Hologic Cenova R2 2.0 User manual

User Manual
MAN-01975 Rev 002
R2 Cenova™2.0
T
he Women’s Health Company.

R2 Cenova™2.0
User Manual
MAN-01975 Rev 002

ii R2 Cenova 2.0 User Manual – MAN-01975 Rev 002
Technical Support
For support in North America contact:
Toll Free: +1.866.243.2533 (+1.866.CHECKED)
Email: [e-mail]
Hours: Monday – Friday, 6:00 AM – 5:00 PM, PT (GMT –8:00)
Website: www.hologic.com
For support in Europe, South America, or Asia, contact your local dealer or distributor.
© 2010, Hologic Inc. All rights reserved. Duplication or distribution without written permission is
prohibited. Hologic reserves the right to revise this manual. Issued November 2010.
Protected by one or more of the following U.S. Patents: 5133020, 5452367, 5491627, 5537485,
5622171, 5657362, 5673332, 5729620, 5732697, 5740268, 5815591, 5828774, 5832103, 5917929,
6014452, 6035056, 6075879, 6078680, 6185320, 6198838, 6263092, 6266435, 6301378, 6404908,
6434262, 6477262, 6574357, 6580818, 6640001, 6628815, 6909795, 7054473, 7072498, 7146031,
7174515
Hologic, the Hologic logo, Cenova, ImageChecker, R2, SecurView, and Selenia are trademarks or
registered trademarks of Hologic in the USA and other countries.
Hologic Inc.
35 Crosby Drive
Bedford, MA 01730-1401 USA
Tel: [phone]
Sales: +1.781.999.7453
Fax: [phone]
Hologic N.V.
Authorized Representative
Leuvensesteenweg 250A
1800 Vilvoorde, Belgium
Tel: [phone]
Fax: [phone]
For more information about
Hologic products, services, and
facilities, visit www.Hologic.com.
MergeCOM-3 Advanced Integrator’s
Tool Kit is a product of Merge Healthcare.

R2 Cenova 2.0 User Manual – MAN-01975 Rev 002 iii
Contents
Part 1: Introduction....................................................... 1
1.1. Overview ........................................................... 1
1.2. Resources Available ................................................... 2
1.3. Warnings and Precautions .............................................. 3
System Operation ..................................................... 3
Installation and Maintenance ............................................ 4
Part 2: System Description ............................................... 5
2.1. Indications for Use .................................................... 5
2.2. System Inputs and Outputs ............................................. 5
Inputs to R2 Cenova ................................................... 5
Results from R2 Cenova ................................................ 5
2.3. R2 ImageChecker 3D Calc CAD ........................................... 6
2.4. Data Flow with ImageChecker 3D Calc CAD................................. 6
Part 3: System Operation ................................................. 7
3.1. General Usage ....................................................... 7
3.2. Sending Images to the Server ........................................... 8
3.3. Displaying Results .................................................... 9
3.4. Server Startup and Shutdown .......................................... 10
Shutting Down the Server .............................................. 10
Starting Up the Server ................................................. 11
Restarting the Server .................................................. 11
3.5. Using Case Manager.................................................. 12
Index .................................................................. 15

iv R2 Cenova 2.0 User Manual – MAN-01975 Rev 002

R2 Cenova 2.0 User Manual – MAN-01975 Rev 002 1
Part 1: Introduction
1.1. Overview
1.2. Resources Available
1.3. Warnings and Precautions
1.4. Product Complaints
1.1. Overview
This manual provides instructions for the operation and maintenance of the
R2 Cenova™ 2.0 server in the clinical environment. The server processes Digital Breast
Tomosynthesis (DBT) datasets using proprietary software algorithms.
R2 Cenova 2.0 software runs exclusively on the R2 Cenova T-Series server, which is a
high-performance computer capable of processing DBT datasets. The server supports
the following software application:
•R2 ImageChecker 3D Calc CAD 1.0, computer-aided detection software used to
identify and mark clusters of microcalcifications on breast tomosynthesis images.

