Quality

Control
1

FDR Mammography QC Overview

2
Program Guidebook Installation
of FDR
(For FDR-3000AWS V6.0 or Later) Mammography
QC Program
3
(1 Shot Phantom M Plus 24×30)
1st Edition April 2015 Daily/Weekly
Test
4

Quarterly Test
5

Semi-annual
Test
6

Annual Test
7

Assistance
Material
8

This Guidebook provides detailed information about

Technical
Information
9
how to use the FDR Mammography QC Program as well
Original Instructions
as important points to note when using it. Before using When the manual is provided in
this product, be sure to read this Guidebook thoroughly. languages other than English, it is Image Processing
considered to be a “Translation of
After reading this Guidebook, store it nearby so that
the original instructions”.
Parameters
you can see it whenever necessary. Please also read
“FDR MS-3500 Operation Manual”, “FDR-3000AWS In this case, it must bear the (for Mammography QC)
Operation Manual”, “Mammography QC Software words “Translation of the original
Operation Manual” and “1 Shot Phantom M Plus 24×30 instructions” in place of “Original
Instructions” above.
Operation Manual”.

897N120636
ii FDR Mammography QC Program Guidebook 897N120636
 Introduction

The FDR Mammography QC Program Guidebook (the Guidebook 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.

In this Guidebook, the contents are based on the premise that the 1 Shot Phantom
M Plus 24 ×30 will be used. Different Phantom sizes cannot be used. If the Phantom
of different sizes has been used before, be sure to re-create the baseline values and
to re-examine criteria.

Exclusive Clauses
1. No part or all of this Guidebook (except Chapter 8) may be reproduced in any form without
prior permission.
2. The information contained in this Guidebook 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 Guidebook.
7. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from use
under environment conditions outside the range of using conditions for this product such as
power supply, installation environment, etc. contained in this Guidebook.
8. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from natural
disasters such as fires, earthquakes, floods, lightning, etc.

Trademark
FCR and FDR are trademarks or registered trademarks of FUJIFILM Corporation.

Copyright © 2015 FUJIFILM Corporation. All rights reserved.

FDR Mammography QC Program Guidebook 897N120636 iii

iv FDR Mammography QC Program Guidebook 897N120636
 Contents at a Glance

Chapter 1 Quality Control 1

This chapter describes the relevant quality control standards.

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

Chapter 3 Installation of FDR Mammography QC Program 3

This chapter describes the operational procedure for installing the FDR
Mammography QC Program.

Chapter 4 Daily/Weekly Test 4

This chapter describes the Daily/Weekly Test procedure.

Chapter 5 Quarterly Test 5

This chapter describes the Quarterly Test procedure.

Chapter 6 Semi-annual Test 6

This chapter describes the Semi-annual Test procedure.

Chapter 7 Annual Test 7

This chapter describes the Annual Test procedure.

Chapter 8 Assistance Material

This chapter consists of material that helps quality control tests and
8
includes the explanation of the calculation function, the software operation
quick guide and the worksheets.

Chapter 9 Technical Information 9

This chapter consists of a brief specification of 1 Shot Phantom M Plus
24×30 and a glossary.

I mage Processing Parameters

(for Mammography QC)

FDR Mammography QC Program Guidebook 897N120636 v

 Indications
The 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.

Conventions
The names of the buttons in the window are shown as described below.
(Example) [Start study.]
The button name is shown in brackets ([ ]) regardless of
the feature.

vi FDR Mammography QC Program Guidebook 897N120636

 Contents

Chapter 1 Quality Control

1.1 Quality Control.................................................................................. 1-2
1.1.1 Acceptance Test.................................................................. 1-2
1.1.2 Constancy Test..................................................................... 1-2
1.1.3 Status Test............................................................................. 1-2
1.2 Quality Control of the Mammography System..................... 1-3
1.2.1 Quality Control Tests and Frequency.......................... 1-3
1.2.2 Types of Quality Control Tests....................................... 1-5
1.2.3 Definition of Criteria............................................................ 1-6

Chapter 2 Overview
2.1 Product Outline................................................................................. 2-2
2.2 QC Test Items................................................................................... 2-5
2.2.1 Daily/Weekly Test................................................................ 2-7
2.2.2 Quarterly Test........................................................................ 2-11
2.2.3 Semi-annual Test................................................................. 2-11
2.2.4 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................................................................. 3-12
3.4.1 Baseline Values for Annual Test.................................... 3-13
3.4.2 Baseline Values for Semi-annual Test......................... 3-17
3.4.3 Baseline Values for Daily/Weekly Test........................ 3-21
3.5 Checking Equipment Conditions at the Time of Program
Installation........................................................................................... 3-29

FDR Mammography QC Program Guidebook 897N120636 vii

 Chapter 4 Daily/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 Conducting Daily Test ................................................................... 4-6
4.5.1 Procedure............................................................................... 4-6
4.5.2 Test Result Evaluation and Judgment......................... 4-11
4.5.3 Solutions for Failed Test Items....................................... 4-11
4.6 Conducting Weekly Test............................................................... 4-12
4.6.1 Procedure............................................................................... 4-12
4.6.2 Test Result Evaluation and Judgment......................... 4-16
4.6.3 Solutions for Failed Test Items....................................... 4-17

Chapter 5 Quarterly Test

5.1 Test Flow............................................................................................. 5-2
5.2 Test Items........................................................................................... 5-3
5.3 Conducting Quarterly Test........................................................... 5-4
5.3.1 Procedure............................................................................... 5-4
5.3.2 Test Result Evaluation and Judgment......................... 5-6
5.3.3 Solutions for Failed Test Items ..................................... 5-6

Chapter 6 Semi-annual Test

6.1 Test Flow............................................................................................. 6-2
6.2 Test Items........................................................................................... 6-3
6.3 Tools...................................................................................................... 6-4
6.4 Setting Confirmation....................................................................... 6-5
6.5 Conducting Semi-annual Test.................................................... 6-6
6.5.1 Procedure............................................................................... 6-6
6.5.2 Test Result Evaluation and Judgment......................... 6-12
6.5.3 Solutions for Failed Test Items....................................... 6-12

viii FDR Mammography QC Program Guidebook 897N120636

 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 ............................................................... 7-7
7.5.1 Image Performance Test.................................................. 7-7
1. Procedure................................................................................ 7-7
2. Test Result Evaluation and Judgment....................................... 7-13
3. Solutions for Failed Test Items.................................................. 7-13
7.5.2 Spatial Resolution Test...................................................... 7-15
1. Procedure................................................................................ 7-15
2. Test Result Evaluation and Judgment....................................... 7-18
3. Solutions for Failed Test Items.................................................. 7-18
7.5.3 X-ray Equipment Performance Test............................. 7-19
1. Procedure................................................................................ 7-19
2. Test Result Evaluation and Judgment....................................... 7-31
3. Solutions for Failed Test Items.................................................. 7-31
7.5.4 AEC System Performance Test..................................... 7-33
1. Procedure................................................................................ 7-33
2. Test Result Evaluation and Judgment....................................... 7-45
3. Solutions for Failed Test Items.................................................. 7-45

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..................................................................................... 8-19

Chapter 9 Technical Information

9.1 Specification Outline of 1 Shot Phantom M Plus 24×30....... 9-2
9.2 Glossary............................................................................................... 9-3
9.3 CSV Output........................................................................................ 9-6

Image Processing Parameters (for Mammography QC)

FDR Mammography QC Program Guidebook 897N120636 ix

x FDR Mammography QC Program Guidebook 897N120636
 Chapter 1
1

Quality Control
Page

1.1 Quality Control________________________________________ 1-2

1.1.1 Acceptance Test__________________________________ 1-2
1.1.2 Constancy Test___________________________________ 1-2
1.1.3 Status Test_______________________________________ 1-2
1.2 Quality Control of the Mammography System_________ 1-3
1.2.1 Quality Control Tests and Frequency_________________ 1-3
1.2.2 Types of Quality Control Tests_______________________ 1-5
1.2.3 Definition of Criteria________________________________ 1-6

FDR Mammography QC Program Guidebook 897N120636 1-1

 1.1 Quality Control

Quality control is defined as “operational techniques and activities that are used to fulfill requirements
for quality”.
1 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
Quality Control

providing adequate information on quality control is included so that any quality assurance program
may be effectively implemented.
For detailed information on quality control and quality assurance programs, see IEC 61223-1 “Evaluation
and routine testing in medical imaging departments”.
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 Test

The purpose of the acceptance test is to check the compliance of the equipment with specifications and
contractual agreement between the manufacturer (seller) and customer. An acceptance test is normally
carried out when new equipment has been installed, or when existing equipment has been remodeled.

1.1.2 Constancy Test

The constancy test is intended to monitor the constancy of the functional performance of the equipment
by means of a test method that is simple, quick and easy to carry out, usually involving measurements
of relative values. In FDR Mammography QC Program (Program hereafter), all tests are regarded as
constancy tests.
For some particular tests, the upper or lower limit is established by a law or guideline. These tests are
not constancy tests defined in IEC standards, to be exact. However, in this Program, even these tests
are regarded as constancy tests since they also focus on the constancy of the functional performance.

1.1.3 Status Test

A status test is executed when components or sub-assemblies have been added, remodeled, replaced,
or removed, or when the results of a constancy test indicate a substantial change in equipment
performance.

1-2 FDR Mammography QC Program Guidebook 897N120636

 1.2 Quality Control of the Mammography
System

International standards and guidelines regarding the quality control of the mammography system are
as follows.
1
• European guidelines for quality assurance in breast cancer screening and diagnosis; Fourth

Quality Control
Edition (European Commission) (Hereafter abbreviated as EUREF Ed.4)
• IEC 61223-3-2 Ed.2 (International Electrotechnical Commission)
• ACR Quality Control Manual (American College of Radiology)

In this Program, test items and their implementation frequencies for the mammography system using
the FDR are determined based on IEC 61223-3-2 Ed.2. Test items consist of quantitive tests and visual
inspections, and the 1 Shot Phantom M Plus 24×30 for quantitive measurement and QC Software are
used for evaluation.
This program is only applicable to 2D images, and cannot be used for 3D images.

1.2.1 Quality Control Tests and Frequency

QC Software Installation QC Software Operation
Equipment
Baseline Value 15 18 21
Condition 3 months 6 months 9 months 1 year 2 years
Measurement months months months
Check
Daily/Weekly Every Day/Week
Test Chapter 4

Quarterly Test Chapter 5

Semi-annual Test Chapter 6

Annual Test Chapter 7

Chapter 3

[1] Daily/Weekly Test

Daily/Weekly Tests using the 1 Shot Phantom M Plus 24×30 and ACR Phantom are executed for
detecting changes in image quality or subtle changes of the mammography system that are not
reflected in actual images.
These tests are executed as constancy tests for monitoring daily changes in the mammography
system. Quantitive tests can be executed by using the 1 Shot Phantom M Plus 24×30. 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.

[2] Quarterly Test

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.

FDR Mammography QC Program Guidebook 897N120636 1-3

 [3] Semi-annual/Annual Test
As Semi-annual/Annual Tests, performance verification tests of the mammography system are
executed using measuring instruments and materials such as a dosimeter and PMMA phantom.

Performance Verification Test

In this Guidebook, constancy tests involving measurements of relative values are executed. In
1 addition, a performance verification test is executed when a lower limit is specified in a guideline
(e.g. scores of the tests using the ACR Phantom), or when absolute values are used for evaluation
(e.g. measured values of the tests using the 1 Shot Phantom M Plus 24×30).
Quality Control

Although performance verification tests are not defined in IEC, these tests are similar to acceptance
tests and status tests since absolute values are used for evaluation. However, performance
verification tests are distinguished from the two tests above since the implementation frequency is
different and these tests are not based on the specification.

1-4 FDR Mammography QC Program Guidebook 897N120636

 1.2.2 Types of Quality Control Tests
All test items for quality control of the mammography system focus on change of measurement values.
Accordingly, based on the definition in IEC, 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 1
equipment. Since the performance varies depending on the types of the X-ray equipment and

Quality Control
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”.

Fail

Established Test Results

Criteria Pass
Baseline Value

Fail

Installation 6 Months 1 Year

[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. (These tests are not defined in
IEC. 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).

When the upper limit is specified

Fail
Upper Limit

Test Results
Pass

Installation 6 Months 1 Year

When the lower limit is specified

Pass
Test Results

Lower Limit
Fail

Installation 6 Months 1 Year

FDR Mammography QC Program Guidebook 897N120636 1-5

 1.2.3 Definition of Criteria
This Program consists of constancy tests and performance verification tests. However, in this Guidebook,
criteria for constancy tests and upper and lower limits for performance verification tests are collectively
called “criteria”.

1
Quality Control

1-6 FDR Mammography QC Program Guidebook 897N120636

 Chapter 2
2
Overview
Page

2.1 Product Outline_______________________________________ 2-2

2.2 QC Test Items_________________________________________ 2-5
2.2.1 Daily/Weekly Test__________________________________ 2-7
2.2.2 Quarterly Test_____________________________________ 2-11
2.2.3 Semi-annual Test__________________________________ 2-11
2.2.4 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

FDR Mammography QC Program Guidebook 897N120636 2-1

 2.1 Product Outline
This Program is a dedicated program developed for implementing quality control of
the FDR mammography system. Conducting this Program enables appropriate quality
control on a FDR system in medical institutions to be carried out through the Daily/
Weekly, Quarterly, Semi-annual and Annual Tests.

• The Program consists of the following three components.

• Guidebook (FDR Mammography QC Program)
It (this document) provides instructions for implementing quality control of the FDR
mammography system.
2 • Exclusive Phantom (1 Shot Phantom M Plus 24×30)
1 Shot Phantom M Plus 24×30 (1 Shot Phantom hereafter) was developed for quality control of
Overview

the FCR systems and can produce the image quality test results on 10 items by single exposure.
For the FDR systems as well, 1 Shot Phantom enables wide-ranging analysis of a system in a
relatively short time with high reproducibility.
• Exclusive Quality Control Software (Mammography QC Software)
Mammography QC Software (hereafter QC Software) is designed for performing periodic quality
control, data analysis, and QC test log management.

[QC test categories]

• Daily/Weekly Test................... ‌ Quantitative/Visual inspection with 1 Shot 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 CNR and
AGD in addition to that of the items in each test.

[Calculation functions]
• CNR.......‌Used for calculating the values in AEC (Automatic Exposure Control) function
adjustment or when determining the CNR baseline values.
• AGD.......Used for calculating the values in AEC.

2-2 FDR Mammography QC Program Guidebook 897N120636

 [Equipment to be evaluated]

Overview
X-ray equipment Viewing box

[Test categories and their implementation frequencies]

The QC test items are categorized by the required implementation frequency. The test categories and
their implementation frequency are as shown below.
QC Software Installation QC Software Operation
Equipment
Baseline Value 15 18 21
Condition 3 months 6 months 9 months 1 year 2 years
Measurement months months months
Check
Daily/Weekly Every Day/Week
Test Chapter 4

Quarterly Test Chapter 5

Semi-annual Test Chapter 6

Annual Test Chapter 7

Chapter 3

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

FDR Mammography QC Program Guidebook 897N120636 2-3

 [The Program implementation procedure]
When installing the QC Software

1. Initial Settings

2. Criteria Confirmation and Change the criteria as necessary.

Determination

3. Baseline Value Settings

2
4. Checking Equipment Qualities Annual Test
at the Time of the Program
Installation
Semi-annual Test
Overview

Daily/Weekly Test

When implementing the QC Program

Daily/Weekly Test

3 months Quarterly Test

Semi-annual Test
6 months
Quarterly Test

9 months Quarterly Test

Annual Test

1 year Semi-annual Test Conduct tests in order of their potential influence

on images (Annual Test → Semi-annual Test →
Daily/Weekly Test). The Quarterly Test can be
Quarterly Test
conducted regardless of order.

15 months Quarterly Test

Semi-annual Test
18 months
Quarterly Test

2-4 FDR Mammography QC Program Guidebook 897N120636

 2.2 QC Test Items
Test components in each test category are shown below.
“Exposure Menus” are the menu items to be selected on a FUJIFILM workstation to
start the corresponding tests.

NOTE
All tests are to be performed with grid set to [IN], unless specified otherwise.

NOTE
Use a standard compression plate, unless otherwise specified. If a small or flex type compression plate is
used, tests may not be conducted successfully.
2
[Daily/Weekly Test]

Overview
Test Items Exposure Menus Responsibility
Test with 1 Shot Phantom
1 Shot PhantomM
Good practice Technologist
Test with ACR Phantom ACR Phantom

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

[Quarterly Test]
Test Items Exposure Menus Responsibility
Repeat analysis –– *1 Technologist

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

[Semi-annual Test]
Test Items Exposure Menus Responsibility
Image Basic Test
Compression device confirmation Semi-annual 1/1 Technologist
Viewing box maintenance

FDR Mammography QC Program Guidebook 897N120636 2-5

 [Annual Test]
Test Items Exposure Menus Responsibility Test Types
Additive lag effects (Lag)
Multiplicative lag effects (Ghost)
Missed tissue on chest wall edge Annual 1/6 Image performance
(40 mm height) *2
Visual and Functional test
Spatial Resolution (Magnification) Annual 2/6 Spatial Resolution
2 kVp accuracy and reproducibility
Medical Physicist
Half Value Layer (HVL)
Overview

X-ray equipment
Annual 3/6
Collimation assessment performance

Radiation output
AEC density control function
AEC reproducibility Annual 4/6 through AEC system
CNR modes 1 to 3 Annual 6/6 performance

AGD modes 1 to 3

*2 ‌The Missed tissue on chest wall edge (40 mm height) in Annual Test is a required test item to be conducted in some areas.

NOTE
The responsibility depends on local regulations where the equipment is to be used.

[Calculation functions]
Test Items Exposure Menus
CNR Calculation 1/2
AGD Calculation 2/2

When an exposure menu includes multiple test items/contents, make sure to conduct the test on all of
them.
(If any of the test items/contents remain untested, the QC Software malfunctions.)
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: 1 Shot PhantomM).
See the Operation Manual for FUJIFILM workstation for detailed FUJIFILM workstation operations.

Explanations of test items/contents are shown on the following pages.

2-6 FDR Mammography QC Program Guidebook 897N120636

 2.2.1 Daily/Weekly Test
The Daily Test is conducted to evaluate image quality by making an exposure using a 1 Shot Phantom
and check that the X-ray equipment normally used in clinical practice is kept clean.
The Weekly Test is conducted to evaluate image quality by making an exposure using an ACR Phantom.
The 1 Shot Phantom is manufactured to comply with IEC standards and EUREF guidelines. Only with
a single exposure using the Phantom, the QC Software auto-calculates the necessary image quality
parameters, enabling image quality variations to be monitored (some test items require visual inspection).
The image evaluation using the ACR Phantom is specified to be conducted at least once a week in the
“ACR Quality Control Manual (American College of Radiology, 1999)”, and when used in combination
with the QC Software, the results can be managed efficiently.

(1) 1 Shot Phantom Image

2

Overview
<Judgment method>
• Auto-calculation based on
the image
• Visual inspection

(2) ACR Phantom Image

Make an exposure using (1) 1

Shot Phantom (daily) or
(2) ACR Phantom (weekly).

<Judgment method>
• Density measurement
• Visual inspection

FDR Mammography QC Program Guidebook 897N120636 2-7

 Phantoms Used for Exposure [1] Test with 1 Shot Phantom
(1) Missed tissue on chest wall edge

1 Shot Phantom (24×30)

2 ACR Phantom/Step Phantom/Acrylic disk

Overview

Check that the degree of missed tissue on

chest wall edge of the exposure table is within
Step Phantom
the criteria.

NOTE (2) CNR

The test using a Step Phantom is required to
be conducted in some areas. Conduct the test
in compliance with local regulations where the
equipment is to be used.

NOTE
In this Program, the 1 Shot Phantom M Plus 24 ×30
must be used.

Check that the CNR variation is within the

criteria.

2-8 FDR Mammography QC Program Guidebook 897N120636

 (3) 1 Shot Phantom sensitivity constancy (6) Uniformity

Overview
Check that the 1 Shot Phantom sensitivity Check that the uniformity variation is within
variation is within the criteria. the criteria.
(4) Geometric distortion (7) Dynamic range

Horizontal
direction
Vertical
direction

Check that the image dimension variation Check that the dynamic range variation is
(geometric distortion) in horizontal/vertical within the criteria.
direction is within the criteria. (8) Spatial Resolution (SR)
Visually check that there is no distortion or
jitter in the image.
(5) System artifact evaluation

Check that the spatial resolution variation is

within the criteria.

Visually check that there are no artifacts

affecting diagnosis in the image.

FDR Mammography QC Program Guidebook 897N120636 2-9

 (9) Low Contrast Detectability (LCD) [2] Good practice
Check that the following equipment is kept
clean.
• X-ray equipment
• Softcopy output equipment
• Viewing box

[3] Test with ACR Phantom

2
Overview

Check that the low contrast detectability

meets or exceeds the criteria.

(10) Linearity/Beam quality constancy

Make exposures using the ACR Phantom and Step

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
• ‌Number of density steps on the Step Phantom
• Specks on the Step Phantom
• Masses on the Step Phantom
Check that the X-ray linearity and radiation NOTE
quality variations are within the criteria. The test using a Step Phantom is required to
TIP be conducted in some areas. Conduct the test
in compliance with local regulations where the
equipment is to be used.

This member is not used.

2-10 FDR Mammography QC Program Guidebook 897N120636

 2.2.2 Quarterly Test [2] Compression device confirmation

In the Quarterly Test, the Repeat analysis is

prepared as the test item.

NOTE
The Repeat analysis is a required test item to be
conducted in some areas. Conduct the analysis
in compliance with local regulations where the
equipment is to be used.

[1] Repeat analysis

Calculate data for analyzing the rejected
2
images.

Overview
2.2.3 Semi-annual Test
The Semi-annual Test includes the Image basic
test, Compression device confirmation and
Viewing box maintenance.
[1] Image basic test

Check the display accuracy of the

compression force and compressed breast
thickness, and then measure the maximum
compression force and its sustainability.

[3] Viewing box maintenance

Check that the relative sensitivity variation, Check if the viewing box luminance is
the degree of artifacts in the image are satisfactory, the equipment functions
within the criteria. correctly and optimum conditions for viewing
are provided.

FDR Mammography QC Program Guidebook 897N120636 2-11

 2.2.4 Annual Test
The Annual Test contains the following test items [1] to [12] regarding X-ray equipment performance.

[3] Missed tissue on chest [5] Spatial Resolution

[1] Additive lag effects (Lag) wall edge (40 mm height) (Magnification)
Check that no lag image remains.
Check for missed tissue on Check that the spatial resolution
chest wall edge 40 mm above variation at the magnified
[2] Multiplicative lag effects the exposure table. exposure is within the criteria.

2
(Ghost)
Check the temporal sensitivity [4] Visual and Functional test
change due to X-ray exposure. Check the X-ray equipment
Overview

function and visually check for

any problem.

[6] kVp accuracy and [9] Radiation output

reproducibility Check that variation in air kerma
Check the variation in the kVp of under the specified exposure
the X-ray equipment and its display condition on the X-ray equipment
accuracy. is within the criteria.

[10] AEC density control function

[7] Half Value Layer (HVL)
Check that variation of the mAs
Check the half value layer.
at the AEC tap switching is within
the criteria.

[8] Collimation assessment

Check the gap between the X-ray [11] AEC reproducibility
field and the light field. Check that variation in air kerma
under the AEC is within the criteria.

[12] CNR modes 1 to 3

Check CNR under the AEC.
[13] AGD modes 1 to 3
Check AGD under the AEC.

NOTE
The Missed tissue on chest wall edge (40 mm height) in Annual Test is the required test item to be conducted
in some areas. Conduct the test in compliance with local regulations where the equipment is to be used.

2-12 FDR Mammography QC Program Guidebook 897N120636

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

...Required ...Optional
Daily/Weekly Test Semi-annual Calculation
Tools Annual Test
Daily Weekly Test Functions

[ A ] QC Software
[B] Worksheet (See Chapter 8)
[C] 1 Shot Phantom 2
[D] Viewing box (if film is used)

Overview
[ E ] Timer or watch/clock
ACR Phantom
[F] *1
(including an acrylic disk)
[G] Step Phantom *2
[H] Dosimeter
[ I ] Luminance meter
[ J ] kVp meter
[ K ] Force scale
[ L ] Illuminance meter
[M] Densitometer (if film is used)
PMMA phantoms (available, in
[N] combination, for 20, 40, 60 and 70 mm
in thickness)
Aluminum plate (0.2 mm) for CNR
[O]
measurement
Aluminum plates for half value layer
[ P ] measurement
(0.5 and 0.6 mm)
[Q] Scale
[R] Coins
[ S ] Jig for 1 Shot Phantom *3
[ T ] Lead sheet *4 *4

*1 The acrylic disk is not needed.

*2 Required only when conducting visual inspection of the Step Phantom image.
*3 Required only in the Missed tissue on chest wall edge (40 mm height) measurement in the Annual Test.
*4 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. Hardcopy/Softcopy output equipment (laser imager or diagnostic monitor)
B. X-ray equipment
C. FUJIFILM workstation

FDR Mammography QC Program Guidebook 897N120636 2-13

 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] 1 Shot Phantom

The 1 Shot 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.
2 NOTE
Scratches, deformation, or dirt on the Phantom not only affects the image evaluation or measured values
but may damage the compression plate of the X-ray equipment. Make sure that there is no scratch,
Overview

deformation, or dirt on the Phantom before use.

[D] Viewing box
A viewing box 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 viewing box 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).

[G] Step Phantom

The Phantom is used for image evaluation. The AGH-D210 manufactured by Kyoto Kagaku Co., Ltd or equivalent is necessary.

NOTE
Scratches, deformation, or dirt on the ACR or Step 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.
NOTE
A Step Phantom is required only when conducting visual inspection of it.
[H] 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.

[I] 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.

[J] 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.

[K] 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 other material not damaging to the X-ray equipment to allow
proper measurement.

[L] Illuminance meter

An illuminance meter is used for measuring illuminance under viewing conditions.

2-14 FDR Mammography QC Program Guidebook 897N120636

 [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) NOTE

20 21 Scratches, deformation, or dirt on the phantom not
40 45 only affect the image evaluation or measured values
60 75 but may damage the compression plate of the X-ray
70 90

(Reference: EUREF Ed.4)

equipment. Make sure that there are no scratches,
deformation, or dirt on the phantom before use.
2
[O] Aluminum plate (0.2 mm) for CNR measurement

Overview
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 (0.5 and 0.6 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
A millimeter scale is required.

[R] Coin
Some familiar-sized coins are to be used.

[S] Jig for 1 Shot Phantom

In the Missed tissue on chest wall edge measurement in Annual Test, a jig as shown below is necessary for raising and holding
the 1 Shot Phantom 40 mm above the exposure table while aligning its corner edge and the chest wall-side edge of the exposure
table.

1 Shot Phantom

40 mm Jig

Chest wall side

NOTE
This item is required only in the Missed tissue on chest wall edge (40 mm height) measurement performed
on the exposure table. Prepare the jig if necessary.

[T] Lead sheet

A lead sheet is used to completely block the X-ray when conducting the test on additive lag effects. This sheet is also used as
necessary to protect the image receptor when measuring the air kerma.

FDR Mammography QC Program Guidebook 897N120636 2-15

 Equipment details
A Hardcopy/Softcopy output equipment
A hardcopy/softcopy output equipment (laser imager/diagnostic monitor) is to be used for visually checking and evaluating
images on film/display.
The output equipment quality is required to be assured for the purpose.

B X-ray equipment
An X-ray equipment to be used is the FDR MS-3500.

NOTE
In this Program, methods of exposure condition setting of an X-ray equipment are defined as follows:
2 • “Manu (manual)” mode
‌The mode allows manual setting of the kVp, mAs and target/filter of the X-ray equipment.
• “Semi (semi auto)” mode
Overview

‌The mode automatically specifies the mAs but allows manual setting of the kVp and target/filter of
the X-ray equipment.
• “Auto (full auto)” mode
‌The mode automatically specifies kVp, mAs and target/filter of the X-ray equipment depending on
the subject.
When conducting a QC test, turn off the Intelligent AEC.
C FUJIFILM workstation
A workstation to be used is the FDR-3000AWS.

