Senographe

Crystal
Quality Control Manual
5573538-1EN Revision6
English

Manufactured by GE Ultrasound Korea, LTD

#301, 3F, 14, Samsung 1ro- 1gil,

Hwaseong-si, Gyeonggi-do, Korea

Copyright by GE Ultrasound Korea, LTD Confidential and proprietary information

About this manual Senographe Crystal

About this manual

 Publisher: Manufactured by GE Ultrasound Korea, LTD

 Address: #301, 3F, 14, Samsung 1ro- 1gil,Hwaseong-si, Gyeonggi-do, Korea
The information in this document is subject to change without notice and does not represent a commitment on the part of
the vendor.
This document contains materials protected under International Copyright Laws. All rights reserved. No part of this manual
may be reproduced, transmitted, or transcribed without the expressed written permission of the manufacturer and authors
of this manual.
If the device is not properly set causing it to malfunction or fail, we cannot guarantee any responsibility.
(Copyright by © 2014 GE Ultrasound Korea Confidential and proprietary information)

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Senographe Crystal Preface

Preface
Applicability of Manual

It describes Quality Control (QC) Tests for the Senographe Crystal, which constitutes the digital image
acquisition sub-system of a full-field digital mammography (FFDM) system.

Overview of this Manual

This Quality Control (QC) Manual consists of three main sections:

• QC Tests for the Radiologic Technologist.

• QC Tests for the Medical Physicist.

• APPENDIX

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Definition of Warnings and Notes

Before using, familiarize yourself with the icons and symbols you will see in this manual:

WARNING

Indicates that there is an immediate danger that leads to death or serious physical injury.

CAUTION
Indicates a risk of danger that if disregarded, it leads or may lead to a potential situation that may result
in an undesirable result or state other than death, physical injury or property damage.

NOTE

Indicates notes, usage tips, or additional information.

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Senographe Crystal Preface

Acronyms Glossary
This manual uses the following terminology:

 ACR: American College Radiology

 AEC: Automatic Exposure Control
 Collimator: Device at the X-ray tube to control the area of the receptor that is exposed
 DICOM: Digital Imaging and Communications in Medicine
 FFDM: Full Field Digital Mammography
 Grid: Element within the Digital Image Receptor that reduces scatter Radiation during the exposure
 GUI: Graphic User Interface
 PACS: Picture Archiving and Communications System
 FOV : Field Of View

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Document Revision History

This table is intentionally left in English.
Date
Revision Part Description
(dd/mm/yyyy)
1 5573538-1EN 27/08/2014 First Release for Part 5573538-1EN
Add Section 2.6 MTF Measurement
2 5573538-1EN 27/04/2015
Add Section 3.1 SDNR Measurement
3 5573538-1EN 02/06/2015 Corrected the error of page numbering.
4 5573538-1EN 15/06/2015 Corrected the error of revision information
5 5573538-1EN 07/07/2015 Removed the CE mark in Cover page

Updated Section 2.3 Flat Field Test

6 5573538-1EN 25/08/2015 - Change Flat Field Test UI
Added Section 2.11 Uncorrected Defective Pixels

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Senographe Crystal Table of Contents

Table of Contents
Preface ...........................................................................................................................................................................3
Applicability of Manual ........................................................................................................................................................................................3
Overview of this Manual ....................................................................................................................................................................................3
Definition of Warnings and Notes ........................................................................................................................................................................... 4
Acronyms Glossary.......................................................................................................................................................................................................... 5
Document Revision History......................................................................................................................................................................................... 6

SECTION 1: INTRODUCTION ............................................................................................................................9

1.1 Training ........................................................................................................................................................................................................................ 11
Medical Physicist .................................................................................................................................................................................................... 11
Radiologic Technologist ...................................................................................................................................................................................... 11
1.2 Tools............................................................................................................................................................................................................................... 11
Image Quality .......................................................................................................................................................................................................... 11
Measuring Meters.................................................................................................................................................................................................. 13
1.3 Quality Control Test Interval ............................................................................................................................................................................. 14
1) QC Test Interval for Radiologic Technologist ........................................................................................................................................ 14
2) QC Test Interval for Medical Physicist ...................................................................................................................................................... 14
1.4 How to locate Raw files ....................................................................................................................................................................................... 15
1.5 How to open the Pattern Images................................................................................................................................................................... 16
Overview.................................................................................................................................................................................................................... 16
Accessing the images .......................................................................................................................................................................................... 17
1.6 How to review the Raw image......................................................................................................................................................................... 18
1.7 How to set the Maximum Compression Force........................................................................................................................................ 19
SETTINGS Mode ...................................................................................................................................................................................................... 19
Capture Mode.......................................................................................................................................................................................................... 19
1.8 How to use QC Exposure Tool .......................................................................................................................................................................... 20

SECTION 2: QC TESTS FOR RADIOLOGIC TECHNOLOGIST ....................................................................... 21

Introduction ....................................................................................................................................................................................................................... 23
2.1 Monitor Cleaning..................................................................................................................................................................................................... 24
2.2 DICOM Printer Quality........................................................................................................................................................................................... 25
2.3 Flat Field Test ............................................................................................................................................................................................................ 26
2.4 Phantom Image Quality Test ............................................................................................................................................................................ 29
2.5 Viewbox and Viewing Conditions Test......................................................................................................................................................... 31
2.6 MTF Measurement ................................................................................................................................................................................................. 32
2.7 Visual Checklist ........................................................................................................................................................................................................ 36
2.8 Repeat and Reject Analysis ............................................................................................................................................................................... 37

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2.9 Review Workstation Quality ............................................................................................................................................................................. 38

2.10 Compression Force Test .................................................................................................................................................................................. 40
2.11 Uncorrected Defective Pixels ........................................................................................................................................................................ 41

SECTION 3: TESTS FOR MEDICAL PHYSICIST .............................................................................................. 45

Introduction ...................................................................................................................................................................................................................... 47
3.1 Signal Difference to Noise Ratio (SDNR) Measurement ..................................................................................................................... 48
3.2 Monitor Quality (For Control station)............................................................................................................................................................ 50
3.3 Collimation Assessment ..................................................................................................................................................................................... 51
3.4 Evaluation of Focal Spot Performance ....................................................................................................................................................... 53
3.5 kVp Accuracy and Reproducibility ................................................................................................................................................................ 55
3.6 Beam Quality Assessment (HVL) .................................................................................................................................................................... 56
3.7 Average Glandular Dose Measurement..................................................................................................................................................... 58
3.8 Artifact Evaluation ................................................................................................................................................................................................. 60
3.9 AEC Performance and Reproducibility........................................................................................................................................................ 61

SECTION 4: APPENDIX .................................................................................................................................... 63

1. Mammography QA Checklist (Daily, Weekly)............................................................................................................................ 65
2. DICOM Printer Quality Checklist (Weekly)................................................................................................................................... 66
3. Phantom Image Quality Checklist (Weekly) .............................................................................................................................. 67
4. MTF Measurement Test Record (Weekly).................................................................................................................................... 68
5. SDNR Measurement Test Record (Weekly) ................................................................................................................................ 69
6. Visual Checklist (Monthly) ..................................................................................................................................................................... 70
7. Repeat and Reject Analysis Checklist (Quarterly)................................................................................................................... 71
8. Review Workstation Quality Checklist (Quarterly) ................................................................................................................. 73
9. Compression Force Checklist (Semi-annually)......................................................................................................................... 74
10. Monitor Quality for Control Station Checklist (Semi-annually) ........................................................................................ 75
11. Uncorrected Defective Pixels (Semi-annually)......................................................................................................................... 76
12. Collimator Assessment Checklist (Annually) ............................................................................................................................. 77
13. Evaluation of Focal Spot Performance Checklist (Annually)............................................................................................. 78
14. kVp Accuracy and Reproducibility Checklist (Annually) ...................................................................................................... 79
15. Beam Quality Assessment Checklist (Annually) ...................................................................................................................... 80
16. Average Glandular Dose Checklist (Annually) .......................................................................................................................... 82
17. Artifact Evaluation Checklist (Annually)....................................................................................................................................... 83
18. AEC Performance and Reproducibility Checklist (Annually) ............................................................................................. 84

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Senographe Crystal QC TESTS FOR RADIOLOGIC TECHNOLOGIST

SECTION 1: INTRODUCTION

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1.1 Training
Basic training in digital mammography is required before becoming qualified to use the Senographe Crystal. The required
training is as follows.

