Hologic R2 DM User manual
User Manual
Software Version 8.5
PN MAN-00709 Rev 001
R2™DM
Mammography
R2™ DM User Manual
Software Version 8.5
PN MAN-00709 Rev 001
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.r2tech.com
For support in Europe, South America, or Asia, contact your local dealer or distributor.
© 2007, Hologic, Inc. All rights reserved. Duplication or distribution without written permission
is prohibited. Hologic reserves the right to revise this manual. Issued March 2007.
Protected by one or more of the following U.S. Patents: 4907156, 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
Hologic, the Hologic logo, CheckMate, DigitalNow, Earlier. Smarter. Better, ELC, EmphaSize,
Gold Standard CAD, GreenLight, ImageChecker, Malc, PeerView, R2, R2 Technology, and the
R2 Logo are trademarks or registered trademarks of Hologic, Inc. in the USA. Microsoft, and
Windows are registered trademarks of Microsoft Corporation. MagView is a registered
trademark of MagView Corporation. MergeCOM-3 is a trademark of Merge Healthcare. MRS is
a registered trademark of Mammography Reporting System, Inc. PenRad is a registered
trademark of PenRad Technologies, Inc.
Hologic Inc.
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Bedford, MA 01730-1401 USA
Tel: +1.781.999.7300
Sales: +1.781.999.7453
Fax: +1.781.280.0668
www.hologic.com
Asia Pacific
Room 302, Hung Kei Building
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Central, Hong Kong
Tel: +852.3102.9200
Hologic N.V.
Authorized Representative
Leuvensesteenweg 250A
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Tel: +32.2.711.4680
Fax: +32.2.725.2087
MergeCOM-3 Advanced Integrator’s
Tool Kit is a product of Merge
Healthcare.
ii R2 DMax User Manual – PN MAN-00709 Rev 001
Contents
Part 1: Introduction....................................................... 1
1.1. Available Resources ................................................... 1
1.2. How to Use this Manual ................................................ 2
1.3. Warnings and Cautions ................................................ 4
Manual Organization .................................................. 2
Conventions Used in this Manual ......................................... 2
Symbols Used ........................................................ 3
Radiological Interpretation .............................................. 4
Warnings: System Operation............................................. 5
Warnings: Maintenance ................................................ 5
Cautions: System Operation ............................................. 6
Cautions: Installation and Maintenance .................................... 7
Part 2: Description........................................................ 9
2.1. Overview ........................................................... 9
2.2. System Components ................................................. 12
2.3. Overview of Operation ................................................ 14
Studies Screen Overview ............................................... 14
Scanning and Processing ............................................... 16
System Alerts........................................................ 17
Controls Screen ...................................................... 19
2.4. System Features..................................................... 20
Feature Licensing Flexibility ............................................ 20
Other System Features................................................. 22
2.5. ImageChecker Film-Screen CAD......................................... 23
Intended Use ........................................................ 23
CAD Marks ......................................................... 23
EmphaSize.......................................................... 23
CAD Operating Points ................................................ 24
Number of CAD Marks ................................................ 25
2.6. System Inputs and Outputs ............................................ 26
CAD-Supported Views ................................................ 26
View Modifiers ...................................................... 27
Digital Image Output Options........................................... 28
R2 DMax User Manual – PN MAN-00709 Rev 001 iii
Contents
Part 3: Studies........................................................... 29
3.1. Working with Films .................................................. 30
Film Requirements ................................................... 30
R2-Supported Lead Markers ............................................ 30
Lead Marker Placement................................................ 31
Separator Sheets ..................................................... 31
Scanning Protocols ................................................... 32
3.2. Preparing Cases to Be Scanned ......................................... 34
3.3. Scanning with the Auto Protocol ........................................ 35
3.4. Scanning with a Manual Protocol ....................................... 37
3.5. Scanning with the Any Protocol......................................... 40
3.6. Adding Cases to the Stack ............................................. 42
3.7. Stopping Scanning and Removing a Case ................................. 43
3.8. Viewing Study Information ............................................ 44
3.9. Verifying Scanned Cases .............................................. 46