2-16 FDR Mammography QC Program Guidebook 897N120636

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

FUJIFILM workstation startup

Exposure

QC Software startup Operations on a FUJIFILM workstation

2

Overview
“QC window” Film output etc.

User input Log display

Auto-calculation

Judgment
Operations on the QC Software

The “QC window” composition is described below.

Exposure region list

Exposure
submenu list

Exposure menu list

Patient information
display field

FDR Mammography QC Program Guidebook 897N120636 2-17

 FUJIFILM workstation startup

Exposure

QC Software startup

2
Overview

“QC window”
The following functions can be executed on the “QC window”. The relevant button functions are described below.
Exposure condition display field

(10) Displays the test log.

(9) Check exposure

conditions.

(1) Sets the initial values.

(8) Quits the QC Software.

(7) Saves the study results.

(2) Changes the criteria.

(6) Executes measurement based on entered
image and values, and displays [Pass/Fail]
judgment.
(3) Outputs an image (4) Outputs an image
on film. to the network.
(5) Opens the user input screen for
necessary information.

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

2-18 FDR Mammography QC Program Guidebook 897N120636

 (5) User input

The results of measurement and visual inspection can be entered in the window below (Example: Daily/Weekly
Test).

Overview
(6) Measurement execution

Each test result is auto-calculated based on the entered image and values, and the judgment (Pass/Fail) is
displayed in the window as shown below.

Judgment results
Pass/Fail

Calculated results

(10) Log display

The past measurement and judgment results of each test item/content are displayed in the graph.

Log

FDR Mammography QC Program Guidebook 897N120636 2-19

 2.5 Notes on Conducting the Program
Operational notes regarding the Program are described below.

Notes on Performing QC Tests

(1) 1 Shot/ACR Phantom position
The positions of the Phantoms vary depending on the test item/content. See the test procedure for
each item.

2 (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
Overview

specified by using an appropriate jig. In the X-ray reproducibility test, the dosimeter position differs
since the air kerma is measured under the AEC.
(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. Be careful not to
scratch the compression plate when conducting a test.
(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 1 Shot 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.
If the image processing parameters are changed, streak artifacts may appear on the image due to
the resolution of digital data. It is recommended to perform visual inspection by using the default
parameters set to each exposure submenu.
(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-3000AWS Operation Manual” for details.
(8) AEC exposure modes
To conduct a test item which requires the AEC in this program, use a mode most frequently used
for normal mammography (H-mode, N-mode or L-mode) unless otherwise specified. Also, turn off
the Intelligent AEC. Use the same exposure mode every time the tests which require the AEC are
conducted.

2-20 FDR Mammography QC Program Guidebook 897N120636

 Chapter 3
Installation of FDR
Mammography QC Program 3
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_______________________________ 3-12
3.4.1 Baseline Values for Annual Test______________________ 3-13
3.4.2 Baseline Values for Semi-annual Test_________________ 3-17
3.4.3 Baseline Values for Daily/Weekly Test_________________ 3-21
3.5 Checking Equipment Conditions at the Time of Program
Installation____________________________________________ 3-29

FDR Mammography QC Program Guidebook 897N120636 3-1

 3.1 Installation Procedure
When installing the Program, perform the following.

Initial Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2

Specify the information for conducting the tests, such as dosimeter position.
NOTE
Make 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. (Check the latest recommended
values in “List of Reference Values for Criteria and Baseline Values”.)

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

Measured values for some test items vary depending on the environment where the X-ray
Installation of FDR Mammography QC Program

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. 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)

Daily/Weekly Test (Chapter 4)

NOTE
When 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.

3-2 FDR Mammography QC Program Guidebook 897N120636

 3.2 Initial Settings
The following items are required to be specified in the initial settings.
• Dosimeter - Exposure table distance 5 Press [QC] to display the “QC window”.
• Target / Filter and tube voltage (HVL)
• Air kerma unit
• Viewing box setting
6 Press [Initial setting].
• 1 Shot Phantom size
• Use the function for adjusting X-ray dose
• Use the magnification exposure stand

Setting Procedure
7 Enter values for items requiring initial
1 Enter patient information and press [Next]. settings.
For details on each item, see the following
descriptions in (1) through (5).
3

Installation of FDR Mammography QC Program

(4)

(1) (5)
(2)
(3) (6)

(7)
Select [QC/TEST] in the exposure region (8)
2
list and [1 Shot PhantomM] in the exposure
menu list, and then press [Start study.].
(1) Dosimeter - Exposure table distance
• Measure the distance (mm) in the figure below
and enter the value. The recommended value
for h is 40 mm (This Guidebook 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.
Reference point

3 The following exposure submenu is

displayed.
• 1 Shot PhantomM

Specify the following and make an TIP

4
exposure in “Manu” mode. Check the reference point of the dosimeter
23 kV, 2 mAs and W/Rh in its operation manual.
NOTE
It may take some time until you can press [QC] (2) Magnification table - Exposure table’s top
after completing the exposure process. surface distance
• Enter 247 mm.

FDR Mammography QC Program Guidebook 897N120636 3-3

 (3) Target / Filter and tube voltage (HVL)
• Specify the kVp to be used for measuring half
value layer in the Annual Test.
The recommended kVp is 28 kV that is
specified in IEC 61223-3-2. If the HVL is
measured other than at 28 kV, enter the kV
most frequently used in normal exposures for
clinical practice.
(4) Air kerma unit
• Select the measurement unit (mR or µGy) for
the dosimeter.
(5) Viewing box setting
• Put a checkmark when using a viewing box.
When the viewing box to be used has a
luminance adjustment and/or masking
3 function, also put a checkmark in the relevant
box.
(6) 1 Shot Phantom size
Installation of FDR Mammography QC Program

• Select the size of the Phantom to be used.

When changing the Phantom size, be sure
to re-create the baseline values and to re-
examine criteria.

(7) Use the function for adjusting X-ray dose

• Put a checkmark when using the X-ray dose
adjustment function.

(8) Use the magnification exposure stand

• Put a checkmark when using the magnification
table.

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.

3-4 FDR Mammography QC Program Guidebook 897N120636

 3.3 Criteria Confirmation and Determination

The criteria should be specified on your own 3 The following exposure submenu is
responsibility based on the measurement results displayed.
obtained at the time of the Program installation. • 1 Shot PhantomM
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”. Specify the following and make an
The reference criteria are preset for each item. 4
exposure in “Manu” mode.
The criteria can be changed by following “Criteria 23 kV, 2 mAs and W/Rh
Change Procedure” below.
NOTE
Criteria Change Procedure
When changing the criteria following “3.2 Initial
It may take some time until you can press [QC]
after completing the exposure process. 3
5 Press [QC] to display the “QC window”.
Settings”, start from Step 6 .

Installation of FDR Mammography QC Program

1 Enter patient information and press [Next].

6 Press [Criteria setting].

7 Select a tab and enter values for items to

be changed.
NOTE
If the Phantom size has been changed, be sure
to re-examine criteria.

2 Select [QC/TEST] in the exposure region

list and [1 Shot PhantomM] in the exposure
menu list, and then press [Start study.].

FDR Mammography QC Program Guidebook 897N120636 3-5

 n Daily/Weekly Tests 1/2 and 2/2

[Items allowing criteria change]

3 Test Item/Contents Judgment Items
Missed tissue on chest wall edge (Right) [mm]
Criteria
___ mm or less
Missed tissue on chest wall edge
Installation of FDR Mammography QC Program

Missed tissue on chest wall edge (Left) [mm] ___ mm or less

CNR CNR Baseline value ± ___%
1 Shot Phantom sensitivity constancy System sensitivity Baseline value ± ___%
Dimension (Horizontal) [mm] Baseline value ± ___%
Geometric distortion
Dimension (Vertical) [mm] Baseline value ± ___%
Pixel Value (PV) ratio (Top-Right) [%] Baseline value ± ___%
Pixel Value (PV) ratio (Top-Left) [%] Baseline value ± ___%
Pixel Value (PV) ratio (Bottom-Right) [%] Baseline value ± ___%
Pixel Value (PV) ratio (Bottom-Left) [%] Baseline value ± ___%
Pixel Value (PV) ratio (Top center) [%] Baseline value ± ___%
Uniformity
SNR ratio (Top-Right) [%] Baseline value ± ___%
SNR ratio (Top-Left) [%] Baseline value ± ___%
SNR ratio (Bottom-Right) [%] Baseline value ± ___%
SNR ratio (Bottom-Left) [%] Baseline value ± ___%
SNR ratio (Top center) [%] Baseline value ± ___%
Dynamic range Average QL at thinnest step wedge [QL] Baseline value ± ___ QL
2lp/mm [%] Baseline value ± ___ %
Spatial Resolution (SR)
4lp/mm [%] Baseline value ± ___ %
Low Contrast Detectability (Light) [%] Baseline value ± ___ %
Low Contrast Detectability (LCD)
Low Contrast Detectability (Dark) [%] Baseline value ± ___ %
QL gap (1 step-2 step) [QL] Baseline value ± ___ QL
QL gap (2 step-3 step) [QL] Baseline value ± ___ QL
Linearity/Beam quality constancy
QL gap (3 step-4 step) [QL] Baseline value ± ___ QL
QL gap (4 step-5 step) [QL] Baseline value ± ___ QL
Density at center of Phantom image ___ ± ___
Density difference (disk/outside) ___ or more and baseline value ± ___
Fibers (ACR Phantom) ___ points or more
Specks (ACR Phantom) ___ points or more
Test with ACR Phantom
Masses (ACR Phantom) ___ points or more
Visible step wedge (Step Phantom) *1 ___ steps
Specks (Step Phantom) *1 ___ steps or more
Masses (Step Phantom) *1 ___ steps or more

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

3-6 FDR Mammography QC Program Guidebook 897N120636

 n Quarterly Test
There is no item related to the criteria.

n Semi-annual Test

3
[Items allowing criteria change]

Installation of FDR Mammography QC Program

Test Items Judgment Items Criteria
Image Basic Test Relative sensitivity (S value) Baseline value ± ___%

Compressed breast thickness accuracy [mm] ± ___ mm or less

Compression device confirmation Compression force accuracy [N] ± ___ N or less
Maximum compression force [N] ___ to ___ N
Luminance [cd/m ] 2
___ cd/m2 or more
Viewing box maintenance
Interpretation room illuminance (Ambient light) [lx] ___ lx or less

FDR Mammography QC Program Guidebook 897N120636 3-7

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

3 [Items allowing criteria change]

Test Items Judgment Items Criteria
Additive lag effects (Lag) Lag factor [QL] ___ QL or less
Installation of FDR Mammography QC Program

Multiplicative lag effects (Ghost) Ghost factor Below ___

MTF (4lp/mm)[%] Baseline value ± ___%
Spatial Resolution (Magnification)
MTF (8lp/mm)[%] Baseline value ± ___%
Low volt. accuracy (LFS) [kV] Specified kVp ± ___ kV
Mid. volt. accuracy (LFS) [kV] Specified kVp ± ___kV
High volt. accuracy (LFS) [kV] Specified kVp ± ___ kV
kVp accuracy and reproducibility Low volt. accuracy (SFS) [kV] Specified kVp ± ___ kV
Mid. volt. accuracy (SFS) [kV] Specified kVp ± ___ kV
High volt. accuracy (SFS) [kV] Specified kVp ± ___ kV
Mid. volt. reproducibility (LFS) [kV] Reproducibility ± ___kV or less

3-8 FDR Mammography QC Program Guidebook 897N120636

 n Annual Test 2/3

[Items allowing criteria change]

Test Items Judgment Items
X-ray / Light field gap (Right/Left) [mm]
Criteria
Total gap criteria = SID X ___ or less
3

Installation of FDR Mammography QC Program

X-ray / Light field gap (Chest/Nipple) [mm] Total gap criteria = SID X ___ or less

Collimation assessment X-ray / Image receptor field gap (Left) [mm] SID X ___ or less
X-ray / Image receptor field gap (Right) [mm] SID X ___ or less
X-ray / Image receptor field gap (Nipple) [mm] SID X ___ or less
X-ray field / Exposure table gap [mm] ___ mm or less
Reproducibility Variation coefficient ___ or less
Air kerma rate [mGy/s] ___ mGy/s or more
Radiation output
Specific radiation output [μGy/mAs] ___ μGy/mAs or more

FDR Mammography QC Program Guidebook 897N120636 3-9

 n Annual Test 3/3

[Items allowing criteria change]

3 Test Items
AEC density control function
Judgment Items
mAs variation (/Step)
Criteria
___ to ___ %
Entrance air kerma accuracy [%] Average ± ___% or less
Installation of FDR Mammography QC Program

AEC reproducibility
Entrance air kerma reproducibility Variation coefficient ___ or less
CNR relative value 20mm [%] Baseline value ___ or more
CNR relative value 40mm [%] Baseline value ___ or more
CNR modes 1
CNR relative value 60mm [%] Baseline value ___ or more
CNR relative value 70mm [%] Baseline value ___ or more
CNR relative value 20mm [%] Baseline value ___ or more
CNR relative value 40mm [%] Baseline value ___ or more
CNR modes 2
CNR relative value 60mm [%] Baseline value ___ or more
CNR relative value 70mm [%] Baseline value ___ or more
CNR relative value 20mm [%] Baseline value ___ or more
CNR relative value 40mm [%] Baseline value ___ or more
CNR modes 3
CNR relative value 60mm [%] Baseline value ___ or more
CNR relative value 70mm [%] Baseline value ___ or more
AGD 20 mm [mGy] ___ mGy or less
AGD 40 mm [mGy] ___ mGy or less
AGD modes 1 to 3
AGD 60 mm [mGy] ___ mGy or less
AGD 70 mm [mGy] ___ mGy or less

TIP
• The criteria can be specified for each of the CNR modes (1 to 3).
• [CNR_H-mode], [CNR_N-mode] and [CNR_L-mode] in the window correspond to the CNR modes 1, 2
and 3, respectively.
• As in CNR modes, AGD modes 1 to 3 correspond to the respective AEC modes. However, a value is
commonly specified as the criteria for AGD modes (1 to 3).

3-10 FDR Mammography QC Program Guidebook 897N120636

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

9 Press [Close] to exit the “QC window”. 3

Installation of FDR Mammography QC Program

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

10 Select [Study completed] to finish the

test.

FDR Mammography QC Program Guidebook 897N120636 3-11

 3.4 Baseline Value Settings
This section describes how to determine and specify the baseline values of each test
item as the basis of judgment.
Make sure to perform these settings, otherwise judgment cannot be made correctly.

In this Program, the judgment is made based on how much the measured values deviates from the
baseline values.
Since the measured values for some test items depend on the X-ray equipment and/or exposure
conditions, it is necessary to specify the baseline values for the test items.

[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
Missed tissue on chest wall edge

3
CNR
1 Shot Phantom sensitivity constancy
Geometric distortion
Installation of FDR Mammography QC Program

System artifact evaluation

1 Shot PhantomM Test with 1 Shot Phantom
Daily/Weekly Test Uniformity
Dynamic range
Spatial Resolution (SR)
Low Contrast Detectability (LCD)
Linearity/Beam quality constancy
ACR Phantom Test with ACR Phantom
Image Basic Test
Semi-annual Test Semi-annual 1/1 Compression device confirmation
Viewing box maintenance
Annual 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 →
Daily/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 daily/weekly, semi-annual and annual tests have been conducted properly.
• ‌When conducting a QC test, turn off the Intelligent AEC.
• ‌If the Phantom size has been changed, be sure to re-create the baseline values.

3-12 FDR Mammography QC Program Guidebook 897N120636

 3.4.1 Baseline Values for Annual Test
Among the Annual Test items, the Spatial Resolution (Magnification) requires the baseline setting.
Test Category Exposure Menu Test Item
Annual Test Annual 2/6 Spatial Resolution Spatial Resolution (Magnification)

[5] Spatial Resolution (Magnification)

If magnification is not used in clinical practice, the baseline value setting is not required, as it is not a
test item for quality control.

[Test flow]

1. Patient information entry and exposure

menu selection

2. Spatial Resolution (Magnification)

3
(exposure)

Installation of FDR Mammography QC Program

Repeat several times.
(Recommended number
3. QC Software startup of times: 5)

4. Exposure condition confirmation

5. Auto-calculation

6. Baseline value setting

7. QC Software shutdown

[Tools]
1 Shot Phantom

FDR Mammography QC Program Guidebook 897N120636 3-13

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

1 Enter patient information and press [Next].

NOTE
If the area is out of the X-ray field while the
3 Phantom is positioned by pressing its corners
against the chest wall-side edge of the
Select [QC/TEST] in the exposure region magnification table, shift the Phantom to the
2
Installation of FDR Mammography QC Program

list and [Annual 2/6] in the exposure menu front.

list, and then press [Start study.]. Make sure that the shifted Phantom is parallel
to the chest wall-side edge.

3 The following exposure submenu is

displayed.
• 1 ShotM(Magnification) NOTE
The Phantom position must be the same for
every exposure (the allowable positional error is
within ± 5 mm). Record how much the Phantom
is shifted to the right-hand side and front side.
• Fill in the following item in the worksheet.
1 Shot Phantom position
Lateral shift distance: _____mm

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.

5 Position the 1 Shot Phantom being shifted

to the right-hand side so that the area
indicated by the broken line in the below
figure is at the lateral center of the X-ray
field.

3-14 FDR Mammography QC Program Guidebook 897N120636

 6 Specify “Manu” mode for the X-ray 5. Auto-calculation
equipment and make a magnified
exposure under the exposure conditions 9 Press [Measurement execution]. The
most often used in clinical practice. The results are displayed at the bottom of the
following setting is recommended. window.
28 kV, approx. 125 to 160 mAs and W/Rh
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____ TIP
Compressed breast thickness: If “No baseline value is input.” appears,
_____mm press [OK].
Compression force: _____N
NOTE
In the last time measurement, skip Steps 10
through 12 and go to Step 13 .

10 When the results are displayed, press

3
[Save] and then [Close] to exit the QC

Installation of FDR Mammography QC Program

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

11 Select [Study completed] to finish the

3. QC Software startup test.

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

12 Repeat Steps 1 through 11 several
times (5 is recommended) to specify the
averages of the multiple measured values
4. Exposure condition confirmation as the baseline values.
Check the exposure conditions. NOTE
8 Make 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].

FDR Mammography QC Program Guidebook 897N120636 3-15

 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].

3
Installation of FDR Mammography QC Program

7. QC Software shutdown

15 Press [Save] and then [Close] to exit the

QC Software.

16 Select [Study completed] to finish the

test.

3-16 FDR Mammography QC Program Guidebook 897N120636

 3.4.2 Baseline Values for Semi-annual Test
Among the Semi-Annual Test items, the Image basic test requires the baseline setting.
Test Category Exposure Menu Test Item
Image Basic Test
Semi-Annual Test Semi-annual 1/1 Compression device confirmation
Viewing box maintenance

[1] Image basic test

[Test flow]

1. Patient information entry and exposure

menu selection

2. Image basic test (exposure)

3. QC Software startup Repeat several times.

3
(Recommended number

Installation of FDR Mammography QC Program

of times: 5)
4. Exposure condition confirmation

5. Image basic test (user input)

6. Auto-calculation

7. Baseline value setting

8. QC Software shutdown

[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.
Make an exposure with 25 kV and W/Rh, and record the mAs when the air kerma is closest
to 30 mR.
• Fill in the following item in the worksheet.
mAs: _____mAs

2 Specify “Manu” mode for the X-ray equipment. Specify the following and then measure the air
kerma 3 times with the mAs recorded in Step 1 .
25 kV and W/Rh
• Fill in the following item in the worksheet.
Entrance air kerma: ‌_____mR µGy , _____µGy , _____µGy
mR mR

3 Remove the dosimeter.

Select [Study completed] to finish the test.

FDR Mammography QC Program Guidebook 897N120636 3-17

 1. Patient information entry and exposure 2. Image basic test (exposure)
menu selection
7 Set [Grid] to [OUT], and then make an
4 Enter patient information and press [Next]. exposure with the same conditions as
those used in Step 2 .
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____

3 5 Select [QC/TEST] in the exposure region

NOTE
It may take some time until you can press [QC]
list and [Semi-annual 1/1] in the exposure after completing the exposure process.
Installation of FDR Mammography QC Program

menu list, and then press [Start study.].

3. QC Software startup

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

4. Exposure condition confirmation

9 Check the exposure conditions.

6 The following exposure submenu is

displayed.
• Uniform Expo(Image Basic)

3-18 FDR Mammography QC Program Guidebook 897N120636

 5. Image basic test (user input) 6. Auto-calculation

10 Press [User input], enter the measured 11 Press [Measurement execution]. The
entrance air kerma and visual inspection results are displayed at the bottom of the
results (Pass/Fail), and then press [OK]. window.

TIP
(4)
(1) If “No baseline value is input.” appears,
press [OK].
(2)
NOTE
(3) In the last time measurement, skip Steps 12
through 14 and go to Step 15 .

When the result is displayed, press [Save]

3
12
and then [Close] to exit the QC Software.

Installation of FDR Mammography QC Program

(1) Enter the measured entrance air kerma
13 Select [Study completed] to finish the
recorded in Step 2 .
test.
(2) Select either of [Pass/Fail] for [Artifact] and
[White out].
(3)(4) Enter any values for items. 14 Repeat Steps 1 through 13 several
NOTE times (5 is recommended) to specify the
Some dosimeters may require correction of the averages of the multiple measured values
measured value according to the beam quality. as the baseline values.
NOTE NOTE
Enter values or select [Pass/Fail] for all of the Make sure to repeat the same procedure until
items. The Pass/Fail selection does not affect the test is finished. Do not add an exposure
the baseline value determination. submenu when repeating.
NOTE 15 When the result is displayed, press [Save]
Enter any value (e.g. “0” for all items) except for and then [Test data log].
negative or significantly large one. Otherwise,
an error occurs.

FDR Mammography QC Program Guidebook 897N120636 3-19

 7. Baseline value setting

16 Select the results to be used for calculating

the baseline values among the measured
results, and then press [Baseline value
creation]. This completes the baseline
value setting. Press [Close].

3
Installation of FDR Mammography QC Program

8. QC Software shutdown

17 Press [Save] and then [Close] to exit the

QC Software.

18 Select [Study completed] to finish the

test.

3-20 FDR Mammography QC Program Guidebook 897N120636

 3.4.3 Baseline Values for Daily/Weekly Test
The following Daily/Weekly Test items/contents require the baseline setting: CNR, 1 Shot Phantom
sensitivity constancy, Geometric distortion, Uniformity, Dynamic range, Spatial Resolution (SR), Low
Contrast Detectability (LCD) and Linearity/Beam quality constancy in Test with 1 Shot Phantom, and
Density difference (disk/outside) in Test with ACR Phantom. For each item, make exposures several
times using the 1 Shot 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.
NOTE
For performing image diagnosis on a softcopy display, the baseline value setting for the Test with ACR
Phantom is not needed.
Test Category Exposure Menu Test Items/Contents

Missed tissue on chest wall edge

CNR
1 Shot Phantom sensitivity constancy

Geometric distortion
3
System artifact evaluation

Installation of FDR Mammography QC Program

1 Shot PhantomM Test with 1 Shot Phantom
Daily/Weekly Test Uniformity

Dynamic range

Spatial Resolution (SR)

Low Contrast Detectability (LCD)

Linearity/Beam quality constancy

ACR Phantom Test with ACR Phantom

[1] Test with 1 Shot Phantom

[Test flow]

1. Patient information entry and exposure

menu selection

2. Test with 1 Shot Phantom

(exposure)
Repeat several times.
3. QC Software startup (Recommended number
of times: 5)
4. Exposure condition confirmation

5. Test with 1 Shot Phantom (user input)

6. Auto-calculation

7. Baseline value setting

8. QC Software shutdown

[Tools]
1 Shot Phantom

FDR Mammography QC Program Guidebook 897N120636 3-21

 [Baseline value setting procedure] 2. Test with 1 Shot Phantom (exposure)
1. Patient information entry and exposure Position the 1 Shot Phantom on the
menu selection 4
exposure table. Make sure that the
Enter patient information and press [Next]. compression plate is larger than the
1 phantom.
TIP
Use the 24 ×30 cm compression plate.

NOTE
Do not use the compression plate of the
following sizes: 24 × 30 cm (Small), 24 x 30 cm
(SSmall) or 18 x 24 cm (Small)
NOTE

3 Position the Phantom at the lateral center of the

exposure table by pressing the corners against
the chest wall-side edge of the exposure table.
If the positioning of the Phantom is unsuitable,
Installation of FDR Mammography QC Program

2 Select [QC/TEST] in the exposure region

list and [1 Shot PhantomM] in the exposure the test may not be conducted accurately.
menu list, and then press [Start study.].
1 Shot Phantom

3 The following exposure submenu is Exposure table

displayed.
• 1 Shot PhantomM Corner of the
1 Shot Phantom

5 Position the compression plate 45 mm

above the exposure table.

3-22 FDR Mammography QC Program Guidebook 897N120636

 6 Specify the following and make an 10 Select either of [Pass/Fail] for [1 Shot
exposure in “Semi” mode. Phantom image confirmation] and [Good
28 kV and W/Rh practice] items, and then press [OK].
• Fill in the following items in the worksheet.
NOTE
kVp: _____kV Enter values or select [Pass/Fail] for all of the
mAs: _____mAs items. The Pass/Fail selection does not affect
Target/Filter: _____/_____ the baseline value determination.
Compressed breast thickness: _____mm
Compression force: _____N
AEC density control function value: _____

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

3. QC Software startup

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

3

Installation of FDR Mammography QC Program

4. Exposure condition confirmation
6. Auto-calculation
8 Check the exposure conditions.
11 Press [Measurement execution]. The
results are displayed at the bottom of the
window.

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

5. Test with 1 Shot Phantom (user input) NOTE

In the last time measurement, skip Steps 12
9 Press [User input]. through 14 and go to Step 15 .

12 When the result is displayed, press [Save]

and then [Close] to exit the QC Software.

13 Select [Study completed] to finish the

test.

FDR Mammography QC Program Guidebook 897N120636 3-23

 14 Repeat Steps 2 through 13 several 8. QC Software shutdown
times (5 is recommended) to specify the
averages of the multiple measured values 17 Press [Save] and then [Close] to exit the
as the baseline values. QC Software.

NOTE
Make sure to repeat the same procedure until
the test is finished. Do not add an exposure
submenu when repeating. Select [Study completed] to finish the
18
test.
15 When the result is displayed, press [Save]
and then [Test data log].

3
Installation of FDR Mammography QC Program

7. Baseline value setting

16 Select the results to be used for calculating

the baseline values among the measured
results, and then press [Baseline value
creation].

3-24 FDR Mammography QC Program Guidebook 897N120636

 [2] Test with ACR Phantom
For performing image diagnosis on a softcopy display, the baseline value setting is not required.
[Test flow]

1. Patient information entry and exposure

menu selection

2. ACR Phantom (exposure)

Repeat several times.
3. QC Software startup (Recommended number
of times: 5)
4. Exposure condition confirmation

5. Image output

6. ACR Phantom (user input) 3

Installation of FDR Mammography QC Program

7. Auto-calculation

8. Baseline value setting

9. QC Software shutdown

[Tools]
ACR Phantom, an acrylic disk, a Step Phantom, and a densitometer
NOTE
The Step Phantom is required only when conducting visual inspection of it.

FDR Mammography QC Program Guidebook 897N120636 3-25

 [Baseline value setting procedure] 2. ACR Phantom (exposure)
1. Patient information entry and exposure Position the ACR Phantom at the lateral
menu selection 4
center of the exposure table while
Enter patient information and press [Next]. aligning its edge with the chest wall-side
1 edge of the exposure table.

5 Position the Step Phantom components

respectively 20 mm right and left of the
ACR Phantom, so that the blocks “1” and
“6” in the figure are located 20 mm away
from the chest wall-side edge.
NOTE
Skip this Step when visual inspection of the
Step Phantom is not conducted.

6 Position the acrylic disk wherever it does

3 not interfere with the visual inspection of
the ACR Phantom (as shown in the figure
2 Select [QC/TEST] in the exposure region below).
Installation of FDR Mammography QC Program

list and [ACR Phantom] in the exposure Nipple side

menu list, and then press [Start study.]. Step Phantom

20 mm
Step Phantom

ACR Phantom
Mass
Thickness:
0.5 mm

Specks
Diameter:
0.2 mm

20 mm

Chest wall side

Acrylic disk

7 Position the compression plate so that it

3 The following exposure submenu is
comes in contact with the ACR Phantom.
displayed.
• ACR Phantom NOTE
Make sure that excessive pressure is not
applied to the Phantom.

