Aspire HD Plus / HD -s 2 Overview Quality Control ...Operation Manual” and “FCR 1Shot Phantom M Plus Operation Manual”. 9 Aspire HD Plus / HD -s Quality Control Program Manual

FDR Mammography QC Manual - 897N102579

Quality Control

Overview

Installation of FDR Mammography QC Program

Weekly Test

Quarterly Test

Semi-annual Test

Annual Test

Assistance Material

Technical Information

Image Processing Parameters (for Mammography QC)

2

3

4

5

1

6

7

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- MS-2500/FDR MS-2000 Operation Manual”, “FDR-2000AWS Operation Manual”, “FDR Mammography QC Software Operation Manual” and “FCR 1Shot Phantom M Plus Operation Manual”.

9

Aspire HD Plus / HD -sQuality Control

Program Manual1st Edition - January 2013

897N102579

ii FDR Mammography QC Manual - 897N102579

iiiFDR Mammography QC Manual - 897N102579

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.

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.

Exclusive Clauses

TrademarkFCR and FDR are trademarks or registered trademarks of FUJIFILM Corporation.

Copyright © 2008 FUJIFILM Corporation. All rights reserved.

iv FDR Mammography QC Manual - 897N102579

vFDR Mammography QC Manual - 897N102579

9

8

6

5

4

7

Contents at a Glance

Chapter 1 Quality ControlThis chapter describes the relevant quality control standards.

Chapter 2 OverviewThis chapter describes the features of FDR Mammography QC Program and the purpose of each quality control test.

Chapter 3 Installation of FDR Mammography QC ProgramThis chapter describes the operational procedure for installing the FDR Mammography QC Program.

Chapter 4 Weekly TestThis chapter describes the Weekly Test procedure performed by the Technologist (and during MEE and Annual testing by the Medical Physicist).

Chapter 5 Quarterly TestThis chapter describes the Quarterly Test procedure performed by the Technologist.

Chapter 6 Semi-annual TestThis chapter describes the Semi-annual Test procedure performed by the Technologist.

Chapter 7 Annual TestThe test procedures performed by the Medical Physicist during the Medical Equipment Evaluation (MEE) and Annual testing.

Chapter 8 Assistance MaterialThis 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 InformationThis chapter consists of a brief specification of 1Shot Phantom M Plus and a glossary.


1

2

3

vi FDR Mammography QC Manual - 897N102579

IndicationsThe following indications are used in the descriptions to show the supplementary information and what must be observed while using the software.

NOTE 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.

ConventionsThe 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.

viiFDR Mammography QC Manual - 897N102579

Chapter 1 Quality Control

1.1 Quality Control ................................................................................................................ 1-21.1.1 Acceptance Test ............................................................................................ 1-21.1.2 Constancy Test ............................................................................................... 1-21.1.3 Status Test .......................................................................................................... 1-2

1.2 Quality Control of the Mammography System .................................................... 1-31.2.1 Quality Control Tests and Frequency .......................................... 1-31.2.2 Types of Quality Control Tests .......................................................... 1-4

Chapter 2 Overview

2.1 Product Outline .............................................................................................................. 2-2

2.2 QC Test Items .................................................................................................................... 2-52.2.1 Weekly Test ........................................................................................................ 2-72.2.2 Quarterly Test .................................................................................................. 2-112.2.3 Semi-annual Test .......................................................................................... 2-112.2.4 Annual Test ........................................................................................................ 2-12

2.3 Tools ......................................................................................................................................... 2-13

2.4 QC Software Outline ................................................................................................... 2-17

2.5 Notes on Conducting the Program .................................................................... 2-20

Chapter 3 Installation of FDR Mammography QC Program

3.1 Installation Procedure ............................................................................................. 3-2

3.2 Initial Settings .................................................................................................................. 3-3

3.3 Criteria Confirmation and Determination ................................................................................. 3-5

3.4 Baseline Value Settings ............................................................................................ 3-123.4.1 Baseline Values for Annual Test ....................................................... 3-133.4.2 Baseline Values for Semi-annual Test.......................................... 3-173.4.3 Baseline Values for Weekly Test ....................................................... 3-21

3.5 Checking Equipment Conditions at the Time of Program Installation .......................................................................................................................... 3-30

Contents

viii FDR Mammography QC Manual - 897N102579

Chapter 4 Weekly Test

4.1 Test Flow .............................................................................................................................. 4-2

4.2 Test Items ............................................................................................................................. 4-3

4.3 Tools ......................................................................................................................................... 4-4

4.4 Setting Confirmation ................................................................................................. 4-5

4.5 1 Shot Phantom Test ................................................................................................ 4-6

4.6 ACR Phantom Test ....................................................................................................... 4-12

4.7 Printer Quality Control ............................................................................................. 4-18

4.8 Monitor Quality Control .......................................................................................... 4-20

Chapter 5 Quarterly Test

5.1 Test Flow .............................................................................................................................. 5-2

5.2 Test Items ............................................................................................................................. 5-3

5.3 Repeat Analysis ............................................................................................................... 5-4

Chapter 6 Semi-annual Test

6.1 Test Flow .............................................................................................................................. 6-2

6.2 Test Items ............................................................................................................................. 6-2

6.3 Tools ......................................................................................................................................... 6-2

6.4 Compression Device Confirmation ............................................................... 6-2

Chapter 7 Annual Test

7.1 Test Flow .............................................................................................................................. 7-2

7.2 Test Items ............................................................................................................................. 7-3

7.3 Tools ......................................................................................................................................... 7-4

7.4 Setting Confirmation ................................................................................................. 7-5

7.5 Conducting Annual Test ........................................................................................ 7-77.5.1 Initial Performance Test .......................................................................... 7-77.5.1 Image Performance Test ........................................................................ 7-197.5.2 Spatial Resolution Test ............................................................................ 7-277.5.3 X-ray Equipment Performance Test ............................................. 7-317.5.4 AEC System Performance Test .......................................................... 7-45

ixFDR Mammography QC Manual - 897N102579

Chapter 8 Assistance Material

8.1 Calculation Functions ................................................................................................ 8-2

8.2 Quick Guide for Software Operation .......................................................................... 8-6

8.3 Worksheets ......................................................................................................................... 8-8

8.4 Report Forms .................................................................................................................... 8-20

Chapter 9 Technical Information

9.1 Specification Outline of 1Shot Phantom M Plus ................................ 9-2

9.2 Glossary ................................................................................................................................. 9-3

x FDR Mammography QC Manual - 897N102579

1-1

1


Chapter 1Quality Control

Page

1.1 Quality Control ________________________________________ 1-21.1.1 Acceptance Test __________________________________ 1-21.1.2 Constancy Test ___________________________________ 1-21.1.3 Status Test _______________________________________ 1-2

1.2 Quality Control of the Mammography System _____________ 1-31.2.1 Quality Control Tests and Frequency __________________ 1-31.2.2 Types of Quality Control Tests _______________________ 1-4

1-2

Quality Control

1

1.1 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 61223-3-2 Ed.2 (International Electrotechnical Commission)

Always follow applicable laws and regulations for your jurisdiction. If anything in this manual isin 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.

1.1.1 Acceptance TestThe 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.

1.1.2 Constancy TestThe 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.

1.1.3 Status TestA 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.


1-3

Quality Control

1


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.

1.2.1 Quality Control Tests and FrequencyQC Software Installation QC Software Operation

Baseline Value Measurement

Equipment Condition

Check3 months 6 months 9 months 1 year 15

months18

months21

months 2 years

M a m m o g r a p h y E q u i p m e n t Evaluation (MEE)

Chapter 7

Chapter 4

Weekly Test Every Week Chapter 4

Quarterly Test Chapter 5

Semi-annual Test Chapter 6

Annual Test Chapter 7

Chapter 4

Chapter 3

[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.

At time of FDR installation / major component replacement

Quality Control

1

1-4 FDR Mammography QC Manual - 897N102579

Quality Control

1

1.2.2 Types of Quality Control TestsAll 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”.

[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).

2-1

2

FDR Mammography QC Manual - 897N102579 2-1

2

Chapter 2Overview

Page

2.1 Product Outline ________________________________________ 2-2

2.2 QC Test Items __________________________________________ 2-52.2.1 Weekly Test ______________________________________ 2-72.2.2 Quarterly Test ____________________________________ 2-112.2.3 Semi-annual Test _________________________________ 2-112.2.4 Annual Test ______________________________________ 2-12

2.3 Tools _________________________________________________ 2-13

2.4 QC Software Outline____________________________________ 2-17

2.5 Notes on Conducting the Program _______________________ 2-20

2-2

Overview

2

FDR Mammography QC Manual - 897N1025792-2

Overview

2

2.1 Product OutlineThis 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.

• 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.

2-3

Overview

2


Overview

2

[Equipment to be evaluated]

[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.

QC Software Installation QC Software Operation

Baseline Value Measurement

Equipment Condition

Check

3

months

6

months

9

months

1

year

15

months

18

months

21

months

2

years

Mammography Equipment

Evaluation (MEE)

(Medical Physicist)

At time of FDR mammography installation / major component replacement Chapter 7

Chapter 4

Weekly Test

(Technologist)Every Week

Chapter 4

Quarterly Test

(Technologist) Chapter 5

Semi-annual Test

(Technologist) Chapter 6

Annual Test

(Medical Physicist) Chapter 7

Chapter 4

Chapter 3

See Chapters 3 to 7 as necessary for details on each test procedure.

2-4

Overview

2


Overview

2

[The Program implementation procedure]

Initial S ettings1.

C riteria C onfirmation and Determination

2. C hange the c riteria as nec es s ary.

C hec king E quipment Qualitiesat the Time of the P rogram Ins tallation

Annual Tes t

S emi-annual Tes t

Weekly Tes t

6 months

3 months

1 year

S emi-annual Tes t

9 months Quarterly Tes t

Quarterly Tes t

Quarterly Tes t

Quarterly Tes t

S emi-annual Tes t

Quarterly Tes t15 months

4.

When ins talling the QC S oftware

Daily/Weekly Tes t

When implementing the QC P rogram

S emi-annual Tes t

Quarterly Tes t

18 months

Annual Tes t

C onduc t tes ts in order of their potential influenc e on images (Annual T es t → S emi-annual T es t → W eekly T es t). T he Quarterly T es t c an be c onduc ted regardles s of order.

B as eline Value S ettings3.

2-5

Overview

2


Overview

2

2.2 QC Test ItemsTest 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 Phantom1Shot PhantomM

TechnologistGood practice

Test with ACR Phantom ACR Phantom

NOTEConduct the Test with 1Shot Phantom and Good practice in the Daily Test, and the Test with ACR Phantom in the Weekly Test.

[Quarterly Test]


Repeat analysis –– *1 Technologist

*1 No Exposure Menu for the Repeat analysis in Quarterly Test

[Semi-annual Test]


Compression device confirmation –– *2 Technologist

*2 No Exposure Menu for the Compression device confirmation in the Semi-annual Test

2-6

Overview

2


Overview

2

[Annual Test]

Test Items Exposure Menus Responsibility Test Types

Image Basic Test Annual A

Medical Physicist

Image performance Additive lag effects (Lag)

Annual 1/6Multiplicative lag effects (Ghost)

Visual and Functional test

Spatial Resolution (Magnification) Annual 2/6 Spatial Resolution

kVp accuracy and reproducibility

Annual 3/6 X-ray equipment performance

Half Value Layer (HVL)

Collimation assessment

Radiation output

AEC reproducibilityAnnual 4/6 through

Annual 6/6AEC system

performance CNR modes 1 to 3

AGD modes 1 to 3

Test with 1 Shot Phantom

ACR Phantom Evaluation1 Shot Phantom M

ACR PhantomImage 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.

2-7

Overview

2


Overview

2

2.2.1 Weekly TestThe 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.

<J udgment method>• Auto-c alc ulation bas ed on

the image• Vis ual Ins pec tion

<J udgment method>• Dens ity meas ur ement (if us ing

• Vis ula Ins pec tion

(1) 1S hot P hantom Image

(2) AC R P hantom Image

hardc opies for diagnos is )

* NOTE: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.

2-8

Overview

2


Phantoms Used for Exposure

1Shot Phantom

ACR Phantom/Acrylic disk

NOTEThe 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.

[1] Test with 1Shot Phantom(1) Missed tissue on chest wall edge

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.

2-9

Overview

2


(6) Uniformity

Check that the uniformity variation is within the criteria.

(7) Dynamic range

Check that the dynamic range variation is within the criteria.

(8) Spatial Resolution (SR)

Check that the spatial resolution variation is within the criteria.

(3) 1Shot Phantom sensitivity constancy

Check that the 1Shot Phantom sensitivity variation is within the criteria.

(4) Geometric distortion

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

Visually check that there are no artifacts affecting diagnosis in the image.

2-10

Overview

2


(9) Low Contrast Detectability (LCD)

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.

[2] Good practiceCheck that the following equipment is kept clean.• X-ray equipment• Softcopy output equipment• Viewbox

[3] Test with ACR Phantom

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

* NOTEACR 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.

2-11

Overview

2


2.2.3 Semi-annual TestDuring the Semi-annual Test, Compression device confirmation is performed..

[1] Compression device confirmation

Check that minimum and maximum compression forces can be applied.

2.2.2 Quarterly TestDuring the Quarterly Test, Repeat analysis is performed.

[1] Repeat analysis

Calculate data for analyzing the rejected images.

2-12

Overview

2


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

NOTEThe Missed tissue on chest wall edge (40 mm height) is the Annual Test is not required as part of this QC program.

2-13

Overview

2


2.3 Tools

Tools to be used for QC test are shown in the table below.

