Hologic Cenova C Series Manual

Cenova
™
Image Analytics Server
Installation and Service Manual
For Software Version 3.0
Part Number MAN-05205
Revision 003
September 2019

© 2017-2019 Hologic, Inc. Printed in the USA. This manual was originally written in English.
Hologic, Cenova, ImageChecker, Quantra, DigitalNow, and associated logos are trademarks and/or registered trademarks of
Hologic, Inc., and/or its subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks,
and product names are the property of their respective owners.
This product may be protected by one or more U.S. or foreign patents as identified at www.Hologic.com/patents.
Product Support
USA: +1.877.371.4372
Europe: [phone]
Asia: [phone]
Australia: [phone]
All Other: [phone]
Email: [e-mail]

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What's New
The Cenova™ Image Analytics Server processes digital mammography images using
proprietary software algorithms.
The software applications available for the Cenova server are:
• ImageChecker®CAD (2D and synthesized 2D)
• ImageChecker®3D Calc CAD
• Quantra™ application
• DigitalNow™ HD
Certain applications may not be approved for use within the United States.1Each
application requires a valid software license. Instructions for installing and configuring
the software can be found in this manual.
Upgrade kits are available that allow any qualified Cenova server to be updated with
the current Cenova software. Customers can be upgraded as long as:
• Their system is covered by a Hologic warranty or service agreement. Certain
restrictions apply.
• Their server hardware meets the minimum requirements. Only Windows 7 is
supported. Kits to upgrade Windows XP hardware to Windows 7 are available.
Important
Ensure the minimum hardware requirements to run Windows 7 are met (refer
to the Cenova™ Image Analytics Server System Requirements).
• Their diagnostic review workstations can render the Cenova output.
Customers are eligible for free Cenova application upgrades as long as the above
requirements are met. Upgrades can also be purchased separately.
The Cenova T-Series server is required to run ImageChecker 3D Calc CAD.
1Check with your Hologic Product Specialist to find out which applications are available in the US.

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Cenova Image Analytics Server 3.0 Installation & Service Manual
Table of Contents
MAN-05205 Revision 003 vii
Table of Contents
1: Introduction __________________________________________________________________1
1.1 Using This Manual..................................................................................................................................................2
1.2 Service Policies and Procedures............................................................................................................................3
1.3 Warnings and Precautions..................................................................................................................................... 4
1.3.1 General Precautions .................................................................................................................................5
1.3.2 Electrical Safety......................................................................................................................................... 5
1.3.3 Electromagnetic Emissions......................................................................................................................7
1.4Warranty Statement................................................................................................................................................ 8
2: System Description____________________________________________________________9
2.1 Overview................................................................................................................................................................10
2.2 System Inputs and Outputs................................................................................................................................. 11
2.2.1Inputs to the Cenova Server..................................................................................................................11
2.2.2 Results from the Cenova Server ........................................................................................................... 12
2.3 Clinical Workflow................................................................................................................................................. 14
2.4 Data Flows ............................................................................................................................................................. 15
2.4.1 Data Flow with ImageChecker CAD (2D) and Biomarkers.............................................................. 15
2.4.2 Data Flow with ImageChecker CAD (2D) for Synthesized 2D and Biomarkers ...........................16
2.4.3 Data Flow with ImageChecker 3D Calc CAD .................................................................................... 17
2.4.4 Data Flow with DigitalNow HD .......................................................................................................... 18
2.5 System Components .............................................................................................................................................19
2.6 Control Panel Overview ......................................................................................................................................20
2.6.1 Status Indicators .....................................................................................................................................21
3: Installing the System _________________________________________________________23
3.1 Installing the Server Hardware........................................................................................................................... 24
3.1.1 Required Tools and Materials............................................................................................................... 24
3.1.2 Unpacking the System ........................................................................................................................... 25
3.1.3 Setting Up the New Server Hardware................................................................................................. 26
3.2 Entering the Server Network Identifiers ...........................................................................................................27
3.3 Installing the Server Software ............................................................................................................................. 28
3.4 Configuring the System Settings ........................................................................................................................ 29
3.4.1 Starting Up the Cenova Control Panel ................................................................................................ 30
3.4.2 Entering the Connectivity Settings....................................................................................................... 32
3.4.3 Configuring DICOM Destination and Source Devices ..................................................................... 34
3.4.4 Configuring Licensing ...........................................................................................................................44
3.4.5 Verifying License Settings .....................................................................................................................49
3.4.6 Configuring Algorithm Processing Options.......................................................................................51
3.4.7 Configuring Processing – DigitalNow HD ......................................................................................... 61
3.4.8 Configuring the Hologic Connect Service...........................................................................................65
3.5 Configuring the Site’s Workstations and PACS Devices................................................................................. 69

