 kV) l l4. Exposure (kVmean– 0.5 kV) ≤ kVpmeas ≤ (kVmean+ 0.5 kV) l lMean value (kVmean)

Parameters kVmeas Performance criteria Passed Failed

24 kV Accuracy: < ± 1.0 kV l l27 kV Accuracy: < ± 1.0 kV l l30 kV Accuracy: < ± 1.0 kV l l33 kV Accuracy: < ± 1.0 kV l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 8: Artifact detection


Clinically relevant artifacts

Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________



No clinically relevant arti-facts visible

l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 9: AEC: Safety test


AEC: Safety test

Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________

Test Passed Failed

AEC: Safety cut-off l lError 504, 578 or 579 l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 10: AEC: Reproducibility of automatic exposure control


Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________



AEC: Reproducibility of automatic exposure control

Anode/Filter: ________________________ kV: _________ H/D: _________

Exposureno.

mAs Mean pixel value

1

2

3

4

5

Value Performance criteria

Passed Failed

Mean value(mAs)

Max. deviation from mean value (mAs)

≤ 5% l l

Mean value (mean pixel value)

Max. deviation from mean value (mean pixel value)

≤ 5% l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 11: AEC: Long-term reproducibility of automatic exposure control


AEC: Long-term reproducibility of automatic exposure control

Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________

Date mAs kV Anode/Filter

AEC H/D

Mean pixel value

Deviation mean pixel value (%)

Performance criterionDeviation

max. ± 10%

Baseline Passed Failed

1 l l2 l l3 l l4 l l5 l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 12: AEC: Tracking test


Object thickness and tube voltage compensation

Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________

Thickness of PMMA (mm)

mAs kV Anode/Filter AEC H/D Mean pixel value

20

30

40

50

60

70

Mean value (mean pixel

value)

Maximum deviation

(%)

Criteria Passed Failed

≤ 15% l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 13: Linearity and noise evaluation


Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________



Linearity

doffset = __________

NOTE!NOTE!The last 3 columns and the last row will help you calculate R2; if an ap-propriate computer program is used, the entries may be unnecessary.

Anoden/filter combination: __________ __________ kV

Exposure number:


d

Air kerma K (mGy)

d2 K2 K•d

1 5

2 10

3 20

4 50

5 80

6 100

7 200

8 320

9 450

10 500

Mean valuedmean Kmean (d2)mean (K2)mean

(K•d)mean

Test Value Performance criterion

Passed Failed

Linear correlation R2 ≥ 0.99 l l



Noise evaluation

28 kV, AEC H

Anode/fil-ter combi-

nation

mAs Air kerma (mGy)

Mean pixel value

d

Standard deviation

SNR Perfor-mance crite-rion

Passed Failed

Mo/Mo ≥ 40 l lW/Rh ≥ 40 l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 14: Detector uniformity


Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________



Detector uniformity

Results from ROI statistics

Mo/Mo Mo/Rh W/Rh

Anode/filter combination used l l l

Mean pixel value

% deviation from mean


Passed Failed

Required

Area 1 ≤ 5% l lArea 2 ≤ 5% l lArea 3 ≤ 5% l lArea 4 ≤ 5% l lArea 5 ≤ 5% l lMean value

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 15: Phantom image quality


Contrast resolution

Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________

Anode/Filter: _________

kV: _________

mAs: _________


Passed Failed

Fibers ≥ 5 l lSpecks (Microcalci-fications)

≥ 4 l l

Masses ≥ 4 l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 16: Phantom image quality – Maximum resolution


Resolution

Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________

Anode/Filter: ___________

kV: ___________

mAs: ___________


Resolution measured

lp: _________

≥ 7 lp/mm l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 17: Mean glandular dose


Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________



Prerequisites for calculating the mean glandular dose

Formula used:

D = K•g•c•s*

D Mean glandular dose

K Incident air kerma (without backscatter) at the upper surface of the PMMA

g Coupling factor between incident air kerma and mean glandular dose for a glandu-larity of 50% and for the Mo/Mo anode/filter combination

c Correction factor for deviations from the standard 50% glandularity

s Correction factor for anode/filter combinations other than Mo/Mo

The c and g factors are listed in the following table for different HVL values. They can be interpolated correspondingly for other HVL values. The values listed were derived from the typical breast thickness corresponding to a PMMA thickness of 50 mm on which the simulation calculation* is based.

