DICOM DRYVIEW6850

7/26/2019 DICOM DRYVIEW6850

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DRYVIEW 6850 Laser Imager

Quality Control Manual for Mammography

Publ ished by:

Carestream Health, Inc.Rochester, NY 14608

This document is based upon the following template:

NEMA Standards Publication XR 23-2006

Quality Control Manual Template for Manufacturers ofHardcopy Output Devices

Labeled for Final Interpretation in Full-field Digital Mammography

Published by:

National Electrical Manufacturers Association1300 North 17th Street, Suite 1752

Rosslyn, Virginia 22209

www.nema.org


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NOTICE AND DISCLAIMERfrom the NEMA Template

The information in this publication was considered technically sound by the consensus of personsengaged in the development and approval of the document at the time it was developed.

Consensus does not necessarily mean that there is unanimous agreement among every personparticipating in the development of this document.

The National Electrical Manufacturers Association (NEMA) standards and guideline publications, ofwhich the document contained herein is one, are developed through a voluntary consensusstandards development process. This process brings together volunteers and/or seeks out theviews of persons who have an interest in the topic covered by this publication. While NEMAadministers the process and establishes rules to promote fairness in the development ofconsensus, it does not write the document and it does not independently test, evaluate, or verifythe accuracy or completeness of any information or the soundness of any judgments contained inits standards and guideline publications.

NEMA disclaims liability for any personal injury, property, or other damages of any naturewhatsoever, whether special, indirect, consequential, or compensatory, directly or indirectlyresulting from the publication, use of, application, or reliance on this document. NEMA disclaimsand makes no guaranty or warranty, express or implied, as to the accuracy or completeness of anyinformation published herein, and disclaims and makes no warranty that the information in thisdocument will fulfill any of your particular purposes or needs. NEMA does not undertake toguarantee the performance of any individual manufacturer or sellers products or services by virtueof this standard or guide.

In publishing and making this document available, NEMA is not undertaking to render professionalor other services for or on behalf of any person or entity, nor is NEMA undertaking to perform anyduty owed by any person or entity to someone else. Anyone using this document should rely onhis or her own independent judgment or, as appropriate, seek the advice of a competentprofessional in determining the exercise of reasonable care in any given circumstances.Information and other standards on the topic covered by this publication may be available from

other sources, which the user may wish to consult for additional views or information not coveredby this publication.

NEMA has no power, nor does it undertake to police or enforce compliance with the contents ofthis document. NEMA does not certify, test, or inspect products, designs, or installations for safetyor health purposes. Any certification or other statement of compliance with any health or safetyrelated information in this document shall not be attributable to NEMA and is solely theresponsibility of the certifier or maker of the statement.


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DRYVIEW 6850 Laser Imager, Quality Control Manual for Mammography Page i

Carestream Health, Inc. May 11, 20108H5323 Rev. A

CONTENTS

Foreword.iii

Section 1OVERVIEW OF THE QUALITY CONTROL MANUAL...............................................................1

1.1

Scope of the Document .............................................................................................................1

1.2 Regulatory Considerations ........................................................................................................ 1

1.3 Structure of the Document......................................................................................................... 1

1.4 Elements of a QC/Constancy Test ............................................................................................2

1.5

The Need for Calibration ........................................................................................................... 2

1.6

Test Summary ........................................................................................................................... 2

Section 2QC TESTS FOR THE RADIOLOGIC TECHNOLOGIST............................................................ 4

2.1 Density Constancy Test.............................................................................................................4

2.1.1

Objective....................................................................................................................... 4

2.1.2

Establishing Operating Levels...................................................................................... 4

2.1.3

Performing the QC/Constancy Test ...........................................................................102.2 Fixer Retention Test (N/A).......................................................................................................11

2.3 Low-contrast Visibility Test...................................................................................................... 11

2.3.1 Objective..................................................................................................................... 112.3.2 Establishing Operating Levels.................................................................................... 112.3.3 Performing the QC/Constancy Test ...........................................................................13

2.4

Spatial Resolution Test............................................................................................................13


2.5 (Darkroom) Fog Test (N/A)......................................................................................................15

2.6

Artifact Test.............................................................................................................................. 15

2.6.1

Objective..................................................................................................................... 15

2.6.2 Establishing Operating Levels.................................................................................... 152.6.3

Performing the QC/Constancy Test ...........................................................................17

Section 3 QC TESTS FOR THE MEDICAL PHYSICIST........................................................................... 18

3.1

Grayscale Response Function Test ........................................................................................ 18


3.2 Geometry Test......................................................................................................................... 20

3.2.1 Objective..................................................................................................................... 203.2.2

Establishing Operating Levels.................................................................................... 21

3.2.3


3.3

Phantom Image Quality Test................................................................................................... 23

3.3.1

Objective..................................................................................................................... 23

3.3.2

Establishing Operating Levels.................................................................................... 23

3.3.3


Section 4 GUIDANCE................................................................................................................................25

4.1 QC Test Images ...................................................................................................................... 25

4.2 Density Constancy Test (2.1) .................................................................................................. 26

4.3

Fixer Retention Test (2.2) (N/A) .............................................................................................. 26


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DRYVIEW 6850 Laser Imager, Quality Control Manual for Mammography Page ii


4.4

Low-Contrast Visibility Test (2.3).............................................................................................26

4.5

Spatial Resolution Test (2.4) ................................................................................................... 26

4.6 (Darkroom) Fog Test (2.5) (N/A) .............................................................................................26

4.7 Artifact Test (2.6) .....................................................................................................................26

4.8

Grayscale Response Function Test (3.1)................................................................................ 27

4.9 Geometry Test (3.2) ................................................................................................................ 27

4.10 Phantom Image Quality Test (3.3) ..........................................................................................27

4.11 Mammography Equipment Evaluation (MEE) .........................................................................27


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DRYVIEW 6850 Laser Imager, Quality Control Manual for Mammography Page iii


Foreword

Quality Control (QC) is important in any imaging system, but it is especially important in mammography.When full-field digital mammography (FFDM) systems were first introduced, all components (e.g., image

receptor, acquisition workstation, diagnostic workstation/monitor, hardcopy output device) were providedor qualified for use by the image receptor manufacturer (IRM). The IRM also provided a comprehensiveQC plan to enable mammography facilities to meet their responsibilities under the Mammography QualityStandards Act

1 (MQSA). Subsequently, FDA approved manufacturers other than the IRMs to market

hardcopy and softcopy displays for FFDM images. This has made system QC more difficult since, underMQSA regulations, the facility is required to follow a quality assurance program substantially the same asthe one recommended by the IRM. However, the QC plan of the IRM may not adequately address theneeds of components developed by other manufacturers.