...Required ...Optional

Tools Weekly Test Semi-annual Test Annual TestCalculation Functions

[ A ] QC Software

[ B ] Worksheet (See Chapter 8)

[ C ] 1Shot Phantom

[ D ] Viewbox (if film is used)

[ E ] Timer or watch/clock

[ F ]ACR Phantom

(including an acrylic disk) *1

[ G ] Dosimeter

[ H ] Luminance meter

[ I ] kVp meter

[ J ] Force scale / Bathroom scale

[ K ] Towels *2 *2

[ L ] Illuminance meter

[M] Densitometer

[ 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 (ruler)

[ R ] Coins

[ S ] Lead sheet *3 *3

*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 equipmentC. FUJIFILM workstation

2-14

Overview

2


Tool Details

[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.

NOTEScratches, 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.), 18-220 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).

NOTEScratches, 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/m2 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.

2-15

Overview

2


[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 ± 0.02.

[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) NOTEScratches, 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.

20 21

40 45

60 75

70 90

(Reference: EUREF Ed.4)

[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.

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Equipment details

A Hardcopy/Softcopy output equipment FDA-cleared hardcopy/softcopy output devices (laser imager/diagnostic monitor).

B X-ray equipment The Fujifilm FFDM X-Ray exposure unit is to be used.

NOTEIn 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 and mAs of the X-ray equipment.

• “Semi (semi auto)” mode The mode automatically specifies the mAs but allows manual setting of the kVp of the X-ray equipment.

• “Auto (full auto)” mode The mode automatically specifies kVp and mAs of the X-ray equipment depending on the subject.

C FUJIFILM workstation The workstation to be used is the Fujifim Acquisition Workstation (FDR-2000AWS).

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2.4 QC Software Outline

This section describes the operational procedure for the QC Software and the relevant window (“QC window” hereafter).

The “QC window” composition is described below.

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See the “FDR Mammography QC Software Operation Manual” and/or operation manual for a FUJIFILM workstation for detailed QC software operation.

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2.5 Notes on Conducting the Program

Operational notes regarding the Program are described below.

Notes on Performing QC Tests

(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. Auto-calculation 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-2000AWS Operation Manual” for details.

(8) AEC exposure modes In this Program, use the mode (H-mode, N-mode or L-mode) used most frequently for clinical

mammography (for test items that require AEC) unless otherwise sepcified. Use this same exposure mode everytime you perform tests that require AEC.

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Chapter 3Installation of FDR Mammography QC Program

Page

3.1 Installation Procedure __________________________________ 3-2

3.2 Initial Settings _________________________________________ 3-3

3.3 Criteria Confirmation and Determination _________________ 3-5

3.4 Baseline Value Settings _________________________________ 3-123.4.1 Baseline Values for Annual Test ______________________ 3-133.4.2 Baseline Values for Annual A Test ____________________ 3-173.4.3 Baseline Values for Weekly Test ______________________ 3-21

3.5 Checking Equipment Conditions at the Time of Program Installation ____________________________________________ 3-30

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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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2

Specify the information for conducting the tests, such as dosimeter position.

NOTEMake sure to perform these settings, otherwise the auto-calculation of the QC Software cannot run.

Criteria Confirmation and Determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3

The reference criteria are preset.Check the criteria and change the values as necessary.

Baseline Value Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4

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 . . . . . . . . . . . . . . . . . . . . . . 3.5

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)

NOTEWhen a new equipment or 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 3.

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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

Setting Procedure

1 Enter patient information and press [Next].

2 Select [QC/TEST] in the exposure region list and [1Shot PhantomM] in the exposure menu list, and then press [Start study.].

3 The following exposure submenu is displayed.

• 1Shot PhantomM

4 Specify 23 kV, 2 mAs and W/Rh and make an exposure in “Manu” mode.

NOTEIt may take some time until you can press [QC] after completing the exposure process.

5 Press [QC] to display the “QC window”.

6 Press [Initial setting].

7 Enter values for items requiring initial settings.For details on each item, see the following descriptions in (1) through (5).

（1）

（2）

（3）

（4）

（5）

(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.

Check the reference point of the dosimeter in its operation manual.

TIP

(2) Magnification table - Exposure table’s top surface distance. Enter 247 mm.

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(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

• 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.

8 Press [OK].

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.

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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 .



3 The following exposure submenu is displayed.• 1Shot PhantomM

4 Specify 23 kV, 2 mAs and W/Rh and make an exposure in “Manu” mode.



6 Press [Criteria setting].

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7 Select a tab and enter values for items to be changed.

Weekly Tests 1/2 and 2/2

[Items allowing criteria change]Test Item/Contents Judgment Items Criteria

Missed tissue on chest wall edgeMissed tissue on chest wall edge (Right) [mm] 7 mm or less

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 %

Geometric distortionDimension (Horizontal) [mm] Baseline value ± 2 %

Dimension (Vertical) [mm] Baseline value ± 2 %

Uniformity

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 %

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)2lp/mm [%] Baseline value ± 6 %

4lp/mm [%] Baseline value ± 15 %

Low Contrast Detectability (LCD)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] Baseline value ± 50 [QL]



QL gap (4 step-5 step) [QL] Baseline value ± Baseline value [QL]

Test with ACR Phantom

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) 4 or more and no more than 0.5 lower than baseline

Specks (ACR Phantom) 3 or more and no more than 0.5 lower than baseline

Masses (ACR Phantom) 3 or more and no more than 0.5 lower than baseline

*1 When these items are not checked, leave the preset values as they are. Do not delete the preset values.

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Quarterly TestThere is no item related to the criteria.

Semi-annual TestThere is no item related to the criteria.

Annual A Test

[Items allowing criteria change]Test Items Judgment Items Criteria

Image Basic Test Relative sensitivity (S value) Baseline value ± 40 %

Compression device confirmation

Compressed breast thickness accuracy [mm] ± 5 mm

Compression force accuracy [N] ± 20 N

Maximum compression force [N] 111 to 200 N

Viewbox maintenanceLuminance [cd/m2] 3500 cd/m2 or more

Interpretation room illuminance (Ambient light) [lx] 50 lx or less

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Annual Test 1/3 (Annual Test consists of tabs 1/3 to 3/3)


Additive lag effects (Lag) Lag factor [QL] 75 QL or less

Multiplicative lag effects (Ghost) Ghost factor Below 0.045

Spatial Resolution (Magnification)MTF (4lp/mm)[%] Baseline value ± 12 %

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

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

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Annual Test 2/3



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

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

Radiation output

Reproducibility Variation coefficient 0.05 or less

Air kerma rate [mGy/s] 2.7 mGy/s or more

Specific radiation output [μGy/mAs] 9 μGy/mAs or more

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Annual Test 3/3


AEC reproducibilityEntrance air kerma accuracy [%] Average ± 15 % or less

Entrance air kerma reproducibility Variation coefficient 0.05 or less

CNR modes 1 to 3

CNR relative value 20mm [%] Baseline value 105 % or more




AGD modes 1 to 3

AGD 20 mm [mGy] 1 mGy or less


AGD 60 mm [mGy] 4.5 mGy or less


AGD modes 1 to 3 -ACR Phantom AGD-ACR Phantom [mGy] 3 mGy or less

• [CNR_H-mode], [CNR_N-mode] and [CNR_L-mode] in the window correspond to CNR modes 1, 2 and 3, respectively.

TIP

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8 Complete checking and changing all the necessary items, then press [OK].

9 Press [Close] to exit the “QC window”.

NOTEIf “The test result is not saved.” is displayed, press [OK].

10 Select [Study completed] to finish the test.

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3.4 Baseline Value SettingsThis 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.

[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 Test1Shot PhantomM Test with 1Shot 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)


ACR Phantom Test with ACR Phantom

Semi-annual Test Compression device confirmation

Annual TestAnnual 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.

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3.4.1 Baseline Values for Annual TestAmong 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

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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.

NOTEIf 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.

NOTEThe 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

[Baseline value setting procedure]1. Patient information entry and exposure

menu selection


2 Select [QC/TEST] in the exposure region list and [Annual 2/6] in the exposure menu list, and then press [Start study.].

3 The following exposure submenu is displayed.• 1ShotM(Magnification)

2. Spatial Resolution (Magnification) (exposure)

4 Mount the magnification table of the X-ray equipment and the compression plate normally used in magnification exposure in clinical practice.

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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, 125 to 160 mAs and W/Rh is recommended).

• Fill in the following items in the worksheet. kVp: _____kV mAs: _____mAs Target/Filter: _____/_____ Compressed breast thickness: _____mm Compression force: _____N


3. QC Software startup


4. Exposure condition confirmation

8 Check the exposure conditions.

5. Auto-calculation

9 Press [Measurement execution]. The results are displayed at the bottom of the window.

If “No baseline value is input.” appears, press [OK].

TIP

NOTEIn the last time measurement, skip Steps 10 through 12 and go to Step 13 .

10 When the results are displayed, press [Save] and then [Close] to exit the QC Software.


12 Repeat Steps 1 through 11 several times (5 is recommended) to specify the averages of the multiple measured values as the baseline values.

NOTEMake sure to repeat the same procedure until the test is finished. Do not add an exposure submenu when repeating.

13 When the result is displayed, press [Save] and then [Test data log].

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6. Baseline value setting

14 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].

7. QC Software shutdown

15 Press [Save] and then [Close] to exit the QC Software.


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3.4.2 Baseline Values for Annual A TestAmong the Annual A Test items, the Image basic test requires the baseline setting.

Test Category Exposure Menu Test Item

Annual A Test Annual A 1/1

Image Basic Test


Viewing box maintenance

[1] Image basic test[Test flow]

[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 wall-side 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 W/Rh. Then record the mAs when the air kerma becomes approximate to 30 mR.

• Fill in the following item in the worksheet. mAs: _____mAs

2 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 W/Rh in Step 1 .

• Fill in the following item in the worksheet. Entrance air kerma: _____mR

µGy , _____mRµGy , _____mR

µGy

3 Remove the dosimeter.Select [Study completed] to finish the test.

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2. Image basic test (exposure)

7 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: _____/_____






1. Patient information entry and exposure menu selection


5 Select [QC/TEST] in the exposure region list and [Annual A] in the exposure menu list, and then press [Start study.].

6 The following exposure submenu is displayed.• Uniform Expo(Image Basic)

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6. Auto-calculation



TIP

NOTEIn the last measurement, skip Steps 12 through 14 and go to Step 15 .

12 When the result is displayed, press [Save] and then [Close] to exit the QC Software.





5. Image basic test (user input)

10 Press [User input], enter the measured entrance air kerma and visual inspection results (Pass/Fail), and then press [OK].

(1)

(2)

(3)

(4)

(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.

NOTESome dosimeters may require correction of the measured value according to the beam quality.

NOTEEnter values or select [Pass/Fail] for all of the items. The Pass/Fail selection does not affect the baseline value determination.

NOTEEnter any value (e.g. “0” for all items) except for negative or significantly large one. Otherwise, an error occurs.

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3.4.3 Baseline Values for Weekly TestThe 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.

*NOTEThe 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 Test1Shot PhantomM Test with 1Shot Phantom


CNR



System artifact evaluation

Uniformity

Dynamic range




ACR Phantom Test with ACR Phantom

[1] Test with 1Shot Phantom

[Test flow]


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2. Test with 1Shot Phantom (exposure)

4 Position the 1Shot Phantom on the exposure table.

NOTEPosition 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.

5 Position the compression plate 40 mm above the exposure table.

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10 Select either of [Pass/Fail] for [1Shot Phantom image confirmation] and [Good practice] items, and then press [OK].

NOTEEnter values or select [Pass/Fail] for all of the items. The Pass/Fail selection does not affect the baseline value determination.

6. Auto-calculation



TIP

NOTEIn the last time measurement, skip Steps 12 through 14 and go to Step 15 .



6 Specify 28 kV and W/Rh and make an exposure in “Semi” mode.







5. Test with 1Shot Phantom (user input)

9 Press [User input].

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17 Create baseline values for “Low Contrast Detectability (Light)” and “Low Contrast Detectability (Dark)” in “LCD”.

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, 62.27 and 65.19.

(59.66+60.33+55.25+62.27+65.19)/5 = 60.54

Round to the whole number. = 612. 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.





16 Select the results to be used for calculating the baseline values among the measured results, and then press [Baseline value creation].

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• 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, 67.65 and 68.70.

(67.03+68.65+63.03+67.65+68.70)/5 = 67.012

Round to the whole number. = 67

18 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 61. 61-14 = 472. 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 67. 67-14 = 53

19 Press [Criteria setting].

20 Select the [Daily/Week/y test (1/2)] tab.Enter the criteria for “Light” and “Dark” in “LCD” and press [OK].




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[2] Test with ACR PhantomThe baseline value setting for the test with ACR Phantom/Acrylic Disk is only required if the facility uses hardcopy for primary interpretation

[Test flow]

[Tools]ACR Phantom, an acrylic disk, and a densitometer

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2. ACR Phantom (exposure)

4 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).

AC R P hantom

C hest wall s ide

Nipple s ide

Acrylic disk

6 Position the compression plate so that it comes in contact with the ACR Phantom.

NOTEMake sure that excessive pressure is not applied to the Phantom.

7 Make an exposure in “Auto” or “Semi” mode.







2 Select [QC/TEST] in the exposure region list and [ACR Phantom] in the exposure menu list, and then press [Start study.].

3 The following exposure submenu is displayed.• ACR Phantom

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13 Enter the densities measured in Step 11 .

NOTEMake 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].

NOTEEnter 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.




5. Image output

10 Select an image exposed using Exposure Submenu [ACR Phantom] from the exposure condition display field and press [Film output].

11 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)


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amm

ography QC Program


7. Auto-calculation



TIP

NOTEIn the last measurement, skip Steps 15 through 17 and go to Step 19 .








NOTEMake sure that the results for the Test with ACR Phantom are selected. They are displayed below those for the Test with 1Shot Phantom.




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ography QC Program


3.5 Checking Equipment Conditions at the Time of Program Installation

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.

Conduct the tests in the order of their potential influence on displayed images.

