Cenova™ Image Analytics Server 2.4
Contents
1. e For Processing images to Cenova 7 which processes the images and distributes the CAD results according to its configuration and or e ImageChecker CAD results and or For Presentation images to the review workstations 8 8 Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 2 3 Data Flows 3 For Presentation Images 8 For Presentation Images Mammography CAD SR Objects or CAD SC Images y 2 For Presentation Images For Processing Images PA ane j SecurView DX i or other diagnostic 7 For Processing Images 5 Mammography workstations ifarchived CAD SR Objects or I CAD SC Images E 4 Mammography Y CAD SR Objects or Image Acquisition CAD SC Images System s 1 For Processing Images 6 Images with CAD Results Note Elements shown in italic type and or dashed lines are optional Cenova Printer ImageChecker CAD Data Flow Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 9 Chapter 2 System Description 2 3 2 ImageChecker CAD with DICOM 6000 Data Flow Typically diagnostic review workstations and PACS devices support the Mammography CAD SR results format If the review workstation or PACS does not support Mammography CAD SR but does support DICOM 6000 overlays a supplementary interface solution can be installed F2. 7 review workstations 14 in system data flow 8 12 S screening views 7 SecurView diagnostic review workstation 7 8 11 12 shutting down the server 15 16 Siemens AG 5 starting up the server 16 support technical ii T training 2 U Unique Device Identifier 13 17 W warnings Cenova 3 4 Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 21 Index 22 Cenova M Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 At Hologic we turn passion into action and action into change Hologic is defining the standard of care in women s health Our technologies help doctors see better Know sooner reach further and touch more lives BREAST IMAGING SOLUTIONS e INTERVENTIONAL BREAST SOLUTIONS e BONE HEALTH PRENATAL HEALTH e GYNECOLOGIC HEALTH e MOLECULAR DIAGNOSTICS HOLOGIC www hologic com info hologic com 1 781 999 7300 North America Latin America Europe Asia Pacific Australia New Zealand 35 Crosby Drive Everest Cross Point 7th Floor Biotech Centre 2 Suite 402 Level 4 Bedford MA 01730 1401 Leuvensesteenweg 250A No 11 Science Park West Avenue 2 Lyon Park Road USA 1800 Vilvoorde Hong Kong Science Park Macquarie Park NSW 2113 all Belgium Shatin New Territories Australia Hong Kong
3. Using This Manual 1 3 Resources Available v v v y 1 4 Server Warnings and Precautions 1 1 Overview This manual provides instructions for operating and maintaining the Cenova Image Analytics Server in the clinical environment The server processes mammography images using proprietary software algorithms The Cenova server is a high performance application server that provides proprietary software applications to assist radiologists in the analysis of digital mammography images 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 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 e DICOM Digital Mammography X Ray Image For Processing e DICOM Digital Mammography X Ray Image For Presentation e DICOM Secondary Capture Image Raw C View To simplify this manual shortens these designations to For Processing images For Prese
4. which processes the images and distributes the Biomarker results according to its configuration and or Biomarker results and or For Presentation images to the review workstations 7 1 For Presentation Images 2 For Processing Images Image Acquisition System s Note Elements shown in italic type and or dashed lines are optional 3 For Presentation Images For Processing Images if archived 4 DICOM SR Objects and or DICOM SC Images SecurView DX or other diagnostic workstations DICOM SR Objects 5 116 For Processing A and or DICOM SC Images Images if archived Y PACS 7 For Presentation Images DICOM SR Objecis and or DICOM SC Images Hologic Imaging Biomarkers Data Flow Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 11 Chapter 2 System Description 2 3 4 DigitalNow HD Data Flow The figure below shows the data flows among the various devices Source Image Device 1 The Hologic film scanning system sends DigitalNow For Presentation images to the Cenova server Cenova Server 2 The Cenova server processes the images and sends new DigitalNow HD For Presentation images to a PACS device 3 As an option the server can also send the images directly to one or more diagnostic review workstation s Diagnostic Review Workstation s and PACS 4 The PACS is configu
