Quality Control Procedure (Sectra-Branded) - Philips MicroDose L30 SW 8.4 8.4P1

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Quality Control Procedures
Sectra MicroDose Mammography L30

Software 8.3
Quality Control Procedures – Sectra MicroDose Mammography L30, Software 8.3
Quality Control Procedures -

Sectra MicroDose Mammography L30
Software 8.3
This document describes the quality control procedures for the Sectra MicroDose
Mammography™ system.
The content of later versions may be modified without prior notice. The Quality Control
Procedures document is only available in English.
As part of our commitment to providing the highest quality products and services, we would
like to encourage feedback on the quality of this documentation.
If you think we can improve this document in any way, please send your suggestions to
info.imtec@sectra.se
Quality Control Procedures - Sectra MicroDose Mammography L30

Document Title
Software 8.3
Doc. No & Revision 1007995 F
Date 2010-10-22
1007995 F 2(66) © Sectra 2010

Contents
1. Introduction..................................................................................................................... 5
1.1 Purpose ...................................................................................................................... 5
1.2 Scope ......................................................................................................................... 5
1.3 Acceptance testing .................................................................................................... 5
1.4 General information about quality control procedures ............................................. 5
1.5 Intended readers ........................................................................................................ 6
1.6 Related documents .................................................................................................... 6
1.7 References ................................................................................................................. 6
1.8 Symbols used in this document ................................................................................. 7
1.9 Terms, definitions and typographic conventions ...................................................... 8
2. Equipment and preparatory information..................................................................... 9
2.1 Equipment required for procedures performed at least monthly............................... 9
2.2 Equipment for procedures performed less frequently than once a month ................. 9
2.3 Sending to PACS of For Processing (unprocessed) images .................................... 11
2.4 Copy of For Processing (unprocessed) images to external memory ....................... 11
3. Daily (User).................................................................................................................... 12
3.1 Daily quality control ............................................................................................... 12
3.2 Guidance system daily procedure ........................................................................... 14
4. Weekly (QC Technologist) ........................................................................................... 15
4.1 Full calibration ........................................................................................................ 15
5. Monthly (QC Technologist) ......................................................................................... 17
5.1 Spatial resolution..................................................................................................... 17
5.2 Contrast-to-noise ratio............................................................................................. 19
5.3 Visual checklist ....................................................................................................... 22
6. Semi-annual (Medical physicist).................................................................................. 26
6.1 Thickness indication ............................................................................................... 26
6.2 Compression force .................................................................................................. 28
6.3 X-ray tube output (Air kerma) ................................................................................ 30
6.4 Air kerma reproducibility........................................................................................ 32
6.5 AEC system: Breast thickness and exposure .......................................................... 33
7. Annual (Medical physicist) .......................................................................................... 37
7.1 AEC system: Density compensation ....................................................................... 37
7.2 Tube Voltage ........................................................................................................... 39
7.3 Half value layer ....................................................................................................... 40
7.4 Contrast detail resolution ........................................................................................ 42
7.5 Detector linearity..................................................................................................... 44
7.6 Image field and x-ray field agreement .................................................................... 46
7.7 Missed tissue at chest wall ...................................................................................... 50
7.8 Guidance system precision control ......................................................................... 51
8. Unscheduled calibrations (User).................................................................................. 53
8.1 Quick calibration ..................................................................................................... 53
9. Summary of Quality control procedures and Tests ................................................... 55
Appendix A – Weekly record ............................................................................................... 58
Appendix B – Monthly record .............................................................................................. 59
1007995 F 3(66) © Sectra 2010

Appendix C – Semi-annual and annual record................................................................... 62
1007995 F 4(66) © Sectra 2010

1. Introduction
1.1 Purpose
This document, delivered together with Sectra MicroDose Mammography L30, describes
Quality Control Procedures that have to be performed on regular basis.
1.2 Scope
The information in this document applies to the Sectra MicroDose Mammography L30.
This document describes all necessary quality control procedures that shall be performed in
order to secure a stable operation and verify that the product comply with regulatory
requirements. Country specific regulatory requirements may exist.
This document contains all the quality control procedures for the L30, which shall be
performed to verify that the system fulfils the specification for image and radiation quality.
The procedures require special equipment for dosimetry and radiation quality control. This
equipment is not delivered with the system.
Chapter 3-5 in this document contains quality control procedures that shall be performed at
least once a month. Since these procedures can be performed by a regular user and a QC
Technologist, the content of chapter 3-5 is also included in the User Manual [1].
Appendix A, B and C contain pre-printed records for the weekly, monthly, semi-annual and
annual measurements.
The term “quality control” has been applied liberally in this document and contains some
elements that may be considered calibration procedures. These calibrations are an important
part of the quality assurance.
The quality control procedures described in this document shall be

Notice followed in order to make sure that the system meets its specification and
delivers high quality images at low radiation dose.
The procedure for handling any deviations is described in each test case. If any doubt, contact
the supplier.
1.3 Acceptance testing

 It is recommended that all tests in the quality control procedures are performed by the
customer as acceptance testing. The acceptance testing performed by the customer is
preferable performed together with the Sectra SE.
 The quality control procedures rely on reference values for CNR (section 5.2) and
HVL (section 7.3). The reference values must either be delivered with the machine or
measured at the acceptance testing of the machine since subsequent tests for CNR and
HVL compare to these reference values. Note that new reference values can be
acquired by either the customer or Sectra SE, but only if the CDMAM (section 7.4)
test is performed at the same time.
1.4 General information about quality control procedures

 Several tests described in this document use phantoms mounted in a frame
(e.g. Figure 1 on page 13). It is important that the frame is carefully placed on the
patient support in order to avoid damages or scratches on the patient support. Slide the
phantom on the patient support so that the metal guiding edge of the phantom reaches
the front end of the patient support.
1007995 F 5(66) © Sectra 2010

 When the user is instructed to create a new examination while performing a test it is
recommended that a “patient” named “default”, “test” or similar is used in order to
avoid confusion.
 For extended sequences of measurement exposures it is recommended to keep the
anode rotating while inside an examination. In the Tools menu in the application, select
Service Tool - Anode brake settings. Uncheck Brake anode and click OK. Be sure to
restore the original setting after the measurement session is completed.
1.5 Intended readers

Service Engineers certified by Sectra and medical physicists. It is presumed that the readers
have experience of similar procedures and are familiar with the Sectra MicroDose
Mammography system, or has the User Manual [1] at his or her disposal.
1.6 Related documents

[1] 1007994 User Manual - Sectra MicroDose Mammography
1.7 References
The quality control procedures follow certain international guidelines and standards [2]-[6].
When possible, the same or similar tests are performed as for film-based mammography. In
some cases, these must be modified for a digital system. They also include tests that are only
relevant to digital mammography systems. In these cases, [2] has served as a guide.
[2] European Guidelines for Quality Assurance in Breast Screening and Diagnosis, 4th
Edition, 2006.
[3] International standard, IEC 61223-2-10, Evaluation and routine testing in medical
imaging departments – Part 2-10: Consistency tests – X-ray equipment for
mammography, 1999.
[4] MQSA – Mammography Quality Standards Act, U.S. Public Law 102-539, U.S.
Public Law 105-248.
[5] Mammography Quality Control Manual, American College of Radiology, 1999.
[6] European Protocol on Dosimetry in Mammography, EUR 16263 EN, 1996.
1007995 F 6(66) © Sectra 2010

1.8 Symbols used in this document

Warning!
Warning is used when severe danger for patient, personnel or system
exists.
Caution! Caution is used when danger for patient, personnel or system exists.
Notice Notice is used to underline information of importance.
Exposure
The exposure symbol is used when an exposure is made.
1007995 F 7(66) © Sectra 2010

1.9 Terms, definitions and typographic conventions

“User” A person that is expected to have basic knowledge in radiology and has
been trained by Sectra personnel.
“QC Technologist” Radiographer with deeper knowledge in the system compared
to “User”.
“Medical physicist” Physicist with special knowledge in medical physics.
“Sectra SE” Sectra Service Engineer or Physicist from Sectra, educated in related
radiation physics and image quality.
“application” Refers to the Sectra MicroDose Mammography application.
“system” Refers to Sectra MicroDose Mammography unless the context
indicates otherwise.
BR12 Plastic material that has the same X-ray characteristics as a typical
breast.
PMMA From the chemical designation polymethyl methacrylate, a.k.a. acrylic
or plexiglass.
HVL Half value layer. The thickness of aluminium needed to reduce the air
kerma to half.
SNR Signal-to-Noise Ratio. Defined in an image area as the mean through
standard deviation of the pixel values.
CNR Contrast-to-Noise Ratio (sometimes designated SDNR – signal
difference to noise ratio). Defined for two image areas as the difference
in pixel mean through standard deviation for the area designated as
reference (background).
ROI Region Of Interest. Selected area in the image.
AGD Average Glandular Dose.
AEC Automatic Exposure Control.
SmartAEC™ The Auto exposure control used by Sectra. The SmartAEC exposure
mode continuously adjusts the exposure, during the image scan,
according to feedback from an exposure sensor. The resulting image
has a target image quality (CNR) that is maintained over the AEC
sensor area, which is 19x16 cm and laterally centered from the front of
the patient support. The exposure mode is selectable for normal breast
examination and phantom examination types.
1007995 F 8(66) © Sectra 2010