The increasing heterogeneity of FFDM systems has created a desire to delegate the responsibility fordeveloping QC procedures for the individual system components to the manufacturers of thosecomponents. This manual provides such procedures for the 6850 Laser Imager, a hardcopy outputdevice that receives images from an FFDM system, and reproduces them on film for final interpretation.

The procedures in this manual cover two main performance dimensions: grayscale fidelity andspatial/geometric fidelity. The grayscale dimension addresses the ability of the hardcopy device toachieve and maintain constancy in its tone reproduction characteristics relative to established operatinglevels. The spatial dimension measures the ability of the device to achieve and maintain the appropriatelevel of spatial resolution, geometric constancy, and freedom from artifacts.

1The United States Mammography Quality Standards Act of 1992, as amended by the Mammography

Quality Standards Reauthorization Acts of 1998 and 2004 (MQSRA).


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DRYVIEW 6850 Laser Imager, Quality Control Manual for Mammography Page iv


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DRYVIEW 6850 Laser Imager, Quality Control Manual for Mammography Page 1


Section 1OVERVIEW OF THE QUALITY CONTROL MANUAL

1.1 SCOPE OF THE DOCUMENT

This document defines the minimum set of quality control (QC) tests to be applied to the DRYVIEW 6850Laser Imaging System, a hardcopy output device that receives images from an FFDM system, andreproduces them on film for final interpretation. It should be considered as one element of themammography facilitys Quality Assurance Plan.

The tests in this manual generally focus on device constancy, that is, the ability of the hardcopy device tomaintain its expected imaging performance over time. They do not address system quality control, forexample, the ability of the various system components (image receptor, acquisition workstation,diagnostic workstations, hardcopy output device) to communicate properly with each other, and to usethe communicated information correctly. Such system QC activities are assumed to have occurred

during initial system installation, initial system acceptance, or as part of a Mammography EquipmentEvaluation (see 4.11).

1.2 REGULATORY CONSIDERATIONS

Facilities subject to the provisions of the Mammography Quality Standards Act (MQSA) that use imagereceptors other than screen/film must follow a quality assurance program substantially the same asthe one recommended by the image receptor manufacturer (21 CFR 900.12(e)(6)). It remains theresponsibility of the facility to determine whether or not this QC plan is substantially the same as the onerecommended by the image receptor manufacturer for the FFDM system(s) in use at that facility.

1.3 STRUCTURE OF THE DOCUMENT

This QC manual is categorized according to whether the test must be performed by a:

Radiologic technologist (Section 2), or a

Medical physicist (Section 3).

Within each category, QC tests are arranged according to test frequency, starting with daily/weekly tests,and moving on to quarterly, semi-annual, and annual tests. Each QC test is further split into two parts:

Establishing operating levelsThe operating levels are the values against which subsequent, periodic QC test results for thedevice must be compared. While they change relatively infrequently, certain events can triggerthe (re)establishment of operating levels. Examples of such events are significant changes tohardware or software, changes in output media (e.g., film) type, or media batch/lot number, andanything that would require the performance of a Mammography Equipment Evaluation. Media

type is defined on the labeling provided by its manufacturer, and relates to properties such asbase, tint, tone, density range, or other differentiating characteristics.

Performing the QC/Constancy testThis test determines if, and by how much, the hardcopy output device is deviating from thecurrently valid operating levels.

Finally, a Guidance section (Section 4) is included that summarizes Carestream Health, Inc.s currentthinking on performing the various QC tests.


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1.4 ELEMENTS OF A QC/CONSTANCY TEST

Each QC/Constancy test contains a set of standard elements consistent with the requirements and intentof the MQSA:

Objective of the test Frequency of testing

Equipment required for the test (beyond the calibrated hardcopy output device)

Procedures and conditions to perform the test

Action limits, or tolerances, for the test results

Use of test results (see 21 CFR 900.12(e)(8))If the test results are outside the action limits, the necessary user actions are specified. For thetests in this manual, this action is generally to stop further printing of mammograms with thefailing device until the source of the problem has been identified and corrected. For only onetest (2.2, Fixer Retention, which is not applicable to the 6850 Laser Imager), does MQSAcurrently allow the corrective action to be taken within 30 days of the test.

Equipment lists, procedures, action limits, and actions based on state-of-the-art devices or current

practice are provided for each test.

1.5 THE NEED FOR CALIBRATION

All test procedures in this manual assume a properly calibrated hardcopy output device. The calibrationprocedure for the 6850 Laser Imager is described in the online Help or the Users Guide for the 6850Laser Imager. The user shall ensure that the hardcopy device is calibrated any time operating levels areestablished, and any time QC/Constancy testing is done.

Several tests also require a calibrated densitometer.

A commercial, external densitometer must be used for these tests. Its calibration shallconform to the frequency and procedure specified by the densitometer manufacturer. Further,the user shall ensure that the densitometer is calibrated at the time of use, and maintain

records documenting its calibration history.

1.6 TEST SUMMARY

Table 1-1 summarizes the tests covered in this QC manual, their minimum frequencies, the personresponsible for each test, and the sections of this manual in which details about each test can be found.


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Table 1-1QUALITY CONTROL TESTS WITH TIMING REQUIREMENTS AND RESPONSIBILIT

Test Name Test Type ResponsibilityWhen to (re)establish

operating levelsWh

Density Constancy Grayscale

Radiologic

Technologist

See 2.1.2.1 for

triggering events (an

Fixer Retention* GrayscaleNot Applicableto 6850 Laser

Imager

Not Applicable to 6850 LaserImager

MQSA defines levels:21 CFR 900.12(e)(3)(i)

No685

Low-contrast Visibility GrayscaleRadiologic

TechnologistSee 2.3.2.1 for

triggering eventsS

an

Spatial Resolution Spatial/GeometricRadiologic


triggering eventsS

an

(Darkroom) Fog* GrayscaleNot Applicableto 6850 Laser

Imager

Not Applicable to 6850 Laser

Imager

MQSA defines levels:21 CFR 900.12(e)(4)(i)

No685

Artifact Spatial/GeometricRadiologic


triggering events an

Grayscale Response Function GrayscaleMedicalPhysicist

See 3.1.2.1 fortriggering events an

Geometry Spatial/GeometricMedicalPhysicist

See 3.2.2.1 fortriggering events an

Phantom Image Quality SystemMedicalPhysicist

Mammography EquipmentEvaluation (MEE) an

*This test is required only under certain conditions. See the listed Section and the Guidance (Section 4) for more

NOTE All of the above QC tests, with the exception of Fixer Retention and (Darkroom) Fog, must be done as part of any Mammography Ethe hardcopy device. An MEE must be done, for example, when new equipment is installed, or existing equipment undergoes changesperformance. See the Guidance (4.11) for more information.


