Quality Control (QC) Manual: Planmed Nuance & Nuance Excel FFDM Systems

EN
Planmed Nuance & Nuance Excel FFDM systems
Quality Control (QC) Manual

20008109_7
Table of contents
1 INTRODUCTION ................................................................................................................. 1
2 RESPONSIBILITIES ........................................................................................................... 2
2.1 Medical physicist .................................................................................................................... 2
2.2 Radiologic technologist ........................................................................................................... 2
2.3 Interpreting physician ............................................................................................................. 2
2.4 Facility .................................................................................................................................... 2
3 ACCESSING QUALITY CONTROL VIEW ............................................................................. 3
4 SCHEDULED TESTS .......................................................................................................... 4
5 REQUIRED TEST PHANTOMS ........................................................................................... 5
6 ACQUIRING TEST PHANTOM IMAGE ................................................................................ 5
7 USING PHANTOM IMAGE TOOLS ...................................................................................... 6
8 SUMMARY OF QUALITY CONTROL (QC) TESTS ............................................................... 7
8.1 QC test procedure .................................................................................................................. 7
8.2 Tests to be performed by Radiologic Technologist (RT) ........................................................ 8
8.3 Tests to be performed by Medical Physicist ......................................................................... 12
8.4 Alternative QC standard ....................................................................................................... 15
8.5 QC test results ...................................................................................................................... 16
9 QUALITY CONTROL TESTS FOR RADIOLOGIC TECHNOLOGIST .................................... 18
9.1 Monitor cleaning check ......................................................................................................... 18
9.2 Monitor Quality Control Test (TG-18QC) .............................................................................. 19
9.3 Phantom image quality test for AWS and RWS ................................................................... 20
9.4 Viewbox and viewing conditions ........................................................................................... 23
9.5 Signal homogeneity check (homogeneity) ............................................................................ 24
9.6 Uncorrected Defect Elements (DEL) analysis ...................................................................... 25
9.7 Printer Quality Control .......................................................................................................... 27
9.8 Signal-to-Noise Ratio (SNR) test .......................................................................................... 28
9.9 Contrast-to-Noise Ratio (CNR) Test ..................................................................................... 29
9.10 Planmed Nuance & Nuance Excel FFDM system visual checklist
(A and B) .............................................................................................................................. 31
9.11 Repeat analysis .................................................................................................................... 32
9.12 Defect acceptance test ......................................................................................................... 33
9.13 Compression force test for Radiologic Technologist (RT) .................................................... 34
9.14 System fault report ............................................................................................................... 35
10 QUALITY CONTROL TESTS FOR MEDICAL PHYSICIST .................................................. 36
10.1 Ghosting test ........................................................................................................................ 36
10.2 Modulation Transfer Function test (MTF) ............................................................................. 39
10.3 Linearity / noise linearity test ................................................................................................ 40
10.4 Automatic Exposure Control (AEC) tests ............................................................................. 42
10.5 Compression force test for Medical Physicist (MP) .............................................................. 44
10.6 Mammography unit assembly evaluation ............................................................................. 45
10.7 kVp accuracy test (kV) .......................................................................................................... 46
10.8 Collimation assessment test ................................................................................................. 47
10.9 Radiation output rate test ..................................................................................................... 49
10.10 Beam quality assessment - Half-Value Layer (HVL) measurement ..................................... 50
10.11 Breast entrance exposure and Average Glandular Dose (AGD) measurement ................... 53
Quality Control manual Planmed Nuance & Planmed Nuance Excel 1

Table of contents
11 DETECTOR CALIBRATION ............................................................................................... 56

11.1 Required configuration .......................................................................................................... 56
11.2 Preparing the system for calibration ..................................................................................... 57
11.3 Calibration modes ................................................................................................................. 59
11.4 Performing calibration ........................................................................................................... 59
11.5 Cancelling calibration ............................................................................................................ 61
11.6 After calibration ..................................................................................................................... 61
12 ABBREVIATIONS AND ACRONYMS ................................................................................. 62
13 VARIOUS SYSTEM CONFIGURATION GUIDELINES ........................................................ 64
Appendix A: QC TEST FORMS

Form 1. Monitor Cleaning Check (AWS and RWS)
Form 2. Monitor Quality Test / TG-18 QC (AWS and RWS) Test
Form 3. Phantom Image Quality for AWS Test
Form 4. Phantom Image Quality Test for RWS
Form 5. Signal Homogeneity Check
Form 6. Uncorrected Defective Elements (DEL) Analysis
Form 7. Large focus calibration
Form 8. Small focus calibration when performing magnification exams
Form 9. Signal-to-Noise Ratio (SNR) Test
Form 10. Contrast-to-Noise Ratio (CNR) Test
Form 11. Planmed Nuance & Nuance Excel FFDM System Visual Checklist (A)
Form 12. Planmed Nuance & Nuance Excel FFDM System Visual Checklist (B)
Form 13. Repeat Analysis record form A
Form 14. Repeat Analysis record form B
Form 15. Defect Acceptance Test for Planmed Nuance
Form 16. Defect Acceptance Test for Planmed Nuance Excel
Form 17. Compression Force Test for Radiologic Technologist (RT)
Form 18. System Fault Report
Form 19. Ghosting Test
Form 20. Modulation Transfer Function (MTF) Test
Form 21. Linearity / Noise Linearity Test
Form 22. Automatic Exposure Control (AEC) Test
Form 23. Compression Force Test for Medical Physicist (MP)
Form 24. Mammography Unit Assembly Evaluation
Form 25. kVp accuracy test
Form 26. Collimation assessment test
Form 27. Radiation output rate test
Form 28. Beam Quality Assessment - HVL measurement
Form 29. Breast Entrance Exposure Measurement and Average Glandular Dose (AGD)
2 Planmed Nuance & Planmed Nuance Excel Quality Control manual

Table of contents

Table of contents
The manufacturer, assembler and importer are responsible for the safety, reliability and
performance of the unit only if:
- installation, calibration, modification and repairs are carried out by qualified author-
ised personnel
- electrical installations are carried out according to the appropriate requirements such
as IEC 60364
- equipment is used according to the operating instructions.
Planmeca pursues a policy of continual product development. Although every effort is

made to produce up-to-date product documentation this publication should not be re-
garded as an infallible guide to current specifications. We reserve the right to make
changes without prior notice.
COPYRIGHT PLANMECA
Publication number 20008109 Revision 7
Released 08 March 2017

1 INTRODUCTION
1 INTRODUCTION
This manual describes the Quality Control (QC) and calibration procedures recommended
by Planmed to ensure optimal operation of the Planmed Full Field Digital Mammography
system. Its purpose is to assist the operator in the testing and maintenance of the system
and to make a recording of the test results. It includes a detailed description on how to
perform the QC tests and how to record the test results by using the Planmed Nuance
Manager 3 Quality Control (QC) application as well detailed instructions for calibrating
Planmed Full Field Digital Mammography system.
The goal of Planmed’s Nuance Manager 3 Quality Control Program is to provide an
effective means to discover and identify any image quality problems.
This manual contains the Quality Control procedures that must be performed by the
radiologic technologist and medical physicist to assure optimal system operation and
image quality. The methodology for each test, performance criteria, corrective action and
test result documentation forms are found in this manual.
The tests to be performed by Radiologic Technologist include Monitor Cleaning Check,
Monitor Quality Test, Phantom image quality test for acquisition workstation (AWS) and for
review workstation (RWS), Signal Homogeneity Check, Uncorrected Defective Elements
Analysis, Large Focus Calibration, Signal-to-noise Ratio Test, Contrast-to-Noise Ratio
Test Planmed Nuance & Nuance Excel Visual Checklist, Small Focus Calibration, Repeat
Analysis, Defect Acceptance Test, System Fault Report and Compression Force Test.
The annual tests are designed to be performed by Medical Physicist. The tests include
Ghosting Test, Modulation Transfer Function Test, Linearity/Noise Linearity Test,
Compression Force Test, AEC Tracking and Reproducibility Test, Mammography Unit
Assembly Evaluation, kVp accuracy test, Collimation Assessment, Radiation Output Rate,
Beam Quality Assessment, and Breast Entrance Exposure / Average Glandular Dose
Test.
The final regulations of the MQSA (Mammography Quality Standards Act) and EUREF
(European Reference Organization for Quality Assured Breast Screening and Diagnostic
Services) guidelines along with the Quality Control (QC) procedures determined
necessary by the digital image receptor manufacturer collectively contributed to the
materials and test requirements in this manual.
CAUTION
Quality control is essential part of the system maintenance, and neglecting to per-
form the necessary tests might affect harmfully the performance of the device.
CAUTION
Local regulations regarding the viewing conditions in the viewing room (e.g. light-
ning) have to be taken into account.
CAUTION
The quality of monitors used in viewing the images have to be assured according to
the quality control instructions given by the monitor manufacturer.
In case a QC test fails, corrective actions must be taken immediately according to the
corrective action procedure which is described in each QC test section.
Blank QC forms for the Radiologic Technologist and Medical Physicist are included for
recording the QC test results in the end of this manual.
With the System Fault Report (Form 18.) any fault or problem occurring with the Nuance
FFDM system can be reported.

2 RESPONSIBILITIES
2 RESPONSIBILITIES
2.1 Medical physicist

It is the responsibility of the medical physicist to carry out the Planmed FFDM System
Equipment Evaluations before clinical use commences after the equipment is first
installed, moved or significantly modified -see CFR 900.12(e)(10). The Planmed FFDM
System Equipment Evaluations must include all QC tests listed under both Quality Control
Activities for the Radiologic Technologist in accordance to 900.12(b) and 900.12(e) where
applicable.
The medical physicist must provide operating levels and control limits to the technologist
for the QC tests pertained to the radiologic technologist, where appropriate, e.g., SNR and
CNR Tests. Such operating levels and control limits must follow the guidelines of the
Planmed FFDM System QC Manual.
The medical physicist is also responsible to perform all QC tests listed under Quality
Control Tests for Medical Physicist at least annually and monitor the overall Quality
Assurance and Quality Control program for the Planmed FFDM System.
The medical physicist must review the results of the technologist’s QC tests at least
annually. The results of the overall Quality Assurance and Quality Control program must
be reviewed by the medical physicist with the responsible interpreting physician at least
annually.
2.2 Radiologic technologist

It is the responsibility of the radiologic technologist to carry out the QC tests listed in the
Quality Control Tests for the Radiologic Technologist at the specified frequency, review
the results and request timely corrective action as necessary. The technologist must
review the QC results with the medical physicist and supervising interpreting physician at
least annually and consult with the medical physicists any time there are questions about
the procedure or the results of these QC tests.
2.3 Interpreting physician

The supervising interpreting physician must review the results of the quality control
program with the medical physicist and radiologic technologist at least annually.
2.4 Facility
The facility must keep records of all Quality Control Tests and all applicable corrective
actions for at least 12 months since the last annual inspection which verified compliance
(until the next physicist’s and inspector’s visits), or until the test has been done two
additional times at the required frequency, whichever is longer. If the test results exceed
the control limits, corrective action must be take within time frames as specified for each
QC test in this QC Manual.

3 ACCESSING QUALITY CONTROL VIEW
3 ACCESSING QUALITY CONTROL VIEW

To enter the Planmed Nuance Manager 3 Quality Control window click the Quality button
on the Planmed Nuance Manager 3 main window.

