Aspire HD. Program Manual. 2nd Edition - October 2012

Transcription

1 Quality Control 1 Aspire HD Quality Control Program Manual 2nd Edition - October 2012 Overview Installation of FDR Mammography QC Program Weekly Test Quarterly Test 5 Semi-annual Test 6 Annual Test 7 Assistance Material 8 This Manual provides detailed information about how to use the FDR Mammography QC Program as well as important points to note when using it. Before using this product, be sure to read this Manual thoroughly. After reading this Manual, store it nearby so that you can refer to it whenever necessary. Please also read FDR-1000DRSZ Operation Manual, FDR- 1000AWS Operation Manual, FDR Mammography QC Software Operation Manual and FCR 1Shot Phantom M Plus Operation Manual. Technical Information Image Processing Parameters (for Mammography QC) 9 897N101461A

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3 Introduction The FDR Mammography QC Program Manual (the Manual hereafter) provides the procedures for quality control and constancy test, technical explanation and other information necessary for managing the quality of the FDR digital mammography system. This quality control program primarily uses quantitative measurements and provides the ability to see gradual changes in X-ray equipment performances, as these changes are difficult to notice by visual checks alone. Exclusive Clauses 1. No part or all of this Manual (except Chapter 8) may be reproduced in any form without prior permission. 2. The information contained in this Manual may be subject to change without prior notice. 3. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from installation, relocation, remodeling, maintenance, and repair performed by other than dealers specified by FUJIFILM Corporation. 4. FUJIFILM Corporation shall not be liable for malfunctions and damages of FUJIFILM Corporation products due to products of other manufacturers not supplied by FUJIFILM Corporation. 5. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from remodeling, maintenance, and repair using repair parts other than those specified by FUJIFILM Corporation. 6. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from negligence of precautions and operating methods contained in this Manual. 7. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from use under environment conditions outside the range of using conditions for this product such as power supply, installation environment, etc. contained in this Guidebook. 8. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from natural disasters such as fires, earthquakes, floods, lightning, etc. Trademark FCR and FDR are trademarks or registered trademarks of FUJIFILM Corporation. Copyright 2008 FUJIFILM Corporation. All rights reserved. iii

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5 Contents at a Glance Chapter 1 Quality Control This chapter describes the relevant quality control standards. Chapter 2 Overview This chapter describes the features of FDR Mammography QC Program and the purpose of each quality control test. Chapter 3 Installation of FDR Mammography QC Program This chapter describes the operational procedure for installing the FDR Mammography QC Program. Chapter 4 Weekly Test This chapter describes the Weekly Test procedure performed by the Technologist (and during MEE and Annual testing by the Medical Physicist). Chapter 5 Quarterly Test This chapter describes the Quarterly Test procedure performed by the Technologist. Chapter 6 Semi-annual Test This chapter describes the Semi-annual Test procedure performed by the Technologist. Chapter 7 Annual Test The test procedures performed by the Medical Physicist during the Medical Equipment Evaluation (MEE) and Annual testing. Chapter 8 Assistance Material This chapter consists of material that helps with quality control tests and includes explanations of the calculation functions, software operation quick guides and the worksheets. Chapter 9 Technical Information This chapter consists of a brief specification of 1Shot Phantom M Plus and a glossary v

6 Indications The following indications are used in the descriptions to show the supplementary information and what must be observed while using the software. Indicates operational information that should be noted. TIP Indicates operational information that may be helpful. Indicates an item that provides details of the procedure or related information. Indicates a procedure that is dependent on the situation. Conventions The names of the buttons in the window are shown as described below. (Example) [Start study.] The button name is shown in brackets ([ ]) regardless of the feature. vi FDR Mammography QC Manual N101461A

7 Contents Chapter 1 Quality Control Chapter 2 Chapter Quality Control Acceptance Test Constancy Test Status Test Quality Control of the Mammography System Quality Control Tests and Frequency Types of Quality Control Tests Overview 2.1 Product Outline QC Test Items Weekly Test Quarterly Test Semi-annual Test Annual Test Tools QC Software Outline Notes on Conducting the Program Installation of FDR Mammography QC Program 3.1 Installation Procedure Initial Settings Criteria Confirmation and Determination Baseline Value Settings Baseline Values for Annual Test Baseline Values for Semi-annual Test Baseline Values for Weekly Test Checking Equipment Conditions at the Time of Program Installation vii

8 Chapter 4 Weekly Test Chapter 5 Chapter 6 Chapter Test Flow Test Items Tools Setting Confirmation Shot Phantom Test ACR Phantom Test Printer Quality Control Monitor Quality Control Quarterly Test 5.1 Test Flow Test Items Repeat Analysis Semi-annual Test 6.1 Test Flow Test Items Tools Compression Device Confirmation Annual Test 7.1 Test Flow Test Items Tools Setting Confirmation Conducting Annual Test Initial Performance Test Image Performance Test Spatial Resolution Test X-ray Equipment Performance Test AEC System Performance Test viii FDR Mammography QC Manual -897N101461A

9 Chapter 8 Assistance Material Chapter Calculation Functions Quick Guide for Software Operation Worksheets Report Forms Technical Information 9.1 Specification Outline of 1Shot Phantom M Plus Glossary ix

10 Revision History Revision Issue Date Reason First Edition 897N New Release 2nd Edition 897N101461A ) Revised Linearity/Beam Quality constancy test criteria for QL gap (4 step-5 step). 2) Revised corrective action limits for 1 Shot Phantom m Plus tests. 3) Revised compression plate heights for AGD Mode 1 testing. x

11 Chapter 1 1 Quality Control Page 1.1 Quality Control Acceptance Test Constancy Test Status Test Quality Control of the Mammography System Quality Control Tests and Frequency Types of Quality Control Tests

12 1.1 Quality Control 1 Quality Control This document provides information necessary for a facility using the FDR Mammography system to maintain an effective QA & QC program and meet the requirements of the MQSA regulations and Fujifilm Corp. Detailed instructions for carrying out quality control (e.g. when and who carries out quality control) are established as a quality assurance program. In addition to quality control techniques, training for providing adequate information on quality control is included so that any quality assurance program may be effectively implemented. International standards and guidelines regarding the quality control of the mammography system are as follows. MQSA (Mammography Quality Standards Act) 21CFR Part 900 (hereafter MQSA). ACR (American College of Radiology) Quality Control Manual European guidelines for quality assurance in breast cancer screening and diagnosis; Fourth Edition (European Commission) (Hereafter abbreviated as EUREF Ed.4) IEC Ed.2 (International Electrotechnical Commission) Always follow applicable laws and regulations for your jurisdiction. If anything in this manual is in conflict with applicable laws or regulations, the applicable law or regulation shall take precedence Tests for quality control are called performance tests. There are three types of performance tests, acceptance test, constancy test and status test, depending on their purpose or implementation frequency Acceptance Test The purpose of the acceptance test is to check the compliance of the equipment with specifications. An acceptance test is normally carried out when new equipment has been installed, when existing equipment has been remodeled, or when required by local juisdictions Constancy Test The constancy test is intended to monitor the constancy of the functional performance of the equipment by means of a test method that is simple, quick and easy to carry out, usually involving measurements of relative values. In FDR Mammography QC Program (Program hereafter), all tests are regarded as constancy tests. For some particular tests, the upper or lower limit is established by a law or guideline Status Test A status test is executed when components or sub-assemblies have been added, remodeled, replaced, or removed, or when the results of a constancy test indicate a substantial change in equipment performance. 1-2 FDR Mammography QC Manual - 897N101461

13 1.2 Quality Control of the Mammography System In this document, test items and their frequencies for the FDR Mammography system are deteremined so that facilities may be in compliance with the requirements of MQSA. Test items consist of quantitive tests and visual inspections, and the FDR 1Shot Phantom M Plus for quantitive measurement and QC Software are used for evaluation Quality Control Tests and Frequency Mammography E q u i p m e n t Evaluation (MEE) Weekly Test QC Software Installation Baseline Value Measurement Equipment Condition Check 3 months 6 months 9 months 1 year QC Software Operation 15 months 18 months 21 months At time of FDR installation / major component replacement 2 years Chapter 7 Chapter 4 Quality Control Every Week Chapter 4 Quarterly Test Chapter 5 Semi-annual Test Chapter 6 Annual Test Chapter 3 Chapter 7 Chapter 4 [1] Mammography Equipment Evaluation (MEE) - Medical Physicist The MEE tests should be performed when a new FDR Mammography system has been installed, and whenever changes that might affect performance (disassembly, major component repair, etc.) have been made to an existing FDR Mammography system. [2] Weekly Test - Technologist Weekly Tests using the FCR 1Shot Phantom M Plus and ACR Phantom are executed for detecting changes in image quality or subtle changes of the mammography system that may not reflected in actual images. These tests are executed as constancy tests for monitoring weekly changes in the mammography system. Quantitive tests can be executed by using the FCR 1Shot Phantom M Plus. However, a control limit needs to be determined for each quantitive test based on a series of measurements executed when installing this Program. For better performance, it is important that these control limits (criteria) are reviewed consistently taking into account other factors such as the scores of the tests using the ACR Phantom. [3] Quarterly Test - Technologist The Quarterly Test is designed to determine the number and cause of repeated radiographs. Analysis of this data will help identify ways to avoid repeat exposures and reduce costs, as well as reduce patient exposure. 4] Semi-annual Test - Technologist During the Semi-annual Test, performance verification tests of the compression system are executed.. [5] Annual Test- Medical Physicist During Annual Tests, performance verification tests of the components of the mammography system are executed using measuring instruments and materials such as a dosimeter and PMMA phantom. 1-3

14 1 Quality Control Types of Quality Control Tests All test items for quality control of the mammography system focus on change of measurement values. Accordingly, all test items are classified as constancy tests. However, there are two types of tests depending on evaluation methods. [1] Constancy Test Constancy tests are intended to monitor the constancy of the functional performance of the equipment. Since the performance varies depending on the types of the X-ray equipment and measurement environment, the same test is executed multiple times and its average value is defined as a baseline value, and the variation of measured values is defined as an established criteria. When the measured value is within the acceptable range (baseline value plus or minus criteria), the test result is regarded as Pass. If it is out of the acceptable range, the test result is regarded as Fail. 1 Quality Control [2] Performance Verification Test In performance verification tests, the upper or lower limit is specified by a law or guideline. These tests need to be passed irrespective of the type of X-ray equipment. Items of the performance verification test include scores of the tests using the ACR Phantom and measured values of Missed tissue on chest wall edge). 1-4

15 Chapter 2 Overview 2 Page 2.1 Product Outline QC Test Items Weekly Test Quarterly Test Semi-annual Test Annual Test Tools QC Software Outline Notes on Conducting the Program

16 2.1 Product Outline This Program is a dedicated program developed for implementing quality control of the FDR mammography system. Conducting this Program enables appropriate quality control on a FDR system in medical institutions to be carried out through the Weekly, Quarterly, Semi-annual and Annual Tests. The Program consists of the following three components. 2 Overview Manual (FDR Mammography QC Program) It (this document) provides instructions for implementing quality control of the FDR mammography system. Exclusive Phantom (1Shot Phantom M Plus) 1Shot Phantom M Plus (1Shot Phantom hereafter) was developed for quality control of the FDR mammography system and can produce the image quality test results on 10 items with a single exposure. The 1Shot Phantom enables wide-ranging analysis of a system in a relatively short time with high reproducibility. Exclusive Quality Control Software (FDR Mammography QC Software) FDR Mammography QC Software (hereafter QC Software) is designed for performing periodic quality control, data analysis, and QC test log management. [QC test categories] Weekly Test... Quantitative/Visual inspection with 1Shot Phantom/ ACR Phantom Quarterly Test...Repeat analysis Semi-annual Test...Quantitative/Visual inspection Annual Test...Quantitative/Visual inspection Comprehensive quality control on the FDR mammography system can be ensured by conducting these periodical tests and validating the results. The QC Software allows the auto-calculation of the CNR and AGD in addition to that of the items in each test. [Calculation functions] CNR... Used for calculating the values in AEC (Automatic Exposure Control) function adjustment or when determining the CNR baseline values. AGD...Used for calculating the values in AEC. 2-2

17 [Equipment to be evaluated] 2 Overview [Test categories and their implementation frequencies] The QC test items are categorized by the required implementation frequency. The test categories, their implementation frequency and personnel responsibilities are as shown below. Mammography Equipment Evaluation (MEE) (Medical Physicist) Weekly Test (Technologist) Quarterly Test (Technologist) Semi-annual Test (Technologist) Annual Test (Medical Physicist) QC Software Installation Baseline Value Measurement Chapter 3 Equipment Condition Check 3 6 months months QC Software Operation months year months months months years Chapter 7 At time of FDR mammography installation / major component replacement Chapter 4 Every Week Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 4 See Chapters 3 to 7 as necessary for details on each test procedure. FDR Mammography QC Manual -897N101461A 2-3

18 [The Program implementation procedure] 2 Overview 2-4

19 2.2 QC Test Items Test components in each test category are shown below. Exposure Menus are the menu items to be selected on a FUJIFILM workstation to start the corresponding tests. [Weekly Test] Test Items Exposure Menus Responsibility Test with 1Shot Phantom Good practice Test with ACR Phantom 1Shot PhantomM ACR Phantom Technologist 2 Conduct the Test with 1Shot Phantom and Good practice in the Daily Test, and the Test with ACR Phantom in the Weekly Test. [Quarterly Test] Test Items Exposure Menus Responsibility Repeat analysis *1 Technologist Overview *1 No Exposure Menu for the Repeat analysis in Quarterly Test [Semi-annual Test] Test Items Exposure Menus Responsibility Compression device confirmation *2 Technologist *2 No Exposure Menu for the Compression device confirmation in the Semi-annual Test 2-5

20 [Annual Test] Test Items Exposure Menus Responsibility Test Types Image Basic Test Additive lag effects (Lag) Multiplicative lag effects (Ghost) Visual and Functional test Annual A Annual 1/6 Image performance 2 Overview Spatial Resolution (Magnification) Annual 2/6 Spatial Resolution kvp accuracy and reproducibility Half Value Layer (HVL) Collimation assessment Radiation output AEC reproducibility CNR Mode 1 AGD Mode 1 Annual 3/6 Annual 4/6 Medical Physicist X-ray equipment performance AEC system performance Test with 1 Shot Phantom ACR Phantom Evaluation 1 Shot Phantom M ACR Phantom Image Performance [Calculation functions] Test Items Exposure Menus CNR Calculation 1/2 AGD Calculation 2/2 When an exposure menu includes multiple test items/contents, perform all tests. (If any of the test items/contents remain untested, the QC Software will not calculate the results.) An exposure menu can be selected on the following window of a FUJIFILM workstation. When an exposure menu is selected, the relevant exposure submenu(s) is displayed (Example: 1Shot PhantomM). See the Operation Manual for FUJIFILM workstation for detailed FUJIFILM workstation operations. Explanations of test items/contents are shown on the following pages. 2-6

21 2.2.1 Weekly Test The Weekly Test is conducted to evaluate image quality by making an exposure using a 1Shot Phantom and the ACR Phantom, and to check that the X-ray equipment normally used in clinical practice is kept clean. The 1Shot Phantom is designed to identify subtle changes in FDR Mammography system performance. With a single exposure using this Phantom, the QC Software auto-calculates the necessary image quality parameters, enabling image quality variations to be monitored (some test items require visual inspection). As required by MQSA regulations, image evaluation using the ACR Phantom is to be conducted at least once a week., and, when used in combination with the QC Software, the results can be managed efficiently. 2 Overview * : The ACR phantom density measurement is required to be performed weekly if the facility routinely prints hardcopy images for primary interpretation. If images are only occasionally printed for final interpretation, such as upon request of a patient for images for interpretation elsewhere, then the test must be performed in advance of, but not more than one week before printing the films. FDR Mammography QC Manual -897N101461A 2-7

22 Phantoms Used for Exposure [1] Test with 1Shot Phantom (1) Missed tissue on chest wall edge 1Shot Phantom 2 ACR Phantom/Acrylic disk Overview The ACR phantom density measurement (using the acrylic disk) is required to be performed weekly if the facility routinely prints hardcopy images for primary interpretation. If images are only occasionally printed for final interpretation, such as upon request of a patient for images for interpretation elsewhere, then the test must be performed in advance of, but not more than one week before printing the films. Check that the degree of missed tissue on chest wall edge of the exposure table is within the criteria. (2) CNR Check that the CNR variation is within the criteria. 2-8 FDR Mammography QC Manual - 897N101461

23 (3) 1Shot Phantom sensitivity constancy (6) Uniformity 2 Check that the 1Shot Phantom sensitivity variation is within the criteria. (4) Geometric distortion Check that the uniformity variation is within the criteria. (7) Dynamic range Overview Check that the image dimension variation (geometric distortion) in horizontal/vertical direction is within the criteria. Visually check that there is no distortion or jitter in the image. (5) System artifact evaluation Check that the dynamic range variation is within the criteria. (8) Spatial Resolution (SR) Check that the spatial resolution variation is within the criteria. Visually check that there are no artifacts affecting diagnosis in the image. FDR Mammography QC Manual - 897N

24 (9) Low Contrast Detectability (LCD) [2] Good practice Check that the following equipment is kept clean. X-ray equipment Softcopy output equipment Viewbox [3] Test with ACR Phantom 2 Overview Check that the low contrast detectability meets or exceeds the criteria. (10) Linearity/Beam quality constancy Check that the X-ray linearity and radiation quality variations are within the criteria. Make exposures using the ACR Phantom and then output the images to check that the densities of the specified areas in the images are within the criteria*. In addition, visually check and evaluate the images. Density at center of Phantom image* Density difference (disk/outside)* Fibers Specks Masses * ACR phantom density measurements are required to be performed weekly if the facility routinely prints hardcopy images for primary interpretation. If images are only occasionally printed for final interpretation, such as upon request of a patient for images for interpretation elsewhere, then the test must be performed in advance of, but not more than one week before printing the films. 2-10

25 2.2.2 Quarterly Test During the Quarterly Test, Repeat analysis is performed. [1] Repeat analysis Calculate data for analyzing the rejected images Semi-annual Test During the Semi-annual Test, Compression device confirmation is performed.. [1] Compression device confirmation 2 Overview Check that minimum and maximum compression forces can be applied. 2-11

26 2.2.4 Annual Test The Annual Test contains test items [1] to [12] for X-ray equipment performance and test item [13] for display device performance. 2 Overview 2-12

27 2.3 Tools Tools to be used for QC test are shown in the table below....required Tools Weekly Test Semi-annual Test Annual Test...Optional Calculation Functions [A] QC Software [B] Worksheet (See Chapter 8) [C] 1Shot Phantom [D] Viewbox (if film is used) [E] Timer or watch/clock ACR Phantom [F] (including an acrylic disk) *1 [G] Dosimeter [H] Luminance meter [I] kvp meter [J] Force scale / Bathroom scale [ K ] Towels [L] Illuminance meter [M] Densitometer PMMA phantoms (available, in [N] combination, for 20, 40, 60 and 70 mm in thickness) [O] Aluminum plate (0.2 mm) for CNR measurement Aluminum plates for half value layer [P] measurement (0.3 and 0.5 mm) [Q] Scale (ruler) [R] Coins [S] Lead sheet *2 *2 *3 *3 2 Overview *1 The ACR phantom density measurement is required to be performed weekly if the facility routinely prints hardcopy images for primary interpretation. If images are only occasionally printed for final interpretation, such as upon request of a patient for images for interpretation elsewhere, then the test must be performed in advance of, but not more than one week before printing the films. *2 Used to protect the exposure table and compression plate during Compression device confirmation *3 Placed on the exposure table to protect the image receptor when measuring the air kerma. The following equipment is used for the QC tests: A. FDA-cleared Hardcopy/Softcopy output equipment (laser imager/diagnostic monitor) B. X-ray equipment C. FUJIFILM workstation 2-13