* [D.R. Dance, C.L. Skinner, K.C. Young, J.R. Beckett. C.J. Kotre: Additional factors for the estimation of mean glandular breast dose using the UK mammography dosimetry protocolPhysics in Medicine and Biology 45, 3225-3240, 2000]

HVL (mm Al)

0.30 0.35 0.40 0.45 0.50 0.55 0.60

g factor 0.135 0.154 0.172 0.192 0.214 0.236 0.261

c factor 1.164 1.160 1.151 1.150 1.144 1.139 1.134

Mo/Mo Mo/Rh W/Rh

s factor 1.000 1.017 1.042



Mean glandular doseValues (at 28 kV) for the calculation

Calculation of the mean glandular dose

Anode/Filter mAs Air kerma(mGy)

HVL value (mm Al)

Mo/Mo

Mo/Rh

W/Rh

Anode/Filter

D = Kgcs (mGy) Performance criteria

Passed Failed

Mo/Mo

≤ 3.0 mGy

l lMo/Rh l lW/Rh l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 18: Ghost image evaluation


Site: ________________________________________________

________________________________________________

Room: ________________________________________________

Type of test: ________________________________________________

Performed by: ________________________________________________

Date: ________________________________________________



Ghost image evaluation

Offset = _______

Position Mean pixel value Ghosting factor(%)

PV1 PV2

1

2

3

4

Mean value ghost image factor (%)Performance

criteriaPassed Failed

< 3 % l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 19: AWS monitor checkNOTE!NOTE!

Copy this Appendix, record the measured values on the copy and file it together with this QC manual.

AWS monitor check and viewing conditions

Site: ________________________________________________

________________________________________________

Room: ________________________________________________

Type of test: ________________________________________________

Performed by: ________________________________________________

Date: ________________________________________________

Grayscale contrast: Yes No

5% square is visible inside 0% square

l l

Performance criteria: Yes


l l


Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Spatial resolution: Yes No

All lines in all bar patterns can be differentiated

l l


Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________

Visual inspection:

Yes No

Streaking l lPerformance criteria: No

Flicker l lPerformance criteria: No

Shadows l lPerformance criteria: No

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 20: Printer check

This test is required only if a laser camera and a printer are used.


Site: ________________________________________________

________________________________________________

Room: ________________________________________________

Type of test: ________________________________________________

Performed by: ________________________________________________

Date: ________________________________________________



Printer check

* LUT = Look-up table

Customer-specific values for "min. density" and "max. density"

Min. density

Max. density

Step Corr16b-bspline (LUT) Linear LUT*

Ref. LUT

Maximum density

Minimum density

Ref. density

Maximum density

Minimum density

1 0.20 0.23 0.17 0.20 0.23 0.17

2 0.34 0.38 0.30 0.52 0.56 0.49

3 0.47 0.51 0.43 0.86 0.90 0.82

4 0.64 0.69 0.59 1.18 1.23 1.13

5 0.81 0.87 0.75 1.52 1.58 1.46

6 1.05 1.12 0.99 1.84 1.91 1.78

7 1.31 1.38 1.24 2.18 2.25 2.11

8 1.66 1.74 1.58 2.52 2.60 2.44

9 2.10 2.19 2.01 2.85 2.94 2.77

10 2.68 2.77 2.59 3.18 3.27 3.08

11 3.50 3.60 3.40 3.50 3.60 3.40

Step MG1_5bCorr-bspline (LUT)

Ref. LUT Maximumdensity

Minimumdensity

1 0.20 0.23 0.17

2 0.44 0.48 0.40

3 0.68 0.72 0.64

4 0.94 0.99 0.89

5 1.18 1.24 1.12

6 1.45 1.52 1.39

7 1.73 1.80 1.66

8 2.01 2.09 1.93

9 2.32 2.41 2.23

10 2.73 2.82 2.64

11 3.50 3.60 3.40




Step Corr16b-bspline (LUT)