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Section 2QC TESTS FOR THE RADIOLOGIC TECHNOLOGIST

2.1 DENSITY CONSTANCY TEST

2.1.1 Objective

To ensure that the hardcopy output device reproduces consistently a representative set of densitieswithin its output density range.

2.1.2 Establishing Operating Levels

2.1.2.1 Triggering Events

Equipment installation/acceptance, major changes to the hardcopy devices exposure and processinghardware components, software, image processing parameters or other events that would necessitate aMammography Equipment Evaluation (MEE). Operating levels must also be reestablished if the

densitometer used in these tests is replaced, repaired or changed in any way other than normal user-performed calibration using a valid (not expired) density step tablet.

2.1.2.2 Equipment Required

For Procedure 1 below, digital test image containing a density step wedge that produces at least thefollowing nominal output optical densities. (See Table 1 below for the definitions of the four nominaloutput optical densities.) For the 6850 Laser Imager, these four densities are measured using fourselected steps from an internally stored 21-step Density QC test pattern. Specifically, either the DensityQC, 8X10, Density QC, 10x12 or Density QC, 11x14 should be selected for printing from the imagersuser interface, depending on the film size that will be used in these QC tests. Each of these test patternsincludes two columns (step wedges), each having 21 density steps, as shown next:


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Example of a QC Test Pattern (Density QC, 8X10)


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As a convenience to the user, writing space is provided in boxes on the right side of these filmswhere the user can record the step numbers that are being used and the densitometermeasurements of those steps. On initial prints that are made to establish operating levels, onlythe four final reference density values and their step numbers (as determined in section 2.1.2.3below) are recorded in the Reference boxes. On the films subsequently printed for density

constancy testing, the previously established reference density values (and their step numbers)are reentered in the Reference boxes, the current films measured values (from the same stepnumbers that were previously used) are entered in the Measured boxes, and calculatedmeasured reference values are entered in the Difference boxes.

Here are the four nominal output optical densities:

Table 1. Nominal Output Optical Densities

-Minimum density (Dmin): must correspond to the digital driving level that produces theminimum density on the specified output medium undernormal operating conditions In a Density QC step wedge,the step labeled 1 is always the step to be used formeasuring D

min.

-Low Density: density closest to, but not less than 0.45-Mid-Density: density closest to, but not less than 1.20-High Density: density closest to, but not less than 2.20

Calibrated densitometer. The step wedge that is closest to the film edge can be read, in itsentirety, with an automatic strip-reading densitometer such as the X-RITE Model 391Densitometer. Alternatively, the step wedge that is closest to the middle of the film can be read,one step at a time, with a densitometer such as the X-RITE Model 301.

Quality Control charts to track the density variation of each of the above steps over time.Measured densities are recorded for the operating levels, and variations from these are chartedusing the Laser Imager Quality Control Chart. User remarks and actions are recorded in theLaser Imager Quality Control Chart Log. These forms are illustrated below.


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Laser Imager Quality Control Chart

Imager___________ Film Lot_________________Month/Year_____ Densitometer__________Wedge_________

MonthDate 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

+ 0.15

- 0.15

High D=

Step#__

+ 0.07

- 0.07

Low D=Step#__

+ 0.03

- 0.03

Dmin=Step# 1

+ 0.15

- 0.15

Mid D=Step#__


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Laser Imager Quality Control Chart Log

Remarks Date Action

2.1.2.3 Procedure

1) Print the digital test image which is matched to the film size being used (Density QC, 8X10 for 8X10,Density QC, 10x12 for 10X12, or Density QC, 11x14 for 11X14 film) twice and measure the following

density steps in each printed image:

DminLow DensityMid-DensityHigh Density

To determine and record these four measured densities, and their associated step numbers, the followingprocedure is used:

1. To ensure that the imager is calibrated, first print an imager calibration sheet using film from thecartridge that will be used in the subsequent density constancy tests. This will cause the imagerto automatically update its built-in calibration.

2. Next, make two prints of the Density QC test image corresponding to this same film size, from thesame cartridge.

3. Starting with a new, blank Laser Imager Quality Control Chart, fill in the top line with:a. The Laser Imager Serial #b. The film lot from the cartridge being usedc. The month and year of the current dated. The Model # and Serial # of the calibrated densitometer which will be used throughout

these testse. The wedge choice (center or edge) which will be used throughout these tests

4. Starting with a new, blank worksheet such as the following, record all 21 densities from thewedge being used on each of the two films just printed and enter those data into the second and

third columns of the worksheet.


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Worksheet for Determining Operating Levels Densities

Step # MeasuredDensity,

QC Test Print

#1

MeasuredDensity,

QC Test Print

#2

MeasuredDensity,

Average

Step Usage

1 Dmin

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21


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5. From the second and third columns of data, calculate the average measured density of each ofthe 21 steps and enter these averages into the fourth column.

6. Take the average density for Step 1 and write it on the Laser Imager Quality Control Chart

immediately to the right of Dmin=. This average density value will be used as the Dminreference density value for all subsequent Dmin (Step 1) constancy measurements, untiloperating levels are reestablished and a new chart is started.

7. To determine which step to use as the Low Density step, scan, from the top through the data inthe second and third columns, stopping at the first step in which the measured densities in bothof the first two columns are at least 0.45. On the worksheet, write Low Density in the StepUsage column on the row for this step number. Take the average density at that step and write iton the Laser Imager Quality Control Chart immediately to the right of Low D=. Also write thestep number on the next line of the chart, after Step#. This step number and average densityvalue will be used as the Low Density step number and reference density value for allsubsequent Low Density constancy measurements, until operating levels are reestablished and anew chart is started.

8. To determine which step to use as the Mid Density step, scan, from the top through the data inthe second and third columns, stopping at the first step in which the measured densities in bothof the first two columns are at least 1.20. On the worksheet, write Mid Density in the StepUsage column on the row for this step number. Take the average density at that step and write iton the Laser Imager Quality Control Chart immediately to the right of Mid D=. Also write thestep number on the next line of the chart, after Step#. This step number and average densityvalue will be used as the Mid Density step number and reference density value for all subsequentMid Density constancy measurements, until operating levels are reestablished and a new chart isstarted.