28 Tool Details 2 Overview [A] QC Software The Software is designed for performing periodic quality control, data analysis, and QC test log management. This is to be installed and used on a FUJIFILM workstation. [B] Worksheet Worksheets for recording or documenting QC test measurement and judgment results are contained in 8.3 Worksheets. Make a copy of those worksheets as necessary. [C] 1Shot Phantom The 1Shot Phantom enables an image quality test on 10 items by a single exposure, allowing analysis of the wide-ranging system quality in a short time with high reproducibility. Scratches, deformation, or dirt on the Phantom not only affects the image evaluation or measured values but may damage the compression plate of the X-ray equipment. Make sure that there is no scratch, deformation, or dirt on the Phantom before use. [D] Viewbox A viewbox is used for visually checking an image output on film. Maintenance including surface cleaning or lamp replacement should be performed by following the manufacturer s instructions. If using a viewbox having a luminance adjustment function, make sure to keep the luminance constant for every test. [E] Timer or watch/clock A timer or watch/clock is used for measuring the duration of the compression plate. [F] ACR Phantom The Phantom is used for image evaluation. The model 156 manufactured by RMI (Radiation Measurements Inc.), by NA (Nuclear Associates), 15 by CIRS (Computerized Imaging Reference System, Inc.) or equivalent is necessary. The above mentioned Phantoms are qualified by ACR (American College of Radiology). Scratches, deformation, or dirt on the ACR Phantom not only affects the image evaluation or measured values but may damage the compression plate of the X-ray equipment. Make sure that there are no scratches, deformation, or dirt on the Phantom before use. [G] Dosimeter A dosimeter is used for measuring air kerma (exposure). Some dosimeters may require correction of the measured value according to the beam quality. See the operation manual for the dosimeter for details. The dosimeter should be calibrated using low energy (at least 10 kev to 40 kev), allowing air kerma rate or exposure time measurement, in addition to air kerma (exposure) measurement. [H] Luminance meter A luminance meter is used for measuring the luminance of a viewing box. The luminance meter allowing correct measurement of luminance around 3500 cd/m 2 is required. [I] kvp meter A kvp meter is used for measuring X-ray tube voltage of the X-ray equipment. The required kvp meter is the one of non-contact type and having measurement accuracy within ± 1.5 kv and reproducibility within ± 0.5 kvp under the tube voltage range used for mammography. [J] Force scale A force scale is used for measuring the force of the compression plate. If the compression force cannot be applied properly on the measurement portion of the force scale, use soft rubber or towels so as to not damage the X-ray equipment and allow proper measurement. [K] Towels Towels should be used to protect the exposure table and compression plate during the Compression device confirmation. [L] Illuminance meter An illuminance meter is used for measuring illuminance under viewing conditions. 2-14

29 [M] Densitometer A densitometer is used for measuring density of an image output on film. The densitometer should have a measurement range of 0 to 3.5 (0 to 4.0 is preferable) and measurement accuracy within ± [N] PMMA phantom Acrylic plates large enough for covering the exposure table and 20, 40, 60 and 70 mm in thickness are required. These plates can be used in combination. The breast thickness where the average glandular dose becomes equal to the dose on each PMMA phantom is as shown in the table below. PMMA thickness (mm) Equivalent breast thickness (mm) (Reference: EUREF Ed.4) Scratches, deformation, or dirt on the phantom not only affect the image evaluation or measured values but may damage the compression plate of the X-ray equipment. Make sure that there are no scratches, deformation, or dirt on the phantom before use. [O] Aluminum plate (0.2 mm) for CNR measurement A 99.9% or higher purity aluminum plate of sufficient size for covering ROI is required. The plate can be also used as [P] Aluminum plates for half value layer measurement. Multiple plates of 0.2 mm or less in thickness can be used in combination. [P] Aluminum plates (0.3 and 0.5 mm) for half value layer measurement A 99.9% or higher purity aluminum plate of sufficient size for covering the detection surface of the dosimeter is required. The plate can also be used as [O] Aluminum plate for CNR measurement. Multiple plates of 0.3 mm or less in thickness can be used in combination. [Q] Scale (ruler) A millimeter scale is required. [R] Coin Some familiar-sized coins are to be used. [S] Lead sheet A lead sheet is used to fully cover the receptor to completely block X-Rays when conducting the test on additive lag effects, and is also used as necessary to protect the image receptor when measuring the air kerma. 2 Overview FDR Mammography QC Manual - D 897N101461A 2-15

30 Equipment details A B Hardcopy/Softcopy output equipment FDA-cleared hardcopy/softcopy output devices (laser imager/diagnostic monitor). X-ray equipment The Fujifilm FFDM X-Ray exposure unit is to be used. 2 Overview C In this Program, methods of exposure condition setting of an X-ray equipment are defined as follows: Manu (manual) mode The mode allows manual setting of the kvp, mas and target/filter of the X-ray equipment. Semi (semi auto) mode The mode automatically specifies the mas but allows manual setting of the kvp and target/filter of the X-ray equipment. Auto (full auto) mode The mode automatically specifies kvp, mas and target/filter of the X-ray equipment depending on the subject. FUJIFILM workstation The workstation to be used is the Fujifim Acquisition Workstation (AWS). 2-16

31 2.4 QC Software Outline This section describes the operational procedure for the QC Software and the relevant window ( QC window hereafter). 2 Overview The QC window composition is described below. 2-17

32 2 Overview 2-18

33 2 2 Overview Overview See the FDR Mammography QC Software Operation Manual and/or operation manual for a FUJIFILM workstation for detailed QC software operation. FDR Mammography QC Manual -897N101461A 2-19

34 2 2 Overview Overview 2-20

35 2.5 Notes on Conducting the Program Operational notes regarding the Program are described below. Notes on Performing QC Tests 2 Overview (1) 1Shot/ACR Phantom position The positions of the Phantoms vary depending on the test item/content. See the test procedure for each item. (2) Dosimeter Position the X-ray detector of the dosimeter 40 mm above the exposure table unless indicated otherwise. Make sure of the X-ray detection position of the dosimeter and adjust the height as specified by using an appropriate jig. In the X-ray reproducibility test, the dosimeter position differs since the air kerma is measured using AEC technique. (3) Compression plate Some test items/contents require the compression plate to be installed, while some do not. See the test procedure for each item. Use a normal compression plate for mammography unless otherwise specified. (4) Solutions for failed test items Actions required when a test item judged as Fail are described for each test item. (5) Artifacts Artifacts may be seen in the Spatial Resolution chart on the 1Shot Phantom. This characteristic does not affect clinical images since there are no such special structures in a human body. Autocalculation is also not affected. (6) AGD AGD (Average glandular dose) values measured in this Program may be different from those in the test results displayed on a FUJIFILM workstation. In this Program, AGD values are measured based on the assumption that a uniform PMMA phantom is used and enable the user to evaluate the AEC (Automatic Exposure Control) performance of the X-ray equipment quantitatively. On the other hand, AGD values on a workstation are calculated for actual AGD values per mammogram. Due to this difference, the parameters used for calculations are different. Conduct tests by following the procedures in this Program. (7) Regular backup Regularly back up the results of the test conducted by using this Program. See FDR-1000AWS Operation Manual for details. (8) AEC exposure modes In this Program, only the (H-mode) exposure mode is used for clinical mammography (for test items that require AEC). Use this same exposure mode everytime you perform tests that require AEC. 2 Overview 2-21

36 Chapter 3 Installation of FDR Mammography QC Program 3 Page 3.1 Installation Procedure Initial Settings Criteria Confirmation and Determination Baseline Value Settings Baseline Values for Annual Test Baseline Values for Annual A Test Baseline Values for Daily/Weekly Test Checking Equipment Conditions at the Time of Program Installation

37 3.1 Installation Procedure The following steps shall be conducted by an authorized Fujifilm dealer prior to QC software use. These steps establish the criteria and baseline values that will be referenced for all QC tests supported by the QC software. Initial Settings Specify the information for conducting the tests, such as dosimeter position. Make sure to perform these settings, otherwise the auto-calculation of the QC Software cannot run. 3 Criteria Confirmation and Determination The reference criteria are preset. Check the criteria and change the values as necessary. Installation of FDR Mammography QC Program Baseline Value Settings Measured values for some test items vary depending on the environment where the X-ray equipment is used and measurements are performed. For these items, conduct the tests several times when installing the Program and set the averages of the measured values as the baseline values. Checking Equipment Conditions at the Time of Program Installation Conduct all of the test items provided in this Program except for Repeat Analysis to check the equipment conditions at the time of program installation. This will help correct a test item judged as [Fail] in a future QC test by providing the initial data for comparison. Conduct tests in the order of their potential influence on displayed images. Annual Test (Chapter 7) Semi-annual Test (Chapter 6) Weekly Test (Chapter 4) When new equipment or a system has been installed or existing equipment has been remodeled, perform the procedures described in 3.4 Baseline Value Settings and later sections in Chapter

38 3.2 Initial Settings The following items are required to be specified in the initial settings. Dosimeter - Exposure table distance Target / Filter and tube voltage (HVL) Air kerma unit Viewbox setting 6 Press [Initial setting]. 1 Setting Procedure Enter patient information and press [Next]. 7 Enter values for items requiring initial settings. For details on each item, see the following descriptions in (1) through (5). 3 2 Select [QC/TEST] in the exposure region list and [1Shot PhantomM] in the exposure menu list, and then press [Start study.]. (1) Dosimeter - Exposure table distance Measure the distance (mm) in the figure below and enter the value. The recommended value for h is 40 mm (This Manual assumes h is 40 mm in the following explanation). Set the distance l between the center of the dosimeter and chest wall-side edge of the exposure table as 60 mm. Installation of FDR Mammography QC Program 3 The following exposure submenu is displayed. 1Shot PhantomM 4 5 Specify 23 kv, 2 mas and Mo/Mo and make an exposure in Manu mode. It may take some time until you can press [QC] after completing the exposure process. Press [QC] to display the QC window. TIP Check the reference point of the dosimeter in its operation manual. (2) Magnification table - Exposure table s top surface distance Enter 247 mm. 3-3

39 3 (3) Target / Filter and tube voltage (HVL) Specify the kvp to be used for measuring half value layer in the Annual Test. The recommended kvp is 28 kv. (4) Air kerma unit Select the measurement unit (mr or µgy) for the dosimeter. (5) Viewbox setting 8 Put a checkmark when using a viewbox. When the viewbox to be used has a luminance adjustment and/or masking function, also put a checkmark in the relevant box. Press [OK]. Installation of FDR Mammography QC Program To continue to the criteria confirmation and determination, go to Step 6 in 3.3 Criteria Confirmation and Determination. To complete the initial setting without setting the criteria, press [Close] to exit the window. 3-4

40 3.3 Criteria Confirmation and Determination The criteria should be specified on your own responsibility based on the measurement results obtained at the time of the Program installation. Enter the percentage or the absolute value of variations from the baseline value for each item. The reference criteria are shown on the List of Reference Values for Criteria and Baseline Values. The reference criteria are preset for each item. The criteria can be changed by following Criteria Change Procedure below. Criteria Change Procedure When changing the criteria following 3.2 Initial Settings, start from Step 6. Enter patient information and press [Next]. 1 2 Select [QC/TEST] in the exposure region list and [1Shot PhantomM] in the exposure menu list, and then press [Start study.] The following exposure submenu is displayed. 1Shot PhantomM Specify 23 kv, 2 mas and Mo/Mo and make an exposure in Manu mode. It may take some time until you can press [QC] after completing the exposure process. Press [QC] to display the QC window. Press [Criteria setting]. 3 Installation of FDR Mammography QC Program 3-5

41 7 Select a tab and enter values for items to be changed. Daily/Weekly Tests 1/2 and 2/2 3 Installation of FDR Mammography QC Program [Items allowing criteria change] Test Item/Contents Judgment Items Criteria Missed tissue on chest wall edge (Right) [mm] 7 mm or less Missed tissue on chest wall edge Missed tissue on chest wall edge (Left) [mm] 7 mm or less CNR CNR Baseline value ± 20 % 1Shot Phantom sensitivity constancy System sensitivity Baseline value ± 35 % Dimension (Horizontal) [mm] Baseline value ± 2 % Geometric distortion Dimension (Vertical) [mm] Baseline value ± 2 % Pixel Value (PV) ratio (Top-Right) [%] Baseline value ± 15 % Pixel Value (PV) ratio (Top-Left) [%] Baseline value ± 15 % Pixel Value (PV) ratio (Bottom-Right) [%] Baseline value ± 15 % Pixel Value (PV) ratio (Bottom-Left) [%] Baseline value ± 15 % Uniformity SNR ratio (Top-Right) [%] Baseline value ± 15 % SNR ratio (Top-Left) [%] Baseline value ± 15 % SNR ratio (Bottom-Right) [%] Baseline value ± 15 % SNR ratio (Bottom-Left) [%] Baseline value ± 15 % Dynamic range Average QL at thinnest step wedge [QL] Baseline value ± 400 [QL] Spatial Resolution (SR) Low Contrast Detectability (LCD) Linearity/Beam quality constancy Test with ACR Phantom 2lp/mm [%] Baseline value ± 6 % 4lp/mm [%] Baseline value ± 15 % Low Contrast Detectability (Light) [%] > Baseline value - 14 % Low Contrast Detectability (Dark) [%] > Baseline value - 14 % QL gap (1 step-2 step) [QL] QL gap (2 step-3 step) [QL] QL gap (3 step-4 step) [QL] QL gap (4 step-5 step) [QL] Baseline value ± 50 [QL] Baseline value ± 50 [QL] Baseline value ± 50 [QL] Baseline value ± Baseline value [QL] Density at center of Phantom image 1.40 ± 0.2 Density difference (disk/outside) 0.4 or more and baseline value ± 0.05 Fibers (ACR Phantom) Specks (ACR Phantom) Masses (ACR Phantom) Visible step wedge (Step Phantom) *1 Specks (Step Phantom) *1 Masses (Step Phantom) *1 4 or more and no more than 0.5 lower than baseline 3 or more and no more than 0.5 lower than baseline 3 or more and no more than 0.5 lower than baseline 10 steps 4 steps or more 5 steps or more 3-6

42 Quarterly Test There is no item related to the criteria. Semi-annual Test There is no item related to the criteria. Annual A Test 3 [Items allowing criteria change] Test Items Judgment Items Criteria Image Basic Test Relative sensitivity (S value) Baseline value ± 40 % Compressed breast thickness accuracy [mm] ± 5 mm Compression device confirmation Compression force accuracy [N] ± 20 N Maximum compression force [N] 111 to 200 N Luminance [cd/m 2 ] 3500 cd/m 2 or more Viewbox maintenance Interpretation room illuminance (Ambient light) [lx] 50 lx or less Installation of FDR Mammography QC Program 3-7

43 Annual Test 1/3 (Annual Test consists of tabs 1/3 to 3/3) 3 Installation of FDR Mammography QC Program [Items allowing criteria change] Test Items Judgment Items Criteria Additive lag effects (Lag) Lag factor [QL] 75 QL or less Multiplicative lag effects (Ghost) Ghost factor Below MTF (4lp/mm)[%] Baseline value ± 12 % Spatial Resolution (Magnification) MTF (8lp/mm)[%] Baseline value ± 15 % Low volt. accuracy (LFS) [kv] Specified kvp ± 1 kv Mid. volt. accuracy (LFS) [kv] Specified kvp ± 1 kv High volt. accuracy (LFS) [kv] Specified kvp ± 1 kv kvp accuracy and reproducibility Low volt. accuracy (SFS) [kv] Specified kvp ± 1 kv Mid. volt. accuracy (SFS) [kv] Specified kvp ± 1 kv High volt. accuracy (SFS) [kv] Specified kvp ± 1 kv Mid. volt. reproducibility (LFS) [kv] Reproducibility ± 0.5 kv or less 3-8

44 Annual Test 2/3 [Items allowing criteria change] Test Items Judgment Items Criteria X-ray / Light field gap (Right/Left) [mm] Total gap criteria = SID X 0.02 or less X-ray / Light field gap (Chest/Nipple) [mm] Total gap criteria = SID X 0.02 or less Collimation assessment X-ray / Image receptor field gap (Left) [mm] SID X 0.02 or less X-ray / Image receptor field gap (Right) [mm] SID X 0.02 or less X-ray / Image receptor field gap (Nipple) [mm] SID X 0.02` or less X-ray field / Exposure table gap [mm] 5 mm or less Reproducibility Variation coefficient 0.05 or less Air kerma rate [mgy/s] 7 mgy/s or more Radiation output Specific radiation output [μgy/mas] 30 μgy/mas or more 3 Installation of FDR Mammography QC Program 3-9

45 Annual Test 3/3 3 Installation of FDR Mammography QC Program [Items allowing criteria change] Test Items Judgment Items Criteria AEC reproducibility CNR mode 1 Entrance air kerma accuracy [%] Entrance air kerma reproducibility CNR relative value 20mm [%] CNR relative value 40mm [%] CNR relative value 60mm [%] CNR relative value 70mm [%] Average ± 15 % or less Variation coefficient 0.05 or less Baseline value 105 % or more Baseline value 95 % or more Baseline value 63 % or more Baseline value 60 % or more AGD 20 mm [mgy] 1 mgy or less AGD 40 mm [mgy] 2 mgy or less AGD mode 1 AGD 60 mm [mgy] 4.5 mgy or less AGD 70 mm [mgy] 6.5 mgy or less AGD-ACR Phantom AGD-ACR Phantom 3 mgy or less TIP [CNR_H-mode] in the window corresponds to CNR mode 1. As with CNR mode, AGD mode 1 corresponds to H-mode. 3-10

46 8 Complete checking and changing all the necessary items, then press [OK] Press [Close] to exit the QC window. If The test result is not saved. is displayed, press [OK]. Select [Study completed] to finish the test. 3 Installation of FDR Mammography QC Program 3-11

47 3.4 Baseline Value Settings This section describes how to determine and specify the baseline values of each test item as the basis of judgment. Make sure to perform these settings, otherwise judgment cannot be made correctly. In this Program, the judgment is made based on how much the measured values deviates from the baseline values. Since the measured values for some test items depend on the X-ray equipment and/or exposure conditions, it is necessary to specify the baseline values for the test items. 3 Installation of FDR Mammography QC Program [Test items requiring baseline value setting] The items in the shadowed cells of the below table require the baseline settings. Test Categories Exposure Menus Test Items/Contents Weekly Test 1Shot PhantomM Test with 1Shot Phantom ACR Phantom Test with ACR Phantom Semi-annual Test Compression device confirmation Annual Test Missed tissue on chest wall edge CNR 1Shot Phantom sensitivity constancy Geometric distortion System artifact evaluation Uniformity Dynamic range Spatial Resolution (SR) Low Contrast Detectability (LCD) Linearity/Beam quality constancy Annual A Image Basic Test Annual 2/6 Spatial Resolution Spatial Resolution (Magnification) [Points to be noted] Baseline values vary depending on the exposure environment. Measurements must be conducted several times under uniform conditions to specify the baseline values. However, the operational procedure for the QC Software is different in the last measurement. Test items are categorized into an exposure menu as shown in the above table. Enter baseline values for all of the test items in an exposure menu, including the items not requiring the baseline setting, to proceed with the operation in the QC software. It is recommended to enter 0 in order not to mistake the entered value from the measured value when checking the setting later. It is recommended to specify the baseline values in the order of Annual Test Semi-annual Test Weekly Test, according to their potential influence on images. It is recommended to save image data based on which baseline values are determined to later confirm that weekly, semi-annual and annual tests have been conducted properly. 3-12

48 3.4.1 Baseline Values for Annual Test Among the Annual Test items, the Spatial Resolution (Magnification) requires the baseline setting. Test Category Exposure Menu Test Item Annual Test Annual 2/6 Spatial Resolution Spatial Resolution (Magnification) [1] Spatial Resolution (Magnification) [Test flow] [Tools] 1Shot Phantom 3 Installation of FDR Mammography QC Program 3-13

49 [Baseline value setting procedure] 1. Patient information entry and exposure menu selection 1 Enter patient information and press [Next]. 5 Position the 1Shot Phantom being shifted to the right-hand side so that the area indicated by the broken line in the below figure is at the lateral center of the X-ray field. 3 Installation of FDR Mammography QC Program 2 3 Select [QC/TEST] in the exposure region list and [Annual 2/6] in the exposure menu list, and then press [Start study.]. The following exposure submenu is displayed. 1ShotM(Magnification) If the area is out of the X-ray field while the Phantom is positioned by pressing its corners against the chest wall-side edge of the magnification table, shift the Phantom to the front. Make sure that the shifted Phantom is parallel to the chest wall-side edge Spatial Resolution (Magnification) (exposure) Mount the magnification table of the X- ray equipment and the compression plate normally used in magnification exposure in clinical practice. The Phantom position must be the same for every exposure (the allowable positional error is within ± 5 mm). Record how much the Phantom is shifted to the right-hand side and front side. Fill in the following items in the worksheet. 1 Shot Phantom position Lateral shift distance: mm 3-14

