MQSA Quality Control Manual
Contents
1. MOSA Quality Control Manual for IF2105MP 3 6 3 Chart 3 Display Luminance and Gray Scale Calibration Check Facility Room Date Luminance Photometer Model Ser No NOTE Use the display serial number if the photometer is internal to the display or does not have its own serial number Photometer calibration date NOTE Calibration may be established by intercomparison of the photometer reading with another photometer known to be in calibration Attach printout from Basic DICOM Conformance test 3 6 4 Chart 4 Image Quality Check Facility Room Date Left Display Right Display Test Pass Fail Pass Fail Artifacts non uniformities Grayscale continuity Borders lines centering 0 5 contrast 95 100 contrast Gray steps Alphanumerics Line pair images center Line pair images corners Document No OMI 1034 Rev No 1 5 Page 19 MOSA Quality Control Manual for IF2105MP SECTION 4 GUIDANCE MQSA final regulations consider performance of the image receptor manufacturer s QC Test procedures to be a requirement for compliance with the regulations This Guidance section is not considered an element of those regulations It is intended to provide guidance to mammography facilities and their personnel It represents the equipment manufacturer s current thinking on appropriate procedures for conducting the QC tests Proce2. 5 ACTION IT Ee EE EG GE De OD EE 1 246 se af TEST RS SUING os 11 2 5 Image Quality Check for the Display iss ees RS EE Ge SR EES ESE EES RES EE GER Gee eek ee GR ee 11 ZO MG elle SR EE AR AE ER N EE aari iE Eeee 1 232 ODJECIVE MEEN BG KERR N ee Ge Ge Ge oe NG GE ee N Ge EE EE EE 11 2 5 3 EQUIPMENT Required cccceccesssscccccaeeceecseceeceeceeceeceecceecceeeeeeeeeeeeeeeeseeeeeeeseeseereetteetteaeea 11 ca A RE de N Ge Oe ee De Ene kn EG EE ED ede ER DoE N 12 2 5 DANG MOM BIN EG DR DE Ee oe Ge E RE OR EE De Oe is 12 20 6 Use Of PSST TOE OE OE AE OE EE ON N EO ED 13 Section 3 QC TESTS FOR THE MEDICAL PHYSICIST 000 cccccsssssssseeceeccccececssesseseesseeees 13 3l MAREN CMON EER EE EO A N 13 3 2 QC ISTE sie A A 13 3 3 VIEWING Conditions Check and Setting se iii sc ee 13 33 l FREQUENCY AR AR N EE IE ii 14 3 3 2 OE IG E aia cased nena ica ed a 14 3 3 9 EQUIDIMENT REGUS O Ee Es DE id 14 A ol is AO AO O ER 14 330 ele nd AE EA OO N OE N iat 14 GE Ad led N EE EE IE N EE ER OO eran eeaeendantes 15 Document No OMI 1034 Rev No 1 5 Page 2 MOSA Quality Control Manual for IF2105MP 3 4 Display Luminance and Gray Scale Calibration Check sesse sesse 15 SA sii QUINCY ELE SE EE EE EE E OE ee ie 15 34 2 OEI A at 15 34 34 EQUIDIMEMT REQUIRE ua 15 34A PIO SOUS see eed E De Ge ee GE Re We Ge ee ee Ee ge ed de ed 15 SEE ers sd EE N ER EE ORE A 15 3 4 6 Use of Test Results se GEREG N Ge ee Ge D
3. Broadcast calibration execution e Overview reports of test results and monitor status e Network control of LumiCal advanced Client licensing LumiCal advanced Client uses a sensor to measure the monitor luminance when carrying out calibration LumiCal advanced Client can also control a monitor s built in luminance sensor IQ sensor NOTE For more details refer to the user s manual of LumiCal advanced 1 5 Quality Control software CFS Alternatively WIDE Corporation medical displays operate with CFS Calibration Software which is a monitor quality management software tool Made up of two applications CFS Local and CFS WebManager CFS is qualified for use in the following environment e Microsoft Windows 2000 SP3 or later Windows XP Windows Vista or Windows 7 e A workstation with af least one graphics card from the following series with the appropriate driver Realvision VREngine SMD series ATI FireGL series nVidia FX series Matrox Med series CFS is a calibration utility for maintaining LCD monitors at a constant luminance response It functions both standalone or as a node in a networked system CFS is qualified for use in the following environment e Microsoft Windows 2000 SP3 or later Windows XP Windows Vista or Windows 7 CFS WebManager provides the following network management features e Central control of calibration schedules e Broadcast calibration execution e Overview r
