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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• When this manual directs you to press a key on the computer keyboard, the key names are outlined; for example, ‘Press [×Enter] ’. • If you are reading this manual online, click on the blue hyperlinked text to jump to the referenced section. R2 DM User Manual – PN MAN-01044 Rev 001...
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 DM User Manual – PN MAN-01044 Rev 001...
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 DM User Manual – PN MAN-01044 Rev 001...
• When necessary, shut down the system according to the procedures recommended in this user manual. • Do not attempt to install or repair the R2 system. Only trained personnel, authorized by Hologic, are qualified to install or repair the system. R2 DM User Manual – PN MAN-01044 Rev 001...
• Use Hologic’s DigitalNow™ feature to transmit the digital mammography image files to an output device such as a PACS for archiving. • 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 ImageChecker results to an output device such as the R2 CheckMate™...
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Part 2: Description The R2 DM 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, all housed in a movable cart. When using the system, the technologist loads a stack of cases into the film scanner.
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For more information about the CAD marks and the ImageChecker algorithm, see Understanding ImageChecker 8.5-8.7. PACS Review Workstation Films CheckMate Ultra R2 DM Film-Scanning Platform Printer System Diagram R2 DM User Manual – PN MAN-01044 Rev 001...
Use to type search criteria when searching for studies, and to enter Keyboard: patient information. • Use to select screen objects as an alternative to the touch screen. Mouse: Scanner Control Panel (closed) Scanner Interlock Computer Power Strip Power Switch Exterior Components R2 DM User Manual – PN MAN-01044 Rev 001...
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• Processes the scanned films and images. Computer: • Provides power to the scanner. Scanner Power Supply: Scanner Control Panel (closed) Scanner Interlock Computer Power Strip Power Switch Interior Components R2 DM User Manual – PN MAN-01044 Rev 001...
Images the system scans the films. • includes the patient flash from the scanned film and other Patient Information data imported from a patient database. R2 DM User Manual – PN MAN-01044 Rev 001...
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Start button scanning begins, the button changes to Stop. • The field, which appears above the Start button, indicates the scanner Status status, for example, ‘ ’, ‘ ’, etc. Ready Scanning R2 DM User Manual – PN MAN-01044 Rev 001...
Case is complete, but a fault condition has occurred that may require user intervention. Case has failed. A fault condition has occurred that requires user intervention. For more about using the Studies screen, see ‘Part 3: Studies’. R2 DM User Manual – PN MAN-01044 Rev 001...
In some cases you will want to refer to ‘Part 4: Alerts’ for more information about a particular alert. This study generated a non-fatal alert. Alert description This study generated a ‘case-failed’ alert. R2 DM User Manual – PN MAN-01044 Rev 001...
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Touch to hide a selected alert. 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. R2 DM User Manual – PN MAN-01044 Rev 001...
Touch a screen name to display its contents. For details about the settings, utilities, and information on the screen, see Controls ‘Part 5: Controls’. R2 DM User Manual – PN MAN-01044 Rev 001...
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.
2.5. Other Features 2.5. Other Features In addition to the licensed features, the R2 DM system includes the following standard features, which are described further below: • Automatic Film Marker Identification • Patient Database Connectivity • Reimbursement Barcode Report Automatic Film Marker Identification...
** Implant-displaced views with a maximum of 2.5 cm (1 in) of implant imaged. Important! Certain view modifiers prevent the system from performing CAD processing. For more information, see the manual, Understanding ImageChecker 8.5– 8.7. R2 DM User Manual – PN MAN-01044 Rev 001...
• provides backward compatibility with previous Mammography CAD SR 5.x releases of ImageChecker 5.x products. The 5.x format provides RightOn Calc and Mass marks but not EmphaSize or PeerView. R2 DM User Manual – PN MAN-01044 Rev 001...
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 screen, which is shown below: Studies R2 DM User Manual – PN MAN-01044 Rev 001...
(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 –...
Incorrect Auto Protocol Lead Marker Placement Separator Sheets The R2 DM system is shipped with 1000 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.
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. R2 DM User Manual – PN MAN-01044 Rev 001...
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• Have non-standard views or views with modifiers, or • Have more than four views per case • Include views that do not conform to any available scanning 3.5. Scanning with protocols the Any Protocol R2 DM User Manual – PN MAN-01044 Rev 001...
