Senographe DS

Contrast Enhanced Spectral Mammography
Quality Control Manual
5391271-3-1EN
Revision 1
© 2010-2014 by General Electric Company
All Rights Reserved.
Contrast Enhanced Spectral Mammography 5391271-3-1EN
Quality Control Manual Revision 1
This page is intentionally left blank.
Page no. 2 Cover.fm

IMPORTANT...X-RAY PROTECTION
CAUTION
If not properly used, x-ray equipment may cause injury. Accordingly, it is your obligation to
confirm that the instructions herein contained are thoroughly read and understood by everyone
who will use the equipment before you attempt to place this equipment in operation. The General
Electric Company, Healthcare Technologies, will be glad to assist and cooperate in placing this
equipment in use.
Although this apparatus incorporates a high degree of certain protections against x-radiation
other than the useful beam, no feasible design of equipment can provide complete protection
from all potential injury. Nor can any feasible design force the operator to take adequate
precautions to prevent the possibility of any persons carelessly exposing themselves or others to
radiation.
It is important that anyone having anything to do with x-radiation be properly trained and fully
knowledgeable about the recommendations of the National Council on Radiation Protection and
Measurements as published in NCRP Reports available from NCRP Publications, 7910
Woodmont Avenue, Room 1016, Bethesda, Maryland 20814, and of the International
Commission on Radiation Protection. It is your obligation and responsibility to take adequate
steps to protect against injury.
The equipment is sold with the understanding that the General Electric Company, Healthcare
Technologies, its agents, and representatives have no responsibility for injury or damage, which
may result from improper use of the equipment. Various protective materials and devices are
available. It is urged that such materials or devices be used in accordance your site’s clinical
practice.
radiation warning.fm Page no. 3

Page no. 4 radiation warning.fm

Table of Contents
Table of Contents
IMPORTANT...X-RAY PROTECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1. Applicability of Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2. How to order a paper version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3. How to access the electronic version of a manual on a website . . . . . . . . . . . . . . . . . . . 7
4. Legal information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4-1. Copyright information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4-2. Trademark information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
5. Regulatory considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
6. Scope of this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7. Overview of this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Chapter 1. QC Tests for the Radiologic Technologist

1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2. QC Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3. Data Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4. Flat field Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5. CESM AUTO Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6. Test Results Record Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Chapter 2. QC Tests for the Medical Physicist

1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Chart 0. Site and System Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Job Card VF-CESM01 - Breast Entrance Exposure and Reproducibility . . . . . . . . . . . . 21
Chart 1 - Breast Entrance Exposure and Reproducibility . . . . . . . . . . . . . . . . . . . . . . . . 25
Job Card VF-CESM02 - Artifact Evaluation and Flat field Uniformity . . . . . . . . . . . . . . . 27
Chart 2 - Artifact Evaluation and Flat field Uniformity . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Job Card VF-CESM03 - Half-Value Layer Measurement . . . . . . . . . . . . . . . . . . . . . . . . 31
Chart 3. Half Value Layer Test Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Chapter 3. Guidance
1. Flat field Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
2. CESM AUTO Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
3. Annual Physicist Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
3-1. Beam Quality Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
4. Breast Entrance Exposure and Reproducibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
TOC.fm Page no. 5

Table of Contents
5. Artifact Evaluation and Flat field Uniformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Page no. 6 TOC.fm

Foreword
Foreword
1 Applicability of Manual
This document “Quality Control Manual” is an element of the Quality Assurance Plan (QAP) of the
mammographic facility. It describes Quality Control (QC) Tests for Contrast Enhanced Spectral
Mammography application, which constitutes an option of the acquisition system Senographe DS or
Senographe Essential. This Quality Control Manual is an addendum to the Senographe DS Quality
Control Manual or Senographe Essential Quality Control Manual.
Application of this manual is MANDATORY for facilities subject to the rules of the United States
Mammography Quality Standards Act (MQSA).
Application of this manual is RECOMMENDED for facilities in locations not subject to the rules of the
MQSA.
WARNING
Quality control tests must be performed regularly to ensure that CESM operates properly.
2 How to order a paper version

A paper copy of this Quality Control Manual can be ordered at no additional cost.
Please send a request to your Sales or Service representative. They will transfer your request to
CEMEURDIST@med.ge.com. In the European Union, in application of the EU Commission Regulation
on electronic instructions for use of medical devices, your request should be processed within seven
days.
3 How to access the electronic version of a manual on a website

The Quality Control Manual is available on the Internet at:
http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library
Note:
A file compression/archival (zip/unzip) utility must be installed on the user’s computer.
1. On the home page, enter the manual direction number (QC_5391271-3-199) in the search field and
click [Search] to launch the search.
search field
2. Click on the underlined Filename.
foreword.fm Page no. 7

Foreword
3. In the next window, click [ACCEPT] to view the file.

