Siemens MAMMOMAT Inspiration Quality Control Manual
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Siemens MAMMOMAT Inspiration Quality Control Manual

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Quality Control Manual
MAMMOMAT Inspiration
VA10

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Summary of Contents for Siemens MAMMOMAT Inspiration

  • Page 1 Quality Control Manual MAMMOMAT Inspiration VA10...
  • Page 2 The original version of this manual was written in English language. CONFIDENTIALITY STATEMENT This document is the confidential property of Siemens AG Medical Solutions. No part of it maybe transmitted, reproduced, published, or used by other persons without the permission of Siemens AG Medical...
  • Page 3 In this case we request you to use as reference the complete print number in the footer of this page. Thank you very much for supporting us in our efforts to improve our products. My notes Optional information Name Hospital City/country E-mail Telephone/fax Number of fax pages MAMMOMAT Inspiration SPB7-330.640.01.01.02...

  • Page 5: Table Of Contents

    Performance Criteria and Corrective Action ................24 Test form Test 3 ........................25 Test 4: Detector Linearity Objective ..........................27 Required Equipment......................27 Procedure ..........................27 Performance Criteria and Corrective Action ................29 Test form Test 4 ........................30 MAMMOMAT Inspiration SPB7-330.640.01.01.02...
  • Page 6 Contents Test 5: Phantom Imaging Quality Objective..........................33 Required Equipment......................33 Procedure ..........................33 Performance Criteria and Corrective Action ................35 Test form Test 5 ........................36 Test 6: Spatial Resolution (optional) Objective..........................37 Required Equipment......................37 Procedure ..........................37 Performance Criteria and Corrective Action ................
  • Page 7 Position of Phantom.................. 34 Figure 7 ACR (RMI 156) phantom ................35 Figure 8 Indication of inferior spatial resolution ............39 Figure 9 Location of 5 % and 95 % squares............43 Figure 10 Location of bar patterns ................44 MAMMOMAT Inspiration SPB7-330.640.01.01.02...
  • Page 8 Figures Quality Control Manual SPB7-330.640.01.01.02...

  • Page 9: List Of Common Abbreviations

    Automatic Exposure Control Acquisition Work station Flat Detector Kilovolt milliAmperesecond Mammography Equipment Evaluation Mo/Mo Molybdenum/Molybdenum Mo/Rh Molybdenum/Rhodium Medical Physicist PMMA Poly Methyl Methacrylate Region of Interest SMPTE Society of Motion Picture and Television Engineers Signal-to-Noise-Ratio Technologist W/Rh Tungsten/Rhodium MAMMOMAT Inspiration SPB7-330.640.01.01.02...
  • Page 10 Abbreviations For notes Quality Control Manual SPB7-330.640.01.01.02...

  • Page 11: Introduction

    Mammography Equipment Evaluation (MEE) - Medical Physicist (MP) The MEE tests of the MAMMOMAT Inspiration should be performed whenever a new MAMMOMAT Inspiration system has been installed and whenever changes that might affect performance have been made to an existing system. For example, the MEE tests shall be performed if the system has been disassembled and reassembled or if major components have been changed or repaired.

  • Page 12: Recommended Frequency Of Qc Tests

    Introduction Recommended Frequency of QC Tests The following table describes when the different tests must be performed and by whom. Test Annually Monthly When needed 1. AEC Test 2. Artifact Detection 3. Detector Uniformity 4. Detector Linearity 5. Phantom Imaging Quality 6.

  • Page 13: Important Notes

    Important Notes Before performing any quality control test, be sure to be familiar with the operating instructions described in the MAMMOMAT Inspiration Operator Manual. The enclosed test form tables can be used to document test parameters used and results obtained during each test.

  • Page 14: Required Equipment

    Introduction Required Equipment The measurement devices listed below must always display a valid calibration stamp to ensure compliance with the described measurement and calibration intervals. • Lint-free, non-woven cotton or gauze (100% cotton) • Water or lukewarm diluted aqueous solution of household dishwashing liquid •...

  • Page 15: Prerequisites

    Calibrate the detector according to the chapter Calibrating the detector in the MAMMOMAT Inspiration Operator Manual. CAUTION! Improper operation can lead to reduced image quality. Let the MAMMOMAT Inspiration warm up for at least 30 minutes to ensure optimum results when performing an image quality test or a calibration. CAUTION! For startup and login, see MAMMOMAT Inspiration Operator Manual.

