Siemens MAMMOMAT Inspiration Use and maintenance manual

Quality Control Manual
MAMMOMAT Inspiration
VA10
MAMMOMAT Inspiration

The original version of this manual was written in English language.
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.

MAMMOMAT Inspiration
SPB7-330.640.01.01.02
Do you have any notes on this
operator manual?
Your opinion matters a lot to us! 0
We make every effort to continuously improve our product documentation.
Therefore, we would like to offer you the opportunity of giving us your direct
feedback concerning your requests, suggestions and criticism with respect to
this operator manual.
oFor feedback by fax, please use the following fax number:
+49 9131/84-2378
oIf you prefer notification by mail, please send this to:
[email protected]
In this case we request you to use as reference the complete print number in
the footer of this page.
Thank you very much for supporting us in our efforts to improve our products.
My notes
Optional information
Name
Hospital
City/country
E-mail
Telephone/fax
Number of fax pages

Contents
MAMMOMAT Inspiration 1
SPB7-330.640.01.01.02
Table of Contents
List of Figures
List of Common Abbreviations
Introduction
Mammography Equipment Evaluation (MEE) - Medical Physicist (MP) .................................. 7
Annually - Medical Physicist (MP)............................................................................................ 7
Monthly - Technologist (T) ....................................................................................................... 7
When Needed - Technologist (T) ............................................................................................. 7
Recommended Frequency of QC Tests .................................................................................. 8
Important Notes ...................................................................................................................... 9
Recommended Corrective Action ........................................................................................... 9
Required Documents............................................................................................................... 9
Required Equipment..............................................................................................................10
Prerequisites
Objective ............................................................................................................................... 11
Required Equipment..............................................................................................................11
Procedure .............................................................................................................................. 11
Performance Criteria and Corrective Action .......................................................................... 11
Calculations ........................................................................................................................... 12
Test 1: AEC Test
Objective ............................................................................................................................... 15
Required Equipment..............................................................................................................15
Procedure .............................................................................................................................. 15
Performance Criteria and Corrective Action .......................................................................... 18
Test form Test 1 .................................................................................................................... 19
Test 2: Artifact Detection
Objective ............................................................................................................................... 20
Required Equipment..............................................................................................................20
Procedure .............................................................................................................................. 20
Performance Criteria and Corrective Action .......................................................................... 21
Test form Test 2 .................................................................................................................... 22
Test 3: Detector Uniformity
Objective ............................................................................................................................... 23
Required Equipment..............................................................................................................23
Procedure .............................................................................................................................. 23
Performance Criteria and Corrective Action .......................................................................... 24
Test form Test 3 .................................................................................................................... 25
Test 4: Detector Linearity
Objective ............................................................................................................................... 27
Required Equipment..............................................................................................................27
Procedure .............................................................................................................................. 27
Performance Criteria and Corrective Action .......................................................................... 29
Test form Test 4 .................................................................................................................... 30

Contents
2Quality Control Manual
SPB7-330.640.01.01.02
Test 5: Phantom Imaging Quality
Objective................................................................................................................................ 33
Required Equipment..............................................................................................................33
Procedure .............................................................................................................................. 33
Performance Criteria and Corrective Action .......................................................................... 35
Test form Test 5 .................................................................................................................... 36
Test 6: Spatial Resolution (optional)
Objective................................................................................................................................ 37
Required Equipment..............................................................................................................37
Procedure .............................................................................................................................. 37
Performance Criteria and Corrective Action .......................................................................... 38
Test form Test 6 .................................................................................................................... 39
Test 7: Mechanical Tests
Objective................................................................................................................................ 40
Required Equipment..............................................................................................................40
Procedure .............................................................................................................................. 40
Performance Criteria and Corrective Action .......................................................................... 41
Test form Test 7 .................................................................................................................... 42
Test 8: Acquisition Workstation Monitor Check
Objective................................................................................................................................ 43
Required Equipment..............................................................................................................43
Procedure .............................................................................................................................. 43
Performance Criteria and Corrective Action .......................................................................... 45
Test form Test 8 .................................................................................................................... 46
Test 9: Printer Check (optional)
Objective................................................................................................................................ 47
Required Equipment..............................................................................................................47
Procedure .............................................................................................................................. 47
Performance Criteria and Corrective Action .......................................................................... 47
Test form Test 9 .................................................................................................................... 48