4. From the zip file, choose your language (EN).
4 Legal information
4-1 Copyright information
All licensed software is protected by the copyright laws of the United States and by applicable
international treaties.
4-2 Trademark information

• GE and GE Monogram are trademarks of General Electric Company.
• All other product names and logos are trademarks or registered trademarks of their respective
owners.
5 Regulatory considerations
In facilities subject to the MQSA, the procedures in the document “Contrast Enhanced Spectral
Mammography QC Manual” must be followed. Failure to follow these quality assurance procedures can
result in loss of MQSA certification at facilities subject to U.S. regulations.
6 Scope of this Manual

The scope of this quality control (QC) manual is to add specific requirements related to the Contrast
Enhanced Spectral Mammography (CESM) option and not mentioned within the Senographe DS or
Senographe Essential QC manuals. These two manuals remain applicable to the system equipped with
the Contrast Enhanced Spectral Mammography option.
WARNING
This manual provides appropriate user instructions on Quality Control procedures.
7 Overview of this Manual

This Quality Control (QC) Manual consists of three main sections:
1. QC Tests for the Radiologic Technologist.
2. QC Tests for the Medical Physicist.
3. Guidance.
The QC Test sections contain full descriptions of test procedures, testing frequency, and action limits for
tests specific to Digital Mammography. For tests not specific to Digital Mammography, testing
frequencies and action limits are provided but procedures are not fully described.
The Guidance section contains recommendations on procedures for performing tests not specific to
Digital Mammography, as well as supplementary material for user information. References to this
section are made at appropriate points in the QC Test sections.
Page no. 8 foreword.fm

QC Tests for the Radiologic Technologist
Chapter 1 QC Tests for the Radiologic Technologist
1 Introduction
QC tests are simple checks which ensure that the CESM application is operating to its design standards.
They are designed to detect any changes in settings which might compromise image quality, as well as
any deterioration in equipment performance over time.
QC tests for CESM are described in the following sections:
• Section 4 Flat field Test on page 10. Checks for consistency of image quality.
• Section 5 CESM AUTO Mode on page 12. Checks for correct operation of CESM AUTO mode.
• Section 6 Test Results Record Forms on page 15 provides charts for use in recording the results of
the various checks. It is recommended that you make copies of the chart pages and use them to
record the test results.
For further analysis, data generated on the Acquisition Workstation (AWS) for Flat Field tests can be
exported as text files to a CD-R.
2 QC Intervals
As a minimum, the Quality Assurance Procedures described must be performed at the intervals
specified in the test descriptions and summarized below.
Minimum Procedure Section
Frequency
Weekly Flat field Test 4
Monthly CESM AUTO Mode 5
Refer to Chapter 3 Guidance for additional information regarding the QC Tests results.
3 Data Export
To export the QC data files:
• From the Browser, click the QAP button, then select Extract Data.
• A pop-up is displayed instructing you to insert a blank CD-R. Insert the CD-R and click OK.
This action saves the data generated since the last data export.
Exported files can be easily opened on a computer using a word processing application. They contain
the data displayed on the screen after the test is completed.
Note:
Files can only be exported once.
Chap 1 QC_tests_technologist.fm Page no. 9 Chapter 1

4 Flat field Test

• Frequency:
Weekly.
• Objective:
Three tests are carried out when the Flat field Test is selected. They check brightness non–
uniformity, High Frequency Modulation and SNR non–uniformity.
• Equipment required:
Flat field test object. This is an X–ray attenuator composed of 25 mm thick acrylic (PMMA) covering
the entire image receptor.
! Notice:
To avoid false results, the acrylic must be clean and free from imperfections.
Note:
To allow for temperature stabilization of the detector, the system must be powered on for at least
10 minutes before performing any measurements related to detector image quality. If any test fails
after allowing a 10-minute warm-up period, see Chapter 3 Guidance section 1 Flat field Test on
page 37.
• Procedure:
1. Click on the QAP button .

2. Click on CESM, then select Flat field MoCu.
3. Using the light field, check that the collimator is set for the largest available field of view.
4. Set the tube arm angle to zero degrees.
5. Follow the on–screen instructions.
6. After the last image has been captured, the results of the test are displayed. If all of the tests are
passed, record the results in Chart 1. Flat field Test Record on page 15.
7. Perform steps 1 to 6 replacing Mo/Cu with Rh/Cu track/filter (QAP/CESM/Flat field RhCu).
Parameters selected automatically are: large focal spot, Rh/Cu track/filter, 48 kV, 125 mAs.
Note:
The display of test results will indicate if any test failure has been detected during the procedure.
Possible failures are:
- brightness non-uniformity test failed,
- High Frequency Modulation test failed
- SNR non-uniformity test failed
Chapter 1 Page no. 10 Chap 1 QC_tests_technologist.fm

8. If any test fails, check the test conditions and repeat the test after correction.
- Check that the detector has been allowed to warm up for at least 10 minutes before acquiring the
test images.
- Check that the compression paddle has been removed.
- Check that no object except the Flat field Test Object is present in the field of view.
- Check that the collimator is open to the largest available field size.
- Check that the tube arm angle is at zero degrees.
- Check that the surface of the image receptor is clean.
- Check that the Flat field Test Object fully covers the field of view of the image receptor.
- Check that the Flat field Test Object is clean and free from scratches or other imperfections:
- Clean or replace the test object as necessary.
- If there is a scratch or defect near an edge of the test object, attempt to orient the test object
so that the imperfection is outside the field of view of the image receptor. After re-orienting the
test object, ensure that it still fills the field of view of the image receptor.
• Action Limit:
All Flat field tests must pass.
• Use of Test Results:
If the system fails the test, the source of the problem must be identified, and corrective action taken,
before any further mammographic images are acquired using the CESM application. Refer to
Chapter 3 Guidance section 1 Flat field Test on page 37.

