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KODAK DIRECTVIEW CR Mammography Feature User`s Guide

1. 48 CR Mammography Feature 1 CR Mammography Feature The information contained herein is based on the experience and knowledge relating to the subject matter gained by Carestream Health Inc prior to publication No patent license is granted by this information Carestream Health reserves the right to change this information without notice and makes no warranty express or implied with respect to this information Carestream Health shall not be liable for any loss or damage including consequential or special damages resulting from any use of this information even if loss or damage is caused by Carestream Health s negligence or other fault Document Conventions About This Guide This manual uses three types of messages to emphasize information or potential risks to personnel or equipment Notes Important and Caution NOTE Notes provide additional information such as expanded explanations hints or reminders IMPORTANT Important highlights critical policy information that affects how you use this manual and this product 44 CAUTION Cautions point out procedures that you must follow precisely to avoid injury to yourself others damage to the system or any of its components loss of data or corruption of files in software applications Use the KODAK DIRECTVIEW CR Mammography Feature User s Guide for specific information on the use of the CR Mammography Feature This guide doe
2. Take the exposed cassettes to the CR System and load them correctly See the CR Systems User Guide Information The CR System reads the cassette bar code scans and stores the image from the cassette then erases the cassette for its next use If the CR System cannot read the cassette bar code the following messages will appear Take the appropriate actions as described in Scanner Bar Code Messages on page 1 22 Scanner Bar Code Messages Cause Message Action When the scanner is unable to read the bar code and cannot identify the size this message appears so that you can select the size manually from the following screen e Select Cancel to remove the cassette or e Select the cassette size to continue processing the cassette If this occurs the image will be unassigned Assign the image and apply the correct view Reviewing and Accepting Images See the KODAK DIRECTVIEW CR Systems User Guide Information for information about viewing images and maintaining image quality on a CR System amp CAUTION The CR System or ROP monitor displays a sub sampled lower resolution version of the full resolution stored mammography image Do NOT use the sub sampled mammography image displayed on the CR System or ROP monitor for screening or diagnostic interpretation purposes The CR System monitor or ROP must only be used to verify correct positioning and image processing selection Do not use the
3. The act of transferring an image from the CR System to a specified destination A collection set consisting of a series of images Technical factors in the design of the Mammography machine that affect production of the mammographic image The goal is to produce consistent diagnostic images A graduated range of gray values constructed to optimize an image for clinical diagnosis by highlighting the body structures of interest to a Radiologist See Projection The list of patient records that describes the patients to be examined during a given time interval 9G3741 1 47 CR Mammography Feature r UrUEUEUIGIO UU UNS a a IMEEM Te eer en eem Acronyms AC Applications Consultant CR System Computed Radiography System for mammography imaging this refers to the following CR 850 950 975 or Classic Elite CR Systems DICOM Digital Imaging and Communication in Medicine EHR Enhanced High Resolution type of phosphor screen used with CARESTREAM CR Mammography Cassettes SNP M1 Type of screen used with CARESTREAM CR Mammography Cassettes EHR Scan Sub 50 micron scan capability used within the CR System for CARESTREAM CR Mammography Mode Cassettes with EHR M type screens EVP Enhanced Visualization Processing a contrast enhancement algorithm contained within the IPL GUI Graphical User Interface the user interface observed at the CR System monitor HIS Hospital Information System HIS RIS See
4. each with a minimum image array size of five megapixels d CAUTION Primary interpretation of hardcopy images shall be performed on a printer cleared for mammography and supporting the DICOM 3 0 standard The printer shall have a 50 micrometer um pixel pitch or less and maximum film optical density of at least 3 6 9G3741 1 3 CR Mammography Feature EEUU URS m CAUTION Use CR Mammography Cassettes only for Mammographic Imaging Do not use CR Mammography Cassettes for general radiography imaging applications Do not use CR Cassettes intended for general radiography for Mammography imaging applications d CAUTION KODAK DIRECTVIEW CR Systems allow CR Mammography Cassettes with EHR M EHR M2 EHR M3 and SNP M1 screen types to be scanned Only scan cassettes with the same screen type on the CR System and do not intermix the cassette screen types when performing a patient exam Intermixing the cassette screen types may result in an inconsistency in the quality of the image NOTE For hardcopy printing of Mammography images Carestream Health recommends that you configure the CR System for use with a KODAK DRYVIEW Mammography Laser Imager using KODAK DRYVIEW Mammography Laser Imaging Film Contact your Carestream Health Sales Representative for more product information NOTE For softcopy viewing of Mammography images Carestream Health recommends that you configure the CR System for use with a KODAK DIRECT
5. used in place of the screen film density setting for CR exposures 5 Repeat steps 1 to 4 for PMMA thicknesses of 2cm and 6cm and for each operational mode of the system IMPORTANT The X ray exposure influences the level of noise in the image Increasing the density control setting increases the exposure and patient dose but reduces the perceived noise in the image Conversely a lower density control setting lowers the exposure and patient dose but may increase the perceived noise in the image IMPORTANT Ifyou cannot achieve a similar technique it may be necessary for a qualified X ray equipment service representative to recalibrate the X ray System s Automatic Exposure Control AEC using the CR Mammography Cassette CR without an existing Screen Film System The AEC system must be specifically calibrated using the CR Mammography Cassettes by a qualified X ray equipment Service Representative 1 18 9G3741 CR Mammography Feature UEETTTINEUEU TU Exposure Index The system provides an exposure index EI which is displayed on the CR Console s image viewer screen This is a measure of the X ray exposure incident on the CR Mammography Cassette The EI is calculated from knowledge of the signal values in the clinically relevant portion of the patient image EI can be useful as a guide to understanding the exposure in a given image IMPORTANT The Exposure Index is a measure of cassette input exposure and IS NOT a measu
6. HIS and RIS this term refers to both systems at a single site but does not imply that they are linked or even exist on the same network IPL Image Processing Library the suite of image processing algorithms used in the CR System as applied to the captured image kV Kilovolts thousands of volts measurement unit for X ray beam strength kVp Kilovolts Peak LCC Left Cranio Caudal view of the left breast taken from the anterior to the posterior LM Latero Medial lateral view of the breast taken from the lateral axilla to the medial side LMLO Left Medio Lateral Oblique view of the left breast taken from an oblique angle from the medial to the lateral where the pectoralis muscle should be seen down to the level of the nipple mAs Milliamp seconds measurement unit for the amount of X ray energy delivered ML Medio Lateral view of the breast taken from the center of the chest outward mR Millirads measurement unit for X ray exposure RCC Right Cranio Caudal view of the right breast taken from the anterior to the posterior RMLO Right Medio Lateral Oblique view of the right breast taken from an oblique angle from the medial to the lateral where the pectoralis muscle should be seen down to the level of the nipple RIS Radiology Information System ROP Remote Operations Panel a networked connected device with the CR System used for performing an exam UID Unique identifier a number assigned to ensure unambiguous identi
7. Manual Black Surround feature lets you apply Surround Masking to the image and adjust the masked area manually You can move the mask to a variety of four sided geometric shapes by dragging the edges of the mask on the Image Viewer Screen When the image reprocesses you can view the result on the Image Viewer Screen or on the thumbnail on the Patient Input Screen Use this feature when the Automatic Mask fails To mask selected image areas 1 Make sure the Edit Mask check box is selected 2 Circles appear at guide points on the mask 3 Touch the edge of the mask at one of the arrows and slowly drag the edge across the screen to change the position 4 Select Reset to return to the original mask 5 Select Reprocess 6 Select Save Changes For more information about applying masking see the CR System Online Help 9G3741 1 43 CR Mammography Feature _ UNUS GUT KG Em Uu o CO TUUMEUUI IUE IE nU Ue err en er ODAK Directview System VoLabConsole7 Image Viewer Rick Morningstar X View Name Breast LCC o Invert Grayscale B Grid Suppression Y Noise Suppression p eI s Manual Black Surround 1 44 9G3741 CR Mammography Feature IU UUETTTINNUUU Up Overscan Check Getting Help The CR System overscans the CR Mammography Cassette to e Capture all the image data at the chest wall edge e Support proper operation of the Surround Mask feature When the CR System is properly calibrated the no
8. Workflow and Operation Collect patient demographic data HIS RIS Broker D Enter Patient Data Manually enter the Patient data on the Scan the Patient ID bar code e ROP Query the Local database CR System or guys Henle Remote Patient Data Entry Station 1 Enter Exam data p 2 Scan the cassette bar code label qo 3 Touch Save Changes Scheduled Workflow YES NO Y Option Y Message sent to HIS RIS that the Procedure Step is started Status on CR changes Status on CR changes from Scheduled to Started from Scheduled to Started 5 Position the patient 6 Collimate properly A 7 Expose the cassette y Expose additional cassettes if necessary Y Load the cassette s in the CR System y Review and evaluate images If acceptable send to destinations and release patient y Select End Study when complete or D C to cancel Procedure Step 1 10 9G3741 CR Mammography Feature UETTTIIEUUUU UU Performing a Mammography Exam Preparing the Cassettes This section describes the steps necessary to perform a typical four view breast exam using the CR System e CC e MLO IMPORTANT See the KODAK DIRECTVIEW CR Systems User Guide Information for configuration use differences entering patient and exam data viewing