4. MedSMP Realvision SMD series SMDSW SMD5 Adv Graphics board drivers are subject to change Please ensure you are using the most recent recommended driver for the graphics card series by contacting your IF2105MP system representative or WIDE USA Corporation directly 1 4 Quality Control software LumiCal advanced WIDE Corporation medical displays operate with LumiCal advanced Network which is a monitor management solution Made up of two applications LumiCal advanced Server and LumiCal advanced Client LumiCal advanced Client is qualified for use in the following environment e Microsoft Windows 2000 SP3 or later or Windows XP Windows VISA Windows 7 e WIDE Corporation recommended Graphics boards see the section 1 3 LumiCal advanced Client is a calibration utility for maintaining LCD monitors at a constant luminance response It functions both standalone or as a node in a networked system When used as a network node inter node communication uses the Simple Network Management Protocol SNMP LumiCal advanced Server is qualified for use in the following environment Document No OMI 1034 Rev No 1 5 Page 7 MOSA Quality Control Manual for IF2105MP e Microsoft Windows 2000 SP3 or later Windows XP Windows Vista or Windows 7 LumiCal advanced Server provides the following network management features for LumiCal advanced Client e Central control of calibration schedules e
5. See Section 4 3 SECTION 3 QC TESTS FOR THE MEDICAL PHYSICIST 3 1 Introduction The QC tests listed in this section must be performed by the Medical Physicist to ensure that the IF2105MP display provides a high level of mammographic image quality These tests also form the basis of the mammography equipment evaluations MEEs that must be performed following the installation of the IF2105MP display the repair or replacement of a major component of the system the relocation of the display to a new viewing environment or substantial change of the illumination of an existing viewing environment Additional information regarding changes of viewing conditions is included in Section 4 2 Additional information regarding the tests to be done for MEEs can be found in Section 4 6 NOTE When performed as part of an MEE all required tests must pass before the device may be used to interpret clinical images In addition to MEE testing the QC tests described in this section must be performed at least as frequently as specified in the test descriptions and as summarized in Table 3 1 These tests are described in Sections 3 2 3 3 3 4 and 3 5 Charts for recording the results of the QC tests or MEEs are provided in Section 3 6 3 2 QC Intervals Table 3 1 Procedure Frequency Section Viewing Conditions Check for the Display Annually 3 3 Disolay Luminance and Grayscale Annually 3 4 Calibration Check Image Quality Check Annually 3
6. alternative Calibration Software 1 2 Feb 2008 Added 3 6 MEDICAL PHYSICIST QC TEST RESULTS RECORD FORMS 1 3 Oct 2008 Changed Model Name from IF2105M to IF2105MP Added the list of Graphics boards as alternative Graphics board 1 4 June 2010 Changed the list of Graphics boards 1 5 July 2013 Revised list of supported Graphic Cards Document No OMI 1034 Rev No 1 5 Page 4 MOSA Quality Control Manual for IF2105MP Documents for Reference 1 User s Manual for IF2105MP 2 User s Manual for LumiCal advanced for Client and Server 3 User s Manual for CFS for Local and WebManager Document No OMI 1034 Rev No 1 5 Page 5 MOSA Quality Control Manual for IF2105MP PREAMBLE Digital mammography is a radiographic examination of the breast in which the image is acquired as an electronic signal in digital format Technological advancement in the field can be expected Hence Quality Control is important in any imaging system but it is especially important in mammography MQSA regulations mandate that each facility shall establish and maintain a quality assurance program to ensure the safety reliability clarity and accuracy of mammography services performed at a facility This manual provides Quality Control procedures for WIDE IF2105MP that receives images from a Full Field Digital Mammography system and presents them for final interpretation The procedures