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 DM User Manual – PN MAN-01044 Rev 001...
Note: You cannot change the scanning protocol if a case is currently being scanned. Touch . The system status changes from ‘Ready’ to ‘Scanning’, and the Start Start button becomes a button. Stop R2 DM User Manual – PN MAN-01044 Rev 001...
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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. R2 DM User Manual – PN MAN-01044 Rev 001...
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 DM User Manual – PN MAN-01044 Rev 001...
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• The arrow on the top separator sheet pointing into the scanner. • The leading edges of the films and separator sheets aligned flush. You can load up to 100 sheets – including films and separator sheets. Loading Films R2 DM User Manual – PN MAN-01044 Rev 001...
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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. R2 DM User Manual – PN MAN-01044 Rev 001...
Load the stack into the input tray. Insert the stack with: • The arrow on the top separator sheet pointing into the scanner. • The leading edges of the films and separator sheets aligned flush. R2 DM User Manual – PN MAN-01044 Rev 001...
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If necessary, keep the separator sheet with the case for CAD display. Note: After scanning the case, the system returns to the default protocol configured on the Controls Scanning screen. R2 DM User Manual – PN MAN-01044 Rev 001...
Insert the new stack of cases into the feeder. If necessary, select the scanning protocol you want to use. Touch to resume scanning. Start R2 DM User Manual – PN MAN-01044 Rev 001...
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 to resume scanning. Start R2 DM User Manual – PN MAN-01044 Rev 001...
(if present), Patient Information 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 DM User Manual – PN MAN-01044 Rev 001...
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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. R2 DM User Manual – PN MAN-01044 Rev 001...
‘5.2. Connectivity Options’). Important! Hologic recommends that facilities using DigitalNow always verify 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: 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.) R2 DM User Manual – PN MAN-01044 Rev 001...
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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 R2 DM User Manual – PN MAN-01044 Rev 001...
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• Automatically sends the results to the output devices (PACS, display unit, printer, etc.) if Verification is off. • Waits for you to click the Done button if Verification is on before sending the results. R2 DM User Manual – PN MAN-01044 Rev 001...
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 the films are not rescanned, the results for the case will be identical to the original. R2 DM User Manual – PN MAN-01044 Rev 001...
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. R2 DM User Manual – PN MAN-01044 Rev 001...
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. Enter your Queue Manager database password (h0spital spelled with a ‘zero’), and click login R2 DM User Manual – PN MAN-01044 Rev 001...
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(run next), delete them, or stop processing them. When you are finished, exit the web browser. R2 DM User Manual – PN MAN-01044 Rev 001...
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Part 3: Studies R2 DM User Manual – PN MAN-01044 Rev 001...
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: •...
• If films for two or more patients were scanned under a single separator sheet, rescan the case. • 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.).
Reprocess the study in the Image Correction screen and print. • 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.
Reprocess the study in the Image Correction screen and print. • 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.
• Check that the separator sheet is oriented correctly in the scanner input tray. See diagram on separator sheet. • If the separator sheet is oriented correctly and the problem persists, call Hologic Technical Support. No output jobs scheduled for case (3054) The R2 system was not configured with any output destinations for CAD results.
System’) and rerun the tests again. • 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. R2 DM User Manual – PN MAN-01044 Rev 001...
Hologic Technical Support is working on your system, and you’ll need to wait until they are done. • Wait two minutes. The Ready message will appear above the Start button. • 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’.
• Reload the case and restart scanning. • 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...
• If the 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 DM User Manual – PN MAN-01044 Rev 001...
If printing is turned off, turn it on and reprocess the study in the Image Correction screen. • 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.
• Verify that the image views and view modifiers are supported for CAD processing. ‘2.6. System Inputs and Outputs’ for more information. Even though no processing was possible, the scanned images are archived as usual. R2 DM User Manual – PN MAN-01044 Rev 001...
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Part 4: Alerts R2 DM User Manual – PN MAN-01044 Rev 001...
Touch a screen name to display its contents. Note: The Connectivity and Printing options appear only if they were configured by the Hologic service engineer when the system was installed. R2 DM User Manual – PN MAN-01044 Rev 001...
(if the About screen does not appear). Controls About 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 •...