Figures
MAMMOMAT Inspiration 3
SPB7-330.640.01.01.02
List of Figures
Figure 1 Placing the PMMA plate ........................................................................... 16
Figure 2 ROI within the AEC region ........................................................................ 17
Figure 3 ROIs on the detector................................................................................. 24
Figure 4 Positioning the dose meter....................................................................... 28
Figure 5 ROI Positioning ......................................................................................... 29
Figure 6 Position of Phantom.................................................................................. 34
Figure 7 ACR (RMI 156) phantom........................................................................... 35
Figure 8 Indication of inferior spatial resolution ...................................................... 39
Figure 9 Location of 5 % and 95 % squares........................................................... 43
Figure 10 Location of bar patterns ............................................................................ 44

Figures
4Quality Control Manual
SPB7-330.640.01.01.02

Abbreviations
MAMMOMAT Inspiration 5
SPB7-330.640.01.01.02
List of Common Abbreviations
AEC Automatic Exposure Control
AWS Acquisition Work station
FD Flat Detector
kV Kilovolt
mAs milliAmperesecond
MEE Mammography Equipment Evaluation
Mo/Mo Molybdenum/Molybdenum
Mo/Rh Molybdenum/Rhodium
MP Medical Physicist
PMMA Poly Methyl Methacrylate
ROI Region of Interest
SMPTE Society of Motion Picture and Television Engineers
SNR Signal-to-Noise-Ratio
T Technologist
W/Rh Tungsten/Rhodium

Abbreviations
6Quality Control Manual
SPB7-330.640.01.01.02
For notes

Introduction
MAMMOMAT Inspiration 7
SPB7-330.640.01.01.02
Introduction
Mammography Equipment Evaluation (MEE) - Medical
Physicist (MP)
The MEE tests of the MAMMOMAT Inspiration should be performed whenever a
new MAMMOMAT Inspiration system has been installed 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 Inspiration involve performance of all 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.
Annually - Medical Physicist (MP)
These tests may be performed by the MP. The tests include comparisons to values
measured during the MEE tests to ensure that performance has not degraded.
Monthly - Technologist (T)
These tests shall be done on a monthly basis. They shall be done on the first working-
day of the month before patients are examined with the MAMMOMAT Inspiration
system.
When Needed - Technologist (T)
These tests shall be done whenever there is suspicion of artifacts or incorrect settings
to determine if patients can be examined.

Introduction
8Quality Control Manual
SPB7-330.640.01.01.02
Recommended Frequency of QC Tests
The following table describes when the different tests must be performed and by
whom.
Table 1 Frequency of Tests
Te s t MEE Annually Monthly When
needed
1. AEC Test MP MP
2. Artifact Detection MP T
3. Detector Uniformity MP T
4. Detector Linearity MP MP
5. Phantom Imaging Quality MP T
6. Spatial Resolution (optional) T
7. Mechanical Tests MP MP
8. Acquisition Workstation Monitor Check MP MP
9. Printer Check (optional) MP MP

Introduction
MAMMOMAT Inspiration 9
SPB7-330.640.01.01.02
For the qualification of the printer please follow the printer manufacturer’s
recommendations.
Important Notes
Before performing any quality control test, be sure to be familiar with the operating
instructions described in the MAMMOMAT Inspiration Operator Manual.
The enclosed test form tables can be used to document test parameters used and
results obtained during each test.
Recommended Corrective Action
Whenever there is a result from a test described in this manual that fails to reach the
action level stated, the problem must be detected and corrected before further
examinations are performed with the system. The result shall be reported to a service
engineer and proper corrective action shall be taken to address the problem.
If a result meets the action level, but a clear degradation is seen compared to the
result obtained during the latest test, the system may continue to be used, but the
degradation shall be reported to a service engineer, and it is recommended that
corrective action be taken within 30 days.
More details are given in association with each test.
Required Documents
•MAMMOMAT Inspiration Operator Manual
•Quality Control Manual of used viewing station (optional - for systems that
use softcopy review station)