Ref. LUT*

Recommenda-tion maximum

density

Recommenda-tion minimum

density

Required maximum

density

RequiredMinimumdensity

1 0.20 0.23 0.17 0.30 0.10

2 0.34 0.38 0.30 0.44 0.24

3 0.47 0.51 0.43 0.57 037

4 0.64 0.69 0.59 0.74 0.54

5 0.81 0.87 0.75 0.91 0.71

6 1.05 1.12 0.99 1.15 0.95

7 1.31 1.38 1.24 1.41 1.21

8 1.66 1.74 1.58 1.76 1.56

9 2.10 2.19 2.01 2.20 2.00

10 2.68 2.77 2.59 2.78 2.58

11 3.50 3.60 3.40 3.60 3.40


Ref. LUT Recommenda-tion maximum

density


density

Required maximum

density

Required minimumdensity

1 0.20 0.23 0.17 0.30 0.10

2 0.44 0.48 0.40 0.54 0.34

3 0.68 0.72 0.64 0.68 0.58

4 0.94 0.99 0.89 1.04 0.84

5 1.18 1.24 1.12 1.28 1.08

6 1.45 1.52 1.39 1.55 1.35

7 1.73 1.80 1.66 1.83 1.53

8 2.01 2.09 1.93 2.11 1.91

9 2.32 2.41 2.23 2.42 2.22

10 2.73 2.82 2.64 2.83 2.63

11 3.50 3.60 3.40 3.60 3.40



If your values do not meet the values specified above, then please refer to the printer manufacturer's quality control procedure. You can create your own baseline with the measured values resulting during the initial installation of the printer per the manufac-turer's QC procedure.

* OD = Optical density

Quality control manual of printer manufacturer complied with:

SMPTE [%] Step Measured OD* Passed Failed

100 1 l l90 2 l l80 3 l l70 4 l l60 5 l l50 6 l l40 7 l l30 8 l l20 9 l l10 10 l l0 11 l l

Compliance Yes No

Date _______________ l lDate _______________ l lDate _______________ l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Appendix 2 – Test forms for installationMAMMOMAT NovationDR



For notes



Test form Test 1: Clinical settings


Site: ________________________________________________

________________________________________________

Room: ________________________________________________

Type of test: ________________________________________________

Performed by: ________________________________________________

Date: ________________________________________________



Opdose setting used (enter only if setting deviates from the factory settings indicated in brackets):

Opdose AEC H AEC D Manual

Main exposure technique used

l l l l

Mo/Mo Mo/Rh W/Rh

Main anode/filter combination used l l l

Program Compression height range


kV value AEC

1(0 ... 29 mm) (W/Rh) (27) (H)

2(30 ... 45 mm) (W/Rh) (27) (H)

3(45 ... 59 mm) (W/Rh) (28) (H)

4(≥ 60 mm) (W/Rh) (32) (H)

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 2: Mechanical inspection and follow-up


Site: ________________________________________________

________________________________________________

Room: ________________________________________________

Type of test: ________________________________________________

Performed by: ________________________________________________

Date: ________________________________________________



Mechanical inspection and follow-up

Test no.: Performance criteria

Passed Failed

1. Inspection of cables --- l l2. Control panel lights up --- l l3. LED indicates tube close to floor --- l l4. Test of motorized movements --- l l5. Movements disabled --- l l6. Emergency Stop button --- l l7. Manual compression buttons --- l l8. Decompression button --- l l9. No sharp edges --- l l10. Radiation shield --- l l11. Focal spot position --- l l12. Vertical movements --- l l13. Foot switches --- l l14. Attachments --- l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 3: Compression


Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________



Compression

Test Display value (kp)


Compression force 19 - 21 kp l lCompression force after 1 minute

Change ≤ ± 2 kp l l

Automatic decompression


On Decompression at the end of the exposure

l l

Off No decompression at the end of the exposure

l l

Compression height displayed

(mm)


