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R2 DX/LS User Manual - The Science of Sure – HOLOGIC

1. 9 R2 DX LS User Manual PN MAN 01043 Rev 001 81 Part 6 Maintenance 82 R2 DX LS User Manual PN MAN 01043 Rev 001 Part 7 Using DigitalNow and the R2 Patient ID System gt 7 1 Overview gt 7 2 DigitalNow Archiving gt 7 3 Using the R2 Patient ID System gt 7 4 Querying an External Database 7 1 Overview Part 7 provides information about DigitalNow which provides archiving features and the R2 Patient ID system R2 DX and R2 LS systems support the archiving of digitized film images and CAD results for supported DICOM views You can enable and disable the archiving features by means of the Connectivity option on the Controls screen At the time of installation the features are set either to On or Off based on your preference The Archiving feature requires a patient information database from which to draw the necessary patient information This ensures that the images and CAD results are stored properly in the archive Therefore the Patient ID feature must be enabled and the system configured to communicate with a patient information database in order for the Archiving feature to function In addition the R2 system must be configured to communicate with the archive system If both Patient ID and Archiving are enabled the images and any CAD results are sent to the archive system after the images are processed The archived images and CAD results like any other
2. 5 When the cases have been scanned successfully put the films and corresponding separator sheets together in the patient folders for hanging A Note If the system has been configured to use a different scanning protocol by default on the Controls Scanning screen then after scanning a stack of films the system returns to the default protocol 30 R2 DX LS User Manual PN MAN 01043 Rev 001 3 3 Scanning with the Auto Protocol Loading Films and Separator Sheets into the DX or LS Scanner s Feeder When loading the stack into the feeder it is possible for the leading separator sheet to slide past the feeder and into the scanner If this happens the scan will fail and you will have to reload the cases and then restart scanning To avoid this problem load the stack as described below gt To load films Look down into the feeder chute and find the opening at the bottom with a triangular stop at each corner Ensure that the stack is loaded in front of these two stops Position the stack parallel to and touching the face of the feeder above the foam roller then slide the stack down into the feeder chute This creates correct alignment and guides the leading separator sheet in front of the triangular stops Separator sheet with text facing toward the back Press top of stack against the backstop Roller Correct Loading Films R2 DX LS User Manual PN MAN 01043 Rev 001 31 Part 3 Studie
3. e To add or change the DICOM study description touch the field and edit the study description as desired 4 Touch OK when finished or touch Cancel to cancel changes to the scanning protocol Note You can edit any scanning protocol except the Auto protocol If you delete all views trom a Manual protocol the protocol will be equivalent to the Any protocol R2 DX LS User Manual PN MAN 01043 Rev 001 75 Part 5 Controls 5 8 Service Utilities The Service option on the Controls screen allows e Calibrating the touch screen e Access to the service tools only for Hologic trained service personnel gt To display the Service screen Touch the Controls tab and then select Service e Fh E ImageChecker R2 Patient ID Search About Touch Screen SuN Connectivity aaalllt Screening Calibrate Touch Screen ere Maintenance Uni Right Off Uni Left Performance gt Screening Imp Printing Any Scanning Service Service Tool E Connect to the Service Tool Status Ready eso Studies oT Controls Start Calibrating the Touch Screen Calibrating the touch screen can make it easier to precisely touch the buttons and other controls Touch Screen Calibrate Touch Screen To calibrate first touch Calibrate Touch Screen and then follow the simple on screen instructions When you finish you will have to restart the system to save the new settings Connecting to the Serv
4. When you touch Reboot or Shutdown a confirmation window appears which requires you to either confirm or cancel the power down command R2 DX LS User Manual PN MAN 01043 Rev 001 5 5 Performance Options 5 5 Performance Options The Performance option on the Controls screen provides access to the e Film ejection procedure e Results of system verification testing gt To display the Performance screen Touch the Controls tab and then select Performance ImageChecker S R2 Patient ID Search About Scanner Performance Auto Connectivity aaalllt Screening Moroes Eject Current Film In case a film gets stuck Uni Right Off s Uni Left Performance a Screening Imp Printing gt Any Scanning Service Test Results CPU Jul 24 2008 PASSED Algorithm Test Jul 24 2008 COMPLETE Processor Test Jul 24 2008 COMPLETE Scanner Film 1 Jul 23 2008 PASSED Scanner Film 2 Jul 23 2008 PASSED Studies oT Controls R2 DX LS User Manual PN MAN 01043 Rev 001 67 Part 5 Controls Ejecting Films Use the following procedure if a film seems to be jammed inside the scanner gt To remove a jammed film 1 Display the Performance screen by touching the Controls tab and selecting Performance 2 Touch the Eject Current Film button and wait to see if the scanner ejects the film If the film is not ejected then gently try to remove the film by hand 4 Ifthe preceding step doesn t eject the film power cycle the system S
5. 2 Gently pat the auto feed roller with the tape while rotating the roller with the other hand Auto Feed Roller Cleaning the Auto Feed Roller 3 Carefully replace the input tray Tilt the tray up about 20 degrees and gently slide it in Be sure that the plastic rails on the sides of the input tray slide under the metal flange on the mounting tracks Push in tray until it snaps into place Caution After cleaning the suction cups wait at least five minutes before scanning any films Residual alcohol can damage the films 4 Switch on the power as described in 6 2 Power Cycling the System R2 DX LS User Manual PN MAN 01043 Rev 001 79 Part 6 Maintenance 6 4 Running the Weekly Tests Three tests must be run weekly to ensure optimal system performance Always run the tests together and in this order Algorithm on top then Processor then Scanner think APS gt Torun the weekly tests 1 Stack the test sheets and films as shown Note that the test films are ordered as if they were ordinary films A Important If your system does not have the CAD license do not run the Algorithm and Processor tests Run only the Scanner test films Sheet 1 Algorithm Algorithm _ Sheet 2 Processor Processor Film 1 Processor Film 2 Processor Sheet 3 Scanner Film 1 Scanner Step Scanner Film 2 Scanner MTF 2 Place the stack in the input tray and touch Start The computer reco
6. To use the system successfully please read and understand the film requirements and modes used to scan the films Film Requirements All films must meet the following requirements e Original films only no copies e No bent damaged or curled films e 18 x 24cm or 24 x 30 cm standard full field views e No sticky residue wax or grease pencil marks on films e No labels over the edges of films or curled labels e MQSA or other required standards Because the scanner uses suction cups to lift each film into the scanner anything that interferes with the suction cups such as a patient label placed improperly or a wax pen mark may cause the scanner to drop films R2 Supported Lead Markers The R2 film scanning platform can scan any film based mammograms that meet the requirements listed above However when you use R2 supported lead markers with the four standard views there is an additional degree of convenience you can load the films in any orientation and in any order For more information see Scanning Protocols on page 26 R2 supported lead markers are available from Livingston Products Siemens Techno Aide All Craft Wellman and Hologic An illustration of the supported type from each company is shown below Livingston www livingstonproducts com Siemens www siemens com Rcc Techno Aide www technoaide com All Craft Wellman www all craftwellman com Hologic www hologic com 24 R2 DX LS User Man
7. it will not print out e Ifthe system couldn t find the printer it will generate an alert To find out if there was an alert check the Alerts screen e Ifthe study processed correctly check to make sure that printing is enabled See Configuring CAD Results Printing on page 70 for information on turning printing on off If printing is turned off turn it on and reprocess the study in the Image Correction screen e If none of these steps fixes the problem contact Hologic Technical Support Note Not all scanned images are printed Only four images appear on the printout Images which have not been processed by CAD and reversed views do not print Images do not appear on my display unit Typically this happens when there is a delay on the processing unit e Check the processing unit for alerts e If there were no alerts wait ten minutes check the display unit again e Ask your system administrator if there have been network problems e If after ten minutes the images don t display and your network is up contact your Hologic Service Representative Note R2 display units do not display all scanned images For more information see 2 6 System Inputs and Outputs Monitor isn t working The monitor power switch may have been accidentally turned off The processor unit is probably still working Switch the monitor back on If this doesn t work verify that the monitor power cable is securely fastened Main scr
8. or only partly on film as shown on page 25 or e Have non standard views or views with modifiers or e Have more than four views per case e Include views that do not conform to any available scanning 3 5 Scanning with protocols the Any Protocol R2 DX LS User Manual PN MAN 01043 Rev 001 27 Part 3 Studies 3 2 Preparing Cases to Be Scanned 28 Use this procedure to create a stack of cases to be scanned 1 Place a separator sheet on top of each film case 0000009896 ES 0000009896 Write the last four digits of the separator sheet barcode number on each patient s file optional HOLOGIC Ro 0000009896 No Labels or Marks 24x HOLOGIC Ro Place small films 18 x 24 in landscape orientation large films 24 x 30 in portrait 24 x 30 Creating a Stack of Cases A Important It is critical that ImageChecker users keep the separator sheet with the films until after the radiologist has read the films and CAD results 2 Create a neat stack of films and separator sheets Observe the following guidelines Put small film cases at the top of the stack mixed film cases in the middle and large film cases on the bottom If the number of films in the case does not match any of the defined scanning protocols use the Any protocol Use the correct number of films per case as specified by the selected scanning protocol If you pl
9. which is the time film scanning began for the selected study The study Status Depending upon the case the Status field can display a variety of messages see table next page Thumbnail Images of films These images appear as they are processed and can be viewed at any time after processing is complete Touch any thumbnail image to open the Image Correction screen Patient Information shows the patient flash from the scanned film if present followed by the Patient ID Name and Accession number from the patient information system The patient flash image appears for each film as it is scanned R2 DX LS User Manual PN MAN 01043 Rev 001 39 Part 3 Studies After the system scans the last film for a study it retains the patient flash image from that film as part of the study information Note the following To prevent errors always compare the patient information with the information appearing on the patient flash The image thumbnails always appear in film scanning order Once the films have been scanned you cannot change the order The thumbnails should always appear in anatomic orientation e g with the RCC nipple pointing left If they are not reorient the images as described in 3 10 Correcting Scanned Images For ImageChecker users CAD marks do not appear on the touch screen monitor The CAD marks appear only on the output devices display units review workstations printouts etc Th
10. PACS workstation as described under 7 4 Querying an External Database on page 88 e Enter the correct Study Date The Study Date defaults to the current date e Enter the R2 barcode number into the Accession Number field by either scanning the barcode on the separator sheet or typing it in Note Some archives generate a Study Instance UID unique ID that is used to identify a given study If you query to retrieve patient information and then enter new information or change the information then the R2 system generates a new Study Instance UID that it will send to the PACS with the study results R2 DX LS User Manual PN MAN 01043 Rev 001 7 3 Using the R2 Patient ID System 4 Click submit The system confirms that you have added the patient Patient ID You will not be able to verify that the information you enter is correct If you believe you made a mistake enter the information again If an identical record is entered it will simply overwrite the previous one Once you have submitted the patient information and R2 barcode you can scan the case Important Be careful when entering the information This is the mechanism that links the images to the correct patient When viewing digitized images from an archive always check the patient flash to ensure the case corresponds to the desired patient To enter multiple studies from different dates for the same patient you will need to enter the studi
11. Studies screen just below the Status field for the study currently displayed e On the Alerts screen where you can view all recent alerts R2 Patient ID ImageChecker Touch to sort alerts Time PID R2ID Description by Time R2 ID or alert Description Oct 10 14 13 0000000541 Oct 10 14 09 0000000655 Oct 10 14 05 0000001691 Oct 10 14 03 0000001376 Date and time alert PEPEN was generated Oct 09 15 29 Oct 09 14 51 Oct 09 12 10 R2 ID Oct 09 12 07 Oct 09 10 04 0000022598 Oct 09 10 04 Touch to view or hide alerts you ve Oct 09 09 14 hidden Oct 09 09 14 Touch to hide 2 Act NO ale nm all alerts Da Touch to hide a fis selected alert Studies No patient record information is associate No patient record information is associate No patient record information is associate No patient record information is associate Calibrating the scanner It may take up to Rebooting the operating system please Shutting down the R2 software please we Restarting R2 software please wait Restarting R2 software please wait Not all films in case 0000022598 are spe No output jobs scheduled for case 00000 Calibration is complete The scanner is re Calibrating the scanner It may take up to MEE eE Hide All Alerts View Past Alerts mn Alerts Controls Search Auto Screening Uni Right Uni Left Screening Imp Any Status Ready wW_ _ Start Also whenever the syst
12. User Manual PN MAN 01043 Rev 001 iii Contents iv 3 4 3 5 3 6 3 7 3 8 3 9 3 10 3 11 3 12 3 13 Part 4 4 1 Scanning with a Manual Protocol e 32 Scanning with the Any Protocol 0 0 0000 cee 35 Adding Cases to the Stack eee eee 0c ee 37 Stopping Scanning and Removing aCase 0 0000 38 Viewing Study Information 0 020 000 0 ee 39 Verifying Scanned Cases 0 0 eee aaa eee 41 Correcting Scanned Images aaa 42 Printing CAD Results 0 000 0000 ee 45 Searching for a Study eh ae echoes eed Capes ok BARE a be eS 46 Using Queue Manager 0 0 0 eee 47 PIGIAS rec ore Gt 2 ee te eee ee S N EGE a ete eee es ees 49 Alerts Listed Alphabetically 00000000000 a 50 Archiving was cancelled for case 3045 0 00 ee 50 Cannot process image successfully 1063 0 0000 000 cee eee 50 Cannot process this case 1062 3426s tee eG ene oe I oe Se he 50 ImageChecker attempted but could not send case 3016 3018 3031 3032 50 ImageChecker attempted but could not print reimbursement report 2008 51 ImageChecker cannot contact the scanner 1010 0 00 02 202000004 51 ImageChecker cannot identify the lead markers 3023 00 0 51 ImageChecker cannot read the barcode 1041 00000 200000005 51 ImageChecker is b
13. a Scanning Protocol The scanning protocol you choose depends on the views present in the case and the condition of the films In general you will want to select a scanning protocol that suits about 90 of the cases in the stack which will minimize the adjustments that you have to make after scanning However sometimes it may be faster simply to scan with the Any protocol and correct the images afterwards A Important Many scanning errors including scanning films in the wrong order or scanning a film in the wrong orientation can be overcome using the GreenLight Image Correction feature When in doubt scan the films as best you can and fix any problems after scanning However note that if multiple patients are scanned under one separator sheet this error cannot be corrected via Greenlight the cases must be rescanned to ensure that each patient has a different separator sheet The following table provides basic guidelines for selecting a scanning protocol If your films Then see e Are the four standard screening views RCC LCC RMLO 3 3 Scanning with LMLO and the Auto Protocol e Were taken using an R2 supported lead marker those shown on page 24 and e Have well placed lead markers In all cases include the same number and type of views and 3 4 Scanning with e Have unsupported missing or bad lead markers or a Manual Protocol e Have incorrectly placed lead markers e g over a breast image under an ID label
14. identifying the patient associated with the digitized film images This allows for the proper identification storage and retrieval of digitized film images in the archive system The system can be configured to produce 50 or 100 micron output images for any output device For digitized film images the processing units perform dynamic window leveling on each image as well as blacken image areas that lie outside the film edges ImageChecker Screen Film CAD The ImageChecker license provides Hologic s CAD algorithm which is used to identify and mark regions of interest on routine screening and diagnostic mammograms to bring them to the attention of the radiologist after the initial reading has been completed ImageChecker provides three types of RightOn CAD marks Mass Calc and Malc that can appear in the results Each mark identifies a region of interest for the radiologist to review A Calc Marks regions suggestive of calcifications Mass Marks regions suggestive of masses or architectural distortions 4 Malc Composite mark indicates an overlap of Calc and Mass marks The CAD marks can be augmented using the EmphaSize and PeerView features For more information see the manual Understanding ImageChecker 8 5 8 7 18 R2 DX LS User Manual PN MAN 01043 Rev 001 2 5 Other Features 2 5 Other Features In addition to the licensed features the R2 DX and R2 LS systems include the following stan