  • Page 16: Calculations

    Prerequisites Calculations Statistical calculations For all numerical calculations necessary in this quality control manual the testing person should use the formulae indicated in the following text together with a pocket calculator or appropriate software for numerical evaluations. Preliminaries: From the knowledge of any finite set of measurement values x , ..., x following fundamental statistical quantities can be established.
  • Page 17 Calculate global average of all pixel values (x ) and global average of all input air kerma values (K Calculate average of pixel and input air kerma values (x and K ⋅ ⋅ ⋅ ⋅ ------------------------------------------------------------------------------------------------ ⋅ -------------------------------------------------------- - MAMMOMAT Inspiration SPB7-330.640.01.01.02...
  • Page 18 Prerequisites Calculate standard deviation of all pixel values (σ ) and standard deviation of all input air kerma values σ Calculate linear correlation coefficient R ⋅ – ⋅ ----------------------------------------------- - σ ⋅ σ The offset (zero input signal) d of the X-ray detector is derived from ⋅...

  • Page 19: Test 1: Aec Test

    Check that the radiation signal lights up very shortly and exposure is interrupted, tube load is below 5 mAs. Check that a warning is shown. Note result in Test form Test 1. 10. Deactivate examination, remove shielding plate. MAMMOMAT Inspiration SPB7-330.640.01.01.02...
  • Page 20 Test 1: AEC Test AEC stability (step 11 - 23) 11. Select exposure technique Opdose grid in auto decompression on OPCOMP on AEC segmentation on low dose mode off 12. Position 20 mm PMMA plate on object table according to Figure 1. Detector PMMA plate Chest wall side...
  • Page 21 22. For each PMMA thickness calculate the relative deviation between the detected mean pixel value and the global average of all mean pixel values and note result in Test form Test 1. 23. Identify and note the maximum relative deviation out of the results from step 22. MAMMOMAT Inspiration SPB7-330.640.01.01.02...

  • Page 22: Performance Criteria And Corrective Action

    Test 1: AEC Test Performance Criteria and Corrective Action The AEC security cut-off mechanism shall work properly in such a way that in cases where no radiation reaches the detector no tube load beyond 5 mAs can be delivered. The AEC segmentation should be able to select an AEC region that: - completely remains inside the shadow of the PMMA plates, and - whose borders are close to the ones of the PMMA.

  • Page 23: Test Form Test 1

    Global average of mean pixel values over all PMMA thicknesses Standard deviation of mean pixel values from global aver- age over all PMMA thick- nesses Resulting coefficient of < ± 5 % variation Maximum relative < ± 10 % deviation MAMMOMAT Inspiration SPB7-330.640.01.01.02...

  • Page 24: Test 2: Artifact Detection

    Test 2: Artifact Detection Test 2: Artifact Detection Objective To determine if the detector is dusty, damaged or shows artifacts of any kind. Required Equipment Collimator mountable PMMA phantom Compression plate 24 x 30 cm Procedure Create a new patient record in the local database. Fill in: Last Name: Test_Two First Name: Artifact Detection...

  • Page 25: Performance Criteria And Corrective Action

    Test 2: Artifact Detection 10. If artifacts are still visible on any image after step 9 call Siemens customer service. 11. Note result in Test form Test 2. 12. Close examination. Performance Criteria and Corrective Action No clinically relevant artifacts shall be visible on image.

  • Page 26: Test Form Test 2

    Test 2: Artifact Detection Test form Test 2 Target/filter Target/filter Target/filter combination combination combination Mo/Mo Mo/Rh W/Rh Passed Failed Passed Failed Passed Failed No clinically relevant artifacts detected Quality Control Manual SPB7-330.640.01.01.02...

  • Page 27: Test 3: Detector Uniformity

    Mount compression plate and perform compression. Select exposure technique AEC 28 kV target/filter combination Mo/Mo grid in auto decompression off OPCOMP off AEC segmentation off low dose mode off Change all projection views to L-CC Perform exposure. MAMMOMAT Inspiration SPB7-330.640.01.01.02...

  • Page 28: Performance Criteria And Corrective Action

    Test 3: Detector Uniformity Define an ROI with a size of approximately 20 x 20 mm in arbitrary position inside the image. Move this ROI subsequently to each of the five positions indicated in Figure 3. If helpful switch off image text, menu View > No Text. 2 cm 2 cm 2 cm...