Medical Physicist
Before using the digital mammography machine independently, a medical physicist should first meet all requirements such
as behavior regulations on breast quality including training on new mammogram machines.

Radiologic Technologist
The radiologic technologist should receive all necessary training, including the use of the machine, before using the digital
mammography alone.

1.2 Tools
Image Quality

Tools Test
Calibration PMMA Block (40mm)

Section 2.3) Flat Field Test

Section 3.8) Artifact Evaluation

Acrylic plates Set

- 20mm, 40mm, 60mm

Section 3.9) AEC Performance and reproducibility

Bar pattern
- Fluke Bio Medical 07-521

Section 2.6) MTF Measurement

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MTM100 Phantom
- CIRS Model 011A

Section 3.1) SDNR Test

ACR Standard Phantom

- CIRS Model 015
- GAMMEX 156

Section2.4) Phantom Image Quality Test

Section3.7) Average Glandular dose measurement

Aluminum HVL Attenuator Set :

- Gammex 115H

Section3.6) Beam Quality Assessment(HVL)

Resolution Test Pattern

- CIRS Model 016A

Section3.4) Evaluation of Focal Spot Performance

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Measuring Meters

Tools Test
X-ray Field Alignment Tool
- Unfors DXR+
Section3.3) Collimation Assessment

X-ray Dosimeter
- Radical9015RM

Section3.6) Beam Quality Assessment(HVL)

Section3.7) Average Glandular Dose Measurement

- Unfors XI-P (Compatible with W/Rh)

kVp Dosimeter
- Unfors XI-P (Compatible with W/Rh)

Section3.5) kVp Accuracy and Reproducibility

Scale (Off-the-Shelf) Section2.10) Compression force test

Section3.3) Collimation Assessment
Radiation Protection Plate Section3.5) kVp Accuracy and Reproducibility
Section3.6) Beam Quality Assessment(HVL)

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1.3 Quality Control Test Interval

1) QC Test Interval for Radiologic Technologist
Frequency Item Section
Daily Monitor Cleaning 2.1
DICOM Printer Quality 2.2
Flat Field Test 2.3
Weekly Phantom Image Quality test 2.4
Viewbox and Viewing Conditions Test 2.5
MTF Measurement 2.6
Monthly Visual Checklist 2.7
Repeat and Reject Analysis 2.8
Quarterly
Review Workstation Quality 2.9
Compression Force Test 2.10
Semi-annually
Uncorrected Defective Pixels 2.11

2) QC Test Interval for Medical Physicist

Frequency Item Section

Weekly Signal Difference to Noise Ratio (SDNR) 3.1
Semi-annually Monitor Quality (For Control Station) 3.2
Collimation Assessment 3.3
Evaluation of Focal Spot Performance 3.4
kVp Accuracy and Reproducibility 3.5
Annually Beam Quality Assessment (HVL) 3.6
Average Glandular Dose Measurement 3.7
Artifact Evaluation 3.8
AEC Performance and Reproducibility 3.9

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1.4 How to locate Raw files

1. The raw image files are stored in the folder mentioned in the "Image Data Path" section in the "SETTINGS" tab of
the SenoCrystal application, with one subfolder per day of acquisition. The default location is “C:\ImageData”.

<Path setting to save raw files>

2. For example, if an image is taken on March 5, 2011, it is saved in the folder “C:\ImageData\”20110305'.
3. The file is saved in the format “OyyyyMMdd_hhmmss.dcm”.
O : Prefix for raw image file
yyyy : Recorded Year
MM : Recorded Month
dd : Recorded Date
hh : Recorded Hour
mm : Recorded Minute
ss : Recorded Second
dcm : File Extension
4. The images can be opened in the DICOM Viewer.

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1.5 How to open the Pattern Images

Overview

The following pattern images are available on the system:

PG18 – PQC TG18 – UNL10

Used for checking the quality of the printer Used for checking the quality of the monitor/printer

TG18 – QC TG18 – UNL80

Used for checking the quality of the monitor/printer Used for checking the quality of the monitor/printer

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Accessing the images

To display any of these pattern images, in the Browser tab, search for the following patient:

• Patient Name: TestQC

• Patient ID: TG18PQC

The four pattern images appear in the bottom right-hand corner.

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1.6 How to review the Raw image

To review the Raw image on SenoCrystal S/W.

1. Start SenoCrystal S/W as administrator mode (Default administrator ID : crystal / PW : 1234)

2. Click the Browser Tab and Double click the list on Study list
3. You can enter the Viewer mode and processed image is displayed.
4. Click the “Raw” button on the lower-left, you can see the Raw image.

5. If you want to send the Raw image to PACS server, Click the Send icon.

6. If you want to print the Raw image, Click the Printer icon.

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1.7 How to set the Maximum Compression

Force
There are two ways of setting the maximum compression force.

SETTINGS Mode

1. Start SenoCrystal S/W as administrator mode (Default administrator ID: crystal / PW: 1234)

2. Click the SETTNGS button on the top of SenoCrystal S/W

3. Enter the desired maximum compression force. (The available range of Maximum compression force is 3~20kg).

4. To apply the changes, click the Apply button in the lower-left, and the present setting will be saved.

Capture Mode

1. Start SenoCrystal S/W as administrator mode or operator mode.

2. Entry the Capture mode.

3. Click the compression force icon and the popup windows appear.

4. Enter the desired maximum compression force. (The available range of Maximum compression force is 3~20kg).

5. To apply the changes, click the OK button.

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1.8 How to use QC Exposure Tool

This QAP tool is to set X-ray exposure condition as below. The exposure condition setting is used to choose the
detailed exposure condition than normal Manual exposure condition.

1. Double-click the CrystalQAP icon on the desktop.

2. Enter the administrator account of SenoCrystal S/W ID and PW to log into the SenoCrystal QAP S/W.
(Default administrator ID : crystal / PW : 1234)

3. CrystalQAP S/W windows appear as shown below.

<Crystal QAP Window>

4. Click the QC Exposure button on top of CrystalQAP S/W.

5. Click the “Start” button and Input exposure condition on the right of CrystalQAP S/W
6. Take an exposure.
7. You can see that the acquired image (Raw image) and exposure condition are displayed.

NOTE

If you want to use raw images, you can confirm images to save in “C:\ImageData\YYYYMMDD

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SECTION 2: QC TESTS FOR

RADIOLOGIC TECHNOLOGIST

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Introduction
QC tests for the Radiologic Technologist are listed below.

Section Item Frequency Purpose

Prepare the optimal environment for image
2.1 Monitor Cleaning Daily
reading
Maintain the DICOM printer for consistent
2.2 DICOM Printer Quality Weekly
performance
2.3 Flat Field Test Weekly Guarantee the detector uniformity
Phantom Image Maintain the stable image quality for the acquired
2.4 Weekly
Quality Test images
Viewbox and Viewing Maintain the optimal reading environment of the
2.5 Weekly
Conditions Test View box and RWS
Check a parameter that describes the transfer object
2.6 MTF Measurement Weekly contrast by the imaging system as a function of
spatial frequency
2.7 Visual Checklist Monthly Check the system stability
2.8 Repeat Analysis Quarterly Analyze the cause of retakes and improper images
Review Workstation Maintain a constant environment for the image
2.9 Quarterly
Quality reading monitor
Semi- Check if the breast compression Paddle works
2.10 Compression Force Test
annually properly
Uncorrected Defective Semi-
2.11 Check the uncorrected defective pixels.
Pixels annually
For more information on the procedures for each test, please check the applicable section.

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2.1 Monitor Cleaning

1) Maintenance Interval

Daily

2) Purpose

To create the optimal environment for reading images, wipe the dust, fingerprints or other stains off the monitor.

3) Supplies to prepare
The Soft cloth or other cleaning tools for the monitor. If necessary, the cloth may be moistened with either water or
ethyl alcohol (up to 96%).
Notice: Do not use isopropyl (“rubbing”) alcohol. Do not use cleaning agents which attack the surface, such as
petroleum (mineral) spirits. The front panel is extremely sensitive to mechanical damage. Avoid all scratches,
knocks, etc. Do not apply the cleaning liquid directly to the monitor housing or screen. Do not allow the cleaning
liquid to enter the monitor housing; be sure to dampen the cloth sparingly.

4) Procedure
1. Use cloth to wipe dust, fingerprints or other stains off of the monitor.
2. Check for any other foreign substances on the monitor.
3. Take notes on the checklist of the items checked.

