Aspire HD
Quality Control
Program Manual
Quality
Control
1
Overview
2
Installation
of FDR
Mammography
QC Program
3
Weekly Test
4
Quarterly Test
5
Semi-annual
Test
6
Annual Test
7
Assistance
Material
8
Technical
Information
9
2nd Edition - October 2012
This Manual provides detailed information about how to use the FDR
Mammography QC Program as well as important points to note when using
it. Before using this product, be sure to read this Manual thoroughly. After
reading this Manual, store it nearby so that you can refer to it whenever
necessary. Please also read “FDR-1000DRSZ Operation Manual”, “FDR1000AWS Operation Manual”, “FDR Mammography QC Software Operation
Manual” and “FCR 1Shot Phantom M Plus Operation Manual”.
897N101461A
FDR Mammography QC Manual - 897N101461A
Image Processing
Parameters
(for Mammography QC)
ii
FDR Mammography QC Manual - 897N101461A
Introduction
The FDR Mammography QC Program Manual (the “Manual” hereafter) provides the
procedures for quality control and constancy test, technical explanation and other
information necessary for managing the quality of the FDR digital mammography
system.
This quality control program primarily uses quantitative measurements and provides
the ability to see gradual changes in X-ray equipment performances, as these
changes are difficult to notice by visual checks alone.
Exclusive Clauses
1. No part or all of this Manual (except Chapter 8) may be reproduced in any form without prior
permission.
2. The information contained in this Manual may be subject to change without prior notice.
3. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from
installation, relocation, remodeling, maintenance, and repair performed by other than dealers
specified by FUJIFILM Corporation.
4. FUJIFILM Corporation shall not be liable for malfunctions and damages of FUJIFILM
Corporation products due to products of other manufacturers not supplied by FUJIFILM
Corporation.
5. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from
remodeling, maintenance, and repair using repair parts other than those specified by FUJIFILM
Corporation.
6. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from negligence
of precautions and operating methods contained in this Manual.
7. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from use
under environment conditions outside the range of using conditions for this product such as
power supply, installation environment, etc. contained in this Guidebook.
8. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from natural
disasters such as fires, earthquakes, floods, lightning, etc.
Trademark
FCR and FDR are trademarks or registered trademarks of FUJIFILM Corporation.
Copyright © 2008 FUJIFILM Corporation. All rights reserved.
FDR Mammography QC Manual - 897N101461A
iii
iv
FDR Mammography QC Manual - 897N101461A
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
Weekly Test
4
This chapter describes the Weekly Test procedure performed by the
Technologist (and during MEE and Annual testing by the Medical Physicist).
Chapter
5
Quarterly Test
5
This chapter describes the Quarterly Test procedure performed by the
Technologist.
Chapter
6
Semi-annual Test
6
This chapter describes the Semi-annual Test procedure performed by the
Technologist.
Chapter
7
Annual Test
7
The test procedures performed by the Medical Physicist during the Medical
Equipment Evaluation (MEE) and Annual testing.
Chapter
8
Assistance Material
8
This chapter consists of material that helps with quality control tests and
includes explanations of the calculation functions, software operation quick
guides and the worksheets.
Chapter
9
Technical Information
9
This chapter consists of a brief specification of 1Shot Phantom M Plus
and a glossary.
FDR Mammography QC Manual - 897N101461A
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)
vi
[Start study.]
The button name is shown in brackets ([ ]) regardless of
the feature.
FDR Mammography QC Manual - - 897N101461A
Contents
Chapter
Chapter
1
Quality Control
1.1 Quality Control ................................................................................................................
1.1.1 Acceptance Test ............................................................................................
1.1.2 Constancy Test ...............................................................................................
1.1.3 Status Test ..........................................................................................................
1-2
1-2
1-2
1-2
1.2 Quality Control of the Mammography System ....................................................
1.2.1 Quality Control Tests and Frequency ..........................................
1.2.2 Types of Quality Control Tests ..........................................................
1-3
1-3
1-4
2
Overview
2.1 Product Outline ..............................................................................................................
2-2
2.2 QC Test Items.................................................................................................................... 2-5
2.2.1 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 ............................................................................................
3.4.1 Baseline Values for Annual Test .......................................................
3.4.2 Baseline Values for Semi-annual Test..........................................
3.4.3 Baseline Values for Weekly Test .......................................................
3-12
3-13
3-17
3-21
3.5 Checking Equipment Conditions at the Time of Program
Installation .......................................................................................................................... 3-29
FDR Mammography QC Manual - 897N101461A
vii
Chapter
4
Weekly Test
4.1 Test Flow ..............................................................................................................................
4-2
4.2 Test Items.............................................................................................................................
4-3
4.3 Tools .........................................................................................................................................
4-4
4.4 Setting Confirmation .................................................................................................
4-5
4.5 1 Shot Phantom Test
4-6
................................................................................................
4.6 ACR Phantom Test ....................................................................................................... 4-12
4.7 Printer Quality Control ............................................................................................. 4-18
4.8 Monitor Quality Control .......................................................................................... 4-20
Chapter
Chapter
Chapter
viii
5
Quarterly Test
5.1 Test Flow ..............................................................................................................................
5-2
5.2 Test Items.............................................................................................................................
5-3
5.3 Repeat Analysis ...............................................................................................................
5-4
6
Semi-annual Test
6.1 Test Flow ..............................................................................................................................
6-2
6.2 Test Items.............................................................................................................................
6-2
6.3 Tools .........................................................................................................................................
6-2
6.4 Compression Device Confirmation ...............................................................
6-2
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 ........................................................................................
7.5.1 Initial Performance Test ..........................................................................
7.5.1 Image Performance Test ........................................................................
7.5.2 Spatial Resolution Test ............................................................................
7.5.3 X-ray Equipment Performance Test .............................................
7.5.4 AEC System Performance Test ..........................................................
7-7
7-7
7-19
7-27
7-31
7-45
FDR Mammography QC Manual -897N101461A
Chapter
8
Assistance Material
8.1 Calculation Functions................................................................................................
8-2
8.2 Quick Guide for Software Operation ..........................................................................
8-6
8.3 Worksheets .........................................................................................................................
8-8
8.4 Report Forms .................................................................................................................... 8-20
Chapter
9
Technical Information
9.1 Specification Outline of 1Shot Phantom M Plus ................................
9-2
9.2 Glossary .................................................................................................................................
9-3
FDR Mammography QC Manual - 897N101461A
ix
Revision History
Revision
x
Issue Date
Reason
First Edition 897N101461
11.2011
New Release
2nd Edition 897N101461A
10.2012
1) Revised Linearity/Beam Quality constancy test
criteria for QL gap (4 step-5 step).
2) Revised corrective action limits for 1 Shot Phantom
m Plus tests.
3) Revised compression plate heights for AGD Mode 1
testing.
FDR Mammography QC Manual - 897N101461A
Chapter 1
1
Quality Control
Page
1.1
Quality Control ________________________________________
1.1.1
1.1.2
1.1.3
1.2
Quality Control of the Mammography System_____________
1.2.1
1.2.2
FDR Mammography QC Manual - 897N101461A
Acceptance Test __________________________________
Constancy Test ___________________________________
Status Test _______________________________________
Quality Control Tests and Frequency__________________
Types of Quality Control Tests _______________________
1-2
1-2
1-2
1-2
1-3
1-3
1-4
1-1
1.1
Quality Control
This document provides information necessary for a facility using the FDR Mammography system to
maintain an effective QA & QC program and meet the requirements of the MQSA regulations and Fujifilm
Corp.
1
Quality Control
Detailed instructions for carrying out quality control (e.g. when and who carries out quality control) are
established as a quality assurance program. In addition to quality control techniques, training for providing
adequate information on quality control is included so that any quality assurance program may be
effectively implemented.
International standards and guidelines regarding the quality control of the mammography system are as
follows.
• MQSA (Mammography Quality Standards Act) 21CFR Part 900 (hereafter MQSA).
• ACR (American College of Radiology) Quality Control Manual
• European guidelines for quality assurance in breast cancer screening and diagnosis; Fourth
Edition (European Commission) (Hereafter abbreviated as EUREF Ed.4)
• IEC 61223-3-2 Ed.2 (International Electrotechnical Commission)
Always follow applicable laws and regulations for your jurisdiction. If anything in this manual is
in conflict with applicable laws or regulations, the applicable law or regulation shall take
precedence
Tests for quality control are called performance tests. There are three types of performance tests, acceptance
test, constancy test and status test, depending on their purpose or implementation frequency.
1.1.1
Acceptance Test
The purpose of the acceptance test is to check the compliance of the equipment with specifications. An
acceptance test is normally carried out when new equipment has been installed, when existing equipment
has been remodeled, or when required by local juisdictions.
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.
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 Manual - 897N101461
1.2
Quality Control of the Mammography
System
In this document, test items and their frequencies for the FDR Mammography system are deteremined so
that facilities may be in compliance with the requirements of MQSA. Test items consist of quantitive tests
and visual inspections, and the FDR 1Shot Phantom M Plus for quantitive measurement and QC Software are
used for evaluation.
Quality Control
1.2.1
Quality Control Tests and Frequency
QC Software Installation
Baseline Value
Measurement
Equipment
Condition
Check
QC Software Operation
3 months 6 months 9 months
Mammography
E q u i p m e n t
Evaluation (MEE)
1 year
15
months
18
months
21
months
At time of FDR installation / major component replacement
1
2 years
Chapter 7
Chapter 4
Every Week
Weekly Test
Chapter 4
Quarterly Test
Chapter 5
Semi-annual Test
Chapter 6
Chapter 7
Annual Test
Chapter 4
Chapter 3
[1] Mammography Equipment Evaluation (MEE) - Medical Physicist
The MEE tests should be performed when a new FDR Mammography system has been installed, and
whenever changes that might affect performance (disassembly, major component repair, etc.) have
been made to an existing FDR Mammography system.
[2] Weekly Test - Technologist
Weekly Tests using the FCR 1Shot Phantom M Plus and ACR Phantom are executed for detecting
changes in image quality or subtle changes of the mammography system that may not reflected in
actual images.
These tests are executed as constancy tests for monitoring weekly changes in the mammography
system. Quantitive tests can be executed by using the FCR 1Shot Phantom M Plus. However, a control
limit needs to be determined for each quantitive test based on a series of measurements executed
when installing this Program.
For better performance, it is important that these control limits (criteria) are reviewed consistently
taking into account other factors such as the scores of the tests using the ACR Phantom.
[3] Quarterly Test - Technologist
The Quarterly Test is designed to determine the number and cause of repeated radiographs. Analysis
of this data will help identify ways to avoid repeat exposures and reduce costs, as well as reduce patient
exposure.
4] Semi-annual Test - Technologist
During the Semi-annual Test, performance verification tests of the compression system are executed..
[5] Annual Test- Medical Physicist
During Annual Tests, performance verification tests of the components of the mammography system
are executed using measuring instruments and materials such as a dosimeter and PMMA phantom.
FDR Mammography QC Manual - 897N101461A
1-3
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, all test items are classified as constancy tests. However, there are two types of tests depending
on evaluation methods.
1
[1] Constancy Test
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[2] Performance Verification Test
In performance verification tests, the upper or lower limit is specified by a law or guideline. These tests
need to be passed irrespective of the type of X-ray equipment. Items of the performance verification
test include scores of the tests using the ACR Phantom and measured values of Missed tissue on chest
wall edge).
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FDR Mammography QC Manual - 897N101461A
1
Quality Control
Quality Control
Constancy tests are intended to monitor the constancy of the functional performance of the equipment.
Since the performance varies depending on the types of the X-ray equipment and measurement
environment, the same test is executed multiple times and its average value is defined as a baseline
value, and the variation of measured values is defined as an established criteria. When the measured
value is within the acceptable range (baseline value plus or minus criteria), the test result is regarded as
“Pass”. If it is out of the acceptable range, the test result is regarded as “Fail”.
Chapter 2
2
Overview
Page
2.1
2.2
Product Outline ________________________________________
2-2
QC Test Items __________________________________________
2-5
2.2.1
2.2.2
2.2.3
2.2.4
FDR Mammography QC Manual - 897N101461A
Weekly Test ______________________________________ 2-7
Quarterly Test ____________________________________ 2-11
Semi-annual Test _________________________________ 2-11
Annual Test ______________________________________ 2-12
2.3
Tools _________________________________________________ 2-13
2.4
QC Software Outline____________________________________ 2-17
2.5
Notes on Conducting the Program _______________________ 2-20
2-1
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 Weekly, Quarterly, Semi-annual and
Annual Tests.
• The Program consists of the following three components.
•
2
Manual (FDR Mammography QC Program)
It (this document) provides instructions for implementing quality control of the FDR
mammography system.
•
Overview
Exclusive Phantom (1Shot Phantom M Plus)
1Shot Phantom M Plus (1Shot Phantom hereafter) was developed for quality control of the FDR
mammography system and can produce the image quality test results on 10 items with a single
exposure. The 1Shot Phantom enables wide-ranging analysis of a system in a relatively short time
with high reproducibility.
•
Exclusive Quality Control Software (FDR Mammography QC Software)
FDR Mammography QC Software (hereafter QC Software) is designed for performing periodic
quality control, data analysis, and QC test log management.
[QC test categories]
•
•
•
•
Weekly Test ........................................ Quantitative/Visual inspection with 1Shot Phantom/ ACR
Phantom
Quarterly Test ....................................Repeat analysis
Semi-annual Test .............................Quantitative/Visual inspection
Annual Test ........................................Quantitative/Visual inspection
Comprehensive quality control on the FDR mammography system can be ensured by conducting these
periodical tests and validating the results. The QC Software allows the auto-calculation of the CNR and
AGD in addition to that of the items in each test.
[Calculation functions]
•
•
2-2
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.
FDR Mammography QC Manual - 897N101461A
[Equipment to be evaluated]
2
Overview
[Test categories and their implementation frequencies]
The QC test items are categorized by the required implementation frequency. The test categories, their
implementation frequency and personnel responsibilities are as shown below.
QC Software Installation
QC Software Operation
Equipment
3
Baseline Value
Condition
Measurement
months
Check
Mammography
Equipment
Evaluation (MEE)
6
9
1
15
18
21
2
months
months
year
months
months
months
years
At time of FDR mammography installation / major component replacement
Chapter 7
Chapter 4
(Medical Physicist)
Weekly Test
Every Week
(Technologist)
Chapter 4
Quarterly Test
Chapter 5
(Technologist)
Semi-annual Test
Chapter 6
(Technologist)
Annual Test
Chapter 7
(Medical Physicist)
Chapter 4
Chapter 3
See Chapters 3 to 7 as necessary for details on each test procedure.
FDR Mammography QC Manual -897N101461A
2-3
[The Program implementation procedure]
2
Overview
2-4
FDR Mammography QC Manual - 897N101461A
2.2
QC Test Items
Test components in each test category are shown below.
“Exposure Menus” are the menu items to be selected on a FUJIFILM workstation to
start the corresponding tests.
[Weekly Test]
Test Items
Exposure Menus
Responsibility
Test with 1Shot Phantom
1Shot PhantomM
Good practice
Test with ACR Phantom
Technologist
2
ACR Phantom
Conduct the Test with 1Shot Phantom and Good practice in the Daily Test, and the Test with ACR Phantom
in the Weekly Test.
Overview
NOTE
[Quarterly Test]
Test Items
Repeat analysis
Exposure Menus
Responsibility
–– *1
Technologist
*1 No Exposure Menu for the Repeat analysis in Quarterly Test
[Semi-annual Test]
Test Items
Exposure Menus
Responsibility
Compression device confirmation
–– *2
Technologist
*2 No Exposure Menu for the Compression device confirmation in the Semi-annual Test
FDR Mammography QC Manual - 897N101461A
2-5
[Annual Test]
Test Items
Image Basic Test
Exposure Menus
Responsibility
Test Types
Annual A
Additive lag effects (Lag)
Image performance
Multiplicative lag effects (Ghost)
Annual 1/6
Visual and Functional test
Spatial Resolution (Magnification)
2
Annual 2/6
Spatial Resolution
kVp accuracy and reproducibility
Half Value Layer (HVL)
Overview
Annual 3/6
Medical Physicist
Collimation assessment
X-ray equipment
performance
Radiation output
AEC reproducibility
CNR Mode 1
Annual 4/6
AEC system
performance
1 Shot Phantom M
ACR Phantom
Image Performance
AGD Mode 1
Test with 1 Shot Phantom
ACR Phantom Evaluation
[Calculation functions]
Test Items
Exposure Menus
CNR
Calculation 1/2
AGD
Calculation 2/2
When an exposure menu includes multiple test items/contents, perform all tests.
(If any of the test items/contents remain untested, the QC Software will not calculate the results.)
An exposure menu can be selected on the following window of a FUJIFILM workstation. When an exposure
menu is selected, the relevant exposure submenu(s) is displayed (Example: 1Shot PhantomM).
See the Operation Manual for FUJIFILM workstation for detailed FUJIFILM workstation
operations.
Explanations of test items/contents are shown on the following pages.
2-6
FDR Mammography QC Manual - 897N101461A
2.2.1
Weekly Test
The Weekly Test is conducted to evaluate image quality by making an exposure using a 1Shot Phantom
and the ACR Phantom, and to check that the X-ray equipment normally used in clinical practice is kept
clean.
The 1Shot Phantom is designed to identify subtle changes in FDR Mammography system performance.
With a single exposure using this Phantom, the QC Software auto-calculates the necessary image quality
parameters, enabling image quality variations to be monitored (some test items require visual inspection).
As required by MQSA regulations, image evaluation using the ACR Phantom is to be conducted at least
once a week., and, when used in combination with the QC Software, the results can be managed efficiently.
2
Overview
* NOTE:
The ACR phantom density measurement is required to be performed weekly if the facility routinely prints hardcopy
images for primary interpretation. If images are only occasionally printed for final interpretation, such as upon request
of a patient for images for interpretation elsewhere, then the test must be performed in advance of, but not more
than one week before printing the films.
FDR Mammography QC Manual -897N101461A
2-7
Phantoms Used for Exposure
[1]
Test with 1Shot Phantom
(1) Missed tissue on chest wall edge
1Shot Phantom
2
ACR Phantom/Acrylic disk
Overview
NOTE
The ACR phantom density measurement (using the
acrylic disk) is required to be performed weekly if the
facility routinely prints hardcopy images for primary
interpretation. If images are only occasionally printed
for final interpretation, such as upon request of a
patient for images for interpretation elsewhere, then
the test must be performed in advance of, but not more
than one week before printing the films.
Check that the degree of missed tissue on
chest wall edge of the exposure table is within
the criteria.
(2) CNR
Check that the CNR variation is within the
criteria.
2-8
FDR Mammography QC Manual - 897N101461
(3) 1Shot Phantom sensitivity constancy
(6) Uniformity
2
Check that the uniformity variation is within
the criteria.
(4) Geometric distortion
(7) Dynamic range
Overview
Check that the 1Shot Phantom sensitivity
variation is within the criteria.
(ORIZONTAL
DIRECTION
6ERTICAL
DIRECTION
Check that the image dimension variation
(geometric distortion) in horizontal/vertical
direction is within the criteria.
Visually check that there is no distortion or
jitter in the image.
Check that the dynamic range variation is
within the criteria.
(8) Spatial Resolution (SR)
(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 Manual - 897N101461
2-9
(9) Low Contrast Detectability (LCD)
[2]
Good practice
Check that the following equipment is kept
clean.
• X-ray equipment
• Softcopy output equipment
• Viewbox
[3]
Test with ACR Phantom
2
Overview
Check that the low contrast detectability
meets or exceeds the criteria.
(10) Linearity/Beam quality constancy
Make exposures using the ACR Phantom and then
output the images to check that the densities of the
specified areas in the images are within the criteria*. In
addition, visually check and evaluate the images.
• Density at center of Phantom image*
• Density difference (disk/outside)*
• Fibers
• Specks
• Masses
* NOTE
Check that the X-ray linearity and radiation
quality variations are within the criteria.
2-10
ACR phantom density measurements are required
to be performed weekly if the facility routinely prints
hardcopy images for primary interpretation. If images
are only occasionally printed for final interpretation,
such as upon request of a patient for images for
interpretation elsewhere, then the test must be
performed in advance of, but not more than one week
before printing the films.
FDR Mammography QC Manual - 897N101461A
2.2.2
Quarterly Test
During the Quarterly Test, Repeat analysis is
performed.
[1] Repeat analysis
2.2.3
Semi-annual Test
During the Semi-annual Test, Compression device
confirmation is performed..
[1] Compression device confirmation
Calculate data for analyzing the rejected
images.
2
Overview
Check that minimum and maximum
compression forces can be applied.
FDR Mammography QC Manual - 897N101461A
2-11
2.2.4
Annual Test
The Annual Test contains test items [1] to [12] for X-ray equipment performance and test item [13] for
display device performance.
2
Overview
2-12
FDR Mammography QC Manual - 897N101461A
2.3
Tools
Tools to be used for QC test are shown in the table below.
...Required
Tools
Weekly Test
Semi-annual Test
Annual Test
...Optional
Calculation
Functions
[ A ] QC Software
[ B ] Worksheet (See Chapter 8)
2
[ C ] 1Shot Phantom
[ D ] Viewbox (if film is used)
[F]
Overview
[ E ] Timer or watch/clock
ACR Phantom
(including an acrylic disk) *1
[ G ] Dosimeter
[ H ] Luminance meter
[ I ] kVp meter
[ J ] Force scale / Bathroom scale
[ K ] Towels
*2
*2
[ L ] Illuminance meter
[M] Densitometer
PMMA phantoms (available, in
[ N ] combination, for 20, 40, 60 and 70 mm
in thickness)
[O]
Aluminum plate (0.2 mm) for CNR
measurement
Aluminum plates for half value layer
[ P ] measurement
(0.3 and 0.5 mm)
[ Q ] Scale (ruler)
[ R ] Coins
[ S ] Lead sheet
*3
*3
*1 The ACR phantom density measurement is required to be performed weekly if the facility routinely prints hardcopy images
for primary interpretation. If images are only occasionally printed for final interpretation, such as upon request of a patient
for images for interpretation elsewhere, then the test must be performed in advance of, but not more than one week
before printing the films.
*2 Used to protect the exposure table and compression plate during Compression device confirmation
*3 Placed on the exposure table to protect the image receptor when measuring the air kerma.
The following equipment is used for the QC tests:
A. FDA-cleared Hardcopy/Softcopy output equipment (laser imager/diagnostic monitor)
B. X-ray equipment
C. FUJIFILM workstation
FDR Mammography QC Manual - 897N101461A
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] 1Shot Phantom
2
The 1Shot Phantom enables an image quality test on 10 items by a single exposure, allowing analysis of the wide-ranging
system quality in a short time with high reproducibility.
NOTE
Overview
Scratches, deformation, or dirt on the Phantom not only affects the image evaluation or measured values
but may damage the compression plate of the X-ray equipment. Make sure that there is no scratch,
deformation, or dirt on the Phantom before use.
[D] Viewbox
A viewbox is used for visually checking an image output on film. Maintenance including surface cleaning or lamp replacement
should be performed by following the manufacturer’s instructions. If using a viewbox having a luminance adjustment function,
make sure to keep the luminance constant for every test.
[E] Timer or watch/clock
A timer or watch/clock is used for measuring the duration of the compression plate.
[F] ACR Phantom
The Phantom is used for image evaluation. The model 156 manufactured by RMI (Radiation Measurements Inc.), 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).
NOTE
Scratches, deformation, or dirt on the ACR Phantom not only affects the image evaluation or measured values but
may damage the compression plate of the X-ray equipment. Make sure that there are no scratches, deformation,
or dirt on the Phantom before use.
[G] Dosimeter
A dosimeter is used for measuring air kerma (exposure). Some dosimeters may require correction of the measured value
according to the beam quality. See the operation manual for the dosimeter for details. The dosimeter should be calibrated using
low energy (at least 10 keV to 40 keV), allowing air kerma rate or exposure time measurement, in addition to air kerma (exposure)
measurement.
[H] Luminance meter
A luminance meter is used for measuring the luminance of a viewing box. The luminance meter allowing correct measurement
of luminance around 3500 cd/m2 is required.
[I] kVp meter
A kVp meter is used for measuring X-ray tube voltage of the X-ray equipment.
The required kVp meter is the one of non-contact type and having measurement accuracy within ± 1.5 kV and reproducibility
within ± 0.5 kVp under the tube voltage range used for mammography.
[J] Force scale
A force scale is used for measuring the force of the compression plate. If the compression force cannot be applied properly on
the measurement portion of the force scale, use soft rubber or towels so as to not damage the X-ray equipment and allow proper
measurement.
[K] Towels
Towels should be used to protect the exposure table and compression plate during the Compression device confirmation.
[L] Illuminance meter
An illuminance meter is used for measuring illuminance under viewing conditions.
2-14
FDR Mammography QC Manual - 897N101461A
[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)
20
21
40
45
60
75
70
90
(Reference: EUREF Ed.4)
NOTE
Scratches, deformation, or dirt on the phantom not
only affect the image evaluation or measured values
but may damage the compression plate of the X-ray
equipment. Make sure that there are no scratches,
deformation, or dirt on the phantom before use.
A 99.9% or higher purity aluminum plate of sufficient size for covering ROI is required. The plate can be also used as [P]
Aluminum plates for half value layer measurement. Multiple plates of 0.2 mm or less in thickness can be used in combination.
[P] Aluminum plates (0.3 and 0.5 mm) for half value layer measurement
Overview
[O] Aluminum plate (0.2 mm) for CNR measurement
2
A 99.9% or higher purity aluminum plate of sufficient size for covering the detection surface of the dosimeter is required. The
plate can also be used as [O] Aluminum plate for CNR measurement. Multiple plates of 0.3 mm or less in thickness can be used
in combination.
[Q] Scale (ruler)
A millimeter scale is required.
[R] Coin
Some familiar-sized coins are to be used.
[S] Lead sheet
A lead sheet is used to fully cover the receptor to completely block X-Rays when conducting the test on additive lag effects, and is
also used as necessary to protect the image receptor when measuring the air kerma.
FDR Mammography QC Manual - D 897N101461A
2-15
Equipment details
A
Hardcopy/Softcopy output equipment
FDA-cleared hardcopy/softcopy output devices (laser imager/diagnostic monitor).
B
X-ray equipment
The Fujifilm FFDM X-Ray exposure unit is to be used.
NOTE
In this Program, methods of exposure condition setting of an X-ray equipment are defined as follows:
• “Manu (manual)” mode
The mode allows manual setting of the kVp, mAs and target/filter of the X-ray equipment.
2
Overview
• “Semi (semi auto)” mode
The mode automatically specifies the mAs but allows manual setting of the kVp and target/filter of
the X-ray equipment.
• “Auto (full auto)” mode
The mode automatically specifies kVp, mAs and target/filter of the X-ray equipment depending on
the subject.
C
FUJIFILM workstation
The workstation to be used is the Fujifim Acquisition Workstation (AWS).
2-16
FDR Mammography QC Manual - 897N101461A
2.4
QC Software Outline
This section describes the operational procedure for the QC Software and the relevant
window (“QC window” hereafter).
&5*)&),-WORKSTATIONSTARTUP
%XPOSURE
1#3OFTWARESTARTUP
/PERATIONSONA&5*)&),-WORKSTATION
5SERINPUT
,OGDISPLAY
Overview
&ILMOUTPUTETC
h1#WINDOWv
2
!UTOCALCULATION
*UDGMENT
/PERATIONSONTHE1#3OFTWARE
The “QC window” composition is described below.
%XPOSUREREGIONLIST
%XPOSURE
SUBMENULIST
%XPOSUREMENULIST
0ATIENTINFORMATION
DISPLAYFIELD
FDR Mammography QC Manual - 897N101461A
2-17
2
Overview
2-18
FDR Mammography QC Manual - 897N101461A
&5*)&),-WORKSTATIONSTARTUP
%XPOSURE
1#3OFTWARESTARTUP
2
2
Overview
Overview
h1#WINDOWv
4HEFOLLOWINGFUNCTIONSCANBEEXECUTEDONTHEh1#WINDOWv4HERELEVANTBUTTONFUNCTIONSAREDESCRIBEDBELOW
%XPOSURECONDITIONDISPLAYFIELD
$ISPLAYSTHETESTLOG
#HECKEXPOSURE
CONDITIONS
3ETSTHEINITIALVALUES
1UITSTHE1#3OFTWARE
3AVESTHESTUDYRESULTS
#HANGESTHECRITERIA
/UTPUTSANIMAGE
ONFILM
%XECUTESMEASUREMENTBASEDONENTERED
IMAGEANDVALUESANDDISPLAYS;0ASS&AIL=
JUDGMENT
/UTPUTSANIMAGE
TOTHENETWORK
/PENSTHEUSERINPUTSCREENFOR
NECESSARYINFORMATION
See the “FDR Mammography QC Software Operation Manual” and/or operation manual for a FUJIFILM workstation
for detailed QC software operation.
FDR Mammography QC Manual -897N101461A
2-19
5SERINPUT
4HERESULTSOFMEASUREMENTANDVISUALINSPECTIONCANBEENTEREDINTHEWINDOWBELOW%XAMPLE$AILY7EEKLY
4EST
2
2
Overview
Overview
!UTOCALCULATION
%ACHTESTRESULTISAUTOCALCULATEDBASEDONTHEENTEREDIMAGEANDVALUESANDTHEJUDGMENT0ASS&AILIS
DISPLAYEDINTHEWINDOWASSHOWNBELOW
*UDGMENTRESULTS
0ASS&AIL
#ALCULATEDRESULTS
2-20
FDR Mammography QC Manual - 897N101461A
2.5
Notes on Conducting the Program
Operational notes regarding the Program are described below.
