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Quality Control Manual

MAMMOMAT Novation DR
Order No: SPB7-250.623.50.05.24
Version 05 / AG 04/07

Siemens AG Medical Solutions


Special Systems
Henkestrae 127
D-91052 Erlangen
Germany

CONFIDENTIALITY STATEMENT
This document is the confidential property of Siemens AG Medical Solutions.
No part of it maybe transmitted, reproduced, published, or used by other
persons without the permission of Siemens AG Medical Solutions.

The original version of this manual was written in the English


language.

Contents
Table of Contents
List of Tables

List of Figures

11

List of Common Abbreviations

13

1. Introduction

15

1.1 Mammography Equipment Evaluation (MEE) - Medical Physicist (MP) ........... 15


1.2 Annually or Every Six Months - Medical Physicist (MP) ................................... 15
1.3 Daily - Technologist (T) .................................................................................... 15
1.4 Weekly - Technologist (T)................................................................................. 15
1.5 Technologist (T)................................................................................................ 15
1.6 Soft Copy Viewing Station ................................................................................ 16
1.7 Laser Camera/Printer ....................................................................................... 16
1.8 Frequency of Required Tests - Technologist.................................................... 17
1.9 Recommended Frequency of QC Tests - Medical Physicist ............................ 18
1.10 Important Notes ................................................................................................ 19
1.11 Required Corrective Action............................................................................... 19
1.12 Required Equipment - Annual Survey, MEE .................................................... 20

2. Start Up and Login

21

2.1 Procedure ......................................................................................................... 21

3. Required Tests - Technologist

22

3.1 Phantom Image Quality .................................................................................... 22


3.1.1
3.1.2
3.1.3
3.1.4
3.1.5

Objective ........................................................................................................................ 22
Required Equipment....................................................................................................... 22
Procedure....................................................................................................................... 22
Analysis .......................................................................................................................... 25
Performance Criteria and Corrective Action ................................................................... 26

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Contents
3.2 Detector Calibration ..........................................................................................27
3.2.1 Objective......................................................................................................................... 27
3.2.2 Required Equipment....................................................................................................... 27
3.2.3 Procedure ....................................................................................................................... 27

3.3 Artifact Detection...............................................................................................30


3.3.1
3.3.2
3.3.3
3.3.4

Objective......................................................................................................................... 30
Required Equipment....................................................................................................... 30
Procedure ....................................................................................................................... 30
Performance Criteria and Corrective Action ................................................................... 31

3.4 Signal-to-Noise Ratio (SNR) and


Contrast-To-Noise Ratio (CNR) Measurements ...............................................32
3.4.1
3.4.2
3.4.3
3.4.4
3.4.5

Objective......................................................................................................................... 32
Required Equipment....................................................................................................... 32
Procedure ....................................................................................................................... 32
Analysis .......................................................................................................................... 34
Performance Criteria and Corrective Action ................................................................... 34

3.5 Repeat Analysis ................................................................................................35


3.5.1
3.5.2
3.5.3
3.5.4

Objective......................................................................................................................... 35
Procedure ....................................................................................................................... 35
Analysis .......................................................................................................................... 36
Performance Criteria and Corrective Action ................................................................... 36

3.6 Compression Force...........................................................................................37


3.6.1
3.6.2
3.6.3
3.6.4

Objective......................................................................................................................... 37
Required Equipment....................................................................................................... 37
Procedure ....................................................................................................................... 37
Performance Criteria and Corrective Action ................................................................... 37

3.7 Printer Check ....................................................................................................38


3.7.1
3.7.2
3.7.3
3.7.4

Objective......................................................................................................................... 38
Required Equipment....................................................................................................... 38
Procedure ....................................................................................................................... 38
Performance Criteria and Corrective Action ................................................................... 38

4. Initial Checks - Physicist

39

4.1 Site Audit / Evaluation of Technologist QC Program ........................................39


4.1.1 Objective......................................................................................................................... 39
4.1.2 Procedure ....................................................................................................................... 39

4.2 Mechanical Inspection ......................................................................................40


4.2.1 Objective......................................................................................................................... 40
4.2.2 Procedure ....................................................................................................................... 40

4.3 Acquisition Workstation Monitor Check ............................................................43


4.3.1
4.3.2
4.3.3
4.3.4

Objective......................................................................................................................... 43
Required Equipment....................................................................................................... 43
Procedure ....................................................................................................................... 43
Performance Criteria and Corrective Action ................................................................... 44

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Contents
5. Required Tests - Physicist

45

5.1 Detector Uniformity and Artifact Detection ....................................................... 45


5.1.1
5.1.2
5.1.3
5.1.4

Objective ........................................................................................................................ 45
Required Equipment....................................................................................................... 45
Procedure....................................................................................................................... 45
Performance Criteria and Corrective Action ................................................................... 47

5.2 Collimation, Dead Space and Compression Paddle Position ........................... 48


5.2.1
5.2.2
5.2.3
5.2.4

Objective ........................................................................................................................ 48
Required Equipment....................................................................................................... 48
Procedure....................................................................................................................... 48
Performance Criteria and Corrective Action ................................................................... 51

5.3 AEC Thickness Tracking Test .......................................................................... 52


5.3.1
5.3.2
5.3.3
5.3.4

Objective ........................................................................................................................ 52
Required Equipment....................................................................................................... 52
Procedure....................................................................................................................... 52
Performance Criteria and Corrective Action ................................................................... 53

5.4 Spatial Resolution............................................................................................. 54


5.4.1 Objective ........................................................................................................................ 54
5.4.2 Procedure....................................................................................................................... 54
5.4.3 Performance Criteria and Corrective Action ................................................................... 55

5.5 SNR, CNR and AEC repeatability .................................................................... 56


5.5.1
5.5.2
5.5.3
5.5.4
5.5.5

Objective ........................................................................................................................ 56
Required Equipment....................................................................................................... 56
Procedure....................................................................................................................... 56
Analysis .......................................................................................................................... 58
Performance Criteria and Corrective Action ................................................................... 58

5.6 Image Quality and Radiation Dose ................................................................... 59


5.6.1
5.6.2
5.6.3
5.6.4
5.6.5

Objective ........................................................................................................................ 59
Required Equipment....................................................................................................... 59
Procedure....................................................................................................................... 59
Analysis .......................................................................................................................... 61
Performance Criteria and Corrective Action ................................................................... 62

5.7 HVL and Radiation Output................................................................................ 63


5.7.1
5.7.2
5.7.3
5.7.4
5.7.5

Objective ........................................................................................................................ 63
Required Equipment....................................................................................................... 63
Procedure....................................................................................................................... 63
Calculating HVL.............................................................................................................. 65
Performance Criteria and Corrective Action ................................................................... 65

5.8 Tube Voltage Measurement & Reproducibility ................................................. 66


5.8.1
5.8.2
5.8.3
5.8.4
5.8.5

Objective ........................................................................................................................ 66
Required Equipment....................................................................................................... 66
Procedure....................................................................................................................... 66
Calculations .................................................................................................................... 67
Performance Criteria and Corrective Action ................................................................... 68

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5.9 Printer Check ....................................................................................................69
5.9.1
5.9.2
5.9.3
5.9.4

Objective......................................................................................................................... 69
Required Equipment....................................................................................................... 69
Procedure ....................................................................................................................... 69
Performance Criteria and Corrective Action ................................................................... 69

6. Optional Test

70

6.1 Ghost Image Evaluation....................................................................................70


6.1.1
6.1.2
6.1.3
6.1.4
6.1.5

Objective......................................................................................................................... 70
Required Equipment....................................................................................................... 70
Pre Requisites ................................................................................................................ 70
Procedure ....................................................................................................................... 70
Performance Criteria and Corrective Action ................................................................... 72

7. Appendix 1 QC Forms Technologist Tests

73

Test Form 3.1 Phantom Image Quality .....................................................................75


Phantom image quality .............................................................................................................. 75

Test Form 3.2 Detector Calibration ...........................................................................77


Test Form 3.3 Artifact Detection................................................................................79
Clinically Relevant Artifacts ....................................................................................................... 79

Test Form 3.4 Signal-to-Noise Ratio (SNR) and


Contrast-To-Noise Ratio (CNR) Measurements........................................................81
Signal-to-Noise Ratio and Contrast-To-Noise Ratio Measurements ......................................... 82

Test Form 3.5 Repeat Analysis .................................................................................83


Mammography Repeat Analysis................................................................................................ 83

Test Form 3.6 Compression Force............................................................................85


Test Form 3.7 Printer Check .....................................................................................87
Printer Check ............................................................................................................................. 88

8. Appendix 2 QC Forms Physicist Tests

91

Test Form 4.1 Site Audit / Evaluation of Technologist QC Program .........................93


Test Form 4.2 Mechanical Inspection .......................................................................95
Mechanical Inspection and Follow Up ....................................................................................... 95

Test Form 4.3 Acquisition Workstation Monitor Check .............................................97


Acquisition Monitor Check and Viewing Conditions................................................................... 97

Test Form 5.1 Detector Uniformity and Artifact Detection.........................................99


Detector uniformity..................................................................................................................... 99
Results from ROI statistics ...................................................................................................... 100
Clinically Relevant Artifacts ..................................................................................................... 100

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Contents
Test Form 5.2 Collimation, Dead Space and Compression Paddle Position .......... 101
Collimator Assessment ............................................................................................................ 101
Compression Paddle Overlap on Chest Wall Side .................................................................. 105
Chest Wall Missed Tissue ....................................................................................................... 106

Test Form 5.3 AEC Thickness Tracking Test ......................................................... 107


Test Form 5.4 Spatial Resolution............................................................................ 109
Spatial Resolution.................................................................................................................... 109

Test Form 5.5 SNR, CNR and AEC repeatability.................................................... 111


AEC Image Stability and Reproducibility and Signal-to-Noise Ratio (SNR) ............................ 111

Test Form 5.6 Image Quality and Radiation Dose .................................................. 113
Phantom image quality ............................................................................................................ 113
Mean Glandular Dose.............................................................................................................. 114
HVL Values from Test Form 5.7 HVL and Radiation Output .................................................. 114
Compression release............................................................................................................... 114
Compression thickness ........................................................................................................... 114

Test Form 5.7 HVL and Radiation Output............................................................... 117


Beam Quality (HVL)................................................................................................................. 117
Calculated HVL Values............................................................................................................ 118
Radiation Output...................................................................................................................... 118

Test Form 5.8 Tube Voltage Measurement & Reproducibility ................................ 119
Tube voltage and reproducibility.............................................................................................. 119

Test Form 5.9 Printer Check ................................................................................... 121


Printer Check ........................................................................................................................... 121

Test Form 6.1 Ghost Image Evaluation .................................................................. 125


Ghost Image Evaluation .......................................................................................................... 126

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Tables
List of Tables
Table 1
Table 2
Table 3
Table 4
Table 5

Frequency of QC Tests - Technologist ..................................................... 17


Frequency of QC Tests - Medical Physicist .............................................. 18
Object Score Criteria for the accreditation phantom Test ......................... 26
Object Score Criteria for the accreditation phantom Test ......................... 62
HVL action limits for the different Anode/Filter combinations ................... 65

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Tables

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Figures
List of Figures
Figure 1

Patient Registration Icon........................................................................... 22

Figure 2

Positioning of the accreditation phantom .................................................. 23

Figure 3

Service Patient.......................................................................................... 24

Figure 4

Potentially Visible Objects in the accreditation phantom .......................... 25

Figure 5

Calibration image ...................................................................................... 28

Figure 6

Accept/Reject Calibration Images............................................................. 29

Figure 7

Patient Registration Window..................................................................... 31

Figure 8

Positioning of the accreditation phantom .................................................. 32

Figure 9

CNR Measurement ................................................................................... 33

Figure 10

Discarded images ..................................................................................... 35

Figure 11

Stand display ............................................................................................ 37

Figure 12

Error Indication Lamp Symbol................................................................... 40

Figure 13

Manual compression................................................................................. 41

Figure 14

Light Field Luminance Measurement........................................................ 42

Figure 15

Location of Squares .................................................................................. 43

Figure 16

Location of Contrast Bar Patterns............................................................. 44

Figure 17

Pixel Test Areas on the Detector .............................................................. 46

Figure 18

ROI Statistics ............................................................................................ 46

Figure 19

Placing the Coin........................................................................................ 49

Figure 20

Placing the Coins ...................................................................................... 50

Figure 21

Positioning the PMMA (seen from above) ................................................ 52

Figure 22

Placing the Resolution Phantom............................................................... 55

Figure 23

Selection of an AEC Sensor ..................................................................... 57

Figure 24

Positioning of the accreditation phantom .................................................. 60

Figure 25

Potentially Visible Objects in the accreditation phantom .......................... 60

Figure 26

Image Attributes........................................................................................ 64

Figure 27

Ghosting 180 sec measurement. .............................................................. 71

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Figures

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Abbreviations
List of Common Abbreviations
AEC

Automatic Exposure Control

AEC D Button AEC Detail Mode Button


AEC H Button AEC Low Dose Button
AWS

Acquisition Work Station

CFR

Code of Federal Regulations

CNR

Contrast-to-Noise Ratio

CSE

Customer Service Engineer

FD

Flat Detector

FFDM

Full Field Digital Mammography

HVL

Half Value Layer

kVp

Kilovolt Peak

mAs

milli Ampere seconds

MEE

Mammography Equipment Evaluation

Mo/Mo

Molybdenum/Molybdenum

Mo/Rh

Molybdenum/Rhodium

MP

Medical Physicist

PMMA

Poly Methyl Methacrylate

QC

Quality Control

ROI

Region of Interest

SID

Source Image Distance

SMPTE

Society of Motion Picture and Television Engineers

SNR

Signal-to-Noise Ratio

SOD

Source Object Distance

SP

Special Systems

Technologist

W/Rh

Tungsten/Rhodium

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Abbreviations
For notes

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Introduction
Mammography Equipment Evaluation (MEE) - Medical Physicist (MP)

1. Introduction
1.1 Mammography Equipment Evaluation (MEE) Medical Physicist (MP)
The MEE tests of the MAMMOMAT NovationDR must be performed whenever a new
MAMMOMAT NovationDR system has been installed, reassembled, and whenever
changes that might affect performance have been made to an existing system. For
example, the MEE tests shall be performed if the system has been disassembled and
reassembled or if major components have been changed or repaired.
The MEE tests of the MAMMOMAT NovationDR involve performance of all relevant
QC procedures in this Quality Control Manual, ensuring that a basic minimum image
quality criteria is met before the system is used on patients. For each part of the MEE
tests, action levels that must be met are specified. Furthermore, the values obtained
during the MEE tests are to be used as baseline values, and then referred to during
future tests to determine if equipment performance is stable or changing.
In facilities under US jurisdiction, the MEE tests must be performed by a qualified
medical physicist who meets the final regulation requirements of CFR 900.12(a)(3).