4 SCHEDULED TESTS
4 SCHEDULED TESTS
The Quality Control window displays a list of image quality tests categorized according to
the recommended test frequency (daily, weekly, monthly, quarterly, half yearly or yearly).
For each test, there is also a check mark in the To Do or Passed column.
If the check mark is on the To Do column, the test should be performed during that day.
If the check mark is in the Passed column, the test has already been passed during the
testing period (day, week, month, or year quarter).
The system is ready for acquiring images when the detector temperature is shown at the
bottom of the screen.
The image files are located in the folder C:\Planmed\qc_images.

5 REQUIRED TEST PHANTOMS
5 REQUIRED TEST PHANTOMS

The following test phantoms are required to acquire test phantom images:
• Detector calibration phantom, 4 cm acrylic block (20003912)
• a set of 1 cm thick PMMA calibration phantoms (20003913)
• X-ray test pattern (line pair (lp) phantom) (20004682)
• RMI-156 phantom (07003001)
• 0.1 mm thick Aluminium foil (20005671)
6 ACQUIRING TEST PHANTOM IMAGE

1. Click the desired button to acquire an image for a required test.
NOTE
A test phantom image can be acquired only when the detector temperature is shown on the
status line at the bottom of the screen.
You need to acquire the test image only once for each test per day. The test image file is
saved into the test result file and if you perform the same test again during the same day,
the same image is loaded automatically.
2. The Planmed Nuance/Nuance Excel FFDM System will automatically set the exposure
parameters and settings.
3. Place the correct test phantom on the Bucky or on the collimator frame.
4. Take the exposure.
5. Click Done or Cancel.
6. Click OK to close the information pop-up window.
The image is saved automatically into the folder C:\Planmed\qc_images with a name of
the following form:
qc_DDMMYYYY_ttmmss<TestName>.tif,
where:
DD = day,
MM = month,
YYYY =year,
tt =hours,
mm = minutes,
ss = seconds
<TestName> = the name of the related test.

7 USING PHANTOM IMAGE TOOLS
7 USING PHANTOM IMAGE TOOLS

Zoom to fit tool
Clicking this tools automatically fits the image to the window. If the image is already fitted
to window clicking the tool will not modify the view.
Zoom in tool
Use this tool to zoom in the image. On the image click on the area where you would like to
zoom in.
Zoom out tool
Zooms out the image. Click on the area in the image you would like to zoom out.
Actual pixels tool
Shows the image in actual size. One image pixel is equal to one screen pixel.
Magnifier tool
Use the tool to take a closer look on a specific area in the image. You can move the
magnifier freely over the image with your mouse to take a closer look on a desired area of
interest.
Pan (move) tool
Use the tool to pan (move) the image, ROIs or the annotations by clicking the desired
object and dragging it with the left mouse button.
Contrast and brightness adjustment tool
Use the tool to increase or decrease brightness and contrast in the image.
Click on the tool and place your mouse over the image. Press down the mouse button
while moving the mouse.

8 SUMMARY OF QUALITY CONTROL (QC) TESTS

The following procedure should be followed when performing the QC tests.
For detailed instructions for performing each individual test refer to the subsequent
sections in this chapter.
8.1 QC test procedure

1. Open the Quality Control window in Planmed Nuance Manager 3 .
2. Review the QC test(s) that need to be performed.
3. Select the first QC test to be performed.
4. Prepare the Planmed FFDM System according to the requirements of each test and as
instructed on top of the screen.
5. Acquire the test phantom image.
NOTE
If you want to acquire the test image again, you need to RESET the test before acquiring a
new test image (see section 8.5.2 “Resetting test results ” on page 17).
6. Follow the instructions given on the screen to analyze the image.

7. Record the test results on the QC form.
8. Close the Results window by clicking OK.
9. The application will return to Quality Control main window.
10.Repeat the above procedure for all required QC tests.
NOTE
If a test result exceeds the acceptance limit, it is indicated with a check mark in the Passed
column of the Quality Control window.
The QC tests, evaluation execution, the minimum test frequencies, performance criteria
and corrective actions and performance criteria are listed in the following tables (sections
8.2 "Tests to be performed by Radiologic Technologist (RT)" on page 8 and 8.3 "Tests to
be performed by Medical Physicist" on page 12). A detailed description of each test and
instructions on how to perform them is provided in subsequent sections.
NOTE
A facility must retain Quality Control records as well as any applicable corrective action
measures verifying compliance for 12 months, or until the next annual Medical Physicist
and MQSA inspection has been completed.
Abbreviations used in the following tables are the following:

MEE = Mammography Equipment Evaluation
RT = Radiologic Technologist
MP = Medical Physicist

8.2 Tests to be performed by Radiologic Technologist (RT)

QC test name Minimum Action Performance Section in Corrective actions
test category criteria the manual
frequency
Monitor Cleaning Daily A Screen must be Section 9.1 Problem identified

Check free of dust, on page 18. and system
(AWS and RWS) fingerprints or repaired before
smudges. patient images
can be acquired.
Form 1.
Monitor Quality Daily B No obvious Section 9.2 Monitor must be

Test (TG-18 QC artifacts 0 to 5% on page 19. repaired before
test pattern) and 95% to used to interpret
(AWS and RWS) 100% equally patients or
visualized. phantom images.
Form 2.
Phantom Image Daily A Minimum Section 9.3 Problem identified

Quality Test for visualization: on page 20. and system
AWS 4 Fibers repaired before
3 Spec group patient images
can be acquired.
Form 4. 4 Masses
Phantom Image Daily A Minimum Section 9.3 Problem identified

Quality Test for visualization: on page 20. and system
RWS 4 Fibers repaired before
4 Spec group patient images
can be acquired.
Form 3. 4 Masses
Viewbox and Weekly B No visible marks Section 9.4 Viewbox or

viewing seen. on page 23. Viewing conditions
conditions must be repaired
before used to
interpret patients
-
or phantom
images.
Signal Weekly A Within 5% of the Section 9.5 Problem identified

Homogeneity average signal. on page 24. and system
Check repaired before
patient images
can be acquired.
Form 5.
Uncorrected Weekly C 10 Section 9.6 Radiologist

Defective on page 25. determines if
Elements (DEL) imaging continues
Analysis if the clinical
quality is
compromised the
Form 6.
problem must be
identified and
system repaired
before patient
images can be
acquired.


frequency
Printer QC Weekly B As defined by Section 9.7 The printer must

(if applicable) the printer on page 27. be repaired before
manufacturer. In used for printing
case no criteria patient or phantom
has been images.
defined National
Electrical
Manufacturer
Association
(NEMA) criteria
shall be used.
Large focus Weekly A Performance Section 11.3 If the message

calibration criteria: The on page 59. does not appear
message on the status bar,
Calibration the calibration has
Form 7.
completed failed for some
appears on the reason. Please
status line of the contact your local
calibration Planmed sales
window, and the representative.
current time is
displayed on the
time/force
display of the X-
ray unit.
Small focus Weekly* A Performance Section 11.4 If the message

calibration when If criteria: The on page 59. does not appear
performing magnificati message on the status bar,
magnification on exams Calibration the calibration has
exams with small completed failed for some
focus are appears on the reason. Please
performed status line of the contact your local
Form 8.
regularly calibration Planmed sales
calibration window, and the representative.
must be current time is
performed displayed on the
once a time/force
week. If no display of the X-
magnificati ray unit.
on exams
are
performed
no
calibration
for small
focus is
necessary.
Signal-to-Noise Monthly A > 50.0 Section 9.8 Problem identified

(SNR) Test on page 28. and system
repaired before
patient images
Form 9.
can be acquired.


frequency
Contrast-to- Monthly A > 2.0 Section 9.9 Problem identified

Noise Ratio on page 29. and system
(CNR) Test repaired before
patient images
can be acquired.
Form 10.
Visual Checklist Monthly or C Each of the Section 9.10 Items not passing
after any items listed in on page 31. the visual check
service or the Visual should be
Form 11.
maintenan Checklist should replaced or
and ce pass and receive corrected
Form 12. on the a immediately.
mammogr check mark. Items missing
aphic X- from the room
ray system should be
replaced
immediately.
Malfunctioning
equipment should
be reported to the
X-ray service
engineer for
repair or
replacement as
soon as possible.
Repeat Analysis Quarterly C The repeat rate Section 9.11 If the above
should not differ on page 32. criteria are not
more than 2% met, the source of
Form 13.
from the the problem shall
and previously be identified and
Form 14. determined corrective action
repeat rate. shall be taken
within thirty days
of the test date.


frequency
Defect Twice a C Planmed Section 9.12 If the above

Acceptance Test year Nuance Excel: on page 33. criteria are not
Defective single met, the source of
pixels < 5000 the problem shall
Dead rows and be identified and
Form 15. corrective action
columns < 10,
shall be taken
Correctable within thirty days
defect clusters < of the test date.
150,
Uncorrectable
defect clusters 0
Planmed
Nuance:
Defective single
pixels < 2500
Dead rows and
columns < 10,
Correctable
defect clusters <
100,
Uncorrectable
defect clusters 0
Compression Twice a A Automatic Section 9.13 Problem identified

Force Test (RT) year compression on page 34. and system
force must be repaired before
between 111 patient images
Form 17.
and 200 Newton can be acquired.
and must
maintain at least
for one minute.
System Fault When C Refer to Section 9.14 Defined by

Report needed Planmed on page 35. Planmed
Nuance/Nuance representative.
Excel User’s
Form 18.
Manual if Error
Code appears.

8.3 Tests to be performed by Medical Physicist

QC test name Minimum Action Performance Section in the Corrective actions
test criteria criteria manual
frequency
Ghosting Test Annually C Ghost factor: Section 10.1 If the above

±0.3 on page 36. criteria are not
met, the source of
Form 19.
the problem shall
be identified and
corrective action
shall be taken
within thirty days
of the test date.
Modulation Annually A > 0.5 at 5 lp/mm Section 10.2 Problem identified

Transfer on page 39. and system
Function repaired before
(MTF) Test patient images
can be acquired.
Form 20.
Linearity / Annually A R2 > 0.975 Section 10.3 Problem identified

Noise on page 40. and system
Linearity Test repaired before
patient images
can be acquired.
Form 21.
AEC Test Annually A Any of the signal Section 10.4 Problem identified
values must not on page 42. and system
deviate more than repaired before
Form 22.
10% average. patient images
can be acquired.
Compression Annually A Automatic Section 10.5 Problem identified

Force Test compression on page 44. and system
(MP) force must be repaired before
between 111 and patient images
200 Newton and can be acquired.
Form 23.
must maintain at
least for one
minute.
Mammograph Annually C The system shall Section 10.6 If the

y Unit perform on page 45. recommended
Assembly according to the performance
Evaluation 1999 ACR criteria are not
Mammography met, the source of
Quality Control the problem shall
Form 24.
Manual, be identified and
Mammographic corrective action
Unit Assembly shall be taken
Evaluation within thirty days
section. of the test date.


frequency
kVp accuracy Annually C The measured Section 10.7 If the test results
test kVp values shall on page 46. do not fall within
be within ± 2 kV the acceptable
of the set values. range described in
Form 25.
the performance
criteria, the source
of the problem
shall be identified
and corrective
action shall be
taken within thirty
days of the test
date.
Collimation Annually C There shall be no Section 10.8 If the

assessment white stripes on on page 47. recommended
test any of the edges. performance
The amount of criteria are not
balls visible at met, the source of
Form 26.
each edge is 2,5 the problem shall
balls minimum. be identified and
corrective action
shall be taken
within thirty days
of the test date.
Radiation Annually C Performance Section 10.9 If the

Output Rate criteria on page 49. recommended
The radiation performance
output for Filter 1 criteria are not
Form 27.
shall be within 32 met, the source of
to 52 µGy/mAs the problem shall
and for Filter 2 be identified and
within 44 to 64 corrective action
µGy/mAs. shall be taken
within thirty days
of the test date.