9. To determine which step to use as the High Density step, scan, from the top through the data inthe second and third columns, stopping at the first step in which the measured densities in bothof the first two columns are at least 2.20. On the worksheet, write High Density in the Step

Usage column on the row for this step number. Take the average density at that step and write iton the Laser Imager Quality Control Chart immediately to the right of High D=. Also write thestep number on the next line of the chart, after Step#. This step number and average densityvalue will be used as the High Density step number and reference density value for allsubsequent High Density constancy measurements, until operating levels are reestablished anda new chart is started.

2.1.2.4 Action Limits

If the imagers printed QC wedges do not contain densities ranging from 0.45 through 2.20, the imagerrequires a service call, and no further printing of mammograms may be done until the imager is repaired.

2.1.3 Performing the QC/Constancy Test

2.1.3.1 FrequencyBecause the 6850 Laser Imager is a hardcopy device that utilizes a dry development process and self-calibration, this test needs only to be done on a weekly basis.


Digital Density QC Test Pattern test image printed under the same conditions (e.g., look-uptables, interpolation, maximum density) used to establish operating levels

Calibrated densitometer (preferably, the same densitometer used to establish operating levels)

Quality Control chart containing the current operating levels established in 2.1.2


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2.1.3.3 Procedure

Print the test image once and measure the relevant density steps (D min, low, mid-, and high densities).Record the step numbers and their corresponding densities on the QC chart.


Dminmust be within: 0.03 of the operating levelLow density must be within: 0.07 of the operating levelMid-density must be within: 0.15 of the operating levelHigh density must be within: 0.15 of the operating level

2.1.3.5 Use of Test Results

If the device fails the test, further printing of mammograms with the device must stop until the source ofthe problem is identified and corrected. As a first step towards correcting the problem, initiate a print ofan imager calibration sheet, then print the Density QC Test Pattern again and check its four densitiesagainst the existing reference baseline values. If the four new measured-reference values are all withinthe action limits defined above, mammograms may continue to be printed, and these newest measured-

reference values may be charted, but the recalibration of the imager should be noted in the log. If any ofthe four new measured-reference values lie outside the above action limits, initiate a completely newcharting cycle using the procedure of section 2.1.2.3, and note the need to do this in the logs of both theprevious and the new charts. If the test failure is likely due to use of a new batch/lot number from thesame media type, note this in the logs, after performing the procedure of section 2.1.2.3.

2.2 FIXER RETENTION TEST (N/A)

This test, which is included in the NEMA template, is not applicable to DRYVIEW Laser Imagers sincethey do not utilize wet chemical processing with a chemical fixing agent.

2.3 LOW-CONTRAST VISIBILITY TEST

2.3.1 ObjectiveTo assess the ability of the hardcopy output device to reproduce low-contrast structures across its densityrange.



Equipment installation/acceptance, major changes to the hardcopy devices hardware or software, otherevents that would necessitate a Mammography Equipment Evaluation (MEE).2.3.2.2 Equipment Required

Digital test image containing low-contrast structures embedded in known surrounding densities (allstructures with known gray levels). For the 6850 Laser Imager, the test image Multipurpose QC Test Image should be selected from the user interface, for true-size printing on whatever film size

is in current use for these QC tests. The Multipurpose QC Test Image is shown next.


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Multipurpose QC


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2.3.2.3 Procedure

From the 6850 user interface, make one print of the Multipurpose QC.

Place the printed film on a light box that is normally used for viewing mammograms, and ensure thatviewing conditions (such as ambient light and shuttering) are as they normally would be for diagnosticinterpretation of mammograms.

In the central part of the test pattern, which is designed to approximately simulate a mammographyaccreditation phantom image (but without x-ray capture system noise), count the numbers of visible(simulated) fibrils, speck groups and masses and write those numbers in the spaces provided on the film.


All six fibrils, all five speck groups, and all five masses in the simulated phantom must be visible. If theyare not all visible, as a first step towards correcting the problem, initiate a print of an imager calibration

sheet, then re-print the Multipurpose QC and re-check the visibilities of all the simulated fibrils, speckgroups and masses. If some are still not visible, a service call must be placed.


2.3.3.1 Frequency

Semi-annually.


Digital Multipurpose QC Test Image printed under the same conditions (e.g., look-up tables,interpolation, maximum density) used to produce hardcopy reference image.

2.3.3.3 Procedure

Print the test image and evaluate the visibility of low-contrast structures.


All six fibrils, all five speck groups, and all five masses in the simulated phantom must be visible.


If the device fails the test, further printing of mammograms with the device must stop until the source ofthe problem is identified and corrected. As a first step towards correcting the problem, initiate a print ofan imager calibration sheet, then re-print the Multipurpose QC Image and re-check the visibilities of allthe simulated fibrils, speck groups and masses. If some are still not visible, a service call must be placed.

2.4 SPATIAL RESOLUTION TEST

2.4.1 Objective

To assess the ability of the hardcopy output device to reproduce fine spatial details.



Equipment installation/acceptance, major changes to the hardcopy devices hardware or software, otherevents that would necessitate a Mammography Equipment Evaluation (MEE).


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Digital test image containing spatial-resolution targets/test patterns. For the 6850 Laser Imager, the testimage Multipurpose QC , as described previously, should be selected from the user interface,for true-size printing on whatever film size is in current use for these QC tests.

2.4.2.3 Procedure

From the 6850 user interface, make one print of the Multipurpose QC. (Alternatively, a film that was justprinted for the Low-Contrast Visibility Test previously described may also be used for this test.)

Place the printed film on a light box that is normally used by radiologists for viewing mammograms, andensure that viewing conditions (such as ambient light and shuttering) are as they normally would be fordiagnostic interpretation of mammograms.

Using a loupe or other magnifier with 5X 10X magnification, look near the top of the image, in thehorizontal strip containing vertical bar patterns at various spatial frequencies. See if all, including thefinest bars (labeled 12.8 Line pairs per millimeter), can be seen (i.e., there is not just a uniform shade of

gray there).

Similarly, using the same loupe or other magnifier, look near the right side of the image, in the verticalstrip containing horizontal bar patterns at various spatial frequencies. See if all, including the finest bars(labeled 12.8 Line pairs per millimeter), can be seen (i.e., there is not just a uniform shade of graythere).

On the film, answer the question Are all line pairs per millimeter bars visible? by checking either theYes box or the No box on the film. A Yes answer here means that all were visible, including thefinest (12.8 line pairs per mm), on both the horizontal strip and the vertical strip.


The answer to the question Are all line pairs per millimeter bars visible? must be Yes. If the answer isNo, as a first step towards correcting the problem, initiate a print of an imager calibration sheet, then re-print the Multipurpose QC and re-check, with magnification as defined above, the visibilities of all the barpatterns. If some are still not visible, try printing the Multipurpose QC using film from a different filmcartridge. If this does not solve the problem, a service call must be placed.