50 6 Specify Manu mode for the X-ray equipment and make a magnified exposure under the exposure conditions most often used in clinical practice (about 28 kv, 80 to 100 mas and Mo/Mo is recommended). Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N 9 5. Auto-calculation Press [Measurement execution]. The results are displayed at the bottom of the window. TIP If No baseline value is input. appears, press [OK]. In the last time measurement, skip Steps 10 through 12 and go to Step It may take some time until you can press [QC] after completing the exposure process. 3. QC Software startup Press [QC] to display the QC window. 4. Exposure condition confirmation Check the exposure conditions When the results are displayed, press [Save] and then [Close] to exit the QC Software. Select [Study completed] to finish the test. 12 Repeat Steps 1 through 11 several times (5 is recommended) to specify the averages of the multiple measured values as the baseline values. Make sure to repeat the same procedure until the test is finished. Do not add an exposure submenu when repeating. Installation of FDR Mammography QC Program 13 When the result is displayed, press [Save] and then [Test data log]. 3-15

51 14 6. Baseline value setting Select the results to be used for calculating the baseline values among the measured results, and then press [Baseline value creation]. This completes the baseline value setting. Press [Close]. 3 Installation of FDR Mammography QC Program QC Software shutdown Press [Save] and then [Close] to exit the QC Software. Select [Study completed] to finish the test. 3-16

52 3.4.2 Baseline Values for Annual A Test Among the Annual A Test items, the Image basic test requires the baseline setting. Test Category Exposure Menu Test Item Image Basic Test Annual A Test Annual A 1/1 [1] Image basic test [Test flow] Compression device confirmation Viewing box maintenance 3 [Tools] A dosimeter, scale, and lead sheet [Baseline value setting procedure] 1 Determine the exposure conditions used in the test. Remove the compression plate, place a lead sheet on the exposure table, and then position the dosimeter at the lateral center of the exposure table, 60 mm away from the chest wallside edge, and also 40 mm above the exposure table. Select [QC/TEST] in the exposure region list and [Calculation 1/2] in the exposure menu list, and then press [Start study.]. Specify Manu mode for the X-ray equipment and make an exposure with 25 kv and Mo/Mo. Then record the mas when the air kerma becomes approximate to 20 mr in the worksheet. Fill in the following item in the worksheet. mas: mas Installation of FDR Mammography QC Program 2 3 Specify Manu mode for the X-ray equipment and measure the air kerma 3 times with the mas derived from the exposure with 25 kv and Mo/Mo in Step 1. Fill in the following item in the worksheet. Entrance air kerma: mr µgy, mr µgy, mr µgy Remove the dosimeter. Select [Study completed] to finish the test. 3-17

53 4 1. Patient information entry and exposure menu selection Enter patient information and press [Next] Image basic test (exposure) Set [Grid] to [OUT], and then make an exposure with the same conditions as those used in Step 2. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / 3 Installation of FDR Mammography QC Program 5 6 Select [QC/TEST] in the exposure region list and [Annual A] in the exposure menu list, and then press [Start study.]. The following exposure submenu is displayed. Uniform Expo(Image Basic) 8 9 It may take some time until you can press [QC] after completing the exposure process. 3. QC Software startup Press [QC] to display the QC window. 4. Exposure condition confirmation Check the exposure conditions. 3-18

54 10 5. Image basic test (user input) Press [User input], enter the measured entrance air kerma and visual inspection results (Pass/Fail), and then press [OK] Auto-calculation Press [Measurement execution]. The results are displayed at the bottom of the window. TIP If No baseline value is input. appears, press [OK]. In the last measurement, skip Steps 12 through 14 and go to Step (1) Enter the measured entrance air kerma recorded in Step 2. (2) Select either of [Pass/Fail] for [Artifact] and [White out]. (3)(4) Enter any values for these items. Some dosimeters may require correction of the measured value according to the beam quality. Enter values or select [Pass/Fail] for all of the items. The Pass/Fail selection does not affect the baseline value determination. Enter any value (e.g. 0 for all items) except for negative or significantly large one. Otherwise, an error occurs When the result is displayed, press [Save] and then [Close] to exit the QC Software. Select [Study completed] to finish the test. 14 Repeat Steps 1 through 13 several times (5 is recommended) to specify the averages of the multiple measured values as the baseline values. Make sure to repeat the same procedure until the test is finished. Do not add an exposure submenu when repeating. 15 When the result is displayed, press [Save] and then [Test data log]. Installation of FDR Mammography QC Program 3-19

55 7. Baseline value setting 16 Select the results to be used for calculating the baseline values among the measured results, and then press [Baseline value creation]. This completes the baseline value setting. Press [Close]. 3 Installation of FDR Mammography QC Program QC Software shutdown Press [Save] and then [Close] to exit the QC Software. Select [Study completed] to finish the test. 3-20

56 3.4.3 Baseline Values for Weekly Test The following Weekly Test items/contents require the baseline setting: CNR, 1Shot Phantom sensitivity constancy, Geometric distortion, Uniformity, Dynamic range, Spatial Resolution (SR) and Linearity/Beam quality constancy in Test with 1Shot Phantom, and Density difference (disk/outside) in Test with ACR Phantom*. For each item, make exposures several times using the 1Shot Phantom, or the ACR Phantom, Step Phantom and acrylic disk, and then derive the average from the calculated results to determine it as the baseline value. * The baseline value setting for the test with ACR Phantom/Acrylic Disk is only required if the facility uses hardcopy for primary interpretation Test Category Exposure Menu Test Items/Contents Daily/Weekly Test [1] Test with 1Shot Phantom [Test flow] 1Shot PhantomM Test with 1Shot Phantom ACR Phantom Test with ACR Phantom Missed tissue on chest wall edge CNR 1Shot Phantom sensitivity constancy Geometric distortion System artifact evaluation Uniformity Dynamic range Spatial Resolution (SR) Low Contrast Detectability (LCD) Linearity/Beam quality constancy 3 Installation of FDR Mammography QC Program [Tools] 1Shot Phantom 3-21

57 [Baseline value setting procedure] 1 1. Patient information entry and exposure menu selection Enter patient information and press [Next] Test with 1Shot Phantom (exposure) Position the 1Shot Phantom on the exposure table. Position the Phantom at the lateral center of the exposure table by pressing the corners against the chest wall-side edge of the exposure table. If there are obstacles at the time of positioning, the test may not be conducted accurately. 3 Installation of FDR Mammography QC Program 2 3 Select [QC/TEST] in the exposure region list and [1Shot PhantomM] in the exposure menu list, and then press [Start study.]. The following exposure submenu is displayed. 1Shot PhantomM 5 Position the compression plate 40 mm above the exposure table. 3-22

58 6 Specify 28 kv and Mo/Mo and make an exposure in Semi mode. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N It may take some time until you can press [QC] after completing the exposure process. 10 Select either of [Pass/Fail] for [1Shot Phantom image confirmation] and [Good practice] items, and then press [OK]. Enter values or select [Pass/Fail] for all of the items. The Pass/Fail selection does not affect the baseline value determination QC Software startup Press [QC] to display the QC window Exposure condition confirmation Check the exposure conditions. 5. Test with 1Shot Phantom (user input) Press [User input] Auto-calculation Press [Measurement execution]. The results are displayed at the bottom of the window. TIP If No baseline value is input. appears, press [OK]. In the last time measurement, skip Steps 12 through 14 and go to Step 15. Installation of FDR Mammography QC Program 12 When the result is displayed, press [Save] and then [Close] to exit the QC Software. 13 Select [Study completed] to finish the test. 3-23

59 14 Repeat Steps 2 through 13 several times (5 is recommended) to specify the averages of the multiple measured values as the baseline values. Make sure to repeat the same procedure until the test is finished. Do not add an exposure submenu when repeating. 17 Create baseline values for Low Contrast Detectability (Light) and Low Contrast Detectability (Dark) in LCD. 15 When the result is displayed, press [Save] and then [Test data log]. 3 Installation of FDR Mammography QC Program Baseline value setting Select the results to be used for calculating the baseline values among the measured results, and then press [Baseline value creation]. 1. Average measured results for Low Contrast Detectability (Light). This is the baseline value for Low Contrast Detectability (Light). If measured results for Low Contrast Detectability (Light) are respectively w1, w2, w3, w4 and w5, the average can be calculated by the following formula: (w1+w2+w3+w4+w5)/5. Round the calculated value to the whole number. Fill in the following item in the worksheet. Baseline value for Low Contrast Detectability (Light) : % E.g.: Assuming that measured results for Low Contrast Detectability (Light) are respectively 59.66, 60.33, 55.25, and ( )/5 = Round to the whole number. = Similarly, average measured results for Low Contrast Detectability (Dark). This is the baseline value for Low Contrast Detectability (Dark). If measurement results for Low Contrast Detectability (Dark) are respectively b1, b2, b3, b4 and b5, the average can be calculated by the following formula: (b1+b2+b3+b4+b5)/5. Round the calculated value to the whole number. 3-24

60 18 19 Fill in the following item in the worksheet. Baseline value for Low Contrast Detectability (Dark) : % E.g.: Assuming that measured results for Low Contrast Detectability (Dark) are respectively 67.03, 68.65, 63.03, and ( )/5 = Round to the whole number. = 67 Create criteria to be entered in Low Contrast Detectability (Light) and Low Contrast Detectability (Dark) in LCD. 1. Subtract 14 from the baseline value for Low Contrast Detectability (Light) in consideration of variations in the measurement. This is the criteria for Low Contrast Detectability (Light). Fill in the following item in the worksheet. Criteria for Low Contrast Detectability (Light) : % E.g.: Assuming that baseline value for Low Contrast Detectability (Light) is = Similarly, subtract 14 from the baseline value for Low Contrast Detectability (Dark). This is the criteria for Low Contrast Detectability (Dark). Fill in the following item in the worksheet. Criteria for Low Contrast Detectability (Dark) : % E.g.: Assuming that baseline value of Low Contrast Detectability (Dark) is = 53 Press [Criteria setting] Select the [Daily/Week/y test (1/2)] tab. Enter the criteria for Light and Dark in LCD and press [OK]. 8. QC Software shutdown Press [Save] and then [Close] to exit the QC Software. Select [Study completed] to finish the test. 3 Installation of FDR Mammography QC Program 3-25

61 [2] Test with ACR Phantom The baseline value setting for the test with ACR Phantom/Acrylic Disk is only required if the facility uses hardcopy for primary interpretation [Test flow] 3 Installation of FDR Mammography QC Program [Tools] ACR Phantom, an acrylic disk, and a densitometer 3-26

62 [Baseline value setting procedure] 1. Patient information entry and exposure menu selection 1 Enter patient information and press [Next] ACR Phantom (exposure) Position the ACR Phantom at the lateral center of the exposure table while aligning its edge with the chest wall-side edge of the exposure table. 5 Position the acrylic disk wherever it does not interfere with the visual inspection of the ACR Phantom (as shown in the figure below). Nipple side ACR Phantom Select [QC/TEST] in the exposure region list and [ACR Phantom] in the exposure menu list, and then press [Start study.]. The following exposure submenu is displayed. ACR Phantom 6 Acrylic disk Chest wall side Position the compression plate so that it comes in contact with the ACR Phantom. Make sure that excessive pressure is not applied to the Phantom. Installation of FDR Mammography QC Program 7 Make an exposure in Auto or Semi mode. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N It may take some time until you can press [QC] after completing the exposure process. 3. QC Software startup 3-27

63 3 8 9 Press [QC] to display the QC window. 4. Exposure condition confirmation Check the exposure conditions. 13 Enter the densities measured in Step 11. Make sure to enter values for [Density inside the disk/density outside the disk] in the correct position. Enter any values for [Density at center of Phantom image] and the image evaluation, then press [OK]. Enter values for all of the items. The values except those for [Density inside the disk/density outside the disk] do not affect the baseline value determination. Installation of FDR Mammography QC Program Image output Select an image exposed using Exposure Submenu [ACR Phantom] from the exposure condition display field and press [Film output] Measure the following items using the image output on film. Fill in the following items in the worksheet. Density inside the disk: Density outside the disk: 6. ACR Phantom (user input) Press [User input]. 3-28

64 Auto-calculation Press [Measurement execution]. The results are displayed at the bottom of the window. TIP If No baseline value is input. appears, press [OK]. In the last measurement, skip Steps 15 through 17 and go to Step 19. When the result is displayed, press [Save] and then [Close] to exit the QC Software. Select [Study completed] to finish the test. 17 Repeat Steps 1 through 16 several times (5 is recommended) to specify the averages of the multiple measured values as the baseline values. Make sure to repeat the same procedure until the test is finished. Do not add an exposure submenu when repeating. 18 When the result is displayed, press [Save] and then [Test data log] Baseline value setting Select the results to be used for calculating the baseline values among the measured results, and then press [Baseline value creation]. This completes the baseline value setting. Press [Close]. Make sure that the results for the Test with ACR Phantom are selected. They are displayed below those for the Test with 1Shot Phantom. 9. QC Software shutdown Press [Save] and then [Close] to exit the QC Software. Select [Study completed] to finish the test. 3 Installation of FDR Mammography QC Program 3-29

65 3.5 Checking Equipment Conditions at the Time of Program Installation 3 Installation of FDR Mammography QC Program Conduct all of the test items provided in this Program except for Repeat analysis to confirm that the all judgment items result in [Pass]. This enables to find defects in the X-ray equipment or hardcopy/softcopy output equipment when installed. In addition, this will help correct a test item judged as Fail in a future QC test by providing the initial data for comparison. For this reason, it is recommended to save the image data when equipment conditions are checked at the time of the Program installation. The specified baseline values or reference criteria are shown on the List of Reference Values for Criteria and Baseline Values. For visual inspections, it is recommended to clearly relate an output image and the judgment result in the condition check performed when the Program has been installed. Furthermore, it is advisable to observe an output image in the condition check at the time of the Program installation with some people (conductors of the QC tests in the Program are recommended) to share the points for evaluation in visual inspections. See the relevant Chapters for the test procedures. TIP Conduct the tests in the order of their potential influence on displayed images. Annual Test (Chapter 7) Semi-annual Test (Chapter 6) Daily/Weekly Test (Chapter 4) Conducting these Tests complete the condition check at the time of the Program installation. 3-30

66 3 Installation of FDR Mammography QC Program 3-31

67 Chapter 4 Weekly Test Page 4.1 Test Flow Test Items Tools Setting Confirmation Conducting Weekly 1 Shot Phantom Test Procedure Test Result Evaluation and Judgment Performance Criteria and Corrective Action Conducting Weekly ACR Phantom Test Procedure Test Result Evaluation and Judgment Performance Criteria and Corrective Action Conducting Weekly Printer QC Conducting Weekly Monitor QC

68 4.1 Test Flow Based on quantitative measurements that enable the identification of gradual changes in image quality over time, the Weekly test is performed : 1) Weekly by the Technologist 2) Annually by the Medical Physicist during the Medical Equipment Evaluation (MEE) and subsequent Annual testing. 4 Weekly Test The Weekly Test is comprised of constancy tests and performance verification tests of the system. The constancy tests are designed for determining if variations of regularly-measured system performance values are within the allowable range (criteria) based on baseline values that were established at the time of QC program / system installation. The performance test is intended to check that system performance values are within the upper or lower limits specified by the baselines. It is necessary to determine the criteria before conducting the Weekly Test. The reference criteria are shown on the The List of Reference Vales for Criteria and Baseline Values. See 3.3 Criteria Confirmation and Determination for details. When conducting the Weekly Test for the first time after setting the criteria, specify the baseline values to be used in the future Weekly Tests. In the second or later Weekly Test, check that the variation from the specified baseline values is within the criteria. See 3.4 Baseline Value Settings for details. 4-2

69 4.2 Test Items The Weekly Test consists of the following test items. Test Items/Contents Exposure Menus Exposure Submenus Missed tissue on chest wall edge Items Autocalculated and Judged Based on Input Data 1. Exposure 2. Input Values Items Judged [Pass/Fail] Based on Visual Inspection by a User CNR 1Shot Phantom sensitivity constancy Geometric distortion Test with 1Shot System artifact evaluation 1Shot PhantomM Phantom Uniformity 1Shot PhantomM Dynamic range Spatial Resolution (SR) Low Contrast Detectability (LCD) Linearity/Beam quality constancy Good practice - Test with ACR Phantom ACR Phantom* ACR Phantom* Three judgment methods: 1. Auto-calculation by the QC Software based on the image data acquired by making an exposure. 2. Auto-calculation by the QC Software based on the input measurement data. 3. User selection of [Pass/Fail] based on visual inspection of the image. 4 Weekly Test Each Weekly Test item is tested by normally using an output image. Most of the test results can be auto-calculated from the image data by the QC Software, though some items require visual inspection. * The Test with ACR Phantom is required to be conducted at a Weekly frequency. On the day that you would conduct both the Test with 1Shot Phantom and the Test with ACR Phantom, select Exposure Menu [1Shot/ACR]. In other cases, do not use the exposure menu. Otherwise, an incorrect test data log will be created. 4-3

70 4.3 Tools Tools to be used for the Weekly Test based on this Guidebook are shown below. See 2.3 Tools for details. Tools [A] QC Software [B] Worksheet (See Chapter 8) [C] 1Shot Phantom [D] Viewbox* 1 [F] ACR Phantom (including an acrylic disk* 1 ) [M] Densitometer (if film is used) *1 The ACR phantom density measurement (using the acrylic disk) is required to be performed weekly if the facility routinely prints hardcopy images for primary interpretation. If images are only occasionally printed for final interpretation, such as upon request of a patient for images for interpretation elsewhere, then the test must be performed in advance of, but not more than one week before printing the films. 4 Weekly Test 4-4

71 4.4 Setting Confirmation The following items described in Chapter 3 are required to be specified before conducting the Weekly Test. Initial settings Initial Settings Criteria Criteria Confirmation and Determination Baseline values Baseline Value Settings [Items allowing criteria change] Test Items/Contents Judgment Items Criteria Missed tissue on chest wall edge Missed tissue on chest wall edge (Right) [mm] Missed tissue on chest wall edge (Left) [mm] 7 mm or less 7 mm or less CNR CNR Baseline value ± 20 % 1Shot Phantom sensitivity constancy Geometric distortion System sensitivity Baseline value ± 35 % Dimension (Horizontal) [mm] Baseline value ± 2 % Dimension (Vertical) [mm] Baseline value ± 2 % Pixel Value (PV) ratio (Top-Right) [%] Baseline value ± 15 % Pixel Value (PV) ratio (Top-Left) [%] Baseline value ± 15 % Pixel Value (PV) ratio (Bottom-Right) [%] Baseline value ± 15 % 4 1Shot PhantomM Uniformity Pixel Value (PV) ratio (Bottom-Left) [%] Baseline value ± 15 % SNR ratio (Top-Right) [%] Baseline value ± 15 % SNR ratio (Top-Left) [%] Baseline value ± 15 % SNR ratio (Bottom-Right) [%] Baseline value ± 15 % SNR ratio (Bottom-Left) [%] Baseline value ± 15 % Weekly Test Dynamic range Average QL at thinnest step wedge [QL] Baseline value ± 400 [QL] Spatial Resolution (SR) Low Contrast Detectability (LCD) 2lp/mm [%] Baseline value ± 6 [%] 4lp/mm [%] Baseline value ± 15 [%] Low Contrast Detectability (Light) [%] > Baseline value - 14 % Low Contrast Detectability (Dark) [%] > Baseline value - 14 % Linearity/Beam quality constancy QL gap (1 step-2 step) [QL] QL gap (2 step-3 step) [QL] QL gap (3 step-4 step) [QL] QL gap (4 step-5 step) [QL] Baseline value ± 50 [QL] Baseline value ± 50 [QL] Baseline value ± 50 [QL] Baseline value ± Baseline value [QL] Density at center of Phantom image 1.4 ± 0.2 Density difference (disk/outside) 0.4 or more and baseline value ± 0.5 ACR Phantom Fibers (ACR Phantom) Specks (ACR Phantom) Masses (ACR Phantom) Visible step wedge (Step Phantom) *1 Specks (Step Phantom) *1 Masses (Step Phantom) *1 4 points or more 3 points or more 3 points or more 10 steps 4 steps or more 5 steps or more TIP The criteria setting is not required for visual inspection. *1 When not checking these items, leave the preset values as they are. Do not delete the preset values. 4-5