frequency
Beam Quality Annually C The Half-Value Section 10.10 If the

Assessment - Layer should be on page 50. recommended
HVL between 0.54mm performance
Measurement and 0.59mm for criteria are not
W(Tungsten)/Rh met, the source of
(Rhodium) and the problem shall
Form 28.
between 0.67 and be identified and
0.72 for corrective action
W/Ag (Silver). shall be taken
Mo(Molybdenum) within thirty days
/Mo and Mo/Rh of the test date.
must perform
according to the
ACR (American
College of
Radiology)
Mammography
Quality Control
Manual, Beam
Quality
Assessment
(Half-Value Layer
Measurement)
section.
Breast Annually A The coefficient of Section 10.11 If the

Entrance variation for both on page 53. reproducibility
Exposure and exposure and criteria are not
Average mAs shall not met, the source of
Glandular exceed 0.05. the problem shall
Dose The mean be identified and
glandular dose to corrective action
a standard, 4.5 shall be taken
Form 29.
cm compressed within thirty days
breast of 50-50 of the test date.
tissue If the average
composition must glandular dose
not exceed 3 criteria are not met
mGy (0.3 rad) per a qualified service
view at the engineer must
recommended correct the
techniques for problem before
imaging an using the system
average breast. for clinical imaging

8.4 Alternative QC standard

Federal regulations, 90.12(e), specify that any time quality control test results fall outside
of the action limits for systems with image receptor modalities other than screen-film, the
source of the problem shall be identified and corrective action shall be taken before any
further examinations are performed.
If any test results fall outside the action limits according to this Alternative Standard, three
different action categories apply:
Category A
If any of the following quality control tests that evaluate the performance of the image
acquisition components of the Planmed FFDM system produces results that fall outside
the action limits as specified by the manufacturer, the source of the problem shall be
identified and corrective action shall be taken before any further examinations are
performed.
Applicable QC tests:
1. Modulation Transfer Function (MTF) Test
2. Phantom Image Quality Test for AWS and RWS
3. Signal-to-Noise and Contrast-to-Noise Measurements
4. Compression Force Test
5. Monitor Cleaning Check for AWS and RWS
6. Linearity / Noise Linearity Test
7. Small and Large Focus Calibration
8. Signal Homogeneity Test
9. Automatic Exposure Control (AEC) Test
10.Breast Entrance Exposure and Average Glandular Dose
Category B
If any of the following quality control tests that evaluate the performance of a diagnostic
device used for mammographic image interpretation (i.e. DICOM printer, physician’s
review station) produces results that fall outside the action limits as specified by the
manufacturer, the source of the problem shall be identified and corrective action shall be
taken before that device can be used for mammographic image interpretation. Clinical
imaging can be continued and alternative approved diagnostic devices shall be used for
mammographic image interpretation.
1. Printer Quality Control
2. Viewbox and Viewing Conditions
3. Monitor Quality Test for AWS & RWS

Category C:
If any of the following quality control tests that evaluate the performance of components
other than the digital image receptor or the diagnostic devices used for mammography
image interpretation produces results that fall outside the action limits as specified by the
manufacturer, the source of the problem shall be identified and corrective action shall be
taken within thirty days of the test date. Clinical imaging and mammography image
interpretation can be continued during this period.
1. Mammographic Unit Assembly Evaluation
2. Uncorrected Defective Elements
3. Beam Quality Assessment - HVL Measurement
4. Visual Checklist
5. Repeat Analysis
6. Defect Acceptance Test
7. Ghosting Test
8. System Fault Report
9. kVp accuracy test
8.5 QC test results

All the test results are automatically saved after the tests are completed. The results are
saved into the application folder (by default C:\Planmed\qc_images).
The results are organized in daily result files named in format: YYYYMMDD, where
YYYY=Year, MM=Month, and DD=Day.
A check mark appears in the Passed column after the test has been satisfactorily
completed. In case a QC test fails, corrective actions must be taken immediately
according to the corrective action procedure which is described in each QC test section.
8.5.1 Viewing history of test results

The test reports should be checked periodically to note gradually deteriorating image
quality components before image quality reaches an unacceptable level.
1. To view the results select one or more tests from the list in the Planmed Nuance Manager
3 QC Tool window.
2. Click the View history button on the row of the test(s) you would like to view.
The test results for each selected test are displayed in graphic form. The scale of the X-
axis is 30 days backwards from the current day (that is, the current day is on the right
edge). The Y-axis displays the test values.

8.5.2 Resetting test results

In case a phantom test image has been already acquired during the same day and it is
necessary to erase it or acquire a new test phantom image for the QC test, the old test
result has to be erased first.
NOTE
Test results older than the current day cannot be reset.
1. To reset a test results select the particular test by clicking the button on the desired row in
the test list.
The following warning pop-up window appears.
2. Click Yes to confirm reset, or No to cancel the operation.

The old test result is erased, a new test image can be acquired, and the QC test can be
performed again (see section section 6 “ACQUIRING TEST PHANTOM IMAGE ” on page
5 for instructions).

9 QUALITY CONTROL TESTS FOR RADIOLOGIC TECHNOLOGIST
9 QUALITY CONTROL TESTS FOR RADIOLOGIC

TECHNOLOGIST
9.1 Monitor cleaning check
Objective
To ensure that the Acquisition Workstation (AWS) and Review Workstation (RWS)
monitors are clean and free from dust and fingerprints.
Test equipment
Lint-free cloth
Mammography equipment evaluation

Radiologic Technologist
Frequency
Daily: Also prior to clinical image acquisition or review is necessary.
Procedure
1. Inspect the monitor screen for dust, fingerprints or any other marks.
2. Clean the acquisition monitor screen surface with a lint free cloth
3. Repeat the procedure for all acquisition and review station monitors.
4. Record the results daily for each workstation monitor on the Monitor Cleaning Check form.
(Form 1.)
NOTE
Only use cleaning products which are recommended by the monitor manufacturer.
Unauthorized cleaning products may damage the anti-reflective coating on the screen.
Performance criteria
Acquisition and Review monitor surfaces must pass inspection check daily before
acquiring and reviewing images.
Corrective action
Inspect and clean again. If screen surface is not free of dust, fingerprints or any other
marks, contact the company providing service for the monitors.

9.2 Monitor Quality Control Test (TG-18QC)
Objective
To make sure that the Acquisition and High Resolution monitors are operating with
adequate brightness and contrast for that the images are displayed consistently.
Test equipment
TG-18QC test pattern which is available in the Planmed Nuance QC Tool.

Radiologic Technologist (RT)
Frequency
Daily
Procedure
1. Display the TG-18QC pattern image on the monitor.
Black area White area

2. Follow the directions given in the Instructions window.

3. Close the image window.
4. Click Done. The outcome appears in the Results Window on the screen.
5. Record the results on the Monitor Quality TG-18QC test forms provided. (Form 2. for AWS
and for RWS).
NOTE
Perform this procedure for all Acquisition and Review Workstation Monitors.
The TG-18QC pattern display must be without any obvious Artifacts. Examine the 0/
5%(black) and 95/100% (white) areas of the test pattern. Both of these contain a smaller
box of the discernible grey value. Check the following box in case the smaller box is
discernible from the outer area.
Corrective action
If the test does not meet the performance criteria, recalibrate the monitor and perform the
test again. If the test is still unsuccessful contact your local service representative
immediately. Problem source must be identified and corrected before any further images
can be reviewed or interpreted.
NOTE
Always ensure that the monitor manufacturers quality control procedures are followed and
that the monitors are calibrated.
9.3 Phantom image quality test for AWS and RWS
Objective
To ensure that the quality of the images acquired remain at consistently high level with
little or no significant variation over time.
Test equipment
RMI-156 (07003001)

Radiologic Technologist (RT)
Frequency
Daily. Additionally, this test should be performed whenever any change in image quality is
suspected or after any servicing of the system.

Procedure
1. Place the phantom on the Bucky surface making sure to align the chest wall edge of the
phantom with the chest wall edge of the receptor.
phantom_position002.eps
2. The unit will set the exposure values automatically. These settings apply for those tests in
which an exposure is required.
If necessary you can modify the exposure values by entering enter new values in the
corresponding fields.

4. Once the image appears on the monitor adjust the window level so that the objects are
visible.
5. Calculate the amount of Fibers, Speck groups and Masses visualized according to ACR
recommendations. At the Acquisition monitor, type the results in the space provided in the
instruction window.
6. Look for any visible artifacts and check the box in the instruction window if artifacts are
found.
7. Click Done. The outcome appears in the screen.

8. Record the results on the Phantom Image Quality Form provided (Form 4. (AWS) and
Form 3. (RWS).
Viewing conditions
Phantom images should be viewed and scored with optimal viewing conditions by the
same person.
For AWS: 4 Fibers, 3 Speck Groups and 4 Masses
For RWS: 4 Fibers, 4 Speck Groups and 4 Masses
Corrective Action
If a greater change in the number of test objects visualized is noted, then the most recent
phantom image should be compared to the original image to determine if the change is
real or if the viewing conditions may be deteriorating. If the recommended performance
criteria is not met, a second phantom image should be taken and evaluated. If the criteria
is still not met, patient exams must be suspended until the reason for failure is determined
and the failure is corrected.

9.4 Viewbox and viewing conditions
Objective
To assure that the viewbox and viewing conditions are optimized and their performance
stays constant over time
Test equipment
• Window cleaner
• Soft towels

Frequency
Weekly
Procedure
Perform this test in the same manner as described in the 1999 ACR Mammography
Quality Control Manual, Viewbox and Viewing Conditions section. Record the results in
the 1999 ACR Mammography Quality Control Manual’s record form Mammography
Quality Control Checklist, Daily and Weekly Tests. For data analysis and interpretation
follow the directions under the 1999 ACR Mammography Quality Control Manual, Viewbox
and Viewing Conditions section.
Performance criteria and corrective action

The procedure must be evaluated according to the 1999 ACR Mammography Quality
Control Manual, Viewbox and Viewing Conditions section.

9.5 Signal homogeneity check (homogeneity)
Objective
To verify that the signal is homogeneous over the entire imaging area.
Test equipment
Detector calibration phantom, 4cm acrylic block (20003912).

Frequency
Weekly
Procedure
1. Before starting remove the compression paddle and chin guard if attached.
2. Place the 4cm acrylic block under the collimator.
3. The unit will set the exposure values automatically. Please see section "Modifying
exposure values for tests" in Planmed Nuance Manager 3 Installation manual on how to
configure exposure values.
5. Click Done.
6. The outcome appears in the Results Window on the screen.

ROI 1 = Upper left

ROI 2 = Upper right
ROI 3 = Lower right
ROI 4 = Lower left
ROI 5 = Center
7. Record the highest “Deviation from Average” value on the Signal Homogeneity Check
form (Form 5.).
The signal in all Regions of Interests is within 5% of the average signal.
Corrective action
If the test does not meet performance criteria, check all exposure settings and the correct
test equipment is used and repeat the test.
If the test still fails perform the detector calibration and repeat the test. If the test fails
repeatedly contact your local service representative. Patient exams must be suspended
until the reason of the test failure is determined and corrected.
9.6 Uncorrected Defect Elements (DEL) analysis
Objective
To verify that the number of uncorrected defect elements (DEL) is acceptable.
Test equipment
Detector calibration phantom 4cm acrylic block (20003912).