2. Equipment and preparatory information

2.1 Equipment required for procedures performed at least
monthly
The equipment needed for the quality controls performed at least once a month are
found in Table 1.
Type of Equipment Specification Qty. Model/Brand
Calibration phantom Step-shaped structure of PMMA 1 Part No. 1009703
(acrylic plastic) (delivered with the
system)
Daily quality phantom Block of PMMA with contrast 1 Part No. 1010909
markers. (delivered with the
system)
Line pair phantom Plastic casing containing metal bars 1 E.g. CIRS 016A or
in two directions, 5–20 line Part No. 1001675
pairs/mm and a 4,5 cm PMMA or
BR12 base.
Mammographic Block of PMMA containing a wax 1 E.g. RMI 156 or
accreditation phantom. insert with simulated objects of Nuclear Associates
varying size; 6 fibers, 5 groups of 18-220.
micro-calcifications and 5 tumors.
Table 1 Equipment needed for quality checks.
2.2 Equipment for procedures performed less frequently than

once a month
The additional equipment needed for tests that are rarely performed is found in Table 2. It is
important that the dose meter and kVp meter are calibrated for the radiation quality in
question. It is the duty of the medical physicist in charge to check this. If in doubt, consult the
supplier.
Type of Equipment Specification Qty. Model
PMMA plates It should be possible to vary the At least Not specific
thickness between 1 and 7 cm in 0.5 6x1cm and
cm steps. Size: at least 8x8 cm 2x0.5cm
PMMA
Dose meter, e.g. Calibrated for correct radiation 1 Not specific
ionization chamber and quality. Accuracy: < 5%
electrometer. Reproducibility: < 1%
kVp meter Calibrated for correct radiation 1 Not specific
quality. Accuracy: < 0.5 kV
Reproducibility: < 0.2 kV
Table 2 Equipment needed for quality checks performed less frequent than monthly.
1007995 F 9(66) © Sectra 2010

Aluminium filter Purity: > 99.9%. Thickness accuracy Approx. 4 Not specific.
<3%.
A number of 0.5, 0.2, 0.1 and 0.05
mm filters with a minimum area of 4
cm2. It should be possible to vary the
thickness between 0.3 and 0.7 mm in
0.05 mm steps.
Contrast detail phantom PMMA block that contains discs of 1 CDMAM 3.4
varying thickness and diameter
Compression force Accuracy: < 5%. Range up to at 1 Not specific
measurement tool least 300 N.
Vernier calliper or ruler Vernier calliper or a ruler (with 1 Not specific

accuracy  0.5 mm. Range 0-10 cm).
Lead plate with a hole The size of the hole should match 1 Not specific
the size of the dose meter.
(The lead plate is used to collimate
the beam so that it irradiates only the
dose meter in the HVL
measurement. This is done in order
to improve the accuracy of the
measurement.)
Coins Regular metal coins 7 Not specific
Fluorescent paper Sheets of X-ray fluorescent paper 3 Not specific or
Part No.
1008279
Compressible material Compressible material (such as 1 Not specific
Styrofoam) to simulate a breast.
Diagnostic workstation Diagnostic workstation with 1 Not specific
calibrated 5 mega pixel monitors.
1007995 F 10(66) © Sectra 2010

2.3 Sending to PACS of For Processing (unprocessed) images

If Phantom mode is selected and image setting is set to Raw when acquiring an image, the
displayed image is not processed but will contain default window level (window width and
window center). This image will be sent to PACS when approving the examination.
2.4 Copy of For Processing (unprocessed) images to external

memory
1. Find the examination number.
a. Select an image in the examination.
b. Select “Dump DICOM elements…” in the Tools menu.
c. Find the value of DICOM tag 0020,000d
Example:
0020 000d 26 //REL Study Instance UID //1.2.276.0.7230010.3.2.102
2. Find the examination on the disk.
It is located as a subfolder with the examination number as name in
D:\SectraMDM\AWStorage\yyyy\mm\dd, where yyyy is the year, mm is the month
and dd is the day for the examination.
Example:
D:\SectraMDM\AWStorage\2010\08\25\1.2.276.0.7230010.3.2.102
3. Copy the odd-numbered (unprocessed) image files from examination folder to a
portable storage device.
1007995 F 11(66) © Sectra 2010

3. Daily (User)
The calibrations and quality controls in this chapter are to be performed by the user on a
regular basis. This chapter is also included in the User Manual [1] in each local language.
The second part of Daily quality control (i.e. Image Quality) should also be performed when a
Quick calibration (Section 8.1) or a Full calibration (Section 4.1) has been performed.
3.1 Daily quality control

Objective
To verify a high and consistent level of image quality.
Performed by
User.
Frequency
Before the first examination of the day.
Required test equipment

 Daily quality phantom (Part No. 1010909).
 Standard compression paddle (Part No. 1005258)
or high edge compression paddle
If the patient support or the collimator collides with something and the
user suspects that the part moved as a result of this collision, a new Daily
Notice quality control shall be performed.
If the result of the control is not satisfactory, stop performing
examinations. The user should contact technical support immediately.
Procedure
Compression Paddle
Visually check all compression paddles for scratches or sign of wear. The compression
paddles must not have scratches, cracks or other defects that may distort the image or harm
the patient.
Image Quality
1. The standard or high edge compression paddle must be used.
2. Select the Daily quality control menu option in the application (or press the Quality
Control shortcut key on the keypad). Daily quality control examination automatically
opens.
3. Place the Daily quality phantom on the patient support. The phantom has a metal
guiding edge. Slide the phantom on the patient support so that the guiding edge of the
phantom reaches the front end of the patient support. The contrast markers should be
on the chest wall side; see Figure 1.
1007995 F 12(66) © Sectra 2010

Figure 1 How to place the Daily quality phantom on the patient support.
4. Follow the displayed instructions and lower the compression paddle till it stops
against the phantom.
5. Press Compression done.
6. Perform an exposure with the default settings.
7. Study the acquired phantom image. Search for vertical or horizontal lines or other
irregularities in the image. Pay no attention to the added contrast markers. Check that
the image is homogeneous and without artifacts. Document any findings in the
examination notes.
8. If no disturbing irregularities are found, the system is ready for patient examinations.
The user must approve the image actively by pressing the Approve button. Then an
additional dialog box will appear. Here, the user should approve or disapprove the
image.
(Pressing the Approve button in the dialog box will approve the image and send it to
PACS, pressing the Disapprove button will disapprove the image and send it to
PACS and the Cancel button will cancel the operation.)
Expected results
The compression paddles should not have scratches or other defects that can affect image
quality or harm the patient.
The acquired phantom image should not have any disturbing irregularities.
Handling irregularities
If scratches or other defects are discovered on a compression paddle, it may no longer be used
for examinations and must be replaced.
If the image is unacceptable, perform a Quick calibration (Section 8.1), and then perform a
new Daily quality control.
Repeat this cycle (Quick calibration + Daily quality control) up to two times if the system still
does not pass the Daily quality control.
If this fails, a Full calibration (Section 4.1) must be performed followed by a Daily quality
control. If the image still is unacceptable upon completion of the calibrations, do not perform
any examinations. Report the irregularity to technical support.
1007995 F 13(66) © Sectra 2010

3.2 Guidance system daily procedure

Objective
To verify that the guidance system is not damaged.
Performed by
User.
Frequency
If the guidance system is used, perform this procedure before the first Wire Localization
examination of the day.

