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Part 1: Introduction

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1.1. Resources Available

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1.2. How to Use this Manual

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1.3. Warnings and Cautions

This manual provides instructions for the operation and maintenance of the R2 DM
system in the clinical environment. R2 DM is used in radiology clinics to scan and
digitize mammography films. The two options available for the R2 DM system are:

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DigitalNow™, used to produce archivable DICOM For Presentation
mammography images from the scanned films.

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ImageChecker®, computer-aided detection (CAD) software used to assist in the
evaluation of regions of the breast on routine screening and diagnostic
mammograms.

R2 DM User Manual – PN MAN-01044 Rev 001

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Summary of Contents for R2 DM

Page 1: ...User Manual Software Versions 8 6 8 7 PN MAN 01044 Rev 001 R2 DM...

Page 2: ......

Page 3: ...Screen Film Mammography R2 DM User Manual Software Versions 8 6 8 7 PN MAN 01044 Rev 001...

Page 4: ...301378 6404908 6434262 6477262 6574357 6580818 6640001 6628815 6909795 7054473 7072498 7146031 7174515 Hologic the Hologic logo CheckMate DigitalNow Earlier Smarter Better EmphaSize GreenLight ImageCh...

Page 5: ...12 Studies Screen Overview 12 Scanning and Processing 14 System Alerts 15 Controls Screen 17 2 4 Licensed Features 18 DigitalNow DICOM Export 18 ImageChecker Screen Film CAD 18 2 5 Other Features 19...

Page 6: ...1041 51 ImageChecker is busy 3012 1029 1030 51 ImageChecker license not found 1024 52 ImageChecker could not print a CAD report 2007 52 ImageChecker could not send results 2005 52 Images didn t transf...

Page 7: ...ist needs CAD quickly 58 Scanned case before entering patient information 59 Yellow X appears on my image thumbnails 59 Part 5 Controls 61 5 1 About Option 62 5 2 Connectivity Options 63 Retrieving Pa...

Page 8: ...Films Needed 77 Preventive maintenance is required 77 6 2 Power Cycling the System 78 6 3 Cleaning the Scanner 80 6 4 Running the Weekly Tests 82 6 5 Resetting the Handheld Barcode Scanner 83 Part 7...

Page 9: ...DM is used in radiology clinics to scan and digitize mammography films The two options available for the R2 DM system are DigitalNow used to produce archivable DICOM For Presentation mammography image...

Page 10: ...anual R2 DMax DM DX LS Release Notes R2 DMax DM DX LS DICOM Conformance Statement You can obtain additional copies of printed manuals through your Hologic Account Manager The DICOM Conformance Stateme...

Page 11: ...Part 6 Maintenance provides instructions for cleaning the system and running the weekly tests f Part 7 Using DigitalNow and the R2 Patient ID System provides information about archiving images with t...

Page 12: ...thdraw your arm and hit it against something To minimize possibility of shock maintain greater than 40 relative humidity in the room where the unit is kept use shoes with natural material soles place...

Page 13: ...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 ma...

Page 14: ...tain equipment in a well ventilated air conditioned environment When necessary shut down the system according to the procedures recommended in this user manual Do not attempt to install or repair the...

Page 15: ...to retrieve patient information which can then be integrated with the study images Use Hologic s DigitalNow feature to transmit the digital mammography image files to an output device such as a PACS...

Page 16: ...gist 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...

Page 17: ...f 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 syste...

Page 18: ...e images it stacks the films in the same order in the output tray The DM system scans each film in about 60 seconds Barcode Scanner Use to select a study to display by scanning a barcoded patient ID o...

Page 19: ...ormation see 6 4 Running the Weekly Tests 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...

Page 20: ...triangle indicates the study icon linked to the study information currently on screen The following items appear on the Studies screen Study icons each represent one study Scroll the study icon list...

Page 21: ...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...

Page 22: ...e 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 Note Before the study results are sent to the dis...

Page 23: ...e 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 se...

Page 24: ...Touch to sort alerts by Time R2 ID or alert Description Date and time alert was generated R2 ID Touch to view or hide alerts you ve hidden Touch to hide all alerts Touch to hide a selected alert When...

Page 25: ...tem settings to meet your particular needs run maintenance procedures and display system information Touch a screen name to display its contents For details about the settings utilities and informatio...

Page 26: ...sociated 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...

Page 27: ...ng 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 Patie...

Page 28: ...Cranio Caudal RMLO Right Medio Lateral Oblique LMLO Left Medio Lateral Oblique The Four Standard Views The following table lists all supported views and the output devices that can accept these views...