7. check artificial lighting the adjustment of variable lighting natural lighting and main lighting curtains or door openings environmental conditions If the system fails the Viewing Conditions Check and Setting it is recommended that you contact your field service engineer 4 5 Display Luminance and Gray Scale Calibration Check If the system fails the Display Luminance and Gray Scale Calibration Check it is recommended to contact your field service engineer for re calibration of the display 4 6 MAMMOGRAPHY EQUIPMENT EVALUATIONS The Food and Drug Administration FDA requires a mammography facility to have a medical physicist perform a Mammography Equipment Evaluation MEE when a new mammography unit is installed a unit is disassembled and reassembled at the same or a new location or major components of a mammography unit are changed or repaired This MEE must determine whether the system meets the MQSA requirements for mammography equipment 21 CFR 900 12 b in addition to the quality assurance requirements 21 CFR 900 12 e Note that the allowance of 30 days to take corrective action in the event of failure of specified quality control tests applies only to an annual QC survey In the case of an MEE All problems shall be corrected before the new or changed equipment is put into service for examinations 21 CFR 900 12 e 10 The MQSA Quality Mammography Standard on MEES 21 CFR 900 12 e 10 states that when major rep
8. thin LCD screens are softer than CRT glass screens so they require extra tender care Keep your fingers and sharp objects away from these screens since they are susceptible to damage and scratches Use a soft dry cotton cloth to remove fingerprints and smudges from the screen If this does not completely remove the dirt and splotches use a small amount of special screen cleansing agent designed for LCD screens on the cleaning cloth that has been dampened with water Spray the liquid on the cloth and never directly onto the screen Do not use paper towels on an LCD screens as they can scratch the screen Never use ammonia ammonia based cleaners or strong cleaners which can cause the surface damage and become brittle It is good to have a special clean cloth that is dedicated to use on the LCD screen Do not use any old rag as dirt particles in the rag can scratch the surface of the screen The best cleaning method is to stroke the cloth across the display in one direction moving from the top of the display to the bottom Document No OMI 1034 Rev No 1 5 Page 9 MOSA Quality Control Manual for IF2105MP NOTE Do not use the following materials for the screen cleaning Lye or Cleaning solution containing lye Acid Detergents with abrasives Detergents with ammonia Detergents with fluoride 2 3 4 Procedure 1 Unplug the power supply cord and cable from the back of the unit 2 Dry cloth
9. value is greater than the specified limit adjust the room ambient light and or the room configuration in such a way that the luminance does not exceed that limit Record a description of the room configuration established as optimal in the data form as detailed in Steps 9 through 11 Fill out a check list of the condition of major elements in the reading room for example display positions room lights desk lights curtains Record the luminance on the data form Technologist to reproduce the illumination conditions as they were at the time the luminance level was set Post the form in the reading room so thot it wil be readily available for the Radiologic Technologist s daily Viewing Conditions Check Restore each display to its normal condition i e undo any measures taken in Step 4 to darken the display 3 3 5 Action Limit The ambient light level must not exceed 20 lux The measured value must be stable over one minute with a tolerance of 4 5 lux over the measuring time with regards to the nominal lighting value If the system fails the test the source of the problem must be Document No OMI 1034 Rev No 1 5 Page 14 MOSA Quality Control Manual for IF2105MP identified and corrective action taken before any further mammographic images are reviewed or interpreted 3 3 6 Use of Test Results If the system fails the test the source of the problem must be identified and corrective actio
10. www widecorp com WIDE Korea T 82 31 218 1600 e mail info widecorp com WIDE USA T 1 949 305 9933 e mail infousa widecorp com WIDE Europe T 31 20 311 9797 e mail infoeu widecorp com WIDE Japan T 81 45 473 7398 e mail infojapan widecorp com Document No OMI 1034 Rev No 1 5 Page 22 MOSA Quality Control Manual for IF2105MP