TIP

Annual Test (Chapter 7)

Semi-annual Test (Chapter 6)

-Weekly Test (Chapter 4)

Conducting these Tests complete the condition check at the time of the Program installation.

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ography QC Program


4-1

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FDR Mammography QC Manual -897N102579

Chapter 4Weekly Test

Page

4.1 Test Flow ______________________________________________ 4-2

4.2 Test Items _____________________________________________ 4-3

4.3 Tools _________________________________________________ 4-4

4.4 Setting Confirmation ___________________________________ 4-5

4.5 Conducting Weekly 1 Shot Phantom Test ________________ 4-64.5.1 Procedure _______________________________________ 4-64.5.2 Test Result Evaluation and Judgment _________________ 4-114.5.3 Performance Criteria and Corrective Action ____________ 4-11

4.6 Conducting Weekly ACR Phantom Test ___________________ 4-124.6.1 Procedure _______________________________________ 4-124.6.2 Test Result Evaluation and Judgment _________________ 4-164.6.3 Performance Criteria and Corrective Action ____________ 4-17

4.7 Conducting Weekly Printer QC __________________________ 4-12

4.8 Conducting Weekly Monitor QC _________________________ 4-12

4-2

Weekly Test

4


4.1 Test FlowBased 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.

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.

NOTEThe 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.

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Weekly Test


4.2 Test Items The Weekly Test consists of the following test items.

Test Items/Contents Exposure Menus Exposure Submenus

Items Auto-calculated and

Judged Based on Input Data

Items Judged [Pass/Fail]

Based on Visual Inspection by a

User1. Exposure

2. Input Values

Test with 1Shot Phantom


1Shot PhantomM1Shot PhantomM ✓

CNR


Geometric distortion ✓

System artifact evaluation ✓

Uniformity

Dynamic range




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.

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.

*NOTEThe 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.

4-4

Weekly Test

4


4.3 ToolsTools 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 NOTEThe 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.

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Weekly Test


4.4 Setting ConfirmationThe following items described in Chapter 3 are required to be specified before conducting the Weekly Test.

• Initial settings ...................................3.2 Initial Settings• Criteria..................................................3.3 Criteria Confirmation and Determination• Baseline values ..................................3.4 Baseline Value Settings

[Items allowing criteria change]Test Items/Contents Judgment Items Criteria

1Shot PhantomM


Missed tissue on chest wall edge (Right) [mm] 7 mm or less

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 %

Geometric distortionDimension (Horizontal) [mm] Baseline value ± 2 %

Dimension (Vertical) [mm] Baseline value ± 2 %

Uniformity

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 %

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)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 (4 step-5 step) [QL] Baseline value ± Baseline value [QL]

ACR Phantom

Density at center of Phantom image 1.4 ± 0.2

Density difference (disk/outside) 0.4 or more and baseline value ± 0.5

Fibers (ACR Phantom) 4 or more and no more than 0.5 lower than baseline

Specks (ACR Phantom) 3 or more and no more than 0.5 lower than baseline

Masses (ACR Phantom) 3 or more and no more than 0.5 lower than baseline

The criteria setting is not required for visual inspection.

TIP

*1 When not checking these items, leave the preset values as they are. Do not delete the preset values.

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4.5 Conducting Weekly 1 Shot Phantom Test

4.5.1 Procedure

[Test flow]

4-7

4

Weekly Test






2. Test with 1Shot Phantom (exposure)

4 Follow the instructions below to conduct the test item.


1. Position the 1Shot Phantom on the exposure table.

NOTEPosition 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. Position the compression plate 40 mm above the exposure table.

4-8

Weekly Test

4


3. Specify the same kVp and target/filter as those determined in the “3.4.3 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

NOTEMake 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 “3.4.3 Baseline Values for Daily/Weekly Test”.

3. Good practice (cleaning)


[Tools]See the respective operation manuals for the FDR-2000AWS, 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.

3. 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






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Weekly Test


8. Good practice (user input)

11 Enter the results of Good practice, and then press [OK].

NOTEMake sure that the result is selected for all items. If there is an item left unentered, an error occurs.

9. Auto-calculation


6. Image output

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.

9 Check or measure the following items using the image output on film.

For performing image diagnosis on a softcopy display, check the items on the display.

TIP

• 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.

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10. Test result confirmation

13 Check the displayed judgment results.

If there is a [Fail], see “4.5.3 Performance Criteria and Corrective Action”.




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Weekly Test


4.5.2 Test Result Evaluation and JudgmentEvaluate 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 “4.5.3. Performance Criteria and Corrective Action”.

4.5.3 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 %

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 practiceClean the equipment.

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4.6 Conducting Weekly ACR Phantom Test

4.6.1 Procedure

[Test flow]

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Weekly Test




2 Select [QC/TEST] in the exposure region list and [ACR Phantom] in the exposure menu list, and then press [Start study.].

3 The following exposure submenu is displayed.• ACR Phantom

2. Test with ACR Phantom (exposure)


[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).

*NOTEThe acrylic sisk and densitometer are required only if the facility uses hardcopy (film) for primary interpretation.

AC R P hantom

C hest wall s ide

Nipple s ide

Acrylic disk

3. Position the compression plate so that it comes in contact with the ACR Phantom.

NOTEMake sure that excessive pressure is not applied to the Phantom.

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Weekly Test

4


4. Make an exposure in “Auto” or “Semi” mode.• Fill in the following items in the worksheet.







5. Image output

7 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.

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.

For performing image diagnosis on a softcopy display, check the items on the display.

TIP

• 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

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Weekly Test


6. Test with ACR Phantom (user input)

9 Press [User input]. Enter the measured density and visual inspection results, and then press [OK].

NOTEThough 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.

7. Auto-calculation



11 Check the displayed judgment results.

If there is a [Fail], see “4.6.3 Performance Criteria and Corrective Action”.




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4.6.2 Test Result Evaluation and JudgmentEvaluate 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 “4.6.3. Performance Criteria and Corrective Action”.

See “8.2 Quick Guide for Software Operation” for test log display procedure.

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Weekly Test



[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

P oints to be c hec ked

If any of the above is not c orrec t/appropriate, c orrec t the problem.

• The c orrec t expos ure s ubmenu was s elec ted.

• The s ame X-ray equipment s ettings (target/filter, kVp and AE C s ettings ) have

been us ed.

• The AC R P hantom, and ac rylic dis k (if us ed) were c orrec tly pos itioned.

• The s ame c ompres s ion plate has been us ed during the tes t.

• The c ompres s ion plate has been in the s ame pos ition during the tes t.

• The dens itometer was c orrec tly us ed.

• The dens ity was meas ured on the c orrec t pos ition.

• The quality c ontrol of the viewing c ondition is c onduc ted.

P as s

F ail

C ontac t a FUJ IF ILM dealer.

The tes t is finis hed.Make s ure that the AC R

P hantom is c orrec tly pos itioned

and then redo the tes t.

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.

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4.7 Conducting Printer Quality Control

4.7.1 Procedure

[Test flow]

1. TP rinter Quality C ontrol

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Weekly Test


3. Printer Quality Control (measurement)

1 Follow the instructions below to conduct the Printer Quality Control test.

NOTEThe 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. NOTEFollow 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 1.20. 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 2.20. 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 0.45. 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 8.

8. 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.

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4.8 Conducting Monitor Quality Control

4.8.1 Procedure

[Test flow]

1. Monitor Quality C ontrol

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4. Monitor Quality Control (measurement)


NOTEThe 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. NOTECommercial 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.

NOTEFollow 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

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[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.

NOTE]

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.

5-1FDR Mammography QC Manual - 897N102579

5

Chapter 5Quarterly Test

Page

5.1 Test Flow ______________________________________________ 5-2

5.2 Test Items _____________________________________________ 5-3

5.3 Conducting Quarterly Test ______________________________ 5-45.3.1 Procedure _______________________________________ 5-45.3.2 Test Result Evaluation and Judgment _________________ 5-65.3.3 Performance Criteria and Corrective Action ____________ 5-6


5

Quarterly Test

5.1 Test FlowPerformed 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-2000AWS, 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.

NO

YES


5

Quarterly Test

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



User1. Exposure 2. Input Values

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 Conducting Quarterly Test

5.3.1 Procedure

[Test flow]

1. Repeat analysis (collecting rejected images)

1 Start by removing all existing rejected images in the department taken prior to the start of the analysis.

2 Take inventory of the image supply as a starting point to determine the total number of images consumed during this test.

3 Start collecting all rejected images. Continue to collect for the length of time needed to radiograph at least 250 consecutive patients.

4 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.).

NOTERejected 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”.

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.

TIP

2. Repeat analysis (calculating repeat rates)

5 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

Quarterly Test

7 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.

8 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 100.


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

5.3.2 Test Result Evaluation and JudgmentEvaluate and judge the Quarterly Test results. If the criteria are satisfied, the test is completed. If not satisfied, take corrective actions by following “5.3.3 Performance Criteria and Corrective Action”.

5.3.3 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.

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Chapter 6Semi-annual Test

Page

6.1 Test Flow ______________________________________________ 6-2

6.2 Test Items _____________________________________________ 6-2

6.3 Tools _________________________________________________ 6-2

6.5 Conducting Semi-annual Test ___________________________ 6-26.5.1 Procedure _______________________________________ 6-26.5.2 Test Result Evaluation and Judgment _________________ 6-46.5.3 Performance Criteria and Corrective Action ____________ 6-4

6-2

6

Semi-annual Test


6.1 Test FlowPerformed 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 SubmenusItems Judged Based on Input Data Items Judged [Pass/

Fail] Based on Visual Inspection by a User1. Exposure 2. Input Values

Compression device confirmation --- --- --- ✓

Judgment methods:

1. User selection of [Pass/Fail] based on force / bathrrom scale measurements.

6.3 ToolsTools to be used for the Semi-annual Test based on this Manual are shown below.


Tools[ B ] Worksheet (See Chapter 8)[ J ] Analog bathroom scale or Force scale[ K ] Towels

6.5 Conducting Semi-annual Test6.5.1 Procedure

[Test flow]

1. C ompres s ion devic e c onfirmation (meas urment)

6-3

6

Semi-annual Test


1. Compression device confirmation (measurement)


[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

BathroomScale

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.

6-4

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Semi-annual Test


6.5.2 Test Result Evaluation and JudgmentA 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. .


[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)

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

Chapter 7Annual Test

Page

7.1 Test Flow ______________________________________________ 7-2

7.2 Test Items _____________________________________________ 7-3

7.3 Tools _________________________________________________ 7-4

7.4 Setting Confirmation ___________________________________ 7-5

7.5 Conducting Annual Test ________________________________ 7-77.5.1 Initial Performance Test ____________________________ 7-7

1. Procedure ____________________________________ 7-72. Test Result Evaluation and Judgment ____________ 7-163. Performance Criteria and Corrective Action ______ 7-16

7.5.2 Image Performance Test ____________________________ 7-191. Procedure ____________________________________ 7-192. Test Result Evaluation and Judgment ____________ 7-253. Performance Criteria and Corrective Action ______ 7-25

7.5.3 Spatial Resolution Test _____________________________ 7-271. Procedure ____________________________________ 7-272. Test Result Evaluation and Judgment ____________ 7-303. Performance Criteria and Corrective Action ______ 7-30

7.5.4 X-ray Equipment Performance Test ___________________ 7-311. Procedure ____________________________________ 7-312. Test Result Evaluation and Judgment ____________ 7-433. Performance Criteria and Corrective Action ______ 7-43

7.5.5 AEC System Performance Test _______________________ 7-451. Procedure ____________________________________ 7-452. Test Result Evaluation and Judgment ____________ 7-563. Performance Criteria and Corrective Action ______ 7-56


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Annual Test

7.1 Test FlowPerformed 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.

NOTEThe 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.

Annual Test

Taking corrective actions

First Annual Test

Initial setting, criteria andbaseline value settings

E quipment use

The result is within the criteria

(1) Image performance (2) S patial R esolution (3) X-ray equipment performance(4) AE C system performance

E xposure and measurement

C heck that the variation from the specified baseline values is within the

criteria, or that the values indicating system performance satis fy the criteria.

If the criteria are satis fied, equipment can be used as is until the next Annual

Test day. If not satis fied, take corrective actions by following

"P erformance C riteria and C orrective Action" in the relevant subsection.

QC S oftware User input

Auto-calculation

J udgment

Viewing conditions

Measurement andperformance check

C ompress ion device

Measurement

confirmation

NO

Y E S(5) 1 S hot P hantom tests (6) AC R P hantom test


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Annual Test

7.2 Test Items The Annual Test consists of the following test items.

Test Types/Items Exposure Menus Exposure Submenus

Items Auto-calculated and

Judged Based on Input Data



User1. Exposure

2. Input Values

Viewing Conditions

Viewing environment - - ✓

Viewbox maintenance Annual A - ✓ ✓

Printer Quality Control - - ✓

Monitor Quality Control - - ✓


Force, display accuracy and sustainability Annual A ✓ ✓

Image performance

Image basic test Annual A Uniform Expo(Image Basic) ✓ ✓ ✓

Additive lag effects (Lag)

Annual 1/6

ACR Phantom1(Lag) ✓

Non Exposure(Lag) ✓

Multiplicative lag effects (Ghost)

Uniform Expo.1(Ghost) ✓

ACR Phantom2(Ghost) ✓

Uniform Expo.2(Ghost) ✓

Visual and Functional test - ✓

Spatial Resolution Spatial Resolution (Magnification) Annual 2/6 1ShotM(Magnification) ✓

X-ray equipment performance


Annual 3/6

- ✓

Half Value Layer (HVL) - ✓

Collimation assessment Uniform Expo.3(Collimation) ✓ ✓

Radiation output - ✓

AEC system performance

AEC reproducibility

Annual 4/6

- ✓

CNR modes 1 to 3

Mode1 through Mode3 CNR(PMMA20mm) ✓




AGD modes 1 to 3 - ✓

AGD-ACR Phantom-modes 1 to 3 Calcualtion 2/2 - ✓ ✓

Constancy Performance 1 Shot Phantom tests 1ShotPhantomM ✓ ✓ ✓

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.