2.4.3.1 Frequency

Semi-annually.


Digital test image containing spatial-resolution targets/test patterns. For the 6850 Laser Imager, the test

image Multipurpose QC , as described previously, should be selected from the user interface,for true-size printing on whatever film size is in current use for these QC tests.

2.4.3.3 Procedure

Print the digital test image and check the visibility of the specified spatial-resolution targets/structures.


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Using a loupe or other magnifier with 5X 10X magnification, the viewers answer to the question Are allline pairs per millimeter bars visible? must be Yes.


If the device fails the test, further printing of mammograms with the device must stop until the source ofthe problem is identified and corrected. If the printer fails this test, then, as a first step towards correctingthe problem, initiate a print of an imager calibration sheet. Then re-print the Multipurpose QC and re-check, with magnification as defined above, the visibilities of all the bar patterns. If some are still notvisible, try printing the Multipurpose QC using film from a different film cartridge. If this does not solve theproblem, a service call must be placed.

2.5 (DARKROOM) FOG TEST (N/A)

This test, which is included in the NEMA template, is not applicable to the 6850 Laser Imager since itscartridge design prevents unintended exposure of media during normal daylight handling.

2.6 ARTIFACT TEST

2.6.1 Objective

To assess the ability of the hardcopy output device to produce images that are free from clinicallysignificant artifacts (i.e., artifacts that mimic or obscure clinical information).



Equipment installation/acceptance, major changes to the hardcopy devices hardware or software, otherevents that would necessitate a Mammography Equipment Evaluation (MEE). This test may also betriggered by an observation of a possible artifact on a printed clinical film.


Digital test image(s) containing large, mid-density, flat-field areas that aid in detecting relevant artifacts.For the 6850 Laser Imager, the Carestream Health, Inc. test image TG18 QC should be selected fromthe user interface. The TG18 QC is shown next.


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TG18 QC


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2.6.2.3 Procedure

Print the test image and evaluate for any artifacts seen in the hardcopy output that mimic or obscureclinical information.


There must be no artifacts that mimic or obscure clinical information. If these, or any other artifact whichmay mimic or obscure clinical information, are seen, a different film cartridge should be placed in theimager and the test repeated, to see if the artifact is associated with a particular cartridge of film. If theartifact still occurs, the imager may require cleaning or other maintenance. In this case, a service callmust be placed and clinical printing suspended until the problem is corrected. If the artifact disappearedwhen the original cartridge was replaced, the original cartridge must no longer be used for clinicalprinting.2.6.3 Performing the QC/Constancy Test

2.6.3.1 Frequency

Annually.


Digital test images printed under the same conditions (e.g., look-up tables, interpolation, maximumdensity) used to produce hardcopy reference images.

2.6.3.3 Procedure

Print the two test images and evaluate for any artifacts seen in the hardcopy output that mimic or obscureclinical information.


There must be no artifacts that mimic or obscure clinical information.


If the device fails the test, further printing of mammograms with the device must stop until the source of

the problem is identified and corrected. If any artifact is seen which may mimic or obscure clinicalinformation, a different film cartridge should be placed in the imager and the test repeated, to see if theartifact is associated with a particular cartridge of film. If the artifact still occurs, the imager may requirecleaning or other maintenance. In this case, a service call must be placed and clinical printing suspendeduntil the problem is corrected. If the artifact disappeared when the original cartridge was replaced, theoriginal cartridge must no longer be used for clinical printing.


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Section 3QC TESTS FOR THE MEDICAL PHYSICIST

The following QC tests shall be done by a medical physicist or by an individual under the directsupervision of a medical physicist, typically in conjunction with the annual mammography facility survey.These tests also form the basis of the Mammography Equipment Evaluation (see 4.11).

3.1 GRAYSCALE RESPONSE FUNCTION TEST

3.1.1 Objective

To ensure that the grayscale response of the hardcopy output device conforms to the expected grayscaleresponse.



Equipment installation/acceptance, major changes to the hardcopy devices hardware or software,changes in media (e.g., film) type, other events that would necessitate a Mammography EquipmentEvaluation (MEE).


Digital test image containing a sufficient number of density steps with known gray levels.Depending on the film size in use, one of the three Density QC images, previously described insection 2.1, may be printed for use with this test. Specifically, if printing on 8x10 film, print theDensity QC, 8x10 test image; if printing on 10x12 film, print the Density QC, 10x12 test image;if printing on 11x14 film, print the Density QC, 11x14 test image. In all cases, the central 21-stepwedge of the test image is used for this test. The steps in this wedge contain pixel values ranging

from 0 (0% = black) through 4095 (100% = white), with a uniform increment of 5% in pixel valueper step.

Calibrated X-Rite Model 301 densitometer or other densitometer with equivalent accuracy andvisual spectral response may be used for this test. Before this test is performed, thedensitometer must be calibrated with a current and valid X-Rite Part No. 301-27 densityreference plaque.

3.1.2.3 Procedure

The following procedure describes how the accuracy of printed densities, throughout the printablegrayscale range, is tested, using a prescribed look-up table, in conjunction with prescribed printing andfilm parameters.

First, to ensure that the imager is calibrated, print an imager calibration sheet using film from the cartridge

that will be used in the subsequent test pattern print. This will cause the imager to automatically updateits built-in calibration.

Next, the appropriate Density QC is printed from the user interface. For this test, print parameters areautomatically set to the following:

Look-up table: Transfer Function Table VER693C0, contrast 6

Dmax Setting: 3.60

Print Format: 1-up (single image, magnified to fill most of the film)

Interpolation: Replicate


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The Automatic Image Quality Control (AIQC) feature of the 6850 Laser Imager automatically expands thechosen lookup table to span the full available density range from the current films Dmin to the requestedDmax. Therefore, the expected densities on the printed film will depend to some extent on the Dmin ofthe film in the cartridge that is currently being used. Film Dmin can be determined by measuring the

density of the brightest step (Step 1) of the printed wedge. For the print parameters being used here, anda range of Dmin possibilities, the expected printed densities for all 21 steps are given, along with theirtolerances, in the following table.