11. 3 5 5 Action Limit See Sec 2 5 5 3 5 6 Use of Test Results If the system fails the test the source of the problem must be identified and corrective action taken before any further mammographic images are reviewed or interpreted using the display See Section 4 3 Document No OMI 1034 Rev No 1 5 Page 16 MOSA Quality Control Manual for IF2105MP 3 6 MEDICAL PHYSICIST QC TEST RESULTS RECORD FORMS 3 6 1 Chart 1 Site and System Summary Facility Name Address Room Date of Installation Date of Test Type of Test Annual Survey Mammography Equipment Evaluation circle the applicable one Room ID Serial Numbers Mammographic Unit Diagnostic Workstation Left Display Right Display Medical Physicist Signature 3 6 2 Chart 2 Viewing Conditions Check and Setting Facility Room Date Room description Document No OMI 1034 Rev No 1 5 Page 17 MOSA Quality Control Manual for IF2105MP Display positions Room lighis Desk Lights Document No OMI 1034 Rev No 1 3 Page 17 MQSA Quality Control Manual for IF2105MP Others Ambient Illuminance NOTE Confirmation of this value is not part of the daily check by the Radiologic Technologist Requirement Display Type Ambient luminance Pass Fail CRT lt 20 LUX LCD lt 20 LUX Room Layout Document No OMI 1034 Rev No 1 5 Page 18
12. 4 View the display from the position that would be used by a single viewer seated directly in front of the display The observer must be at least 50 cm from the display screen NOTE For detailed calibration software information see LumiCal advanced or CFS user s manual NOTE2 It is intended that the test pattern be viewed without modification of its size or gray scale The pattern is displayed with each pixel of the pattern represented by one pixel of the display For the test to remain valid magnification or zoom features of the display must not be used when evaluating the appearance of the features described below Additionally the intensity levels used in the pattern are intended to enable evaluation of the gray scale calibration of the display Adjustment of contrast brightness window width window level or other gray scale modifications must not be applied 5 Examine each image on each display carefully for the following features a Verify that there are no new artifacts or non uniformities b Verify that a continuous gray scale ramp appears continuous and free from contrast reversal That is along the length of the ramp the brightness must not include dark light dark or light dark light transitions c Verify that borders and lines of the pattern are visible and straight and that the pattern appears to be centered in the active area of the display d Verify that the 0 5 contrast pattern is visible e Verify th
13. 5 3 3 Viewing Conditions Check and Setting 3 3 1 Frequency Annually Document No OMI 1034 Rev No 1 5 Page 13 MOSA Quality Control Manual for IF2105MP 3 3 2 Objective To ensure optimal viewing conditions 3 3 3 Equipment Required luminance photometer with a minimum resolution not exceeding 1 lux 3 3 4 Procedure 1 2 Place the displays in optimal positions in the room See Section 4 4 Reduce any lighting coming from sources such as view boxes or overhead or task lighting to the minimum to reproduce typical ambient lighting conditions that would be set for reading digital images on the display Check that the ambient lighting set at Step 2 is stable no flickering effect due to any of the lighting sources that are turned on Make each display as dark as possible For example minimize the application windows or display a black flat field Obtain the luminance reading at each display Position the photometer with its sensitive area facing away from the surface of the disolay and located at the center of the display and on the display surface NOTE The medical physicist must take care not to block any light that could be detected by the photometer 6 10 Draw a room layout on the data form sufficiently accurate to enable the Radiologic 11 12 13 Read the luminance value and verify that it does not exceed the value specified in the Action Limit If the