5 CESM AUTO Mode

• Frequency:
Monthly.
• Objective:
The test is designed to check the correct choice of parameters in CESM AUTO mode.
• Equipment required:
Set of triangular acrylic - PMMA- plates allowing thicknesses of 25 ± 0.1 mm, 50 ± 0.1 mm and
60 ± 0.1 mm.
! Notice:
To avoid false results, the plates must be clean and free from scratches.
Note:
10 minutes before performing any measurements related to detector image quality. If any test is
not passed after allowing a 10-minute warm–up period, see Chapter 3 Guidance section 2 CESM
AUTO Mode on page 37.
• Procedure:
1. Start a CESM exam.
2. Click on No Contrast Agent on the Contrast Agent panel.
3. Click on Confirm.
4. Install the 19 x 23 cm compression paddle for Senographe DS or the 24 x 31 cm compression
paddle for Senographe Essential.
5. Place the 25 mm stack of acrylic plates on the breast support surface of the Bucky so that the
stack lies flat on the surface, the longest side is aligned with the chest wall edge of the bucky, and
it is centered left to right.
6. Apply a compression force of 5 daN to the plates.
7. Make sure the CESM AUTO mode is selected in the console.
8. Select laterality and take an exposure.
9. Repeat steps 5. to 8. using the 50 mm stack of acrylic plates and then the 60 mm ones.
10. Close the exam.
11. In the Browser, find the exam already closed and highlight the first raw series (25 mm acrylic set).
Click on the Review icon and the raw series will be displayed.
12. Make sure Full Annotation Level is selected. Read on the screen the exposure parameters
annotations (kV, mAs, Target, Filter) for the raw low energy and raw high energy images and
record them in Chart 2. CESM AUTO Mode on page 16. See Chapter 3 Guidance section
2 CESM AUTO Mode on page 37 regarding a method to record these results.
13. Repeat steps 10. to 12. to record the values obtained for the second and third raw series (50 and
60 mm acrylic set).

• Action Limit:
- The Auto test is successful if the exposure parameters are within the ranges specified in the
following table:
Acrylic Exposure Parameters for Auto mode
Thickness
Low energy High energy
(mm)
Track/Filter mAs kV Track/Filter mAs kV
25 Mo/Rh 32-56 27 Mo/Cu 56-100 46
50 Rh/Rh 50-89 29 Rh/Cu 128-224 45
60 Rh/Rh 56-100 31 Rh/Cu 144-252 47
If the system fails the test, the source of the problem must be identified, and corrective action taken,
before any further mammographic images are acquired using the CESM application. See
Chapter 3 Guidance section 2 CESM AUTO Mode on page 37.


Chapter 1
6 Test Results Record Forms

Chart 1. Flat field Test Record
Use this form to record the results of Flat field measurement tests:
Frequency: Weekly
Room: ......................... Unit: .........................
Year
Date
Initials
Flat field MoCu Result Pass/ Result Pass/ Result Pass/ Result Pass/ Result Pass/ Result Pass/
Fail Fail Fail Fail Fail Fail
brightness non-
uniformity
High Frequency
Modulation
SNR non-uniformity
Flat field RhCu Result Pass/ Result Pass/ Result Pass/ Result Pass/ Result Pass/ Result Pass/
Fail Fail Fail Fail Fail Fail
brightness non-
uniformity
High Frequency
Modulation
SNR non-uniformity
Chap 1 Test_Results_Record_Forms.fm Page no. 15 Chapter 1

Chart 2. CESM AUTO Mode

Frequency: Monthly
Room: ......................... Unit: .........................
Year
Month
Date
Initials
CESM AUTO Mode Check; mAs or F/n. See Chapter 3 Guidance section 2 CESM AUTO Mode on
page 37 regarding a method to record these results.
Track/ mAs kV Pass/ Track/ mAs kV Pass/ Track/ mAs kV Pass/
Filter Fail Filter Fail Filter Fail
Low energy:
25 mm acrylic
50 mm acrylic
60 mm acrylic
High energy:
25 mm acrylic
50 mm acrylic
60 mm acrylic
Notes:
Chapter 1 Page no. 16 Chap 1 Test_Results_Record_Forms.fm

QC Tests for the Medical Physicist
Chapter 2 QC Tests for the Medical Physicist
1 Introduction
The QC tests listed in this section must be performed by the Medical Physicist to ensure that the CESM
application provides an acceptable level of mammographic image quality. These tests also form the
basis of the mammography equipment evaluation (MEE) that must be performed following the
installation of a new mammography system or the repair or replacement of a major component of the
system.
The QC tests to be performed by the Medical Physicist are listed in the following three tables.
- The following tests are described in Chapter 1 QC Tests for the Radiologic Technologist:
Radiologic Technologist’s QC section Minimum Section
Frequency
1. Flat field Test Annually Chapter 1 section 4 Flat field Test, page 10
2. CESM AUTO Mode Annually Chapter 1 section 5 CESM AUTO Mode, page
12
- Additional tests that must be performed by the Physicist are listed below.
Specific Medical Physicist tests Minimum Section
Frequency
3. Artifact Evaluation; Flat Field Annually Job Card VF-CESM02 - Artifact Evaluation
Uniformity and Flat field Uniformity on page 27
4. Breast Entrance Exposure and Annually Job Card VF-CESM01 - Breast Entrance
Reproducibility Exposure and Reproducibility on page 21
5. Beam Quality Assessment Annually Job Card VF-CESM03 - Half-Value Layer
(Half–value Layer Measurement) Measurement on page 31
Tests 3, 4 and 5 are described in Job Cards VF-CESM01 through VF-CESM03.
Charts for recording the results of the tests are provided as Charts 0-3.
Chap 2 QC_tests_med_physicist.fm Page no. 17 Chapter 2