 Guidance Bracket (Part No. 1017822)
 Laser Holder (Part No. 1017764)
If the user suspects that guidance system has been exposed to undesired
forces, e.g. guidance system has been dropped to the ground, a Guidance
system precision check shall be performed according to section 7.8 in this
Notice document.
If the result of the control is not satisfactory, stop performing
examinations. The user should contact technical support immediately.
Procedure
Guidance arm
Visually check the Guidance arm. The guidance arm, including the rounded mounting
surface, must not be physically damaged or deformed.
Laser unit
Visually check the Laser unit. The laser unit must not be physically damaged or deformed.
Check that the laser unit is properly attached to the laser unit magnet foot.
Power on the laser unit and check that the laser beam is lit and properly reflected by the
mirror.
Expected results
The guidance arm or laser unit must not be physically damaged or deformed. The laser beam
must be properly projected.
If guidance arm or laser unit is physically damaged or deformed, it may no longer be used for
examinations and must be replaced. Report the irregularity to technical support.
If laser unit is not lit, change the battery according to instructions in the User manual.
1007995 F 14(66) © Sectra 2010

4. Weekly (QC Technologist)

This chapter is also included in the User Manual [1] in each local language.
4.1 Full calibration

Objective
To achieve a high and consistent level of image quality and ensure image uniformity over the
entire field of view. This test includes an automatic Flat Field test.
Performed by
QC Technologist.
Frequency
A Full calibration is to be performed weekly, preferably Monday morning, before the first
examination. (The exact day for the weekly Full calibration can be changed depending on
local conditions, but performing this calibration once each Monday morning is the
recommended schedule.)
This calibration can also be necessary to perform in case of special circumstances (See
“Handling irregularities” in section 3.1) or upon recommendation of the supplier’s technical
support.
If a Full calibration is not performed within two weeks, the system will not
Notice
allow image acquisition without performing a Full calibration.

 Calibration phantom (step-wedge phantom) (Part No. 1009703)
 Procedure
2. Select the menu option Full calibration in the application (or press the Full
calibration shortcut key on the keypad).
3. Instructions appear on the screen describing how to place the Calibration phantom on
the patient support (see Figure 2). The phantom has a metal guiding edge. Slide the
phantom on the patient support so that the guiding edge of the phantom reaches the
front end of the patient support.
Figure 2 Calibration phantom placed on the patient support (seen from front)
1007995 F 15(66) © Sectra 2010

5. Press the Compression done button.
6. Wait until the system is ready for exposure (the exposure button is lit).
7. Press and hold the exposure button until the X-ray warning symbol (shown in the
lower part of the dialog) has appeared and disappeared.
8. The system will now process the data of the phantom image for a few moments.
9. Repeat step 6 to 8 above by following the on screen instructions. Please note that
pressing the Compression done button is not required between exposures.
During this procedure, the system continues to be ready for exposure.

Caution! Before leaving the system, please finish the procedure, or release
compression using the compression pedals.
10. After the final exposure, compression is released automatically.

11. When the calibration is complete the dialog box will close.
12. Perform Daily quality control.
Expected results
The expected result of a normal Full calibration is that the calibration procedure is performed
without any errors or warnings.
Report all irregularities to technical support. Discontinue operation if the expected result is
not met.
1007995 F 16(66) © Sectra 2010

5. Monthly (QC Technologist)

This chapter is also included in the User Manual [1] in each local language.
5.1 Spatial resolution

Objective
To verify that the spatial resolution of the system is adequate.
Performed by
QC Technologist.
Frequency
Performed once a month.

 Line pair phantom, e.g. CIRS 016A including 4,5 cm PMMA or BR12 base.
Procedure
1. Place the line pair phantom on top of its 4.5 cm base.
2. The line pair phantom should be laterally centered and the centre of the phantom’s
pattern approximately 6 cm from the chest wall. The bars should be slightly slanted
(2-5 degrees) with respect to the chest wall edge. See Figure 3 below.
Figure 3 Example of how to place the line-pair phantom.

The phantom should be slightly slanted 2-5 degrees ( ).
X = 6 cm from the chest wall.
Y = 4.5 cm above the patient support.
3. Create a new examination in the application.
4. Select image type Phantom to avoid thickness equalization.
5. Set exposure parameters manually to 35 kV and the highest available mAs-value.
8. Perform an exposure.
1007995 F 17(66) © Sectra 2010

9. Use zoom and adjust window setting to optimize contrast and brightness.
10. For each direction there are several groups of lines. The density of the lines increases
gradually.
For each direction start with the group with the widest lines and go to narrower (and
denser) lines until the space between the lines in a group is no longer discernable. The
groups with the narrowest visible patterns correspond to the systems linear resolution
(1) along and (2) perpendicular to chest wall.
Note the greatest visible line density in each direction and enter it in the record. See
example image in Figure 4 below.
Figure 4 Example image of the line pair phantom.
The different line groups are numbered 5 to 20 (both horizontally and

Notice
vertically). Each group consists of 5 lines.
Expected result
In both directions, the visible line density should be at least 6 lp/mm.
not met.
1007995 F 18(66) © Sectra 2010

5.2 Contrast-to-noise ratio

Objective
To verify an operating level of CNR at a specific exposure, and to monthly confirm that the
CNR remains consistent within limits over time at the same exposure setting.
Performed by
QC Technologist.
Frequency
Performed once a month.
Ref [2] recommends that a test of long-term stability (dose or signal-to-

noise ratio) shall be performed each week.
Notice
This test is a long-term stability test because it is performed on regular
basis and the result is compared to a reference value.

 Daily quality phantom (Part No. 1010909).
Procedure
1. Place the Daily quality phantom on the patient support. The phantom has a metal
guiding edge. Slide the phantom on the patient support so that the guiding edge of the
phantom reaches the front end of the patient support. The contrast markers should be
on the chest wall side; see Figure 5 below.
Contrast markers
(3 light and
3 dark)
Figure 5 How to place the Daily quality phantom on the patient support.
2. Choose “Daily quality control” from the Edit menu in the application or press the
shortcut key on the keypad.
5. Acquire an image.
6. Right click on the image and select “Relabel\Raw”
1007995 F 19(66) © Sectra 2010

7. Right click on the image and select "Measurements\CNR measurement”

a. Place ROI 1 (Signal) in the centre of the top left contrast marker (disc)
b. Place ROI 2 (Background) right between the top two discs
c. Resize/reposition the ROIs if needed and note that:
 ROI 1 (Signal) must not be outside the designated disc area
 ROI 2 (Background) must not cover any disc area and should be at the same
distance as ROI 1 from the chest wall (the bottom of the image)
8. The ROIs marked in the previous steps are ROI 1A and ROI 2A. Repeat the above
step but use the top right disc for the signal ROI instead. These new ROIs are ROI 1B
and ROI 2B.
9. The final result should resemble that shown in Figure 6
Tip: If necessary, it is possible to adjust window level by pressing and holding the
scroll wheel while moving the mouse.
Figure 6 Example on how to perform the CNR Measurements

10. A result box is shown in connection with each ROI pair. Note down the following
results in the record (Appendix B) for both measurements (A & B):
a. Signal (ROI 1) mean
b. Signal (ROI 1) standard deviation (StdDev)
c. CNR
11. Sum the values of the two CNR-values. Summed CNR = CNR 1 + |CNR 2|.
CNR 1 should be positive when measuring.
CNR 2 should be negative when measuring.
Disregard the negative sign for CNR 2 when summing CNR 1 and CNR 2.
(If the summed CNR is negative or close to zero, the ROIs have been measured in the
wrong order or the negative sign for CNR 2 has not been disregarded.)
Note both the summed CNR and tube voltage.
1007995 F 20(66) © Sectra 2010

Expected result
Depending on the tube voltage used, the acquired CNR value must be multiplied with a factor
in order to compare acquired CNR and reference CNR. Note that the reference CNR should
also be multiplied with the factor.
These are the factors to use:
26 kV: 1.13
29 kV: 1.06
32 kV: 1
35 kV: 0.95
38 kV: 0.90
The sum of the CNR-values should be within ±10% of the reference CNR. The reference
CNR is to be measured at installation in conjunction with the contrast-detail resolution test
(section 7.4). The reference CNR is measured in the same way as described above, but should
be averaged over at least three images.
not met.
1007995 F 21(66) © Sectra 2010

5.3 Visual checklist

Objective
To assure that the system’s indicator buttons, display and buttons are working properly.
Verify that the mechanical stability and rigidity of the system is optimal.
Performed by
QC Technologist.
Frequency
Once a month.