Target Densities and Tolerances for the QC Wedge, Printed as Specified, for Various Dmins

StepDmin0.17

Dmin0.18

Dmin0.19

Dmin0.20

Dmin0.21

Dmin0.22

Dmin0.23

Dmin0.24

Dmin0.25

Dmin0.26

Dmin0.27

1 0.17 0.18 0.19 0.20 0.21 0.22 0.23 0.24 0.25 0.26 0.27

2 0.240.1

0.250.1

0.260.1

0.270.1

0.280.1

0.290.1

0.300.1

0.310.1

0.320.1

0.330.1

0.340.1

3 0.300.1

0.310.1

0.320.1

0.330.1

0.340.1

0.350.1

0.360.1

0.370.1

0.380.1

0.390.1

0.400.1

4 0.370.1 0.380.1 0.390.1 0.400.1 0.410.1 0.420.1 0.430.1 0.440.1 0.450.1 0.460.1 0.470.1

5 0.440.1

0.450.1

0.460.1

0.470.1

0.480.1

0.490.1

0.500.1

0.510.1

0.520.1

0.530.1

0.540.1

6 0.520.1

0.530.1

0.540.1

0.550.1

0.560.1

0.570.1

0.580.1

0.590.1

0.600.1

0.610.1

0.620.1

7 0.600.1

0.610.1

0.620.1

0.630.1

0.640.1

0.650.1

0.660.1

0.670.1

0.680.1

0.690.1

0.700.1

8 0.690.1

0.700.1

0.710.1

0.720.1

0.730.1

0.730.1

0.740.1

0.750.1

0.760.1

0.770.1

0.780.1

9 0.780.1

0.790.1

0.800.1

0.810.1

0.820.1

0.830.1

0.840.1

0.850.1

0.850.1

0.860.1

0.870.1

10 0.88

0.1

0.89

0.1

0.90

0.1

0.91

0.1

0.92

0.1

0.93

0.1

0.94

0.1

0.95

0.1

0.96

0.1

0.96

0.1

0.97

0.111 0.990.1

1.000.1

1.010.1

1.020.1

1.030.1

1.040.1

1.050.1

1.060.1

1.060.1

1.070.1

1.080.1

12 1.110.1

1.120.11

1.130.11

1.130.11

1.140.12

1.150.12

1.160.13

1.170.13

1.180.14

1.190.14

1.200.14

13 1.240.15

1.240.15

1.250.15

1.260.15

1.270.15

1.280.15

1.290.15

1.300.15

1.310.15

1.320.15

1.330.15

14 1.380.15

1.390.15

1.400.15

1.410.15

1.420.15

1.430.15

1.440.15

1.440.15

1.450.15

1.460.15

1.470.15

15 1.550.15

1.560.15

1.560.15

1.570.15

1.580.15

1.590.15

1.600.15

1.610.15

1.610.15

1.620.15

1.630.15

16 1.730.15

1.740.15

1.740.15

1.750.15

1.760.15

1.770.15

1.780.15

1.780.15

1.790.15

1.800.15

1.810.15

17 1.940.15 1.950.15 1.950.15 1.960.15 1.970.15 1.980.15 1.990.15 1.990.15 2.000.15 2.010.15 2.020.15

18 2.210.15

2.220.15

2.220.15

2.230.15

2.240.15

2.240.15

2.250.15

2.260.15

2.270.15

2.270.15

2.280.15

19 2.540.15

2.550.15

2.550.15

2.560.15

2.560.15

2.570.15

2.580.15

2.580.15

2.590.15

2.590.15

2.600.15

20 2.950.15

2.950.15

2.950.15

2.960.17

2.960.17

2.970.19

2.970.19

2.970.19

2.980.21

2.980.21

2.990.23

21 3.600.25

3.600.25

3.600.25

3.600.25

3.600.25

3.600.25

3.600.25

3.600.25

3.600.25

3.600.25

3.600.25


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The expected step densities and tolerances on a given print are found by taking the column from theabove table that corresponds to the current films measured Dmin. (Since this column is freely chosen tomatch (to within 0.01) the current films measured Dmin, there is no difference between the target andmeasured densities at Step 1. Thus no tolerance is indicated for the Step 1 density.)


Taking the target densities and tolerances from the column above that corresponds to the Dmin (Step 1density) of the current film, the measured and target densities must agree to within the defined tolerancesfor all 21 steps of the wedge. If they do not, this procedure (3.1.2.3) should be repeated. If acceptableresults are still not obtained, the current film cartridge should be replaced with a new one and the entireprocedure (3.1.2.3) repeated one more time. If results are still unsatisfactory, a service call must beplaced to correct the problem before these tests, or any clinical image printing, may be resumed.

3.1.3 Performing the QC/Constancy

3.1.3.1 Frequency

Annually.


The same digital test image used in section 3.1.2.2, to be printed under the same conditions(e.g., look-up tables, interpolation, maximum density).

Calibrated densitometer (preferably, the same densitometer used to establish operating levels).

3.1.3.3 Procedure

First, to ensure that the imager is calibrated, print an imager calibration sheet using film from the cartridgethat will be used in the subsequent test pattern print. This will cause the imager to automatically updateits built-in calibration.

Next, the appropriate Density QC is printed, as previously described in section 3.1.2.3.

As in section 3.1.2.3, measure the densities of the 21 steps, and compare them with the column from theTarget Densities and Tolerances table above that corresponds to the Dmin (Step 1 density value) of thenewly printed film. (The new films Dmin need not be the same as that of the film used in section 3.1.2.3.)


The new measured densities must agree with the target densities to within the defined tolerances for all21 steps of the newly printed wedge.


If the device fails the test, further printing of mammograms with the device must stop until the source ofthe problem is identified and corrected. If any out-of tolerance results were obtained, procedure 3.1.3.3

should be repeated. If acceptable results are still not obtained, the current film cartridge should bereplaced with a new one and the entire procedure, starting with section 3.1.2.3, should be repeated. Ifresults are still unsatisfactory, a service call must be placed to correct the problem before these tests, orany clinical image printing, may be resumed.

3.2 GEOMETRY TEST

3.2.1 Objective

To ensure that the hardcopy output device preserves linearity and distance in both horizontal and verticaldimensions.


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Equipment installation/acceptance, major changes to the hardcopy devices hardware or software, otherevents that would necessitate a Mammography Equipment Evaluation (MEE).3.2.2.2 Equipment Required

Digital test image containing multiple horizontal and vertical lines having a specified spatialrelationship (e.g., fixed distance) to each other. Specifically, for the 6850 Laser Imager, theTG18-QC, described previously, is printed.

A precision flat steel ruler, marked in mm increments, longer than the longest dimension of thefilms used in this test.

QC Chart. The Geometry Test QC Chart shown below is used to record the results of this test.When new operating levels are established using this procedure, a new Geometry Test QC Chartis begun, and the new operating levels are recorded on the top line of the new chart.