5. 32 2 725 2087 For more information about Hologic products and services visit www Hologic com MergeCOM 3 Advanced Integrator s Tool Kit is a product of Merge Healthcare ii Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 Contents Chapter 1 Introduccion a Y Y FF Fd 1 Teter COVeINIGWAc Gi eu dol bw FYD yd Y Y Yy WN y Yy MR yd 1 dds Using This Manual un iu FU TI I GI DU DG DC GA i 2 423 ResourcessAvailabl amp ue Gyn If Y ga vi odes den Fyd ddd a FRO id saivagast diag N 2 TA Server Warnings and PrecautiOniSii enu issue GW be WY FFY anneddu Wy ddy GWY Nyd nyny Fer 3 LER System OperdtiOn iie ss vedetia ss esa seeded GRUD na FC YG FN UO Saeed ed GAY DG UWD Fd ean teen antennae 3 14 2 lnstallation and Maintenanc amp i iei ne ua dyt Ui a LU yy GUY df 4 Chapter 2 System Description ississsssscsesssesscesssosusseserasesevanesssesososevasavavanevevasesvevaosonnuiaass 5 P EA tO CENOVa E Ge re E T E E E AE aries 5 2 11 INPUL DEVICES ss teri cee actin YF a E ESAE YDI GU YG YG AUD TY 5 22 lmaseTPormat5 en ey eT YG Ed YY NF NN y te E dd dnd Yd GAF E FYNWY Bagednsgegedeet 6 2 1 3 Input Ports and Application Licenses cceecceeseeseeeneeseceessecssecsseceseceseceseceeeeseeseneeeneesaes 6 2 2 Results romrGCenovauic ee wie Ed Cf FFY YC FO y nantes 7 2 35 DatasFlOWS lt cun ed Manne seeds cosh Bald utils DIFF AW DYFI YW FT DN Ea 8 2 3 1 lmageChecker CAD Data FIOW cee ceeccseeeeseeeeeeee
6. 1 View Patient ID 10100191 View Modifier Study Date 20060508 State PROCESSED Algorithm MAMMO Start Time 1 31 2009 12 45 47 AM Case Result SUCCESS End Time 1431 2008 12 46 11 AM AlgoName Result Masses SUCCESS Calcifications SUCCESS Volumetric Assessment SUCCESS ImageDetails aspx id 90 20 Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 Index A acguisition workstations 10 antivirus products 4 C Case Manager 18 20 Cenova server configuration 14 in system data flow 8 12 restarting 16 sending results to DICOM 6000 interface 10 shutdown 15 16 startup 16 system operation 13 20 usage guidelines 13 customer support resources 2 C View 1 6 cybersecurity 4 D data flows 8 12 DICOM 1 image classes 8 11 DICOM 6000 interface 7 in system data flow 10 DigitalNow HD 7 clinical workflow 13 F FFDM systems in system data flow 10 11 models supported 5 G GE Healthcare 5 H Hologic film scanning systems 5 Selenia systems 5 Hologic Imaging Biomarkers 7 13 ImageChecker CAD 7 clinical workflow 13 with DICOM 6000 10 inputs to Cenova 5 6 M Mammography CAD SC 7 8 Mammography CAD SR 7 8 P PACS 5 7 11 12 in system data flow 8 12 ports input 6 precautions Cenova 3 4 printer 7 printout 8 Q Quantra 11 R resources 2 restarting the server 16 results displaying 13 results Cenova archiving 5 formats 7 printed
7. AU DigitalNowHD DigitalNowHD DigitalNowHD MAMMO To clear selected search criteria click Clear Filters To export Biomarker results Export Biomarkers Note Biomarker results are not available for cases that contain only C View 2D images e g TomoHD You can collect Biomarker results and export the results to a csv file which can be opened using a spreadsheet application To use this feature the server must be configured with a valid Hologic Imaging Biomarkers license Select one or more cases using the Case Manager search function If you do not select any cases then the server will export all Biomarker results Click Export Biomarkers to display the File Download window Click Save In the Save As window navigate to the location where you wish to save the file and click Save gt To delete cases Delete Display the case you want to delete and click the checkbox next to the case Then click Delete Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 19 Chapter 3 System Operation gt To review details for a study Click 4 to expand the case and review the Images and Output Jobs details 87800006 PROCESSED SUCCESS State PROCESSED View Modifier Case Processing PROCESSED PROCESSED PROCESSED Destination DVT_STORE2 Click to view additional details for each image Case Image Case ID 26 Image ID Patient Name 1010019