Introduction
10 Quality Control Manual
SPB7-330.640.01.01.02
Required Equipment
The measurement devices listed below must always display a valid calibration stamp
to ensure compliance with the described measurement and calibration intervals.
•Lint-free, non-woven cotton or gauze (100% cotton)
•Water or lukewarm diluted aqueous solution of household dishwashing liquid
•Compression plate 24 x 30 cm2
•Radiation shielding plate in object table size (e.g. 2 mm steel or lead plate)
•PMMA plates of 10 x 10 cm2and 20 mm, 30 mm, 40 mm, 50 mm, 60 mm,
70 mm thicknesses
•Collimator mountable PMMA phantom (40 mm thick)
•Dose meter for air kerma measurement usable for target/filter combinations
Mo/Mo, Mo/Rh, W/Rh
•ACR (RMI 156) phantom
•Bar pattern phantom applicable for mammography
•Compressible phantom
•Stop watch
•Calibrated densitometer (option)

Prerequisites
MAMMOMAT Inspiration 11
SPB7-330.640.01.01.02
Prerequisites
Objective
To determine whether the detector is damaged or has dust on it and is calibrated.
Required Equipment
a) Lint-free, non-woven cotton or gauze (100% cotton)
b) Water or lukewarm diluted aqueous solution of household dishwashing liquid
Procedure
1. Wipe the detector surface with a wet lint-free, non-woven cotton cloth or cotton
(100%) pad. For moistening, use water or lukewarm diluted aqeous solution of
household dishwashing liquid.
NOTE!NOTE!
Do not spray the unit! The cleaning fluid must under no circumstances
penetrate into the unit.
2. Calibrate the detector according to the chapter Calibrating the detector in the
MAMMOMAT Inspiration Operator Manual.
CAUTION!
Improper operation can lead to reduced image quality.
Let the MAMMOMAT Inspiration warm up for at least 30 minutes to
ensure optimum results when performing an image quality test or a
calibration.
CAUTION!
For startup and login, see MAMMOMAT Inspiration Operator Manual.
CAUTION!
Before starting the quality control tests the detector calibration shall be
performed to ensure that the tests are based on correct detector
settings, see MAMMOMAT Inspiration Operator Manual.
Performance Criteria and Corrective Action
No visual damage to the detector should be observable.
No artifacts should be visible.

Prerequisites
12 Quality Control Manual
SPB7-330.640.01.01.02
Calculations
1 Statistical calculations
For all numerical calculations necessary in this quality control manual the testing
person should use the formulae indicated in the following text together with a pocket
calculator or appropriate software for numerical evaluations.
Preliminaries:
From the knowledge of any finite set of measurement values x1, x2, ..., xNthe
following fundamental statistical quantities can be established.
1.1 Global average of values
xN= each value (e.g. x1= value of pixel 1, x2= value of pixel 2)
N = number of measurement values (e.g. 6, for 6 PMMA thicknesses)
xav = global average of values
1.2 Standard deviation
σx= standard deviation
With the average value xav calculated according to Global average of values.
1.3 Coefficient of variation
cvar, x= coefficient of variation
With the average value xav and the standard deviation σx calculated according to
Global average of values and Standard deviation respectively.
xav
x1x2x3... xN ++++
N
---------------------------------------------------
=
σx
1
N
----x1xav
–()
2x2xav
–()+2... xNxav –()
2
++()⋅=
cvar,x
σx
xav
-------
=