9. and maintaining image quality and printing and managing images You will need four unexposed CR Mammography Cassettes 18 x 24 cm or 24 x 30 cm as needed for the four views NOTE Ifyou have purchased the X ray Interface it is not necessary to apply a reusable sticker on each cassette to indicate the image view RCC LCC LMLO or RMLO that will be exposed on the cassette or the kVp and mAs settings used for the exposure or a possible comment regarding the patient exam See Mammography X ray Interface on page 1 19 IMPORTANT Erase CR Mammography Cassettes each day prior to clinical imaging when you suspect the cassettes have been exposed to any X ray radiation or when you use the local user interface on the Classic Elite CR System Insert the cassette into the CR System This procedure erases all information on the cassette KODAK Direcrview Systeu VBLabConsole7 Main Menu Rick Morningstar Xj Version 5 1 Copyright 2008 Carestream Health Inc All Rights Reserved n Main Menu 9G3741 1 11 CR Mammography Feature mmm Creating a Patient Record To create a patient record at the CR System or on a Remote Operations Panel ROP 1 Atthe Main Menu touch Study Data The Patient Query Screen appears Kopak DirectView V5test34 Patient Query admin 3 s Patient Last Name Patient First Name Study Status Time Window Modality ALL Unrestricted ALL
10. can be used for changing from screen film to CR Control AEC Mammography Cassettes by using the density control adjustment of the X ray machine Calibration IMPORTANT This procedure assumes that the AEG function of the X ray equipment is properly calibrated for use with the current screen film system to meet applicable regulations IMPORTANT This procedure must be performed for each mammography unit Attempting to use the same density control change for multiple mammography units without verification is strongly discouraged The effect of changing a single step e g from 0 to 1 density of density control can vary dramatically among different manufacturers or even for the same manufacturer and model number depending on the AEC software revision level 1 Use a standard phantom that represents the average breast If no standard phantom is available use 4 cm of PMMA or BR 12 breast equivalent material 2 Under AEC control determine the mAs for an exposure of the phantom with the X ray unit settings exposure mode filtration kVp density setting that would be used with the current film screen system or CR Mammography Cassette type 3 For the same X ray unit settings determine the mAs for the image of the same phantom taken with the CR Mammography Cassette 4 If there is a difference in the mAs then adjust the density setting to lower mAs to raise mAs to achieve the closest match in mAs This density setting should be
11. decreases Narrows the latitude or increases the the global contrast global contrast Controls the local contrast of medium sized structures such as joint spaces vertebral body spacings and ribs in lower density regions of the image NOTE In the Image Viewer and the Key Operator Image Viewer the low and high contrast controls are linked together and adjusted simultaneously by the Contrast control This affects the appearance of the image to the Technologist The Technologist can affect the appearance of only one image at a time Increasing the Slider Decreasing the Slider Makes medium sized structures in Makes medium sized structures in brighter areas more pronounced brighter areas less pronounced Controls the sharpness of finer structures such as bony trabeculae lung markings and microcalcifications in lower density regions of the image Increasing the Slider Decreasing the Slider Increases the sharpness of finer Decreases the sharpness of finer structures in the lower density structures in lower density regions of regions of the image the image Controls the level of noise suppression applied to the image Each slider click produces a 0 03 change in noise suppression level relative to the selected look Increasing the Slider Decreasing the Slider Reduces the level of noise Decreases the appearance of noise in suppression the image or increases the level of noi
12. e Remove the screen and plate before cleaning the cassette s outer shell See Opening the Cassette on page 1 37 Do not allow water or cleaning solution to enter the shell Clean the outer shell surfaces with any of the following solutions 1 38 9G3741 CR Mammography Feature IU UUETTTINNUUUU Uu Handling and Maintaining the Screen Mild soap and water e KODAK Screen Cleaner d CAUTION Do not pour the cleaning solution directly onto cassettes or screens Apply the solution to a lint free cloth CAUTION Do not use soaps or detergents with brightening agents as they will damage the storage phosphor screen Handle phosphor screens with care Hold screens by the edges Avoid contact with the screen s white phosphor side Make sure hands are clean and dry For best results wear clean soft lint free Nitrile gloves 44 CAUTION Under normal use conditions phosphor screens will eventually show wear Screen wear can result in artifacts on radiographs This wear may occur from abrasion of the protective overcoat or inadvertent physical damage to the surface 44 CAUTION Screen damage can result from contact with certain materials used in facilities performing radiography Contact with Isopropyl alcohol peroxides citrus based cleaners hand lotions and water less hand sanitizers as well as surfactants and lubricants may cause visible or hidden damage to the screen and could result in immediate or future
13. image artifacts AVOID CONTACT BETWEEN THESE MATERIALS AND PHOSPHOR SCREENS 44 CAUTION Moisture can cause immediate or future screen damage and image artifacts Minimize contact with moisture and ALWAYS DRY SCREENS IMMEDIATELY 4 CAUTION Read and follow instructions in Material Safety Data Sheets MSDS for KODAK Screen Cleaner 9G3741 1 39 CR Mammography Feature UEUEUEUEGIO UU URS a IM LI en ees Cleaning the Screen Do not expose screens to e materials containing peroxides e Isopropyl alcohol e citrus based hand cleaners e hand lotions e water less hand sanitizers e surfactants e lubricants excessive moisture Use a clean dry soft lint free cloth to remove dust Use one of the following approved cleaners to remove other dirt NOTE When using a cleaning solution apply the solution to a clean soft lint free cloth Do not pour the cleaning solution directly onto the screen Catalog Number Cleaning Material 845 4977 KODAK Screen Cleaner Cleaning Method Wear soft lint free gloves Do not touch the white phosphor side with bare hands 1 See Opening the Cassette on page 1 37 Place the screen with the white phosphor side up on a clean dry non abrasive surface 2 Wipe the screen gently to remove dust 3 Follow the directions for the cleaning product being used 4 Wipe the surface dry with a clean soft lint free cloth NOTE Do NOT allow the screen to air d
14. ined OPE Ule Rx aeons 34 Presentation Of ILIUM HER 34 Printing Mammography Images oriente eet ciebeh ee eee te reb eie ib te HERE RH AE YRHE AER e Y VEUR d 35 Creating Multi tormat PUI s oda moo Rol cuca n Sa tct PN Ua EENS PEDE 35 Mammography Cassette Use Instructions eene nennen nennen 37 Opening th Cassette baie oi Gri aa ER e tc Q RM ORI DURO E aE E Qs UND IR DUM UIN Gu aN 37 Eleanor tbe Cassette Dll e pcena tasche ctn UG iaon Bem ticU Sn tcI e Muro dese 38 Handling and Maintaining the SC GBIL au code bta ett gent top etti opqel e updated Dr d 39 Cleaning the Screens N 40 Cedo Meth d E ese ruta tbt See eR ee qM nidi aue Nee ta 40 Disinfectng the Sere ehh or the CASSOLIG ai eos cct intento ndi aret nda i l Disposing ofthe SCEGefLua uae erased i d ha enduro qute EE ed pa NR ER ENa l Quality CONO E sesto re di thua Main E E E E RUN Nd 42 Acceptance and Quality Control Testing es sssessssssssissssieesresssresssessreessttssreessressrenssressstssreessreesrensreessrese 42 Troubleshooting NNNM EN EVEA AEN EEEE ERNE NENN ESVE ENEE 42 Black Surround Masking siessen niers niren cad noaa Sa AR ENESE EN A EAEE ENES M P MU 43 nar Noris 43 vets CAML Check e M X X 45 Geo HEB Gc auos ced NR enna ee een Ree eee es een a CE NNNM UE 45 UT m EL A E 46 L uinnjyn M
15. of the full resolution stored mammography image Do NOT use the mammography image displayed on the CR System or ROP monitor for screening or diagnostic interpretation purposes The CR System monitor or ROP are not diagnostic monitors and must only be used to verify correct positioning and image processing selection Do not use the display to evaluate CR performance 9G3741 1 23 CR Mammography Feature ERE ESSE UESTRE eR SIGUE ESSE USER cmn nm enn 4 Review the image and check the following a All breast tissue is present b The image is correctly captured c There is no motion d Markers are visible e Exposure index value is as expected See Exposure Index on page 1 19 If any of these items are unacceptable re exposure may be necessary Ifimage quality is not acceptable ensure that the correct body part and projection have been selected See the CR System Online Help for information on making image quality adjustments such as Brightness and Contrast and Image Tonescale NOTE Image Processing Parameters are turned on and off by touching the check box on one of the four the Image Processing Parameters Tabs To apply a parameter select a check box for the following adjustments on the Tabs in the Image Viewer Screen and touch Save Changes For more information on using the Image Viewer Screen see the CR System Online Help Features and Adjustments Image Adjustment Tab brightness latitude and det
16. pertains to the way in which an exam is performed Exam Type View Body part and projection from the Exam Information and optionally position Exposure Factor Technical factors in the design of the mammography machine that affect production of the mammographic image The goal is to produce consistent high contrast diagnostic images Focal Spot Size The focal spot dimensions Half Value Layer The thickness of a specified substance which when introduced into the path of a given beam of radiation reduces the exposure rate by one half HVL is a measure of beam quality and usually is specified by millimeters of aluminum for diagnostic units The higher the HVL the more penetrating the X ray beam Image A data structure that contains image data patient information and information relating to the method of creating the image data in a DICOM compliant format Image Receptor The screen film combination is the standard image receptor used in mammography For Computed Radiography the image receptor is the phosphor screen kVp Accuracy and Test used to ensure that the indicated peak X ray beam energy is accurate and Reproducibility reproducible so that consistent X ray output and contrast are maintained Mammography Also described as a softcopy electronic display viewing station the workstation is Workstation designed for and used by Radiologists to read mammograms Medical Physicist A trained specialist who conducts a number of mam