1.2 Annually or Every Six Months - Medical


Physicist (MP)
For facilities under US jurisdiction, these tests shall be performed at least yearly by a
qualified medical physicist as part of the annual physics survey of the mammography
unit. Elsewhere, some of them may be performed by a technologist. The tests include
comparisons to values measured during the MEE tests to ensure that performance
has not degraded.

1.3 Daily - Technologist (T)


The purpose of the daily test(s) is to ensure proper and safe performance of the
MAMMOMAT NovationDR system. Daily test(s) shall be performed each day before
any clinical images are taken.

1.4 Weekly - Technologist (T)


These test(s) shall be done on a weekly basis. Weekly test(s) shall be done
approximately the same day of the week before patients are examined with the
MAMMOMAT NovationDR system.

1.5 Technologist (T)


These tests shall be done whenever is suspicion of artifacts or incorrect settings to
determine if patients can be examined.

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Introduction
Soft Copy Viewing Station

1.6 Soft Copy Viewing Station


When using a soft copy viewing station, a QC program must be implemented. This
program should be substantially equivalent to the program recommended by the
manufacturer of the imaging system or the review workstation if they are not the same.
* * The Siemens syngo MammoReport Quality Manual is supplied with the purchase
of the syngo MammoReport.

1.7 Laser Camera/Printer


When using a laser camera/printer to print mammographic or accreditation images,
the printer manufacturer's QC procedure must be followed.

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Introduction
Frequency of Required Tests - Technologist

1.8 Frequency of Required Tests - Technologist


Table 1 describes when the tests must be performed by the Technologist.

Test

Frequency

3.1 Phantom Image Quality

Daily

3.2 Detector Calibration

As Needed Weekly

3.3. Artifact Evaluation

As Needed Weekly

3.4 SNR and CNR Measurements

Weekly

3.5 Repeat Analysis

Quarterly

3.6 Compression Force

Semi-Annually

3.7 Printer Check

When required*

* Printer QA is required on days when clinical mammograms or accreditation images are to be printed.

Table 1

Frequency of QC Tests - Technologist

NOTE!
NOTE!
If there is a softy copy diagnostic workstation, a QC program must
be implemented.
Follow the manufacturers recommended procedures or any other
substantially equivalent soft copy QC program.

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Introduction
Recommended Frequency of QC Tests - Medical Physicist

1.9 Recommended Frequency of QC Tests - Medical


Physicist
Table 2 describes when the tests must be performed by the medical physicist.

Test

Frequency
Required Tests

4.1 Site Audit / Evaluation of Technologist


QC Program

MEE, Annually

4.2 Mechanical Checks

MEE, Annually

4.3 Acquisition Workstation Monitor Check

MEE, Annually

5.1 Detector Uniformity and artifact Detection

MEE, Annually

5.2 Collimation, Dead Space and


Compression Paddle Position

MEE, Annually

5.3 AEC Thickness Tracking

MEE, Annually

5.4 Spatial Resolution

MEE, Annually

5.5 SNR, CNR and AEC Repeatability

MEE, Annually

5.6 Image Quality and Radiation Dose

MEE, Annually

5.7 HVL and Radiation Output

MEE, Annually

5.8 Tube Voltage and Repeatability

MEE, Annually

5.9 Printer Check

MEE, Annually

Optional Test
6.1 Ghost Image Evaluation

Table 2

18

MEE, Annually

Frequency of QC Tests - Medical Physicist

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Introduction
Important Notes

1.10 Important Notes


While performing quality control test(s), it will be helpful to be familiar with the
operating instructions described in the MAMMOMAT NovationDR Operator Manual.
Appendix 1 contains test report tables to be completed to document test parameters
used and results obtained during each test.

1.11 Required Corrective Action


Whenever there is a result from a test described in this manual that fails to be within
the action level stated, the source of the problem must be identified and corrected by
a Siemens customer support engineer. Consult with your MP to determine if further
testing is required. The system cannot be used on patients until the medical physicist
(where applicable) has consented that the test results are acceptable. After the
problem has been corrected, a medical physicist or technologist (depending on the
test) must conduct the test that failed again to confirm that the problem has been
corrected.

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Introduction
Required Equipment - Annual Survey, MEE

1.12 Required Equipment - Annual Survey, MEE


Line pair phantom (2-10 lp/mm)
FDA approved accreditation phantom
One collimator mounted PMMA (40 mm thick) absorber*
Three PMMA absorbers, each with a thickness of 20 mm (150x150 mm)
Lint free non-woven cotton or gauze (100% cotton)
Water or lukewarm diluted aqueous solution of household dishwashing liquid
Illuminance meter
Densitometer
A non-invasive kV meter
Dosimeter calibrated at the mammography X-ray beam energies
Film or CR cassette 24x30 cm or larger
Compression paddle simulator**
2 mm steel plate (FD object table size)*
2 mm thick steel bars (approx. 30x100 mm)*
Pure Aluminum (each 0.10 mm thick) sheets to perform half value layer
measurement
Ruler with a mm scale

* Provided with every system.


**Provided with every system. Testing device allows exposures to be performed
without compression paddle attached. Detach compression paddle and insert metal
plug compression paddle simulator. Radiation field 24x29 cm.

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Start Up and Login


Procedure

2. Start Up and Login


2.1 Procedure
1.

Turn on the MAMMOMAT NovationDR, using the button (


) on the control panel
to enable the MAMMOMAT. Allow a warm up time of approximately 5 minutes.
The internal monitoring system automatically performs a functional check of the
MAMMOMAT. "DR" is displayed on the density display on the control panel to
indicate that the MAMMOMAT NovationDR system is operational.

2.

Switch on the acquisition workstation computer.

CAUTION!

3.

If the MAMMOMAT NovationDR has been without power for an


extended period of time, the detector will require one hour of warm up.
Every second week a message about calibration of the detector is
displayed, this is the maximum interval between detector calibrations.
Exposures will be locked out unless detector is calibrated every two
weeks.

Login to the acquisition workstation.

CAUTION!
If the MAMMOMAT is started from being completely shut down (for
details about complete shut down, see Instructions for Use for (power
interrupted at breaker) MAMMOMAT NovationDR) the detector should
be powered on at least one hour before intended use. Otherwise,
image quality can be affected.

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Required Tests - Technologist


Phantom Image Quality

3. Required Tests - Technologist


3.1 Phantom Image Quality
3.1.1 Objective
To ensure that adequate image quality is achieved.

3.1.2 Required Equipment


a)

Accreditation phantom

b)

Compression paddle 24x30

3.1.3 Procedure
1.

Login according to the section 2. Start Up and Login.

2.

Enter a new patient by pressing Patient Registration icon, see Figure 1,


Position 1.

Figure 1 Patient Registration Icon

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Required Tests - Technologist


Phantom Image Quality
3.

Create a new patient record in the local database, see Figure 7.


Fill in: Last Name: Test_One
First Name: Phantom Image
Patient ID: day+time when the test is performed
(example: 200411281350)
DOB:
05 05 1955
Gender:
Other

4.

Press Exam button.

5.

Choose procedure FD QC processed, see Figure 3, Position 1.

6.

Position the accreditation phantom on the breast support, see Figure 2.

Figure 2 Positioning of the accreditation phantom

NOTE!
NOTE!
Make sure there is no gap between phantom and chest wall.
7.

Install the compression paddle.

8.

Select the clinically used setting by selecting Opdose program 2 on the control
console. AEC sensor 2 shall be selected at the AWS.

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Required Tests - Technologist


Phantom Image Quality
9.

Double click on the first image in the icon gallery, see Figure 3, Position 2.

Figure 3 Service Patient

10. Make an exposure.


11. Examine the image at acquisition size (full resolution) and optimize window level
settings. Determine how many fibers, specks and masses can be visualized.
Always count the number of visible objects from the largest object of a given type
downward. Note the results in Appendix 1, Test Form 3.1 Phantom Image
Quality.
12. If a problem exists while looking at the image on the AWS send the image to the
diagnostic review station or printer and then examine the image.
13. Choose the Close patient tab card and close patient by clicking this button.

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Required Tests - Technologist


Phantom Image Quality

XXX XXX

Fibers

Specks

Masses

Figure 4 Potentially Visible Objects in the accreditation phantom

3.1.4 Analysis
Count each fiber as one point if the full length of the fiber is visible and both
its location and orientation is correct. Count a fiber as 0.5 points if not all but
more than half of the fiber is visible and its location and orientation are
correct. If a fiber-like artifact appears anywhere in the image but is not in an
appropriate location or orientation, deduct the "artifactual" fiber from the last
"real" fiber scored if the artifactual fiber is equally or more apparent.
When studying the specks, it can be useful to take advantage of the zoom
and invert function. Each speck group shall be counted as one point. A full
speck group is counted if four or more specks are visible in the group in the
proper locations. Count a speck group as 0.5 points if two or three specks of
the group are visible. If noise or speck-like artifacts are visible in the wrong
locations in the phantom image, subtract each speck-like artifact one for one
from the last real speck counted.
Count each mass as one point if a density difference is visible in the correct
location and the full mass is visible against the background. Count each mass
as 0.5 points if a density difference is visible in the correct location but not the
full mass is visible, so that the mass does not have a circular appearance. If
there is a mass-like artifact in the wrong location anywhere in the image,
deduct the "artifactual" mass from the last "real" mass scored if the artifactual
mass is equally or more apparent.

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Required Tests - Technologist


Phantom Image Quality

3.1.5 Performance Criteria and Corrective Action


The number (total present: 6 fibers, 5 speck groups and 5 masses) of fibers, speck
groups and masses that shall be identifiable are given in the table below.
Phantom used

Accreditation phantom

Table 3

Required
Fibers

Speck groups

Masses

Object Score Criteria for the accreditation phantom Test

If any level is found to be beyond any action level stated, the source of the
problem must be identified and the problem corrected by a Siemens customer
support engineer. Consult with your MP to determine if further testing is
required.

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Required Tests - Technologist


Detector Calibration

3.2 Detector Calibration


3.2.1 Objective
To determine that the system has been correctly calibrated with respect to its gain.

3.2.2 Required Equipment


a)

Collimator mounted PMMA phantom (40 mm thick)

b)

Compression paddle simulator

3.2.3 Procedure
Calibration of the detector must be done:
Weekly
When the room temperature differs by more than 3 C (5.4 F) since the last
calibration.
When the artifact detection test (see section 3.3 Artifact Detection) fails.

NOTE!
NOTE!
Record the values in the form enclosed in Appendix 1, Test Form
3.2 Detector Calibration.
1.

Install the collimator mounted PMMA phantom.

2.

Install the compression paddle simulator.

3.

Set the exposure parameters 28 kV, 250 mAs on the control console.

4.

Set the anode/filter combination that is used in most clinical cases, see section
4.1 Site Audit / Evaluation of Technologist QC Program.

5.

Select Patient > Detector Calibration from the top menu bar of the Examination
task card.
The Service Patient is automatically registered.

6.

Click the Gain button.


A message window is displayed in which you are prompted to confirm the
overwriting of old calibration data.

7.

Confirm with Yes.

8.

Double click on the first image in the icon gallery, see Figure 3, Position 2.

9.