Notes on Performing QC Tests
(1) 1Shot/ACR Phantom position
The positions of the Phantoms vary depending on the test item/content. See the test procedure for
each item.
2
(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.
2
Overview
Overview
(2) Dosimeter
Position the X-ray detector of the dosimeter 40 mm above the exposure table unless indicated
otherwise. Make sure of the X-ray detection position of the dosimeter and adjust the height as specified
by using an appropriate jig. In the X-ray reproducibility test, the dosimeter position differs since the air
kerma is measured using AEC technique.
(4) Solutions for failed test items
Actions required when a test item judged as “Fail” are described for each test item.
(5) Artifacts
Artifacts may be seen in the Spatial Resolution chart on the 1Shot Phantom. This characteristic
does not affect clinical images since there are no such special structures in a human body. Autocalculation is also not affected.
(6) AGD
AGD (Average glandular dose) values measured in this Program may be different from those in the
test results displayed on a FUJIFILM workstation.
In this Program, AGD values are measured based on the assumption that a uniform PMMA phantom
is used and enable the user to evaluate the AEC (Automatic Exposure Control) performance of the
X-ray equipment quantitatively. On the other hand, AGD values on a workstation are calculated for
actual AGD values per mammogram. Due to this difference, the parameters used for calculations
are different. Conduct tests by following the procedures in this Program.
(7) Regular backup
Regularly back up the results of the test conducted by using this Program.
See “FDR-1000AWS Operation Manual” for details.
(8) AEC exposure modes
In this Program, only the (H-mode) exposure mode is used for clinical mammography (for test items
that require AEC). Use this same exposure mode everytime you perform tests that require AEC.
FDR Mammography QC Manual - 897N101461A
2-21
Chapter 3
Installation of FDR
Mammography QC Program
3
Page
FDR Mammography QC Manual - 897N101461A
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 Annual A 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 ____________________________________________ 3-30
3-1
3.1
Installation Procedure
The following steps shall be conducted by an authorized Fujifilm dealer prior to QC software
use. These steps establish the criteria and baseline values that will be referenced for all QC tests
supported by the QC software.
Initial Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2
Specify the information for conducting the tests, such as dosimeter position.
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.
3
Installation of FDR Mammography QC Program
Baseline Value Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4
Measured values for some test items vary depending on the environment where the X-ray
equipment is used and measurements are performed. For these items, conduct the tests several
times when installing the Program and set the averages of the measured values as the baseline
values.
Checking Equipment Conditions at the Time of Program Installation . . . . . . . . . . . . . . . . . . . . . . 3.5
Conduct all of the test items provided in this Program except for Repeat Analysis to check the
equipment conditions at the time of program installation. This will help correct a test item judged as
[Fail] in a future QC test by providing the initial data for comparison.
Conduct tests in the order of their potential influence on displayed images.
Annual Test (Chapter 7)
Semi-annual Test (Chapter 6)
Weekly Test (Chapter 4)
NOTE
When new equipment or a system has been installed or existing equipment has been remodeled, perform the
procedures described in “3.4 Baseline Value Settings” and later sections in Chapter 3.
3-2
FDR Mammography QC Manual - 897N101461A
3.2
Initial Settings
The following items are required to be specified in the initial settings.
•
•
•
•
Dosimeter - Exposure table distance
Target / Filter and tube voltage (HVL)
Air kerma unit
Viewbox setting
Setting Procedure
1
Enter patient information and press [Next].
6
Press [Initial setting].
7
Enter values for items requiring initial
settings.
For details on each item, see the following
descriptions in (1) through (5).
3
（4）
（5）
（2）
（3）
2
Select [QC/TEST] in the exposure region
list and [1Shot PhantomM] in the exposure
menu list, and then press [Start study.].
(1) Dosimeter - Exposure table distance
• Measure the distance (mm) in the figure
below and enter the value. The recommended
value for h is 40 mm (This Manual assumes h is
40 mm in the following explanation). Set the
distance l between the center of the dosimeter
and chest wall-side edge of the exposure table
as 60 mm.
2EFERENCEPOINT
3
The following exposure
displayed.
• 1Shot PhantomM
submenu
4
Specify 23 kV, 2 mAs and Mo/Mo and
make an exposure in “Manu” mode.
is
NOTE
It may take some time until you can press [QC]
after completing the exposure process.
5
Press [QC] to display the “QC window”.
FDR Mammography QC Manual - 897N101461A
Installation of FDR Mammography QC Program
（1）
TIP
Check the reference point of the dosimeter
in its operation manual.
(2) Magnification table - Exposure table’s top
surface distance Enter 247 mm.
3-3
(3) Target / Filter and tube voltage (HVL)
• Specify the kVp to be used for measuring half
value layer in the Annual Test.
The recommended kVp is 28 kV.
(4) Air kerma unit
• Select the measurement unit (mR or µGy) for
the dosimeter.
(5) Viewbox setting
• Put a checkmark when using a viewbox.
When the viewbox to be used has a luminance
adjustment and/or masking function, also put
a checkmark in the relevant box.
8
3
Press [OK].
Installation of FDR Mammography QC Program
 To
continue to the criteria confirmation
and determination, go to Step 6 in “3.3
Criteria Confirmation and Determination”.
 To
complete the initial setting without
setting the criteria, press [Close] to exit the
window.
3-4
FDR Mammography QC Manual - 897N101461A
3.3
Criteria Confirmation and Determination
The criteria should be specified on your own
responsibility based on the measurement results
obtained at the time of the Program installation.
Enter the percentage or the absolute value of
variations from the baseline value for each item.
The reference criteria are shown on the “List
of Reference Values for Criteria and Baseline
Values”.
The reference criteria are preset for each item.
The criteria can be changed by following “Criteria
Change Procedure” below.
3
The following
displayed.
• 1Shot PhantomM
4
Specify 23 kV, 2 mAs and Mo/Mo and
make an exposure in “Manu” mode.
Enter patient information and press [Next].
2
Select [QC/TEST] in the exposure region
list and [1Shot PhantomM] in the exposure
menu list, and then press [Start study.].
FDR Mammography QC Manual - 897N101461A
is
3
It may take some time until you can press [QC]
after completing the exposure process.
5
Press [QC] to display the “QC window”.
6
Press [Criteria setting].
Installation of FDR Mammography QC Program
1
submenu
NOTE
Criteria Change Procedure
When changing the criteria following “3.2 Initial
Settings”, start from Step 6 .
exposure
3-5
7
Select a tab and enter values for items to be changed.
„ Daily/Weekly Tests 1/2 and 2/2
3
Installation of FDR Mammography QC Program
[Items allowing criteria change]
Test Item/Contents
Judgment Items
Criteria
Missed tissue on chest wall edge (Right) [mm]
7 mm or less
Missed tissue on chest wall edge
CNR
1Shot Phantom sensitivity constancy
Missed tissue on chest wall edge (Left) [mm]
7 mm or less
CNR
Baseline value ± 20 %
System sensitivity
Baseline value ± 35 %
Dimension (Horizontal) [mm]
Baseline value ± 2 %
Dimension (Vertical) [mm]
Baseline value ± 2 %
Pixel Value (PV) ratio (Top-Right) [%]
Baseline value ± 15 %
Pixel Value (PV) ratio (Top-Left) [%]
Baseline value ± 15 %
Pixel Value (PV) ratio (Bottom-Right) [%]
Baseline value ± 15 %
Pixel Value (PV) ratio (Bottom-Left) [%]
Baseline value ± 15 %
SNR ratio (Top-Right) [%]
Baseline value ± 15 %
SNR ratio (Top-Left) [%]
Baseline value ± 15 %
SNR ratio (Bottom-Right) [%]
Baseline value ± 15 %
SNR ratio (Bottom-Left) [%]
Baseline value ± 15 %
Average QL at thinnest step wedge [QL]
Baseline value ± 400 [QL]
2lp/mm [%]
Baseline value ± 6 %
Geometric distortion
Uniformity
Dynamic range
Spatial Resolution (SR)
4lp/mm [%]
Baseline value ± 15 %
Low Contrast Detectability (Light) [%]
> Baseline value - 14 %
Low Contrast Detectability (LCD)
Low Contrast Detectability (Dark) [%]
> Baseline value - 14 %
QL gap (1 step-2 step) [QL]
Baseline value ± 50 [QL]
QL gap (2 step-3 step) [QL]
Baseline value ± 50 [QL]
Linearity/Beam quality constancy
QL gap (3 step-4 step) [QL]
Baseline value ± 50 [QL]
QL gap (4 step-5 step) [QL]
Baseline value ± Baseline value [QL]
Density at center of Phantom image
1.40 ± 0.2
Density difference (disk/outside)
0.4 or more and baseline value ± 0.05
Fibers (ACR Phantom)
Specks (ACR Phantom)
Test with ACR Phantom
Masses (ACR Phantom)
3-6
4 or more and no more than 0.5 lower than
baseline
3 or more and no more than 0.5 lower than
baseline
3 or more and no more than 0.5 lower than
baseline
Visible step wedge (Step Phantom) *1
10 steps
Specks (Step Phantom) *1
4 steps or more
Masses (Step Phantom) *1
5 steps or more
FDR Mammography QC Manual - 897N101461A
„ Quarterly Test
There is no item related to the criteria.
„ Semi-annual Test
There is no item related to the criteria.
„ Annual A Test
3
Test Items
Judgment Items
Criteria
Image Basic Test
Relative sensitivity (S value)
Baseline value ± 40 %
Compressed breast thickness accuracy [mm]
± 5 mm
Compression force accuracy [N]
± 20 N
Compression device confirmation
Maximum compression force [N]
111 to 200 N
Luminance [cd/m2]
3500 cd/m2 or more
Interpretation room illuminance (Ambient light) [lx]
50 lx or less
Viewbox maintenance
FDR Mammography QC Manual - 897N101461A
Installation of FDR Mammography QC Program
[Items allowing criteria change]
3-7
„ Annual Test 1/3 (Annual Test consists of tabs 1/3 to 3/3)
3
[Items allowing criteria change]
Installation of FDR Mammography QC Program
Test Items
Judgment Items
Criteria
Additive lag effects (Lag)
Lag factor [QL]
75 QL or less
Multiplicative lag effects (Ghost)
Ghost factor
Below 0.045
MTF (4lp/mm)[%]
Baseline value ± 12 %
Spatial Resolution (Magnification)
kVp accuracy and reproducibility
3-8
MTF (8lp/mm)[%]
Baseline value ± 15 %
Low volt. accuracy (LFS) [kV]
Specified kVp ± 1 kV
Mid. volt. accuracy (LFS) [kV]
Specified kVp ± 1 kV
High volt. accuracy (LFS) [kV]
Specified kVp ± 1 kV
Low volt. accuracy (SFS) [kV]
Specified kVp ± 1 kV
Mid. volt. accuracy (SFS) [kV]
Specified kVp ± 1 kV
High volt. accuracy (SFS) [kV]
Specified kVp ± 1 kV
Mid. volt. reproducibility (LFS) [kV]
Reproducibility ± 0.5 kV or less
FDR Mammography QC Manual - 897N101461A
„ Annual Test 2/3
3
[Items allowing criteria change]
Test Items
Criteria
Total gap criteria = SID X 0.02 or less
X-ray / Light field gap (Chest/Nipple) [mm]
Total gap criteria = SID X 0.02 or less
X-ray / Image receptor field gap (Left) [mm]
SID X 0.02 or less
X-ray / Image receptor field gap (Right) [mm]
SID X 0.02 or less
X-ray / Image receptor field gap (Nipple) [mm]
SID X 0.02` or less
X-ray field / Exposure table gap [mm]
5 mm or less
Reproducibility
Variation coefficient 0.05 or less
Air kerma rate [mGy/s]
7 mGy/s or more
Specific radiation output [μGy/mAs]
30 μGy/mAs or more
Radiation output
FDR Mammography QC Manual - 897N101461A
Installation of FDR Mammography QC Program
Collimation assessment
Judgment Items
X-ray / Light field gap (Right/Left) [mm]
3-9
„ Annual Test 3/3
3
[Items allowing criteria change]
Test Items
Installation of FDR Mammography QC Program
3-10
Judgment Items
Criteria
Entrance air kerma accuracy [%]
Average ± 15 % or less
Entrance air kerma reproducibility
Variation coefficient 0.05 or less
CNR relative value 20mm [%]
Baseline value 105 % or more
CNR relative value 40mm [%]
Baseline value 95 % or more
CNR relative value 60mm [%]
Baseline value 63 % or more
CNR relative value 70mm [%]
Baseline value 60 % or more
AGD 20 mm [mGy]
1 mGy or less
AGD 40 mm [mGy]
2 mGy or less
AGD 60 mm [mGy]
4.5 mGy or less
AGD 70 mm [mGy]
6.5 mGy or less
AGD-ACR Phantom
3 mGy or less
AEC reproducibility
CNR mode 1
AGD mode 1
AGD-ACR Phantom
TIP
• [CNR_H-mode] in the window corresponds to CNR mode 1.
• As with CNR mode, AGD mode 1 corresponds to H-mode.
FDR Mammography QC Manual - 897N101461A
8
Complete checking and changing all the
necessary items, then press [OK].
3
Press [Close] to exit the “QC window”.
NOTE
If “The test result is not saved.” is displayed,
press [OK].
10
Select [Study completed] to finish the
test.
FDR Mammography QC Manual - 897N101461A
Installation of FDR Mammography QC Program
9
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
3
Installation of FDR Mammography QC Program
3-12
Missed tissue on chest wall edge
CNR
1Shot Phantom sensitivity constancy
Geometric distortion
System artifact evaluation
1Shot PhantomM
Test with 1Shot Phantom
Weekly Test
Uniformity
Dynamic range
Spatial Resolution (SR)
Low Contrast Detectability (LCD)
Linearity/Beam quality constancy
ACR Phantom
Semi-annual Test
Test with ACR Phantom
Compression device confirmation
Annual A
Image Basic Test
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 →
Weekly Test, according to their potential influence on images.
• It is recommended to save image data based on which baseline values are determined to later confirm
that weekly, semi-annual and annual tests have been conducted properly.
FDR Mammography QC Manual - 897N101461A
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
Annual Test
Annual 2/6
[1]
Test Item
Spatial Resolution
Spatial Resolution (Magnification)
Spatial Resolution (Magnification)
[Test flow]
0ATIENTINFORMATIONENTRYANDEXPOSURE
MENUSELECTION
1#3OFTWARESTARTUP
%XPOSURECONDITIONCONFIRMATION
!UTOCALCULATION
"ASELINEVALUESETTING
1#3OFTWARESHUTDOWN
[Tools]
1Shot Phantom
FDR Mammography QC Manual - 897N101461A
3
2EPEATSEVERALTIMES
2ECOMMENDEDNUMBER
OFTIMES
Installation of FDR Mammography QC Program
3PATIAL2ESOLUTION-AGNIFICATION
EXPOSURE
3-13
[Baseline value setting procedure]
5
1. Patient information entry and exposure
menu selection
1
Enter patient information and press [Next].
2
Select [QC/TEST] in the exposure region
list and [Annual 2/6] in the exposure menu
list, and then press [Start study.].
Position the 1Shot Phantom being shifted
to the right-hand side so that the area
indicated by the broken line in the below
figure is at the lateral center of the X-ray
field.
3
Installation of FDR Mammography QC Program
3
The following exposure
displayed.
• 1ShotM(Magnification)
submenu
NOTE
If the area is out of the X-ray field while the
Phantom is positioned by pressing its corners
against the chest wall-side edge of the
magnification table, shift the Phantom to the
front.
Make sure that the shifted Phantom is parallel
to the chest wall-side edge.
is
NOTE
2. Spatial Resolution (Magnification)
(exposure)
4
3-14
The Phantom position must be the same for
every exposure (the allowable positional error is
within ± 5 mm). Record how much the Phantom
is shifted to the right-hand side and front side.
• Fill in the following items in the worksheet.
1 Shot Phantom position
Lateral shift distance: _____mm
Mount the magnification table of the Xray equipment and the compression plate
normally used in magnification exposure
in clinical practice.
FDR Mammography QC Manual - 897N101461A
6
Specify “Manu” mode for the X-ray
equipment and make a magnified exposure
under the exposure conditions most often
used in clinical practice (about 28 kV, 80 to
100 mAs and Mo/Mo is recommended).
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness:
_____mm
Compression force: _____N
5. Auto-calculation
9
Press
[Measurement
execution].
The
results are displayed at the bottom of the
window.
TIP
If “No baseline value is input.” appears,
press [OK].
NOTE
In the last time measurement, skip Steps 10
through 12 and go to Step 13 .
When the results are displayed, press
[Save] and then [Close] to exit the QC
Software.
11
Select [Study completed] to finish the
test.
12
Repeat Steps 1 through 11 several
times (5 is recommended) to specify the
averages of the multiple measured values
as the baseline values.
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”.
4. Exposure condition confirmation
8
Check the exposure conditions.
NOTE
Make sure to repeat the same procedure until
the test is finished. Do not add an exposure
submenu when repeating.
13
FDR Mammography QC Manual - 897N101461A
Installation of FDR Mammography QC Program
10
3
When the result is displayed, press [Save]
and then [Test data log].
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
3-16
7. QC Software shutdown
15
Press [Save] and then [Close] to exit the
QC Software.
16
Select [Study completed] to finish the
test.
FDR Mammography QC Manual - 897N101461A
3.4.2
Baseline Values for Annual A Test
Among the Annual A Test items, the Image basic test requires the baseline setting.
Test Category
Exposure Menu
Annual A Test
Annual A 1/1
Test Item
Image Basic Test
Compression device confirmation
Viewing box maintenance
[1]
Image basic test
[Test flow]
0ATIENTINFORMATIONENTRYANDEXPOSURE
MENUSELECTION
3
)MAGEBASICTESTEXPOSURE
%XPOSURECONDITIONCONFIRMATION
2EPEATSEVERALTIMES
2ECOMMENDEDNUMBER
OFTIMES
)MAGEBASICTESTUSERINPUT
!UTOCALCULATION
"ASELINEVALUESETTING
1#3OFTWARESHUTDOWN
[Tools]
A dosimeter, scale, and lead sheet
[Baseline value setting procedure]
1
Determine the exposure conditions used in the test.
Remove the compression plate, place a lead sheet on the exposure table, and then position
the dosimeter at the lateral center of the exposure table, 60 mm away from the chest wallside edge, and also 40 mm above the exposure table.
Select [QC/TEST] in the exposure region list and [Calculation 1/2] in the exposure menu list,
and then press [Start study.].
Specify “Manu” mode for the X-ray equipment and make an exposure with 25 kV and Mo/Mo.
Then record the mAs when the air kerma becomes approximate to 20 mR in the worksheet.
Installation of FDR Mammography QC Program
1#3OFTWARESTARTUP
• Fill in the following item in the worksheet.
mAs: _____mAs
2
Specify “Manu” mode for the X-ray equipment and measure the air kerma 3 times with the
mAs derived from the exposure with 25 kV and Mo/Mo in Step 1 .
• Fill in the following item in the worksheet.
mR
mR
Entrance air kerma: _____mR
µGy , _____µGy , _____µGy
3
Remove the dosimeter.
Select [Study completed] to finish the test.
FDR Mammography QC Manual - 897N101461A
3-17
1. Patient information entry and exposure
menu selection
2. Image basic test (exposure)
7
4
Enter patient information and press [Next].
5
Select [QC/TEST] in the exposure region list
and [Annual A] in the exposure menu list, and
then press [Start study.].
Set [Grid] to [OUT], and then make an
exposure with the same conditions as
those used in Step 2 .
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
3
Installation of FDR Mammography QC Program
3-18
NOTE
It may take some time until you can press [QC]
after completing the exposure process.
3. QC Software startup
8
Press [QC] to display the “QC window”.
4. Exposure condition confirmation
9
6
The following exposure
displayed.
• Uniform Expo(Image Basic)
submenu
Check the exposure conditions.
is
FDR Mammography QC Manual - 897N101461A
6. Auto-calculation
5. Image basic test (user input)
10
Press [User input], enter the measured
entrance air kerma and visual inspection
results (Pass/Fail), and then press [OK].
11
Press
[Measurement
execution].
The
results are displayed at the bottom of the
window.
TIP
(4)
If “No baseline value is input.” appears,
press [OK].
(1)
(2)
NOTE
In the last measurement, skip Steps 12 through 14
and go to Step 15 .
(3)
When the result is displayed, press [Save]
and then [Close] to exit the QC Software.
13
Select [Study completed] to finish the
test.
14
Some dosimeters may require correction of the
measured value according to the beam quality.
Repeat Steps 1 through 13 several
times (5 is recommended) to specify the
averages of the multiple measured values
as the baseline values.
NOTE
NOTE
Enter values or select [Pass/Fail] for all of the
items. The Pass/Fail selection does not affect
the baseline value determination.
Make sure to repeat the same procedure until
the test is finished. Do not add an exposure
submenu when repeating.
(1) Enter the measured entrance air kerma
recorded in Step 2 .
(2) Select either of [Pass/Fail] for [Artifact] and
[White out].
(3)(4) Enter any values for these items.
NOTE
NOTE
Enter any value (e.g. “0” for all items) except for
negative or significantly large one. Otherwise,
an error occurs.
FDR Mammography QC Manual - 897N101461A
15
Installation of FDR Mammography QC Program
12
3
When the result is displayed, press [Save]
and then [Test data log].
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
3-20
8. QC Software shutdown
17
Press [Save] and then [Close] to exit the
QC Software.
18
Select [Study completed] to finish the
test.
FDR Mammography QC Manual - 897N101461A
3.4.3
Baseline Values for Weekly Test
The following Weekly Test items/contents require the baseline setting: CNR, 1Shot Phantom sensitivity
constancy, Geometric distortion, Uniformity, Dynamic range, Spatial Resolution (SR) and Linearity/Beam
quality constancy in Test with 1Shot Phantom, and Density difference (disk/outside) in Test with ACR
Phantom*. For each item, make exposures several times using the 1Shot Phantom, or the ACR Phantom,
Step Phantom and acrylic disk, and then derive the average from the calculated results to determine it as
the baseline value.
*NOTE
The baseline value setting for the test with ACR Phantom/Acrylic Disk is only required if the facility uses hardcopy for
primary interpretation
Test Category
Exposure Menu
Test Items/Contents
Missed tissue on chest wall edge
CNR
1Shot Phantom sensitivity constancy
System artifact evaluation
1Shot PhantomM
Test with 1Shot Phantom
Uniformity
Daily/Weekly Test
Dynamic range
Spatial Resolution (SR)
Low Contrast Detectability (LCD)
Linearity/Beam quality constancy
ACR Phantom
Test with ACR Phantom
[1]Test with 1Shot Phantom
[Test flow]
0ATIENTINFORMATIONENTRYANDEXPOSURE
MENUSELECTION
4ESTWITH3HOT0HANTOM
EXPOSURE
1#3OFTWARESTARTUP
Installation of FDR Mammography QC Program
Geometric distortion
3
2EPEATSEVERALTIMES
2ECOMMENDEDNUMBER
OFTIMES
%XPOSURECONDITIONCONFIRMATION
4ESTWITH3HOT0HANTOMUSERINPUT
!UTOCALCULATION
"ASELINEVALUESETTING
1#3OFTWARESHUTDOWN
[Tools]
1Shot Phantom
FDR Mammography QC Manual - 897N101461A
3-21
[Baseline value setting procedure]
2. Test with 1Shot Phantom (exposure)
1. Patient information entry and exposure
menu selection
1
4
Enter patient information and press [Next].
Position the 1Shot
exposure table.
Phantom
on
the
NOTE
Position the Phantom at the lateral center of the
exposure table by pressing the corners against
the chest wall-side edge of the exposure table.
If there are obstacles at the time of positioning,
the test may not be conducted accurately.
3HOT0HANTOM
3
Installation of FDR Mammography QC Program
3-22
2
Select [QC/TEST] in the exposure region
list and [1Shot PhantomM] in the exposure
menu list, and then press [Start study.].
%XPOSURETABLE
#ORNEROFTHE
3HOT0HANTOM
5
3
The following exposure
displayed.
• 1Shot PhantomM
submenu
Position the compression plate 40 mm
above the exposure table.
is
FDR Mammography QC Manual - 897N101461A
6
Specify 28 kV and Mo/Mo and make an
exposure in “Semi” mode.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
10
Select either of [Pass/Fail] for [1Shot
Phantom image confirmation] and [Good
practice] items, and then press [OK].
NOTE
Enter values or select [Pass/Fail] for all of the
items. The Pass/Fail selection does not affect
the baseline value determination.
NOTE
It may take some time until you can press [QC]
after completing the exposure process.
3. QC Software startup
7
3
Press [QC] to display the “QC window”.
8
Check the exposure conditions.
6. Auto-calculation
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 1Shot Phantom (user input)
9
Press [User input].
NOTE
In the last time measurement, skip Steps 12
through 14 and go to Step 15 .
FDR Mammography QC Manual - 897N101461A
12
When the result is displayed, press [Save]
and then [Close] to exit the QC Software.
13
Select [Study completed] to finish the
test.
Installation of FDR Mammography QC Program
4. Exposure condition confirmation
3-23
14
Repeat Steps 2 through 13 several times (5
is recommended) to specify the averages of
the multiple measured values as the baseline
values.
17
Create baseline values for “Low Contrast
Detectability (Light)” and “Low Contrast
Detectability (Dark)” in “LCD”.
NOTE
Make sure to repeat the same procedure until the
test is finished. Do not add an exposure submenu
when repeating.
15
When the result is displayed, press [Save] and
then [Test data log].
3
Installation of FDR Mammography QC Program
7. Baseline value setting
16
3-24
Select the results to be used for calculating the
baseline values among the measured results,
and then press [Baseline value creation].
1. Average measured results for “Low
Contrast Detectability (Light)”. This is
the baseline value for “Low Contrast
Detectability (Light)”.
If measured results for “Low Contrast
Detectability (Light)” are respectively
w1, w2, w3, w4 and w5, the average can
be calculated by the following formula:
(w1+w2+w3+w4+w5)/5.
Round
the
calculated value to the whole number.
• Fill in the following item in the worksheet.
Baseline value for “Low Contrast Detectability
(Light)”: _____%
E.g.: Assuming that measured results for
“Low Contrast Detectability (Light)”
are respectively 59.66, 60.33, 55.25,
62.27 and 65.19.
(59.66+60.33+55.25+62.27+65.19)/5 =
60.54
Round to the whole number. = 61
2. Similarly, average measured results for
“Low Contrast Detectability (Dark)”. This
is the baseline value for “Low Contrast
Detectability (Dark)”.
If measurement results for “Low Contrast
Detectability (Dark)” are respectively b1, b2,
b3, b4 and b5, the average can be calculated by
the following formula: (b1+b2+b3+b4+b5)/5.
Round the calculated value to the whole
number.
FDR Mammography QC Manual - 897N101461A
• Fill in the following item in the worksheet.
Baseline value for “Low Contrast Detectability
(Dark)”: _____%
E.g.: Assuming that measured results for
“Low Contrast Detectability (Dark)”
are respectively 67.03, 68.65, 63.03,
67.65 and 68.70.
(67.03+68.65+63.03+67.65+68.70)/5 =
67.012
Round to the whole number. = 67
18
Press [Criteria setting].
FDR Mammography QC Manual - 897N101461A
Select the [Daily/Week/y test (1/2)] tab.
Enter the criteria for “Light” and “Dark” in
“LCD” and press [OK].
3
8. QC Software shutdown
21
Press [Save] and then [Close] to exit the QC
Software.
22
Select [Study completed] to finish the test.
Installation of FDR Mammography QC Program
19
Create criteria to be entered in “Low Contrast
Detectability (Light)” and “Low Contrast
Detectability (Dark)” in “LCD”.
1. Subtract 14 from the baseline value
for “Low Contrast Detectability (Light)”
in consideration of variations in the
measurement. This is the criteria for “Low
Contrast Detectability (Light)”.
• Fill in the following item in the worksheet.
Criteria for “Low Contrast Detectability
(Light)”: _____%
E.g.: Assuming that baseline value for “Low
Contrast Detectability (Light)” is 61.
61-14 = 47
2. Similarly, subtract 14 from the baseline
value for “Low Contrast Detectability
(Dark)”. This is the criteria for “Low Contrast
Detectability (Dark)”.
• Fill in the following item in the worksheet.
Criteria for “Low Contrast Detectability
(Dark)”: _____%
E.g.: Assuming that baseline value of “Low
Contrast Detectability (Dark)” is 67.
67-14 = 53
20
3-25
[2]Test with ACR Phantom
The baseline value setting for the test with ACR Phantom/Acrylic Disk is only required if the facility uses hardcopy for
primary interpretation
[Test flow]
0ATIENTINFORMATIONENTRYANDEXPOSURE
MENUSELECTION
!#20HANTOMEXPOSURE
1#3OFTWARESTARTUP
2EPEATSEVERALTIMES
2ECOMMENDEDNUMBER
OFTIMES
%XPOSURECONDITIONCONFIRMATION
3
)MAGEOUTPUT
Installation of FDR Mammography QC Program
!#20HANTOMUSERINPUT
!UTOCALCULATION
"ASELINEVALUESETTING
1#3OFTWARESHUTDOWN
[Tools]
ACR Phantom, an acrylic disk, and a densitometer
3-26
FDR Mammography QC Manual - 897N101461A
[Baseline value setting procedure]
2. ACR Phantom (exposure)
1. Patient information entry and exposure
menu selection
1
4
Position the ACR Phantom at the lateral
center of the exposure table while aligning
its edge with the chest wall-side edge of
the exposure table.