17. protect it from sunlight ultraviolet rays fluorescent light X ray and gamma ray sources Do not discard or incinerate Please consult federal state and local regulations for proper disposal IMPORTANT When cleaning a cassette and screen take care to maintain the integrity of the phosphor screen and avoid introducing artifacts Inspect all phosphor screens monthly and clean as necessary with KODAK Screen Cleaner used according to the manufacturer s instructions When wear is evident replace the screen Opening the Cassette The following steps require a small pointed tool such as the end of a paper clip H226 1043HC 9G3741 1 37 CR Mammography Feature 1 Position the cassette on a flat surface such as a table with the Tube Side up 2 Place the pointed tool in Slot A and slide the latch to the right H226 1044HC 3 Pull out the screen and plate using the flat surface as a guide to avoid touching the phosphor on the cassette shell 4 Inspect the screen and plate and clean as described in the following procedures 5 Slide the screen and plate back into the cassette using the flat surface as a guide 6 Place the pointed tool in the opening at Slot B and press lightly to lock 7 Make sure the screen and plate are secure in the cassette Cleaning the Cassette NOTE Read and Follow instructions in the Material Safety Data Sheets Shell MSDS for KODAK Screen Cleaner prior to use
18. times the CR Mammography Cassette can be used for image exposure before replacement is required IMPORTANT CR Mammography Cassettes should not be stored or left unattended in the exam room When an X ray exposure occurs scatter radiation can expose the cassettes that are located in the exam room resulting in fogged or low contrast appearance in image quality You can use the Erase Cassette function on the CR System to assure the cassette is fully erased prior to using for patient exposure Before You Begin After installing the CR Mammography Feature in the CR System and before clinical use 1 A trained Service Representative should check that the CR System Is properly configured and contains KODAK DIRECTVIEW CR Software Version 5 or higher Has the CR Mammography Feature enabled Is calibrated for use with CR Mammography Cassettes Operates within specification to produce expected image quality 2 A Medical Physicist or if permitted by applicable regulations qualified personnel under direction of a Medical Physicist should Performs the necessary acceptance testing according to applicable regulations Check the Mammography X ray Unit s Automatic Exposure Control AEC is properly calibrated for use with CR Mammography Cassettes and meets applicable regulations AEC calibration is to be performed by a qualified X ray equipment service representative Establish and or approve the use of an exposure tec
19. KODAK DIRECTVIEW CR Mammography Feature User s Guide 17 September 2010 9G3741 Version 1 0 Carestream Carestream Health Inc 150 Verona Street Rochester NY 14608 CARESTREAM DIRECTVIEW and DRYVIEW are trademarks of Carestream Health Inc The Kodak trademark and trade dress are used under license from Kodak Carestream Health Inc 2010 Table of Contents 1 CR Mammography Feature Peu EFI M 1 Finger m 1 For European Markets asia acabas Qu dvd uut geb tub pd debug pi apu Dd udin eM el etd 2 Safety and Related Unformation cissicscssescscsssssesesssoosessseossnsspeessenssencorsnseuensosensacassanioseasonsnesuasseasssntsnssenesesarsonsenoses 2 Mammography Imaging Chaiti soscace reete tete ta evertere ted iere iret eed eere de UR eek edd edere 4 ACQUISITION t 5 Capture and PEO CES SURE ees oeaoste mde hen oU UMF eH PU UU RF tH tiep ta MR one UNES 5 Softcopy Viewing Storage RM 6 Hardcopy Printing 7 VIGWIDE aui odere siet tor tete uh uunc tutu t der hut actos 6 CR Mammography Feature P 6 Tad ados f r Useren E AERE TEE p cu ESTEE 6 CRUS SUIS osse esr aiia eere bu DVD UR REEF UNDIS E EEEE EL NER ANM UM aT ES i 6 CR Mammography COSSPllOSoosonsnot pitis sei pdqtuta minus tan PRU ee ee eee 7 B fore You Beggin
20. NE 8 W WorkHos and Op r t n sssini desc cvanciesinkostatenavenves tavadlpasaheaulantaeyeashantionsciancuatsaannadanehaeseathanacbanumecennaabenaaen 10 Performing a Mammography Exam eese netten tenete tenent tnter 1 Preparing the Cassetes M 11 Creating a Patient sro P C Q 12 Using CR Mammography Cassettes esee ennt nennen tret tnnt tree totae ntn tute tta toa tinto netten 14 Ihr SPACE oir M 14 Compatibility with Xray Systems x cccsanstessnwvnaichesschannstnawunsbasctesnslasbidanb ausisanosiaawtsioncnsaiss Vd pellit uuu d 15 Technique COUSIOSEIUDESC stia mirati eret Ei mtis im hum team xt Pd stasd iaa rp Rn S pui B RUE 16 X ray Techiig es E ETE OQ T 16 Automatic Exposure Control AEC ahcsacueeci tss Rode ti rl optet aa rca dato uut Com partea Rep 17 Automatic Exposure Control AEC Calibration sssesseeeeenneertn tnnt 18 Exposure UN ice mota Redeem eu pst uti blind ceca nda deanna 19 Recordine Exposure PAGuftelels suapte uiia eiiiai aiie dts tiu 19 Mammography X ray Interface CREER NES TTE Lm 19 General Radiosraphy WOPBBOS d eise tipi bucina a sen trt brad tee iie ER inie ieiki 20 Mammography diari P 20 ben dr c ae 21 WIRE S SI RETE C QT T TO eee 22 mmc Scanner Bar Code Messages sto
21. Patient Query Screen 2 To search for an existing patient already in the system Use the bar code scanner or virtual keyboard to enter known search criteria Touch Find Local to search the CR System s database Touch Find Remote to search the HIS RIS The Patient Worklist Screen appears with a list of patient studies that match the search criteria To open the patient record you searched for touch anywhere in the row For more information about using the Patient Worklist Screen see the CR System Online Help 3 To create a record for a new patient not in the system or unavailable a Touch New Patient The button appears on the Main Menu or in Study Data The Patient Input Screen appears b Enter the required yellow highlighted information using the virtual keyboard or by using the bar code scanner Select the Mammography category for Procedure e If your system uses Procedure Mapping the four views will appear automatically RCC LCC RMLO LMLO or as programmed by your Key Operator 1 12 9G3741 CR Mammography Feature mmm C e f your system does not use Procedure Mapping select Add View and manually add each view and configure the Laterality for each image The image icons appear for the four views These icons are associated when you scan the cassette bar code Patient Input Mammography View Selection NOTE Select the cassette for the RCC view Scan the cassette s bar
22. Resolution Black Surround Masking covers up 1 mm of image area along the chest wall edge Reprocess the image with Manual Surround Black Surround Masking covers up image information along short edges due to collimation Reprocess the image with Manual Surround Make sure the X ray beam has not been collimated into the cassette Black Surround Masking may occasionally have a jagged edge Reprocess the image with Manual Surround or perform the Overscan Check Black Surround Masking may mask off the entire image or may not be applied at all Reprocess the image with Manual Surround or perform the Overscan check 1 42 9G3741 CR Mammography Feature mmm Black Surround Masking Manual Black Surround Black Surround Masking darkens the unexposed area around the image and masks that area from the rest of the image Black Surround Masking should be turned on by default for mammography images by the Key Operator To apply Black Surround Masking 1 At the CR System Image Viewer Screen touch the Image Processing Tab 2 Touch the Surround Mask check box to select it 3 Touch Save Changes The image is masked automatically making it easier to see soft tissue and low contrast areas To turn off Black Surround Masking 1 Select the Surround Mask check box to clear it 2 Select Save Changes The masking process stops immediately Unexposed areas are not darkened The
23. VIEW Mammography Workstation Contact your Carestream Health Sales Representative for more product information Mammography Imaging Chain The Mammography Imaging Chain with the KODAK DIRECTVIEW CR System diagram shows an overview of the equipment necessary for producing diagnostic quality mammograms Obtaining high quality mammography images is dependent on many factors All equipment in the Mammography Imaging Chain must be properly calibrated for use and quality control checked for proper functionality per each manufacturer s recommendations The Technologist plays a key role in successfully achieving high quality digital mammograms by understanding the best exposure techniques to use based on breast thickness and composition and the capabilities of the equipment in the imaging chain In addition to the KODAK DIRECTVIEW CR System with CR Mammography Feature Carestream Health provides Mammography Workstation and Mammography Printer solutions thus optimizing the system performance of this equipment in the Mammography Imaging Chain 1 4 9G3741 CR Mammography Feature Se TQNUUTSCUEUEUEG MALAE Ee e Ur emu mein ar e As depicted in the diagram the equipment can be described under these main functional categories a Acquisition b Capture and Processing c Softcopy Viewing and Storage d Hardcopy Printing Viewing Acquisition Mammography X ray Unit Generate Target Filtration T Softcopy Viewing Storage Captu
24. ages that comply with all local and national regulations on patient dose It should also ensure the image quality is consistent with the local clinical expectations IMPORTANT The dose shall be determined with technique factors and conditions used clinically for a standard breast The maximum dose must comply with applicable regulations The following sections provide general guidance on X ray techniques to use with the CR System and on configuration of the AEC X ray The selection of X ray technique includes the selection of specific beam parameters Techniques kilovoltage target filtration and the exposure level mAs as a function of patient thickness and glandularity e Personnel familiar with screen film mammography have become accustomed to X ray technique factors designed for the screen film image receptor For example if film processing is maintained in control the use of insufficient X ray technique produces images that are too light Likewise the use of excessive X ray technique produces images that are unacceptably dark As with all digital imaging modalities CR Mammography images may not appear too light or too dark if inappropriate X ray technique is used Hence it is essential to develop and consistently utilize an appropriate X ray technique chart to avoid suboptimal image quality or excessive radiation dose e Due to the wide variety of different X ray machine capabilities user preference for noise and image sharpness