Frequency
Weekly

Procedure
2. Place the 4 cm acrylic block under the collimator.
4. Take an exposure and wait for the image to appear.
5. The procedure application detects the defective DEL elements or pixels automatically and
displays the area where the defective pixels are located on the image window.
6. To accept the image click Done.
7. Record the results on the Uncorrected Defective Elements Analysis form (Form 6.).
8. To close the image Results window click OK.
10.
Corrective action
If the test results do not meet the performance criteria, check all technical factors and
repeat the procedure for a second time. If the test still fails, perform detector calibration
and repeat the test again. If the result still does not meet the performance criteria, consult
the interpreting physician to determine whether the image quality is compromised. The
image acquisition can be continued in case the quality is sufficient. Make a note on the
sheet that image acquisition was continued.
If the clinical image quality is compromised contact your local Service Representative. The
patient exams must be suspended until the reason of the test failure is determined and
corrected.
NOTE
In some cases individual defective pixels do not prevent one from continuing image
acquisition. The defective pixels may be located in an area that is not clinically significant.
The area where defective pixels are found is indicated on the test image. Continue image
acquisition only if instructed to do so by the interpreting physician.

9.7 Printer Quality Control
Objective
To verify the printing quality.
Test equipment
As defined by the printer manufacturer.

Frequency
Weekly
Procedure
As defined by the printer manufacturer. Please follow the manufacturer’s guidelines for QC
procedures.
As defined by the printer manufacturer. In case no criteria has been defined National
Electrical Manufacturer Association (NEMA) criteria shall be used. If the above criteria are
not met, the source of the problem shall be identified and corrective action shall be taken
within thirty days of the test date.
Corrective action
If the test does not meet performance criteria call your local service representative. The
problem source must be identified and corrected before any images can be printed.

9.8 Signal-to-Noise Ratio (SNR) test
Objective
To verify that the noise is sufficiently low in proportion to signal strength.
Test equipment
Detector calibration phantom 4 cm acrylic block (20003912)

Frequency
Monthly
Procedure
5. The ROIs are set automatically.
6. Click Done. The outcome appears in the Results window on the screen.
7. Record results on the Signal-to-Noise Ratio Test form (Form 9.).
Greater than 50.0
Corrective action
test equipment is used. If the test still fails to perform detector calibration and repeat test. If
the test still fails contact your local service representative. Patient exams must be
suspended until the reason of the test failure is determined and corrected.

9.9 Contrast-to-Noise Ratio (CNR) Test
Objective
To verify that sufficient contrast is achieved in each image that is acquired.
Test equipment
The RMI-156 mammography phantom

Frequency
Monthly
NOTE
The required frequency may vary locally. Always perform the test according to local
requirements.
Procedure
1. Place the phantom on the Bucky surface making sure to align the chest wall edge of the
phantom with the chest wall edge of the receptor.
2. Lower the compression paddle to touch the phantom, compressing to about 4.5 cm.
4. Take the exposure and wait for the image to appear.
5. Position the large (solid) Region Of Interest (ROI) to a flat area of the phantom image.

6. Position the small (dashed) ROI inside the largest and the most visible mass area of the
phantom image.
7. Click Done.
The Results window opens.
8. Record the results on the Contrast-To-Noise Ratio form (Form 10.).
2.0 or Greater
Corrective action
If the test does not meet performance criteria, verify all the exposure settings and make
sure that the correct test equipment is used. If the test still fails perform the detector
calibration repeat the test. If the test continually fails contact your local service
representative. Patient exams must be discontinued until the reason for the test failure is
determined and corrected.

9.10 Planmed Nuance & Nuance Excel FFDM system visual checklist
(A and B)
Objective
To assure that mammographic x-ray system indicator lights, displays, mechanical locks
and detents are working properly and that the mechanical rigidity and stability of the
equipment is optimum.
Test equipment
Visual checklist record forms Form 11. and Form 12.

Frequency
Monthly or after any service or maintenance on the mammographic X-ray system.
Procedure
1. Review all of the items listed on the visual checklist and indicate their status.
2. Rotate the C-arm as you would for patient imaging.
3. Fill in the date and initials where indicated in the checklist.
Some of the items on the visual checklist are operator convenience features. Many of the
items, however, are essential for patient safety and high-quality diagnostic images. It may
be necessary to add additional items to the list that are specific to no particular equipment
or procedure. These should be included on the checklist and in each evaluation.
Corrective action
Each of the items listed in the Visual Checklist should pass the visual check and receive a
check mark. Items not passing the visual check should be replaced or corrected
immediately.
Items missing from the room should be replaced immediately. Malfunctioning equipment
should be reported to the X-ray service engineer for repair or replacement as soon as
possible.

9.11 Repeat analysis
Objective
To determine the number and reason for repeated exposures.
Test equipment
Repeat analysis Forms (Form 13. and Form 14.)

Frequency
Quarterly
Procedure
1. Each time the operator must make a repeat exposure, it must be recorded. When an
image is rejected a screen will appear which displays the reason for the repeat.
2. Click on the reason for the repeat exposure. (Example: Patient motion, positioning, etc.).
3. Record the cause for a repeated exposure on the Repeat Analysis form.
4. Tabulate the total number of repeated exposures from all 8 categories listed on the Repeat
Analysis form for the quarterly testing period.
5. Determine the total number of acquired images taken during the quarterly testing period:
• The overall reject rate is determined by dividing the total number of rejects (total of
categories 1 – 8) by the total number of exposures acquired during the analysis
period, and multiply by 100%.
• The percentage of repeats in each “Category” is determined by dividing the repeats in
each category by the total number of repeated exposures (categories 1 – 8) and
multiply by 100%.
The established initial reject rate should be considered to be a baseline for subsequent
quarterly repeat analysis. The overall repeat rate ideally is 2% or less, but a rate of 5% or
less may be accepted.
Subsequent overall reject rates should be ± 2% of the total number of images acquired
during the analysis period as referenced to the baseline rate. For example, if the baseline
reject rate is 4%, a range of 2% to 6% of the total number of images acquired is allowed
before corrective action is required.
Corrective action
If the total repeat or reject rate changes from the previously determined rate by more than
2% of the total images included in the analysis, the reason for the change must be
determined. Any corrective actions should be recorded on the Repeat Analysis form. The
results of the corrective actions shall be assessed. If the above criteria are not met, the
source of the problem shall be identified and corrective action shall be taken within thirty
days of the test date.

9.12 Defect acceptance test
Objective
To verify that the number of defects does not exceed the acceptance limits caused during
the calibration procedure.
Test equipment
None

Frequency
Twice a year
Procedure
1. Press the test button in the Planmed Nuance QC Tool window. The software will
automatically detect the amount defective pixels and load the defect map.
2. Click Done.
3. The results are displayed in the Results window after the test.
The values presented in this image are for Planmed Nuance FFDM system
4. Record the test result on Defect Acceptance test form (Form 15. for Planmed Nuance
FFDM system, Form 16. for Planmed Nuance Excel FFDM system).

Planmed Nuance Excel FFDM system Planmed Nuance FFDM system
Defective single pixels < 5000 Defective single pixels < 2500
Dead rows and columns < 10 Dead rows and columns < 10
Correctable defect clusters < 150 Correctable defect clusters < 100
Uncorrectable defect clusters 0 Uncorrectable defect clusters 0
Corrective action
Clean the detector and Bucky surfaces as well as the calibration phantom and re-perform
the calibration. If the test does not meet performance criteria contact your local service
representative. Patient exams must be suspended until the reason of the test failure is
determined and corrected.
9.13 Compression force test for Radiologic Technologist (RT)
Objective
To assure that the Planmed Nuance/Nuance Excel FFDM System provides adequate
compression in the power drive and manual mode and that the equipment does not allow
too much compression to be applied.
Test equipment
Calibration gauge (20002069)

Frequency
Initially after the equipment is installed and then semi-annually thereafter, or whenever
reduced compression is suspected.
Procedure
Automatic compression mode
1. Position the calibration gauge so the read-out display is easily visible when covered by the
compression paddle.
2. Step on the downward foot switch to activate the compression drive. Allow it to operate
until it stops automatically.
3. Make a note of the time.
4. Record these values in the Initial Reading column on the Compression Force Test form
(Form 17.).
5. Wait for one minute.
6. Note the amount of compression force seen in the calibration gauge readout and on the
LED (Light-Emitting Diode) readout of the compression force.

7. Record these values in the Readings after one minute column on the Compression Force
Test form (Form 17.).
8. Release the compression paddle.
The maximum compression force for the automatic compression must be between 111
and 200 Newton (approx. 11 and 20 kg) and must maintain at least for one minute. The
indicated compression force should be within 20 Newton (approx. 2 kg) of the measured
value.
Corrective action
If the test results do not fall within the acceptable range mentioned in the performance
criteria, the problem must be identified and corrected before any further examinations can
be performed.
9.14 System fault report
Objective
To report any malfunction in Planmed Nuance/Nuance Excel FFDM System
Test equipment
Form 18.

Frequency
When needed
Procedure
This form can be used to report any faults or problems occurring with the Planmed
Nuance/Nuance Excel FFDM System. Describe the fault as detailed as possible and write
down the error code or message.
Refer to Planmed Help and Error Codes manual (20006722).
Corrective action
Defined by Planmed representative.

10 QUALITY CONTROL TESTS FOR MEDICAL PHYSICIST
10 QUALITY CONTROL TESTS FOR MEDICAL

PHYSICIST
10.1 Ghosting test
Objective
To verify that there is no residue of a previous image on the present image.
Test equipment
4 x 1 cm PMMA calibration phantoms (20003913) and 0.1 mm thick Aluminum foil
(20005671)

Medical Physicist
Frequency
Annually
Procedure
1. Place the 4 phantoms on the Bucky so that only the left half of the Bucky is covered.
2. Wait for the message Ready to appear on the status line. The unit will set the exposure
values automatically. Please see section "Modifying exposure values for tests" in Planmed
Nuance Manager 3 Installation manual on how to configure exposure values.
3. Start the QC test from the Nuance QC Tool main window and select ghosting test before
you take an exposure.
4. Take the exposure. Another exposure can be taken when 60 seconds time-out has
expired and the counter is at zero.
5. Place the phantoms on the Bucky so that both halves of the Bucky is covered and place
the Aluminum foil centrally on the phantoms.
6. Take the exposure when the message Ready appears on the Status line.

7. Position the red (dotted) ROI to the area on the ghostless side of the center line outside
the aluminum object (see the figure below).
8. Position the green (dashed) ROI inside the aluminum area on the ghostless side.

9. Position the white (solid line) ROI inside the aluminum area on the ghost side.
Aluminium foil phantom
Ghostless side of the image
Ghost side of the image

(left half of the Bucky)
10.Accept the image by clicking Done.

11.The results are displayed in the Results window after the test is completed.
NOTE
If the ghost factor is less than -0.3 or more than +0.3, check that the phantoms and the
Aluminum foil are correctly placed on the Bucky and that the ROIs are correctly positioned
on the image.
12.Record the test result on Ghosting test form (Form 19.).
Click OK to close the Results dialog.
Ghost factor: ±0.3
Corrective action
If the test does not meet performance criteria, check the exposure settings and that the
correct test equipment is used. If the test still fails perform the detector calibration and
repeat test. If the test continues to fail contact your local service representative. If the
above criteria are not met, the source of the problem shall be identified and corrective
action shall be taken within thirty days of the test date.