3-26 FDR Mammography QC Program Guidebook 897N120636

 8 Make an exposure in “Auto” or “Semi” 12 Measure the following items using the
mode. image output on film.
• Fill in the following items in the worksheet. • Fill in the following items in the worksheet.
kVp: _____kV Density inside the disk: _____
mAs: _____mAs Density outside the disk: _____
Target/Filter: _____/_____
Compressed breast thickness: _____mm 6. ACR Phantom (user input)
Compression force: _____N
AEC density control function value: _____ 13 Press [User input].
NOTE
It may take some time until you can press [QC]
after completing the exposure process.

3. QC Software startup 14 Enter the densities measured in Step 11 .

NOTE
9 Press [QC] to display the “QC window”.
Make sure to enter values for [Density inside
the disk/Density outside the disk] in the correct
3
position.

Installation of FDR Mammography QC Program

4. Exposure condition confirmation Enter any values for [Density at center of
Phantom image] and the image evaluation,
10 Check the exposure conditions.
then press [OK].
NOTE
Enter values for all of the items. The values
except those for [Density inside the disk/
Density outside the disk] do not affect the
baseline value determination.

5. Image output

11 Select an image exposed using Exposure

Submenu [ACR Phantom] from the
exposure condition display field and
press [Film output].

FDR Mammography QC Program Guidebook 897N120636 3-27

 7. Auto-calculation 8. Baseline value setting

15 Press [Measurement execution]. The 20 Select the results to be used for calculating
results are displayed at the bottom of the the baseline values among the measured
window. results, and then press [Baseline value
creation]. This completes the baseline
value setting. Press [Close].
NOTE
Make sure that the results for the Test with
TIP
ACR Phantom are selected. They are displayed
If “No baseline value is input.” appears, below those for the Test with 1 Shot Phantom.
press [OK].

NOTE
In the last time measurement, skip Steps 16

3
through 18 and go to Step 19 .

16 When the result is displayed, press [Save]

and then [Close] to exit the QC Software.
Installation of FDR Mammography QC Program

17 Select [Study completed] to finish the

test.

9. QC Software shutdown
18 Repeat Steps 1 through 17 several
21 Press [Save] and then [Close] to exit the
times (5 is recommended) to specify the QC Software.
averages of the multiple measured values
as the baseline values.
NOTE
Make sure to repeat the same procedure until
the test is finished. Do not add an exposure 22 Select [Study completed] to finish the
submenu when repeating. test.

19 When the result is displayed, press [Save]

and then [Test data log].

3-28 FDR Mammography QC Program Guidebook 897N120636

 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
3
result in the condition check performed when the Program has been installed.

Installation of FDR Mammography QC Program

Furthermore, it is advisable to observe an output image in the condition check at the time of
the Program installation with some people (conductors of the QC tests in the Program are
recommended) to share the points for evaluation in visual inspections.
See the relevant Chapters for the test procedures.
TIP
Conduct the tests in the order of their potential influence on displayed images.

Annual Test (Chapter 7)

Semi-annual Test (Chapter 6)

Daily/Weekly Test (Chapter 4)

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

FDR Mammography QC Program Guidebook 897N120636 3-29

3
Installation of FDR Mammography QC Program

3-30 FDR Mammography QC Program Guidebook 897N120636

 Chapter 4
Daily/Weekly 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
4.5 Conducting Daily Test ________________________________ 4-6
4.5.1Procedure________________________________________ 4-6
4.5.2Test Result Evaluation and Judgment_________________ 4-11
4.5.3Solutions for Failed Test Items_______________________ 4-11
4.6 Conducting Weekly Test______________________________ 4-12
4.6.1 Procedure________________________________________ 4-12
4.6.2 Test Result Evaluation and Judgment_________________ 4-16
4.6.3 Solutions for Failed Test Items_______________________ 4-17

FDR Mammography QC Program Guidebook 897N120636 4-1

 4.1 Test Flow
The Daily/Weekly Test is based on the quantitative measurement, enabling to catch a
gradual change in the image quality over time difficult to notice by visual checking.

6 months 1 year 1.5 years 2 years 2.5 years

Every day/week
Daily/Weekly Test

The Daily/Weekly Test is comprised of the constancy test and the performance verification test of the
system.
The constancy test is designed for judging if variations of regularly measured values regarding system
performance are within the allowable range (criteria) based on the values measured at a certain point as
the baseline values. The performance test is intended to check if the values regarding system performance
satisfy the upper or lower limit of judgment criteria specified by the guidelines.
It is necessary to determine the criteria before conducting the Daily/Weekly Test.

NOTE

4
The reference criteria are shown on the “The List of Reference Vales for Criteria and Baseline Values”.
See “3.3 Criteria Confirmation and Determination” for details.
Daily/Weekly Test

When conducting the Daily/Weekly Test the first time after setting the criteria, specify the baseline
values to be used in the future Daily/Weekly Tests. In the second or later Daily/Weekly Test, check that
the variation from the specified baseline values is within the criteria.
See “3.4 Baseline Value Settings” for details.

Initial setting, and criteria and baseline

value settings

First Daily/Weekly Test Exposure

1 Shot Phantom
Equipment use ACR Phantom

Daily/Weekly Test Cleaning

QC Software User input
Good practice

The result is within Auto-calculation

YES the criteria

NO Judgment

Taking corrective actions

Check that the variation from the specified baseline values is within the
criteria, or that the values indicating system performance satisfy the criteria.
If the criteria are satisfied, equipment can be used as is until the next
Daily/Weekly Test day. If the criteria are not satisfied, take corrective actions
by following "4.5.3 Solutions for Failed Test Items."

4-2 FDR Mammography QC Program Guidebook 897N120636

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

Items Auto-
calculated and Items Judged
Judged Based on [Pass/Fail]
Test Items/Contents Exposure Menus Exposure Submenus Input Data Based on Visual
Inspection by a
1. 2. Input User
Exposure Values
Missed tissue on chest
wall edge (40 mm height)
CNR
1 Shot Phantom
sensitivity constancy
Geometric distortion 3

 est with 1 Shot

T System artifact evaluation 3
1 Shot PhantomM 3
Phantom Uniformity 1 Shot PhantomM
Dynamic range
Spatial Resolution (SR)
Low Contrast
Detectability (LCD)

4
Linearity/Beam quality
constancy
Good practice - 3
Test with ACR Phantom ACR Phantom ACR Phantom 3 3

Daily/Weekly Test
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 Daily Test and 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.

NOTE
The Test with ACR Phantom is required to be conducted at a frequency defined by local regulations where
the equipment is to be used. If conducting the Test with ACR Phantom every day in addition to the Test with
1 Shot Phantom, select Exposure Menu [1 Shot/ACR].
In other cases, do not use the exposure menu. Otherwise, an incorrect test data log will be created.

FDR Mammography QC Program Guidebook 897N120636 4-3

 4.3 Tools
Tools to be used for the Daily/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 ] 1 Shot Phantom
[ D ] Viewing box (if film is used)
[ F ] ACR Phantom (including an acrylic disk)
[ G ] Step Phantom *1
[ M ] Densitometer (if film is used)
*1 Required only when conducting visual inspection of the Phantom.

4
Daily/Weekly Test

4-4 FDR Mammography QC Program Guidebook 897N120636

 4.4 Setting Confirmation
The following items described in Chapter 3 are required to be specified before conducting
the Daily/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
Missed tissue on chest wall edge (Right)
[mm] ___ mm or less
Missed tissue on chest wall
edge Missed tissue on chest wall edge
(Left) [mm] ___ mm or less

CNR CNR Baseline value ± ___%

1 Shot Phantom sensitivity
System sensitivity Baseline value ± ___%
constancy
Dimension (Horizontal) [mm] Baseline value ± ___%
Geometric distortion
Dimension (Vertical) [mm] Baseline value ± ___%
Pixel Value (PV) ratio (Top-Right) [%] Baseline value ± ___%
Pixel Value (PV) ratio (Top-Left) [%]
Pixel Value (PV) ratio (Bottom-Right) [%]
Baseline value ± ___%
Baseline value ± ___%
4
Pixel Value (PV) ratio (Bottom-Left) [%] Baseline value ± ___%

Daily/Weekly Test
Pixel Value (PV) ratio (Top center) [%] Baseline value ± ___%
Uniformity
SNR ratio (Top-Right) [%] Baseline value ± ___%
1 Shot PhantomM SNR ratio (Top-Left) [%] Baseline value ± ___%
SNR ratio (Bottom-Right) [%] Baseline value ± ___%
SNR ratio (Bottom-Left) [%] Baseline value ± ___%
SNR ratio (Top center) [%] Baseline value ± ___%

Dynamic range Average QL at thinnest step wedge [QL] Baseline value ± ___ QL

2lp/mm [%] Baseline value ± ___ %

Spatial Resolution (SR)
4lp/mm [%] Baseline value ± ___ %

Low Contrast Detectability Low Contrast Detectability (Light) [%] Baseline value ± ___ %
(LCD) Low Contrast Detectability (Dark) [%] Baseline value ± ___ %
QL gap (1 step-2 step) [QL] Baseline value ± ___ QL

Linearity/Beam quality QL gap (2 step-3 step) [QL] Baseline value ± ___ QL

constancy QL gap (3 step-4 step) [QL] Baseline value ± ___ QL
QL gap (4 step-5 step) [QL] Baseline value ± ___ QL
Density at center of Phantom image ___ ± ___

___ or more and baseline value ±

Density difference (disk/outside)
___

Fibers (ACR Phantom) ___ points or more

ACR Phantom Specks (ACR Phantom) ___ points or more
Masses (ACR Phantom) ___ points or more
Visible step wedge (Step Phantom) *1 ___ steps
Specks (Step Phantom) *1
___ steps or more
Masses (Step Phantom) *1
___ steps or more

TIP
The criteria setting is not required for visual inspection.

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

FDR Mammography QC Program Guidebook 897N120636 4-5

 4.5 Conducting Daily Test

4.5.1 Procedure

[Test flow]

1. Patient information entry and exposure menu selection

2. Test with 1 Shot Phantom (exposure)

3. Good practice (cleaning)

4. QC Software startup

5. Exposure condition confirmation

4 6. Image output

7. Test with 1 Shot Phantom (user input)

Daily/Weekly Test

8. Good practice (user input)

9. Auto-calculation

10. Test result confirmation

11. QC Software shutdown

TIP
When also conducting the Test with ACR Phantom every day, use Exposure Submenu [1 Shot/ACR] to
perform the “exposure” and “user input” steps of the Test with ACR Phantom immediately after performing
the respective steps of the Test with 1 Shot Phantom.

4-6 FDR Mammography QC Program Guidebook 897N120636

 1. Patient information entry and exposure 2. Test with 1 Shot Phantom (exposure)
menu selection
4 Follow the instructions below to conduct
1 Enter patient information and press [Next]. the test item.

[Tools]
1 Shot Phantom

1. Position the 1 Shot Phantom on the

exposure table.
TIP
Use the 24 ×30 cm compression plate.

NOTE
Position the Phantom at the lateral center
of the exposure table by pressing the
corners against the chest wall-side edge of
2 Select [QC/TEST] in the exposure region the exposure table. If there are obstacles at
list and [1 Shot PhantomM] in the exposure the time of positioning, the test may not be
menu list, and then press [Start study.]. conducted accurately.

1 Shot Phantom 4

Daily/Weekly Test
3 The following exposure submenu is
displayed.
Exposure table
• 1 Shot PhantomM
Corner of the
1 Shot Phantom

2. Position the compression plate 45 mm

above the exposure table.

FDR Mammography QC Program Guidebook 897N120636 4-7

 3. Specify the same kVp and target/filter as 3. Viewing box cleaning
those determined in the “3.4.3 Baseline Wipe clean the surface of the viewing box
Values for Daily/Weekly Test”. Then and check that the luminance is uniform.
make an exposure in “Semi” mode. Follow the instructions given by the
• Fill in the following items in the worksheet. manufacturer if any.
kVp: _____kV • Fill in the following items in the worksheet.
mAs: _____mAs X-ray equipment cleanliness: Pass/Fail
Target/Filter: _____/_____ Screen cleanliness: Pass/Fail
Compressed breast thickness: _____mm Viewing box cleanliness: Pass/Fail
Compression force: _____N
NOTE
AEC density control function value: It may take some time until you can
_____ press [QC] after completing the exposure
NOTE process.
Make sure to specify the same exposure
conditions as those used in the baseline 4. QC Software startup
value setting.
If they are not certain, newly determine Press [QC] to display the “QC window”.
6
the exposure conditions for the 1 Shot
Phantom by following “3.4.3 Baseline
Values for Daily/Weekly Test”.

4 5. Exposure condition confirmation

7 Check the exposure conditions.

Daily/Weekly Test

3. Good practice (cleaning)

5 Follow the instructions below to conduct

the test item.
[Tools]
See the respective operation manuals for the
FDR MS-3500, FDR-3000AWS, and viewing
box 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 given by the
manufacturer if any.

4-8 FDR Mammography QC Program Guidebook 897N120636

 6. Image output 8. Good practice (user input)

8 Select Exposure Submenu [1 Shot 11 Enter the results of Good practice, and
PhantomM] from the exposure condition then press [OK].
display field and press [Film output]. For
performing image diagnosis on a softcopy
display, press [Network output] to output
the image to the network.

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

Check or measure the following items

occurs.
4
9
using the image output on film. 9. Auto-calculation

Daily/Weekly Test
TIP
12 Press [Measurement execution]. The
For performing image diagnosis on a softcopy results are displayed at the bottom of the
display, check the items on the display.
window.

• Fill in the following items in the worksheet.

1 Shot Phantom
Geometric distortion: Pass/Fail
Artifact: Pass/Fail

7. Test with 1 Shot Phantom (user input)

10 Press [User input]. Enter the visual

inspection results.

FDR Mammography QC Program Guidebook 897N120636 4-9

 10. Test result confirmation

13 Check the displayed judgment results.

If there is a [Fail], see “4.5.3 Solutions for
Failed Test Items”.

4 11. QC Software shutdown

Daily/Weekly Test

14 Press [Save] and then [Close] to exit the

QC Software.

15 Select [Study completed] to finish the

test.

4-10 FDR Mammography QC Program Guidebook 897N120636

 4.5.2 Test Result Evaluation and Judgment
Evaluate and judge the Daily Test results. If all items are judged as [Pass], the Daily Test is finished.
If there is an item judged as [Fail], take corrective actions by following “4.5.3. Solutions for Failed Test
Items”.
See “8.2 Quick Guide for Software Operation” for test log display procedure.

4.5.3 Solutions for Failed Test Items

[1] Test with 1 Shot Phantom

Points to be checked
• The correct exposure submenu was selected.
• The same X-ray equipment settings (target/filter, kVp and AEC settings) have been
used during the test.
• The 1 Shot Phantom was correctly positioned.
• The same compression plate has been used during the test.
• The compression plate has been in the same position during the test.
• The 1 Shot Phantom of the correct size has been used. (If the size is different from
the one set in the initial setting window, calculation is not possible.)
• The size of the compression plate has been correct. (The 24 ×30 cm compression 4
plate is required.)

Daily/Weekly Test
If any of the above is not correct/appropriate, correct the problem.

n Only [System artifact evaluation] resulted in [Fail]

Remove the 1 Shot Phantom, Pass The 1 Shot Phantom may be
and then make a blank defective.
exposure to check for artifacts.

Clean the 1 Shot Phantom.

Fail

Contact a FUJIFILM dealer.

n Items other than above resulted in [Fail]

Make sure the size and position of the 1 Shot Pass
The test is finished.
Phantom are correct, and then redo the test.

Fail

Contact a FUJIFILM dealer.

[2] Good practice

Clean the equipment.

FDR Mammography QC Program Guidebook 897N120636 4-11

 4.6 Conducting Weekly Test

4.6.1 Procedure

[Test flow]

1. Patient information entry and exposure menu selection

2. Test with ACR Phantom (exposure)

3. QC Software startup

4. Exposure condition confirmation

5. Image output

4 6. Test with ACR Phantom (user input)

7. Auto-calculation
Daily/Weekly Test

8. Test result confirmation

9. QC Software shutdown

4-12 FDR Mammography QC Program Guidebook 897N120636

 1. Patient information entry and exposure 2. Test with ACR Phantom (exposure)
menu selection
4 Follow the instructions below to conduct
1 Enter patient information and press [Next]. the test item.

[Tools]
ACR Phantom, an acrylic disk, a Step
Phantom, 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 Step Phantom components
respectively 20 mm right and left of the
ACR Phantom, so that the blocks “1”
and “6” in the figure are located 20 mm
Select [QC/TEST] in the exposure region away from the chest wall-side edge.
2
list and [ACR Phantom] in the exposure NOTE
menu list, and then press [Start study.]. The Step Phantom is required only when
conducting visual inspection of it.
3. Position the acrylic disk wherever it does
4
not interfere with the visual inspection of

Daily/Weekly Test
the ACR Phantom (as shown in the figure
below).
Nipple side

Step Phantom Step Phantom

20 mm

ACR Phantom
Mass
Thickness:
0.5 mm

3 The following exposure submenu is Specks

Diameter:

displayed.
0.2 mm

• ACR Phantom
20 mm

Chest wall side

Acrylic disk

4. Position the compression plate so that it

comes in contact with the ACR Phantom.
NOTE
Make sure that excessive pressure is not
applied to the Phantom.

FDR Mammography QC Program Guidebook 897N120636 4-13

 5. Make an exposure in “Auto” or “Semi” 5. Image output
mode.
• Fill in the following items in the worksheet. 7 Select Exposure Submenu [ACR
kVp: _____kV Phantom] from the exposure condition
mAs: _____mAs display field and press [Film output].
Target/Filter: _____/_____ For performing image diagnosis on a
Compressed breast thickness: _____mm softcopy display, press [Network output]
Compression force: _____N to output the image to the network.
NOTE
It may take some time until you can press [QC]
after completing the exposure process.

3. QC Software startup

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

4. Exposure condition confirmation

4 6 Check the exposure conditions.

8 Check or measure the following items

Daily/Weekly Test

using the image output on film. Follow the

recommended image evaluation method
for the Phantom to evaluate the image.
TIP
For performing image diagnosis on a
softcopy display, check the items on the
display.

• Fill in the following items in the worksheet.

ACR Phantom
Density at center of Phantom image:
_____
Density inside the disk: _____
Density outside the disk: _____
Fibers (ACR Phantom): _____ points
Specks (ACR Phantom) : _____ points
Masses (ACR Phantom): _____ points
When using a Step Phantom:
Step Phantom
Visible step wedge (Step Phantom):
_____ steps
Specks (Step Phantom): _____ steps
Masses (Step Phantom): _____ steps

4-14 FDR Mammography QC Program Guidebook 897N120636

 6. Test with ACR Phantom (user input)

9 Press [User input]. Enter the measured

density and visual inspection results, and
then press [OK].
NOTE
Enter any integer from 0 to 10 when visual
inspection of the Step Phantom is not
conducted. If an item is left unentered, or a
negative value or value over 11 is entered, an
error occurs.
9. QC Software shutdown

12 Press [Save] and then [Close] to exit the

QC Software.

13 Select [Study completed] to finish the

test.
4

Daily/Weekly Test
NOTE
If a viewing box was set not to be used in “3.2
Initial Settings”, the density input fields will be
grayed out.

7. Auto-calculation

10 Press [Measurement execution]. The

results are displayed at the bottom of the
window.

8. Test result confirmation

11 Check the displayed judgment results.

If there is a [Fail], see “4.6.3 Solutions for
Failed Test Items”.

FDR Mammography QC Program Guidebook 897N120636 4-15

 4.6.2 Test Result Evaluation and Judgment
Evaluate and judge the Weekly Test results. If all items are judged as [Pass], the Weekly Test is finished.
If there is an item judged as [Fail], take corrective actions by following “4.6.3. Solutions for Failed Test
Items”.
See “8.2 Quick Guide for Software Operation” for test log display procedure.

4
Daily/Weekly Test

4-16 FDR Mammography QC Program Guidebook 897N120636

 4.6.3 Solutions for Failed Test Items

[3] Test with ACR Phantom

Points to be checked
• The correct exposure submenu was selected.
• The same X-ray equipment settings (target/filter, kVp and AEC settings) have
been used.
• The ACR Phantom, Step Phantom and acrylic disk were correctly positioned.
• The same compression plate has been used during the test.
• The compression plate has been in the same position during the test.
• The dosimeter was correctly used.
• The density was measured on the correct position.
• The quality control of the viewing condition is conducted.
If any of the above is not correct/appropriate, correct the problem.

Pass
Make sure that the ACR The test is finished.
Phantom is correctly positioned
and then redo the test.

4
Fail

Daily/Weekly Test
Contact a FUJIFILM dealer.

FDR Mammography QC Program Guidebook 897N120636 4-17

4
Daily/Weekly Test

4-18 FDR Mammography QC Program Guidebook 897N120636

 Chapter 5
Quarterly Test
Page

5.1 Test Flow_____________________________________________ 5-2

5.2 Test Items_____________________________________________ 5-3
5.3 Conducting Quarterly Test____________________________ 5-4
5.3.1 Procedure________________________________________ 5-4
5.3.2 Test Result Evaluation and Judgment_________________ 5-6
5.3.3 Solutions for Failed Test Items ______________________ 5-6

FDR Mammography QC Program Guidebook 897N120636 5-1

 5.1 Test Flow
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.

Installation 3 months 6 months 9 months 1 year 15 months

Quarterly Test

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.
The Repeat analysis is the required test item to be conducted in some areas. Conduct the analysis in
compliance with local regulations where the equipment is to be used.
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, an optional software for the FDR-3000AWS, is convenient for organizing
and managing the repeat analysis data.

Equipment use
Rejected image

5 Quarterly Test
analysis
Repeat analysis
Quarterly Test

The result is within

YES the criteria

NO

Taking corrective actions

Check if the criteria are satisfied.

If not satisfied, take corrective actions by following "5.3.3 Solutions for
Failed Test Items."

5-2 FDR Mammography QC Program Guidebook 897N120636

 5.2 Test Items
The Quarterly Test has the following test item.

Items Auto-calculated and Judged Based Items Judged

on Input Data [Pass/Fail]
Exposure
Test Items Exposure Menus Based on Visual
Submenus
1. Exposure 2. Input Values Inspection by a
User
Repeat analysis --- --- --- --- ---

The Quarterly Test requires no settings since the QC Software is not used in the Test.
The Test also requires no tool.
Simply record the result of the Repeat analysis in the report form.

Quarterly Test

FDR Mammography QC Program Guidebook 897N120636 5-3

 5.3 Conducting Quarterly Test

5.3.1 Procedure
[Test flow]
1. Repeat analysis (collecting rejected images)

2. Repeat analysis (calculating repeat rates)

3. Test result confirmation

1. Repeat analysis (collecting rejected TIP

images) Good images (they appear to be acceptable
mammograms when retrospectively
1 Start by removing all existing rejected evaluated during the Repeat analysis) may
images (hardcopy) in the department have also been repeated.
taken prior to the start of the analysis. Some images may not have resulted in
Take inventory of the image supply as an additional exposure of the patient
2
5 a starting point to determine the total
number of images consumed during this
but may have also been rejected. These
include clear and QC images. Although it
is appropriate to include wire localization
test.
Quarterly Test

images as part of the reject analysis,

3 Start collecting all rejected images. they should not be included in the repeat
Continue to collect for the length of analysis because they are taken as part of
time needed to radiograph at least 250 the wire localization process.
consecutive patients.

4 Sort the rejected images into categories

2. Repeat analysis (calculating repeat
such as poor positioning, motion,
rates)
compression, under exposure, (these
might be due to exposure or processing), Some facilities placing all images
artifacts (streaks, spots, etc.).
5
(repeated and good images) in the
NOTE patient’s film jacket have no repeated
Rejected images are all images that are in images in the department. In this case, the
the reject bin, including repeated images. reject/repeat analysis chart is completed
Repeated images are images that are retaken as patient examinations are carried out.
because of inadequate quality. The reject bin
does not include additional views required to 6 Tabulate the counts from Steps 4 and 5 ,
image selected tissue seen on the first image. determining the total number of repeated
It also does not include images taken for the images, rejected images, and the total
purposes of including tissue that could not be number of images exposed during the
positioned on the image receptor due to the analysis period.
size of the breast. For facilities using softcopy
for final interpretation maintain a list of repeated
images using the “REPEAT RATE ANALYSIS“
in “8.3 Worksheets”.

5-4 FDR Mammography QC Program Guidebook 897N120636

 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.

3. Test result confirmation

The overall repeat rate ideally should be

approximately 2% or less, but a rate of
5% is probably adequate if the radiologist
and medical physicist agree that this is a
reasonable level.
These rates should be based on an image
volume of at least 250 patients to be
meaningful.
A “reason for repeat” that is significantly
5
higher than the others indicates an area

Quarterly Test
for potential improvement.

FDR Mammography QC Program Guidebook 897N120636 5-5

 5.3.2 Test Result Evaluation and Judgment
Evaluate and judge the Quarterly Test results. If the criteria are satisfied, the test is completed. If not
satisfied, take corrective actions by following “5.3.3 Solutions for Failed Test Items”.

5.3.3 Solutions for Failed Test Items

Any corrective action should be recorded on the bottom of the “REPEAT RATE ANALYSIS” in “8.4
Report Forms”.
The effectiveness of the corrective actions must be assessed by performing another repeat analysis
after the corrective actions have been implemented.
It is important to study films that are too dark or too light to determine if the underlying cause is
the exposure equipment, image printer, patient positioning, technique or sub-optimal setting of digital
image processing.
If this test produces results that fall outside the action limits as specified, the source of the problem shall
be identified and corrective action shall be taken within thirty days of the test date. Clinical imaging and
mammographic image interpretation may be continued during this period.

5
Quarterly Test

5-6 FDR Mammography QC Program Guidebook 897N120636

 Chapter 6
Semi-annual Test
Page

6.1 Test Flow_____________________________________________ 6-2

6.2 Test Items_____________________________________________ 6-3
6.3 Tools__________________________________________________ 6-4
6.4 Setting Confirmation__________________________________ 6-5
6.5 Conducting Semi-annual Test_________________________ 6-6
6.5.1Procedure________________________________________ 6-6
6.5.2Test Result Evaluation and Judgment_________________ 6-12
6.5.3Solutions for Failed Test Items_______________________ 6-12

FDR Mammography QC Program Guidebook 897N120636 6-1

 6.1 Test Flow
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.

Installation 6 months 1 year 1.5 years 2 years 2.5 years

Semi-annual Test

The Semi-annual Test is comprised of the constancy test and the performance verification test of the
system.
The constancy test is designed for judging if variations of regularly measured values regarding system
performance are within the allowable range (criteria) based on the values measured at a certain point
as the baseline values. The performance test is intended to check if the values regarding system
performance satisfy the upper or lower limit of judgment criteria specified by the guidelines.
It is necessary to determine the criteria before conducting the Semi-annual Test.
NOTE
The reference criteria are shown on the “List of Reference Values for Criteria and Baseline Values”.
See “3.3 Criteria Confirmation and Determination” for details.
When conducting the Semi-annual Test the first time after setting the criteria, specify the baseline values
to be used in the future Semi-annual Tests. In the second or later Semi-annual Test, check that the
variation from the specified baseline values is within the criteria.
See “3.4 Baseline Value Settings” for details.

Initial setting, and criteria and baseline

6 value settings

First Semi-annual Test Exposure and

Semi-annual Test

measurement
Image basic test
Equipment use
Measurement

Semi-annual Test Compression device

confirmation
User input
QC Software
Measurement and
The result is within
performance check Auto-calculation
YES the criteria
Viewing box maintenance
Judgment
NO

Taking corrective actions

Check that the variation from the specified baseline values is within the
criteria, or that the values indicating system performance satisfy the criteria.
If the criteria are satisfied, equipment can be used as is until the next Semi-
annual Test day. If not satisfied, take corrective actions by following “6.5.3
Solutions for Failed Test Items”.

6-2 FDR Mammography QC Program Guidebook 897N120636

 6.2 Test Items
The Semi-annual Test consists of the following test items.

Items Auto-calculated and Judged Based Items Judged

on Input Data [Pass/Fail]
Exposure
Test Items Exposure Menu Based on Visual
Submenus
1. Exposure 2. Input Values Inspection by a
User
Uniform Expo
Image Basic Test 3 3 3
(Image Basic)
Compression device confirmation Semi-annual1/1 --- 3 3
Viewing box maintenance --- 3 3

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.