72 4.5 Conducting Weekly 1 Shot Phantom Test Procedure [Test flow] 4 Weekly Test 4-6

73 1 1. Patient information entry and exposure menu selection Enter patient information and press [Next] Test with 1Shot Phantom (exposure) Follow the instructions below to conduct the test item. [Tools] 1Shot Phantom 1. Position the 1Shot Phantom on the exposure table. Position the Phantom at the lateral center of the exposure table by pressing the corners against the chest wall-side edge of the exposure table. If there are obstacles at the time of positioning, the test may not be conducted accurately. 2 Select [QC/TEST] in the exposure region list and [1Shot PhantomM] in the exposure menu list, and then press [Start study.]. 4 Weekly Test 3 The following exposure submenu is displayed. 1Shot PhantomM 2. Position the compression plate 40 mm above the exposure table. 4-7

74 3. Specify the same kvp and target/filter as those determined in the Baseline Values for Daily/Weekly Test. Then make an exposure in Semi mode. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N Make sure to specify the same exposure conditions as those used in the baseline value setting. If they are not certain, newly determine the exposure conditions for the 1Shot Phantom by following Baseline Values for Daily/Weekly Test Viewbox cleaning Wipe clean the surface of the viewbox and check that the luminance is uniform. Follow the instructions given by the manufacturer if any. Fill in the following items in the worksheet. X-ray equipment cleanliness: Pass/Fail Screen cleanliness: Pass/Fail Viewbox cleanliness: Pass/Fail It may take some time until you can press [QC] after completing the exposure process. 4. QC Software startup Press [QC] to display the QC window Exposure condition confirmation Weekly Test 5 3. Good practice (cleaning) Follow the instructions below to conduct the test item. [Tools] See the respective operation manuals for the FDR-1000DRSZ, FDR-1000AWS, and viewbox for the necessary cleaning tools. 1. X-ray equipment cleaning Clean the following parts of the X-ray equipment. Compression surface of the breast compression plate Patient support and chest wall-side surface of the exposure table Surfaces of X-ray tube assembly (incorporating X-ray tube and collimator) including the mounted and removable accessories Armrests 2. Softcopy output equipment cleaning Wipe off any dust, finger marks and other dirt on all of the softcopy output equipment by using a lint-free soft cloth. Follow the instructions provided by the manufacturer. 7 Check the exposure conditions. 4-8

75 6. Image output 8. Good practice (user input) 8 Select Exposure Submenu [1Shot PhantomM] from the exposure condition display field and press [Film output]. For performing image diagnosis on a softcopy display, press [Network output] to output the image to the network. 11 Enter the results of Good practice, and then press [OK]. 9 Check or measure the following items using the image output on film. TIP For performing image diagnosis on a softcopy display, check the items on the display. 12 Make sure that the result is selected for all items. If there is an item left unentered, an error occurs. 9. Auto-calculation Press [Measurement execution]. The results are displayed at the bottom of the window. 4 Weekly Test Fill in the following items in the worksheet. 1Shot Phantom Geometric distortion: Pass/Fail Artifact: Pass/Fail 7. Test with 1Shot Phantom (user input) 10 Press [User input]. Enter the visual inspection results. 4-9

76 10. Test result confirmation 13 Check the displayed judgment results. If there is a [Fail], see Performance Criteria and Corrective Action. 4 Weekly Test QC Software shutdown Press [Save] and then [Close] to exit the QC Software. 15 Select [Study completed] to finish the test. 4-10

77 4.5.2 Test Result Evaluation and Judgment Evaluate and judge the Weekly Test results. If all items are judged as [Pass], the Weekly Test is finished. If there is an item judged as [Fail], take corrective actions by following Performance Criteria and Corrective Action Performance Criteria and Corrective Action [1] Test with 1Shot Phantom [Any failed test item} During the MEE / Annual survey performed by the Medical Phyiscist, If any of the items still results in [Fail], the source of the problem shall be identified and corrective action shall be taken before any further examinations are performed with the system. During the Weekly test performed by the QC technologist, if any of the following items still results in [Fail], the source of the problem shall be identified and corrective action shall be taken before any further examinations are performed with the system: CNR. Performance Criteria: Baseline value ± 20 % 4 Weekly Test Spatial Resolution. 2lp/mm: Baseline value ± 6 %, 4lp/mm: Baseline value ± 15 % Missed Tissue at Chest Wall. Less than 7mm. Uniformity. Performance Criteria: Baseline value ± 15 % Linearity/Beam Quality. Performance Criteria: Baseline value ± x [QL] During the Weekly test performed by the QC technologist, if an item other than those listed above still results in [Fail], the source of the problem shall be identified and corrective action shall be taken within 30 days of the test date. Clinical imaging and mammographic image interpretation may be continued during this period. [2] Good practice Clean the equipment. 4-11

78 4.6 Conducting Weekly ACR Phantom Test Procedure [Test flow] 4 Weekly Test 4-12

79 1 1. Patient information entry and exposure menu selection Enter patient information and press [Next] Test with ACR Phantom (exposure) Follow the instructions below to conduct the test item. [Tools] ACR Phantom, an acrylic disk*, and a densitometer*. 1. Position the ACR Phantom at the lateral center of the exposure table while aligning its edge with the chest wall-side edge of the exposure table. 2. Position the acrylic disk* wherever it does not interfere with the visual inspection of the ACR Phantom (as shown in the figure below). 2 Select [QC/TEST] in the exposure region list and [ACR Phantom] in the exposure menu list, and then press [Start study.]. * The acrylic sisk and densitometer are required only if the facility uses hardcopy (film) for primary interpretation. Nipple side 4 AC R Phantom Weekly Test Chest wall side 3 The following exposure submenu is displayed. ACR Phantom Acrylic disk 3. Position the compression plate so that it comes in contact with the ACR Phantom. Make sure that excessive pressure is not applied to the Phantom. 4-13

80 4. Make an exposure in Auto or Semi mode. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N It may take some time until you can press [QC] after completing the exposure process Image output Select Exposure Submenu [ACR Phantom] from the exposure condition display field and press [Film output]. For performing image diagnosis on a softcopy display, press [Network output] to output the image to the network. 3. QC Software startup 5 Press [QC] to display the QC window. 4 Weekly Test 6 4. Exposure condition confirmation Check the exposure conditions. 8 Check or measure the following items using the image output on film. Follow the recommended image evaluation method for the Phantom to evaluate the image. TIP For performing image diagnosis on a softcopy display, check the items on the display. Fill in the following items in the worksheet. ACR Phantom Density at center of Phantom image: Density inside the disk: Density outside the disk: Fibers (ACR Phantom): points Specks (ACR Phantom) : points Masses (ACR Phantom): points 4-14

81 9 6. Test with ACR Phantom (user input) Press [User input]. Enter the measured density and visual inspection results, and then press [OK]. Though the Step Phantom is not part of this QC program, values for it must be entered. Enter any integer from 0 to 10. If an item is left unentered, or a negative value or value over 11 is entered, an error occurs QC Software shutdown Press [Save] and then [Close] to exit the QC Software. Select [Study completed] to finish the test. 4 Weekly Test Auto-calculation Press [Measurement execution]. The results are displayed at the bottom of the window. 8. Test result confirmation 11 Check the displayed judgment results. If there is a [Fail], see Performance Criteria and Corrective Action. 4-15

82 4.6.2 Test Result Evaluation and Judgment Evaluate and judge the Weekly Test results. If all items are judged as [Pass], the Weekly ACR Phantom test is finished. If there is an item judged as [Fail], take corrective actions by following Performance Criteria and Corrective Action. See 8.2 Quick Guide for Software Operation for test log display procedure. 4 Weekly Test 4-16

83 4.6.3 Performance Criteria and Corrective Action [3] Test with ACR Phantom Performance Criteria: Fibers = 4 or more Specks = 3 or more Masses = 3 or more Density at center = 1.40 ± 0.2 Density difference disk / outside = 0.4 or more and baseline value ± 0.05 Points to be checked The corr ect exposure submenu was selected. The s ame X-ray equipment s ettings (target/filter, kvp and AE C settings) have been used. The AC R P hantom, and acrylic disk (if used) were correctly positioned. The same compr ession plate has been used during the test. The compr ession plate has been in the same position during the test. The densitometer was correctly used. The density was measur ed on the corr ect pos ition. The quality contr ol of the viewing condition is conducted. If any of the above is not ect/appropriate, corr correct the pr oblem. Make sure that the ACR Phantom is corr ectly positioned and then edo r the tes t. Pass The test is finished. 4 Weekly Test Fail Contact a FUJIFILM dealer. If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be taken before any further examinations are performed with the system. 4-17

84 4.7 Conducting Printer Quality Control Procedure [Test flow] 1. TP rinter Quality C ontrol 4 Weekly Test 4-18

85 1 3. Printer Quality Control (measurement) Follow the instructions below to conduct the Printer Quality Control test. The printer used to produce films for final interpretation of mammography images must be cleared by FDA for that purpose. The objective of this test is to assure that the printer used for final interpretation is performing according to the manufacturer s specifications. Follow the printer manufacturer s QC program for test frequency, procedure, performance and corrective action. If the manufacturer does not provide a mammography printer QC program, use the following: [Tools] QC pattern with a fixed digital value grayscale (e.g. TG18-QC or TG18-PQC (contact your printer manufacturer for details), calibrated densitometer, Report Form (available from printer manufacturer). 1. Print the QC Pattern. 2. Measure the image to identify the step which has an optical density closest to, but not less than Designate this step as the Mid-Density (MD) step. 3. Measure the image to identify the step with an optical density closest to, but not less than Designate this step as the High-Density (HD) step. 4. Measure the image to identify the step with an optical density closest to, but not less than Designate this step as the Low-Density (LD) step. 5. The difference between the HD step and the LD step is designated as the Density Difference (DD). 6. Measure the lightest (Base+Fog or unexposed) portion of the image. This is designated as B+F. 7. Plot the Mid-Density (MD), the Density Difference (DD) and the Base+Fog (B+F) on the control chart. 7. Determine if any of the data points exceed the control limits. If not, proceed to step 9. If so, print a second QC pattern, double checking that the correct procedure is followed. If the same results are obtained, proceed to step Circle any out-of-control data points and repeat the test. If any data point is still out of control, correct the cause of the problem and repeat the test to confirm that the problem has been corrected. Note the cause of the problem and the corrective action and plot the in-control point. 9. Determine if there are any trends, i.e., three or more data points moving in one direction (either upwards or downwards) in MD, DD or B+F. If trends are present but the data points have not, as yet, exceeded the control limits, clinical mammogram images can be printed. It is necessary to determine the cause of the trend and to monitor the processor closely to assure that control limits are not exceeded. 7. Write the data and time on the film. label the film with the printer ID if there is more than one printer. Retain the film for the MQSA prescibed period, e.g. the last full month for daily QC and the last 12 weeks for weekly QC. [PERFORMANCE AND CORRECTIVE ACTION] If the MD and DD are within ± 0.15 of their respective operating levels, and the B+F is within ± 0.03 of its operating level, the printer is in control, and no further action is required. If the MD and DD fall outside the above control limits, corrective action must be performed and then confirmed by performing the QC test again. If this test produces results that fall outside the action limits as specified above or by the manufacturer (whichever is applicable), the source of the problem shall be identified and corrected before the device can be used for mammographic image interpretation. Clinical image acquisition may be continued. If available, an alternative FDA-approved for mammography display device may be used for mammographic image interpretation, provided it has passed the applicable QC tests. 4 Weekly Test 4-19

86 4.8 Conducting Monitor Quality Control Procedure [Test flow] 1. Monitor Quality C ontrol 4 Weekly Test 4-20

87 1 4. Monitor Quality Control (measurement) Follow the instructions below to conduct the test item. The objective of this test is to assure that monitors are performing according to the monitor manufacturer s specifications and that they are calibrated (or configured) to perform the DICOM Grayscale Standard Display Function (GSDF). Both the monitors used fro final interpretation of mammography images (primary monitors), and monitors used for acquisition QC (secondary monitors) must be tested. An additional requirement is that monitors used for final interpretation must have been cleared by the FDA for that purpose. Commercial calibration software programs supporting the American Association of Physicists in Medicine (AAPM) Assessment of Display Performance for Medical Imaging Systems (AAPM On-Line Report No. 03, www. aapm.org) are available for use with this test. Follow the monitor manuafacturer s QC program for test frequency, procedure, performance and corrective action. If the manufacturer does not provide a mammography monitor QC program, use the following: [Tools] Monitor image quality pattern:. AAPM TG18-QC, SMPTE RP133 or other patterns appropriate for the monitor to tested (contact your monitor or QC software manufacturer for details) For monitor luminance response: gray scale images (supplied by the monitor or QC software manufacturer or AAPM TG18-LN). Calibrated photometer Monitor QC (Annual) report form, your own, or the QC software manufacturer-provided report form. 2 Follow the instructions below to conduct the Monitor Image Quality Test. 1. For both primary and secondary monitors: display the QC pattern. 2. Record the maximum and minimum luminance levels as directed by your monitor or QC software manufacturer. The maximum luminance (Lmax) is typically specified by the monitor manufacturer as the highest value that can be used without compromising other performance characteristics, such as lifetime or resolution. The minimum brightness (Lmin) is influenced by Lmax. 3. Examine the image carefully to determine the visibility of the following features and record the results on the report form: Verify that the 5% signal level inset is visible in the larger 0% signal field (a). Pass/Fail Verify that the 95% signal level inset is visible in the larger 100% signal field (b). Pass/Fail Verify that each gray level step from 0% to 100% can be distinguished individually (c). Pass/Fail Verify that the alphanumeric characters in the image appear sharp and in focus (d). Pass/Fail Verify that the high-contrast Line-pair patterns in the center and at the corners of the QC pattern are distinguishable (e). The low-contrast patterns are not evaluated in this test. Pass/Fail 4 Weekly Test 4-21

88 [PRECAUTIONS AND CAVEATS] Perform this test using only the test patterns described above. Some test patterns are specific to the image matrix size and bit depth. Using other patterns could yield erroneous results. [PERFORMANCE] If the following conditions are met, the Monitor QC (Annual) test is acceptable: 4 Weekly Test The maximum luminance value (Lmax) is within the reange specified by the manufacturer. For reference, the AAPM report recommends that once set, the target level (Lmax) is maintained within ±10% of the desired value.. The 5% inset in the 0% field, and the 95% inset in the 100% field shall be visible, and the 0% to 100% gray level steps shall be distinguishable from the adjacent steps. The alphanumeric characters appear sharp and focused. The high contrast line-pair patterns are distinguishable at the center and at the corners of the display in both the horizontal and vertical orientations. ] For monitors featuring DICOM GSDF display functionality, confirm that the monitors are set for DICOM DISPLAY (GSDF) and that the monitors successfully meet the criterai of Monitor Image Quality Test Procedure step. 4-22

89 Chapter 5 Quarterly Test Page 5.1 Test Flow Test Items Conducting Quarterly Test Procedure Test Result Evaluation and Judgment Performance Criteria and Corrective Action

90 5.1 Test Flow Performed by the technologist, the Quarterly Test is designed to determine the number and cause of repeated radiographs. Analysis of this data will help identify ways to avoid multiple X-raying and reduce costs, as well as reduce patient exposure. Repeated images shall be evaluated quarterly. In order for the repeat rates to be meaningful, a patient volume of at least 250 patients or 1,000 exposures is needed. As described above, the Quarterly Test is neither a constancy test nor a performance test of the system. Specify the criteria when conducting the test, not in advance. The Retake Analysis software, a software module for the FDR-1000AWS, is convenient for organizing and managing the repeat analysis data. Detailed operation of the Repeat Analysis software module can be found in Aspire HD (Amulet) Options Operation Manual. 5 Quarterly Test 5-2

91 5.2 Test Items The Quarterly Test has the following test item. Test Items Exposure Menus Exposure Submenus Items Auto-calculated and Judged Based on Input Data 1. Exposure 2. Input Values Items Judged [Pass/Fail] Based on Visual Inspection by a User Repeat analysis The Quarterly Test requires no settings since the QC Software is not used in the Test. The Test also requires no tool. Simply record the result of the Repeat analysis in the report form. 5 Quarterly Test 5-3

92 5.3 Conducting Quarterly Test Procedure [Test flow] 5 Quarterly Test Repeat analysis (collecting rejected images) Start by removing all existing rejected images in the department taken prior to the start of the analysis. Take inventory of the image supply as a starting point to determine the total number of images consumed during this test. Start collecting all rejected images. Continue to collect for the length of time needed to radiograph at least 250 consecutive patients. Sort the rejected images into categories such as poor positioning, motion, compression, under exposure, (these might be due to exposure or processing), artifacts (streaks, spots, etc.). Rejected images are all images that are in the reject bin, including repeated images. Repeated images are images that are retaken because of inadequate quality. The reject bin does not include additional views required to image selected tissue seen on the first image. It also does not include images taken for the purposes of including tissue that could not be positioned on the image receptor due to the size of the breast. For facilities using softcopy for final interpretation maintain a list of repeated images using the REPEAT RATE ANALYSIS in 8.3 Worksheets. 5 TIP Good images (they appear to be acceptable mammograms when retrospectively evaluated during the Repeat analysis) may have also been repeated. Some images may not have resulted in an additional exposure of the patient but may have also been rejected. These include clear and QC images. Although it is appropriate to include wire localization images as part of the reject analysis, they should not be included in the repeat analysis because they are taken as part of the wire localization process. 2. Repeat analysis (calculating repeat rates) Some facilities placing all images (repeated and good images) in the patient s film jacket have no repeated images in the department. In this case, the reject/repeat analysis chart is completed as patient examinations are carried out. 6 Tabulate the counts from Steps 4 and 5, determining the total number of repeated images, rejected images, and the total number of images exposed during the analysis period. 5-4

93 7 8 Determine the overall percentage of repeated images by dividing the total number of repeated images by the total number of images exposed during the analysis period, then multiply by 100. Next, determine the overall percentage of rejected images by dividing the total number rejected images by the total number of images exposed during the analysis period, and multiply by 100. Determine the percentage of repeats in each reason for repeat category by dividing the repeats in the category by the total number of repeated images and multiply by Test result confirmation If the total repeat or reject rate changes from the previously determined rate by more than 2.0 percent of the total films included in the analysis, the reason(s) for the change shall be determined. Any corrective actions shall be recorded and the results of these corrective actions shall be assessed.. 5 Quarterly Test 5-5

94 5.3.2 Test Result Evaluation and Judgment Evaluate and judge the Quarterly Test results. If the criteria are satisfied, the test is completed. If not satisfied, take corrective actions by following Performance Criteria and Corrective Action Performance Criteria and Corrective Action If the total repeat or reject rate changes from the previously determined rate by more than 2.0 percent of the total films included in the analysis, the reason(s) for the change shall be determined. Any corrective actions shall be recorded and the results of these corrective actions shall be assessed. Any corrective action should be recorded on the bottom of the REPEAT RATE ANALYSIS in 8.4 Report Forms. The effectiveness of the corrective actions must be assessed by performing another repeat analysis after the corrective actions have been implemented. It is important to study films that are too dark or too light to determine if the underlying cause is the exposure equipment, image printer, patient positioning, technique or sub-optimal setting of digital image processing. If this test produces results that fall outside the action limits as specified, the source of the problem shall be identified and corrective action shall be taken within thirty days of the test date. Clinical imaging and mammographic image interpretation may be continued during this period. 5 Quarterly Test 5-6

95 Chapter 6 Semi-annual Test Page 6.1 Test Flow Test Items Tools Conducting Semi-annual Test Procedure Test Result Evaluation and Judgment Solutions for Failed Test Items