Make an exposure.
If the image is a uniformly gray you can use it for the calibration. If the image
contains disturbing elements, e.g. lines or spots, it is not suitable for calibration.

NOTE!
NOTE!
You should reject an image if it exhibits any edge cut-off (sharp white
line at the borders) due to collimation or misalignment or if there are any
artifacts from debris or obstructions.
Rectangular segments in the image are acceptable, see Figure 5.

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Detector Calibration

Figure 5 Calibration image

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Detector Calibration
10. Click Accept if the image is suitable for the calibration, see Figure 6.
Or
Click Reject if the image is not suitable.
In the latter case the calibration image is discarded.
11. Continue making calibration images until you have accepted 8 exposures.
The number of accepted and discarded calibration images will be displayed.
The detector is re-calibrated on the basis of the calibration image.

Figure 6 Accept/Reject Calibration Images

12. Choose the Close patient tab card and close patient by clicking this button.
13. Proceed to section 3.3 Artifact Detection.

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Artifact Detection

3.3 Artifact Detection


3.3.1 Objective
To determine if the detector is dusty, damaged, or has other artifacts.

3.3.2 Required Equipment


a)

Collimator mounted PMMA phantom (40 mm thick)

b)

Compression paddle simulator

3.3.3 Procedure
1.

Login according to the section 2. Start Up and Login, if required.

2.

Enter a new patient by pressing Patient Registration icon, see Figure 1,


Position 1.

3.

Create a new patient record in the local database, see Figure 7.


Fill in: Last Name: Test_Three
First Name: Artifact_Detect
Patient ID: day+time when the test is performed
(example: 200411281350)
DOB:
05 05 1955
Gender:
Other

4.

Press Exam button.

5.

Choose procedure FD QC Raw.

6.

Mount a compression paddle simulator.

7.

Assemble the collimator-mounted PMMA phantom (40 mm).

8.

Double click on the first image in the icon gallery, see Figure 3, Position 2.

9.

Make an exposure using the anode/filter combination used in calibration and


28 kV, 90 mAs.

10. Look at the image for clinical relevant artifacts by magnifying to full resolution. To
get full resolution click top "image" drop down menu" and choose "acquisition
size.
If artifacts appear go to step 11.
If no artifacts appear the artifact detection test is completed.
11. If the image has white pixels contact Siemens customer service engineer.
If the image has no white pixels, go to section 3.2 Detector Calibration.
12. Choose the Close patient tab card and close patient by clicking this button.

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3.3.4 Performance Criteria and Corrective Action


No clinically relevant artifacts shall be seen on the image.
If any level is found to be beyond any action level stated, the source of the
problem must be identified and the problem corrected by a Siemens customer
support engineer. Consult with your MP to determine if further testing is
required.

Figure 7 Patient Registration Window

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Signal-to-Noise Ratio (SNR) and Contrast-To-Noise Ratio (CNR) Measurements

3.4 Signal-to-Noise Ratio (SNR) and Contrast-ToNoise Ratio (CNR) Measurements


3.4.1 Objective
To assure proper functioning of the solid-state detector by evaluating the signal-tonoise ratio (SNR) and the contrast-to-noise ratio (CNR) of the detector. During the
MEE testing the obtained values for SNR and CNR should be used as baseline values
for further constancy testing.

3.4.2 Required Equipment


a)

Accreditation phantom

b)

Compression paddle 24x30

3.4.3 Procedure
1.

Login according to the section 2. Start Up and Login.

2.

Enter a new patient by pressing Patient Registration icon, see Figure 1,


Position 1.

3.

Create a new patient record in the local database.


Fill in: Last Name: Test_Four
First Name: SNR_CNR
Patient ID:
day+time when the test is performed
(example: 200411281350)
DOB:
05 05 1955
Gender:
Other

4.

Press Exam button.

5.

Choose procedure FD QC Raw.

6.

Install the compression paddle.

7.

Center the accreditation phantom left to right on the breast support so that it
covers all three AEC sensor regions.

Figure 8 Positioning of the accreditation phantom

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Signal-to-Noise Ratio (SNR) and Contrast-To-Noise Ratio (CNR) Measurements
8.

Select the clinically used setting by selecting 2 (Opdose) on the control console.
AEC sensor 2 shall be selected at the AWS, see Figure 23.

9.

Double click on the first image in the icon gallery, see Figure 3, Position 2.

10. Make an exposure.


11. Draw an ROI by choosing Tools > Circle, size to fit slightly within large mass, see
Figure 9, and record the mean pixel value in Appendix 1, Test Form 3.4 Signalto-Noise Ratio (SNR) and Contrast-To-Noise Ratio (CNR) Measurements.

Mass ROI
Background ROI

Figure 9 CNR Measurement

12. To measure the CNR, repeat the same procedure as in step 11 for the
background ROI by moving the circular ROI just to the inside of the mass as
shown in Figure 9. Move circle laterally adjacent to large mass. Record the mean
pixel value and the standard deviation (background) in Appendix 1, Test Form
3.4 Signal-to-Noise Ratio (SNR) and Contrast-To-Noise Ratio (CNR)
Measurements.
13. Choose the Close patient tab card and close patient by clicking this button.

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Signal-to-Noise Ratio (SNR) and Contrast-To-Noise Ratio (CNR) Measurements

3.4.4 Analysis
SNR should be calculated by using the values in Appendix 1, Test Form 3.4 Signalto-Noise Ratio (SNR) and Contrast-To-Noise Ratio (CNR) Measurements, (see also
Figure 18) and the following formula:

( mean background DC offset )


SNR = -------------------------------------------------------------------------SD background
Where the DCoffset has a value of 50.
CNR should be calculated by using the values in Appendix 1, Test Form 3.4 Signalto-Noise Ratio (SNR) and Contrast-To-Noise Ratio (CNR) Measurements, and the
following formula:

( mean background mean mass )


CNR = -----------------------------------------------------------------------------SD background
Deviation from the baseline value (determined during the mammography equipment
evaluation) can be calculated by using the following formula:

( Baseline ActualValue )
Deviation = ------------------------------------------------------------------------- 100
Baseline

3.4.5 Performance Criteria and Corrective Action


The SNR and CNR must not differ by more than 15% of the baseline values that the
medical physicist determined during the mammography equipment evaluation (MEE)
(which is required during installation). SNR must also be equal to or greater than 40.
If any level is found to be beyond any action level stated, the source of the
problem must be identified and the problem corrected by a Siemens customer
support engineer. Consult with your MP to determine if further testing is
required.

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Repeat Analysis

3.5 Repeat Analysis


3.5.1 Objective
To monitor the causes of repeated patient exposures as part of an effort to correct any
problems that might exist.

3.5.2 Procedure
1.

Login according to the chapter 2. Start Up and Login.

2.

Open the Patient Browser and click on the Reject button, see Figure 10
Position 1.

Figure 10 Discarded images

3.

View each discarded image from the previous month. Use Appendix 1, Test Form
3.5 Repeat Analysis and sort each image into the listed categories.

4.

Repeat the procedure at least every 3 months.

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Repeat Analysis

3.5.3 Analysis
1.

Sort the images and sum the amount of discarded images for each category.

2.

Determine the total number of repeated exposures for all categories and record
in Appendix 1, Test Form 3.5 Repeat Analysis

3.

Determine the percentage of discarded images for each category by dividing the
number of images in each category by the total number of discarded images.

Total number images (per category)


% of repeats = 100 -------------------------------------------------------------------------------------Total number of discarded images

3.5.4 Performance Criteria and Corrective Action


If a single cause of repeated exposures is discovered, efforts should be made to
correct the problem.
Any corrective actions shall be recorded and the results of these corrective actions
shall be assessed.

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Compression Force

3.6 Compression Force


3.6.1 Objective
To measure the compression force in Opcomp and the full automatic max/min and
manual (optional) mode of operation.

3.6.2 Required Equipment


a)

Bathroom scale or compression force measurement tool

b)

Stiff foam block or towel

3.6.3 Procedure
1.

Place bathroom scale on breast support with weight indicator window toward you
or use other compression force measurement tool according to manufacturers
instructions.

2.

If bathroom scale is used, place foam block or folded towel between scale and
compression paddle.

3.

Press compression foot switch until Opcomp light (OC) is lit see Figure 11.

mm
OC

OC

Figure 11 Stand display

4.

Press compression foot switch again to measure maximum automated


compression force. Record force.

5.

Increase manual compression using knobs and column to maximum value.


Record force. (optional)

NOTE!
NOTE!
Compression force readout is kilograms (kg).
Convert to pounds multiply by 2.2.
Convert to Newtons multiply by 10.

3.6.4 Performance Criteria and Corrective Action


Maximum automated compression must be between 12 and 20 kg (25 - 45 pounds).

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Printer Check

3.7 Printer Check


This test is only required on days when the printer/laser camera is used to print
mammograms or accreditation images.

3.7.1 Objective
To assess the quality of the laser camera.

3.7.2 Required Equipment


a)

Calibrated densitometer

3.7.3 Procedure
1.

Login according to the section 2. Start Up and Login.

2.

Choose the service patient in the Patient Browser.

3.

Select SMPTE image from group [1] Technical Images in the service image
patient. Open it in the Viewing task card by double clicking.

4.

Send the image to the mammography laser camera/printer.

5.

The printer/laser camera shall be configured to Min Density 20 (corresponding to


0.2 optical density) and Max Density to 350 (corresponding to 3.5 optical
density), if applicable.

6.

Evaluate the printed SMPTE image by measuring the eleven density values from
0 to 100% with the densitometer and note the measured values in
Appendix 1, Test Form 3.7 Printer Check.

NOTE!
NOTE!
This procedure or the printer/laser camera manufacturer's QC
procedure must be followed whenever the printer/laser camera is used
to print mammographic images or accreditation images.

3.7.4 Performance Criteria and Corrective Action


The values for the different optical densities must be within the action limits as stated
in Appendix 1, Test Form 3.7 Printer Check or as recommended by the printer/laser
camera manufacturer.
If any level is found to be beyond any action level stated, the source of the
problem must be identified and the problem corrected by a Siemens customer
support engineer. Consult with your MP to determine if further testing is
required.
For the qualification of the printer you may follow the printer/laser camera
manufacturers recommendations.

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Site Audit / Evaluation of Technologist QC Program

4. Initial Checks - Physicist


4.1 Site Audit / Evaluation of Technologist QC
Program
4.1.1 Objective
To determine the site settings.
To ensure compliance to the Technologist QC tests. Refer to Table 1.

4.1.2 Procedure
1.

List all compression paddles that will be used routinely in Appendix 2, Test Form
4.1 Site Audit / Evaluation of Technologist QC Program

2.

Identify the modes chosen for technique selection and note in Appendix 2, Test
Form 4.1 Site Audit / Evaluation of Technologist QC Program

3.

Define the clinical techniques (used to image accreditation phantom) and note in
Appendix 2, Test Form 4.1 Site Audit / Evaluation of Technologist QC Program

4.

Determine if other target/filter combinations are used clinically and note in


Appendix 2, Test Form 4.1 Site Audit / Evaluation of Technologist QC Program.

5.

Make sure that the compliance to the technologist QC tests refered in Table 1 is
met.

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Mechanical Inspection

4.2 Mechanical Inspection


4.2.1 Objective
Acceptance MEE:
As deemed appropriate by Medical Physicist to ensure system performance.
Annually:
To ensure the mechanical integrity of the unit and cables do not show any
mechanical damage.

4.2.2 Procedure
1.

Wipe the breast support and compression paddle with a wet lint free non-woven
cotton cloth or cotton (100%) pad. For moistening, use water or lukewarm diluted
aqueous solution of household dishwashing liquid. (No visual damages should be
observed. No artifacts should be seen on the calibration images.)

NOTE!
NOTE!
Do not spray the unit! The cleaning fluid must under no
circumstances penetrate into the unit.
2.

Check that the cables are free from visual damages. Note the outcome in
Appendix 2, Test Form 4.2 Mechanical Inspection.

3.

Check that the control panel lights up to show that the power is switched on. Note
the outcome in Appendix 2, Test Form 4.2 Mechanical Inspection.

4.

Turn the swivel-arm system 180 so that the tube head is upside down. Lower the
system as close to the floor as possible. Check that the error indication lamp on
the generator console (see Figure 12) is lit. Raise and turn the swivel-arm system
back again and check that the lamp goes out. Note the outcome in
Appendix 2, Test Form 4.2 Mechanical Inspection.

Figure 12 Error Indication Lamp Symbol

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Mechanical Inspection
5.

Check the motorized movements for smooth running and normal function. Note
the outcome in Appendix 2, Test Form 4.2 Mechanical Inspection.

6.

Check that the height adjustment and rotation of the swivel-arm system are
blocked, when the displayed compression force is 3 kg (7 lbs). Note the
outcome in Appendix 1, Test Form 4.2 Mechanical Inspection.

7.

Check the self-braking of the compression motor. Run the compression paddle
against the FD object table, until the applied compression force reaches 15 kg
(33 lbs). After 1/2 minute in this condition, this value must not change by more
than 2 kg (4 lbs). Note the outcome in Appendix 2, Test Form 4.2 Mechanical
Inspection.