10.2 Modulation Transfer Function test (MTF)
Objective
To verify that the spatial resolution and image sharpness is satisfactory.
Test equipment
4 x 1 cm PMMA calibration phantoms (20003913) and lp/mm phantom (20004682)

Medical Physicist
Frequency
Annually
Procedure
2. Place the X-ray test pattern at a small angle on top of the phantoms on the Bucky.
4. Take the exposure and wait for the image to appear on the screen.
5. Position the black ROI inside the white area of the phantom.
6. Position the grey ROI on the black area of the phantom.
7. Position the dotted ROI around the 5 line pair area of the phantom.
8. Accept the image by clicking Done.

9. The outcome appears on the Results Window.
10.Record the results on the MTF test form (Form 20.).

MTF above 0.5 at 5 lp/mm
Corrective action
If the test does not meet performance criteria, verify the exposure settings and make sure
the correct test equipment is used. If the test still fails perform the detector calibration and
repeat test. If the test continues to fail contact your local service representative. Patient
exams must be discontinued until the reason for the test failure is determined and
corrected.
10.3 Linearity / noise linearity test
Objective
To verify the linearity of the signal.
Test equipment
Detector calibration phantom, 4 cm acrylic block (20003912)

Medical Physicist
Frequency
Annually
Procedure
2. Take exposures (6 for Molybdenum (Mo) tube, 6 for Tungsten (W) tube) in kV setting used
for 4 cm compressed breast.
The exposure values are:
10.0, 20.0, 40.0, 80.0, 100.0, 140.0 mAs.
Between the exposures allow up to 30 seconds for the mammography to become ready to
take an exposure.
3. After taking the exposures the image will appear on the screen.
4. Accept the image by clicking Done.

5. The outcome and the Linearity plot graphs appear in the Test Results window.
6. Record the test result from the Result window on the Linearity test form (Form 21.).
R2 > 0.975
Corrective action
test equipment is used. If the test still fails perform detector calibration and repeat test. If
the test still fails contact your local service representative. Patient exams must be
suspended until the reason of the test failure is determined and corrected.

10.4 Automatic Exposure Control (AEC) tests
Objective
To ensure that the AEC interrupts the exposure after pre-pulse if no or very little radiation
reaches the detector and that the AEC keeps the average signal level constant
independent of the object thickness.
Test equipment
AEC test form (Form 22.)

Medical Physicist
Frequency
Annually
Procedure
10.4.1 Accessing Diagnostics mode

1. To enter the Planmed Nuance Manager 3 Diagnostic mode window click the Quality
button on the Planmed Nuance Manager 3 window and select Diagnostics tab.
2. Enable acquisition in Diagnostics mode by clicking the Enable Acquisition button.
10.4.2 Interrupted exposure test

1. Select AAEC (Advanced Automatic Exposure Control) mode from the X-ray unit control
panel.
2. Place a steel or lead plate on the Bucky to cover all the AEC area.
3. Place a 4 cm acrylic phantom plate on the Bucky and compress the phantom.
4. Take an exposure.
5. The exposure will stop after the prepulse with ErA0 indication.
6. Remove the steel or lead plate from the Bucky.

10.4.3 AEC tracking and reproducibility

1. In order to enable the AEC signal level display, turn the CNR display on by clicking the
CNR button. The signal values (circled) of the ROIs will then show on top of the image.
2. Select the AAEC mode on the X-ray unit control panel.

3. Set the CNR/Dose parameter to +4 (note the original value) to set the AEC for constant,
non-thickness dependent signal level. See section “CNR / dose setting - W target” in
Planmed Nuance/Nuance Excel Technical Manual for details.
4. Enter the test acquisition mode and turn on the CNR display.
5. Place a 30 mm acrylic phantom plate on the Bucky and compress the plate.
6. Verify that the Ag (silver) -filter is on. If not turn on the filter 1 on the X-ray unit control
panel.
7. Take five exposures and note the average signal values at the top of the image.
8. Repeat the above procedure using 40, 50, 60 and 70 mm phantoms.
9. Calculate the average of the twenty five signal values.
10.Set the CNR/Dose parameter back to its original value.
11.When closing the diagnostic mode, click Disable Acquisition button to return back to other
views.

Any of the signal values must not deviate more than 10% from the average.
Corrective action
If the above criteria are not met, the source of the problem shall be identified and
corrective action shall be taken within thirty days of the test date.
10.5 Compression force test for Medical Physicist (MP)
Objective
To assure that the Planmed Nuance/Nuance Excel FFDM System provides adequate
compression in the power drive and manual mode and that the equipment does not allow
too much compression to be applied.
Test equipment
Calibration gauge (20002069)

Medical Physicist
Frequency
Initially after the equipment is installed and then semi-annually thereafter, or whenever
reduced compression is suspected.
Procedure
Automatic compression mode
1. Position the calibration gauge so the read-out display is easily visible when covered by the
compression paddle.
2. Step on the downward foot switch to activate the compression drive. Allow it to operate
until it stops automatically.
3. Make a note of the time.
4. Record these values in the Initial Reading column on the Compression Force Test form
(Form 23.).
5. Wait for one minute.
6. Note the amount of compression force seen in the calibration gauge readout and on the
LED (Light-Emitting Diode) readout of the compression force.
7. Record these values in the Readings after one minute column on the Compression Force
Test form (Form 23.).
8. Release the compression paddle.
The maximum compression force for the automatic compression must be between 111
and 200 Newton (approx. 11 and 20 kg) and must maintain at least for one minute. The
indicated compression force should be within 20 Newton (approx. 2 kg) of the measured
value.

Corrective action
If the test results do not fall within the acceptable range mentioned in the performance
criteria, the problem must be identified and corrected before any further examinations can
be performed.
10.6 Mammography unit assembly evaluation
Objective
To ensure good and safe working conditions of all interlocks, mechanical detents and
safety switches and to ensure mechanical integrity of the x-ray tube and digital image
receptor assembly.

Medical Physicist
Frequency
Annually
Procedure
Perform this test in the same manner as described in the 1999 ACR Mammography
Quality Control Manual, Mammographic Unit Assembly Evaluation section. Use
Mammography Unit Assembly Evaluation form (Form 24.) to record the results.
The system shall perform according to the 1999 ACR Mammography Quality Control
Manual, Mammographic Unit Assembly Evaluation section.
Corrective action
If the recommended performance criteria are not met, the source of the problem shall be
identified and corrective action shall be taken within thirty days of the test date.

10.7 kVp accuracy test (kV)
Objective
To verify that the anode voltage follows accurately enough the set values and does not
fluctuate from one exposure to another.
Test equipment
• non-invasive kVp meterfor example, Unfors Model Xi
NOTE
The kVp meter must be calibrated for mammographic X-ray beam energies and anode/filter
material combinations in use.

Medical Physicist
Frequency
Initially after the equipment is installed and then annually thereafter.
Procedure
1. Place the kVp meter on the breast support table so that it is centered and 5cm in from the
chest wall edge, wire pointing backwards
2. Set the exposure parameters: manual mode, 28 kV, 50 mAs, Filter 3 (Rh), large focus.
3. Make sure that the Automatic kV selection and the AEC modes are not selected.
4. Take five exposures and read the kVp values from the display of the kVp meter.
5. Use the calibration coefficients to determine the actual kVp and record them onto Form 25.
6. Repeat the procedure using 32 kV and 35 kV.
The measured kVp values shall be within ± 2 kV of the set values.
Corrective action
If the test results do not fall within the acceptable range described in the performance
criteria, the source of the problem shall be identified and corrective action shall be taken
within thirty days of the test date.

10.8 Collimation assessment test
Objective
To verify that the X-Ray beam is properly aligned with the detector active area.
Test equipment
Planmed X-Ray field alignment Tool (Planmed Code 20004787)

Medical Physicist
Frequency
Procedure
1. Slide the X-Ray field alignment tool (Planmed code 20004787) onto the Bucky until the
step on the tool front edge comes in contact with the Bucky edge.
2. Align the alignment tool sideways to the center of the Bucky (visual check is sufficient).
3. Start Nuance Manager and select Test Acquisition tab.
4. Set exposure values: Manual mode, 30 kV, 140 mAs, large focus.
5. Protect yourself against radiation by standing behind a radiation shield.
6. Press and hold down the exposure button. The X-Ray field can be seen on the X-Ray field
alignment tool.
7. Check that the exposed area extends beyond the edge line (marked in green) of the X-
Ray field alignment tool but NOT beyond the first dashed line (in red).
X-RAY FIELD PLANMED X-RAY FIELD ALIGNMENT TOOL

24x30
18x24 X-RAY FIELD
17x24 X-RAY FIELD

x-ray_areas2.eps
BUCKY FRONT EDGE

8. Check that the X-Ray field is sideways symmetrical in relation to the alignment tool. If not,
adjust the tool sideways to make it symmetrical.
9. Check on both sides that the exposed area extends beyond the side edge lines but nor
beyond the 1st dashed lines.
10.Observe the image on the AWS screen (Figure NN+1) and record the amount of iron balls
visible at each edge to the Form 26.
There shall be no white stripes on any of the edges. The amount of balls visible at each
edge is 2,5 balls minimum.
Corrective action

10.9 Radiation output rate test
Objective
To verify that the X-Ray tube radiation output has not fallen too low to generate excessive
long exposure times.
Test equipment
• non-invasive radiation meter, for example, Unfors Model Xi
NOTE
The radiation meter must be calibrated for mammographic X-ray beam energies and
anode/filter material combinations in use.

Medical Physicist
Frequency
Procedure
1. Place the radiation meter sensor 4.5 cm above the Bucky, 5 cm in from the chest wall
edge and laterally centered.
2. Remove the compression paddle.
3. Set the exposure parameters: manual mode, large focus, 30 kV, 100 mAs and Filter 1.
4. Take an exposure.
5. Make sure that the radiation meter sensor is fully exposed.
6. Use the calibration coefficients to determine the actual dose and record it onto Form 27.
7. Divide the reading by the mAs used, so that as a result you will get μGy/mAs.
8. Select Filter 2 and repeat the above from 4.
The radiation output for Filter 1 shall be within 32 to 52 µGy/mAs and for Filter 2 within 44
to 64 µGy/mAs.
Corrective action

10.10 Beam quality assessment - Half-Value Layer (HVL) measurement
Objective
To assure that the half-value layer (HVL) of the x-ray beam is adequate to minimize
patient dose without being too excessive to compromise image contrast.

Medical Physicist
Frequency
Annually
Required equipment
• Calibrated mammographic ionization meter and electrometer as per the 1999 ACR
Mammography Quality Control Manual Beam Quality Assessment section.
• Five to eight aluminium 1145 or 1100 alloy sheets of 0.1 mm thickness as per the
ACR Mammography Quality Control Manual Beam Quality Assessment section.
Procedure
1. In the Planmed Nuance Manager 3 application go to the Local Patient Registry window
and click the Create Patient button to create a new patient.

2. The New Patient window appears.
3. Enter the Patient ID, Last Name and First Name in the corresponding fields. Other
information is optional. When finished click OK.
4. From the Planmed FFDM unit control panel switch on the Manual mode by clicking the
AAEC/AEC/MAN button. Select 30 kV.
5. Perform this test in the same manner as for screen-film mammography systems described
in the 1999 ACR Mammography Quality Control Manual, Beam Quality Assessment (Half-
Value Layer Measurement) section.
6. Record the results to the (Form 28.).

7. To return to the AEC/AAEC mode press the button again.
Lmam_keyboard_outline.eps
The Half-Value Layer should be between 0.54mm and 0.59mm for W(Tungsten)/Rh
(Rhodium) and between 0.67 and 0.72 for W/Ag(Silver). Mo(Molybdenum)/Mo and Mo/Rh
must perform according to the ACR Mammography Quality Control Manual, Beam Quality
Assessment (Half-Value Layer Measurement) section.
Corrective action

10.11 Breast entrance exposure and Average Glandular Dose (AGD)

measurement
Objective
To measure the typical entrance exposure and calculate the corresponding glandular dose
for an average patient with approximately 4.5 cm compressed breast thickness of 50%
adipose, 50% glandular tissue composition.