25. ail contrast Markers Tab adding moving deleting markers Surround Mask Tab applying moving removing surround mask View Look Adjustment Tab change views apply grid suppression invert image Crop Box Adjustment Tab True size Printing Manual Cropping Multi format Printing Print Tab add text boxes rotate flip image Magnification Tab pan and zoom change magnification Comments Tab add comments to the image using the virtual keyboard Quick Menu Logout Shutdown Flag image for review Place a Left or Right digital marker on the LCC LMLO and RCC RMLO views a With the LCC or LMLO image displayed select the Left marker check box or With the RCC or RMLO image displayed select the Right marker check box 1 24 9G3741 CR Mammography Feature KODAK Directview System V5LabConsole7 Image Viewer F Window i Level z Mode vivivil CRO ED AP PA LATERAL SUPINE PRONE CONTROL PORTABLE CROSS TABLE gaam g d b Select the point on the image where you want to locate the marker The marker appears on the image c To move the marker select another location d To remove the marker clear the check box e Select Save Changes when finished NOTE When you select Save Changes the marker is stored and printed as part of the image 7 Select the Accept Image button when the review and image processing are complete The image is sent to its default destination such as a Mammo
26. and the range of applicable regulations that control the allowed patient dose there is no single specific recommendation for acquisition techniques that can be provided for use with the CR System As a guide a typical acquisition technique for a standard 4 5 cm thick breast with 50 50 composition might be 26 kVp Mo Mo and 100 mAs This technique produces a mean glandular dose MGD of 2 mGy There could be considerable variation from this typical technique as an institution adjusts for its local preferences 1 16 9G3741 CR Mammography Feature UETTTIIEUUU Uu Automatic Exposure Control AEC e In general when imaging thinner or more fatty breasts it is common to use a softer X ray spectrum and lower mAs values Softer X ray spectra are achieved by using lower kVp settings as well as choosing the molybdenum target and filter combination When imaging thicker and denser breasts it is common practice to use a harder X ray spectrum and higher mAs values Harder X ray spectra are achieved by using higher kVp settings as well as choosing the rhodium filter and rhodium or tungsten target where available e Increasing the mAs for a given beam spectra will lower the noise and increase the dose Conversely lowering the mAs for a given beam spectra will lower the dose and increase the level of noise in the image It is important to operate the system at a dose that meets applicable regulations Consult a Medical Physicist for
27. aphy Feature 1 Purchase and install the CR Mammography Feature Option 2 Log on as the Key Operator 3 Enter the Mammography Feature code to automatically enable the feature When the CR Mammography Feature is enabled the KODAK DIRECTVIEW CR System produces high resolution Mammography images using CR Mammography Cassettes Only CR Systems with the CR Mammography Feature enabled will support the use of the CR Mammography Cassettes Digital images are produced as follows Cassette Size Sampling Rate Image Size Pixel Spacing approximate 18 x 24 cm 20 pixels mm 34 MegaBytes image 48 5 microns 24 x 50 cm 20 pixels mm 57 Megabytes image 48 5 microns CR CR Mammography Cassettes are designed for Mammography applications only They Mammography contain a high resolution Mammography storage phosphor screen and are available in Cassettes two sizes 18 x 24 cm and 24 x 30 cm To readily identify that a CR System can accept a Accepts Kodak DirectView CR Mammography Cassette CR Mammography Cassette one of the following two labels will be attached to the CR System ELS 6 Ko gt MAMMO QUALITY 9G3741 1 7 CR Mammography Feature ri UU UU Mg mW a IUE LUE euer ene The Mammography storage phosphor screen is not physically contacted when transported or scanned by the CR System Not withstanding possible wear conditions there is no established total number of
28. assettes do not use a flash exposure device and a cassette ID window as traditional screen film cassettes do For more information see Text Box Configuration in the CR Systems User Guide Information The DIRECTVIEW Mammography X ray Interface is an accessory device that automatically transfers technique information from the X ray generator to the CR image The information is displayed at the CR System on the More Information Tab on the Patient Input Screen If you purchase the CR Mammography Feature you may want to add the Mammography X ray Interface to your workflow This device is installed by your Carestream Health Service Representative and sends exposure information from the Mammography X ray generator to the CR System or ROP The Mammography X ray Interface associates exposure information from selected X ray generators and automatically associates with the Mammography image that is highlighted on the Patient Input Screen 9G3741 1 19 CR Mammography Feature a a IUNII euer en enm The Mammography X ray Interface has three elements e Interface box e Connecting cable e Installations and connection to the X ray device To ensure that the data associates with the correct image make sure the following is true e Connect the Mammography X ray Interface to an ROP whenever the CR System is shared between Mammography and General Radiography exams or when shared among several Radiographers e The highlighted icon on the Patient Inp
29. code and confirm that the Cassette ID field displays the bar code number To change the default view select the image and go to the Image Viewer Screen Select View Name and select the appropriate view from the list Select Reprocess Select the proper Laterality Use Right for RCC and RMLO views and Left for LCC and LMLO views Touch Save Changes This records all of the patient exam and cassette ID information in the CR System database For more information about search techniques or entering patient data see the CR System Online Help 9G3741 1 13 CR Mammography Feature UEzUEUEUIGIO UU URS a IUE IE nU eren eem Using CR e Use only CR Mammography Cassettes for creating Mammograms Mammography Do not use CR Mammography Cassettes for general radiography imaging Cassettes applications Do not use CR Cassettes intended for general radiography for Mammography imaging applications See CR Mammography Cassettes on page 1 7 e Carestream Health recommends using the same type of CR Mammography screen for all images within the study Exposing the Take the CR Mammography Cassettes to the Mammography X ray unit where the patient Cassette is prepared for the exam 1 Insert the cassette into the Mammography unit s cassette holder the same way you would insert a traditional mammography screen film cassette Chest Wall Edge 2 Make sure the cassette is oriented with the narrow edge next
30. display to evaluate CR System performance NOTE Carestream Health recommends that you set your viewing mode to QA by image mode to review and accept the mammography images before sending them to their destinations Pass through mode which delivers images to destinations without inspection can be used but is not recommended For more information about viewing modes see the CR System Online Help 1 22 9G3741 CR Mammography Feature UU ETIN uU 1 On the CR System monitor or the ROP display make sure that a thumbnail image is present on the Patient Input Screen for each cassette scanned If the thumbnail images do not display open another image or exit and re enter the Patient Input Screen NOTE Wait for all of the images to appear If they do not appear exit the Patient Input Screen and re enter 2 Enter the kVp and mAs if recorded on the More Image Information Screen and any comment information on the More Patient Information Screen Press Save Changes to store this information as part of the Patient Record 3 Select the thumbnail image you want to review The Image Viewer Screen appears Verify that the View displayed on the Image Processing Tab is correct D a T m Show ao wv View Name Breast CC Standing B invert Grayscale g Grid Suppression 7 Noise Suppression Image Viewer Screen CAUTION The CR System or ROP monitor displays a sub sampled lower resolution version
31. e image while the View icon is still highlighted The X ray Interface forwards the exposure report to the CR System The next View icon is automatically highlighted The CR System can read the cassettes in any sequence To change the sequence select any unexposed View and proceed with step 2 Repeat steps 2 and 3 to select assign and expose for the remaining views 1 20 9G3741 CR Mammography Feature IU UNTIL Transmitted Data 4 Scan the cassette When the X ray Interface is used with the CR System the highlight on the Patient Input Screen moves to the next icon when the System receives the exposure report from the Interface Scanning the bar code on a cassette does not advance the highlight to the next icon NOTE When General Radiography and Mammography workflows are both needed on the same CR System attach the Interface to an ROP with mammo workflow and use the General Radiography workflow at the CR Console The DIRECTVIEW Mammography Interface can receive most data sent by the generator The specific data fields vary by generator but generally include the following items kVp mAs Source to Image Distance SID Compressed Thickness Compression Force N Angle of Exposure Anode Target Material Filter Magnification Ratio NOTE The Key Operator can select from 15 different screen layouts that accommodate this data 9G3741 1 21 CR Mammography Feature a SEEN a a a cee Scanning the Cassette
32. ed as a starting point for a view the sliders are set to a neutral position or zero All slider adjustments are relative to the look being used for that view except for the kernel grid suppression and skin line enlargement sliders which adjust absolute values The adjustment of a slider by one click is designed to produce a difference that is just noticeable or a difference that matters The Brightness parameter defines the log exposure code value that is mapped by the tone scale LUT to mid density The slider adjustment is in output density space in order to produce a change that is perceptually meaningful across images The density change is mapped back through the tone scale LUT to calculate the log exposure code value which is used in EVP Plus Software Each slider click produces a 0 05 density change relative to the selected look Increasing the Slider Decreasing the Slider Brightens the image Darkens the image 1 32 9G3741 CR Mammography Feature IU UETTTINEUUUUU Uu Latitude Contrast Sharpness Noise Latitude is proportional to the number of shades of gray or range of exposures that are visible in an image and is inversely proportional to the degree of difference between the lightest and darkest areas of an image global contrast Each slider click produces a 5 change in latitude relative to the selected look Increasing the Slider Decreasing the Slider Widens the latitude or