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3.6 Completing the Installation .................................................................................................................................69
4: Administrative Functions _____________________________________________________71
4.1 Shutting Down and Restarting the System .......................................................................................................72
4.2 Starting and Stopping DICOM and Processing Services.................................................................................75
4.3 Backing Up and Restoring the Server Settings .................................................................................................77
4.4 Configuring a Redundant Server........................................................................................................................79
4.5 Managing Disk Space ...........................................................................................................................................80
4.6 Updating the Licenses ..........................................................................................................................................81
4.7 Running the Self Test............................................................................................................................................81
4.8 Configuring Access Control ................................................................................................................................84
4.9 Using Case Manager.............................................................................................................................................85
4.9.1 Case Manager Options...........................................................................................................................88
5: Service Procedures ___________________________________________________________91
5.1 Maintaining the Server.........................................................................................................................................92
5.2 Reinstalling the Server Application....................................................................................................................94
5.3 Recovering a Server ..............................................................................................................................................96
5.4 Replacing the Computer ......................................................................................................................................99
6: Troubleshooting Procedures__________________________________________________101
6.1Sending and Receiving Results .........................................................................................................................102
6.2 Reviewing License Dongle Messages...............................................................................................................106
6.3 Reviewing Log Files............................................................................................................................................107
6.4 DICOM Troubleshooting ...................................................................................................................................108
6.5 Printer Troubleshooting.....................................................................................................................................109
7: Configuration Procedures ____________________________________________________111
7.1 Configuring the Laptop IP Settings..................................................................................................................112
7.2 Configuring an HTTPS Port ..............................................................................................................................113
7.2.1 Assigning a Security Certificate..........................................................................................................113
7.2.2 Adding an HTTPS Port ........................................................................................................................113
7.3 Configuring a Printer .........................................................................................................................................114
7.4 Adding a Cenova Server to a Domain .............................................................................................................116
7.5 Bypassing the Proxy Server for Local Addresses ...........................................................................................117
7.6 Safety and Regulatory Standards .....................................................................................................................117
Index ________________________________________________________________________119

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Chapter 1: Introduction
MAN-05205 Revision 003 Page 1
1: Introduction
Using This Manual on page 2
Service Policies and Procedures on page 3
Warnings and Precautions on page 4
Warranty Statement on page 8
This manual provides installation, configuration, maintenance, and troubleshooting
procedures for Hologic’s Cenova Image Analytics Server.
The Cenova Image Analytics Server is a high-performance application server that
provides proprietary software applications to assist radiologists in the analysis of digital
mammography images.
DICOM Conventions
DICOM (Digital Imaging and Communications in Medicine) is an international
standard used for developing, transmitting, printing, and archiving medical
imaging information. Hologic uses the following DICOM standard designations for
digital mammography images:
•DICOM Digital Mammography X-Ray Image – For Processing
•DICOM Digital Mammography X-Ray Image – For Presentation
•DICOM Secondary Capture Image – Raw Projection
•DICOM Secondary Capture Image –Raw Synthesized 2D
To simplify, this manual shortens these designations to ‘For Processing images’,
‘For Presentation images’, ‘Raw Projection images’, and ‘Raw Synthesized 2D
images.’
Chapter 1

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1.1 Using This Manual
This service manual is written for use solely by Field Engineers from Hologic and
Hologic’s service partners. Only individuals trained and certified by Hologic to repair,
maintain, and install Hologic products are qualified to perform the procedures described
in this manual.
Before servicing the system, be sure to observe all safety precautions provided (see
Warnings and Precautions on page 4). Read this manual carefully to streamline the on-site
visit. Consult with clinic personnel to determine whether procedures given in the
operator’s manual have been followed correctly.
Be sure to read and understand each procedure before you perform it. If a problem
occurs or something is unclear during the visit, first refer to this manual. If you have
questions about a procedure or there is something you do not understand, contact the
Hologic Technical Assistance Center (TAC).
This manual is organized as follows:
• Introduction on page 1 describes the purpose of the manual and how it is organized,
general service policies, and warnings and precautions.
• System Description on page 9 describes the principal components and provides
background information on the system.
• Installing the System on page 23 provides instructions for setting up and configuring
the computer, configuring DICOM devices, and verifying the installation.
• Administrative Functions on page 71 provides administrative procedures for the server
such as backing up configuration settings, working with site licenses, and running
the Self Test.
• Service Procedures on page 91 provides procedures for reinstalling the software and
replacing the computer.
• Troubleshooting Procedures on page 101 provides instructions for diagnosing and
solving common problems.
• Configuration Procedures on page 111 provides server configuration procedures.
For further information concerning the Cenova server, see:
• Cenova Image Analytics Server User Guide
• Cenova Image Analytics Server Release Notes
• Cenova Image Analytics Server DICOM Conformance Statement
• Cenova Image Analytics Server Cybersecurity Product Report
• Cenova Image Analytics Server System Requirements
• Cenova Image Analytics Server Quick Installation Guide
• Cenova Upgrade to 3.0 FMI