40 ± 3 mm l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 4: Chest wall missed tissue


Chest wall missed tissue

Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________


Coin diameter (d1):

Rear coin edgeto front detector edge dis-tance (d2)

Calculated chest wall missed tissue, α = d1 - d2: ≤ 5 mm l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 5: Compression plate alignment


Compression plate overlapPerformance criteria: Measured value + α ≤ 6.5 mm

Chest wall edge of compression plate not visible in the image

Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________

Compression plates Measured value+ α

Passed Failed


l l


l l


l l


l l

High edge, 24x30 cm, Flex Part number: 10048517

l l


l l

High edge, 20 x 22 cm, Flex Part number: 10048521

l l

High edge, 20 x 24 cm Part number: 10390201

l l



High edge, 20 x 24 cm, FlexPart number: 10390202

l lDetail compression plate 9 x 9Part number: 10048513

l l

Perforated biopsy compression platePart number: 10046676

l l

Alphanumeric plate Part number: 10140380

l l

SpotPlus plate Part number: 10253164

l l

Axilla plate Part number: 10040381

l l


l l


l l


l l


l l

l l

l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 6: Collimator assessmentNOTE!NOTE!

Copy Appendix 1, record the measured values on the copy and file it together with this QC manual.

Collimator assessmentB is the deviation between radiation field and active detector area.

A is the deviation between radiation field and light field.

If B is positive, the X-ray field is larger than the detector area.

If B is negative, the X-ray field is smaller than the detector area.

If A is positive, the X-ray field is smaller than the light field.

If A is negative, the X-ray field is larger than the light field.

Site: ___________________________________________________

___________________________________________________

Room: ___________________________________________________

Type of test: ___________________________________________________

Performed by: ___________________________________________________

Date: ___________________________________________________



Distances measured with large focal spot

Distances measured with small focal spot (optional)





A = VSF - VLF (mm)

B = VDF - VLF (mm)


Mo/Mo

Right edge (pos. 2)


Left edge (pos. 4)


W/Rh

Right edge (pos. 2)


Left edge (pos. 4)





A = VSF - VLF (mm)

B = VDF - VLF (mm)


Mo/Mo

Right edge (pos. 2)


Left edge (pos. 4)


W/Rh

Right edge (pos. 2)


Left edge (pos. 4)



For notes



Test form Test 8: Artifact detection


Clinically relevant artifacts

Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________



No clinically relevant arti-facts visible

l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 11: AEC: Long-term reproducibility of automatic exposure control


AEC: Long-term reproducibility of automatic exposure control

Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________

Date mAs kV Anode/Filter

AEC H/D

Mean pixel value

Deviation mean pixel value (%)

Performance criterionDeviation

max. ± 10%

Baseline Passed Failed

1 l l2 l l3 l l4 l l5 l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 12: AEC: Tracking test


Object thickness and tube voltage compensation

Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________

Thickness of PMMA (mm)

mAs kV Anode/Filter AEC H/D Mean pixel value

20

30

40

50

60

70

Mean value (mean pixel

value)

Maximum deviation

(%)

Criteria Passed Failed

≤ 15% l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 13: Linearity and noise evaluation


Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________



Linearity

doffset = __________

NOTE!NOTE!The last 3 columns and the last row will help you calculate R2; if an ap-propriate computer program is used, the entries may be unnecessary.

Anoden/filter combination: __________ __________ kV

Exposure number:


d

Air kerma K (mGy)

d2 K2 K•d

1 5

2 10

3 20

4 50

5 80

6 100

7 200

8 320

9 450

10 500

Mean valuedmean Kmean (d2)mean (K2)mean

(K•d)mean

Test Value Performancecriterion

Passed Failed

Linear correlation R2 ≥ 0.99 l l



Noise evaluation

28 kV, AEC H

Anode/fil-ter combi-

nation

mAs Air kerma (mGy)

Mean pixel value

d

Standard deviation

SNR Perfor-mance crite-rion

Passed Failed

Mo/Mo ≥ 40 l lW/Rh ≥ 40 l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 14: Detector uniformity


Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________



Detector uniformity

Results from ROI statistics

Mo/Mo Mo/Rh W/Rh

Anode/filter combination used l l l

Mean pixel value

% deviation from mean


Passed Failed

Required

Area 1 ≤ 5% l lArea 2 ≤ 5% l lArea 3 ≤ 5% l lArea 4 ≤ 5% l lArea 5 ≤ 5% l lMean value

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 15: Phantom image quality


Contrast resolution

Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________

Anode/Filter: _________

kV: _________

mAs: _________


Passed Failed

Fibers ≥ 5 l lSpecks (Microcalci-fications)

≥ 4 l l

Masses ≥ 4 l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 16: Phantom image quality – Maximum resolution


Resolution

Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________

Anode/Filter: ___________

kV: ___________

mAs: ___________


Resolution measured

lp: _________

≥ 7 lp/mm l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 17: Mean glandular dose


Site: ___________________________________________________________

___________________________________________________________

Room: ___________________________________________________________

Type of test: ___________________________________________________________

Performed by: ___________________________________________________________

Date: ___________________________________________________________



Prerequisites for calculating the mean glandular dose

Formula used:

D = K•g•c•s*

D Mean glandular dose

K Incident air kerma (without backscatter) at the upper surface of the PMMA

g Coupling factor between incident air kerma and mean glandular dose for a glandu-larity of 50% and for the Mo/Mo anode/filter combination

c Correction factor for deviations from the standard 50% glandularity

s Correction factor for anode/filter combinations other than Mo/Mo

The c and g factors are listed in the following table for different HVL values. They can be interpolated correspondingly for other HVL values. The values listed were derived from the typical breast thickness corresponding to a PMMA thickness of 50 mm on which the simulation calculation* is based.

* [D.R. Dance, C.L. Skinner, K.C. Young, J.R. Beckett. C.J. Kotre: Additional factors for the estimation of mean glandular breast dose using the UK mammography dosimetry protocolPhysics in Medicine and Biology 45, 3225-3240, 2000]

HVL (mm Al)

0.30 0.35 0.40 0.45 0.50 0.55 0.60

g factor 0.135 0.154 0.172 0.192 0.214 0.236 0.261

c factor 1.164 1.160 1.151 1.150 1.144 1.139 1.134

Mo/Mo Mo/Rh W/Rh

s factor 1.000 1.017 1.042



Mean glandular doseValues (at 28 kV) for the calculation

Calculation of the mean glandular dose

Anode/Filter mAs Air kerma(mGy)

HVL value (mm Al)

Mo/Mo

Mo/Rh

W/Rh

Anode/Filter

D = Kgcs (mGy) Performance criteria

Passed Failed

Mo/Mo

≤ 3.0 mGy

l lMo/Rh l lW/Rh l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



For notes



Test form Test 18: Ghost image evaluation


Site: ________________________________________________

________________________________________________

Room: ________________________________________________

Type of test: ________________________________________________

Performed by: ________________________________________________

Date: ________________________________________________



Ghost image evaluation

Offset = _______

Position Mean pixel value Ghosting factor(%)

PV1 PV2

1

2

3

4

Mean value ghost image factor (%)Performance

criteriaPassed Failed

< 3 % l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 19: AWS monitor checkNOTE!NOTE!

Copy this Appendix, record the measured values on the copy and file it together with this QC manual.

AWS monitor check and viewing conditions

Site: ________________________________________________

________________________________________________

Room: ________________________________________________

Type of test: ________________________________________________

Performed by: ________________________________________________

Date: ________________________________________________

Grayscale contrast: Yes No


l l



l l


Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Spatial resolution: Yes No

All lines in all bar patterns can be differentiated

l l


Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________

Visual inspection:

Yes No

Streaking l lPerformance criteria: No

Flicker l lPerformance criteria: No

Shadows l lPerformance criteria: No

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________



Test form Test 20: Printer check

This test is required only if a laser camera and a printer are used.