8.

Check that the manual compression/decompression functions properly. Note the


outcome in Appendix 2, Test Form 4.2 Mechanical Inspection.

9.

Check that the decompression button on the control console functions correctly.
Note the outcome in Appendix 2, Test Form 4.2 Mechanical Inspection.

Maximum compression force


presetting knob

MAM00664

Knobs for manual


compression/decompression

Figure 13 Manual compression

10. For power driven compression, the compression device must apply a force with a
maximum value between 111 N (approx. 12 kg, 11 on the display of the stand)
and 200 N (approx 20 kg, 20 on the display of the stand). Note the outcome in
Appendix 2, Test Form 4.2 Mechanical Inspection.

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Mechanical Inspection
11. There should be no sharp edges or cracks that could create sharp edges on the
compression paddles, detector, etc. which may injure the patient. Note the
outcome in Appendix 2, Test Form 4.2 Mechanical Inspection.
12. All foot switches should operate correctly. Note the outcome in Appendix 2, Test
Form 4.2 Mechanical Inspection.
13. All attachments should latch securely and their locks should function effectively.
Note the outcome in Appendix 2, Test Form 4.2 Mechanical Inspection.
14. Use a luminance meter to measure the light intensity from the X-ray field on the
object table in the four areas described in Figure 14. Note the outcome in
Appendix 2, Test Form 4.2 Mechanical Inspection.
Light field
1

Figure 14 Light Field Luminance Measurement

15. The location of the exposure control should confine the operator to the protected
area during exposure. Note the outcome in Appendix 2, Test Form
4.2 Mechanical Inspection.
16. Check the emergency stop button for proper function. Note that with the button
depressed, all motorized movements shall be blocked. Note the outcome in
Appendix 2, Test Form 4.2 Mechanical Inspection.

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Acquisition Workstation Monitor Check

4.3 Acquisition Workstation Monitor Check


4.3.1 Objective
To assess the quality of the acquisition workstation monitor.

4.3.2 Required Equipment


a)

SMPTE test pattern

4.3.3 Procedure
1.

Clean the monitor


a) The monitor surface should be cleaned with a soft tissue material, such as
cotton or lens cleaning paper.
b) If necessary, stubborn stains can be removed by moistening part of a cloth
with water to enhance its cleaning power.

3.

Select the Viewing task card on the right edge of the monitor.

4.

Select the Service images in the local data base in the Patient Browser.

5.

Open the image labeled Group [1] Technical Images. Double click on the image
for display. Make sure that the SMPTE is covering the entire viewing area i.e. the
window should not be divided in four viewing areas.
Check that the window width is set to 4096 and that the window center is set to
2048. Display image in acquisition size under Image > Acquisition Size. Erase
text using View > No Text.

6.

The gray scale is shown as a series of squares in the central part of the SMPTE
image, ranging from black (0%) to white (100%). The 0% and 100% squares each
contain smaller squares within them that represent signal level steps of 5% and
95% respectively (see Figure 15). You should be able to differentiate the inner
square from the larger square that contains it. The 5% square is normally quite
difficult to differentiate. If this is not possible then perform this test again with
dimmed room light.

5%

95 %

Figure 15 Location of Squares

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Acquisition Workstation Monitor Check
7.

Visually check the monitors performance by looking for streaking, fluttering and
shadows.

8.

The spatial resolution (linearity) and aliasing (distortion) of the monitor are
considered to be within acceptable limits if the high contrast bar patterns in the
test image can be seen as patterns of white and black pairs. To use the pattern,
inspect all six of the high contrast patterns in each corner (see Figure 16) of the
images as well as in the center. You should be able to differentiate all the lines in
all the high contrast patterns.

Figure 16 Location of Contrast Bar Patterns

9.

Choose the Close patient tab card and close patient by clicking this button.

4.3.4 Performance Criteria and Corrective Action


The 5% and 95% squares must be visible.
All high contrast bar patterns in the four corners and in the center of the image
(see Figure 16) shall be resolved.
If any level is found to be beyond any action level stated, the source of the
problem must be identified and the problem corrected by a Siemens customer
support engineer. Consult with your MP to determine if further testing is
required.

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Detector Uniformity and Artifact Detection

5. Required Tests - Physicist


5.1 Detector Uniformity and Artifact Detection
5.1.1 Objective
To measure the uniformity of the detector response over its entire surface and to
determine if the detector is dusty, damaged, or has other artifacts.

5.1.2 Required Equipment


a)

Collimator mounted plexi (40 mm)

b)

Compression paddle 24x30

5.1.3 Procedure
1.

Login according to the section 2. Start Up and Login.

2.

Enter a new patient by pressing Patient Registration icon, see Figure 1,


Position 1.

3.

Create a new patient record in the local database.


Fill in: Last Name: Test_One
First Name: Detector Uniformity
Patient ID: day+time when the test is performed
(example: 200411281350)
DOB:
05 05 1955
Gender:
Other

4.

Press Exam button.

5.

Choose procedure FD QC Raw.

6.

Install the collimator-mounted plexi (40 mm).

7.

Install the compression paddle. Set at height of 4.5 cm.

8.

Double click on the first image in the icon gallery, see Figure 3, Position 2.

9.

Make an exposure with 28 kV, AEC mode H and the anode/filter combination that
the system has been calibrated with, see section 4.1 Site Audit / Evaluation of
Technologist QC Program.

10. Check that there are no defective columns and no grid lines in the image.
Optimize window and center (start with W = 500 and C = 600).
11. Choose Postprocessing sub tab card.
12. Choose rectangular ROI Tool.

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Detector Uniformity and Artifact Detection
13. Make an ROI (Region Of Interest) by choosing Tools > Rectangle with the size
of the ROI approximately 10x10 mm according to Figure 17 and located appro.
20 mm of the edges as shown in Figure 17. (Annotation can be removed by
clicking on View > No Text.)

Figure 17 Pixel Test Areas on the Detector

14. ROI Statistics will be shown. see Figure 18.


Record the mean value in the selected area in Appendix 2, Test Form
5.1 Detector Uniformity and Artifact Detection.

Mean Value
Figure 18 ROI Statistics

15. Move the ROI four times until you have measured all five areas shown in Figure
17.

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Detector Uniformity and Artifact Detection
16. Look at the image for clinical relevant artifacts by magnifying to full resolution.
To get full resolution click top "image" drop down menu and choose "acquisition
size. Activate zoom/pan under image menu. Image may be panned when cursor
is displayed as crossed arrows.
If artifacts appear go to step 17.
If no artifacts appear go to step 18.
17. If the image has white pixels go to step 19.
If the image has no white pixels, make a calibration, see section 3.2 Detector
Calibration. If artifacts still appear, call Siemens customer service engineer
otherwise go to step 12.
18. If no artifacts can be detected, continue with the examinations.
19. For pixel correction, please call Siemens customer service engineer.
20. Choose the Close patient tab card and close patient by clicking this button.

5.1.4 Performance Criteria and Corrective Action


The required performance criteria: The mean pixel value inside each of the five ROI
locations shall not differ by more than 10% from the mean value of the means.
The desired performance criteria: The mean pixel value inside each of the five ROI
locations shall not differ by more than 5% from the mean value of the means.
No clinically relevant artifact shall be seen in the image.
If any level is found to be beyond any action level stated, the source of the
problem must be identified and the problem corrected by a Siemens customer
support engineer. Consult with your MP to determine if further testing is
required

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Collimation, Dead Space and Compression Paddle Position

5.2 Collimation, Dead Space and Compression


Paddle Position
5.2.1 Objective
To ensure that the collimator does not allow significant radiation beyond the
edges of the image detector.
To ensure that the chest wall missed tissues are within the tolerance of 5 mm
maximum.
To ensure that the position of the chest wall side of each standard
compression paddle allows for complete imaging of the chest wall tissues.

5.2.2 Required Equipment


a)

Seven identical coins

b)

Ruler

c)

24x30 Compression paddle, 20x22 (coned) Compression Paddle

d)

Film or CR cassette (24x30 or larger)

5.2.3 Procedure

48

1.

Login according to the section 2. Start Up and Login.

2.

Enter a new patient by pressing Patient Registration icon, see Figure 1,


Position 1.

3.

Create a new patient record in the local database.


Fill in: Last Name: Test_Two
First Name: Chest Wall Missed Tissue
Patient ID: day+time when the test is performed
(example: 200411281350)
DOB:
05 05 1955
Gender:
Other

4.

Press Exam button see Figure 7.

5.

Choose procedure FD QC Raw, see Figure 3, Position 1.

6.

Install the 24 x 30 Compression paddle.

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Collimation, Dead Space and Compression Paddle Position
7.

Place the X-ray Tube in 0 position.

Figure 19 Placing the Coin

8.

Tape the coin (3) on the breast support so that its edge is exactly tangent to the
chest wall edge of the FD object table. See Figure 19.

9.

Tape a coin on the lower surface of the 24x30 compression paddle tangent to the
chest wall edge.

10. Place a film or CR cassette 24x30 or larger on top of the FD object table and turn
it so the mid points of each edge of the light field are within the film in the cassette,
see Figure 20.
11. Install the compression paddle and set the compression paddle position about
4-5 cm above the breast support. Wait until collimation according to paddle size
is done and remove paddle.
12. Turn on the light field.
13. Place 4 coins (1, 2, 4, 6) on the film cassette as markers on the mid point of each
light field edge so that the edges of the coins are tangent to the outer light field
edges. Place coin (7) on the film cassette, see Figure 20.
14. Install the compression paddle 24 x 30

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Collimation, Dead Space and Compression Paddle Position

Figure 20 Placing the Coins

15. Double click on the first image in the icon gallery, see Figure 3, Position 2.
16. Using a film cassette make an exposure with 28 kV, 50 mAs and using the clinical
target/filter combination (see section 4.1 Site Audit / Evaluation of Technologist
QC Program). For CR cassettes use appropriate technique.
17. Develop the film in the cassette and mark it with anode/filter combination used.
18. On the acquisition workstation monitor measure the distance e for coin 7,
distance x for coin 3 and y for coin 5 and measure the distance g for coin 1, 2, 4,
6 in Figure 20.
Drawing distance lines
Click on the Distance button on the Tools sub task card.
Draw a line with the left mouse button kept pressed. The distance is displayed
immediately while dragging the line.
Also measure the distance f for coin 1, 2, 4 and 6 on the developed film or CR
cassette with a ruler, according to Figure 20 and note in Appendix 2, Test Form
5.2 Collimation, Dead Space and Compression Paddle Position.
19. Repeat steps 7- 18 with 28 kV, 50 mAs, using alternative filter/anode combination.
20. Remove all coins.
21. Tape a coin on the lower surface of the 20x22 compression paddle tangent to the
chest wall edge (coin 5). Place coin 7 on to the detector.

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Collimation, Dead Space and Compression Paddle Position
22. Install the compression paddle and set the compression paddle position about
4-5 cm above the breast support.
23. Make an exposure with 25 kV, 20 mAs, and using the clinical target/filter
combination (see section 4.1 Site Audit / Evaluation of Technologist QC
Program).
24. On the acquisition workstation monitor measure the distance e and y for the coin
and note in Appendix 2, Test Form 5.2 Collimation, Dead Space and
Compression Paddle Position.
25. Repeat step 22 to 23 with 25 kV, 20 mAs, using alternative filter/anode
combination.
26. Repeat step 20 to 24 with all standard compression paddles.
27. Choose the Close patient tab card and close patient by clicking this button.

NOTE!
NOTE!
Do not use Flex paddles for this test.

5.2.4 Performance Criteria and Corrective Action


Detector Dead Space indicated by the missing part of the coin on the Breast
support must be 5 mm.
The X-ray/light-field misalignment (sum of misalignments on opposite sides),
must not exceed 2% of SID (13 mm).
The X-ray field must not extend beyond the detector's active area at any one
side by more than 2% of SID (13 mm).
The X-ray field shall cover all of the detector's active area on the chest wall
side (e.g., it cannot be inside the detector on the chest wall side).
The compression paddle must not extend beyond the active detector area at
the chest wall by more than 6.5 mm.
If any level is found to be beyond any action level stated, the source of the
problem must be identified and the problem corrected by a Siemens customer
support engineer. Consult with your MP to determine if further testing is
required.

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AEC Thickness Tracking Test

5.3 AEC Thickness Tracking Test


5.3.1 Objective
To assure that the AEC function is tracking by evaluation images acquired with
different thicknesses and techniques.

5.3.2 Required Equipment


a)

Three PMMA absorbers, 20 mm thick each

b)

Compression paddle 24x30

5.3.3 Procedure
1.

Login according to the section 2. Start Up and Login.

2.

Enter a new patient by pressing Patient Registration icon, see Figure 1,


Position 1.

3.

Create a new patient record in the local database.


Fill in: Last Name: Test_Three
First Name: AEC Tracking
Patient ID: day+time when the test is performed
(example: 200411281350)
DOB:
05 05 1955
Gender:
Other

4.