5
Position the acrylic disk wherever it does
not interfere with the visual inspection of
the ACR Phantom (as shown in the figure
below).
Enter patient information and press [Next].
Nipple s ide
3
AC R P hantom
Select [QC/TEST] in the exposure region
list and [ACR Phantom] in the exposure
menu list, and then press [Start study.].
C hes t wall s ide
Acrylic dis k
6
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.
3
The following
displayed.
• ACR Phantom
exposure
submenu
is
7
Installation of FDR Mammography QC Program
2
Make an exposure in “Auto” or “Semi”
mode.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
NOTE
It may take some time until you can press [QC]
after completing the exposure process.
3. QC Software startup
FDR Mammography QC Manual - 897N101461A
3-27
8
Press [QC] to display the “QC window”.
13
Enter the densities measured in Step 11 .
NOTE
4. Exposure condition confirmation
9
Check the exposure conditions.
Make sure to enter values for [Density inside
the disk/Density outside the disk] in the correct
position.
Enter any values for [Density at center of
Phantom image] and the image evaluation,
then press [OK].
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.
3
Installation of FDR Mammography QC Program
5. Image output
10
Select an image exposed using Exposure
Submenu [ACR Phantom] from the
exposure condition display field and
press [Film output].
11
Measure the following items using the
image output on film.
• Fill in the following items in the worksheet.
Density inside the disk: _____
Density outside the disk: _____
6. ACR Phantom (user input)
12
3-28
Press [User input].
FDR Mammography QC Manual - 897N101461A
7. Auto-calculation
14
Press
[Measurement
execution].
The
results are displayed at the bottom of the
window.
8. Baseline value setting
19
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].
NOTE
Make sure that the results for the Test with
ACR Phantom are selected. They are displayed
below those for the Test with 1Shot Phantom.
TIP
If “No baseline value is input.” appears,
press [OK].
NOTE
3
In the last measurement, skip Steps 15 through 17
and go to Step 19 .
When the result is displayed, press [Save]
and then [Close] to exit the QC Software.
16
Select [Study completed] to finish the
test.
9. QC Software shutdown
17
Repeat Steps 1 through 16 several
times (5 is recommended) to specify the
averages of the multiple measured values
as the baseline values.
20
Press [Save] and then [Close] to exit the
QC Software.
21
Select [Study completed] to finish the
test.
NOTE
Make sure to repeat the same procedure until
the test is finished. Do not add an exposure
submenu when repeating.
18
When the result is displayed, press [Save]
and then [Test data log].
FDR Mammography QC Manual - 897N101461A
Installation of FDR Mammography QC Program
15
3-29
3.5
Checking Equipment Conditions
the Time of Program Installation
at
Conduct all of the test items provided in this Program except for Repeat analysis to confirm
that the all judgment items result in [Pass].
3
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.
Installation of FDR Mammography QC Program
The specified baseline values or reference criteria are shown on the “List of Reference Values
for Criteria and Baseline Values”.
For visual inspections, it is recommended to clearly relate an output image and the judgment
result in the condition check performed when the Program has been installed.
Furthermore, it is advisable to observe an output image in the condition check at the time of
the Program installation with some people (conductors of the QC tests in the Program are
recommended) to share the points for evaluation in visual inspections.
See the relevant Chapters for the test procedures.
TIP
Conduct the tests in the order of their potential influence on displayed images.
Annual Test (Chapter 7)
Semi-annual Test (Chapter 6)
Daily/Weekly Test (Chapter 4)
Conducting these Tests complete the condition check at the time of the Program
installation.
3-30
FDR Mammography QC Manual - 897N101461A
3
Installation of FDR Mammography QC Program
FDR Mammography QC Manual - 897N101461A
3-31
Chapter 4
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
4.5
Conducting Weekly 1 Shot Phantom Test ________________
4-6
4.5.1
4.5.2
4.5.3
4.6
4
Procedure _______________________________________ 4-6
Test Result Evaluation and Judgment _________________ 4-11
Performance Criteria and Corrective Action ____________ 4-11
Conducting Weekly ACR Phantom Test ___________________ 4-12
Procedure _______________________________________ 4-12
Test Result Evaluation and Judgment _________________ 4-16
Performance Criteria and Corrective Action ____________ 4-17
4.6.1
4.6.2
4.6.3
FDR Mammography QC Manual - 897N101461A
4.7
Conducting Weekly Printer QC __________________________ 4-12
4.8
Conducting Weekly Monitor QC _________________________ 4-12
4-1
4.1
Test Flow
Based on quantitative measurements that enable the identification of gradual changes in image
quality over time, the Weekly test is performed :
1) Weekly by the Technologist
2) Annually by the Medical Physicist during the Medical Equipment Evaluation (MEE) and
subsequent Annual testing.
The Weekly Test is comprised of constancy tests and performance verification tests of the system.
The constancy tests are designed for determining if variations of regularly-measured system performance
values are within the allowable range (criteria) based on baseline values that were established at the time of
QC program / system installation. The performance test is intended to check that system performance values
are within the upper or lower limits specified by the baselines.
4
It is necessary to determine the criteria before conducting the Weekly Test.
Weekly Test
NOTE
The reference criteria are shown on the “The List of Reference Vales for Criteria and Baseline Values”.
See “3.3 Criteria Confirmation and Determination” for details.
When conducting the Weekly Test for the first time after setting the criteria, specify the baseline values to
be used in the future Weekly Tests. In the second or later Weekly Test, check that the variation from the
specified baseline values is within the criteria.
See “3.4 Baseline Value Settings” for details.
4-2
FDR Mammography QC Manual - 897N101461A
4.2
Test Items
The Weekly Test consists of the following test items.
Test Items/Contents
Exposure Menus
Exposure Submenus
Items Autocalculated and
Judged Based on
Input Data
1.
Exposure
2. Input
Values
Items Judged
[Pass/Fail]
Based on Visual
Inspection by a
User
Missed tissue on chest
wall edge
CNR
1Shot Phantom
sensitivity constancy
✓
Geometric distortion
Test with 1Shot
Phantom
System artifact evaluation
Uniformity
1Shot PhantomM
1Shot PhantomM
✓
✓
Dynamic range
Spatial Resolution (SR)
Low Contrast
Detectability (LCD)
Linearity/Beam quality
constancy
Good practice
ACR Phantom*
ACR Phantom*
✓
✓
Three judgment methods:
1. Auto-calculation by the QC Software based on the image data acquired by
making an exposure.
2. Auto-calculation by the QC Software based on the input measurement
data.
3. User selection of [Pass/Fail] based on visual inspection of the image.
Weekly Test
Test with ACR Phantom
4
✓
-
Each Weekly Test item is tested by normally using an output image.
Most of the test results can be auto-calculated from the image data by the QC Software, though some
items require visual inspection.
*NOTE
The Test with ACR Phantom is required to be conducted at a Weekly frequency. On the day that you would conduct
both the Test with 1Shot Phantom and the Test with ACR Phantom, select Exposure Menu [1Shot/ACR].
In other cases, do not use the exposure menu. Otherwise, an incorrect test data log will be created.
FDR Mammography QC Manual - 897N101461A
4-3
4.3
Tools
Tools to be used for the Weekly Test based on this Guidebook are shown below.
See “2.3 Tools” for details.
Tools
[ A ] QC Software
[ B ] Worksheet (See Chapter 8)
[ C ] 1Shot Phantom
[ D ] Viewbox*1
[ F ] ACR Phantom (including an acrylic disk*1)
[ M ] Densitometer (if film is used)
*1 NOTE
The ACR phantom density measurement (using the acrylic disk) is required to be performed weekly if the facility
routinely prints hardcopy images for primary interpretation. If images are only occasionally printed for final
interpretation, such as upon request of a patient for images for interpretation elsewhere, then the test must be
performed in advance of, but not more than one week before printing the films.
4
Weekly Test
4-4
FDR Mammography QC Manual - 897N101461A
4.4
Setting Confirmation
The following items described in Chapter 3 are required to be specified before conducting the
Weekly Test.
•
•
•
Initial settings ...................................3.2 Initial Settings
Criteria..................................................3.3 Criteria Confirmation and Determination
Baseline values..................................3.4 Baseline Value Settings
[Items allowing criteria change]
Test Items/Contents
Judgment Items
Criteria
Missed tissue on chest wall
edge
Missed tissue on chest wall edge (Right)
[mm]
Missed tissue on chest wall edge
(Left) [mm]
CNR
CNR
Baseline value ± 20 %
1Shot Phantom sensitivity
constancy
System sensitivity
Baseline value ± 35 %
Dimension (Horizontal) [mm]
Baseline value ± 2 %
7 mm or less
7 mm or less
Geometric distortion
Dimension (Vertical) [mm]
Baseline value ± 2 %
Pixel Value (PV) ratio (Top-Right) [%]
Baseline value ± 15 %
Baseline value ± 15 %
Baseline value ± 15 %
Pixel Value (PV) ratio (Bottom-Left) [%]
Baseline value ± 15 %
SNR ratio (Top-Right) [%]
Baseline value ± 15 %
SNR ratio (Top-Left) [%]
Baseline value ± 15 %
SNR ratio (Bottom-Right) [%]
Baseline value ± 15 %
SNR ratio (Bottom-Left) [%]
Baseline value ± 15 %
Average QL at thinnest step wedge [QL]
Baseline value ± 400 [QL]
2lp/mm [%]
Baseline value ± 6 [%]
Uniformity
1Shot PhantomM
Dynamic range
4
Weekly Test
Pixel Value (PV) ratio (Top-Left) [%]
Pixel Value (PV) ratio (Bottom-Right) [%]
Spatial Resolution (SR)
Low Contrast Detectability
(LCD)
4lp/mm [%]
Baseline value ± 15 [%]
Low Contrast Detectability (Light) [%]
> Baseline value - 14 %
Low Contrast Detectability (Dark) [%]
> Baseline value - 14 %
QL gap (1 step-2 step) [QL]
Baseline value ± 50 [QL]
QL gap (2 step-3 step) [QL]
Baseline value ± 50 [QL]
Linearity/Beam quality
constancy
ACR Phantom
QL gap (3 step-4 step) [QL]
Baseline value ± 50 [QL]
QL gap (4 step-5 step) [QL]
Baseline value ± Baseline value [QL]
Density at center of Phantom image
1.4 ± 0.2
Density difference (disk/outside)
0.4 or more and baseline value ± 0.5
Fibers (ACR Phantom)
4 points or more
Specks (ACR Phantom)
3 points or more
Masses (ACR Phantom)
3 points or more
Visible step wedge (Step Phantom) *1
10 steps
Specks (Step Phantom) *1
4 steps or more
Masses (Step Phantom) *1
5 steps or more
TIP
The criteria setting is not required for visual inspection.
*1 When not checking these items, leave the preset values as they are. Do not delete the preset values.
FDR Mammography QC Manual - 897N101461A
4-5
4.5
4.5.1
Conducting Weekly 1 Shot Phantom Test
Procedure
[Test flow]
0ATIENTINFORMATIONENTRYANDEXPOSUREMENUSELECTION
4ESTWITH3HOT0HANTOMEXPOSURE
'OODPRACTICECLEANING
1#3OFTWARESTARTUP
%XPOSURECONDITIONCONFIRMATION
4
)MAGEOUTPUT
Weekly Test
4ESTWITH3HOT0HANTOMUSERINPUT
'OODPRACTICEUSERINPUT
!UTOCALCULATION
4ESTRESULTCONFIRMATION
1#3OFTWARESHUTDOWN
4-6
FDR Mammography QC Manual - 897N101461A
1. Patient information entry and exposure
menu selection
1
Enter patient information and press [Next].
2. Test with 1Shot Phantom (exposure)
4
Follow the instructions below to conduct
the test item.
[Tools]
1Shot Phantom
1. Position the 1Shot Phantom on the
exposure table.
NOTE
Position the Phantom at the lateral center
of the exposure table by pressing the
corners against the chest wall-side edge of
the exposure table. If there are obstacles at
the time of positioning, the test may not be
conducted accurately.
2
Select [QC/TEST] in the exposure region
list and [1Shot PhantomM] in the exposure
menu list, and then press [Start study.].
3HOT0HANTOM
4
Weekly Test
%XPOSURETABLE
3
The following exposure submenu is
displayed.
• 1Shot PhantomM
#ORNEROFTHE
3HOT0HANTOM
2. Position the compression plate 40 mm
above the exposure table.
FDR Mammography QC Manual - 897N101461A
4-7
3. Viewbox cleaning
Wipe clean the surface of the viewbox and
check that the luminance is uniform.
Follow the instructions given by the
manufacturer if any.
• Fill in the following items in the worksheet.
X-ray equipment cleanliness: Pass/Fail
Screen cleanliness: Pass/Fail
Viewbox cleanliness: Pass/Fail
3. Specify the same kVp and target/filter as
those determined in the “3.4.3 Baseline
Values for Daily/Weekly Test”. Then make
an exposure in “Semi” mode.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
NOTE
It may take some time until you can
press [QC] after completing the exposure
process.
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 1Shot Phantom
by following “3.4.3 Baseline Values for
Daily/Weekly Test”.
4. QC Software startup
6
4
Press [QC] to display the “QC window”.
5. Exposure condition confirmation
Weekly Test
3. Good practice (cleaning)
5
7
Check the exposure conditions.
Follow the instructions below to conduct
the test item.
[Tools]
See the respective operation manuals for the
FDR-1000DRSZ, FDR-1000AWS, and viewbox
for the necessary cleaning tools.
1. X-ray equipment cleaning
Clean the following parts of the X-ray
equipment.
• Compression surface of the breast
compression plate
• Patient support and chest wall-side
surface of the exposure table
• Surfaces of X-ray tube assembly
(incorporating X-ray tube and collimator)
including the mounted and removable
accessories
• Armrests
2. Softcopy output equipment cleaning
Wipe off any dust, finger marks and
other dirt on all of the softcopy output
equipment by using a lint-free soft cloth.
Follow the instructions provided by the
manufacturer.
4-8
FDR Mammography QC Manual - 897N101461A
6. Image output
8. Good practice (user input)
Select
Exposure
Submenu
[1Shot
PhantomM] from the exposure condition
display field and press [Film output]. For
performing image diagnosis on a softcopy
display, press [Network output] to output
the image to the network.
8
11
Enter the results of Good practice, and
then press [OK].
NOTE
Make sure that the result is selected for all
items. If there is an item left unentered, an error
occurs.
TIP
For performing image diagnosis on a softcopy
display, check the items on the display.
9. Auto-calculation
12
Press
[Measurement
execution].
The
results are displayed at the bottom of the
window.
4
Weekly Test
Check or measure the following items
using the image output on film.
9
• Fill in the following items in the worksheet.
1Shot Phantom
Geometric distortion: Pass/Fail
Artifact: Pass/Fail
7. Test with 1Shot Phantom (user input)
10
Press [User input].
inspection results.
Enter
FDR Mammography QC Manual - 897N101461A
the
visual
4-9
10. Test result confirmation
13
Check the displayed judgment results.
If there is a [Fail], see “4.5.3 Performance
Criteria and Corrective Action”.
4
Weekly Test
4-10
11. QC Software shutdown
14
Press [Save] and then [Close] to exit the
QC Software.
15
Select [Study completed] to finish the
test.
FDR Mammography QC Manual - 897N101461A
4.5.2
Test Result Evaluation and Judgment
Evaluate and judge the Weekly Test results. If all items are judged as [Pass], the Weekly Test is finished.
If there is an item judged as [Fail], take corrective actions by following “4.5.3. Performance Criteria and
Corrective Action”.
4.5.3
[1]
Performance Criteria and Corrective Action
Test with 1Shot Phantom [Any failed test item}
0OINTSTOBECHECKED
s4HECORRECTEXPOSURESUBMENUWASSELECTED
s4HESAME8RAYEQUIPMENTSETTINGSTARGETFILTERK6PAND!%#SETTINGSHAVEBEEN
USEDDURINGTHETEST
s4HE3HOT0HANTOMWASCORRECTLYPOSITIONED
s4HESAMECOMPRESSIONPLATEHASBEENUSEDDURINGTHETEST
s4HECOMPRESSIONPLATEHASBEENINTHESAMEPOSITIONDURINGTHETEST
)FANYOFTHEABOVEISNOTCORRECTAPPROPRIATECORRECTTHEPROBLEM
During the MEE / Annual survey performed by the Medical Phyiscist, If any of the items still results
in [Fail], the source of the problem shall be identified and corrective action shall be taken before
any further examinations are performed with the system.
„
CNR. Performance Criteria: Baseline value ± 20 %
„
Spatial Resolution. 2lp/mm: Baseline value ± 6 %, 4lp/mm: Baseline value ± 15 %
„
Missed Tissue at Chest Wall. Less than 7mm.
„
Uniformity. Performance Criteria: Baseline value ± 15 %
„
Linearity/Beam Quality. Performance Criteria: Baseline value ± x [QL]
Weekly Test
During the Weekly test performed by the QC technologist, if any of the following items still results
in [Fail], the source of the problem shall be identified and corrective action shall be taken before
any further examinations are performed with the system:
4
During the Weekly test performed by the QC technologist, if an item other than those listed
above still results in [Fail], the source of the problem shall be identified and corrective action
shall be taken within 30 days of the test date. Clinical imaging and mammographic image
interpretation may be continued during this period.
[2]
Good practice
Clean the equipment.
FDR Mammography QC Manual - 897N101461A
4-11
4.6
4.6.1
Conducting Weekly ACR Phantom Test
Procedure
[Test flow]
4
Weekly Test
4-12
FDR Mammography QC Manual - 897N101461A
1. Patient information entry and exposure
menu selection
1
Enter patient information and press [Next].
2. Test with ACR Phantom (exposure)
4
Follow the instructions below to conduct
the test item.
[Tools]
ACR Phantom, an acrylic disk*, and a
densitometer*.
1. Position the ACR Phantom at the lateral
center of the exposure table while aligning
its edge with the chest wall-side edge of
the exposure table.
2. Position the acrylic disk* wherever it does
not interfere with the visual inspection of
the ACR Phantom (as shown in the figure
below).
2
Select [QC/TEST] in the exposure region
list and [ACR Phantom] in the exposure
menu list, and then press [Start study.].
*NOTE
The acrylic sisk and densitometer are required
only if the facility uses hardcopy (film) for
primary interpretation.
Nipple s ide
Weekly Test
AC R P hantom
4
C hes t wall s ide
3
The following exposure submenu is
displayed.
• ACR Phantom
Acrylic dis k
3. 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 Manual - 897N101461A
4-13
4. Make an exposure in “Auto” or “Semi”
mode.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
5. Image output
7
Select Exposure Submenu [ACR Phantom]
from the exposure condition display field
and press [Film output]. For performing
image diagnosis on a softcopy display,
press [Network output] to output the
image to the network.
8
Check or measure the following items
using the image output on film. Follow the
recommended image evaluation method
for the Phantom to evaluate the image.
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.
Weekly Test
TIP
For performing image diagnosis on a
softcopy display, check the items on the
display.
•
4-14
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
FDR Mammography QC Manual - 897N101461A
6. Test with ACR Phantom (user input)
Press [User input]. Enter the measured
density and visual inspection results, and
then press [OK].
9
9. QC Software shutdown
12
Press [Save] and then [Close] to exit the
QC Software.
13
Select [Study completed] to finish the
test.
NOTE
Though the Step Phantom is not part of this QC
program, values for it must be entered. Enter any
integer from 0 to 10. If an item is left unentered,
or a negative value or value over 11 is entered, an
error occurs.
4
Weekly Test
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 Performance
Criteria and Corrective Action”.
FDR Mammography QC Manual - 897N101461A
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 ACR Phantom test
is finished.
If there is an item judged as [Fail], take corrective actions by following “4.6.3. Performance Criteria and
Corrective Action”.
See “8.2 Quick Guide for Software Operation” for test log display procedure.
4
Weekly Test
4-16
FDR Mammography QC Manual - 897N101461A
4.6.3
[3]
Performance Criteria and Corrective Action
Test with ACR Phantom
Performance Criteria:
Fibers = 4 or more
Specks = 3 or more
Masses = 3 or more
Density at center = 1.40 ± 0.2
Density difference disk / outside = 0.4 or more and baseline value ± 0.05
Make s ure that the AC R
P hantom is c orr
ec tly pos itioned
and then edo
r
the tes t.
P as s
The tes t is finis hed.
4
Weekly Test
P oints to be c hec ked
• The c orr
ec t expos ure s ubmenu was s elec ted.
• The s ame X-ray equipment s ettings (target/filter
, kVp and AE C s ettings ) have
been us ed.
• The AC R P hantom, and ac rylic dis k (if us ed) were c orrec tly pos itioned.
• The s ame c ompr
es s ion plate has been us ed during the tes t.
• The c ompr
es s ion plate has been in the s ame pos ition during the tes t.
• The dens itometer was c orrec tly us ed.
• The dens ity was meased
ur on the c orr
ec t pos ition.
• The quality c ontr
ol of the viewing c ondition is c onduc ted.
If any of the above is notecc t/appropriate,
orr
c orre c t the pr
oblem.
F ail
C ontac t a F UJ IF IL M dealer
.
If the item still results in [Fail], the source of the problem shall be identified and corrective
action shall be taken before any further examinations are performed with the system.
FDR Mammography QC Manual - 897N101461A
4-17
4.7
4.7.1
Conducting Printer Quality Control
Procedure
[Test flow]
1. TP rinter Quality C ontrol
4
Weekly Test
4-18
FDR Mammography QC Manual - 897N101461A
3. Printer Quality Control (measurement)
1
Follow the instructions below to conduct the
Printer Quality Control test.
NOTE
The printer used to produce films for final
interpretation of mammography images must
be cleared by FDA for that purpose.
The objective of this test is to assure that
the printer used for final interpretation is
performing according to the manufacturer’s
specifications.
NOTE
Follow the printer manufacturer’s QC program
for test frequency, procedure, performance
and corrective action.
If the manufacturer does not provide a
mammography printer QC program, use the
following:
[Tools]
1. Print the QC Pattern.
2. Measure the image to identify the step
which has an optical density closest to,
but not less than 1.20. Designate this step
as the Mid-Density (MD) step.
3. Measure the image to identify the step
with an optical density closest to, but not
less than 2.20. Designate this step as the
High-Density (HD) step.
4. Measure the image to identify the step
with an optical density closest to, but not
less than 0.45. Designate this step as the
Low-Density (LD) step.
5. The difference between the HD step and
the LD step is designated as the Density
Difference (DD).
6. Measure the lightest (Base+Fog or
unexposed) portion of the image. This is
designated as B+F.
7. Plot the Mid-Density (MD), the Density
Difference (DD) and the Base+Fog (B+F)
on the control chart .
FDR Mammography QC Manual - 897N101461A
4
Weekly Test
QC pattern with a fixed digital value grayscale
(e.g. TG18-QC or TG18-PQC (contact your printer
manufacturer for details), calibrated densitometer,
Report Form (available from printer manufacturer).
7. Determine if any of the data points exceed
the control limits. If not, proceed to step
9. If so, print a second QC pattern, double
checking that the correct procedure is
followed. If the same results are obtained,
proceed to step 8.
8. Circle any out-of-control data points and
repeat the test. If any data point is still out
of control, correct the cause of the problem
and repeat the test to confirm that the
problem has been corrected. Note the cause
of the problem and the corrective action
and plot the in-control point.
9. Determine if there are any trends, i.e., three
or more data points moving in one direction
(either upwards or downwards) in MD,
DD or B+F. If trends are present but the
data points have not, as yet, exceeded the
control limits, clinical mammogram images
can be printed. It is necessary to determine
the cause of the trend and to monitor the
processor closely to assure that control
limits are not exceeded.
7. Write the data and time on the film. label the
film with the printer ID if there is more than
one printer. Retain the film for the MQSA
prescibed period, e.g. the last full month for
daily QC and the last 12 weeks for weekly
QC.
[PERFORMANCE AND CORRECTIVE ACTION]
If the MD and DD are within ± 0.15 of their
respective operating levels, and the B+F is
within ± 0.03 of its operating level, the printer
is in control, and no further action is required.
If the MD and DD fall outside the above control
limits, corrective action must be performed
and then confirmed by performing the QC
test again. If this test produces results that fall
outside the action limits as specified above or
by the manufacturer (whichever is applicable),
the source of the problem shall be identified
and corrected before the device can be used
for mammographic image interpretation.
Clinical image acquisition may be continued.
If available, an alternative FDA-approved for
mammography display device may be used
for mammographic image interpretation,
provided it has passed the applicable QC tests.
4-19
4.8
4.8.1
Conducting Monitor Quality Control
Procedure
[Test flow]
1. Monitor Quality C ontrol
4
Weekly Test
4-20
FDR Mammography QC Manual - 897N101461A
4. Monitor Quality Control (measurement)
1
Follow the instructions below to conduct the
test item.
NOTE
The objective of this test is to assure that
monitors are performing according to the
monitor manufacturer’s specifications and
that they are calibrated (or configured) to
perform the DICOM Grayscale Standard
Display Function (GSDF). Both the monitors
used fro final interpretation of mammography
images (primary monitors), and monitors
used for acquisition QC (secondary monitors)
must be tested. An additional requirement
is that monitors used for final interpretation
must have been cleared by the FDA for that
purpose.
Follow the instructions below to conduct the
Monitor Image Quality Test.
1. For both primary and secondary monitors:
display the QC pattern.
2. Record the maximum and minimum
luminance levels as directed by your
monitor or QC software manufacturer.
The maximum luminance (Lmax) is
typically specified by the monitor
manufacturer as the highest value that
can be used without compromising
other performance characteristics, such
as lifetime or resolution. The minimum
brightness (Lmin) is influenced by Lmax.
3. Examine the image carefully to determine
the visibility of the following features and
record the results on the report form:
• Verify that the 5% signal level inset is
visible in the larger 0% signal field (a).
Pass/Fail
• Verify that the 95% signal level inset is
visible in the larger 100% signal field (b).
Pass/Fail
NOTE
Follow the monitor manuafacturer’s QC
program for test frequency, procedure,
performance and corrective action.
If the manufacturer does not provide a
mammography monitor QC program, use the
following:
[Tools]
•
•
•
•
Monitor image quality pattern:. AAPM
TG18-QC, SMPTE RP133 or other patterns
appropriate for the monitor to tested (contact
your monitor or QC software manufacturer for
details)
For monitor luminance response: gray scale
images (supplied by the monitor or QC
software manufacturer or AAPM TG18-LN).
Calibrated photometer
Monitor QC (Annual) report form, your own,
or the QC software manufacturer-provided
report form.
FDR Mammography QC Manual - 897N101461A
• Verify that each gray level step from 0% to
100% can be distinguished individually (c).
Pass/Fail
4
Weekly Test
NOTE
Commercial calibration software programs
supporting the American Association of
Physicists in Medicine (AAPM) Assessment
of Display Performance for Medical Imaging
Systems (AAPM On-Line Report No. 03, www.
aapm.org) are available for use with this test.
2
• Verify that the alphanumeric characters in
the image appear sharp and in focus (d).
Pass/Fail
• Verify that the high-contrast Line-pair
patterns in the center and at the corners of
the QC pattern are distinguishable (e). The
low-contrast patterns are not evaluated in
this test.
Pass/Fail
4-21
[PRECAUTIONS AND CAVEATS]
Perform this test using only the test patterns
described above. Some test patterns are specific to
the image matrix size and bit depth. Using other
patterns could yield erroneous results.
[PERFORMANCE]
If the following conditions are met, the
Monitor QC (Annual) test is acceptable:
4
Weekly Test
4-22
• The maximum luminance value (Lmax)
is within the reange specified by the
manufacturer. For reference, the AAPM
report recommends that once set, the
target level (Lmax) is maintained within
±10% of the desired value ..
• The 5% inset in the 0% field, and the 95%
inset in the 100% field shall be visible, and
the 0% to 100% gray level steps shall be
distinguishable from the adjacent steps.
• The alphanumeric characters appear sharp
and focused.
• The high contrast line-pair patterns are
distinguishable at the center and at
the corners of the display in both the
horizontal and vertical orientations.
NOTE]
For monitors featuring DICOM GSDF display
functionality, confirm that the monitors are
set for DICOM DISPLAY (GSDF) and that the
monitors successfully meet the criterai of
Monitor Image Quality Test Procedure step.
FDR Mammography QC Manual - 897N101461A
Chapter 5
Quarterly Test
Page
5.1
Test Flow ______________________________________________
5-2
5.2
Test Items _____________________________________________
5-3
5.3
Conducting Quarterly Test ______________________________
5-4
5-4
5-6
5-6
5.3.1
5.3.2
5.3.3
Procedure _______________________________________
Test Result Evaluation and Judgment _________________
Performance Criteria and Corrective Action ____________
5
FDR Mammography QC Manual - 897N101461A
5-1
5.1
Test Flow
Performed by the technologist, the Quarterly Test is designed to determine the number and cause of
repeated radiographs.
Analysis of this data will help identify ways to avoid multiple X-raying and reduce costs, as well as
reduce patient exposure.
)NSTALLATION
MONTHS
MONTHS
MONTHS
YEAR
MONTHS
1UARTERLY4EST
Repeated images shall be evaluated quarterly. In order for the repeat rates to be meaningful, a patient
volume of at least 250 patients or 1,000 exposures is needed.
As described above, the Quarterly Test is neither a constancy test nor a performance test of the system.
Specify the criteria when conducting the test, not in advance.