5) Record keeping form

Appendix1. Mammography QA Checklist (Daily, Weekly).

6) Maintenance Standards

The screen must be free from dust, finger prints, and other marks.
If these results are not obtained, the source of the problem must be identified, and corrective action taken, before
any further mammographic images are acquired using the Senographe Crystal.

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2.2 DICOM Printer Quality

1) Maintenance Interval

Weekly

2) Purpose

To ensure optimal quality of the film printer output, follow the QC program developed by the manufacturer of the
device. Refer to the Printer Operator’s Manual.

3) Maintenance Standards

The printer must pass all tests in the manufacturer's QC program.

If the printer fails a test, the source of the problem must be identified and corrective action taken, before the
printer is used for any further reviews.

4) Record keeping form

Appendix2. DICOM Printer Quality Checklist (Weekly).

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2.3 Flat Field Test

1) Maintenance Interval

Weekly

2) Purpose
It is intended to guarantee the detector uniformity.

3) Supplies to prepare
 Calibration PMMA Block (40mm)

4) Procedure

1. Wipe the Calibration PMMA block clean.

2. Set the C-arm angle to zero degrees.
3. Insert the Standard Collimation Plate.
4. Remove the face shield and insert the PMMA block into the face shield rail.

PMMA Block attached in the face shield rail

5. Remove the Compression Paddle and Bucky.

CAUTION
Recommend that operator need to firstly insert the PMMA block in the face shield rails then
remove the Bucky for protect the detector.

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6. For start CrystalQAP S/W, Double-click the CrystalQAP icon on the desktop.

7. Enter the administrator account of SenoCrystal S/W ID and PW to log into the SenoCrystal QAP S/W.
(Default administrator ID: crystal / PW: 1234)

8. CrystalQAP S/W windows appear as shown below.

9. Click the Flat Filed Test button on top of CrystalQAP S/W.

10. Click the “Start” button and then Current focus/Exposure Condition are displayed on the right of CrystalQAP S/W
– Current Focus: Large
- Current Exposure Condition: 28kVp / 100mAs
11. Take an Exposure.

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12. Raw image is displayed and then results of the test are displayed.
(The results Pop-up windows contain the each Mean Values of 4 ROIs and Pass/Fail result.)

13. Note in Appendix 1. Mammography QA Checklist (Daily, Weekly) that the test was completed,

5) Record keeping form

Appendix 1. Mammography QA Checklist (Daily, Weekly).

6) Maintenance Standards
1. If all tests are not passed, check the test conditions and repeat the test conditions and repeat the test.

-Ensure that the compression paddle and Bucky have been removed.
-Ensure that the C-arm angle is at zero degrees.
-Ensure that the PMMA block is clean and free from scratches.
-Ensure that the surface of the image receptor is clean.

2. If the re-test result does not meet the requirements, contact the technical support of the manufacturer to have the
system correct.

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2.4 Phantom Image Quality Test

1) Maintenance Interval

Weekly

2) Purpose
The test is designed to ensure adequate and consistent quality of the images acquired by the detector.

3) Supplies to prepare
ACR Phantom

4) Procedure

1. Install the compression paddle and Bucky.

2. Start SenoCrystal S/W and create a random patient as “Manual Entry”.
3. Click 'Capture' button to open 'Study'.
4. Set the Maxim Compression Force as 5kg (Refer to Section “Section 1.7 How to set the maximum compression
force).
5. Place the ACR phantom as follows:
One edge of the phantom must be flush with the chest wall edge of the breast support surface. When viewed from
the patient’s position, i.e., facing the mammography unit, the cut-out corner of the wax insert of the phantom must
be opposite to the chest wall and toward the left side of the detector, as indicated below

<ACR Phantom Positioning>

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6. Apply 5kg of compression force to the ACR Phantom.

7. Take an exposure in Manual Mode (28kV, 100mAs).
8. Click “Close study” button and then click” Yes” button to send it to PACS.
9. Exit SenoCrystal.

5) Analysis

1. Open the images on the Review Workstation.

2. Set the images to the optimal condition and adjust using Zoom and Windowing tools.
3. Score the fibers, specks and masses separately and take note of them in the checklist.

6) Action limit

The score for fibers must be at least 4, the score for masses must be at least 3, and the score for speck groups must
be at least 3.
The ACR phantom is an acrylic block containing 16 cells as below image. Each cell simulates an anatomical
structure which may be found in breast tissue. Starting from the top left hand corner, as shown in the illustration, the
cells are of three types:

- Fibers: Six cells represent fibrous structures; they contain fibers.

- Speck groups: Five cells represent micro-calcifications.
- Masses: Five cells represent tumors or masses.

7) Record keeping form

Appendix 3. Phantom Image Quality Checklist (Weekly)

8) Maintenance Standards

If it doesn't meet the requirements, try retaking the image. If the re-imaging result does not meet the requirements,
contact your GE Medical System Service Engineer to have the system corrected.

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2.5 Viewbox and Viewing Conditions Test

1) Maintenance Interval

Weekly

2) Purpose
To ensure good image review conditions by keeping the View box free of dust, finger prints, and other marks and
the viewing conditions optimized.

3) Supplies to prepare
 Glass cleansing solution
 Soft cloth

4) Procedure
1. Remove all the dust, finger prints, and other marks the surface of the reading box by using a glass cleansing
solution and a soft cloth.
2. Check if the brightness of the reading box is uniform.
3. Check if the switches or devices of the reading box works normally.
4. Check the degree of indoor lighting, check if there are any light-producing materials in the room, or any lights
reflecting off of the surface of the reading box.
5. Check the lighting, ventilation, temperature and noise in the image reading room to make sure that no unnecessary
elements exist.
6. Take notes of maintenance results and save them.

5) Record keeping form

Appendix1. Mammography QA Checklist (Daily, Weekly).

6) Action Limit

The viewbox must be free from dust, finger prints, and other marks. Viewing conditions must meet accepted
standards for mammographic image review.

7) Maintenance Standards

If these results are not obtained, the source of the problem must be identified and corrective action taken, before
any further mammographic images are reviewed or interpreted using the view boxes.

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2.6 MTF Measurement

1) Maintenance Interval

Weekly

2) Purpose
The test is designed to ensure that contrast is adequate over the 0-5 lp/mm spatial frequency range by obtaining
an estimate of the MTF (Modulation Transfer Function) values at 2 and 4 lp/mm.

3) Supplies to prepare
 Bar pattern
 DICOM Viewer including ROI measuring function (ex. ImageJ)

4) Procedure

1. Install Standard Collimator Plate and remove the paddle.

2. Set the C-arm angle to 0°.
3. Start SenoCrystal S/W.
4. Place the Bar pattern on the surface of Bucky as picture below.
a. Orient the pattern’s bars parallel to the anode-cathode axis (perpendicular to the chest wall edge of the
Bucky)
b. Position the edge of the bar pattern 60 mm from the chest wall surface of Bucky.

60mm

<MTF parallel>
5. Make an exposure in Manual Mode (28kV, 80mAs).
6. Place the Bar pattern on the surface of Bucky as picture below.
a. Orient the pattern’s bars perpendicular to the anode-cathode axis (parallel to the chest wall edge of the Bucky)
b. Position the edge of the bar pattern 60 mm from the chest wall surface of Bucky.

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60mm

< MTF Perpendicular>

7. Make an exposure in Manual Mode (28kV, 80mAs).
8. Run the ImageJ Program on the Desktop.

9. Open the (4) Raw image (Refer to section 1.4 How to locate Raw files)
10. Adjust the image size for optimum visibility by using “Magnifying glass” icon ( ).
11. Click the “Elliptical” icon ( ) to make ROI measurement.

12. Make the total 4 ROI as picture below.

a. Select an ROI containing only “space” material and then press “Ctrl + T” on Keyboard.
- When appear Result pop-up window, record the Mean and Std value in Appendix 4. MTF Measurement Test
Record (Weekly).
b. Select an ROI containing only “bar” material and then press “Ctrl + T” on Keyboard.
- When appear Result pop-up window, record the Mean and Std value in Appendix 4. MTF Measurement Test
Record (Weekly).
c. Set the largest ROI containing only the 2 lp/mm pattern. Adjust the size of the ROI to include as much of the
2p/mm pattern group as possible. And press “Ctrl + T” on Keyboard
- When appear Result pop-up window, record the Mean and Std value in Appendix 4. MTF Measurement Test
Record (Weekly).
d. Set the largest ROI containing only the 4 lp/mm pattern. Adjust the size of the ROI to include as much of the
4p/mm pattern group as possible. And press “Ctrl + T” on Keyboard
- When appear Result pop-up window, record the Mean and Std value in Appendix 4. MTF Measurement Test
Record (Weekly).