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1.2 Service Policies and Procedures
This section summarizes Hologic’s service policies.
Understanding the Field Engineer’s Role
Your primary role as a Field Engineer is to install and configure the system, and address
system problems when the customer requires on-site support.
On-site support is usually required when the problem cannot be resolved by operator
intervention and when a TAC representative cannot resolve the problem remotely.
When performing an on-site service call, you may contact a Hologic service
representative at any time for assistance.
On-Site Service Protocol
Field Engineers work closely with Hologic’s TAC representatives, who can gain access to
the systems directly from the factory by way of the system Hologic Connect™
connection. In this way, they can recognize and diagnose complicated software or faulty
hardware components, and direct you, the local Field Engineer, in the best course of
action to repair the system.
Understanding Service Call Handling and Escalation
The TAC representative who receives the incoming service call at Hologic determines the
severity of the problem. If the problem cannot be resolved immediately through simple
operator intervention, the following steps take place:
1. The TAC representative analyzes the problem using the Hologic Connect service. If
the problem can be resolved remotely, the TAC representative does so at that time.
2. If the TAC representative cannot resolve the problem from the factory, a local Field
Engineer is dispatched to contact the site.
3. The TAC representative may interact with the Field Engineer to resolve the problem,
which may require recommending that the Field Engineer order replacement parts.
The TAC representative can recommend which parts to replace and provide part
numbers to the Field Engineer.
4. If the TAC representative in consultation with Service Engineering is not able to
resolve the problem, the problem is escalated to Engineering.
5. The local Field Engineer completes related online service documentation.

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Before You Leave the Site
Before you leave the site, verify that the system is running correctly by running the
verification procedures (see Completing the Installation on page 69).
Complete the online Installation Report on the Hologic intranet site.
Communicate any issues. If you cannot verify that the system is running correctly,
contact the TAC at [email protected]. In your e-mail, briefly describe the issue
and provide the clinic name and location (city, state, zip).
1.3 Warnings and Precautions
This manual uses the following conventions to provide technical and safety information
of special interest.
WARNING!
An instruction that, if not followed, can result in a hazardous
condition.
Caution:
An instruction that, if not followed, can result in damage to the system.
Important
An instruction provided to ensure correct results and optimal performance,
or to clarify limitations of the device.
Note
Information provided to clarify a particular step or procedure.

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1.3.1 General Precautions
Important:
Before working with the system, be sure to read and understand the following
precautions:
•Intended use. Review this manual thoroughly prior to servicing the equipment.
Do not use the instrument in a way other than specified in this manual. Failure
to do so may cause injury or equipment damage.
•Training and certification. Only individuals trained and certified by Hologic to
repair, maintain, and install Hologic products are qualified to perform the
procedures described in this manual.
•Shutdown. Always shut the computer down according to the shutdown
procedures recommended in this manual. Failure to shut the system down
properly can cause loss of data or damage to the computer operating system,
injury, or death. Always use the shutdown procedures before you:
•Disassemble any components.
•Remove a cover.
•Disconnect or reconnect any cable.
•Clean any component.
•Environment. Operate and store the computer in an environment that meets
the Environmental Specifications for the system. Failure to do so may cause
system malfunction or damage.
1.3.2 Electrical Safety
WARNING!
Observe the following instructions that, if not followed, can result in a hazardous
condition.
•Liquids. Liquid spills and splashes can cause damage to the system
components. Turn off the system, including any attached peripherals.
Disconnect the system from the electrical outlet. Wipe up all spills immediately.
Do not operate the system if internal components have been exposed to liquid.
•Electrical grounding. 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. Always connect each
grounding type (3-core) power cord directly to a three-prong receptacle with a
functional ground.