14. E IR GR EG EG Ge Ee ee 15 A Made QUO EER RR ER sac RS 16 SN el ale RE OE EE RR N N OE OE EE 16 332 ODJECIVE ace eta RE A 16 3 53 EQUIDIMENT Required ccccisesssoedzacetuessineseceosiecdtaessetnesectencesugesusdbucondesao assendso dense cedenscsuntsses 16 o cet secrete ON AE EEN OT OE ME EE EE Ne 16 A TOM EED EE OE N EN N N N OG 16 3 9 6 Use Of Test REUSE esse KO eg ee ee KERE GESE SG EE PR ee Ee ee 16 3 6 MEDICAL PHYSICIST QC TEST RESULTS RECORD FORMS curso 17 3 6 1 Chart 1 Site and System SUMMOFY esse ee ER ono RR Re Re Re ee Re ee Re ee ee ee ee ee 17 3 6 2 Chart 2 Viewing Conditions Check and Setting us IS REK ada 17 3 6 3 Chart 3 Display Luminance and Gray Scale Calibration Check sesse se 19 3 6 4 Chait 4 IMS Quality CISC ti 19 Section 4 GUIDANCE rai 19 4 1 Display Screen Cleanliness eie EE RR RR Re ER ee Re Re ee ee ee de ee ee 20 4 2 Viewing Conditions Check FOr The Display ESE RES Ee SEA gese ede Dee De ERG EG 20 AS IMAGES Q ality CHECK iros 20 4 4 Viewing Condition Check and Setting HE EER EE Ee ERG EE es se ibarra 20 4 5 Display Luminance and Gray Scale Calibration Check sesse 21 4 6 MAMMOGRAPHY EQUIPMENT EVALUATIONS sees see ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee 21 Document No OMI 1034 Rev No 1 5 Page 3 MOSA Quality Control Manual for IF2105MP REVISION HISTORY Revision No Date Comment 1 0 Aug 2007 Initial Draft 1 1 Sep 2007 Allow for CFS as
15. MQSA Quality Control Manual For The IF2105MP 5 Mega pixel LCD Monitor Maximum Visual Precision WIDE Corporation Document No OMI 1034 Rev No 1 5 Page 1 MOSA Quality Control Manual for IF2105MP CONTENTS Revision HISTO suscitan N OR RE EE ed 4 Documents Torre el OE SEGE EG ED GE De Ge EG Ge Ge De Dei 5 SECTION OVEIVISW aria dic 7 PUND OSES nta 7 12 SSO Oe EDE EE ED EE GE Gus anes gatavacsiseteeeeeens 7 1 3 Materials amp EQUIPMENT iaa 7 14 Gual Control sore Unai EE GE Ge 7 1 5 Quality Controlsoftware ESO aiii 8 Section 2 QC TEST FOR THE RADIOLOGICAL TECHONOLOGIST se sesse sesse sesse se ee 9 PR dn ike GU CMON st ac EE RE OE OE OO EE ie 9 PAPE mad UNS OS OE EE OR OR EE EE TE EO ON 9 2 3 Display Screen CIeQnliness ss EE EE ER ER ee ee Re eed ee ee ee ee de de ee ee ee ee 9 ZII ME QUEEN ot 9 di OE SEINE ER DE oe eie a GE EE ER E EG teen ee Du Op ee eea ag 9 2 3 3 Equipment Required ssssssssssessesseeesereeerreeereereeserssesssessessssssssssossessessteessessteeeeeeeeeeeeeeerees 9 a A A be Dk BR RE EG DE ei HG ER Ge EG oiia 10 2395 ACTION LIMIT AE AR N ER EE EE EE EE ON 10 2 3 6 User of Test REIS iia 10 2 4 Viewing Conditions Check for the Display ese se Ee EA RE Re ee 10 DAA EQU AE AE AR RE EEN 10 242 OP ele ias 10 2 43 EQUIPMENT REGUS O ES Se ER GR Se ge eg Re ee EE GE ee ee GE Ee Ee Ee 1 2 AAs PIOESOUIE see e COn RR ER GE Ge ee Ge EG Rd ed Ge Eg 1 24
16. airs are performed on existing equipment an MEE must be performed by a medical physicist or under the direct supervision of a medical physicist i e the medical physicist must be in the room during the performance of the individual equipment tests In its guidance the FDA has classified particular repairs as being major and for repairs not considered major and thus not requiring an MEE has identified the level of medical physicist involvement required Table 4 1 provides similar information for repairs to the Manufacturer to specify display or workstation FDA Guidance states there are adjustments changes or repairs for which verification can be performed by other qualified personnel e g radiologic technologist or service representative with appropriate training experience without involving the medical physicist Generally in the event of a system repair or upgrade if actions supplemental to the procedures in this manual are required to be taken by other qualified personnel those actions will be specified in documentation to be provided by the field service engineer However the calibration of the display setting the black and white levels and performing the grayscale display function calibration is intended to remain the responsibility of the field service engineer Document No OMI 1034 Rev No 1 5 Page 21 MQSA Quality Control Manual for IF2105MP WIDE Contact Visit WIDE at
17. at the 95 100 contrast pattern is visible f Verify that each gray level step of a discontinuous gray scale ramp can be distinguished from the adjacent steps g Verify that the alohanumeric characters that appear on the pattern are h sharp and in focus 2 5 5 Action Limit If any of the following conditions are not met the display fails the test Take action as specified in 2 5 6 a There must be no artifacts or non uniformities that mimic or obscure clinical information b There must be no discontinuities or contrast reversals in the continuous grayscale ramps c Borders and lines of the pattern must be visible and straight and the pattern must appear to be centered in the active area of the display d The 0 5 contrast shall be visible e The 95 100 contrast shall be visible Each gray level step shall be distinguishable from the adjacent ones Document No OMI 1034 Rev No 1 5 Page 12 MASA Quality Control Manual for IF2105MP g The alphanumeric characters shall appear sharply focused h The high contrast line pair patterns must be distinguishable at the center and the corners of the display screen for both the horizontal and vertical orientations of the line pair patterns 2 5 6 Use of Test Results If the system fails the test the source of the problem must be identified and corrective action taken before any further mammographic images are reviewed or interpreted using the display