33. ervice Representative is to install and verify the CR System is set up and functioning properly for use of the Mammography Feature See Before You Begin on page 1 8 1 2 9G3741 CR Mammography Feature m d CAUTION Calibrate all components in the Mammography Imaging Chain at the recommended intervals according to the manufacturer s instructions and before use See Mammography Imaging Chain on page 1 4 CAUTION A Medical Physicist or qualified personnel is to establish or approve the exposure techniques used A technique chart should be posted near the X ray unit generator control panel See Technique Considerations on page 1 16 44 CAUTION The Medical Physicist or qualified personnel is to perform the Acceptance and Quality Control Tests as mandated by applicable regulations Ay CAUTION Follow and perform the Quality Control procedures for all components in the Mammography Imaging Chain at the recommended intervals according to the manufacturer s instructions and per applicable regulations The facility must ensure that the image quality produced by all equipment in the Mammography Imaging Chain meets the requirements for clinical use See Mammography Imaging Chain on page 1 4 d CAUTION Primary interpretation of softcopy images shall be performed on a workstation cleared for mammography and supporting the DICOM 3 0 standard The workstation shall have at least two displays
34. f 4 0 the darkest part of the image to display soft tissue without adding contrast Creating To create a multi format print Multi format 1 Touch a 2 3 or 4 up layout in crosswise or lengthwise format Prints ODAK Directview System V5LabConsole7 Multi Format Print Configuration Rick Morningstar Ne Patient ID 76766786 Tech ID um fn Gee Em EE Multi format Configuration Screen 2 Touch a thumbnail and touch the layout where you want the image to appear 9G3741 1 35 CR Mammography Feature KODAK Directview Systen V5LabConsole7 Multi Format Print Configuration Rick Morningstar Y 2 Breast RML Oblique Multi Format Prints Image Internal Text Boxes Page External Text Box B True Size 9 N Justification g Left 3 Select from the following True size Printing Justification right left center Page External Text Box Image Internal or External Text Box Flip an image horizontally Rotate 90 degrees clockwise 4 If images have been acquired select Print For more information about multi format printing see the CR System Online Help 1 36 9G3741 CR Mammography Feature m Mammography Cassette Use Instructions d CAUTION The CR Mammography cassettes and phosphor screens are fragile Take care when handling the plate Do not drop bend or apply pressure to the plate Protect it from scratching and contamination Do not leave the plate in hot or moist places and
35. fication of a logical object in software usually for a set of data 1 48 9G3741 Index bar code error message 22 reading 22 selecting the cassette size 22 Black Surround Mask automatic 43 automatic applying 43 automatic turning off 43 manual 43 manual applying 43 manual reset button 43 overscan check 43 brightness 32 brightness tab 30 C cassette exposing 11 cassettes placing on bucky 2 category display 30 collimating the cassette 14 CR Mammography Feature compatible CR Systems 6 enabling 7 CR System requirements 8 CR Systems 6 creating a patient record 12 new patient 12 D definition 30 detail contrast 26 31 32 diagnosing from monitor 24 DICOM 46 48 DICOM compatible 6 DICOM compatible printer 6 documentation additional 1 EHR Scanning mammography cassette 7 Equipment and Cassettes cleaning storage phosphor screens 40 erasing 11 erasing cassettes frequency 11 G Grid Suppression 30 grid suppression 32 grid suppression tab 30 Image Processing Preference Editor accessing 26 image quality rejecting the image 24 image viewer window 30 K key operator preference editor 32 kVp 5 11 23 46 46 48 entering 23 L labeling 11 laterality selecting 13 looks 27 mammography imaging chain Acquisition 5 capture and processing 5 hardcopy printing and viewing 6 softcopy viewing and storage 6 mammography label 7 manual black su
36. for Use CR Systems The CR Mammography Feature together with CR Mammography Cassette comprise a device which when used in conjunction with a KODAK DIRECTVIEW CR System and a mammographic X ray machine generates digital mammographic images that can be used for screening and diagnosis of breast cancer It is intended for use in the same clinical applications as traditional screen film based mammographic systems The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation You can install and use the CR Mammography Feature in the following KODAK DIRECTVIEW CR Systems e CR850 e CR950 e CR975 e Classic Elite CR NOTE See the KODAK DIRECTVIEW CR System Hardware Guide for descriptions of these systems Older manufactured CR 850 950 975 Systems may require hardware and software updates in order to use the CR Mammography Feature Contact your Carestream Health Sales Representative for information 9G3741 CR Mammography Feature IU UETTTINNUUUU UU NOTE The KODAK DIRECTVIEW CR System with CR Mammography Feature using CR Mammography Cassettes is designed to work under normal room light conditions IMPORTANT Keep the CR System its surrounding area and the storage locations for the CR Mammography Cassettes clean This will help prevent dust or debris from entering the CR System and cassettes which can result in image artifacts To enable the CR Mammogr
37. ge processing has failed Quick Menu Accesses Logout and Shutdown functions Enter Look Code values here Select New View Selects a Primary Category Secondary Category or an individual view When you select an entire Category the changes you make affect every view in that category Change Look Process the image with a different look Deliver Selects the workstation or printer View Before and After Displays the image before adjustment and after 90 Save Changes Submits the change to the database Save Changes becomes active whenever you change the settings on the Preference Editor Screen NOTE There is no way to undo changes Save configurations before making changes See Backup and Restore in the Key Operator Online Help Zoom Enlarges image for evaluation To return to normal view select Zoom to clear the check box In Zoom mode you can Pan across the image or select the image and drag across Main Menu Exits the Preference Editor and returns you to the Main Menu Cancel Returns you to the previous function without changing to another screen Cancel toggles to the Back button after you select Save Changes 9G3741 1 31 CR Mammography Feature a a IUE LUI ene Slider Control Behavior Defining a Look Brightness Two user image adjustment interfaces reside on the Console They are selected based on the login
38. graphy Workstation or Printer for a Radiologist to read You can configure Destinations at installation or the Key Operator can select them For complete information about Key Operator Functions see the CR System Online Help Skin Line Skin Line Enhancement increases or decrease the amount of enlargement of the skin Enhancement line in mammography images modified on the Surround Mask Tab in the Image Viewer Screen The Skinline Enlargement slider influences the amount of non mask border that is created around the breast when you send an image to PACS This capability is only used by PACS systems and is a requirement of Integrating the Healthcare Enterprise IHE for mammography This mask enables the direct exposure of a mammography image to 9G3741 1 25 CR Mammography Feature always present black even when black bone or reverse polarity is utilized If you want to see more of the direct exposure skin line margin increase the skin line enlargement slider Surround Mask Tab Using the Image Processing Preference Editor To access the Image Processing Preference Editor 1 Log in as a Key Operator 2 From the Main Menu select Image Review 3 Select an image Select Image Processing Preferences NOTE KODAK DIRECTVIEW EVP Plus Software enables the creation of custom looks which are recipes for processing the images Looks consider the degree of brightness latitude detail contrast sharpness and noise suppression
39. harpness screen film Small structures with qualities similar to the MCCs are enhanced 5 Premium Processing with more latitude Look 5 is similar to the updated Look 3 with even more enhancement to details 1 28 9G3741 CR Mammography Feature UNTIL For Software Version 5 4 SNP In Software Version 5 4 additional mammography looks were incorporated to support the CARESTREAM CR Mammography Cassette with SNP M1 screen Looks 1 6 in the alat dodi SNP looks database use a specially tailored recombination of seven frequency bands to acupase uniquely handle the small and medium edges This new processing is a second generation algorithm of Enhanced Frequency Processing EFP Looks 7 9 use first generation EFP processing as developed for EHR M screens Look Look Name Up date Description Code No Premium Processing with noise suppression Default Look from factory no biases Employs a smooth noise texture 2 Fixed Processing with medium contrast detail and sharpness 3 Premium Processing with brighter processing more detail and sharpness Fixed Processing with medium contrast detail and sharpness Employs a smooth noise texture Premium Processing with brighter processing more detail and sharpness Employs a smooth noise texture 4 Premium Processing with high contrast and detail Premium Processing with high contrast and detail Employs a slightly coarse noise textu