QC Tests for the Medical Physicist
Chapter 2 Page no. 18 Chap 2 QC_tests_med_physicist.fm

Chart 0. Site and System Summary

Chapter 2
Facility Name:
Address:
Date of Installation
Date of Survey
Room ID
Mammographic Unit Serial Number
Medical Physicist
Signature
Chap 2 Chart_0_Site_&_System_Summary.fm Page no. 19 Chapter 2

Chapter 2 Page no. 20 Chap 2 Chart_0_Site_&_System_Summary.fm

Job Card VF-CESM01 - Breast Entrance Exposure and Reproducibility

Chapter 2
• Objective:
To measure the typical entrance exposure for an average patient (approximately 4.2 cm compressed
breast thickness, 50% adipose, 50% glandular composition), and to assess short-term exposure
reproducibility.
• Required Test Equipment:
- Ionization chamber and electrometer calibrated at mammographic X-ray beam energies
(calibration factor constant to within ± 1% over the Half-Value Layer (HVL) range from 0.2 to
5 mm Al)
Note:
Not all dosimeters are compatible with such a large range. In particular, when using a semi-
conduction sensor, ensure that it can maintain its accuracy over that HVL range.
Note:
CESM acquisitions are made of two consecutive exposures: Low Energy and High Energy. This
procedure requires the total entrance dose to be measured, which includes both Low Energy and
High Energy exposures. Check if the dosimeter is capable of integrating both exposures in a single
measurement. If the dosimeter is resetting the dose measurement automatically after each
exposure, only the entrance dose corresponding to high energy exposure will be considered. In
that case, the corresponding low energy entrance dose can be deduced from a separated manual
exposure.
- Mammographic phantom (equivalent to approximately 4.2 cm compressed breast tissue 50/50
composition at mammographic energies). Acceptable phantoms are listed in Chapter 3 Guidance
section 4 Breast Entrance Exposure and Reproducibility on page 39.
• Procedure:
1. Prepare the mammographic imaging system as follows:
- Install the Bucky for contact mode.
- Select 24 cm x 31 cm field of view for Senographe Essential or 19 cm x 23 cm field of view for
Senographe DS.
2. Position the mammographic phantom on the breast support surface of the image receptor
assembly, laterally centered in the X-ray field with one edge coincident 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 at the chest wall
side and toward the right side of the detector (see Illustration 1).
3. Position the ionization chamber in the X-ray field with its center approximately 4 cm in from the
chest wall edge of the image receptor and with the top surface of the chamber near the top
surface of the phantom. The interior edge of the chamber must be no more than 3.5 cm from the
lateral edge of the X-ray field as indicated by the light localizer (See Illustration 1 and Illustration
2).
Chap 2 Job_Card_VFCESM01.fm Page no. 21 Chapter 2

4 cm
3.5 cm
Ion chamber Ion chamber must not be
placed further inside the field
Chest wall edge of of view
image receptor
30.7 cm for Essential / 23 cm for DS
Phantom
Cut out corner of Wide edge of wax insert

wax insert frame
X-ray field as indicated by
light field
24 cm for Essential / 19 cm for DS
Illustration 1 - Set up to monitor output reproducibility in CESM AUTO mode (top view)
Paddle
Ion chamber (5 daN compression)
Phantom
Bucky
30.7 cm
Edge of X-ray field

Illustration 2 - Set up to monitor output reproducibility in CESM AUTO mode (front view)
4. Secure the chamber in position and do not change the position of the chamber during the
following measurements.
Note:
Mammographic imaging systems have a significant X-ray intensity gradient in the X-ray field along
the anode-cathode direction. Maintaining a constant chamber position during measurements is
critical. When measurements are to be compared with others made previously, it is also critical that
the original measurement position be re-established as closely as possible.
5. Position the compression device in the X-ray beam, just in contact with the phantom and
chamber.
Note:
If measurements are done using CESM AUTO, apply a compression force of 5 daN to activate the
algorithm. The compressed breast thickness is used by the CESM AUTO algorithm to determine
the imaging parameters. Therefore, it is important to position the phantom and apply the
compression force consistently for each measurement since variations in paddle deflection may
be interpreted as variations in compressed breast thickness leading to inconsistency in parameter
selection.
Chapter 2 Page no. 22 Chap 2 Job_Card_VFCESM01.fm

6. Select the image acquisition mode, most commonly used clinically, i.e., CESM AUTO or CESM
Manual, to image the standard breast equivalent phantom using the CESM application. For
Manual mode select the clinically used settings of kVp, anode track, X-ray beam filter, and mAs.
Record the settings on the data form.
7. Make an exposure in CESM mode.
8. Record the mAs for Low and High energy, and the reading of the ion chamber E (Entrance Skin
Exposure), and the selections of kVp, anode track, and filter.
9. Make additional exposures and record the results until a total of four exposures have been
recorded.
10. Compute the averages and standard deviations for mAs and exposure for the four exposures
acquired with identical technique settings. Record the values. Determine the coefficients of
variation (standard deviation divided by the mean).
• Action Limit: mAs and Air Kerma Reproducibility
The maximum acceptable coefficient of variation for both mAs and air kerma in the reproducibility test
is 0.05.
If these conditions are not met, the source of the problem must be identified, and corrective action
taken, within 30 days of the test date.