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<MTF paralle>

13. Open the step(6) Raw image and Repeat the perpendicular MTF measurement in the same way as described above.

<MTF Perpendicular>

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5) Record keeping form

Appendix4. MTF Measurement Test Record (Weekly)

6) MTF Calculations

Use the following equations to estimate the MTF for the two frequency points :

𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆2𝑙𝑙𝑙𝑙/𝑚𝑚𝑚𝑚
𝑀𝑀𝑀𝑀𝑀𝑀2𝑙𝑙𝑙𝑙/𝑚𝑚𝑚𝑚 = × 222
𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 − 𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑏𝑏𝑏𝑏𝑏𝑏

𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆4𝑙𝑙𝑙𝑙/𝑚𝑚𝑚𝑚
𝑀𝑀𝑀𝑀𝑀𝑀4𝑙𝑙𝑙𝑙/𝑚𝑚𝑚𝑚 = × 222
𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 − 𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑏𝑏𝑏𝑏𝑏𝑏

7) Action Limit

The system passes the MTF Measurement test if all of the following conditions are met:
- MTF Parallel at 2 lp/mm > 50% / MTF Parallel at 4 lp/mm > 15%
- MTF Perpendicular at 2 lp/mm >50% / MTF Perpendicular at 4 lp/mm > 15%
For each condition that is met, the Status will be Passing

8) Maintenance Standards

Failure of MTF Measurement Test: If the system fails the MTF Measurement Test, you should ensure that all test
conditions are met and then repeat the test. If the system still fails, it is recommended that you contact your GE
Medical Systems Service Engineer.
-

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2.7 Visual Checklist

1) Maintenance Interval

Monthly

2) Purpose
It is intended to find out if the system displays, locking devices, and mechanical parts work well and if the system is
mechanically stable.

3) Supplies to prepare
None

4) Procedure
Check the system parts below to determine normal working order and take note of the results in the checklist.
 Base display
: Check that all base display values are consistent with C-arm rotation, compression force and compression
thickness.
 Locks (all)
: Check if the device stops properly when releasing rotation and lift motion buttons and footswitches.
 Smoothing of motion
: Check if the device moves smoothly.
 Check all Paddles for cracks.
 Paddle movement
: Check Paddle movement by using keypad and pressing Footswitch.

5) Record keeping form

Appendix 6. Visual Checklist (Monthly)

6) Maintenance Standards

If you find any inappropriate results in the checklist, contact your GE Medical System Service Engineer to have the
system corrected.

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2.8 Repeat and Reject Analysis

1) Maintenance Interval

Quarterly
For the repeat rates to be meaningful, an analysis period that yields a patient volume of at least 250 patients or
1,000 exposures is needed.

2) Purpose

Determining the number and cause of re-imaging and problem images is intended to improve efficiency, reduce
cost, and reduce radiation exposure to patients.

3) Supplies to prepare

None

4) Procedure
1. Collect the re-taken images for the period to be checked.
2. Classify and divide the images based on the reason re-imaging and note their numbers in the checklist.
3. Calculate the total number of re-imaged and rejected images.
4. The percentage of re-taken images can be found as follows:

The percentage of Total Number of re-taken images

= x 100
re-taken images Total number of images taken
during the analysis period
5. The percentage of re-taken images by cause can be found as follows:

Percentage of Number of re-taken images by cause

re-taken images = Total number of re-taken images x 100
by cause

5) Record keeping form

Appendix 7. Repeat Analysis Checklist (Quarterly)

6) Action limit
The total repeat rate or reject rate must not change by more than 2.0% of the total exposures included in the
analysis from the rate determined for the previous analysis period.

7) Maintenance Standards

The images taken for quality control are not counted in the re-imaging control analysis.
If the total repeat rate or reject rate changes from the rate determined for the previous analysis period by more
than 2.0% of the total exposures included in the analysis, the source of the problem must be identified, and
corrective action taken, within 30 days of the test date. Any corrective actions taken must be recorded, and an
assessment must be made of their effectiveness.

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2.9 Review Workstation Quality

1) Maintenance Interval

Quarterly

2) Purpose
It is intended to keep the brightness and contrast consistent for the image reading monitor.

3) Supplies to prepare

 SMPTE Pattern (Off-the-shelf)

 AAPM TG18-UNL10, TG18-UNL80 Pattern (Off-the-shelf)

4) Procedure
1. Start SenoCrystal and click the ”Browser” Tap
2. Enter “TestQC” at the Patient Name blank or “TG18PQT” at Patient ID and click the “Search Patient” button.
3. Open the SMPTE pattern Image.(Refer to Section 1.5 “How to open Pattern Image)
4. Send the SMPTE pattern image to image reading monitor.

<SMPTE Test Pattern for Maintaining the Image Reading Monitor>

5. Brightness and Contrast
Observe the changes of the dotted arrow on the pattern. Check the changes of contrast from black 0% to white
100% in this example. The small squares of 5% and 95% within the squares 0% and 100% in the arrow area should
be shown clearly.

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6. Artificial Shade
When any artificial shade is shown in the pattern, take note of it and adjust it accordingly.
7. Geometrical Distortion
The pattern has horizontal and vertical white lines. The square should be seen as a regular tetragon, and must
have no distortions. If there is any protruding or concave lines, mark the degree of the greatest distortion in mm.
The lines cannot stray more than 5mm anywhere on the monitor.
8. Spatial Resolution
The four corners and the pair of white and black lines in the light green square in the center of the pattern must be
distinguishable. The six sections must be clearly distinguishable, and not a single one of the five cells can have a
problem.
9. Open the TG18-UNL10 and TG18-UNL80 pattern on the image reading monitor.

<TG18-UNL10, TG18-UNL80 Pattern>

10. Measure the brightness of the five areas and record each on the checklist. Then take note of the values of
brightness uniformity in % by dividing the maximum brightness value and minimum brightness value by the center
value.
 Black Color Brightness: The highest measured latitude value in the five areas in TG18-UNL10 must be less than
1.2 cd/m2.
 White Color Brightness: The lowest measured latitude value in the five areas in TG18-UNL80 must be over 200
cd/m2.
 Uniform Brightness: The difference between the highest value and the lowest value of measured brightness
must be less than 30% based on the center value.

5) Record keeping form

Appendix 8. Review Workstation Quality Checklist (Quarterly).

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2.10 Compression Force Test

1) Maintenance Interval

Semi-annually

2) Purpose
It is intended to find out if the mammography compression Paddle provides the proper amount of compression and not
excessive compression.

3) Supplies to prepare
 Scale
 Towels

4) Procedure
1. Install the compression paddle and Bucky.
2. Put a towel on the Bucky to protect the system, and put the scale on top of that. Place the scale over the center of
the compression paddle.
3. Put a towel on the scale to prevent the compression paddle from breaking it.

<Setting for Checking the Breast Compression>

4. Start SenoCrystal and create a random patient as “Manual Entry”.
5. Click 'Capture' button to open 'Study'.
6. Set the maximum compression force as 20kg(Refer to section1.7 how to set the maximum compression force)
7. Apply a maximum compression force to scale during 1 minute.
8. Read the compression force from the scale and note it in the checklist.
9. Release the compression.
10. Exit SenoCrystal.

5) Record keeping form

Appendix 9. Compression Force Checklist (Semi-annually)

6) Action limit

The maximum compression force for the initial power drive must be between 11 and 20 kg

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2.11 Uncorrected Defective Pixels

1) Maintenance Interval

Semi-annually

2) Supplies to prepare
 Calibration PMMA Block (40mm)
 Blank CD or DVD
 Flat field test software (available in EUREF website)

3) Procedure

1. Enter the SenoCrystal S/W.

2. Remove the face shield and insert the PMMA block into the face shield rail.

3. Change Small Focus to Large Focus by toggling the focal spot button.

This is because the focal spot is automatically changed to ‘Small Focus’ after the Bucky is removed.
4. The test configuration is as below for finding Uncorrected Defective Pixels (aka, UDP). This test is performed using
Calibration PMMA block in the Manual Exposure Mode (28kV, 100mAs).
5. Take an exposure to get an image.
6. Acquire 4 more images. Note that PMMA blocks should be detached and attached for each image acquisition.
7. Collect 5 raw image files and burn them into CD or DVD. (Refer to Secction1.4 How to locate Raw files)
8. Launch the flat field test software, and set the parameters as below.