15. images and searching for a study gt Part 4 Alerts provides a listing of alert conditions with instructions for resolving the alerts and diagnosing and solving common problems gt Part 5 Controls provides instructions for using the system configuration and maintenance options that appear on the Controls screen gt Part 6 Maintenance provides instructions for cleaning the system and running the weekly tests gt Part 7 Using DigitalNow and the R2 Patient ID System provides information about archiving images with the R2 DigitalNow feature and the R2 Patient ID system Conventions Used in this Manual This manual uses the following conventions to provide technical and safety information of special interest A Note Background information provided to clarify a particular step or procedure A Important An instruction provided to ensure correct results and optimal performance Caution An instruction that if not followed can result in damage to the system Z Warning An instruction that if not followed can result in a hazardous condition Also note the following conventions e Italicand boldface typefaces are used for emphasis Examples Press carefully to engage Do not press down e When this manual directs you to touch a button on the touch screen monitor the name of the button is shown in boldface type for example Touch Start e When this manual directs you to press a key on the computer k
16. includes six preconfigured scanning protocols Auto Screening Uni Right Uni Left Screening Imp and Any You can also create your own site specific scanning protocols see 5 7 Scanning Protocols The default 1 e preselected scanning protocol is Auto You can change the default scanning protocol using the Controls Scanning screen as described on page 73 Auto Protocol When using the Auto protocol the system recognizes the lead markers and uses them to properly identify orient and process films with the four standard views You can load the films for each case in any order e g RMLO LCC RCC LMLO and in any orientation e g rotated 180 emulsion side up or down The system automatically scans all films in the stack Each case in the stack can have any number of films up to four The system automatically adjusts if there are fewer than four films However in Auto mode the system will not process duplicate views within the same case e g two RCC films After you touch the Start button the system processes all cases in the stack up to 20 films and separator sheets in all Manual Protocols R2 provides four preconfigured Manual scanning protocols Screening Uni Right Uni Left and Screening Imp Each protocol requires you to load films with specific views in a predefined sequence For the views used with each predefined scanning protocol see 3 4 Scanning with a Manual Protocol You can also define cust
17. is in the proper position e g is not half fed in the feeder and is not damaged e Reload the stack and restart scanning e If these steps do not solve the problem call Hologic Technical Support ImageChecker is busy 3012 1029 1030 The images for the study have not yet been sent e Wait about ten minutes the problem should resolve itself e Ifit doesn t ensure the destination i e display unit or printer is up and ready to receive images e Check that all cables between the processing unit and the destination are connected and that the network is up e If these steps do not solve the problem call Hologic Technical Support R2 DX LS User Manual PN MAN 01043 Rev 001 51 Part 4 Alerts ImageChecker license not found 1024 This message means the system could not verify a valid license e Ensure that the license dongle is present and properly connected If this does not solve the problem call Hologic Technical Support ImageChecker could not print a CAD report 2007 The system has canceled the print request for the study You will only see this alert after several Printer not found alerts The system tries repeatedly to print and displays this message when it gives up To fix e Verify that the printer is on on line and has enough paper After correcting any of these problems ensure that printing is set to on and reprocess the study in the Image Correction screen e Ifthe Printer not fo
18. or label images by using the Image Correction screen For more information see 3 10 Correcting Scanned Images Repeat these steps for each case needing verification R2 DX LS User Manual PN MAN 01043 Rev 001 41 Part 3 Studies 3 10 Correcting Scanned Images After you scan a case you use the Image Correction screen to reorient images change film view labels and modifiers or add a DICOM study description For example you must correct the scanned images if a case includes one or more non standard views or view modifiers or if the system is unable to identify a lead marker In addition you must use the Image Correction screen for all cases scanned with the Any protocol In many cases the system issues an alert to let you know that it could not completely process the case However you can use the Image Correction screen even with cases that have been completely processed without alerts The Image Correction screen allows you to e Reorient scanned images flip or rotate them e Change the film view labels and modifiers e g RCC to LCC e Edit the DICOM study description for the case A Note If films for two or more patients were scanned under a single separator sheet you must rescan the case with a different separator sheet for each patient gt To correct scanned images 1 Open the Image Correction screen Touch the study icon for the study you want to work with Then touch one of the thumbnail images The Im
19. problems ensure that printing is set to on and reprocess the study in the Image Correction screen e Ifthe Printer not found or similar alert appears again check that all cables between the printer and the processing unit are connected Check with your system administrator that your network is up Reprocess the study in the Image Correction screen and print e If these steps do not solve the problem call Hologic Technical Support ImageChecker cannot contact the scanner 1010 This message may occur during system start up or if the scanner was inadvertently turned off The system does not allow scanning films until the problem is fixed e Ifthe system is rebooting wait about 5 minutes e Power cycle the system See 6 2 Power Cycling the System e If these steps do not solve the problem call Hologic Technical Support ImageChecker cannot identify the lead markers 3023 This message appears when scanning with the Auto protocol It means that the system did not recognize the lead markers Either they are not one of the supported types or there is a problem with marker position and or placement on the film s To fix e Identify and label the views on the Image Correction screen and reprocess the study If this doesn t fix the problem call Hologic Technical Support ImageChecker cannot read the barcode 1041 The scanner is not able to read the barcode on the separator sheet e Ensure that the separator sheet
20. records e Replace the duplicate barcode number with a new barcode number Use this new sheet to scan the case The scanner is not responding 1007 The internal scanner software is not responding to signals from the processing unit By power cycling the system you can reset the internal scanner software e Power cycle the system See 6 2 Power Cycling the System e If this doesn t fix the problem call Hologic Technical Support The scanner might be empty 3033 The scanner is not detecting any films in the scanner e Ensure that the films and separator sheets are properly loaded e g are not half fed in the feeder R2 DX LS User Manual PN MAN 01043 Rev 007 55 Part 4 Alerts e Reload the case and restart scanning e If these steps do not solve the problem call Hologic Technical Support X films were found when Y were expected 1017 1018 This usually happens when 1 a separator sheet is missing from the stack or is upside down 2 the system failed to read the barcode for the next case in the stack the barcode is obscured smudged or damaged or 3 a case did not have the number of films specified by protocol e Check to see if the next case is missing its separator sheet or if the barcode is obscured somehow Add a separator sheet or clean the separator sheet If films for two or more patients were scanned under a single separator sheet rescan the case e In many situations you can simply correct
21. solve the problem call Hologic Technical Support Image transfer was interrupted 3013 The system is trying to transmit results but cannot find the specified output device display unit PACS etc The system will try repeatedly to send the results To fix e Make sure the destination device on If this was the problem the results should appear within about ten minutes e Check that all cables between the processing unit and the destination device are connected and that the network is up 52 R2 DX LS User Manual PN MAN 01043 Rev 001 4 1 Alerts Listed Alphabetically e If these steps do not solve the problem call Hologic Technical Support No output jobs scheduled for case 3054 The R2 system was not configured with any output destinations for CAD results If your system is set up to output to the printer only verify that printing is turned on at the Controls screen See 5 6 Printing Options for more information No patient record information is associated with barcode 3501 This alert appears when you are attempting to transmit the study results to an archive It means that there is no patient record in the database with that specific barcode When this alert is issued the results will not be archived Although you can print the results for the study any patient information in the database will not be listed on the printout The images in the R2 system are linked to the patient record in the database by the se
22. 55 The scanner is not responding 1007 0 0 0 aaan 55 R2 DX LS User Manual PN MAN 01043 Rev 001 4 2 Part 5 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 Contents The scanner might be empty 3033 0000000000 55 X films were found when Y were expected 1017 1018 56 Common OQUGStiONnS 6 244544 here whe speied the eh aida ered eee dt ines debts 57 CAD does not run on views with implants 0 00 000000 e eee eee 57 CAD marks do not appear on thumbnails 0 0 0 c cee ee 57 Case icons become yellow alerts there are no images 57 Film is missing inside the scanner She eo eee eee eee eee 57 Image is missing from a case 1 2 eee 57 Images are reversed in the thumbnails 0 00 00000 eee eee 57 Images at PACS workstation are of poor quality 57 Images didi Cpr COME scsi caine Ge be Say wiles a A ei ae eee BS 58 Images do not appear on my display unit 0 00000 58 Monitor isn t working sso vs 4 aes e se oes PERE ee eee SS eee EARS 58 Main screen is frozen and I can t do anything 02 20 0002 2000 58 Patient ID flash on the printout is backwards 0 0 0 0 0 000000 000 cece 58 Radiologist needs CAD quickly 2 2 0 0 0 00 000 ee 58 Scanned case before entering patient information 00004 59 Yellow X appears on my im
23. AN e Maintain equipment in a well ventilated air conditioned environment e When necessary shut down the system according to the procedures recommended in this user manual e Do not attempt to install or repair the R2 system Only trained personnel authorized by Hologic are qualified to install or repair the system 6 R2 DX LS User Manual PN MAN 01043 Rev 001 Part 2 Description gt 2 1 Overview 2 2 System Components 2 3 Overview of Operation gt gt gt 2 4 Licensed Features gt 2 5 Other Features gt 2 6 System Inputs and Outputs Part 2 provides an overview of the system a description of system components an overview of system operation and features and information about CAD processing 2 1 Overview The R2 DX and R2 LS systems are full featured mammography film scanning platforms designed to e Scan mammography X ray films and convert them into digital image files e Allow users to review the scanned images and to reorient label and reprocess the images as needed e Interface with a patient database to retrieve patient information which can then be integrated with the study images e Use Hologic s DigitalNow feature to transmit the digital mammography image files to an output device such as a PACS for archiving e Use Hologic s ImageChecker CAD algorithm to analyze the images in order to mark regions of interest on routine screening and diagnostic mammograms and transmit the I
24. IEW serete 2S SE Sete eee ee Ebates a Shee BREEN ES 12 Scanning and PFOCESSING ua wen REDER ERA eB eS CARRE SS ETE WERE RSA ES 14 OV SCCM ERGs oe et aces ee Ao ede eek oh nea dot eared ee Bose 15 CGH GIS Ce Clit see earn atin Gok ee TRA RER bos Ee Ses bla ei eee 17 Licensed Features 4 0 444 465 5402424 555 So OS8 a 18 DigitalNow DICOM Export 2324 4 4 030 vowed oooh GaSe Ge ee eee ea 18 ImasetChecker Seere Film CAD rer a xa coe eee ee ees FA Rhee ERE A EO 18 Other Features 2 oad ete tale a eet eee te wa ee hes eee 19 System Inputs and Qutputs 00 eee eee een eee 20 SUpPOMed Views oss seks eae yee en RES Soe eee he ees eee eee een 20 NIEWAVIOCINEDS er 85 5 ote oe lg BA OY ete hg haa eee ee BE ee 21 Results Output OPON ov na rr ee eae n EDER eee ed Ree ee Pee ORAS 22 DUUGIES 2 septs ee ey send ieee oh ae Lobe eee eee eee ene 23 Working with Films 22264 4 4 45 42S REE Ow eb RES 8 PREROA RARER ES ORS 24 PPT MAY TRG CI TANCES i song cn ae AEE cas dua tee ne he Dace cao hak on Seis 24 R2 Supported Lead Markers g5456 wid eee hdd BE BANDE nd Od WEE 24 ead Marker Placement eenander ahald tock dant on SE a lede erne Ra 25 Sepatd OP ONeets acu wed ae ete hdd Ja lse d Ce gl heute d Ewes eaten eee wee ee 25 Scanning Proloco 23 4 abaceterdeteeeanetoogsendusdueesetentoenieteeaes 26 Preparing Cases to Be Scanned eee een ee 28 Scanning with the Auto Protocol 0 0 0 0 000 ee 29 R2 DX LS
25. Image Correction screen 42 44 image verification configuring 63 ImageChecker 7 9 18 22 images R2 DX LS User Manual PN MAN 01043 Rev 001 91 Index 92 correcting scanned 42 44 labeling 44 not appearing on display unit 58 not being printed 58 not sent to display unit 52 output formats 22 reorienting 43 thumbnails 12 thumbnails reversed 57 thumbnails X icon 59 verifying 41 implants breast 21 44 57 74 K keyboard 10 L lead markers automatic film orientation detection 19 placement 25 supported 24 27 system cannot identify 51 license system cannot verify 52 licensed features 18 M maintenance cleaning scanner 79 information 65 power cycling 78 procedures 77 81 reminders 77 weekly tests 80 Maintenance screen 65 mammogram films See films Mammolux motorized viewer 22 Manual protocols overview 26 scanning films with 32 34 Screening 32 Screening Imp 32 Uni Left 32 Uni Right 32 markers See lead markers messages 77 See also alerts monitor touch screen calibrating 76 R2 DX LS User Manual PN MAN 01043 Rev 001 not working 58 uses 10 O Off screen 66 operation overview 12 P patient context 19 flash 12 39 40 58 information 12 39 40 64 patient ID archived images 83 entering 85 entry after scanning 59 querying external database 88 R2 system 85 89 PeerView 18 Performance screen 67 power cycling 78 printer syste
26. MAN 01043 Rev 001 11 Part 2 Description 2 3 Overview of Operation The R2 GreenLight user interface is designed to guide you as you use the system The system s touch screen interface provides quick access to all system functions The user interface features three main screens Studies Alerts and Controls plus a common area with film scanning and search options at the right You can go to each screen by touching one of the tabs at the bottom of the display Onscreen messages appear when appropriate and provide helpful instructions Studies Screen Overview The Study icon at the top represents the study currently being processed or the study most recently processed The Study icons below represent studies processed earlier The white triangle indicates the study icon linked to the study information currently on screen When scanning films you will use the Studies screen which is shown below Search R2 Patient ID Auto Screening Uni Right Uni Left Screening Imp ImageChecker R2 ID 0000022609 Receive Time Oct1015 26 Status Processing Images RCC es Any Patient Information 823075cl img FILM FOR ImageChecker M1000 SYSTEM R2 TECHNOLOGY INC 325 DISTEL CIRCLE LOS ALTOS CA 94022 Patient ID 123456test Name Tester4Teresa Accession Status Ready ee Studies ay Controls Start The following items appear on the Studies screen e Study icons each represen
27. R2 DigitalNow R2 ImageChecker R2 DX LS User Manual Software Versions 8 6 8 7 PN MAN 01043 Rev 001 HOLOGIC Screen Film Mammography R2 DX LS User Manual Software Versions 8 6 8 7 PN MAN 01043 Rev 001 HOLOGIC Technical Support For support in North America contact Toll Free 1 866 243 2533 866 CHECKED Email techsupport r2tech com Hours Monday Friday 6 00 AM 5 00 PM PT GMT 8 00 Website www hologic com For support in Europe South America or Asia contact your local dealer or distributor 2008 Hologic Inc All rights reserved is prohibited Hologic reserves the right to Protected by one or more of the following U S Patents 5133020 5452367 5491627 9622171 5657362 5673332 5729620 5917929 6014452 6035056 6075879 6301378 6404908 6434262 6477262 7054473 7072498 7146031 7174515 Hologic the Hologic logo CheckMate Duplication or distribution without written permission revise this manual Issued August 2008 5537485 5832103 6266435 6909795 5732697 5740268 5815591 5828774 6078680 6185320 6198838 6263092 6574357 6580818 6640001 6628815 DigitalNow Earlier Smarter Better EmphaSize GreenLight ImageChecker Malc PeerView RightOn R2 and the R2 Logo are trademarks or registered trademarks of Hologic Inc in the USA Microsoft and Windows are registered trademarks of Microsoft Corporation MergeCOM 3 is a trademark of Merge He