40. help in ensuring the technique is appropriate IMPORTANT est or change X ray exposure factors only after consultation with a qualified Medical Physicist The site is responsible for ensuring that the system is in compliance with applicable regulations or restrictions on X ray exposures IMPORTANT The dose shall be determined with technique factors and conditions used clinically for a standard breast The maximum dose must comply with applicable regulations The KODAK DIRECTVIEW CR System is compatible for use with the AEC function of the X ray equipment e Ifyou are currently using a screen film system it is possible to adjust the density setting of the X ray machine to account for the difference in X ray transmission between your current screen film cassette and the CR Mammography Cassette see below e Ifyou are not using a screen film system it is necessary to contact a qualified service professional to perform a calibration of the AEC function to implement your specific technique chart IMPORTANT Test or change X ray exposure factors only after consultation with a qualified Medical Physicist The site is responsible for ensuring that the system is in compliance with applicable regulations or restrictions on X ray exposures 9G3741 1 17 CR Mammography Feature r UrUEUEUIGIO UU UNS a a IMEEM Te eer en eem Automatic CR replacing an existing Screen Film Combination Exposure The following procedure
41. hnique control chart 3 A Carestream Health Applications Consultant can Configure various interface features and functions as desired Train Key Operators Radiographers on use of the CR System CR Mammography Cassettes and on the use of an established technique control chart Work with Key Operators Radiographers Radiologists to make X ray exposures modify mammography views and optimize image quality 1 8 9G3741 CR Mammography Feature UEETTTINEUEUU Tu IMPORTANT See the KODAK DIRECTVIEW CR System User Guide Information for information on operating barameters and configuring tbe CR System Recommended Mammograpby specific configurations include Mammography views to use for producing mammography images IMPORTANT New CR Systems are configured from the factory with default views NOTE to be used for General Radiography and Mammography applications Breast Type Breast Breast Homogeneously Dense Breast Heterogeneously Dense Breast Implant Breast Fatty Mammography Projection Cranio Caudal CC Mediolateral Oblique MLO Lateral ML and LM MLO_Mag Mediolateral Oblique_Magnification CC_Mag Craniocaudal_Magnification These 36 combinations with both Left and Right laterality result in 72 Mammography Views Select the view that matches the exam 9G3741 1 9 CR Mammography Feature r UrzUEUIGIO UU MNT GURFGKG a a IUNCTI IM ere en eee
42. minal overscan width is 2 5 mm on a flat field exposure printed True size for an 18 x 24 cm or 24 x 30 cm CR Mammography Cassette In the image above the bright image at the chest wall is the overscan Overscan is cropped when the image is sent to destinations Before you contact Carestream Health for help see Troubleshooting for more information Next contact your Key Operator If the problem persists in the U S and Canada call the Technical Service Center at 800 328 2910 Elsewhere in the world contact your Carestream Health Service Representative 9G3741 1 45 CR Mammography Feature UEUEUEUIGIO UU URS GUREUKG a IMMER LIU en ee Glossary Accession Number A DICOM term it is a number assigned to an exam and linked to the site s billing system Surround Mask Fills in the area outside of the Region of Interest with a dark background Compression To uniformly reduce the thickness of the breast using a rigid plastic device so that the breast is more readily and uniformly penetrated by the X ray beam Dose The measure of the amount of energy using a dosimeter deposited in tissue due to Measurements X ray exposure Entrance That amount of radiation at the skin of the breast quantitated by measuring the amount Exposure of ionization in air caused by the radiation Exam A collection set consisting of a raw image its versions Exam Information and Patient Information Exam Information The data that
43. mography related tests at least annually intended to assess the continuing performance of mammography equipment Pass Through The operating mode in which the CR System accepts processes and routes the exam Mode without user intervention Patient The demographic data pertaining to a patient Information Processed Image An image that has been tone scaled and unsharp masked 1 46 9G3741 Phantom Positioning Projection QA Mode Radiographer Tec h nologist Radiopaque Marker Raw Image Routing Study Technique Tonescale View Worklist CR Mammography Feature UEETTTINNUUU Uu A test object that simulates the average composition of various structures within the breast The art and skill the Radiographer Technologist uses to adequately demonstrate the breast tissue in different projections known as the craniocaudal and mediolateral projections Also referred to as a View Is the demonstration of breast tissue from a specific angle depending on what area of the breast needs to be seen The operating mode in which the CR System requires user input to route an exam Trained person who performs the mammography examination that creates the images needed for diagnosis A permanent identification label to indicate right or left laterality and projection This marker is placed on the top of the cassette holder near the auxiliary portion of the breast The image that is read from the storage phosphor plate
44. nce Editor Display Displays the selected image Lets you see the changes applied to the image processing values 3 Patient Name Searches the local database for a patient by name or by Patient Patient ID ID 4 Brightness Tab Access to brightness latitude and detail contrast controls including the kernel which influences the detail frequency band tone scale kernel Sharpness Tab Access to the sharpness controls Noise Suppression Tab Access to the noise suppression controls Q Grid Suppression Tab Access to the Grid detection and suppression processing Detects if a stationary grid was used and if found suppresses the appearance of the grid lines 1 30 9G3741 CR Mammography Feature IU UNTIL Item Description Category Display Displays the Primary Category the Secondary Category the View Name and the Look selected Region of Interest Provides image information such as mean pixel value standard deviation minimum maximum of a touched region on the image Useful to determine if exposure in a specific anatomical region is adequate Slider Controls Controls fine independent changes for image processing values that affect all images in a view such as brightness latitude detail contrast sharpness and noise Histogram Displays a graph of the distribution of pixel values in the image If the histogram displays a linear LUT straight line Look Up Table ima
45. nd sharpness detailed renderings than Look 1 Premium Processing with noise suppression 4 Premium Processing with high contrast and Default Look biased to be higher in contrast less latitude detail and detail than Look 1 Premium Processing with noise suppression 5 Premium Processing with more latitude Default Look biased to provide slightly greater latitude and detail than Look 1 Premium Processing with noise suppression 6 Premium Processing with medium latitude Default Look biased to be less digital in appearance in line with a medium latitude analog film look 7 Baseline Image Processing Mimics Non EVP Plus processing 8 European Mammography For general radiography Look 8 is the same as Look 1 default For mammography the look is based upon the European preference 9 Premium 2 Image Processing with noise An alternate premium look suppression 9G3741 1 27 CR Mammography Feature rr a ET EUNURETRKGENAUEU Ue nU rien e For Software Version 5 2 Additional Looks Looks 6 and 9 from the table on Page 1 27 were updated to address the overall concerns about the noise texture and amplitude These new looks overwrite the previous looks if the Additional Looks Mammography Patch is added to the Software Mammography Patch and Version 5 2 or if you are using the Version 5 4 Default Version 5 4 Default Look Look Name Update Description Code No 6 Premium Processing with medium la
46. rage phosphor screen to the outside edge wall of the cassette is specified to be 3 mm or less IMPORTANT Mammography X ray systems use anti scatter moving grids or cassette holders As with screen film systems failure of the grid to reciprocate especially during a short exposure time may result in a wavy artifact in the produced image known as a moire pattern when using a CR Mammography Cassette Ensuring proper operation of the reciprocating grid will prevent this artifact from occurring 9G3741 1 15 CR Mammography Feature UrEUEUIGIO UU URS a INCUN LU eue eren Technique e The KODAK DIRECTVIEW CR System has a wide exposure latitude and will operate Considerations over a broad range of mammographic exposure conditions but is intended for use with acquisition techniques similar to those used with modern screen film systems e When using the CR System the same care and attention to detail should be taken to ensure high quality images as was practiced with screen film systems e Medical Physicist should be consulted for assistance with technique factor selections and to ensure that the patient dose complies with applicable regulations e When using the Automatic Exposure Control AEC of the X ray machine the facility should ensure the AEC is appropriately calibrated e A technique chart should be produced and posted near each X ray unit The chart should summarize the acquisition parameters for producing X ray im
47. rdcopy Printing Viewing search Patient Worklist information from a site s HIS RIS and use it to create the patient s exam record on the CR System The patient record and images are then sent via the DICOM network to the desired output destination for diagnostic interpretation From the KODAK DIRECTVIEW CR System digital mammogram images can be sent to a DICOM compatible Mammography Workstation where a diagnostic review can be performed in softcopy The workstation consists of a mammography capable high resolution display monitor keyboard mouse and computer The Technologist uses the mouse and keyboard to select review and manipulate images for desired viewing You can save preferences for selecting digital images and patient information and recall them for later use The operator can send images from the workstation to an archive image storage system or to other network DICOM compatible devices including hardcopy printers From the KODAK DIRECTVIEW CR System digital mammogram images can be sent to a DICOM compatible Mammography Printer The Mammography Printer can produce high resolution diagnostic quality hardcopy film output of the digital mammogram images The hardcopy print is then viewed for diagnosis on a View Box The View Box must be of adequate brightness with uniform light output across the entire viewing area to ensure that the image captured on the film can be effectively diagnosed CR Mammography Feature Indications