3.10. Correcting Scanned Images ............................................ 47
3.11. Printing CAD Results ................................................. 50
3.12. Searching for a Study ................................................. 51
3.13. Using Queue Manager ................................................ 52
Part 4: Alerts ............................................................ 55
4.1. Alerts Listed Alphabetically ............................................ 56
Archiving was cancelled for case (3045).................................... 56
Cannot process image successfully (1063) .................................. 56
Cannot process this case (1062).......................................... 56
Could not connect to reporting system database (3503) ....................... 56
ImageChecker attempted but could not send case (3016, 3018, 3031, 3032) ........ 56
ImageChecker attempted but could not print reimbursement report (2008)........ 57
ImageChecker cannot contact the scanner (1010) ............................ 57
ImageChecker cannot identify the lead markers (3023)........................ 57
ImageChecker cannot read the barcode (1041) .............................. 57
ImageChecker is busy (3012, 1029, 1030) .................................. 57
ImageChecker license not found (1024) ................................... 58
ImageChecker could not print a CAD report (2007) .......................... 58
ImageChecker could not send results (2005) ................................ 58
Images didn’t transfer (1031) ........................................... 58
Image transfer was interrupted (3013)..................................... 58
Missing or invalid barcode at top of stack (1016) ............................ 59
No output jobs scheduled for case (3054) .................................. 59
No patient record information is associated with barcode (3501) ................ 59
Not all films in case are specified by scanning protocol (3024) .................. 59
Printer not found (3014)............................................... 59
iv R2 DMax User Manual – PN MAN-00709 Rev 001
Contents
Rebooting the operating system, please wait (5021) .......................... 60
Reporting system query error (3502)...................................... 60
Restarting R2 software, please wait (5019).................................. 60
Scanner lock lever is raised (3051)........................................ 60
Scanner not ready! (5002) .............................................. 60
Scanner test failed (3025) .............................................. 60
Scanning is disabled, remote maintenance in progress (5010, 5059) .............. 61
Scheduled reimbursement report (5050)................................... 61
Shutting down the operating system, please wait (5020) ....................... 61
Shutting down the R2 software, please wait (5018) ........................... 61
The same barcode has been assigned to multiple patients (3500) ................ 61
The scanner is not responding (1007) ..................................... 62
The scanner might be empty (3033) ...................................... 62
X films were found when Y were expected. (1017, 1018) ....................... 62
4.2. Common Questions .................................................. 63
CAD does not run on views with implants ................................. 63
CAD marks do not appear on thumbnails .................................. 63
Case icons become yellow alerts; there are no images ......................... 63
Film is ‘missing’ inside the scanner ....................................... 63
Image is missing from a case ............................................ 63
Images are reversed in the thumbnails..................................... 63
Images at PACS/workstation are of poor quality ............................. 63
Images didn’t print out ................................................ 64
Images do not appear on my display unit .................................. 64
Monitor isn’t working ................................................. 64
Main screen is frozen and I can’t do anything ............................... 64
Patient ID flash on the printout is backwards ............................... 64
Radiologist needs CAD quickly .......................................... 65
Scanned case before entering patient information ............................ 65
Yellow ‘X’ appears on my image thumbnails ................................ 65
Part 5: Controls.......................................................... 67
5.1. About Option ....................................................... 68
5.2. Maintenance Options ................................................. 69
5.3. Shutdown and Reboot Options ......................................... 70
5.4. Outputs Options ..................................................... 71
5.5. Patient ID Option .................................................... 72
5.6. Performance Options ................................................. 73
Ejecting Films ....................................................... 74
Resetting the Clean Scanner Timer ....................................... 74
Reviewing System Verification Results .................................... 74
5.7. Printing Options ..................................................... 75
R2 DMax User Manual – PN MAN-00709 Rev 001 v
Contents
Configuring CAD Results Printing ....................................... 76