The Retake Analysis software, a software module for the FDR-1000AWS, is convenient for organizing and
managing the repeat analysis data. Detailed operation of the Repeat Analysis software module can be
found in Aspire HD (Amulet) Options Operation Manual.
%QUIPMENTUSE
2EJECTEDIMAGE
ANALYSIS
5
1UARTERLY4EST
Quarterly Test
YES
2EPEATANALYSIS
4HERESULTISWITHIN
THECRITERIA
NO
4AKINGCORRECTIVEACTIONS
#HECKIFTHECRITERIAARESATISFIED
)F NOT SATISFIED TAKE CORRECTIVE ACTIONS BY FOLLOWING 3OLUTIONS FOR
&AILED4EST)TEMS
5-2
FDR Mammography QC Manual - 897N101461A
5.2
Test Items
The Quarterly Test has the following test item.
Test Items
Repeat analysis
Exposure Menus
---
Exposure
Submenus
---
Items Auto-calculated and Judged Based
on Input Data
1. Exposure
2. Input Values
---
---
Items Judged
[Pass/Fail]
Based on Visual
Inspection by a
User
---
The Quarterly Test requires no settings since the QC Software is not used in the Test.
The Test also requires no tool.
Simply record the result of the Repeat analysis in the report form.
5
Quarterly Test
FDR Mammography QC Manual - 897N101461A
5-3
5.3
5.3.1
Conducting Quarterly Test
Procedure
[Test flow]
2EPEATANALYSISCOLLECTINGREJECTEDIMAGES
2EPEATANALYSISCALCULATINGREPEATRATES
4ESTRESULTCONFIRMATION
TIP
1. Repeat analysis (collecting rejected
images)
5
Quarterly Test
1
Start by removing all existing rejected images
in the department taken prior to the start of
the analysis.
2
Take inventory of the image supply as
a starting point to determine the total
number of images consumed during this
test.
3
Start collecting all rejected images.
Continue to collect for the length of
time needed to radiograph at least 250
consecutive patients.
4
Sort the rejected images into categories
such
as
poor
positioning,
motion,
compression, under exposure, (these
might be due to exposure or processing),
artifacts (streaks, spots, etc.).
Good images (they appear to be acceptable
mammograms
when
retrospectively
evaluated during the Repeat analysis) may
have also been repeated.
Some images may not have resulted in
an additional exposure of the patient
but may have also been rejected. These
include clear and QC images. Although it
is appropriate to include wire localization
images as part of the reject analysis,
they should not be included in the repeat
analysis because they are taken as part of
the wire localization process.
2. Repeat analysis (calculating repeat
rates)
5
Some facilities placing all images (repeated
and good images) in the patient’s film
jacket have no repeated images in the
department. In this case, the reject/repeat
analysis chart is completed as patient
examinations are carried out.
6
Tabulate the counts from Steps 4 and 5 ,
determining the total number of repeated
images, rejected images, and the total
number of images exposed during the
analysis period.
NOTE
Rejected images are all images that are in the
reject bin, including repeated images. Repeated
images are images that are retaken because
of inadequate quality. The reject bin does not
include additional views required to image
selected tissue seen on the first image. It also
does not include images taken for the purposes
of including tissue that could not be positioned
on the image receptor due to the size of the
breast. For facilities using softcopy for final
interpretation maintain a list of repeated images
using the “REPEAT RATE ANALYSIS“ in “8.3
Worksheets”.
5-4
FDR Mammography QC Manual - 897N101461A
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
If the total repeat or reject rate changes from
the previously determined rate by more than
2.0 percent of the total films included in the
analysis, the reason(s) for the change shall be
determined. Any corrective actions shall be
recorded and the results of these corrective
actions shall be assessed..
5
Quarterly Test
FDR Mammography QC Manual - 897N101461A
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 Performance Criteria and Corrective Action”.
5.3.3
Performance Criteria and Corrective Action
If the total repeat or reject rate changes from the previously determined rate by more than 2.0 percent of
the total films included in the analysis, the reason(s) for the change shall be determined. Any corrective
actions shall be recorded and the results of these corrective actions shall be assessed.
Any corrective action should be recorded on the bottom of the “REPEAT RATE ANALYSIS” in “8.4 Report
Forms”.
The effectiveness of the corrective actions must be assessed by performing another repeat analysis
after the corrective actions have been implemented.
It is important to study films that are too dark or too light to determine if the underlying cause is
the exposure equipment, image printer, patient positioning, technique or sub-optimal setting of digital
image processing.
If this test produces results that fall outside the action limits as specified, the source of the problem shall
be identified and corrective action shall be taken within thirty days of the test date. Clinical imaging and
mammographic image interpretation may be continued during this period.
5
Quarterly Test
5-6
FDR Mammography QC Manual - 897N101461A
Chapter 6
Semi-annual Test
Page
6.1
Test Flow ______________________________________________
6-2
6.2
Test Items _____________________________________________
6-2
6.3
Tools _________________________________________________
6-2
6.5
Conducting Semi-annual Test ___________________________
6.5.1 Procedure _______________________________________
6.5.2 Test Result Evaluation and Judgment _________________
6.5.3 Solutions for Failed Test Items _______________________
6-2
6-2
6-4
6-4
6
FDR Mammography QC Manual - 897N101461A
6-1
6.1
Test Flow
Performed by the technologist, the Semi-annual Test provides the basic test items for checking
that performance of the X-ray equipment is maintained. Detailed tests for this purpose are
conducted in the Annual Test.
)NSTALLATION
MONTHS
YEAR
YEARS
YEARS
YEARS
3EMIANNUAL4EST
6.2 Test Items
The Semi-annual Test consists of the following test items.
Items Judged Based on Input Data
Test Items
Exposure Menu
Exposure Submenus
Compression device confirmation
---
---
1. Exposure
2. Input Values
Items Judged [Pass/
Fail] Based on Visual
Inspection by a User
---
✓
Judgment methods:
1. User selection of [Pass/Fail] based on force / bathrrom scale measurements.
6
Semi-annual Test
6.3
Tools
Tools to be used for the Semi-annual Test based on this Manual are shown below.
See “2.3 Tools” for details.
Tools
[ B ] Worksheet (See Chapter 8)
[ J ] Analog bathroom scale or Force scale
[ K ] Towels
6.5
6.5.1
Conducting Semi-annual Test
Procedure
[Test flow]
1. C ompres s ion devic e c onfirmation (meas urment)
6-2
FDR Mammography QC Manual - 897N101461A
1. Compression device confirmation
(measurement)
1
Follow the instructions below to conduct the
test item.
[Tools]
A analog bathroom (or force) scale and several
towels.
1. Place a towel on the cassette holder (to
protect the cassette holder), then place
the analog bathroom scale on the towel,
with the dial or read-out positioned for
easy reading. Locate the center of the
scale directly under the compression
device. .
2. Place several towels on top of the scale
to prevent damage to the compression
device..
Towels
Bathroom
Scale
4.
Read the bathroom scale measurement
and record it on the worksheet.
• Automatic compression force measured
value: _____lbs.
5. Release the compression device
6
Semi-annual Test
3. Using the power drive, activate the
compression device and allow operation
until it stops automatically.
6. Using the manual drive, move the
compression device downward until it
stops.
7. Read the bathroom scale measurement
and record it on the worksheet.
• Manual compression force measured
value: _____lbs.l
8. Release the compression device.
FDR Mammography QC Manual - 897N101461A
6-3
6.5.2
Test Result Evaluation and Judgment
A compression force of at least 111 newtons (25pounds) shall be provided. The maximum compression
force for the initial power drive mode must be between 111 newtons (25 pounds) and 200 newtons (45
pounds).
If these requirements are not met, a qualified service engineer must make the appropriate internal
adjustments and the system retested and pass the test before further exams are performed. .
6.5.3
[1]
Performance Criteria and Corrective Action
Compression device confirmation
Performance Criteria:
Compression force: At least 111 newtons (25 pounds)
Maximum compression force: between111 newtons (25 pounds) and 200
newtons (45 pounds)
6
Semi-annual Test
If the item still results in [Fail], the source of the problem shall be identified and corrective
action shall be taken before any further examinations are performed with the system
6-4
FDR Mammography QC Manual - 897N101461A
Chapter 7
Annual Test
Page
FDR Mammography QC Manual - 897N101461A
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 ________________________________
7.5.1 Initial Performance Test ____________________________
1. Procedure ____________________________________
2. Test Result Evaluation and Judgment ____________
3. Performance Criteria and Corrective Action ______
7.5.2 Image Performance Test____________________________
1. Procedure ____________________________________
2. Test Result Evaluation and Judgment ____________
3. Performance Criteria and Corrective Action ______
7.5.3 Spatial Resolution Test _____________________________
1. Procedure ____________________________________
2. Test Result Evaluation and Judgment ____________
3. Performance Criteria and Corrective Action ______
7.5.4 X-ray Equipment Performance Test ___________________
1. Procedure ____________________________________
2. Test Result Evaluation and Judgment ____________
3. Performance Criteria and Corrective Action ______
7.5.5 AEC System Performance Test _______________________
1. Procedure ____________________________________
2. Test Result Evaluation and Judgment ____________
3. Performance Criteria and Corrective Action ______
7-7
7-7
7-7
7-16
7-16
7-19
7-19
7-25
7-25
7-27
7-27
7-30
7-30
7-31
7-31
7-43
7-43
7-45
7-45
7-56
7-56
7
7-1
7.1
Test Flow
Performed by the Medical Physicist during the Medical Equipment Evaluation (MEE) and
subsequent Annual testing, these tests are designed for checking the overall performance of the
FDR Mammography system.
The Annual Test is comprised of constancy tests and performance verification tests of the system.
The constancy tests are designed for determining if variations of regularly-measured system performance
values are within the allowable range (criteria) based on baseline values that were established at the time of
QC program / system installation. The performance test is intended to check that system performance values
are within the upper or lower limits specified by the baselines.
It is necessary to determine the criteria before conducting the Annual Test.
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 s etting, criteria and
bas eline value s ettings
Meas urement and
performance check
Viewing conditions
7
Firs t Annual Tes t
Meas urement
Annual Test
E quipment us e
Annual Tes t
YES
The res ult is within
the criteria
NO
C ompres s ion device
confirmation
E xpos ure and
meas urement
(1) Image performance
(2) S patial R es olution
(3) X-ray equipment performance
(4) AE C s ys tem performance
(5) 1 S hot P hantom tes ts
(6) AC R P hantom tes t
QC S oftware
Us er input
Auto-calculation
J udgment
Taking corrective actions
C heck that the variation from the s pecified bas eline values is within the
criteria, or that the values indicating s ys tem performance s atis fy the criteria.
If the criteria are s atis fied, equipment can be us ed as is until the next Annual
Tes t day. If not s atis fied, take corrective actions by following
"P erformance C riteria and C orrective Action" in the relevant s ubs ection.
7-2
FDR Mammography QC Manual - 897N101461A
7.2
Test Items
The Annual Test consists of the following test items.
Test Types/Items
Exposure Menus
Exposure Submenus
Items Autocalculated and
Judged Based on
Input Data
1.
Exposure
✓
Viewing environment
-
-
Viewbox maintenance
Annual A
-
Printer Quality Control
-
-
✓
Monitor Quality Control
-
-
✓
✓
Viewing Conditions
Compression device
confirmation
Force, display accuracy and
sustainability
Image basic test
Annual A
Annual A
Uniform Expo
(Image Basic)
✓
ACR Phantom1(Lag)
✓
Additive lag effects (Lag)
Image performance
Multiplicative lag effects
(Ghost)
Spatial Resolution
(Magnification)
Half Value Layer (HVL)
✓
✓
ACR Phantom2(Ghost)
✓
Uniform Expo.2(Ghost)
✓
Annual 2/6
Annual 3/6
Collimation assessment
1ShotM(Magnification)
✓
✓
✓
-
✓
-
AEC reproducibility
-
AGD mode 1
✓
✓
✓
✓
Mode1 CNR (PMMA20mm)
✓
Mode1 CNR (PMMA40mm)
✓
Mode1 CNR (PMMA60mm)
✓
Mode1 CNR (PMMA70mm)
✓
Annual 4/6
AEC system performance
✓
✓
Radiation output
CNR mode 1
✓
-
Uniform Expo.3(Collimation)
7
✓
-
✓
✓
Constancy Performance 1 Shot Phantom tests
1Shot PhantomM
-
✓
✓
Test with ACR Phantom ACR phantom scoring
ACR Phantom
✓
✓
✓
Three judgment methods:
1. Auto-calculation by the QC Software based on the image data acquired by
making an exposure.
2. Auto-calculation by the QC Software based on the input measurement
data.
3. User selection of [Pass/Fail] based on visual inspection of the image.
Annual Test
Calcualtion 2/2
AGD-ACR Phantom
✓
✓
-
kVp accuracy and
reproducibility
X-ray equipment
performance
Non Exposure(Lag)
Uniform Expo.1(Ghost)
Annual 1/6
Visual and Functional test
Spatial Resolution
2. Input
Values
Items Judged
[Pass/Fail]
Based on Visual
Inspection by a
User
.
FDR Mammography QC Manual - 897N101461A
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 ] 1Shot Phantom
[ D ] Viewing box (if film is used)
[ E ] Timer or watch/clock
[ F ] ACR Phantom
[ G ] Dosimeter
[ H ] Luminance meter
[ I ] kVp meter
[ J ] Force scale
[ N ] PMMA phantoms (available, in combination, for 20, 40, 60 and 70 mm in
thickness)
[ O ] Aluminum plate (0.2 mm) for CNR measurement
[ P ] Aluminum plates for half value layer measurement (0.3 and 0.5 mm)
[ Q ] Scale
[ R ] Coins
[ S ] Lead sheet
7
Annual Test
7-4
FDR Mammography QC Manual - 897N101461A
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
Luminance (cd/m2)
3500 cd/m2 or more
Interpretation room illuminance / ambient light (lx)
50 lx or less
Compressed breast thickness accuracy (mm)
±5 mm or less
Compression force accuracy (N)
± 20 N or less
Maximum compression force (N)
111 to 200 N
Image basic test
Relative sensitivity (S value)
Baseline value ± 40 %
Additive lag effects (Lag)
Lag factor [QL]
75 QL or less
Multiplicative lag effects (Ghost)
Ghost factor
Below 0.045
MTF (4lp/mm)
Baseline value ± 12 %
MTF (8lp/mm)
Baseline value ± 15 %
Low volt. accuracy (LFS) [kV]
Specified kVp ± 1 kV
Mid. volt. accuracy (LFS) [kV]
Specified kVp ± 1 kV
High volt. accuracy (LFS) [kV]
Specified kVp ± 1 kV
Viewbox mainitenance
Compression device confirmation
Spatial Resolution (Magnification)
kVp accuracy and reproducibility
Half Value Layer (HVL)
Specified kVp ± 1 kV
Specified kVp ± 1 kV
High volt. accuracy (SFS) [kV]
Specified kVp ± 1 kV
Mid. volt. reproducibility (LFS) [kV]
Reproducibility ± 0.5 kV or less
HVL (Mo/Mo)
kVp / 100
HVL (Mo/Rh)
kVp / 100
HVL (W/Rh)
kVp / 100
X-ray / Light field gap (Right/Left) [mm]
Total gap criteria = SID X 0.02 or less
X-ray / Light field gap (Chest/Nipple) [mm]
Total gap criteria = SID X 0.02 or less
X-ray / Image receptor field gap (Left) [mm]
SID X 0.02 or less
X-ray / Image receptor field gap (Right) [mm]
SID X 0.02 or less
X-ray / Image receptor field gap (Nipple) [mm]
SID X 0.02 or less
X-ray field / Exposure table gap [mm]
5 mm or less
Reproducibility
Variation coefficient 0.05 or less
Collimation assessment
Radiation output
FDR Mammography QC Manual - 897N101461A
Air kerma rate [mGy/s]
7 mGy/s or more
Specific radiation output [μGy/mAs]
30 μGy/mAs or more
7
Annual Test
Low volt. accuracy (SFS) [kV]
Mid. volt. accuracy (SFS) [kV]
7-5
[Items allowing criteria change]
Test Items
Judgment Items
Criteria
Entrance air kerma accuracy [%]
Average ± 15 % or less
Entrance air kerma reproducibility
Variation coefficient 0.05 or less
CNR relative value 20mm [%]
Baseline value 105 % or more
CNR relative value 40mm [%]
Baseline value 95 % or more
CNR relative value 60mm [%]
Baseline value 63 % or more
CNR relative value 70mm [%]
Baseline value 60 % or more
AGD 20 mm [mGy]
1 mGy or less
AEC reproducibility
CNR mode 1
AGD 40 mm [mGy]
2 mGy or less
AGD 60 mm [mGy]
4.5 mGy or less
AGD 70 mm [mGy]
6.5 mGy or less
AGD-ACR Phantom
3 mGy or less
AGD mode 1
AGD-ACR Phantom
TIP
• The criteria setting is not required for visual inspection.
• CNR mode 1 corresponds to the CNR_H-mode
• AGD mode 1 corresponds to the AGD_H-mode
7
Annual Test
7-6
FDR Mammography QC Manual - 897N101461A
7.5
Conducting Annual Test
The Annual Test items are classified into “7.5.1 Initial Performance Test”, “7.5.2 Image Performance
Test”, “7.5.3 Spatial Resolution Test”, “7.5.4 X-ray Equipment Performance Test”, “7.5.5 AEC System
Performance Test” and “7.5.6 ACR Phantom Evaluation”; these five tests can be conducted
separately.
7.5.1
Initial Performance Test
1. Procedure
[Test flow]
The Initial performance test consists of the Viewing environment evaluation, Viewbox maintenance,
Printer Quality Control, Monitor Quality Control, Image basic test, and Compression device confirmation.
1. Viewing environment (meas urement)
2. Viewbox maintenanc e (meas urement)
3. P rinter Quality C ontrol
(meas urement)
4. Monitor Quality C ontrol (meas urement)
5. Image bas ic tes t (meas urement)
6. P atient information entry and expos ure menu s elec tion
7. Image bas ic tes t (expos ure)
8. C ompres s ion devic e c onfirmation (meas urement)
9. QC S oftware s tartup
7
10. E xpos ure c ondition c onfirmation
12. Image bas ic tes t (us er input)
Annual Test
11. Image output
13. C ompres s ion devic e c onfirmation (us er input)
14. Viewbox maintenanc e (us er input)
15. Auto-c alc ulation
16. Tes t res ult c onfirmation
17. QC S oftware s hutdown
FDR Mammography QC Manual - 897N101461A
7-7
1. Viewing Environment (measurement)
1
Follow the instructions below to conduct the
Viewing Environment evaluation.
NOTE
This evaluation is specific to the viewbox and
reading room conditions, for images for final
interpretation.
NOTE [HARDCOPY]
When interpreting hardcopy (film) images, it
is suggested that you view the printed Aspire
HD images under the same conditions as you
would screen-film mammography images.
Film masking devices and “hot” lights must be
available for use by the interpreting physician.
The 1999 ACR mammography Quality Control
Manual includes a section on viewbox
luminance, room illuminance, and msking,
which may be used as a reference.
NOTE [SOFTCOPY]
When interpreting softcopy images, follow the
monitor manufacturer’s quality control procedures.
For monitors without a manufacturer-provided
QC program, follow the monitor QC procedures
provided in this manual.
Set the final interpretation
illumination to the lower of:
environment
• that recommended in the monitot
manufacturer’s quality control program, if
applicable, or
• 20lux or lower.
7
Annual Test
If the illumination is greater than the value set
as described above, the source of the problem
must be identified and corrective action taken
before interpreting mammograms under these
conditions.
2. Viewbox maintenance (measurement)
2
Follow the instructions below to conduct the
test item.
[Tools]
A viewbox, luminance meter, and illuminance
meter
NOTE
Check the viewbox performance under the normal
use condition.
1. Turn on the viewbox and wait until the
luminance becomes stable.
2. Measure the luminance at the center of
the viewbox by using a luminance meter.
• Fill in the following item in the worksheet.
Luminance: _____cd/m2
3. Visually check if the viewbox luminance is
uniform.
• Fill in the following item in the worksheet.
Viewbox uniformity: Pass/Fail
4. When the viewbox has a luminance
adjustment function, check if the function
works correctly.
• Fill in the following item in the worksheet.
Luminance adjustment function:
Pass/Fail
5. When the viewbox has a masking function,
check if the function works correctly.
• Fill in the following item in the worksheet.
Masking: Pass/Fail
6. Measure the illuminance near the viewbox,
as a sample illuminance in the viewing
condition, by using an illuminance meter.
• Fill in the following item in the worksheet.
Interpretation room illuminance (Ambient
light): _____lx
NOTE
See the operation manuals for the viewbox,
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.
7-8
FDR Mammography QC Manual - 897N101461A
3. Printer Quality Control (measurement)
3
Follow the instructions below to conduct the
Printer Quality Control test.
NOTE
The printer used to produce films for final
interpretation of mammography images must
be cleared by FDA for that purpose.
The objective of this test is to assure that
the printer used for final interpretation is
performing according to the manufacturer’s
specifications.
NOTE
Follow the printer manufacturer’s QC program
for test frequency, procedure, performance
and corrective action.
If the manufacturer does not provide a
mammography printer QC program, use the
following:
[Tools]
QC pattern with a fixed geometric pattern (e.g.
TG18-QC or SMPTE RP133 (contact your printer
manufacturer for details)), Metric Ruler, Report
Form (available from your printer manufacturer).
1. Print the QC Pattern.
2. Identify lines in each dimension that have
a specified relationship (e.g. fixed length
or distance between lines). Use these
same lines for subsequent testing.
4. Using the ruler, confirm that the lines are
straight and undistorted.
5. Inspect the image for artifacts.
6. Inspect the image for banding and jagged
edges of the straight lines.
[PERFORMANCE AND CORRECTIVE ACTION]
The tolerance for film printer artifacts should
be similar to the tolerance in screen-film
mammography.
According to the 1999
American College of Radiology Mammography
Quality Control Manual, not all artifacts can
be totally eliminated. It may be useful to use
the concept of ALARA (as low as reasonably
achievable) when assessing artifacts. If they
can be easliy eliminated, they should. If the
artifact is difficult or expensive to eliminate and
is subtle (not mimicking or obscuring clinical
information), it may be tolerable. The medical
physicist should consult with the interpreting
physician as to whether the artifact is tolerable.
Tolerances for artifacts should be lower with
new imaging equipment.
If any of the following conditions exist:
• The lines are bowed, bent or distorted
• The lines exhibit jagged borders
• The printer exhibits print or processing
artifact that is judged intolerable
• Measured distances vary by more than 1%
from the tolerance standards
• Artifacts are objectionable and can mimic
or obscure clinical information
The source of the problem shall be identified
and corrective action shall be taken before the
device can be used for mammographic image
interpretation.
Clinical image acquisition may be continued. If
available, an alternative approved diagnostic
display device may be used for mammographic
image interpretation:
7
Annual Test
3. Measure the length of lines in the step
above to establish a baseline. If the
printer manufacturer provides a test
image with specified distances, compare
your measurement to the provided
specification.
Unless otherwise specified by the printer
manufacturer, the visual observations should
be made without magnification.
7. Note any unusual mechanical noises or
other observations.
[PRECAUTIONS AND CAVEATS]
Perform this test using the QC pattern supplied
(or recommended) by the manufacturer for that
printer model. If none is available, use a QC test
pattern recommended by the AAPM or by one
of the approved MQSA accreditation bodies for
this purpose. Using other patterns could yield
erroneous results.
FDR Mammography QC Manual - 897N101461A
7-9
4. Monitor Quality Control (measurement)
4
Follow the instructions below to conduct the
test item.
NOTE
The objective of this test is to assure that
monitors are performing according to the
monitor manufacturer’s specifications and
that they are calibrated (or configured) to
perform the DICOM Grayscale Standard
Display Function (GSDF). Both the monitors
used fro final interpretation of mammography
images (primary monitors), and monitors
used for acquisition QC (secondary monitors)
must be tested. An additional requirement
is that monitors used for final interpretation
must have been cleared by the FDA for that
purpose.
NOTE
Commercial calibration software programs
supporting the American Association of
Physicists in Medicine (AAPM) Assessment
of Display Performance for Medical Imaging
Systems (AAPM On-Line Report No. 03, www.
aapm.org) are available for use with this test.
5
Follow the instructions below to conduct the
Monitor Image Quality Test.
1. For both primary and secondary monitors:
display the QC pattern.
2. Record the maximum and minimum
luminance levels as directed by your
monitor or QC software manufacturer.
The maximum luminance (Lmax) is
typically specified by the monitor
manufacturer as the highest value that
can be used without compromising
other performance characteristics, such
as lifetime or resolution. The minimum
brightness (Lmin) is influenced by Lmax.
3. Examine the image carefully to determine
the visibility of the following features and
record the results on the report form:
• Verify that the 5% signal level inset is
visible in the larger 0% signal field (a).
Pass/Fail
• Verify that the 95% signal level inset is
visible in the larger 100% signal field (b).
Pass/Fail
NOTE
Follow the monitor manuafacturer’s QC
program for test frequency, procedure,
performance and corrective action.
If the manufacturer does not provide a
mammography monitor QC program, use the
following:
7
[Tools]
•
Annual Test
•
•
•
7-10
Monitor image quality pattern:. AAPM
TG18-QC, SMPTE RP133 or other patterns
appropriate for the monitor to tested (contact
your monitor or QC software manufacturer for
details)
For monitor luminance response: gray scale
images (supplied by the monitor or QC
software manufacturer or AAPM TG18-LN).
Calibrated photometer
Monitor QC (Annual) report form, your own,
or the QC software manufacturer-provided
report form.
• Verify that each gray level step from 0% to
100% can be distinguished individually (c).
Pass/Fail
• Verify that the alphanumeric characters in
the image appear sharp and in focus (d).
Pass/Fail
• Verify that the high-contrast Line-pair
patterns in the center and at the corners of
the QC pattern are distinguishable (e). The
low-contrast patterns are not evaluated in
this test.
Pass/Fail
FDR Mammography QC Manual - 897N101461A
[PRECAUTIONS AND CAVEATS]
Perform this test using only the test patterns
described above. Some test patterns are specific to
the image matrix size and bit depth. Using other
patterns could yield erroneous results.
[PERFORMANCE]
If the following conditions are met, the
Monitor QC (Annual) test is acceptable:
• The maximum luminance value (Lmax)
is within the reange specified by the
manufacturer. For reference, the AAPM
report recommends that once set, the
target level (Lmax) is maintained within
±10% of the desired value ..
• The 5% inset in the 0% field, and the 95%
inset in the 100% field shall be visible, and
the 0% to 100% gray level steps shall be
distinguishable from the adjacent steps.
• The alphanumeric characters appear sharp
and focused.
• The high contrast line-pair patterns are
distinguishable at the center and at
the corners of the display in both the
horizontal and vertical orientations.
NOTE]
For monitors featuring DICOM GSDF display
functionality, confirm that the monitors are
set for DICOM DISPLAY (GSDF) and that the
monitors successfully meet the criterai of
Monitor Image Quality Test Procedure step
5. If so, you have successfully completed the
Monitor QC (Annual) test. Proceed to step 7
FDR Mammography QC Manual - 897N101461A
Follow the instructions below to conduct the
Monitor Luminance Response Test.
1. Perform the luminance response test as
described in the AAPM report.
2. Record the results of the evaluation on the
report form.
[PRECAUTIONS AND CAVEATS]
Perform this test using only the test patterns
described above. Some test patterns are specific to
the image matrix size and bit depth. Using other
patterns could yield erroneous results.
[PERFORMANCE]
Both primary and secondary monitors must be
calibrated to DICOM Grayscale Standard Display
Function (GSDF). The luminance differences
between each measured value must agree with
the expected difference associated with the GSDF
and the measured contrast response at any given
point must not exceed 10% of the standard for
primary monitors and must not exceed 20% for the
secondary monitors.
[CORRECTIVE ACTION]
For primary monitors (used for final interpretation):
If the test produces results that fall outside the
action limits as specified by the manufacturer,
the source of the problem shall be identified
and corrective action shall be taken before that
device can be used for mammographic image
interpretation. Clinical image acquisition may be
continued. If available, an alternative approved
diagnostic device may be used for mammographic
image interpretation, provided it has passed the
applicable QC tests.
For secondary monitors (used for image acquisition
QC):
If this test produces results that fall outside the
action limits as specified by the manufacturer,
the source of the problem shall be identified and
corrective action shall be taken before any further
examinations are performed using that monitor. If
the monitor that failed is replaced by an alternative
monitor that passes all tests, image acquisition
may resume using the alternative monitor.
7
Annual Test
For monitors that do not provide DICOM
DISPLAY (GSDF), or fail the Monitor Image
Quality Test Procedure step 5, perform the
GSDF calibration and proceed to step 6
6
7-11
5. Image basic test (measurement)
7
Follow the instructions below to conduct the
test item.
6. Patient information entry and exposure
menu selection
8
Enter patient information and press [Next].
9
Select [QC/TEST] in the exposure region list
and [Annual A 1/1] in the exposure menu list,
and then press [Start study.].
10
The following exposure submenu is displayed.
• Uniform Expo(Image Basic)
[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.
.IPPLESIDE
%XPOSURETABLE
,ATERALCENTER
MM
$OSIMETERPOSITION
#HESTWALLSIDE
%XPOSURETABLE
MM
#HEST WALL SIDE
7
MM
.IPPLE SIDE
Annual Test
3. Select [QC/TEST] in the exposure region
list and [Calculation 1/2] in the exposure
menu list, and then press [Start study.].