96 6.1 Test Flow Performed by the technologist, the Semi-annual Test provides the basic test items for checking that performance of the X-ray equipment is maintained. Detailed tests for this purpose are conducted in the Annual Test. 6.2 Test Items The Semi-annual Test consists of the following test items. Test Items Exposure Menu Exposure Submenus Items Judged Based on Input Data 1. Exposure 2. Input Values Items Judged [Pass/ Fail] Based on Visual Inspection by a User Compression device confirmation Judgment methods: 6 Semi-annual Test 6.3 Tools 1. User selection of [Pass/Fail] based on force / bathrrom scale measurements. Tools to be used for the Semi-annual Test based on this Manual are shown below. See 2.3 Tools for details. Tools [B] Worksheet (See Chapter 8) [ J ] Analog bathroom scale or Force scale [K] Towels 6.5 Conducting Semi-annual Test Procedure [Test flow] 1. Compression device confirmation (measurment) 6-2

97 1. Compression device confirmation (measurement) 1 Follow the instructions below to conduct the test item. [Tools] A analog bathroom (or force) scale and several towels. 1. Place a towel on the cassette holder (to protect the cassette holder), then place the analog bathroom scale on the towel, with the dial or read-out positioned for easy reading. Locate the center of the scale directly under the compression device.. 2. Place several towels on top of the scale to prevent damage to the compression device.. Towels Bathroom Scale 3. Using the power drive, activate the compression device and allow operation until it stops automatically. 4. Read the bathroom scale measurement and record it on the worksheet. Automatic compression force measured value: lbs. 5. Release the compression device 6. Using the manual drive, move the compression device downward until it stops. 7. Read the bathroom scale measurement and record it on the worksheet. Manual compression force measured value: lbs.l 8. Release the compression device. 6 Semi-annual Test 6-3

98 6.5.2 Test Result Evaluation and Judgment A compression force of at least 111 newtons (25pounds) shall be provided. The maximum compression force for the initial power drive mode must be between 111 newtons (25 pounds) and 200 newtons (45 pounds). If these requirements are not met, a qualified service engineer must make the appropriate internal adjustments and the system retested and pass the test before further exams are performed Performance Criteria and Corrective Action [1] Compression device confirmation Performance Criteria: Compression force: At least 111 newtons (25 pounds) Maximum compression force: between111 newtons (25 pounds) and 200 newtons (45 pounds) 6 Semi-annual Test If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be taken before any further examinations are performed with the system 6-4

99 Chapter 7 Annual Test Page 7.1 Test Flow Test Items Tools Setting Confirmation Conducting Annual Test Initial Performance Test Procedure Test Result Evaluation and Judgment Performance Criteria and Corrective Action Image Performance Test Procedure Test Result Evaluation and Judgment Performance Criteria and Corrective Action Spatial Resolution Test Procedure Test Result Evaluation and Judgment Performance Criteria and Corrective Action X-ray Equipment Performance Test Procedure Test Result Evaluation and Judgment Performance Criteria and Corrective Action AEC System Performance Test Procedure Test Result Evaluation and Judgment Performance Criteria and Corrective Action

100 7.1 Test Flow Performed by the Medical Physicist during the Medical Equipment Evaluation (MEE) and subsequent Annual testing, these tests are designed for checking the overall performance of the FDR Mammography system. The Annual Test is comprised of constancy tests and performance verification tests of the system. The constancy tests are designed for determining if variations of regularly-measured system performance values are within the allowable range (criteria) based on baseline values that were established at the time of QC program / system installation. The performance test is intended to check that system performance values are within the upper or lower limits specified by the baselines. It is necessary to determine the criteria before conducting the Annual Test. The reference criteria are shown on the List of Reference Values for Criteria and Baseline Values. See 3.3 Criteria Confirmation and Determination for details. When conducting the Annual Test the first time after setting the criteria, specify the baseline values to be used in the future Annual Tests. In the second or later Annual Test, check that the variation from the specified baseline values is within the criteria. See 3.4 Baseline Value Settings for details. Initial setting, criteria and baseline value settings Measurement and performance check 7 Annual Test YES First Annual Test Equipment use Annual Test The res ult is within the criteria NO Viewing conditions Measurement C ompression device confirmation Exposure and measurement (1) Image performance (2) S patial R es olution (3) X-ray equipment performance (4) AEC system performance (5) 1 S hot P hantom tes ts (6) AC R P hantom tes t QC Software User input Auto-calculation Judgment Taking corrective actions Check that the variation from the specified baseline values is within the criteria, or that the values indicating s ys tem performance s atis fy the criteria. If the criteria are satisfied, equipment can be used as is until the next Annual Test day. If not satisfied, take corrective actions by following "P erformance C riteria and C orrective Action" in the relevant s ubs ection. 7-2

101 7.2 Test Items The Annual Test consists of the following test items. Viewing Conditions Compression device confirmation Image performance Spatial Resolution X-ray equipment performance Test Types/Items Exposure Menus Exposure Submenus Items Autocalculated and Judged Based on Input Data 1. Exposure 2. Input Values Items Judged [Pass/Fail] Based on Visual Inspection by a User Viewing environment - - Viewbox maintenance Annual A - Printer Quality Control - - Monitor Quality Control - - Force, display accuracy and sustainability Annual A Image basic test Annual A Uniform Expo (Image Basic) Additive lag effects (Lag) ACR Phantom1(Lag) Non Exposure(Lag) Uniform Expo.1(Ghost) Multiplicative lag effects Annual 1/6 ACR Phantom2(Ghost) (Ghost) Uniform Expo.2(Ghost) Visual and Functional test - Spatial Resolution (Magnification) Annual 2/6 1ShotM(Magnification) kvp accuracy and reproducibility - Half Value Layer (HVL) Annual 3/6 - Collimation assessment Uniform Expo.3(Collimation) Radiation output - AEC reproducibility CNR mode 1 AEC system performance Annual 4/6 - Mode1 CNR (PMMA20mm) Mode1 CNR (PMMA40mm) Mode1 CNR (PMMA60mm) Mode1 CNR (PMMA70mm) AGD mode 1 - AGD-ACR Phantom Calcualtion 2/2 - Constancy Performance 1 Shot Phantom tests 1Shot PhantomM - Test with ACR Phantom ACR phantom scoring ACR Phantom Three judgment methods: 1. Auto-calculation by the QC Software based on the image data acquired by making an exposure. 2. Auto-calculation by the QC Software based on the input measurement data. 3. User selection of [Pass/Fail] based on visual inspection of the image.. 7 Annual Test 7-3

102 7.3 Tools Tools to be used for the Annual Test based on this Guidebook are shown below. See 2.3 Tools for details. Tools [A] QC Software [B] Worksheet (See Chapter 8) [C] 1Shot Phantom [D] Viewing box (if film is used) [ E ] Timer or watch/clock [F] ACR Phantom [G] Dosimeter [ H ] Luminance meter [ I ] kvp meter [ J ] Force scale [N] PMMA phantoms (available, in combination, for 20, 40, 60 and 70 mm in thickness) [O] Aluminum plate (0.2 mm) for CNR measurement [P] Aluminum plates for half value layer measurement (0.3 and 0.5 mm) [Q] Scale [R] Coins [S] Lead sheet 7 Annual Test 7-4

103 7.4 Setting Confirmation The following items described in Chapter 3 are required to be specified before conducting the Annual Test. Initial settings Initial Settings Criteria Criteria Confirmation and Determination Baseline values Baseline Value Settings [Items allowing criteria change] Test Items Judgment Items Criteria Viewbox mainitenance Compression device confirmation Luminance (cd/m 2 ) Interpretation room illuminance / ambient light (lx) Compressed breast thickness accuracy (mm) Compression force accuracy (N) Maximum compression force (N) 3500 cd/m 2 or more 50 lx or less ±5 mm or less ± 20 N or less 111 to 200 N Image basic test Relative sensitivity (S value) Baseline value ± 40 % Additive lag effects (Lag) Lag factor [QL] 75 QL or less Multiplicative lag effects (Ghost) Ghost factor Below Spatial Resolution (Magnification) MTF (4lp/mm) Baseline value ± 12 % MTF (8lp/mm) Baseline value ± 15 % kvp accuracy and reproducibility Low volt. accuracy (LFS) [kv] Mid. volt. accuracy (LFS) [kv] High volt. accuracy (LFS) [kv] Low volt. accuracy (SFS) [kv] Mid. volt. accuracy (SFS) [kv] High volt. accuracy (SFS) [kv] Specified kvp ± 1 kv Specified kvp ± 1 kv Specified kvp ± 1 kv Specified kvp ± 1 kv Specified kvp ± 1 kv Specified kvp ± 1 kv Half Value Layer (HVL) Collimation assessment Mid. volt. reproducibility (LFS) [kv] Reproducibility ± 0.5 kv or less HVL (Mo/Mo) kvp / 100 HVL (Mo/Rh) kvp / 100 HVL (W/Rh) kvp / 100 X-ray / Light field gap (Right/Left) [mm] Total gap criteria = SID X 0.02 or less X-ray / Light field gap (Chest/Nipple) [mm] Total gap criteria = SID X 0.02 or less X-ray / Image receptor field gap (Left) [mm] SID X 0.02 or less X-ray / Image receptor field gap (Right) [mm] SID X 0.02 or less 7 Annual Test Radiation output X-ray / Image receptor field gap (Nipple) [mm] X-ray field / Exposure table gap [mm] Reproducibility Air kerma rate [mgy/s] Specific radiation output [μgy/mas] SID X 0.02 or less 5 mm or less Variation coefficient 0.05 or less 7 mgy/s or more 30 μgy/mas or more 7-5

104 [Items allowing criteria change] Test Items Judgment Items Criteria AEC reproducibility CNR mode 1 Entrance air kerma accuracy [%] Entrance air kerma reproducibility CNR relative value 20mm [%] CNR relative value 40mm [%] CNR relative value 60mm [%] CNR relative value 70mm [%] Average ± 15 % or less Variation coefficient 0.05 or less Baseline value 105 % or more Baseline value 95 % or more Baseline value 63 % or more Baseline value 60 % or more AGD 20 mm [mgy] 1 mgy or less AGD 40 mm [mgy] 2 mgy or less AGD mode 1 AGD 60 mm [mgy] 4.5 mgy or less AGD 70 mm [mgy] 6.5 mgy or less AGD-ACR Phantom AGD-ACR Phantom 3 mgy or less TIP The criteria setting is not required for visual inspection. CNR mode 1 corresponds to the CNR_H-mode AGD mode 1 corresponds to the AGD_H-mode 7 Annual Test 7-6

105 7.5 Conducting Annual Test The Annual Test items are classified into Initial Performance Test, Image Performance Test, Spatial Resolution Test, X-ray Equipment Performance Test, AEC System Performance Test and ACR Phantom Evaluation ; these five tests can be conducted separately Initial Performance Test 1. Procedure [Test flow] The Initial performance test consists of the Viewing environment evaluation, Viewbox maintenance, Printer Quality Control, Monitor Quality Control, Image basic test, and Compression device confirmation. 1. Viewing environment (measurement) 2. Viewbox maintenance (measurement) 3. P rinter Quality C ontrol (meas urement) 4. Monitor Quality C ontrol (measurement) 5. Image basic test (measurement) 6. Patient information entry and exposure menu selection 7. Image basic test (exposure) 8. Compression device confirmation (measurement) 9. QC Software startup 10. E xposure condition confirmation Image output 12. Image basic test (user input) 13. C ompres s ion device confirmation (us er input) Annual Test 14. Viewbox maintenance (user input) 15. Auto-calculation 16. Test result confirmation 17. QC S oftware shutdown 7-7

106 7 Annual Test 1 1. Viewing Environment (measurement) Follow the instructions below to conduct the Viewing Environment evaluation. This evaluation is specific to the viewbox and reading room conditions, for images for final interpretation. [HARDCOPY] When interpreting hardcopy (film) images, it is suggested that you view the printed Aspire HD images under the same conditions as you would screen-film mammography images. Film masking devices and hot lights must be available for use by the interpreting physician. The 1999 ACR mammography Quality Control Manual includes a section on viewbox luminance, room illuminance, and msking, which may be used as a reference. [SOFTCOPY] When interpreting softcopy images, follow the monitor manufacturer s quality control procedures. For monitors without a manufacturer-provided QC program, follow the monitor QC procedures provided in this manual. Set the final interpretation environment illumination to the lower of: that recommended in the monitot manufacturer s quality control program, if applicable, or 20lux or lower. If the illumination is greater than the value set as described above, the source of the problem must be identified and corrective action taken before interpreting mammograms under these conditions Viewbox maintenance (measurement) Follow the instructions below to conduct the test item. [Tools] A viewbox, luminance meter, and illuminance meter Check the viewbox performance under the normal use condition. 1. Turn on the viewbox and wait until the luminance becomes stable. 2. Measure the luminance at the center of the viewbox by using a luminance meter. Fill in the following item in the worksheet. Luminance: cd/m 2 3. Visually check if the viewbox luminance is uniform. Fill in the following item in the worksheet. Viewbox uniformity: Pass/Fail 4. When the viewbox has a luminance adjustment function, check if the function works correctly. Fill in the following item in the worksheet. Luminance adjustment function: Pass/Fail 5. When the viewbox has a masking function, check if the function works correctly. Fill in the following item in the worksheet. Masking: Pass/Fail 6. Measure the illuminance near the viewbox, as a sample illuminance in the viewing condition, by using an illuminance meter. Fill in the following item in the worksheet. Interpretation room illuminance (Ambient light): lx See the operation manuals for the viewbox, luminance meter or illuminance meter for how to measure the luminance or illuminance. It may take some time until you can press [QC] after completing the exposure process. 7-8

107 3 3. Printer Quality Control (measurement) Follow the instructions below to conduct the Printer Quality Control test. The printer used to produce films for final interpretation of mammography images must be cleared by FDA for that purpose. The objective of this test is to assure that the printer used for final interpretation is performing according to the manufacturer s specifications. Follow the printer manufacturer s QC program for test frequency, procedure, performance and corrective action. If the manufacturer does not provide a mammography printer QC program, use the following: [Tools] QC pattern with a fixed geometric pattern (e.g. TG18-QC or SMPTE RP133 (contact your printer manufacturer for details)), Metric Ruler, Report Form (available from your printer manufacturer). 1. Print the QC Pattern. 2. Identify lines in each dimension that have a specified relationship (e.g. fixed length or distance between lines). Use these same lines for subsequent testing. 3. Measure the length of lines in the step above to establish a baseline. If the printer manufacturer provides a test image with specified distances, compare your measurement to the provided specification. 4. Using the ruler, confirm that the lines are straight and undistorted. 5. Inspect the image for artifacts. 6. Inspect the image for banding and jagged edges of the straight lines. 7. Note any unusual mechanical noises or other observations. [PRECAUTIONS AND CAVEATS] Perform this test using the QC pattern supplied (or recommended) by the manufacturer for that printer model. If none is available, use a QC test pattern recommended by the AAPM or by one of the approved MQSA accreditation bodies for this purpose. Using other patterns could yield erroneous results. Unless otherwise specified by the printer manufacturer, the visual observations should be made without magnification. [PERFORMANCE AND CORRECTIVE ACTION] The tolerance for film printer artifacts should be similar to the tolerance in screen-film mammography. According to the 1999 American College of Radiology Mammography Quality Control Manual, not all artifacts can be totally eliminated. It may be useful to use the concept of ALARA (as low as reasonably achievable) when assessing artifacts. If they can be easliy eliminated, they should. If the artifact is difficult or expensive to eliminate and is subtle (not mimicking or obscuring clinical information), it may be tolerable. The medical physicist should consult with the interpreting physician as to whether the artifact is tolerable. Tolerances for artifacts should be lower with new imaging equipment. If any of the following conditions exist: The lines are bowed, bent or distorted The lines exhibit jagged borders The printer exhibits print or processing artifact that is judged intolerable Measured distances vary by more than 1% from the tolerance standards Artifacts are objectionable and can mimic or obscure clinical information The source of the problem shall be identified and corrective action shall be taken before the device can be used for mammographic image interpretation. Clinical image acquisition may be continued. If available, an alternative approved diagnostic display device may be used for mammographic image interpretation: 7 Annual Test 7-9

108 7 Annual Test 4 4. Monitor Quality Control (measurement) Follow the instructions below to conduct the test item. The objective of this test is to assure that monitors are performing according to the monitor manufacturer s specifications and that they are calibrated (or configured) to perform the DICOM Grayscale Standard Display Function (GSDF). Both the monitors used fro final interpretation of mammography images (primary monitors), and monitors used for acquisition QC (secondary monitors) must be tested. An additional requirement is that monitors used for final interpretation must have been cleared by the FDA for that purpose. Commercial calibration software programs supporting the American Association of Physicists in Medicine (AAPM) Assessment of Display Performance for Medical Imaging Systems (AAPM On-Line Report No. 03, www. aapm.org) are available for use with this test. Follow the monitor manuafacturer s QC program for test frequency, procedure, performance and corrective action. If the manufacturer does not provide a mammography monitor QC program, use the following: [Tools] Monitor image quality pattern:. AAPM TG18-QC, SMPTE RP133 or other patterns appropriate for the monitor to tested (contact your monitor or QC software manufacturer for details) For monitor luminance response: gray scale images (supplied by the monitor or QC software manufacturer or AAPM TG18-LN). Calibrated photometer Monitor QC (Annual) report form, your own, or the QC software manufacturer-provided report form. 5 Follow the instructions below to conduct the Monitor Image Quality Test. 1. For both primary and secondary monitors: display the QC pattern. 2. Record the maximum and minimum luminance levels as directed by your monitor or QC software manufacturer. The maximum luminance (Lmax) is typically specified by the monitor manufacturer as the highest value that can be used without compromising other performance characteristics, such as lifetime or resolution. The minimum brightness (Lmin) is influenced by Lmax. 3. Examine the image carefully to determine the visibility of the following features and record the results on the report form: Verify that the 5% signal level inset is visible in the larger 0% signal field (a). Pass/Fail Verify that the 95% signal level inset is visible in the larger 100% signal field (b). Pass/Fail Verify that each gray level step from 0% to 100% can be distinguished individually (c). Pass/Fail Verify that the alphanumeric characters in the image appear sharp and in focus (d). Pass/Fail Verify that the high-contrast Line-pair patterns in the center and at the corners of the QC pattern are distinguishable (e). The low-contrast patterns are not evaluated in this test. Pass/Fail 7-10

109 [PRECAUTIONS AND CAVEATS] Perform this test using only the test patterns described above. Some test patterns are specific to the image matrix size and bit depth. Using other patterns could yield erroneous results. [PERFORMANCE] If the following conditions are met, the Monitor QC (Annual) test is acceptable: The maximum luminance value (Lmax) is within the reange specified by the manufacturer. For reference, the AAPM report recommends that once set, the target level (Lmax) is maintained within ±10% of the desired value.. The 5% inset in the 0% field, and the 95% inset in the 100% field shall be visible, and the 0% to 100% gray level steps shall be distinguishable from the adjacent steps. The alphanumeric characters appear sharp and focused. The high contrast line-pair patterns are distinguishable at the center and at the corners of the display in both the horizontal and vertical orientations. ] For monitors featuring DICOM GSDF display functionality, confirm that the monitors are set for DICOM DISPLAY (GSDF) and that the monitors successfully meet the criterai of Monitor Image Quality Test Procedure step 5. If so, you have successfully completed the Monitor QC (Annual) test. Proceed to step 7 For monitors that do not provide DICOM DISPLAY (GSDF), or fail the Monitor Image Quality Test Procedure step 5, perform the GSDF calibration and proceed to step 6 6 Follow the instructions below to conduct the Monitor Luminance Response Test. 1. Perform the luminance response test as described in the AAPM report. 2. Record the results of the evaluation on the report form. [PRECAUTIONS AND CAVEATS] Perform this test using only the test patterns described above. Some test patterns are specific to the image matrix size and bit depth. Using other patterns could yield erroneous results. [PERFORMANCE] Both primary and secondary monitors must be calibrated to DICOM Grayscale Standard Display Function (GSDF). The luminance differences between each measured value must agree with the expected difference associated with the GSDF and the measured contrast response at any given point must not exceed 10% of the standard for primary monitors and must not exceed 20% for the secondary monitors. [CORRECTIVE ACTION] For primary monitors (used for final interpretation): If the test produces results that fall outside the action limits as specified by the manufacturer, the source of the problem shall be identified and corrective action shall be taken before that device can be used for mammographic image interpretation. Clinical image acquisition may be continued. If available, an alternative approved diagnostic device may be used for mammographic image interpretation, provided it has passed the applicable QC tests. For secondary monitors (used for image acquisition QC): If this test produces results that fall outside the action limits as specified by the manufacturer, the source of the problem shall be identified and corrective action shall be taken before any further examinations are performed using that monitor. If the monitor that failed is replaced by an alternative monitor that passes all tests, image acquisition may resume using the alternative monitor. 7 Annual Test 7-11