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Box dimension: 1cm

Pixel offset: 0
Deviating ROI’s: 5%
Deviating Pixels: 20%

9. Click “Open DICOM File” button and select the image to get UDP analysis report.
10. Click “Output File” button, and set the destination directory and file name (e.g. 1.txt) to save analysis report.
11. Click “Calculate” button to start UDP analysis.
12. Repeat 4 more times from step 4 to 6 to analyze each of all 5 images.
13. Open 5 reports and check if there is any defective pixel. A pixel is considered defective if its coordinates are the
same on 5 images.
14. Pass the test if there is no defective pixel. Below is an example of a passing result with zero defective pixel.

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15. If failed, try above procedure once more.

16. If the problem persists, please contact your GE Medical System Service Engineer to have the system corrected.

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SECTION 3: TESTS FOR

MEDICAL PHYSICIST

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Introduction
QC Test for the medical physicist is as follows:

Section Item Frequency Purpose

Check the consistency of the digital image
3.1 SDNR Measurement Weekly
receptor by evaluating the signal-to-noise ratio.
Monitor Quality Maintain a constant environment for the imaging
3.2 Semi-annually
(For Control Station) monitor
3.3 Collimation Assessment Annually Check to maintain the proper X-ray field
Evaluation of Focal Spot Evaluate the performance of the tube filament
3.4 Annually
Performance and the resolution of the image receptor
kVp Accuracy and
3.5 Annually Check for the consistency of the tube voltage
Reproducibility
Beam Quality Check if it is proper to minimize the glandular
3.6 Annually
Assessment (HVL) dosage of a patient
Measure the incident exposure dosage from a
Average Glandular
3.7 Annually normal patient to measure the average glandular
Dose Measurement
dose
Evaluate if any artifact is found in the images
3.8 Artifact Evaluation Annually from the detector analyze the cause, and try to
remove it
AEC Performance and Check the accuracy and reproducibility in AEC
3.9 Annually
Reproducibility mode
For more information on the procedures for each test, please check the applicable sections.

CAUTION
When test procedures are run which do not require the capture of X-rays by the detector and
require the presence of an object in the X-ray beam (e.g., the measurement of dose using a
dosimeter), the detector must be protected by a Lead plate or equivalent attenuator. This will prevent
any possibility of ghost images.

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3.1 Signal Difference to Noise Ratio (SDNR)

Measurement
1) Maintenance Interval

Weekly

2) Purpose

To assure consistency of the digital image receptor by evaluating the signal-to-noise ratio(SDNR).

3) Supplies to prepare
MTM 100 Phantom

4) Procedure
1. Install Bucky, standard compression paddle and normal collimation plate.

2. Start the SenoCrystal S/W and Click the “Manual Entry” to create new study.
3. Click 'Capture' button to enter Capture mode.
4. Place the MTM100 phantom on surface of Bucky.
5. Apply a compression force of 5kg to the MTM100 Phantom.
6. Take an exposure in Auto Mode.

7. Close Capture mode and enter “Viewer mode” to measure the SDNR on acquired image.
8. Open the raw image. (Refer to Section.1.6 How to review the Raw image) and then adjust the windowing level.

9. Click the SDNR icon( )near the middle left of the screen.
10. Click the 2 ROI as picture below and then appear the SDNR value on screen.

11. Record the SDNR value in Appendix 5. SDNR Measurement Test Record (weekly)

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5) Action Limit

The system passes the SDNR Measurement test:

- If the change in SDNR does not exceed 0.2 when computed with an existing SDNRoI value, such that change
in SDNR = |SDNR - SDNR𝐨𝐨𝐨𝐨| /SDNR𝐨𝐨𝐨𝐨.
If this condition is met, the Status will be Passing

6) Record keeping form

Appendix 5 SDNR Measurement Test Record (weekly)

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3.2 Monitor Quality (For Control station)

1) Maintenance Interval

Semi-annually

2) Purpose
It is intended to keep the brightness and contrast consistent for the imaging monitor.

3) Supplies to prepare
SMPTE Pattern (Off-the-shelf)

4) Procedure

1. Start SenoCrystal and click the “Browser “Tap to open the pattern images.
2. Enter “TestQC” at the Patient Name blank or “TG18PQT” at the Patient ID and click the “Search Patient” button.
(Refer to Section 1.5 “How to open the Pattern Image)
3. Open SMPTE pattern on the imaging monitor.

<SMPTE Test Pattern for Maintaining the Imaging Monitor>

4. Check the following and note them in the checklist.
 Check if a small square (left arrow) inside of the square of 0%~5% is visible.
 Check if a small square (right arrow) inside the square of 95%~100% is visible.
 Check if each step for 0~100% (dotted arrow) is divided and visible.
 Check if the SMPTE Patterns around the corner and in the center are distinguishable.

5) Record keeping form

Appendix 11 Monitor Quality (for Control Station) Checklist (Semi-annually)

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3.3 Collimation Assessment

1) Maintenance Interval

Annually

2) Purpose
Check the difference between the X-ray field and Light field, and the X-ray field and Image Receptor to determine if
the proper X-ray field is being maintained.

3) Supplies to prepare
 1 sheet of white paper
 4 coins of the same size
 Radiation Protection Plate (in a size that can cover the detector completely)
 X-ray Light Field Alignment tool

4) Procedure
Check the difference between the X-ray and Light Fields
1. Install Bucky and remove the compression paddle.
2. Place the Radiation Protection Plate on the surface of the Bucky to prevent detector ghost.
3. Start SenoCrystal and create a random patient as “Manual Entry”.
4. Click 'Capture' button to open 'Study'.
5. Press the footswitch slightly to turn the light on.
6. Fit the X-ray Light Field Alignment Tool to the edge of the collimator shadow. Use the white paper at this time to fit
the tool in more easily.

<X-ray Light Field Alignment Tool Positioning>

7. Take the image manually at 32kVp and 125mAs.
8. Read the result of the X-ray light field alignment tool and note it in the checklist. At this time, when X-ray extends to
the outside of the FOV, record it as “+”, but when it enters inside the FOV, record it as “-”.

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9. Make an exposure for the remaining three edges and note the results in the checklist.
Check the difference between Light Field and Image Receptor
1. Install Bucky and remove the compression paddle.
2. Start SenoCrystal and create a random patient as “Manual Entry”.
3. Click 'Capture' button to open 'Study'.
4. Press the footswitch slightly to turn the light on.
5. Place four coins inside the collimator. Each coin has to touch one of the edges of the collimator shadow.
6. Use the white paper at this time to fit the tool in more easily.

<Coin Positioning to Check the Difference between Light Field and Image Receptor>
7. Make an exposure as manual mode 28kVp and 50mAs.
8. Close the Capture mode and Enter the viewer mode to display the captured image.
9. Check the difference between Light Field and Image Receptor
10. Measure how many the coins on each edge come off of the image, and note the results in the checklist.
11. Check the difference between the X-ray field and the image receptor
12. Measure how many the coins on each edge come off of the image, and note the results in the checklist.

5) Record keeping form

Appendix 12. Collimator Assessment Checklist (Annually)

6) Action Limit

1. Congruence of the light field with the X-ray field must be such that the total misalignment (sum of misalignments
on opposite sides) is within 2% of the SID.
2. The difference of X-ray field and image receptor should not exceed 1% of SID to each edge

7) Maintenance Standards

If the result does not meet the requirements, contact your GE Medical System Service Engineer to have the system
corrected.

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3.4 Evaluation of Focal Spot Performance

1) Maintenance Interval

Annually

2) Purpose
To evaluate focal spot performance by using a high-contrast resolution pattern

3) Supplies to prepare
 Resolution Test Pattern

4) Procedure

1. Install the compression paddle and Bucky.

2. Start SenoCrystal and create a random patient as “Manual Entry”.
3. Click 'Capture' button to open 'Study'.
4. Place the resolution test pattern on surface of Bucky.