Press Exam button.

5.

Choose procedure FD QC Raw. AEC Sensor 1 shall be used, see Figure 23.

6.

Put the 20 mm PMMA on the breast support (Figure 21).

PMMA

Figure 21 Positioning the PMMA (seen from above)

7.

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Install the compression paddle.

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AEC Thickness Tracking Test
8.

Use the anode/filter combination with which the system is calibrated, see section
4.1 Site Audit / Evaluation of Technologist QC Program and AEC mode H for all
exposure.
Use the kVp values shown below.
2cm - 26 kVp
4cm - 28 kVp
6cm - 32 kVp

9.

Double click on the first image in the icon gallery, see Figure 3, Position 2.

10. Make an exposure.


11. Click the Postprocessing sub tab card or select an ROI (Region of Interest) by
choosing Tools > Rectangle. Set size of ROI approximately 10x10 mm and 60
mm from the chest wall side. Measure the mean pixel value and the standard
deviation and fill them in the table in Appendix 2, Test Form 5.3 AEC Thickness
Tracking Test
12. Calculate SNR according to the following formula:

( mean background DC offset )


SNR = -------------------------------------------------------------------------SD background
Where the DCoffset has a value of 50.
13. Repeat the same procedure from step 8 - 13 for all thicknesses and techniques
listed in step 8.
14. Choose the Close patient tab card and close patient by clicking this button.
15. Calculate the mean value for the mean of the SNR values for the different
thicknesses. Fill in the values in the table.
16. Calculate the maximum deviation from the mean value of the pixel value and SNR
measurements using the following formula:
Maximum deviation = (Maximum difference / Mean Value) x 100 %

5.3.4 Performance Criteria and Corrective Action


The minimum SNR must be 40 and the maximum deviation from the mean value
must be 15 %.
If any level is found to be beyond any action level stated, the source of the
problem must be identified and the problem corrected by a Siemens customer
support engineer. Consult with your MP to determine if further testing is
required.

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Spatial Resolution

5.4 Spatial Resolution


5.4.1 Objective
To ensure that adequate spatial resolution is obtained with the MAMMOMAT
NovationDR system.
a)

Line pair phantom

b)

40 mm (PMMA) phantom

c)

Compression paddle 24x30

5.4.2 Procedure

54

1.

Login according to the section 2. Start Up and Login.

2.

Enter a new patient by pressing Patient Registration icon, see Figure 1,


Position 1.

3.

Create a new patient record in the local database.


Fill in: Last Name: Test_Four
First Name: Spatial Resolution
Patient ID: day+time when the test is performed
(example: 200411281350)
DOB:
05 05 1955
Gender:
Other

4.

Press Exam button.

5.

Choose procedure FD QC Raw.

6.

Mount the compression paddle.

7.

Select the clinically used setting by selecting Opdose program 3 on the control
console. AEC sensor 3 shall be selected at the AWS (sensor 3 shall be covered
with the PMMA phantom). Be sure that the resolution phantom doesnt cover the
AEC sensor area, see Figure 23.

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Spatial Resolution
8.

Place the 40 mm PMMA phantom parallel to the chest wall edge. Place the line
pair phantom on the phantom with the bars at an angle of approximately 45
degrees (see Figure 22) to the tube axis, about 1 cm from the chest wall and with
the largest pattern toward the chest wall.

45
AEC 3

Figure 22 Placing the Resolution Phantom

9.

Double click on the first image in the icon gallery, see Figure 3, Position 2.

10. Make an exposure.


11. Examine the image and starting with the largest bars determine the highest linepair resolution where the bars can be clearly seen. Make a magnification to full
resolution of the image using Image > Acquisition size. Optimize window/level.
Start at W = 500 and C = 250 (Magnifier window over the patterns may help). Note
the outcome in Appendix 2, Test Form 5.4 Spatial Resolution.
12. Choose the Close patient tab card and close patient by clicking this button.

5.4.3 Performance Criteria and Corrective Action


The measured resolution shall be at least 7 lp/mm.
If any level is found to be beyond any action level stated, the source of the
problem must be identified and the problem corrected by a Siemens customer
support engineer. Consult with your MP to determine if further testing is
required.

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SNR, CNR and AEC repeatability

5.5 SNR, CNR and AEC repeatability


5.5.1 Objective
To assure proper functioning of the solid-state detector by evaluating the signal-tonoise ratio (SNR) and the contrast-to-noise ratio (CNR) of the detector. During the
MEE testing the obtained values for SNR and CNR should be used as baseline values
for further constancy testing.
To measure the AEC image stability and the AEC reproducibility.

5.5.2 Required Equipment


a)

Dosimeter calibrated at the mammography X-ray beam energies

b)

Accreditation phantom

c)

Compression paddle 24x30

5.5.3 Procedure

56

1.

Login according to the section 2. Start Up and Login.

2.

Enter a new patient by pressing Patient Registration icon, see Figure 1,


Position 1.

3.

Create a new patient record in the local database.


Fill in: Last Name: Test_Five
First Name: AEC
Patient ID: day+time when the test is performed
(example: 200411281350)
DOB:
05 05 1955
Gender:
Other

4.

Press Exam button.

5.

Choose procedure FD QC Raw.

6.

Install the compression paddle.

7.

Center the accreditation phantom left to right on the breast support so that it
covers all three sensor regions.

8.

Place the dosimeter to the side of the phantom and with its center at 40 mm from
the chest wall edge of the patient support. Refer to Figure 24. Put the dose meter
at the same level as the top surface of the accreditation phantom.

9.

Check that the phantom covers all three regions of the AEC sensors by
compressing the compression paddle. See Figure 24.

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SNR, CNR and AEC repeatability
10. Select the clinically used setting by selecting 2 (Opdose) on the control console.
AEC sensor 2 shall be selected at the AWS, see Figure 23.

Figure 23 Selection of an AEC Sensor

11. Double click on the first image in the icon gallery, see Figure 3, Position 2.
12. Make an exposure and record the mAs and entrance dose in Appendix 2, Test
Form 5.5 SNR, CNR and AEC repeatability.
13. Repeat steps 11 to 12 until 5 exposures have been made.
14. Select an ROI (Region Of Interest) by choosing Tools > Circle or click on the
Postprocessing sub tab card.
15. Set the size of the ROI to be slightly smaller than the largest mass, about 0.4 cm.
See Figure 9.
16. Measure the mean pixel value and standard deviation adjacent to the largest
mass. See Figure 9 (Try to measure the same area for all images).
17. For image number 5 also measure the contrast to noise value (CNR). Measure
the mean pixel value inside the largest mass. Record values in Appendix 2, Test
Form 5.5 SNR, CNR and AEC repeatability.
18. Choose the Close patient tab card and close patient by clicking this button.

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SNR, CNR and AEC repeatability

5.5.4 Analysis
SNR should be calculated by using the values in Appendix 2, Test Form 5.5 SNR,
CNR and AEC repeatability, (see also Figure 18) and the following formula:

( mean background DC offset )


SNR = -------------------------------------------------------------------------SD background
Where the DCoffset has a value of 50.
CNR should be calculated by using the values in Appendix 2, Test Form 5.5 SNR,
CNR and AEC repeatability, and the following formula:

( mean background mean mass )


CNR = -----------------------------------------------------------------------------SD background
Calculate the mean value of the mAs, entrance air kerma or exposure, mean pixel
value and SNR. Record these values in Appendix 2, Test Form 5.5 SNR, CNR and
AEC repeatability
Calculate the coefficient of variation for the mAs and air kerma/exposure and the
maximum deviation from the mean for mean pixel value and SNR.

5.5.5 Performance Criteria and Corrective Action


The coefficient of variation for the mAs and entrance kerma/exposure must be less
than 5%. The maximum deviation of the mean pixel values and SNR measurements
must be less than or equal to 15% of the mean values for the measurements.

NOTE!
NOTE!
The SNR and CNR values measured by the medical physicist during
installation or MEE should be communicated to the QC Technologist
and will define the base line values for these measurements.
If any level is found to be beyond any action level stated, the source of the
problem must be identified and the problem corrected by a Siemens customer
support engineer. Consult with your MP to determine if further testing is
required.

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Image Quality and Radiation Dose

5.6 Image Quality and Radiation Dose


5.6.1 Objective
To ensure that adequate image quality is achieved.
Measure the mean glandular dose to ensure that it does not exceed 3.0 mGy, which
is the maximum value allowed in the regulations for screen-film systems as well as for
full field digital mammography (FFDM) systems.

5.6.2 Required Equipment


a)

Dosimeter calibrated at the mammography X-ray beam energies

b)

Accreditation phantom

c)

Compression paddle 24x30

NOTE!
NOTE!
HVL Values will be required to calculate Radiation Dose.

5.6.3 Procedure
1.

Login according to the section 2. Start Up and Login.

2.

Enter a new patient by pressing Patient Registration icon, see Figure 1,


Position 1.

3.

Create a new patient record in the local database.


Fill in: Last Name: Test_Six
First Name: Mean Glandular Dose
Patient ID: day+time when the test is performed
(example: 200411281350)
DOB:
05 05 1955
Gender:
Other

4.

Press Exam button.

5.

Choose procedure FD QC processed.

6.

Install the compression paddle.

7.

Center the phantom left to right and place dosimeter next to phantom and about
4 cm from chest wall edge, see Figure 24. Try to get the dosimeter at the same
height as the phantom top. Compress phantom until OpComp indicator light is lit,
see Figure 11.

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Image Quality and Radiation Dose

Figure 24 Positioning of the accreditation phantom

8.

Choose Opdose 2 on the control console. Select AEC sensor 2 at AWS, see
section 4.1 Site Audit / Evaluation of Technologist QC Program.

9.

Use H mode.

10. Double click on the first image in the icon gallery, see Figure 3, Position 2.
11. Select the automatic decompression button on the control console.
12. Make an exposure and check if an automatic release of the compression paddle
was performed and note in Appendix 2, Test Form 5.6 Image Quality and
Radiation Dose.

NOTE!
NOTE!
Record all values in the appropriate place in section 5.6 Image Quality
and Radiation Dose and calculate the mean glandular dose. Other
accepted methods for calculating mean glandular dose may also be
used.
13. Examine the image at acquisition size (To get full resolution click top image ->
acquisition size.) optimize window level settings. Determine how many fibers,
specks and masses can be visualized. Always count the number of visible objects
from the largest object of a given type downward. Note the results in
Appendix 2, Test Form 5.6 Image Quality and Radiation Dose.

XXX XXX

Fibers

Specks

Masses

Figure 25 Potentially Visible Objects in the accreditation phantom

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Image Quality and Radiation Dose
14. If a problem exists while looking at the image on the AWS send the image to the
diagnostic reviewstation or printer and then examine the image.
15. Record the thickness reported in the image annotation, see Appendix 2, Image
Quality and Radiation Dose.
16. Optional: Repeat radiation dose and image quality tests for D Mode. (Unless D
Mode is the clinical Technique).
17. Choose the Close patient tab card and close patient by clicking this button.

5.6.4 Analysis
Count each fiber as one point if the full length of the fiber is visible and the
location and orientation of the fiber are correct. Count a fiber as 0.5 point if
not all but more than half of the fiber is visible and its location and orientation
are correct. If a fiber-like artifact appears anywhere in the image but is not in
an appropriate location or orientation, deduct the "artifactual" fiber from the
last "real" fiber scored if the artifactual fiber is equally or more apparent.
When studying the specks, it can be useful to take advantage of the zoom
and invert function. Each speck group shall be counted as one point. A full
speck group is counted if four or more specks are visible in the group in the
proper locations. Count a speck group as 0.5 point if two or three specks of
the group are visible. If noise or speck-like artifacts are visible in the wrong
locations in the phantom insert, subtract each speck-like artifact one for one
from the last real speck counted.
Count each mass as one point if a density difference is visible in the correct
location and the full mass is visible against the background. Count each mass
as 0.5 point if a density difference is visible in the correct location but the full
mass is not visible, so that the mass does not have a circular appearance. If
there is a mass-like artifact in the wrong location anywhere in the image,
deduct the "artifactual" mass from the last "real" mass scored if the artifactual
mass is equally or more apparent.

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Image Quality and Radiation Dose

5.6.5 Performance Criteria and Corrective Action


The required performance criteria:
The mean glandular dose must not exceed 3 mGy (3 mRad).
The desired performance criteria:
The mean glandular dose should not exceed 2 mGy (2mRad).
The number (total present: 6 fibers, 5 speck groups and 5 masses) of fibers, speck
groups and masses that shall be identifiable are given in the table below.
Phantom used

Accreditation phantom

Table 4

Required
Fibers

Speck groups

Masses

Object Score Criteria for the accreditation phantom Test

If any level is found to be beyond any action level stated, the source of the
problem must be identified and the problem corrected by a Siemens customer
support engineer. Consult with your MP to determine if further testing is
required.

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HVL and Radiation Output

5.7 HVL and Radiation Output


5.7.1 Objective
Calculate the half value layer (HVL) from measured exposure data. The HVL value obtained is subsequently used in the Dose Calculation.
To measure the radiation output of the system when operating at 28 kVp in standard
mammography mode.