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•Power rating. Be sure the system is connected to a power receptacle that
provides voltage and current within the specified rating. Use of an
incompatible power receptacle can produce electrical shock and fire hazards.
•Cables. Before connecting or disconnecting cables, always shut down the
system according to the shutdown procedures in this manual and disconnect
the power cord.
•When connecting a cable, be sure to insert each connector securely. Insert
the power cord securely into the AC outlet. Do not touch the exposed metal
prongs of the plug to metal surfaces.
•When disconnecting a cable, always grasp the plug or connector, not the
cord.
•Do not place anything heavy on the cables, step on them, pull them, bend
them or bundle them. Never cut or attempt to modify the cables.
•Internal voltages. Do not disassemble or modify the computer unless you are
authorized to do so by Hologic. The components incorporate parts that can
cause electrical shock as well as other hazardous parts that if touched, can cause
death or serious injury.
•Covers. Only trained personnel should remove computer covers and work with
internal components. Before removing any cover, always:
•Remove watches and jewelry.
•Shut down the system according to the shutdown procedures in this
manual.
•Disconnect the power cord.
•Electrostatic discharge. A wrist grounding strap is recommended when
servicing the system. If a wrist grounding strap is not available, touch an
unpainted metal surface on the back of the computer or on the computer
chassis.

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1.3.3 Electromagnetic Emissions
Important
Observe the following instructions provided to ensure correct results and optimal
performance:
•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 and can radiate radio frequency energy and, if not installed in
accordance with the procedures in this 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 own expense.
•This equipment can be affected by electromagnetic emissions coming from
nearby equipment, which in some cases, can cause the equipment to
malfunction. The equipment has been tested to the limits of International
Electrotechnical Commission (IEC) standard CISPR 22:1997. (‘CISPR’ is the
International Special Committee on Radio Interference.)
Important
Do not install the Cenova server in a room with magnetic resonance imaging (MRI)
equipment. The emissions from an MRI room can interfere with proper operation.

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1.4 Warranty Statement
Except as otherwise expressly stated in the Agreement: i) Equipment manufactured by
Hologic is warranted to the original Customer to perform substantially in accordance
with published product specifications for one (1) year starting from the date of shipment,
or if Installation is required, from the date of Installation (“Warranty Period”); ii) digital
imaging mammography x-ray tubes are warranted for twenty-four (24) months, during
which the x-ray tubes are fully warranted for the first twelve (12) months and are
warranted on a straight-line prorated basis during months 13-24; iii) replacement parts
and remanufactured items are warranted for the remainder of the Warranty Period or
ninety (90) days from shipment, whichever is longer; iv) consumable Supplies are
warranted to conform to published specifications for a period ending on the expiration
date shown on their respective packages; v) licensed Software is warranted to operate in
accordance with published specifications; vi) Services are warranted to be supplied in a
workman-like manner; vii) non-Hologic Manufactured Equipment is warranted through
its manufacturer and such manufacturer’s warranties shall extend to Hologic’s
customers, to the extent permitted by the manufacturer of such non-Hologic
Manufactured Equipment. Hologic does not warrant that use of Products will be
uninterrupted or error-free, or that Products will operate with non-Hologic authorized
third-party products. These warranties do not apply to any item that is: (a) repaired,
moved, or altered other than by Hologic authorized service personnel; (b) subjected to
physical (including thermal or electrical) abuse, stress, or misuse; (c) stored, maintained,
or operated in any manner inconsistent with applicable Hologic specifications or
instructions, including Customer’s refusal to allow Hologic recommended Software
upgrades; or (d) designated as supplied subject to a non-Hologic warranty or on a pre-
release or “as-is” basis.

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Chapter 2: System Description
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2: System Description
Overview on page 10
System Inputs and Outputs on page 11
Clinical Workflow on page 14
Data Flows on page 15
System Components on page 19
Control Panel Overview on page 20
This chapter provides an overview of the Cenova server including its components and
web-based user interface.
Chapter 2

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2.1 Overview
The Cenova Image Analytics Server is a high-performance application server that
provides proprietary software applications to assist radiologists in the analysis of digital
mammography images. Hologic has developed the following software applications for
use with the server:
• ImageChecker CAD (2D), computer-aided detection software used to identify and
mark regions of interest on routine screening and diagnostic mammograms, and
synthesized 2D images from Hologic 3D MammographyTM systems.
• ImageChecker 3D Calc CAD, computer-aided detection software used to identify
and mark regions of interest on Hologic 3D MammographyTM datasets.
• Hologic Imaging Biomarkers, comprising the following application:
• Quantra application, to calculate breast density categories from Hologic
conventional digital mammography and 3D MammographyTM images.
• DigitalNow HD, used to process digitized screen-film mammograms so that the
resulting images more closely resemble digital mammography images.
The Cenova server is designed to be used by radiologists working in a hospital,
outpatient clinic, or a breast imaging center. The server may also 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.