Setting When the Reimbursement Barcode Report will be Printed ............... 76
Printing a Reimbursement Barcode Report ................................. 76
5.8. Scanning Protocols................................................... 78
Changing Scanning Protocol Order....................................... 79
Changing the Default Scanning Protocol................................... 79
Deleting a Scanning Protocol ........................................... 79
Creating Scanning Protocols ............................................ 80
Editing Scanning Protocols ............................................. 81
5.9. Service Utilities...................................................... 82
Calibrating the Touch Screen ........................................... 82
Connecting to the Service Tool .......................................... 82
Part 6: Maintenance ..................................................... 83
6.1. Maintenance Reminders............................................... 83
Diagnostic tests failed ................................................. 83
Reminder: Please clean the scanner ....................................... 83
Test Films: Needed ................................................... 83
Preventive maintenance is required....................................... 83
6.2. Cleaning the Scanner ................................................. 84
6.3. Power-Cycling the System ............................................. 86
6.4. Running the Weekly Tests ............................................. 88
6.5. Resetting the Handheld Barcode Scanner ................................. 89
Part 7: Using DigitalNow and the R2 Patient ID System .................. 91
7.1. Overview .......................................................... 91
7.2. DigitalNow Archiving ................................................. 92
7.3. Using the R2 Patient ID System ......................................... 93
Querying an External Database .......................................... 95
7.4. Assigning R2 Barcodes in Other Databases ................................ 97
Assigning a Barcode in PenRad .......................................... 97
Assigning a Barcode in MagView......................................... 97
Assigning a Barcode in MRS ............................................ 97
Index .................................................................... 99
vi R2 DMax User Manual – PN MAN-00709 Rev 001
Part 1: Introduction
f 1.1. Available Resources
f
1.2. How to Use this Manual
f
1.3. Warnings and Cautions
Part 1 provides a brief description of resources available from Hologic | R2,
information about using this manual, and safety information.
1.1. Available Resources
When you are working with the R2 DM system, the following resources are available
from Hologic | R2:
• Onscreen Messages: The R2 GreenLight™ user interface is designed to guide you
as you use the system. Onscreen messages appear when appropriate and provide
friendly instructions.
• Technical Support and Service: For contact information, see ‘Technical Support’
on the back of the title page of this manual.
•
User Manuals: This user manual describes the use of the R2 DM system and
provides maintenance and troubleshooting instructions in a simple, streamlined
format. You can purchase additional copies of the user manual through your
Hologic | R2 Account Manager.
•
Customer Bulletins: Hologic | R2 is committed to making our products safe and
easy to use. If an issue arises or new features become available, you will receive a
Customer Bulletin.
•
Training: On-line training materials are available through the R2 Member Center,
which is available at http://www.r2tech.com/main/member_login.php. Simply
register for access to a wide range of training courses on v8.5 software. In addition,
the Hologic | R2 Applications team is available to train your staff, should you feel
they need additional training. Contact your Hologic | R2 Account Manager if you
want personalized instruction.
R2 DMax User Manual – PN MAN-00709 Rev 001 1
Part 1: Introduction
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:
f
Part 1: Introduction provides a list of resources available from Hologic | R2,
information about using this manual, and safety information.
f
Part 2: Description provides background information on the system, component and
feature descriptions, an overview of operation, and CAD processing information.
f
Part 3: Studies provides instructions for working with films, scanning them,
displaying study results, verifying and labeling images, and searching for a study.
f
Part 4: Alerts provides a listing of alert conditions with instructions for resolving the
alerts and diagnosing and solving common problems.
f
Part 5: Controls provides instructions for using the system configuration and
maintenance options that appear on the Controls screen.
f
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 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.
Note: Background information provided to clarify a particular step or procedure.
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.
WARNING! An instruction that, if not followed, can result in a hazardous condition.
Also note the following conventions:
• Italic and
engage,’ ‘
• 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
boldface typefaces are used for emphasis. Examples: ‘Press carefully to
Do not press down.’
Start’.