• Enable or disable the DigitalNow archiving feature • Verify DigitalNow images before sending 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.
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 Retrieve Patient Information setting on the Connectivity screen.
To display the Maintenance screen Touch the tab and then select Controls Maintenance The screen identifies any required maintenance procedures with a yellow alert icon. For further information, see ‘Part 6: Maintenance’. R2 DM User Manual – PN MAN-01044 Rev 001...
For further information, see ‘6.2. Power-Cycling System’. When you touch Reboot or Shutdown, a confirmation window appears which requires you to either confirm or cancel the power down command. R2 DM User Manual – PN MAN-01044 Rev 001...
The Performance option on the Controls screen provides access to the: • Film ejection procedure • Scanner cleaning procedure • Results of system verification testing To display the Performance screen Touch the tab and then select Controls Performance R2 DM User Manual – PN MAN-01044 Rev 001...
If the preceding step doesn’t eject the film, power-cycle the system. See ‘Error! Reference source not found.’. If the preceding steps do not fix the problem, call Hologic Technical Support. Resetting the Clean Scanner Timer When you touch the button, the system displays:...
‘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. Note: Not all scanned images are sent to the printer. For more information, see ‘2.6.
• To disable automatic printing of the reimbursement report, touch Printing a Reimbursement Barcode Report To print a reimbursement report Touch . A calendar window appears. Print Now Specify the date range and touch Print R2 DM User Manual – PN MAN-01044 Rev 001...
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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.
‘Deleting a Scanning Protocol’ on page • ‘Creating Scanning Protocols’ on page • ‘Editing Scanning Protocols’ on page To display the Scanning screen Touch the tab and then select Controls Scanning R2 DM User Manual – PN MAN-01044 Rev 001...
Touch the desired scanning protocol in the list at the left of the screen. Touch Remove Confirm that you want to delete the protocol. Note: You can delete any scanning protocol except the Auto protocol. R2 DM User Manual – PN MAN-01044 Rev 001...
• To remove the view from the scanning protocol, touch a view name in the list at left and then touch Remove • To enter a study description, touch the field. DICOM Study Description Touch when finished. R2 DM User Manual – PN MAN-01044 Rev 001...
Cancel Note: You can edit any scanning protocol except the Auto protocol. If you delete all views from a Manual protocol, the protocol will be equivalent to the Any protocol. R2 DM User Manual – PN MAN-01044 Rev 001...
Part 5: Controls 5.8. Service Utilities The Service option on the Controls screen allows: • Calibrating the touch screen • Access to the service tools (only for Hologic-trained service personnel) To display the Service screen Touch the tab and then select...
Options’.) Preventive maintenance is required 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.
WARNING! In the next step, be careful when lifting the cover; it’s heavy. Lift the cover up to free its top lip from the frame on which it hangs, and then set it aside. R2 DM User Manual – PN MAN-01044 Rev 001...
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System Power Switch 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. R2 DM User Manual – PN MAN-01044 Rev 001...
Note: If you are running less than 80 cases daily, you can clean the scanner once each day. If you are running 80 or more cases daily, Hologic | R2 recommends that you clean the scanner twice each day.
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Controls Performance Touch the button. The system displays: Clean Scanner Touch . When you touch OK, the Scanner Cleaning message on the Maintenance screen changes from ‘Needed’ to ‘OK’. R2 DM User Manual – PN MAN-01044 Rev 001...
If any test fails again, power-cycle the system (see ‘6.2. Power-Cycling the System’) and rerun all the tests. • If any test fails again, call your Hologic service representative. R2 DM User Manual – PN MAN-01044 Rev 001...
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. R2 DM User Manual – PN MAN-01044 Rev 001...
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Part 6: Maintenance R2 DM User Manual – PN MAN-01044 Rev 001...
R2 Patient ID system. 7.1. Overview R2 DM supports 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.
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 case. R2 DM User Manual – PN MAN-01044 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.
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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.
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(The keyboard shortcut is [Alt] + [left arrow].) At that point, you would need to change only the study date and accession number. R2 DM User Manual – PN MAN-01044 Rev 001...
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: •...
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To select a study and copy its data onto the patient information entry page, touch its entry in the Patient Name column. R2 DM User Manual – PN MAN-01044 Rev 001...
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