Medical Physicist
Frequency
Annually
Required equipment
• 24 x 30 cm compression paddle
• Calibrated mammographic ionization meter and electrometer as per the 1999 ACR
Mammography Quality Control Manual Breast entrance exposure, AEC
Reproducibility, Average glandular dose, and Radiation Output Rate section.
• ACR mammographic accreditation phantom that approximates 4.5 cm compressed
breast of 50-50 tissue composition (i.e., RMI 156 by Radiation Measurement, Inc.; 18-
220 by Nuclear Associates).
Procedure
1. In the Planmed Nuance Manager 3 application go to the Local Patient Registry window
and click the Create Patient button to create a new patient.

2. The New Patient window appears.
3. Enter the Patient ID, Last Name and First Name in the corresponding fields. Other
information is optional. When finished click OK.
4. Install the 24 x 30 cm compression paddle in the compression device.
5. Center the ACR phantom laterally on the image receptor and position it so the chest wall
edge of the phantom is aligned with the chest wall edge of the image receptor.
6. Position the ionization chamber in the x-ray field beside the mammographic phantom,
centered 4.0 cm in from the chest-wall edge of the image receptor and with the center of
the chamber level with the top surface of the phantom as shown in the figure below.
Assure that the entire chamber is exposed.¨
4 cm
Calibrated
level
4,5 cm
QC_Excel.eps

7. Secure the chamber in position and do not change the position of the chamber during the
following measurements.
8. Lower the compression device so that the compression paddle sits right above the
phantom and chamber trying to achieve a compression thickness as close to 4.5 cm as
possible. If it is not possible to achieve compression thickness of 4.5 cm, use the
Alternative Equivalent AEC Method.
9. Take four exposures in the selected AEC mode and record the measurements in the
Breast entrance exposure and average glandular dose record form (Form 29.).
Data analysis and interpretation

1. Record the HVL (previously measured in Beam Quality Assessment Test) on the record
form assuring that it matches the kVp used to take exposures.
2. Compute the mean exposure and mAs values and corresponding standard deviations for
the four acquired exposures. Record the results in the record form.
3. If necessary, correct the average exposure with the chamber’s appropriate energy
correction factor and with an inverse-square correction factor to obtain the exposure at
skin entrance level.
4. Use the appropriate glandular dose table from the 1999 ACR Mammography Quality
Control Manual Breast entrance exposure and Average glandular dose section to
determine the exposure to glandular dose conversion factor for the kVp and target-filter
combination used and measured HVL.
For target/filter combinations not covered by the MQSA publication another source of
information shall be used, for example “Further factors for the estimation of mean
glandular dose using the United Kingdom, European and IAEA breast dosimetry protocols.
- Physics in medicine and biology, June 23, 2009. Table 3.
5. Multiply conversion factor obtained in step 4 by the average entrance exposure value
computed in steps 2 and 3 paying attention to units. The product represents the mean
glandular dose for that specific energy, breast composition, and compressed thickness
and is an approximation of the actual patient dose.
NOTE
The average glandular dose computed using the 1999 ACR Mammography Quality Control
Manual, Breast Entrance Exposure, AEC Reproducibility, Average Glandular Dose, and
Radiation Output Rate section only applies to a 4.5 compressed breast of 50-50 tissue
composition.
The coefficient of variation for both exposure and mAs shall not exceed 0.05.
The mean glandular dose to a standard, 4.5 cm compressed breast of 50-50 tissue
composition must not exceed 3 mGy (0.3 rad) per view at the recommended techniques
for imaging an average breast.
Corrective action
If the reproducibility criteria are not met, the source of the problem shall be identified and
corrective action shall be taken within thirty days of the test date.
If the average glandular dose criteria are not mer a qualified service engineer must correct
the problem before using the system for clinical imaging.

11 DETECTOR CALIBRATION
In the Calibration tab you can:
• Select calibration mode between Contact mode and Magnification mode.
• Freely set a delay time for calibration start up
• Check the calibration status
• Delete temporary calibration files
To start calibration click this button.
11.1 Required configuration

The following configuration is required to perform the calibration:
NOTE
See also section on page 58.
• Planmed Nuance / Nuance Excel FFDM System

• Acquisition Workstation (AWS) with Planmed Nuance Manager 3 software version 3.0
or later.
• Nuance PC interface adapter (20004086)
• Remote control cable (07827752)
• Radiation protection screen

11.2 Preparing the system for calibration
WARNING
Protect yourself from radiation during calibration. The X-ray unit takes automatic
exposures during calibration.
1. Connect the Mammotool connection cable between the COM1 port of the Acquisition
Workstation (AWS) and the Planmed Nuance PC interface adapter.
2. Connect the Remote control cable to the Planmed Nuance / Nuance Excel FFDM System
and to the Planmed Nuance PC interface adapter.
3. Turn the key on the interface adapter to autocal mode. The interface adapter is integrated
into the Nuance Acquisition Station. The key is located on the front panel.
Planmed
DigiPad
Manager_wiring2.eps
Planmed
DigiPad
kg
cm
1 RWS 2 Private network

3 Planmed Radiation Shield 4 Medical grade isolation
5 Planmed Nuance / Nuance Excel X-ray unit 6 Planmed Nuance Acquire Station (NAS)
7 Acquisition Workstation (AWS) 8 Ethernet cable
9 Planet cable

NOTE
Make sure the key at the front bottom of Planmed Nuance Acquire Station is turned to
AUTO CAL position.
NOTE
The key in the Interface adapter box needs to be in autocal position (in case Planmed
Nuance Acquire Station is not connected).
4. Remove the compression paddle and chin guard from the Planmed Nuance / Nuance
Excel FFDM System.
5. Attach the Bucky to the Planmed Nuance / Nuance Excel FFDM System.
6. Attach the detector calibration phantom (20003912) to the collimator frame of the Planmed
Nuance /Nuance Excel FFDM system starting from the direction indicated by the arrow.
NOTE
The illustrated setup is for large focus calibration. If you are performing small focus
calibration magnification platform is required.
7. Select the view from the mammography system.
NOTE
Images cannot be taken if the view hasn’t been selected. If no view has been selected the
most recent view will be automatically copied to the new image.

11.3 Calibration modes

A separate calibration is required for large and small focus. Large focus is used in contact
mode (screening). Small focus is used in magnification mode imaging.
NOTE
The names and the duration time may differ from the default values. The calibrations are
configured during the installation of the Planmed Nuance/Nuance Excel FFDM System
based on local requirements.
Table 10: Description of calibration types
Calibration type Estimated duration of calibration When to perform
Large focus 35 min Once a week
Small focus 35 min Once a week*
NOTE
*If magnification exams with small focus are performed regularly calibration must be
performed once a week. If no magnification exams are performed no calibration for small
focus is necessary.
11.4 Performing calibration

The digital detector of Planmed Nuance/Nuance Excel FFDM System is calibrated by
using the calibration tool on the Planmed Nuance Manager 3 main window. Ensure
efficient air conditioning in the examination room. It is recommended to keep the room
temperature between +20°C to +25°C at all times.
The maximum deviation should not exceed from calibration temperature ± 3°C. Ensure
that detector temperature is stabilized between +30°C and +33°C (+86°F to +91.4°F)
before starting the calibration.
After the system has been switched on wait at least 35 minutes before starting the
calibration.
To perform calibration:
1. Click Quality on top of the Planmed Nuance Manager 3 main window and then click the
Calibration tab.
The calibration main window lists the available calibrations.

2. Select the desired calibration by clicking one of the Mode / Focus buttons.
3. Check that the Detector temperature is displayed on the bottom of the main window.
If necessary it is possible to delay the starting of calibration by writing the appropriate time
in the Delay field.
4. Click Start Calibration.

5. A Calibration window opens giving detailed information about the set-up of the Planmed
Nuance / Nuance Excel mammography X-ray unit and the calibration.
6. Click OK to start calibration.
NOTE
After having started the calibration hang the Calibration Running -sign on the calibration
room door.
During calibration the required number of exposures are taken automatically,

approximately one in every 2 minutes.
7. Wait until the calibration is completed.
The message “Calibration completed” appears on the status line of the main window.
8. Turn the key located at the front bottom of Planmed Nuance Acquire Station back to
normal Operation mode.
NOTE
It is recommended that Defect Acceptance test is performed after the calibration.

11.5 Cancelling calibration

If it is necessary to cancel calibration before it has been completed, follow these
instructions.
To cancel the calibration:
1. Click Cancel Calibration while the calibration is ongoing.
A Calibration pop-up window appears.
2. Click Yes to confirm.
NOTE
The actual cancelling of the calibration will take place only after the ongoing calibration
phase is completed. This may take up to 3 minutes. Do not operate the system before the
canceling has been completed.
When the calibration has been cancelled, the message “Calibration canceled” appears on
the status line of the calibration window.
11.6 After calibration

The Planmed Nuance / Nuance Excel FFDM System is ready for use immediately after the
calibration has been successfully completed. The message “Calibration completed”
appears on the status line of the calibration window, and the current time is displayed on
the time/force display of the X-ray unit.
If the text message “Calibration completed” does not appear on the status bar, the
calibration has failed for some reason. Please contact your local Planmed sales
representative.
NOTE
To return back to imaging mode turn the key at the front bottom of Planmed Nuance
Acquire Station into Normal position.

12 ABBREVIATIONS AND ACRONYMS

Here are the definitions for the abbreviations and acronyms used in this user’s manual.
Abbreviation Definition
ACR American College of Radiology
AEC Automatic Exposure Control
AGD Average Glandular Dose
AWS Acquisition Workstation
CNR Contrast-to-Noise Ratio
DEL Defective Element
DICOM Digital Imaging and Communications in Medicine
EUREF European Reference Organisation for Quality Assured Breast

Screening and Diagnostic Services
FFDM Full Field Digital Mammography
HIS/RIS/MIS Hospital Information System / Radiology Information System /

Mammography Information System
HV High Voltage
HVL Half-Value Layer
LED Light-Emitting Diode
lp/mm line pair per millimeter
LUT Look Up Evaluator
mA Milliamperes. The generator setting for the amount of electrical

current applied to the X-ray tube
MEE Mammography Equipment Evaluation
MG Mammography
mm Millimeter
MP Medical Physicist
MQSA Mammography Quality Standards Act
MTF Modulation Transfer Function
NEMA National Electrical Manufacturers Association
PC Personal Computer
PIG Panel Image Grabber
QC Quality Control

ROI Region of Interest
RT Radiologic Technologist
RWS Review Workstation
SNR Signal-to-Noise Ratio

13 VARIOUS SYSTEM CONFIGURATION GUIDELINES
13 VARIOUS SYSTEM CONFIGURATION

GUIDELINES
To perform MTF test without 4cm PMMA, please use the following exposure values:
• with Mo/Mo X-ray tube: 28kV 16mAs
• with W/Rh X-ray tube: 31kV 16mAs.
Limits are MTF @ 2lp/mm > 60% and MTF @ 4lp/mm > 40%.
To perform Homogeneity test with only one ROI area,

• for Nuance please use 1500 x 2300 area
• for Nuance Excel use 2300 x 3100.
The area is observed from the centre.