• When this manual directs you to press a key on the computer keyboard, the key
names are outlined; for example, ‘Press
• If you are reading this manual online, click on the blue hyperlinked text to jump to
the referenced section.
2 R2 DMax User Manual – PN MAN-00709 Rev 001
[×Enter]’.
Symbols Used
The following internationally recognized symbols may be used in this manual and on
R2 products.
1.2. How to Use this Manual
Type B Equipment Off
OnDangerous Voltage
StandbyFuse
Alternating CurrentProtective Earth Ground
Attention: Consult accompanying documents, or
pay special attention to the note next to the symbol.
Common Symbols
R2 DMax User Manual – PN MAN-00709 Rev 001 3
Part 1: Introduction
1.3. Warnings and Cautions
Radiological Interpretation
• The radiologist should base interpretation only on the original images and not
depend on the CAD marks for interpretation.
• The device is a detection aid, not an interpretative aid. Activate the CAD marks
only after the first reading.
• The device marks calcification features with triangles (Calc marks) and mass
features with asterisks (Mass marks). Where mass and calcification features
overlap within a specified distance (10-mm default), the device marks overlapping
features with pointed crosses (Malc™ marks). These features may not represent
cancer, and the skill of the user is still required for proper interpretation of areas
marked by the device.
• EmphaSize (variable-size) marks – Sites may choose to display prominence detail,
in which case the size of a Calc, Mass, or Malc mark is proportional to the ranking
of the feature by the algorithm. The marked features may not represent cancer,
and the skill of the user is still required for proper interpretation of areas marked
by the device.
• For proper system operation, the technical quality of the original films or images
(e.g., contrast) should meet relevant MQSA standards (or the appropriate national
standards) and be acceptable to the mammographer.
• The use of digitized images (scanned film images) for primary reading has not
been approved by MQSA. Digitized film images retrieved from archive should be
used only for the purpose of comparison with digital images meeting the current
standard.
• The device does not identify all areas that are suspicious for cancer.
– Some lesions are not marked by the device and a user should not be dissuaded
from working up a finding if the device fails to mark that site.
– The device is not designed to detect changes from prior mammograms.
– The device is not designed to detect skin thickening or nipple retractions.
– Conditions of the breast that diminish mammographic sensitivity, such as
density of normal tissue, also diminish the sensitivity of the device.
– The device is more sensitive for detection of calcifications than masses, and the
sensitivity depends on the site-specific operating points chosen. For sensitivity
values, see ‘
masses, the algorithm has a lower sensitivity for masses greater than 2.5 cm in
diameter.
– Individual practice patterns may influence results obtained when using this
device. Therefore, each facility and radiologist should carefully monitor the results
that this device has on their practice of mammography in order to optimize its
effectiveness.
• Safety and effectiveness have not been established for analyzing mammograms
from patients with breast implants. For patients with breast implants, only
CAD Operating Points’ on page 24. In addition to not marking all
4 R2 DMax User Manual – PN MAN-00709 Rev 001
Implant-Displaced Views can be processed by the system and only in cases with a
maximum of 2.5 cm (1 in) of the breast implant appearing on the image.
• The performance of the system has not been characterized for special diagnostic
views (e.g., magnified views or spot-compressed views). Process only full-view
diagnostic images.
• The performance of the system has not been characterized for segmented views of
the breast (e.g., ‘mosaic’ views) where there is not a clear breast border. Process
only views with breast borders.
Warnings: System Operation
• 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 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.
1.3. Warnings and Cautions
• 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 than 40% relative
humidity, 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.
Warnings: Maintenance
• Barcode scanners used with the system are Class I Laser/LED products – do not
stare into the beam.
• 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 DMax User Manual – PN MAN-00709 Rev 001 5
Part 1: Introduction
Cautions: System Operation
• Operators should review this user 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 | R2.
• 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 × 24 cm or 24 × 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.
• 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.
6 R2 DMax User Manual – PN MAN-00709 Rev 001
Cautions: Installation and Maintenance
This product contains no user-serviceable parts. To prevent damage to the system:
• Maintain 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 R2 system. Only trained personnel,
authorized by Hologic | R2, are qualified to install or repair the system.