Page 29: ...ollowing table lists the supported DICOM view modifiers View Modifier Label View Modified Axillary Tail AT MLO Cleavage CV CC Partial View none Any Rolled Lateral RL Any Rolled Medial RM Any Rolled In...

Page 30: ...r 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...

Page 31: ...ng a Case f 3 8 Viewing Study Information f 3 9 Verifying Scanned Cases f 3 10 Correcting Scanned Images f 3 11 Printing CAD Results f 3 12 Searching for a Study f 3 13 Using Queue Manager Part 3 prov...

Page 32: ...properly 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 Howeve...

Page 33: ...ugh 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 separat...

Page 34: ...ing 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 Scannin...

Page 35: ...s 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 resca...

Page 36: ...use the Any protocol Use the correct number of films per case as specified by the selected scanning protocol If you plan to scan with the Auto protocol you can use from one to four films as long as th...

Page 37: ...s for example two RCC films or two LMLO films Use a Manual protocol or the Any protocol for cases with duplicate views X To scan with the Auto protocol 1 Prepare the cases to be scanned as described i...

Page 38: ...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...

Page 39: ...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 An...

Page 40: ...ll side down Small landscape Large portrait 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 selecte...

Page 41: ...e results the icon appears solid green Verification Required If verification of cases is required then you must review the scanned image thumbnails and patient information and confirm that the results...

Page 42: ...in the stack saves time adjusting the orientation later via the Image Correction screen X To scan with the Any protocol 1 Prepare the case to be scanned as described in 3 2 Preparing Cases to Be Scann...

Page 43: ...cting 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 to...

Page 44: ...reparing Cases to Be Scanned 2 If the system is currently scanning touch Stop The scanner will stop after it finishes the current film Important When you touch Stop the system always resets to the def...

Page 45: ...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 yo...

Page 46: ...ocessed or the study most recently processed The Study icons below represent studies processed earlier For any scanned case the system displays the following The R2 ID which is the barcode number from...

Page 47: ...units review workstations printouts etc The following table shows the Status conditions that the system can display for a case Case Status Message Meaning Processing The system is scanning and process...

Page 48: ...m 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...

Page 49: ...ange the film view labels and modifiers e g RCC to LCC Edit the DICOM study description for the case Note If films for two or more patients were scanned under a single separator sheet you must rescan...

Page 50: ...tely 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 t...

Page 51: ...r as TAN can be used with any view 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...

Page 52: ...tomatically printed when processing is complete The following is an example of a CAD Results Report If you want to create an additional paper printout of the CAD results touch any of the thumbnail ima...

Page 53: ...rcode 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...

Page 54: ...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 brows...

Page 55: ...can sort the list of cases by clicking on any of the column headers Clicking it again reverses the sort order When you click on a patient name the information associated with the study is shown in th...

Page 56: ...Part 3 Studies 48 R2 DM User Manual PN MAN 01044 Rev 001...

Page 57: ...they occur the alerts appear in two places On the Studies screen just below the Status field for the study currently displayed On the Alerts screen where you can view all recent alerts Touch to sort...

Page 58: ...ported 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 Correct the images as necessary v...

Page 59: ...ling the System 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 m...

Page 60: ...he results Reprocess the images via the Image Correction screen See 3 10 Correcting Scanned Images for more information If the problem persists call Hologic Technical Support Images didn t transfer 10...

Page 61: ...to the patient record in the database by the separator 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 i...

Page 62: ...nd fix the problem Restarting R2 software please wait 5019 Wait about 10 minutes Once the system comes back up you will see the Ready message above the Start button If the system doesn t come back up...

Page 63: ...means the system is shutting down It will shut down the R2 software then the operating system Let the system shut down Usually it shuts down only when instructed to do so If this happened on its own...

Page 64: ...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...

Page 65: ...the separator sheet barcode through the last film of a case 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...

Page 66: ...e 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 Th...

Page 67: ...ID System for more information on entering patient information See 3 10 Correcting Scanned Images for information on reprocessing a study Yellow X appears on my image thumbnails The yellow X icon ind...

Page 68: ...Part 4 Alerts 60 R2 DM User Manual PN MAN 01044 Rev 001...

Page 69: ...g 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 a...

Page 70: ...isplay the About screen Touch the Controls tab and then select About if the About screen does not appear This screen provides some important data that you may need to provide to a Hologic service supp...

Page 71: ...res 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 re...

Page 72: ...eature simply touch On or Off as desired Enabling DigitalNow The DigitalNow option on the Connectivity screen allows you to enable or disable DigitalNow To enable or disable this feature touch On or O...

Page 73: ...review whether scheduled maintenance is needed X To display the Maintenance screen Touch the Controls tab and then select Maintenance The screen identifies any required maintenance procedures with a...