28. age touch its entry in the Patient Name column R2 DX LS User Manual PN MAN 01043 Rev 001 89 90 R2 DX LS User Manual PN MAN 01043 Rev 001 Index A About screen 62 alerts list of recent 16 listed 49 59 overview of 15 screen 16 algorithm CAD 18 Any protocol overview 27 scanning films with 35 36 archiving configuring 63 overview 83 workflow DigitalNow 84 Auto protocol overview 26 scanning films 29 31 B Barcode Reimbursement Report system cannot print 51 barcode scanner handheld resetting 81 search 13 uses 10 barcode separator sheet system cannot read 51 C CAD marks not in thumbnails 57 CAD Results Report configuring 70 example 45 system cannot print 52 calibrating touch screen monitor 76 cases adding to stack 37 defined 7 prepare for scanning 28 verifying 41 CheckMate Ultra display unit 22 computer 11 Connectivity screen 63 controls 61 76 controls screen described 17 customer support resources 2 D DICOM study description 44 DigitalNow 7 9 18 22 83 display unit cannot connect 50 cannot transmit images 52 E EmphaSize 18 F films ejecting 68 jammed 68 number per case 14 orientation detection 19 preparing for scanning 28 requirements 24 scanner 10 scanning See scanning films scanning protocols 26 27 thumbnail images on Studies screen 39 thumbnails 12 working with 24 27 frequently asked questions 57 59
29. age Correction screen opens as shown in the following example Vv 2 ImageCnecker Sa e T Film LMLO Modifiers M SE mm Partial View __ Implant Present T venenatis ener amet 7 oe DICOM Study Description Mammography Digitized Film Cancel Reprocess The image thumbnails for the case appear at the top of the screen The image you selected appears enlarged at left To navigate through the study images touch the arrow buttons below the enlarged image or touch any of the image thumbnails A Note If the displayed images their labels and DICOM Study Description are all correct then simply touch Cancel to return to the Studies screen Cancel does not cancel the study it simply returns to the previous screen 42 R2 DX LS User Manual PN MAN 01043 Rev 001 3 10 Correcting Scanned Images 2 Reorient image as needed a Touch the enlarged thumbnail at the left of the screen Each time you touch the image it alternately flips 90 along the vertical and horizontal axes Flipping the image a total of four times restores the original orientation b Check the image orientation with the indicators on the four sides of the image Left Right Anterior Posterior Head Foot When the orientation is correct go on to step 3 R2 DX LS User Manual PN MAN 01043 Rev 001 43 Part 3 Studies 3 Modify the view label as needed To define or change the view label build it from left to right select a sid
30. age thumbnails 000000005 59 COM TUOIS 55 nye fare PES OE BOR aN Looe Ea 61 ADOUL ORTON 3 556 2rie ri ane ree ee eek eek a ree 62 Connectivity Options 0 000 eee 63 Retrieving Patient Information 2 25 22g6 00486424 eun PREg eS Ge BLE PERS 64 Enabling DisitaINOWeivses en esther shee eek eee eyes Ste eA aes SE DE tee ee es 64 Enabling Verica 2 00 aen eee e eh oder coy ieee t ie yee coe eee ees 64 Maintenance Options lt 24 24 3 aos8s eee ed Gb Sh Boe ee eS Se Be Lee 65 Shutdown and Reboot Options 0 000 0 eee 66 Performance Options 0 0 0 0 000 ce 67 FOC UI TING hia to mh ede ua es Batre ahs ho ae ot Bee ek dele aE ete aie ade 68 Reviewing System Verification Results 0 0 0 00000 000 ee ee 68 Printing ODUONS reisean rt eaa CA 2 Or ee eh eee De HEER er Andere 69 Configuring CAD Results Printing in 2 ce0iceotaoanitacakier ead Sead pacees 70 Setting When the Reimbursement Barcode Report will be Printed 70 Printing a Reimbursement Barcode Report 0 00000000 cee eee 70 Scanning Protocols 1 0 eee 72 Changing Scanning Protocol Order n n aaau anaa 73 Changing the Default Scanning Protocol 00 000000 ee eee 73 Deleting a Scanning Protocol 0 00 0 000000 73 Creating Scanmine Protocols 2 2 syn met eos adie Coed Mees eee ease ee es 74 Editing Scanning Protocols cans s sata Ree eee ood kd PRR adtoa es SEER 75 Servic
31. althcare CE Hologic Inc 35 Crosby Drive Bedford MA 01730 1401 USA Tel 1 781 999 7300 Sales 1 781 999 7453 Fax 1 781 280 0668 Asia Pacific Room 302 Hung Kei Building 5 8 Queen Victoria Street Central Hong Kong Tel 852 3102 9200 il R2 DX LS User Manual PN Hologic N V Authorized Representative Leuvensesteenweg 250A 1800 Vilvoorde Belgium Tel 32 2 711 4680 Fax 32 2 725 2087 MergeCOM 3 Advanced Integrator s Tool Kit is a product of Merge Healthcare MAN 01043 Rev 001 Contents Part 1 1 1 1 2 1 3 Part 2 2 1 2 2 2 3 2 4 2 5 2 6 Part 3 3 1 3 2 3 3 Introduction eee 1 Resources Available 62 0420 d 200 e eed ieee bea dee BOS Ue eee bese oe ESS Ss 2 How to Use this Manual 0000000 ce 3 Manual Organization 3455 3 20oreca cee Meee oes PEt wae Bee Aes eee cede eds 3 Conventions Used in this Manual 0 0 aana es 3 Warnings and Cautions 0 0 0 00 0 eee 4 Warnings System Operator riak e7e tien ns aed ke doe een ea eek CRESS 4 Warnings Maintenance sytera eu0rg Meet ocd tent aoe Seeder ahead omg Reales s 4 Cautions System Operation 0 0 0 0 00 ee 5 Cautions Installation and Maintenance 000000 ee 6 DESCHIDUON cc aie oooh EE 7 OVGIVICW 4 oon tule OU Aes ok ee ee Oe his 7 System Components 0 0 0 0 0 0c eee 10 Overview of Operation 0 00 00 0000 eee 12 Studies Screen OVERV
32. an 40 relative humidity in the room where the unit is kept use shoes with natural material soles place equipment on nonpolymer floors such as concrete wood or floors treated with static dissipative and or routinely touch metal with a metal object such as a key to painlessly discharge the charge from your body Do not place liquid containers on the device In the event of a spill shut down power to all components prior to cleaning to minimize the possibility of electrical shock Do not operate the device if internal components are exposed to liquid Contact your service representative Before moving the R2 DX system be sure to remove the scanner from the cart The scanner is not permanently connected to the cart it sits on top of it Warnings Maintenance A Before cleaning the computer always shut down the system according to the shutdown procedures in this user manual and disconnect the power cord to prevent the possibility of electrical shock Never use alcohol benzene thinner or other flammable cleaning agents Never use a two prong plug or extension cord to connect primary power to the system Use of a two prong adapter disconnects the utility ground and creates a severe shock hazard The R2 scanners are heavy It is recommended that two people participate when moving equipment R2 DX LS User Manual PN MAN 01043 Rev 001 1 3 Warnings and Cautions Cautions System Operation A Operators should review this u
33. an to scan with the Auto protocol you can use from one to four films as long as they have supported lead markers and are from the four standard views with no duplicate views You can arrange the films in any order and in any orientation See 3 3 Scanning with the Auto Protocol Load only the four standard views with no duplicates If you plan to scan with a Manual protocol you must arrange the films exactly as defined by the desired scanning protocol See 3 4 Scanning with a Manual Protocol If you plan to use the Any protocol to scan a special case one that doesn t conform to any available scanning protocol then see 3 5 Scanning with the Any Protocol Note If you make a mistake when preparing a case for scanning you can correct it after scanning is complete via the Image Correction screen See 3 10 Correcting Scanned Images for more information R2 DX LS User Manual PN MAN 01043 Rev 001 3 3 Scanning with the Auto Protocol 3 3 Scanning with the Auto Protocol Use this procedure to scan cases using R2 s Automatic Film Marker Identification AFMI feature The Auto protocol accepts up to four films per case You can scan with the Auto protocol if all cases in the stack include only the four standard mammography views RCC LCC RMLO LMLO and were processed using a supported lead markers those shown on page 24 that were well placed e For cases that do not meet these criteria but conform
34. an use this screen to decide how you want to use the printer gt To display the Printing screen Touch the Controls tab and then select Printing ImageChecker R2 Patient ID Search About Print CAD results for every case Connectivity On Off Maintenance Off Performance Printing Scanning Service Reimbursement Barcode Report Weekly off Monthly as Print Now Print a reimbursement report right now Studies Pil Controls pu Auto Screening Uni Right Uni Left Screening Imp Any Status Ready Start R2 DX LS User Manual PN MAN 01043 Rev 007 69 Part 5 Controls Configuring CAD Results Printing You can configure the system so that it e Prints images with CAD results for every case or e Does not print at all To enable or disable this feature touch On or Off as desired Print CAD results for every case son Of Setting When the Reimbursement Barcode Report will be Printed You can choose to print a Reimbursement Barcode Report either automatically on a weekly or monthly basis or not at all e To specify automatic printing of the reimbursement report touch Weekly or Monthly e To disable automatic printing of the reimbursement report touch Off Reimbursement Barcode Report _ Weekly _ Off J Monthly Print Now Print a reimbursement report right now Printing a Reimbursement Barcode Report gt To print a reimbursement report 1 Touch Print Now A ca
35. ase R2 DX LS User Manual PN MAN 01043 Rev 001 7 3 Using the R2 Patient ID System 7 3 Using the R2 Patient ID System For sites that do not have a patient database but want to use DigitalNow Hologic provides the R2 Patient ID system The purpose of this patient identification database is to enter the patient information necessary to archive images and or CAD results You cannot query the database view or manipulate records The information remains in the R2 database for only 96 hours four days from time of entry The R2 Patient ID system can be used in conjunction with the DICOM Modality Worklist Study Root or Patient Root Queries as described in 7 4 Querying an External Database on page 88 to retrieve information from your Modality Worklist or PACS To enter patient information your service representative must have configured your system to use the R2 Patient ID system In addition connectivity with the patient database must be enabled by a service engineer You need the following information e Database password hOspital the second character is a zero not the letter O e IP address for the R2 DX or R2 LS system see the Controls About screen Once you have this information you can enter patient information Note For sites with multiple film scanning units When you access the Patient ID database make sure you access the R2 system that you will be using to scan the studies Each system maintains
36. atient information from the patient database such as the patient name medical record number and birth date and links this information to the patient images Patient information can be printed on the CAD Results Report see page 45 and on the Reimbursement Barcode Report see page 19 Each case fed into the R2 film scanning system must have its own separator sheet with an R2 ID barcode which the system uses to associate the patient films with the images in the system To link the patient database information to R2 images you use a keyboard or barcode scanner to enter the R2 ID from the separator sheet Reimbursement Barcode Report The Reimbursement Barcode Report is a listing of all separator sheet barcode numbers scanned in a specific time period You can schedule it to run monthly weekly or on demand for a specified date range The report lists the date the cases processed on that date and the time the case was processed This can be correlated to the patient using the R2 barcode number written in the patient file thereby completing the reimbursement audit trail The report lists only cases that were successfully processed For an example printout see Printing a Reimbursement Barcode Report on page 70 R2 DX LS User Manual PN MAN 01043 Rev 001 19 Part 2 Description 2 6 System Inputs and Outputs 20 The R2 processing unit supports up to 24 images per case All DigitalNow scanned film images can be viewe
37. ay system information ImageChecker 3 R2 Patient ID Search About System Information a Connectivity Host Name DMAX1 r2mfg i Screening Maintenance Host IP 10 85 9 81 nite Touch ead Off Software Version ImageChecker Build 8 7 118 Uni Left name to display its Paar Serre contents Printing Serial Number CD450 Any Scanning Clinic Name SQA DMAX1 Service Algorithm Mass R8 2 Calc R8 2 SCP AE DMAX1 SCU AE DMAX1 Protected by one or more of the following U S Patents 5133020 5452367 5491627 5537485 5622171 5657362 5673332 5729620 5732697 5740268 5815591 5828774 5832103 5917929 6014452 6035056 6075879 6078680 6185320 6198838 6263092 Status 6266435 6301378 6404908 6434262 6477262 6574357 6580818 6640001 6628815 6909795 7054473 7072498 7146031 7174515 Ready aj YT Studies Alerts Pil Controls Start Note The Connectivity and Printing options appear only if they were configured by the Hologic service engineer when the system was installed R2 DX LS User Manual PN MAN 01043 Rev 001 61 Part 5 Controls 5 1 About Option The About option on the Controls screen displays information about the configuration of your R2 film scanning system on the network This information is configured by service personnel when the system is installed 62 gt To display the About screen Touch the Controls tab and then select About if the About screen does not appear I
38. can display or print no more than four views per case If your system has been configured with the ImageChecker license the R2 processing unit can produce ImageChecker CAD results for all supported views However ImageChecker results for certain views may not be available with some output devices and formats View Modifiers View modifiers can be added to describe any supported view The following table lists the supported DICOM view modifiers View Modifier View Modified Axillary Tail AT MLO Cleavage CV CC Partial View none Any Rolled Lateral cadens Any Rolled Medial RM Any Rolled Inferior RI Any Rolled Superior RS Any Magnification M Any Spot Compression S Any Implant Displaced ID Any Implant Present none Any Tangential TAN Any The Partial View and Implant Present modifier labels are NOT added to the view description but are present in the DICOM header of the DigitalNow image Implant displaced views with a maximum of 2 5 cm 1 in of implant imaged A Important Certain view modifiers prevent the system from performing CAD processing For more information see the manual Understanding ImageChecker 8 5 8 7 R2 DX LS User Manual PN MAN 01043 Rev 001 21 Part 2 Description 22 Results Output Options The R2 processing unit can send results with any of the following formats to a PACS or review workstation DigitalNow is a traditional DICOM Digital Mammography X Ray For Presentation
39. commends that facilities using DigitalNow always verity the images before archiving them to reduce the chance of improperly oriented or identified images being sent to a PACS Also from time to time be sure to check images received at the PACS to confirm that films continue to be properly scanned and digitized Note The Verification option is only available for systems configured with the DigitalNow license Systems that are configured with just the ImageChecker license do not provide the Verification option If your system has been configured to require verification then after the system processes the cases it displays a blinking question mark on each study icon The question mark also appears on the Studies screen tab at the lower left of the screen gt To verify cases 1 Touch the study icon for the case you want to verify The system displays the results for the selected study Status Needs verification Images RCC Review the case results Check to see that the images are oriented correctly and that the patient information was retrieved successfully from the archive Touch the Done button or make corrections e Ifthe results are acceptable touch the Done button In response the system transmits the results to the archive or other output device e Ifthe results are not acceptable or if the system produced an alert for the case you may need to take corrective action In some situations you may need to reorient
40. con at the top of the study list and a white circle on the icon flashes to indicate that the films are being processed If you touch this icon you can monitor the progress of the study as the films are processed There are three possible outcomes e Success If the system processes the case successfully and verification of cases is not required then the system automatically sends the study results to the output device display unit printer and or PACS archive An arrow on the icon flashes to indicate that the system is sending the results After the system sends the results the icon appears solid green e Verification Required If verification of cases is required then you must review the scanned image thumbnails and patient information and confirm that the results are acceptable If no Alert has been issued then the Done button appears on the Studies screen When you touch Done the system sends the results to the output device display unit printer and or PACS archive R2 DX LS User Manual PN MAN 01043 Rev 001 29 Part 3 Studies e Alerts If the system replaces the study icon with an Alert icon you may be required to take corrective action In many situations instead of rescanning the Alet case you can often correct the alert and reprocess the images via the Image Correction screen For more information on the study icons see the table on page 14 Also see 3 10 Correcting Scanned Images and Part 4 Alerts