Appendix A: QC TEST FORMS

Form 1. Monitor Cleaning Check (AWS and RWS)
Facility: Room:
Year: Unit:
Month: Site #:
Mammography Equipment Evaluation: Radiologic Technologist
Frequency: Daily
Date 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Clean
AWS
monitor
Clean
RWS
monitors
Remarks: Initials = Clean or Passed
Check: The monitor screens of the AWS and RWS to verify that they are free from dust, finger prints, and other marks. If you observe any dust, finger prints, or other marks, clean
the monitor screens using a cloth or cleaning tissue. Clean the monitors according to the monitor manufacturer’s instructions.
Form 2. Monitor Quality Test / TG-18 QC (AWS and RWS) Test
Facility: Room:
Year: Unit:
Month: Site#:
Frequency: Daily
TG-18QC pattern check, left monitor
Date 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Check
TG-18QC pattern check, right monitor
Date 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Check
Check: Is the 5% square visible within the 0% square, and is the 95% square visible within the 100% square?
Remarks: Initials = Passed

Form 3. Phantom Image Quality for AWS Test
Facility: Room:
Year: Unit:
Month: Site#:
Phantom ID#:
Frequency: Daily
Date 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Speck
Fibers
Mass
Artifacts
Initials
Remarks: Note, Initials = Passed, Phantom ID = XXXXXXWWYYYY, where XXXXX=Phantom ID, WW=Week, YYYY=Year
Performance criteria:
4 Fibers, 4 Speck Groups and 4 Masses
Procedure:
RMI/ACR phantom. The unit will set the exposure values automatically.
Form 4. Phantom Image Quality Test for RWS
Facility: Room:
Year: Unit:
Month: Site#:
Phantom ID#:
Frequency: Daily
Date 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Speck
Fibers
Mass
kV/mAs
Artifacts
Initials
Remarks: Note, Initials = Passed, Phantom ID = XXXXXXWWYYYY, where XXXXX = Phantom ID, WW = Week, YYYY = Year
4 Fibers, 3 Speck Groups and 4 Masses
Procedure:
RMI/ACR phantom. The unit will set the exposure values automatically.
Form 5. Signal Homogeneity Check
Facility: Room:
Year: Unit:
Month: Site#:
Frequency: Weekly
Week 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
kV / mAs
Initials
Week 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52
kV / mAs
Initials

D = Maximum deviation
Performance criteria: Signal in all ROIs within 5% of the average signal
Procedure: Detector calibration phantom, 4 cm acrylic block (20003912).

Form 6. Uncorrected Defective Elements (DEL) Analysis
Facility: Room:
Year: Unit:
Month: Site#:
Frequency: Weekly
Week 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
DEL
Initials
Week 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52
DEL
Initials

DEL = Number of uncorrected defective elements (pixels)
Performance criteria: 10
If the test results do not meet the performance criteria, check all technical factors and repeat the procedure for a second time. If the test still fails, perform the short calibration
(refer to section) and repeat the test again. If the result still does not meet the performance criteria, consult the interpreting physician to determine whether image acquisition can
be continued. Make a note on Form 6. that image acquisition was continued.
Procedure:
Detector calibration phantom, 4 cm acrylic block (20003912). The unit will set the exposure values automatically.
Form 7. Large focus calibration
Facility: Room:
Year: Unit:
Month: Site#:
Frequency: Weekly
Week 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Initials
Week 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52
Initials
The message Calibration completed appears on the status line of the calibration window, and the current time is displayed on the time/force display of the X-ray unit.
If the message does not appear on the status bar, the calibration sequence has failed for some reason. Please contact your local Planmed sales representative
Form 8. Small focus calibration when performing magnification exams
Facility: Room:
Year: Unit:
Month: Site#:
Phantom ID#:
Frequency: Monthly.
NOTE: If magnification exams with small focus are performed regularly calibration must be performed once a week.
If no magnification exams are performed no calibration for small focus is necessary.
Month 01 02 03 04 05 06 07 08 09 10 11 12
Initials
Week 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Initials
Week 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52
Initials
Form 9. Signal-to-Noise Ratio (SNR) Test
Facility: Room:
Year: Unit:
Site#:
Phantom ID:
Frequency: Monthly
Month 01 02 03 04 05 06 07 08 09 10 11 12
Mean
Std
SNR
Initials
Mean = Mean Signal in ROI, Std = Std. Deviation in ROI, SNR = Signal-to -Noise Ratio
Performance criteria: > 50.0
Procedure:
Detector calibration phantom, 4 cm acrylic block (20003912). The unit will set exposure values automatically.
Form 10. Contrast-to-Noise Ratio (CNR) Test
Facility: Room:
Year: Unit:
Site#:
Phantom ID:
Frequency: Monthly
Month 01 02 03 04 05 06 07 08 09 10 11 12
Std
CNR
Initials
Remarks: Initials = Passed,

Phantom patient ID = XXXXXXWWYYYY, where XXXXX = Phantom ID, WW = Week, YYYY = Year
B = Mean signal in Background ROI, M = Mean signal in Contrast ROI, Std = Std. Deviation in Background ROI, CNR = Contrast to Noise Ratio
Performance criteria: CNR > 2.0
Procedure: RMI/ACR phantom, The unit.

Form 11. Planmed Nuance & Nuance Excel FFDM System Visual Checklist (A)
Facility: Room: Unit: Site#:

Year:
Frequency: Monthly
Visual and audible inspection: PASS FAIL
The X-ray indicator on the display panel and behind the lead shield is illuminated for the duration of the exposure
During the exposure an audible alarm is activated
All control panel indicator lights are working
Patient or operator is not exposed to any sharp or rough surfaces or edges
Paddles, face-shield and other accessories are free of cracks and sharp edges
Elevation:
With the C-arm at 0°, lower the unit to its lowest position. Verify that it moves smoothly with no unusual noise.
With the C-arm at 0°, rise the unit to its highest position. Verify that it moves smoothly with no unusual noise.
Rotation:
Rotate the C-arm clockwise until it stops. Verify that the C-arm moves smoothly and that the maximum angle of rotation of +180° is shown on the display
panel.
Rotate the C-arm counter clockwise until it stops. Verify that the C-arm moves smoothly and the maximum angle of rotation of -135° is shown on the control
panel display.
Verify that the fine tuning rotation switches on either side of tube head and c-arm are active
Compression:
The compression force and thickness indicator is easily visible at the display
The compression paddle drives up and down smoothly when using either footswitch
The auto release feature works as designed
Remarks: Initials = Pass/Fail

Form 12. Planmed Nuance & Nuance Excel FFDM System Visual Checklist (B)
Emergency: PASS FAIL
The emergency paddle release works as designed if there is a power failure
Press the emergency “STOP” button. Verify that no motorized movements are possible.
Pull up the emergency “STOP” button. Verify that all motions are now active.
Procedure: Review all of the items listed on the visual checklist and indicate their status. Rotate the C-arm as you would for patient imaging.Fill in the date and initials where
indicated in the checklist.
Performance criteria: Each of the items listed in the Visual Checklist should pass and receive a check mark. Items not passing the visual check should be replaced or corrected
immediately. Items missing from the room should be replaced immediately. Malfunctioning equipment should be reported to the X-ray service engineer for repair or replacement as
soon as possible.
Form 13. Repeat Analysis record form A
Facility: Room:
Year: Unit:
Site#:
Frequency: When needed (follow-up four times a year) NOTE: Keep this sheet at AWS at all times.
Study Cause Exposures Date Initials Study Cause Exposures Date Initials Study Cause Exposures Date Initials
number number number
Cause identifiers:
1 = Patient positioning, 2 = Patient motion,
3 = Improper detector exposure, 4 = Incorrect patient ID,
5 = X-ray unit failure, 6 = Software failure,
7 = Blank image, 8 = Other, please describe:
Form 14. Repeat Analysis record form B
Facility: Room:
Year: Unit:
Dates From: To: Site#:
Frequency: Quarterly NOTE: Keep this sheet at AWS at all times.
Cause Description Number of repeated exposures Number of all exposures % of repeated exposures by category =
identifier (Number of repeated exposures / Total number of
repeated exposures) x 100%
1 Patient positioning
2 Patient motion
3 Improper detector exposure
4 Incorrect patient ID
5 X-ray unit failure
6 Software failure
7 Blank image
8 Other, please describe
Total of repeated exposures: Total of all exposures: Repeat rate = Total of repeated exposures /
Total of all exposures) x 100%
Performance criteria: The repeat rate should be < 5%. If exceeded, the sources of the repeated exposures must be investigated and corrective actions taken before any further
examinations are performed. If the primary cause of excessive repeated exposures is an system or detector problem, contact your service engineer. If the primary cause of
excessive repeated exposures is a patient positioning or other motion problem, corrective actions such as additional training on patient positioning and compression must be
taken. If the total repeat rate changes from the rate determined for the previous analysis period by more than 2%, the reasons for the change must be determined. Any
corrective actions taken must be recorded and an assessment must be made of their effectiveness.
Form 15. Defect Acceptance Test for Planmed Nuance
Facility: Room:
Year: Unit:
Site#:
Frequency: Twice a year
Year Year Year Year
Date Date Date Date
Defective single pixels < 2500
Dead rows and columns < 10
Correctable defect clusters < 100
Uncorrectable defect clusters 0
Result
Initials
Uncorrectable defect cluster 0
Procedure:
Press the test button in the Planmed Nuance QC Tool window.The software will automatically detect the amount defective pixels and load the defect map. Close the white image
window. The results are displayed in the Results window after the test.
Form 16. Defect Acceptance Test for Planmed Nuance Excel
Facility: Room:
Year: Unit:
Site#:
Frequency: Twice a year
Year Year Year Year
Date Date Date Date
Uncorrectable defect clusters 0
Result
Initials
Uncorrectable defect cluster 0
Procedure:
Press the test button in the Planmed Nuance QC Tool window.The software will automatically detect the amount defective pixels and load the defect map. Close the white image
window. The results are displayed in the Results window after the test.
Form 17. Compression Force Test for Radiologic Technologist (RT)
Facility: Room:
Year:
Unit:
Site#:
Mammography Equipment Evaluation: Radiologic Technologist Frequency: Twice a year
Year Year Year
Date Date Date
Initial readings Readings after one Initial readings Readings after one Initial readings Readings after one
minute minute minute
Calibration LED Calibration LED Calibration LED Calibration LED Calibration LED Calibration LED
gauge display gauge read- display gauge read- display gauge read- display gauge read- display gauge read- display
read-out out out out out out
Result
Initials
Remarks:
Initials =
Passed
Check: The amount of the recorded compression force in the automatic compression is at least equal to the amount of the achievable compression force.
The maximum compression force for the automatic compression must be between 111 and 200 Newton (approx.11 and 20 kg) and must be maintained at least for one minute.
The indicated compression force should be within 20 Newton (approx. about 2 kg) of the measured value.
Form 18. System Fault Report
Facility: Room:
Year: Unit:
Site#:
Frequency: When needed
Date Description Date Corrective actions (Planmed representative)
This form can be used to report any faults or problems occurring with the Planmed Nuance FFDM system. Describe the fault as detailed as possible and write down the error
code or message.
Form 19. Ghosting Test
Facility: Room:
Unit:
Site#:
Mammography Equipment Evaluation: Medical Physicist
Frequency: Annually
Year: Year: Year: Year:
Date: Date: Date: Date:
Mean signal in ROI 1
Ghost factor
Initials
Action limit: Ghost factor ±0.3
Procedure:
4x1 cm PMMA calibration phantoms and a Aluminum foil (thickness 0.1 mm). The unit will set the exposure values automatically.
Form 20. Modulation Transfer Function (MTF) Test
Facility: Room:
Year: Unit:
Site#:
Frequency: Annually
Year quarter Q1 Q2 Q3 Q4
Date
Vertical line pair phantom check 5 lp/mm
Initials
Performance criteria: MTF > 0.5 at 5 lp/mm
Procedure:
X-ray test pattern (line pair phantom). The unit will set the exposure values automatically.
Form 21. Linearity / Noise Linearity Test
Facility: Room:
Unit:
Site#:
Frequency: Annually
Year: Year: Year: Year:
Date: Date: Date: Date:
R2
Initials
Performance criteria: R2 >0.975
Procedure:
4x1 cm PMMA calibration phantoms or Detector calibration phantom, 4 cm acrylic block (20003912), kV setting normally used in 4 cm compressed breast and 10.0, 20.0, 40.0,
80.0, 100.0, and140.0 mAs.
Form 22. Automatic Exposure Control (AEC) Test
Facility: Year: Room Unit Site
Frequency: Annually
Passed Failed
AEC security cut-off
Warning shown
Thickness of PMMA mm kV Signal 1 Signal 2 Signal 3 Signal 4 Signal 5
30
40
50
60
70
Average
Maximum deviation Performance Criteria Passed Failed
<± 10%
Performance criteria: Any of the signal values must not deviate more than 10% average.
Corrective action: Problem identified and system repaired before patient images can be acquired.
Form 23. Compression Force Test for Medical Physicist (MP)
Facility Room:
Year Unit:
Site#:
Frequency: Annually
Year Year Year
Date Date Date
Initial readings Readings after one Initial readings Readings after one Initial readings Readings after one
minute minute minute
Calibration LED Calibration LED Calibration LED Calibration LED Calibration LED Calibration LED
gauge read- display gauge read- display gauge display gauge read- display gauge display gauge display
out out read-out out read-out read-out
Result
Initials
Check: The amount of the recorded compression force in the automatic compression is at least equal to the amount of the achievable compression force.
The maximum compression force for the automatic compression must be between 111 and 200 Newton (approx.11 and 20 kg) and must maintained at least for one minute. The
indicated compression force should be within 20 Newton (approx. about 2 kg) of the measured value.
Form 24. Mammography Unit Assembly Evaluation
Facility: Year: Room: Unit: Site#:
Date: Phantom ID:
Frequency: Annually
Stability Movements Locks Image Sharp Technique Radiation Indicator Compression Compression
Receptor Edges Charts Shielding Lights Release Emergency
Override Release
PASS
FAIL
Remarks: Initials =
Passed/Failed
Procedure: Perform this test in the same manner as described in the 1999 ACR Mammography Quality Control Manual, Mammographic Unit Assembly Evaluation
section.
Use Mammography Equipment Evaluation form to record the results.
Performance criteria: The system shall perform according to the 1999 ACR Mammography Quality Control Manual, Mammographic Unit Assembly Evaluation section.
Corrective action: If the recommended performance criteria are not met, the source of the problem shall be identified and corrective action shall be taken within thirty days
of the test date.
Form 25. kVp accuracy test
Date:
Frequency: Annually
kV First Second Third Fourth Fifth