.


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Annual Test

7.3 ToolsTools to be used for the Annual Test based on this Guidebook are shown below.


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


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Annual Test

7.4 Setting ConfirmationThe following items described in Chapter 3 are required to be specified before conducting the Annual Test.

• Initial settings ....................................3.2 Initial Settings• Criteria..................................................3.3 Criteria Confirmation and Determination• Baseline values ..................................3.4 Baseline Value Settings


Viewbox mainitenanceLuminance (cd/m2) 3500 cd/m2 or more

Interpretation room illuminance / ambient light (lx) 50 lx or less


Compressed breast thickness accuracy (mm) ±5 mm or less

Compression force accuracy (N) ± 20 N or less

Maximum compression force (N) 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 0.045

Spatial Resolution (Magnification)MTF (4lp/mm) Baseline value ± 12 %

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

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

Half Value Layer (HVL) 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

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

Radiation output

Reproducibility Variation coefficient 0.05 or less

Air kerma rate [mGy/s] 2.7 mGy/s or more

Specific radiation output [μGy/mAs] 9 μGy/mAs or more


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Annual Test


AEC reproducibilityEntrance air kerma accuracy [%] Average ± 15 % or less

Entrance air kerma reproducibility Variation coefficient 0.05 or less

CNR modes 1 to 3





AGD modes 1 to 3





AGD modes 1 to 3 -ACR Phantom AGD-ACR Phantom 3 mGy or less

• The criteria setting is not required for visual inspection.• CNR modes 1, 2 and 3 correspond to the CNR_H-mode, CNR_N-mode and CNR_L-mode.• AGD modes 1, 2 and 3 correspond to the AGD_H-mode, AGD_N-mode and AGD_L-mode.

TIP


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Annual Test

7.5 Conducting Annual Test The Annual Test items are classified into “7.5.1 Initial Performance Test”, “7.5.2 Image Performance Test”, “7.5.3 Spatial Resolution Test”, “7.5.4 X-ray Equipment Performance Test”, “7.5.5 AEC System Performance Test” and “7.5.6 ACR Phantom Evaluation”; these five tests can be conducted separately.

7.5.1 Initial Performance Test1. 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.

6. P atient information entry and expos ure menu s elec tion

9. QC S oftware s tartup

17. QC S oftware s hutdown

1. Viewing environment (meas urement)

13. C ompres s ion devic e c onfirmation (us er input)

14. Viewbox maintenanc e (us er input)

15. Auto-c alc ulation

16. Tes t res ult c onfirmation

10. E xpos ure c ondition c onfirmation

11. Image output

12. Image bas ic tes t (us er input)

7. Image bas ic tes t (expos ure)

8. C ompres s ion devic e c onfirmation (meas urement)

2. Viewbox maintenanc e (meas urement)

4. Monitor Quality C ontrol (meas urement)

3. P rinter Quality C ontrol (meas urement)

5. Image bas ic tes t (meas urement)


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Annual Test

2. Viewbox maintenance (measurement)


[Tools]A viewbox, luminance meter, and illuminance meter

NOTECheck 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/m2

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

NOTESee the operation manuals for the viewbox, luminance meter or illuminance meter for how to measure the luminance or illuminance.


1. Viewing Environment (measurement)

1 Follow the instructions below to conduct the Viewing Environment evaluation.

NOTEThis evaluation is specific to the viewbox and reading room conditions, for images for final interpretation. NOTE [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.

NOTE [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.


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Annual Test

3. Printer Quality Control (measurement)

3 Follow the instructions below to conduct the Printer Quality Control test.

NOTEThe 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. NOTEFollow 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:


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Annual Test

4. Monitor Quality Control (measurement)


NOTEThe 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. NOTECommercial 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.

NOTEFollow 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


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Annual Test


[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.

NOTE]

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.


[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



9 Select [QC/TEST] in the exposure region list and [Annual A 1/1] in the exposure menu list, and then press [Start study.].

10 The following exposure submenu is displayed.• Uniform Expo(Image Basic)

5. Image basic test (measurement)


[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.

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 “3.4.2 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 , _____mRµGy , _____mR

µGy

NOTEMake 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 “3.4.2 Baseline Values for Annual A Test”.

4. Remove the dosimeter & lead sheet. Select [Study completed] to finish the test.


7

Annual Test

7. Image basic test (exposure)


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)


[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.

60mm

NOTEEnsure 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


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Annual Test

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)


18 Enter the measured air kerma (from Substep 3 in Step 7 .) and visual inspection results ([Pass/Fail]).






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.


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Annual Test

13. Compression device confirmation (user input)

19 Enter the measured values, display values and visual inspection result (Pass/Fail).

14. Viewing box maintenance (user input)

20 Enter the measured value and visual inspection results, and then press [OK].

NOTEMake sure that the values are entered for all items. If there is an item left unentered, an error occurs.

15. Auto-calculation



22 Check the displayed judgment results. If there is a [Fail], see “7.5.3 Performance Criteria and Corrective Action”.





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Annual Test

2. Test Result Evaluation and JudgementEvaluate 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 “6.5.3 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.

[Relative sensitivity] resulted in [Fail]

Performance Criteria: Baseline value ± 40%



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Annual Test

[White out] resulted in [Fail]

Performance Criteria: No white out shall be visible.


[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

The X-ray equipment may be defec tive.

C ontac t a FUJ IF ILM dealer.

Fail

P oints to be c hec ked• The forc e s c ale or bathroom s c ale was c orrec tly us ed.• [lbs ] is s pec ified as the unit of forc e.

R edo the tes t. The tes t is finis hed.P as s

If any of the above is not c orrec t/appropriate, c orrec t the problem.

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.


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Annual Test

[3] Viewing box maintenance

[Viewing box luminance] resulted in [Fail]

Performance Criteria: 3500 cd/m2 or more

[Interpretation room illuminance (Ambient light)] resulted in [Fail]

Performance Criteria: 50 lx or less


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Annual Test

7.5.2 Image Performance Test1. 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.

NOTEAs 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.


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Annual Test

2. Additive lag effects (Lag) (exposure)

4 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.


3. Specify 28 kV, 80 mAs and W/Rh 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 W/Rh, and then make an exposure in “Manu” mode.

NOTEMake exposures in Substeps 3 and 4 consecutively without much interval between them to obtain high-quality results.




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)


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Annual Test

3. Multiplicative lag effects (Ghost) (exposure)

5 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



3. Position the ACR Phantom on the right-hand 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.

NOTEThe 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.


5. Remove the ACR Phantom.


4. Missed tissue on chest wall edge (40 mm height) (exposure)

6 Follow the instructions below to conduct the test item.Make an exposure using the following exposure submenu:[1Shot PhantomM(40mm)]

NOTEThis 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

NOTEThe 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.

Use the same exposure conditions as those used for the Phantom exposure in the Daily/Weekly Test. See “3.4.3 Baseline Values for Daily/Weekly Test” for details.

TIP


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Annual Test

1. Position the 1Shot Phantom using the jig above the exposure table.

NOTEPosition 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.

Reinstall the compression plate removed for the Multiplicative lag effects (Ghost) test.

TIP

NOTEBeware 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


5. Visual and Functional test (Checking)


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




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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 .

10 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


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Annual Test

9. Missed tissue on chest wall edge (40 mm height) (user input)


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 14 .

10. Visual and Functional test (user input)

14 Select the results ([Pass/Fail]) and press [OK].

NOTEMake sure that the result is selected for all items. If there is an item left unentered, an error occurs.




16 Check the displayed judgment results. If there is a [Fail], see “7.5.1 3. Performance Criteria and Corrective Action”.





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Annual Test

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 “7.5.2 3. Performance Criteria and Corrective Action”.



[1] Additive lag effects (Lag)

Performance Criteria: 75 QL or less


[2] Multiplicative lag effects (Ghost)

Performance Criteria: Below 0.045



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Annual Test

[3] Missed tissue on chest wall edge (40 mm height)This test is not required in this QC program.

[4] Visual and Functional test


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Annual Test

7.5.3 Spatial Resolution TestThis 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.


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Annual Test

2. Spatial Resolution (Magnification) (exposure)

4 Follow the instructions below to conduct the test item.Make an exposure using the following exposure submenu:[1ShotM(Magnification)]


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.

NOTEPosition the Phantom for exposure, the same as in “3.4.1 Baseline Values for Annual Test”.

NOTEIf 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 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.




3 The following exposure submenu is displayed.• 1ShotM(Magnification)


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Annual Test

NOTEThe 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 “3.4.1 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






5. Auto-calculation








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Annual Test


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 “7.5.3 3. Performance Criteria and Corrective Action”.




Performance Criteria: 4lp/mm: Baseline value ± 12% 8lp/mm: Baseline value ± 15%



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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.

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.

TIP


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Annual Test

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.

NOTEMeasurement with the Small Focal Spot (SFS) cannot be performed unless the magnification table is used. When measuring the SFS kV, place the meter on top of the magnification table.

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

1. kVp accuracy and reproducibility


[Tools]A kVp meter and lead sheet


2. Place a lead sheet on the exposure table, and then position the kVp meter on the sheet.

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.

TIP


4. Specify the Large Focal Spot (LFS) and “Manu” mode for the X-ray equipment.

NOTEThe “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

Select the kVp most frequently used in clinical practice, and the adjacent upper and lower values (e.g. 25 kV, 28 kV, 31 kV).

TIP


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Annual Test

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


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: ____mRµGy

NOTEWear 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: ____

NOTEMake 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.

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.

TIP


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.


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Annual Test

NOTEA 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 = 8.73 × 10-3 mGy)

6. Select [Study completed] to finish the test.




6 The following exposure submenu is displayed.

• Uniform Expo.3(Collimation)

3. Radiation output


[Tools]A dosimeter and lead sheet


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 28 kV, 80 mAs and W/Rh for the X-ray equipment in “Manu” mode.


4. Make an exposure and measure the air kerma and mAs. In this Substep, measure air kerma 5 times under the same exposure conditions. • Fill in the following items in the worksheet.

kVp: _____kV mAs: _____mAs Target/Filter: _____/_____ Entrance air kerma (1): _____mR

µGy

Entrance air kerma (2): _____mRµGy




5. Specify 28 kV, 300 mAs and W/Rh and measure the air kerma rate.

Air kerma rate: _____mGy/s (Exposure time: _____s)


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3. Specify 23 kV, 2 mAs and W/Rh and make an exposure in “Manu” mode.• Fill in the following items in the worksheet.


NOTEThe “Semi” and “Auto” modes may not work correctly for this test. Make sure to use “Manu” mode for exposure.






8. Collimation assessment (measurement)

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.

5. Collimation assessment (exposure)


Make an exposure using the following exposure submenus:[Uniform Expo.3(Collimation)]

NOTEGo 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.

2. Move the compression plate down onto the exposure table.

NOTETake care that the compression plate is not scratched by the coin.


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Annual Test

NOTEBe 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 2.

2. Position 2 cassettes (Cassettes B1 and B2, hereafter) over the exposure table by aligning their chest wall-side edges.

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 B2.

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.

JudgmentA 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)

NOTEThe Medical Physicist may perform collimation assessment using the methods that he/she typically uses, then, go to Step 17 .

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>


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)

NOTEA 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.


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Annual Test

6. Specify 28 kV, 80 mAs and W/Rh and make an exposure in “Manu” mode.• Fill in the following items in the worksheet.


NOTEThe “Semi” and “Auto” modes may not work correctly for this test. Make sure to use “Manu” mode for exposure.






NOTEBe 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.

NOTEBe 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 B2.

NOTETake care that the compression plate is not scratched by the coins.


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Annual Test

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)].

The values measured for Coins (b) to (e) in Substep 2 indicate the gap amount. Record the values measured in Substep 2.

TIP

• 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

8. Collimation assessment (measurement) <details>

15 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.

16 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.

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.

TIP

• 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


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Annual Test

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.

TIP

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).

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.

TIP

• Fill in the following item in the worksheet. Chest: _____mm

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.

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.

TIP

• Fill in the following items in the worksheet. Left: _____mm Right: _____mm Nipple side: _____mm

FDR mammography system Cassette B1/B2

X-ray/Image receptor field

gap X calculation formula

Eg: 1

Not needed. The size of the gap can be calculated only from the image read from the FDR m a m m o g r a p h y system.

X=x(Measure the distance x of the area not exposed to X-rays in the image read from the FDR mammography system.)

Eg: 2 X=A+B

Eg: 3 X=A-B

Eg: 4 X=B-A


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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.

JudgmentA part of Coin (f) image is missing →

Pass (no gap)Coin (f) is completely reflected →

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)

9. kVp accuracy and reproducibility (user input)


18 Select [Annual test 3-1].Enter the display values and measured values.

FDR mammography system Cassette B1/B2

X-ray field/exposure table

gap Y calculation formula

Eg: 1

Not needed. The size of the gap can be calculated only from the image read from the FDR mammography system.

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.)

Eg: 2 Y=(A-e)-{(A-a)+(B-e)}

Eg: 3 Y=(A-e)+{(B-e)-(A-a)}

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.

TIP


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Annual Test

10. Half Value Layer (HVL) (user input)

19 Select [Annual Test 3-2].Enter the measured entrance air kerma for the target/filter used.


11. Collimation assessment (user input)

20 Select [Annual test 3-3]. Enter the measured values and visual inspection result (Pass/Fail).

NOTEEnter 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.

12. Radiation output (user input)

21 Enter the measured entrance air kerma, mAs and air kerma rate, and then press [OK].








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Annual Test

2. Test Result Evaluation and JudgementEvaluate 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 “7.5.4 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



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[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.