41. d Your system is due for its quarterly preventive maintenance servicing Call Hologic Technical Support to schedule an appointment In the meantime you can continue scanning If the system is not serviced within 180 days the alert will appear continuously R2 DX LS User Manual PN MAN 01043 Rev 001 77 Part 6 Maintenance 6 2 Power Cycling the System Power cycling means to shut down the computer and then switch it back on By power cycling once a week you will help keep the processing unit computer operating properly gt To power cycle the system 1 Touch the Controls tab and then select Off 2 Touch the Shutdown button After the software application shuts down the monitor displays Power down 3 Switch off the system using the power switch on the side of the cart R2 DX or connected to the power strip R2 LS System Power Switch System Power Switch R2 DX R2 LS Shutting Off the System Wait ten 10 seconds Switch on the system using the power switch When the Studies screen appears the system will be ready for use 78 R2 DX LS User Manual PN MAN 01043 Rev 001 6 3 Cleaning the Scanner 6 3 Cleaning the Scanner To ensure optimum scanner performance once a week clean the scanner s auto feed roller To clean the auto feed roller 1 Wrap a long piece of light adhesive tape transparent office type around your fingers with the adhesive side out
42. d at a digital review workstation and or archived on a PACS Other devices such as the CheckMate Ultra display unit can display up to four views per case if the views are supported by the display unit Supported Views The R2 processing unit allows you to scan and digitize all standard mammography views and then label them appropriately The four standard views processed automatically are e RCC Right Cranio Caudal e RMLO Right Medio Lateral Oblique e LCC Left Cranio Caudal e LMLO Left Medio Lateral Oblique KJ i The Four Standard Views The following table lists all supported views and the output devices that can accept these views Supported Views DICOM Display Unit Workstation Printer Standard View View Label PACS or CAD SC Cranio Caudal CC e e Medio Lateral Oblique MLO e Equivalent View Medio Lateral ML e Exaggerated Cranio Caudal XCC Cranio Caudal Exaggerated Laterally XCCL e e Cranio Caudal Exaggerated Medially XCCM e Latero Medial LM e Latero Medial Oblique LMO Cranio Caudal From Below FB Superolateral to Inferomedial Oblique SIO e Output supported to this device Output not supported to this device or format R2 DX LS User Manual PN MAN 01043 Rev 001 2 6 System Inputs and Outputs In the preceding table Display Unit refers to a CheckMate Ultra display unit or Mammolux motorized viewer These devices and the R2 postscript printer
43. dard features which are described further below e Automatic Film Marker Identification e Patient Database Connectivity e Reimbursement Barcode Report Automatic Film Marker Identification If your four standard view films were processed using R2 supported lead markers and the markers are well placed you can scan the films using Auto film detection mode This means your cases can consist of any number of films up to four and you can place them in the scanner in any orientation e g rotated or emulsion side up or down and in any order This timesaving feature enables sites to scan as many cases as possible in as short a time as possible The lead markers must be a supported type they must not be attached with putty or other opaque substances and they must be placed properly as per MQSA standards R2 suported lead markers are available from Hologic Livingston Products Siemens Techno Aide or All Craft Wellman For the supported marker types see R2 Supported Lead Markers on page 24 Patient Database Connectivity When scanning films for digital archiving sites need the ability to retrieve patient information in order to add the required identification information to the resulting Digital Mammography X Ray images Sites can retrieve patient data by querying a PACS or RIS Radiology Information System As an alternative sites can enter patient data manually by using the R2 Patient ID feature The R2 software retrieves p
44. e Although extremely rare this can result in a case where the last image is missing Sometimes an alert will appear X films were found when Y were expected but not always This situation is most likely to occur with an LMLO image from a film with a light pectoral muscle or with any film that has an extremely light area in the upper left corner If you suspect that the film scanner has read a separator sheet barcode through a film then reorient the film and rescan the case As an alternative run the case at the bottom of the next stack of cases Images are reversed in the thumbnails Typically this happens either when you are scanning with a Manual protocol and did not stack the films in the order expected by the R2 system or when you are scanning with the Auto protocol and the lead markers are bad or obscured e Use the Image Correction screen to flip the images to the correct orientation and reprocess See 3 10 Correcting Scanned Images e Ifthe problem persists contact Hologic Technical Support Images at PACS workstation are of poor quality Contact Hologic Technical Support In some cases a service representative may need to adjust the contrast and brightness settings for your system R2 DX LS User Manual PN MAN 01043 Rev 001 57 Part 4 Alerts 58 Images didn t print out e Make sure the study processed successfully or that there were no printer alerts If a case did not scan and or process successfully
45. e a view and then modifiers as needed Modifiers M S RL RM RI RS _ Partial View Implant Present a Touch the proper Side selection Left Right or Both for cleavage view b Touch the proper View selection Note the two additional selections below the view area for Partial View and Implant Present c Touch to select Modifiers as needed As you build the view label invalid selections are eliminated For example if you choose Both for the side the system automatically sets the view to CC and the modifier to CV You can chain valid modifiers together as needed Some modifiers for example M and S appear before the view designation other modifiers such as ID and TAN appear after the view designation See Supported Views on page 20 for a complete list of views and modifiers A Note You must select a view when using the TAN modifier as TAN can be used with any view A Note ImageChecker will not process views modified with the Partial View or IP modifiers For further information see Understanding ImageChecker 8 5 8 7 4 Repeat steps 2 and 3 for each image Modify the DICOM study description as needed If desired touch the DICOM Study Description field and use the keyboard to change the DICOM study description for the case The default description is R2 Mammography Digitized Film Note All images in the case will contain the same DICOM Study Description modifying it in one image chang
46. e the Status field changes to Completed A white arrow on the study icon flashes to indicate that the system is sending study results to the display unit PACS workstation or printer on your network A Note Before the study results are sent to the display or archive device you may be required to verify that the system scanned the films correctly This option is contigured on the Controls Connectivity screen For more information see 5 2 Connectivity Options The appearance of the study icon indicates the status of the case Study Icon Status Om blinking circle Case films are being scanned or processed or Slice anew Case results are being sent to a display or archive device 5 a Scanned images for the case require 2 blinking question mark HER For o men Case films are being scanned or processed but om blinking exclamation mark a non fatal fault condition has occurred Fo blinki Case results are being transmitted but a non i doii i fatal fault condition has occurred Scanned images for the case require GR blinking question mark verification and a non fatal fault condition has occurred agr Case is complete results have been sent aD Case is complete but a fault condition has occurred that may require user intervention Alert Case has failed A fault condition has occurred that requires user intervention For more about using the Studies screen see Pa
47. e Utilities isc does Yh ews doe ea hee eee ee a ee ee Mdr den 76 Calibratine the Touch Scleen lt 2 225 nean nb a Ron teow SE Radh Rees 76 R2 DX LS User Manual PN MAN 01043 Rev 001 Vv Contents vi Connecting to the Service Tool 244 ese ee ees BB AR KRANSE RE HE Ha daa Rs 76 Part 6 Maintenance ee 77 6 1 Maintenance Reminders aaa eee 77 PigenOsic tests tated ances eae a SE etn eed owe ane d a eae 77 Mest Films Needed tec rs mee rene dele ares acer Hite rad ae Snes Een bre nere wine ed 2 77 Preventive maintenance is required 0 0 kr taia eee 77 6 2 Power Cycling the System 0 0 0 0 0 cc ee 78 6 3 Cleaning the Scanner 0 0 0 ee ee 79 6 4 Running the Weekly Tests saae eee eee een ee 80 6 5 Resetting the Handheld Barcode Scanner 005 81 Part 7 Using DigitalNow and the R2 Patient ID System 83 FA OVGIVIEW 6 245264 ERE 644 ge DEGRADE aE A AG GEER ENDE aH S DES KOR ES 83 7 2 DigitalINow Archiving 0 0 0 0 0 0 eee 84 7 3 Using the R2 Patient ID System 000 00 00 0000 a 85 7 4 Querying an External Database 0 00 00 uee 88 ge ON se se se crass bh EAT A E T teeter ae Sean we EE EE toe Ae a aegis 91 R2 DX LS User Manual PN MAN 01043 Rev 001 Part 1 Introduction gt 1 1 Resources Available gt 1 2 How to Use this Manual gt 1 3 Warnings and Cautions Thi
48. e films are not rescanned the results for the case will be identical to the original R2 DX LS User Manual PN MAN 01043 Rev 001 45 Part 3 Studies 3 12 Searching for a Study You can search for and display the information from any previously processed study using any of the following study data e R2 ID from the separator sheet barcode e Patient ID e Name The search is limited to the 200 most recently processed studies or fewer depending on the available disk space in the processing unit s computer gt To search for a study and display its results 1 Type the data for the study you want to find You can just start typing you don t need to touch the Search field first You can also enter data by using the handheld scanner to scan a barcode from a patient record or separator sheet Note The system does not accept or need wildcard characters e g The search function will find any data that partially or completely matches the text you enter If you leave the search field blank the search returns all studies on the system 2 Touch Search The search results appear e If only one study matches the search criteria the system displays the study information automatically e If multiple matches occur the system displays the Search Results window as shown in the following example e ImageChecker R2 Patient ID Search Search Results iis Pa R2 ID oc Receive Time Se Status Fz screening Jni Righ
49. e following table shows the Status conditions that the system can display for a case Case Status Message Meaning Processing The system is scanning and processing the selected case Needs Verification The system requires you to review and verify the case images before it will send the study results to a display device or archive Transmitting The system is transmitting the scanned images to a display device or archive Completed The system has finished transmitting the study Failed The system was unable to complete the processing or study transfer and has issued an alert If one or more images in the study could not be processed for any reason a yellow X appears on the image However all scanned images will still be sent to the PACS if your system is configured for archiving See Part 4 Alerts for more information on alert messages Can not process image RLM successfully Some outputs for this image were not generated This image was archived without enhancement Images 40 R2 DX LS User Manual PN MAN 01043 Rev 001 3 9 Verifying Scanned Cases 3 9 Verifying Scanned Cases When using DigitalNow at some facilities the system will require you to verify scanned cases before you archive them The verification step is configured by going to the Controls Connectivity screen and setting Verification before sending Output to On see 5 2 Connectivity Options A Important Hologic re
50. e information about a particular alert ImageChecker R2PatientID Search This study generated a non fatal alert Auto R2 ID 0000000942 i Receive Time Feb 26 13 21 Screening Status Transmitting Uni Right Alert description 1 ImageChecker attempted but could not send case Uni Left 0000000942 format Screening Imp FMT_R2_DU_HIGH_RES_WITH_FLASH to destination A CMU6 r2mfg ImageChecker will try again fy New Protocol 2 ImageChecker attempted but could not print a CAD report for case 0000000942 ImageChecker will try again Images RCC This study generated a Patient Information Status ha ME eae arc5 newcases s23169cl ima n Studies Alerts aT Controls Start R2 DX LS User Manual PN MAN 01043 Rev 001 15 Part 2 Description When an alert is issued the yellow alert icon 4 appears on the Alerts tab at the bottom of the screen If you touch the Alerts tab you can see recent system alerts ImageChecker R2 Patient ID Search a Auto Touch to sort alerts Time a PID R2ID Description Screening by Time R2 ID or TNE Uni Right ati Oct 10 14 13 0000000541 No patient record information is associate alert Description Uni Left Oct 10 14 09 0000000655 No patient record information is associate Oct 10 14 05 0000001691 No patient record information is associate Oct 10 14 03 0000001376 No patient record information is associate Date and time alert Oct 09 23 00 Calib
51. ed scanning protocol in the list at the left of the screen 2 Touch Remove 3 Confirm that you want to delete the protocol Note You can delete any scanning protocol except the Auto protocol R2 DX LS User Manual PN MAN 01043 Rev 001 73 Part 5 Controls Creating Scanning Protocols The Scanning option on the Controls screen allows you to create custom scanning protocols and edit or delete existing protocols gt To create a new scanning protocol 1 Touch New on the Controls Scanning screen to display the Edit Protocol Screen 2 Touch or click in the Protocol Name field and enter a name for your new protocol ImageChecker Protocol Name New Protocol eeseseseses i it w SS FEER New ne BE Film RCC RCC Side Modifiers D Left gt Ey M Right F mis J Both Partial View lt A Up Down Implant Present _ DICOM Study Description Cancel 3 Touch New to add a film view to the protocol Build the film view from left to right select a side a view and any modifiers a Touch the proper Side selection Left Right or Both if cleavage view b Touch to select the View Note the two additional selections below the view area for Partial View and Implant Present c Touch to select any modifiers needed Note As you build the film view invalid selections are eliminated For example if you choose Both for the side t
52. ee 6 2 Power Cycling the System 5 Ifthe preceding steps do not fix the problem call Hologic Technical Support Scanner Performance Eject Current Film In case a film gets stuck Reviewing System Verification Results The Test Results portion of the Performance screen provides the results of the most recent system verification testing including the scanner test Test Results CPU Jul 24 2008 PASSED Algorithm Test Jul 24 2008 COMPLETE Processor Test Jul 24 2008 COMPLETE Scanner Film 1 Jul 23 2008 PASSED Scanner Film 2 Jul 23 2008 PASSED For more information on the tests see 6 4 Running the Weekly Tests 68 R2 DX LS User Manual PN MAN 01043 Rev 001 5 6 Printing Options The Printing option on the Controls screen allows you to 5 6 Printing Options e Configure the system to send images and CAD results to a printer on your network See Configuring CAD Results Printing on page 70 e Configure the system to print the barcode reimbursement report on a weekly or monthly basis or not at all e Print the barcode reimbursement report See Setting When the Reimbursement Barcode Report will be Printed on page 70 Note Printing options appear only if configured by the Hologic service engineer when the system was installed A Note Not all scanned images are sent to the printer For more information see 2 6 System Inputs and Outputs Once configured you c
53. een is frozen and I can t do anything Contact Hologic Technical Support They will log in remotely using HologicConnect and troubleshoot the system DO NOT just turn off the system if you do the software may not shut down properly which can result in other problems Patient ID flash on the printout is backwards e Typically this happens when you scan the case with a Manual protocol and loaded the stack or case upside down See 3 10 Correcting Scanned Images for instructions on adjusting the image orientation e This problem can also occur if the service configuration is incorrect If the problem persists contact Hologic Technical Service Radiologist needs CAD quickly For sites that archive images to PACS a radiologist may request a quick turnaround for CAD results from certain films without waiting for the system to scan all films Splitting the films into two cases may be undesirable because that produces separate studies at the PACS for the case In such a situation you can turn off Archiving see R2 DX LS User Manual PN MAN 01043 Rev 001 4 2 Common Questions 5 2 Connectivity Options scan and process the requested views and send the results to the CAD display unit Then turn Archiving back on scan and process all films for the case and send the results to the PACS Scanned case before entering patient information You can enter the patient information after scanning and reprocess the study to link the images t
54. em generates a new alert an alert icon 4 appears on the Alert tab R2 DX LS User Manual PN MAN 01043 Rev 001 49 Part 4 Alerts 4 1 Alerts Listed Alphabetically The alert messages are presented here in alphabetical order with instructions for addressing each problem Archiving was cancelled for case 3045 The barcode has no associated patient information in the patient information database Enter the patient information into the patient database including the R2 barcode on the separator sheet scanned with the case then reprocess the case via the Image Correction screen See 3 10 Correcting Scanned Images for more information Cannot process image successfully 1063 The system is unable to perform CAD processing or image enhancement on the image due to poor film quality A yellow X appears on the image thumbnails on the Studies tab Even though no processing was possible the scanned images are archived as usual e Verify that the images have the correct view labels if not correct the view labels on the Image Correction screen See 3 10 Correcting Scanned Images for more information e Verify that the image views and view modifiers are supported for CAD processing See 2 6 System Inputs and Outputs for more information Cannot process this case 1062 The R2 software cannot work with the images as they are e Correct the images as necessary via the Image Correction screen and reprocess the s