Part 1: Introduction
2R2 Cenova 2.0 User Manual – MAN-01975 Rev 002
1.2. Resources Available
In addition to this manual, the following resources are available to assist you when
working with the R2 Cenova server.
•Hologic Training Center: This website provides quick access to manuals and
training materials for Hologic products and is available at no charge to our
customers under warranty or Hologic service contract. You can find the Hologic
Training Center by visiting the Hologic website (www.hologic.com/training-
center). See the R2U flyer that accompanies this product for more instructions.
•Training: The Hologic Training Center (see above) provides training materials for
R2 Cenova applications. The Hologic Applications team is available to train your
staff, should you feel they need additional training. To purchase additional
personalized instruction, contact your Hologic Account Manager.
•Manuals: The manuals for the R2 Cenova server and its applications are listed
below:
–Understanding R2 ImageChecker 3D Calc CAD
–R2 Cenova User Manual
–R2 Cenova Release Notes
You can obtain additional copies of printed manuals through your Hologic
Account Manager.
•Technical Support and Service: For support in North America contact:
Toll Free: +1.866.243.2533 (+1.866.CHECKED)
Email: [e-mail]
Hours: Monday – Friday, 6:00 AM – 5:00 PM, PT (GMT –8:00)
Website: www.hologic.com
For support in Europe, South America, or Asia, contact your local dealer or
distributor.

1.3. Warnings and Precautions
R2 Cenova 2.0 User Manual – MAN-01975 Rev 002 3
1.3. Warnings and Precautions
This manual uses the following conventions to provide technical and safety
information of special interest.
mWARNING!An instruction that, if not followed, can result in a hazardous condition.
mCAUTION:An instruction that, if not followed, can result in damage to the system.
mImportant: An instruction provided to ensure correct results and optimal
performance, or to clarify the limitations of the device.
mNote: Information provided to clarify a particular step or procedure.
Before using the R2 Cenova server, read the following warnings and precautions.
System Operation
mWARNING!Observe the following instructions, that if not followed, can result in a
hazardous condition:
•The system is intended for use only by personnel who have read this manual and
received training on how to use the system. Hologic does not accept responsibility for
injury or damage associated with improper or unsafe system operation.
•Use the system only outside the patient environment. The system is rated for use
only in an office environment.
•The symbol next to the power connector indicates a potential shock hazard. To reduce
the likelihood of electrical shock or fire hazard, connect the computer only to a power
receptacle that is grounded properly and provides voltage and current within the
specifications of the system.
•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. If
internal components are exposed to liquid, do not operate the device – contact your
service representative.
mCAUTION:Always shut down the computer according to the procedures provided in
this manual. Improper system shutdown can cause loss of data or damage to the
computer operating system.
mImportant: Observe the following instructions that are provided to ensure correct
results and optimal performance, or to clarify the limitations of the device.
•For proper system operation, the technical quality of the images (e.g., contrast) should
be acceptable to the mammographer and meet the requirements of the
Mammography Quality Standards Act (MQSA) or the appropriate national standards.
•The device design and mode of operation are consistent with current standard
mammography clinical practices, as governed by the MQSA. Users are advised to
comply with the MQSA for the United States, or the appropriate national standards,
when implementing R2 Cenova mammography applications in clinical protocols.
•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 the
user’s expense.
m
c
b