Semi-annual Test

FDR Mammography QC Program Guidebook 897N120636 6-3

 6.3 Tools
Tools to be used for the Semi-annual Test based on this Guidebook are shown below.
See “2.3 Tools” for details.

Tools
[ A ] QC Software
[ B ] Worksheet (See Chapter 8)
[ D ] Viewing box (if film is used)
[ E ] Timer or watch/clock
[ H ] Dosimeter
[ I ] Luminance meter
[ K ] Force scale
[ L ] Illuminance Meter
[ N ] PMMA phantom
[ Q ] Scale
[ T ] Lead sheet

6
Semi-annual Test

6-4 FDR Mammography QC Program Guidebook 897N120636

 6.4 Setting Confirmation
The following items described in Chapter 3 are required to be specified before conducting
the Semi-annual 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 Judgment Items Criteria

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

Compressed breast thickness accuracy [mm] ± __ mm or less

Compression device confirmation Compression force accuracy [N] ± __ N or less

Maximum compression force [N] __ to __ N

Luminance [cd/m2] __ cd/m2 or more

Viewing box maintenance
Interpretation room illuminance (Ambient light) [lx] __ lx or less

TIP
The criteria setting is not required for visual inspection.

Semi-annual Test

FDR Mammography QC Program Guidebook 897N120636 6-5

 6.5 Conducting Semi-annual Test

6.5.1 Procedure
[Test flow]
1. Image basic test (measurement)

2. Patient information entry and exposure menu selection

3. Image basic test (exposure)

4. Compression device confirmation (measurement)

5. Viewing box maintenance (measurement)

6. QC Software startup

7. Exposure condition confirmation

8. Image output

9. Image basic test (user input)

10. Compression device confirmation (user input)

6 11. Viewing box maintenance (user input)

12. Auto-calculation
Semi-annual Test

13. Test result confirmation

14. QC Software shutdown

6-6 FDR Mammography QC Program Guidebook 897N120636

 1. Image basic test (measurement) 2. Patient information entry and exposure
menu selection
1 Follow the instructions below to conduct
the test item. 2 Enter patient information and press [Next].
[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.
Nipple side

Exposure table

3 Select [QC/TEST] in the exposure region

list and [Semi-annual 1/1] in the exposure
Lateral center
menu list, and then press [Start study.].

60 mm

Dosimeter position Chest wall side

Exposure table
60 mm 40 mm

Chest wall side Nipple side

3. Select [QC/TEST] in the exposure region

list and [Calculation 1/2] in the exposure
6
4 The following exposure submenu is
menu list, and then press [Start study.].

Semi-annual Test
displayed.
Specify the kVp, mAs and target/filter
• Uniform Expo(Image Basic)
determined in “3.4.2 Baseline Values for
Semi-annual 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 , _____µGy , _____µGy
mR mR

NOTE
Make sure to specify the same exposure
conditions as those used in the baseline
value setting.
If they are not certain, newly determine the
exposure conditions for the Semi-annual
Test by following “3.4.2 Baseline Values for
Semi-annual Test”.
4. Remove the dosimeter.
Select [Study completed] to finish the test.

FDR Mammography QC Program Guidebook 897N120636 6-7

 3. Image basic test (exposure) 4. Remove the PMMA phantom, then
position the force scale at the lateral
5 Follow the instructions below to conduct center of the exposure table, about 60
the test item. mm away from the chest wall-side edge.
Set [Grid] to [OUT], and then make an
exposure with the same conditions as those
used in Substep 3 in Step 1 .
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____

4. Compression device confirmation

(measurement) 60mm

6 Follow the instructions below to conduct

the test item. NOTE
[Tools] Ensure that the compression force is
A force scale, timer or watch/clock, PMMA evenly applied to the measurement part of
phantom (40 mm), and scale the force scale. If compression is not even,
the measurement may result in an incorrect
1. Position the PMMA phantom (40 mm) on value.
the exposure table.
5. Apply the same compression force
2. Apply compression force most frequently as that used in Substep 2 and record
used in clinical practice and record the the display value for the compression
display value for compressed breast force on the X-ray equipment and the
thickness on the X-ray equipment. measured value.
• Fill in the following item in the worksheet. • Fill in the following items in the worksheet.
Compressed breast thickness Compression force display value:

6
measured value: _____mm _____N
Compression force measured value:
_____N
Semi-annual Test

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.
3. Measure thickness of the compressed Maximum compression force:
PMMA phantom (40 mm) by using a _____N
scale.
• Fill in the following item in the worksheet.
Compressed breast thickness measured
value: _____mm

6-8 FDR Mammography QC Program Guidebook 897N120636

 5. Viewing box maintenance 6. QC Software startup
(measurement)
8 Press [QC] to display the “QC window”.
7 Follow the instructions below to conduct
the test item.
[Tools]
A viewing box, luminance meter, and 7. Exposure condition confirmation
illuminance meter
9 Check the exposure conditions.
NOTE
Check the viewing box performance under the
normal use condition.
1. Turn on the viewing box and wait until the
luminance becomes stable.
2. Measure the luminance at the center of
the viewing box by using a luminance
meter.
• Fill in the following item in the worksheet.
Luminance: _____cd/m2
3. Visually check if the viewing box
luminance is uniform. 8. Image output
• Fill in the following item in the worksheet.
10 Select Exposure Submenu [Uniform
Viewing box uniformity: Pass/Fail
Expo(Image Basic)] from the exposure
4. When the viewing box has a luminance condition display field and press [Film
adjustment function, check if the function output]. For performing image diagnosis
works correctly. on a softcopy display, press [Network
• Fill in the following item in the worksheet. output] to output the image to the network.
Luminance adjustment function:

5. When the viewing box has a masking

Pass/Fail
6
function, check if the function works

Semi-annual Test
correctly.
• Fill in the following item in the worksheet.
Masking: Pass/Fail
6. Measure the illuminance near the viewing
box, 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
NOTE
See the operation manuals for the viewing
box, luminance meter or illuminance meter
for how to measure the luminance or
illuminance.
NOTE
It may take some time until you can
press [QC] after completing the exposure
process.

FDR Mammography QC Program Guidebook 897N120636 6-9

 11 Check for artifacts and white-out in the 10. Compression device confirmation (user
printed image. In image diagnosis on a input)
softcopy display, check these items on
the display. 14 Enter the measured values, display values
• Fill in the following items in the worksheet. and visual inspection result (Pass/Fail).
Artifact: Pass/Fail
White out: Pass/Fail
Image frame

White-out

9. Image basic test (user input)

Press [User input]. 11. Viewing box maintenance (user input)

12
15 Enter the measured value and visual
inspection results, and then press [OK].

13 Enter the measured air kerma and visual

inspection results ([Pass/Fail]).
NOTE
Some dosimeters may require correction of the
6 measured value according to the beam quality.
Semi-annual Test

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

12. Auto-calculation

16 Press [Measurement execution]. The

results are displayed at the bottom of the
window.

6-10 FDR Mammography QC Program Guidebook 897N120636

 13. Test result confirmation

17 Check the displayed judgment results.

If there is a [Fail], see “6.5.3 Solutions for
Failed Test Items”.

14. QC Software shutdown

18 Press [Save] and then [Close] to exit the

QC Software.

19 Select [Study completed] to finish the

test.

Semi-annual Test

FDR Mammography QC Program Guidebook 897N120636 6-11

 6.5.2 Test Result Evaluation and Judgment
Evaluate and judge the Semi-annual Test results. If all items are judged as [Pass], the Semi-annual Test
is finished. If there is an item judged as [Fail], take corrective actions by following “6.5.3 Solutions for
Failed Test Items”.
See “8.2 Quick Guide for Software Operation” for test log display procedure.

6.5.3 Solutions for Failed Test Items

[1] Image basic test

n [Artifact] resulted in [Fail]
Points to be checked
• The correct exposure submenu was selected.
• The X-ray equipment settings (target/filter, kVp) were correct.
• The air kerma used for the exposures was appropriate.
• There are no scratches or dirt on the exposure table or compression plate.
• The quality control of the softcopy/hardcopy output equipment is conducted.
• The viewing condition is appropriate.
If any of the above is not correct/appropriate, correct the problem.

Pass
Redo the test. The test is finished.

Fail

Contact a FUJIFILM dealer.

6
n [Relative sensitivity] resulted in [Fail]
Semi-annual Test

Points to be checked
• The correct exposure submenu was selected.
• The X-ray equipment settings (target/filter, kVp) were correct.
• The air kerma used for the exposures was appropriate.
• The dosimeter was correctly positioned.
• The dosimeter was correctly used.
If any of the above is not correct/appropriate, correct the problem.

Pass
Redo the test. The test is finished.
Fail
The X-ray equipment or
dosimeter may be defective.

Contact a FUJIFILM dealer.

6-12 FDR Mammography QC Program Guidebook 897N120636

 n [White out] resulted in [Fail]
Points to be checked
• The correct exposure submenu was selected.
• The X-ray equipment settings (target/filter, kVp) were correct.
• There are no scratches or dirt on the exposure table or compression plate.
• The quality control of the softcopy/hardcopy output equipment is conducted.
• The viewing condition is appropriate.
If any of the above is not correct/appropriate, correct the problem.

Pass
Redo the test. The test is finished.
Fail

The X-ray equipment may be defective.

Contact a FUJIFILM dealer.

[2] Compression device confirmation

Points to be checked
• The force scale was correctly used.
• [N] is specified as the unit of force.
• [mm] is specified as the unit of compressed breast thickness.
• The compressed breast thickness was measured at the correct position.
If any of the above is not correct/appropriate, correct the problem.

Redo the test.

Fail
Pass
The test is finished.
6

Semi-annual Test
The X-ray equipment may be defective.

Contact a FUJIFILM dealer.

[3] Viewing box maintenance

n [Viewing box luminance] resulted in [Fail]
Points to be checked
• The luminance meter was correctly used.
• [cd/m2] is specified as the unit of luminance.
• The luminance was measured at the correct position.
If any of the above is not correct/appropriate, correct the problem.

Pass
Redo the test. The test is finished.

Fail

Contact a dealer of the viewing box manufacturer.

FDR Mammography QC Program Guidebook 897N120636 6-13

 n [Interpretation room illuminance (Ambient light)] resulted in [Fail]
Points to be checked
• The illuminance meter was correctly used.
• [lx] is specified as the unit of illuminance.
• The illuminance was measured at the correct position.
If any of the above is not correct/appropriate, correct the problem.

Pass
Redo the test. The test is finished.
Fail

Improve the viewing condition.

6
Semi-annual Test

6-14 FDR Mammography QC Program Guidebook 897N120636

 Chapter 7
Annual 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 ______________________________ 7-7
7.5.1 Image Performance Test____________________________ 7-7
1. Procedure____________________________________ 7-7
2. Test Result Evaluation and Judgment___________ 7-13
3. Solutions for Failed Test Items__________________ 7-13
7.5.2 Spatial Resolution Test_____________________________ 7-15
1. Procedure____________________________________ 7-15
2. Test Result Evaluation and Judgment___________ 7-18
3. Solutions for Failed Test Items__________________ 7-18
7.5.3 X-ray Equipment Performance Test___________________ 7-19
1. Procedure____________________________________ 7-19
2. Test Result Evaluation and Judgment___________ 7-31
3. Solutions for Failed Test Items__________________ 7-31 7
7.5.4 AEC System Performance Test______________________ 7-33
1. Procedure____________________________________ 7-33
2. Test Result Evaluation and Judgment___________ 7-45
3. Solutions for Failed Test Items__________________ 7-45

FDR Mammography QC Program Guidebook 897N120636 7-1

 7.1 Test Flow
The Annual Test is designed for checking that performance of the X-ray equipment is
maintained.
Since the Annual Test has more test items than the Semi-annual Test, further detailed
quality control of the system can be performed.

Installation 6 months 1 year 1.5 years 2 years 2.5 years

Annual Test

The Annual Test is comprised of the constancy test and the performance verification test of the system.
The constancy test is designed for judging if variations of regularly measured values regarding system
performance are within the allowable range (criteria) based on the values measured at a certain point
as the baseline values. The performance test is intended to check if the values regarding system
performance satisfy the upper or lower limit of judgment criteria specified by the guidelines.
It is necessary to determine the criteria before conducting the Annual Test.

NOTE
The reference criteria are shown on the “List of Reference Values for Criteria and Baseline Values”.
See “3.3 Criteria Confirmation and Determination” for details.
When conducting the Annual Test the first time after setting the criteria, specify the baseline values to
be used in the future Annual Tests. In the second or later Annual Test, check that the variation from the
specified baseline values is within the criteria.
See “3.4 Baseline Value Settings” for details.

Initial setting, and criteria and baseline

value settings

First Annual Test Exposure and

7 measurement
QC Software User input
Equipment use (1) Image performance
Annual Test

(2) Spatial Resolution

Auto-calculation
(3) X-ray equipment
Annual Test performance
(4) AEC system performance Judgment

The result is within

YES the criteria

NO

Taking corrective actions

Check that the variation from the specified baseline values is within the
criteria, or that the values indicating system performance satisfy the criteria.
If the criteria are satisfied, equipment can be used as is until the next Annual
Test day. If not satisfied, take corrective actions by following "3 Solutions for
Failed Test Items" in the relevant subsection.

7-2 FDR Mammography QC Program Guidebook 897N120636

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

Items Auto-
calculated and Items Judged
Judged Based on [Pass/Fail]
Test Types/Items Exposure Menus Exposure Submenus Input Data Based on Visual
Inspection by a
1. 2. Input User
Exposure Values
ACR Phantom1(Lag) 3
Additive lag effects (Lag)
Non Exposure(Lag) 3
Uniform Expo.1(Ghost) 3
 ultiplicative lag effects
M
Image performance Annual 1/6 ACR Phantom2(Ghost) 3
(Ghost)
Uniform Expo.2(Ghost) 3
 issed tissue on chest
M
1 Shot PhantomM(40mm) 3 3
wall edge (40 mm height)
Visual and Functional test - 3
Spatial Resolution
Spatial Resolution Annual 2/6 1 ShotM(Magnification) 3
(Magnification)
k Vp accuracy and
- 3
reproducibility
X-ray equipment Half Value Layer (HVL) - 3
Annual 3/6
performance
Collimation assessment Uniform Expo.3(Collimation) 3 3
Radiation output - 3
AEC reproducibility - 3
Mode1 through Mode3
CNR(PMMA20mm) 3

Mode1 through Mode3

CNR(PMMA40mm) 3
AEC system Annual 4/6 through
CNR modes 1 to 3
performance Annual 6/6 Mode1 through Mode3
CNR(PMMA60mm) 3

Mode1 through Mode3

CNR(PMMA70mm) 3

AGD modes 1 to 3 - 3

Three judgment methods:

1. Auto-calculation by the QC Software based on the image data acquired by 7
making an exposure.
2. Auto-calculation by the QC Software based on the input measurement data. Annual Test
3. User selection of [Pass/Fail] based on visual inspection of the image.

NOTE
The Missed tissue on chest wall edge (40 mm height) is the required test item to be conducted in some areas.
Conduct the analysis in compliance with local regulations where the equipment is to be used.

FDR Mammography QC Program Guidebook 897N120636 7-3

 7.3 Tools
Tools to be used for the Annual Test based on this Guidebook are shown below.
See “2.3 Tools” for details.

Tools
[ A ] QC Software
[ B ] Worksheet (See Chapter 8)
[ C ] 1 Shot Phantom
[ D ] Viewing box (if film is used)
[ F ] ACR Phantom
[ H ] Dosimeter
[ J ] kVp meter
[ 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 (0.5 and 0.6 mm)
[ Q ] Scale
[ R ] Coins
[ S ] Jig for 1 Shot Phantom*1
[ T ] Lead sheet

*1 ‌
The jig for 1 Shot Phantom is required only in the Missed tissue on chest wall edge
(40 mm height) measurement.

7
Annual Test

7-4 FDR Mammography QC Program Guidebook 897N120636

 7.4 Setting Confirmation
The 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

[Items allowing criteria change]

Test Items Judgment Items Criteria

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

Multiplicative lag effects (Ghost) Ghost factor Below ___

MTF (4lp/mm) Baseline value ± ___%

Spatial Resolution (Magnification)
MTF (8lp/mm) Baseline value ± ___%

Low volt. accuracy (LFS) [kV] Specified kVp ± ___ kV

Mid. volt. accuracy (LFS) [kV] Specified kVp ± ___ kV

High volt. accuracy (LFS) [kV] Specified kVp ± ___ kV

kVp accuracy and reproducibility Low volt. accuracy (SFS) [kV] Specified kVp ± ___ kV

Mid. volt. accuracy (SFS) [kV] Specified kVp ± ___ kV

High volt. accuracy (SFS) [kV] Specified kVp ± ___ kV

Mid. volt. reproducibility (LFS) [kV] Reproducibility ± ___% or less

X-ray / Light field gap (Right/Left) [mm] Total gap criteria = SID X ___ or less

X-ray / Light field gap (Chest/Nipple) [mm] Total gap criteria = SID X ___ or less

X-ray / Image receptor field gap (Left) [mm] SID X ___ or less
Collimation assessment
X-ray / Image receptor field gap (Right) [mm] SID X ___ or less

X-ray / Image receptor field gap (Nipple) [mm] SID X ___ or less

X-ray field / Exposure table gap [mm] ___ mm or less

7
Reproducibility Variation coefficient ___ or less

Radiation output Air kerma rate [mGy/s] ___ mGy/s or more

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

Annual Test

FDR Mammography QC Program Guidebook 897N120636 7-5

 [Items allowing criteria change]
Test Items Judgment Items Criteria
Entrance air kerma accuracy [%] Average ± ___ or less
AEC reproducibility
Entrance air kerma reproducibility Variation coefficient ___ or less
CNR relative value 20mm [%] Baseline value ___ or more
CNR relative value 40mm [%] Baseline value ___ or more
CNR modes 1
CNR relative value 60mm [%] Baseline value ___ or more
CNR relative value 70mm [%] Baseline value ___ or more
CNR relative value 20mm [%] Baseline value ___ or more
CNR relative value 40mm [%] Baseline value ___ or more
CNR modes 2
CNR relative value 60mm [%] Baseline value ___ or more
CNR relative value 70mm [%] Baseline value ___ or more
CNR relative value 20mm [%] Baseline value ___ or more
CNR relative value 40mm [%] Baseline value ___ or more
CNR modes 3
CNR relative value 60mm [%] Baseline value ___ or more
CNR relative value 70mm [%] Baseline value ___ or more
AGD 20 mm [mGy] ___ mGy or less
AGD 40 mm [mGy] ___ mGy or less
AGD modes 1 to 3
AGD 60 mm [mGy] ___ mGy or less
AGD 70 mm [mGy] ___ mGy or less

TIP
• The criteria can be specified for each of the CNR modes (1 to 3).
The criteria setting is not required for visual inspection.
• [CNR_H-mode], [CNR_N-mode] and [CNR_L-mode] in the window correspond to the CNR modes 1, 2
and 3, respectively.
• As in CNR modes, AGD modes 1 to 3 correspond to the respective AEC modes. However, a value is
commonly specified as the criteria for AGD modes (1 to 3).

7
Annual Test

7-6 FDR Mammography QC Program Guidebook 897N120636

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

7.5.1 Image Performance Test

1. Procedure
[Test flow]
The image performance test consists of the Additive lag effects (Lag), Multiplicative lag effects (Ghost),
Missed tissue on chest wall edge (40 mm height) and Visual and Functional test.

1. Patient information entry and exposure menu selection

2. Additive lag effects (Lag) (exposure)

3. Multiplicative lag effects (Ghost) (exposure)

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

5. Visual and Functional test (checking)

6. QC Software startup

7. Exposure condition confirmation

8. Missed tissue on chest wall edge (40 mm height) (measurement)

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

10. Visual and Functional test (user input)

11. Auto-calculation 7
12. Test result confirmation Annual Test

13. QC Software shutdown

NOTE
The Missed tissue on chest wall edge (40 mm height) is a required test item to be conducted in some areas.
Conduct the analysis in compliance with local regulations where the equipment is to be used.
If not conducting the test item, the above Step “8. Missed tissue on chest wall edge (40 mm height)
(measurement)” can be skipped, but not 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)”. Perform operations in these Steps by
following the procedure without conducting the test item.

FDR Mammography QC Program Guidebook 897N120636 7-7

 1. Patient information entry and exposure 2. Additive lag effects (Lag) (exposure)
menu selection
4 Follow the instructions below to conduct
1 Enter patient information and press [Next]. the test item.
Make 2 exposures using the following exposure
submenus:
[ACR Phantom1(Lag)]
[Non Exposure(Lag)]
[Tools]
ACR Phantom
1. Position the ACR Phantom at the lateral
center of the exposure table while
aligning its edge with the chest wall-side
edge of the exposure table.
2. Remove the compression plate.
Nipple side

2 Select [QC/TEST] in the exposure region Exposure table

list and [Annual 1/6] in the exposure menu

list, and then press [Start study.]. ACR Phantom

Chest wall side

3. Specify the following and make an

exposure in “Manu” mode.
28 kV, 80 mAs and W/Rh
• Fill in the following items in the worksheet.
kVp: ______kV
mAs: ______mAs
Target/Filter: ______/______
3 The following exposure submenus are
displayed. 4. Place a lead sheet on the exposure table,
• ACR1: ACR Phantom1(Lag) specify the following, and then make

7 • NON: Non Exposure(Lag)

• UNI 1: Uniform Expo.1(Ghost)
anexposure in “Manu” mode.
23 kV, 2 mAs and W/Rh
• ACR 2: ACR Phantom2(Ghost)
Annual Test

• UNI 2: Uniform Expo.2(Ghost)

• 1ST40: 1 Shot PhantomM(40mm)

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

7-8 FDR Mammography QC Program Guidebook 897N120636

 3. Multiplicative lag effects (Ghost) 5. Remove the ACR Phantom.
(exposure) 6. Specify the following and make an
exposure in “Manu” mode.
5 Follow the instructions below to conduct 28 kV, 10 mAs and W/Rh
the test item.
• Fill in the following items in the worksheet.
Make 3 exposures using the following exposure kVp: ______kV
submenus:
mAs: ______mAs
[Uniform Expo.1(Ghost)] Target/Filter: ______/______
[ACR Phantom2(Ghost)]
[Uniform Expo.2(Ghost)]
[Tools]
ACR Phantom
1. Remove the compression plate.
2. Specify the following and make an
exposure in “Manu” mode. 4. Missed tissue on chest wall edge
28 kV, 10 mAs and W/Rh (40 mm height) (exposure)
• Fill in the following items in the worksheet.
kVp: ______kV 6 Follow the instructions below to conduct
mAs: ______mAs the test item.
Target/Filter: ______/______ Make an exposure using the following exposure
submenu:
3. Position the ACR Phantom on the right-
[1 Shot PhantomM(40mm)]
hand half of the exposure table while
aligning the edges with the lateral center NOTE
line and the chest wall-side edge of the If this test item is not conducted, make an
exposure using Exposure Submenu [1 Shot
exposure table as shown in the figure
PhantomM(40mm above)] and go to Step 7 .
below.
[Tools]
NOTE
1 Shot Phantom and a jig for 1 Shot Phantom
The ACR Phantom position differs from
the normal position used for the exposure. NOTE
Make sure that the phantom covers the The 1 Shot Phantom must be positioned 40
Calculation Area 2 without protruding into mm above the exposure table in this test. Use
the left-hand half of the exposure table. the jig to position the Phantom at the specified
height.

Exposure table
Nipple side
See “Tool Details” in “2.3 Tools” for details 7
on the jig for 1 Shot Phantom.
Annual Test
Calculation Areas TIP
(20 mm x 20 mm) ACR Phantom
Use the same exposure conditions as those
used for the Phantom exposure in the Daily/
1 2 Weekly Test. See “3.4.3 Baseline Values for
20 mm Daily/Weekly Test” for details.
60 mm

Chest wall side

4. Specify the following and make an

exposure in “Manu” mode.
28 kV, 80 mAs and W/Rh
• Fill in the following items in the worksheet.
kVp: ______kV
mAs: ______mAs
Target/Filter: ______/______

FDR Mammography QC Program Guidebook 897N120636 7-9

 1. Position the 1 Shot Phantom using the jig 5. Visual and Functional test (Checking)
above the exposure table.
7 Follow the instructions below to conduct
NOTE
Position the Phantom by pressing the
the test item.
corners against the chest wall-side edge of Check the following points and enter the
the jig. judgment results (Pass/Fail) in the worksheet.
2. Move the compression plate as close to n I‌ tems under [X-ray equipment test 2 - Visual
the Phantom as possible without making and Functional test] on the [Annual1-1] tab
contact. • Verify mechanical stability
TIP • Verify that all moving parts move smoothly
Reinstall the compression plate removed • All locks and detents work properly
for the Multiplicative lag effects (Ghost) • No sharp, rough edges or other hazards
test. including electrical hazards
• Operator technique control charts are
posted
Measurement points
for missed tissue on • Operator protected during exposure by
the chest wall edge adequate radiation shielding
• All indicator lights working properly
• Auto decompression can be overridden
and status displayed
• Compression can be manually released / in
any failure

NOTE
Beware that the jig does not overlap with
the measurement points of the Missed
tissue on chest wall edge.
3. Specify the exposure conditions closest
to those used for the 1 Shot Phantom
exposure in the Daily/Weekly Test in
7 “Manu” mode and make an exposure.
• Fill in the following items in the worksheet.
kVp: ______kV 6. QC Software startup
Annual Test

mAs: ______mAs Press [QC] to display the “QC window”.

Target/Filter: ______/______ 8
Compressed breast thickness:
_____mm
Compression force: _____N

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

7-10 FDR Mammography QC Program Guidebook 897N120636

 7. Exposure condition confirmation 11 Measure the missed tissue on the right
and left sides of the chest wall edge in the
9 Check the exposure conditions. 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
8. Missed tissue on chest wall edge (40 mm
height)

If not measuring the Missed tissue on

chest wall edge (40 mm height), go to
Step 12 .

10 Select the Exposure Submenu [1 Shot

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.

10 mm
9 mm
8 mm
7 mm

7
6 mm
5 mm
4 mm
3 mm
2 mm Annual Test
1 mm

Chest wall side

B

FDR Mammography QC Program Guidebook 897N120636 7-11

 9. Missed tissue on chest wall edge (40 mm 11. Auto-calculation
height) (user input)
15 Press [Measurement execution]. The
12 Press [User input]. results are displayed at the bottom of the
window.

13 Select the [Annual1-1] tab and enter the

results (Pass/Fail). 12. Test result confirmation
If not measuring the Missed tissue on
16 Check the displayed judgment results.
chest wall edge (40 mm height), select
either of [Pass/Fail] and go to Step 14 . If there is a [Fail], see “7.5.1 3. Solutions
for Failed Test Items”.

13. QC Software shutdown

10. Visual and Functional test (user input) 17 Press [Save] and then [Close] to exit the
QC Software.
14 Select the results ([Pass/Fail]) and press
[OK].

7 18 Select [Study completed] to finish the

test.
Annual Test

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

7-12 FDR Mammography QC Program Guidebook 897N120636

 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 “7.5.1 3. Solutions for Failed Test Items”.
See “8.2 Quick Guide for Software Operation” for test log display procedure.

3. Solutions for Failed Test Items

[1] Additive lag effects (Lag)
Points to be checked
• The correct exposure submenus were selected.
• The X-ray equipment settings (target/filter, kVp) were correct.
• The air kerma used for the exposures was appropriate.
• The test was done following correct procedure.
• The ACR Phantom was correctly positioned.
If any of the above is not correct/appropriate, correct the problem.

Pass
Redo the test. The test is finished.
Fail

Contact a FUJIFILM dealer.

[2] Multiplicative lag effects (Ghost)

Points to be checked
• The correct exposure submenus were selected.
• The X-ray equipment settings (target/filter, kVp) were correct.
• The air kerma used for the exposures was appropriate.
• The test was done following correct procedure.
• The ACR Phantom was correctly positioned.
If any of the above is not correct/appropriate, correct the problem.
7
Pass Annual Test
Redo the test. The test is finished.
Fail

Contact a FUJIFILM dealer.