For service training, contact your technical service representative or call Hologic | R2
Technical Support (see ‘
manual).
Technical Support’ on the back of the title page of this
1.3. Warnings and Cautions
R2 DMax User Manual – PN MAN-00709 Rev 001 7
Part 1: Introduction
8 R2 DMax User Manual – PN MAN-00709 Rev 001
Part 2: Description
f 2.1. Overview
f
2.2. System Components
f
2.3. Overview of Operation
f
2.4. System Features
f
2.5. ImageChecker Film-Screen CAD
f
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 DM system is a full-featured mammography film-scanning platform designed
to:
• Scan mammography x-ray films and convert them into digital image files
• Analyze the images using R2 Technology’s proprietary ImageChecker® CAD
algorithm to detect regions of the breast that may be cancerous
• Allow users to review the scanned images, and to reorient, label, and reprocess the
images as needed
• Interface with mammography reporting systems to retrieve patient information,
which can then be integrated with the study images
• Transmit the study results to an output device such as an R2 CheckMate™ Ultra
display unit or PACS where they can be viewed or archived
Note: This manual uses the following terms to describe mammography images and
media:
• Case: a series of x-ray films associated with a particular patient.
• Stack: a group of cases including a separator sheet on top of each case.
• Study: a series of digitized images associated with a particular patient.
R2 DMax User Manual – PN MAN-00709 Rev 001 9
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 ImageChecker CAD and
DigitalNow processing, all housed in a movable cart.
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 softcopy
review workstations.
10 R2 DMax User Manual – PN MAN-00709 Rev 001
R2 DM System
2.1. Overview
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.
After making an initial interpretation from the original mammograms, the radiologist
displays the CAD marks and chooses whether or not to reinspect the marked regions
on the original mammogram. The ImageChecker algorithm marks visually
perceptible structures that have some of the generally accepted geometric
characteristics of calcifications or masses. The marked areas may be something other
than an actual abnormality, which is generally recognized by the radiologist upon a
second review of the original mammogram.
R2 software version 8.5 now includes the ability to send images and/or CAD results to
virtually any DICOM-conformant workstation and/or archive (using R2
Technology’s DigitalNow feature), allowing CAD results to be displayed, stored, and
managed universally.
Films
For more information about the CAD marks and the ImageChecker algorithm, see
‘
2.5. ImageChecker Film-Screen CAD’.
PACS
Review Workstation
CheckMate Ultra
R2 DM
Film-Scanning Platform
Printer
System Diagram
R2 DMax User Manual – PN MAN-00709 Rev 001 11
Part 2: Description
2.2. System Components
This section describes the major system components.
•
Touch-Screen Monitor: Use to control and monitor the system (start scanning,
select studies, view system status, etc.).
Scanner: Use to convert the mammogram films to digital images. You stack the
•
films and place them in the input tray. After the scanner digitizes the images, it
stacks the films 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 or the barcode on a separator sheet.
•
Keyboard: Use to type search criteria when searching for studies, and to enter
patient information.
•
Mouse: Use to select screen objects as an alternative to the touch screen.
Scanner
Interlock
Computer
Scanner
Control Panel
(closed)
Power Strip
Power Switch
Exterior Components
12 R2 DMax User Manual – PN MAN-00709 Rev 001
2.2. System Components
• 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.
•
Test Sheets and Films: Use for the weekly tests to ensure optimal system
performance. For more information, see ‘
•
Lead Markers: Read by the R2 system to identify standard views automatically. For
more information on lead markers, see ‘
6.4. Running the Weekly Tests’.
R2-Supported Lead Markers’ on page 30.
The following components are located behind the front cover. You’ll only need to
access these components for certain maintenance procedures.
•
Computer: Processes the scanned films and images.
•
Scanner Power Supply: Provides power to the scanner.