Part 1: Introduction
4R2 Cenova 2.0 User Manual – MAN-01975 Rev 002
Installation and Maintenance
mWARNING!Observe the following instructions, that if not followed, can result in a
hazardous condition:
•To connect primary power to the system, always use a three-conductor grounded
power cable that meets local regulatory standards. Use of a two-prong adapter
disconnects the utility ground and creates a severe shock hazard.
•Cenova servers are heavy! If you have concerns about lifting or positioning the server,
request assistance.
•Before cleaning the computer, always shut down the system according to the
procedures in this manual and disconnect the power cord to prevent electrical shock.
Never use alcohol, benzene, thinner, or other flammable cleaning agents.
mCAUTION:This product contains no user-serviceable parts. To prevent damage to the
system:
•Maintain equipment in a well-ventilated, air-conditioned environment that meets the
temperature and humidity specifications provided in the product service manual.
•Do not install or repair the R2 Cenova server. Only trained personnel, authorized by
Hologic, are qualified to install or repair the system.
•Disconnect power cord before moving or servicing.
•Install the system behind the institution firewall for network security and antivirus
protection. Network security and antivirus provisions are the responsibility of the user.
No computer virus protection or network security for the system is provided. If
antivirus software is required, visit the Hologic website for information on Hologic’s
cybersecurity program and validated antivirus products.
1.4. Product Complaints
Any healthcare professional who has complaints or is dissatisfied with the quality,
durability, reliability, safety, effectiveness, and/or performance of this product should
notify Hologic.
If there is reason to believe the device caused or contributed to a serious injury of a
patient, notify Hologic immediately by telephone, fax, or written correspondence.
c

R2 Cenova 2.0 User Manual – MAN-01975 Rev 002 5
Part 2: System Description
2.1. Indications for Use
2.2. System Inputs and Outputs
2.3. R2 ImageChecker 3D Calc CAD
2.4. Data Flow with ImageChecker 3D Calc CAD
2.1. Indications for Use
R2 Cenova is a high-performance application server that provides proprietary
software applications to assist radiologists in the analysis of digital mammography
images. The following software application is available for use with R2 Cenova 2.0:
•R2 ImageChecker 3D Calc CAD, computer-aided detection software used to
identify and mark clusters of microcalcifications on breast tomosynthesis images.
R2 Cenova is designed to be used by radiologists working in a hospital, outpatient
clinic, or a breast imaging center. The server also may be used for research-related
activities.
The server can be located in any non-patient environment, provided it is connected
to the mammography network. Once configured, little direct interaction with the
server is necessary. Any interaction is through a user-friendly web browser interface.
2.2. System Inputs and Outputs
This section provides a summary of image specifications and data formats passed
between R2 Cenova and other devices that may be installed at your site. For more
detailed information see the application manual, Understanding R2 ImageChecker 3D
Calc CAD.
Inputs to R2 Cenova
R2 Cenova 2.0 processes breast tomosynthesis datasets originating from the Hologic
Selenia Dimensions image acquisition system or sent from a PACS. The software
does not process some datasets, depending upon the application and mammography
view shown in the image. For each R2 Cenova server, you can purchase one
ImageChecker 3D Calc CAD license.
The diagram in section 2.4. Data Flow with ImageChecker 3D Calc CAD shows that
the server processes DICOM For Processing Projection images (also known as ‘raw’
images). The DICOM header for each image includes an identifier that indicates the
device from which the image originated.
Results from R2 Cenova
R2 Cenova sends its results to Hologic SecurView workstations in the form of a
Hologic Secondary Capture Image with proprietary content.

Part 2: System Description
6R2 Cenova 2.0 User Manual – MAN-01975 Rev 002
2.3. R2 ImageChecker 3D Calc CAD
The R2 Cenova server configured with ImageChecker 3D Calc CAD software
analyzes digital breast tomosynthesis datasets produced by the Selenia Dimensions
system. The proprietary ImageChecker 3D Calc CAD algorithm identifies regions of
interest that include clusters of bright spots (suggestive of calcification clusters). The
server generates results in the form of proprietary Hologic Secondary Capture Image
objects that include CAD marks and other data identifying and characterizing the
regions of interest. At the review workstation, the results are matched with the
tomosynthesis images produced by Selenia Dimensions.
After making an initial interpretation from the original diagnostic-quality images, the
radiologist displays the ImageChecker 3D Calc CAD results and chooses whether or
not to reinspect the marked regions on the original images. The ImageChecker 3D
Calc CAD algorithm marks visually perceptible structures that have some of the
generally accepted geometric characteristics of calcifications. 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 images.
For more information on ImageChecker features, refer to the manual Understanding
R2 ImageChecker 3D Calc CAD.
2.4. Data Flow with ImageChecker 3D Calc CAD
The diagram below shows the flow of images to the server and results from the server.
Data Flow with ImageChecker 3D Calc CAD