Chart 1 - Breast Entrance Exposure and Reproducibility

Chapter 2
Dosimetry system .........................

used
Field size .........................
Phantom ID .........................
Imaging Parameters and Reproducibility
Breast thickness 4.2 cm

Phantom
Exposure Control Mode (CESM AUTO, Manual)
Low energy Nominal kVp setting
Target/Filter
mAs setting
High energy Nominal kVp setting
Target/Filter
mAs setting
Exposure Readings mAs (low) mAs (high) E (total)
Exposure #1
Exposure #2
Exposure #3
Exposure #4
Mean Values
Standard Deviations (SD)
Coefficients of Variation (CV)
Action Limit:
The Coefficient of Variation for both air kerma and mAs must not exceed 0.05.
Use of Test Results:
If these conditions are not met, the source of the problem must be identified, and corrective action
taken, within 30 days of the test date.
Chap 2 Chart 1 - Breast Entrance Exposure.fm Page no. 25 Chapter 2

Chapter 2 Page no. 26 Chap 2 Chart 1 - Breast Entrance Exposure.fm

Job Card VF-CESM02 - Artifact Evaluation and Flat field Uniformity

Chapter 2
• Objective:
To assess the degree and source of artifacts visualized in full field digital mammograms or phantom
images.
To assure that the Flat field image is uniform.
- A 25 mm thick uniform sheet of acrylic (PMMA) that is clean and free from defects. The acrylic
sheet must be sufficiently large to cover the entire image receptor.
Note:
10 minutes before performing any measurements related to detector image quality. If any test is
not passed after allowing a 10-minute warm–up period, see Chapter 3 Guidance section 5 Artifact
Evaluation and Flat field Uniformity on page 39.
• Procedure:
Note:
Since it is not possible to perform a single energy acquisition, the tester shall perform a CESM dual
energy acquisition and take into account only the high energy image.
1. Select technique factors normally used clinically in the CESM application, choosing the lowest kVp
setting (to be most sensitive to artifacts) for high energy (any parameters for low energy since it is not
assessed in this test). Record the high energy technique factors on the data form.
2. Install the Bucky. Place the attenuator sheet on top of the image receptor. Set collimation that
permits irradiation of the entire image receptor.
3. Make a CESM exposure.
4. Repeat steps 1 through 3 for the Mo/Cu and Rh/Cu target/filter combinations.
5. Select the High energy Raw image for review.
6. Set the window width in the range of about 100 to 150 and the window level to a setting that allows
visualization of artifacts if present. 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.
7. With a window width in the range of about 100 to 150, examine the image for Flat Field uniformity.
8. Review the images for the two target/filter combinations.
9. Review at least one of the images on all display devices, e.g., acquisition workstation, laser printer.
10. If any artifacts or non-uniformities are present, rotate the acrylic sheet 90° and repeat the exposure
and acquisition procedure.

11. If any artifacts or non-uniformities keep a fixed orientation relative to the image receptor in both
images and are expected to simulate or mask visualization of breast structures or breast pathology,
determine whether the artifact or non-uniformity is due to the detector or the display.
If and then
The artifact or non- the artifact can be related a. Remove the PMMA sheet and the
uniformity is present on all to a latent image from Bucky.
monitors or the artifact previous exposures, for b. Remove the compression paddle.
moves as the image is example the artifact has c. Make sure that no object is present in
moved using the Roam a breast shape, or looks the X-ray field of view.
tool, it is most likely like collimator blades
d. Make five exposures using the following
associated with the image corresponding to a
technique: Rh/Rh, 30kV, 125mAs.
acquisition system collimated view
The artifact appears only - Clean the faceplate of the display (See
on one monitor Senographe DS Quality Control Manual or
Senographe Essential Quality Control Manual)
The artifact appears only - Follow the directions provided by the
on printed images manufacturer of the printer
12. If any corrective actions in the table above were taken, repeat the artifact evaluation and review the
image.
• Action Limit:
There must be no artifact or non-uniformity that could mimic or obscure clinical information.
If the artifact or non-uniformity is still present, and can mimic or obscure clinical information, the
source of the problem must be identified and corrective actions taken within 30 days of the test date.
See Chapter 3 Guidance section 5 Artifact Evaluation and Flat field Uniformity on page 39.

Chart 2 - Artifact Evaluation and Flat field Uniformity

Chapter 2
Type of Attenuator .........................

Thickness of Attenuator .........................
kVp setting (high energy) .........................
mAs setting (high energy) .........................
Image Receptor size .........................
Patient ID # .........................
Field size .........................
Mo/Cu Rh/Cu
kVp (high energy)
mAs (high energy)
Artifact visible?
Flat Field Non-Uniformity
Equipment Artifact
Detector
Grid
Attenuator Defect
Other
Description of Artifacts:
Use of Test Results:

If an artifact or non-uniformity is present, and is expected to mimic or obscure clinical information, the
source of the problem must be identified and corrective actions taken within 30 days of the test date.
Chap 2 Chart 2 - Artifact Evaluation.fm Page no. 29 Chapter 2