Page 74: ...e 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 i...

Page 75: ...on on the Controls screen provides access to the Film ejection procedure Scanner cleaning procedure Results of system verification testing X To display the Performance screen Touch the Controls tab an...

Page 76: ...t found 4 If the preceding steps do not fix the problem call Hologic Technical Support Resetting the Clean Scanner Timer When you touch the Clean Scanner button the system displays Clean the scanner a...

Page 77: ...int 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 t...

Page 78: ...rinted You can choose to print a Reimbursement Barcode Report either automatically on a weekly or monthly basis or not at all To specify automatic printing of the reimbursement report touch Weekly or...

Page 79: ...1234 Eastside Drive Northside CA 95014 United States CASE HISTORY REPORT Mar 07 2007 Mar 13 2007 Mar 07 2005 Wed Barcode 0000095458 Case Time 17 38 53 Barcode 0000095460 Case Time 17 41 09 Barcode 000...

Page 80: ...ing Protocol Order on page 73 Changing the Default Scanning Protocol on page 73 Deleting a Scanning Protocol on page 73 Creating Scanning Protocols on page 74 Editing Scanning Protocols on page 75 X T...

Page 81: ...scanning protocol appears at the top of the scanning protocol list X To change the default scanning protocol 1 Touch the desired default scanning protocol in the list at the left of the screen 2 Touch...

Page 82: ...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 the view is set to CC and...

Page 83: ...tocol touch the view name then touch Remove To enter a new name for the protocol touch the Protocol name then enter a new name To add a new view to the protocol touch New Build the view from left to r...

Page 84: ...he Touch Screen Calibrating the touch screen can make it easier to precisely touch the buttons and other controls To calibrate first touch Calibrate Touch Screen and then follow the simple on screen i...

Page 85: ...til 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 Reminder Please clean the...

Page 86: ...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 Release the front cover as shown below Magnetic Str...

Page 87: ...ower switch beneath the power strip Power Strip System Power Switch Shutting Off the System 6 Wait ten 10 seconds Switch on the system using the power switch When the Studies screen appears the system...

Page 88: ...eaner Control Panel Cleaning Strip Diffuser Cleaner 2 Lift the cover so you can see the scanner control panel 3 On the scanner control panel a Press QUIT b Press MENU until 4 CLEANING MODE appears on...

Page 89: ...rs on the control panel display and then press ENTER c SUCTION PAD CLEANING appears on the display Press ENTER to continue d When SET CLN_PLATE PUSH START STOP appears on the display press START STOP...

Page 90: ...r MTF 1 2 Test 2 Processor 9999999905 P ro c e s s o r Te s t 1 P ro c e s s o r Te s t 2 Test 1 Algorithm No films required 9999999906 P N 10743 Rev B 2 Place the stack in the input tray and touch St...

Page 91: ...de labels provided in this section to reset it X 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 th...

Page 92: ...Part 6 Maintenance 84 R2 DM User Manual PN MAN 01044 Rev 001...

Page 93: ...e 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 Therefo...

Page 94: ...t 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 sys...

Page 95: ...rd h0spital the second character is a zero not the letter O IP address for the R2 DM system see the Controls About screen Once you have this information you can enter patient information Note For site...

Page 96: ...t information either by typing it in or by querying a PACS workstation as described under 7 4 Querying an External Database on page 90 Enter the correct Study Date The Study Date defaults to the curre...

Page 97: ...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 mult...

Page 98: ...t field With either button the query result returns data for just the fields in the Patient Information section DICOM Study Root Query If this was configured only the query button in the Study Informa...

Page 99: ...ase 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 To select a study and co...

Page 100: ...92 R2 DM User Manual PN MAN 01044 Rev 001...

Page 101: ...Reimbursement Report system cannot print 53 ejecting 72 jammed 72 barcode scanner handheld number per case 16 resetting 95 orientation detection 21 search 15 preparing for scanning 30 uses 10 require...

Page 102: ...tify 53 printer system cannot find 54 license system cannot verify 54 Printing screen 75 licensed features 20 printout postscript 24 M Q maintenance Queue Manager 48 cleaning scanner 11 56 72 84 87 92...

Page 103: ...9 frozen 62 manual protocols 28 33 35 overview 14 overview 16 study description DICOM 45 protocol list 15 study icon starting 15 described 14 stopping 39 flashing arrow 16 scanning protocols flashing...

Page 104: ...Index V verifying cases 42 configuring 67 views labeling 45 modifiers 23 supported 22 96 R2 DM User Manual PN MAN 01044 Rev 001...

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