18. dures described in guidance represent supplementary information on acceptable ways of doing a test but unlike regulations do not bind the facility to using that way only An alternative procedure may be used if such a procedure satisfies the requirements of the applicable statute regulations or both Mandatory language such as shall must and require is used when referring 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 beyond those specified under MQSA and its implementing regulations A facility may want to check with the state or local authorities regarding their requirements Tests may be performed more frequently than specified in the QC tests if required by local regulations or hospital requirements QC tests may be used as a check for correct operation for example after a change of operating parameters The following sections provide specific guidance for sections in the QC tests 4 1 Display Screen Cleanliness If a display cannot be satisfactorily cleaned it is recommended that you contact your field service engineer 4 2 Viewing Conditions Check for The Display Particular attention should be given to changes that substantially af
19. eports of test results and monitor status CFS Local uses a sensor to measure the monitor luminance when carrying out calibration and also control a monitor s built in luminance sensor IQ SensorTM NOTE For more details refer to the user s manual or on line help of CFS SECTION 2 QC TEST FOR THE RADIOLOGICAL TECHONOLOGIST Document No OMI 1034 Rev No 1 5 Page 8 MASA Quality Control Manual for IF2105MP 2 1 Introduction QC tests are simple checks which ensure that the IF2105MP is operating to its design standards They are intended to detect any changes in settings which might compromise image quality as well as any deterioration in equipment performance over time 2 2 QC Intervals The QC tests described in this section must be performed at least as frequently as specified in the test descriptions and as summarized in Table 2 1 Table 2 1 Procedure Frequency Section Display Screen Cleanliness Daily or When its 2 3 needed Viewing Conditions Check for the Display Daily or When its 2 4 needed Image Quality Check Weekly 2 5 2 3 Display Screen Cleanliness 2 3 1 Frequency Daily or before clinical image reviews or when it s needed 2 3 2 Objective To ensure accurate image review conditions by keeping the display screens free of dust finger prints and other marks 2 3 3 Equipment Required LCD screens are often called flat panel monitors because they are flat and
20. fect the luminance at the display screens for example moving the display to a new location in the room moving the display to another room or introducing new light sources into the room such as view boxes or room lighting If the illumination condition has changed and cannot be reset to the original condition have your Medical Physicist or your field service engineer check the luminance level The procedure given in Section 3 3 can be performed 4 3 Image Quality Check If the system fails the Image Quality Check it is possible that re calibration of the display is needed It is recommended to have your Medical Physicist or your field service engineer perform the display calibration check described in Section 3 3 If the display does not pass the display calibration check it is recommended that you contact your field service engineer to re calibrate the display or identify any other source of the problem and plan corrective action Document No OMI 1034 Rev No 1 5 Page 20 MQSA Quality Control Manual for IF2105MP 4 4 Viewing Condition Check and Setting For a workstation incorporating more than one display it is recommended that the displays be positioned at angles such that the light from one screen does not illuminate the adjacent screen For reading it is recommended that the distance between the user and a display be approximately 50 cm In order to obtain the optinum ambient luminance it is recommended to