Specify the kVp, mAs and target/filter
determined in “3.4.2 Baseline Values for
Annual A Test”, and measure the air kerma
3 times in “Manu” mode.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
mR
mR
µGy , _____µGy , _____µGy
Air kerma: _____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 test by following
“3.4.2 Baseline Values for Annual A Test”.
4. Remove the dosimeter & lead sheet.
Select [Study completed] to finish the test.
7-12
FDR Mammography QC Manual - 897N101461A
7. Image basic test (exposure)
11
Follow the instructions below to conduct the
test item.
4. Remove the PMMA phantom, then
position the force scale at the lateral
center of the exposure table, about 60
mm away from the chest wall-side edge.
Set [Grid] to [OUT], and then make an exposure
with the same conditions as those used in
Substep 3 in Step 7 .
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
8. Compression device confirmation
(measurement)
12
Follow the instructions below to conduct the
test item.
[Tools]
A force scale, timer or watch/clock, PMMA
phantom (40 mm), and scale
1. Position the PMMA phantom (40 mm) on
the exposure table.
2. Apply compression force most frequently
used in clinical practice and record the
display value for compressed breast
thickness on the X-ray equipment.
• Fill in the following item in the worksheet.
Compressed breast thickness displayed
value: _____mm
60mm
NOTE
Ensure that the compression force is evenly
applied to the measurement part of the
force scale. If compression is not even, the
measurement may result in an incorrect value.
5. Apply the same compression force as that
used in Substep 2 and record the display
value for the compression force on the
X-ray equipment and the measured value.
• Fill in the following items in the worksheet.
Compression force display value:
_____N
Compression force measured value:
_____N
6. Check that the compression applied in
Substep 5 lasts 1 minute or more.
• Fill in the following item in the worksheet.
Compression force sustainability:
Pass/Fail
3. Measure thickness of the compressed
PMMA phantom (40 mm) by using a scale.
• Fill in the following item in the worksheet.
Compressed breast thickness measured
value: _____mm
FDR Mammography QC Manual - 897N101461A
7
Annual Test
7. Increment the compression force from
that applied in Substep 6 and record the
maximum compression force measured
on the force scale.
• Fill in the following item in the worksheet.
Maximum compression force:
_____N
7-13
9. QC Software startup
13
16
Press [QC] to display the “QC window”.
Check for artifacts and white-out in the printed
image. In image diagnosis on a softcopy
display, check these items on the display.
• Fill in the following items in the worksheet.
Artifact: Pass/Fail
White out: Pass/Fail
10. Exposure condition confirmation
14
)MAGEFRAME
Check the exposure conditions.
7HITEOUT
12. Image basic test (user input)
17
Press [User input].
18
Enter the measured air kerma (from Substep
3 in Step 7 .) and visual inspection results
([Pass/Fail]).
11. Image output
15
Select
Exposure
Submenu
[Uniform
Expo(Image Basic)] from the exposure
condition display field and press [Film output].
For performing image diagnosis on a softcopy
display, press [Network output] to output the
image to the network.
NOTE
Some dosimeters may require correction of the
measured value according to the beam quality.
7
Annual Test
7-14
FDR Mammography QC Manual - 897N101461A
13. Compression device confirmation (user
input)
19
Enter the measured values, display values and
visual inspection result (Pass/Fail).
16. Test result confirmation
22
Check the displayed judgment results.
If there is a [Fail], see “7.5.3 Performance
Criteria and Corrective Action”.
17. QC Software shutdown
14. Viewing box maintenance (user input)
20
23
Press [Save] and then [Close] to exit the QC
Software.
24
Select [Study completed] to finish the test.
Enter the measured value and visual inspection
results, and then press [OK].
7
Make sure that the values are entered for all items.
If there is an item left unentered, an error occurs.
15. Auto-calculation
21
Annual Test
NOTE
Press [Measurement execution]. The results
are displayed at the bottom of the window.
FDR Mammography QC Manual - 897N101461A
7-15
2. Test Result Evaluation and Judgement
Evaluate and judge the Annual A Test results. If all items are judged as [Pass], the Annual A Test is finished.
If there is an item judged as [Fail], take corrective actions by following “6.5.3 Performance Criteria and
Corrective Action”.
3. Performance Criteria and Corrective Action
[1]
Image basic test
„
[Artifact] resulted in [Fail]
Performance Criteria: No clinically relevant artifacts shall be visible.
0OINTSTOBECHECKED
s4HECORRECTEXPOSURESUBMENUWASSELECTED
s4HE8RAYEQUIPMENTSETTINGSTARGETFILTERK6PWERECORRECT
s4HEAIRKERMAUSEDFORTHEEXPOSURESWASAPPROPRIATE
s4HEREARENOSCRATCHESORDIRTONTHEEXPOSURETABLEORCOMPRESSIONPLATE
s4HEQUALITYCONTROLOFTHESOFTCOPYHARDCOPYOUTPUTEQUIPMENTISCONDUCTED
s4HEVIEWINGCONDITIONISAPPROPRIATE
)FANYOFTHEABOVEISNOTCORRECTAPPROPRIATECORRECTTHEPROBLEM
2EDOTHETEST
0ASS
4HETESTISFINISHED
&AIL
#ONTACTA&5*)&),-DEALER
If the item still results in [Fail], the source of the problem shall be identified and corrective
action shall be taken within 30 days of the test date. Clinical imaging and mammographic
image interpretation may be continued during this period.
„
7
[Relative sensitivity] resulted in [Fail]
Performance Criteria: Baseline value ± 40%
Annual Test
0OINTSTOBECHECKED
s4HECORRECTEXPOSURESUBMENUWASSELECTED
s4HE8RAYEQUIPMENTSETTINGSTARGETFILTERK6PWERECORRECT
s4HEAIRKERMAUSEDFORTHEEXPOSURESWASAPPROPRIATE
s4HEDOSIMETERWASCORRECTLYPOSITIONED
s4HEDOSIMETERWASCORRECTLYUSED
)FANYOFTHEABOVEISNOTCORRECTAPPROPRIATECORRECTTHEPROBLEM
2EDOTHETEST
0ASS
4HETESTISFINISHED
&AIL
4HE8RAYEQUIPMENTOR
DOSIMETERMAYBEDEFECTIVE
#ONTACTA&5*)&),-DEALER
If the item still results in [Fail], the source of the problem shall be identified and corrective
action shall be taken within 30 days of the test date. Clinical imaging and mammographic
image interpretation may be continued during this period.
7-16
FDR Mammography QC Manual - 897N101461A
„
[White out] resulted in [Fail]
Performance Criteria: No white out shall be visible.
0OINTSTOBECHECKED
s4HECORRECTEXPOSURESUBMENUWASSELECTED
s4HE8RAYEQUIPMENTSETTINGSTARGETFILTERK6PWERECORRECT
s4HEREARENOSCRATCHESORDIRTONTHEEXPOSURETABLEORCOMPRESSIONPLATE
s4HEQUALITYCONTROLOFTHESOFTCOPYHARDCOPYOUTPUTEQUIPMENTISCONDUCTED
s4HEVIEWINGCONDITIONISAPPROPRIATE
)FANYOFTHEABOVEISNOTCORRECTAPPROPRIATECORRECTTHEPROBLEM
2EDOTHETEST
0ASS
4HETESTISFINISHED
&AIL
4HE8RAYEQUIPMENTMAYBEDEFECTIVE
#ONTACTA&5*)&),-DEALER
If the item still results in [Fail], the source of the problem shall be identified and corrective
action shall be taken within 30 days of the test date. Clinical imaging and mammographic
image interpretation may be continued during this period.
[2]
Compression device confirmation
Performance Criteria:
Compressed breast thickness accuracy: ± 5mm or less
Compression force accuracy (N): ±20N or less
Maximum compression force (N): 111N to 200N
7
Annual Test
If the item still results in [Fail], the source of the problem shall be identified and corrective
action shall be taken before any further examinations are performed with the system.
FDR Mammography QC Manual - 897N101461A
7-17
[3]
Viewing box maintenance
„ [Viewing box luminance] resulted in [Fail]
Performance Criteria: 3500 cd/m2 or more
0OINTSTOBECHECKED
s4HELUMINANCEMETERWASCORRECTLYUSED
s;CDM=ISSPECIFIEDASTHEUNITOFLUMINANCE
s4HELUMINANCEWASMEASUREDATTHECORRECTPOSITION
)FANYOFTHEABOVEISNOTCORRECTAPPROPRIATECORRECTTHEPROBLEM
2EDOTHETEST
0ASS
4HETESTISFINISHED
&AIL
#ONTACTADEALEROFTHEVIEWINGBOXMANUFACTURER
„ [Interpretation room illuminance (Ambient light)] resulted in [Fail]
Performance Criteria: 50 lx or less
0OINTSTOBECHECKED
s4HEILLUMINANCEMETERWASCORRECTLYUSED
s;LX=ISSPECIFIEDASTHEUNITOFILLUMINANCE
s4HEILLUMINANCEWASMEASUREDATTHECORRECTPOSITION
)FANYOFTHEABOVEISNOTCORRECTAPPROPRIATECORRECTTHEPROBLEM
2EDOTHETEST
0ASS
4HETESTISFINISHED
&AIL
)MPROVETHEVIEWINGCONDITION
7
Annual Test
7-18
FDR Mammography QC Manual - 897N101461A
7.5.2
Image Performance Test
1. Procedure
[Test flow]
The image performance test consists of the Additive lag effects (Lag), Multiplicative lag effects (Ghost),
Missed tissue on chest wall edge (40 mm height) and Visual and Functional test.
0ATIENTINFORMATIONENTRYANDEXPOSUREMENUSELECTION
!DDITIVELAGEFFECTS,AGEXPOSURE
-ULTIPLICATIVELAGEFFECTS'HOSTEXPOSURE
-ISSEDTISSUEONCHESTWALLEDGEMMHEIGHTEXPOSURE
6ISUALAND&UNCTIONALTESTCHECKING
1#3OFTWARESTARTUP
%XPOSURECONDITIONCONFIRMATION
-ISSEDTISSUEONCHESTWALLEDGEMMHEIGHTMEASUREMENT
-ISSEDTISSUEONCHESTWALLEDGEMMHEIGHTUSERINPUT
6ISUALAND&UNCTIONALTESTUSERINPUT
!UTOCALCULATION
4ESTRESULTCONFIRMATION
1#3OFTWARESHUTDOWN
As Missed tissue on chest wall edge (40 mm height) is not required in this QC program, the above Step “8. Missed
tissue on chest wall edge (40 mm height) (measurement)” can be skipped, but to satisfy the QC software input, Steps
“4. Missed tissue on chest wall edge (40 mm height) (exposure)” and “9. Missed tissue on chest wall edge (40 mm
height) (user input)” must be performed.
FDR Mammography QC Manual - 897N101461A
Annual Test
NOTE
7
7-19
2. Additive lag effects (Lag) (exposure)
1. Patient information entry and exposure
menu selection
1
4
Enter patient information and press [Next].
Follow the instructions below to conduct
the test item.
Make 2 exposures using the following exposure
submenus:
[ACR Phantom1(Lag)]
[Non Exposure(Lag)]
[Tools]
ACR Phantom
1. Position the ACR Phantom at the lateral
center of the exposure table while aligning
its edge with the chest wall-side edge of
the exposure table.
2. Remove the compression plate.
.IPPLESIDE
2
%XPOSURETABLE
Select [QC/TEST] in the exposure region
list and [Annual 1/6] in the exposure menu
list, and then press [Start study.].
!#20HANTOM
#HESTWALLSIDE
3
7
Annual Test
The following exposure submenus
displayed.
• ACR1: ACR Phantom1(Lag)
• NON: Non Exposure(Lag)
• UNI 1: Uniform Expo.1(Ghost)
• ACR 2: ACR Phantom2(Ghost)
• UNI 2: Uniform Expo.2(Ghost)
• 1ST40: 1Shot PhantomM(40mm)
are
3. Specify 28 kV, 56 mAs and Mo/Mo and
make an exposure in “Manu” mode.
• Fill in the following items in the worksheet.
kVp: ______kV
mAs: ______mAs
Target/Filter: ______/______
4. Place a lead sheet on the exposure
table, specify 23 kV, 2 mAs and Mo/Mo,
and then make an exposure in “Manu”
mode.
NOTE
Make exposures in Substeps 3 and 4
consecutively without much interval between
them to obtain high-quality results.
7-20
FDR Mammography QC Manual - 897N101461A
5. Remove the ACR Phantom.
3. Multiplicative lag effects (Ghost)
(exposure)
5
6. Specify 28 kV, 6.3 mAs and Mo/Mo and
make an exposure in “Manu” mode.
• Fill in the following items in the worksheet.
kVp: ______kV
mAs: ______mAs
Target/Filter: ______/______
Follow the instructions below to conduct
the test item.
Make 3 exposures using the following exposure
submenus:
[Uniform Expo.1(Ghost)]
[ACR Phantom2(Ghost)]
[Uniform Expo.2(Ghost)]
[Tools]
ACR Phantom
1. Remove the compression plate.
2. Specify 28 kV, 6.3 mAs and Mo/Mo and
make an exposure in “Manu” mode.
• Fill in the following items in the worksheet.
kVp: ______kV
mAs: ______mAs
Target/Filter: ______/______
3. Position the ACR Phantom on the righthand half of the exposure table while
aligning the edges with the lateral center
line and the chest wall-side edge of the
exposure table as shown in the figure
below.
NOTE
The ACR Phantom position differs from
the normal position used for the exposure.
Make sure that the phantom covers the
Calculation Area 2 without protruding into
the left-hand half of the exposure table.
.IPPLESIDE
%XPOSURETABLE
!#20HANTOM
MM
MM
6
Follow the instructions below to conduct
the test item.
Make an exposure using the following exposure
submenu:
[1Shot PhantomM(40mm)]
NOTE
This test is not required as part of this QC Program,
but you must make an exposure to satisfy the
QC software. Make an exposure using Exposure
Submenu [1Shot PhantomM(40mm above)] and
go to Step 7 .
[Tools]
1Shot Phantom and a jig for 1Shot Phantom
NOTE
The 1Shot Phantom must be positioned 40 mm
above the exposure table in this test. Use the jig to
position the Phantom at the specified height.
TIP
Use the same exposure conditions as
those used for the Phantom exposure in
the Daily/Weekly Test. See “3.4.3 Baseline
Values for Daily/Weekly Test” for details.
7
Annual Test
#ALCULATION!REAS
MMXMM
4. Missed tissue on chest wall edge
(40 mm height) (exposure)
#HESTWALLSIDE
4. Specify 28 kV, 56 mAs and Mo/Mo and
make an exposure in “Manu” mode.
• Fill in the following items in the worksheet.
kVp: ______kV
mAs: ______mAs
Target/Filter: ______/______
FDR Mammography QC Manual - 897N101461A
7-21
1. Position the 1Shot Phantom using the jig
above the exposure table.
NOTE
5. Visual and Functional test (Checking)
7
Position the Phantom by pressing the
corners against the chest wall-side edge of
the jig.
Follow the instructions below to conduct
the test item.
Check the following points and enter
the judgment results (Pass/Fail) in the
worksheet.
2. Move the compression plate as close to
the Phantom as possible without making
contact.
■ Items under [X-ray equipment test 2 - Visual
and Functional test] on the [Annual1-1] tab
•
•
•
•
TIP
Reinstall the compression plate removed
for the Multiplicative lag effects (Ghost)
test.
•
•
•
•
•
Verify mechanical stability
Verify that all moving parts move smoothly
All locks and detents work properly
No sharp, rough edges or other hazards
including electrical hazards
Operator technique control charts are
posted
Operator protected during exposure by
adequate radiation shielding
All indicator lights working properly
Auto decompression can be overridden
and status displayed
Compression can be manually released / in
any failure
NOTE
Beware that the jig does not overlap with
the measurement points of the Missed
tissue on chest wall edge.
7
Annual Test
3. Specify the exposure conditions closest
to those used for the 1Shot Phantom
exposure in the Daily/Weekly Test in
“Manu” mode and make an exposure.
• Fill in the following items in the worksheet.
kVp: ______kV
mAs: ______mAs
Target/Filter: ______/______
Compressed breast thickness:
_____mm
Compression force: _____N
6. QC Software startup
8
Press [QC] to display the “QC window”.
NOTE
It may take some time until you can press [QC]
after completing the exposure process.
7-22
FDR Mammography QC Manual - 897N101461A
7. Exposure condition confirmation
9
Check the exposure conditions.
11
Measure the missed tissue on the right
and left sides of the chest wall edge in the
output image.
The circles in Figure A indicate the measurement
points of missed tissue on chest wall edge.
Figure B shows the enlarged view of the
measurement points. Measure how much of
the points is reflected in the exposure image.
Use the same Pass/Fail judgment criteria as
those used for the Missed tissue on chest wall
edge measurement in the Daily/Weekly Test.
• Fill in the following items in the worksheet.
Missed tissue on chest wall edge (Right)
[mm]: Pass/Fail
Missed tissue on chest wall edge (Left)
[mm]: Pass/Fail
8. Missed tissue on chest wall edge (40 mm
height) (measurement)
The Missed tissue on chest wall edge (40
mm height) is not required as part of this QC
program, go to Step 12 .
10
Select the Exposure Submenu [1Shot
PhantomM(40mm)] from the exposure
condition display field and press [Film
output]. For performing image diagnosis
on a softcopy display, press [Network
output] to output the image to the
network.
A
B
FDR Mammography QC Manual - 897N101461A
#HESTWALLSIDE
7
Annual Test
MM
MM
MM
MM
MM
MM
MM
MM
MM
MM
7-23
9. Missed tissue on chest wall edge
(40 mm height) (user input)
12
Press [User input].
13
Select the [Annual1-1] tab and enter the
results (Pass/Fail).
If not measuring the Missed tissue on
chest wall edge (40 mm height), select
either of [Pass/Fail] and go to Step 14 .
11. Auto-calculation
15
Press
[Measurement
execution].
The
results are displayed at the bottom of the
window.
12. Test result confirmation
16
Check the displayed judgment results.
If there is a [Fail], see “7.5.1 3. Performance
Criteria and Corrective Action”.
13. QC Software shutdown
10. Visual and Functional test (user input)
14
17
Press [Save] and then [Close] to exit the
QC Software.
18
Select [Study completed] to finish the
test.
Select the results ([Pass/Fail]) and press
[OK].
7
Annual Test
NOTE
Make sure that the result is selected for all
items. If there is an item left unentered, an error
occurs.
7-24
FDR Mammography QC Manual - 897N101461A
2. Test Result Evaluation and Judgment
Evaluate and judge the results of the image performance test in the Annual Test. If all items are judged as
[Pass], the image performance test is finished. If there is an item judged as [Fail], take corrective actions by
following “7.5.2 3. Performance Criteria and Corrective Action”.
See “8.2 Quick Guide for Software Operation” for test log display procedure.
3. Performance Criteria and Corrective Action
[1]
Additive lag effects (Lag)
Performance Criteria: 75 QL or less
0OINTSTOBECHECKED
s4HECORRECTEXPOSURESUBMENUSWERESELECTED
s4HE8RAYEQUIPMENTSETTINGSTARGETFILTERK6PWERECORRECT
s4HEAIRKERMAUSEDFORTHEEXPOSURESWASAPPROPRIATE
s4HETESTWASDONEFOLLOWINGCORRECTPROCEDURE
s4HE!#20HANTOMWASCORRECTLYPOSITIONED
)FANYOFTHEABOVEISNOTCORRECTAPPROPRIATECORRECTTHEPROBLEM
2EDOTHETEST
0ASS
4HETESTISFINISHED
&AIL
#ONTACTA&5*)&),-DEALER
If the item still results in [Fail], the source of the problem shall be identified and corrective
action shall be taken within 30 days of the test date. Clinical imaging and mammographic
image interpretation may be continued during this period.
[2]
Multiplicative lag effects (Ghost)
7
Performance Criteria: Below 0.045
2EDOTHETEST
0ASS
Annual Test
0OINTSTOBECHECKED
s4HECORRECTEXPOSURESUBMENUSWERESELECTED
s4HE8RAYEQUIPMENTSETTINGSTARGETFILTERK6PWERECORRECT
s4HEAIRKERMAUSEDFORTHEEXPOSURESWASAPPROPRIATE
s4HETESTWASDONEFOLLOWINGCORRECTPROCEDURE
s4HE!#20HANTOMWASCORRECTLYPOSITIONED
)FANYOFTHEABOVEISNOTCORRECTAPPROPRIATECORRECTTHEPROBLEM
4HETESTISFINISHED
&AIL
#ONTACTA&5*)&),-DEALER
If the item still results in [Fail], the source of the problem shall be identified and corrective
action shall be taken within 30 days of the test date. Clinical imaging and mammographic
image interpretation may be continued during this period.
FDR Mammography QC Manual - 897N101461A
7-25
[3]
Missed tissue on chest wall edge (40 mm height)
This test is not required in this QC program.
[4]
Visual and Functional test
#ONTACTA&5*)&),-DEALER
7
Annual Test
7-26
FDR Mammography QC Manual - 897N101461A
7.5.3
Spatial Resolution Test
This test measures spatial resolution in magnification mode. For contact mode, spatial resolution
is measured and performed as a constancy test on a weekly basis by the QC technologist. See
section 4.5 of this QC program for details.
1. Procedure
[Test flow]
The spatial resolution test has only a single test item.
0ATIENTINFORMATIONENTRYANDEXPOSUREMENUSELECTION
3PATIAL2ESOLUTION-AGNIFICATIONEXPOSURE
1#3OFTWARESTARTUP
%XPOSURECONDITIONCONFIRMATION
!UTOCALCULATION
4ESTRESULTCONFIRMATION
1#3OFTWARESHUTDOWN
7
Annual Test
FDR Mammography QC Manual - 897N101461A
7-27
1. Patient information entry and exposure
menu selection
1
2. Spatial Resolution (Magnification)
(exposure)
Enter patient information and press [Next].
4
Follow the instructions below to conduct
the test item.
Make an exposure using the following exposure
submenu:
[1ShotM(Magnification)]
[Tools]
1Shot Phantom
1. Install the magnification table of the X-ray
equipment and the compression plate
normally used in magnified exposure in
clinical practice.
2
Select [QC/TEST] in the exposure region
list and [Annual 2/6] in the exposure menu
list, and then press [Start study.].
2. Position the 1Shot Phantom being shifted
to the right-hand side so that the area
indicated by the broken line in the below
figure is at the lateral center of the X-ray
field.
NOTE
Position the Phantom for exposure, the
same as in “3.4.1 Baseline Values for
Annual Test”.
3
7
Annual Test
7-28
The following exposure
displayed.
• 1ShotM(Magnification)
submenu
is
NOTE
If the area in the broken line is out of the Xray field when the Phantom is positioned by
pressing its corners against the chest wallside edge of the magnification table, shift
the Phantom to the front. Make sure that
the shifted Phantom is parallel to the chest
wall-side edge.
FDR Mammography QC Manual - 897N101461A
4. Exposure condition confirmation
6
NOTE
The Phantom position must be the same
for every exposure (the allowable positional
error is within ± 5 mm).
Check the exposure conditions.
5. Auto-calculation
7
• Fill in the following items in the worksheet.
Press
[Measurement
execution].
The
results are displayed at the bottom of the
window.
1 Shot Phantom position
Lateral shift distance: _____mm
3. Specify “Manu” mode for the X-ray
equipment and make an exposure under
the same exposure conditions as those
used in “3.4.1 Baseline Values for Annual
Test”.
• Fill in the following items in the worksheet.
kVp: ______kV
mAs: ______mAs
Target/Filter: ______/______
Compressed breast thickness: _____mm
Compression force: _____N
6. Test result confirmation
8
Check the displayed judgment results.
If there is a [Fail], see “7.5.2 3. Performance
Criteria and Corrective Action”.
7
It may take some time until you can press [QC]
after completing the exposure process.
9
Press [Save] and then [Close] to exit the
QC Software.
10
Select [Study completed] to finish the
test.
Annual Test
7. QC Software shutdown
NOTE
3. QC Software startup
5
Press [QC] to display the “QC window”.
FDR Mammography QC Manual - 897N101461A
7-29
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 “7.5.3 3. Performance Criteria and Corrective Action”.
See “8.2 Quick Guide for Software Operation” for test log display procedure.
3. Performance Criteria and Corrective Action
[5]
Spatial Resolution (Magnification)
Performance Criteria:
4lp/mm: Baseline value ± 12%
8lp/mm: Baseline value ± 15%
0OINTSTOBECHECKED
s4HECORRECTEXPOSURESUBMENUWASSELECTED
s4HE8RAYEQUIPMENTSETTINGSTARGETFILTERK6PWERECORRECT
s4HE3HOT0HANTOMWASCORRECTLYPOSITIONED
4HECALCULATIONAREAOFSPATIALRESOLUTIONISATTHECENTEROFTHE8RAYFIELD
4HE3HOT0HANTOMISPOSITIONEDINPARALLELWITHTHECHESTWALLSIDEOFTHE
MAGNIFICATIONTABLE
s4HECOMPRESSIONPLATEWASCORRECTLYPOSITIONED
)FANYOFTHEABOVEISNOTCORRECTAPPROPRIATECORRECTTHEPROBLEM
4HE3PATIAL2ESOLUTION32INTHE
$AILY7EEKLY4ESTHASBEEN
OCCASIONALLYJUDGEDASh&AILv
#HANGETHE3HOT0HANTOM
POSITIONANDREDOTHETEST
4HE3PATIAL2ESOLUTION32INTHE
$AILY7EEKLY4ESTHASBEEN
JUDGEDASh0ASSvINEVERYTEST
0ASS
4HETESTISFINISHED
&AIL
7
Annual Test
7-30
4HE8RAYEQUIPMENTMAYBEDEFECTIVE
#ONTACTA&5*)&),-DEALER
If the item still results in [Fail], the source of the problem shall be identified and corrective
action shall be taken within 30 days of the test date. Clinical imaging and mammographic
image interpretation may be continued during this period.
FDR Mammography QC Manual - 897N101461A
7.5.4
X-ray Equipment Performance Test
1. Procedure
[Test flow]
The X-ray equipment performance test consists of the kVp accuracy and reproducibility, Half Value
Layer (HVL), Collimation assessment and Radiation output.
TIP
In this test, conduct the three test items not requiring an X-ray image first and then enter their measured
values all at once to save time and simplify QC Software operation.
K6PACCURACYANDREPRODUCIBILITY
(ALF6ALUE,AYER(6,
2ADIATIONOUTPUT
0ATIENTINFORMATIONENTRYANDEXPOSUREMENUSELECTION
#OLLIMATIONASSESSMENTEXPOSURE
1#3OFTWARESTARTUP
%XPOSURECONDITIONCONFIRMATION
#OLLIMATIONASSESSMENTMEASUREMENT
K6PACCURACYANDREPRODUCIBILITYUSERINPUT
(ALF6ALUE,AYER(6,USERINPUT
#OLLIMATIONASSESSMENTUSERINPUT
!UTOCALCULATION
Annual Test
2ADIATIONOUTPUTUSERINPUT
7
4ESTRESULTCONFIRMATION
1#3OFTWARESHUTDOWN
FDR Mammography QC Manual - 897N101461A
7-31
6. Make exposures with the selected kVps
and measure the values by using a kVp
meter. In this Substep, make 5 exposures
with the middle kVp.
• Fill in the following items in the worksheet.
LFS - volt. Low: _____kV
LFS - volt. Mid.-1: _____kV
1. kVp accuracy and reproducibility
1
Follow the instructions below to conduct
the test item.
[Tools]
A kVp meter and lead sheet
1. Remove the compression plate.
LFS - volt. Mid.-2: _____kV
LFS - volt. Mid.-3: _____kV
2. Place a lead sheet on the exposure table,
and then position the kVp meter on the
sheet.
LFS - volt. Mid.-4: _____kV
LFS - volt. Mid.-5: _____kV
LFS - volt. High: _____kV
TIP
Position the X-ray detector of the kVp
meter at the lateral center of the exposure
table and near the chest wall-side edge.
The position must be the same for every
measurement for reproducibility.
7. Mount the magnification table of the X-ray
equipment and specify the Small Focal
Spot (SFS) for it.
NOTE
Measurement with the Small Focal Spot
(SFS) cannot be performed unless the
magnification table is used.
3. Select [QC/TEST] in the exposure region
list and [Calculation 1/2] in the exposure
menu list, and then press [Start study.].
8. Make exposures with the selected kVps
and measure the values by using a kVp
meter. In measurement with the Small
Focal Spot (SFS), make one exposure
with each kVp.
• Fill in the following items in the worksheet.
SFS - volt. Low: _____kV
SFS - volt. Mid.: _____kV
SFS - volt. High: _____kV
4. Specify the Large Focal Spot (LFS) and
“Manu” mode for the X-ray equipment
and select Mo/Mo for the target/filter.
NOTE
The “Semi” and “Auto” modes may not
work correctly for this measurement. Make
sure to use “Manu” mode for exposure.
7
Annual Test
5. Select 3 kVp values used for the
measurement.
• Fill in the following items in the worksheet.
kVp used for the tests
Low: _____kV
Mid.: _____kV
High: _____kV
TIP
Select the kVp most frequently used in
clinical practice, and the adjacent upper
and lower values (e.g. 25 kV, 28 kV, 31 kV).
2. Half Value Layer (HVL)
2
Following the instructions
conduct the test item.
below
to
[Tools]
A dosimeter, aluminum plates (0.3 and 0.5
mm), and a lead sheet
7-32
FDR Mammography QC Manual - 897N101461A
NOTE
Make the size of the X-ray field approximately
equal to that of the detector of dosimeter by
using a diaphragm (e.g. lead mask). If the size
cannot be reduced to that extent, make the Xray field as small as possible.