Site: ________________________________________________

________________________________________________

Room: ________________________________________________

Type of test: ________________________________________________

Performed by: ________________________________________________

Date: ________________________________________________



Printer check


Customer-specific values for "min. density" and "max. density"

Min. density

Max. density

Step Corr16b-bspline (LUT) Linear LUT*

Ref. LUT

Maximum density

Minimum density

Ref. density

Maximum density

Minimum density

1 0.20 0.23 0.17 0.20 0.23 0.17

2 0.34 0.38 0.30 0.52 0.56 0.49

3 0.47 0.51 0.43 0.86 0.90 0.82

4 0.64 0.69 0.59 1.18 1.23 1.13

5 0.81 0.87 0.75 1.52 1.58 1.46

6 1.05 1.12 0.99 1.84 1.91 1.78

7 1.31 1.38 1.24 2.18 2.25 2.11

8 1.66 1.74 1.58 2.52 2.60 2.44

9 2.10 2.19 2.01 2.85 2.94 2.77

10 2.68 2.77 2.59 3.18 3.27 3.08

11 3.50 3.60 3.40 3.50 3.60 3.40


Ref. LUT Maximumdensity

Minimumdensity

1 0.20 0.23 0.17

2 0.44 0.48 0.40

3 0.68 0.72 0.64

4 0.94 0.99 0.89

5 1.18 1.24 1.12

6 1.45 1.52 1.39

7 1.73 1.80 1.66

8 2.01 2.09 1.93

9 2.32 2.41 2.23

10 2.73 2.82 2.64

11 3.50 3.60 3.40




Step Corr16b-bspline (LUT)

Ref. LUT*

Recommenda-tion maximum

density


density

Required maximum

density

RequiredMinimumdensity

1 0.20 0.23 0.17 0.30 0.10

2 0.34 0.38 0.30 0.44 0.24

3 0.47 0.51 0.43 0.57 037

4 0.64 0.69 0.59 0.74 0.54

5 0.81 0.87 0.75 0.91 0.71

6 1.05 1.12 0.99 1.15 0.95

7 1.31 1.38 1.24 1.41 1.21

8 1.66 1.74 1.58 1.76 1.56

9 2.10 2.19 2.01 2.20 2.00

10 2.68 2.77 2.59 2.78 2.58

11 3.50 3.60 3.40 3.60 3.40


Ref. LUT Recommenda-tion maximum

density


density

Required maximum

density

Required minimumdensity

1 0.20 0.23 0.17 0.30 0.10

2 0.44 0.48 0.40 0.54 0.34

3 0.68 0.72 0.64 0.68 0.58

4 0.94 0.99 0.89 1.04 0.84

5 1.18 1.24 1.12 1.28 1.08

6 1.45 1.52 1.39 1.55 1.35

7 1.73 1.80 1.66 1.83 1.53

8 2.01 2.09 1.93 2.11 1.91

9 2.32 2.41 2.23 2.42 2.22

10 2.73 2.82 2.64 2.83 2.63

11 3.50 3.60 3.40 3.60 3.40



If your values do not meet the values specified above, then please refer to the printer manufacturer's quality control procedure. You can create your own baseline with the measured values resulting during the initial installation of the printer per the manufac-turer's QC procedure.

* OD = Optical density

Quality control manual of printer manufacturer complied with:

SMPTE [%] Step Measured OD* Passed Failed

100 1 l l90 2 l l80 3 l l70 4 l l60 5 l l50 6 l l40 7 l l30 8 l l20 9 l l10 10 l l0 11 l l

Compliance Yes No

Date _______________ l lDate _______________ l lDate _______________ l l

Comments: ____________________________________________________________________________

___________________________________________________________________________________________

___________________________________________________________________________________________

Order No.: SPB7-250.623.02.04.02Printed in GermanyAG 09/07

© Siemens AG 2007All rights reserved

Contact address:

Siemens AG Siemens AG, Medical SolutionsWittelsbacherplatz 2 Special SystemsD-80333 Muenchen Henkestraße 127Germany D-91052 Erlangen

Germany