Scanner
Computer
Scanner
Power Supply
Scanner Power Switch
Interior Components
R2 DMax User Manual – PN MAN-00709 Rev 001 13
Part 2: Description
t
t
2.3. Overview of Operation
The system’s touch-screen interface provides quick access to all system functions. The
GreenLight user interface features three main screens –
– 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.
Studies Screen Overview
When scanning films, you will use the Studies screen, which is shown below:
The Study icon at
he top represents
the study currently
being processed or
he 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.
Studies, Alerts, and Controls
The following items appear on the Studies screen:
•
Study icons each represent 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
•
Study Information appears for each case of films as they are scanned and
16.
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 film
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 associated with each study (in particular, data imported from a
mammography reporting system).
• 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’.
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2.3. Overview of Operation
• 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 protocols 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 DMax User Manual – PN MAN-00709 Rev 001 15
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 ‘
To scan films you simply:
• Arrange the films with a separator sheet on top of each case.
• Organize films and separator sheets in a stack.
• Place the stack in the film input tray.
3.1. Working with Films’ for more information).
• 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 case, 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.
Note: Before the study results are sent to the display/archive device, you may be
required to ‘verify’ that the system scanned the films correctly. This option is configured
on the Controls Outputs screen. For more information, see ‘
The appearance of the study icon indicates the status of the case:
Study Icon Status
(blinking circle)
(blinking arrow)
(blinking question mark)
(blinking exclamation point)
(blinking arrow)
(blinking question mark)
Case films are being scanned or processed.
Case results are being sent to a display or
archive device.
Scanned images for the case require
verification.
Case films are being scanned or processed, but
a non-fatal fault condition has occurred.
Case results are being transmitted, but a nonfatal fault condition has occurred.
Scanned images for the case require
verification, and a non-fatal fault condition
has occurred.
5.4. Outputs Options’.
For more about using the Studies screen, see ‘
16 R2 DMax User Manual – PN MAN-00709 Rev 001
Case is complete, results have been sent.
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.
Part 3: Studies’.
System Alerts
2.3. Overview of Operation
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
A non-fatal fault condition has occurred. This alert appears on the case
study icons (see previous table).
The software has processed the images successfully, but a fault
condition has occurred that may require user intervention.
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.
This study
generated a
non-fatal alert.
Alert description
This study
generated a
‘case-failed’ alert.
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 more information about a particular alert.
R2 DMax User Manual – PN MAN-00709 Rev 001 17
Part 2: Description
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.
When an alert is issued, the yellow alert icon ( ) appears on the Alerts tab at the
bottom of the screen. If you touch the
Alerts tab, you can see recent system alerts.
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.
18 R2 DMax User Manual – PN MAN-00709 Rev 001
Controls Screen
Touch a screen
name to display its
contents.
2.3. Overview of Operation
The Controls screen is used to configure system settings to meet your particular
needs, run maintenance procedures, and display system information.
For details about the settings, utilities, and information on the Controls screen, see
‘
Part 5: Controls’.
R2 DMax User Manual – PN MAN-00709 Rev 001 19
Part 2: Description
2.4. System Features
This section describes the principal features of the R2 DM system.
Feature Licensing Flexibility
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:
•
ImageChecker Film-Screen CAD
•
DigitalNow DICOM Export
•
Reporting System Interface
•
PeerView and PeerView Digital
These features are described further in the following sections.
ImageChecker Film-Screen CAD
The ImageChecker license provides R2 Technology’s Gold Standard CAD™
algorithm, which provides the medical-imaging industry’s highest sensitivity at any
given false-mark rate. The algorithm offers three operating points to accommodate
differing radiologist preferences. The performance of the system for each of the three
operating points as measured on R2 Technology’s film database is summarized below:
When your system is installed, you can select different operating points for
calcifications and masses. For more information, see ‘
CAD
’.
Note: Every time films are rescanned, the image created is subtly different. This
difference is of no consequence to a human observer, but slight rotation, shift, and
electronic noise differences will cause some CAD marks to vary with each rescan. This is
expected behavior.