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Geometry Test QC Chart

Date Horizontal Distance, mm Vertical Distance, mm Straightness of Lines


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3.2.2.3 Procedure

Print the test image and measure horizontal and vertical reference distances within the image. Recordthese on a QC chart. Examine the printed lines.


Lines must be straight and undistorted. If it appears that the vertical lines on the film are not straight andundistorted, measure the horizontal distance between them at three locations: near the top edge of thefilm, across the middle of the film, and near the bottom edge of the film. If the difference between thelongest and the shortest of these distances exceeds 2% of the average distance, a service call must beplaced and the problem resolved before clinical images can be printed. Similarly, if it appears that thehorizontal lines on the film are not straight and undistorted, measure the vertical distance between themat three locations: near the left edge of the film, near the vertical centerline of the film, and near the rightedge of the film. If the difference between the longest and the shortest of these distances exceeds 2% ofthe average distance, a service call must be placed and the problem resolved before clinical images canbe printed.


3.2.3.1 FrequencyAnnually.


Digital test image printed under the same conditions (e.g., look-up tables, interpolation, maximumdensity) used to produce hardcopy reference image

QC Chart containing the current operating levels established in 3.2.2

3.2.3.3 Procedure

Print the test image and measure the horizontal and vertical reference distances within the image.Record these on the QC chart, and compare with the reference values. Examine the printed lines.

3.2.3.4 Action LimitsMeasured distances must not deviate by more than 1% from the reference distances. Lines must bestraight and undistorted.


If the device fails the test, further printing of mammograms with the device must stop until the source ofthe problem is identified and corrected. A service call is required.

3.3 PHANTOM IMAGE QUALITY TEST

3.3.1 Objective

To ensure that the quality of images acquired at the acquisition workstation remains adequate after theimages are transmitted to and printed on the hardcopy output device.


The Image Receptor Manufacturer (IRM) should provide the operating levels, that is, the image qualitycriteria used for scoring the printed image of the phantom.


3.3.3.1 Frequency

Annually.


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Calibrated FFDM system, including at least: an acquisition modality (needed only if the acquisition workstation that will send clinical

images to the hardcopy device does not contain a phantom image that has recently been

acquired from the modality and that has met the image quality requirements of the imagereceptor manufacturer),

an acquisition workstation

FDA-approved mammographic phantom

3.3.3.3 Procedure

Acquire an image of the accreditation phantom on a full-field digital mammography (FFDM) imageacquisition system from which images will be sent to the hardcopy device, and send the image to thehardcopy device for printing. Alternatively, if such an image already exists on the acquisition workstation,send that image to the hardcopy device for printing. Score the output image according to the imagequality criteria specified by the IRM. If multiple FFDM systems will be sending images to the samehardcopy device, repeat the test for each such system.


The printed image must meet the image quality criteria/action limits set by the image receptormanufacturer of each FFDM system that will send images to the hardcopy device.


If the device fails the test for a particular FFDM system from which it will receive images for printing andfinal interpretation, further printing of mammograms with the device from that FFDM system must stopuntil the source of the problem is identified and corrected. If the Imager passes all other applicable QCtests described in this manual, it is likely that this image quality failure is the result of either (1) a problemin the acquisition system or (2) a configuration issue, such as the choice of the grayscale lookup table(i.e., Transfer Function Table (TFT)) which is being used in the imager. The first possibility may beinvestigated by carefully reviewing the same acquired image on a softcopy display (preferably at a fixed

grayscale window setting) to verify that the image itself is satisfactory. The second possibility may beinvestigated by switching to alternative lookup tables (TFTs), or an alternate printing mode (PresentationLUT mode), as may be recommended by Carestream Health, Inc., especially if acquisition systemparameters have changed.


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Section 4

GUIDANCE

MQSA final regulations consider performance of the image receptor manufacturers QC Test procedures

to be a requirement for compliance with the regulations. This Guidance section is not considered anelement of those regulations. It is intended to provide guidance to mammography facilities and theirpersonnel. It represents the equipment manufacturers current thinking on appropriate procedures forconducting the QC tests. Procedures described in guidance represent supplementary information onacceptable ways of doing a test, but, unlike regulations, do not bind the facility to using only those ways.

An alternative procedure may be used if such a procedure satisfies the requirements of the applicablestatute, regulations, or both. Mandatory language, such as shall, must, and require, is used whenreferring to statutory or regulatory requirements. Non-mandatory language, such as should, may,can, and recommend is used when referring to guidance. It is the responsibility of the facility to read,understand, and follow the final regulations.

Under its own authority, a state may impose more stringent requirements than those specified underMQSA and its implementing regulations. A facility may want to check with the state or local authorities

regarding their requirements. Tests may need to be performed more frequently than specified in thismanual if required by local regulations or the facilitys standard operating procedures.

4.1 QC TEST IMAGES

The equipment section of each QC test specifies one or more test images appropriate for that test. Table4-1 lists some publicly available test images that can be used for this purpose.

Table 4-1QC TEST IMAGES

Test Image Source/Information/Description

TG-18-QC

TG-18-PQC

AAPM Online Report #3: Assessment of Display Performance for Medical

Imaging Systems. Imaging Informatics Subcommittee Task Group #18,and Supplemental Files

General test pattern for QC of output devices (-PQC is printer-specific)

http://www.aapm.org/pubs/reports

http://www.aapm.org/pubs/reports/public/OR_03_Supplemental/

TG-18-QCTG-18-PQC

AAPM Online Report #3: Assessment of Display Performance for MedicalImaging Systems. Imaging Informatics Subcommittee Task Group #18,and Supplemental Files

General test pattern for QC of output devices (-PQC is printer-specific)

http://www.aapm.org/pubs/reports

http://www.aapm.org/pubs/reports/public/OR_03_Supplemental/

SMPTE Test Pattern SMPTE Recommended Practice RP 133-1991 - Specifications for Medical

Diagnostic Imaging Test Pattern for Television Monitors and Hard-CopyRecording Cameras

General test pattern for QC of output devices

http://www.smpte.org/smpte_store/standards/

The test pattern only, without the Recommended Practice document, isalso downloadable from a number of Internet sources, such as:http://brighamrad.harvard.edu/research/topics/vispercep/tutorial.html


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4.2 DENSITY CONSTANCY TEST (2.1)

This is a test that determines tone reproduction consistency, in other words, whether the hardcopy devicealways produces the same output density (within the action limits) for a specified input gray level.Hardcopy devices that use wet chemistry to produce an output image have more potential sources of driftthan dry printing systems, and should, therefore, be tested more frequently (daily). Dry printing systemssuch as the 6850 Laser Imager also can calibrate themselves by monitoring internal parameters,recognizing media characteristics, and adjusting their internal look-up tables to produce more consistentresults. Dry systems may have standard factory settings to which the printer should adhere, which mayobviate the need to establish operating levels (2.1.2) independently. If it is not possible to achieve thesefactory settings despite repeated attempts, it is recommended that you contact your field serviceengineer.