TIP
Position the aluminum plates within 300
mm away from the focal spot without using
the compression plate as shown below.
This may require careful effort.
3. Specify the kVp values for all the target/
filter combinations in “Manu” mode,
and calculate the mAs producing the air
kerma of 500 to 850 mR (≈ 4365 to 7420
µGy) without using an aluminum plate.
Then measure the air kerma for each
setting.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Entrance air kerma - w/o Al: _____mR
µGy
NOTE
The “Semi” and “Auto” modes may not
work correctly for this measurement. Make
sure to use “Manu” mode for exposure.
&OCALSPOT
MM
!DDITIONALFILTERS
!LUMINUMPLATESFORHALF
VALUELAYERMEASUREMENT
4. Position the 0.3 mm aluminum plate and
make an exposure under the condition
calculated in Substep 3 using each of the
kVp and target/filter to measure the air
kerma after the X-ray transmitted through
the plate.
• Fill in the following item in the worksheet.
Entrance air kerma – Al 0.3 mm: ____mR
µGy
$IAPHRAGM,EADMASK
$ETECTOROFTHEDOSIMETER
MM
%XPOSURETABLE
MM
1. Remove the compression plate.
2. Place a lead sheet on the exposure table,
and position the dosimeter at the lateral
center of the table, 60 mm away from the
chest wall-side edge, and also 40 mm
above the table.
%XPOSURETABLE
,ATERALCENTER
Wear gloves when using the aluminum
plate to keep it clean.
5. Position the 0.5 mm aluminum plate and
make an exposure under the condition
calculated in Substep 3 using each of the
kVp and target/filter to measure the air
kerma after the X-ray transmitted through
the plate.
• Fill in the following item in the worksheet.
Entrance air kerma – Al 0.5 mm: ____
7
Annual Test
.IPPLESIDE
NOTE
MM
$OSIMETERPOSITION
#HESTWALLSIDE
%XPOSURETABLE
MM
#HEST WALL SIDE
MM
.IPPLE SIDE
FDR Mammography QC Manual - 897N101461A
7-33
NOTE
3. Radiation output
3
A dosimeter allowing air kerma rate or
exposure time measurement is necessary.
Air kerma rate [mGy/s] can be calculated
from exposure time [s] as follows:
Air kerma rate [mGy/s] = air kerma [mGy] /
exposure time [s]
(1 mR = 8.73 × 10-3 mGy)
Follow the instructions below to conduct
the test item.
[Tools]
A dosimeter and lead sheet
1. Remove the compression plate.
2. Place a lead sheet on the exposure table,
and position the dosimeter at the lateral
center of the table, 60 mm away from the
chest wall-side edge, and also 40 mm
above the table.
.IPPLESIDE
5. Select [Study completed] to finish the
test.
4. Patient information entry and exposure
menu selection
4
Enter patient information and press [Next].
5
Select [QC/TEST] in the exposure region
list and [Annual 3/6] in the exposure menu
list, and then press [Start study.].
6
The following
displayed.
%XPOSURETABLE
,ATERALCENTER
MM
$OSIMETERPOSITION
#HESTWALLSIDE
%XPOSURETABLE
MM
#HEST WALL SIDE
MM
.IPPLE SIDE
3. Specify 28 kV, 56 mAs and Mo/Mo for
the X-ray equipment in “Manu” mode.
NOTE
7
Annual Test
7-34
The “Semi” and “Auto” modes may not work
correctly for this measurement. Make sure to
use “Manu” mode for exposure.
4. Make an exposure and measure the air
kerma, mAs and air kerma rate. In this
Substep, measure air kerma 5 times
under the same exposure conditions. If
the air kerma rate cannot be measured,
measure the exposure time for
calculating the air kerma rate.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Entrance air kerma (1): _____mR
µGy
Entrance air kerma (2): _____mR
µGy
Entrance air kerma (3): _____mR
µGy
Entrance air kerma (4): _____mR
µGy
Entrance air kerma (5): _____mR
µGy
Air kerma rate: _____mGy/s
(Exposure time: _____s)
exposure
submenu
• Uniform Expo.3(Collimation)
FDR Mammography QC Manual - 897N101461A
is
3. Specify 23 kV, 2 mAs and Mo/Mo and
make an exposure in “Manu” mode.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
5. Collimation assessment (exposure)
7
Follow the instructions below to conduct
the test item.
Make an exposure using the following
exposure submenus:
[Uniform Expo.3(Collimation)]
NOTE
Go to Step 12 when using the Image Reader,
which uses a cassette exclusively for
mammography, as well as the X-ray equipment.
A more detailed test can be conducted.
NOTE
[Tools]
NOTE
A coin
It may take some time until you can press [QC]
after completing the exposure process.
1. Attach a coin to the bottom surface of
the compression plate while aligning the
edge with the chest wall-side edge of the
plate.
The “Semi” and “Auto” modes may not
work correctly for this test. Make sure to
use “Manu” mode for exposure.
6. QC Software startup
8
Press [QC] to display the “QC window”.
7. Exposure condition confirmation
9
Check the exposure conditions.
2. Move the compression plate down onto
the exposure table.
7
NOTE
Take care that the compression plate is not
scratched by the coin.
FDR Mammography QC Manual - 897N101461A
10
Annual Test
8. Collimation assessment
(measurement)
Select
Exposure
Submenus
[Uniform
Expo.3(Collimation)] from the exposure
condition display field and press [Film
output]. For performing image diagnosis
on a softcopy display, press [Network
output] to output the image to the
network.
7-35
11
Visually check the gap between the image
and compression plate edge by using the
chest wall side as reference.
Observe the position of the Coin in the output
image and record the result.
Judgment
A part of Coin image is missing
→ Pass (no gap)
Coin is completely imaged
→ Fail (with gap)
A
&AIL
0ASS
NOTE
#OIN
#OIN
• Fill in the following item in the worksheet.
Compression plate edge (Chest wall
side as reference): Pass/Fail
Visual inspection result: Pass (no gap)/
Fail (with gap)
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
Substep 2.
2. Position 2 cassettes (Cassettes B1 and
B2, hereafter) over the exposure table by
aligning their chest wall-side edges.
#ASSETTE"
#ASSETTE"
The Medical Physicist may perform collimation
assessment using the methods that he/she
typically uses, then, go to Step 17 .
Steps 12 to 16 are the detailed test procedure
for the X-ray equipment and the FCR Image
Reader, which uses a cassette exclusively for
mammography.
7
5. Collimation assessment (exposure)
<details>
12
Annual Test
Follow the instructions below to conduct
the test item.
Make an exposure using the following
exposure submenus:
[Uniform Expo.3(Collimation)]
3. Turn on the light field lamp of the X-ray
equipment and position 4 coins (Coins
(b) to (e), hereafter) respectively on the 4
sides of the light field on the Cassettes
B1 and B2.
[Tools]
The same size 2 cassettes (no need to be
QC exclusive), a scale and 6 coins (familiar
sized)
NOTE
A cassette for general exposure cannot be
used.
1. Position a coin (Coin (a), hereafter) on
the exposure table while aligning the
edge with the chest wall-side edge of the
exposure table.
7-36
FDR Mammography QC Manual - 897N101461A
6. Specify 28 kV, 56 mAs and Mo/Mo and
make an exposure in “Manu” mode.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
,IGHTFIELD
C
D
E
B
NOTE
The “Semi” and “Auto” modes may not
work correctly for this test. Make sure to
use “Manu” mode for exposure.
NOTE
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
Be careful not to position the Coin (f) where
it overlaps with the Coins (a) to (e) or on the
boundary of the cassettes.
5. Move the compression plate down onto
the Cassettes B1 and B2.
14
Check the exposure conditions.
7
Annual Test
NOTE
Take care that the compression plate is not
scratched by the coins.
FDR Mammography QC Manual - 897N101461A
7-37
8. Collimation assessment
(measurement) <details>
15
16
Select
Exposure
Submenus
[Uniform
Expo.3(Collimation)] from the exposure
condition display field and press [Film
output]. For performing image diagnosis
on a softcopy display, press [Network
output] to output the image to the
network.
Output the images read from the 2
cassettes positioned on the exposure
table on film or on a softcopy display in
the same way.
Measure the values required for judging
the items below.
.IPPLESIDE
!D
!B
C
D
B
,EFT
E
F
!F
2IGHT
A
#HESTWALLSIDE
!E
!A
)MAGEREADFROM
THE&$2MAMMOGRAPHY
SYSTEM
2. Measure and record the distances
between the coins and the adjacent
edges of the X-ray field on the output
images read from Cassettes B1 and B2.
If a part of coin image is missing, measure
the length of the missing part.
8RAYFIELD
,IGHTFIELD
• X-ray/Light field gap (Right/Left, Chest/
Nipple) [mm]
• X-ray/Image receptor field gap (Right/Left/
Nipple) [mm]
!C
.IPPLESIDE
"C
C
D
B
,EFT
2IGHT
• Compression plate edge (Chest wall side)
1. Measure and record the distances
between the coins and the adjacent
edges of the output image. If a part of
coin image is missing, measure the
length of the missing part.
TIP
7
Annual Test
Coin (a) →
Positioned on the chest wall-side edge
of the exposure table.
Coins (b), (c), (d), (e) →
Positioned on the 4 sides of the light
field.
Coin (f) →
Positioned on the bottom chest wall-side
edge of the compression plate.
• Fill in the following items in the worksheet.
Coin (a) A-a: _____mm
Coin (b) A-b: _____mm
Coin (c) A-c: _____mm
Coin (d) A-d: _____mm
Coin (e) A-e: _____mm
Coin (f) A-f: _____mm
7-38
E
"E
F
"D
#HESTWALLSIDE
)MAGEREADFROM
#ASSETTE"
"B
"F
)MAGEREADFROM
#ASSETTE"
• Fill in the following items in the worksheet.
Coin (b) B-b: _____mm
Coin (c) B-c: _____mm
Coin (d) B-d: _____mm
Coin (e) B-e: _____mm
Coin (f) B-f: _____mm
3. Make a record of the [X-ray / Light field
gap (Right/Left, Chest/Nipple)].
TIP
The values measured for Coins (b) to (e) in
Substep 2 indicate the gap amount. Record
the values measured in Substep 2.
• Fill in the following items in the worksheet.
Left: B-d: _____mm
Right: B-b: _____mm
Chest wall: B-e: _____mm
Nipple side: B-c: _____mm
FDR Mammography QC Manual - 897N101461A
4. Calculate the X-ray/Image receptor field
gap (Right/Left/Nipple).
Observe how the coins are reflected
in the images read from the FDR
mammography system and Cassette
B1/B2 and judge which of the 4
examples the reflected images belong
to. Then calculate the gap by using the
corresponding formula.
TIP
When the X-ray field is inside of the image
receptor edge in the image read from the
FDR mammography system, as shown in
Eg: 1, the size of the gap can be determined
by measuring the distance (“x” in the figure)
from the image receptor edge to the X-ray
field.
TIP
TIP
Check the following coin images.
Left: Coin (d)
Right: Coin (b)
Nipple side: Coin (c)
Assign the value recorded in Substeps
1 and 2 for each coin to A and B in the
corresponding formula.
• Fill in the following items in the worksheet.
Left: _____mm
Right: _____mm
Nipple side: _____mm
FDR mammography
system
Cassette B1/B2
X-ray/Image
receptor field
gap X calculation
formula
Not needed.
The size of the
gap
can
be
calculated only
from the image
read from the FDR
mammography
system.
X=x
(Measure the
distance x of the
area not exposed
to X-rays in
the image read
from the FDR
mammography
system.)
)0
Eg: 1
!
X
8RAYFIELD
)0
X=A+B
Eg: 2
!
When the X-ray field is outside of the image
receptor edge in the image read from the
FDR mammography system as shown in
Egs: 2, 3 and 4, the size of the gap can
be calculated. Measure the distance “B”
between the image receptor edge and
that of Coin (on the chest wall-side edge)
and the distance “A” between the image
receptor edge and the edge of Coin (on the
light field) in the image read from Cassette
B, and the distance “X” between the edge of
Coin and X-ray field edge, and then assign
the measured values to the formula.
5. Calculate the X-ray field/exposure table
gap.
Observe how the coins are reflected
in the images read from the FDR
mammography system and Cassette B1/
B2 and judge which of the 3 examples
the reflected images belongs to. Then
calculate the size of the gap by using the
corresponding formula (If the calculated
value is a negative, derive the absolute
value).
"
TIP
Eg: 3
X=A-B
"
!
7
Annual Test
)0
Check the following coin images.
Chest wall: Coins (a) and (e)
Assign the value recorded in Substeps
1 and 2 for each coin to A and B in the
corresponding formula.
• Fill in the following item in the worksheet.
Chest: _____mm
)0
Eg: 4
X=B-A
!
"
FDR Mammography QC Manual - 897N101461A
7-39
FDR mammography
system
)0
8RAYFIELD
Eg: 1
Y
!A
#OINA
Cassette B1/B2
Not needed.
The size of
the gap can
be calculated
only from the
image read
from the FDR
mammography
system.
6. Visually check the gap between the
image and compression plate edge by
using the chest wall side as reference.
Observe the position of the Coin (f) in the
image read from the FDR mammography
system and record the result.
X-ray field/
exposure table
gap Y calculation
formula
Y=y
(Measure the
distance y
between the
edges of Coin (a)
and X-ray field in
the image read
from the FDR
mammography
system.)
Judgment
A part of Coin (f) image is missing →
Pass (no gap)
Coin (f) is completely reflected →
Fail (with gap)
Y=(A-e)-{(Aa)+(B-e)}
Eg: 2
!E
#OINE
!A
#OINA
Eg: 3
#OINE
"E
!E
#OINE
Y=(A-e)+{(B-e)(A-a)}
#OINF
#OINF
!A
#OINA
#OINE
• Fill in the following item in the worksheet.
Compression plate edge (Chest wall
side as reference): Pass/Fail
Visual inspection result: Pass (no gap)/
Fail (with gap)
TIP
When the X-ray field is inside of the image
receptor edge in the image read from the
FDR mammography system, as shown in
Eg: 1, the size of the gap can be determined
by measuring the distance (“y” in the figure)
from the image receptor edge to the X-ray
field.
TIP
7
Annual Test
7-40
&AIL
0ASS
"E
When the X-ray field is outside of the image
receptor edge in the image read from the
FDR mammography system as shown in
Egs: 2 and 3, the size of the gap can be
calculated. Measure the distance ”A-a”
between the image receptor edge and
that of Coin (a) (on the chest wall-side
edge) and the distance “A-e” between
the image receptor edge and the edge of
Coin (e) (on the light field) in the image read
from Cassette B, and the distance “B-e”
between the edge of Coin (e) and X-ray
field edge, and then assign the measured
values to the formula.
9. kVp accuracy and reproducibility (user
input)
17
Press [User input].
18
Select [Annual test 3-1].
Enter the display values and measured
values.
FDR Mammography QC Manual - 897N101461A
10. Half Value Layer (HVL) (user input)
19
Select [Annual Test 3-2].
Enter the measured entrance air kerma
for each target/filter.
12. Radiation output (user input)
21
NOTE
NOTE
Some dosimeters may require correction of the
measured value according to the beam quality.
Some dosimeters may require correction of the
measured value according to the beam quality.
NOTE
11. Collimation assessment (user input)
20
Enter the measured entrance air kerma,
mAs and air kerma rate, and then press
[OK].
Make sure that the values are entered for all
items. If there is an item left unentered, an error
occurs.
Select [Annual test 3-3]. Enter the
measured values and visual inspection
result (Pass/Fail).
13. Auto-calculation
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
value or significantly large one causes an error
to occur.
22
Press
[Measurement
execution].
The
results are displayed at the bottom of the
window.
7
23
FDR Mammography QC Manual - 897N101461A
Check the displayed judgment results.
If there is a [Fail], see “7.5.4 3. Performance
Criteria and Corrective Action”.
Annual Test
14. Test result confirmation
7-41
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
7-42
FDR Mammography QC Manual - 897N101461A
2. Test Result Evaluation and Judgement
Evaluate and judge the results of the X-ray equipment performance test in the Annual Test. If all items are
judged as [Pass], the test is finished. If there is an item judged as [Fail], take corrective actions by following
“7.5.4 3. Performance Criteria and Corrective Action”.
3. Performance Criteria and Corrective Action
[6]
kVp accuracy and reproducibility
Performance Criteria: Accuracy ± 1kVp, Reproducibility ± 0.5kVp
0OINTSTOBECHECKED
s4HEK6PMETERWASCORRECTLYPOSITIONED
s4HEK6PMETERWASCORRECTLYUSED
s4HE8RAYEQUIPMENTSETTINGSTARGETFILTERK6PANDM!SWERECORRECT
s4HEEXPOSUREWASAPPROPRIATE
)FANYOFTHEABOVEISNOTCORRECTAPPROPRIATECORRECTTHEPROBLEM
2EDOTHETEST
0ASS
4HETESTISFINISHED
&AIL
4HE8RAYEQUIPMENTMAYBEDEFECTIVE
#ONTACTA&5*)&),-DEALER
If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be
taken within 30 days of the test date.
[7]
Half Value Layer (HVL)
Performance Criteria: HVL > kVp/100
7
Annual Test
0OINTSTOBECHECKED
s4HEDOSIMETERWASCORRECTLYPOSITIONED
s4HEDOSIMETERWASCORRECTLYUSED
s4HE8RAYEQUIPMENTSETTINGSTARGETFILTERK6PANDM!SWERECORRECT
s4HEEXPOSUREWASAPPROPRIATE
s4HEUNITOFAIRKERMAM2OR«'YWASCORRECTLYUSED
s4HEALUMINUMPLATEUSEDHASTHESPECIFIEDPURITY
s4HEALUMINUMPLATETHICKNESSANDORPOSITIONWASCORRECTLYARRANGED
s4HEREARENOSCRATCHESORDIRTONTHEALUMINUMPLATE
)FANYOFTHEABOVEISNOTCORRECTAPPROPRIATECORRECTTHEPROBLEM
2EDOTHETEST
0ASS
4HETESTISFINISHED
&AIL
4HE8RAYEQUIPMENTMAYBEDEFECTIVE
#ONTACTA&5*)&),-DEALER
If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be
taken within 30 days of the test date.
FDR Mammography QC Manual - 897N101461A
7-43
[8]
Collimation assessment
Performance Criteria:
• Anterior edge of compression plate shall not appear on image, and shall not extend
beyond chest wall edge of the image receptor by more than 1% of SID.
• Collimation Total / Individual Gap Criteria = SID X 0.02 or less
Additonal performance criteria can be found on page 7-5.
0OINTSTOBECHECKED
s4HE8RAYEQUIPMENTSETTINGSTARGETFILTERK6PWERECORRECT
s4HECOINSWERECORRECTLYPOSITIONED
s4HEDISTANCESWEREMEASUREDATTHECORRECTPOSITION
s4HEUNITOFDISTANCEMMWASCORRECTLYUSED
)FANYOFTHEABOVEISNOTCORRECTAPPROPRIATECORRECTTHEPROBLEM
2EDOTHETEST
0ASS
4HETESTISFINISHED
&AIL
4HE8RAYEQUIPMENTMAYBEDEFECTIVE
#ONTACTA&5*)&),-DEALER
If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be
taken within 30 days of the test date.
[9]
Radiation output
Performance Criteria:
Variation coefficient = 0.05 or less, Air kerma rate = 7mGy/sec or more
7
Annual Test
0OINTSTOBECHECKED
s4HEDOSIMETERWASCORRECTLYPOSITIONED
s4HEDOSIMETERWASCORRECTLYUSED
s4HE8RAYEQUIPMENTSETTINGSTARGETFILTERK6PANDM!SWERECORRECT
s4HEEXPOSUREWASAPPROPRIATE
s4HEUNITOFAIRKERMAM2OR«'YWASCORRECTLYUSED
s4HEUNITOFAIRKERMARATEM'YSWASCORRECTLYUSED
)FANYOFTHEABOVEISNOTCORRECTAPPROPRIATECORRECTTHEPROBLEM
2EDOTHETEST
0ASS
4HETESTISFINISHED
&AIL
4HE8RAYEQUIPMENTMAYBEDEFECTIVE
#ONTACTA&5*)&),-DEALER
If the item still results in [Fail], the source of the problem shall be identified and corrective action shall be
taken within 30 days of the test date.
7-44
FDR Mammography QC Manual - 897N101461A
7.5.5
AEC System Performance Test
1. Procedure
[Test flow]
The AEC system performance test consists of AEC reproducibility, CNR mode 1, AGD mode 1, and AGD-ACR
Phantom.
The test items are intended to conduct constancy tests on the following items for checking the AEC
system performance.
Reproducibility of air kerma .................................... AEC reproducibility
Change in CNR to target thickness ....................... CNR mode 1
Change in AGD to target thickness ....................... AGD mode 1
AGD (standard breast phantom) ........................ AGD-ACR Phantom
TIP
In this test, specify the baseline values for CNR mode 1, conduct the two test items not requiring an
X-ray image, and then enter their measured values all at once to save time and simplify QC Software
operation.
7
Annual Test
FDR Mammography QC Manual - 897N101461A
7-45
[Tools]
PMMA phantom (40 mm)
4
Select [QC/TEST] in the exposure region
list and [Calculation 1/2] in the exposure
menu list, and then press [Start study.].
5
The following
displayed.
• CNR
[Exposure condition setting procedure]
1
Determine the exposure conditions used
in the test.
Position the PMMA phantom (40mm) on the
exposure table and the compression plate
45mm above the patient support.
2
Select [QC/TEST] in the exposure region
list and [Calculation 1/2] in the exposure
menu list, and then press [Start study.].
Select H-mode under “Auto” mode for the
X-ray equipment and make an exposure.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
exposure
submenu
is
2. CNR mode 1 (exposure)
[Tools]
PMMA phantom (40 mm) and aluminum
plate (0.2 mm) for CNR measurement
6
7
Annual Test
7-46
Position the PMMA phantom (40mm) on
the exposure table.
1. Patient information entry and exposure
menu selection
3
Enter patient information and press [Next].
FDR Mammography QC Manual - 897N101461A
7
Position the 0.2 mm aluminum plate for
CNR measurement as shown in the figure
below.
3. QC Software startup
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.
.IPPLESIDE
0--!
#ALCULATION!REAS
MMXMM
MM
4. Exposure condition confirmation
11
Check the exposure conditions.
!LUMINUMPLATE
MM
#HESTWALLSIDE
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.
!LUMINUMPLATE
Specify the exposure conditions closest
to those recorded in Step 2 in “Manu”
mode. Then make an exposure.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
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].
7
Annual Test
9
5. Auto-calculation
NOTE
It may take some time until you can press [QC]
after completing the exposure process.
FDR Mammography QC Manual - 897N101461A
7-47
6. Baseline value setting
14
Select the result calculated in Step 12 ,
and then press [Baseline value creation].
This completes the baseline value setting.
Press [Close].
2. Position the dosimeter aside the PMMA
phantom (40 mm) as shown in the figure
below.
NOTE
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
15
7
16
Press [Save] and then [Close] to exit the
QC Software.
Select [Study completed] to finish the test.
Annual Test
8. AEC reproducibility
17
Follow the instructions below to conduct
the test item.
[Tools]
A dosimeter and PMMA phantom (40 mm)
1. Position the PMMA phantom (40 mm) on
the exposure table.
NOTE
Position the PMMA phantom (40 mm) on
the exposure table leaving a space on a
side.
7-48
In the AEC reproducibility test, the
dosimeter position differs since the air
kerma is measured under the “Semi” mode.
Position the dosimeter where it does not
affect the AEC function but receives the
X-ray exposure.
See “FDR MS-1000 Operation Manual”
for details on the AEC areas.
3. Move the compression plate as close to
the PMMA phantom as possible without
making contact.
4. Select [QC/TEST] in the exposure region
list and [Calculation 1/2] in the exposure
menu list, and then press [Start study.].
5. Specify the kVp and target/filter to be used
(28 kV and Mo/Mo is recommended) for
the exposure in “Semi” mode.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
6. Make 5 exposures and measure the air
kerma.
• Fill in the following items in the worksheet.
Entrance air kerma (1): _____mR
µGy
Entrance air kerma (2): _____mR
µGy
Entrance air kerma (3): _____mR
µGy
Entrance air kerma (4): _____mR
µGy
Entrance air kerma (5): _____mR
µGy
FDR Mammography QC Manual - 897N101461A
9. AGD mode 1
18
Follow the instructions below to conduct
the test item.
[Tools]
PMMA phantoms (20, 40, 60 and 70 mm),
aluminum plates (0.3 and 0.5 mm) for half
value layer measurement, a dosimeter, and
a lead sheet
1. Position the PMMA phantom (20 mm) on
the exposure table.
4. Using PMMA phantoms 60 mm and 70
mm, repeat the operation described in
Substeps 1 to 3. For these thicknesses, the
compression plate should be positioned
at 75mm and 90mm, respectively, above
the exposure table.
TIP
The exposure conditions for the PMMA
phantom 40 mm has been determined
in Step 2 . Enter the conditions in the
worksheet.
• Fill in the following items in the worksheet.
PMMA phantom 40 mm exposure
conditions
kVp: _____kV
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
2. Position the compression plate 21mm
above the exposure table.
3. Make an exposure in H-mode under
“Auto” mode.
• Fill in the following items in the worksheet.
PMMA phantom 20 mm exposure
conditions
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
PMMA phantom 60 mm exposure
conditions
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
PMMA phantom 70 mm exposure
conditions
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
.IPPLESIDE
Annual Test
5. Remove the PMMA phantom, place a
lead sheet on the exposure table, and
then position the dosimeter as shown in
the figure below.
7
%XPOSURETABLE
,ATERALCENTER
MM
$OSIMETERPOSITION
#HESTWALLSIDE
%XPOSURETABLE
MM
#HESTWALLSIDE
FDR Mammography QC Manual - 897N101461A
MM
.IPPLESIDE
7-49
6. Move the compression plate as close to
the dosimeter as possible without making
contact.
NOTE
Wear gloves when using the aluminum
plate to keep it clean.
NOTE
NOTE
Do not reposition the compression plate
during measurement.
Make sure that the aluminum plate covers
the detector of the dosimeter from the
above.
10. Make an exposure with the exposure
conditions used in Substep 7 and
measure the air kerma.
• Fill in the following item in the worksheet.
Entrance air kerma – Al 0.3 mm:
_____mR
µGy
11. Position the 0.5 mm aluminum plate for
half value layer measurement in the same
way.
7. Specify “Manu” mode for the X-ray
equipment and make an exposure under
exposure conditions for the PMMA
phantom 20 mm recorded in Substep 3.
If the mAs value determined in Substep 3
cannot be applied, specify the closest
applicable value.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
12. Make an exposure with the exposure
conditions used in Substep 7 and
measure the air kerma.
• Fill in the following item in the worksheet.
Entrance air kerma – Al 0.5 mm:
_____mR
µGy
13. Repeat the operation described in
Substeps 7 to 12 using the exposure
conditions determined in Substep 4 for
PMMA phantoms 40 mm, 60 mm and 70
mm to measure and record the air kerma.
14. Select [Study completed] to finish the test.
NOTE
7
Annual Test
7-50
The “Semi” and “Auto” modes may not
work correctly for this measurement. Make
sure to use “Manu” mode for exposure.
8. Make an exposure and measure the air
kerma.
• Fill in the following item in the worksheet.
Entrance air kerma - w/o Al: _____mR
µGy
9. Position the 0.3 mm aluminum plate
for half value layer measurement on the
compression plate.
FDR Mammography QC Manual - 897N101461A
22
10. Patient information entry and
exposure menu selection
19
The procedure for testing CNR mode 1 is
described below.
Make 4 exposures using the following exposure
submenus:
[H-mode CNR(PMMA20mm)]
[H-mode CNR(PMMA40mm)]
[H-mode CNR(PMMA60mm)]
[H-mode CNR(PMMA70mm)]
Enter patient information and press [Next].
[Tools]
PMMA phantoms (20, 40, 60, 70 mm)
and aluminum plate (0.2 mm) for CNR
measurement
TIP
In CNR mode 1, use the same H-mode of the
AEC as that used in AGD mode 1.
11. CNR mode 1 (exposure)
20
Select [QC/TEST] in the exposure region
list and [Annual 4/6] in the exposure menu
list, and then press [Start study.].
NOTE
Wear gloves when using the aluminum plate to
keep it clean.
1. Position the PMMA phantom (20 mm) on
the exposure table.
2. Position the 0.2 mm aluminum plate
for CNR measurement as shown in the
figure below.
.IPPLESIDE
0--!
#ALCULATION!REAS
MMXMM
21
The following
displayed.
submenus
HCN20: H-mode CNR(PMMA20mm)
HCN40: H-mode CNR(PMMA40mm)
HCN60: H-mode CNR(PMMA60mm)
HCN70: H-mode CNR(PMMA70mm)
FDR Mammography QC Manual - 897N101461A
are
MM
MM
7
#HESTWALLSIDE
NOTE
Make sure that the aluminum plate covers
the Calculation Area 2 without protruding
into the left-hand half of the phantom.
Annual Test
•
•
•
•
exposure
!LUMINUMPLATE
7-51
3. Move the compression plate as close to
the PMMA phantom as possible without
making contact.
12. QC Software startup
23
Press [QC] to display the “QC window”.
13. Exposure condition confirmation
24
Check the exposure conditions.
25
Press [User input].