<Resolution Test Pattern Positioning>

5. Apply a compression force of 5kg to resolution test pattern.
6. Make an exposure it in the AEC Mode
7. Close the Capture mode and then enter the Viewer mode to measure the bar pattern images.
8. Use the Zoom and windowing on resolution pattern image to make optimal condition.
9. Record the highest frequency pattern whose lines are distinctly visible throughout at least half of the bar length
and record the highest frequency visible for each test image.

5) Record keeping form

Appendix 13. Evaluation of Focal Spot Performance Checklist (Annually)

6) Action Limit

Measurements made with the bars parallel to the anode-cathode axis must be at least 7 lp/mm; measurements with
the bars perpendicular to the anode-cathode axis must be at least 5 lp/mm.

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7) Maintenance Standards

If it doesn't meet the requirements, try retaking the image. If the re-imaging result does not meet the requirements,
contact your GE Medical System Service Engineer to have the system corrected.

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3.5 kVp Accuracy and Reproducibility

1) Maintenance Interval

Annually

2) Purpose
It is intended to check if the selected tube voltage is accurately measured in the limited range and if it shows
consistent tube voltage in repetitive imaging.

3) Supplies to prepare
 kVp meter
 Radiation Protection Plate (in a size that can cover the detector completely)

4) Procedure
1. Install Bucky and remove the compression paddle.
2. Turn off ‘Auto Release’ mode.
3. Place the Radiation Protection Plate on the surface of the Bucky to prevent detector ghost.
4. Place the kVp meter probe 6 cm away from the center of the chest wall.
5. Start SenoCrystal and create a random patient as “Manual Entry”.
6. Click 'Capture' button to open 'Study'.
7. Take an exposure in Manual Mode (28kV, 100mAs).
8. Note the measured kVp value in the checklist.
9. Note in the checklist of the kVp values measured by taking three more exposures in the same conditions.
10. Exit SenoCrystal.

5) Record keeping form

Appendix 14. kVp Accuracy and Reproducibility Checklist (Annually)

6) Action Limit

- The kVp shall be accurate within ± 5 percent of the indicated or selected kVp at each of the above measurement
points.
- At the most commonly used clinical setting of kVp, the coefficient of variation of reproducibility of the kVp shall be
equal to or less than 0.02

7) Maintenance Standards

- If it doesn't meet the requirements, try retaking the image. If the re-imaging result does not meet the requirements,
contact your GE Medical System Service Engineer to have the system corrected.

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3.6 Beam Quality Assessment (HVL)

1) Maintenance Interval

Annually

2) Purpose
It is intended to check if HVL (Half Value Layer) of the X-ray beam is suitable to minimize the glandular dose of a
patient without reducing contrast

3) Supplies to prepare
 X-ray Dosimeter
 5 - 6 thin plates with 0.1 mm thickness consisting of 99.9% pure aluminum (1145-Type aluminum alloy) or 99%
pure aluminum (1100-Type aluminum alloy) that can cover the collimator completely. The use of type 1100
aluminum alloy for HVL measurement can give (depending on specific samples) HVL values up to 7.5% lower than
those measured using pure aluminum. If type 1100 aluminum is used, results should be corrected to agree with
those obtained using pure aluminum.
 Radiation Protection Plate (in a size that can cover the detector completely)
 Tapes to attach the thin aluminum plates

4) Procedure
1. Install Bucky and remove the compression paddle.
2. Turn off ‘Auto Release’ mode.
3. Place the Radiation Protection Plate on the surface of the Bucky to prevent detector ghost.
4. Place the dosimeter 6cm away from the center of the chest wall.
5. Start SenoCrystal and create a random patient as “Manual Entry”.
6. Click 'Capture' button to open 'Study'.
7. Make an exposure as manual mode 26kVp and 80mAs and note the dose in the checklist.
8. Note : If dosimeter can directly measures HVL, measure it directly instead of using the aluminum thin plates and
skip to analysis chapter
9. Attach the thin aluminum plates with the 0.2 mm thickness in front of the collimator.
10. Make an exposure as manual under the same condition and note the dose in the checklist.
11. Add thin aluminum plates with a thickness of 0.1 mm in front of the collimator, and note the value of the dose every
time until it drops to less than half of the original exposure dose (this is the does without the aluminum plates
inserted between the X-ray tube and the ionization chamber).
12. Repeat these 11 step 3times and note the dose in the checklist
13. Exit SenoCrystal.

5) Analysis

To calculate the Half-Value Layer (HVL) by logarithmic interpolation, use the following notation and procedure.

- Denote the direct exposure reading, without any added aluminum, as𝐸𝐸0 .
- Divide this value in half and find the two exposure readings and added aluminum thicknesses that bracket the
𝐸𝐸0 /2 exposure.
- Let 𝐸𝐸𝑎𝑎 be the exposure reading that is just greater than one-half of 𝐸𝐸0 and ta be the corresponding aluminum
thickness.

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- Let 𝐸𝐸𝑏𝑏 be the exposure reading that is just less than one-half of 𝐸𝐸0 and 𝑇𝑇𝑏𝑏 the corresponding aluminum
thickness.

- 𝐸𝐸𝑎𝑎 will be greater than𝐸𝐸𝑏𝑏 , while ta will be less than𝑇𝑇𝑏𝑏 .

- With this notation, the HVL may be computed using the formula:

𝑇𝑇𝑏𝑏 *ln [2𝐸𝐸𝑎𝑎 /𝐸𝐸0 ] – 𝑇𝑇𝑎𝑎 *ln [2𝐸𝐸𝑏𝑏 /𝐸𝐸0 ]

HVL(mm AL) = x 100
ln[𝐸𝐸𝑎𝑎 /𝐸𝐸𝑏𝑏 ]

6) Record keeping form

Appendix 15 Beam Quality Assessment Checklist (Annually)

7) Action Limit
kV/100 + 0.03 (in mm Al) ≤ Measured HVL ≤ kV/100 + 0.3(in mm Al)

8) Maintenance Standards

If it doesn't meet the requirements, try retaking the image. If the re-imaging result does not meet the requirements,
Contact your GE Medical System Service Engineer to have the system corrected.

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3.7 Average Glandular Dose Measurement

1) Maintenance Interval

Annually

2) Purpose
It is intended to measure the typical incident exposure dose from a normal patient (about 4.2 cm compressed
breast thickness - 50% fatty substance, 50% mammary alveolar system) to calculate the corresponding average
glandular dose.

3) Supplies to prepare

 ACR Phantom
 X-ray Dosimeter

4) Procedure
1. Install the compression paddle and Bucky.
2. Start SenoCrystal and create a random patient as “Manual Entry”.
3. Click 'Capture' button to open 'Study'.
4. Place the ACR Phantom on the center of the surface of Bucky and align edge with chestwall
5. Apply a compression force of 5kg to the ACR Phantom.
6. Take an exposure in AEC Mode, and note the conditions.
7. Turn off ‘Auto Release’.
8. Set the compression paddle to 4.5 cm high by pressing the two footswitches simultaneously.
9. Place the dosimeter probe 6cm away from the chest wall, with the upper part of the phantom level with the center
of the dosimeter.
10. Select the Manual mode and set the kV, mAs as close as possible to the kV, mAs used in Auto Mode. (Refer to
Section “1.8 How to use QC Exposure tool”)
11. Take four manual exposures.
12. Note the dose values in the checklist.
13. Exit SenoCrystal.

5) Analysis

1. Take note of the average value of the measured dose value in mGy. 1R in the air is 8.73mGy.
2. Note the average glandular dose by using the formula below.

𝑚𝑚𝑚𝑚𝑚𝑚
𝐀𝐀𝐀𝐀𝐀𝐀 (𝐦𝐦𝐦𝐦𝐦𝐦) = 𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴 𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀 (𝑚𝑚𝑚𝑚𝑚𝑚)𝑥𝑥 𝐷𝐷𝐷𝐷𝐷𝐷( )
𝑚𝑚𝑚𝑚𝑚𝑚
3. Refer to the table below.

HVL DgN(mGy/mGy)
(mm) : Average Glandular Dose conversion factor W-Rh (50 μm thick)
0.338 0.184
0.365 0.206
0.392 0.227

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HVL DgN(mGy/mGy)
(mm) : Average Glandular Dose conversion factor W-Rh (50 μm thick)
0.420 0.248
0.444 0.267
0.462 0.279
0.477 0.289
0.489 0.296
0.500 0.304
0.509 0.310
0.518 0.315
0.527 0.321
0.535 0.327
0.544 0.332
0.552 0.338
0.560 0.344
0.569 0.350
0.577 0.356
0.585 0.362
0.593 0.369
0.601 0.374
4. When an applicable HVL is unavailable for the Average Glandular Dose conversion factor, use it by interpolation.
(Use the value of HVL(mm Al) calculated in Section 3.6 Beam Quality Assessment(HVL)

6) Record keeping form

Appendix16. Average Glandular Dose Checklist (Annually)

7) Action Limit

- The mean glandular dose to the Standard breast must not exceed 3 mGy (0.3 rad) per view.