Note: If the ImageChecker software has been upgraded to a newer revision since the
mammograms were first processed, the resulting CAD marks may be different if a newer
algorithm is used to process the cases.
Operating Point 0 1 2
Calcification Sensitivity 95% 96% 97%
Mass Sensitivity 83% 88% 90%
False Marks per Case 1.0 1.5 2.0
2.5. ImageChecker Film-Screen
DigitalNow DICOM Export
R2 film-scanning platforms can send digitized film images to a DICOM-conformant
archiving system for future review. Sites using full-field digital mammography can
scan prior studies and compare those priors with the current digital study on a
softcopy review workstation. Sites planning to move to digital in the near future can
plan ahead and send the digitized images to an archive system now, and retrieve them
for comparison later to current digital studies.
R2 systems configured with DigitalNow utilize the separator sheet barcode (‘R2 ID’)
for identifying the patient associated with the digitized film images. This allows for
20 R2 DMax User Manual – PN MAN-00709 Rev 001
2.4. System Features
the proper identification, storage, and retrieval of digitized film images in the archive
system.
The system can be configured to generate 50 or 100 micron output images, or both.
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.
DigitalNow enables sites with ImageChecker CAD to archive CAD marks to PACS, if
desired. The CAD marks can also be printed and archived with other paper-based
patient records.
Important! From time to time, be sure to check images received at the review
workstation/PACS to confirm that films continue to be properly scanned and digitized.
Reporting System Interface
R2 DM systems can interface with PenRad, MRS, and MagView mammography
reporting systems. The R2 software retrieves patient information from the reporting
system 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
(see page
CAD Results Report (see page 50), and on the Reimbursement Barcode Report
22).
To link reporting system records to R2 Technology images, you use a keyboard or
barcode scanner to enter the R2 ID from the separator sheet that will be used when
the system scans the films.
Important! Be sure to enter the R2 ID into the reporting system before entering it on
the R2 film-scanning platform.
PeerView and PeerView Digital
PeerView™ and PeerView™ Digital are optional features that help radiologists better
understand why a region of interest was marked. PeerView and PeerView Digital
display a close-up, high-resolution section of the image and highlight physical
features found by the algorithm, facilitating the radiologist’s reassessment of the
mammograms.
• PeerView is licensed on CheckMate Ultra display units and Mammolux motorized
viewers. When licensed, PeerView asks the R2 DM system to send the additional
high-resolution CAD information to the display unit.
• PeerView Digital is licensed on the DM system. When licensed, PeerView Digital
creates extra CAD information in the Mammography CAD SR output, viewable on
some softcopy review workstations. It displays a close-up, high-resolution section
of the image, highlights physical features found by the algorithm, and produces
measurements of the physical features.
R2 DMax User Manual – PN MAN-00709 Rev 001 21
Part 2: Description
Other System Features
In addition to the licensed features, the R2 DM system includes the following
standard features:
•
Establish Patient Identification
•
Automatic Film Marker Identification
•
Reimbursement Barcode Report
These features are described further below.
Establish Patient Identification
Each case fed into the R2 film-scanning system must have its own separator sheet.
The R2 system uses the barcoded R2 ID on the separator sheet to associate the patient
films with the images in the system.
When processing a patient’s films, you write the R2 ID from the separator sheet on
the patient file. If using a mammography reporting system, you also enter the R2 ID
into the appropriate field in the patient’s reporting system record.
Important! It is a good idea to record the R2 ID on the outside of the patient film
jacket. In addition, it is critical that ImageChecker CAD users keep the separator sheet
with the films until after the radiologist has read the films and CAD results.
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 | R2,
Livingston Products, Siemens, Techno-Aide, or All-Craft Wellman. For the supported
marker types, see ‘
R2-Supported Lead Markers’ on page 30.
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. When using a mammography
reporting system, additional patient information can be listed with each report entry.
For an example printout, see ‘
Printing a Reimbursement Barcode Report’ on page 76.
22 R2 DMax User Manual – PN MAN-00709 Rev 001
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