!LUMINUMPLATE
4. Specify the exposure conditions for
PMMA phantom 20 mm determined
in Substep 3 of the AGD mode 1 test
procedure. Then make an exposure in
“Manu” mode.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
NOTE
The “Semi” and “Auto” modes may not
work correctly for this measurement. Make
sure to use “Manu” mode for exposure.
7
Annual Test
5. Using PMMA phantoms 40 mm, 60
mm and 70 mm, repeat the operation
described in Substeps 1 to 4. Use the
exposure conditions for the PMMA
phantom of each thickness determined
in Substep 4 of the AGD mode 1 test
procedure.
14. AEC reproducibility (user input)
26
Select [Annual test 4-1].
measured entrance air kerma.
Enter
the
NOTE
It may take some time until you can press [QC]
after completing the exposure process.
7-52
FDR Mammography QC Manual - 897N101461A
15. AGD mode 1 (user input)
27
Select [Annual Test 4-2]. Enter the measured
entrance air kerma and target/filter for each,
and then press [OK].
17. Test result confirmation
29
Check the displayed judgment results.
If there is a [Fail], see “7.5.4 3. Performance
Criteria and Corrective Action”.
NOTE
Some dosimeters may require correction of the
measured value according to the beam quality.
18. QC Software shutdown
30
Press [Save] and then [Close] to exit the
QC Software.
31
Select [Study completed] to finish the
test.
NOTE
Make sure that the values are entered for all
items. If there is an item left unentered, an error
occurs.
16. Auto-calculation
28
Press
[Measurement
execution].
The
results are displayed at the bottom of the
window.
7
Annual Test
FDR Mammography QC Manual - 897N101461A
7-53
ACR phantom, aluminum plates (0.3 and 0.5 mm),
a dosimeter and a lead sheet.
6. Make an exposure with the exposure
conditions used in Step 29 and measure
the air kerma.
• Fill in the following item in the worksheet.
Entrance air kerma - w/o Al: _____
1. Select [QC/TEST] in the exposure region
list and [Calculation 2/2] in the exposure
menu list, and then press [Start study].
7. Position the 0.3 mm aluminum plate on
the compression plate so that it covers the
detector of the dosimeter..
19. AGD - ACR Phantom
[Tools]
32
8. Make an exposure with the exposure
conditions used in Step 29 and measure
the air kerma.
• Fill in the following item in the worksheet.
Entrance air kerma - Al 0.3mm: _____
2. Select H-mode under “Auto” mode for the
X-ray equipment and make an exposure
of the ACR phantom.
• Fill in the following items in the worksheet.
kVp: _____kV
mAs: _____mAs
Target/Filter: _____/_____
Compressed breast thickness: _____mm
Compression force: _____N
9. Position the 0.5 mm aluminum plate on
the compression plate so that it covers the
detector of the dosimeter.
10. Make an exposure with the exposure
conditions used in Step 29 and measure
the air kerma.
• Fill in the following item in the worksheet.
Entrance air kerma - Al 0.5mm: _____
3. Remove the ACR phantom and cover the
exposure table with the lead sheet.
4. Position the dosimeter at the lateral center
of the exposure table, 60 mm away from
the chest wall-side edge, and also 40 mm
above the table.
33
Enter patient information and press [Next].
34
Select [QC/TEST] in the exposure region list
and [Calculation 2/2] in the exposure menu
list, and then press [Start study.].
.IPPLESIDE
%XPOSURETABLE
,ATERALCENTER
MM
$OSIMETERPOSITION
7
#HESTWALLSIDE
%XPOSURETABLE
MM
Annual Test
#HEST WALL SIDE
MM
.IPPLE SIDE
5. Move the compression plate as close to
the dosimeter as possible without making
contact.
NOTE: Do not reposition the compression plate
during measurement.
7-54
FDR Mammography QC Manual - 897N101461A
35
Make an exposure under any conditions (e.g.
23 kV, 2 mAs and Mo/Mo) to start up the QC
Software.
39
Press [Measurement execution]. The results
are displayed at the bottom of the window.
40
Confirm that the calculation result does
not exceed 3mGy. If it does, see “7.5.4.3.
Performance Criteria and Corrective Action”.
41
Press [Save] and then [Close] to exit the QC
Software.
42
Select [Study completed] to finish the test.
43
To complete MEE / Annual tesing, please
perform Sections 4-5 and 4-6 in Chapter 4 of
this QC Manual.
NOTE
It may take some time until you can press [QC] after
completing the exposure process.
36
Press [QC] to display the “QC window”.
37
Press [User input].
38
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.
7
Annual Test
FDR Mammography QC Manual - 897N101461A
7-55
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 “7.5.5 3. Performance Criteria and Corrective Action”.
See “8.2 Quick Guide for Software Operation” for test log display procedure.
3. Performance Criteria and Corrective Action
[10] AEC reproducibility
Performance Criteria: Variation coefficient = 0.05 or less
0OINTSTOBECHECKED
s4HEDOSIMETERWASCORRECTLYPOSITIONED
s4HEDOSIMETERWASCORRECTLYUSED
s4HE8RAYEQUIPMENTSETTINGSTARGETFILTERK6PWERECORRECT
s4HEUNITOFAIRKERMAM2OR«'YWASCORRECTLYUSED
)FANYOFTHEABOVEISNOTCORRECTAPPROPRIATECORRECTTHEPROBLEM
2EDOTHETEST
0ASS
4HETESTISFINISHED
&AIL
4HE8RAYEQUIPMENTMAYBEDEFECTIVE
#ONTACTA&5*)&),-DEALER
If the item still results in [Fail], the source of the problem shall be identified and corrective
action shall be taken within 30 days of the test date.
7
Annual Test
7-56
FDR Mammography QC Manual - 897N101461A
[11] CNR mode 1
Performance Criteria:
CNR Relative Value 20mm [%] = 105% of baseline value or more
CNR Relative Value 40mm [%] = 95% of baseline value or more
CNR Relative Value 60mm [%] = 63% of baseline value or more
CNR Relative Value 70mm [%] = 60% of baseline value or more
0OINTSTOBECHECKED
s4HECORRECTEXPOSURESUBMENUSWERESELECTED
s4HE8RAYEQUIPMENTSETTINGSTARGETFILTERK6PWERECORRECT
s4HEEXPOSURESWEREMADEINTHECORRECTORDER
s4HEALUMINUMPLATEUSEDHASTHESPECIFIEDPURITY
s4HEALUMINUMPLATETHICKNESSANDORPOSITIONWASCORRECTLYARRANGED
s4HEREARENOSCRATCHESORDIRTONTHEALUMINUMPLATE
)FANYOFTHEABOVEISNOTCORRECTAPPROPRIATECORRECTTHEPROBLEM
4HE#.2INTHE$AILY7EEKLY
4ESTHASBEENJUDGEDAS;0ASS=INEVERYTEST
2EDOTHETEST
2UN;#ALCULATION=ANDTHENCALCULATETHERATIOOF
THE#.2OFEACH0--!PHANTOMTHICKNESSTOTHE
BASELINEVALUEBYUSINGACALCULATORANDTHENJUDGE
THERESULT
0ASS
4HETESTISFINISHED
&AIL
4HE8RAYEQUIPMENTMAYBEDEFECTIVE
#ONTACTA&5*)&),-DEALER
If the item still results in [Fail], the source of the problem shall be identified and corrective
action shall be taken within 30 days of the test date.
7
Annual Test
FDR Mammography QC Manual - 897N101461A
7-57
[12] AGD mode 1
Performance Criteria:
AGD 20mm [mGy] = 1 mGy or less
AGD 40mm [mGy] = 2 mGy or less
AGD 60mm [mGy] = 4.5 mGy or less
AGD 70mm [mGy] = 6.5 mGy or less
[13] AGD - ACR Phantom
Performance Criteria:
AGD-ACR Phantom [mGy] = 3 mGy or less
0OINTSTOBECHECKED
s4HEDOSIMETERWASCORRECTLYPOSITIONED
s4HEDOSIMETERWASCORRECTLYUSED
s4HE8RAYEQUIPMENTSETTINGSTARGETFILTERK6PWERECORRECT
s4HEUNITOFAIRKERMAM2OR«'YWASCORRECTLYUSED
s4HEALUMINUMPLATEUSEDHASTHESPECIFIEDPURITY
s4HEALUMINUMPLATETHICKNESSANDORPOSITIONWASCORRECTLYARRANGED
s4HEREARENOSCRATCHESORDIRTONTHEALUMINUMPLATE
)FANYOFTHEABOVEISNOTCORRECTAPPROPRIATECORRECTTHEPROBLEM
#HECKTHERESULTOF!%#REPRODUCIBILITYTEST
0ASS
2EDOTHETEST
4HE8RAYEQUIPMENTMAYBEDEFECTIVE
0ASS
4HETESTISFINISHED
&AIL
7
Annual Test
7-58
&AIL
#ONTACTA&5*)&),-DEALER
4HE8RAYEQUIPMENTMAYBEDEFECTIVE
#ONTACTA&5*)&),-DEALER
If the item still results in [Fail], the source of the problem shall be identified and corrective
action shall be taken before any further examinations are performed with the system.
FDR Mammography QC Manual - 897N101461A
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
8
Assistance Material
FDR Mammography QC Manual - 897N101461A
8-1
8.1
Calculation Functions
The CNR and AGD of PMMA phantom at a given thickness can be auto-calculated by
the QC Software.
Items Auto-calculated and Judged Based on Input Data
Test Items
Exposure Menus
Exposure Submenus
1. Exposure
CNR
Calculation 1/2
CNR
AGD
Calculation 2/2
AGD
2. Input Values
✓
✓
The measurement procedure of each item is described below.
[1]
CNR
3
The following
displayed.
• CNR
4
Position the PMMA phantom of the
desired thickness to be measured and
0.2 mm aluminum plate as shown in the
figure below.
[Tools]
exposure
submenu
is
PMMA phantom (of a given thickness) and
aluminum plate (0.2 mm)
1
Enter patient information and press [Next].
NOTE
Make sure that the aluminum plate covers the
Calculation Area 2 without protruding into the
left-hand half of the phantom.
2
Select [QC/TEST] in the exposure region
list and [Calculation 1/2] in the exposure
menu list, and then press [Start study.].
.IPPLESIDE
0--!
#ALCULATION!REAS
MMXMM
MM
8
!LUMINUMPLATE
MM
#HEST WALL SIDE
NOTE
Assistance Material
Wear gloves when using the aluminum plate to
keep the plate clean.
8-2
FDR Mammography QC Manual - 897N101461A
5
Move the compression plate as close to
the PMMA phantom as possible without
making contact.
10
Check the calculation result.
11
Press [Save] and then [Close] to exit the
QC Software.
12
Select [Study completed] to finish the
test.
!LUMINUMPLATE
6
Specify the exposure conditions 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.
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.
8
Assistance Material
FDR Mammography QC Manual - 897N101461A
8-3
[2]
AGD
5
Position the 0.3 mm aluminum plate on
the compression plate.
[Tools]
NOTE
A dosimeter and aluminum plates (0.3 and 0.5
mm)
Wear gloves when using the aluminum plate to
keep the plate clean.
1
Position the dosimeter at the lateral center
of the exposure table, 60 mm away from
the chest wall-side edge, and also 40 mm
above the table.
.IPPLESIDE
NOTE
Make sure that the aluminum plate covers the
detector of the dosimeter from the above.
6
Make an exposure with the exposure
conditions used in Step 3 and measure
the air kerma.
7
Position the 0.5 mm aluminum plate in the
same way.
8
Make an exposure with the exposure
conditions used in Step 3 and measure
the air kerma.
9
Enter patient information and press [Next].
10
Select [QC/TEST] in the exposure region
list and [Calculation 2/2] in the exposure
menu list, and then press [Start study.].
%XPOSURETABLE
,ATERALCENTER
MM
$OSIMETERPOSITION
#HESTWALLSIDE
%XPOSURETABLE
MM
#HEST WALL SIDE
2
MM
.IPPLE SIDE
Move the compression plate as close to
the dosimeter as possible without making
contact.
NOTE
Do not reposition the compression plate during
measurement.
8
3
Assistance Material
Specify the desired exposure conditions
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
8-4
Record the air kerma.
FDR Mammography QC Manual - 897N101461A
11
12
The following
displayed.
• AGD
exposure
submenu
is
16
Press
[Measurement
execution].
The
results are displayed at the bottom of the
window.
17
Check the calculation result.
18
Press [Save] and then [Close] to exit the
QC Software.
19
Select [Study completed] to finish the
test.
Make an exposure under any conditions
(e.g. 23 kV, 2 mAs and Mo/Mo) to start up
the QC Software.
NOTE
It may take some time until you can press [QC]
after completing the exposure process.
13
Press [QC] to display the “QC window”.
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.
8
Assistance Material
FDR Mammography QC Manual - 897N101461A
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.
„ Basic Procedure
1
Starting FUJIFILM workstation
Start a FUJIFILM workstation and enter
patient information, and then press
[Next].
!UTOCALCULATESTHERESULTBASEDON
ENTEREDIMAGEANDVALUESAND
DISPLAYS;0ASS&AIL=JUDGMENT
2
3
Exposure
Make an exposure using all
displayed exposure submenus.
4
Starting QC Software
Press [QC].
5
Main button operations in “QC window”
8
Assistance Material
8-6
Starting QC test
Select [QC/TEST] in the exposure region
list and an exposure submenu displayed
in the exposure menu list, and then press
[Start study.].
of
3AVESTHESTUDY
RESULTS
1UITSTHE
1#3OFTWARE
/UTPUTSANIMAGE
FORVISUAL
INSPECTION
6
$ISPLAYSTHEUSERINPUT
SCREENFORTHEMEASUREMENT
ANDVISUALINSPECTIONRESULTS
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.
the
FDR Mammography QC Manual - 897N101461A
„ Log Confirmation Procedure
1
Starting FUJIFILM workstation
Start a FUJIFILM workstation and enter
patient information, and then press
[Next].
4
Main button operations in “Test Data Log
window”
3WITCHESTHEGRAPHDISPLAYSCALE
3WITCHESTHENUMBER
OFLOGSDISPLAYEDIN
THEGRAPH
3WITCHESINFORMATION
DISPLAYEDINTHETEST
ITEMFIELDBETWEEN
MEASUREDVALUESAND
JUDGMENTRESULTS
$ISPLAYSEXPOSURE
CONDITIONS
2
#REATESBASELINE
VALUES
Starting QC test
Select [QC/TEST] in the exposure region
list and press [Start study.] without
selecting an exposure submenu.
/UTPUTSTHETESTRESULTINTOA#36FILE
5
3
Finishing the test
Press [Close] and then [Study completed]
to finish the test.
Starting QC Software
Press [QC].
8
Assistance Material
FDR Mammography QC Manual - 897N101461A
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 Manual - 897N101461A
Baseline Value Settings
<Baseline Values for Annual Test>
Test Items
Steps
5
[5] Spatial Resolution
(Magnification)
6
Exposure Conditions/Measurement and Judgment Results
1Shot Phantom position
Exposure conditions for
Exposure Submenu
[1ShotM(Magnification)]
Purposes
Lateral shift distance:
mm
kVp:
kV
mAs:
mAs
Target/Filter:
/
Compressed breast thickness:
mm
Compression force:
Phantom positioning in
Annual Test
Exposure condition
confirmation ( 8 )
N
<Baseline Values for Semi-annual Test>
Test Items
[1] Image Basic Test
Steps
Exposure Conditions/Measurement and Judgment Results
1
mAs
2
Air kerma
7
Exposure conditions for
Exposure Submenu [Uniform
Expo(Image Basic)]
Input Steps
mAs
mR
µGy
mR
µGy
mR
µGy
kVp:
kV
mAs:
mAs
Target/Filter:
/
Exposure condition
determination ( 7 )
Result input (
10 )
Exposure condition
confirmation ( 9 )
White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8.
Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired
automatically.)
[1]
8
Assistance Material
FDR Mammography QC Manual - 897N101461A
8-9
<Baseline Values for Weekly Test>
Test Items
Steps
Exposure Conditions/Measurement and Judgment Results
Purposes
kVp:
kV
mAs:
[1] Test with 1Shot
Phantom
6
1Shot Phantom exposure
conditions
Target/Filter:
mAs
/
Compressed breast thickness:
mm
Compression force:
N
kVp:
8
[2] Test with ACR
Phantom
Exposure conditions for
Exposure Submenu
[ACR Phantom]
kV
mAs:
Target/Filter:
Compressed breast thickness:
Compression force:
Exposure condition
confirmation ( 8 )
mAs
/
mm
Exposure condition
confirmation ( 10 )
N
Density inside the disk
12
Result input (
Density outside the disk
14 )
White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8.
Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired
automatically.)
[2]
[1]
8
Assistance Material
8-10
FDR Mammography QC Manual - 897N101461A
<Weekly Test>
Test Items
Steps
Exposure Conditions/Measurement and Judgment Results
Purposes
kVp:
[1] Test with 1Shot
Phantom
4 -3
Exposure conditions for
Exposure Submenu
[1Shot PhantomM]
kV
mAs:
mAs
Target/Filter:
/
Compressed breast thickness:
mm
Compression force:
[2] Good practice
[1] Test with 1Shot
Phantom
N
5 -1
X-ray equipment cleanliness
Pass
Fail
5 -2
Screen cleanliness
Pass
Fail
5 -3
Viewing box cleanliness
Pass
Fail
Distortion
Pass
Fail
Artifact
Pass
Fail
9
4 -5
Exposure conditions for
Exposure Submenu
[ACR Phantom]
kVp:
kV
mAs:
mAs
Target/Filter:
Compressed breast thickness:
Compression force:
Exposure condition
confirmation ( 7 )
Result input (
11 )
Result input (
10 )
Exposure condition
confirmation ( 7 )
/
mm
N
Density at center of Phantom image
Density inside the disk
[3] Test with ACR
Phantom
Density outside the disk
8
Fibers (ACR Phantom)
points
Specks (ACR Phantom)
points
Masses (ACR Phantom)
points
Visible step wedge (Step
Phantom)
Result input (
10 )
steps
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]
8
Assistance Material
FDR Mammography QC Manual - 897N101461A
8-11
Semi-annual Test
Test Items
[1] Compression
device
confirmation
Steps
1 -4
Exposure Conditions/Measurement and Judgment Results
Automatic
Compression
Date:
Measured
value:
lbs.
Acceptance Limits
Automatic (25 45 lbs)
PASS
FAIL
Corrective Action
needed ?
YES
NO
YES
NO
PASS
FAIL
Corrective Action
description
Corrective Action
taken?
Corrective Date:
Results of new
test
1 -7
Manual
Compression
Date:
Measured
lbs.
value:
Comments _______________________________________________________________________________________________________________
_________________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________________
White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8.
8
Assistance Material
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FDR Mammography QC Manual - 897N101461A
Annual Test (Initial Performance Test)
Test Items
Steps
1 -3
Exposure Conditions/Measurement and Judgment Results
Exposure conditions for
Exposure Submenu [Uniform
Expo(Image Basic)]
kV
mAs:
mAs
Target/Filter:
5
Exposure conditions for
Exposure Submenu [Uniform
Expo(Image Basic)]
/
mR
µGy
Air kerma
[1] Image Basic Test
Purposes
kVp:
mR
µGy
mR
µGy
kVp:
kV
mAs:
mAs
Target/Filter:
/
Exposure condition
determination ( 9 )
Result input (
13 )
Exposure condition
confirmation ( 9 )
Artifact
Pass
Fail
Result input (
13 )
White out
Pass
Fail
Result input (
13 )
Result input (
14 )
Result input (
15 )
11
6 -2, 3
[2] Compression device
confirmation
[3] Viewibox maintenance
Compressed breast thickness
Display value:
mm
Measured value:
mm
Display value:
mm
6 -5
Compression force
6 -6
Compression force sustainability
6 -7
Maximum compression force
7 -2
Luminance
7 -3
Viewing box uniformity
Pass
Fail
7 -4
Luminance adjustment function
Pass
Fail
7 -5
Masking
Pass
Fail
7 -6
Interpretation room illuminance
(Ambient light)
Measured value:
Pass
mm
Fail
N
cd/m2
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
FDR Mammography QC Manual - 897N101461A
8-13
Annual Test (Image Performance Test)
Test Items
Steps
Exposure Conditions/Measurement and Judgment Results
Purposes
kVp:
[1] Additive lag effects
(Lag)
4 -3
Exposure conditions for Exposure Submenu
[ACR Phantom1(Lag)]
kV
mAs:
mAs
Target/Filter:
5 -2
Exposure conditions for Exposure Submenu
[Uniform Expo.1(Ghost)]
/
kVp:
kV
mAs:
mAs
Target/Filter:
/
kVp:
[2] Multiplicative lag
effects (Ghost)
5 -4
Exposure conditions for Exposure Submenu
[ACR Phantom2(Ghost)]
kV
mAs:
mAs
Target/Filter:
5 -6
Exposure conditions for Exposure Submenu
[Uniform Expo.2(Ghost)]
/
kVp:
kV
mAs:
mAs
Target/Filter:
[3] Missed tissue on
chest wall edge
(40 mm height)
6 -3
/
kVp:
kV
mAs:
mAs
Target/Filter:
Compressed breast
thickness:
7
mm
N
Missed tissue on chest wall edge (Right)
Pass
Fail
Missed tissue on chest wall edge (Left)
Pass
Fail
Verify mechanical stability
Pass
Fail
Verify that all moving parts move smoothly
Pass
Fail
All locks and detents work properly
Pass
Fail
No sharp, rough edges or other hazards
including electrical hazards
Pass
Fail
Operator technique control charts are posted
Pass
Fail
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
Operator protected during
adequate radiation shielding
exposure
by
Exposure condition
confirmation ( 9 )
/
Compression force:
11
[4] Visual and Functional
test
Exposure conditions for Exposure Submenu
[1Shot PhantomM(40mm)]
Exposure condition
confirmation ( 9 )
Result input (
13 )
Result input (
14 )
White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8.
Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired
automatically.)
[3]
[4]
8
Assistance Material
8-14
FDR Mammography QC Manual - 897N101461A
Annual Test (Spatial Resolution Test)
Test Items
Steps
4 -2
[5] Spatial Resolution
(Magnification)
4 -3
Exposure Conditions/Measurement and Judgment Results
1Shot Phantom position
Exposure conditions
for Exposure Submenu
[1ShotM(Magnification)]
Purposes
Lateral shift distance:
mm
kVp:
kV
mAs:
mAs
Target/Filter:
Exposure condition
confirmation ( 6 )
/
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
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8-15
Annual Test (X-ray Equipment Performance Test)
Test Items
Steps
Exposure Conditions/Measurement and Judgment Results
kVp used for the tests
[6] kVp accuracy and
reproducibility
1 -5, 6
1 -8
LFS - volt.
SFS - volt.
Low
kV Mid.
kV High
kV
Low
kV Mid.-1
kV Mid.-2
kV
Mid.-3
kV Mid.-4
kV Mid.-5
kV
High
kV
Low
kV Mid.
kV High
kV
kVp
[7] Half Value Layer
(HVL)
2
-3, 4, 5
mAs
Al 0.3 mm
)
kV
mAs
mR
µGy
mR
µGy
mR
µGy
Target/Filter (
/
)
kV
mAs
mR
µGy
mR
µGy
mR
µGy
Target/Filter (
/
)
kV
mAs
mR
µGy
mR
µGy
mR
µGy
kVp:
kV
mAs:
mAs
Target/Filter:
3 -4
Entrance air kerma
mR
µGy
(4)
mR
µGy
mR
µGy
(5)
mR
µGy
mR
µGy
(3)
Exposure conditions
mAs
Target/Filter:
/
Compressed breast thickness:
mm
Compression force:
16 -3
8
Assistance Material
8-16
Distance between image
edges
X-ray / Light field gap
X-ray / Light field gap
mm A-b
mm
A-c
mm A-d
mm
A-e
mm A-f
mm
B-b
mm B-c
mm
B-d
mm B-e
mm
B-f
mm
Left:
mm
Right:
mm
Chest wall side:
mm
mm
Left:
mm
Right:
mm
Nipple side:
mm
16 -5
X-ray field / Exposure table
gap
Chest wall side:
mm
16 -6
Compression paddle edge
(Chest wall side)
Pass
X-ray / Image receptor field
gap
Exposure condition
confirmation ( 9 )
N
A-a
Nipple side:
16 -4
21 )
kV
mAs:
16 -2
Result input (
s
kVp:
[8] Collimation
assessment
19 )
mGy/s
(Exposure time)
16 -1
Result input (
/
(2)
Air kerma rate
7 -3
18 )
Al 0.5 mm
/
(1)
Result input (
Air kerma
w/o Al
Target/Filter (
Exposure conditions
[9] Radiation output
Purposes
Result input (
20 )
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.)
[6]
[7]
[8]
[9]
FDR Mammography QC Manual - 897N101461A
Annual Test (AEC System Performance Test)
Test Items
Steps
Exposure Conditions/Measurement and Judgment Results
Purposes
kVp:
kV
mAs:
2
Exposure conditions
mAs
Target/Filter:
Compressed breast thickness:
mm
Compression force:
[11] CNR mode 1
N
kVp:
9
Exposure conditions
kV
mAs:
mAs
Target/Filter:
/
Compressed breast thickness:
mm
Compression force:
kV
mAs:
Exposure conditions
mAs
Target/Filter:
/
Compressed breast thickness:
[10] AEC reproducibility
mm
Compression force:
17 -6
N
(1)
mR
µGy
(2)
mR
µGy
(4)
mR
µGy
(5)
mR
µGy
Entrance air kerma
Exposure condition
confirmation ( 11 )
N
kVp:
17 -5
Exposure condition
determination ( 9 )
/
mR
µGy
(3)
Result input (
26 )
White numbers on black squares indicate the relevant Steps in the test procedures described in Chapters 3 to 8.
Dark shaded columns indicate that the items in the columns require user input in the QC Software. (Exposure conditions are acquired
automatically.)
[10]
Test Items
Steps
Exposure Conditions/Measurement and Judgment Results
PMMA
thickness
[11] CNR mode 1
22 -4
Exposure Mode 1
kVp
mAs
Target/
Filter
Purposes
Compressed
breast
thickness
Compression
force
20 mm
kV
mAs
/
mm
N
40 mm
kV
mAs
/
mm
N
60 mm
kV
mAs
/
mm
N
mAs
/
mm
N
70 mm
kV
Exposure condition
confirmation ( 29 )
FDR Mammography QC Manual - 897N101461A
8
Assistance Material
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.)
8-17
Test Items
Steps
Exposure Conditions/Measurement and Judgment Results
PMMA
thickness
18
-3, 4
Exposure
20 mm
Mode 1:
Exposure
40 mm
condition
determination 60 mm
70 mm
[12] AGD Mode 1
PMMA
thickness
18
-7, 8,
10, 12
Exposure
Mode 1
20 mm
40 mm
kVp
mAs
Target/
Filter
Compressed
breast
thickness
Compression
force
kV
mAs
/
mm
N
kV
mAs
/
mm
N
kV
mAs
/
mm
N
kV
mAs
/
mm
N
Compressed
breast
thickness
Compression
force
mm
N
kVp
kV
kV
mAs
mAs
mAs
Target/
Filter
/
/
mm
Purposes
Exposure condition
( for 18 -7, 13)
determination
Air kerma
w/o Al
Al 0.3 mm
Al 0.5 mm
mR
µGy
mR
µGy
mR
µGy
N
mR
µGy
mR
µGy
mR
µGy
mR
µGy
mR
µGy
mR
µGy
mR
µGy
60 mm
kV
mAs
/
mm
N
mR
µGy
70 mm
kV
mAs
/
mm
N
mR
µGy
Result input (
27 )
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]
8
Assistance Material
8-18
FDR Mammography QC Manual - 897N101461A
Test Items
Steps
32
Exposure Conditions/Measurement and Judgment Results
ACR Phantom:
Exposure
condition
determination
kV
kVp
32
-6, 8,
10,
kVp
mAs
mAs
mAs
Exposure ACR
Phantom
Target/
Filter
/
Target/
Filter
Compressed
breast
thickness
mAs
Exposure condition
( for
mm
N
Compressed
breast
thickness
Compression
force
mm
32 -6, 8, 10) determination
Air kerma
w/o Al
mR
µGy
/
kV
Purposes
Compression
force
Al 0.3 mm
Al 0.5 mm
mR
µGy
mR
µGy
Result input (
38 )
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
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8-19
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
8
Assistance Material
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FDR Mammography QC Manual - 897N101461A
1/1/
Facility Information
Client
Date
Exposure Room
Operator
Time
Department
Manufacturer
Name
Model
S/N
Installation Date
Manufacturer
Model
S/N
Installation Date
Manufacturer
Model
S/N
Calibration Expiration
Date
X-ray
Equipment
FUJIFILM
Workstation
FUJIFILM
Measurement Equipment/Tool Information
Laser Imager
Diagnostic
monitor
Viewing box
1Shot Phantom
M
FUJIFILM
ACR Phantom
Step Phantom
Densitometer
Density control
strip
Dosimeter
Force scale
Luminance
meter
Illuminance
meter
kVp meter
Signature
1/3
Weekly Test Report
Test with 1Shot Phantom
Exposure Conditions
kVp
1Shot
PhantomM
mAs
Target/Filter
Compressed
Breast
Thickness
kV
Compression
Force
mm
S Value
N
Test Result
Criteria
Judgment Item
Judgment Result
Lower Limit
Missed tissue on chest wall
edge
CNR
1Shot Phantom sensitivity
constancy
Geometric distortion
System artifact evaluation
Upper Limit
Missed tissue on
chest wall edge
(Right)
mm
-
PASS
FAIL
Missed tissue on
chest wall edge
(Left)
mm
-
PASS
FAIL
CNR
PASS
FAIL
System sensitivity
PASS
FAIL
Horizontal direction
mm
PASS
FAIL
Vertical direction
mm
PASS
FAIL
Geometric distortion
-
-
PASS
FAIL
Artifacts
-
-
PASS
FAIL
Pixel Value (PV)
ratio (Top-Right)
%
PASS
FAIL
Pixel Value (PV)
ratio (Top-Left)
%
PASS
FAIL
Pixel Value (PV)
ratio (Bottom-Right)
%
PASS
FAIL
Pixel Value (PV)
ratio (Bottom-Left)
%
PASS
FAIL
SNR ratio
(Top-Right)
%
PASS
FAIL
SNR ratio
(Top-Left)
%
PASS
FAIL
SNR ratio
(Bottom-Right)
%
PASS
FAIL
SNR ratio
(Bottom-Left)
%
PASS
FAIL
Average QL at
thinnest step
wedge
QL
PASS
FAIL
2 lp/mm
%
PASS
FAIL
4 lp/mm
%
PASS
FAIL
Low Contrast
Detectability (Light)
%
PASS
FAIL
Low Contrast
Detectability (Dark)
%
PASS
FAIL
Uniformity
Dynamic range
Spatial Resolution (SR)
Low Contrast Detectability
(LCD)
2/3
Criteria
Judgment Item
Judgment Result
Lower Limit
Linearity/Beam quality
constancy
Upper Limit
QL gap (1 step-2
step)
QL
PASS
FAIL
QL gap (2 step-3
step)
QL
PASS
FAIL
QL gap (3 step-4
step)
QL
PASS
FAIL
QL gap (4 step-5
step)
QL
PASS
FAIL
Remarks
Signature
3/3/
Good practice
Criteria
Judgment Item
Judgment Result
Lower Limit
Upper Limit
X-ray equipment cleanliness
-
-
Screen cleanliness
-
-
Viewing box cleanliness
-
-
PASS
Remarks
Signature
FAIL
1/3/
Weekly Test Report
Test with ACR Phantom
Exposure Conditions
kVp
ACR Phantom
mAs
Target/Filter
Compressed
Breast
Thickness
kV
Compression
Force
mm
S Value
N
Test Result
Criteria
Judgment Item
Judgment Result
Lower Limit
Upper Limit
Density at center of Phantom
image
PASS
FAIL
Density difference
(disk/outside)
PASS
FAIL
Fibers (ACR Phantom)
-
PASS
FAIL
Specks (ACR Phantom)
-
PASS
FAIL
Masses (ACR Phantom)
-
PASS
FAIL
Visible step wedge (Step
Phantom)
-
PASS
FAIL
Specks (Step Phantom)
-
PASS
FAIL
Masses (Step Phantom)
-
PASS
FAIL
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
Specks
Masses
+0.5
- 0.5
- 0.5
+0.5
+0.5
- 0.5
- 0.5
+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
Specks
Masses
+0.5
- 0.5
- 0.5
+0.5
+0.5
- 0.5
- 0.5
+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
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1/1/
Semi-annual Test Report
Compression device confirmation
Test Items
[1] Compression
device
confirmation
Exposure Conditions/Measurement and Judgment Results
Automatic
Compression
Date:
Measured
value:
lbs.