[9] Radiation output Performance Criteria: Variation coefficient = 0.05 or less, Air kerma rate = 2mGy/sec or more



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7.5.5 AEC System Performance Test

1. Procedure[Test flow]The AEC system performance test consists of AEC reproducibility, CNR modes 1 to 3, AGD modes 1 to 3, and AGD-ACR Phantom in modes 1 to 3.The test items are intended to conduct constancy tests on the following items for checking the AEC system performance.

Reproducibility of air kerma .................................... AEC reproducibilityChange in CNR to target thickness ....................... CNR modes 1 to 3Change in AGD to target thickness ....................... AGD mode 1 to 3AGD (standard breast phantom) ........................ AGD-ACR Phantom modes 1 to 3

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.

TIP


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Annual Test

4 Select [QC/TEST] in the exposure region list and [Calculation 1/2] in the exposure menu list, and then press [Start study.].

5 The following exposure submenu is displayed.• CNR

2. CNR mode 1 (exposure)

[Tools]PMMA phantom (40 mm) and aluminum plate (0.2 mm) for CNR measurement

6 Position the PMMA phantom (40mm) on the exposure table.

[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.





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7 Position the 0.2 mm aluminum plate for CNR measurement as shown in the figure below.

NOTEMake sure that the aluminum plate covers the Calculation Area 2 without protruding into the left-hand half of the phantom.


8 Move the compression plate as close to the PMMA phantom as possible without making contact.

9 Specify the exposure conditions closest to those recorded in Step 2 in “Manu” mode. Then make an exposure.







5. Auto-calculation




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Annual Test

2. Position the dosimeter aside the PMMA phantom (40 mm) as shown in the figure below.

NOTEIn 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-2500/FDR MS-2000 Operation Manual” for details on the AEC areas.

3. Move the compression plate as close to the PMMA phantom as possible without making contact.


5. Specify the kVp and target/filter to be used (28 kV and W/Rh is recommended) for the exposure in “Semi” mode.• Fill in the following items in the worksheet.


6. Make 5 exposures and measure the air kerma.• Fill in the following items in the worksheet.







14 Select the result calculated in Step 12 , and then press [Baseline value creation].This completes the baseline value setting. Press [Close].

NOTEThe “baseline values” above means the reference CNR for recognizing the change in image quality depending on the target thickness (target thickness dependence).




8. AEC reproducibility


[Tools]A dosimeter and PMMA phantom (40 mm)


NOTEPosition the PMMA phantom (40 mm) on the exposure table leaving a space on a side.


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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.

The exposure conditions for the PMMA phantom 40 mm has been determined in Step 2 . Enter the conditions in the worksheet.

TIP

• 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





5. Remove the PMMA phantom, place a lead sheet on the exposure table, and then position the dosimeter as shown in the figure below.

9. AGD mode 1 to 3


[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


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.




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NOTEMake 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. Conduct the same tests in N-mode (Mode 2) and L-mode (Mode 3).

15. Select [Study completed] to finish the test.

6. Move the compression plate as close to the dosimeter as possible without making contact.

NOTEDo 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.



8. Make an exposure and measure the air kerma.• Fill in the following item in the worksheet.

Entrance air kerma - w/o Al: _____mRµGy

9. Position the 0.3 mm aluminum plate for half value layer measurement on the compression plate.


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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

In CNR mode 1, use the same H-mode of the AEC as that used in AGD mode 1.

TIP



2. Position the 0.2 mm aluminum plate for CNR measurement as shown in the figure below.




11. CNR mode 1 (exposure)


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)


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14. AEC reproducibility (user input)

26 Select [Annual test 4-1]. Enter the measured entrance air kerma.

3. Move the compression plate as close to the PMMA phantom as possible without making contact.

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.



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.



7

Annual Test






NOTESelect Exposure Submenus [Exposure Mode 2] and [Exposure Mode 3], and then conduct the CNR test in N-mode and L-mode. Repeat Steps 1 to 16 , 19 to 24 and 28 to 31 while being aware of the exposure menus and modes.

15. AGD mode 1 (user input)

27 Select [Annual Test 4-2]. Enter the measured entrance air kerma and target/filter for each, and then press [OK].






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Annual Test

6. Make an exposure with the exposure conditions used in Step 32 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..


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.


Entrance air kerma - Al 0.5mm: _____



19. AGD - ACR Phantom

[Tools]ACR phantom, aluminum plates (0.3 and 0.5 mm), a dosimeter and a lead sheet.

32 1. 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.


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.

5. Move the compression plate as close to the dosimeter as possible without making contact.

NOTE: Do not reposition the compression plate during measurement.


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Annual Test

35 Make an exposure under any conditions (e.g. 23 kV, 2 mAs and Mo/Mo) to start up the QC Software.




38 Enter the target/filter used and measured entrance air kerma, and then press [OK].



40 Confirm that the calculation result at 40mm does not exceed 3mGy. If it does, see “7.5.4.3. Performance Criteria and Corrective Action”.



43 Repeat Steps 32 to 42 , for N-mode and L-mode.

44 To complete MEE / Annual tesing, please perform Sections 4-5 and 4-6 in Chapter 4 of this QC Manual.


7

Annual Test


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 “7.5.5 3. Performance Criteria and Corrective Action”.



[10] AEC reproducibility Performance Criteria: Variation coefficient = 0.05 or less



7

Annual Test

[11] CNR mode 1 (H mode) Performance Criteria: CNR Relative Value 20mm [%] = 105% of baseline value or more

CNR Relative Value 40mm [%] = 95% of baseline value or more




10098550

長方形


7

Annual Test

[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

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.

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Chapter 8Assistance Material

Page

8.1 Calculation Functions __________________________________ 8-2

8.2 Quick Guide for Software Operation _____________________ 8-6

8.3 Worksheets ____________________________________________ 8-8

8.4 Report Forms __________________________________________ 8-20

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8.1 Calculation FunctionsThe CNR and AGD of PMMA phantom at a given thickness can be auto-calculated by the QC Software.

Test Items Exposure Menus Exposure SubmenusItems Auto-calculated and Judged Based on Input Data

1. Exposure 2. Input Values

CNR Calculation 1/2 CNR ✓

AGD Calculation 2/2 AGD ✓

The measurement procedure of each item is described below.

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.


NOTEWear gloves when using the aluminum plate to keep the plate clean.

[1] CNR

[Tools]PMMA phantom (of a given thickness) and aluminum plate (0.2 mm)



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10 Check the calculation result.



5 Move the compression plate as close to the PMMA phantom as possible without making contact.

6 Specify the exposure conditions for the X-ray equipment and make an exposure in “Manu” mode.


7 Repeat Steps 4 to 6 as many times as necessary to capture the desired number of images to be calculated (max. 32 images).




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5 Position the 0.3 mm aluminum plate on the compression plate.

NOTEWear gloves when using the aluminum plate to keep the plate clean.

NOTEMake sure that the aluminum plate covers the detector of the dosimeter from the above.

6 Make an exposure with the exposure conditions used in Step 3 and measure the air kerma.

7 Position the 0.5 mm aluminum plate in the same way.

8 Make an exposure with the exposure conditions used in Step 3 and measure the air kerma.



[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.

2 Move the compression plate as close to the dosimeter as possible without making contact.

NOTEDo not reposition the compression plate during measurement.

3 Specify the desired exposure conditions for the X-ray equipment and make an exposure in “Manu” mode.


4 Record the air kerma.

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11 The following exposure submenu is displayed.• AGD

12 Make an exposure under any conditions (e.g. 23 kV, 2 mAs and Mo/Mo) to start up the QC Software.




15 Enter the target/filter used and measured entrance air kerma, and then press [OK].



17 Check the calculation result.



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8.2 Quick Guide for Software OperationThis 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

6 Finishing the testPress [Study completed] to finish the test.When finishing the test, the window in Step 1 is redisplayed. To conduct another test, repeat the procedure.

1 Starting FUJIFILM workstationStart a FUJIFILM workstation and enter patient information, and then press [Next].

2 Starting QC testSelect [QC/TEST] in the exposure region list and an exposure submenu displayed in the exposure menu list, and then press [Start study.].

3 ExposureMake an exposure using all of the displayed exposure submenus.

4 Starting QC SoftwarePress [QC].

5 Main button operations in “QC window”

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4 Main button operations in “Test Data Log window”

5 Finishing the testPress [Close] and then [Study completed] to finish the test.

1 Starting FUJIFILM workstationStart a FUJIFILM workstation and enter patient information, and then press [Next].

2 Starting QC testSelect [QC/TEST] in the exposure region list and press [Start study.] without selecting an exposure submenu.

3 Starting QC SoftwarePress [QC].

Log Confirmation Procedure

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8.3 WorksheetsThe 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.

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Baseline Value Settings<Baseline Values for Annual Test>

Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes


5 1Shot Phantom position Lateral shift distance: mm Phantom positioning in Annual Test

6Exposure conditions for Exposure Submenu [1ShotM(Magnification)]

kVp: kV

Exposure condition confirmation ( 8 )

mAs: mAs

Target/Filter: /

Compressed breast thickness: mm

Compression force: N

<Baseline Values for Semi-annual Test>

Test Items Steps Exposure Conditions/Measurement and Judgment Results Input Steps

[1] Image Basic Test

1 mAs mAs Exposure condition determination ( 7 )

2 Air kerma mRµGy

mRµGy

mRµGy Result input ( 10 )

7Exposure conditions for Exposure Submenu [Uniform Expo(Image Basic)]

kVp: kVExposure condition confirmation ( 9 )

mAs: mAs

Target/Filter: /

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.)

[1]

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<Baseline Values for Weekly Test>


[1] Test with 1Shot Phantom 6 1Shot Phantom exposure

conditions

kVp: kV


mAs: mAs

Target/Filter: /




8Exposure conditions for Exposure Submenu [ACR Phantom]

kVp: kV


mAs: mAs

Target/Filter: /



12Density inside the disk

Result input ( 14 )Density outside the disk


[2] [1]

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<Weekly Test>


[1] Test with 1Shot Phantom 4 -3

Exposure conditions for Exposure Submenu [1Shot PhantomM]

kVp: kV


mAs: mAs

Target/Filter: /



[2] Good practice

5 -1 X-ray equipment cleanliness Pass Fail

Result input ( 11 )5 -2 Screen cleanliness Pass Fail

5 -3 Viewing box cleanliness Pass Fail

[1] Test with 1Shot Phantom 9

Distortion Pass FailResult input ( 10 )

Artifact Pass Fail


4 -5Exposure conditions for Exposure Submenu [ACR Phantom]

kVp: kV


mAs: mAs

Target/Filter: /



8

Density at center of Phantom image

Result input ( 10 )

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


[1]

[2]

[3]

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Semi-annual TestTest Items Steps Exposure Conditions/Measurement and Judgment Results Acceptance Limits


1 -4AutomaticCompression Date: Measured

value: lbs.

Automatic (25 - 45 lbs) PASS FAIL

Corrective Action needed ? YES NO

Corrective Action description

Corrective Actiontaken? YES NO

Corrective Date:

Results of new test PASS FAIL

1 -7ManualCompression Date: Measured value:

lbs.

Comments _______________________________________________________________________________________________________________

_________________________________________________________________________________________________________________________

_________________________________________________________________________________________________________________________

White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8.

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Annual Test (Initial Performance Test)Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes

[1] Image Basic Test

1 -3

Exposure conditions for Exposure Submenu [Uniform Expo(Image Basic)]

kVp: kVExposure condition determination ( 9 )

mAs: mAs

Target/Filter: /

Air kerma mRµGy

mRµGy

mRµGy Result input ( 13 )

5Exposure conditions for Exposure Submenu [Uniform Expo(Image Basic)]

kVp: kVExposure condition confirmation ( 9 )

mAs: mAs

Target/Filter: /

11Artifact Pass Fail Result input ( 13 )

White out Pass Fail Result input ( 13 )


6 -2, 3 Compressed breast thicknessDisplay value: mm

Result input ( 14 )

Measured value: mm

6 -5 Compression forceDisplay value: mm

Measured value: mm

6 -6 Compression force sustainability Pass Fail

6 -7 Maximum compression force N

[3] Viewibox maintenance

7 -2 Luminance cd/m2

Result input ( 15 )

7 -3 Viewing box uniformity Pass Fail

7 -4 Luminance adjustment function Pass Fail

7 -5 Masking Pass Fail

7 -6Interpretation room illuminance (Ambient light) lx


[1]

[3]

[2]

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Annual Test (Image Performance Test)Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes

[1] Additive lag effects (Lag) 4 -3

Exposure conditions for Exposure Submenu [ACR Phantom1(Lag)]

kVp: kV


mAs: mAs

Target/Filter: /

[2] Multiplicative lag effects (Ghost)

5 -2Exposure conditions for Exposure Submenu [Uniform Expo.1(Ghost)]

kVp: kV

mAs: mAs

Target/Filter: /

5 -4Exposure conditions for Exposure Submenu [ACR Phantom2(Ghost)]

kVp: kV

mAs: mAs

Target/Filter: /

5 -6Exposure conditions for Exposure Submenu [Uniform Expo.2(Ghost)]

kVp: kV

mAs: mAs

Target/Filter: /

[3] Missed tissue on chest wall edge (40 mm height)

6 -3Exposure conditions for Exposure Submenu [1Shot PhantomM(40mm)]

kVp: kV


mAs: mAs

Target/Filter: /Compressed breast thickness: mm


11Missed tissue on chest wall edge (Right) Pass Fail

Result input ( 13 )Missed tissue on chest wall edge (Left) Pass Fail

[4] Visual and Functional test 7

Verify mechanical stability Pass Fail

Result input ( 14 )

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

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


[4]

[3]

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Annual Test (Spatial Resolution Test)Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes


4 -2 1Shot Phantom position Lateral shift distance: mm

4 -3Exposure conditions for Exposure Submenu [1ShotM(Magnification)]

kVp: kV


mAs: mAs

Target/Filter: /




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Annual Test (X-ray Equipment Performance Test)


[6] kVp accuracy and reproducibility

1 -5, 6

kVp used for the tests Low kV Mid. kV High kV

Result input ( 18 )LFS - volt.