 Visual checklist chart found in Appendix B.
Figure 7 Items on Visual checklist – Stand

1. Face protection shield 7. C-arm
2. Compression paddle 8. Laterality buttons
3. Upper keypad 9. Compression done button
4. Lower keypad 10. Collimator
5. Working light button 11. Emergency stop button
6. Stand Display 12. Reset button
13. Foot pedals
1007995 F 22(66) © Sectra 2010

Procedure
 Review each item on the visual checklist and indicate the status.
 Date and initial the checklist when indicated.
Visual checks – C-arm

 Verify that the Face shield (1) is free from scratches and cracks.
 Make sure all compression paddles (2) are free from scratches and cracks.
 Verify that all five keys on the four blue keypads (3, 4) positioned on the C-arm are
working. Test this by pressing the buttons while making sure the system is
performing the expected action.
 Verify that the lamps (5) on both sides are working.
 Make sure that the display (6) shows the angulation while turning the C-arm and that
the chosen angle seems to be correct. You can test this with the CC and MLO short-
cut buttons on the shortcut keypad or manually by using one of the keypads (3, 4) on
the C-arm.
 Make sure that there is no bad noise and that the C-arm's motion (7) is smooth and
silent while moving. You can test this with the CC and MLO shortcut buttons on the
shortcut keypad or manually by using one of the keypads (3, 4) on the C-arm.
 Make sure that both laterality buttons (8) - Sin/L and Dx/R - are working by pressing
the buttons. The buttons should light up when activated.
 Verify that the "Compression done" (9) buttons are working.
 Verify that there is no bad noise from the collimator (10) when it is moving.
Visual checks - Stand

 Make sure there are no visible damages or scratches on the stand that might affect
patient or system safety.
 Verify that both Emergency stop buttons (11) on the main cabinet are working
correctly. (Turn the Emergency Stop button after test in order to reset the button to its
initial state. The Reset-button of the stand must also be pressed after this test.)
 Test that the Reset button (12) is working by pressing it. The system should now
perform a Reset and the display should show "---".
 Verify that the display (6) shows the compressed breast thickness by lowering the
compression paddle.
 Verify that the display (6) shows the compression force by compressing a soft
material/phantom with the compression paddle. Use a compressible material to
simulate a breast, e.g. foamed rubber.
 Make sure that both foot pedals (13) are working correctly by pressing the up- and
down pedal on both foot pedals. Also test the "Compression done" button on both
foot pedals (round button in the middle of the foot pedal) by performing a "Daily
quality control".
1007995 F 23(66) © Sectra 2010

Figure 8 Items on Visual checklist - AW-table

14. Emergency stop button
15. Exposure buttons
16. Exposure pedal (optional)
Visual checks - AW table

 Verify that the Emergency stop button (14) on the AW table is working correctly.
(Turn the Emergency Stop button after test in order to reset the button to its initial state.
The Reset-button of the stand must also be pressed after this test.)
 Verify that both Exposure buttons (15) on the AW table are working correctly.
Test the exposure buttons by
(a) starting the AW software,
(b) create an examination,
(c) press compression done,
(d) perform an exposure by pressing the left button.
Repeat the procedure for the right exposure button.
 Verify that the Exposure foot-pedal (16) connected to the AW table is working
correctly. Test the exposure button by
(a) starting the AW software,
(b) create an examination,
(c) press compression done,
(d) perform an exposure by pressing the pedal.
Expected result
All items are expected to pass the test and receive a check mark.
1007995 F 24(66) © Sectra 2010

If any item does not pass the test, the source of the problem must be identified and corrective
action must be taken before the next examination is performed. Any item missing from the
room must be replaced immediately. Malfunctioning equipment shall immediately be reported
to technical support and either be replaced or repaired before the next examination.
1007995 F 25(66) © Sectra 2010

6. Semi-annual (Medical physicist)

6.1 Thickness indication
Objective
To verify the accuracy of the thickness measurement indicated on the stand display. The
measured thickness is one of the input parameters used by the system’s exposure control.
Performed by
Medical physicist (or Sectra SE).
Frequency
Performed once every six months.

 Use a compressible material to simulate a breast, such as Styrofoam. (Various amounts
of the material will be needed in order to vary thickness during the test.)
 Vernier calliper or a ruler.
Procedure
2. Position the compressible material centred laterally and with one edge along the chest
wall edge (so that it simulates a breast positioned in the CC view).
3. Compress and then measure the distance, 'x' in Figure 9, between the patient support
and the compression paddle using the vernier calliper.
Figure 9 Illustration of how to measure compressed breast thickness.
4. Read the indicated breast thickness on the stand display.

5. Repeat this procedure at least nine times. Spread the compression force within the
interval 5 to 20 dN and breast thickness within 20 to 90 mm. See table below.
6. Note the average error (mm) in the record.
1007995 F 26(66) © Sectra 2010

Thickness / 5–8 daN 11–14 daN 17–20 daN

force interval
20–30 mm
40–60 mm
70–90 mm
Table 3 Average error in thickness indication
Expected result
For each measurement, the difference between the indicated and the measured breast
thickness should be less than or equal to 3 mm. If a measurement indicates a bigger difference
than 3 mm, try again with the same combination of thickness and force in order to make sure
it was not due to an error.
not met.
1007995 F 27(66) © Sectra 2010

6.2 Compression force

Objective
To verify that the system can provide adequate and safe compression in order to reduce
scattered radiation, increase contrast and sharpness, and to minimize patient motion.
To verify that the compression force cannot exceed 20 daN.
Performed by
Medical physicist or Sectra SE. (This test can also be performed by QC Technologist.)
Frequency
Performed twice a year.

 Compression force measurement tool
 Compressible material to simulate a breast, such as Styrofoam.
Procedure
Testing the systems Compression force indication
1. Place the compression force measurement tool on the patient support. Protect the
patient support from scratches.
2. Place the compressible material between the compression force measurement tool and
the compression paddle.
In order to perform this test successfully it is important that the “soft”

Notice object can withstand the compression force and is not deformed during
compression.
3. For at least five compression force values (between 12 and 20 dN):

 Compress and read the value indicated on the stand, Fstand. Convert the
weight indicated on the compression measurement tool to force, Fscale.
 Calculate the difference Fdiff = | Fstand – Fscale | and note the value.
4. Note the largest value of Fdiff.
5. Compress (between 12 and 20 dN) and note the value indicated on the compression
measurement tool. Wait one minute and verify that the compression force has been
maintained.
Testing maximum compression force

1. Place the compression force measurement tool on the patient support. Protect the
patient support from scratches.
2. Place a “soft” object (e.g. foamed rubber) between the compression force
measurement tool and the compression paddle.
3. Try to compress beyond 20 daN. Make sure that this is not possible by measuring the
compression with the compression force measurement tool. It should stop at 20 daN.
(If the compression would continue the software compression safety coupling would
disengage the compression and put the stand in Reset-state.)
1007995 F 28(66) © Sectra 2010

4. Look at the dial of the compression force measurement tool and note at which force
the compression was disengaged.
Expected result
 The largest difference between indicated and measured force must be less than 20 N.
 During compression maintained for a minute, the measured compression force may not
fluctuate more than 5 N.
 It should not be possible to compress more than 20 daN.
not met.
1007995 F 29(66) © Sectra 2010

6.3 X-ray tube output (Air kerma)

Objective
To verify that the air kerma estimated by the system is correct.
Performed by
Frequency

 Dose meter, e.g. ionization chamber and electrometer.
The dose meter must be calibrated for the radiation quality in question and be able to
handle pulsed radiation.
Procedure
See [6] for general information on dosimetry. Air kerma 4.5 cm above the patient support is
to be measured for all five clinically available tube voltages and for three mAs values. (I.e. a
total of 15 measurements.)
Before exposure
1. Place the dose meter on the patient support, laterally centered and 6 cm in
from the edge of the chest wall. Make sure it is secured. Note the height above the
patient support.
3. Use manual exposure parameters.
4. Select Service Tool – Anode brake settings in the Tools menu. Uncheck Brake anode
and click OK.
Exposure
5. Do the following for each value of tube voltage:
a. For three mAs values (minimum, maximum and one in between):
 Place the compression paddle at about 9 cm height from the patient support.
Note the compression paddle must not be removed.
 Reset the dose meter, perform an exposure and read the measured air kerma.
b. Calculate the average of the three air-kerma measurements in units of mGy/mAs.
6. Use the inverse square law to rescale the values to a point 4.5 cm above the patient
support. I.e. if the reference plane of the dose meter is D mm above the patient
support, the measured value should be scaled by a factor (source to patient support
distance is 640 mm.1)
1
The position of the focal spot is marked on the tube housing. In order to view this, the right C-arm
cover must be removed.
1007995 F 30(66) © Sectra 2010

7. Enter the values in the record.

8. Select Service Tool – Anode brake settings in the Tools menu. Restore the original
setting.
The measured values shall be compared to the values found in the Service Tool – X-ray tube
status, accessed from the Tools menu in the application. See an example of values in Figure
10 below.
Figure 10 Example of the X-ray tube status window
Expected result
These values shall not differ by more than ±15% from the values estimated by the system,
which can be found in the Auto exposure control status window. See example of values in
Figure 10.
The tube output at 32 kV shall be at least 0.11 mGy/mAs.
Report all irregularities to technical support. Discontinue operation if the expected result
is not met.
1007995 F 31(66) © Sectra 2010

6.4 Air kerma reproducibility

Objective
To verify that the entrance dose does not deviate during repeated exposures using the same
parameters.
Performed by
Frequency