exposure exposure exposure exposure exposure
28 kV
32 kV
35 kV
Remarks: Passed Failed

Initials = Passed
Procedure: Place the kVp meter on the breast support table so that it is centered and 5cm in from the chest wall edge, wire pointing backwards. Set the exposure parameters:
manual mode, 28 kV, 50 mAs, Filter 3 (Rh), large focus. Make sure that the Automatic kV selection and the AEC modes are not selected. Take five exposures and read the kVp
values from the display of the kVp meter. Use the calibration coefficients to determine the actual kVp and record them onto the form. Repeat the procedure using 32 kV and 35 kV.
Performance criteria: The measured values shall be within ± 2 kV of the set values.
Corrective action: If the test results do not fall within the acceptable range described in the performance criteria, the source of the problem shall be identified and corrective action
shall be taken within thirty days of the test date.
Form 26. Collimation assessment test
Date:
Frequency: Annually
Number of balls visible White edge visible
Front
Back
Left
Right
Remarks: Passed Failed

Initials = Passed
Procedure:
Slide the X-Ray field alignment tool (Planmed code 20004787) onto the Bucky until the step on the tool front edge comes in contact with the Bucky edge. Align the alignment tool
sideways to the center of the Bucky (visual check is sufficient).Start Nuance Manager and select Test Acquisition tab.Set exposure values: Manual mode, 30 kV, 140 mAs, large
focus. Protect yourself against radiation by standing behind a radiation shield. Press and hold down the exposure button. The X-Ray field can be seen on the X-Ray field alignment
tool. Check that the exposed area extends beyond the front edge line of the X-Ray field alignment tool but not beyond the 1st dashed line. Check that the X-Ray field is sideways
symmetrical in relation to the alignment tool. If not, adjust the tool sideways to make it symmetrical. Check on both sides that the exposed area extends beyond the side edge lines
but nor beyond the 1st dashed lines. Observe the image on the AWS screen (Figure NN+1) and record the amount of iron balls visible at each edge to this form.
There shall be no white stripes on any of the edges. The amount of balls visible at each edge is 2,5 balls minimum.
Corrective action:
If the recommended performance criteria are not met, the source of the problem shall be identified and corrective action shall be taken within thirty days of the test date.
Form 27. Radiation output rate test
Date:
Frequency: Annually
Dose µGy / mAs
30 kV 100 mAs Filter 1
30 kV 100 mAs Filter 2
Procedure:
Place the radiation meter sensor 4.5 cm above the Bucky, 5 cm in from the chest wall edge and laterally centered. Remove the compression paddle. Set the exposure
parameters: manual mode, large focus, 30 kV, 100 mAs and Filter 1. Take an exposure. Make sure that the radiation meter sensor is fully exposed. Use the calibration
coefficients to determine the actual dose and record it onto the form. Divide the reading by the mAs used, so that as a result you will get μGy/mAs. Select Filter 2 and repeat the
above procedure.
The radiation output for Filter 1 shall be within 32 to 52 µGy/mAs and for Filter 2 within 44 to 64 µGy/mAs.
Corrective action:
Form 28. Beam Quality Assessment - HVL measurement

Date
Frequency: Annually
FILTER MATERIAL HVL
Procedure:
In the Planmed Nuance Manager 3 application go to the Local Patient Registry window and click the Create Patient button to create a new patient. The New Patient window
appears. Enter the Patient ID, Last Name and First Name in the corresponding fields. Other information is optional. When finished click OK. From the Planmed FFDM unit
control panel switch on the Manual mode by clicking the AAEC/AEC/MAN button. Select 30 kV. To return to the AEC/AAEC mode press the button again.
The Half-Value Layer should be between 0.54mm and 0.59 mm for W (Tungsten)/ Rh (Rhodium) and between 0.67 and 0.72 for W/Ag (Silver).
Molybdenum (Mo)/Mo and Mo/Rh must perform according to the ACR (American College of Radiology) Mammography Quality Control Manual, Beam Quality Assessment
(Half-Value Layer Measurement) section.
Corrective action:
Form 29. Breast Entrance Exposure Measurement and Average Glandular Dose (AGD)
Date: Phantom ID:
Frequency: Annually
HVL
EXP1 EXP2 EXP3 EXP4 AVERAGE
mGy
mAs
AGD
PASS / FAIL
Procedure: Perform this test in the same manner as described in the 1999 ACR Mammography Quality Control Manual, Mammographic Unit Assembly Evaluation section.
Use Mammography Equipment Evaluation form to record the results.
The coefficient of variation for both exposure and mAs shall not exceed 0.05.
The mean glandular dose to a standard, 4.5 cm compressed breast of 50-50 tissue composition must not exceed 3 mGy (0.3 rad) per view at the recommended techniques
for imaging an average breast.
Corrective action:
If the reproducibility criteria are not met, the source of the problem shall be identified and corrective action shall be taken within thirty days of the test date.
If the average glandular dose criteria are not met a qualified service engineer must correct the problem before using the system for clinical imaging.
Planmed Oy | Sorvaajankatu 7 | 00880 Helsinki | Finland
tel. +358 20 7795 300 | fax +358 20 7795 664 | sales@planmed.com | www.planmed.com

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Planmed Nuance & Nuance Excel FFDM systems

Quality Control (QC) Manual

Quality Control manual Planmed Nuance & Planmed Nuance Excel 1

11 DETECTOR CALIBRATION ............................................................................................... 56

Appendix A: QC TEST FORMS

2 Planmed Nuance & Planmed Nuance Excel Quality Control manual

Quality Control manual Planmed Nuance & Planmed Nuance Excel 3

Planmeca pursues a policy of continual product development. Although every effort is

4 Planmed Nuance & Planmed Nuance Excel Quality Control manual

Quality Control manual Planmed Nuance & Planmed Nuance Excel 1

2.1 Medical physicist

2.2 Radiologic technologist

2.3 Interpreting physician

2 Planmed Nuance & Planmed Nuance Excel Quality Control manual

3 ACCESSING QUALITY CONTROL VIEW

Quality Control manual Planmed Nuance & Planmed Nuance Excel 3

4 Planmed Nuance & Planmed Nuance Excel Quality Control manual

5 REQUIRED TEST PHANTOMS

6 ACQUIRING TEST PHANTOM IMAGE

Quality Control manual Planmed Nuance & Planmed Nuance Excel 5

7 USING PHANTOM IMAGE TOOLS

6 Planmed Nuance & Planmed Nuance Excel Quality Control manual

8 SUMMARY OF QUALITY CONTROL (QC) TESTS

8.1 QC test procedure

6. Follow the instructions given on the screen to analyze the image.

Abbreviations used in the following tables are the following:

Quality Control manual Planmed Nuance & Planmed Nuance Excel 7

8.2 Tests to be performed by Radiologic Technologist (RT)

Monitor Cleaning Daily A Screen must be Section 9.1 Problem identified

Monitor Quality Daily B No obvious Section 9.2 Monitor must be

Phantom Image Daily A Minimum Section 9.3 Problem identified

Phantom Image Daily A Minimum Section 9.3 Problem identified

Viewbox and Weekly B No visible marks Section 9.4 Viewbox or

Signal Weekly A Within 5% of the Section 9.5 Problem identified

Uncorrected Weekly C 10 Section 9.6 Radiologist

8 Planmed Nuance & Planmed Nuance Excel Quality Control manual

QC test name Minimum Action Performance Section in Corrective actions

Printer QC Weekly B As defined by Section 9.7 The printer must

Large focus Weekly A Performance Section 11.3 If the message

Small focus Weekly* A Performance Section 11.4 If the message

Signal-to-Noise Monthly A > 50.0 Section 9.8 Problem identified

Quality Control manual Planmed Nuance & Planmed Nuance Excel 9

QC test name Minimum Action Performance Section in Corrective actions

Contrast-to- Monthly A > 2.0 Section 9.9 Problem identified

10 Planmed Nuance & Planmed Nuance Excel Quality Control manual

QC test name Minimum Action Performance Section in Corrective actions

Defect Twice a C Planmed Section 9.12 If the above

Compression Twice a A Automatic Section 9.13 Problem identified

System Fault When C Refer to Section 9.14 Defined by

Quality Control manual Planmed Nuance & Planmed Nuance Excel 11

8.3 Tests to be performed by Medical Physicist

Ghosting Test Annually C Ghost factor: Section 10.1 If the above

Modulation Annually A > 0.5 at 5 lp/mm Section 10.2 Problem identified

Linearity / Annually A R2 > 0.975 Section 10.3 Problem identified

Compression Annually A Automatic Section 10.5 Problem identified

Mammograph Annually C The system shall Section 10.6 If the