Chapter 2 Page no. 30 Chap 2 Chart 2 - Artifact Evaluation.fm

Job Card VF-CESM03 - Half-Value Layer Measurement

Chapter 2
• Objective:
The purpose of this procedure is to measure the Half-Value layer (HVL) of the X-ray beam in High
Energy (HE) configuration. An acceptable value of HVL will ensure patient safety by demonstrating
the combination of kVp and filtration. A follow up of the HVL value with time will ensure the stability of
the equipment in the HE configuration.
- Standard 24 x 31 compression paddle for Essential systems and Standard 19 x 23 compression
paddle for DS systems
- Dosimeter calibrated over the HVL range 1.5 to 5 mm Al.
Note:
Mammographic ionisation chamber dosimeters generally cover both usual mammographic energy
range (LE) and the extended High Energy range. The latter may require using a general
radiography dosimeter instead of a mammographic dosimeter. In particular, when using a semi-
conduction sensor, ensure that it can maintain its accuracy over that HVL range.
Note:
CESM acquisitions are made of two exposures, Low Energy and High Energy. Check if the
dosimeter is capable to integrate both exposures, or gives provision to select first or second, or to
measure both independently.This Job Card addresses only the second exposure (High Energy).
In regular use, the High Energy (HE) exposure (kV>45, Cu filter) of a CESM acquisition cannot be
performed separately, but only following the Low Energy (LE) exposure. When using a dosimeter
integrating the two exposures (in particular ionization chamber dosimeters) the HVL in High
Energy conditions can be measured by:
- minimizing the Low Energy contribution by adjusting the related parameters to the minimum
possible (22 kV, 4 mAs for Molybdenium, 25 kV, 4 mAs for Rhodium);
- measuring separately the air kerma relative to the Low Energy exposure in Routine (non
CESM) mode;
- substracting this Low Energy contribution from the total air kerma measured in CESM mode.
Note:
The Low Energy contribution affects mainly the exposure without added aluminium filter. It
becomes more and more negligible when additional aluminium filtration is placed in the beam.
- Plates of aluminum (type 1100 aluminium alloy, 99.0% Pure), allowing to reach a total thickness
of, 2.0, 3.0 and 4.0 mm, of length and width sufficient to fully cover the ionization chamber. The
stated thickness should be accurate within ±1%.
- A regular HVL measuring stand as provided by the dosimeter manufacturer.
Alternatively, the standard compression paddle can be used to hold the aluminium filters.
- It is recommended to protect the detector from raw high level radiation during HVL measurement
by placing a high attenuation metallic plate on the breast support such as the radiation protection
plate.

• Procedure:
1. Install the Bucky on the image receptor.
2. Place the radiation protection plate on the surface of the Bucky. Each side of the radiation protection
plate must extend about 4 cm beyond each edge of the light field.
Note:
The X-ray doses used in this procedure can saturate the image receptor if the radiation protection
plate is not used and not correctly positioned. If the radiation protection plate does not completely
cover the field of view, a ghost image may be imposed on the digital image receptor at the edge of
the radiation protection plate.
Note:
It is recommended to place a mechanical protection (paper, cardboard, cloth, etc.) between the
radiation protection plate and the breast support to avoid possible damaging.
3. Position a HVL filter holder. If none is available, the Aluminium plates will be placed on the
compression paddle.
4. Install the 19 x 23 cm compression paddle for Senographe DS or the 24 x 31 cm compression paddle
for Senographe Essential, and position it approximately half way between the tube head and the
dosimeter.
5. Ensure that paddle decompression at end of exposure is set to “NO”. From the X-ray Console menu,
press the SET UP menu key , then select MEDICAL/DECOMP/DECOMP/NO. Position the
compression paddle plane at approximately 30 cm from the focal spot.
6. Select the 9 x 9 collimator format.
7. Using the light beam, position the dosimeter sensor in the center of the X-ray field.
If the sensor is a semi-conductor, it can be placed directly on the radiation protection plate. If an
ionization chamber is used, it is recommended to place it at approximately 10 cm above it, using a
block of light foam (e.g. expanded Polystyrene) or a holder out of the X-ray beam. Secure the
chamber in position and do not change the position of the chamber during the following
measurements.
8. Select the CESM Manual image acquisition mode.
9. Select the Molybdenum anode.
10. Adjust the Low Energy parameters to the minimum possible (22kV, 4 mAs).
11. Adjust the High Energy high voltage to 47 kV. If the dosimeter is an ionization chamber integrating
the two successive LE and HE exposures, select 160 mAs so that the LE air kerma is small relative
to the HE air kerma.
12. Make an exposure and record the settings on the Mo table of the data form with the corresponding
measured air kerma (line Total CESM “E0” in Chart 3. Half Value Layer Test Record on page 35).
13. Position the 2 mm sheet of aluminium in the filter holder or on the compression paddle. Using the
light beam, check that the x-ray beam is entirely blocked.
14. Make an exposure and record the settings on the data form with the corresponding measured air
kerma (line Total CESM “E (2 mm)” in Chart 3. Half Value Layer Test Record on page 35).
15. Repeat steps 13. and 14. with respectively 3 and 4 mm aluminium sheets.
16. Go to regular non CESM (manual) mode.
17. Repeat steps 9. to 15., with the exception of 11. and write down the measured doses in the
corresponding LE lines of Chart 3. Half Value Layer Test Record on page 35.
18. Subtract the LE values from the Total values, and write down the difference in the HE lines of Chart
3. Half Value Layer Test Record on page 35.