8) Maintenance Standards

- If it doesn't meet the requirements, try retaking the image. If the re-imaging result does not meet the requirements,
contact your GE Medical System Service Engineer to have the system corrected.

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3.8 Artifact Evaluation

1) Maintenance Interval

Annually

2) Purpose
To assess the degree and source of artifacts visualized in full field digital mammograms or phantom

3) Supplies to prepare
Calibration PMMA Block(40mm)

4) Procedure

1. Wipe the Flat Filed Phantom clean.

2. Remove the Bucky, compression paddle and face shield
3. Set the C-arm 0° for default position
4. Insert the PMMA block into the face shield rail.
5. Start SenoCrystal and create a random patient as “Manual Entry”.
6. Click Capture' button to open 'Study'.
7. Take an exposure in Manual Mode (28kV, 100mAs).
8. Exit SenoCrystal.

5) Analysis

1. Open the raw file of the image in Viewer mode.(Refer to section 1.6 How to review the raw image)
2. Check for any artifacts in the image by using Zoom and Windowing tools. Examine the image for gridlines, plus or
minus signal variations, streaking in the horizontal or vertical directions, residual images left over from repeated
test or clinical exposures, acrylic sheet artifacts, or bad pixels.
3. Take note of the results in the checklist.

6) Record keeping form

Appendix 17 Artifact Evaluation Checklist (Annually)

7) Action Limit

- There must be no artifact or non-uniformity that is expected to mimic or obscure clinical information.

8) Maintenance Standards

- If it doesn't meet the requirements, try retaking the image. If the re-imaging result does not meet the requirements,
contact your GE Medical System Service Engineer to have the system corrected.

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3.9 AEC Performance and Reproducibility

1) Maintenance Interval

Annually

2) Purpose

It is intended to check the accuracy and reproducibility of the conditions in AEC (Automatic Exposure Control) Mode.

3) Supplies to prepare

 20mm, 40mm, 60mm thick Acrylic Plates

4) Procedure

1. Install the compression paddle and Bucky.

2. Set the compression force limit to 5kg and turn off ‘Auto Release’ mode.
3. Start SenoCrystal and create a random patient as “Manual Entry”.
4. Click 'Capture' button to open 'Study'.
5. Place the 20mm thickness acrylic plate on the surface of Bucky,
6. Apply a compression force of 5kg to the acrylic Plate.
7. Take an exposure in Auto Mode, and note the kVp and mAs used in the checklist.
8. Open the raw file of the image taken with the DICOM Viewer. For more information, refer to section1.4 How to
locate Raw files.
9. Set the 2cm x 2cm ROI at a point 6 cm away from the center of the chest wall, and note the average value in the
"the average value of pixels” of the checklist.
10. Take 3 additional exposures in the same conditions.
11. Repeat the steps above for the 40mm and 60mm Acrylic Plate.
12. Exit SenoCrystal.

5) Analysis
1. Compute the average value and the standard deviation of mAs values for each exposure.
2. Compute the average value and the standard deviation of the pixel values, recorded for each image.
3. Note the standard deviation divided by the average value as a % value in the "coefficient of variation" of the
checklist.
𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆 𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑(𝑠𝑠𝑠𝑠)
𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂 𝐨𝐨𝐨𝐨 𝐯𝐯𝐯𝐯𝐯𝐯𝐢𝐢𝐚𝐚𝐚𝐚𝐚𝐚𝐚𝐚𝐚𝐚 (%) = × 100
𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀 (𝑀𝑀)

6) Record keeping form

Appendix 18 AEC Performance and Reproducibility Checklist (Annually)

7) Action Limit

- The coefficient of variation of mAs and average pixel values must not exceed 5%

8) Maintenance Standards

- If it doesn't meet the requirements, try retaking the image. If the re-imaging result does not meet the requirements,
contact your GE Medical System Service Engineer to have the system corrected.

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SECTION 4: APPENDIX

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1. Mammography QA Checklist (Daily, Weekly)

Year Month

Date 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Monitor cleaning
(Daily)

Viewboxes and
Viewing Conditions
(Weekly)

Flat FieldTest
(Weekly)

Year Month

Date 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Monitor cleaning
(Daily)

Viewboxes and
Viewing
Conditions
(Weekly)

Flat FieldTest
(Weekly)

• Monitor Cleaning / Viewboxes and Viewing Conditions:

Note the checklist by “O” or “X”, if inspections are carried out.

• Flat Field Test:

Note the result by “Pass”, If test is passed.

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2. DICOM Printer Quality Checklist (Weekly)

Year

Month

Date

Control
Operating Level
Limit

Mid Density
±0.15
Value (40%)

Density
Difference
±0.15
Value
(10%-40%)

Lower Density
±0.15
Value (90%)

PASS / FAIL

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3. Phantom Image Quality Checklist (Weekly)

Year

Month

Date

Fibers
Speck
groups
Masses

PASS/FAIL

• Action Limit:
If this condition is met, the Result will be Passing
ACR Mammography
Fibers Speck Groups Masses
Accreditation Phantom
Minimum Passing Score 4.0 4.0 3.0

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4. MTF Measurement Test Record (Weekly)

Year

Month

Date

MTF Parallel
Mean Sd. MTF (%) PASS / FAIL

Space

Bar

MTF 2lp/mm

MTF 4lp/mm

MTF Perpendicular
Mean Sd. MTF (%) PASS / FAIL

Space

Bar

MTF 2lp/mm

MTF 4lp/mm

• MTF Calculations:
𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆2𝑙𝑙𝑙𝑙/𝑚𝑚𝑚𝑚
𝑀𝑀𝑀𝑀𝑀𝑀2𝑙𝑙𝑙𝑙/𝑚𝑚𝑚𝑚 = × 222
𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 −𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑏𝑏𝑏𝑏𝑏𝑏

𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆4𝑙𝑙𝑙𝑙/𝑚𝑚𝑚𝑚
𝑀𝑀𝑀𝑀𝑀𝑀4𝑙𝑙𝑙𝑙/𝑚𝑚𝑚𝑚 = × 222
𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 − 𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑏𝑏𝑏𝑏𝑏𝑏

• Action Limit:
The system passes the MTF Measurements test if all of the following conditions are met:
- MTF Parallel at 2 lp/mm > 50%/MTF parallel at 4 lp/mm > 15%
- MTF Perpendicular at 2 lp/mm > 50%/MTF Perpendicular at 4 lp/mm > 15%

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5. SDNR Measurement Test Record (Weekly)

Year

Month

Weekly

SDNR
Value

PASS/
FAIL

• Action Limit:
The system passes the SDNR Measurement test:
- If the change in SDNR does not exceed 0.2 when computed with on existing SDNR value, such that
change in SDNR = l SDNR – SDNR𝐨𝐨𝐨𝐨 l / SDNR𝐨𝐨𝐨𝐨
- If this condition is met, the Status will be Pass

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6. Visual Checklist (Monthly)

Year

Month

Date

Gantry
Base display

Locks (all)

Collimator Lamp

Smoothness of
motion
Inspect all paddles
for cracks
Switches
(Keypad, Footswitch)

Record the checklist by “O” or “X”, if inspections are carried out.