55. emove the films and produce the alert than to wait for the films to be scanned and processed A Important Verify that cases you add to the stack conform to the selected scanning protocol or select the desired protocol before scanning the case gt To add cases to the stack 1 2 Prepare the cases to be scanned as described in 3 2 Preparing Cases to Be Scanned If the system is currently scanning touch Stop The scanner will stop after it finishes the current film A Important When you touch Stop the system always resets to the default scanning protocol If the system generates an alert touch OK in the pop up window Remove the films and separator sheets from the feeder Rebuild the stack in the order you want to run the cases making sure the films and separator sheets are in the correct order e Ifyou want to run the new cases first add them at the top of the stack e Ifthe system did not scan all the films from the last case take the scanned films from the output tray and put them together with the films that were not scanned Insert the new stack of cases into the feeder If necessary select the scanning protocol you want to use Touch Start to resume scanning R2 DX LS User Manual PN MAN 01043 Rev 001 37 Part 3 Studies 3 7 Stopping Scanning and Removing a Case 38 You cannot cancel a study but if you don t want to continue scanning the current set of films you can stop the system a
56. es it for all images in the case 6 Reprocess the case Once the images and their labels are correct touch Reprocess The system cancels the old case removes the old study icon reprocesses the case all images and creates a new study icon at the top of the study icon list If the system does not issue an alert it e Automatically sends the results to the output devices PACS display unit printer etc if Verification is off e Waits for you to click the Done button if Verification is on before sending the results 44 R2 DX LS User Manual PN MAN 01043 Rev 001 3 11 Printing CAD Results 3 11 Printing CAD Results If you have configured the system to print CAD results for every study as described in 5 6 Printing Options the CAD results are automatically printed when processing is complete The following is an example of a CAD Results Report Ro ImageChecker Report Patient Name test test oe R2 SOA Lab DMAX2 Birth Date ID 2585 Augustine Dr Sex F Ral Physician __ Sania Clara CA 95054 LEC CC LMLO RZ Bar Code 0000062528 CAD Marker Stats si0305ml img TEST FILM FOR ImageChecker H1000 SYSTEM Process Date Time 2005 10 23 17 33 47 Males 325 DISTEL CIRCLE LOS ALTOS CA 94072 Processor DMAX2 Masses 2 Software Ver Mammo 8 5 Total Tee mme Sl If you want to create an additional paper printout of the CAD results touch any of the thumbnail images for the case and reprocess it Because th
57. es separately using a different separator sheet with a different R2 barcode for each study To avoid entering the patient data twice use the back arrow on your web browser to return to the patient data entry page The keyboard shortcut is Alt left arrow At that point you would need to change only the study date and accession number R2 DX LS User Manual PN MAN 01043 Rev 001 87 Part 7 Using DigitalNow and the R2 Patient ID System 7 4 Querying an External Database You can enter patient information onto the patient information entry page by querying a PACS workstation configured by the Hologic service engineer when the system was installed There are three types of queries the type you can run was configured by the Hologic service engineer The following types are available e DICOM Patient Root Query If this was configured only the query buttons in the Patient Information section of the patient information entry page are active When you query by touching the query button to the right of the patient name fields the system queries using only those fields When you query by touching the query button to the right of Site Patient ID Medical Record field the system queries using only that field With either button the query result returns data for just the fields in the Patient Information section e DICOM Study Root Query If this was configured only the query button in the Study Information section of the patien
58. es to Be Scanned 2 Arrange the films and their separator sheets in the order shown on the screen below the selected scanning protocol and with the orientation shown below HOLOGIC R2 Orientation e Emulsion dull side down Small landscape e Large portrait A Important When using a Manual scanning protocol use the same film views for all cases in the stack and arrange the films in the order defined by the selected protocol 3 Load the stack into the scanner s feeder see box on page 31 Insert the stack with e The arrow on the top separator sheet pointing into the scanner e The leading edges of the films and separator sheets aligned flush You can load up to 25 sheets including films and separator sheets up to five four film cases A Important To prevent separator sheets and films from misfeeding be sure to load them properly into the scanner s feeder For additional details see the box on page Auto 4 Touch the desired scanning protocol In the example shown at left Screening is selected The views defined for the selected protocol are Screenin displayed below the protocol list Uni Right Note You cannot change the scanning protocol while a case is being Uni Left scanned Screening Imp 5 Touch Start The system status changes from Ready to Scanning and the Start button changes to Stop Any 6 A new study icon appears at the top of the study list and a white c
59. est fails Usually you can clear the alert by rerunning ALL tests again e First make sure the test films and separator sheets are not bent or damaged in any way If they are call Hologic Technical Support for replacements e Rerun all test films See 6 4 Running the Weekly Tests Usually this fixes the problem e If any tests fail again power cycle the system see 6 2 Power Cycling the System and rerun the tests again e If any tests fail at this point call Hologic Technical Support Hologic does not recommend that you use the system if any of the tests failed Scanning is disabled remote maintenance in progress 5010 5059 Hologic Technical Support is working on your system and you ll need to wait until they are done e Wait two minutes The Ready message will appear above the Start button e If your Hologic Technical support is done and the message does not go away power cycle the system See 6 2 Power Cycling the System e If this doesn t fix the problem call Hologic Technical Support 54 R2 DX LS User Manual PN MAN 01043 Rev 001 4 1 Alerts Listed Alphabetically Scheduled reimbursement report 5050 Appears when the system prints a reimbursement report automatically weekly or monthly depending upon the system configuration This is normal The message does not appear when you print a reimbursement report manually See 5 6 Printing Options for more information Shutting down t
60. eyboard the key names are outlined for example Press Enter e Ifyou are reading this manual online click on the blue hyperlinked text to jump to the referenced section R2 DX LS User Manual PN MAN 01043 Rev 001 3 Part 1 Introduction 1 3 Warnings and Cautions 4 Note For radiological warnings and precautions associated with R2 ImageChecker see the manual Understanding R2 ImageChecker Warnings System Operation NE A A Use the system only outside the patient environment The system is rated for use only in an office environment Remove all potentially obstructive jewelry and clothing before loading films in the processing unit to minimize the possibility of injury due to moving parts or damage to the system The hand held barcode reader is a Class II laser device that emits laser light Do not stare into beam The symbol next to the power connector indicates a potential shock hazard Ensure that the system is connected to a power receptacle that is properly grounded and provides voltage and current within the specifications of the system to reduce the likelihood of electrical shock or fire hazard There is a small risk of electrostatic discharge static electricity It is mostly a nuisance and not likely to cause harm However a shock can cause accidental injury if for example you suddenly withdraw your arm and hit it against something To minimize possibility of shock maintain greater th
61. g the list of cases and the status of each case Click Help at the upper right corner for detailed instructions Logout Help Patient ID Study Date Priority Status Al a Fr E a a E E a Patiento19 Description Output Jobs Destination Format Status PatientName PatientID StudyDate e You can filter the list of cases by entering search criteria in any of the fields in the Search panel at the top of the screen and then clicking the search button e You can sort the list of cases by clicking on any of the column headers Clicking it again reverses the sort order e When you click on a patient name the information associated with the study is shown in the Description panel at the bottom of the screen 3 Select one or more cases using the checkboxes on the left side of the queue 4 Use the run next delete and stop buttons to move the selected case s to the top of the queue run next delete them or stop processing them 5 When you are finished exit the web browser 48 R2 DX LS User Manual PN MAN 01043 Rev 001 Part 4 Alerts gt 4 1 Alerts Listed Alphabetically gt 4 2 Common Questions Part 4 provides a listing of alert conditions with instructions for resolving the alerts and diagnosing and solving common problems The Alerts are designed to help you and Hologic service personnel diagnose problems when they arise When they occur the alerts appear in two places e On the
62. gnizes the test film barcode numbers and automatically changes to Test mode The test requires about five minutes to complete 3 When done review the results by touching the Controls tab and then selecting the Performance option 4 Verify that all test results read PASSED e If all tests pass you re done for the week e If any test reads FAILED rerun ALL the tests Be sure that the test sheets and films are loaded in the correct order If any test fails again power cycle the system see 6 2 Power Cycling the System and rerun all the tests e If any test fails again call your Hologic service representative 80 R2 DX LS User Manual PN MAN 01043 Rev 001 6 5 Resetting the Handheld Barcode Scanner 6 5 Resetting the Handheld Barcode Scanner Occasionally it is necessary to reset the handheld barcode scanner software to its default settings If the barcode scanner stops reading barcodes properly use the barcode labels provided in this section to reset it gt To reset the handheld barcode scanner 1 Scan the Enter Exit Configuration Mode barcode shown below When you scan the barcode the scanner should beep three times Enter Exit Configuration Mode 9 9 9 9 9 2 Scan the Recall Defaults barcode When you scan the barcode the scanner should beep once This erases all previous settings and returns the barcode scanner to its factory default communications settings Recall Defaults 9 8 i 9 9 9
63. he operating system please wait 5020 This means the system is shutting down e Let the system shut down Usually it shuts down only when instructed to do so e If this happened on its own power cycle the system to bring the system back up See 6 2 Power Cycling the System e Ifthe alert continues to appear contact Hologic Technical Support Shutting down the R2 software please wait 5018 This means the system is shutting down It will shut down the R2 software then the operating system e Let the system shut down Usually it shuts down only when instructed to do so e If this happened on its own power cycle the system to bring the system back up See 6 2 Power Cycling the System e Ifit happens again contact Hologic Technical Support The same barcode has been assigned to multiple patients 3500 This alert appears when you are sending results to the patient database It means you assigned the same R2 barcode number to two different patients in the database The images in the R2 system are associated to the patient record in the database by the barcode number on the separator sheet When you scan the studies the R2 system searches for the patient record in the database that has that barcode and associates the images to that patient record If there is more than one patient record with the same barcode the system does not know which patient the images belong to e Access the database and check the patient
64. he view is set to CC and the modifier is set to CV Valid modifiers can be chained together as needed Some modifiers for example M and S are added before the view designation other modifiers such as ID and TAN are added after For a list of supported views see Supported Views on page 20 4 Repeat step 3 for each film view you wish to add to the scanning protocol e To move a view touch a view name in the list at left and then touch Up or Down e To remove the view from the scanning protocol touch a view name in the list at left and then touch Remove e To enter a study description touch the DICOM Study Description field 5 Touch OK when finished 74 R2 DX LS User Manual PN MAN 01043 Rev 001 5 7 Scanning Protocols Editing Scanning Protocols You can edit scanning protocols from the Controls Scanning screen gt To edit a scanning protocol 1 Touch a scanning protocol in the list at the left of the screen 2 Touch Edit to open the Edit Protocol screen 3 Edit the Protocol You have the following options e To change the view order touch a view name in the list at the left then touch Up or Down as needed e To remove the view from the scanning protocol touch the view name then touch Remove e To enter a new name for the protocol touch the Protocol name then enter a new name e To add anew view to the protocol touch New Build the view from left to right starting with the side then a view then modifiers
65. ice Tool Access to the service tool is password protected and intended solely for use by authorized Hologic service personnel 76 R2 DX LS User Manual PN MAN 01043 Rev 001 Part 6 Maintenance gt 6 1 Maintenance Reminders 6 2 Power Cycling the System 6 3 Cleaning the Scanner 6 4 Running the Weekly Tests v Vv vy iy 6 5 Resetting the Handheld Barcode Scanner Part 6 provides maintenance procedures that must be performed weekly to ensure optimal system performance Hologic strongly recommends you follow all maintenance instructions given in this manual 6 1 Maintenance Reminders The system automatically issues a reminder message whenever a required maintenance procedure must be performed The reminder messages are listed below Diagnostic tests failed The scanner diagnostic tests failed Each time the system starts up the scanner performs tests to make sure all internal systems are working properly You cannot scan until the scanner passes its tests To fix the problem power cycle the system See 6 2 Power Cycling the System If this doesn t resolve the problem call Hologic Technical Support Test Films Needed The system test films have not been run are overdue or have failed To fix the problem see 6 4 Running the Weekly Tests More information about individual film tests is available on the Controls Performance page see 5 5 Performance Options Preventive maintenance is require
66. ieve Patient Information setting on the Connectivity screen Retrieve Patient Information for New Cases On _ Off To enable or disable this feature simply touch On or Off as desired Enabling DigitalNow The DigitalNow option on the Connectivity screen allows you to enable or disable DigitalNow DigitalNow On _ Off To enable or disable this feature touch On or Off as desired Enabling Verification The Verification option on the Connectivity screen allows you to specify whether a verification step will be required after you scan the films For more information see 3 9 Verifying Scanned Cases Verification before sending Output On Poff To enable or disable this feature touch On or Off as desired Note Changing the Verification status On or Off has no effect on studies currently waiting to be verified or those currently processing You must still manually verify each case A Note Verification can be turned On only if the DigitalNow option is also On 64 R2 DX LS User Manual PN MAN 01043 Rev 001 5 3 Maintenance Options 5 3 Maintenance Options The Maintenance option on the Controls screen allows you to review whether scheduled maintenance is needed gt To display the Maintenance screen Touch the Controls tab and then select Maintenance a ImageChecker S R2 Patient ID Search About Maintenance Information gt Auto Connectivity Test Fi
67. image to display the Image Correction screen See 3 10 Correcting Scanned Images for further information on reorienting and labeling images Identify each image and correct the orientation as needed 7 When you have correctly reoriented and labeled all images touch Reprocess on the Image Correction screen to reprocess the images The system returns to the Studies screen and a white circle on the study icon flashes to indicate that the system is processing the views When processing is complete a white arrow on the icon flashes to indicate that the results are being transmitted to a display unit printer and or archive system After the system transmits the study the icon appears solid green 8 When the cases have been scanned successfully the films can be returned to the patients film folders If necessary keep the separator sheet with the case for CAD display Note After scanning the case the system returns to the default protocol contigured on the Controls Scanning screen 36 R2 DX LS User Manual PN MAN 01043 Rev 001 3 6 Adding Cases to the Stack 3 6 Adding Cases to the Stack You can add one or more cases anywhere in the stack If you re not in a hurry for the case add it to the bottom If you re in a hurry add it to the top Cases at the top are processed first Note This procedure can produce an alert indicating there were too few films for the previous case However it is often faster to r