4.3 FIXER RETENTION TEST (2.2) (N/A)

This test, which is included in the NEMA template, is not applicable to dry media.

4.4 LOW-CONTRAST VISIBILITY TEST (2.3)

The importance of low-contrast targets in mammography demands a test for the reproducibility of densitydifferences (note that 2.1.1 is a test of the reproducibility only of selected absolute densities). For thistest, it is important that you reproduce as closely as possible the viewing conditions defined by themanufacturer. If, after repeated attempts to visualize the low-contrast targets specified in the procedure,the device is not performing as expected, it is recommended that you contact your field service engineer.

4.5 SPATIAL RESOLUTION TEST (2.4)

The results of the spatial resolution test are sensitive to a number of boundary conditions. One is the sizeof the output medium. If the image is magnified or reduced in size to fit the output medium, the intendedresults of the test may not be achieved. In a related issue, the type of interpolation used to reconstructthe analog output image from the digital (pixel) data can have a marked effect on the reproduction ofhigh-spatial-frequency details. For these reasons, these parameters must be defined explicitly.

It is also important that you reproduce the viewing conditions defined by the manufacturer as closely aspossible since the 12.8 lp/mm bar pattern is normally difficult to discern in the multi-purpose QC pattern.

If the device fails this test, it is recommended first to repeat the test, paying particular attention to theparameters cited above. If, after repeated attempts to visualize the spatial-resolution targets specified inthe procedure, the device is not performing as expected, it is recommended that you contact your fieldservice engineer.

4.6 (DARKROOM) FOG TEST (2.5) (N/A)

This test, which is included in the NEMA template, is not applicable to the 6850 Laser Imager since itscartridge design prevents unintended exposure of media during normal daylight handling.

4.7 ARTIFACT TEST (2.6)

It is important to the diagnostic process that there be no artifacts in the image that could mimic or obscureclinically significant information. However, not all possible image artifacts fall into this category. Forexample, low levels of streaks or bands, minus density points, or test pattern ghosting may not affect thediagnostic process.Ghosting artifacts observed in the TG18-QC Pattern could occur at black to gray transitions. The TG18-QC image has two large areas of the pattern that are set to 0 pixel value (or 0%) and occur over longexcursions that suddenly increase into long excursions of 50% pixel value. One is the Cross Talk bars


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and the other is the Cx background. Extended areas of maximum density which occur through or near anadjacent 50% gray background in an image could result in a ghost streak observed within the gray field.Extended areas of maximum density that abruptly transition to gray do not occur in mammographyimages. Therefore the appearance of ghosting in the TG-18QC pattern at these transitions is notpredictive of diagnostic concerns in the printed film.

It will be helpful to use the concept of ALARA (as low as reasonably achievable) when judging artifacts.The medical physicist should consult with the interpreting physician as to whether an artifact is tolerableby comparing a clinical image to the film with the noted artifact.

4.8 GRAYSCALE RESPONSE FUNCTION TEST (3.1)

The Density Constancy Test (2.1) checks the tone reproduction consistency only at a few key outputdensities. The Grayscale Response Function test verifies that the tone reproduction curve conforms(within the action limits) to an established reference curve. Such reference curves can be manufacturer-dependent, and can be tuned to a particular application based on clinical testing, or other criteria. Othercurves, such as the DICOM Grayscale Standard Display Function (DICOM Part 3.14) have beenproposed as universal reference curves that mimic human visual response to luminance.

A hardcopy device such as the 6850 Laser Imager is designed to recalibrate itself when necessary (forexample, when the film lot number changes) to return to the desired curve.

The actual curve used in clinical image printing can be different from the curve used in this test. It can bechosen from a large number of available curves. For the 6850 Laser Imager, any of a large number ofTransfer Function Tables (TFTs) or User Look-Up Tables (ULUTs) can be selected. Some of these arebased on the DICOM Grayscale Standard Display Function (GSDF), tailored for various combinations ofDmax, lightbox luminance, and reflected ambient light. It is also possible to print in the DICOMPresentation Lookup Table (PLUT) mode, which allows GSDF-based response based on density andviewing parameters specified by the printing modality.

4.9 GEOMETRY TEST (3.2)

Geometric distortion of image features can lead to misleading information about clinical structures and

pathology. This test requires accurate measurements of distances between specific landmarks on thetest image. Make sure that the measurement tool (preferably, a metal ruler) has sufficient accuracy andprecision for the task.

4.10 PHANTOM IMAGE QUALITY TEST (3.3)

This is the only system test included in the QC manual: it tests the transfer of information from theacquisition modality through to the output device. If the hardcopy device fails the Phantom Image QualityTest, ensure that all other elements of the imaging chain are working as intended, and repeat the test. Ifthe system still fails the test, it is recommended that you contact the appropriate field service engineer.

4.11 MAMMOGRAPHY EQUIPMENT EVALUATION (MEE)

Sections 2 and 3 describe periodic QC tests. There are other occasions when QC/acceptance tests must

be done ad hoc after interventions that might affect imaging performance. These include changes orrepairs to the hardcopy devices exposure and processing hardware components and software updates,or the installation of a new host device. In order to verify that all functions that may have been affected bythe change/repair have been successfully restored/initialized, the hardcopy output device must pass amammography equipment evaluation (MEE). MEEs shall be performed by a medical physicist or by anindividual under the direct supervision of a medical physicist and all problems shall be corrected beforethe new or changed equipment is put into service for examinations... (21 CFR 900.12(e)(10)).


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If the MEE is for the purpose of evaluating/accepting a newly installed hardcopy output device, first verifythat the installer has completed all tasks defined by the manufacturer as necessary for proper installation.These include:

Out-of-box equipment inspection

Equipment setup

Equipment configuration

Equipment verification testing

Once the hardcopy device is functional and communicating with the rest of the FFDM system, the MEEconsists of the following tests:

MEE Test Name Section

Density Constancy 2.1

Low-contrast Visibility 2.3

Spatial Resolution 2.4

Artifact 2.6

Grayscale Response Function 3.1

Geometry 3.2

Phantom Image Quality 3.3

DRYVIEW is a trademark of Carestream Health, Inc.

150 Verona StreetRochester, NY 14608 USA

Printed in U.S.A. 05/10 Carestream Health, Inc., 2010

DICOM DRYVIEW6850

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