5.7.2 Required Equipment


a)

Dosimeter calibrated at the mammography X-ray beam energies

b)

2 mm steel plate (object table size)

c)

Spot compression paddle

d)

Sheets of 99.9 % pure aluminium covering thicknesses from 0.2 to 0.6 mm.

5.7.3 Procedure
1.

Login according to the section 2. Start Up and Login.

2.

Enter a new patient by pressing Patient Registration icon, see Figure 1,


Position 1.

3.

Create a new patient record in the local database.


Fill in: Last Name: Test_Seven
First Name: HVL
Patient ID: day+time when the test is performed
(example: 200411281350)
DOB:
05 05 1955
Gender:
Other

4.

Press Exam button.

5.

Choose procedure FD QC processed.

6.

Install the spot compression paddle to collimate the X-ray beam.

7.

Raise the compression paddle to its highest position and place the 2 mm steel
plate on the object table.

NOTE!
NOTE!
It is important that the 2 mm steel or lead is covering the detector during
the entire test.
8.

Place the dosimeter on the object table. Make sure the receptive area is fully
within the X-ray field, use the light field as a guidance.

9.

Set 28 kVp and anode/filter combination see section 4.1 Site Audit / Evaluation of
Technologist QC Program (Opdose 2, clinical technique) and set mAs = 50.

10. Double click on the first image in the icon gallery, see Figure 3, Position 2.

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HVL and Radiation Output
11. Make an exposure. Note the dosimeter reading in Appendix 2, Test Form
5.7 HVL and Radiation Output period.
12. For Mo/Mo place 0.3 mm aluminum sheets on top of the compression paddle. For
Mo/Rh place 0.4 mm aluminum and for W/Rh place 0.5 mm aluminum on top of
the compression paddle. Make sure the Al sheets cover the whole active detector
area of the dosimeter.
13. Make another exposure. Record the dosimeter reading and the Al thickness in
Appendix 2, Test Form 5.7 HVL and Radiation Output.
14. Place an additional 0.1 Al sheet on top of the compression paddle.
15. Repeat steps 13 to 14 until the dosimeter reading is less than half the first
exposure reading that you made without any Al sheets.
16. Remove all Al sheets, make an exposure and record the dosimeter reading. If the
value differs more than 2% from the first exposure reading, repeat from step 11.
17. Make one more exposure using 28 kVp 400mAs Mo/Mo. Record the radiation air
kerma/exposure and exposure time in Appendix 2, Test Form 5.7 HVL and
Radiation Output
18. Note the time of the exposure that is displayed in the Image Attributes ... by
clicking on the right mouse button on the image icon.

Figure 26 Image Attributes

19. Calculate the radiation output with the following formula:


radiation output rate = air kerma / time or exposure / time
20. Choose the Close patient tab card and close patient by clicking this button.
21. Calculate the HVL values for each anode/filter combination following the formula
and note the values in Appendix 2, Test Form 5.7 HVL and Radiation Output.

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HVL and Radiation Output

5.7.4 Calculating HVL


From the previous measurements, the HVL value can be calculated. The formula to
use is:
HVL

( t b ln [ 2D a D 0 ] ) ( t a ln [ 2D b D 0 ] )
= --------------------------------------------------------------------------------------ln [ D a D b ]

where
D0 = air kerma/exposure reading without aluminum
Da = air kerma/exposure reading just greater than half of D0
Db = air kerma/exposure reading just less than half of D0
ta = aluminum layer thickness corresponding to Da
tb = aluminum layer thickness corresponding to Db
ln is short for the natural logarithm

5.7.5 Performance Criteria and Corrective Action


The radiation output rate must be higher than 7.0 mGy air kerma per second,
alternatively 800 mR per second.

Anode/Filter

HVL value at 28kVp


(kVp/100)

Mo/Mo

0.28

Mo/Rh

0.28

W/Rh

0.28

Table 5

HVL action limits for the different Anode/Filter combinations

The HVL for all anode filter combinations must be greater or equal to kVp/100.
If any level is found to be beyond any action level stated, the source of the
problem must be identified and the problem corrected by a Siemens customer
support engineer. Consult with your MP to determine if further testing is
required.

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Tube Voltage Measurement & Reproducibility

5.8 Tube Voltage Measurement & Reproducibility


5.8.1 Objective
To verify that the accuracy of the tube voltage value displayed is in accordance with
the specifications.

5.8.2 Required Equipment


a)

Non-invasive kVp meter calibrated in the mammography range.

b)

Compression paddle simulator

c)

2 mm steel plate

5.8.3 Procedure
1.

Login according to the section 2. Start Up and Login.

2.

Enter a new patient by pressing Patient Registration icon, see Figure 1,


Position 1.

3.

Create a new patient record in the local database.


Fill in: Last Name: Test_Eight
First Name: Tube Voltage
Patient ID: day+time when the test is performed
(example: 200411281350)
DOB:
05 05 1955
Gender:
Other

4.

Press Exam button.

5.

Choose procedure FD QC processed.

6.

Make sure that the Mammomat system has been powered on for at least
15 minutes.

7.

Install the compression paddle simulator.

8.

Place the 2 mm steel plate on the detector.

9.

Place the detector part of the digital kVp meter on top of the steel plate. Care
should be taken to position the detector in accordance with the manufacturer's
recommendations. (Alternative procedure: place kVp meter on top of
compression paddle. Center active area in the beam.)

10. Double click on the first image in the icon gallery, see Figure 3, Position 2.

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Tube Voltage Measurement & Reproducibility
11. Make 4 exposures at the clinical kVp (see section 4.1 Site Audit / Evaluation of
Technologist QC Program) using 50 mAs and Mo/Mo.
For each measurement, record the tube voltage value kVp from the kV meter in
Appendix 2, Test Form 5.8 Tube Voltage Measurement & Reproducibility.
12. For each of the following kVp's one exposure is required:
26kVp, 28kVp, 30kVp, 32kVp and 34kVp (50 mAs, Mo/Mo).
For each measurement, record the tube voltage value kVp from the kV meter in
Appendix 2, Test Form 5.8 Tube Voltage Measurement & Reproducibility.
13. Choose the Close patient tab card and close patient by clicking this button.

5.8.4 Calculations
These calculations can be easily performed with an inexpensive calculator.
1.

Formula for Accuracy (expressed in percent):

kV p
meas kVp set
---------------------------------------------- 100
kVp set

kVpmeas =
=
kVpset
2.

Measured kVp
The set value of the tube voltage

Coefficient of variations Cv (expressed in percent):

1--2
n ( kVp kVp
2
1
i
mean ) - 100
Cv = ------------------------ ------------------------------------------------kVp mean
n1
i=1

Mean value for the tube voltage measurement:


kVp 1 + kVp 2 + kVp 3 + kVp 4
kVpmean = ----------------------------------------------------------------------4
kVpi
n

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= The sampled measurement


= The number of measurements sampled (n here = 4)

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Tube Voltage Measurement & Reproducibility
Example: Calculating the kVp reproducibility coefficient of variations Cv:
a) Settings: kVpset = 27kVp, 50mAs and Mo/Mo
Record the four consecutive measurements and calculate the mean value kVpmean in
Appendix 2, Test Form 5.8 Tube Voltage Measurement & Reproducibility.
Measurement no

kVp1

kVp2

kVp3

kVp4

Tube voltage [kV]

27.2

27.1

27.0

27.3

kVpmean

(kVp1+kVp2+kVp3+kVp4)/4=27.15

b) Subtract each individual measurement sample from the mean value kVpmean and
square each difference.
Difference

0.05

-0.05

-0.15

0.15

Difference squared

0.0025

0.0025

0.0225

0.0225

c) Sum up the 4 squared differences and divide the sum by 3.


The summed difference divided by 3 is: 0.05/3=0.0167
d) Take the square root of the result and divide by the mean value kVpmean and
multiply by 100 to get the result in percent.
1

0.0167 2
100 = 0.476% 0.5%
27.15

The result is within the specified design criteria.

5.8.5 Performance Criteria and Corrective Action


Accuracy:

The measured tube voltage kVp shall be accurate to within 5%


of the selected kVp

Reproducibility:

The coefficient of variation of the kVp reproducibility shall be


equal to or less than 2%.

If any level is found to be beyond any action level stated, the source of the
problem must be identified and the problem corrected by a Siemens customer
support engineer. Consult with your MP to determine if further testing is
required.

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Printer Check

5.9 Printer Check


This test is only required on days when the printer/laser camera is used to print
mammograms or accreditation images.

5.9.1 Objective
To assess the quality of the laser camera.

5.9.2 Required Equipment


a)

Calibrated densitometer

5.9.3 Procedure
1.

Login according to the section 2. Start Up and Login.

2.

Choose the service patient in the Patient Browser.

3.

Select SMPTE image from group [1] Technical Images in the service image
patient. Open it in the Viewing task card by double clicking.

4.

Send the image to the mammography laser camera/printer.

5.

The printer/laser camera shall be configured to Min Density 20 (corresponding to


0.2 optical density) and Max Density to 350 (corresponding to 3.5 optical
density), if applicable.

6.

Evaluate the printed SMPTE image by measuring the eleven density values from
0 to 100% with the densitometer and note the measured values in
Appendix 2, Test Form 5.9 Printer Check.

NOTE!
NOTE!
This procedure or the printer/laser camera manufacturer's QC
procedure must be followed whenever the printer/laser camera is used
to print mammographic images or accreditation images.

5.9.4 Performance Criteria and Corrective Action


The values for the different optical densities must be within the action limits as stated
in Appendix 2, Test Form 5.9 Printer Check or as recommended by the printer/laser
camera manufacturer.
If any level is found to be beyond any action level stated, the source of the
problem must be identified and the problem corrected by a Siemens customer
support engineer. Consult with your MP to determine if further testing is
required.
For the qualification of the printer you may follow the printer/laser camera
manufacturers recommendations.

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Optional Test
Ghost Image Evaluation

6. Optional Test
6.1 Ghost Image Evaluation
6.1.1 Objective
Ghosting could be described as "shadows" of the previous exposure.
The ghost image caused by a 2600 mR exposure will decay to less than 3% in a
subsequent 8 mR exposure after 180 sec. Contrast is defined as the difference
between the digital pixel value measured within the ghost image and outside the ghost
image relative to the average pixel value inside and outside the ghost image. The
digital pixel value will be the average of pixel values inside a square of 10x10 mm.
The objective of this test is to ensure that the ghosting is within an acceptable level.

6.1.2 Required Equipment


a)

2 mm steel plate (breast support)

b)

2 mm small steel bars (approx. 30x100 mm)

c)

40 mm PMMA phantom (collimator mounted)

d)

Compression paddle simulator

e)

4 paper clips

f)

Timer

6.1.3 Pre Requisites


A gain calibration shall recently have been done but the detector shall not have been
exposed on within 30 minutes.

6.1.4 Procedure

70

1.

Login according to the section 2. Start Up and Login.

2.

Enter a new patient by pressing Patient Registration icon, see Figure 1,


Position 1.

3.

Create a new patient record in the local database.


Fill in: Last Name: Test_One
First Name: Ghosting
Patient ID: day+time when the test is performed
(example: 200411281350)
DOB:
05 05 1955
Gender:
Other

4.

Press Exam button.

5.

Choose procedure FD QC Raw.

6.

Cover the FD object table with the 2 mm steel.

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Optional Test
Ghost Image Evaluation
7.

Install a compression paddle simulator.

8.

Double click on the first image in the icon gallery, see Figure 3, Position 2.

9.

Make the first exposure using 23 kV, 2 mAs and Mo/Mo.

10. Remove the 2 mm steel plate and place the 2 mm steel bar on the FD object table,
see Figure 27 second exposure. Place also the paper clips to point out the
corners of the steel bar.
11. Make a second exposure using 28 kV, 200 mAs and Mo/Mo. Start the timer when
pressing the exposure buttons.
12. Remove the steel bar without moving the paper clips and place the 40 mm
collimator mounted plexi.
13. After approximately 180 seconds make a third exposure using 28 kV, 14 mAs and
Mo/Mo.
14. Measure the offset in the first image. Select an ROI (Region of Interest) by
choosing Tools > Circle, size approximately 10 x10 mm, in the center of the
image, 20 mm from the chest wall side. Measure the mean value of a region at
the PMMA and note the value in Appendix 2, Test Form 6.1 Ghost Image
Evaluation.
Position 2

Position 3

Steel bar
Paper clip

Position 1
Second exposure

Position 4
Third exposure after 180 seconds

Figure 27 Ghosting 180 sec measurement.


PV1 is the mean from the ROI within the former position of the steel bar.
i.e. PV2 is the mean from the ROI outside the former position of the steel bar.