Acceptance Limits
Automatic (25 45 lbs)
PASS
FAIL
Corrective Action
needed ?
YES
NO
YES
NO
PASS
FAIL
Corrective Action
description
Corrective Action
taken?
Corrective Date:
Results of new
test
Manual
Compression
Date:
Measured
lbs.
value:
Remarks
Signature
1/15
Annual Test Report
Image basic test
Exposure Conditions
kVp
mAs
Compressed
Breast Thickness
Target/Filter
Compression
Force
S Value
S Value
kV
mm
N
Visual
Inspection
kV
mm
N
Measured Values
Entrance air
kerma 1
mR (μC/kg)
Entrance air
kerma 2
mR (μC/kg)
Entrance air
kerma 3
mR (μC/kg)
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
2/15
Compression device confirmation
Measured Values
Compressed breast thickness
- Display value
mm
Compressed breast thickness
- Measured value
mm
Compression force - Display
value
N
Compression force Measured value
N
Maximum compression force
N
Test Result
Criteria
Judgment Item
Judgment Result
Lower Limit
Compressed breast thickness
accuracy
Upper Limit
mm
PASS
FAIL
Compression force accuracy
N
PASS
FAIL
Maximum compression force
N
PASS
FAIL
PASS
FAIL
Compression force sustainability
-
-
Remarks
Signature
3/15
Viewing box maintenance
Test Result
Criteria
Judgment Item
Judgment Result
Lower Limit
Luminance
cd/m2
Upper Limit
-
PASS
FAIL
Viewing box uniformity
-
-
PASS
FAIL
Luminance adjustment function
-
-
PASS
FAIL
Masking
-
-
PASS
FAIL
PASS
FAIL
Interpretation room
illuminance (Ambient light)
lx
-
Remarks
Signature
2/15
Annual Test Report
MONITOR QUALITY CONTROL (ANNUAL) REPORT FORM
Room:
Workstation:
Left Monitor Serial Number:
Right Monitor Serial Number:
Final interpretation?
YES
NO
Cleared by FDA?
YES
NO
N/A
MONITOR IMAGE QUALITY REPORT
Monitor has DICOM Display Functionality feature applied
Left or Single Monitor
Right Monitor
YES / NO
YES / NO
%
%
Lmax target:
Lmax measured:
(Lmax measured - Lmax target)/Lmax target x 100%
Lmax Within 10% ?
YES / PASS
NO / FAIL
YES / PASS
NO / FAIL
5% patch is visible in 0% patch?
YES / PASS
NO / FAIL
YES / PASS
NO / FAIL
95% patch is visible in 100% patch?
YES / PASS
NO / FAIL
YES / PASS
NO / FAIL
Gray steps distinguishable?
YES / PASS
NO / FAIL
YES / PASS
NO / FAIL
Alphanumeric characters sharp?
YES / PASS
NO / FAIL
YES / PASS
NO / FAIL
Line-pair pattern (center) distinguishable?
YES / PASS
NO / FAIL
YES / PASS
NO / FAIL
Line-pair patterns (corner) distinguishable?
YES / PASS
NO / FAIL
YES / PASS
NO / FAIL
Overall, all tests pass ?
YES / PASS
NO / FAIL
YES / PASS
NO / FAIL
MONITOR RESPONSE REPORT
Room:
Left or Single Monitor
Right Monitor
Measured contrast response at any given point does not
deviate more than a) 10% of the standard for final
interpretation or, b) 20% of the standard for other use.
YES / PASS
NO / FAIL
Signature
4/15
Annual Test Report
Additive lag effects (Lag)
Exposure Conditions
kVp
mAs
Target/Filter
Compressed
Breast Thickness
Compression
Force
S Value
ACR Phantom1(Lag)
kV
mm
N
Non
Exposure(Lag)
kV
mm
N
Test Result
Criteria
Judgment Item
Judgment Result
Lower Limit
Lag Factor
QL
Upper Limit
-
PASS
Remarks
Signature
FAIL
5/15
Multiplicative lag effects (Ghost)
Exposure Conditions
kVp
mAs
Target/Filter
Compressed
Breast Thickness
Compression
Force
S Value
Uniform
Expo.1(Ghost)
kV
mm
N
ACR Phantom2(Ghost)
kV
mm
N
Uniform
Expo.2(Ghost)
kV
mm
N
Test Result
Criteria
Judgment Item
Judgment Result
Lower Limit
Ghost Factor
Upper Limit
-
PASS
Remarks
Signature
FAIL
6/15
Missed tissue on chest wall edge (40 mm height)
Exposure Conditions
kVp
1Shot Phantom
M(40 mm)
mAs
Compressed
Breast Thickness
Target/Filter
kV
Compression
Force
mm
S Value
N
Test Result
Criteria
Judgment Item
Judgment Result
Lower Limit
Upper Limit
Missed tissue on chest wall
edge (Right)
-
-
PASS
FAIL
Missed tissue on chest wall
edge (Left)
-
-
PASS
FAIL
Remarks
Signature
7/15
Visual and Functional test
Test Result
Judgment Item
Judgment Result
Verify mechanical stability
PASS
FAIL
Verify that all moving parts move smoothly
PASS
FAIL
All locks and detents work properly
PASS
FAIL
No sharp, rough edges or other hazards including electrical hazards
PASS
FAIL
Operator technique control charts are posted
PASS
FAIL
Operator protected during exposure by adequate radiation shielding
PASS
FAIL
All indicator lights working properly
PASS
FAIL
Auto decompression can be overridden and status displayed
PASS
FAIL
Compression can be manually released / in any failure
PASS
FAIL
Remarks
Signature
8/15
Spatial Resolution (Magnification)
Exposure Conditions
kVp
1ShotM
(Magnification)
mAs
Target/Filter
Compressed
Breast Thickness
kV
Compression
Force
mm
S Value
N
Test Result
Criteria
Judgment Item
Judgment Result
Lower Limit
Upper Limit
MTF (4lp/mm)
%
PASS
FAIL
MTF (8lp/mm)
%
PASS
FAIL
Remarks
Signature
9/15
kVp accuracy and reproducibility
Measurement Conditions
kVp Display Values
Low
kV
Mid.
kV
High
kV
Low
kV
Mid.-1
kV
Mid.-2
kV
Mid.-3
kV
Mid.-4
kV
Mid.-5
kV
High
kV
Low
kV
Mid.
kV
High
kV
Measured Values
Large Focal Spot
(LFS)
Small Focal Spot
(SFS)
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
10/15
Half Value Layer (HVL)
Measured Values
w/o Al
Al 0.3 mm
Al 0.5 mm
Measured HVL (Mo/Mo)
mR(μC/kg)
mR(μC/kg)
mR(μC/kg)
Measured HVL (Mo/Rh)
mR(μC/kg)
mR(μC/kg)
mR(μC/kg)
Measured HVL (W/Rh)
mR(μC/kg)
mR(μC/kg)
mR(μC/kg)
Test Result
Criteria
Judgment Item
Judgment Result
Lower Limit
Upper Limit
HVL (Mo/Mo)
mmAl
-
PASS
FAIL
HVL (Mo/Rh)
mmAl
-
PASS
FAIL
HVL (W/Rh)
mmAl
-
PASS
FAIL
Remarks
Signature
11/15
Collimation assessment
Exposure Conditions
kVp
Uniform Expo.3
(Collimation)
mAs
Target/Filter
Compressed
Breast Thickness
kV
Compression
Force
mm
S Value
N
Test Result
Criteria
Judgment Item
Judgment Result
Lower Limit
Upper Limit
X-ray / Light field gap
(Right/Left)
mm
-
PASS
FAIL
X-ray / Light field gap
(Chest/Nipple)
mm
-
PASS
FAIL
X-ray / Image receptor field
gap (Left)
mm
-
PASS
FAIL
X-ray / Image receptor field
gap (Right)
mm
-
PASS
FAIL
X-ray / Image receptor field
gap (Nipple)
mm
-
PASS
FAIL
X-ray field / Exposure table
gap
mm
-
PASS
FAIL
PASS
FAIL
Compression paddle edge (Chest wall)
-
-
Remarks
Signature
12/15
Radiation output
Measured Values
mAs
Entrance air
kerma 1
mR(μC/kg)
Entrance air
kerma 2
mR(μC/kg)
Entrance air
kerma 3
mR(μC/kg)
Entrance air
kerma 4
mR(μC/kg)
Entrance air
kerma 5
mR(μC/kg)
Test Result
Criteria
Judgment Item
Judgment Result
Lower Limit
Reproducibility
Air kerma rate
Specific radiation output
Upper Limit
-
PASS
FAIL
mGy/s
-
PASS
FAIL
μGy/mAs
-
PASS
FAIL
Remarks
Signature
13/15
AEC reproducibility
Measured Values
mAs
Entrance air
kerma 1
mR(μC/kg)
Entrance air
kerma 2
mR(μC/kg)
Entrance air
kerma 3
mR(μC/kg)
Entrance air
kerma 4
mR(μC/kg)
Entrance air
kerma 5
mR(μC/kg)
Test Result
Criteria
Judgment Item
Judgment Result
Lower Limit
Entrance air kerma accuracy
%
Entrance air kerma
reproducibility
Remarks
Signature
Upper Limit
PASS
FAIL
PASS
FAIL
14/15
CNR mode 1
Exposure Conditions
Exposure Mode
kVp
mAs
Target/Filter
Compressed
Breast Thickness
Compression
Force
S Value
Mode n CNR
(PMMA20mm)
kV
mm
N
Mode n CNR
(PMMA40mm)
kV
mm
N
Mode n CNR
(PMMA60mm)
kV
mm
N
Mode n CNR
(PMMA70mm)
kV
mm
N
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
15/15
AGD mode 1
Measured Values
Exposure Mode
Mode 1
w/o Al
Al 0.3 mm
Al 0.5 mm
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
-
1 mGy
PASS
FAIL
AGD 40mm
mGy
-
2 mGy
PASS
FAIL
AGD 60mm
mGy
-
4.5 mGy
PASS
FAIL
AGD 80mm
mGy
-
6.5 mGy
PASS
FAIL
AGD - ACR Phantom
Measured Values
Exposure Mode
Mode 1
w/o Al
Entrance air kerma (
Al 0.3 mm
mR(μC/kg)
Al 0.5 mm
mR(μC/kg)
mR(μC/kg)
Test Result
Criteria
Judgment Item
AGD-ACR Phantom
Judgment Result
mGy
Lower Limit
Upper Limit
-
3 mGy
Remarks
Signature
PASS
FAIL
Chapter 9
Technical Information
Page
9.1
Specification Outline of 1Shot Phantom M Plus ___________
9-2
9.2
Glossary_______________________________________________
9-3
9
FDR Mammography QC Manual - 897N101461A
9-1
9.1
Specification Outline of 1Shot
Phantom M Plus
Test Contents
Missed tissue on chest wall
edge
CNR
1Shot Phantom sensitivity
constancy
Geometric distortion
System artifact evaluation
Uniformity (Uniform Exposure
Region)
Dynamic range
Spatial Resolution (SR)
Low Contrast Detectability
(LCD)
Linearity/Beam quality
constancy
Applicable Phantom
Outline of Calculation Method
Bar patterns (1 mm spacing)
The amount of missed tissue on the chest wall-side edge
is calculated by using coordinate information of the slit.
Al (0.2 mm)
CNR is calculated according to the definitional equation
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.
Uniform exposure region at 60 mm from the chest wall- Based on the pixel value in this calculation area, the value
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.
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 equivalent to 40-mm PMMA N/A
phantom at 28kVp, Mo/Mo.)
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
side edge and uniform exposure regions at four corners calculation region, the pixel value and relative SNR value
of the phantom
are calculated in the calculation regions (10 x 10 mm
each) at four corners of the phantom.
The lightest region of the step wedge
The pixel value in the highest density region of the step
wedge is calculated. According to IEC 61223-3-2,
calculation is executed only in the highest density region.
Bar patterns slanted at 45 degrees (2, 4 and 8 cycles/ SCTF is calculated according to the definitional equation
mm)
described in IEC 61223-3-2.
PMMA phantom ( 2 mm, contrast 1.4%)
A cross-correlation factor is calculated based on the
reference image (ideal image).
The pixel value is calculated in each step of the step
Five step-wedge patterns forming a density region in the
wedge and then the difference between the adjacent
range of the center density plus or minus about one digit
steps is calculated.
9
Technical Information
9-2
FDR Mammography QC Manual - 897N101461A
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
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 Manual - 897N101461A
Technical Information
The ghost factor is an index for representing the degree of change in sensitivity of the
flat panel detector (FPD) caused by the last X-ray exposure. The greater the degree
of change in sensitivity, the greater the ghost factor.
8
9
Ghost Factor
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 Manual - 897N101461A
14 QL Value
This Program executes various calculations regarding image data before EDR
normalization.
With the FCR 1Shot Phantom M Plus, log data equivalent to 4 digits/12 bits is output.
1 QL is equivalent to 0.90%.
12 bits/4 digits 1 QL = 4 (digits)/212 = 9.77 x 10-4 (digits)
-4
When converted to the antilog: 10(9.77 x 10 ) = 1.00225 0.225%
However, dynamic range calculation is performed at 14 bits.
1,6ALUE
BIT
M2
M2
M2
M2
2
$IGITS
$OSE
$IGIT
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 FDR1000DRSZ.
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.
9
19 System Sensitivity
FDR Mammography QC Manual - 897N101461A
Technical Information
The system sensitivity is equivalent to the median value of the histogram of the
digital image at the time of converting the dose on the flat panel detector (FPD) to a
digital value. The system sensitivity is defined depending on the type of FPD. In this
Guidebook, the high-resolution FPD is used. Accordingly, the system sensitivity is
defined as follows.
When uniform exposure is executed under the condition of 25 kVp and 0.03 mm Mo
using X-ray equipment with a molybdenum target, if the dose on FPD is specified as
y (mR) (1 (mR) ≈ 8.7 (µGy)):
S Value = 2400/y
9-5
9
Technical Information
9-6
FDR Mammography QC Manual - 897N101461A
Image Processing
Parameters
(for Mammography QC)
This chapter describes the image processing parameters for study
menus and exposure menus used in this Program.
Page
FDR Mammography QC Manual - 897N101461A
How to Read This Chapter ______________________________
QCParam-2
EDR Mode Table ____________________________________
• Image Processing Parameters for Mammography QC _____
QCParam-3
QCParam-6
QCParam-1
How to Read This Chapter
How to read descriptions included in this chapter is described below.
3
2
1
Exposure Menu
MPM Code
Study Menu
4
5
AP/PA
1
Menu Description
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 Manual - 897N101461A
EDR Mode Table
EDR mode (auto sensitivity adjustment system) applied to exposure menus pre-registered in the system
are described below.
S value : When recording a digital image, the X-ray dose that reaches the exposure unit is
converted to a digital value. S value is the center X-ray dose of the histogram of
the digital image.
L value : A logarithmic value showing the range of X-ray dose when making an exposure.
Semi Fix
S Value
Type
L Value
Type
1
PRIEF
EDR mode
Auto
EDR Mode
EDR mode consists of AUTO mode, SEMI AUTO mode, and FIX mode.
A (AUTO mode)
S (SEMI AUTO mode)
F (FIX mode)
: A mode which adjusts density and contrast automatically.
(S and L values are dependent on this 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.
: 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:
1
1S
2
4
4S
:
:
:
:
:
:
Does not recognize split exposures and irradiated field. (SEMI AUTO mode and type IV described below.)
Does not recognize split exposures and judges a rectangular area as an irradiated field.
Recognizes split exposures and judges individually recognized areas as rectangular irradiated fields.
Recognizes irradiated field of a breast.
Does not recognize split exposures and judges a protrusive area as an irradiated field.
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
II
III
IV
V
VI
VII
3
: 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.)
: A mode that is activated in a stable manner even if there are no direct X-rays.
: A mode applied to contrast exposure.
: A mode that attaches importance to improved representation of soft tissue.
: A mode that attaches importance to improved representation of areas where X-rays are difficult to be
penetrated.
: Neuro analysis mode applied when variations become large on the shape of a histogram.
: Neuro analysis mode applied when the position of a region of interest changes on a histogram.
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 Manual - 897N101461A
QCParam-3
1
2
Image Processing Parameters
1
GA
GT
GC
GS
MRB
MRT
MRE
MDB
MDT
MDE
PRN
PTE
PTC
PRE
1.3
T
1.40
-0.04
G
R
0.5
E
F
0.3
B
R
O
1.0
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.
2ESPONSE
!
" #
$
%
&
'
&REQUENCYCYMM
Figure : MRB types and enhancement curves
A stronger enhancement is applied in high-frequency bands as going from A to F.
2
Image Processing Parameters - PEM (Pattern Enhancement Processing for Mammography) parameters There are the following four PEM processing parameters : PRN, PTE, PTC, and PRE.
PRN : This is a parameter to determine the frequency bands where enhancement is to be applied.
A stronger enhancement is applied in low frequency bands as going from A to E.
A : 8.0 cy/mm
B : 5.66 cy/mm
C : 4.0 cy/mm
D : 2.83 cy/mm
E : 2.0 cy/mm
QCParam-4
FDR Mammography QC Manual - 897N101461A
PTE : This is a parameter to determine edge detection sensitivity.
The edge detection sensitivity decreases as going from A to T, making it difficult to detect portions that
look like calcifications.
PTC : This is a parameter to determine detection sensitivity of an isolated point.
The isolated point detection sensitivity decreases as going from A to T, making it difficult to detect
portions that seem to be calcifications.
PRE : This is a parameter to determine the degree of enhancement.
The larger the value is, the larger the degree of enhancement is. If this parameter is set to 0.0, no PEM
processing will be applied.
* Depending on the exposure conditions applied, radiographic object, and equipment being used, the PEM processing may
be applied excessively, resulting in affecting reading of calcifications, etc. Prior to actually applying PEM processing, make
sure that it does not affect image reading adversely.
* If the PEM processing is judged to be affecting image reading, make sure that the applied parameters are appropriate by,
for example, setting the PRE value smaller to lower the degree of enhancement.
* PEM processing refers to the S value applied to the image and adjusts the degree of image detection, requiring you to
check the value periodically. S value can be controlled effectively by using the QC Tool (optional software). If no QC Tool
is avaialble, you can determine rough behaviors of the S value by using an appropriately controlled X-ray generator and
checking the resulted S value of the image data acquired from an exposure made under certain conditions.
Controllable range of the S value is about twice the resulted value.
FDR Mammography QC Manual - 897N101461A
QCParam-5
QCParam-6
:
:
:
:
Rotation Amount
Gradation Type
Rotation Center
Gradation Shifting Amount
7375
7313
7313
7313
7313
7313
7302
7325
7375
7325
[Daily/Weekly] For checkup of
mammography QC ACR Phantom
AP
AP
AP
AP
AP
AP
[Annual] For checkup of mammography QC
Lag1
[Annual] For checkup of mammography QC
Lag2
[Annual] For checkup of mammography QC
Ghost1
[Annual] For checkup of mammography QC
Ghost2
[Annual] For checkup of mammography QC
Ghost3
[Annual] For checkup of mammography QC
Missed tissue on chest wall edge (40 mm
height)
[Semi-annual] For checkup of
AP mammography QC Uniform
Exposure(Image Basic)
[Daily/Weekly] For checkup of
mammography QC 1Shot Phantom M
[Daily/Weekly] For checkup of
AP
mammography QC ACR Phantom
AP
AP
[Daily/Weekly] For checkup of
mammography QC 1Shot Phantom M
S
F
F
F
F
F
S
S
S
S
S
-
-
-
-
-
-
-
-
-
-
-
V
V
V
V
V
V
V
V
V
V
V
V
III'
I
I
I
I
I
I
III'
III'
III'
III'
I
2
2
2
2
2
2
1
2
2
2
2
1
200
200
200
200
200
200
200
200
200
200
200
200
1.2
1.3
1.3
1.3
1.3
1.3
1.0
1.2
1.2
1.2
1.2
1.0
T
C
C
C
C
C
A
T
T
T
T
A
1.40
1.20
1.20
1.20
1.20
1.20
1.20
1.40
1.40
1.40
1.40
1.20
1.20
-0.05
0.00
0.00
0.00
0.00
0.00
0.00
-0.04
-0.05
-0.04
-0.05
0.00
0.00
G
B
B
B
B
B
B
G
G
G
G
B
B
R
R
R
R
R
R
F
R
R
R
R
F
F
1.5
0.0
0.0
0.0
0.0
0.0
0.0
1.5
1.5
1.5
1.5
0.0
0.0
* 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.
* It is not recommended that you use the PEM processing parameters for the tests other than the Test with ACR Phantom.
1Shot PhantomM (40mm)
Uniform Expo.2 (Ghost)
ACR Phantom2 (Ghost)
Uniform Expo.1 (Ghost)
Non Exposure (Lag)
Annual 1/6
ACR Phantom1 (Lag)
Semi-annual 1/1
Uniform Expo(Image Basic)
ACR Phantom
1Shot/ACR
1Shot PhantomM
MPM Code
ACR Phantom
ACR Phantom
AP/PA
AP
EDR mode
7375
PRIEF
1Shot PhantomM
1Shot PhantomM
Type
-
Type
S
L Value
[Calculation] For checkup of mammography
QC AGD
S Value
AP
GA
7302
GT
A
GC
1.0
GS
200
MRB
1
MRT
I
MRE
V
E
A
A
A
A
A
A
E
E
E
E
A
A
MDB
-
F
A
A
A
A
A
A
F
F
F
F
A
A
MDT
S
0.4
0.0
0.0
0.0
0.0
0.0
0.0
0.4
0.4
0.4
0.4
0.0
0.0
Image Processing
Parameters (PEM)
PEM Enhancement Frequency Ranking
PEM Edge Information Detection Level
PEM Calcification Image Information Detection Level
PEM Enhancement Coefficient
MDE
Calculation 2/2
AGD
[Calculation] For checkup of mammography
QC CNR
:
:
:
:
Image Processing Parameters (MFP)
PRN
PTE
PTC
PRE
B
A
A
A
A
A
A
B
B
B
B
A
A
PRN
AP
Semi Fix
DRN : Dynamic Range Control Rank
DRT : Dynamic Range Control Type
DRE : Dynamic Range Control
Enhancement Level
R
A
A
A
A
A
A
R
R
R
R
A
A
PTE
7302
Menu Description
Auto
RN : Frequency Rank
RT : Enhancing Type
RE : Frequency
Enhancement
O
A
A
A
A
A
A
O
O
O
O
A
A
PTC
Calculation 1/2
CNR
Exposure Menu
Study Menu
• Image Processing Parameters for Mammography QC
GA
GT
GC
GS
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.7
0.0
0.7
0.0
0.0
0.0
PRE
FDR Mammography QC Manual - 897N101461A
FDR Mammography QC Manual - 897N101461A
7302
7302
7302
7302
7302
7302
7302
7302
7302
7302
7302
[Annual] For checkup of mammography QC
W - mode CNR (20 mm height)
[Annual] For checkup of mammography QC
AP
W - mode CNR (40 mm height)
[Annual] For checkup of mammography QC
AP
W - mode CNR (60 mm height)
[Annual] For checkup of mammography QC
AP
W - mode CNR (70 mm height)
AP
[Annual] For checkup of mammography QC
AP
L - mode CNR (40 mm height)
[Annual] For checkup of mammography QC
AP
L - mode CNR (60 mm height)
[Annual] For checkup of mammography QC
AP
L - mode CNR (70 mm height)
[Annual] For checkup of mammography QC
AP L - mode CNR (20 mm height)
[Annual] For checkup of mammography QC
H - mode CNR (20 mm height)
[Annual] For checkup of mammography QC
AP
H - mode CNR (40 mm height)
[Annual] For checkup of mammography QC
AP
H - mode CNR (60 mm height)
[Annual] For checkup of mammography QC
AP
H - mode CNR (70 mm height)
S
S
S
S
S
S
S
S
S
S
S
S
-
-
-
-
-
-
-
-
-
-
-
-
V
V
V
V
V
V
V
V
V
V
V
V
V
I
I
I
I
I
I
I
I
I
I
I
I
I
1
1
1
1
1
1
1
1
1
1
1
1
2
200
200
200
200
200
200
200
200
200
200
200
200
200
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.3
A
A
A
A
A
A
A
A
A
A
A
A
C
1.20
1.20
1.20
1.20
1.20
1.20
1.20
1.20
1.20
1.20
1.20
1.20
1.20
1.40
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
-0.05
B
B
B
B
B
B
B
B
B
B
B
B
B
G
F
F
F
F
F
F
F
F
F
F
F
F
R
R
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
1.5
* 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.
* It is not recommended that you use the PEM processing parameters for the tests other than the Test with ACR Phantom.
W-mode CNR (PMMA70mm)
W-mode CNR (PMMA60mm)
W-mode CNR (PMMA40mm)
Annual 6/6
W-mode CNR (PMMA20mm)
L-mode CNR (PMMA70mm)
L-mode CNR (PMMA60mm)
L-mode CNR (PMMA40mm)
Annual 5/6
L-mode CNR (PMMA20mm)
H-mode CNR (PMMA70mm)
H-mode CNR (PMMA60mm)
MPM Code
H-mode CNR (PMMA40mm)
AP/PA
AP
EDR mode
7302
PRIEF
-
Type
S
Type
Annual 4/6
H-mode CNR (PMMA20mm)
L Value
[Annual] For checkup of mammography QC
Collimation
S Value
AP
GA
7303
GT
T
GC
1.2
GS
200
MRB
2
MRT
III'
MRE
V
A
A
A
A
A
A
A
A
A
A
A
A
A
E
MDB
-
A
A
A
A
A
A
A
A
A
A
A
A
A
F
MDT
S
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.4
MDE
Annual 3/6
Uniform Expo.3 (Collimation)
[Annual] For checkup of mammography QC
Spatial Resolution (Magnification)
Image Processing Parameters (MFP)
Image Processing
Parameters (PEM)
A
A
A
A
A
A
A
A
A
A
A
A
A
B
PRN
AP
Semi Fix
A
A
A
A
A
A
A
A
A
A
A
A
A
R
PTE
7375
Menu Description
Auto
A
A
A
A
A
A
A
A
A
A
A
A
A
O
PTC
Annual 2/6
1ShotM (Magnification)
Exposure Menu
Study Menu
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
PRE
QCParam-7
United States Authorized Representative:
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 WEST AVENUE, STAMFORD, CT 06902, U.S.A.