68. image where the image is comprised of Natural Pixel Values the values actually created by the film scanner DigitalNow images do not include CAD results DigitalNow results can be created as 50 or 100 micron image files The file sizes can vary depend upon the film size and resolution Film Size 50u Image 100yu Image 18 x 24 cm 35 MB 8 6 MB 24 x 30 cm 50 MB 14 4 MB R2 Auto is the format used to display the four screening views with CAD results on a CheckMate Ultra display unit or Mammolux motorized viewer With this format the CAD results appear over a montage of low resolution images Normally the four screening views appear although it is also possible to produce CAD results from films that show Equivalent Views Mammography CAD SC is a Secondary Capture image that provides the same low resolution images and CAD results as appear in the R2 Auto format This format is useful for PACS that do not support CAD SR Postscript files suitable for printing on a postscript printer provide the same low resolution images and CAD results as appear in the R2 Auto format For an example see the CAD Results Report on page 45 Mammography CAD SR 8 x results are derived from the latest version of the ImageChecker algorithm This is the DICOM standard format for CAD results Mammography CAD SR objects are generally useful only when viewed with the images on an advanced diagnostic review workstation Mammography CAD SR 5 x provides backward com
69. ircle on Ar the icon flashes to indicate that the films are being processed If you touch gt this icon you can monitor the progress of the study as the films are re processed There are three possible outcomes LCE e Success If the system processes the case successfully and verification of hie cases is not required then the system automatically sends the study i results to the output device display unit printer and or PACS archive An arrow on the icon flashes to indicate that the system is sending the results After the system sends the results the icon appears solid green e Verification Required If verification of cases is required then you must review the scanned image thumbnails and patient information and confirm that the results are acceptable If no Alert has been issued then R2 DX LS User Manual PN MAN 01043 Rev 001 33 Part 3 Studies the Done button appears on the Studies screen When you touch Done the system sends the results to the output device display unit printer and or PACS archive e Alerts If the study icon is replaced with an Alert icon you may be required to take corrective action In many situations instead of rescanning the case you can often correct the alert and reprocess the images via the Image Correction screen For more information see 3 10 Correcting Scanned Images For information on alert messages see Part 4 Alerts 7 When the cases have been scanned successf
70. its own database you must enter the patient information into the database of the R2 system on which you plan to scan the images Each film scanning unit can be given a unique name during installation and this name is displayed in the R2 Patient ID web page gt To enter patient information 1 Touch the R2 Patient ID button at the top of the screen to access the Patient ID system directly from the system OR To access the Patient ID system from any computer on the same network as the R2 system using any web browser type the IP address for the processing unit followed by id in the Address box and press Enter For example http 12 345 67 89 id The browser will display the log in window Patient ID DMAX2 2 Enter your Patient ID database password hOspital and click login R2 DX LS User Manual PN MAN 01043 Rev 007 85 Part 7 Using DigitalNow and the R2 Patient ID System 86 The system displays the patient information entry page Patient ID SGA DMAX1 Note The query buttons appear on this screen only if they were configured to appear by the Hologic service engineer when the system was installed The service engineer can set any of the three query fields to be the default field when the screen appears 3 Enter the patient information Study Date and R2 barcode number Required fields are marked with an asterisk e Enter the patient information either by typing it in or by querying a
71. lendar window appears 2 Specify the date range and touch Print 70 R2 DX LS User Manual PN MAN 01043 Rev 001 5 6 Printing Options An example of a Reimbursement Report is shown below The clinic information in the header can be configured by a Hologic service engineer For each case the report prints the R2 ID from the separator sheet or the patient information if the system was able to retrieve the patient information from the patient database Ro ImageChecker eee i i Northside CA 95014 Computer Aided Detection United States CASE HISTORY REPORT Mar 07 2007 Mar 13 2007 Mar 07 2005 Wed Barcode 0000095458 Case Time 17 38 53 Birthdate Barcode 0000095460 Case Time 17 41 09 Birthdate Barcode 0000095461 Case Time 17 43 26 Birthdate Name Sellers Patricia Case Time 17 45 32 ID 406893192 Birthdate 19510501 Name Eldridge Jessica ID 289450104 Birthdate 19180702 Name Binder Taylor Case Time 17 49 59 ID 338495028 Birthdate 19530401 R2 DX LS User Manual PN MAN 01043 Rev 001 71 Part 5 Controls 5 7 Scanning Protocols The Scanning option allows you to perform the following procedures e Changing Scanning Protocol Order on page 73 e Changing the Default Scanning Protocol on page 73 e Deleting a Scanning Protocol on page 73 e Creating Scanning Protocols on page 74 e Editing Scanning Protocols on page 75 gt To di
72. lms OK 6 days left i screening Maintenance Reboot OK 7 days left Uni Right Uni Left off PM Service Needed Performance i gt Screening Imp wen Diagnostic Tests OK all tests passed Printing Any Scanning Service Status Ready Studies Pil Controls Start The screen identifies any required maintenance procedures with a yellow alert icon For further information see Part 6 Maintenance Maintenance Information Test Films Needed Reboot OK 7 days left PM Service Needed Diagnostic Tests OK all tests passed R2 DX LS User Manual PN MAN 01043 Rev 007 5 Part 5 Controls 5 4 Shutdown and Reboot Options 66 The Off option on the Controls screen allows you to e Reboot restart the system e Shut down the system gt To display the Off screen Touch the Controls tab and then select Off ImageChecker About Turning the System Off Connectivity Maintenance Off Shutdown Safely power down the ImageChecker Performance Printing Scanning Service Studies ee Reboot Stop and restart the ImageChecker Search Auto Screening Uni Right Uni Left Screening Imp Any Status Ready n p Start Use the Shutdown option whenever you need to power cycle the system Normally you will shut the system down on a weekly basis during routine maintenance and sometimes during troubleshooting For further information see 6 2 Power Cycling the System
73. m cannot find 52 Printing screen 69 printout postscript 22 Q Queue Manager 47 R R2 ID 39 described 19 entering patient info 85 87 study information 39 40 R2 Patient ID 19 R2 Patient ID button 13 Receive Time 39 Reimbursement Barcode Report configuring 70 described 19 example 71 printing 70 reorienting images 43 resources 2 restarting 78 restarting software 66 retrieving patient information 64 review workstation 22 S safety information conventions 3 scanner cleaning 79 film 10 handheld barcode See barcode scanner system cannot connect to 51 scanning films adding cases to the stack 37 Any protocol 27 35 36 Auto mode 19 Auto protocol 26 29 31 Automatic Film Marker Identification 19 choosing protocol 27 manual protocols 26 32 34 overview 14 protocol list 13 starting 13 stopping 38 scanning protocols Any 35 36 Auto 29 31 changing order 73 creating 74 deleting 73 editing 75 Manual 32 34 overview 26 27 setting default 73 viewing 72 Scanning screen 72 Screening Imp protocol 32 Screening protocol 32 search field 13 search studies 46 separator sheet described 11 25 placement 28 scanning overview 14 Service screen 76 service tool 76 software restarting 66 stack of cases See also films preparing for scanning adding cases to 37 Index creating 28 defined 7 removing case from 38 Start button 13 Status field above Stop b
74. mageChecker gt R2 Patient ID Search A About System Information Connectivity Host Name DMAX1 r2mfg Maintenance Host IP 10 85 9 81 Uni Right Off Software Version ImageChecker Build 8 7 118 gt Uni Left Performance Screening Imp Printing Serial Number CD450 Any Scanning Clinic Name SQA DMAX1 Service Algorithm Mass R8 2 Calc R8 2 SCP AE DMAX1 SCU AE DMAX1 Auto Screening Protected by one or more of the following U S Patents 5133020 5452367 5491627 5537485 5622171 5657362 5673332 5729620 5732697 5740268 5815591 5828774 5832103 5917929 6014452 6035056 6075879 6078680 6185320 6198838 6263092 6266435 6301378 6404908 6434262 6477262 6574357 6580818 6640001 6628815 6909795 7054473 7072498 7146031 7174515 Studies Alerts Pi Controls This screen provides some important data that you may need to provide to a Hologic service support specialist Host IP address Software version number Instrument serial number CAD algorithm operating points The example above shows that operating point 2 has been selected for both calcifications and masses R2 DX LS User Manual PN MAN 01043 Rev 001 5 2 Connectivity Options 5 2 Connectivity Options The Connectivity option on the Controls screen allows you to specify whether to e Retrieve patient information when you scan a new case e Enable or disable the DigitalNow archiving feature e Verify DigitalNow images before sending
75. mageChecker results to an output device such as the R2 CheckMate Ultra display unit where they can be viewed Note This manual uses the following terms to describe mammography images and media e Case a series of X ray films associated with a particular patient e Stack a group of cases including a separator sheet on top of each case e Study a series of digitized images associated with a particular patient R2 DX LS User Manual PN MAN 01043 Rev 001 7 Part 2 Description The R2 DX system consists of a touch screen monitor a handheld barcode scanner a keyboard a film scanner and a computer that performs the DigitalNow and ImageChecker processing The R2 LS system has the same basic components as the R2 DX system except that a cart is not provided When using the system the technologist loads a stack of cases into the film scanner Each case can include from 1 to 24 X ray mammography films The technologist inserts a barcoded R2 separator sheet before each case When the technologist touches the Start button on the touch screen the system begins scanning the films converting each film into a digital image and starting a new case each time it encounters a separator sheet After each case is scanned the technologist has the option to review the case and verify that the films were scanned correctly Then the system sends the images or CAD results to output devices such as display units PACS or diagnostic review worksta
76. nd remove any remaining films from the input tray as described below Note This procedure can cause the system to produce an alert indicating there were too few films However it is often faster to remove the films and produce the alert than to wait for the films to be scanned and processed A Important If you changed the scanning protocol from its default setting before you started scanning e g if the default scanning protocol on the Controls Scanning screen is Auto and you touched Screening before touching Start the system resets the scanning protocol to its default when you touch Stop in step 1 of the procedure below If you want to resume scanning with the non default protocol after removing one or more cases you ll need to select that scanning protocol again before touching Start in step 6 gt To stop scanning 1 Touch Stop The scanner will stop after it finishes scanning the current film Note If the system generates an alert touch OK in the pop up window Remove the entire stack from the input tray Remove the remaining films for the cancelled case As desired remove any other case that is the separator sheet and the films associated with it Place the remaining cases back in the input tray A Important Be sure that the next item to be scanned is the separator sheet for the next case Select the desired scanning protocol if not already selected Touch Start to resume scanning R2 DX LS User Ma
77. nual PN MAN 01043 Rev 001 3 8 Viewing Study Information 3 8 Viewing Study Information The Study icon at the top represents the study currently being processed or the study most recently processed The Study icons below represent studies processed earlier As each study is processed the system displays the study information on the Studies screen The results include the image thumbnails patient flash if present and patient information You can display study information in one of three ways You can touch the study icon in the study list You can type the patient identification name or R2 ID separator sheet barcode number and press or touch Search You can use the handheld barcode scanner to scan in the patient identification or R2 barcode number For more information about searching see 3 12 Searching for a Study ImageChecker R2PatientID Search Auto Screening R2 ID 0000022609 Receive Time Oct 10 15 26 Rese Status Processing Uni Right Uni Left Images Screening Imp RCC a Any Patient Information 823075cl img h TEST FILM FOR ImageChecker M1000 SYSTEM R2 TECHNOLOGY INC 325 DISTEL CIRCLE LOS ALTOS CA 94022 Patient ID 123456test Name Tester4Teresa Accession Status Ready ET Studies Sji Controls Start For any scanned case the system displays the following The R2 ID which is the barcode number from the study s separator sheet The Receive Time
78. o the proper patient You must include the barcode from the separator sheet e See Part 7 Using DigitalNow and the R2 Patient ID System for more information on entering patient information e See 3 10 Correcting Scanned Images for information on reprocessing a study Yellow X appears on my image thumbnails The yellow X icon indicates that CAD processing could not be performed on an image e Verify that the images have the correct view labels If they do not correct the view labels on the Image Correction screen See 3 10 Correcting Scanned Images for more information e Verify that the image views and view modifiers are supported for CAD processing See 2 6 System Inputs and Outputs for more information Even though no processing was possible the scanned images are archived as usual R2 DX LS User Manual PN MAN 01043 Rev 007 59 Part 4 Alerts 60 R2 DX LS User Manual PN MAN 01043 Rev 001 Part 5 Controls gt 5 1 About Option gt 5 2 Connectivity Options gt 5 3 Maintenance Options gt 5 4 Shutdown and Reboot Options gt 5 5 Performance Options gt 5 6 Printing Options gt 5 7 Scanning Protocols gt 5 8 Service Utilities Part 5 provides instructions for using the system configuration and maintenance options that appear on the Controls screen The Controls screen is used to configure system settings to meet your particular needs run maintenance utilities and displ
79. ocols created on site The Start button is used to begin scanning and processing a stack of films When scanning begins the button changes to Stop The Status field which appears above the Start button indicates the scanner status for example Ready Scanning etc R2 DX LS User Manual PN MAN 01043 Rev 001 13 Part 2 Description Scanning and Processing To scan a case you must first create a stack of films The case at the top of the stack is scanned first You select a scanning protocol based on the type of cases you will be scanning see 3 1 Working with Films for more information To scan films you simply e Arrange the films with a separator sheet on top of each case e Organize films and separator sheets in a stack e Place the stack in the film input tray e Touch the Start button The scanner picks up the first separator sheet followed by the first film in the stack A new study icon appears at the top of the list and a white circle on the icon flashes to indicate that the system is scanning or processing the films Each separator sheet includes a barcode that the system uses to organize the results When the system scans the barcode on the separator sheet the barcode number appears on the Studies screen as the R2 ID As the films are scanned the system displays thumbnail images the patient flash and any patient information linked to the R2 ID When the system finishes processing the cas
80. om Manual scanning protocols for your site or alter the included protocols as needed When using a Manual scanning protocol the system does not recognize the lead markers Instead it relies on you loading the films e With the views specified by the selected scanning protocol e In the correct order defined by the selected protocol e Inthe correct orientation emulsion dull side down landscape for small films portrait for large films e With the patient flash in the correct orientation The system also assumes that each study includes the same film views as defined by the selected protocol If you are using a Manual protocol because for example you don t use R2 supported lead markers and the cases to be scanned include different numbers of films or different views create stacks of like cases and scan them separately using the appropriate scanning protocol When using a Manual scanning protocol as with the Auto protocol the system automatically scans all cases in the stack When scanning is complete the system switches back to the default scanning protocol as configured on the Controls Scanning screen 26 R2 DX LS User Manual PN MAN 01043 Rev 001 3 1 Working with Films Any Protocol This special scanning protocol allows you to scan any number of films up to 24 per case in any order and orientation When using the Any protocol you must identify all views manually after the case is scanned Choosing
81. parator sheet barcode number R2 ID When you scan the films the R2 system searches for the patient record in the database so it can acquire the patient information Always enter the R2 barcode number into the patient record in the database before you scan the films If there is no patient information associated with the R2 ID you can either e Enter the information into the R2 Patient ID system and reprocess the case or e Enter the information into PenRad MRS or MagView and reprocess the case to requery from their database Not all films in case are specified by scanning protocol 3024 There are more films in the case than defined by the selected scanning protocol Identify the film views via the Image correction screen and reprocess See 3 10 Correcting Scanned Images for more information Printer not found 3014 The processing unit is attempting to send the study results to the printer but the printer is not responding The printer may be unable to respond or there may be a network or configuration problem The system will continue to try to send the study results e Verify that the printer is running e Check all cable connections between the processing unit and the printer i e the network cable from the processing unit to the wall and the printer network cable to the wall Sometimes a cable becomes loose If so wait about ten minutes the system will resend the study results e Ask your system administrator if