MAMMOMAT NovationDR
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71

Optional Test
Ghost Image Evaluation
15. Measure the mean values PV1 and PV2 by using the paper clips as a guidance if
the ghost image is not visible as shown in Figure 27 third exposure. Select an ROI
(Region of Interest) by choosing Tools > Circle size approximately 10x10 mm.
Measure the mean value of a region at the plexi and note the value in
Appendix 2, Test Form 6.1 Ghost Image Evaluation.

NOTE!
NOTE!
PV1 and PV2 are the compensated mean pixel values,
PVi Mean = Pixel value i - Offset Value (Offset Value is 50).
16. Repeat step 15 until all regions has been measured.
17. Choose the Close patient tab card and close patient by clicking this button.
18. Calculate the ghosting in percent [%] according to:

( PV1 PV2 )
Ghosting = 200 ----------------------------------PV1 + PV2

6.1.5 Performance Criteria and Corrective Action


The ghosting figure of merit as defined in step above must be less than 3%.
If any level is found to be beyond any action level stated, the source of the
problem must be identified and the problem corrected by a Siemens customer
support engineer. Consult with your MP to determine if further testing is
required.

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7. Appendix 1 QC Forms Technologist Tests

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For notes

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Test Form 3.1 Phantom Image Quality


NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

Phantom image quality


Anode/Filter:

Performance
criteria (RMI 156)

Passed

Failed

Fibers

Speck
Groups

l
l

l
l

Masses

kV:
mAs:

Comments: _______________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________

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For notes

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Test Form 3.2 Detector Calibration


NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

Year
Month
Day
Time
Temperature
Performed by

Year
Month
Day
Time
Temperature
Performed by

Year
Month
Day
Time
Temperature
Performed by

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Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
Review: ____________________________________

78

Date: ______________________________________

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Test Form 3.3 Artifact Detection


NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

Clinically Relevant Artifacts


Anode/Filter combination

Passed

Failed

Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

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For notes

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Test Form 3.4 Signal-to-Noise Ratio (SNR) and


Contrast-To-Noise Ratio (CNR) Measurements
NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

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Signal-to-Noise Ratio and Contrast-To-Noise Ratio


Measurements
Mean
Background

Mean
Mass

SD Dev. SNR
Background

CNR

Deviation Deviation Performance


SNR
CNR
criteria

Passed

Failed

Baseline
1st

SNR: 40

Dev SNR: 15%

Dev CNR: 15%

2nd

SNR: 40

Dev SNR: 15%

Dev CNR: 15%

3rd

SNR: 40

Dev SNR: 15%

Dev CNR: 15%

4th

SNR: 40

Dev SNR: 15%

Dev CNR: 15%

5th

SNR: 40

Dev SNR: 15%

Dev CNR: 15%

6th

SNR: 40

Dev SNR: 15%

Dev CNR: 15%

7th

SNR: 40

Dev SNR: 15%

Dev CNR: 15%

8th

SNR: 40

Dev SNR: 15%

Dev CNR: 15%

9th

SNR: 40

Dev SNR: 15%

Dev CNR: 15%

10th

SNR: 40

Dev SNR: 15%

Dev CNR: 15%

Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

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Test Form 3.5 Repeat Analysis


Printer manufacturer's QC procedure must be followed whenever the printer is
used to print mammographic images or accreditation images.

NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

Mammography Repeat Analysis


From

________________________

Categories

to

________________________

Projection Repeated
(mark one for each repeated image)
Left
CC

Right
CC

Left
MLO

Right
MLO

Left
Other

Right
Other

Number
of discarded
images/
repeated
images

% of
discarded
images

1. Image artifact(s)
2. Grid artifact(s)
3. Positioning
4. Monitor blur
5. Under exposed
6 Over exposed
7. No image
8. Detector artifact(s)

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9. Artifact(s) other
than grid or detector
10. Mechanical failure
11. Electrical failure
12. Software failure
13. Inappropriate
image processing
14. Other failure
15. Unknown failure
16. Double exposure
Total number of discarded
images/
repeated
images

Corrective actions

Yes

No

Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

Corrective actions: _________________________________________________________________________


__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

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Test Form 3.6 Compression Force


NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

Value

Performance
Criteria

Passed

Failed

Force Opcomp
Maximum Force
Automatic

Force between
12 and 20 kg

Maximum Force
Manually (optional)

Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

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For notes

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Test Form 3.7 Printer Check


Printer manufacturer's QC procedure must be followed whenever the printer is
used to print mammographic images or accreditation images.

NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual. Your physicist can help with this test at
system installation.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

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Printer Check
Customer values for Min and Max Density
Min Density
Max Density

Step

Corr16b-bspline (LUT)

Linear LUT

Ref. LUT

Maximum
density

Minimum
density

Ref. LUT

Maximum
density

Minimum
density

0.20

0.23

0.17

0.20

0.23

0.17

0.34

0.38

0.30

0.52

0.56

0.49

0.47

0.51

0.43

0.86

0.90

0.82

0.64

0.69

0.59

1.18

1.23

1.13

0.81

0.87

0.75

1.52

1.58

1.46

1.05

1.12

0.99

1.84

1.91

1.78

1.31

1.38

1.24

2.18

2.25

2.11

1.66

1.74

1.58

2.52

2.60

2.44

2.10

2.19

2.01

2.85

2.94

2.77

10

2.68

2.77

2.59

3.18

3.27

3.08

11

3.50

3.60

3.40

3.50

3.60

3.40

* LUT = Look-Up-Table

Step

88

MG1_5bCorr-bspline (LUT)
Ref. LUT

Maximum
density

Minimum
density

0.20

0.23

0.17

0.44

0.48

0.40

0.68

0.72

0.64

0.94

0.99

0.89

1.18

1.24

1.12

1.45

1.52

1.39

1.73

1.80

1.66

2.01

2.09

1.93

2.32

2.41

2.23

10

2.73

2.82

2.64

11

3.50

3.60

3.40

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Appendix 1 to MAMMOMAT NovationDR QC Manual

Step

Corr16b-bspline (LUT)
Ref.
LUT*

Recommendation Maximum
density

Recommendation Minimum
density

Required
Maximum
density

Required
Minimum
density

0.20

0.23

0.17

0.30

0.10

0.34

0.38

0.30

0.44

0.24

0.47

0.51

0.43

0.57

037

0.64

0.69

0.59

0.74

0.54

0.81

0.87

0.75

0.91

0.71

1.05

1.12

0.99

1.15

0.95

1.31

1.38

1.24

1.41

1.21

1.66

1.74

1.58

1.76

1.56

2.10

2.19

2.01

2.20

2.00

10

2.68

2.77

2.59

2.78

2.58

11

3.50

3.60

3.40

3.60

3.40

* LUT = Look-Up-Table

Step

MG1_5bCorr-bspline (LUT)
Ref. LUT

Recommendation Maximum
density

Recommendation Minimum
density

Required
Maximum
density

Required
Minimum
density

0.20

0.23

0.17

0.30

0.10

0.44

0.48

0.40

0.54

0.34

0.68

0.72

0.64

0.68

0.58

0.94

0.99

0.89

1.04

0.84

1.18

1.24

1.12

1.28

1.08

1.45

1.52

1.39

1.55

1.35

1.73

1.80

1.66

1.83

1.53

2.01

2.09

1.93

2.11

1.91

2.32

2.41

2.23

2.42

2.22

10

2.73

2.82

2.64

2.83

2.63

11

3.50

3.60

3.40

3.60

3.40

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Appendix 1 to MAMMOMAT NovationDR QC Manual

If your values do not meet the values specified above, then please refer to the printer
manufacturer's quality control procedure. You can create your own baseline with the
measured values that result from the initial install of the printer that was installed per
the manufacturer's QC procedure.

SMPTE [%]

Step

Measured
OD*

Passed

Failed

100

90

80

70

60

50

40

30

20

10

10

11

* OD = Optical Density

Printer manufacturer required QC manual followed:


Compliance

Yes

No

Date _______________

Date _______________

Date _______________

Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

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8. Appendix 2 QC Forms Physicist Tests

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For notes

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Test Form 4.1 Site Audit / Evaluation of Technologist


QC Program
NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

1. List compression paddles that will be used routinely.


________________________________________
________________________________________
________________________________________
________________________________________
________________________________________
________________________________________
__________________________________________

2. Identify the mode chosen for technique selection.


_____

Opdose

_____

AEC H

_____

AEC D

_____

Manual

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Appendix 2 to MAMMOMAT NovationDR QC Manual

3. Define the Clinical Technique (used to image accreditation phantom).

Target material

___________________________

Filter material

___________________________

kVp

___________________________

This should also be the Target/Filter combination used for calibration

4. Will other Target/Filter combination be used clinically?

Yes

which?

No

5. Technologist QC tests are being performed and are in compliance.

Yes

No

Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

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Test Form 4.2 Mechanical Inspection


NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

Mechanical Inspection and Follow Up


Test no.:

Performance criteria

Passed

Failed

1. WIPE breast support

---

2. Check cables

---

3. Control panel lights

---

4. LED indicating tube close to floor

---

5. Check motorized movements

---

6. Movements blocked

---

7. Compression self braking

---

8. Manual compression buttons

---

9. Decompression button

---

10. Power driven compression

---

11. No sharp edges

---

l
l
l
l
l
l
l
l
l
l
l

l
l
l
l
l
l
l
l
l
l
l

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Appendix 2 to MAMMOMAT NovationDR QC Manual

l
l

l
l

Acceptance Criteria

Passed

Failed

> 160 lux

l
l
l

l
l
l

12. Foot switches

---

13. Attachments

---

14. Light Intensity Measurement Test


Value
Area 1
Area 2
Area 3
Area 4
Mean Value
15. Exposure control

---

16. Emergency stop button

---

Comments: ________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________

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Test Form 4.3 Acquisition Workstation Monitor Check


NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

Acquisition Monitor Check and Viewing Conditions


Gray Scale Contrast:

Yes

No

5% square is visible inside 0% square

Performance criteria: Yes


95% square is visible inside 100% square

Performance criteria: Yes

Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

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Spatial resolution:

Yes

No

All lines in all bar patterns can be


differentiated

Performance criteria: Yes

Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

Visual Inspection:

Streaking

Yes

No

Performance criteria: No
Fluttering

Performance criteria: No
Shadows

Performance criteria: No

Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

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Test Form 5.1 Detector Uniformity and Artifact


Detection
NOTE!
NOTE!
Record the measured values on a copy of the Appendix pages and file
it along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

Detector uniformity
Anode/Filter combination used

MAMMOMAT NovationDR
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Mo/Mo

Mo/Rh

W/Rh

99

Appendix 2 to MAMMOMAT NovationDR QC Manual

Results from ROI statistics


Mean pixel
value

% deviation
from mean

Performance
criteria
Desired

Required

Area 1

5%

10%

Area 2

5%

10%

Area 3

5%

10%

Area 4

5%

10%

Area 5

5%

10%

Passed

Failed

l
l
l
l
l

l
l
l
l
l

Mean
value

Comments: ______________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________

Clinically Relevant Artifacts


Anode/Filter combination

Passed

Failed

Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

100

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Test Form 5.2 Collimation, Dead Space and


Compression Paddle Position
NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

Collimator Assessment
a=f-e
b=f-g
ar is a on the right side.
al is a on the left side.
an is a on the nipple side.
ac is a on the chest wall side.
br is b on the right side.
bl is b on the left side.
bn is b on the nipple side.
bc is b on the chest wall side.
If a is positive the X-ray field is larger than the detector area.
If a is negative the X-ray field is smaller than the detector area.
If b is positive the X-ray field is larger than the detector area.
If b is negative the X-ray field is smaller than the detector area.
a is the deviation between the X-ray field and the light field.
b is the deviation between the X-ray field and the detector area.