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2.2 System Inputs and Outputs
2.2.1 Inputs to the Cenova Server
Cenova software processes mammography images that conform to the DICOM standard.
Some DICOM images are not processed by the software, depending upon the application
and mammography view shown in the image.
The server supports inputs from:
• Full Field Digital Mammography Systems: The Cenova server processes two-
dimensional digital mammography images originating from up to four Full Field
Digital Mammography (FFDM) image acquisition systems. Each FFDM device maps
to an input port on the server. The Cenova server supports inputs from FFDM
devices manufactured by Hologic, Inc. (Danbury, CT), GE Healthcare (Waukesha,
WI), and Siemens AG (Munich, Germany). Certain in-country restrictions may apply.
Note
Quantra 2.2 software supports only Hologic FFDMs. Mixed environments of
Hologic and non-Hologic FFDMs using the same Cenova server need a new
Cenova 3.0 server for Quantra 2.2 software, and all necessary licenses for
Hologic FFDMs need to be migrated to the Cenova 3.0 server. Customers can
also choose to leave the non-Hologic FFDMs and licenses on the existing
Cenova server.
• Hologic 3D MammographyTM Image Acquisition Systems: The Cenova server
processes 3D MammographyTM datasets (Raw Projection images) originating from
one or two Hologic FFDM systems. The server processes Raw Synthesized 2D images
originating from up to four Hologic FFDM systems. Each Hologic FFDM device
maps to an input port on the server. Certain in-country restrictions may apply.
• Film Digitizing Systems: For film mammograms, the Cenova server processes
DigitalNow images originating from any of Hologic’s film-scanning systems.
For each Cenova server, sites can purchase:
• Up to four licenses for any or all of the 2D software applications, for the Quantra
application on 3D images, plus a single license for DigitalNow HD, or
• Up to two licenses for ImageChecker 3D Calc CAD, or
• A single license for DigitalNow HD
Note that exceeding these guidelines with a single server can affect system response
times. For specific information about licensing bundles, contact your Hologic Account
Manager.
The diagrams in Data Flows on page 15 show that the server processes four types of
images.

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• Images sent by an FFDM following a conventional mammography examination are
known as For Processing images (also known as ‘raw’ images).
• Hologic 3D MammographyTM images sent by a Hologic FFDM system are known as
Raw Projection images.
• Synthesized 2D images sent by a Hologic FFDM system are known as Raw
Synthesized 2D images.
• Images sent by any of the Hologic film-scanning systems are DigitalNow For
Presentation images.
The DICOM header for each image includes an identifier that indicates the device from
which the image originated.
In addition, images from an FFDM or Hologic film-scanner can be sent to the Cenova
server from a Picture Archiving and Communication System (PACS).
2.2.2 Results from the Cenova Server
The Cenova server sends its results to diagnostic review workstations (such as Hologic
SecurView®DX) and PACS devices. Depending upon the application, the server can
transmit results in one or more forms. The table below shows output formats for each
application.
Application
CAD SR
SC Image
RTSS
Printer
MG Image
ImageChecker
CAD (2D)
   
ImageChecker 3D
Calc CAD

Hologic Imaging
Biomarkers
 
DigitalNow HD

• CAD SR – The Mammography CAD SR format is the DICOM standard used for
ImageChecker CAD (2D) and/or Hologic Imaging Biomarkers results.
• SC Image – Mammography CAD SC (Secondary Capture) provides the case-
processed views (normally the four screening views) with ImageChecker CAD (2D),
an image containing Biomarker results, or proprietary ImageChecker 3D Calc CAD
results. For ImageChecker CAD (2D) and Hologic Imaging Biomarkers, this format is
for workstations that do not support Mammography CAD SR.
• RTSS – The Radiotherapy Structure Set format was developed specifically to display
ImageChecker CAD (2D) results on certain GE review workstations.
• Printer– This format provides ImageChecker CAD (2D) results for the case-processed
views (normally the four screening views).
• MG Image – This format (DICOM Digital Mammography X-Ray Image – For
Presentation) provides DigitalNow HD images.