  • Page 29: Test Form Test 3

    Target/filter combination Mo/Rh Mean pixel value Relative deviation from global average ROI 1 ROI 2 ROI 3 ROI 4 ROI 5 Global average of mean pixel values Performance Passed Failed Criterion Maximum relative ≤ 7 % deviation MAMMOMAT Inspiration SPB7-330.640.01.01.02...
  • Page 30 Test 3: Detector Uniformity Target/filter combination W/Rh Mean pixel value Relative deviation from global average ROI 1 ROI 2 ROI 3 ROI 4 ROI 5 Global average of mean pixel values Performance Passed Failed Criterion Maximum relative ≤ 7 % deviation Quality Control Manual SPB7-330.640.01.01.02...

  • Page 31: Test 4: Detector Linearity

    05 05 1955 Gender: Other Select procedure QC-raw. Select exposure technique Manual, 28 kV 5 mAs target/filter combination Mo/Mo grid in auto decompression off OPCOMP off AEC segmentation off low dose mode off Mount PMMA phantom close to collimator. MAMMOMAT Inspiration SPB7-330.640.01.01.02...
  • Page 32 Test 4: Detector Linearity Position dose meter on object table according to Figure 4. Detector Dose meter Center 2 cm Chest wall side 7 cm Figure 4 Positioning the dose meter Mount compression plate and perform compression. Perform exposure. Note measured input air kerma in Test form Test 4. Define a ROI according to Figure 5, making sure that there is a distance of at least 2 cm between ROI and dose meter.

  • Page 33: Performance Criteria And Corrective Action

    Test form Test 4. 16. Close examination. Performance Criteria and Corrective Action The linear correlation coefficient should be greater than 0.99. The Offset should be between 45 and 55. The SNR should exceed indicated lower thresholds. MAMMOMAT Inspiration SPB7-330.640.01.01.02...

  • Page 34: Test Form Test 4

    Test 4: Detector Linearity Test form Test 4 Target/filter combination: Mo/Mo, tube voltage 28 kV Exposure Tube load Air kerma Mean pixel (mAs) (mGy) value Performance Passed Failed Criteria 40 - 60 Detector offset ________ 0.99 Linear correlation coefficient ________ Quality Control Manual SPB7-330.640.01.01.02...
  • Page 35 Test 4: Detector Linearity Target/filter combination: Mo/Rh, tube voltage 28 kV Exposure Tube load Air kerma Mean pixel (mAs) (mGy) value Performance Passed Failed Criteria 40 - 60 Detector offset ________ 0.99 Linear correlation coefficient ________ MAMMOMAT Inspiration SPB7-330.640.01.01.02...
  • Page 36 Test 4: Detector Linearity Target/filter combination: W/Rh, tube voltage 28 kV Exposure Tube load Air kerma Mean pixel (mAs) (mGy) value Performance Passed Failed Criteria 40 - 60 Detector offset ________ 0.99 Linear correlation coefficient ________ Quality Control Manual SPB7-330.640.01.01.02...

  • Page 37: Test 5: Phantom Imaging Quality

    05 05 1955 Gender: Other Select procedure QC-raw. Select exposure technique AEC 28 kV target/filter combination Mo/Mo grid in auto decompression off OPCOMP off AEC segmentation on low dose mode off Change all projection views to L-CC MAMMOMAT Inspiration SPB7-330.640.01.01.02...
  • Page 38 Test 5: Phantom Imaging Quality Position phantom on object table according to Figure 6. Detector ACR (RMI 156) phantom Chest wall side Figure 6 Position of Phantom Mount compression plate and perform compression. Perform an exposure. Examine the image. For evaluation use magnification, zooming or gray scale inversion, adapt windowing values, if helpful.

  • Page 39: Performance Criteria And Corrective Action

    Repeat steps 6 to 8 for target/filter combinations Mo/Rh and W/Rh. Close examination. Performance Criteria and Corrective Action Figure 7 ACR (RMI 156) phantom Number of objects that shall be detected: Fibers ≥ 5 Specks ≥ 4 Masses ≥ 4 MAMMOMAT Inspiration SPB7-330.640.01.01.02...

  • Page 40: Test Form Test 5

    Test 5: Phantom Imaging Quality Test form Test 5 Target/filter combination Mo/Mo Performance Passed Failed Tube load: ____________ mAs Criteria Fibers ≥ 5 Specks ≥ 4 Masses ≥ 4 Target/filter combination Mo/Rh Performance Passed Failed Criteria Tube load: ____________ mAs Fibers ≥...

  • Page 41: Test 6: Spatial Resolution (Optional)

    OPCOMP off Mount PMMA phantom close to collimator. Move bar pattern phantom on object table to a position where a problem with the spatial resolution of the detector is assumed. Mount compression plate and perform compression. Perform exposure. MAMMOMAT Inspiration SPB7-330.640.01.01.02...