FDR Mammography QC Program Guidebook 897N120636 7-13

 [3] Missed tissue on chest wall edge (40 mm height)
Points to be checked
• The correct exposure submenu was selected.
• The X-ray equipment settings (target/filter, kVp) were correct.
• The 1 Shot Phantom or the jig was correctly positioned.
If any of the above is not correct/appropriate, correct the problem.

Check the result of the Missed tissue on chest

wall edge (40 mm height) in the Daily/Weekly
Test.

The Missed tissue on chest wall The Missed tissue on chest wall
edge (40 mm height) in the edge (40 mm height) in the Daily/Weekly
Daily/Weekly Test has been Test has been judged as “Pass” in
occasionally judged as “Fail”. every test.

Pass
Change the 1 Shot Phantom The test is finished.
position or its jig, and then redo
the test.

Fail

The X-ray equipment may

be defective.

Contact a FUJIFILM dealer.

[4] Visual and Functional test

Contact a FUJIFILM dealer.

7
Annual Test

7-14 FDR Mammography QC Program Guidebook 897N120636

 7.5.2 Spatial Resolution Test
If a magnified exposure is not made in clinical practice, this test is not required. Go to
“7.5.3. X-ray Equipment Performance Test”.

1. Procedure
[Test flow]
The spatial resolution test has only a single test item.

1. Patient information entry and exposure menu selection

2. Spatial Resolution (Magnification) (exposure)

3. QC Software startup

4. Exposure condition confirmation

5. Auto-calculation

6. Test result confirmation

7. QC Software shutdown

7
Annual Test

FDR Mammography QC Program Guidebook 897N120636 7-15

 1. Patient information entry and exposure 2. Spatial Resolution (Magnification)
menu selection (exposure)

1 Enter patient information and press [Next]. 4 Follow the instructions below to conduct
the test item.
Make an exposure using the following exposure
submenu:
[1 ShotM(Magnification)]
[Tools]
1 Shot Phantom

1. Install the magnification table of the X-ray

equipment and the compression plate
normally used in magnified exposure in
clinical practice.
2. Position the 1 Shot Phantom being
2 Select [QC/TEST] in the exposure region shifted to the right-hand side so that the
list and [Annual 2/6] in the exposure menu area indicated by the broken line in the
list, and then press [Start study.]. below figure is at the lateral center of the
X-ray field.
NOTE
Position the Phantom for exposure, the
same as in “3.4.1 Baseline Values for
Annual Test”.

3 The following exposure submenu is

displayed.
• 1 ShotM(Magnification)
7
Annual Test

NOTE
If the area in the broken line is out of the
X-ray field when the Phantom is positioned
by pressing its corners against the chest
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.

7-16 FDR Mammography QC Program Guidebook 897N120636

 4. Exposure condition confirmation

6 Check the exposure conditions.

NOTE
The Phantom position must be the same
for every exposure (the allowable positional 5. Auto-calculation
error is within ± 5 mm).
7 Press [Measurement execution]. The
• Fill in the following item in the worksheet.
results are displayed at the bottom of the
1 Shot Phantom position
window.
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”. 6. Test result confirmation
• Fill in the following items in the worksheet. Check the displayed judgment results.
kVp: ______kV 8
If there is a [Fail], see “7.5.2 3. Solutions
mAs: ______mAs
for Failed Test Items”.
Target/Filter: ______/______
Compressed breast thickness: _____mm
Compression force: _____N

7
NOTE Annual Test
It may take some time until you can press [QC] 7. QC Software shutdown
after completing the exposure process. Press [Save] and then [Close] to exit the
9
QC Software.
3. QC Software startup

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

10 Select [Study completed] to finish the

test.

FDR Mammography QC Program Guidebook 897N120636 7-17

 2. Test Result Evaluation and Judgment
Evaluate and judge the result of the spatial resolution test in the Annual Test. If all items are judged as
[Pass], the spatial resolution test is finished. If there is an item judged as [Fail], take corrective actions
by following “7.5.2 3. Solutions for Failed Test Items”.
See “8.2 Quick Guide for Software Operation” for test log display procedure.

3. Solutions for Failed Test Items

[5] Spatial Resolution (Magnification)
Points to be checked
• The correct exposure submenu was selected.
• The X-ray equipment settings (target/filter, kVp) were correct.
• The 1 Shot Phantom was correctly positioned.
(The calculation area of spatial resolution is at the center of the X-ray field./
The 1 Shot Phantom is positioned in parallel with the chest wall-side of the
magnification table.)
• The compression plate was correctly positioned.
If any of the above is not correct/appropriate, correct the problem.

The Spatial Resolution (SR) in the The Spatial Resolution (SR) in the
Daily/Weekly Test has been Daily/Weekly Test has been
occasionally judged as “Fail”. judged as “Pass” in every test.

Change the 1 Shot Phantom Pass

The test is finished.
position and redo the test.

Fail

The X-ray equipment may be defective.

7
Contact a FUJIFILM dealer.
Annual Test

7-18 FDR Mammography QC Program Guidebook 897N120636

 7.5.3 X-ray Equipment Performance Test
NOTE
If magnified exposure is not performed in clinical practice, a test for the Small Focal Spot (SFS) is not
required. Change the setting in the initial setting window.

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

1. kVp accuracy and reproducibility

2. Half Value Layer (HVL)

3. Radiation output

4. Patient information entry and exposure menu selection

5. Collimation assessment (exposure)

6. QC Software startup

7. Exposure condition confirmation

8. Collimation assessment (measurement)

9. kVp accuracy and reproducibility (user input)

7
Annual Test
10. Half Value Layer (HVL) (user input)

11. Collimation assessment (user input)

12. Radiation output (user input)

13. Auto-calculation

14. Test result confirmation

15. QC Software shutdown

FDR Mammography QC Program Guidebook 897N120636 7-19

 1. kVp accuracy and reproducibility 6. Make exposures with the selected kVps
and measure the values by using a kVp
1 Follow the instructions below to conduct meter. In this Substep, make 5 exposures
the test item. with the middle kVp.
[Tools] • Fill in the following items in the worksheet.
A kVp meter and lead sheet LFS - volt. Low: _____kV
1. Remove the compression plate. LFS - volt. Mid.-1: _____kV
2. Place a lead sheet on the exposure table, LFS - volt. Mid.-2: _____kV
and then position the kVp meter on the LFS - volt. Mid.-3: _____kV
sheet. LFS - volt. Mid.-4: _____kV
TIP LFS - volt. Mid.-5: _____kV
Position the X-ray detector of the kVp LFS - volt. High: _____kV
meter at the lateral center of the exposure 7. Mount the magnification table of the X-ray
table and near the chest wall-side edge. equipment and specify the Small Focal
The position must be the same for every Spot (SFS) for it.
measurement for reproducibility.
NOTE
3. Select [QC/TEST] in the exposure region If magnified exposure is not performed in
list and [Calculation 1/2] in the exposure clinical practice, a test for the Small Focal
menu list, and then press [Start study.]. Spot (SFS) is not required. Proceed with the
next test. (To skip this step, it is necessary
4. Specify the Large Focal Spot (LFS) and to make the setting in the initial setting
“Manu” mode for the X-ray equipment, window.)
and set the target/filter to the following. NOTE
W/Rh Measurement with the Small Focal
Spot (SFS) cannot be performed unless
NOTE the magnification table is used. When
The “Semi” and “Auto” modes may not measuring voltage at the Small Focal Spot
work correctly for this measurement. Make (SFS) using the magnification table, place a
sure to use “Manu” mode for exposure. voltmeter on it.
5. Select 3 kVp values used for the 8. Make exposures with the selected kVps
measurement. and measure the values by using a kVp
• Fill in the following items in the worksheet. meter. In measurement with the Small
7 kVp used for the tests
Low: _____kV
Focal Spot (SFS), make one exposure
with each kVp.
Mid.: _____kV • Fill in the following items in the worksheet.
Annual Test

High: _____kV SFS - volt. Low: _____kV

TIP SFS - volt. Mid.: _____kV
SFS - volt. 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).

kVp meter

Magnification table

7-20 FDR Mammography QC Program Guidebook 897N120636

 Nipple side
2. Half Value Layer (HVL)

2 Following the instructions below to Exposure table

conduct the test item.
[Tools]
A dosimeter, aluminum plates (0.5 and 0.6 Lateral center

mm), and a lead sheet

60 mm
NOTE
Make the size of the X-ray field approximately
Dosimeter position Chest wall side
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 Exposure table
60 mm 40 mm
the X-ray field as small as possible.
TIP
Position the aluminum plates within 300 Chest wall side Nipple side
mm away from the focal spot without using
3. Specify the kVp values for all the target/
the compression plate as shown below.
filter combinations to be used in “Manu”
This may require careful effort.
mode, and calculate the mAs producing
the air kerma of 500 to 850 mR (≈ 4365
TIP to 7420 µGy) without using an aluminum
Aluminum plates of other than 0.5 and 0.6 plate. Then measure the air kerma for
mm thickness can also be used. When each setting.
conducting constancy tests, always use
• Fill in the following items in the worksheet.
the aluminum plate of the same thickness.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Focal spot
Entrance air kerma - w/o Al: _____mR µGy

Additional filters NOTE

< 300 mm

The “Semi” and “Auto” modes may not

Aluminum plates for half work correctly for this measurement. Make
value layer measurement sure to use “Manu” mode for exposure.
Diaphragm (Lead mask) 4. Position the 0.3 mm aluminum plate and
make an exposure under the condition
calculated in Substep 3 using each of 7
the kVp and target/filter to measure the
air kerma after the X-ray transmitted Annual Test
through the plate.
Detector of the dosimeter 40 mm • Fill in the following item in the worksheet.
Exposure table Entrance air kerma – Al 0.3 mm: ____mR µGy

50 mm
NOTE
Wear gloves when using the aluminum
1. Remove the compression plate.
plate to keep it clean.
2. Place a lead sheet on the exposure table,
5. Position the 0.5 mm aluminum plate and
and position the dosimeter at the lateral
make an exposure under the condition
center of the table, 60 mm away from the
calculated in Substep 3 using each of
chest wall-side edge, and also 40 mm
the kVp and target/filter to measure the
above the table.
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: ____

FDR Mammography QC Program Guidebook 897N120636 7-21

 3. Radiation output 5. Make an exposure and measure the
air kerma rate. The following setting is
3 Follow the instructions below to conduct recommended.
the test item. 28 kV, 300 mAs and W/Rh
[Tools] If the air kerma rate cannot be measured,
A dosimeter and lead sheet check the exposure time to calculate the
1. Remove the compression plate. air kerma rate.
• Fill in the following items in the worksheet.
2. Place a lead sheet on the exposure table,
Air kerma rate: _____mGy/s
and position the dosimeter at the lateral (Exposure time: _____s)
center of the table, 60 mm away from the
chest wall-side edge, and also 40 mm NOTE
above the table. A dosimeter allowing air kerma rate or
exposure time measurement is necessary.
Nipple side
Air kerma rate [mGy/s] can be calculated
from exposure time [s] as follows:
Exposure table
Air kerma rate [mGy/s] = air kerma [mGy] /
exposure time [s]
(1 mR = 8.76 × 10-3 mGy)
Lateral center
6. Select [Study completed] to finish the
test.
60 mm

Dosimeter position Chest wall side

4. Patient information entry and exposure
menu selection
Exposure table
40 mm 4 Enter patient information and press [Next].
60 mm

Chest wall side Nipple side

3. Specify “Manu” mode for the X-ray

equipment.
NOTE
The “Semi” and “Auto” modes may not work
correctly for this measurement. Make sure to

7
use “Manu” mode for exposure.
4. Make an exposure and measure the air
kerma and mAs. The following setting is
Annual Test

recommended.
28 kV, 80 mAs and W/Rh 5 Select [QC/TEST] in the exposure region
In this Substep, measure air kerma list and [Annual 3/6] in the exposure menu
5 times under the same exposure list, and then press [Start study.].
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): _____mR µGy

Entrance air kerma (3): _____mR µGy

Entrance air kerma (4): _____mR µGy

Entrance air kerma (5): _____mR µGy

7-22 FDR Mammography QC Program Guidebook 897N120636

 6 The following exposure submenu is NOTE
displayed. Take care that the compression plate is not
scratched by the coin.
• Uniform Expo.3(Collimation)
3. Specify the following and make an
exposure in “Manu” mode.
23 kV, 2 mAs and W/Rh
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
5. Collimation assessment (exposure) Compression force: _____N

7 Follow the instructions below to conduct NOTE

the test item. The “Semi” and “Auto” modes may not
work correctly for this test. Make sure to
Make an exposure using the following
use “Manu” mode for exposure.
exposure submenus:
[Uniform Expo.3(Collimation)] NOTE
It may take some time until you can press
NOTE
[QC] after completing the exposure process.
Go to Step 12 when using the Image Reader,
which uses a cassette exclusively for
6. QC Software startup
mammography, as well as the X-ray equipment.
A more detailed test can be conducted. 8 Press [QC] to display the “QC window”.
[Tools]
A coin
1. Attach a coin to the bottom surface of 7. Exposure condition confirmation
the compression plate while aligning the
edge with the chest wall-side edge of the 9 Check the exposure conditions.
plate.

7
Annual Test

2. Move the compression plate down onto

the exposure table.

FDR Mammography QC Program Guidebook 897N120636 7-23

 8. Collimation assessment [Tools]
(measurement) The same size 2 cassettes (no need to be
QC exclusive), a scale and 6 coins (familiar
10 Select Exposure Submenus [Uniform sized)
Expo.3(Collimation)] from the exposure
condition display field and press [Film NOTE
A cassette for general exposure cannot be
output]. For performing image diagnosis
used.
on a softcopy display, press [Network
output] to output the image to the network. 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.

11 Visually check the gap between the image

and compression plate edge by using the
chest wall side as reference.
Observe the position of the Coin in the output
image and record the result.
Judgment (a)
A part of Coin image is missing
→ Pass (no gap)
Coin is completely reflected
→ Fail (with gap)
Pass Fail
NOTE
Be careful not to position the Coin (a)
where it will be overlapped with the coins
to be positioned in Substeps 3 and 4 or
the boundary of the cassettes placed in
Coin
Coin Substep 2.

• Fill in the following items in the worksheet. 2. Position 2 cassettes (Cassettes B1 and
Compression plate edge (Chest wall B2, hereafter) over the exposure table by
side as reference): Pass/Fail aligning their chest wall-side edges.
Visual inspection result: Pass (no gap)/
7 NOTE
Fail (with gap)
Cassette B1 Cassette B2

Go to Step 17 .
Annual Test

Steps 12 to 16 are the detailed test procedure

for the X-ray equipment and the Image
Reader, which uses a cassette exclusively for
mammography.

5. Collimation assessment (exposure)

<details>

12 Follow the instructions below to conduct

the test item. 3. Turn on the light field lamp of the X-ray
equipment and position 4 coins (Coins
Make an exposure using the following
(b) to (e), hereafter) respectively on the 4
exposure submenus:
sides of the light field on the Cassettes
[Uniform Expo.3(Collimation)]
B1 and B2.

7-24 FDR Mammography QC Program Guidebook 897N120636

 6. The following setting is recommended.
Light field 28 kV, 80 mAs and W/Rh
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
(c) (b) Target/Filter: _____/_____
(d) (e)
Compressed breast thickness: _____mm
Compression force: _____N
NOTE
The “Semi” and “Auto” modes may not
work correctly for this test. Make sure to
NOTE use “Manu” mode for exposure.
Be careful not to position the Coins (b) to (e)
where they overlap with the Coin (a) or on
the boundary of the cassettes.
4. Attach a coin (Coin (f), hereafter) to the
bottom surface of the compression plate
while aligning the edge with the chest
wall-side edge of the plate.
NOTE
It may take some time until you can press
[QC] after completing the exposure process.

(f) 6. QC Software startup

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

7. Exposure condition confirmation

NOTE Check the exposure conditions.
Be careful not to position the Coin (f) where
14
it overlaps with the Coins (a) to (e) or on the

7
boundary of the cassettes.
5. Move the compression plate down onto
the Cassettes B1 and B2.
Annual Test

NOTE
Take care that the compression plate is not
scratched by the coins.

FDR Mammography QC Program Guidebook 897N120636 7-25

 8. Collimation assessment (measurement) Nipple side A-c
A-b
<details> A-d c

15 Select Exposure Submenus [Uniform

d
Expo.3(Collimation)] from the exposure b
Left Right
condition display field and press [Film
output]. For performing image diagnosis
on a softcopy display, press [Network e
f a
output] to output the image to the network.
Output the images read from the 2 Chest wall side Image read from
the FDR mammography
cassettes positioned on the exposure A-e A-f A-a system
table on film or on a softcopy display in
the same way. 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
16 Measure the values required for judging the length of the missing part.
the items below.
Light field Nipple side
• 
X-ray/Light field gap (Right/Left, Chest/ X-ray field
Nipple) [mm] c B-c

• X-ray/Image receptor field gap (Right/Left/

Nipple) [mm] d
Left b Right
• Compression plate edge (Chest wall side)
1. Measure and record the distances
between the coins and the adjacent e
f B-e
edges of the output image. If a part of
B-d Chest wall side B-b
coin image is missing, measure the B-f
length of the missing part.
TIP
Image read from Image read from
Coin (a) → Cassette B1 Cassette B2
Positioned on the chest wall-side edge
of the exposure table. • Fill in the following items in the worksheet.
7 Coins (b), (c), (d), (e) →
Positioned on the 4 sides of the light
Coin (b) B-b: _____mm
Coin (c) B-c: _____mm
field. Coin (d) B-d: _____mm
Annual Test

Coin (f) → Coin (e) B-e: _____mm

Positioned on the bottom chest wall-side Coin (f) B-f: _____mm
edge of the compression plate.
3. Make a record of the [X-ray / Light field
• Fill in the following items in the worksheet. gap (Right/Left, Chest/Nipple)].
Coin (a) A-a: _____mm TIP
Coin (b) A-b: _____mm The values measured for Coins (b) to (e) in
Coin (c) A-c: _____mm Substep 2 indicate the gap amount. Record
Coin (d) A-d: _____mm the values measured in Substep 2.
Coin (e) A-e: _____mm
Coin (f) A-f: _____mm • Fill in the following items in the worksheet.
Left: B-d: _____mm
Right: B-b: _____mm
Chest wall: B-e: _____mm
Nipple side: B-c: _____mm

7-26 FDR Mammography QC Program Guidebook 897N120636

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

TIP
Check the following coin images.
Chest wall: Coins (a) and (e) Annual Test
IP
Assign the value recorded in Substeps
1 and 2 for each coin to A and B in the
Eg: 3 X=A-B corresponding formula.
A B

• Fill in the following item in the worksheet.

Chest: _____mm
IP

Eg: 4 X=B-A
A B

FDR Mammography QC Program Guidebook 897N120636 7-27

 X-ray field/ 6. Visually check the gap between the
FDR mammography exposure table
system
Cassette B1/B2
gap Y calculation image and compression plate edge by
formula using the chest wall side as reference.
Not needed.
Y=y
(Measure the
Observe the position of the Coin (f) in the
The size of image read from the FDR mammography
distance y
X-ray field

the gap can

between the
be calculated system and record the result.
IP
edges of Coin (a)
Eg: 1 only from the
and X-ray field in
y A-a
image read
from the FDR
the image read Judgment
from the FDR
Coin (a) mammography
mammography
A part of Coin (f) image is missing →
system.
system.) Pass (no gap)
Coin (f) is completely reflected →
Fail (with gap)
Y=(A-e)-{(A-
Eg: 2
a)+(B-e)}
B-e
Pass Fail
A-a
A-e
Coin (a) Coin (e)
Coin (e)

Y=(A-e)+{(B-e)-
Eg: 3 B-e
(A-a)} Coin (f)
A-e
A-a Coin (f)
Coin (a) Coin (e)
Coin (e)
• Fill in the following items in the worksheet.
TIP Compression plate edge (Chest wall
side as reference): Pass/Fail
When the X-ray field is inside of the image
receptor edge in the image read from the
Visual inspection result: Pass (no gap)/
FDR mammography system, as shown in Fail (with gap)
Eg: 1, the size of the gap can be determined
by measuring the distance (“y” in the figure) 9. kVp accuracy and reproducibility (user
from the image receptor edge to the X-ray input)
field.
17 Press [User input].
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 Select [Annual test 3-1].
18
7
calculated. Measure the distance ”A-a” Enter the display values and measured
between the image receptor edge and values.
that of Coin (a) (on the chest wall-side
edge) and the distance “A-e” between
Annual Test

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.

7-28 FDR Mammography QC Program Guidebook 897N120636

 10. Half Value Layer (HVL) (user input) 12. Radiation output (user input)

19 Select [Annual Test 3-2]. 21 Enter the measured entrance air kerma,
Enter the measured entrance air kerma mAs and air kerma rate, and then press
for each target/filter. [OK].
NOTE NOTE
Some dosimeters may require correction of the Some dosimeters may require correction of the
measured value according to the beam quality. measured value according to the beam quality.

TIP NOTE
Select the thickness of an aluminum plate Make sure that the values are entered for all
that was used if the thickness is other than items. If there is an item left unentered, an error
0.5 and 0.6 mm. occurs.

13. Auto-calculation
11. Collimation assessment (user input)
22 Press [Measurement execution]. The
20 Select [Annual test 3-3]. Enter the
results are displayed at the bottom of the
measured values and visual inspection
window.
result (Pass/Fail).
NOTE
Enter all items even if the test is conducted
without using cassettes. Although any value
can be entered (e.g. “0” for all items), a negative
7
value or significantly large one causes an error 14. Test result confirmation
Annual Test
to occur.
23 Check the displayed judgment results.
If there is a [Fail], see “7.5.3 3. Solutions
for Failed Test Items”.

FDR Mammography QC Program Guidebook 897N120636 7-29

 15. QC Software shutdown

24 Press [Save] and then [Close] to exit the

QC Software.

25 Select [Study completed] to finish the

test.

7
Annual Test

7-30 FDR Mammography QC Program Guidebook 897N120636

 2. Test Result Evaluation and Judgment
Evaluate and judge the results of the X-ray equipment performance test in the Annual Test. If all items
are judged as [Pass], the test is finished. If there is an item judged as [Fail], take corrective actions by
following “7.5.3 3. Solutions for Failed Test Items”.
See “8.2 Quick Guide for Software Operation” for test log display procedure.

3. Solutions for Failed Test Items

[6] kVp accuracy and reproducibility
Points to be checked
• The kVp meter was correctly positioned.
• The kVp meter was correctly used.
• The X-ray equipment settings (target/filter, kVp and mAs) were correct.
• The exposure was appropriate.
If any of the above is not correct/appropriate, correct the problem.

Pass
Redo the test. The test is finished.

Fail

The X-ray equipment may be defective.

Contact a FUJIFILM dealer.

[7] Half Value Layer (HVL)

Points to be checked
• The dosimeter was correctly positioned.
• The dosimeter was correctly used.
• The X-ray equipment settings (target/filter, kVp and mAs) were correct.
• The exposure was appropriate.
• The unit of air kerma (mR or µGy) was correctly used.
7
• The aluminum plate used has the specified purity.
• The aluminum plate (thickness and/or position) was correctly arranged.
Annual Test
• There are no scratches or dirt on the aluminum plate.
If any of the above is not correct/appropriate, correct the problem.

Pass
Redo the test. The test is finished.

Fail

The X-ray equipment may be defective.

Contact a FUJIFILM dealer.

FDR Mammography QC Program Guidebook 897N120636 7-31

 [8] Collimation assessment
Points to be checked
• The X-ray equipment settings (target/filter, kVp) were correct.
• The coins were correctly positioned.
• The distances were measured at the correct position.
• The unit of distance (mm) was correctly used.
If any of the above is not correct/appropriate, correct the problem.

Pass
Redo the test. The test is finished.

Fail

The X-ray equipment may be defective.

Contact a FUJIFILM dealer.

[9] Radiation output

Points to be checked
• The dosimeter was correctly positioned.
• The dosimeter was correctly used.
• The X-ray equipment settings (target/filter, kVp and mAs) were correct.
• The exposure was appropriate.
• The unit of air kerma (mR or µGy) was correctly used.
• The unit of air kerma rate (mGy/s) was correctly used.
If any of the above is not correct/appropriate, correct the problem.

Pass
Redo the test. The test is finished.

Fail

The X-ray equipment may be defective.

7
Contact a FUJIFILM dealer.
Annual Test

7-32 FDR Mammography QC Program Guidebook 897N120636

 7.5.4 AEC System Performance Test
1. Procedure
[Test flow]
The AEC system performance test consists of AEC reproducibility, CNR modes 1 to 3, and AGD 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 reproducibility
Change in CNR to target thickness ............... CNR modes 1 to 3
Change in AGD to target thickness ............... AGD modes 1 to 3
TIP
In this test, specify the baseline values for CNR mode 1, conduct the two test items not requiring an X-ray
image, and then enter their measured values all at once to save time and simplify QC Software operation.

7
Annual Test

FDR Mammography QC Program Guidebook 897N120636 7-33

 NOTE
In this procedure, X-ray exposures at high voltage are repeated. As repetitive X-ray exposures made in a
short time may damage the X-ray tube, check the recommended exposure interval for this product and allow
a sufficient interval between exposures.
NOTE
Use H-mode under “Auto” mode in CNR mode 1 in which the test is conducted by combining AEC
reproducibility and AGD modes 1 to 3.
In CNR modes 2 and 3, use N-mode and L-mode, respectively, under “Auto” mode.
NOTE
The baseline values for CNR modes 1 to 3 need to be specified before starting the test.
The baseline value setting for CNR mode 1 is required for every test, unlike the settings for other test items,
even without new equipment/system installation or major remodeling of the existing equipment.

1. Patient information entry and exposure menu selection

2. CNR mode 1 (exposure)

3. QC Software startup

4. Exposure condition confirmation

5. Auto-calculation

6. Baseline value setting

7. QC Software shutdown

8. AEC density control function

9. AEC reproducibility

10. AGD modes 1 to 3

7 11. Patient information entry and exposure menu selection

12. CNR mode 1 (exposure)

Annual Test

13. QC Software startup

14. Exposure condition confirmation

15. AEC reproducibility (user input)

16. AGD modes 1 to 3 (user input)

17. Auto-calculation

18. Test result confirmation

19. QC Software shutdown

7-34 FDR Mammography QC Program Guidebook 897N120636

 NOTE
Make sure to select an exposure menu first when starting the test in CNR modes 2 and 3. Beware that the
exposure menus are different in each mode.

1. Patient information entry and exposure menu selection

2. CNR mode 2 (exposure)

3. QC Software startup

4. Exposure condition confirmation

5. Auto-calculation

6. Baseline value setting

7. QC Software shutdown

8. Patient information entry and exposure menu selection

9. CNR mode 2 (exposure)

10. QC Software startup

11. Exposure condition confirmation

12. Auto-calculation

13. Test result confirmation

14. QC Software shutdown

TIP
Select CNR mode 3 in Step 2 and 9 above when conducting the test in the mode. 7
Annual Test

FDR Mammography QC Program Guidebook 897N120636 7-35

 [Tools] 1. Patient information entry and exposure
PMMA phantom (40 mm) menu selection
[Exposure condition setting procedure] Enter patient information and press [Next].
Determine the exposure conditions used
3
1
in the test.
Position the PMMA phantom (40 mm) on the
patient support and the compression plate 45
mm above the patient support.

2 Select [QC/TEST] in the exposure region

list and [Calculation 1/2] in the exposure
menu list, and then press [Start study.].
Select H-mode under “Auto” mode for the
X-ray equipment and make an exposure.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____ 4 Select [QC/TEST] in the exposure region
Compressed breast thickness: _____mm list and [Calculation 1/2] in the exposure
Compression force: _____N menu list, and then press [Start study.].

5 The following exposure submenu is

displayed.
• CNR

7
Annual Test

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.

7-36 FDR Mammography QC Program Guidebook 897N120636

 7 Position the 0.2 mm aluminum plate for 3. QC Software startup
CNR measurement as shown in the figure
below. 10 Press [QC] to display the “QC window”.
NOTE
Make sure that the aluminum plate covers the
Calculation Area 2 without protruding into the
left-hand half of the phantom. 4. Exposure condition confirmation
Nipple side
11 Check the exposure conditions.
PMMA

Calculation Areas
(20 mm x 20 mm) Aluminum plate

1 2
60 mm 20 mm

Chest wall side

NOTE
Wear gloves when using the aluminum plate to
keep it clean.