110 7 5. Image basic test (measurement) Follow the instructions below to conduct the test item. [Tools] A dosimeter, scale, and lead sheet 1. Remove the compression plate. 2. Place a lead sheet on the exposure table, and then position the dosimeter at the lateral center of the table, 60 mm away from the chest wall-side edge, and also 40 mm above the table Patient information entry and exposure menu selection Enter patient information and press [Next]. 9 Select [QC/TEST] in the exposure region list and [Annual A 1/1] in the exposure menu list, and then press [Start study.]. 7 Annual Test 3. Select [QC/TEST] in the exposure region list and [Calculation 1/2] in the exposure menu list, and then press [Start study.]. Specify the kvp, mas and target/filter determined in Baseline Values for Annual A Test, and measure the air kerma 3 times in Manu mode. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Air kerma: mr µgy, mr µgy, mr µgy Make sure to specify the same exposure conditions as those used in the baseline value setting. If they are not certain, newly determine the exposure conditions for the test by following Baseline Values for Annual A Test. 4. Remove the dosimeter & lead sheet. Select [Study completed] to finish the test. 10 The following exposure submenu is displayed. Uniform Expo(Image Basic) 7-12

111 Image basic test (exposure) Follow the instructions below to conduct the test item. Set [Grid] to [OUT], and then make an exposure with the same conditions as those used in Substep 3 in Step 7. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / 8. Compression device confirmation (measurement) Follow the instructions below to conduct the test item. [Tools] A force scale, timer or watch/clock, PMMA phantom (40 mm), and scale 1. Position the PMMA phantom (40 mm) on the exposure table. 2. Apply compression force most frequently used in clinical practice and record the display value for compressed breast thickness on the X-ray equipment. Fill in the following item in the worksheet. Compressed breast thickness displayed value: mm 3. Measure thickness of the compressed PMMA phantom (40 mm) by using a scale. Fill in the following item in the worksheet. Compressed breast thickness measured value: mm 4. Remove the PMMA phantom, then position the force scale at the lateral center of the exposure table, about 60 mm away from the chest wall-side edge. Ensure that the compression force is evenly applied to the measurement part of the force scale. If compression is not even, the measurement may result in an incorrect value. 5. Apply the same compression force as that used in Substep 2 and record the display value for the compression force on the X-ray equipment and the measured value. Fill in the following items in the worksheet. Compression force display value: N Compression force measured value: N 6. Check that the compression applied in Substep 5 lasts 1 minute or more. Fill in the following item in the worksheet. Compression force sustainability: Pass/Fail 7. Increment the compression force from that applied in Substep 6 and record the maximum compression force measured on the force scale. Fill in the following item in the worksheet. Maximum compression force: N 7 Annual Test 7-13

112 QC Software startup Press [QC] to display the QC window. 10. Exposure condition confirmation Check the exposure conditions. 16 Check for artifacts and white-out in the printed image. In image diagnosis on a softcopy display, check these items on the display. Fill in the following items in the worksheet. Artifact: Pass/Fail White out: Pass/Fail 12. Image basic test (user input) 17 Press [User input]. 11. Image output 15 Select Exposure Submenu [Uniform Expo(Image Basic)] from the exposure condition display field and press [Film output]. For performing image diagnosis on a softcopy display, press [Network output] to output the image to the network. 18 Enter the measured air kerma (from Substep 3 in Step 7.) and visual inspection results ([Pass/Fail]). Some dosimeters may require correction of the measured value according to the beam quality. 7 Annual Test 7-14

113 Compression device confirmation (user input) Enter the measured values, display values and visual inspection result (Pass/Fail) Test result confirmation Check the displayed judgment results. If there is a [Fail], see Performance Criteria and Corrective Action. 17. QC Software shutdown Viewing box maintenance (user input) Enter the measured value and visual inspection results, and then press [OK]. 23 Press [Save] and then [Close] to exit the QC Software. 24 Select [Study completed] to finish the test. Make sure that the values are entered for all items. If there is an item left unentered, an error occurs. 15. Auto-calculation 7 Annual Test 21 Press [Measurement execution]. The results are displayed at the bottom of the window. 7-15

114 2. Test Result Evaluation and Judgement Evaluate and judge the Annual A Test results. If all items are judged as [Pass], the Annual A Test is finished. If there is an item judged as [Fail], take corrective actions by following Performance Criteria and Corrective Action. 3. Performance Criteria and Corrective Action [1] Image basic test [Artifact] resulted in [Fail] Performance Criteria: No clinically relevant artifacts shall be visible. If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be taken within 30 days of the test date. Clinical imaging and mammographic image interpretation may be continued during this period. 7 Annual Test [Relative sensitivity] resulted in [Fail] Performance Criteria: Baseline value ± 40% If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be taken within 30 days of the test date. Clinical imaging and mammographic image interpretation may be continued during this period. 7-16

115 [White out] resulted in [Fail] Performance Criteria: No white out shall be visible. If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be taken within 30 days of the test date. Clinical imaging and mammographic image interpretation may be continued during this period. [2] Compression device confirmation Performance Criteria: Compressed breast thickness accuracy: ± 5mm or less Compression force accuracy (N): ±20N or less Maximum compression force (N): 111N to 200N 7 Annual Test If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be taken before any further examinations are performed with the system. 7-17

116 [3] Viewing box maintenance [Viewing box luminance] resulted in [Fail] Performance Criteria: 3500 cd/m 2 or more [Interpretation room illuminance (Ambient light)] resulted in [Fail] Performance Criteria: 50 lx or less 7 Annual Test 7-18

117 7.5.2 Image Performance Test 1. Procedure [Test flow] The image performance test consists of the Additive lag effects (Lag), Multiplicative lag effects (Ghost), Missed tissue on chest wall edge (40 mm height) and Visual and Functional test. As Missed tissue on chest wall edge (40 mm height) is not required in this QC program, the above Step 8. Missed tissue on chest wall edge (40 mm height) (measurement) can be skipped, but to satisfy the QC software input, Steps 4. Missed tissue on chest wall edge (40 mm height) (exposure) and 9. Missed tissue on chest wall edge (40 mm height) (user input) must be performed. 7 Annual Test 7-19

118 Patient information entry and exposure menu selection Enter patient information and press [Next]. Select [QC/TEST] in the exposure region list and [Annual 1/6] in the exposure menu list, and then press [Start study.] Additive lag effects (Lag) (exposure) Follow the instructions below to conduct the test item. Make 2 exposures using the following exposure submenus: [ACR Phantom1(Lag)] [Non Exposure(Lag)] [Tools] ACR Phantom 1. Position the ACR Phantom at the lateral center of the exposure table while aligning its edge with the chest wall-side edge of the exposure table. 2. Remove the compression plate. 7 Annual Test 3 The following exposure submenus are displayed. ACR1: ACR Phantom1(Lag) NON: Non Exposure(Lag) UNI 1: Uniform Expo.1(Ghost) ACR 2: ACR Phantom2(Ghost) UNI 2: Uniform Expo.2(Ghost) 1ST40: 1Shot PhantomM(40mm) 3. Specify 28 kv, 56 mas and Mo/Mo and make an exposure in Manu mode. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / 4. Place a lead sheet on the exposure table, specify 23 kv, 2 mas and Mo/Mo, and then make an exposure in Manu mode. Make exposures in Substeps 3 and 4 consecutively without much interval between them to obtain high-quality results. 7-20

119 5 3. Multiplicative lag effects (Ghost) (exposure) Follow the instructions below to conduct the test item. Make 3 exposures using the following exposure submenus: [Uniform Expo.1(Ghost)] [ACR Phantom2(Ghost)] [Uniform Expo.2(Ghost)] [Tools] ACR Phantom 1. Remove the compression plate. 2. Specify 28 kv, 6.3 mas and Mo/Mo and make an exposure in Manu mode. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / 3. Position the ACR Phantom on the righthand half of the exposure table while aligning the edges with the lateral center line and the chest wall-side edge of the exposure table as shown in the figure below. The ACR Phantom position differs from the normal position used for the exposure. Make sure that the phantom covers the Calculation Area 2 without protruding into the left-hand half of the exposure table Remove the ACR Phantom. 6. Specify 28 kv, 6.3 mas and Mo/Mo and make an exposure in Manu mode. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / 4. Missed tissue on chest wall edge (40 mm height) (exposure) Follow the instructions below to conduct the test item. Make an exposure using the following exposure submenu: [1Shot PhantomM(40mm)] This test is not required as part of this QC Program, but you must make an exposure to satisfy the QC software. Make an exposure using Exposure Submenu [1Shot PhantomM(40mm above)] and go to Step 7. [Tools] 1Shot Phantom and a jig for 1Shot Phantom The 1Shot Phantom must be positioned 40 mm above the exposure table in this test. Use the jig to position the Phantom at the specified height. TIP Use the same exposure conditions as those used for the Phantom exposure in the Daily/Weekly Test. See Baseline Values for Daily/Weekly Test for details. 7 Annual Test 4. Specify 28 kv, 56 mas and Mo/Mo and make an exposure in Manu mode. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / 7-21

120 1. Position the 1Shot Phantom using the jig above the exposure table. Position the Phantom by pressing the corners against the chest wall-side edge of the jig. 2. Move the compression plate as close to the Phantom as possible without making contact. TIP Reinstall the compression plate removed for the Multiplicative lag effects (Ghost) test Visual and Functional test (Checking) Follow the instructions below to conduct the test item. Check the following points and enter the judgment results (Pass/Fail) in the worksheet. Items under [X-ray equipment test 2 - Visual and Functional test] on the [Annual1-1] tab Verify mechanical stability Verify that all moving parts move smoothly All locks and detents work properly No sharp, rough edges or other hazards including electrical hazards Operator technique control charts are posted Operator protected during exposure by adequate radiation shielding All indicator lights working properly Auto decompression can be overridden and status displayed Compression can be manually released / in any failure Beware that the jig does not overlap with the measurement points of the Missed tissue on chest wall edge. 3. Specify the exposure conditions closest to those used for the 1Shot Phantom exposure in the Daily/Weekly Test in Manu mode and make an exposure. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N 7 Annual Test 8 6. QC Software startup Press [QC] to display the QC window. It may take some time until you can press [QC] after completing the exposure process. 7-22

121 Exposure condition confirmation Check the exposure conditions. 8. Missed tissue on chest wall edge (40 mm height) (measurement) The Missed tissue on chest wall edge (40 mm height) is not required as part of this QC program, go to Step 12. Select the Exposure Submenu [1Shot PhantomM(40mm)] from the exposure condition display field and press [Film output]. For performing image diagnosis on a softcopy display, press [Network output] to output the image to the network. 11 Measure the missed tissue on the right and left sides of the chest wall edge in the output image. The circles in Figure A indicate the measurement points of missed tissue on chest wall edge. Figure B shows the enlarged view of the measurement points. Measure how much of the points is reflected in the exposure image. Use the same Pass/Fail judgment criteria as those used for the Missed tissue on chest wall edge measurement in the Daily/Weekly Test. Fill in the following items in the worksheet. Missed tissue on chest wall edge (Right) [mm]: Pass/Fail Missed tissue on chest wall edge (Left) [mm]: Pass/Fail A B 7 Annual Test 7-23

122 12 9. Missed tissue on chest wall edge (40 mm height) (user input) Press [User input] Auto-calculation Press [Measurement execution]. The results are displayed at the bottom of the window. 13 Select the [Annual1-1] tab and enter the results (Pass/Fail). If not measuring the Missed tissue on chest wall edge (40 mm height), select either of [Pass/Fail] and go to Step Test result confirmation Check the displayed judgment results. If there is a [Fail], see Performance Criteria and Corrective Action. 13. QC Software shutdown Visual and Functional test (user input) Select the results ([Pass/Fail]) and press [OK]. 17 Press [Save] and then [Close] to exit the QC Software Select [Study completed] to finish the test. Annual Test Make sure that the result is selected for all items. If there is an item left unentered, an error occurs. 7-24

123 2. Test Result Evaluation and Judgment Evaluate and judge the results of the image performance test in the Annual Test. If all items are judged as [Pass], the image performance test is finished. If there is an item judged as [Fail], take corrective actions by following Performance Criteria and Corrective Action. See 8.2 Quick Guide for Software Operation for test log display procedure. 3. Performance Criteria and Corrective Action [1] Additive lag effects (Lag) Performance Criteria: 75 QL or less If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be taken within 30 days of the test date. Clinical imaging and mammographic image interpretation may be continued during this period. [2] Multiplicative lag effects (Ghost) Performance Criteria: Below Annual Test If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be taken within 30 days of the test date. Clinical imaging and mammographic image interpretation may be continued during this period. 7-25

124 [3] Missed tissue on chest wall edge (40 mm height) This test is not required in this QC program. [4] Visual and Functional test 7 Annual Test 7-26

125 7.5.3 Spatial Resolution Test This test measures spatial resolution in magnification mode. For contact mode, spatial resolution is measured and performed as a constancy test on a weekly basis by the QC technologist. See section 4.5 of this QC program for details. 1. Procedure [Test flow] The spatial resolution test has only a single test item. 7 Annual Test 7-27

126 1. Patient information entry and exposure menu selection 2. Spatial Resolution (Magnification) (exposure) 1 Enter patient information and press [Next]. 4 Follow the instructions below to conduct the test item. Make an exposure using the following exposure submenu: [1ShotM(Magnification)] [Tools] 1Shot Phantom 1. Install the magnification table of the X-ray equipment and the compression plate normally used in magnified exposure in clinical practice. 2. Position the 1Shot Phantom being shifted to the right-hand side so that the area indicated by the broken line in the below figure is at the lateral center of the X-ray field. Position the Phantom for exposure, the same as in Baseline Values for Annual Test. 2 Select [QC/TEST] in the exposure region list and [Annual 2/6] in the exposure menu list, and then press [Start study.]. 7 3 The following exposure submenu is displayed. 1ShotM(Magnification) Annual Test If the area in the broken line is out of the X- ray field when the Phantom is positioned by pressing its corners against the chest wallside edge of the magnification table, shift the Phantom to the front. Make sure that the shifted Phantom is parallel to the chest wall-side edge. 7-28

127 4. Exposure condition confirmation 6 Check the exposure conditions. The Phantom position must be the same for every exposure (the allowable positional error is within ± 5 mm). Fill in the following items in the worksheet. 1 Shot Phantom position Lateral shift distance: mm 3. Specify Manu mode for the X-ray equipment and make an exposure under the same exposure conditions as those used in Baseline Values for Annual Test. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N Auto-calculation Press [Measurement execution]. The results are displayed at the bottom of the window. 6. Test result confirmation Check the displayed judgment results. If there is a [Fail], see Performance Criteria and Corrective Action. 7 It may take some time until you can press [QC] after completing the exposure process QC Software shutdown Press [Save] and then [Close] to exit the QC Software. Annual Test 3. QC Software startup 5 Press [QC] to display the QC window. 10 Select [Study completed] to finish the test. 7-29

128 2. Test Result Evaluation and Judgment Evaluate and judge the result of the spatial resolution test in the Annual Test. If all items are judged as [Pass], the spatial resolution test is finished. If there is an item judged as [Fail], take corrective actions by following Performance Criteria and Corrective Action. See 8.2 Quick Guide for Software Operation for test log display procedure. 3. Performance Criteria and Corrective Action [5] Spatial Resolution (Magnification) Performance Criteria: 4lp/mm: Baseline value ± 12% 8lp/mm: Baseline value ± 15% 7 Annual Test If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be taken within 30 days of the test date. Clinical imaging and mammographic image interpretation may be continued during this period. 7-30

129 7.5.4 X-ray Equipment Performance Test 1. Procedure [Test flow] The X-ray equipment performance test consists of the kvp accuracy and reproducibility, Half Value Layer (HVL), Collimation assessment and Radiation output. TIP In this test, conduct the three test items not requiring an X-ray image first and then enter their measured values all at once to save time and simplify QC Software operation. 7 Annual Test 7-31

130 7 Annual Test 1 1. kvp accuracy and reproducibility Follow the instructions below to conduct the test item. [Tools] A kvp meter and lead sheet 1. Remove the compression plate. 2. Place a lead sheet on the exposure table, and then position the kvp meter on the sheet. TIP Position the X-ray detector of the kvp meter at the lateral center of the exposure table and near the chest wall-side edge. The position must be the same for every measurement for reproducibility. 3. Select [QC/TEST] in the exposure region list and [Calculation 1/2] in the exposure menu list, and then press [Start study.]. 4. Specify the Large Focal Spot (LFS) and Manu mode for the X-ray equipment and select Mo/Mo for the target/filter. The Semi and Auto modes may not work correctly for this measurement. Make sure to use Manu mode for exposure. 5. Select 3 kvp values used for the measurement. Fill in the following items in the worksheet. kvp used for the tests Low: kv Mid.: kv High: kv TIP Select the kvp most frequently used in clinical practice, and the adjacent upper and lower values (e.g. 25 kv, 28 kv, 31 kv). 6. Make exposures with the selected kvps and measure the values by using a kvp meter. In this Substep, make 5 exposures with the middle kvp. Fill in the following items in the worksheet. LFS - volt. Low: kv LFS - volt. Mid.-1: kv LFS - volt. Mid.-2: kv LFS - volt. Mid.-3: kv LFS - volt. Mid.-4: kv LFS - volt. Mid.-5: kv LFS - volt. High: kv 7. Mount the magnification table of the X-ray equipment and specify the Small Focal Spot (SFS) for it. Measurement with the Small Focal Spot (SFS) cannot be performed unless the magnification table is used. 8. Make exposures with the selected kvps and measure the values by using a kvp meter. In measurement with the Small Focal Spot (SFS), make one exposure with each kvp. Fill in the following items in the worksheet. SFS - volt. Low: kv SFS - volt. Mid.: kv SFS - volt. High: kv 2. Half Value Layer (HVL) 2 Following the instructions below to conduct the test item. [Tools] A dosimeter, aluminum plates (0.3 and 0.5 mm), and a lead sheet 7-32

131 Make the size of the X-ray field approximately equal to that of the detector of dosimeter by using a diaphragm (e.g. lead mask). If the size cannot be reduced to that extent, make the X- ray field as small as possible. TIP Position the aluminum plates within 300 mm away from the focal spot without using the compression plate as shown below. This may require careful effort. 1. Remove the compression plate. 2. Place a lead sheet on the exposure table, and position the dosimeter at the lateral center of the table, 60 mm away from the chest wall-side edge, and also 40 mm above the table. 3. Specify the kvp values for all the target/ filter combinations in Manu mode, and calculate the mas producing the air kerma of 500 to 850 mr ( 4365 to 7420 µgy) without using an aluminum plate. Then measure the air kerma for each setting. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Entrance air kerma - w/o Al: mr µgy The Semi and Auto modes may not work correctly for this measurement. Make sure to use Manu mode for exposure. 4. Position the 0.3 mm aluminum plate and make an exposure under the condition calculated in Substep 3 using each of the kvp and target/filter to measure the air kerma after the X-ray transmitted through the plate. Fill in the following item in the worksheet. Entrance air kerma Al 0.3 mm: mr µgy Wear gloves when using the aluminum plate to keep it clean. 5. Position the 0.5 mm aluminum plate and make an exposure under the condition calculated in Substep 3 using each of the kvp and target/filter to measure the air kerma after the X-ray transmitted through the plate. Fill in the following item in the worksheet. Entrance air kerma Al 0.5 mm: 7 Annual Test 7-33