19. Determine the aluminium thicknesses T1 and T2 that give dose values E1 and E2 which are respectively
just above and just below the half of E0 (in general T1 = 3 mm and T2 = 4 mm).
20. Compute the HVL using the following formula and record the value in the line HVL of Chart 3. Half
Value Layer Test Record on page 35.
E1 E2
T 2  ln  2  ------ – T 1  ln  2  ------
 E 0  E 0
HVL = -----------------------------------------------------------------------------
E1
ln  ------
E2
21. Select the rhodium anode; adjust the Low Energy parameters to the minimum possible (25 kV,
4 mAs).
22. Repeat steps 11. to 20. using the Rh table of the data form
• Action Limit:
The HVL at 47 kV should be larger than 3 mm for both Mo and Rh targets.
If these conditions are not met, the source of the problem must be identified and corrective action
taken.


Chart 3. Half Value Layer Test Record
Use this form to record the results of HVL measurement tests:
Frequency: Yearly
Room: ......................... Unit: .........................
Date
Initials
HVL MoCu
Total
E0 LE
HE
Total
E (3mm) LE
HE
Total
E (4mm) LE
HE
Total
E (5mm) LE
HE
HVL MoCu Result Pass/ Result Pass/ Result Pass/ Result Pass/ Result Pass/
Fail Fail Fail Fail Fail
HVL (mm)
Chap 2 Chart 3 - HVLtestRecord.fm Page no. 35

Date
Initials
HVL RhCu
Total
E0 LE
HE
Total
E (3mm) LE
HE
Total
E (4mm) LE
HE
Total
E (5mm) LE
HE
HVL RhCu Result Pass/ Result Pass/ Result Pass/ Result Pass/ Result Pass/
Fail Fail Fail Fail Fail
HVL (mm)
Page no. 36 Chap 2 Chart 3 - HVLtestRecord.fm

Guidance
Chapter 3 Guidance
United States regulations consider the image receptor manufacturer’s QC Test procedures as a
requirement for compliance with the MQSA regulations. This Guidance section is not considered an
element of those regulations. It is intended to provide guidance to mammography facilities and their
personnel. It represents the image receptor manufacturer’s current thinking on appropriate procedures
for conducting the QC tests. Procedures described in guidance represent supplementary information on
acceptable ways of doing a test but, unlike regulations, do not bind the facility to using that way only. An
alternative procedure may be used if such a procedure satisfies the requirements of the applicable
statute, regulations, or both. Mandatory language, such as “shall,” “must”, and “require”, is used when
referring to statutory or regulatory requirements. Non-mandatory language, such as “should”, “may”,
“can” and “recommend” is used when referring to guidance. It is the responsibility of the facility to read,
understand, and follow the final regulations.
Under its own authority, a state may impose more stringent requirements beyond those specified under
MQSA and its implementing regulations. A facility may want to check with the state or local authorities
regarding their requirements. Tests may be performed more frequently than specified in the QC tests if
required by local regulations or hospital policies.
QC tests may be used as a check for correct operation, for example, after a change of operating
parameters.
The following sections provide specific guidance for sections in the Contrast Enhanced Spectral
Mammography QC tests.
Refer to Senographe DS or Senographe Essential Quality Control Manual for a global Mammography
system guidance.
1 Flat field Test

If the system fails any of the elements of the Flat field test, you should ensure that all test conditions are
met and then repeat the test. If the detector has been allowed to warm up for at least 10 minutes, but
less than 30 minutes, allow an additional 20 minutes for the detector to complete warm up (total of
30 minutes) then repeat the test. If the system still fails, it is recommended that you contact your GE
Medical Systems Service Engineer.
2 CESM AUTO Mode

A flow chart illustrating how to access the menu for adjusting the maximum compression force is shown
in the Acquisition system Operator Manual. Press the SET UP menu key , then the button under
“MEDICAL”, then the button under "COMP", and then the button under “FORCE”. Press the button under
the “+” sign to increase the compression force; press the button under the “-” sign to decrease the force.
After achieving the desired maximum force value, press the button under “VALID”, then press the SET
UP menu key until the Applications menu returns and the lamp under the button goes out.
For the CESM AUTO Mode Check, if the test passes enter the mAs observed for each object thickness.
If the test fails, enter “F/n” where “n” refers to the number of a note. Use the same number to record a
note below the table to state the nature of the failure and what was done to correct it.
If the system fails the CESM AUTO Mode Check, you should ensure that all test conditions are met and
then repeat the test. If the detector has been allowed to warm up for at least 10 minutes, but less than 30
minutes, allow an additional 20 minutes for the detector to complete warm up (total of 30 minutes) then
repeat the test. If the system still fails, it is recommended that you contact your GE Medical Systems
Service Engineer.
Chap 3 Guidance.fm Page no. 37 Chapter 3

Guidance
3 Annual Physicist Checks

3-1 Beam Quality Assessment
For CESM as for Routine mode, acceptable procedures for the measurement of half-value layer in low
energy can be found in the Mammography Quality Control Manual published by the American College of
Radiology.
The thicknesses of the aluminum filters should be known to within ± 1%. 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.
As for CESM a single exposure with the Copper filter cannot be performed, the solution is to perform a
dual energy acquisition in CESM mode and record the dose which takes into account both low and high
energy doses. In order to extract the contribution of the high energy dose, an acquisition in Routine
mode with the same parameters as those used for the low energy acquisition in the previous CESM
acquisition shall be performed, the dose recorded and subtracted to the total dose measured for CESM.
In addition, the HVL in High Energy is controlled using the procedure in Job Card VF-CESM03 - Half-
Value Layer Measurement on page 31.
• If the HVL is significantly smaller than the limit value, e.g. comparable to the Low Energy value, you
should ensure that all test conditions are met and then repeat the test. If the HVL remains the same,
CESM operation should not be continued, and you must contact your GE Medical Systems Service
Engineer.
• If the HVL is moderately smaller than the limit value (e.g. between 2.5 mm and 3 mm), 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.
• If the HVL measured is higher than 3.5 mm it is also preferable to contact your GE Medical Systems
Service Engineer.
In these cases it may be useful to check the high voltage of the equipment using a non-invasive kVp-
meter operating over voltages higher than 40 kV and HVL higher than 1.5 mm, such as those used in
general radiology. A non-invasive kVp meter calibrated with a tungsten tube can be used with no
problem.
Chapter 3 Page no. 38 Chap 3 Guidance.fm