Low kV Mid.-1 kV Mid.-2 kV

Mid.-3 kV Mid.-4 kV Mid.-5 kV

High kV

1 -8 SFS - volt. Low kV Mid. kV High kV

[7] Half Value Layer (HVL)

2-3, 4, 5

kVp mAsAir kerma

Result input ( 19 )

w/o Al Al 0.3 mm Al 0.5 mm

Target/Filter ( / ) kV mAs mRµGy

mRµGy

mRµGy


mRµGy

mRµGy


mRµGy

mRµGy

[9] Radiation output 3 -4

Exposure conditions

kVp: kV

Result input ( 21 )

mAs: mAs

Target/Filter: /

Entrance air kerma(1) mR

µGy (2) mRµGy (3) mR

µGy

(4) mRµGy (5) mR

µGy

Air kerma rate mGy/s

(Exposure time) s

[8] Collimation assessment

7 -3 Exposure conditions

kVp: kV


mAs: mAs

Target/Filter: /



16 -1Distance between image edges

A-a mm A-b mm

Result input ( 20 )

A-c mm A-d mm

A-e mm A-f mm

16 -2 X-ray / Light field gap

B-b mm B-c mm

B-d mm B-e mm

B-f mm

16 -3 X-ray / Light field gap

Left: mm

Right: mm

Chest wall side: mm

Nipple side: mm

16 -4X-ray / Image receptor field gap

Left: mm

Right: mm

Nipple side: mm

16 -5 X-ray field / Exposure table gap Chest wall side: mm

16 -6 Compression paddle edge (Chest wall side) Pass Fail


[7][8] [9][6]

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Annual Test (AEC System Performance Test)Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes

[11] CNR mode 1

2 Exposure conditions

kVp: kV

Exposure condition determination ( 9 )

mAs: mAs

Target/Filter: /



9 Exposure conditions

kVp: kV


mAs: mAs

Target/Filter: /��



[10] AEC reproducibility

17 -5 Exposure conditions

kVp: kV

mAs: mAs

Target/Filter: /



17 -6 Entrance air kerma(1) mR

µGy (2) mRµGy (3) mR

µGy

Result input ( 26 )(4) mR

µGy (5) mRµGy


[10]


[11] CNR mode 1 22 -4 Exposure Mode 1

PMMA thickness kVp mAs Target/

FilterCompressed

breast thickness

Compression force


20 mm kV mAs / mm N40 mm kV mAs / mm N60 mm kV mAs / mm N70 mm kV mAs / mm N


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[12] AGD Mode 1

18-3, 4

Exposure Mode 1: Exposure condition determination


FilterCompressed

breast thickness

Compression force

Exposure condition ( for 18 -7, 13) determination

20 mm kV mAs / mm N40 mm kV mAs / mm N60 mm kV mAs / mm N70 mm kV mAs / mm N

18-7, 8,

10, 12

Exposure Mode 1


FilterCompressed

breast thickness

Compression force

Air kerma

Result input ( 27 )


20 mm kV mAs / mm NmR

µGymR

µGymR

µGy


µGymR

µGymR

µGy


µGymR

µGymR

µGy


µGymR

µGymR

µGy


[12] [12]

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32ACR Phantom: Exposure condition determination

kVp mAs Target/Filter

Compressed breast

thickness

Compression force Exposure condition

( for 32 -6, 8, 10) determinationkV mAs

/mm N

32-6, 8, 10,

Exposure ACR Phantom

kVp mAs Target/Filter

Compressed breast

thickness

Compression force

Air kerma

Result input ( 38 )


kV mAs/

mm N

mRµGy

mRµGy

mRµGy


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8.4 Report FormsThe forms on the following pages are provided for recording the test results. It is important to record test results to follow the changes in performance of the X-ray equipment and/or other equipment. Make a copy of these report forms as necessary.

The following report forms are provided on the following pages.

• Daily/Weekly Test Report

• Quarterly Test Report

• Semi-annual Test Report

• Annual Test Report

/

Facility Information

Client Date

Exposure Room Time

Operator Department Name

Manufacturer Model S/N Installation Date

X-ray Equipment FUJIFILM

Workstation FUJIFILM

Measurement Equipment/Tool Information

Manufacturer Model S/N Installation Date

Laser Imager

Diagnostic monitor

Viewing box

Manufacturer Model S/N Calibration Expiration Date

1Shot Phantom M FUJIFILM

ACR Phantom

Step Phantom

Densitometer

Density control strip

Dosimeter

Force scale

Luminance meter

Illuminance meter

kVp meter

Signature

1/1

Weekly Test Report

Test with 1Shot Phantom

Exposure Conditions

kVp mAs Target/FilterCompressed

Breast Thickness

Compression Force S Value

1Shot PhantomM kV mm N

Test Result

Judgment ItemCriteria

Judgment ResultLower Limit Upper Limit


Missed tissue on chest wall edge (Right)

mm - PASS FAIL

Missed tissue on chest wall edge (Left)

mm - PASS FAIL

CNR CNR PASS FAIL

1Shot Phantom sensitivity constancy System sensitivity PASS FAIL


Horizontal direction mm PASS FAIL

Vertical direction mm PASS FAIL

Geometric distortion - - PASS FAIL

System artifact evaluation Artifacts - - PASS FAIL

Uniformity

Pixel Value (PV) ratio (Top-Right) % PASS FAIL

Pixel Value (PV) ratio (Top-Left) % PASS FAIL

Pixel Value (PV) ratio (Bottom-Right) % PASS FAIL

Pixel Value (PV) ratio (Bottom-Left) % PASS FAIL

SNR ratio (Top-Right) % PASS FAIL

SNR ratio (Top-Left) % PASS FAIL

SNR ratio (Bottom-Right) % PASS FAIL

SNR ratio (Bottom-Left) % PASS FAIL

Dynamic rangeAverage QL at thinnest step wedge

QL PASS FAIL

Spatial Resolution (SR)2 lp/mm % PASS FAIL

4 lp/mm % PASS FAIL


Low Contrast Detectability (Light) % � PASS FAIL

Low Contrast Detectability (Dark) % � PASS FAIL

1/3




QL gap (1 step-2 step) QL PASS FAIL




Remarks

Signature

2/3

/3/3

Good practice



X-ray equipment cleanliness - - PASS FAIL

Screen cleanliness - -

Viewing box cleanliness - -

Remarks

Signature

/

Weekly Test Report

Test with ACR Phantom

Exposure Conditions

kVp mAs Target/FilterCompressed

Breast Thickness


ACR Phantom kV mm N

Test Result



Density at center of Phantom image PASS FAIL

Density difference (disk/outside) PASS FAIL

Fibers (ACR Phantom) - PASS FAIL

Specks (ACR Phantom) - PASS FAIL

Masses (ACR Phantom) - PASS FAIL

Visible step wedge (Step Phantom) - PASS FAIL

Specks (Step Phantom) - PASS FAIL

Masses (Step Phantom) - PASS FAIL

1/3

/

HARD COPY PHANTOM CONTROL/CNR CHART

Room: Year:

Month: Date:

Initials:

AEC SETTING : CNR Value:

CNR OK:

-15%

+0.05

-0.05

+0.20

+0.15

-0.15

-0.20

Fibers +0.5

Specks +0.5

- 0.5

- 0.5

- 0.5

Masses +0.5

+15%

Density Difference

Baseline

Background Density

No.Visible

mAs (optional)

+0.05

-0.05

+0.20

+0.15

-0.15

-0.20

+0.5

+0.5

- 0.5

- 0.5

- 0.5

+0.5

-15%

+15%

Baseline

Baseline

2/3

/

SOFT COPY PHANTOM CONTROL/CNR CHART

Month: Date:

Initials:

AEC SETTING : CNR Value:

CNR OK:

-15%

Fibers +0.5

Specks +0.5

- 0.5

- 0.5

- 0.5

Masses +0.5

+15%

No.Visible

mAs (optional)

+0.5

+0.5

- 0.5

- 0.5

- 0.5

+0.5

-15%

+15%

-20%

S Value

-20%

+20% +20%

Baseline

Baseline

Room: Year:

3/3

Remarks

Signature

/

Quarterly Test Report

Repeat analysis

1/1

/

Semi-annual Test Report


Test Items Exposure Conditions/Measurement and Judgment Results Acceptance Limits


AutomaticCompression Date: Measured

value: lbs.

Automatic (25 - 45 lbs) PASS FAIL

Corrective Action needed ? YES NO

Corrective Action description

Corrective Actiontaken? YES NO

Corrective Date:

Results of new test PASS FAIL

ManualCompression Date: Measured value:

lbs.

Remarks

Signature

1/1

Annual Test Report

Image basic test

Exposure Conditions

kVp mAs Target/Filter Compressed Breast Thickness


S Value kV mm N

Visual Inspection kV mm N

Measured Values

Entrance air kerma 1 mR (μC/kg)



Test Result



Relative sensitivity (S value) PASS FAIL



Artifact - - PASS FAIL

White out - - PASS FAIL

Remarks

Signature

1/19


Measured Values

Compressed breast thickness - Display value mm

Compressed breast thickness - Measured value mm

Compression force - Display value N

Compression force - Measured value N

Maximum compression force N

Test Result



Compressed breast thickness accuracy mm PASS FAIL

Compression force accuracy N PASS FAIL

Maximum compression force N PASS FAIL

Compression force sustainability - - PASS FAIL

Remarks

Signature

2/19

Viewing box maintenance

Test Result



Luminance cd/m2 - PASS FAIL

Viewing box uniformity - - PASS FAIL

Luminance adjustment function - - PASS FAIL

Masking - - PASS FAIL

Interpretation room illuminance (Ambient light) lx - PASS FAIL

Remarks

Signature

3/19

Annual Test Report

MONITOR QUALITY CONTROL (ANNUAL) REPORT FORM

Room:

Workstation:

Left Monitor Serial Number:

Right Monitor Serial Number:

Final interpretation? YES NO

Cleared by FDA? YES NO N/A

MONITOR IMAGE QUALITY REPORT

Left or Single Monitor Right Monitor

Monitor has DICOM Display Functionality feature applied YES / NO YES / NO

Lmax target:

Lmax measured:

(Lmax measured - Lmax target)/Lmax target x 100% % %

Lmax Within 10% ? YES / PASS NO / FAIL YES / PASS NO / FAIL

5% patch is visible in 0% patch? YES / PASS NO / FAIL YES / PASS NO / FAIL

95% patch is visible in 100% patch? YES / PASS NO / FAIL YES / PASS NO / FAIL

Gray steps distinguishable? YES / PASS NO / FAIL YES / PASS NO / FAIL

Alphanumeric characters sharp? YES / PASS NO / FAIL YES / PASS NO / FAIL

Line-pair pattern (center) distinguishable? YES / PASS NO / FAIL YES / PASS NO / FAIL

Line-pair patterns (corner) distinguishable? YES / PASS NO / FAIL YES / PASS NO / FAIL

Overall, all tests pass ? YES / PASS NO / FAIL YES / PASS NO / FAIL

MONITOR RESPONSE REPORT

Room: Left or Single Monitor Right Monitor

Measured contrast response at any given point does not deviate more than a) 10% of the standard for final

interpretation or, b) 20% of the standard for other use.YES / PASS NO / FAIL

Signature

4/19

Annual Test Report

Additive lag effects (Lag)

Exposure Conditions



ACR Phantom1(Lag) kV mm N

Non Exposure(Lag) kV mm N

Test Result



Lag Factor QL - PASS FAIL

Remarks

Signature

5/19

Multiplicative lag effects (Ghost)

Exposure Conditions



Uniform Expo.1(Ghost) kV mm N

ACR Phantom2(Ghost) kV mm N

Uniform Expo.2(Ghost) kV mm N

Test Result



Ghost Factor - PASS FAIL

Remarks

Signature

6/19

Missed tissue on chest wall edge (40 mm height)

Exposure Conditions



1Shot Phantom M(40 mm) kV mm N

Test Result



Missed tissue on chest wall edge (Right) - - PASS FAIL

Missed tissue on chest wall edge (Left) - - PASS FAIL

Remarks

Signature

7/19

Visual and Functional test

Test Result

Judgment Item Judgment Result

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

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

Remarks

Signature

8/19

Spatial Resolution (Magnification)

Exposure Conditions



1ShotM(Magnification) kV mm N

Test Result



MTF (4lp/mm) % PASS FAIL

MTF (8lp/mm) % PASS FAIL

Remarks

Signature

9/19


Measurement Conditions

kVp Display Values

Low kV

Mid. kV

High kV

Measured Values

Large Focal Spot (LFS)

Low kV

Mid.-1 kV

Mid.-2 kV

Mid.-3 kV

Mid.-4 kV

Mid.-5 kV

High kV

Small Focal Spot (SFS)

Low kV

Mid. kV

High kV

Test Result



Low volt. accuracy (LFS) kV PASS FAIL

Mid. volt. accuracy (LFS) kV PASS FAIL

High volt. accuracy (LFS) kV PASS FAIL

Low volt. accuracy (SFS) kV PASS FAIL

Mid. volt. accuracy (SFS) kV PASS FAIL

High volt. accuracy (SFS) kV PASS FAIL

Mid. volt. reproducibility (LFS) kV PASS FAIL

Remarks

Signature

10/19

Half Value Layer (HVL)

Measured Values


Measured HVL (Mo/Mo) mR(μC/kg) mR(μC/kg) mR(μC/kg)

Measured HVL (Mo/Rh) mR(μC/kg) mR(μC/kg) mR(μC/kg)

Measured HVL (W/Rh) mR(μC/kg) mR(μC/kg) mR(μC/kg)