82. patibility with previous releases of ImageChecker 5 x products The 5 x format provides RightOn Calc and Mass marks but not EmphaSize or PeerView R2 DX LS User Manual PN MAN 01043 Rev 001 Part 3 Studies 3 1 Working with Films y 3 2 Preparing Cases to Be Scanned 3 3 Scanning with the Auto Protocol 3 4 Scanning with a Manual Protocol 3 5 Scanning with the Any Protocol 3 6 Adding Cases to the Stack 3 7 Stopping Scanning and Removing a Case vY vyv VY V Y Vy Yy 3 8 Viewing Study Information gt 3 9 Verifying Scanned Cases gt 3 10 Correcting Scanned Images gt 3 11 Printing CAD Results gt 3 12 Searching for a Study gt 3 13 Using Queue Manager Part 3 provides instructions for working with films scanning cases working with scanned images displaying study results and searching for a study For most operations you will be using the Studies screen which is shown below ImageChecker R2PatientID Search Auto R2 ID 0000022609 Screening Receive Time Oct 10 15 26 on Status Processing Uni Right Uni Left Images Screening Imp RCC i Ai Any Patient Information s23075c1 img TEST FILM FOR ImageChecker M1000 SYSTEM R2 TECHNOLOGY INC 325 DISTEL CIRCLE LOS ALTOS CA 94022 Patient ID 123456test Name Tester4Teresa Accession Status Ready Studies ay Controls Start R2 DX LS User Manual PN MAN 01043 Rev 001 23 Part 3 Studies 3 1 Working with Films
83. rating the scanner It may take up to was generated Oct 09 15 29 Screening Imp Any Rebooting the operating system please Oct 09 14 51 Shutting down the R2 software please wz Oct 09 12 10 Restarting R2 software please wait R2 ID Oct 09 12 07 Restarting R2 software please wait Oct 09 10 04 0000022598 Not all films in case 0000022598 are spe Oct 09 10 04 No output jobs scheduled for case 00000 Touch to view or Calibration is complete The scanner is re hide oa ve Oct 09 09 14 Calibrating the scanner It may take up to idden Oct 09 09 14 canner hasn t been calibrated in 24 Oct 09 09 11 Rebootitgwthe operating system please i aries lt ape a apenas Pont hoon calihratod in JA Status cm lS Touch to hide a Hide Hide All Alerts View Past Alerts Ready selected alert anaes Studies Alerts OT Controls Start When reviewing alerts you can use the Alerts screen to sort alerts by time issued R2 ID or by description You can also hide one or more alerts 16 R2 DX LS User Manual PN MAN 01043 Rev 001 2 3 Overview of Operation Controls Screen The Controls screen is used to configure system settings to meet your particular needs run maintenance procedures and display system information ImageChecker R2 Patient ID Search HE Auto About Scanning Protocols Sega Maintenance Ago SES Off Auto New LEC Uni Right Outputs Screening beg Uni Left Touch a screen eee Uni Right FE Edi
84. record in the archive system can then be retrieved and viewed on softcopy review workstations and or printed R2 DX LS User Manual PN MAN 01043 Rev 001 83 Part 7 Using DigitalNow and the R2 Patient ID System 7 2 DigitalNow Archiving 84 The workflow for DigitalNow archiving is as follows At any point prior to scanning film mammograms for a case you must enter the R2 barcode on the separator sheet used for the case into the record for the appropriate patient in the patient information database Then you can scan the films The system retrieves the patient information from the patient database and transfers the images to the archive system If Verification is set to On you must verify the images are correct before they can be sent to the archive For more information see 3 9 Verifying Scanned Cases Once the images are stored in the archive they can be manipulated like any other record in the archive system for example you can send them to the softcopy digital review workstation Keep in mind that once film mammograms are digitized and archived they are treated like digital images and will not be sent to display units other than a softcopy digital review workstation If archiving is enabled and no record in the patient database matches the R2 barcode the system does not process the case You can correct this by entering patient information in the R2 database after the case is scanned and reprocessing the c
85. rt 3 Studies 14 R2 DX LS User Manual PN MAN 01043 Rev 001 2 3 Overview of Operation System Alerts If a problem occurs during scanning or processing a case or while transmitting case results the system issues an alert There are three general types of alerts Alert icon Status D A non fatal fault condition has occurred This alert appears on the case study icons see previous table GND The software has processed the images successfully but a fault condition has occurred that may require user intervention Alert Case has failed results have not been sent A description of the alert condition appears for the selected study in the area of the screen below the study s R2 ID The outcome of any alert condition depends upon the nature of the problem the system has encountered In the example shown below the system is experiencing problems as it attempts to send case results to a CheckMate Ultra display unit and to a printer If after repeated attempts it cannot transmit the case results the system may issue a case failed alert and change the study icon accordingly The system produces alerts for a variety of reasons When necessary the alert description provides instructions for resolving the problem In some cases you will want to refer to Part 4 Alerts for mor
86. s 3 4 Scanning with a Manual Protocol 32 When you use a Manual scanning protocol each case in the stack must include the correct number and type of film views as defined in the protocol You may also need to use a Manual protocol if films e Have unsupported missing or bad lead markers or e Have incorrectly placed lead markers e g over a breast image under an ID label or only partly on film as shown on page 25 or e Have non standard views or views with modifiers or e Have more than four views per case If one of the cases in the stack has any of the characteristics listed above and does not have the number of film views specified in any existing Manual protocol use procedure 3 5 Scanning with the Any Protocol for that case The system ships with four predefined Manual scanning protocols Predefined Manual Scanning Protocols Views Included Screening RCC RMLO LCC LMLO Uni Right RCC RXCC RMLO Uni Left LCC LXCC LMLO Screening Imp RCC RCC ID LGC LCC ID RMLO RMLO ID LMLO LMLO ID Your system may have additional user created scanning protocols specific to your site For more information see 5 7 Scanning Protocols For a list of supported views and modifiers see Supported Views on page 20 R2 DX LS User Manual PN MAN 01043 Rev 001 3 4 Scanning with a Manual Protocol gt Toscan with a Manual protocol 1 Prepare the cases to be scanned as described in 3 2 Preparing Cas
87. s manual provides instructions for the operation and maintenance of the R2 DX and R2 LS systems in the clinical environment The systems are is used in radiology clinics to scan and digitize mammography films The two options available for the R2 DX and R2 LS systems are e DigitalNow used to produce archivable DICOM For Presentation mammography images from the scanned films e ImageChecker computer aided detection CAD software used to assist in the evaluation of regions of the breast on routine screening and diagnostic mammograms R2 DX LS User Manual PN MAN 01043 Rev 001 1 Part 1 Introduction 1 1 Resources Available In addition to this manual the following resources are available to assist you when working with the system e R2 Member Center This website provides quick access to electronic pdf versions of Hologic manuals and training materials You can find the R2 Member Center by visiting the Hologic website www hologic com See the R2U flyer that accompanies this product for instructions on accessing the R2 Member Center e Manuals The manuals for the R2 DX and R2 LS systems and their applications are listed below e Understanding R2 ImageChecker e R2 DX LS User Manual e R2 DMax DM DX LS Service Manual e R2 DMax DM DX LS Release Notes e R2 DMax DM DX LS DICOM Conformance Statement You can obtain additional copies of printed manuals through your Hologic Account Manager The DICOM Conformance Statemen
88. ser manual and receive training before using the system To ensure optimal system performance perform the system verification tests and scanner maintenance procedures as instructed in this user manual To ensure proper system operation use only separator sheets and barcodes provided by Hologic To properly identify patients in the archive system be sure to enter the patient information and the barcode from the separator sheet into the patient identification system correctly For sites with multiple processing systems When entering data into the R2 Patient ID web page check the name of the processing unit on the web page to ensure that you are entering the patient information into the processing unit that you will use to scan the case For the display images to correspond correctly to the film position at the display unit be sure to orient and order the films correctly when scanning as described in this user manual Ensure that the case retrieved from the archive to be used for comparison is from the same patient as the current case under review It is recommended that you use the patient flash for this confirmation Use only standard mammographic film 18 x 24 cm or 24 x 30 cm Do not attempt to scan films that have labels or tape with edges within 1 mm of the edge of the film or labels that are not pressed flat or have curled corners as they may jam Do not attempt to scan bent damaged or curled films as they may jam Be
89. splay the Scanning screen Touch the Controls tab and then select Scanning ImageChecker S R2 Patient ID Search About Scanning Protocols Dus Connectivity A RCC Screening uto i TER Maintenance i New SER Uni Right Screening Off LMLO Uni Left Uni Right FF RCC ID Performance g L Edit CCID Screening Imp Uni Left R MLO ID Printing LMLOID Any Screening Imp Remove Scanning r ny Service 1 Move Up Dae a cine Status Move Down Ready gt _w _ S _ Studies Pil Controls Start 72 R2 DX LS User Manual PN MAN 01043 Rev 001 5 7 Scanning Protocols Changing Scanning Protocol Order You can change the order in which the scanning protocols appear in the scanning protocol list on the Studies screen gt To change the scanning protocol order 1 Touch a scanning protocol in the list at the left of the screen 2 Touch the Move Up and Move Down buttons to move the selected scanning protocol up or down in the list Changing the Default Scanning Protocol The default scanning protocol appears at the top of the scanning protocol list gt To change the default scanning protocol 1 Touch the desired default scanning protocol in the list at the left of the screen 2 Touch the Move Up button to bring the desired protocol to the top of the list Deleting a Scanning Protocol You can delete unwanted scanning protocols gt To delete the default scanning protocol 1 Touch the desir
90. sure to remove paper clips or other foreign materials from the films Always shut down the system according to the procedures provided in this user manual Failure to shut the system down properly can cause loss of data or damage to the computer operating system This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at her or his own expense Note The device design and mode of operation are consistent with current standard mammography clinical practices as governed by the requirements of the Mammography Quality Standards Act MQSA of 1992 Users are cautioned to comply with the MQSA or the appropriate national standards when implementing R2 systems in clinical protocols R2 DX LS User Manual PN MAN 01043 Rev 001 5 Part 1 Introduction Cautions Installation and Maintenance This product contains no user serviceable parts To prevent damage to the system
91. t 2 films were found v Jni Left 0000000660 For Name SID R2ID Patient ID Time creening Imp Manual Any is P2 Your search matched multiple cases Please pick one N test2 test2 0000000660 test12 Sep 28 09 26 test test 0000062529 esrtabh Oct 03 17 56 Test4TEST 0000022598 0000022598 Oct 09 10 22 RCC TEST24TEST2 0000001380 TEST2 Oct 09 11 03 as Tester Teresa 0000022609 123456test Oct a OI BA MLO Images Patient Informati Patient ID tes 2 Studies Note To move the window touch and drag the Search Results title bar If more than one study appears touch the study you want to see The Search Results window closes and the results of the study you selected appear on the Studies tab 46 R2 DX LS User Manual PN MAN 01043 Rev 001 3 13 Using Queue Manager 3 13 Using Queue Manager Queue Manager enables you to monitor and manage the queue of cases being processed by the R2 system gt To enter Queue Manager 1 Using any web browser on the same network as the R2 system in the Address box type the IP address for the processing unit followed by qman and press Enter For example http 12 345 67 89 qman The browser will display the log in window help Queue Manager 2 Enter your Queue Manager database password hOspital spelled with a zero and click login R2 DX LS User Manual PN MAN 01043 Rev 001 47 Part 3 Studies The system displays the Queue Manager screen showin
92. t R CCID Screening Imp name to display its auen s L CCID Uni Left R MLO ID Any contents Performance Printing i L MLO ID Screening Imp Remove Scanning Service 24 manual n 1 Move Up Status Move Down Ready STS ay Controls Start For details about the settings utilities and information on the Controls screen see Part 5 Controls R2 DX LS User Manual PN MAN 01043 Rev 001 17 Part 2 Description 2 4 Licensed Features The system features are determined by the licensed options selected by each site allowing you to invest only in the features you want as well as add features at a later date The following features can be obtained by purchasing the appropriate license e DigitalNow DICOM Export e ImageChecker Screen Film CAD These features are described further in the following sections DigitalNow DICOM Export With DigitalNow R2 film scanning platforms send digitized film images to a DICOM conformant archiving system for future review Sites using full field digital mammography FFDM systems can scan prior analog studies and compare those priors with the current digital study on a softcopy review workstation Sites planning to move to digital in the future can plan ahead and send the digitized images to an archive system now and retrieve them for comparison later to future digital studies R2 systems configured with DigitalNow utilize the separator sheet barcode R2 ID for
93. t and Cybersecurity Best Practices documents are available at www hologic com e Training The Hologic Applications team is available to train your staff should you feel they need additional training To purchase additional personalized instruction contact your Hologic Account Manager e Technical Support and Service For support in North America contact Toll Free 1 866 243 2533 1 866 CHECKED Email r2support hologic com Hours Monday Friday 6 00 AM 5 00 PM PT GMT 8 00 Website www hologic com For support in Europe South America or Asia contact your local dealer or distributor 2 R2 DX LS User Manual PN MAN 01043 Rev 001 1 2 How to Use this Manual 1 2 How to Use this Manual This manual was written to ensure safe and proper use of the system Before use read this manual carefully in order to realize the full capabilities of the system If something is unclear during daily use or if a problem occurs please refer to this manual Manual Organization This manual is organized as follows gt Part 1 Introduction provides a listing of support resources available from Hologic information about using this manual and safety information gt Part 2 Description provides background information on the system component and feature descriptions and an overview of operation gt Part 3 Studies provides instructions for working with films scanning them displaying study results verifying and labeling
94. t information entry page is active When you query by touching the query button to the right of the Accession Number field the system queries using only that field The query returns data for all fields on the page e DICOM Modality Worklist Query If this was configured all three query buttons are active When you query by touching any query button the system queries using only the field s to its left The query result returns data for all fields on the page however the data entered into Study Date MM DD YYYY comes from the Scheduled Procedure Step Start Date field in the database Note These queries do not enter the R2 barcode number You ll need to enter it as described in step 3 in the preceding procedure 7 3 Using the R2 Patient ID System 88 R2 DX LS User Manual PN MAN 01043 Rev 001 7 4 Querying an External Database If you leave the field used by the query blank the query will return a list of all studies in the database If you enter into the field one or more characters that appear in the data you want to match the system will return a list of just the studies containing the matching data Fr _ W a e Patient Hame 1 LMLO 1 RMLO 2 LEC RMLO 2 RCC LMLO ID1 LLO IDAR MLO ID2LOCRMLO ID2RCCLMLO Study Date 04242003 g 72003 09082003 04402003 Fatient ID Accession i To select a study and copy its data onto the patient information entry p