Prerequisites
MAMMOMAT Inspiration 13
SPB7-330.640.01.01.02
1.4 Relative deviation from corresponding average
Each sample xnfrom the set of measurements x1, x2, ..., xNpossesses its own
relative deviation ∆xrel, n from the average xav according to the following definition:
n = 1, 2, ..., N
∆xrel, N= relative deviation for each value
Average value xav calculated according to Global average of values.
For maximum relative deviation select highest value of all calculated relative
deviations.
2 Linear correlation coefficient and offset
Calculate for quantity x = pixel value and quantity K= input air kerma value.
Assume that in total N (generally different) sample values K1, K2, ..., KNfor the input
air kerma have been selected and the mean pixel values x1, x2, ..., xNin the
corresponding X-ray images have been recorded.
a) Calculate global average of all pixel values (xav) and global average of all input air
kerma values (Kav)
b) Calculate average of pixel and input air kerma values (x . K)av and K2
∆xrel,n
xnxav –
xav
------------------
=
xK⋅()
av
x1K1 ⋅x2K2 ⋅x3K3 ⋅... xNKN ⋅++++
N
------------------------------------------------------------------------------------------------
=
K2
()
av
K1
2K2
2K3
2... KN
2
++++
N
---------------------------------------------------------
=

Prerequisites
14 Quality Control Manual
SPB7-330.640.01.01.02
c) Calculate standard deviation of all pixel values (σx) and standard deviation of all
input air kerma values σK.
d) Calculate linear correlation coefficient R
e) The offset (zero input signal) doff of the X-ray detector is derived from
3 SNR - Signal-to-noise ratio
Provided that the detector offset doff is known, for each individual X-ray image (or a
region-of-interest located therein) the pixel signal-to-noise ratio SNR can be calculated
from the pixel value xNof each image and the corresponding standard deviation σx:
RxK⋅()
av xav Kav
⋅–
σxσK
⋅
------------------------------------------------
=
doff
K()
2
av xav
⋅Kav Kx⋅()
av
⋅()–
σK
2
-------------------------------------------------------------------------
=
SNR xNdoff
–
σx
------------------
=

Test 1: AEC Test
MAMMOMAT Inspiration 15
SPB7-330.640.01.01.02
Test 1: AEC Test
Objective
To test the AEC security cut-off
To measure AEC stability for different object thicknesses
Required Equipment
a) Shielding plate in object table size, e.g. 2 mm steel or lead plate
b) PMMA plates of 10 x 10 cm² and 20 mm, 30 mm, 40 mm, 50 mm, 60 mm,
70 mm thicknesses
c) Compression plate 24 x 30 cm2
Procedure
1. Create a new patient record in the local database.
Fill in: Last Name: Test_One
First Name: AEC
Patient ID: day+time when the test is performed
(example: 200707071030)
DOB: 05 05 1955
Gender: Other
2. Choose procedure QC-raw.
AEC security (step 3 - 10)
3. Select exposure technique AEC
28 kV
target/filter combination mostly used
grid in
auto decompression off
OPCOMP off
AEC segmentation on
low dose mode off
4. Place shielding plate on object table.
5. Mount compression plate and perform compression.
6. Perform an exposure.
7. Check that the radiation signal lights up very shortly and exposure is interrupted,
tube load is below 5 mAs.
8. Check that a warning is shown.
9. Note result in Test form Test 1.
10. Deactivate examination, remove shielding plate.

Test 1: AEC Test
16 Quality Control Manual
SPB7-330.640.01.01.02
AEC stability (step 11 - 23)
11. Select exposure technique Opdose
grid in
auto decompression on
OPCOMP on
AEC segmentation on
low dose mode off
12. Position 20 mm PMMA plate on object table according to Figure 1.
Figure 1 Placing the PMMA plate
13. Perform compression until OPCOMP is reached.
14. Perform an exposure with the Opdose program according to PMMA thickness,
note exposure data.
15. Select Tools > AEC region to show the AEC region of the acquired image.
16. Check that the AEC region of the acquired image remains inside the edges of the
PMMA plate.
Detector
PMMA plate
Chest wall side