8 Move the compression plate as close to

the PMMA phantom as possible without
making contact. 5. Auto-calculation

12 Press [Measurement execution]. The

results are displayed at the bottom of the
window.

13 When the result is displayed, press [Save]

and then [Test data log].
Aluminum plate
7
9 Specify the exposure conditions closest
to those recorded in Step 2 in “Manu” Annual Test
mode. Then make an exposure.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
NOTE
It may take some time until you can press [QC]
after completing the exposure process.

FDR Mammography QC Program Guidebook 897N120636 7-37

 6. Baseline value setting • Fill in the following items in the worksheet.
kVp: _____kV
14 Select the result calculated in Step 12 , mAs: _____mAs
and then press [Baseline value creation]. Target/Filter: _____/_____
This completes the baseline value setting. Compressed breast thickness: _____mm
Press [Close]. Compression force: _____N
3. Make an exposure for each step and
record the mAs.
• Fill in the following items in the worksheet.
mAs
Step 0: _____mAs
Step 1: _____mAs, Step -1: _____mAs
Step 2: _____mAs, Step -2: _____mAs
Step 3: _____mAs, Step -3: _____mAs

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

7. QC Software shutdown
Press [Save] and then [Close] to exit the 9. AEC reproducibility
15
QC Software.
18 Follow the instructions below to conduct
the test item.
[Tools]
A dosimeter and PMMA phantom (40 mm)
16 Select [Study completed] to finish the test. 1. Position the PMMA phantom (40 mm) on
7 the exposure table.
NOTE
Annual Test

Position the PMMA phantom (40 mm) on

8. AEC density control function
the exposure table leaving a space on a
NOTE side.
If the X-ray dose adjustment function is not 2. Position the dosimeter aside the PMMA
used in clinical practice, a test for the function phantom (40 mm) as shown in the figure
is not required. Change the setting in the initial below.
setting window.

17 Following the instructions below to conduct

the test item.
[Tools]
A PMMA phantom (40 mm)
1. Position the PMMA phantom (40 mm).
2. Move the compression paddle as close
to the PMMA phantom as possible
without making contact.

7-38 FDR Mammography QC Program Guidebook 897N120636

 NOTE 10. AGD modes 1 to 3
In the AEC reproducibility test, the
dosimeter position differs since the air Follow the instructions below to conduct
19
kerma is measured under the “Semi” the test item.
mode. Position the dosimeter where it does
not affect the AEC function but receives the [Tools]
X-ray exposure. PMMA phantoms (20, 40, 60 and 70 mm),
aluminum plates (0.5 and 0.6 mm) for half
See “FDR MS-3500 Operation Manual”
for details on the AEC areas. value layer measurement, a dosimeter, and
a lead sheet
3. Move the compression plate as close to
the PMMA phantom as possible without TIP
making contact. In this Program, H-mode, N-mode and
L-mode are assigned to Exposure Modes 1,
4. Select [QC/TEST] in the exposure region 2 and 3, respectively.
list and [Calculation 1/2] in the exposure
menu list, and then press [Start study.].
TIP
5. Specify the kVp and target/filter to be
Aluminum plates of other than 0.5 and 0.6
used for an exposure in “Semi” mode.
mm thickness can also be used. When
The following setting is recommended. conducting constancy tests, always use the
28 kV and W/Rh aluminum plate of the same thickness.
• Fill in the following items in the worksheet.
kVp: _____kV 1. Position the PMMA phantom (20 mm) on
mAs: _____mAs the exposure table.
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
6. Make 5 exposures and measure the air
kerma.
• Fill in the following items in the worksheet.
Entrance air kerma (1): _____mR µGy

Entrance air kerma (2): _____mR µGy

Entrance air kerma (3): _____mR µGy

Entrance air kerma (4): _____mR µGy

Entrance air kerma (5): _____mR µGy

2. Position the compression plate 21 mm 7

above the patient support.
3. Make an exposure in H-mode under
Annual Test
“Auto” mode.
• Fill in the following items in the worksheet.
PMMA phantom 20 mm exposure
conditions
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N

FDR Mammography QC Program Guidebook 897N120636 7-39

 4. Using the PMMA phantoms 60 mm and 6. Move the compression plate as close
70 mm, repeat the operation described to the dosimeter as possible without
in Substeps 1 to 3. making contact.
At this time, the PMMA phantoms
NOTE
are positioned 75 mm and 90 mm, Do not reposition the compression plate
respectively, above the patient support. during measurement.
TIP
The exposure conditions for the PMMA
phantom 40 mm has been determined
in Step 2 . Enter the conditions in the
worksheet.

• Fill in the following items in the worksheet.


PMMA phantom 40 mm exposure
conditions
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____ 7. Specify “Manu” mode for the X-ray
Compressed breast thickness: _____mm equipment and make an exposure under
Compression force: _____N exposure conditions for the PMMA

PMMA phantom 60 mm exposure phantom 20 mm recorded in Substep 3.
conditions If the mAs value determined in Substep 3
kVp: _____kV cannot be applied, specify the closest
mAs: _____mAs applicable value. (If the difference
Target/Filter: _____/_____ between the mAs value determined in
Compressed breast thickness: _____mm Substep 3 and the closest higher value is
Compression force: _____N the same as that between the mAs value
above and the closest lower value, the

PMMA phantom 70 mm exposure higher value should be specified.)
conditions
• Fill in the following items in the worksheet.
kVp: _____kV
kVp: _____kV
mAs: _____mAs
mAs: _____mAs
Target/Filter: _____/_____
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compressed breast thickness: _____mm
7 Compression force: _____N
5. Remove the PMMA phantom, place a
Compression force: _____N
NOTE
lead sheet on the exposure table, and
Annual Test

The “Semi” and “Auto” modes may not

then position the dosimeter as shown in
work correctly for this measurement. Make
the figure below.
sure to use “Manu” mode for exposure.
Nipple side
8. Make an exposure and measure the air
Exposure table
kerma.
• Fill in the following item in the worksheet.
Entrance air kerma - w/o Al: _____mR µGy

Lateral center

60 mm

Dosimeter position Chest wall side

Exposure table
60 mm 40 mm

Chest wall side Nipple side

7-40 FDR Mammography QC Program Guidebook 897N120636

 9. Position the 0.3 mm aluminum plate 11. Patient information entry and exposure
for half value layer measurement on the menu selection
compression plate.
20 Enter patient information and press [Next].

NOTE
Wear gloves when using the aluminum
plate to keep it clean.
12. CNR mode 1 (exposure)
NOTE
Make sure that the aluminum plate covers Select [QC/TEST] in the exposure region
the detector of the dosimeter from the
21
list and [Annual 4/6] in the exposure menu
above. list, and then press [Start study.].
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
22 The following exposure submenus are
measure the air kerma.
• Fill in the following item in the worksheet.
displayed. 7
Entrance air kerma – Al 0.5 mm: • HCN20: H-mode CNR(PMMA20mm)
_____mR
µGy
• HCN40: H-mode CNR(PMMA40mm) Annual Test
• HCN60: H-mode CNR(PMMA60mm)
13. Repeat the operation described in
• HCN70: H-mode CNR(PMMA70mm)
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 test in N-mode and
L-mode.

15. Select [Study completed] to finish the

test.

FDR Mammography QC Program Guidebook 897N120636 7-41

 23 The procedure for testing CNR mode 1 is 3. Move the compression plate as close to
described below. the PMMA phantom as possible without
Make 4 exposures using the following exposure
making contact.
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
Aluminum plate
TIP
In CNR mode 1, use the same H-mode of
the AEC as that used in AGD mode 1. 4. Specify the exposure conditions for
If multiple exposure modes are used in PMMA phantom 20 mm determined
clinical practice, conduct the test in all in Substep 3 of AGD mode 1 test
of the modes used. Beware that the test procedure. Then make an exposure in
procedure for CNR mode 2 or later differs “Manu” mode.
from that for CNR mode 1.
• Fill in the following items in the worksheet.
kVp: _____kV
NOTE mAs: _____mAs
Wear gloves when using the aluminum plate to Target/Filter: _____/_____
keep it clean. Compressed breast thickness: _____mm
Compression force: _____N
1. Position the PMMA phantom (20 mm) on
the exposure table. NOTE
The “Semi” and “Auto” modes may not
2. Position the 0.2 mm aluminum plate
work correctly for this measurement. Make
for CNR measurement as shown in the sure to use “Manu” mode for exposure.
figure below.
5. Using PMMA phantoms 40 mm, 60
Nipple side
mm and 70 mm, repeat the operation
PMMA described in Substeps 1 to 4. Use the
7 Calculation Areas
Aluminum plate
exposure conditions for the PMMA
phantom of each thickness determined
(20 mm x 20 mm)
in Substep 4 of the AGD mode 1 test
Annual Test

procedure.
1 2
60 mm 20 mm

Chest wall side

NOTE
Make sure that the aluminum plate covers
the Calculation Area 2 without protruding
into the left-hand half of the phantom. NOTE
It may take some time until you can press
[QC] after completing the exposure process.

7-42 FDR Mammography QC Program Guidebook 897N120636

 13. QC Software startup 28 Select [Annual test 4-1]. Enter the
measured entrance air kerma.
24 Press [QC] to display the “QC window”.

14. Exposure condition confirmation

25 Check the exposure conditions.

16. AEC density control function (user

input)

29 Enter the measured mAs.

26 Press [User input].

15. AEC reproducibility (user input)

27 Press [User input].

7
Annual Test

FDR Mammography QC Program Guidebook 897N120636 7-43

 17. AGD modes 1 to 3 (user input) 19. Test result confirmation

30 Select [Annual test 4-2]. Enter the 32 Check the displayed judgment results.
measured entrance air kerma and target/ If there is a [Fail], see “7.5.4 3. Solutions
filter for each, and then press [OK]. for Failed Test Items”.
NOTE
Some dosimeters may require correction of the
measured value according to the beam quality.
TIP
Select the thickness of an aluminum plate
that was used if the thickness is other than
0.5 and 0.6 mm.

20. QC Software shutdown

33 Press [Save] and then [Close] to exit the

QC Software.

34 Select [Study completed] to finish the

NOTE test.
Make sure that the values are entered for all
items. If there is an item left unentered, an error
occurs. Conduct the CNR test in N-mode.
35
Select “CNR mode 2” and conduct the test
18. Auto-calculation
in N-mode.
Press [Measurement execution]. The Follow Steps 1 to 16 to create baseline
7 31
results are displayed at the bottom of the values for N-mode. Follow Steps 20 to 25 ,
window. and 31 to 34 , to proceed with the test in
N-mode.
Annual Test

* Select [QC/TEST] in the exposure region list

and [Annual 5/6] in the exposure menu list.

36 Conduct the CNR test in L-mode.

Select “CNR mode 3” and conduct the test
in L-mode.
Follow Steps 1 to 16 to create baseline
values for L-mode. Follow Steps 20 to 25 ,
and 31 to 34 , to proceed with the test in
L-mode.
* Select [QC/TEST] in the exposure region list
and [Annual 6/6] in the exposure menu list.

7-44 FDR Mammography QC Program Guidebook 897N120636

 2. Test Result Evaluation and Judgment
Evaluate and judge the results of the AEC system performance test in the Annual Test. If all items are
judged as [Pass], the AEC system performance test is finished. If there is an item judged as [Fail], take
corrective actions by following “7.5.4 3. Solutions for Failed Test Items”.
See “8.2 Quick Guide for Software Operation” for test log display procedure.

3. Solutions for Failed Test Items

[10] AEC density control function
Points to be checked
• The X-ray equipment settings (target/filter, kVp) were correct.
• The correct mAs is entered for each step.
If any of the above is not correct/appropriate, correct the problem.

Pass
Redo the test. The test is finished.

Fail

The X-ray equipment may be defective.

Contact a FUJIFILM dealer.

[11] AEC reproducibility

Points to be checked
• The dosimeter was correctly positioned.
• The dosimeter was correctly used.
• The X-ray equipment settings (target/filter, kVp) were correct.

7
• The unit of air kerma (mR or µGy) was correctly used.
If any of the above is not correct/appropriate, correct the problem.

Annual Test
Pass
Redo the test. The test is finished.

Fail

The X-ray equipment may be defective.

Contact a FUJIFILM dealer.

FDR Mammography QC Program Guidebook 897N120636 7-45

 [12] CNR modes 1 to 3
Points to be checked
• The correct exposure submenus were selected.
• The X-ray equipment settings (target/filter, kVp) were correct.
• The exposures were made in the correct order.
• The aluminum plate used has the specified purity.
• The aluminum plate (thickness and/or position) was correctly arranged.
• There are no scratches or dirt on the aluminum plate.
• A test is conducted in H-mode, N-mode or L-mode with the baseline values newly
created for each mode.
If any of the above is not correct/appropriate, correct the problem.

The CNR in the Daily/Weekly

Test has been judged as [Pass] in every test.

Redo the test. Pass

Run [Calculation 1/2] and then calculate the ratio of The test is finished.
the CNR of each PMMA phantom thickness to the
baseline value by using a calculator, and then judge
the result.

Fail

The X-ray equipment may be defective.

Contact a FUJIFILM dealer.

7
Annual Test

7-46 FDR Mammography QC Program Guidebook 897N120636

 [13] AGD modes 1 to 3
Points to be checked
• The dosimeter was correctly positioned.
• The dosimeter was correctly used.
• The X-ray equipment settings (target/filter, kVp) were correct.
• The unit of air kerma (mR or µGy) was correctly used.
• The aluminum plate used has the specified purity.
• The aluminum plate (thickness and/or position) was correctly arranged.
• There are no scratches or dirt on the aluminum plate.
If any of the above is not correct/appropriate, correct the problem.

Check the result of AEC reproducibility test.

Fail

Pass
The X-ray equipment may be defective.

Pass
Redo the test. The test is finished.

Contact a FUJIFILM dealer.

Fail

The X-ray equipment may be defective.

Contact a FUJIFILM dealer.

7
Annual Test

FDR Mammography QC Program Guidebook 897N120636 7-47

7
Annual Test

7-48 FDR Mammography QC Program Guidebook 897N120636

 Chapter 8
Assistance 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

FDR Mammography QC Program Guidebook 897N120636 8-1

 8.1 Calculation Functions
CNR and AGD can be auto-calculated on the PMMA phantom of the following thicknesses
by the QC Software.
CNR can be calculated on the phantom of a given thickness.
AGD can be calculated on the phantom of 20, 30, 40, 45, 50, 60, 70 and 80 mm in
thickness.

Items Auto-calculated and Judged Based on Input Data

Test Items Exposure Menus Exposure Submenus
1. Exposure 2. Input Values
CNR Calculation 1/2 CNR 3
AGD Calculation 2/2 AGD 3

The measurement procedure of each item is described below.

[1] CNR 3 The following exposure submenu is

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

1 Enter patient information and press [Next].

4 Position the PMMA phantom of the

desired thickness to be measured and
0.2 mm aluminum plate as shown in the
figure below.
NOTE
Make sure that the aluminum plate covers the
Calculation Area 2 without protruding into the
left-hand half of the phantom.
Nipple side

2 Select [QC/TEST] in the exposure region PMMA

list and [Calculation 1/2] in the exposure
menu list, and then press [Start study.]. Calculation Areas
(20 mm x 20 mm) Aluminum plate

8 1
20 mm
2
60 mm
Assistance Material

Chest wall side

NOTE
Wear gloves when using the aluminum plate to
keep the plate clean.

8-2 FDR Mammography QC Program Guidebook 897N120636

 5 Move the compression plate as close to 10 Check the calculation result.
the PMMA phantom as possible without
making contact.

Aluminum plate

Specify the exposure conditions for the 11 Press [Save] and then [Close] to exit the
6 QC Software.
X-ray equipment and make an exposure
in “Manu” mode.
NOTE
The “Semi” and “Auto” modes may not work
correctly for this measurement. Make sure to
use “Manu” mode for exposure. 12 Select [Study completed] to finish the
test.
7 Repeat Steps 4 to 6 as many times as
necessary to capture the desired number
of images to be calculated (max. 32
images).
NOTE
It may take some time until you can press [QC]
after completing the exposure process.

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

9 Press [Measurement execution]. The

results are displayed at the bottom of the
window.

FDR Mammography QC Program Guidebook 897N120636 8-3

 [2] AGD 5 Position the 0.3 mm aluminum plate on
the compression plate.
[Tools] NOTE
A dosimeter and aluminum plates (0.5 and 0.6 Wear gloves when using the aluminum plate to
mm) keep the plate clean.

1 Position the dosimeter at the lateral center NOTE

of the exposure table, 60 mm away from Make sure that the aluminum plate covers the
the chest wall-side edge, and also 40 mm detector of the dosimeter from the above.
above the table. Make an exposure with the exposure
6
Nipple side conditions used in Step 3 and measure
the air kerma.
Exposure table

7 Position the 0.5 mm aluminum plate in the

same way.
Lateral center

8 Make an exposure with the exposure

60 mm conditions used in Step 3 and measure
the air kerma.
Dosimeter position Chest wall side

9 Enter patient information and press [Next].

Exposure table
60 mm 40 mm

Chest wall side Nipple side

2 Move the compression plate as close to

the dosimeter as possible without making
contact.
NOTE
Do not reposition the compression plate during
measurement.

10 Select [QC/TEST] in the exposure region

list and [Calculation 2/2] in the exposure
menu list, and then press [Start study.].

8
3 Specify the desired exposure conditions
Assistance Material

for the X-ray equipment and make an

exposure in “Manu” mode.
NOTE
The “Semi” and “Auto” modes may not work
correctly for this measurement. Make sure to
use “Manu” mode for exposure.

4 Record the air kerma.

8-4 FDR Mammography QC Program Guidebook 897N120636

 11 The following exposure submenu is 16 Press [Measurement execution]. The
displayed. results are displayed at the bottom of the
• AGD window.

17 Check the calculation result.

12 Make an exposure under any conditions

to start up the QC Software. For example,
specify the following.
23 kV, 2 mAs and W/Rh

18 Press [Save] and then [Close] to exit the

QC Software.

NOTE
It may take some time until you can press [QC]
after completing the exposure process.
19 Select [Study completed] to finish the
13 Press [QC] to display the “QC window”. test.

14 Press [User input].

15 Enter the target/filter used and measured

entrance air kerma, and then press [OK].
NOTE
Some dosimeters may require correction of the
measured value according to the beam quality.

FDR Mammography QC Program Guidebook 897N120636 8-5

 8.2 Quick Guide for Software Operation
This section provides concise references for the QC Software main operations and the
QC test log confirmation procedure. Make a copy of this section as necessary.

n Basic Procedure
1 Starting FUJIFILM workstation
Start a FUJIFILM workstation and enter
patient information, and then press [Next].

(3) Auto-calculates the result based on

entered image and values, and (4) Saves the study
displays [Pass/Fail] judgment. results.

2 Starting QC test
Select [QC/TEST] in the exposure region (5) Quits the
QC Software.
list and an exposure submenu displayed (1) Outputs an image (2) Displays the user input
in the exposure menu list, and then press for visual
inspection.
screen for the measurement
and visual inspection results.
[Start study.].
6 Finishing the test
Press [Study completed] to finish the test.
When finishing the test, the window in Step 1
is redisplayed. To conduct another test, repeat
the procedure.

3 Exposure
Make an exposure using all of the

8
displayed exposure submenus.

4 Starting QC Software
Press [QC].
Assistance Material

5 Main button operations in “QC window”

8-6 FDR Mammography QC Program Guidebook 897N120636

 n Log Confirmation Procedure
1 Starting FUJIFILM workstation NOTE
Start a FUJIFILM workstation and press A maximum of 365 items are output to one CSV
[FUJIFILM]. file. If a CSV file is opened on external software,
some software may not be able to process large
data. Reduce the number of items to be output as
necessary.

4 Finishing the test

Press [Close] and then [Study completed]
to finish the test.

2 Press [Display of QC history] from the list

that appears.

3 Main button operations in “Test Data Log

window”
Switches the graph display scale.

Switches the number

of logs displayed in
the graph.

Switches information
displayed in the test
item field between
8
measured values and
judgment results.

Displays exposure
conditions.

Creates baseline
values.

Outputs the test result into a CSV file.

FDR Mammography QC Program Guidebook 897N120636 8-7

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

8
Assistance Material

8-8 FDR Mammography QC Program Guidebook 897N120636

 Baseline Value Settings
<Baseline Values for Annual Test>
Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes
Phantom positioning in
5 1 Shot Phantom position Lateral shift distance: mm
Annual Test
kVp:  kV
[5] ‌Spatial Resolution mAs:mAs
(Magnification) Exposure conditions for Exposure condition
6 Exposure Submenu Target/Filter: /
confirmation ( 8 )
[1 ShotM(Magnification)]
Compressed breast thickness: mm
Compression force: N

<Baseline Values for Semi-annual Test>

Test Items Steps Exposure Conditions/Measurement and Judgment Results Input Steps
Exposure condition
1 mAs mAs determination ( 7 )

2 Air kerma mR
µGy
mR
µGy
mR
µGy Result input ( 10 )
[1] Image Basic Test
kVp:  kV
Exposure conditions for Exposure condition
7 Exposure Submenu [Uniform mAs:mAs
confirmation ( 9 )
Expo(Image Basic)]
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]

FDR Mammography QC Program Guidebook 897N120636 8-9

 <Baseline Values for Daily/Weekly Test>
Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes
kVp:  kV
mAs:mAs
[1] ‌Test with 1 Shot 1 Shot Phantom exposure Exposure condition
Phantom 6 conditions
Target/Filter: /
confirmation ( 8 )
Compressed breast thickness: mm
Compression force: N
kVp:  kV
mAs:mAs
Exposure conditions for Exposure condition
8 Exposure Submenu Target/Filter: /
confirmation ( 10 )
[2] ‌Test with ACR [ACR Phantom]
Compressed breast thickness: mm
Phantom
Compression force: N
Density inside the disk
12 Result input ( 14 )
Density outside the disk

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.)

[2] [1]

8
Assistance Material

8-10 FDR Mammography QC Program Guidebook 897N120636

 <Daily/Weekly Test>
Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes
kVp:  kV
mAs:mAs
Exposure conditions for Exposure condition
[1] ‌Test with 1 Shot
Phantom 4 -3 Exposure Submenu Target/Filter: /
confirmation ( 7 )
[1 Shot PhantomM]
Compressed breast thickness: mm
Compression force: N

5 -1 X-ray equipment cleanliness Pass Fail

[2] Good practice 5 -2 Screen cleanliness Pass Fail Result input ( 11 )

5 -3 Viewing box cleanliness Pass Fail

[1] Test
‌ with 1 Shot Distortion Pass Fail
Phantom 9 Result input ( 10 )
Artifact Pass Fail
kVp:  kV
mAs:mAs
Exposure conditions for
Exposure condition
4 -5 Exposure Submenu Target/Filter: /
confirmation ( 7 )
[ACR Phantom]
Compressed breast thickness: mm
Compression force: N
Density at center of Phantom image
Density inside the disk
[3] Test
‌ with ACR
Phantom Density outside the disk
Fibers (ACR Phantom) points
Specks (ACR Phantom) points
8 Result input ( 10 )
Masses (ACR Phantom) points
Visible step wedge (Step
steps
Phantom)
Specks (Step Phantom) steps
Masses (Step Phantom) steps

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.)

[3] [1]

[2]

FDR Mammography QC Program Guidebook 897N120636 8-11

 Semi-annual Test
Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes
kVp:  kV
Exposure conditions for Exposure condition
Exposure Submenu [Uniform mAs:mAs
Expo(Image Basic)] determination ( 9 )
1 -3 Target/Filter: /

Air kerma mR
µGy
mR
µGy
mR
µGy Result input ( 13 )
[1] Image Basic Test kVp:  kV
Exposure conditions for Exposure condition
5 Exposure Submenu [Uniform mAs:mAs
confirmation ( 9 )
Expo(Image Basic)]
Target/Filter: /

Artifact Pass Fail Result input ( 13 )

11
White out Pass Fail Result input ( 13 )
Display value: mm
6 -2, 3 Compressed breast thickness
Measured value: mm
Display value: mm
[2] ‌Compression device 6 -5 Compression force
Measured value: mm
confirmation Result input ( 14 )
Compression force
6 -6 sustainability
Pass Fail

6 -7 Maximum compression force N

7 -2 Luminance cd/m2

7 -3 Viewing box uniformity Pass Fail

[3] ‌Viewing box

maintenance 7 -4 Luminance adjustment function Pass Fail Result input ( 15 )
7 -5 Masking Pass Fail

Interpretation room illuminance

7 -6 (Ambient light)
lx

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]

[3]

[2]

8
Assistance Material

8-12 FDR Mammography QC Program Guidebook 897N120636

 Annual Test (Image Performance Test)
Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes
kVp:  kV
[1] ‌Additive lag effects Exposure conditions for Exposure Submenu
(Lag) 4 -3 [ACR Phantom1(Lag)] mAs:mAs
Target/Filter: /
kVp:  kV
Exposure conditions for Exposure Submenu
5 -2 [Uniform Expo.1(Ghost)] mAs:mAs
Target/Filter: / Exposure condition
kVp:  kV confirmation ( 9 )
[2] M
‌ ultiplicative lag Exposure conditions for Exposure Submenu
effects (Ghost) 5 -4 [ACR Phantom2(Ghost)] mAs:mAs
Target/Filter: /
kVp:  kV
Exposure conditions for Exposure Submenu
5 -6 [Uniform Expo.2(Ghost)] mAs:mAs
Target/Filter: /
kVp:  kV
mAs:mAs
Exposure conditions for Exposure Submenu [1 Target/Filter: / Exposure condition
[3] Missed
‌ tissue on
6 -3 Shot PhantomM(40mm)] confirmation ( 9 )
Compressed breast
chest wall edge thickness:mm
(40 mm height)
Compression force:  N
Missed tissue on chest wall edge (Right) Pass Fail
11 Result input ( 13 )
Missed tissue on chest wall edge (Left) Pass Fail
Verify mechanical stability Pass Fail
Verify that all moving parts move smoothly Pass Fail
All locks and detents work properly Pass Fail
No sharp, rough edges or other hazards
including electrical hazards Pass Fail

Operator technique control charts are posted Pass Fail

[4] Visual
‌ and Functional
test 7 Operator protected during exposure by Result input ( 14 )
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

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.)

[3]

[4]

FDR Mammography QC Program Guidebook 897N120636 8-13

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

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

kVp:  kV

[5] ‌Spatial Resolution mAs:mAs

(Magnification) Exposure conditions for Exposure condition
Target/Filter: /
4 -3 Exposure Submenu [1
confirmation ( 6 )
ShotM(Magnification)] Compressed breast
thickness:mm
Compression force: N

White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8.
Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired
automatically.)

8
Assistance Material

8-14 FDR Mammography QC Program Guidebook 897N120636

 Annual Test (X-ray Equipment Performance Test)
Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes
kVp used for the tests LowkV Mid.kV HighkV
LowkV Mid.-1kV Mid.-2kV
[6] ‌kVp accuracy and
1 -5, 6 LFS - volt. Mid.-3kV Mid.-4kV Mid.-5kV
reproducibility Result input ( 18 )
HighkV

1 -8 SFS - volt. LowkV Mid.kV HighkV

Air kerma
kVp mAs Al 0.3 mm Al 0.5 mm
w/o Al
[7] Half
‌ Value Layer 2 ( ) ( )
(HVL) Target/Filter ( / ) kV mAs mR mR mR Result input ( 19 )
-3, 4, 5 µGy µGy µGy

Target/Filter ( / ) kV mAs mR

µGy
mR
µGy
mR
µGy

kVp:  kV
Exposure conditions mAs:mAs
Target/Filter: /
mR mR mR
[9] Radiation output 3 -4 Entrance air kerma
(1) µGy (2) µGy (3) µGy Result input ( 21 )
mR mR
(4) µGy (5) µGy

Air kerma rate mGy/s

(Exposure time) s
kVp:  kV
mAs:mAs
Exposure condition
7 -3 Exposure conditions Target/Filter: /
confirmation ( 9 )
Compressed breast thickness: mm
Compression force: N
A-amm A-bmm
Distance between image
16 -1 edges
A-cmm A-dmm
A-emm A-fmm
B-bmm B-cmm

16 -2 X-ray / Light field gap B-dmm B-emm

[8] ‌Collimation B-fmm
assessment
Left:mm
Right:mm
16 -3 X-ray / Light field gap
Chest wall side: mm Result input ( 20 )
Nipple side: mm
Left:mm
X-ray / Image receptor field
16 -4 gap
Right:mm
Nipple side: mm
X-ray field / Exposure table
16 -5 gap
Chest wall side: mm

Compression paddle edge

16 -6 (Chest wall side)
Pass Fail

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

8
Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired
automatically.)