21. in this manual represent a minimum set of QC tests that should be included as part of the quality assurance plan of a display or workstation used for final interpretation in an FFDM system 1 The United States Mammography Quality Standards Act as amended by the Mammography Quality Standards Reauthorization Acts of 1998 and 2004 MQSRA Document No OMI 1034 Rev No 1 5 Page 6 MOSA Quality Control Manual for IF2105MP SECTION 1 OVERVIEW 1 1 Purpose The purpose of this document is to provide a procedure for performing Quality Control tests on the WIDE IF2105MP when they are specially used for the clinical review of images acquired by full filled digital mammography FFDM systems 1 2 Scope The scope of this document is the Quality Control tests to be applied to the WIDE IF2105MP a display monitor intended for clinical review of images acquired by a full field digital mammography FFDM image acquisition system 1 3 Materials amp Equipments IF2105MP LCD Displays PC with Windows Operating System SMD5W Graphic board or other Graphic board listed below Graphic board driver Calibration software LumiCal advanced ver 4 0 or later or eZ Cal pro 4 8 0 0 or later WIDE IQ sensor Built in Monitor or Q PuckTM e Display Color Analyzer CA 210 or equivalent e Other Graphics boards ATI FireGL series 8600 7600 5600 3600 5800 D V1 nVidia FX series 1700 3400 3700 4500 4600 Q 2000D Matrox Med series
22. n Limit The viewing conditions must agree with those established during the most recent evaluation by a Medical Physicist 2 4 6 Use of Test Results If the reading room configuration has changed the source of the problem must be identified and corrective action taken before any further mammographic images are reviewed or interpreted using the display See Section 4 2 2 5 Image Quality Check for the Display 2 5 1 Frequency Weekly 2 5 2 Objective To ensure that the display is calibrated for the reading of mammographic images 2 5 3 Equipment Required None Note When performing this test follow explicitly the instructions which are given below so that the source of the AAPM TG18 QC test pattern is the graphics display driver and not the image browser These tests and associated specifications were designed to be performed with the AAPM TG18 QC pattern that is accessible through the graphics display driver Using any other pattern particularly a pattern that is displayed with the usual image browser tool could result in failing the test and being out of compliance with the requirements of this test Document No OMI 1034 Rev No 1 5 Page 11 MQSA Quality Control Manual for IF2105MP 2 5 4 Procedure 1 In the Microsoft Windows system run LumiCal advanced or CFS software 2 Select Test Patterns in display maintenance menu 3 Open AAPM TG18 QC pattern in display test patterns menu
23. n taken before any further mammographic images are reviewed or interpreted using the display See Section 4 4 3 4 Display Luminance and Gray Scale Calibration Check 3 4 1 Frequency Annually 3 4 2 Objective To ensure each display is calibrated for the reading of mammographic images 3 4 3 Equipment Required LumiCal advanced calibration with the CA 210 The CA 210 requires recalibration every 1 year Calibration certificates are provided with the photometer and the last calibration can also be extracted from the photometer using LumiCal advanced Client Date of last calibration should be indicated in Overall notes comments on the Basic DICOM Conformance Test Report Alternatively use CFS Calibration with equivalent calibrated photometer 3 4 4 Procedure 1 In the Microsoft Windows system run LumiCal advanced or CFS software 2 Operate display calibration and conformance test 3 Run AAPMin Quality control test of disolay maintenance NOTE Refer to LumiCal advance or CFS user s manual for calibration and conformance test 3 4 5 Action Limit The black level shall be within 20 of the target value The white level shall be within 10 of the target value The JND root mean square error shall be less than 0 20 3 4 6 Use of Test Results If the system fails the test the failing measurement shall be repeated If a display fails only at the lowest luminance level first ensure that the ambient ill