48. re and Processing kVp JH Breast Compression Positioning Composition Motion Kodak DirectView CR System with Mammography Feature Cassette Bucky 18x14 24x30 Grid CR Mammography ee Cassettes Network Mammography Imaging Chain Acquisition The Mammography X ray Unit is used with the KODAK DIRECTVIEW CR System in the same manner as with conventional screen film mammography The techniques target filtration kVp setting proper positioning and compression etc used are similar for exposing the CR Mammography Cassettes and requires that the X ray Unit components i e X ray generator AEC compression paddles cassette holder grid etc are calibrated and maintained to function according to the manufacturer s stated requirements Capture and The KODAK DIRECTVIEW CR System with CR Mammography Feature using CR Processing Mammography Cassettes provides the means to capture and process mammography images Insert the CR Mammography Cassettes in the Mammography X ray Unit s cassette holder for exposure then place them in the KODAK DIRECTVIEW CR System where they are scanned and image processed to produce high resolution images The patient s exam record is created on the CR System and associated with the patient s images A DICOM compliant network connection with the CR System is used You can 9G3741 1 5 CR Mammography Feature rr a a TUUENVARKGENUUmU UN Uit ern Softcopy Viewing Storage Ha
49. re of entrance skin exposure or patient absorbed dose e Fora correctly calibrated system the equation below provides the nominal relationship between Exposure Index and Cassette Input Exposure Exposure Index 1000 x log10 Cassette Input Exposure in mR 1000 It should be recognized that this relationship between EI and cassette input exposure is only valid for the specific beam conditions used for system calibration i e the service performed CR System calibration using conditions of 28 kVp Mo Mo with added 2 mm Al filtration For other acquisition conditions including different kVp target filter combinations and patient thickness composition this relationship becomes less accurate Typical Exposure Index values displayed for the range of patient thickness composition and acquisition techniques used should be in the range 2100 200 Individual site preference for patient dose and image quality can change this exposure index range e Ifthe Exposure Index value is lower than typically expected check the image for excessive noise To improve noise increase mAs or use a softer X ray spectrum If the Exposure Index value is higher than typically expected check the technique used as patient dose may be higher than necessary Recording Exposure Parameters Mammography X ray Interface Information about the patient the exam and the exposure parameters may be electronically recorded on the Mammography image using a Text Box CR c
50. re that some radiologists prefer 5 Premium Processing with more latitude Premium Processing with more latitude Employs a slightly coarse noise texture that some radiologists prefer 6 Premium Processing with medium latitude Premium Processing with medium latitude Employs a slightly coarse noise texture that some radiologists prefer 7 Baseline Image Processing Baseline Image Processing uses first generation EFP processing as developed for EHR M series screens 8 European Mammography Previous European processing from Software Versions 5 1 5 4 use first generation EFP processing as developed for EHR M series screens 9 Premium 2 Image Processing with noise suppression Previous Image Processing with noise suppression from Software Versions 5 1 5 4 use first generation EFP processing as developed for EHR M series screens 9G3741 1 29 CR Mammography Feature mmc Preference Once a change is made in the Preference Editor and saved the change stays with the Editor view The Key Operator and the Technologist see the changes on their slider controls Controls KODAK Directview System V5LabConsole7 Image Processing Preference Editor admin 3 Patient Last Name Patient ID 9 E Image Processing Preference Editor Item Description Thumbnail Gallery Previews all of the images related to the view selection Prefere
51. riginal CR image print a test page and check the film to see if the lines reappear If the lines are present it could be a film or printer problem Call your Carestream Health Service Representative e Text Box misplaced If the Text Box appears on the chest wall of the image when it is sent to the printer check that the correct view body part projection and laterality were entered on the Patient Input Screen In addition make sure the image on the CR System monitor displays the Text Box in the correct position e Poor image contrast lf the contrast has changed since installation re calibrate for that film size and reprint the image 1 34 9G3741 CR Mammography Feature lt i m Printing Use only a Mammography Printer that is intended for use in Mammography Mammography applications when reviewing hardcopy printed images Images e For hardcopy printing of Mammography images Carestream Health recommends that you configure the CR System for use with a KODAK DRYVIEW Mammography Laser Imager using KODAK DRYVIEW Mammography Laser imaging Film Contact your Carestream Health Sales Representative for more product information e When you select justification on multi format mammography prints only one millimeter separates the prints for comparison viewing e Overscan that occurs during mammography exposures of the chest wall can be configured to automatically crop out or display on both print and PACS e You can achieve a D max o
52. rii iina N T R Ql IEEE ete 22 R viewine and Accepting TIRBS csse caresses nd dS Montt idu E E E a 22 Skin Line Enhancements re dada sad ate da UHR NON QUUM RI CANIT H MUN dE 25 Using the Image Processing Preference Editor iss i cupri Rt t tte bna trud uu Pea Pr Pt DE RE EUN 26 The Family Of TOI asistencia eomaes 27 For Software Versions 5 1 and 5 2 assent teer at er eds QU WU du VIVI cie RI TUR ERN RUE 27 For Software Version 5 2 Additional Looks Mammography Patch and Version 5 4 Default 28 For Software Version 5 4 Mammography Update 2010 01 License Enabled 28 For Software Version 5 4 SNP Parameter Database sese ennemi 29 Preterence TOHOPCIEDISO a Ease dit metes d Rd Etre neers reese eer eee Sear 30 Slider Control BOHIIOE cesera asen imei ann t oee it RDUM S dn Uds 32 Defining a qu 32 PM URIs T REM MM EROR TII E NEUE RUN 32 de 33 ono C M 33 SIE KU lock Renee eevee Eu tenu Mun Os Meum dM nM MEUM E DN T aU 33 NOISE m X M X 33 Delivering Mammography Intages i aoreet tenera epa ienqaaenbopadepadehoucsibnorendenvintensiesvoyndeaveveneds 34 Justification of Right Mammography HIS os qo ep qued tprpi til Qe Svb UR
53. rround mask 43 markers digital 24 9G3741 Index EIU TUUM TUTTI Mor c left right 24 V mAs 11 23 Viewbox 6 masking 43 viewing modes resetting 43 Pass through 23 selected image areas 43 QA mode 22 more buttons viewing thumbnail images 23 More Patient Information 22 N noise suppression tab 30 O overscan line 45 P patient ID 30 patient name 30 phosphor screen cleaning 40 disinfecting 41 harmful materials 40 recommended cleaning products 39 preference editor controls 30 preference editor illustration 30 printing 6 equipment 4 projections 9 R Region of Interest 31 S searching for a patient 12 sharpness tab 30 skin line enlargement 32 slider control behavior 32 slider control behavior image viewer 32 slider controls 31 softcopy viewing workstation 6 Submit button 13 T tabs image viewer 30 thumbnail gallery 30 thumbnail images viewing 23 l 2 9G3741 Carestream ud Carestream Health Inc 150 Verona Street Rochester NY 14608 CARESTREAM DIRECTVIEW and DRYVIEW are trademarks of Carestream Health Inc The Kodak trademark and trade dress are trademarks of Kodak used under license Carestream Health Inc 2010 PN 963741 CE us
54. ry 1 40 9G3741 CR Mammography Feature s e Disinfecting the NOTE Ifthe cassette is visibly contaminated with blood or body fluids Screen or the Cassette removal of the blood and or body fluids followed by intermediate level disinfection is indicated prior to use The following instructions are for low level disinfection CAUTION Dilute bleach solutions may cause eye irritation and dry skin Wash hands with soap and water following use Consult manufacturer s material safety data sheet MSDS prior to use 1 Wipe with a soft lint free cloth thoroughly dampened with a dilute bleach solution dilute one part of 5 25 sodium hypochlorite household bleach with 10 parts of water or use a commercially prepared equivalent solution of dilute bleach NOTE Follow the Center for Disease Control CDC guidelines regarding solution contact time to adequately disinfect the cassette or screen 2 Remove the bleach residue with a soft lint free cloth dampened with water 3 Wipe dry with a soft lint free cloth Allow screens to air dry Disposing of the Dispose of the screens according to applicable regulations They must be Screen managed and transported as hazardous waste d CAUTION The screen when discarded is a hazardous waste EPA waste code D005 under the Resource Conservation and Recover Act RCRA due to the leachability of barium Hazardous waste must be managed and transported in accordance with countr
55. s not provide all operational use information on KODAK DIRECTVIEW CR Systems and is intended to be used in conjunction with the following document e KODAK DIRECTVIEW CR Systems User Guide information 9G3741 1 1 CR Mammography Feature a a IUE LUI ene NOTE All references in this document to CR Mammography Cassettes and screens apply to the following unless otherwise specified e KODAK DIRECTVIEW CR Mammography Cassette with EHR M Screen e KODAK DIRECTVIEW CR Mammography Cassette with EHR M2 Screen e CARESTREAM CR Mammography Cassette with EHR M3 Screen e CARESTREAM CR Mammography Cassette with SNP M1 Screen NOTE CR Mammography Cassettes are not available for sale in the United States NOTE See the Glossary section for a brief description of terms used in this guide NOTE Use ofthe term applicable regulations throughout this document means as per current country state local and or facility specific regulations applicable for use in mammography For European Markets Authorized European Agent sae Carestream Health France LES MERCURIALES 40 rue Jean Jaures 93176 BAGNOLET CEDEX France Safety and Related Information NOTE The following information applies to any KODAK DIRECTVIEW CR System that has the CR Mammography Feature installed For more information see the KODAK DIRECTVIEW CR System Safety and Regulatory Information included in your CR Systems User s Guide Ay CAUTION A trained S