[6] [8] [9]

[7]

FDR Mammography QC Program Guidebook 897N120636 8-15

 Annual Test (AEC System Performance Test)
Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes
kVp:  kV
mAs:mAs
Exposure condition
2 Exposure conditions Target/Filter: /
determination ( 9 )
Compressed breast thickness: mm
Compression force: N
[12] ‌CNR mode 1
kVp:  kV
mAs:mAs
Exposure condition
9 Exposure conditions Target/Filter:/
confirmation ( 11 )
Compressed breast thickness: mm
Compression force: N
kVp:  kV
Target/Filter: /
20 -4 Exposure conditions
Compressed breast thickness: mm

[10] ‌AEC density control Compression force: N

function Step 0: mAs
Step +1: mAs Step -1: mAs
20 -5 Step mAs
Step +2: mAs Step -2: mAs
Result input ( 31 )
Step +3: mAs Step -3: mAs
kVp:  kV
mAs:mAs

17 -5 Exposure conditions Target/Filter: /

‌ EC reproducibility
[11] A Compressed breast thickness: mm
Compression force: N
mR mR mR
(1) µGy (2) µGy (3) µGy
17 -6 Entrance air kerma
mR mR Result input ( 26 )
(4) µGy (5) µGy

White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8.
Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired
automatically.)

[10]

8
Assistance Material

8-16 FDR Mammography QC Program Guidebook 897N120636

 Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes
Exposure
18 Mode 1 2 3
determination
PMMA Target/ Compressed Compression
kVp mAs breast
thickness Filter thickness
force
Exposure
Mode 1: 20 mm kV mAs / mm N Exposure condition
18
Exposure 40 mm / ( for 18 -7, 13)
kV mAs mm N
-3, 4 condition determination
determination 60 mm kV mAs / mm N
70 mm kV mAs / mm N
Compressed Air kerma
PMMA Target/ Compression
kVp mAs breast Al 0.3 mm Al 0.5 mm
thickness Filter thickness
force w/o Al
( ) ( )
18 20 mm kV mAs / mm N
mR
µGy
mR
µGy
mR
µGy
Exposure
-7, 8, Mode 1 40 mm kV mAs / mm N
mR
µGy
mR
µGy
mR
µGy
Result input ( 27 )
10, 12 60 mm kV mAs / mm N
mR
µGy
mR
µGy
mR
µGy
mR mR mR
70 mm kV mAs / mm N µGy µGy µGy
Compressed
PMMA Target/ Compression
kVp mAs breast
thickness Filter thickness
force
Exposure
Mode 2: 20 mm kV mAs / mm N Exposure condition
18
Exposure 40 mm / ( for 18 -7, 13)
kV mAs mm N
-3, 4 condition determination
determination 60 mm kV mAs / mm N
[12] ‌AGD modes
1 to 3 70 mm kV mAs / mm N
Compressed Air kerma
PMMA Target/ Compression
kVp mAs breast Al 0.3 mm Al 0.5 mm
thickness Filter thickness
force w/o Al
( ) ( )
18 20 mm kV mAs / mm N
mR
µGy
mR
µGy
mR
µGy
Exposure
-7, 8, Mode 2 40 mm kV mAs / mm N
mR
µGy
mR
µGy
mR
µGy
Result input ( 27 )
10, 12 60 mm kV mAs / mm N
mR
µGy
mR
µGy
mR
µGy
mR mR mR
70 mm kV mAs / mm N µGy µGy µGy
Compressed
PMMA Target/ Compression
kVp mAs breast
thickness Filter thickness
force
Exposure
Mode 3: 20 mm kV mAs / mm N Exposure condition
18
Exposure 40 mm / ( for 18 -7, 13)
kV mAs mm N
-3, 4 condition determination
determination 60 mm kV mAs / mm N
70 mm kV mAs / mm N
Compressed Air kerma
PMMA Target/ Compression
kVp mAs breast Al 0.3 mm Al 0.5 mm
thickness Filter thickness
force w/o Al
( ) ( )
18 20 mm / mR mR mR
Exposure kV mAs mm N µGy µGy µGy
-7, 8, Mode 3 40 mm kV mAs / mm N
mR
µGy
mR
µGy
mR
µGy
Result input ( 27 )
10, 12 60 mm kV mAs / mm N
mR
µGy
mR
µGy
mR
µGy
mR mR mR
70 mm kV mAs / mm N µGy µGy µGy

White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8.
Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired
automatically.)

[12] [12]

FDR Mammography QC Program Guidebook 897N120636 8-17

 Test Items Steps Exposure Conditions/Measurement and Judgment Results Purposes
Compressed
PMMA Target/ Compression
kVp mAs breast
thickness Filter thickness
force

20 mm kV mAs / mm N
Exposure Mode 1 40 mm /
kV mAs mm N
60 mm kV mAs / mm N
70 mm kV mAs / mm N
Compressed
PMMA Target/ Compression
kVp mAs breast
thickness Filter thickness
force

20 mm kV mAs / mm N
[11] ‌CNR modes Exposure condition
1 to 3 22 -4 Exposure Mode 2 40 mm kV mAs / mm N confirmation ( 29 )
60 mm kV mAs / mm N
70 mm kV mAs / mm N
Compressed
PMMA Target/ Compression
kVp mAs breast
thickness Filter thickness
force

20 mm kV mAs / mm N
Exposure Mode 3 40 mm /
kV mAs mm N
60 mm kV mAs / mm N
70 mm kV mAs / mm N
White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8.
Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired
automatically.)

8
Assistance Material

8-18 FDR Mammography QC Program Guidebook 897N120636

 8.4 Report Forms
The 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

FDR Mammography QC Program Guidebook 897N120636 8-19

 1/1

Facility Information
Client Date
Exposure Room Time
Operator Department Name

Manufacturer Model S/N Installation Date

X-ray
FUJIFILM
Equipment
Workstation FUJIFILM

Measurement Equipment/Tool Information

Manufacturer Model S/N Installation Date
Laser Imager
Diagnostic
monitor
Viewing box

Calibration Expiration
Manufacturer Model S/N
Date
1 Shot Phantom
FUJIFILM
M
ACR Phantom
Step Phantom
Densitometer
Density control
strip
Dosimeter
Force scale
Luminance
meter
Illuminance
meter
kVp meter

Signature
 1/3

Daily Test Report

Test with 1 Shot Phantom

Exposure Conditions
Compressed
Compression
kVp mAs Target/Filter Breast S Value
Force
Thickness
1 Shot
kV mm N
PhantomM

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
Missed tissue on
chest wall edge mm - PASS FAIL
Missed tissue on chest wall (Right)
edge Missed tissue on
chest wall edge mm - PASS FAIL
(Left)
CNR CNR PASS FAIL
1 Shot Phantom sensitivity
System sensitivity PASS FAIL
constancy
Horizontal direction mm PASS FAIL
Geometric distortion Vertical direction mm PASS FAIL
Geometric distortion - - PASS FAIL
System artifact evaluation Artifacts - - PASS FAIL
Pixel Value (PV)
% PASS FAIL
ratio (Top-Right)
Pixel Value (PV)
% PASS FAIL
ratio (Top-Left)
Pixel Value (PV)
% PASS FAIL
ratio (Bottom-Right)
Pixel Value (PV)
% PASS FAIL
ratio (Bottom-Left)
Pixel Value (PV)
% PASS FAIL
ratio (Top center)
Uniformity
SNR ratio
% PASS FAIL
(Top-Right)
SNR ratio
% PASS FAIL
(Top-Left)
SNR ratio
% PASS FAIL
(Bottom-Right)
SNR ratio
% PASS FAIL
(Bottom-Left)
SNR ratio
% PASS FAIL
(Top center)
Average QL at
Dynamic range thinnest step QL PASS FAIL
wedge
2 lp/mm % PASS FAIL
Spatial Resolution (SR)
4 lp/mm % PASS FAIL
 2/3

Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
Low Contrast
% PASS FAIL
Low Contrast Detectability Detectability (Light)
(LCD) Low Contrast
% PASS FAIL
Detectability (Dark)
QL gap (1 step-2
QL PASS FAIL
step)
QL gap (2 step-3
QL PASS FAIL
Linearity/Beam quality step)
constancy QL gap (3 step-4
QL PASS FAIL
step)
QL gap (4 step-5
QL PASS FAIL
step)

Remarks

Signature
 3/3

Good practice
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
X-ray equipment cleanliness - - PASS FAIL
Screen cleanliness - -
Viewing box cleanliness - -

Remarks

Signature
 1/3

Weekly Test Report

Test with ACR Phantom

Exposure Conditions
Compressed
Compression
kVp mAs Target/Filter Breast S Value
Force
Thickness
ACR Phantom kV mm N

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
Density at center of Phantom
PASS FAIL
image
Density difference
PASS FAIL
(disk/outside)
Fibers (ACR Phantom) - PASS FAIL
Specks (ACR Phantom) - PASS FAIL
Masses (ACR Phantom) - PASS FAIL
Visible step wedge (Step
- PASS FAIL
Phantom)
Specks (Step Phantom) - PASS FAIL
Masses (Step Phantom) - PASS FAIL
 2/3

HARD COPY PHANTOM CONTROL/CNR CHART

Room: Year:
Month:
Date:
Initials:
AEC SETTING:
CNR Value:
CNR OK:

Density Difference

+0.05 +0.05

Baseline

-0.05 -0.05

Background Density

+0.20 +0.20

+0.15 +0.15

Baseline

-0.15 -0.15

-0.20 -0.20

No.Visible
Fibers
+0.5 +0.5
- 0.5 - 0.5

Specks
+0.5 +0.5
- 0.5 - 0.5

Masses
+0.5 +0.5
- 0.5 - 0.5

mAs (optional)

+15% +15%

Baseline

-15% -15%
 3/3

SOFT COPY PHANTOM CONTROL/CNR CHART

Room: Year:
Month:
Date:
Initials:
AEC SETTING:
CNR Value:
CNR OK:

No.Visible
Fibers
+0.5 +0.5
- 0.5 - 0.5

Specks
+0.5 +0.5
- 0.5 - 0.5

Masses
+0.5 +0.5
- 0.5 - 0.5

S Value

+20% +20%

Baseline

-20% -20%

mAs (optional)

+15% +15%

Baseline

-15% -15%

Remarks

Signature
 1/1

Quarterly Test Report

Repeat analysis

TOTAL NUMBER OF EXAMS:

TOTAL NUMBER OF FILMS: 18×24 24×30 OTHER TOTAL

PROJECTION
REASON FOR REJECT TOTAL % of
CC MLO ML or LM AXILLARY OTHER
REPEATS REPEATS
POSITIONING

PATIENT MOTION

COMPRESSION

ARTIFACTS
X-RAY EQUIP
MALFUNCTION
SOFTWARE
MALFUNCTION
AEC
MISPLACEMENT
UNDER
EXPOSURE
OVER
EXPOSURE
INCORRECT
PATIENT ID
WASTE
SUB-TOTAL
GRAND TOTAL
REPEATS
REPEAT RATE = REPEAT RATE = %
TOTAL FILMS INCLUDING REPEATS

ALL REJECT FILMS

REJECT RATE = REJECT RATE = %
TOTAL FILMS INCLUDING REPEATS

COMMENTS FOR CORRECTIVE ACTION AND GOALS:

Signature
 1/3

Semi-annual Test Report

Image basic test

Exposure Conditions
Compressed Compression
kVp mAs Target/Filter S Value
Breast Thickness Force
S Value kV mm N
Visual
kV mm N
Inspection

Measured Values
Entrance air
mR (μC/kg)
kerma 1
Entrance air
mR (μC/kg)
kerma 2
Entrance air
mR (μC/kg)
kerma 3

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
Relative sensitivity (S value) PASS FAIL

Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
Artifact - - PASS FAIL
White out - - PASS FAIL

Remarks

Signature
 2/3

Compression device confirmation

Measured Values
Compressed breast thickness
mm
- Display value
Compressed breast thickness
mm
- Measured value
Compression force - Display
N
value
Compression force -
N
Measured value
Maximum compression force N

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
Compressed breast thickness
mm PASS FAIL
accuracy
Compression force accuracy N PASS FAIL
Maximum compression force N PASS FAIL
Compression force sustainability - - PASS FAIL

Remarks

Signature
 3/3

Viewing box maintenance

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
Luminance cd/m2 - PASS FAIL
Viewing box uniformity - - PASS FAIL
Luminance adjustment function - - PASS FAIL
Masking - - PASS FAIL
Interpretation room
lx - PASS FAIL
illuminance (Ambient light)

Remarks

Signature
 1/13

Annual Test Report

Additive lag effects (Lag)

Exposure Conditions
Compressed Compression
kVp mAs Target/Filter S Value
Breast Thickness Force
ACR Phantom1(Lag) kV mm N
Non
kV mm N
Exposure(Lag)

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
Lag Factor QL - PASS FAIL

Remarks

Signature
 2/13

Multiplicative lag effects (Ghost)

Exposure Conditions
Compressed Compression
kVp mAs Target/Filter S Value
Breast Thickness Force
Uniform
kV mm N
Expo.1(Ghost)
ACR Phantom2(Ghost) kV mm N
Uniform
kV mm N
Expo.2(Ghost)

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
Ghost Factor - PASS FAIL

Remarks

Signature
 3/13

Missed tissue on chest wall edge (40 mm height)

Exposure Conditions
Compressed Compression
kVp mAs Target/Filter S Value
Breast Thickness Force
1 Shot Phantom
kV mm N
M(40 mm)

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
Missed tissue on chest wall
- - PASS FAIL
edge (Right)
Missed tissue on chest wall
- - PASS FAIL
edge (Left)

Remarks

Signature
 4/13

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
 5/13

Spatial Resolution (Magnification)

Exposure Conditions
Compressed Compression
kVp mAs Target/Filter S Value
Breast Thickness Force
1 ShotM
kV mm N
(Magnification)

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
MTF (4lp/mm) % PASS FAIL
MTF (8lp/mm) % PASS FAIL

Remarks

Signature
 6/13

kVp accuracy and reproducibility

Measurement Conditions
Low kV
kVp Display Values Mid. kV
High kV

Measured Values
Low kV
Mid.-1 kV
Mid.-2 kV
Large Focal Spot
Mid.-3 kV
(LFS)
Mid.-4 kV
Mid.-5 kV
High kV
Low kV
Small Focal Spot
Mid. kV
(SFS)
High kV

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
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
 7/13

Half Value Layer (HVL)

Measured Values
Al 0.3 mm Al 0.5 mm
w/o Al
( ) ( )
Measured HVL (W/Rh) mR(μC/kg) mR(μC/kg) mR(μC/kg)
Measured HVL (W/Al) mR(μC/kg) mR(μC/kg) mR(μC/kg)

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
HVL (W/Rh) mmAl - PASS FAIL
HVL (W/Al) mmAl - PASS FAIL

Remarks

Signature
 8/13

Collimation assessment

Exposure Conditions
Compressed Compression
kVp mAs Target/Filter S Value
Breast Thickness Force
Uniform Expo.3
kV mm N
(Collimation)

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
X-ray / Light field gap
mm - PASS FAIL
(Right/Left)
X-ray / Light field gap
mm - PASS FAIL
(Chest/Nipple)
X-ray / Image receptor field
mm - PASS FAIL
gap (Left)
X-ray / Image receptor field
mm - PASS FAIL
gap (Right)
X-ray / Image receptor field
mm - PASS FAIL
gap (Nipple)
X-ray field / Exposure table
mm - PASS FAIL
gap
Compression paddle edge (Chest wall) - - PASS FAIL

Remarks

Signature
 9/13

Radiation output

Measured Values
mAs
Entrance air
mR(μC/kg)
kerma 1
Entrance air
mR(μC/kg)
kerma 2
Entrance air
mR(μC/kg)
kerma 3
Entrance air
mR(μC/kg)
kerma 4
Entrance air
mR(μC/kg)
kerma 5

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
Reproducibility - PASS FAIL
Air kerma rate mGy/s - PASS FAIL
Specific radiation output μGy/mAs - PASS FAIL

Remarks

Signature
 10/13

AEC density control function

Measured Values
±0 +1 +2 +3 -1 -2 -3

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
mAs variation (±0 to +1) % PASS FAIL
mAs variation (+1 to +2) % PASS FAIL
mAs variation (+2 to +3) % PASS FAIL
mAs variation (-1 to ±0) % PASS FAIL
mAs variation (-2 to -1) % PASS FAIL
mAs variation (-3 to -2) % PASS FAIL

Remarks

Signature
 11/13

AEC reproducibility

Measured Values
mAs
Entrance air
mR(μC/kg)
kerma 1
Entrance air
mR(μC/kg)
kerma 2
Entrance air
mR(μC/kg)
kerma 3
Entrance air
mR(μC/kg)
kerma 4
Entrance air
mR(μC/kg)
kerma 5

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
Entrance air kerma accuracy % PASS FAIL
Entrance air kerma
PASS FAIL
reproducibility

Remarks

Signature
 12/13

CNR modes 1 to 3

Exposure Conditions
Exposure Mode

Compressed Compression
kVp mAs Target/Filter S Value
Breast Thickness Force
Mode n CNR
kV mm N
(PMMA20mm)
Mode n CNR
kV mm N
(PMMA40mm)
Mode n CNR
kV mm N
(PMMA60mm)
Mode n CNR
kV mm N
(PMMA70mm)

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
CNR relative value 20 mm % - PASS FAIL
CNR relative value 40 mm % - PASS FAIL
CNR relative value 60 mm % - PASS FAIL
CNR relative value 70 mm % - PASS FAIL

Remarks

Signature
 13/13

AGD modes 1 to 3

Measured Values
Exposure Mode

Al 0.3 mm Al 0.5 mm
w/o Al
( ) ( )
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)
Entrance air kerma (60mm) mR(μC/kg) mR(μC/kg) mR(μC/kg)
Entrance air kerma (70mm) mR(μC/kg) mR(μC/kg) mR(μC/kg)

Test Result
Criteria
Judgment Item Judgment Result
Lower Limit Upper Limit
AGD 20mm mGy - PASS FAIL
AGD 40mm mGy - PASS FAIL
AGD 60mm mGy - PASS FAIL
AGD 70mm mGy - PASS FAIL

Remarks

Signature
 Chapter 9
Technical Information
Page

9.1 Specification Outline of 1 Shot Phantom M Plus 24×30___ 9-2

9.2 Glossary___________________________________________ 9-3
9.3 CSV Output________________________________________ 9-6

FDR Mammography QC Program Guidebook 897N120636 9-1

 9.1 Specification Outline of 1 Shot
Phantom M Plus 24×30

Test Contents Applicable Phantom Outline of Calculation Method

Missed tissue on chest wall The amount of missed tissue on the chest wall-side edge
Bar patterns (1 mm spacing)
edge is calculated by using coordinate information of the slit.
CNR is calculated according to the definitional equation
CNR Al (0.2 mm)
described in IEC 61223-3-2.
A calculation area (20 x 20 mm) is set at the lateral
center and also at 60 mm from the chest wall-side edge.
1 Shot Phantom sensitivity Uniform exposure region at 60 mm from the chest wall- Based on the pixel value in this calculation area, the value
constancy side edge 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.
Uniform exposure region made of metal and plastic (The
transmission factor becomes almost equivalent to 40-mm
System artifact evaluation N/A
PMMA phantom when an exposure is made at 28kVp,
W/Rh.)
A calculation area (10 x 10 mm) is set at the lateral center
Uniform exposure region at 60 mm from the chest wall- and also at 60 mm from the chest wall. Based on this
Uniformity (Uniform Exposure
side edge and uniform exposure regions at five corners calculation region, the pixel value and relative SNR value
Region)
of the phantom are calculated in the calculation regions (10 x 10 mm
each) at five corners of the phantom.
The pixel value in the highest density region of the step
Dynamic range The lightest region of the step wedge wedge is calculated. According to IEC 61223-3-2,
calculation is executed only in the highest density region.
Bar patterns slanted at 45 degrees (2, 4 and 8 cycles/ SCTF is calculated according to the definitional equation
Spatial Resolution (SR)
mm) described in IEC 61223-3-2.
Low Contrast Detectability A cross-correlation factor is calculated based on the
(LCD) PMMA phantom ( 2 mm, contrast 1.4%) reference image (ideal image).
The pixel value is calculated in each step of the step
Linearity/Beam quality Five step-wedge patterns forming a density region in the
wedge and then the difference between the adjacent
constancy range of the center density plus or minus about one digit
steps is calculated.

9
Technical Information

9-2 FDR Mammography QC Program Guidebook 897N120636

 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
9
flat panel detector (FPD) caused by the last X-ray exposure. The greater the degree
Technical Information

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.

FDR Mammography QC Program Guidebook 897N120636 9-3

 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
Technical Information

9-4 FDR Mammography QC Program Guidebook 897N120636

 14 QL Value
This Program executes various calculations regarding image data before EDR
normalization.
With the 1 Shot Phantom M Plus 24×30, 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 ) = 1.00225 0.225%
-4

However, dynamic range calculation is performed at 14 bits.

0 1023 2047 3071 4095 QL Value

12bit

0.2mR 2mR 20mR 200mR 2R Dose

Digit
4 Digits
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-
3500.

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 9
The system sensitivity is equivalent to the median value of the histogram of the
Technical Information

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

FDR Mammography QC Program Guidebook 897N120636 9-5

 9.3 CSV Output
NOTE
A maximum of 365 items are output to one CSV file. If a CSV file is opened on external software, some
software may not be able to process large data. Reduce the number of items to be output as necessary.
<Result_DailyTest>
Test contents Judgment items
Missed tissue on chest wall edge (R) [mm]
Missed tissue on chest wall edge
Missed tissue on chest wall edge (L) [mm]
CNR CNR
Sensitivity const. System sensitivity
Dimension (Horizontal) [mm]
Geometric distortion Dimension (Vertical) [mm]
Geometric distortion
System artifact evaluation Artifact
Pixel value ratio (Top-Right)[%]
Pixel value ratio (Top-Left)[%]
Pixel value ratio (Bottom-Right)[%]
Pixel value ratio (Bottom-Left)[%]
Pixel value ratio (Top center)[%]
Uniformity
SNR ratio (Top-Right)[%]
SNR ratio (Top-Left)[%]
SNR ratio (Bottom-Right)[%]
SNR ratio (Bottom-Left)[%]
SNR ratio (Top center)[%]
Dynamic range Average QL at thinnest step wedge [QL]
2lp/mm[%]
SR
4lp/mm[%]
Low Contrast Detectability (Light) [%]
LCD
Low Contrast Detectability (Dark) [%]
QL gap (1step-2step)[QL]
QL gap (2step-3step)[QL]
Linearity / Beam quality constancy
QL gap (3step-4step)[QL]
QL gap (4step-5step)[QL]
Density at center of Phantom image
Density difference (Disk/Outside)
Fibers score
Specks score
Test with ACR Phantom
Masses score
Visible step wedge
Specks step wedge number

9 Masses step wedge number

X-ray equipment cleanliness
Good practice Screen cleanliness
Technical Information

Viewing box cleanliness

Comment
Study time
Operator
Software version
Baseline
Baseline value-used flag

9-6 FDR Mammography QC Program Guidebook 897N120636

 Test contents Judgment items
Missed tissue on chest wall edge (R) [mm]
Missed tissue on chest wall edge
Missed tissue on chest wall edge (L) [mm]
CNR CNR
Sensitivity const. System sensitivity
Dimension (Horizontal) [mm]
Geometric distortion Dimension (Vertical) [mm]
Geometric distortion
System artifact evaluation Artifact
Pixel value ratio (Top-Right)[%]
Pixel value ratio (Top-Left)[%]
Pixel value ratio (Bottom-Right)[%]
Pixel value ratio (Bottom-Left)[%]
Pixel value ratio (Top center)[%]
Uniformity
SNR ratio (Top-Right)[%]
SNR ratio (Top-Left)[%]
SNR ratio (Bottom-Right)[%]
SNR ratio (Bottom-Left)[%]
SNR ratio (Top center)[%]
Dynamic range Average QL at thinnest step wedge [QL]
2lp/mm[%]
SR
4lp/mm[%]
Low Contrast Detectability (Light) [%]
LCD
Low Contrast Detectability (Dark) [%]
QL gap (1step-2step)[QL]
QL gap (2step-3step)[QL]
Linearity / Beam quality constancy
QL gap (3step-4step)[QL]
QL gap (4step-5step)[QL]
Density at center of Phantom image
Density difference (Disk/Outside)
Fibers score
Specks score
Test with ACR Phantom
Masses score
Visible step wedge
Specks step wedge number
Masses step wedge number
X-ray equipment cleanliness
Good practice Screen cleanliness
Viewing box cleanliness

9
Comment
Study time
Operator
Technical Information

Software version
Baseline
Baseline value-used flag

FDR Mammography QC Program Guidebook 897N120636 9-7

 Test contents Judgment items
Density at center of Phantom
Density inside the disk
Density outside the disk
ACR Phantom image confirmation
Fibers score
Specks score
Masses score
Visible step wedge
Step Phantom image confirmation Specks step wedge number
Masses step wedge number
Geometric distortion
1 Shot Phantom image confirmation
Artifact
X-ray equip.cleanliness
Good practice Screen cleanliness
Viewing box cleanliness

Exposure condition
X-ray source individual identification
data
Reader unit individual identification
data
Exposure menu
DetectorID
S Value
Tube voltage (kV)
mAs
Exposure1 Target / Filter
Compressed breast thickness [mm]
Compression force [N]
Exposure Mode
Dose mode
D-Tap
Exposure menu
DetectorID
S Value
Tube voltage (kV)
mAs
Exposure2 Target / Filter
Compressed breast thickness [mm]

9 Compression force [N]

Exposure Mode
Dose mode
Technical Information

D-Tap

9-8 FDR Mammography QC Program Guidebook 897N120636

 <Result_SemiannualTest>
Test contents Judgment items
Artifact
Image Basic Test White out
Relative sensitivity
Compressed breast thickness accuracy [mm]
Compression force accuracy [N]
Compression
Maximum compression force [N]
Force sustainability
Viewing box luminance Luminance [cd/m2]
Viewing box uniformity Viewing box uniformity
Luminance adjustment Luminance adjustment
Masking Masking
Interpretation room ambient light Interpretation room ambient light [lx]
Comment
Study time
Operator
Software version
Baseline
Baseline value-used flag

Test contents Judgment items

Artifact
Image Basic Test White out
Relative sensitivity
Compressed breast thickness accuracy [mm]
Compression force accuracy [N]
Compression
Maximum compression force [N]
Force sustainability
Viewing box luminance Luminance [cd/m2]
Viewing box uniformity Viewing box uniformity
Luminance adjustment Luminance adjustment
Masking Masking
Interpretation room ambient light Interpretation room ambient light [lx]
Comment
Study time
Operator
Software version
Baseline
Baseline value-used flag
9
Technical Information

FDR Mammography QC Program Guidebook 897N120636 9-9

 Test contents Judgment items
Entrance air kerma(1)
Entrance air kerma(2)
Image Basic Test Entrance air kerma(3)
Artifact
White out
Luminance
Viewing box uniformity
Viewing box Luminance adjustment
Masking
Room ambient light
Indicated value of compressed breast
thickness
Measured value of compressed breast
X-ray equipment test thickness
1-Compression Indicated value of compression force
Measured value of compression force
Max force
Force sustainability

Exposure condition
X-ray source individual identification
data
Reader unit individual identification
data
Exposure menu
DetectorID
S Value
Tube voltage (kV)
mAs
Exposure1 Target / Filter
Compressed breast thickness [mm]
Compression force [N]
Exposure Mode
Dose mode
D-Tap