132 3 3. Radiation output Follow the instructions below to conduct the test item. [Tools] A dosimeter and lead sheet 1. Remove the compression plate. 2. Place a lead sheet on the exposure table, and position the dosimeter at the lateral center of the table, 60 mm away from the chest wall-side edge, and also 40 mm above the table. 4 A dosimeter allowing air kerma rate or exposure time measurement is necessary. Air kerma rate [mgy/s] can be calculated from exposure time [s] as follows: Air kerma rate [mgy/s] = air kerma [mgy] / exposure time [s] (1 mr = mgy) 5. Select [Study completed] to finish the test. 4. Patient information entry and exposure menu selection Enter patient information and press [Next]. 3. Specify 28 kv, 56 mas and Mo/Mo for the X-ray equipment in Manu mode. 5 Select [QC/TEST] in the exposure region list and [Annual 3/6] in the exposure menu list, and then press [Start study.]. 7 The Semi and Auto modes may not work correctly for this measurement. Make sure to use Manu mode for exposure. Annual Test 4. Make an exposure and measure the air kerma, mas and air kerma rate. In this Substep, measure air kerma 5 times under the same exposure conditions. If the air kerma rate cannot be measured, measure the exposure time for calculating the air kerma rate. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Entrance air kerma (1): mr µgy Entrance air kerma (2): mr µgy Entrance air kerma (3): mr µgy Entrance air kerma (4): mr µgy Entrance air kerma (5): mr µgy Air kerma rate: mgy/s (Exposure time: s) 6 The following exposure submenu is displayed. Uniform Expo.3(Collimation) 7-34

133 7 5. Collimation assessment (exposure) Follow the instructions below to conduct the test item. Make an exposure using the following exposure submenus: [Uniform Expo.3(Collimation)] Go to Step 12 when using the Image Reader, which uses a cassette exclusively for mammography, as well as the X-ray equipment. A more detailed test can be conducted. [Tools] A coin 1. Attach a coin to the bottom surface of the compression plate while aligning the edge with the chest wall-side edge of the plate. 3. Specify 23 kv, 2 mas and Mo/Mo and make an exposure in Manu mode. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N The Semi and Auto modes may not work correctly for this test. Make sure to use Manu mode for exposure. It may take some time until you can press [QC] after completing the exposure process. 6. QC Software startup 8 Press [QC] to display the QC window. 7. Exposure condition confirmation 9 Check the exposure conditions. 2. Move the compression plate down onto the exposure table Collimation assessment (measurement) Annual Test Take care that the compression plate is not scratched by the coin. 10 Select Exposure Submenus [Uniform Expo.3(Collimation)] from the exposure condition display field and press [Film output]. For performing image diagnosis on a softcopy display, press [Network output] to output the image to the network. 7-35

134 11 Visually check the gap between the image and compression plate edge by using the chest wall side as reference. Observe the position of the Coin in the output image and record the result. Judgment A part of Coin image is missing Pass (no gap) Coin is completely imaged Fail (with gap) Fill in the following item in the worksheet. Compression plate edge (Chest wall side as reference): Pass/Fail Visual inspection result: Pass (no gap)/ Fail (with gap) The Medical Physicist may perform collimation assessment using the methods that he/she typically uses, then, go to Step 17. Be careful not to position the Coin (a) where it will be overlapped with the coins to be positioned in Substeps 3 and 4 or the boundary of the cassettes placed in Substep Position 2 cassettes (Cassettes B1 and B2, hereafter) over the exposure table by aligning their chest wall-side edges. 7 Annual Test 12 Steps 12 to 16 are the detailed test procedure for the X-ray equipment and the FCR Image Reader, which uses a cassette exclusively for mammography. 5. Collimation assessment (exposure) <details> Follow the instructions below to conduct the test item. Make an exposure using the following exposure submenus: [Uniform Expo.3(Collimation)] [Tools] The same size 2 cassettes (no need to be QC exclusive), a scale and 6 coins (familiar sized) A cassette for general exposure cannot be used. 1. Position a coin (Coin (a), hereafter) on the exposure table while aligning the edge with the chest wall-side edge of the exposure table. 3. Turn on the light field lamp of the X-ray equipment and position 4 coins (Coins (b) to (e), hereafter) respectively on the 4 sides of the light field on the Cassettes B1 and B

135 Be careful not to position the Coins (b) to (e) where they overlap with the Coin (a) or on the boundary of the cassettes. 4. Attach a coin (Coin (f), hereafter) to the bottom surface of the compression plate while aligning the edge with the chest wall-side edge of the plate. 6. Specify 28 kv, 56 mas and Mo/Mo and make an exposure in Manu mode. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N The Semi and Auto modes may not work correctly for this test. Make sure to use Manu mode for exposure. It may take some time until you can press [QC] after completing the exposure process. 6. QC Software startup 13 Press [QC] to display the QC window. Be careful not to position the Coin (f) where it overlaps with the Coins (a) to (e) or on the boundary of the cassettes. 5. Move the compression plate down onto the Cassettes B1 and B Exposure condition confirmation Check the exposure conditions. 7 Annual Test Take care that the compression plate is not scratched by the coins. 7-37

136 8. Collimation assessment (measurement) <details> 7 Annual Test Select Exposure Submenus [Uniform Expo.3(Collimation)] from the exposure condition display field and press [Film output]. For performing image diagnosis on a softcopy display, press [Network output] to output the image to the network. Output the images read from the 2 cassettes positioned on the exposure table on film or on a softcopy display in the same way. Measure the values required for judging the items below. X-ray/Light field gap (Right/Left, Chest/ Nipple) [mm] X-ray/Image receptor field gap (Right/Left/ Nipple) [mm] Compression plate edge (Chest wall side) 1. Measure and record the distances between the coins and the adjacent edges of the output image. If a part of coin image is missing, measure the length of the missing part. TIP Coin (a) Positioned on the chest wall-side edge of the exposure table. Coins (b), (c), (d), (e) Positioned on the 4 sides of the light field. Coin (f) Positioned on the bottom chest wall-side edge of the compression plate. Fill in the following items in the worksheet. Coin (a) A-a: mm Coin (b) A-b: mm Coin (c) A-c: mm Coin (d) A-d: mm Coin (e) A-e: mm Coin (f) A-f: mm 2. Measure and record the distances between the coins and the adjacent edges of the X-ray field on the output images read from Cassettes B1 and B2. If a part of coin image is missing, measure the length of the missing part. Fill in the following items in the worksheet. Coin (b) B-b: mm Coin (c) B-c: mm Coin (d) B-d: mm Coin (e) B-e: mm Coin (f) B-f: mm 3. Make a record of the [X-ray / Light field gap (Right/Left, Chest/Nipple)]. TIP The values measured for Coins (b) to (e) in Substep 2 indicate the gap amount. Record the values measured in Substep 2. Fill in the following items in the worksheet. Left: B-d: mm Right: B-b: mm Chest wall: B-e: mm Nipple side: B-c: mm 7-38

137 4. Calculate the X-ray/Image receptor field gap (Right/Left/Nipple). Observe how the coins are reflected in the images read from the FDR mammography system and Cassette B1/B2 and judge which of the 4 examples the reflected images belong to. Then calculate the gap by using the corresponding formula. TIP Check the following coin images. Left: Coin (d) Right: Coin (b) Nipple side: Coin (c) Assign the value recorded in Substeps 1 and 2 for each coin to A and B in the corresponding formula. Fill in the following items in the worksheet. Left: mm Right: mm Nipple side: mm FDR mammography system Eg: 1 Eg: 2 Eg: 3 Cassette B1/B2 Not needed. The size of the gap can be calculated only from the image read from the FDR mammography system. X-ray/Image receptor field gap X calculation formula X=x (Measure the distance x of the area not exposed to X-rays in the image read from the FDR mammography system.) X=A+B X=A-B TIP When the X-ray field is inside of the image receptor edge in the image read from the FDR mammography system, as shown in Eg: 1, the size of the gap can be determined by measuring the distance ( x in the figure) from the image receptor edge to the X-ray field. TIP When the X-ray field is outside of the image receptor edge in the image read from the FDR mammography system as shown in Egs: 2, 3 and 4, the size of the gap can be calculated. Measure the distance B between the image receptor edge and that of Coin (on the chest wall-side edge) and the distance A between the image receptor edge and the edge of Coin (on the light field) in the image read from Cassette B, and the distance X between the edge of Coin and X-ray field edge, and then assign the measured values to the formula. 5. Calculate the X-ray field/exposure table gap. Observe how the coins are reflected in the images read from the FDR mammography system and Cassette B1/ B2 and judge which of the 3 examples the reflected images belongs to. Then calculate the size of the gap by using the corresponding formula (If the calculated value is a negative, derive the absolute value). TIP Check the following coin images. Chest wall: Coins (a) and (e) Assign the value recorded in Substeps 1 and 2 for each coin to A and B in the corresponding formula. Fill in the following item in the worksheet. Chest: mm 7 Annual Test Eg: 4 X=B-A 7-39

138 Eg: 1 Eg: 2 FDR mammography system Cassette B1/B2 Not needed. The size of the gap can be calculated only from the image read from the FDR mammography system. X-ray field/ exposure table gap Y calculation formula Y=y (Measure the distance y between the edges of Coin (a) and X-ray field in the image read from the FDR mammography system.) Y=(A-e)-{(Aa)+(B-e)} 6. Visually check the gap between the image and compression plate edge by using the chest wall side as reference. Observe the position of the Coin (f) in the image read from the FDR mammography system and record the result. Judgment A part of Coin (f) image is missing Pass (no gap) Coin (f) is completely reflected Fail (with gap) 7 Annual Test Eg: 3 Y=(A-e)+{(B-e)- (A-a)} TIP When the X-ray field is inside of the image receptor edge in the image read from the FDR mammography system, as shown in Eg: 1, the size of the gap can be determined by measuring the distance ( y in the figure) from the image receptor edge to the X-ray field. TIP When the X-ray field is outside of the image receptor edge in the image read from the FDR mammography system as shown in Egs: 2 and 3, the size of the gap can be calculated. Measure the distance A-a between the image receptor edge and that of Coin (a) (on the chest wall-side edge) and the distance A-e between the image receptor edge and the edge of Coin (e) (on the light field) in the image read from Cassette B, and the distance B-e between the edge of Coin (e) and X-ray field edge, and then assign the measured values to the formula Fill in the following item in the worksheet. Compression plate edge (Chest wall side as reference): Pass/Fail Visual inspection result: Pass (no gap)/ Fail (with gap) 9. kvp accuracy and reproducibility (user input) Press [User input]. Select [Annual test 3-1]. Enter the display values and measured values. 7-40

139 Half Value Layer (HVL) (user input) Select [Annual Test 3-2]. Enter the measured entrance air kerma for each target/filter. Some dosimeters may require correction of the measured value according to the beam quality Radiation output (user input) Enter the measured entrance air kerma, mas and air kerma rate, and then press [OK]. Some dosimeters may require correction of the measured value according to the beam quality Collimation assessment (user input) Select [Annual test 3-3]. Enter the measured values and visual inspection result (Pass/Fail). Enter all items even if the test is conducted without using cassettes. Although any value can be entered (e.g. 0 for all items), a negative value or significantly large one causes an error to occur Make sure that the values are entered for all items. If there is an item left unentered, an error occurs. 13. Auto-calculation Press [Measurement execution]. The results are displayed at the bottom of the window. 14. Test result confirmation Check the displayed judgment results. If there is a [Fail], see Performance Criteria and Corrective Action. 7 Annual Test 7-41

140 QC Software shutdown Press [Save] and then [Close] to exit the QC Software. 25 Select [Study completed] to finish the test. 7 Annual Test 7-42

141 2. Test Result Evaluation and Judgement Evaluate and judge the results of the X-ray equipment performance test in the Annual Test. If all items are judged as [Pass], the test is finished. If there is an item judged as [Fail], take corrective actions by following Performance Criteria and Corrective Action. 3. Performance Criteria and Corrective Action [6] kvp accuracy and reproducibility Performance Criteria: Accuracy ± 1kVp, Reproducibility ± 0.5kVp If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be taken within 30 days of the test date. [7] Half Value Layer (HVL) Performance Criteria: HVL > kvp/100 7 Annual Test If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be taken within 30 days of the test date. 7-43

142 [8] Collimation assessment Performance Criteria: Anterior edge of compression plate shall not appear on image, and shall not extend beyond chest wall edge of the image receptor by more than 1% of SID. Collimation Total / Individual Gap Criteria = SID X 0.02 or less Additonal performance criteria can be found on page 7-5. If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be taken within 30 days of the test date. 7 Annual Test [9] Radiation output Performance Criteria: Variation coefficient = 0.05 or less, Air kerma rate = 7mGy/sec or more If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be taken within 30 days of the test date. 7-44

143 7.5.5 AEC System Performance Test 1. Procedure [Test flow] The AEC system performance test consists of AEC reproducibility, CNR mode 1, AGD mode 1, and AGD-ACR Phantom. The test items are intended to conduct constancy tests on the following items for checking the AEC system performance. Reproducibility of air kerma... AEC reproducibility Change in CNR to target thickness... CNR mode 1 Change in AGD to target thickness... AGD mode 1 AGD (standard breast phantom)... AGD-ACR Phantom TIP In this test, specify the baseline values for CNR mode 1, conduct the two test items not requiring an X-ray image, and then enter their measured values all at once to save time and simplify QC Software operation. 7 Annual Test 7-45

144 [Tools] PMMA phantom (40 mm) [Exposure condition setting procedure] 1 Determine the exposure conditions used in the test. Position the PMMA phantom (40mm) on the exposure table and the compression plate 45mm above the patient support. 2 Select [QC/TEST] in the exposure region list and [Calculation 1/2] in the exposure menu list, and then press [Start study.]. Select H-mode under Auto mode for the X-ray equipment and make an exposure. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N 4 5 Select [QC/TEST] in the exposure region list and [Calculation 1/2] in the exposure menu list, and then press [Start study.]. The following exposure submenu is displayed. CNR 6 2. CNR mode 1 (exposure) [Tools] PMMA phantom (40 mm) and aluminum plate (0.2 mm) for CNR measurement Position the PMMA phantom (40mm) on the exposure table. 7 Annual Test 3 1. Patient information entry and exposure menu selection Enter patient information and press [Next]. 7-46

145 7 Position the 0.2 mm aluminum plate for CNR measurement as shown in the figure below. Make sure that the aluminum plate covers the Calculation Area 2 without protruding into the left-hand half of the phantom QC Software startup Press [QC] to display the QC window. 4. Exposure condition confirmation Check the exposure conditions. 8 Wear gloves when using the aluminum plate to keep it clean. Move the compression plate as close to the PMMA phantom as possible without making contact Auto-calculation Press [Measurement execution]. The results are displayed at the bottom of the window. 13 When the result is displayed, press [Save] and then [Test data log]. 7 9 Specify the exposure conditions closest to those recorded in Step 2 in Manu mode. Then make an exposure. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N It may take some time until you can press [QC] after completing the exposure process. Annual Test 7-47

146 6. Baseline value setting 14 Select the result calculated in Step 12, and then press [Baseline value creation]. This completes the baseline value setting. Press [Close]. 2. Position the dosimeter aside the PMMA phantom (40 mm) as shown in the figure below. 7 Annual Test The baseline values above means the reference CNR for recognizing the change in image quality depending on the target thickness (target thickness dependence). 7. QC Software shutdown Press [Save] and then [Close] to exit the QC Software. Select [Study completed] to finish the test. 8. AEC reproducibility Follow the instructions below to conduct the test item. [Tools] A dosimeter and PMMA phantom (40 mm) 1. Position the PMMA phantom (40 mm) on the exposure table. Position the PMMA phantom (40 mm) on the exposure table leaving a space on a side. In the AEC reproducibility test, the dosimeter position differs since the air kerma is measured under the Semi mode. Position the dosimeter where it does not affect the AEC function but receives the X-ray exposure. See FDR MS-1000 Operation Manual for details on the AEC areas. 3. Move the compression plate as close to the PMMA phantom as possible without making contact. 4. Select [QC/TEST] in the exposure region list and [Calculation 1/2] in the exposure menu list, and then press [Start study.]. 5. Specify the kvp and target/filter to be used (28 kv and Mo/Mo is recommended) for the exposure in Semi mode. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N 6. Make 5 exposures and measure the air kerma. Fill in the following items in the worksheet. Entrance air kerma (1): mr µgy Entrance air kerma (2): mr µgy Entrance air kerma (3): mr µgy Entrance air kerma (4): mr µgy Entrance air kerma (5): mr µgy 7-48

147 18 9. AGD mode 1 Follow the instructions below to conduct the test item. [Tools] PMMA phantoms (20, 40, 60 and 70 mm), aluminum plates (0.3 and 0.5 mm) for half value layer measurement, a dosimeter, and a lead sheet 1. Position the PMMA phantom (20 mm) on the exposure table. 2. Position the compression plate 21mm above the exposure table. 3. Make an exposure in H-mode under Auto mode. Fill in the following items in the worksheet. PMMA phantom 20 mm exposure conditions kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N 4. Using PMMA phantoms 60 mm and 70 mm, repeat the operation described in Substeps 1 to 3. For these thicknesses, the compression plate should be positioned at 75mm and 90mm, respectively, above the exposure table. TIP The exposure conditions for the PMMA phantom 40 mm has been determined in Step 2. Enter the conditions in the worksheet. Fill in the following items in the worksheet. PMMA phantom 40 mm exposure conditions kvp: kv kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N PMMA phantom 60 mm exposure conditions kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N PMMA phantom 70 mm exposure conditions kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N 5. Remove the PMMA phantom, place a lead sheet on the exposure table, and then position the dosimeter as shown in the figure below. 7 Annual Test 7-49

148 7 Annual Test 6. Move the compression plate as close to the dosimeter as possible without making contact. Do not reposition the compression plate during measurement. 7. Specify Manu mode for the X-ray equipment and make an exposure under exposure conditions for the PMMA phantom 20 mm recorded in Substep 3. If the mas value determined in Substep 3 cannot be applied, specify the closest applicable value. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N The Semi and Auto modes may not work correctly for this measurement. Make sure to use Manu mode for exposure. 8. Make an exposure and measure the air kerma. Fill in the following item in the worksheet. Entrance air kerma - w/o Al: mr µgy 9. Position the 0.3 mm aluminum plate for half value layer measurement on the compression plate. Wear gloves when using the aluminum plate to keep it clean. Make sure that the aluminum plate covers the detector of the dosimeter from the above. 10. Make an exposure with the exposure conditions used in Substep 7 and measure the air kerma. Fill in the following item in the worksheet. Entrance air kerma Al 0.3 mm: mr µgy 11. Position the 0.5 mm aluminum plate for half value layer measurement in the same way. 12. Make an exposure with the exposure conditions used in Substep 7 and measure the air kerma. Fill in the following item in the worksheet. Entrance air kerma Al 0.5 mm: mr µgy 13. Repeat the operation described in Substeps 7 to 12 using the exposure conditions determined in Substep 4 for PMMA phantoms 40 mm, 60 mm and 70 mm to measure and record the air kerma. 14. Select [Study completed] to finish the test. 7-50

149 Patient information entry and exposure menu selection Enter patient information and press [Next]. 11. CNR mode 1 (exposure) Select [QC/TEST] in the exposure region list and [Annual 4/6] in the exposure menu list, and then press [Start study.]. 22 The procedure for testing CNR mode 1 is described below. Make 4 exposures using the following exposure submenus: [H-mode CNR(PMMA20mm)] [H-mode CNR(PMMA40mm)] [H-mode CNR(PMMA60mm)] [H-mode CNR(PMMA70mm)] [Tools] PMMA phantoms (20, 40, 60, 70 mm) and aluminum plate (0.2 mm) for CNR measurement TIP In CNR mode 1, use the same H-mode of the AEC as that used in AGD mode 1. Wear gloves when using the aluminum plate to keep it clean. 1. Position the PMMA phantom (20 mm) on the exposure table. 2. Position the 0.2 mm aluminum plate for CNR measurement as shown in the figure below. 21 The following exposure submenus are displayed. HCN20: H-mode CNR(PMMA20mm) HCN40: H-mode CNR(PMMA40mm) HCN60: H-mode CNR(PMMA60mm) HCN70: H-mode CNR(PMMA70mm) Make sure that the aluminum plate covers the Calculation Area 2 without protruding into the left-hand half of the phantom. 7 Annual Test 7-51