 Dose meter, e.g. ionization chamber and electrometer.
The dose meter must be calibrated for the radiation quality in question and be able to
handle pulsed radiation.
Procedure
1. Place the dose meter on the patient support, laterally centered and 6 cm in
from the edge of the chest wall. Make sure it is secured.
3. Use manual exposure parameters. Choose 32 kV.
Select an intermediate mAs-value.
4. Place the compression paddle at about 9 cm height from the patient support.
Note: The compression paddle must not be removed.
5. Reset the dose meter, perform an expose and note the measured air kerma.
6. Repeat 5 times for the same mAs and tube voltage.
7. Calculate the mean and standard deviation of the six measured air kerma values.
Enter the values in the record.
8. Calculate the relative standard deviation (= standard deviation / mean).
Expected result
The relative standard deviation of the series of air kerma values should be less than 5%.
not met.
1007995 F 32(66) © Sectra 2010

6.5 AEC system: Breast thickness and exposure

Objective
This test verifies that the exposure level, and hence image quality, is appropriately adjusted to
the breast thickness.
Performed by
Frequency

 0.1 mm or 0.2 mm thick aluminium filter.
 PMMA plates. Thickness should be possible to vary between 20 and 70 mm in
increments of 10 mm.
Procedure
Please note that the PMMA plates used for this procedure are not
equivalent to a typical breast. In addition, a flat non-compressible
large object will introduce a bias in the thickness measurement.
We therefore need to override the measured compression height
with the equivalent breast thickness that the PMMA simulates.
By choosing PMMA 20, PMMA 30 etcetera in the drop-down
menu (Figure 11) in the application the equivalent breast thickness
tabulated in [2] are used. Figure 11 Drop-down menu
Assessment of exposure parameters
1. Create a new examination in the application with Examination Code “QACODE1”
2. Place 20 mm PMMA laterally centered on the patient support.
3. Select the image type Phantom and select the PMMA 20 option in the drop-down
menu.
4. Choose the SmartAEC option.
5. Lower the compression paddle and press Compression done.
7. Note the used exposure parameters displayed in the image (tube voltage, mAs).
8. Add 10 mm of PMMA and repeat steps 3 to 8 until 70 mm of PMMA has been used
(choose PMMA30 for 30 mm of PMMA etc)
Acquisition of images and CNR measurement:

1. Place 10 mm of PMMA laterally centered on the patient support.
2. Place the aluminium filter on the PMMA-plate so that the centre of the aluminium
filter is 6 cm in from the chest wall. The right edge of the filter shall be laterally
centered.
3. Place 10 mm of PMMA on top of the filter so that it is not disturbed between
measurements, see Figure 12.
1007995 F 33(66) © Sectra 2010

Figure 12 Placement of the Al-filter between the two PMMA plates.

4. Select the image type Phantom and select manual exposure parameters (you can use
the same examination from before).
5. Choose tube voltage and mAs values retrieved under Assessment of exposure
parameters above.
6. Lower the compression paddle to approximately 9 cm and press Compression done.
a. Place ROI 1 (Signal) inside the aluminium piece, on the right side Figure 13
b. Place ROI 2 (Background) on the right side of the aluminium piece, but as close
as possible
c. Resize/reposition the ROIs if needed and note that:
 ROI 1 (Signal) must not be outside the aluminium area
 ROI 2 (Background) must be outside aluminium and should be at the same
distance as ROI 1 from the chest wall (the bottom of the image)
Tip: If necessary, it is possible to adjust window level by pressing and holding the scroll
wheel while moving the mouse.
1007995 F 34(66) © Sectra 2010

Figure 13 Illustration of how to select ROIs for CNR calculation.
10. A result box is shown in connection with the ROI pair. Note down the CNR value in
the record.
11. Repeat step 4-10 for 30 to 70 mm PMMA, by adding PMMA above the filter in 10
mm steps.
12. Normalize the values by dividing with the result for 50 mm PMMA.
PMMA Breast Acceptable Achievable CNR threshold

thickness thickness AGD (mGy) AGD (mGy) compared to
(mm) (mm) 50 mm of PMMA
20 21 < 0.8 < 0.6 > 130%
30 32 < 1.3 < 1.0 > 110%
40 45 < 2.0 < 1.6 > 100%
50 60 < 3.3 < 2.6 1
60 75 < 5.0 < 4.0 >90%2
70 90 < 7.3 < 5.8 >80%3
Table 4 Conversion between PMMA and breast thickness plus limit values for Average
Glandular Dose (AGD) and minimum CNR relative a standard breast, see [2].
2
For the C120 dose configuration, the value is 85%.
3
For the C120 dose configuration, the value is 70%.
1007995 F 35(66) © Sectra 2010

AGD calculation
The AGD - that a corresponding breast of normal composition should have received - can be
calculated. Use the HVL measured in the section Half value layer (Section 7.3) or take the
values from the last record. Take Air kerma values from section X-ray Tube Output (Section
6.2).
Details on dose calculation and tables for converting input dose to AGD are found in [2] and
[6]. Also remember to use breast thickness and not PMMA thickness.
Enter the calculated AGD value for each thickness in the record.
Also enter the systems AGD value for each thickness displayed in the acquired images.
Expected result
The measured relative CNR values must be above the CNR threshold in Table 4.
The limiting values for AGD must be below the achievable AGD as specified in [2] and
found in Table 4.
The calculated AGD value for each thickness must not deviate more than +/- 10% from the
systems AGD value displayed in the corresponding image.
Report all irregularities to technical support. Discontinue operation if the expected
result is not met.
1007995 F 36(66) © Sectra 2010

7. Annual (Medical physicist)

7.1 AEC system: Density compensation
Objective
This test ensures that the AEC can compensate for the natural variation of breast density, and
deliver a constant SNR independent of the breast transmission. The density variation is here
modeled by a variation of PMMA thickness.
Performed by
Frequency
Performed once a year.

 PMMA plates. Thickness should vary between 30 and 50 mm in increments of 5 mm.
Procedure
2. Place 30 mm of PMMA on the patient support and put the compression paddle at a
height of approximately 9 cm.
3. Choose the SmartAEC option. Select the image type Phantom and select
the PMMA 40 option in the drop-down menu.
Use PMMA 40 throughout the whole test. The system should always
Notice assume a mean composition and compensate for the variation in
glandularity (modeled by a change of thickness).
1007995 F 37(66) © Sectra 2010


a. Place ROI 1 (Signal) about 6 cm from the chest wall and laterally centered,
see Figure 14. (Try to use the same size and position in all coming
measurements)
b. Place ROI 2 (Background) anywhere on the image (it is not used)
Figure 14 Illustration of how to select ROIs for SNR calculation.
7. A result box is shown in connection with the ROI pair. Note down the ROI 1 (Signal)
SNR value in the record.
8. Add 5 mm PMMA. Repeat step 3–7 until 50 mm of PMMA has been exposed.
9. Enter all the SNR values, representing 30 to 50 mm of PMMA, in the record.
Expected results
All measured SNR values must be within ±15% from the average value.
result is not met.
1007995 F 38(66) © Sectra 2010

7.2 Tube Voltage

Objective
To verify that the system delivers a tube voltage that correspond to the set tube voltage in the
application at a high level of accuracy, and that the level of reproducibility is high.
Performed by
Frequency

 kVp meter calibrated for the radiation quality in question.
Procedure
Tube voltage is to be measured at all tube voltages used clinically. Place the kVp meter on the
patient support laterally cantered about 6 cm from the front edge of the patient support.
Consult the manual of the kVp meter for correct handling.
Accuracy
1. Create a new examination.
2. Choose manual exposure parameters. Use an arbitrary mAs-value between
min and max.
3. Measure the voltage for each tube voltage used clinically.
4. Calculate the accuracy for each voltage.
Accuracy = | kVmeasured – kVset |.
5. Average the accuracy of all selectable tube voltages. Enter the value in the record.
Reproducibility
2. Choose manual exposure parameters. Use an arbitrary mAs-value between
min and max.
3. Choose one of the available tube voltages.
4. Measure the tube voltage at least six times.
5. Calculate the reproducibility, defined as the standard deviation of the measurement
series. Enter the value in the record.
Pay attention to that the scanning can influence the measurement. Meters
use several detectors with different filtration, which may not be exposed
Notice
simultaneously depending on how the detector is placed. Be sure that the
kVp meter can handle this effect.
Expected result
Reproducibility better than 0.5 kV.
Accuracy better than 1 kV.
1007995 F 39(66) © Sectra 2010

result is not met.
7.3 Half value layer

Objective
The test is performed in order to ensure that the x-ray beam quality is consistent over time and
sufficient.
Performed by
Frequency