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7. Repeat and Reject Analysis Checklist

(Quarterly)
Period Date : From To

Number of Percentage Number of Percentage of

Cause
Repeat of Repeats Rejects Rejects

Image Artifact

Gird Artifact

Positioning

Motion Blur

Under-exposed

Over-exposed

No Image

Detector Artifact
Artifact other than grid or
detector artifact
Mechanical Failure

Electrical Failure

Software Failure
Inappropriate Image
Processing
Unknown Failure

Double Exposure

Others

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Total Repeats + Rejects

Total Repeats

Total Rejects

Total number of exposures

Total Repeat rate (%)

Total Reject rate (%)

Total Repeat + Reject rate (%)

• Calculation:
100 𝑋𝑋 𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅 + 𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅
𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅 + 𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅 𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟(%) =
𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 𝑛𝑛𝑛𝑛𝑛𝑛𝑛𝑛𝑛𝑛𝑛𝑛 𝑜𝑜𝑜𝑜 𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒

100 𝑋𝑋 𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅

𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅 𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟(%) =
𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 𝑛𝑛𝑛𝑛𝑛𝑛𝑛𝑛𝑛𝑛𝑛𝑛 𝑜𝑜𝑜𝑜 𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒

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8. Review Workstation Quality Checklist

(Quarterly)
RWS S/N
Year
Quarter 1 2 3 4
Date(mm/dd)
Brightness and contrast
Artifact
Geometric Distortion
Spatial Resolution
C
LU
White RU
Luminance LL
RL
Luminance Uniformity
C
LU
Black RU
Luminance LL
RL
Luminance Uniformity

PASS / FAIL

• Calculation:

(𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝑚𝑚𝑚𝑚𝑚𝑚 − 𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝑚𝑚𝑚𝑚𝑚𝑚 )
𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿 𝑈𝑈𝑈𝑈𝑈𝑈𝑈𝑈𝑈𝑈𝑈𝑈𝑈𝑈𝑈𝑈𝑈𝑈𝑈𝑈 = × 100 %
𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐
• Action Limit:
In terms of luminance uniformity, the luminance value measured at the 4 corners should be over 70% of the value at
the center

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9. Compression Force Checklist (Semi-

annually)

Year

The half year The first half year The second half year

Date(mm/dd)

Maximum Compression force(kg)

Measured Compression force(kg)

PASS / FAIL

• Action Limit:
The maximum compression force for the initial power drive must be between 11 and 20 kg.

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10. Monitor Quality for Control Station

Checklist (Semi-annually)
Year

The half year The first half year The second half year

Date (mm/dd)

0 ~ 5 % Patch

95 ~ 100 % Patch

0 ~ 10 % Patch

Center SMPTE Pattern

Corner SMPTE Pattern

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11. Uncorrected Defective Pixels (Semi-

annually)
Year

The half year The first half year The second half year

Number of Uncorrected
Defective Pixels

PASS/Fail

• Action Limit:
The number of uncorrected defective pixel must be “0”.

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12. Collimator Assessment Checklist (Annually)

Year

Field of View (cm) / SID

Deviation between X-ray field and light field

Left Edge Deviation

Right Edge Deviation

Sum of magnitudes of left and right edge deviations

Sum as % of SID

Anterior Edge Deviation

Chest wall Edge Deviation

Sum of magnitude of anterior and chest wall edge deviations

Sum as % of SID

Pass/ Fail

Deviation between X-ray field and light Image receptor

Left Edge Deviation (absolute)

Left Edge Deviation (% of SID)

Right Edge Deviation (absolute)

Right Edge Deviation (% of SID)

Anterior Edge Deviation (absolute)

Anterior Edge Deviation (% of SID)

Chest wall Edge Deviation (absolute)

Chest wall Edge Deviation (% of SID)

PASS / FAIL
• Action Limit:
o Deviation between X-ray field and Light field
: Sum of left plus right edge deviation or anterior plus chest edge deviation must be less than 2% of
SID.
o Deviation between X-ray field and edges of the image receptor:
: Deviation must be less than 1% of SID

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13. Evaluation of Focal Spot Performance

Checklist (Annually)
Year

Date (mm/dd)

KVp

mAs

Bar parallel to cathode-anode (lp/mm)

Bar perpendicular to cathode-anode (lp/mm)

PASS / FAIL

• Action Limit:
The system passes the Focal Spot Performance test if all of the following conditions are met:
≥5lp/mm for line-pair bars perpendicular to anode-cathode axis
≥7lp/mm for line-pair bars parallel to anode-cathode axis.

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14. kVp Accuracy and Reproducibility Checklist

(Annually)
Year

Date (mm/dd)

Nominal kVp setting

Exposure 1 Exposure 2 Exposure 3 Exposure 4

Measured kVp

Average Mean kVp

Average Standard deviation (Sd)

Mean kVp – Nominal kVp

0.05 x Nominal kVp

% Error

Coefficient of Variation
(Sd/Mean kVp)
PASS / FAIL

• Action Limit
- The mean kVp should not differ from the nominal by more than ±5% of the nominal kVp
- The coefficient of variation should not exceed 0.02

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15. Beam Quality Assessment Checklist

(Annually)
Year

Date (mm/dd)

Nominal kVp setting

Nominal mAs setting

Exposure measurements (mR)

Exposure 1 Exposure 2 Exposure 3

No aluminum filtration, 𝑬𝑬𝟎𝟎

0.2mm of added aluminum, 𝑬𝑬𝟏𝟏

0.3mm of added aluminum, 𝑬𝑬𝟐𝟐

0.4mm of added aluminum, 𝑬𝑬𝟑𝟑

0.5mm of added aluminum, 𝑬𝑬𝟒𝟒

0.6mm of added aluminum,𝑬𝑬𝟓𝟓

Calculations

E0=(E0a+E0b)/2

E1/2=E0/2

Exposure greater than E1/2: Ea

Al thickness at Ea: ta

Exposure less than E1/2: Eb

Al thickness at Eb: tb

Calculated HVL (mm Al)

Minimum allowed

Maximum allowed HVL

PASS / FAIL

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• Calculations:
𝑇𝑇𝑏𝑏 *ln[2𝐸𝐸𝑎𝑎 /𝐸𝐸0 ] – 𝑇𝑇𝑎𝑎 *ln[2𝐸𝐸𝑏𝑏 /𝐸𝐸0 ]
x 100
HVL(mmAl)= ln[𝐸𝐸𝑎𝑎 /𝐸𝐸𝑏𝑏 ]

- Minimum allowed HVL = kVp / 100 + 0.03

- Maximum allowed HVL= KVp/100 + 0.3 (in case of W/Rh target /filter combination)
• Action Limit
- kVp/100 + 0.03 (in mm Al) ≤ Measured HVL ≤ kVp/100 + 0.3(in mm Al)

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16. Average Glandular Dose Checklist

(Annually)
Year

Date (mm/dd)

kVp

mAs

Measured
HVL(mm Al)*

DgN*
(mGy/mGy)

Measured Exposure 1 Exposure 2 Exposure 3 Exposure 4

Dose
(mGy)

Mean(mGy)

AGD(mGy)*

PASS/FAIL

• HVL(mm Al) * : Use the value of HVL(mm Al) * calculated in

Section 3.6 Beam Quality Assessment (HVL)
• DgN(mGy/mGy)*
- Average glandular dose conversion factor
- Use the value of DgN from right table to determine for measured HVL.
• AGD(mGy)* : Average Glandular Dose
• AGD Calculations:
𝑚𝑚𝑚𝑚𝑚𝑚
𝐀𝐀𝐀𝐀𝐀𝐀 (𝐦𝐦𝐦𝐦𝐦𝐦) = 𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴 𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀(𝑚𝑚𝑚𝑚𝑚𝑚)𝑥𝑥 𝐷𝐷𝐷𝐷𝐷𝐷( )
𝑚𝑚𝑚𝑚𝑚𝑚
• Action limit
- The average glandular dose must not exceed 3.0 mGy (0.3 rad) for a 4.5 cm effective breast
thickness.

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Senographe Crystal APPENDIX

17. Artifact Evaluation Checklist (Annually)

Year

Date (mm/dd)

KVp

mAs

Artifact (Y/N)

Description

PASS / FAIL

• Action Limit: Artifacts are not apparent.

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APPENDIX Senographe Crystal

18. AEC Performance and Reproducibility

Checklist (Annually)
Year

Date (mm/dd)

Acrylic plates
Thickness 20 mm 40 mm 60 mm
(mm)

Attempt mAs Mean Sd mAs Mean Sd mAs Mean Sd

Exposure 1

Exposure 2

Exposure 3

Exposure 4

Average
Mean(M)

Average
Standard
deviation (Sd)

Coefficient of
variation
(Sd/M, %)

PASS/FAIL

• Calculations:
𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆 𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑(𝑠𝑠𝑠𝑠)
𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂𝐂 𝐨𝐨𝐨𝐨 𝐯𝐯𝐯𝐯𝐯𝐯𝐯𝐯𝐯𝐯𝐯𝐯𝐯𝐯𝐯𝐯𝐯𝐯 (%) = × 100
𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀 (𝑀𝑀)

• Action Limit:
- The coefficient of variation shall not exceed 5%.

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