150 3. Move the compression plate as close to the PMMA phantom as possible without making contact QC Software startup Press [QC] to display the QC window Exposure condition confirmation Check the exposure conditions. 7 Annual Test 4. Specify the exposure conditions for PMMA phantom 20 mm determined in Substep 3 of the AGD mode 1 test procedure. Then make an exposure in Manu mode. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N The Semi and Auto modes may not work correctly for this measurement. Make sure to use Manu mode for exposure. 5. Using PMMA phantoms 40 mm, 60 mm and 70 mm, repeat the operation described in Substeps 1 to 4. Use the exposure conditions for the PMMA phantom of each thickness determined in Substep 4 of the AGD mode 1 test procedure Press [User input]. 14. AEC reproducibility (user input) Select [Annual test 4-1]. Enter the measured entrance air kerma. It may take some time until you can press [QC] after completing the exposure process. 7-52

151 AGD mode 1 (user input) Select [Annual Test 4-2]. Enter the measured entrance air kerma and target/filter for each, and then press [OK]. Some dosimeters may require correction of the measured value according to the beam quality Test result confirmation Check the displayed judgment results. If there is a [Fail], see Performance Criteria and Corrective Action. 18. QC Software shutdown 28 Make sure that the values are entered for all items. If there is an item left unentered, an error occurs. 16. Auto-calculation Press [Measurement execution]. The results are displayed at the bottom of the window Press [Save] and then [Close] to exit the QC Software. Select [Study completed] to finish the test. 7 Annual Test 7-53

152 19. AGD - ACR Phantom [Tools] ACR phantom, aluminum plates (0.3 and 0.5 mm), a dosimeter and a lead sheet Select [QC/TEST] in the exposure region list and [Calculation 2/2] in the exposure menu list, and then press [Start study]. 2. Select H-mode under Auto mode for the X-ray equipment and make an exposure of the ACR phantom. Fill in the following items in the worksheet. kvp: kv mas: mas Target/Filter: / Compressed breast thickness: mm Compression force: N 3. Remove the ACR phantom and cover the exposure table with the lead sheet. 4. Position the dosimeter at the lateral center of the exposure table, 60 mm away from the chest wall-side edge, and also 40 mm above the table Make an exposure with the exposure conditions used in Step 29 and measure the air kerma. Fill in the following item in the worksheet. Entrance air kerma - w/o Al: 7. Position the 0.3 mm aluminum plate on the compression plate so that it covers the detector of the dosimeter.. 8. Make an exposure with the exposure conditions used in Step 29 and measure the air kerma. Fill in the following item in the worksheet. Entrance air kerma - Al 0.3mm: 9. Position the 0.5 mm aluminum plate on the compression plate so that it covers the detector of the dosimeter. 10. Make an exposure with the exposure conditions used in Step 29 and measure the air kerma. Fill in the following item in the worksheet. Entrance air kerma - Al 0.5mm: Enter patient information and press [Next]. 7 Annual Test 5. Move the compression plate as close to the dosimeter as possible without making contact. : Do not reposition the compression plate during measurement. 34 Select [QC/TEST] in the exposure region list and [Calculation 2/2] in the exposure menu list, and then press [Start study.]. 7-54

153 39 Press [Measurement execution]. The results are displayed at the bottom of the window. 35 Make an exposure under any conditions (e.g. 23 kv, 2 mas and Mo/Mo) to start up the QC Software. 40 Confirm that the calculation result does not exceed 3mGy. If it does, see Performance Criteria and Corrective Action. 36 It may take some time until you can press [QC] after completing the exposure process. Press [QC] to display the QC window. 41 Press [Save] and then [Close] to exit the QC Software. 37 Press [User input]. 42 Select [Study completed] to finish the test. 38 Enter the target/filter used and measured entrance air kerma, and then press [OK]. Some dosimeters may require correction of the measured value according to the beam quality. 43 To complete MEE / Annual tesing, please perform Sections 4-5 and 4-6 in Chapter 4 of this QC Manual. 7 Annual Test 7-55

154 2. Test Result Evaluation and Judgment Evaluate and judge the results of the AEC system performance test in the Annual Test. If all items are judged as [Pass], the AEC system performance test is finished. If there is an item judged as [Fail], take corrective actions by following Performance Criteria and Corrective Action. See 8.2 Quick Guide for Software Operation for test log display procedure. 3. Performance Criteria and Corrective Action [10] AEC reproducibility Performance Criteria: Variation coefficient = 0.05 or less 7 If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be taken within 30 days of the test date. Annual Test 7-56

155 [11] CNR mode 1 Performance Criteria: CNR Relative Value 20mm [%] = 105% of baseline value or more CNR Relative Value 40mm [%] = 95% of baseline value or more CNR Relative Value 60mm [%] = 63% of baseline value or more CNR Relative Value 70mm [%] = 60% of baseline value or more If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be taken within 30 days of the test date. 7 Annual Test 7-57

156 [12] AGD mode 1 Performance Criteria: AGD 20mm [mgy] = 1 mgy or less AGD 40mm [mgy] = 2 mgy or less AGD 60mm [mgy] = 4.5 mgy or less AGD 70mm [mgy] = 6.5 mgy or less [13] AGD - ACR Phantom Performance Criteria: AGD-ACR Phantom [mgy] = 3 mgy or less 7 Annual Test If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be taken before any further examinations are performed with the system. 7-58

157 Chapter 8 Assistance Material Page 8.1 Calculation Functions Quick Guide for Software Operation Worksheets Report Forms Assistance Material 8-1

158 8.1 Calculation Functions The CNR and AGD of PMMA phantom at a given thickness can be auto-calculated by the QC Software. Items Auto-calculated and Judged Based on Input Data Test Items Exposure Menus Exposure Submenus 1. Exposure 2. Input Values CNR Calculation 1/2 CNR AGD Calculation 2/2 AGD The measurement procedure of each item is described below. [1] CNR [Tools] PMMA phantom (of a given thickness) and aluminum plate (0.2 mm) Enter patient information and press [Next]. 1 3 The following exposure submenu is displayed. CNR 4 Position the PMMA phantom of the desired thickness to be measured and 0.2 mm aluminum plate as shown in the figure below. Make sure that the aluminum plate covers the Calculation Area 2 without protruding into the left-hand half of the phantom. 2 Select [QC/TEST] in the exposure region list and [Calculation 1/2] in the exposure menu list, and then press [Start study.]. 8 Assistance Material Wear gloves when using the aluminum plate to keep the plate clean. 8-2

159 5 Move the compression plate as close to the PMMA phantom as possible without making contact. 10 Check the calculation result. 6 Specify the exposure conditions for the X-ray equipment and make an exposure in Manu mode. The Semi and Auto modes may not work correctly for this measurement. Make sure to use Manu mode for exposure Press [Save] and then [Close] to exit the QC Software. Select [Study completed] to finish the test. 7 Repeat Steps 4 to 6 as many times as necessary to capture the desired number of images to be calculated (max. 32 images). It may take some time until you can press [QC] after completing the exposure process. 8 Press [QC] to display the QC window. 9 Press [Measurement execution]. The results are displayed at the bottom of the window. 8 Assistance Material 8-3

160 [2] AGD [Tools] A dosimeter and aluminum plates (0.3 and 0.5 mm) 1 Position the dosimeter at the lateral center of the exposure table, 60 mm away from the chest wall-side edge, and also 40 mm above the table Position the 0.3 mm aluminum plate on the compression plate. Wear gloves when using the aluminum plate to keep the plate clean. Make sure that the aluminum plate covers the detector of the dosimeter from the above. Make an exposure with the exposure conditions used in Step 3 and measure the air kerma. Position the 0.5 mm aluminum plate in the same way. Make an exposure with the exposure conditions used in Step 3 and measure the air kerma. Enter patient information and press [Next]. 2 Move the compression plate as close to the dosimeter as possible without making contact. Do not reposition the compression plate during measurement. 10 Select [QC/TEST] in the exposure region list and [Calculation 2/2] in the exposure menu list, and then press [Start study.]. 8 Assistance Material 3 4 Specify the desired exposure conditions for the X-ray equipment and make an exposure in Manu mode. The Semi and Auto modes may not work correctly for this measurement. Make sure to use Manu mode for exposure. Record the air kerma. 8-4

161 11 The following exposure submenu is displayed. AGD 16 Press [Measurement execution]. The results are displayed at the bottom of the window. 17 Check the calculation result. 12 Make an exposure under any conditions (e.g. 23 kv, 2 mas and Mo/Mo) to start up the QC Software. 18 Press [Save] and then [Close] to exit the QC Software. 13 It may take some time until you can press [QC] after completing the exposure process. Press [QC] to display the QC window. 19 Select [Study completed] to finish the test. 14 Press [User input]. 15 Enter the target/filter used and measured entrance air kerma, and then press [OK]. Some dosimeters may require correction of the measured value according to the beam quality. 8 Assistance Material 8-5

162 8.2 Quick Guide for Software Operation This section provides concise references for the QC Software main operations and the QC test log confirmation procedure. Make a copy of this section as necessary. Basic Procedure 1 Starting FUJIFILM workstation Start a FUJIFILM workstation and enter patient information, and then press [Next]. 2 Starting QC test Select [QC/TEST] in the exposure region list and an exposure submenu displayed in the exposure menu list, and then press [Start study.]. 6 Finishing the test Press [Study completed] to finish the test. When finishing the test, the window in Step 1 is redisplayed. To conduct another test, repeat the procedure. 8 Assistance Material 3 Exposure Make an exposure using all of the displayed exposure submenus. 4 Starting QC Software Press [QC]. 5 Main button operations in QC window 8-6

163 Log Confirmation Procedure 1 Starting FUJIFILM workstation Start a FUJIFILM workstation and enter patient information, and then press [Next]. 4 Main button operations in Test Data Log window 2 Starting QC test Select [QC/TEST] in the exposure region list and press [Start study.] without selecting an exposure submenu. 5 Finishing the test Press [Close] and then [Study completed] to finish the test. 3 Starting QC Software Press [QC]. 8 Assistance Material 8-7

164 8.3 Worksheets The forms on the following pages are prepared for recording the exposure conditions used in the tests and measured values. It is recommended to keep the record of each test conditions for reproducibility. Make a copy of these worksheets as necessary. 8 Assistance Material 8-8

165 Baseline Value Settings <Baseline Values for Annual Test> Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes [5] Spatial Resolution (Magnification) 5 1Shot Phantom position Lateral shift distance: mm 6 Exposure conditions for Exposure Submenu [1ShotM(Magnification)] kvp: mas: Target/Filter: / Compressed breast thickness: Compression force: kv mas mm N Phantom positioning in Annual Test Exposure condition confirmation ( 8 ) <Baseline Values for Semi-annual Test> Test Items Steps Exposure Conditions/Measurement and Judgment Results Input Steps 1 mas mas Exposure condition determination ( 7 ) [1] Image Basic Test 2 Air kerma 7 Exposure conditions for Exposure Submenu [Uniform Expo(Image Basic)] kvp: mr µgy mr µgy mas: Target/Filter: / mr µgy Result input ( 10 ) kv mas Exposure condition confirmation ( 9 ) White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8. Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired automatically.) 8 Assistance Material 8-9

166 <Baseline Values for Weekly Test> Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes [1] Test with 1Shot Phantom 6 [2] Test with ACR Phantom Shot Phantom exposure conditions Exposure conditions for Exposure Submenu [ACR Phantom] Density inside the disk Density outside the disk kvp: mas: Target/Filter: / Compressed breast thickness: Compression force: kvp: mas: Target/Filter: / Compressed breast thickness: Compression force: kv mas mm N kv mas mm N Exposure condition confirmation ( 8 ) Exposure condition confirmation ( 10 ) Result input ( 14 ) White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8. Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired automatically.) 8 Assistance Material 8-10

167 <Weekly Test> Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes [1] Test with 1Shot Phantom 4-3 Exposure conditions for Exposure Submenu [1Shot PhantomM] kvp: mas: Target/Filter: / Compressed breast thickness: Compression force: 5-1 X-ray equipment cleanliness Pass Fail kv mas mm N Exposure condition confirmation ( 7 ) [2] Good practice [1] Test with 1Shot Phantom 9 [3] Test with ACR Phantom 5-2 Screen cleanliness Pass Fail 5-3 Viewing box cleanliness Pass Fail Distortion Pass Fail Artifact Pass Fail Exposure conditions for Exposure Submenu [ACR Phantom] Density at center of Phantom image kvp: mas: Target/Filter: / Compressed breast thickness: Compression force: kv mas mm N Density inside the disk Density outside the disk Fibers (ACR Phantom) points Specks (ACR Phantom) points Masses (ACR Phantom) points Visible step wedge (Step Phantom) steps Specks (Step Phantom) steps Masses (Step Phantom) steps Result input ( 11 ) Result input ( 10 ) Exposure condition confirmation ( 7 ) Result input ( 10 ) White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8. Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired automatically.) 8 Assistance Material 8-11

168 Semi-annual Test Test Items Steps Exposure Conditions/Measurement and Judgment Results Acceptance Limits [1] Compression device confirmation Automatic Compression Manual Compression Date: Date: Measured value: Measured lbs. lbs. value: Automatic (25-45 lbs) Corrective Action needed? Corrective Action description Corrective Action taken? Corrective Date: Results of new test PASS YES YES PASS FAIL NO NO FAIL Comments White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8. 8 Assistance Material 8-12

169 Annual Test (Initial Performance Test) Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes [1] Image Basic Test Exposure conditions for Exposure Submenu [Uniform Expo(Image Basic)] Air kerma Exposure conditions for Exposure Submenu [Uniform Expo(Image Basic)] kvp: mas: Target/Filter: / kvp: mr µgy mr µgy mas: Target/Filter: / kv mas Exposure condition determination ( 9 ) mr µgy Result input ( 13 ) kv mas Exposure condition confirmation ( 9 ) 11 Artifact Pass Fail Result input ( 13 ) White out Pass Fail Result input ( 13 ) [2] Compression device confirmation 6-2, 3 Compressed breast thickness Display value: mm 6-5 Compression force Measured value: Display value: Measured value: mm mm mm 6-6 Compression force sustainability Pass Fail 6-7 Maximum compression force N 7-2 Luminance cd/m Viewing box uniformity Pass Fail Result input ( 14 ) [3] Viewibox maintenance 7-4 Luminance adjustment function Pass Fail 7-5 Masking Pass Fail 7-6 Interpretation room illuminance (Ambient light) lx Result input ( 15 ) White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8. Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired automatically.) 8 Assistance Material 8-13

170 Annual Test (Image Performance Test) Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes [1] Additive lag effects (Lag) 4-3 [2] Multiplicative lag effects (Ghost) [3] Missed tissue on chest wall edge (40 mm height) Exposure conditions for Exposure Submenu [ACR Phantom1(Lag)] Exposure conditions for Exposure Submenu [Uniform Expo.1(Ghost)] Exposure conditions for Exposure Submenu [ACR Phantom2(Ghost)] Exposure conditions for Exposure Submenu [Uniform Expo.2(Ghost)] kvp: kv mas: mas Target/Filter: / kvp: mas: Target/Filter: / kvp: mas: Target/Filter: / kvp: mas: Target/Filter: / kvp: kv mas kv mas kv mas mas: mas Exposure conditions for Exposure Submenu Target/Filter: [1Shot PhantomM(40mm)] Compressed breast / thickness: mm Compression force: N Missed tissue on chest wall edge (Right) Pass Fail Missed tissue on chest wall edge (Left) Pass Fail Verify mechanical stability Pass Fail Verify that all moving parts move smoothly Pass Fail All locks and detents work properly Pass Fail No sharp, rough edges or other hazards including electrical hazards Pass Fail kv Exposure condition confirmation ( 9 ) Exposure condition confirmation ( 9 ) Result input ( 13 ) [4] Visual and Functional test 7 Operator technique control charts are posted Pass Fail Operator protected during exposure by adequate radiation shielding Pass Fail All indicator lights working properly Pass Fail Auto decompression can be overridden and status displayed Pass Fail Compression can be manually released / in any failure Pass Fail Result input ( 14 ) White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8. Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired automatically.) 8 Assistance Material 8-14

171 Annual Test (Spatial Resolution Test) Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes [5] Spatial Resolution (Magnification) 4-2 1Shot Phantom position Lateral shift distance: mm 4-3 Exposure conditions for Exposure Submenu [1ShotM(Magnification)] kvp: mas: Target/Filter: / Compressed breast thickness: Compression force: kv mas mm N Exposure condition confirmation ( 6 ) White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8. Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired automatically.) 8 Assistance Material 8-15

172 Annual Test (X-ray Equipment Performance Test) Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes kvp used for the tests Low kv Mid. kv High kv [6] kvp accuracy and reproducibility 1-5, 6 LFS - volt. Low kv Mid.-1 kv Mid.-2 kv Mid.-3 kv Mid.-4 kv Mid.-5 kv High kv Result input ( 18 ) [7] Half Value Layer (HVL) 1-8 SFS - volt. Low kv Mid. kv High kv 2-3, 4, 5 [9] Radiation output 3-4 [8] Collimation assessment kvp mas Target/Filter ( / ) kv mas Target/Filter ( / ) kv mas Target/Filter ( / ) kv mas Exposure conditions Entrance air kerma kvp: Air kerma w/o Al Al 0.3 mm Al 0.5 mm mr µgy mr µgy mr µgy mas: Target/Filter: / (1) (4) mr µgy (2) mr µgy (5) mr µgy (3) Air kerma rate mgy/s (Exposure time) s 7-3 Exposure conditions 16-1 Distance between image edges 16-2 X-ray / Light field gap 16-3 X-ray / Light field gap X-ray / Image receptor field gap X-ray field / Exposure table gap Compression paddle edge (Chest wall side) kvp: mr µgy mas: Target/Filter: / Compressed breast thickness: Compression force: mr µgy mr µgy mr µgy mr µgy mr µgy mr µgy kv mas mr µgy kv mas mm N A-a mm A-b mm A-c mm A-d mm A-e mm A-f mm B-b mm B-c mm B-d mm B-e mm B-f mm Left: Right: Chest wall side: Nipple side: Left: Right: Nipple side: Chest wall side: Pass Fail mm mm mm mm mm mm mm mm Result input ( 19 ) Result input ( 21 ) Exposure condition confirmation ( 9 ) Result input ( 20 ) 8 White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8. Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired automatically.) Assistance Material 8-16

173 Annual Test (AEC System Performance Test) Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes kvp: kv 2 Exposure conditions mas: Target/Filter: / Compressed breast thickness: mas mm Exposure condition determination ( 9 ) [11] CNR mode 1 Compression force: kvp: N kv 9 Exposure conditions mas: mas Target/Filter: / Compressed breast thickness: mm Exposure condition confirmation ( 11 ) Compression force: N kvp: kv mas: mas 17-5 Exposure conditions Target/Filter: / [10] AEC reproducibility Compressed breast thickness: mm Compression force: N 17-6 Entrance air kerma (1) (4) mr µgy (2) mr µgy (5) mr µgy (3) mr µgy mr µgy Result input ( 26 ) White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8. Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired automatically.) Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes [11] CNR mode Exposure Mode 1 PMMA thickness kvp mas Target/ Filter Compressed breast thickness Compression force 20 mm kv mas / mm N 40 mm kv mas / mm N 60 mm kv mas / mm N 70 mm kv mas / mm N Exposure condition confirmation ( 29 ) White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8. Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired automatically.) 8 Assistance Material 8-17

174 Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes [12] AGD Mode , 4 18 PMMA thickness Exposure Mode 1: Exposure condition determination kvp mas Target/ Filter Compressed breast thickness Compression force 20 mm kv mas / mm N 40 mm kv mas / mm N 60 mm kv mas / mm N 70 mm kv mas / mm N PMMA Target/ Compression kvp mas thickness Filter force Compressed breast thickness Air kerma w/o Al Al 0.3 mm Al 0.5 mm mr µgy mr µgy mr µgy Exposure condition ( for 18-7, 13) determination 20 mm kv mas / mm N Exposure mr mr mr -7, 8, Mode 1 40 mm kv mas / mm N Result input ( 27 ) µgy µgy µgy mr mr mr 10, mm kv mas / mm N µgy µgy µgy mr mr mr 70 mm kv mas / mm N µgy µgy µgy White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8. Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired automatically.) 8 Assistance Material 8-18