 Aluminium filter with purity > 99.9% and thickness 0.5, 0.2, 0.1 and 0.05 mm.
 Lead sheet with hole for collimation of the beam.
 Ionization chamber or other dose meter, calibrated for the radiation quality in question.
Procedure
HVL is to be measured for all clinically available tube voltages.
Before measurement
 The compression paddle should be included.
 The dose meter should be positioned similar as when measuring X-ray Tube Output
(Section 6.2).
 “Good geometry” must be used in order to avoid scattered radiation reaching the
detector. I.e. the radiation must be collimated at or before the compression paddle. To
achieve this, put the compression paddle at a height of about 9 cm above the patient
support.
 Put the lead sheet on top of the compression paddle.
 Acquire an image to verify that the collimator is lined up with the dose meter. See
Figure 15 for an example of good line-up.
Measure Air kerma

2. Choose manual exposure settings. Use maximum mAs (in order to minimize
measurement errors).
3. For all clinically available tube voltages:
a. Place the compression paddle at about 9 cm height from the patient support.
Expose and measure Air kerma without filter.
b. Place as many of Air kerma filters as needed on top of the hole in the lead
sheet in order to reduce the Air kerma to just above 50%.
1007995 F 40(66) © Sectra 2010

c. Place the compression paddle at about 9 cm height from the patient support.
Expose.
d. Repeat step “b” and “c” but choose filters that reduce the Air kerma to just
below 50%.
Calculate the half value layer with the following formula
X 1 ln 2 K 2 / K 0   X 2 ln 2 K 1 / K 0 
HVL 
ln K 2 / K 1 
K0 is the Air kerma without filter. K1 and K2 respectively represents Air
kerma with filter. X1 and X2 are the filter thickness above and below 50%
respectively.
4. Note the HVL values in the record.
Figure 15 Example of good line-up of dose meter (ion chamber) and lead collimator.
Expected result
The measured HVL-value should not deviate more than ±0.03 mm from the reference value.4
Report all irregularities to technical support. Discontinue operation if the expected results are
not met.
4
± 0.03 mm is a more strict limit than ref [5] where the requirement is defined as
kV/100+0.03 < HVL (mm) < kV/100 + C. C=0.3given for W/Rh anode filter combination. There is no
value for W/Al, therefore the value for W/Rh is used.
1007995 F 41(66) © Sectra 2010

7.4 Contrast detail resolution

Objective
To verify that the system delivers images with a sufficient contrast detail resolution.
Performed by
Frequency

 Contrast detail phantom CDMAM 3.4 including a total of 4 cm PMMA base.
 Diagnostic workstation with calibrated 5 mega pixel monitors located in a room with
clinical reading conditions, i.e. room lights, light boxes and other display devices
should be at the same luminance level as under clinical conditions.
Figure 16 Correct positioning of Contrast detail phantom CDMAM including

4 cm PMMA base. (2 cm PMMA under the phantom and 2 cm PMMA
above the phantom. The largest discs of the phantom to the left and
the smallest to the right.)
Procedure
The phantom, including its 4 cm PMMA base, corresponds to 5 cm PMMA and 6 cm
breast [2].
1. Place the CDMAM phantom with its base of 4 cm PMMA so that the long side meets
the edge of the image field at the chest wall, see Figure 16. The phantom should be 2
cm above the patient support, i.e. placed on 2 cm PMMA with 2 cm on top. The
largest discs should be to the left seen from the patient’s position.
2. Choose PMMA 50 from the drop-down menu in order to override the system’s
measured breast thickness with the equivalent breast thickness of 50 mm PMMA as
specified in [2].
3. Study the image on the diagnostic workstation using clinical reading conditions. Use
zoom and adjust window levels (contrast and brightness) in order to maximize
1007995 F 42(66) © Sectra 2010

visibility of the details in the displayed images. A minimum of two observers should
score three images each.
4. For each image:
a. For each disc diameter (1.60, 1.00, 0.63, 0.40, 0.25 and 0.1 mm):
 Start with the thickest disc. There is a disc in the centre and one in one of the four
corners. Try to determine in which corner the disc is located.
 When you no longer judge it possible to determine in which corner the disc is located,
proceed with at least one more disc.
 Compare to the proof of the phantom.
 Note the thickness of the thickest disc that could not be identified correctly.
5. For each diameter:
 Average the threshold thickness from the different images and observations.
Note the value in the record.
Expected result
The threshold thickness shall be lower than that required in table for 5 of 6 of the diameters
for the C100 and C120 configuration.
Diameter Required thickness
(mm) threshold (µm) for
C100 and C120 dose
configurations
1.6 0.074
1.0 0.091
0.63 0.123
0.4 0.189
0.25 0.352
0.1 1.68
Table 5 Required threshold thickness for the C100 and C120 configuration for different disc
diameters. The C100 and C120 values correspond to the acceptable limiting values as
specified in [2].
not met.
1007995 F 43(66) © Sectra 2010

7.5 Detector linearity

Objective
To verify that the detector is quantum-limited across a range of exposures, and rule out
additional noise sources besides quantum noise.
Performed by
Frequency

 Daily quality phantom
 The standard compression paddle or high edge compression paddle
Procedure
This test verifies that the squared signal-to-noise ratio is linear with the input dose (mAs).
Since the tube current is constant, this is achieved by varying the scan time.
2. Place the Daily quality control phantom laterally centered on the patient support,
see Figure 5 on page 19.
5. Determine the min and max mAs-values for the system by choosing manual exposure
and 32 kV in the application. The minimum and maximum values can be found in the
drop-down menu. Note the values.
6. Acquire an image using “phantom,” 32 kV and minimum mAs.
7. Right click on the image and select “Relabel\Raw”.
8. Right click on the image and select "Measurements\CNR measurement”, see Figure
17 for a reference.
a. Place ROI 1 (Signal) right between the top two discs (do not resize the ROI)
b. Place ROI 2 (Background) anywhere on the image (it will not be used)
1007995 F 44(66) © Sectra 2010

Figure 17 Placing the ROIs, not that the background ROI placement is not
important
9. A result box is shown in connection with the ROI pair. Use the ROI 1 (Signal) SNR
value to calculate SNR2 and note down this value and the mAs used (will be used for
later calculations).
10. Return to step 5 (above) and repeat this procedure for maximum mAs and at least five
evenly distributed mAs-values between min and max. (I.e. total of 7 measurements.)
11. The squared correlation coefficient is defined by (using y = SNR2 and x = mAs)
2
 
 n xi y i   xi  y i 
R2   i i i 
   
2
  
2
 n  x i    xi    n  y i    y i  
2 2
 i  i    i  i  
where n is the number of measurements.
Functions for calculating the correlation coefficient are included in most spreadsheet
programs.
Note R2 in the record.
Expected result
R2 > 0.99
not met.
1007995 F 45(66) © Sectra 2010

7.6 Image field and x-ray field agreement

Objective
To verify that the indicated image field corresponds to the x-ray field.
Performed by
Frequency
Annually, when changes in image and x-ray field congruence may be suspected, or after
preventative maintenance or service which may impact image and x-ray field congruence.

 Four coins
 Acrylic, at least 0.5 cm thick, approximately 26 x 28 cm
 Ruler
 Three pieces of intensifying screen (fluorescent material), 2 x 26 cm, preferably a 400-
speed screen
 Small flashlight
Procedure
Congruence of indicated and actual image field
1. Center coins on each of the four edges of the indicated image field on the breast
support. (The indicated image field is outlined by the painted area on the side and rear
edge of the field.)
2. Place the coins inside the indicated field and tangential to the edge (Figure 18).
Double-sided tape may be used to hold the coins in place if they tend to slide toward
the center.
Place at least 0.5 cm PMMA on top of the breast support (this allows the actual image
border to be seen on the mammographic image).
Figure 18 Photograph of top surface of patient breast support and showing placement
of coins and painted outline of the indicated image field.
1007995 F 46(66) © Sectra 2010

3. Make an exposure using 32 kVp and approximately 15 mAs.

4. Measure the deviation between the indicated and the actual image field on the sides
and at the rear edge.
5. Move the coins so that they touch the edge of the actual image field.
6. Make another exposure.
7. Repeat steps 4–7 until the coins just touch the edge of the actual image field. The
image should appear similar to the one shown in Figure 19
Figure 19 Radiograph of coins showing appropriate alignment with the edge of the
actual image field.
8. Remove the acrylic sheet.
9. Measure the difference between the outline of the indicated and actual image fields
(indicated by the edges of the coins) on the surface of the patient breast support using
a ruler. (Figure 20)
Figure 20 Photograph showing measurement of difference between the indicated

image field (edge of painted area) and actual image field (edge of coin).
1007995 F 47(66) © Sectra 2010

X-ray and image field congruence

1. Place the pieces of intensifying screens parallel to the side and rear edges of the
actual image field edge (indicated by the coins) and 5 mm outward from the coins
(Figure 21).
2. Put a small strip of the intensifying screen in the middle of the field. (The strip in the
center serves as a comparison source during exposure.)
3. Turn off room lights.
Figure 21 Illustration of coins and intensifying screen strips.