9
Technical Information

9-10 FDR Mammography QC Program Guidebook 897N120636

 <Result_AnnualTest>
Test contents Judgment items
Lag Lag factor[QL]
Ghost Ghost factor
Missed tissue on chest wall edge Missed tissue on chest wall edge (R) [mm]
(40mm height) Missed tissue on chest wall edge (L) [mm]
4lp/mm[%]
Spatial Resolution (Magnification)
8lp/mm[%]
Verify mechanical stability
Verify that all moving parts more smoothly
All locks and detents work properly
No sharp, rough edges or other hazards
including electrical hazards
Operator technique control charts are posted
Visual and functional test 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
case of failure
Low volt. accuracy (LFS) [kV]
Mid. volt. accuracy (LFS) [kV]
Mid. volt. reproducibility N=5 (LFS) [kV]
kVp accuracy and reproducibility High volt. accuracy (LFS) [kV]
Low volt. accuracy (SFS) [kV]
Mid. volt. accuracy (SFS) [kV]
High volt. accuracy (SFS) [kV]
HVL(W/Rh)[mmAl]
Half Value Layer (HVL)
HVL(W/Al)[mmAl]
X-ray / Light field gap (Right/Left) [mm]
X-ray / Light field gap (Chest/Nipple) [mm]
X-ray / Image receptor field gap (Left) [mm]
Collimation assessment X-ray / Image receptor field gap (Right) [mm]
X-ray / Image receptor field gap (Nipple) [mm]
X-ray field / Exposure table gap (Chest)[mm]
Compression paddle edge (Chest wall side)
Reproducibility
Radiation output Air kerma rate [mGy/s]
Specific radiation output[uGy/mAs]
mAs variation (Step+2/Step+3) [%]
mAs variation (Step+1/Step+2) [%]
9
Technical Information

mAs variation (Step 0/Step+1) [%]

AEC density control
mAs variation (Step-1/Step 0) [%]
mAs variation (Step-2/Step-1) [%]
mAs variation (Step-3/Step-2) [%]
Entrance air kerma accuracy [%]
AEC reproducibility
Entrance air kerma reproducibility

FDR Mammography QC Program Guidebook 897N120636 9-11

 CNR ratio 20mm_H - mode[%]
CNR ratio 40mm_H - mode[%]
CNR_H - mode
CNR ratio 60mm_H - mode[%]
CNR ratio 70mm_H - mode[%]
AGD 20mm_H - mode[mGy]
AGD 40mm_H - mode[mGy]
AGD H - mode
AGD 60mm_H - mode[mGy]
AGD 70mm_H - mode[mGy]
CNR ratio 20mm_N - mode[%]
CNR ratio 40mm_N - mode[%]
CNR_N - mode
CNR ratio 60mm_N - mode[%]
CNR ratio 70mm_N - mode[%]
AGD 20mm_N - mode[mGy]
AGD 40mm_N - mode[mGy]
AGD N - mode
AGD 60mm_N - mode[mGy]
AGD 70mm_N - mode[mGy]
CNR ratio 20mm_L - mode[%]
CNR ratio 40mm_L - mode[%]
CNR_L - mode
CNR ratio 60mm_L - mode[%]
CNR ratio 70mm_L - mode[%]
AGD 20mm_L - mode[mGy]
AGD 40mm_L - mode[mGy]
AGD L - mode
AGD 60mm_L - mode[mGy]
AGD 70mm_L - mode[mGy]
Comment
Study time
Operator
Software version
Baseline
Baseline value-used flag

9
Technical Information

9-12 FDR Mammography QC Program Guidebook 897N120636

 Test contents Judgment items
Lag Lag factor[QL]
Ghost Ghost factor
Missed tissue on chest wall edge Missed tissue on chest wall edge (R) [mm]
(40mm height) Missed tissue on chest wall edge (L) [mm]
4lp/mm[%]
Spatial Resolution (Magnification)
8lp/mm[%]
Verify mechanical stability
Verify that all moving parts more smoothly
All locks and detents work properly
No sharp, rough edges or other hazards
including electrical hazards
Operator technique control charts are posted
Visual and functional test 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
case of failure
Low volt. accuracy (LFS) [kV]
Mid. volt. accuracy (LFS) [kV]
Mid. volt. reproducibility N=5 (LFS) [kV]
kVp accuracy and reproducibility High volt. accuracy (LFS) [kV]
Low volt. accuracy (SFS) [kV]
Mid. volt. accuracy (SFS) [kV]
High volt. accuracy (SFS) [kV]
HVL(W/Rh)[mmAl]
Half Value Layer (HVL)
HVL(W/Al)[mmAl]
X-ray / Light field gap (Right/Left) [mm]
X-ray / Light field gap (Chest/Nipple) [mm]
X-ray / Image receptor field gap (Left) [mm]
Collimation assessment X-ray / Image receptor field gap (Right) [mm]
X-ray / Image receptor field gap (Nipple) [mm]
X-ray field / Exposure table gap (Chest)[mm]
Compression paddle edge (Chest wall side)
Reproducibility
Radiation output Air kerma rate [mGy/s]
Specific radiation output[uGy/mAs]
mAs variation (Step+2/Step+3) [%]
mAs variation (Step+1/Step+2) [%]
mAs variation (Step 0/Step+1) [%]
9
AEC density control
Technical Information

mAs variation (Step-1/Step 0) [%]

mAs variation (Step-2/Step-1) [%]
mAs variation (Step-3/Step-2) [%]
Entrance air kerma accuracy [%]
AEC reproducibility
Entrance air kerma reproducibility

FDR Mammography QC Program Guidebook 897N120636 9-13

 CNR ratio 20mm_H - mode[%]
CNR ratio 40mm_H - mode[%]
CNR_H - mode
CNR ratio 60mm_H - mode[%]
CNR ratio 70mm_H - mode[%]
AGD 20mm_H - mode[mGy]
AGD 40mm_H - mode[mGy]
AGD H - mode
AGD 60mm_H - mode[mGy]
AGD 70mm_H - mode[mGy]
CNR ratio 20mm_N - mode[%]
CNR ratio 40mm_N - mode[%]
CNR_N - mode
CNR ratio 60mm_N - mode[%]
CNR ratio 70mm_N - mode[%]
AGD 20mm_N - mode[mGy]
AGD 40mm_N - mode[mGy]
AGD N - mode
AGD 60mm_N - mode[mGy]
AGD 70mm_N - mode[mGy]
CNR ratio 20mm_L - mode[%]
CNR ratio 40mm_L - mode[%]
CNR_L - mode
CNR ratio 60mm_L - mode[%]
CNR ratio 70mm_L - mode[%]
AGD 20mm_L - mode[mGy]
AGD 40mm_L - mode[mGy]
AGD L - mode
AGD 60mm_L - mode[mGy]
AGD 70mm_L - mode[mGy]
Comment
Study time
Operator
Software version
Baseline
Baseline value-used flag

Test contents Judgment items

Image performance test - Missed Missed tissue on chest wall edge (R) [mm]
tissue on chest wall edge (40mm
Missed tissue on chest wall edge (L) [mm]
height)
Verify mechanical stability
Verify that all moving parts more smoothly
All locks and detents work properly
No sharp, rough edges or other hazards

9
including electrical hazards
Operator technique control charts are posted
X-ray equipment test 2 - Visual and
Operator protected during exposure by
functional test
Technical Information

adequate radiation shielding

All indicator lights working properly
Auto decompression can be overridden and
status displayed
Compression can be manually released in
case of failure

9-14 FDR Mammography QC Program Guidebook 897N120636

 Tube voltage (Low)
Tube voltage (Middle)
Tube voltage (High)
LFS - volt. Low
LFS - volt. Mid. - 1
LFS - volt. Mid. - 2
X-ray equipment test2 - kVp
LFS - volt. Mid. - 3
accuracy and reproducibility
LFS - volt. Mid. - 4
LFS - volt. Mid. - 5
LFS - volt. High
SFS - volt. Low
SFS - volt. Mid.
SFS - volt. High
W/Rh Without Al Entrance air kerma
W/Rh Al (thin) Thickness
W/Rh Al (thin) Entrance air kerma
W/Rh Al (thick) Thickness
X-ray equipment test2 - Half Value W/Rh Al (thick) Entrance air kerma
Layer (HVL) W/Al Without Al Entrance air kerma
W/Al Al (thin) Thickness
W/Al Al (thin) Entrance air kerma
W/Al Al (thick) Thickness
W/Al Al (thick) Entrance air kerma
X-ray / Light field gap Left
X-ray / Light field gap Right
X-ray / Light field gap Chest
X-ray / Light field gap Nipple
X-ray equipment test2 - Collimation
X-ray / Image receptor field gap Left
Assessment
X-ray / Image receptor field gap Right
X-ray / Image receptor field gap Nipple
X-ray field / Exposure table gap
Compression paddle edge (Chest wall side)
Entrance air kerma(1)
Entrance air kerma(2)
Entrance air kerma(3)
X-ray equipment test2 - Radiation
Entrance air kerma(4)
output
Entrance air kerma(5)
mAs
Air kerma rate

9
Entrance air kerma(1)
Entrance air kerma(2)
AEC system performance - AEC
Entrance air kerma(3)
reproducibility
Technical Information

Entrance air kerma(4)

Entrance air kerma(5)

FDR Mammography QC Program Guidebook 897N120636 9-15

 Step 0 mAs
Step -1 mAs
Step -2 mAs
AEC system performance - AEC
Step -3 mAs
density control
Step +1 mAs
Step +2 mAs
Step +3 mAs
Entrance air kerma (H - mode)_20mm_Without
Al Entrance air kerma
Entrance air kerma (H - mode)_20mm_Al (thin)
Thickness
Entrance air kerma (H - mode)_20mm_Al (thin)
Entrance air kerma
Entrance air kerma (H - mode)_20mm_Al
(thick) Thickness
Entrance air kerma (H - mode)_20mm_Al
(thick) Entrance air kerma
Entrance air kerma (H - mode)_20mm Target /
Filter
Entrance air kerma (H - mode)_40mm_Without
Al Entrance air kerma
Entrance air kerma (H - mode)_40mm_Al (thin)
Thickness
Entrance air kerma (H - mode)_40mm_Al (thin)
Entrance air kerma
Entrance air kerma (H - mode)_40mm_Al
(thick) Thickness
AEC system performance - Average Entrance air kerma (H - mode)_40mm_Al
Glandular Dose (AGD) (thick) Entrance air kerma
Entrance air kerma (H - mode)_40mm Target /
Filter
Entrance air kerma (H - mode)_60mm_Without
Al Entrance air kerma
Entrance air kerma (H - mode)_60mm_Al (thin)
Thickness
Entrance air kerma (H - mode)_60mm_Al (thin)
Entrance air kerma
Entrance air kerma (H - mode)_60mm_Al
(thick) Thickness
Entrance air kerma (H - mode)_60mm_Al
(thick) Entrance air kerma

9 Entrance air kerma (H - mode)_60mm Target /

Filter
Entrance air kerma (H - mode)_70mm_Without
Technical Information

Al Entrance air kerma

Entrance air kerma (H - mode)_70mm_Al (thin)
Thickness
Entrance air kerma (H - mode)_70mm_Al (thin)
Entrance air kerma

9-16 FDR Mammography QC Program Guidebook 897N120636

 Entrance air kerma (H - mode)_70mm_Al
(thick) Thickness
Entrance air kerma (H - mode)_70mm_Al
(thick) Entrance air kerma
Entrance air kerma (H - mode)_70mm Target /
Filter
Entrance air kerma (N - mode)_20mm_Without
Al Entrance air kerma
Entrance air kerma (N - mode)_20mm_Al (thin)
Thickness
Entrance air kerma (N - mode)_20mm_Al (thin)
Entrance air kerma
Entrance air kerma (N - mode)_20mm_Al
(thick) Thickness
Entrance air kerma (N - mode)_20mm_Al
(thick) Entrance air kerma
Entrance air kerma (N - mode)_20mm Target /
Filter
Entrance air kerma (N - mode)_40mm_Without
Al Entrance air kerma
Entrance air kerma (N - mode)_40mm_Al (thin)
Thickness
Entrance air kerma (N - mode)_40mm_Al (thin)
Entrance air kerma
AEC system performance - Average Entrance air kerma (N - mode)_40mm_Al
Glandular Dose (AGD) (thick) Thickness
Entrance air kerma (N - mode)_40mm_Al
(thick) Entrance air kerma
Entrance air kerma (N - mode)_40mm Target /
Filter
Entrance air kerma (N - mode)_60mm_Without
Al Entrance air kerma
Entrance air kerma (N - mode)_60mm_Al (thin)
Thickness
Entrance air kerma (N - mode)_60mm_Al (thin)
Entrance air kerma
Entrance air kerma (N - mode)_60mm_Al
(thick) Thickness
Entrance air kerma (N - mode)_60mm_Al
(thick) Entrance air kerma
Entrance air kerma (N - mode)_60mm Target /
Filter
Entrance air kerma (N - mode)_70mm_Without
9
Al Entrance air kerma
Technical Information

Entrance air kerma (N - mode)_70mm_Al (thin)

Thickness
Entrance air kerma (N - mode)_70mm_Al (thin)
Entrance air kerma
Entrance air kerma (N - mode)_70mm_Al
(thick) Thickness

FDR Mammography QC Program Guidebook 897N120636 9-17

 Entrance air kerma (N - mode)_70mm_Al
(thick) Entrance air kerma
Entrance air kerma (N - mode)_70mm Target /
Filter
Entrance air kerma (L - mode)_20mm_Without
Al Entrance air kerma
Entrance air kerma (L - mode)_20mm_Al (thin)
Thickness
Entrance air kerma (L - mode)_20mm_Al (thin)
Entrance air kerma
Entrance air kerma (L - mode)_20mm_Al (thick)
Thickness
Entrance air kerma (L - mode)_20mm_Al (thick)
Entrance air kerma
Entrance air kerma (L - mode)_20mm Target /
Filter
Entrance air kerma (L - mode)_40mm_Without
Al Entrance air kerma
Entrance air kerma (L - mode)_40mm_Al (thin)
Thickness
Entrance air kerma (L - mode)_40mm_Al (thin)
Entrance air kerma
Entrance air kerma (L - mode)_40mm_Al (thick)
Thickness
Entrance air kerma (L - mode)_40mm_Al (thick)
AEC system performance - Average
Entrance air kerma
Glandular Dose (AGD)
Entrance air kerma (L - mode)_40mm Target /
Filter
Entrance air kerma (L - mode)_Without Al
Entrance air kerma
Entrance air kerma (L - mode)_Al (thin)
Thickness
Entrance air kerma (L - mode)_Al (thin)
Entrance air kerma
Entrance air kerma (L - mode)_Al (thick)
Thickness
Entrance air kerma (L - mode)_Al (thick)
Entrance air kerma
Entrance air kerma (L - mode) Target / Filter
Entrance air kerma (L - mode)_70mm_Without
Al Entrance air kerma

9 Entrance air kerma (L - mode)_70mm_Al (thin)

Thickness
Entrance air kerma (L - mode)_70mm_Al (thin)
Technical Information

Entrance air kerma

Entrance air kerma (L - mode)_70mm_Al (thick)
Thickness
Entrance air kerma (L - mode)_70mm_Al (thick)
Entrance air kerma
Entrance air kerma (L - mode)_70mm Target /
Filter

9-18 FDR Mammography QC Program Guidebook 897N120636

 Exposure condition
X-ray source individual identification
data
Reader unit individual identification
data
Exposure menu
DetectorID
S Value
Tube voltage (kV)
mAs
Exposure1 Target / Filter
Compressed breast thickness [mm]
Compression force [N]
Exposure Mode
Dose mode
D-Tap
Exposure menu
DetectorID
S Value
Tube voltage (kV)
mAs
Exposure2 Target / Filter
Compressed breast thickness [mm]
Compression force [N]
Exposure Mode
Dose mode
D-Tap
Exposure menu
DetectorID
S Value
Tube voltage (kV)
mAs
Exposure3 Target / Filter
Compressed breast thickness [mm]
Compression force [N]
Exposure Mode
Dose mode
D-Tap
Exposure menu
DetectorID
S Value 9
Tube voltage (kV)
Technical Information

mAs
Exposure4 Target / Filter
Compressed breast thickness [mm]
Compression force [N]
Exposure Mode
Dose mode
D-Tap

FDR Mammography QC Program Guidebook 897N120636 9-19

 Exposure menu
DetectorID
S Value
Tube voltage (kV)
mAs
Exposure5 Target / Filter
Compressed breast thickness [mm]
Compression force [N]
Exposure Mode
Dose mode
D-Tap
Exposure menu
DetectorID
S Value
Tube voltage (kV)
mAs
Exposure6 Target / Filter
Compressed breast thickness [mm]
Compression force [N]
Exposure Mode
Dose mode
D-Tap

9
Technical Information

9-20 FDR Mammography QC Program Guidebook 897N120636

 <Baseline_DailyTest>
Test contents Judgment items
Missed tissue on chest wall edge (R) [mm]
Missed tissue on chest wall edge
Missed tissue on chest wall edge (L) [mm]
CNR CNR
Sensitivity const. System sensitivity
Dimension (Horizontal) [mm]
Geometric distortion Dimension (Vertical) [mm]
Geometric distortion
System artifact evaluation Artifact
Pixel value ratio (Top-Right)[%]
Pixel value ratio (Top-Left)[%]
Pixel value ratio (Bottom-Right)[%]
Pixel value ratio (Bottom-Left)[%]
Pixel value ratio (Top center)[%]
Uniformity
SNR ratio (Top-Right)[%]
SNR ratio (Top-Left)[%]
SNR ratio (Bottom-Right)[%]
SNR ratio (Bottom-Left)[%]
SNR ratio (Top center)[%]
Dynamic range Average QL at thinnest step wedge [QL]
2lp/mm[%]
SR
4lp/mm[%]
Low Contrast Detectability (Light) [%]
LCD
Low Contrast Detectability (Dark) [%]
QL gap (1step-2step)[QL]
QL gap (2step-3step)[QL]
Linearity / Beam quality constancy
QL gap (3step-4step)[QL]
QL gap (4step-5step)[QL]
Density at center of Phantom image
Density difference (Disk/Outside)
Fibers score
Specks score
Test with ACR Phantom
Masses score
Visible step wedge
Specks step wedge number
Masses step wedge number
X-ray equipment cleanliness
Good practice Screen cleanliness

9
Viewing box cleanliness
Baseline value creation
Study time
Technical Information

Operator
Software version

FDR Mammography QC Program Guidebook 897N120636 9-21

 <Baseline_SemiAnnualTest>
Test contents Judgment items
Artifact
Image Basic Test White out
Relative sensitivity
Compressed breast thickness accuracy [mm]
Compression force accuracy [N]
Compression
Maximum compression force [N]
Force sustainability
Viewing box luminance Luminance [cd/m2]
Viewing box uniformity Viewing box uniformity
Luminance adjustment Luminance adjustment
Masking Masking
Interpretation room ambient light Interpretation room ambient light [lx]
Baseline value creation
Study time
Operator
Software version

<Baseline_AnnualTest>
Test contents Judgment items
Lag Lag factor[QL]
Ghost Ghost factor
Missed tissue on chest wall edge Missed tissue on chest wall edge (R) [mm]
(40mm height) Missed tissue on chest wall edge (L) [mm]
4lp/mm[%]
Spatial Resolution (Magnification)
8lp/mm[%]
Verify mechanical stability
Verify that all moving parts more smoothly
All locks and detents work properly
No sharp, rough edges or other hazards
including electrical hazards
Operator technique control charts are posted
Visual and functional test 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

9
case of failure
Low volt. accuracy (LFS) [kV]
Mid. volt. accuracy (LFS) [kV]
Technical Information

Mid. volt. reproducibility N=5 (LFS) [kV]

kVp accuracy and reproducibility High volt. accuracy (LFS) [kV]
Low volt. accuracy (SFS) [kV]
Mid. volt. accuracy (SFS) [kV]
High volt. accuracy (SFS) [kV]

9-22 FDR Mammography QC Program Guidebook 897N120636

 HVL(W/Rh)[mmAl]
Half Value Layer (HVL)
HVL(W/Al)[mmAl]
X-ray / Light field gap (Right/Left) [mm]
X-ray / Light field gap (Chest/Nipple) [mm]
X-ray / Image receptor field gap (Left) [mm]
Collimation assessment X-ray / Image receptor field gap (Right) [mm]
X-ray / Image receptor field gap (Nipple) [mm]
X-ray field / Exposure table gap (Chest)[mm]
Compression paddle edge (Chest wall side)
Reproducibility
Radiation output Air kerma rate [mGy/s]
Specific radiation output[uGy/mAs]
mAs variation (Step+2/Step+3) [%]
mAs variation (Step+1/Step+2) [%]
mAs variation (Step 0/Step+1) [%]
AEC density control
mAs variation (Step-1/Step 0) [%]
mAs variation (Step-2/Step-1) [%]
mAs variation (Step-3/Step-2) [%]
Entrance air kerma accuracy [%]
AEC reproducibility
Entrance air kerma reproducibility
CNR ratio 20mm_H - mode[%]
CNR ratio 40mm_H - mode[%]
CNR_H - mode
CNR ratio 60mm_H - mode[%]
CNR ratio 70mm_H - mode[%]
AGD 20mm_H - mode[mGy]
AGD 40mm_H - mode[mGy]
AGD H - mode
AGD 60mm_H - mode[mGy]
AGD 70mm_H - mode[mGy]
CNR ratio 20mm_N - mode[%]
CNR ratio 40mm_N - mode[%]
CNR_N - mode
CNR ratio 60mm_N - mode[%]
CNR ratio 70mm_N - mode[%]
AGD 20mm_N - mode[mGy]
AGD 40mm_N - mode[mGy]
AGD N - mode
AGD 60mm_N - mode[mGy]
AGD 70mm_N - mode[mGy]
CNR ratio 20mm_L - mode[%]
CNR ratio 40mm_L - mode[%]
CNR_L - mode
CNR ratio 60mm_L - mode[%]

9
CNR ratio 70mm_L - mode[%]
AGD 20mm_L - mode[mGy]
AGD 40mm_L - mode[mGy]
AGD L - mode
Technical Information

AGD 60mm_L - mode[mGy]

AGD 70mm_L - mode[mGy]
Baseline value creation
Study time
Operator
Software version

FDR Mammography QC Program Guidebook 897N120636 9-23

 <InitialSetting>
sample
Dosimeter - Exposure table distance 40
Initial setting
Magnification table - Exposure table distance 247
Target/Filter (W/Rh) Yes
Target / Filter and tube voltage (HVL)
Target/Filter (W/Al) Yes
Target/Filter (W/Rh) 28
Tube voltage
Target/Filter (W/Al) 28
mR ON
Air kerma unit
uGy OFF
Use viewing box Yes
Viewing box setting Luminance adjustment Yes
Masking Yes
18x24 OFF
1 Shot Phantom size
24x30 ON
Use the function for adjusting X-ray dose. Yes
Setting of study items
Use the magnification exposure stand. Yes

9
Technical Information

9-24 FDR Mammography QC Program Guidebook 897N120636

 Image Processing
Parameters
(for Mammography QC)
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

FDR Mammography QC Program Guidebook 897N120636 QCParam-1

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

1 3 4 5
Study Menu

MPM Code

AP/PA
Menu Description
2 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 menu
A 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.

QCParam-2 FDR Mammography QC Program Guidebook 897N120636

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

S Value
L Value
PRIEF
the digital image.
Type
Type
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 algorithm
SP : ‌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 equipment
III' : ‌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.

FDR Mammography QC Program Guidebook 897N120636 QCParam-3

 Image Image Processing Parameters
Format GA GT GC GS MRB MRT MRE MDB MDT MDE
Monitor 1.5 u 0.50 0.03 A T 0.7 G U 1.0
1 Film 1.2 T 1.40 -0.04 G R 1.5 E F 0.4

2
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 affecting 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.

1.2

0.8
Response

0.6 A B C D

0.4 E F G

0.2

0
0.001 0.01 0.1 1 10
Frequency (cy/mm)

Figure : MRB types and enhancement curves

A stronger enhancement is applied in high-frequency bands as going from A to F.

QCParam-4 FDR Mammography QC Program Guidebook 897N120636

FDR Mammography QC Program Guidebook 897N120636 QCParam-5
 • Image Processing Parameters for Mammography QC
Study Menu Auto Semi Fix

MPM Code

EDR mode
AP/PA

S Value
L Value
PRIEF
Menu Description

Type

Type
Exposure Menu

Calculation 1/2
CNR
7302 AP [Calculation] For checkup of mammography QC CNR S - V I 1 200

Calculation 2/2
AGD
7302 AP [Calculation] For checkup of mammography QC AGD S - V I 1 200

1Shot PhantomM
1Shot PhantomM [Daily/Weekly] For checkup of mammography QC
7375 AP 1Shot Phantom M S - V III’ 2 80

ACR Phantom
ACR Phantom [Daily/Weekly] For checkup of mammography QC
7326 AP ACR Phantom S - V III’ 2 80

1Shot/ACR
1Shot PhantomM [Daily/Weekly] For checkup of mammography QC
7375 AP 1Shot Phantom M S - V III’ 2 80

ACR Phantom [Daily/Weekly] For checkup of mammography QC

7326 AP ACR Phantom S - V III’ 2 80

Semi-annual 1/1
Uniform Expo [Semi-annual] For checkup of mammography QC
(Image Basic) 7302 AP 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) [Annual] For checkup of mammography QC

7375 AP Missed tissue on chest wall edge (40 mm height) S - V III’ 2 80

* 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.

QCParam-6 FDR Mammography QC Program Guidebook 897N120636

 GA : Rotation Amount Multi-Objective Frequency Processing Multi-Objective DRC Processing
GT : Gradation Type MRB : Balance Type MDB : Balance Type
GC : Rotation Center MRT : Frequency Type MDT : Frequency Type
GS : Gradation Shifting Amount MRE : Enhancement MDE : Enhancement

Image Processing Parameters

Image
Format
GA GT GC GS MRB MRT MRE MDB MDT MDE

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

FDR Mammography QC Program Guidebook 897N120636 QCParam-7

 Study Menu Auto Semi Fix

MPM Code

EDR mode
AP/PA

S Value
L Value
PRIEF
Menu Description

Type

Type
Exposure Menu

Annual 2/6
1ShotM (Magnification) [Annual] For checkup of mammography QC
7375 AP 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 [Annual] For checkup of mammography QC
(PMMA20mm) 7302 AP H-mode CNR (20 mm height) S - V I 1 200

H-mode CNR [Annual] For checkup of mammography QC

(PMMA40mm) 7302 AP H-mode CNR (40 mm height) S - V I 1 200

H-mode CNR [Annual] For checkup of mammography QC

(PMMA60mm) 7302 AP H-mode CNR (60 mm height) S - V I 1 200

H-mode CNR [Annual] For checkup of mammography QC

(PMMA70mm) 7302 AP H-mode CNR (70 mm height) S - V I 1 200

Annual 5/6
N-mode CNR [Annual] For checkup of mammography QC
(PMMA20mm) 7302 AP N-mode CNR (20 mm height) S - V I 1 200

N-mode CNR [Annual] For checkup of mammography QC

(PMMA40mm) 7302 AP N-mode CNR (40 mm height) S - V I 1 200

N-mode CNR [Annual] For checkup of mammography QC

(PMMA60mm) 7302 AP N-mode CNR (60 mm height) S - V I 1 200

N-mode CNR [Annual] For checkup of mammography QC

(PMMA70mm) 7302 AP N-mode CNR (70 mm height) S - V I 1 200

Annual 6/6
L-mode CNR [Annual] For checkup of mammography QC
(PMMA20mm) 7302 AP L-mode CNR (20 mm height) S - V I 1 200

L-mode CNR [Annual] For checkup of mammography QC

(PMMA40mm) 7302 AP L-mode CNR (40 mm height) S - V I 1 200

L-mode CNR [Annual] For checkup of mammography QC

(PMMA60mm) 7302 AP L-mode CNR (60 mm height) S - V I 1 200

L-mode CNR [Annual] For checkup of mammography QC

(PMMA70mm) 7302 AP L-mode CNR (70 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.

QCParam-8 FDR Mammography QC Program Guidebook 897N120636

 GA : Rotation Amount Multi-Objective Frequency Processing Multi-Objective DRC Processing
GT : Gradation Type MRB : Balance Type MDB : Balance Type
GC : Rotation Center MRT : Frequency Type MDT : Frequency Type
GS : Gradation Shifting Amount MRE : Enhancement MDE : Enhancement

Image Processing Parameters

Image
Format
GA GT GC GS MRB MRT MRE MDB MDT MDE

Monitor 1.5 u 0.50 0.03 A T 0.7 G U 1.0

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

FDR Mammography QC Program Guidebook 897N120636 QCParam-9