Test Result



HVL (Mo/Mo) mmAl - PASS FAIL

HVL (Mo/Rh) mmAl - PASS FAIL

HVL (W/Rh) mmAl - PASS FAIL

Remarks

Signature

11/19


Exposure Conditions



Uniform Expo.3(Collimation) kV mm N

Test Result



X-ray / Light field gap (Right/Left) mm - PASS FAIL

X-ray / Light field gap (Chest/Nipple) mm - PASS FAIL

X-ray / Image receptor field gap (Left) mm - PASS FAIL

X-ray / Image receptor field gap (Right) mm - PASS FAIL

X-ray / Image receptor field gap (Nipple) mm - PASS FAIL

X-ray field / Exposure table gap mm - PASS FAIL

Compression paddle edge (Chest wall) - - PASS FAIL

Remarks

Signature

12/19

Radiation output

Measured Values

mAs

Entrance air kerma 1 mR(μC/kg)





Test Result



Reproducibility - PASS FAIL

Air kerma rate mGy/s - PASS FAIL

Specific radiation output μGy/mAs - PASS FAIL

Remarks

Signature

13/19

AEC reproducibility

Measured Values

mAs






Test Result



Entrance air kerma accuracy % PASS FAIL

Entrance air kerma reproducibility PASS FAIL

Remarks

Signature

14/19

CNR mode 1 [H-mode]

Exposure Conditions

Exposure Mode



Mode n CNR (PMMA20mm) kV mm N




Test Result



CNR relative value 20 mm % 116% - PASS FAIL




CNR mode 2 [N-mode]

Exposure Conditions

Exposure Mode







Test Result







15/19

CNR mode 3 [L-mode]

Exposure Conditions

Exposure Mode







Test Result







Remarks

Signature

16/19

AGD mode 1 [H-mode]

Measured Values

Exposure Mode Mode 1


Entrance air kerma (20 mm) mR(μC/kg) mR(μC/kg) mR(μC/kg)

Entrance air kerma (40mm) mR(μC/kg) mR(μC/kg) mR(μC/kg)



Test Result



AGD 20mm mGy - 1 mGy PASS FAIL


AGD 60mm mGy - 4.5 mGy PASS FAIL


AGD - ACR Phantom

Measured Values



Entrance air kerma ( mR(μC/kg) mR(μC/kg) mR(μC/kg)

Test Result



AGD-ACR Phantom mGy - 3 mGy PASS FAIL

Remarks

Signature

17/19

AGD mode 2 [N-mode]

Measured Values







Test Result







AGD - ACR Phantom

Measured Values




Test Result




Remarks

Signature

18/19

AGD mode 3 [L-mode]

Measured Values







Test Result







AGD - ACR Phantom

Measured Values




Test Result




Remarks

Signature

19/19

9-1

9


Chapter 9Technical Information

Page

9.1 Specification Outline of 1Shot Phantom M Plus ___________ 9-2

9.2 Glossary _______________________________________________ 9-3

9-2


9


9.1 Specification Outline of 1Shot Phantom M Plus

Test Contents Applicable Phantom Outline of Calculation Method

Missed tissue on chest wall edge Bar patterns (1 mm spacing) The amount of missed tissue on the chest wall-side edge

is calculated by using coordinate information of the slit.

CNR Al (0.2 mm) CNR is calculated according to the definitional equation described in IEC 61223-3-2.


Uniform exposure region at 60 mm from the chest wall-side edge

A calculation area (20 x 20 mm) is set at the lateral center and also at 60 mm from the chest wall-side edge. Based on the pixel value in this calculation area, the value inversely proportional to the air kerma is calculated.Note: Although this value is calculated in the same way as S value, this value and S value need to be discriminated.

Geometric distortion Lines indicated with triangle markers (100 mm spacing) The distance between the two lines is calculated.

System artifact evaluationUniform exposure region made of metal and plastic (The transmission factor becomes equivalent to 40-mm PMMA phantom at 28kVp, Mo/Mo.)

N/A

Uniformity (Uniform Exposure Region)

Uniform exposure region at 60 mm from the chest wall-side edge and uniform exposure regions at four corners of the phantom

A calculation area (10 x 10 mm) is set at the lateral center and also at 60 mm from the chest wall. Based on this calculation region, the pixel value and relative SNR value are calculated in the calculation regions (10 x 10 mm each) at four corners of the phantom.

Dynamic range The lightest region of the step wedgeThe pixel value in the highest density region of the step wedge is calculated. According to IEC 61223-3-2, calculation is executed only in the highest density region.

Spatial Resolution (SR) Bar patterns slanted at 45 degrees (2, 4 and 8 cycles/mm)

SCTF is calculated according to the definitional equation described in IEC 61223-3-2.

Low Contrast Detectability (LCD) PMMA phantom ( 2 mm, contrast 1.4%)

A cross-correlation factor is calculated based on the reference image (ideal image).


Five step-wedge patterns forming a density region in the range of the center density plus or minus about one digit

The pixel value is calculated in each step of the step wedge and then the difference between the adjacent steps is calculated.

9-3


9


9.2 Glossary

This section explains the terms used in this Guidebook.

1 Additive Lag Effect

Additive lag effect is a phenomenon in which a faint image that should be present under normal conditions can be seen due to insufficient erasing performance of the X-ray equipment.

2 AGD: Average Glandular Dose

In this Program, calculation formulas*1 adopted in IEC 61223-3-2 Ed.2 and EUREF Ed.4 are used. AGD is an index for adjusting or evaluating the performance of AEC.

*1: DANCE, DR et al. Additional factors for the estimation of mean glandular breast dose using the UK mammography dosimetry protocol. Phys. Med. Biol., 2000, Vol. 45, 3225-3240

3 Air Kerma (Kerma: kinetic energy released in materials)

The air kerma is expressed as the sum of initial kinetic energy of all charged particles released in air by uncharged radiation divided by the air per unit mass. Since the air kerma (exposure) is obtained by measuring secondary electrons released as a result of interaction between radiation and air, the air kerma and secondary electrons are equivalent. The unit of the air kerma is Gy.

4 Air Kerma Rate

In this Program, the air kerma rate means the exposure rate (exposure per unit time).

5 CNR: Contrast to Noise Ratio

CNR is an index for adjusting or evaluating the performance of AEC.The higher the contrast or the lower the noise level, the greater the value of CNR. In this Program, measurement and calculation methods adopted in IEC 61223-3-2 Ed.2 are used.

6 Dynamic range

In IEC 61223-3-2 Ed.2*2, visual evaluation on how many thin steps can be seen at the high dose side is executed using a stepped PMMA phantom. In this Program, based on the principle of IEC, a region for direct line has been reserved in the phantom and dynamic range is quantified by calculating the average pixel value in this region. If this value is the maximum value (in the case of 14 bits: 16384), there is a possibility of image saturation.

*2: IEC 61223-3-2 Ed.2 Committee draft for vote

7 Ghost Factor

The ghost factor is an index for representing the degree of change in sensitivity of the flat panel detector (FPD) caused by the last X-ray exposure. The greater the degree of change in sensitivity, the greater the ghost factor.

8 HVL: Half Value Layer

HVL is defined as the thickness of the aluminum plate that reduces the air kerma rate to half. This is an index for representing the radiation quality. The harder the radiation quality, the greater the value of HVL.

9-4


9


9 Lag Factor

The lag factor is an index for evaluating the erasing performance of the X-ray equipment. A calculated median value of the histogram of the remaining image that was not erased is displayed. In this Program, measurement and calculation methods adopted in AAPM Task Group 10 Report*3 are used.

*3: Ehsan Samei et al. Performance evaluation of computed radiography systems. Medical Physics March 2001 Volume 28, Issue 3, pp. 361-371 Acceptance Testing and Quality Control of Photostimulable Storage Phosphor Imaging Systems. Report of AAPM Task Group 10 October 2006

10 Low Contrast Detectability

This is an index for representing the ability to display a low-contrast sample such as a Burger phantom. The cross-correlation factor between a column-shaped object (concave or convex) and ideal image data is shown quantitatively.

11 Multiplicative Lag Effect

Multiplicative lag effect means change of sensitivity of the flat panel detector (FPD) caused by the last X-ray exposure.

12 Pixel Value Ratio

The pixel value ratio is an index for evaluating image uniformity.(Average Pixel Value in the Intended Calculation Region) / (Average Pixel Value in the Base Calculation Region)Each pixel value (QL value) is converted to an antilog before calculating the average pixel value.

13 PMMA phantom: PolyMethylMethAcrylate phantom

In general, the material of the PMMA phantom is called acrylic or polymethylmethacrylate. The PMMA phantom is used as an object for simulating breasts in standards and guidelines such as IEC 61223-3-2 Ed.2 and EUREF. The relationship between the thickness of the PMMA phantom and that of the compressed breast (mammary gland: 50/fat: 50) is shown in the table below. For example, AGD of 20-mm-thick PMMA and that of 21-mm-thick compressed breast is the same.

PMMA thickness (mm) Equivalent breast thickness (mm)

20 21

40 45

60 75

70 90

(Source: EUREF Ed.4)

9-5


9


14 QL Value

This Program executes various calculations regarding image data before EDR normalization.With the FCR 1Shot Phantom M Plus, log data equivalent to 4 digits/12 bits is output. 1 QL is equivalent to 0.90%.12 bits/4 digits 1 QL = 4 (digits)/212 = 9.77 x 10-4 (digits)When converted to the antilog: 10(9.77 x 10-4) = 1.00225 0.225%However, dynamic range calculation is performed at 14 bits.

Figure 1 Relationship between QL Value and Digit (before EDR Normalization)

15 Relative Sensitivity

The relative sensitivity is a relative value calculated by using the average pixel value in the calculation region exposed under a certain condition, based on the medial value calculated by using the average pixel value in the specified calculation region of the flat panel detector (FPD) to which a standard amount of dose is exposed.

16 SID: Source to Image Distance

SID is the distance between the X-ray focal spot and image receptor.Each X-ray equipment has a specific SID value. The SID is 65 cm for the FDR MS-2500 and FDR MS-2000.

17 SNR: Signal to Noise Ratio

SNR represents the ratio between the signal (intended image) and noise. This is an index for representing image quality. The greater the SNR value, the less the intended image is buried in noise.SNR = (Average Pixel Value in the Calculation Region) / (Standard Deviation of Pixel Value in the Calculation Region)

18 Spatial Resolution

Spatial resolution is an index for representing the ability of the imaging system to clearly define the shape of objects within an image.

19 System Sensitivity

The system sensitivity is equivalent to the median value of the histogram of the digital image at the time of converting the dose on the flat panel detector (FPD) to a digital value. The system sensitivity is defined depending on the type of FPD. In this Guidebook, the high-resolution FPD is used. Accordingly, the system sensitivity is defined as follows.When uniform exposure is executed under the condition of 25 kVp and 0.03 mm Mo using X-ray equipment with a molybdenum target, if the dose on FPD is specified as y (mR) (1 (mR) ≈ 8.7 (µGy)):S Value = 2400/y

9-6


9



This chapter describes the image processing parameters for study menus and exposure menus used in this Program.

Page

How to Read This Chapter ______________________________ QCParam-2

EDR Mode Table ____________________________________ QCParam-3• Image Processing Parameters for Mammography QC _____ QCParam-9

QCParam-1FDR Mammography QC Manual - 897N102579

How to Read This ChapterHow to read descriptions included in this chapter is described below.

Study Menu MPM

Code

AP/PA Menu Description

Exposure Menu

1 Study Menu (Exposure Menu)

The Study Menu is an aggregate of menus to be used for exposure of a series of study. The Exposure Menu included in a Study Menu, as well as order of performing studies is determined by the default, which, however, can be changed in the User Utility.(For details, see the descriptions related to the User Utility in the Operation Manual for the system.)

* Exposure menu in other chapters is defined as study menu in this chapter. * The Study menu field is grayed out for the parameters for high-density film.

2 Exposure Menu (Exposure Submenu)

The Exposure Menu is the name of a single study such as “L MAMMOGRAPHY, CC”.

* Exposure submenu in other chapters is defined as exposure menu in this chapter. * Default settings for each exposure menu can be changed using the User Utility.

3 MPM Code

The MPM Code is a four-digit code number assigned for the purpose of management of exposure menus. The MPM Code determines EDR (a function that corrects image density and contrast automatically) and image processing conditions to be applied. If the assigned MPM Code is the same, images will be output according to the same conditions even though the Exposure Menu used is not the same.

Note that when an exposure menu (for example, L MAMMOGRAPHY, CC: MPM Code 0329) was subject to change of image processing conditions, the change will affect all the menus concerned if there is an exposure menu of the same MPM code (such as R MAMMOGRAPHY, CC). Should you wish to change the image processing condition only for the specified menu, change the 3rd-digit figure to make a different MPM code so that specific conditions are set up appropriately.

1st digit : Represents an exposure technique to be used. (ex. 0: General exposure, 1: Contrast exposure, etc.)2nd digit : Represents an anatomical part to be exposed. (ex. 3: Breast)3rd digit : Any alphanumeric selected from 0 to 9 and A to F. Even if a figure in this digit is changed, EDR will not

be affected.4th digit : Any alphanumeric that determines EDR.

4 AP/PA - Flipping setting for images to be output -

AP : Outputs an image as is without processing it.PA : Outputs an image flipped horizontally.

: Outputs an image rotated by 180 degrees. : Outputs an image flipped vertically.

* Default settings can be changed using the User Utility. It is also possible to change default settings by the currently used mode.

5 Menu Description

The Menu Description describes anatomical parts and exposure techniques suited to a specific exposure menu. Brief precautions to be observed when performing exposures are also included. For details on those precautions to be observed, see the Operation Manual for the system.