  • Page 42: Performance Criteria And Corrective Action

    Test 6: Spatial Resolution (optional) Examine the image. For evaluation use magnification, zooming or full resolution, adapt windowing values, if helpful. If viewing conditions are considered to be inferior while looking at the image on AWS, send image to viewing station for additional examination of the achieved image.

  • Page 43: Test Form Test 6

    Test 6: Spatial Resolution (optional) Test form Test 6 Mark where the required spatial frequency is not reached. Detector Chest wall side Figure 8 Indication of inferior spatial resolution MAMMOMAT Inspiration SPB7-330.640.01.01.02...

  • Page 44: Test 7: Mechanical Tests

    Test 7: Mechanical Tests Test 7: Mechanical Tests Objective To ensure the mechanical integrity of the system Required Equipment Compressible phantom ACR (RMI 156) phantom Stop watch Compression plate 24 x 30 cm Procedure Check that the control panel lights up to show that the power is switched on. Turn the swivel-arm system to 180°...

  • Page 45: Performance Criteria And Corrective Action

    • Select Opdose mode and perform exposure • Read out the indicated thickness from image. Check that displayed thickness is between 39 mm and 45 mm. Performance Criteria and Corrective Action To ensure the mechanical integrity all steps should be passed. MAMMOMAT Inspiration SPB7-330.640.01.01.02...

  • Page 46: Test Form Test 7

    Test 7: Mechanical Tests Test form Test 7 Test no.: Performance Passed Failed Criteria 1. Control panel lights 2. System stops above floor 3. Check motorized movements 4. Foot switches 5. Movements blocked 6. Emergency stop button 7. No sharp edges or cracks on object table surface and compression plates 8.

  • Page 47: Test 8: Acquisition Workstation Monitor Check

    The 5% square is normally quite difficult to differentiate. If the viewing conditions are considered to be inferior, perform this test again with dimmed room light. Figure 9 Location of 5 % and 95 % squares MAMMOMAT Inspiration SPB7-330.640.01.01.02...
  • Page 48 Test 8: Acquisition Workstation Monitor Check Visually check the monitor’s performance by looking for streaking, fluttering and shadows. The spatial resolution and aliasing of the monitor are considered to be within acceptable limits if the high contrast bar patterns in the test image can be seen as patterns of white and black pairs.

  • Page 49: Performance Criteria And Corrective Action

    (see of the Figure 10) shall be visible. If any level is found to be beyond any action level stated, the source of the problem must be identified and the problem corrected by a Siemens customer service engineer and successfully retested by the MP before further examinations are performed using the system.

  • Page 50: Test Form Test 8

    Test 8: Acquisition Workstation Monitor Check Test form Test 8 Gray Scale Contrast: 5% square is visible inside 0% square Performance criteria: Yes 95% square is visible inside 100% square Performance criteria: Yes Spatial resolution: All lines in all bar patterns can be differentiated Performance criteria: Yes Visual Inspection:...

  • Page 51: Test 9: Printer Check (Optional)

    Test form Test 9. If any level is found to be beyond any action level stated, the source of the problem must be identified and the problem corrected by a Siemens customer service engineer and successfully retested by the MP before further examinations are performed using the system.

  • Page 52: Test Form Test 9

    Test 9: Printer Check (optional) Test form Test 9 Customer values for Min and Max Density Min Density Max Density Step Corr16b-bspline (LUT) Linear LUT* Ref. Maximum Minimum Ref. Maximum Minimum density density Density density density 0.20 0.23 0.17 0.20 0.23 0.17 0.34...
  • Page 53 1.04 0.84 1.18 1.24 1.12 1.28 1.08 1.45 1.52 1.39 1.55 1.35 1.73 1.80 1.66 1.83 1.53 2.01 2.09 1.93 2.11 1.91 2.32 2.41 2.23 2.42 2.22 2.73 2.82 2.64 2.83 2.63 3.50 3.60 3.40 3.60 3.40 MAMMOMAT Inspiration SPB7-330.640.01.01.02...
  • Page 54 Test 9: Printer Check (optional) 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 that result from the initial installation of the printer that was installed per the manufacturer's QC procedure.
  • Page 56 © Siemens AG 2007 All rights reserved Contact Address: Siemens AG Siemens AG, Medical Solutions Wittelsbacherplatz 2 Special Systems Order No.: SPB7-330.640.01.01.02 D-80333 München Henkestraße 127 Printed in the Federal Republic of Germany Germany D-91052 Erlangen AG 11/07 Germany...

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