R2 Cenova 2.0 User Manual – MAN-01975 Rev 002 7
Part 3: System Operation
3.1. General Usage
3.2. Sending Images to the Server
3.3. Displaying Results
3.4. Server Startup and Shutdown
3.5. Using Case Manager
3.1. General Usage
Once configured, little direct interaction with the R2 Cenova server is necessary. Any
interaction with the server is through a web browser and a user-friendly interface.
Please note the following concerning the server’s functional design:
•The server accepts the images automatically as they are sent from the FFDM or
archiving device.
•For practical purposes, there is no limit to the number of images that can be
processed together in one study.
For ImageChecker 3D Calc CAD:
•If there is a processing error, the server typically includes a failure indication in the
results sent.
•For studies that include just the four screening views (LCC, RCC, LMLO, and
RMLO or their equivalents), you can send images in any order. The server reads
the information stored with each image in the DICOM header and processes the
image appropriately.
For more information, refer to Understanding R2 ImageChecker 3D Calc CAD.

Part 3: System Operation
8R2 Cenova 2.0 User Manual – MAN-01975 Rev 002
3.2. Sending Images to the Server
The R2 Cenova server groups successive images with the same DICOM study
instance UID (unique identifier) into a case if the images are received within a time-
out period configured by the service representative upon system installation. The
time-out period is not fixed; the server automatically adjusts the time-out period to
maximize throughput. (For more information, see the R2 Cenova Service Manual.)
Server Assigns Images Received Before Timeout Elapses to One Case
The server assigns any image received after the time-out period to a new case using
the same study instance UID. At the review workstation, two sets of results will be
seen, distinguishable by the date and time they were produced by the server.
Server Assigns Images Received After Timeout Elapses to a New Case
To reduce the possibility of multiple results, Hologic recommends that images for
each patient examination be sent from the acquisition device together at the close of
the study and in rapid succession.
mNote: As an alternative, the server can be configured to group all images with the
same study instance UID automatically into a single case, no matter when they were
received (i.e., include images from a previous case). For more information, consult with a
technical support representative.
The server can retain images for several thousand cases on its hard drive. (The exact
number depends on the number of views collected for each case and the size of the
hard drive.) When the hard drive fills up, the server deletes the oldest cases on a first-
in, first-out basis.
It is the service representative’s responsibility to set up your system such that the
images are sent correctly to the server in addition to the review workstation. For
more about the data flow among the various devices, see 2.2. System Inputs and
Outputs.

3.3. Displaying Results
R2 Cenova 2.0 User Manual – MAN-01975 Rev 002 9
3.3. Displaying Results
To view digital mammograms and results from the R2 Cenova server, follow the
guidelines of your workstation vendor. A common reading scenario is as follows:
1 Read the case at the review workstation using your normal protocol. Make an initial
interpretation.
2 Examine the images in detail and form a primary diagnosis.
3 Activate and view the CAD marks. Evaluate the ImageChecker data to determine
whether other regions warrant further review.
4 Make a final assessment and create a report.