56. se suppression 9G3741 1 33 CR Mammography Feature a TU URNVAREGENUUmUU UN UE rrr Delivering Mammography Images Justification of Right Mammography images Presentation of Images See the KODAK DIRECTVIEW CR Systems User Guide Information for information about printing and managing images on a CR System The following information applies specifically to mammography images In previous versions of software it was necessary to select Laterality Right or Left on a Mammography image Selecting Laterality automatically rotated an image for proper chest wall display and printing When using Software Version 5 1 you must select Left and Right Views that have the appropriate Rotation and Flip settings to achieve the proper printing with the KODAK DRYVIEW 8900 Laser Imager or KODAK DRYVIEW 6800 Laser Imager On the Image Viewer Screen fill in the laterality field for PACS systems The KODAK DRYVIEW 5850 Laser Imager supports CR Mammography printing but does not support justification of Mammography images Presentation on the CR System e Ifthe image does not present as expected verify that you are using the correct view e Check that the correct laterality has been used Presentation on a DX Workstation This may be workstation dependent Check that the correct view body part projection position and laterality are correctly entered Presentation on a Printer e Lines lf lines appear in images that are not on the o
57. that Radiologists prefer Each institution chooses its look from a family of looks provided by Carestream Health The institution can then use the Preference Editor to customize the views The Image Processing Preference Editor lets you change and control the image processing defaults for an image all images in a secondary category or all images in a primary category The controls for image processing are located behind the tabbed icons on the Preference Editor Screen These controls work as sliders with the minimum values at the bottom of the slide and the maximum values at the top 1 26 9G3741 CR Mammography Feature TUTTI The Family of Looks For Software Versions 5 1 and The CR System provides a family of looks to choose from The look is described on the interface of the Preference Editor The following table describes the available looks for Software Version 5 1 and 5 2 Updates to this table are described on page 1 28 5 2 Look Look Name General Description Code No 1 Premium Processing with noise Default Look from factory no biases Noise suppression suppression consistent with the Low Exposure Optimization 2 Fixed Processing with medium contrast Models that have fixed rendering tonescale parameters with detail and sharpness noise suppression 3 Premium Processing with brighter Default Look biased to produce brighter sharper more processing more detail a
58. that was used and the task that was performed such as reviewing a single image or defining image preferences The slider control behavior is different for each of these interfaces Image Viewer This simple interface allows the Technologist to adjust contrast latitude and detail contrast Note that the detail contrast slider is a single slider that equally influences both the low and high density detail settings in the rendering process Therefore if the Technologist increases the detail contrast slider by five both the lower and upper density detail contrast settings are increased by the same amount each click is a 5 change roughly a 25 increase for both e Key Operator Preference Editor aA more complex interface where the Key Operator can set preferences deltas on the brightness latitude detail single slider for both upper and lower sharpness single slider for both upper and lower and noise Any changes in detail contrast and sharpness are equally applied to both the upper and lower density controls KODAK DIRECTVIEW EVP Plus Software enables the creation of custom looks which are recipes for processing the images Looks consider the degree of brightness latitude detail contrast sharpness and noise suppression that Radiologists prefer Each institution chooses its look from a family of looks provided by Carestream Health The institution can then use the Preference Editor to customize the views When a look is select
59. titude Softer and more streamlined parenchymal tissues are presented with a finer noise texture The result is an image with a reduction in anatomical clutter and large texture noise DMin areas of the image are brighter 9 Premium 2 Image Processing with noise Look 9 was changed for mammography to enhance the suppression finer detail decrease noise and to make the skin line skin fold areas less apparent For Software Version 5 4 Mammography Update 2010 01 License Enabled Looks 2 3 and 5 from the table on Page 1 27 were updated to address the concerns of handling the small and medium edges All looks introduced in the 5 4 2010 01 update use a specially tailored recombination of seven frequency bands to uniquely handle the small and medium edges If the Mammography Update 2010 01 option is enabled on your system you will have access to these additional looks If enabled these looks will overwrite the previous looks Look Look Name Up date Description Code No 2 Fixed Processing with medium contrast Look 2 is similar in appearance to the updated Look 3 detail and sharpness However small structures with qualities similar to MCCs are enhanced to a lesser degree Look 2 is the recommended starting point for sites using very low dose due to the presence of additional noise 3 Premium Processing with brighter The softness of the parenchymal tissues resembles processing more detail and s
60. to the chest wall and the Tube Side label is facing up IMPORTANT Make sure the collimator blades are fully open to cover the image receptor 3 Position the breast for the selected View and ensure adequate compression is applied 4 Select the appropriate exposure technique for the breast thickness and type See Compatibility with X ray Systems on page 1 15 5 Repeat the above steps for each cassette 1 14 9G3741 CR Mammography Feature i m Compatibility with X ray Systems The KODAK DIRECTVIEW CR System with CR Mammography Feature using CR Mammography Cassettes is specifically designed to be compatible with mammography X ray systems and all other system accessories such as anti scatter grids and magnification options that use screen film cassettes The CR Mammography Cassettes are intended to be used in the same manner as mammographic screen film cassettes They operate over the same range of kVp and target filter combinations as screen film cassettes and can be exposed under manual or automatic exposure control e The X ray tube must have as a minimum a molybdenum target and molybdenum filter Mo Mo combination needed for calibration of the CR System and as is clinicially practiced with screen film support use of the following anode target and filter combinations molybdenum target with rhodium filter Mo Rh rhodium target with rhodium filter Rh Rh and tungsten target with rhodium filter W Rh e Automatic Expos
61. ure Control AEC may be of the type controlling mAs only or mAs and kVp or mAs kVp and filter or mAs kVp filter and target The following items list some of the features of the CR Mammography Cassettes that allow their use in place of conventional screen film cassettes e The physical dimensions of the CR Mammography Cassettes are the same as screen film mammography cassettes 18 x 24 cm and 24 x 30 cm and comply with the ISO 4090 standard for cassette design Therefore CR Mammography Cassettes are physically compatible with modern mammography X ray unit 18 x 24 and 24 x 30 cassette holders e The CR Mammography Cassettes are specifically designed for use with the Mammography X ray unit s Automatic Exposure Control AEC The cassettes contain a low absorption region for compatibility with the X ray systems Automatic Exposure Control AEC detector The dimensions of the low absorption region comply with the ISO 4090 standard for possible placements of the AEC detector NOTE Adjustment of the AEC configuration may be necessary to account for the transmission of the CR Mammography Cassette This is similar to the adjustment necessary when a new screen film system is first introduced into the clinic This should be done under guidance of the X ray equipment service personnel and or a qualified Medical Physicist e The CR Mammography Cassettes are constructed to provide chest wall imaging access The distance between the edge of the sto
62. ut Screen is the next exposure e The Patient Input Screen remains open until the study is complete The following image states may be reflected in the border of the image Unavailable The corresponding image has not been scanned e Exposed Exposure report has been received from the X ray Interface for the indicated view but the image has not been scanned NOTE Unassigned images or image icons that are not highlighted at the time of exposure will not capture the transmitted data There is no way to resend this exposure information from the mammography unit and it must be entered manually into the appropriate fields See General Radiography Workflow on page 1 20 and Mammography Workflow on page 1 20 General In the General Radiography Workflow you use the bar code scanner to enter the Radiography cassette ID prior to exposing and receiving the exposure report The manual selection Workflow of the correct icon is not needed 1 Highlight the View icon 2 Scan the Cassette ID bar code 3 Expose the cassette 4 Scan the cassette The next View icon is automatically highlighted The highlight always moves left to right top to bottom through the Views Mammography In the Mammography Workflow you must manually select the icon assign it and Workflow expose each View one at a time 1 Select the icon of the first View in the exam 2 Assign a cassette to the View by scanning its ID number 3 Expose the cassette with th
63. y federal state and local regulations Please contact your local authorities for disposal or recycling information For additional information call Carestream Health at 1 800 328 2910 If outside the USA contact the Customer Support Center in your country 9G3741 1 41 CR Mammography Feature SR ae a ea a cee Quality Control Acceptance and Quality Control Testing Troubleshooting Carestream Health provides the following information to test the operation of the CR System and CR Mammography Cassettes as part of an overall quality control program amp CAUTION The facility must ensure a quality control program that is established and practiced according to applicable regulations Quality control practices should include the manufacturer s quality control recommendations for all equipment in the Mammography Imaging Chain See the Mammography Imaging Chain on page 3 For specific testing to perform and the methods to record results follow all applicable regulations as per current country state local and or facility specific regulations applicable for use in mammography For information about troubleshooting the CR System see the KODAK DIRECTVIEW CR Systems User Guide Information Black Surround Masking may not always be applied correctly and result in the conditions described in the table below Should these conditions occur reprocess the image using the resolutions listed as follows Condition

KODAK DIRECTVIEW CR Mammography Feature User`s Guide

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