4. Select a manual technique of 35 kVp and the maximum mAs.
5. Make an exposure and observe the fluorescent material during the scan.
6. Re-position the intensifying screen at the chest wall edge (Figure 22). Place a coin at
the edge of the breast support on top of the intensifying screen.
7. Make a manual exposure at 35 kVp and the maximum mAs and observe the
intensifying screen during the scan.
Figure 22 X-ray and image field congruence test for chest wall edge.
Performance criteria and corrective action

The edge of the indicated image field should be within 5 mm of the edge of the actual image
field.
1007995 F 48(66) © Sectra 2010

The radiation field should not extend beyond the actual image field by more than 5 mm on the
right and left sides, and along the rear of the image receptor, i.e., the intensifying screens
should not produce light during the scan.5
No radiation must be visible beyond the chest wall edge of the patient support.
If any of the above criteria are not met, contact the service engineer for Corrective Action.
5
MQSA regulations (MQSA, 1999) require 2% of the SID which is equivalent to 13 mm.
1007995 F 49(66) © Sectra 2010

7.7 Missed tissue at chest wall

Objective
To verify that the level of missed tissue at chest wall is sufficiently small.
Performed by
Frequency

 Coins
 Vernier calliper.
Procedure
1. Use the image from the “Image field and x-ray field agreement” procedure
(Section 7.6) or acquire an image following the instructions found there.
2. On the chest wall side, estimate the difference between the indicated image
field and the actual image field (should be possible within 0.25 mm).
3. Use the vernier calliper to measure the distance from the edge of the patient
support to the edge of the indicated (coloured) image field (should be possible
within 0.5 mm).
4. Together, the two values above indicate the distance from the edge of the
patient support to the edge of the actual image field, i.e. how much tissue is
missed during imaging. Record this value in the record.
Alternative procedure
Use a phantom including objects specifically designed to measure chest wall dead area (e.g.
small steel balls). Follow the instructions given by the phantom manufacturer.
Expected result
The level of missed tissue at the chest wall should be less than 5 mm.
result is not met.
1007995 F 50(66) © Sectra 2010

7.8 Guidance system precision control

Objective
To verify that the precision of the guidance system is adequate.
Performed by
QC Technologist.
Frequency
If the guidance system is used, perform this procedure annually or when the user suspects that
guidance system has been exposed to undesired forces, e.g. if the guidance system has been
dropped to the ground.

 Matrix compression paddle (Part No. 1017956)
 Radio opaque marker, e.g. marker of copper tape or small coin
 Tape
Procedure
1. Create and open a new examination in application.
2. Mount the matrix compression paddle and select matrix compression paddle in
application.
3. Adjust the compression height to 75 mm.
4. Mount the Guidance system.
5. Position the guidance laser unit to point at the tip of the “A” marker line in the
compression paddle coordinate system.
6. Remove the matrix compression paddle.
7. Position the radio opaque marker on the patient support so that the guidance laser unit
is pointing at the tip of this position marker too. Secure the marker position with tape.
8. Re-mount the matrix compression paddle and verify that the laser beam still point at
the tip of the “A” marker line in the compression paddle coordinate system. Seen
from above the “A” marker line and the radio opaque marker shall point towards each
other.
9. Repeat step 5 to 8 for the “F” marker line on the opposite side of the compression
paddle coordinate system.
10. Remove guidance system.
12. Perform an exposure.
13. Magnify the acquired x-ray image and measure the distance between the tip of the
marker lines and the tip of the radio opaque markers with the measurement tool.
1007995 F 51(66) © Sectra 2010

Figure 1: How to align the marker lines and the radio opaque markers
Expected result
The distance between the tip of the marker lines and the tip of the radio opaque markers shall
be less than 1.5 mm.
not met.
1007995 F 52(66) © Sectra 2010

8. Unscheduled calibrations (User)

8.1 Quick calibration
Objective
To achieve a high and consistent level of image quality.
Performed by
User.
Frequency
This calibration routine should only be started if the Daily quality
control is unsatisfactory or if a disturbing image artefact is detected
during normal operation.

 Calibration phantom (step-wedge phantom)
(Part No. 1009703)
Procedure
2. Select the menu option Quick calibration in the application (or press the Quick
calibration shortcut key on the keypad).
3. Instructions appear on the screen describing how to place the Calibration phantom on
the patient support, see Figure 23. The phantom has a metal guiding edge. Slide the
phantom on the patient support so that the guiding edge of the phantom touches the
front end of the patient support.
Figure 23 Calibration phantom placed on the patient support (seen from front).
1007995 F 53(66) © Sectra 2010

5. Press the Compression done button.

6. Wait until the system is ready for exposure (the exposure button is lit).
7. Press and hold the Exposure button until the X-ray warning symbol (shown in the
lower part of the dialog) has appeared and disappeared.
8. The system processes the gathered data.
9. When the calibration is complete the dialog box will close.
10. Perform Daily quality control.
Expected results
The expected result of Quick calibration is that the calibration procedure is performed without
any errors or warnings.
not met.
1007995 F 54(66) © Sectra 2010

9. Summary of Quality control procedures and

Tests
Table 6 Summary of the most common quality controls.
Name of test By Execution Approx. Required result Action if failed
(abridged) Duration
Daily procedure
3.1 Daily User Study image of <5 min No disruptive Perform Quick
quality control Daily quality irregularities in image. calibration
phantom
User Visually 1 min No scratches that can Replace
inspect all distort the image or compression paddle
compression harm the patient.
paddles
3.2 Guidance User Visually 1 min Guidance arm or Laser Replace Guidance
system daily inspect the unit is not damaged or arm or Laser unit if
procedure guidance deformed. Laser beam damaged or
system. properly projected. deformed. Replace
battery if Laser unit
is not lit.
Weekly procedures
4.1 Full QC Tech Imaging of 5 min Error-free execution Contact support

calibration step-wedge
phantom
4.2 Mammo- QC Tech Mammographic 15 min At least 4 fibers, Contact support
graphic accreditation 3 groups of micro- Discontinue
Accreditation phantom calcifications and operation.
Phantom Test 3 masses must be seen
(total score must be at
least 10). The dose
should be <3.0 mGy.
Monthly procedures
5.1 Spatial QC Tech Study an image Minimum: pattern with Contact support
resolution of the line pair density 6 lp/mm must be Discontinue
phantom visible. operation.
10 min
each
5.2 Contrast- QC Tech Measure the CNR within ±10% of Contact support
to-Noise Ratio CNR using ref. CNR measured at Discontinue
contrast discs installation operation
in the Daily
quality
phantom
5.3 Visual QC Tech Visual check of 20 min Error-free execution Contact support
checklist the system Discontinue
operation
1007995 F 55(66) © Sectra 2010

Table 7 Summary of quality controls for medical physicists.

Name of test By Test procedure (abridged) Required result
Semi-annual procedures
Measure distance between
6.1 Thickness Medical compression paddle and patient
Difference < 3 mm
indication physicist support using vernier calliper and
compare to indicated value
Less than 20 N deviation from
indicated force.
6.2 Compression Medical Compression force maintained
Measure force with scale
force6 physicist for one minute.
Compression force may not
exceed 200 N.
6.3 X-ray Tube
Medical Measurement with dose meter, e.g. Tube output at 32 kV shall be
Output
physicist ionization chamber > 0.11 mGy/mAs
(Air kerma)
6.4 Air kerma Medical Measure air kerma for six exposures
<5 % relative standard deviation
reproducibility physicist using the same exposure parameters.
6.5 AEC system: Medical CNR measurement using of Al filter
Breast thickness on PMMA for different PMMA See Table 4.
physicist
and exposure thicknesses.
Annual procedures
7.1 AEC system:
Medical SNR measurement for different ±15% from the average
Density
Pysicist PMMA thicknesses. SNR value.
compensation
Inaccuracy < 1.0 kV
Medical
Measurement using kVp meter at: Reproducibility < 0.5 kV
7.2 Tube Voltage lowest, typical and highest clinical (Complies to FDA regulation
physicist
tube voltages 900.12 (e)(5)(ii). Tolerance +/-
5%.)
HVL > kV/100+0.03
7.3 Half value Medical
Standard procedure HVL within  0.03 mm from the
layer physicist
reference value.
7.4 Contrast detail Medical Evaluate image quality using
See Table 5.
resolution physicist CDMAM 3.4 phantom
7.5 Detector Medical Measure SNR in ROI for different Correlation mAs-SNR2
linearity physicist mAs values R2 > 0.99
6
Can also be performed by a QC Technologist.
1007995 F 56(66) © Sectra 2010