= value for dead space (See Compression Paddle Overlap on Chest Wall Side )

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Measured Distances with Large Focus

Mo/Mo

Right edge
Coin 6

Left edge
Coin 2

Nipple-side edge
Coin 1

Chest-wall edge
Coin 4

(mm)

a=f-e

(mm)

|a|

(mm)

(mm)

b=f-g

(mm)

|b|

(mm)

W/Rh

Right edge
Coin 6

Left edge
Coin 2

Nipple-side edge
Coin 1

Chest-wall edge
Coin 4

(mm)

a=f-e

(mm)

|a|

(mm)

(mm)

b=f-g

(mm)

|b|

(mm)

e = ________________ mm
x = ________________ mm
y = ________________ mm

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Sum of absolute
values right and left

Performance
criteria

Large focus
(Required)
Mo

| ar | + | al |

13 mm

Sum of absolute
values nipple and chest

Performance
criteria

| an | + | ac |

13 mm

Sum of absolute
values right and left

Performance
criteria

| br | + | bl |

13 mm

Sum of absolute
values nipple and chest

Performance
criteria

| bn | + | bc |

13 mm

Sum of absolute values

Performance
criteria

| br | + | bl | + | bn | + | bc |

MAMMOMAT NovationDR
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26 mm

Passed

Failed

Passed

Failed

Passed

Failed

Passed

Failed

Large focus
(Required)
Mo

Large focus
(Required)
Mo

Large focus
(Required)
Mo

Failed

Large focus
(Required)
Mo

Passed

103

Appendix 2 to MAMMOMAT NovationDR QC Manual

Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

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Compression Paddle Overlap on Chest Wall Side

Compression
plates

Measured
Ie - yI

Performance
criteria

No edges
visible

Passed

Failed

Yes

No

6.5 mm

6.5 mm

6.5 mm

6.5 mm

6.5 mm

Comments: ____________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________

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Appendix 2 to MAMMOMAT NovationDR QC Manual

Chest Wall Missed Tissue


Performance criteria

Passed

Failed

5 mm

Coin diameter IeI (mm):


Measured distance in the
image IxI (mm):
Calculated chest wall missed
tissue, = Ie - xI

Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

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Test Form 5.3 AEC Thickness Tracking Test


NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

______________________________________________________________
______________________________________________________________

Room:

______________________________________________________________

Type of test:

______________________________________________________________

Performed by:

______________________________________________________________

Date:

______________________________________________________________

Anode/
Filter
combination

26 kV, 28 kV, 32 kV, Performance Maximum Performance Passed


6 cm
criteria
Deviation
criteria
2 cm
4 cm
PMMA PMMA PMMA
in %

Failed

Mean

SD

SNR

MAMMOMAT NovationDR
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> 40

15 %

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Appendix 2 to MAMMOMAT NovationDR QC Manual

For notes

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Test Form 5.4 Spatial Resolution


NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

Spatial Resolution
Anode/Filter
combination

kV

mAs

Best resolution
visible (lp/mm)

Performance
criteria

Passed

Failed

Mo / Mo

7 lp/mm

W / Rh

7 lp/mm

Comments: _______________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________

MAMMOMAT NovationDR
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Appendix 2 to MAMMOMAT NovationDR QC Manual

For notes

110

Quality Control Manual


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Test Form 5.5 SNR, CNR and AEC repeatability


NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

AEC Image Stability and Reproducibility and Signal-toNoise Ratio (SNR)

Anode/Filter: ________________________
Exposure No

mAs

SNR

Mean
from ROI

kV: _________
Entrance
air kerma
(mGy)

H/D: _________
SD

CNR

1st
2nd
3rd
4th
5th

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Anode/Filter

Value

Performance
criteria

Passed

Failed

5%

5%

15%

15%

____________________
Mean value
(mAs)
SD Dev. (mAs)
Coefficient of
variation
(mAs)
Mean value
(Entrance air kerma)
SD Dev.
(Entrance air kerma)
Coefficient of
variation
(Entrance air kerma)
Mean value of
Mean
Mean value of
SNR
Max. deviation
Mean from Mean value
Max. deviation
SNR from Mean value

Comments: ________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________

112

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Appendix 2 to MAMMOMAT NovationDR QC Manual

Test Form 5.6 Image Quality and Radiation Dose


NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

Phantom image quality


Anode/Filter:

Performance
criteria (RMI 156)

Passed

Failed

Fibers

Speck
Groups

l
l

l
l

Masses

kV:
mAs:

Comments: _______________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________

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Appendix 2 to MAMMOMAT NovationDR QC Manual

Mean Glandular Dose


mGy reading from the dose meter
AEC
mode

kV

Focus

Large

Large

Anode/Filter

mGy

HVL Values from Test Form 5.7 HVL and Radiation


Output

Anode/Filter

kVp

Calculated HVL Values (mm Al)

Compression release
Yes

No

Compression thickness
Thickness

Performance
criteria
44 3 mm

114

Passed

Failed

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SPB7-250.623.50.05.24

Appendix 2 to MAMMOMAT NovationDR QC Manual

Pre-requisites to calculate the mean glandular dose


Use formulae:
D=Kgcs*
D

Mean glandular dose

Entrance air kerma

g-factor for breasts simulated with PMMA

c-factor for breasts simulated with PMMA

s-factor for clinically used spectra

Where K is the incident air kerma (without backscatter) calculated at the upper surface
of the PMMA. The factor g, corresponds to a glandularity of 50%, and is derived from
the values calculated* and is shown below for a range of HVL. The c-factor corrects
for the difference in composition of typical breasts from 50% glandularity* and is given
here for typical breasts in the age range 50 to 64. Note that the c and g-factors applied
are those for the corresponding thickness of typical breast rather than the thickness of
PMMA block used. Where necessary interpolation may be made for different values
of HVL. The factor s shown in the second table corrects for any difference due to the
choice of X-ray spectrum*.

PMMA
thickness
(mm)

Equivalent
breast
thickness
(mm)

0.25

0.30

0.35

0.40

0.45

0.50

0.55

0.60

g-factor

45

53

0.130

0.155

0.177

0.198

0,220

0.245

0,272

0,295

c-factor

45

53

1.109

1.105

1.102

1.099

1.096

1.091

1.088

g-factor

50

60

0.112

0.135

0.154

0.172

0.192

0.214

0.236

0.261

c-factor

50

60

1.164

1.160

1.151

1.150

1.144

1.139

1.134

s-factor

HVL (mm Al)

Mo/Mo

Mo/Rh

W/Rh

1.000

1.017

1.042

* [D.R. Dance, C.L. Skinner, K.C. Young, J.R. Beckett. C.J. Kotre:
Additional factors for the estimation of mean glandular breast dose using the
UK mammography dosimetry protocol
Physics in Medicine and Biology 45, 3225-3240, 2000]

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Appendix 2 to MAMMOMAT NovationDR QC Manual

Calculate the mean glandular dose


AEC
mode

Anode/Filter: ________
kV: ________
mAs: ________

D=Kgcs
D=Kgcs

Performance
criteria
Desired
(mGy)

Required
(mGy)

H
D

Passed

Failed

Comments: ___________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________

116

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Appendix 2 to MAMMOMAT NovationDR QC Manual

Test Form 5.7 HVL and Radiation Output


NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

Beam Quality (HVL)


Only the column for the anode/filter combination used for HVL measurement shall be
filled out:
Anode/Filter

Mo/Mo kVp ______

Mo/Rh kVp ______

W/Rh kVp ______

Exposure reading
without Al (D0)
Exposure reading
0.2 mm Al
Exposure reading
0.3 mm Al
Exposure reading
0.4 mm Al
Exposure reading
0.5 mm Al
Exposure reading
0.6 mm Al
Second exposure reading
without Al (must not differ
more than 2% from D0)

Observe that all fields may not be needed for the different anode/filter combinations.

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Appendix 2 to MAMMOMAT NovationDR QC Manual

Calculated HVL Values


Only the row for the anode/filter combination used for HVL measurement shall be filled
out:

Anode/Filter
combination

Calculated HVL
Values (mm Al)

Criteria for HVL value at


28 kVp
(kVp/100)

Passed

Failed

Mo/Mo

0.28

Mo/Rh

0.28

W/Rh

0.28

Deviation between first


and last exposure

2%

Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

Radiation Output
mGy reading from the dose meter
Anode/
Filter

kV

mAs

Distance
above breast
support
surface (mm)

Mo/Mo

28

400

45

mGy /
mR

Sec

mGy/s /
mR/s

Performance
criteria

> 7 mGy/s /
> 800 mR/s

Passed

Failed

Comments: _________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________

118

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Appendix 2 to MAMMOMAT NovationDR QC Manual

Test Form 5.8 Tube Voltage Measurement &


Reproducibility
NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

Tube voltage and reproducibility


Parameters

kVpmeas

Performance
criteria

Passed

Failed

1st exposure
________ kVp,
50 mAs, Mo/Mo

<2%

2nd exposure
________ kVp,
50 mAs, Mo/Mo

<2%

3rd exposure
________ kVp,
50 mAs, Mo/Mo

<2%

4th exposure
________ kVp,
50 mAs, Mo/Mo

<2%

MAMMOMAT NovationDR
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kVpmean

Coefficient of
variation

119

Appendix 2 to MAMMOMAT NovationDR QC Manual

Parameters

kVpmeas

Performance criteria

Passed

Failed

26 kVp

Accuracy: 5 % kV

28 kVp

Accuracy: 5 % kV

30 kVp

Accuracy: 5 % kV

32 kVp

Accuracy: 5 % kV

34 kVp

Accuracy: 5 % kV

Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

120

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Appendix 2 to MAMMOMAT NovationDR QC Manual

Test Form 5.9 Printer Check


Printer manufacturer's QC procedure must be followed whenever the printer is
used to print mammographic images or accreditation images.

NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

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Appendix 2 to MAMMOMAT NovationDR QC Manual

Printer Check
Customer values for Min and Max Density
Min Density
Max Density

Step

Corr16b-bspline (LUT)

Linear LUT*

Ref.
LUT

Maximumdensity

Minimum
density

Ref.
Density

Maximum
density

Minimum
density

0.20

0.23

0.17

0.20

0.23

0.17

0.34

0.38

0.30

0.52

0.56

0.49

0.47

0.51

0.43

0.86

0.90

0.82

0.64

0.69

0.59

1.18

1.23

1.13

0.81

0.87

0.75

1.52

1.58

1.46

1.05

1.12

0.99

1.84

1.91

1.78

1.31

1.38

1.24

2.18

2.25

2.11

1.66

1.74

1.58

2.52

2.60

2.44

2.10

2.19

2.01

2.85

2.94

2.77

10

2.68

2.77

2.59

3.18

3.27

3.08

11

3.50

3.60

3.40

3.50

3.60

3.40

* LUT = Look-Up-Table

Step

122

MG1_5bCorr-bspline (LUT)
Ref. LUT

Maximum
density

Minimum
density

0.20

0.23

0.17

0.44

0.48

0.40

0.68

0.72

0.64

0.94

0.99

0.89

1.18

1.24

1.12

1.45

1.52

1.39

1.73

1.80

1.66

2.01

2.09

1.93

2.32

2.41

2.23

10

2.73

2.82

2.64

11

3.50

3.60

3.40

Quality Control Manual


SPB7-250.623.50.05.24

Appendix 2 to MAMMOMAT NovationDR QC Manual

Step

Corr16b-bspline (LUT)
Ref.
LUT*

Recommendation Maximum
density

Recommendation Minimum
density

Required
Maximum
density

Required
Minimum
density

0.20

0.23

0.17

0.30

0.10

0.34

0.38

0.30

0.44

0.24

0.47

0.51

0.43

0.57

037

0.64

0.69

0.59

0.74

0.54

0.81

0.87

0.75

0.91

0.71

1.05

1.12

0.99

1.15

0.95

1.31

1.38

1.24

1.41

1.21

1.66

1.74

1.58

1.76

1.56

2.10

2.19

2.01

2.20

2.00

10

2.68

2.77

2.59

2.78

2.58

11

3.50

3.60

3.40

3.60

3.40

* LUT = Look-Up-Table

Step

MG1_5bCorr-bspline (LUT)
Ref. LUT

Recommendation Maximum
density

Recommendation Minimum
density

Required
Maximum
density

Required
Minimum
density

0.20

0.23

0.17

0.30

0.10

0.44

0.48

0.40

0.54

0.34

0.68

0.72

0.64

0.68

0.58

0.94

0.99

0.89

1.04

0.84

1.18

1.24

1.12

1.28

1.08

1.45

1.52

1.39

1.55

1.35

1.73

1.80

1.66

1.83

1.53

2.01

2.09

1.93

2.11

1.91

2.32

2.41

2.23

2.42

2.22

10

2.73

2.82

2.64

2.83

2.63

11

3.50

3.60

3.40

3.60

3.40

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Appendix 2 to MAMMOMAT NovationDR QC Manual

If your values do not meet the values specified above, then please refer to the printer
manufacturer's quality control procedure. You can create your own baseline with the
measured values that result from the initial install of the printer that was installed per
the manufacturer's QC procedure.

SMPTE [%]

Step

Measured
OD*

Passed

Failed

100

90

80

70

60

50

40

30

20

10

10

11

* OD = Optical Density

Printer manufacturer required QC manual followed:


Compliance

Yes

No

Date _______________

Date _______________

Date _______________

Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

124

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Appendix 2 to MAMMOMAT NovationDR QC Manual

Test Form 6.1 Ghost Image Evaluation


NOTE!
NOTE!
Record the measured values on a copy of Appendix 1 pages and file it
along with the QC-manual.

Site:

___________________________________________________
___________________________________________________

Room:

___________________________________________________

Type of test:

___________________________________________________

Performed by:

___________________________________________________

Date:

___________________________________________________

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Appendix 2 to MAMMOMAT NovationDR QC Manual

Ghost Image Evaluation


Area

Mean pixel value


PV1

PV2

1
2
3
4

Anode/Filter:_________

Performance
criteria

Passed

Failed

<3%

kV: _________
mAs: _________
Ghost image factor

Comments: _______________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

126

Quality Control Manual


SPB7-250.623.50.05.24

Siemens AG 2007
All rights reserved

Contact Address:
Siemens AG
Wittelsbacherplatz 2
D-80333 Mnchen
Germany

Siemens AG, Medical Solutions


Special Systems
Henkestrae 127
D-91052 Erlangen
Germany

Order No.: SPB7-250.623.50.05.24


Printed in the Federal Republic of Germany
AG 04/07