95. t one study Scroll the study icon list to view additional studies To display the results of any completed study simply touch the icon for the study The appearance of the study icon indicates the status of the case the various icons that may appear are shown in the table on page 14 Study Information appears for each case of films as they are scanned and processed The Study Information includes the R2 ID Receive Time the time scanning began for the study and current Status as well as thumbnail images of the films and patient information discussed below Thumbnail Images appear as they are scanned and can be viewed at any time after the system scans the films Patient Information includes the patient flash from the scanned film and other data imported from a patient database 12 R2 DX LS User Manual PN MAN 01043 Rev 001 2 3 Overview of Operation The R2 Patient ID button appears only if your system is configured to use the R2 Patient ID system Click the button to access the R2 Patient ID database For more information see 7 3 Using the R2 Patient ID System The Search field allows you to type patient data or a barcode number and quickly find the patient record You can also activate the Search field with the handheld barcode scanner The Scanning Protocol list allows you to select a scanning protocol that matches the number and types of films in your cases Includes R2 standard scanning protocols and any custom prot
96. tal images You stack the films and place them in the input tray After the scanner digitizes the images it stacks the films in the same order in the output tray The R2 DX and LS systems scan each film in about 90 seconds e Barcode Scanner Use to select a study to display by scanning a barcoded patient ID or the barcode on a separator sheet e Keyboard Use to type search criteria when searching for studies and to enter patient information e Mouse Use to select screen objects as an alternative to the touch screen Film Input Tray Barcode Scanner Scanner Power Switch Film Output Exterior Components 10 R2 DX LS User Manual PN MAN 01043 Rev 001 2 2 System Components e Separator Sheets The separator sheet provides a unique R2 ID number a 10 digit barcode that the system reads and uses to identify each case and associate the scanned images with the patient s films Each case fed into the R2 system has its own separator sheet e Test Sheets and Films Use for the weekly tests to ensure optimal system performance For more information see 6 4 Running the Weekly Tests e Lead Markers Read by the R2 system to identify standard views automatically For more information on lead markers see R2 Supported Lead Markers on page 24 The computer located behind the front cover in the R2 DX processes the scanned films and images R2 DX Interior R2 DX LS User Manual PN
97. the image labels and reprocess the images via the Image Correction screen See 3 10 Correcting Scanned Images for more information e If these steps do not fix the problem call Hologic Technical Support 56 R2 DX LS User Manual PN MAN 01043 Rev 001 4 2 Common Questions 4 2 Common Questions This Section provides common issues and solutions for R2 systems CAD does not run on views with implants CAD does not run on images with the Implant Present modifier enabled even if Implant Displaced is also enabled If it is necessary to run CAD on Implant Displaced images do not enable the Implant Present modifier either on the Image Correction screen or in scanning protocols CAD marks do not appear on thumbnails Marks do not display on the thumbnails They only appear on the display unit print out and or archive system if configured Case icons become yellow alerts there are no images Typically an alert will be generated when an image fails to process If it did follow the instructions in the alert or turn to the Alerts tab and look for that alert If an alert did not pop up and there are no alerts in the Alerts screen rescan the case using the appropriate Manual scanning protocol Film is missing inside the scanner If a film jams in the scanner see Ejecting Films on page 68 Image is missing from a case Occasionally the film scanner reads the separator sheet barcode through the last film of a cas
98. the network is down If it is and it is down long enough the system will finally give up and you will have to reprocess the study with printing turned on e If these steps do not solve the problem call Hologic Technical Support R2 DX LS User Manual PN MAN 01043 Rev 001 53 Part 4 Alerts Rebooting the operating system please wait 5021 You ll see this message when the system is rebooting starting up again after being shut down and turned off e Wait about 10 minutes Once the system comes back up you will see the Ready message above the Start button e Ifthe system doesn t come back up after 15 minutes call Hologic Technical Support Reporting system query error 3502 The R2 system could not communicate with the patient database and possibly the system is not set up correctly Contact Hologic Technical Support and they will diagnose and fix the problem Restarting R2 software please wait 5019 e Wait about 10 minutes Once the system comes back up you will see the Ready message above the Start button e Ifthe system doesn t come back up after 15 minutes call Hologic Technical Support Scanner not ready 5002 For some reason the scanner did not turn on properly e Power cycle the system See 6 2 Power Cycling the System e If this doesn t fix the problem call Hologic Technical Support Scanner test failed 3025 This message appears when you run the weekly test films and the scanner t
99. them to an archive In order to use these features a Hologic service engineer must 1 configure the system with the DigitalNow license and enable the license and 2 configure your system to receive information from a patient database and transmit results to an external storage archive Note The Connectivity options appear only if the system has been configured with the DigitalNow license gt To display the Connectivity screen Touch the Controls tab and then select Connectivity ImageChecker R2 Patient ID Search About Retrieve Patient Information for New Cases AUE Connectivity Screening Maintenance an SU Uni Right Off hanced Uni Left Performance Screening Imp Printing Any Scanning DigitalNow Service On off Verification before sending Output On off Status Ready Studies DI Controls Start For more on these settings refer to the next page R2 DX LS User Manual PN MAN 01043 Rev 001 63 Part 5 Controls Retrieving Patient Information This option on the Connectivity screen allows you to specify whether the R2 system should retrieve information from your patient database If set up properly when you scan the R2 ID the R2 system will request that the database system transmit the patient information associated with the case If a Hologic service engineer has configured the R2 system to communicate with the patient database then you can enable or disable the data transfer using the Retr
100. tions R2 DX System R2 LS System 8 R2 DX LS User Manual PN MAN 01043 Rev 001 2 1 Overview If the system is configured with the DigitalNow license the R2 processing unit can send images to virtually any DICOM conformant workstation and or archive allowing images to be displayed stored and managed universally If the system is configured with the ImageChecker CAD license it analyzes the scanned images with a proprietary algorithm i e a set of criteria that identifies regions of interest which can include clusters of bright spots suggestive of calcification clusters and dense regions with or without radiating lines suggestive of masses or architectural distortions The system generates CAD marks identifying the regions of interest Images with CAD results can be sent to an R2 display unit PACS review workstation or printer For more information about the CAD marks and the ImageChecker algorithm see Understanding ImageChecker 8 5 8 7 Review Workstation Films R2 DX Film Scanning Platform Printer System Diagram R2 DX LS User Manual PN MAN 01043 Rev 001 9 Part 2 Description 2 2 System Components This section describes the major system components e Touch Screen Monitor Use to control and monitor the system start scanning select studies view system status etc e Scanner Use to convert the mammogram films to digi
101. to a different scanning protocol see 3 4 Scanning with a Manual Protocol e For cases which do not confirm to any defined scanning protocol see 3 5 Scanning with the Any Protocol A Important The Auto protocol does not support duplicate views for example two RCC films or two LMLO films Use a Manual protocol or the Any protocol for cases with duplicate views gt Toscan with the Auto protocol 1 Prepare the cases to be scanned as described in 3 2 Preparing Cases to Be Scanned You can arrange the films of the four standard views in any order and in any orientation Load the stack into the scanner s feeder Insert the stack with e The arrow on the top separator sheet pointing into the scanner e The leading edges of the films and separator sheets aligned flush You can load up to 25 sheets including films and separator sheets up to five four film cases A Important To prevent separator sheets and films from misfeeding be sure to load them properly into the scanner s feeder For additional details see the box on page Verify that Auto is selected in the Scanning Protocol list on the Studies screen Note You cannot change the scanning protocol if a case is currently being scanned Touch Start The system status changes from Ready to Scanning and the Start button becomes a Stop button e Processing Films After the system scans the first film it displays a new study i
102. tudy See 3 10 Correcting Scanned Images for more information e If films for two or more patients were scanned under a single separator sheet rescan the case e If these steps do not solve the problem call Hologic Technical Support ImageChecker attempted but could not send case 3016 3018 3031 3032 The system is trying to transfer the images but cannot find the specified output device display unit PACS etc The system will try repeatedly to send the images Usually it is either a display unit problem or your computer network is down To fix e Make sure the display unit is up and running If this was the problem the studies should transfer within about ten minutes e If this isn t the problem check to be sure all cables between the processing unit and the display unit are connected and that the computer network is up e If your network is up all cables are connected and the display unit is in working condition call Hologic Technical Support 50 R2 DX LS User Manual PN MAN 01043 Rev 001 4 1 Alerts Listed Alphabetically ImageChecker attempted but could not print reimbursement report 2008 The system has canceled the print request for the study You will only see this alert after several Printer not found alerts The system tries repeatedly to print and displays this message when it gives up To fix e Verify that the printer is on on line and has enough paper After correcting any of these
103. ual PN MAN 01043 Rev 001 3 1 Working with Films Lead Marker Placement Correct placement of the lead markers is essential for optimal results The following examples show lead markers that are easy for the system to read and that are not touching the patient ID label the breast tissue or the film edge KJ i Correct Auto Protocol Lead Marker Placement The following lead markers are incorrectly placed as explained below K i Patient ID Label Edge of Film Breast Incorrect Auto Protocol Lead Marker Placement Separator Sheets The R2 DX and LS systems are shipped with 250 separator sheets Run through all sheets on a rotating basis to ensure that patient barcode numbers are not reused before the images are deleted from the system Do not discard the separator sheets they are reusable The separator sheets are sturdy and able to withstand a great deal of use However be sure to store them flat do not write on them with anything greasy or waxy do not put tape on the edges and keep them clean Most importantly do not obscure the barcode or the barcode number To order additional separator sheets contact your Hologic Account Manager or Technical Support A Important It is critical that ImageChecker users keep the separator sheet with the films until after the radiologist has read the films and CAD results R2 DX LS User Manual PN MAN 01043 Rev 001 25 Part 3 Studies Scanning Protocols The system
104. ully the films can be returned to the patients film folders If necessary keep the separator sheet with the case for CAD display Note If the system has been configured to use a different scanning protocol by default on the Controls Scanning screen then after scanning a stack of films the system returns to the default protocol 34 R2 DX LS User Manual PN MAN 01043 Rev 001 3 5 Scanning with the Any Protocol 3 5 Scanning with the Any Protocol Use the Any protocol to scan cases that do not conform to an existing scanning protocol for example if the case has missing films extra films or views not included in any existing scanning protocol The Any protocol contains no predefined views This allows you to scan any number of films up to 24 with any type of view and later identify the views manually once the case has been scanned A neat and ordered stack can save time spent adjusting the image orientation after scanning Keep the following in mind e Remove films from the stack that would normally be discarded rather than saved for example technical retakes e Orienting the films correctly in the stack saves time adjusting the orientation later via the Image Correction screen gt Toscan with the Any protocol 1 Prepare the case to be scanned as described in 3 2 Preparing Cases to Be Scanned 2 Place the separator sheet on top of the stack for each case You can arrange the films in any order although
105. und or similar alert appears again check that all cables between the printer and the processing unit are connected Check with your system administrator that your network is up Reprocess the study in the Image Correction screen and print e If these steps do not solve the problem call Hologic Technical Support ImageChecker could not send results 2005 The system has tried to send the results to the desired output destination but the time limit to retry has expired without successfully sending the results e Reprocess the images via the Image Correction screen See 3 10 Correcting Scanned Images for more information e Ifthe problem persists call Hologic Technical Support Images didn t transfer 1031 Images couldn t be sent to the output device display unit PACS etc and the transfer was canceled by the system You will see this alert only after several ImageChecker could not send case alerts 3016 have appeared The system tries repeatedly to send the studies and displays this message when it gives up trying e Be sure the display unit is up and running e Check cable connections between the processing unit and the display unit i e the network cable from the system to the wall and the display unit network cable to the wall Reprocess the study in the Image Correction screen e If this doesn t fix the problem ask your system administrator if the network is up e If these steps do not
106. usy 3012 1029 1030 0 0 ee 51 ImageChecker license not found 1024 eroii 2643 84 344423 meer Eo Be eae 52 ImageChecker could not print a CAD report 2007 2 02200004 52 ImageChecker could not send results 2005 2 0 00000 000 eee 52 Images didnt transfer 1031 22 342 24 4b anea i Ih Geek eee Seas tad 52 Image transfer was interrupted 3013 0 0 0000 00 52 No output jobs scheduled for case 3054 nonna anaana ee 53 No patient record information is associated with barcode 3501 53 Not all films in case are specified by scanning protocol 3024 53 Printer NOt ound Ola SLA cae os Oe ete oe ee EER ES le Boe OB SR Ee 53 Rebooting the operating system please wait 5021 2 20200000045 54 Reportime system query crror 3502 ca weed pes eS Lb ek eee eS Be eee 54 Restarting R2 software please wait 5019 00 0 0 000 00 0c ee 54 Scanner not reddy 3002 reie asee a was Aah eka paw ae ey etn Sak 54 Scanner est led QO Oc ote teh ee fr Aes ee tad eed er ee ee a 54 Scanning is disabled remote maintenance in progress 5010 5059 54 scheduled reimbursement report 5050 os oto Rae eh heed oS 55 Shutting down the operating system please wait 5020 55 Shutting down the R2 software please wait 5018 0 2200000000 55 The same barcode has been assigned to multiple patients 3500
107. utton 13 Status field case 39 40 studies defined 7 information viewing 39 prepare for scanning 28 scanning Auto 29 31 manual 32 34 35 36 searching 46 selecting 10 working with films 24 27 Studies screen frozen 58 overview 12 study description DICOM 44 study icon described 12 flashing arrow 14 flashing circle 14 symbol meanings 14 yellow alert 57 system components 10 configuring 61 76 description 7 22 inputs and outputs 20 22 power cycling 78 restarting 78 shutdown 66 test results 68 7 touch screen monitor See monitor touch screen training 2 troubleshooting 57 59 U Uni Left protocol 32 Uni Right protocol 32 V verifying cases 41 R2 DX LS User Manual PN MAN 01043 Rev 001 93 Index configuring 63 views labeling 44 modifiers 21 supported 20 94 R2 DX LS User Manual PN MAN 01043 Rev 001
108. you may wish to use a sequence defined by your site for example the four standard views first followed by additional or equivalent views As needed turn films a quarter turn to match the orientation shown on the separator sheet If you load films in a random order as shown below you will have to reorient the images later via the Image Correction screen 3 Load the stack into the scanner s feeder see box on page 31 Insert the stack with e The arrow on the top separator sheet pointing into the scanner e The leading edges of the films and separator sheets aligned flush R2 DX LS User Manual PN MAN 01043 Rev 001 35 Part 3 Studies You can load up to 25 sheets including films and separator sheets up to 20 five film cases Loading Films 4 Select the Any protocol by touching Any Auto Note You cannot change the scanning protocol while a case Is being Screening skred Uni Right 5 Touch Start The system status changes from Ready to Scanning and Uni Left the Start button changes to Stop Screening Imp A new study icon appears at the top of the study list As soon as the first film is scanned the icon displays the yellow alert symbol The case status shows Failed with an explanation that the image contains an unknown view After the entire case has been scanned you must identify all image views via the Image Correction screen and reprocess the case To do so Any 6 Touch an

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R2 DX/LS User Manual - The Science of Sure – HOLOGIC