Right, left and rear edge: No

radiation beyond 5 mm from
* Measurement of x-ray radiation edge. No radiation must be
outside real image field. visible beyond the front edge of
7.6 Image field and * Resemblance of indicated image the patient support.
Medical
x-ray field field and real image field. Difference between indicated
physicist
agreement
* Radiation beyond the front edge of and actual image field < 5 mm.
patient support. (Complies to MQSA [4]
requirements 2% of SID which
translates to 13 mm.)
7.7 Missed tissue Medical Measurement of the level of missed
< 5 mm
at chest wall physicist tissue at chest wall.
7.8 Guidance Verification of the precision of the Distance between tip of the
system precision QC Tech marker lines and tip of the radio
guidance system.
control opaque markers < 1.5 mm.
Unscheduled procedures
Test run when Daily quality control

8.1 Quick User is unsatisfactory or in order to Error free execution
calibration remove image artefacts.
Note: In addition to the above-described tests for medical physicists, inspection of the
equipment is performed annually by Sectra SE for maintenance purposes.
1007995 F 57(66) © Sectra 2010

Appendix A – Weekly record
Sectra MicroDose Mammography

Quality control: Weekly schedule and record
Installation: Facility:
Year: Week: Month:
Signature: Serial number:7
Comments:
Passed Date, Time

Comments
Weekday Time Event (OK / not and
(if relevant)
OK) Signature
Perform Full
calibration
Monday Morning
Perform Daily
quality control
Perform Daily
Tuesday Morning
quality control
Perform Daily
Wednesday Morning quality control
Perform Daily
Thursday Morning
quality control
Perform Daily
Friday Morning
quality control
Mammographic accreditation phantom test

* Objects/groups seen Passed
Parameters
* Score (OK / not OK)
Fibers
Micro-califications
Masses
Total score
7
The serial number of the stand can be found (1) in documentation delivered with the system, (2) on a
label on the door of the side cabinet or (3) in the “About box” found in the application.
1007995 F 58(66) © Sectra 2010

Appendix B – Monthly record

Quality control: Monthly record
Year: Month: Test date:
Signature: Serial number8:
Comments:
Contrast-to-Noise Ratio
Measured Measured Passed
Parameter Sum
in ROI 1A in ROI 1B (OK / not OK)
Mean (m)
NA No requirement
Standard
NA No requirement
deviation (s)
CNR
Reference CNR NA NA
Conversion
NA NA
factor used
Spatial resolution
Greatest visible line density Passed
Line direction
(per mm) (OK / not OK)
Along chest wall
Perpendicular to chest
wall
8
1007995 F 59(66) © Sectra 2010

Visual checklist
Year: Serial number9:
Comments:
Notation: Pass = P Fail = F Does not apply = NA
Month:
Day:
Time:
Initials:
C-arm
(1) Face Shield
(2) All compression paddles
(3, 4) All five keys on all four blue

keypads
(5) Working light
(6) Angulation Indicator on display
(7) Motion of C-arm
(8) Laterality buttons (Sin/L and

Dx/R)
(7) C-arm
(10) Collimator movement

[ Press “Compression done” (9) or
the round button on the foot
pedals (13) in order to lower the
collimator. ]
Stand
Stand
(11) Both Emergency stop buttons
(12) Reset button
(6) Compressed breast thickness
9
1007995 F 60(66) © Sectra 2010

indicator on the display
(6) Compression force Indicator on

the display
(13) Both sets of foot pedals
AW table
(14) Emergency stop button?
(15) Exposure buttons on AW-

table working?
(16) Exposure foot-pedal working?
1007995 F 61(66) © Sectra 2010

Appendix C – Semi-annual and annual record

Quality control: Record for semi-annual and annual tests
Year: Month: Test date:
Signature: Serial number10:
Comments:
Equipment used
Type Specification Model/serial number
Semi-annual tests
Passed
Name Result Comments
(OK / not OK)
Thickness Average error: mm
indication
4.5 cm above patient support
26 kV: _______ mGy/mAs
29 kV: _______ mGy/mAs
X-ray tube output
(Air kerma) 32 kV: _______ mGy/mAs
35 kV: _______ mGy/mAs
38 kV: _______ mGy/mAs
Used kV:
Used (max) mAs:
Air kerma Reproducibility: %(max mAs)
reproducibility
Used (min) mAs:
Reproducibility: %(min mAs)
10
1007995 F 62(66) © Sectra 2010

Height Meas. CNR AGD System Comments:

(mm CNR relative (mGy) AGD
PMMA) 5 cm
20
30
Breast thickness
40
and exposure
50 =100%
60
70
Passed: (OK / not OK)
Largest value of Fdiff N

Compression force maintained during one
minute, and fluctuation less than 5N?
Compression force (Yes, No)
Indicated Compression Force N
Maximum Compression force N
Annual tests
Passed Commen
Name Result
(OK / not OK) ts
Height SNR
(mm PMMA) Comments:
30
AEC system: 35
Density 40
compensation
45
540
Passed: (OK / not OK)
Long-term stability Relative standard deviation for

CNR values: %
Reproducibility: kV
Tube voltage
Accuracy: kV
Including compression paddle
26 kV: _______ mm Al
29 kV: _______ mm Al
HVL
32 kV: _______ mm Al
35 kV: _______ mm Al
38 kV: _______ mm Al
1007995 F 63(66) © Sectra 2010

kV: mAs:
D Mean Required Pass
(mm) threshold threshold (y/n)
thickness thickness
(µm) (µm) for
C100/
C120
Contrast detail 1.6 0.074
resolution 1.0 0.091
0.63 0.123
0.4 0.189
0.25 0.352
0.1 1.68
Detector linearity R2 =
Confirm that there is no radiation beyond 5 mm

from the rear, right and left edges:
Image field and X- Actual image field relative to indicated image
ray field agreement field.
Left: mm. Right: mm
Rear edge: mm.
Chest wall missed
mm
tissue
Guidance system
mm
precision control
1007995 F 64(66) © Sectra 2010

(This page is intentionally left blank.)
Manufacturer
Sectra Imtec AB
Teknikringen 20
SE-583 30 Linköping, Sweden
Phone: +46 13 23 52 00
E-mail: info.imtec@sectra.se
www.sectra.com/medical
For local contact information, visit

www.sectra.com/medical/contact
© Sectra 2010

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Sectra MicroDose Mammography L30

Quality Control Procedures -

Quality Control Procedures - Sectra MicroDose Mammography L30

Doc. No & Revision 1007995 F

1007995 F 2(66) © Sectra 2010

1007995 F 3(66) © Sectra 2010

Appendix C – Semi-annual and annual record................................................................... 62

1007995 F 4(66) © Sectra 2010

The quality control procedures described in this document shall be

1.3 Acceptance testing

1.4 General information about quality control procedures

1007995 F 5(66) © Sectra 2010

1.5 Intended readers

1.6 Related documents

1007995 F 6(66) © Sectra 2010

1.8 Symbols used in this document

Notice Notice is used to underline information of importance.

The exposure symbol is used when an exposure is made.

1007995 F 7(66) © Sectra 2010

1.9 Terms, definitions and typographic conventions

1007995 F 8(66) © Sectra 2010

2. Equipment and preparatory information

Table 1 Equipment needed for quality checks.

2.2 Equipment for procedures performed less frequently than

1007995 F 9(66) © Sectra 2010

Vernier calliper or ruler Vernier calliper or a ruler (with 1 Not specific

1007995 F 10(66) © Sectra 2010

2.3 Sending to PACS of For Processing (unprocessed) images

2.4 Copy of For Processing (unprocessed) images to external

1007995 F 11(66) © Sectra 2010

3.1 Daily quality control

Required test equipment

1007995 F 12(66) © Sectra 2010

1007995 F 13(66) © Sectra 2010

3.2 Guidance system daily procedure

Required test equipment

1007995 F 14(66) © Sectra 2010

4. Weekly (QC Technologist)

4.1 Full calibration

Required test equipment

1007995 F 15(66) © Sectra 2010

During this procedure, the system continues to be ready for exposure.

10. After the final exposure, compression is released automatically.

1007995 F 16(66) © Sectra 2010

5. Monthly (QC Technologist)

5.1 Spatial resolution

Required test equipment

Figure 3 Example of how to place the line-pair phantom.

1007995 F 17(66) © Sectra 2010

Figure 4 Example image of the line pair phantom.

The different line groups are numbered 5 to 20 (both horizontally and

1007995 F 18(66) © Sectra 2010

5.2 Contrast-to-noise ratio

Ref [2] recommends that a test of long-term stability (dose or signal-to-

Required test equipment

1007995 F 19(66) © Sectra 2010

7. Right click on the image and select "Measurements\CNR measurement”

Figure 6 Example on how to perform the CNR Measurements

Note both the summed CNR and tube voltage.

1007995 F 20(66) © Sectra 2010

1007995 F 21(66) © Sectra 2010

5.3 Visual checklist