24. onditions Check for the Display 2 4 1 Frequency Daily or before clinical image reviews or when it s needed 2 4 2 Objective To ensure optimal viewing conditions 2 4 3 Equipment Required None Document No OMI 1034 Rev No 1 5 Page 10 MQSA Quality Control Manual for IF2105MP 2 4 4 Procedure 1 Review the data form Viewing Conditions Check and Setting posted in the reading room during the most recent Medical Physicist s evaluation On this data form you will find the reading room conditions established as optimal during this evaluation 2 Compare the reading room configuration to the one specified in the data form 3 If differences exist between the configuration specified and the actual one adjust the room configuration to match the configuration specified in the data form For example if desk lights were specified to be turned off turn them off or if Curtains were specified to be closed close them For additional information on maintaining the appropriate luminance level see Section 4 2 NOTE On the Viewing Conditions Check and Setting data form posted by the Medical Physicist you will find the value of the ambient luminance This is a record of the most recent measurement and provides a comparison value for the next Medical Physicist survey The Radiologic Technologist is not required to measure the ambient luminance as part of the Viewing Conditions Check 2 4 5 Actio
25. or lightly dampened cloth with water or special screen cleaning agent and wipe down the outside plastic portions of the computer monitor 3 Gently stroke the cloth across the display screens in one direction moving from the top of the display to the bottom Use a dry or lightly dampened cloth or screen cleaning tissue to illuminate dirt dust finger prints and other marks on screens Do not spray directly onto the screen Chemicals may drop in outside and cause damages 4 Use a dry soft clean cloth to wipe off the residue 5 Check the screen to verify that it is free from dust fingerprints and other marks 6 Record the completion of this procedure on your designated form NOTE If the display has a protective front glass very small size particles are sited behind the protective glass WIDE strongly recommend to contact WIDE service center to have a cleaning service The warranty of the product will be expired when the monitor is opened or the protective glass is removed However you can execute the cleaning on your site if you can work in dust free conditions if it is really requested 2 3 5 Action Limit The screen must be free from dust finger prints and other marks 2 3 6 User of Test Results If these results are not obtained the source of the problem must be identified and corrective action taken before any further mammographic images are reviewed or interpreted using the display that failed See Section 4 1 2 4 Viewing C
26. uminance level requirement is met see Section 3 2 Viewing Conditions Check and Setting and then repeat the measurement If the failure persists the source of the problem must be identified and corrective action taken within 30 days of the test date See Section 4 5 3 5 Image Quality Check 3 5 1 Frequency Document No OMI 1034 Rev No 1 5 Page 15 MOSA Quality Control Manual for IF2105MP Annually 3 5 2 Objective To ensure the display is calibrated for the reading of mammographic images 3 5 3 Equipment Required None 3 5 4 Procedure Complete Section 3 2 Viewing Conditions Check and Setting and Section 3 3 Display Luminance and Gray Scale Calibration Check before performing this test The remainder of this test is the same as the Radiologic Technologist s test Image Quality Check Sec 2 5 NOTE 1t is intended that the test pattern be viewed without modification of its size or gray scale The pattern is disolayed with each pixel of the pattern represented by one pixel of the display For the test to remain valid magnification or zoom features of the disolay must not be used when evaluating the appearance of the features described below Additionally the intensity levels used in the pattern are intended to enable evaluation of the gray scale calibration of the display Adjustment of contrast brightness window width window level or other gray scale modifications must not be applied
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