• When creating a new menuA new menu can be created using the User Utility. (For how to create a new menu, see the descriptions related to the User Utility in the Operation Manual for the system.)For a special exposure that cannot be handled by default exposure menus, the menu can be added as necessary. When doing so, select an exposure menu that involves similar images. See the descriptions related to the User Utility in the Operation Manual for the system to make sure that the MPM code to be used for the new menu is not used, and then determine proper image processing conditions. Also confirm that AP or PA is selected correctly.

1 3 4

2

5

QCParam-2 FDR Mammography QC Manual - 897N102579

EDR Mode TableEDR mode (auto sensitivity adjustment system) applied to exposure menus pre-registered in the system are described below.

EDR m

ode

Auto Semi Fix

PRIEF

Type

Type

L Value

S Value

S value : When recording a digital image, the X-ray dose that reaches the exposure unit is converted to a digital value. S value is the center X-ray dose of the histogram of the digital image.

L value : A logarithmic value showing the range of X-ray dose when making an exposure.

1 EDR Mode

EDR mode consists of AUTO mode, SEMI AUTO mode, and FIX mode.

A (AUTO mode) : A mode which adjusts density and contrast automatically. (S and L values are dependent on this mode.)S (SEMI AUTO mode) : A mode where the dynamic range (L value) of X-ray dose to be recorded as an

image has been determined, and the center point (S value) used for the purpose of image recording is decided based on the average X-ray dose that enters the preset photometric area so that the density is adjusted automatically.

F (FIX mode) : A mode where the range of X-ray dose to be recorded as an image has been determined.

* Default settings for this mode can be changed using the User Utility. It is also possible to change the mode type currently being used.

2 Auto - Parameters used in AUTO mode -

PRIEF (Pattern Recognizer for Iris of Exposure Field) .....This is a generic denomination of processing that recognizes split exposures and irradiated field automatically. PRIEF includes the following technique types:- : Does not recognize split exposures and irradiated field. (SEMI AUTO mode and type IV described below.)1 : Does not recognize split exposures and judges a rectangular area as an irradiated field.1S : Recognizes split exposures and judges individually recognized areas as rectangular irradiated fields.2 : Recognizes irradiated field of a breast.4 : Does not recognize split exposures and judges a protrusive area as an irradiated field.4S : Recognizes split exposures and judges individually recognized areas as protrusive irradiated field. (normal

mode)4* : Judges a protrusive area as an irradiated field by split areas determined.AN : Auto neck algorithmSP : Activates AUTO mode based on a specially determined area, irrespective of the image size specified by DR

equipment.TYPE ..... A type of technique for histogram or neuro analysis subjected after PRIEF processing.

I : A mode that captures regions covering from the skin to the bone in an image (Note that direct X-rays are needed to activate this mode.)

II : A mode that is activated in a stable manner even if there are no direct X-rays.III : A mode applied to contrast exposure.IV : A mode that attaches importance to improved representation of soft tissue.V : A mode that attaches importance to improved representation of areas where X-rays are difficult to be

penetrated.VI : Neuro analysis mode applied when variations become large on the shape of a histogram.VII : Neuro analysis mode applied when the position of a region of interest changes on a histogram.

3 Semi Fix - Parameters used in SEMI AUTO mode and FIX mode -

TYPE ..... Determines layout and size of a photometric area preset in SEMI AUTO mode.I : A 10cm square located at the center of an image exposed by DR equipment.II : A 7cm square located at the center of an image exposed by DR equipment.III : A 5cm square located at the center of an image exposed by DR equipmentIII' : A 5cm square located at a position other than the center of an image when it is divided into nine portions

up-and-down and right-and-left.IV : A special area determined for the chest.

L value ........... A logarithmic value (L value) representing the width of an X-ray dose to be recorded as an image in SEMI AUTO and FIX modes.

S value ........... A center point (S value) pre-determined in FIX mode for recording as an Image.* Default settings for this mode can be changed using the User Utility. It is also possible to change default settings by the

currently used mode.


ImageFormat

Image Processing Parameters

GA GT GC GS MRB MRT MRE MDB MDT MDE

Monitor 1.5 u 0.50 0.03 A T 0.7 G U 1.0Film 1.2 T 1.40 -0.04 G R 1.5 E F 0.4

1 Image Format

Monitor : Image display suitable for reading on the monitor is set (monitor display parameters).

Film : Conventional image display or equivalent is set (film output parameters).

2 Image Processing Parameters - MFP (Multi-Objective Frequency Processing) parameters -

Gradation processing ..... Processing that controls image gradation.GA : Adjusts contrast appropriately. As the numeric value increases, the contrast becomes enhanced.GT : A non-linear gradation curve.GC : Center of a density when the GA value is changed.GS : Adjusts density appropriately. As the numeric value increases, the density appears enhanced.

Frequency processing ..... Processing that controls the image sharpness.MRB : A factor that determines the range of frequency bands when applying image enhancement. As the

numeric value decreases, the range of frequency bands is widened toward lower-frequency bands. (See the figure below.)

MRT : A non-linear curve that changes the degree of enhancement according to the image density. This parameter enhances specific density areas.

Example : F : Applies enhancement uniformly in all density areas. R : Applies stronger enhancement as density rises.MRE : This factor adjusts the degree of enhancement.

DR compression processing .... Processing to make image density areas that appear white or blackened easily visible, without aff ecting the density in the region of interest on an image.

MDB : A factor that determines the smoothing mask for DR compression processing.MDT : A factor that determines density areas where DR compression processing is to be applied.MDE : A factor that determines the degree of DR compression processing to be applied.

Figure : MRB types and enhancement curves A stronger enhancement is applied in high-frequency bands as going from A to F.

2

1



* High luminance is recommended in the environment where high-density film is used and normal luminance in the environment where a monitor, which does not support high-density film, is used.

• Image Processing Parameters for Mammography QCStudy Menu M

PM Code


EDR m

ode

Auto Semi Fix

Exposure Menu

PRIEF

Type

Type

L Value

S Value

Calculation 1/2

CNR7302 AP [Calculation] For checkup of mammography QC CNR S - V I 1 200

Calculation 2/2

AGD7302 AP [Calculation] For checkup of mammography QC AGD S - V I 1 200

1Shot PhantomM

1Shot PhantomM7375 AP [Daily/Weekly] For checkup of mammography QC

1Shot Phantom M S - V III’ 2 80

ACR Phantom

ACR Phantom7325 AP [Daily/Weekly] For checkup of mammography QC

ACR Phantom S - V III’ 2 80

1Shot/ACR

1Shot PhantomM7375 AP [Daily/Weekly] For checkup of mammography QC

1Shot Phantom M S - V III’ 2 80

ACR Phantom7325 AP [Daily/Weekly] For checkup of mammography QC

ACR Phantom S - V III’ 2 80

Semi-annual 1/1

Uniform Expo(Image Basic) 7302 AP [Semi-annual] For checkup of mammography QC

Uniform Exposure (Image Basic) S - V I 1 200

Annual 1/6

ACR Phantom1 (Lag)7313 AP [Annual] For checkup of mammography QC Lag1 F - V I 2 200

Non Exposure (Lag)7313 AP [Annual] For checkup of mammography QC Lag2 F - V I 2 200

Uniform Expo.1 (Ghost)7313 AP [Annual] For checkup of mammography QC Ghost1 F - V I 2 200

ACR Phantom2 (Ghost)7313 AP [Annual] For checkup of mammography QC Ghost2 F - V I 2 200

Uniform Expo.2 (Ghost)7313 AP [Annual] For checkup of mammography QC Ghost3 F - V I 2 200

1Shot PhantomM (40mm)7375 AP [Annual] For checkup of mammography QC

Missed tissue on chest wall edge (40 mm height) S - V III’ 2 80


ImageFormat



Monitor 1.0 a 1.20 0.00 B F 0.0 A A 0.0

Film 1.0 A 1.20 0.00 B F 0.0 A A 0.0

Monitor 1.0 a 1.20 0.00 B F 0.0 A A 0.0

Film 1.0 A 1.20 0.00 B F 0.0 A A 0.0

Monitor 1.5 u 0.50 0.03 A T 0.7 G U 1.0

Film 1.2 T 1.40 -0.04 G R 1.5 E F 0.4

Monitor 1.5 u 0.50 0.03 A T 0.7 G U 1.0

Film 1.2 T 1.40 -0.04 G R 1.5 E F 0.4

Monitor 1.5 u 0.50 0.03 A T 0.7 G U 1.0

Film 1.2 T 1.40 -0.04 G R 1.5 E F 0.4

Monitor 1.5 u 0.50 0.03 A T 0.7 G U 1.0

Film 1.2 T 1.40 -0.04 G R 1.5 E F 0.4

Monitor 1.0 a 1.20 0.00 B F 0.0 A A 0.0

Film 1.0 A 1.20 0.00 B F 0.0 A A 0.0

Monitor 1.3 c 1.20 0.00 B R 0.0 A A 0.0

Film 1.3 C 1.20 0.00 B R 0.0 A A 0.0

Monitor 1.3 c 1.20 0.00 B R 0.0 A A 0.0

Film 1.3 C 1.20 0.00 B R 0.0 A A 0.0

Monitor 1.3 c 1.20 0.00 B R 0.0 A A 0.0

Film 1.3 C 1.20 0.00 B R 0.0 A A 0.0

Monitor 1.3 c 1.20 0.00 B R 0.0 A A 0.0

Film 1.3 C 1.20 0.00 B R 0.0 A A 0.0

Monitor 1.3 c 1.20 0.00 B R 0.0 A A 0.0

Film 1.3 C 1.20 0.00 B R 0.0 A A 0.0

Monitor 1.5 u 0.50 0.03 A T 0.7 G U 1.0

Film 1.2 T 1.40 -0.04 G R 1.5 E F 0.4

GA : Rotation Amount Multi-Objective Frequency Processing Multi-Objective DRC ProcessingGT : Gradation Type MRB : Balance Type MDB : Balance TypeGC : Rotation Center MRT : Frequency Type MDT : Frequency TypeGS : Gradation Shifting Amount MRE : Enhancement MDE : Enhancement


Study Menu MPM

Code


EDR m

ode

Auto Semi Fix

Exposure Menu

PRIEF

Type

Type

L Value

S Value

Annual 2/6

1ShotM (Magnification)7375 AP [Annual] For checkup of mammography QC

Spatial Resolution (Magnification) S - V III’ 2 80

Annual 3/6

Uniform Expo.3 (Collimation) 7303 AP [Annual] For checkup of mammography QC Collimation S - V I 2 200

Annual 4/6

H-mode CNR (PMMA20mm) 7302 AP [Annual] For checkup of mammography QC

H-mode CNR (20 mm height) S - V I 1 200

H-mode CNR(PMMA40mm) 7302 AP [Annual] For checkup of mammography QC






Annual 5/6

N-mode CNR (PMMA20mm) 7302 AP [Annual] For checkup of mammography QC

N-mode CNR (20 mm height) S - V I 1 200

N-mode CNR(PMMA40mm) 7302 AP [Annual] For checkup of mammography QC






Annual 6/6

L-mode CNR(PMMA20mm) 7302 AP [Annual] For checkup of mammography QC

L-mode CNR (20 mm height) S - V I 1 200







* High luminance is recommended in the environment where high-density film is used and normal luminance in the environment where a monitor, which does not support high-density film, is used.


ImageFormat



Monitor 1.5 u 0.50 0.03 A T 0.7 G U 1.0

Film 1.2 T 1.40 -0.04 G R 1.5 E F 0.4

Monitor 1.3 c 1.20 0.00 B R 0.0 A A 0.0

Film 1.3 C 1.20 0.00 B R 0.0 A A 0.0

Monitor 1.0 a 1.20 0.00 B F 0.0 A A 0.0

Film 1.0 A 1.20 0.00 B F 0.0 A A 0.0

Monitor 1.0 a 1.20 0.00 B F 0.0 A A 0.0

Film 1.0 A 1.20 0.00 B F 0.0 A A 0.0

Monitor 1.0 a 1.20 0.00 B F 0.0 A A 0.0

Film 1.0 A 1.20 0.00 B F 0.0 A A 0.0

Monitor 1.0 a 1.20 0.00 B F 0.0 A A 0.0

Film 1.0 A 1.20 0.00 B F 0.0 A A 0.0

Monitor 1.0 a 1.20 0.00 B F 0.0 A A 0.0

Film 1.0 A 1.20 0.00 B F 0.0 A A 0.0

Monitor 1.0 a 1.20 0.00 B F 0.0 A A 0.0

Film 1.0 A 1.20 0.00 B F 0.0 A A 0.0

Monitor 1.0 a 1.20 0.00 B F 0.0 A A 0.0

Film 1.0 A 1.20 0.00 B F 0.0 A A 0.0

Monitor 1.0 a 1.20 0.00 B F 0.0 A A 0.0

Film 1.0 A 1.20 0.00 B F 0.0 A A 0.0

Monitor 1.0 a 1.20 0.00 B F 0.0 A A 0.0

Film 1.0 A 1.20 0.00 B F 0.0 A A 0.0

Monitor 1.0 a 1.20 0.00 B F 0.0 A A 0.0

Film 1.0 A 1.20 0.00 B F 0.0 A A 0.0

Monitor 1.0 a 1.20 0.00 B F 0.0 A A 0.0

Film 1.0 A 1.20 0.00 B F 0.0 A A 0.0

Monitor 1.0 a 1.20 0.00 B F 0.0 A A 0.0

Film 1.0 A 1.20 0.00 B F 0.0 A A 0.0

GA : Rotation Amount Multi-Objective Frequency Processing Multi-Objective DRC ProcessingGT : Gradation Type MRB : Balance Type MDB : Balance TypeGC : Rotation Center MRT : Frequency Type MDT : Frequency TypeGS : Gradation Shifting Amount MRE : Enhancement MDE : Enhancement


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Documents

Aspire HD Plus / HD -s 2 Overview Quality Control ...Operation Manual” and “FCR 1Shot Phantom M Plus Operation Manual”. 9 Aspire HD Plus / HD -s Quality Control Program Manual