Guidance
4 Breast Entrance Exposure and Reproducibility

Phantoms suitable for mammographic dosimetry include mammographic phantoms sold by Radiation
Measurements, Inc., Model 156; by Nuclear Associates, Model 18-220; and by Computerized Imaging
Reference Systems, Model 15.
Methods for dose calculation and dose conversion tables can be found in the Mammography Quality
Control Manual published by the American College of Radiology for the Low Energy image and using the
tables provided in the CESM Operator Manual for the High Energy.
If the system does not pass the Breast Entrance Exposure and Reproducibility 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.
5 Artifact Evaluation and Flat field Uniformity

If the system does not pass the Artifact Evaluation and Flat Field Uniformity test, and the detector has
been allowed to warm up for at least 10 minutes, but less than 30 minutes, allow an additional
20 minutes for the detector to complete warm up (total of 30 minutes) then repeat the test. If the system
still fails, it is recommended that you contact your GE Medical Systems Service Engineer.
Chap 3 Guidance.fm Page no. 39 Chapter 3

Guidance
Chapter 3 Page no. 40 Chap 3 Guidance.fm

Revision History
This table is intentionally left in English.
Date Reference Revision Main modification(s)

July 2010 5391271-S-1EN 1 Creation.
Quality Control Manual
February 2011 5391271-2-1EN 1 CESM AUTO mode test and chart updated.
Quality Control Manual Job Card VF-CESM01 updated.
January 2014 5391271-3-1EN 1 SPR HCSDM00190786 resolved:
Quality Control Manual - required test equipment for JC VF-CESM01
updated
- Chapter Guidance, § Beam Quality
Assessment updated
- Job Card VF-CESM03 Half-Value Layer
Measurement added
SPR HCSDM00241142 resolved:
- mAs values for High Energy (50 & 60mm)
updated in CESM AUTO mode test.
SPR HCSDM00245896 resolved: GE Buc
address updated.
SPR HCSDM00245829 resolved: X-ray
warning updated.
SPR HCSDM00230813 resolved: China
service address updated.
SPR HCSDM00251405 resolved:
"Imagination at work" and "GE Healthcare"
removed.
SPR HCSDM00246499 resolved: Trademark
information added
Revision History.fm Page no. 41

Page no. 42 Revision History.fm

Last Page.fm Page no. 43

To contact your local GE representative, please go to:
http://www.gehealthcare.com/helpcenter.html
China Service Agent Address:

通用电气医疗系统贸易发展（上海）有限公司
( 上海市外高桥保税区意威路 96 号 1 幢，邮编 200131)
Manufacturer and Manufacturing site:

GE MEDICAL SYSTEMS SCS
283 RUE DE LA MINIERE
78530 BUC - FRANCE

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Contrast Enhanced Spectral Mammography

Quality Control Manual

Quality Control Manual Revision 1

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radiation warning.fm Page no. 3

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Chapter 1. QC Tests for the Radiologic Technologist

Chapter 2. QC Tests for the Medical Physicist

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5. Artifact Evaluation and Flat field Uniformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

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Quality Control Manual Revision 1

2 How to order a paper version

3 How to access the electronic version of a manual on a website

2. Click on the underlined Filename.

foreword.fm Page no. 7

Quality Control Manual Revision 1

3. In the next window, click [ACCEPT] to view the file.

4-2 Trademark information

6 Scope of this Manual

7 Overview of this Manual

Page no. 8 foreword.fm

Quality Control Manual Revision 1

QC Tests for the Radiologic Technologist

Chapter 1 QC Tests for the Radiologic Technologist

Chap 1 QC_tests_technologist.fm Page no. 9 Chapter 1

Quality Control Manual Revision 1

QC Tests for the Radiologic Technologist

4 Flat field Test

1. Click on the QAP button .

Chapter 1 Page no. 10 Chap 1 QC_tests_technologist.fm

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QC Tests for the Radiologic Technologist

Chap 1 QC_tests_technologist.fm Page no. 11 Chapter 1

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QC Tests for the Radiologic Technologist

5 CESM AUTO Mode

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QC Tests for the Radiologic Technologist

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Quality Control Manual Revision 1

QC Tests for the Radiologic Technologist

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Chapter 1 Page no. 14 Chap 1 QC_tests_technologist.fm

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6 Test Results Record Forms

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Quality Control Manual Revision 1

Chart 2. CESM AUTO Mode

Chapter 1 Page no. 16 Chap 1 Test_Results_Record_Forms.fm

Quality Control Manual Revision 1

QC Tests for the Medical Physicist

Chapter 2 QC Tests for the Medical Physicist

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QC Tests for the Medical Physicist

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