Part 3: System Operation
10 R2 Cenova 2.0 User Manual – MAN-01975 Rev 002
3.4. Server Startup and Shutdown
The R2 Cenova server does not require regular maintenance. The only procedures
you might need to perform are:
•Starting up the server
•Shutting down the server
•Restarting the server (turning off and on again)
For these procedures, you need to know the IP address for the computer. Ask your IT
administrator for the R2 Cenova server IP address. Write that number here:
R2 Cenova Server IP Address: _________________________
Shutting Down the Server
You might need to shut down the R2 Cenova server if you are going to move the
computer, or if you know the power is going out for a period of time.
mImportant! If you shut down the server from a remote location, be aware that In
order to switch the server back on, you will need to have physical access to the server.
To shut down the server:
1 Using a computer that is on the same network as the server, open a web browser (e.g.,
Internet Explorer).
2 Type the IP address for the server in the address box and press [Enter]. You do not
need to type ‘http’ or anything other than the IP address.
3 At the log-in screen, enter the user name (‘siteadmin’) and password. The ‘About’
screen should appear as shown below.

3.4. Server Startup and Shutdown
R2 Cenova 2.0 User Manual – MAN-01975 Rev 002 11
4 Click ‘System Control’ to display the following screen:
5 Click the Shutdown button. The server prompts ‘Are you sure…’. Click the
Shutdown button once more to switch the server off.
Starting Up the Server
If the server has been powered off, you can switch it back on by pressing the power
switch on the front of the computer. (An indicator light indicates whether the server
is on or off.) The R2 Cenova software starts up automatically, and the server should
be ready for use within 3–5 minutes.
Restarting the Server
You might need to restart the R2 Cenova server if results are not transferring. Often,
restarting the server clears any errors. In some cases, your service representative will
ask you to restart the server.
To restart the server:
1 Using a computer that is on the same network as the R2 Cenova server, open a web
browser.
2 Type the IP address for the R2 Cenova server in the address box and press [Enter].
You do not need to type ‘http’ or anything other than the IP address.
3 At the log-in screen, enter the user name (‘Administrator’) and password. The
‘About’ screen should appear as shown in the previous procedure.
4 On the ‘About’ screen, click ‘System Control’.
5 From the System Control screen, click ‘Restart’. The server prompts ‘Are you sure…’.
Click the Restart button once more. The server should shut down and then restart
automatically. The server should be ready for use within about 5 minutes.
mNote: To continue using the server, you will need to refresh the browser by repeating
steps 1–3.

Part 3: System Operation
12 R2 Cenova 2.0 User Manual – MAN-01975 Rev 002
3.5. Using Case Manager
Case Manager allows you to display, analyze, and troubleshoot cases from within the
Cenova Control Panel. You can use Case Manager to:
•Browse and sort cases
•Search for data such as patient information, date processed, etc.
•Delete cases
•View DICOM information for any image
When you select the Case Manager option from the Cenova control panel, a screen
similar to the following appears:
By default, the cases appear in reverse chronological order (newest first). The records
are arranged in rows and columns. Each row shows one case. The column titles
correspond to image DICOM header fields.
Click Hide Navigation Panel to expand the Case Manager viewing window.

3.5. Using Case Manager
R2 Cenova 2.0 User Manual – MAN-01975 Rev 002 13
To browse and sort cases:
You can sort the values in any column by clicking any of the column headings
(Patient Name, Patient ID, etc.). The server sorts the values in ascending order either
alpha-numerically or by date and time, depending upon the type of data to be sorted.
Click the column heading again to sort in descending order.
To search for data:
In any of the column heading boxes, enter text or numbers you want to find and press
[Enter]. The server searches its database and returns only values containing the
characters you typed.
To remove the filter, click NoFilter in the drop-down list:
For some columns, you can exclude a search criterion by using the ‘Not’ box:
To clear selected search criteria, click Clear Filters.
To delete cases:
Click on the case you want to delete and then click Delete.

Part 3: System Operation
14 R2 Cenova 2.0 User Manual – MAN-01975 Rev 002
To review DICOM information for an image:
Click to expand the case and review the Images and Output Jobs details:
Click to view additional details for each image.