8. BREAST IMAGING SOLUTIONS ill it nU o o 9 o z5 Cenova Image Analytics Server User Guide Software Version 2 4 MAN 03998 Rev 001 Cenova HOLOGIC i The Women s Health Company Image Analytics Servers Cenovar Image Analytics Server Cenova M Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 HOLOGIC The Women s Health Company Technical Support In North America contact Toll Free 1 866 243 2533 41 866 CHECKED Email _ sctechsupport amp hologic com Hours Monday Friday 6 00 AM 5 00 PM PT GMT 8 00 Website www hologic com In Europe South America or Asia contact your local dealer or distributor O 2014 Hologic Inc All rights reserved Duplication or distribution without written permission is prohibited Hologic reserves the right to revise this manual Issued June 2014 Patents http hologic com patents Hologic the Hologic logo Cenova C View DigitalNow Dimensions ELC ImageChecker Ouantra SecurView and Selenia are trademarks or registered trademarks of Hologic 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 Hologic Inc Hologic N V 35 Crosby Drive EU Representative Bedford MA 01730 1401 USA Leuvensesteenweg 250A Tel 1 781 999 7300 1800 Vilvoorde Belgium Sales 1 781 999 7453 Tel 432 2 711 4680 Fax 1 781 280 0668 Fax
9. Data Flow The diagram below shows how information typically flows through systems with ImageChecker CAD A Note ImageChecker CAD also applies to C View 2D images Raw C View images are sent to the Cenova server Corresponding Breast Tomosynthesis Image or For Presentation images are sent to the diagnostic review workstation s and PACS A Note When both conventional 2D mammography and C View 2D images are sent to Cenova for a ComboHD study the Cenova server will produce separate ImageChecker CAD results for the conventional 2D mammography and C View 2D images respectively Image Acquisition System s 1 2 3 FFDM systems can be configured to send digital mammography x ray images to any device that conforms to the DICOM standard The FFDM device sends two types of images For Processing images to the Cenova server and For Presentation images to the diagnostic review workstation s and PACS Cenova Server 4 5 6 The Cenova server sends results for example Mammography CAD SR objects or CAD SC images to one or more diagnostic review workstation s and or PACS devices The Cenova server can also provide printed results showing the four case processed views with CAD marks Diagnostic Review Workstation s and PACS 3 4 8 The review workstation s are configured to receive the For Presentation images 3 8 and ImageChecker CAD results 4 8 which are then reviewed by the radiologist 7 8 The PACS can be configured to send
10. For Presentation Images Interface ImageChecker CAD with DICOM 6000 Overlay Data Flow 10 Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 2 3 Data Flows 2 3 3 Hologic Imaging Biomarkers Data Flow The figure below shows the data flows among the various devices for the Quantra application Image Acquisition Device s 1 2 3 FFDM systems can be configured to send digital mammography x ray images to any device that conforms to the DICOM standard The FFDM device sends two types of images For Processing images to the Cenova server and For Presentation images to the diagnostic review workstation s and PACS Cenova Server 4 5 The Cenova server sends Hologic Imaging Biomarker results DICOM SR objects or DICOM SC images to one or more diagnostic review workstation s and or PACS devices simultaneously Note Because of the complex nature of DICOM SR objects it is likely that only the Hologic SecurView DX workstation will display Biomarker SR objects in the near term It is for this reason that the Cenova server can be configured instead to send Biomarker results as DICOM Secondary Capture images Diagnostic Review Workstation s and PACS 1 4 7 The review workstation s are configured to receive the For Presentation images and Biomarker results which are then reviewed by the radiologist 6 7 As an option the PACS can be configured to send For Processing images to Cenova 6
11. G1 Restart Using a computer that is on the same network as the Cenova server open a web browser Type the IP address for the Cenova server in the address box and press Enter You do not need to type http or anything other than the IP address At the log in screen enter the user name Administrator and password The About screen should appear as shown in the previous procedure On the About screen click System Control 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 Note To continue using the server refresh the browser by repeating steps 1 3 16 Cenova M Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 3 4 Accessing Unique Device Identifier UDI Information 3 4 Accessing Unique Device Identifier UDI Information Unique Device Identifier UDI is a unique numeric or alphanumeric code that identifies a medical device through distribution and use UDI information is displayed in the About screen of the Cenova application gt To access UDI information in Cenova 1 Launch the Cenova application and log in see 3 3 Server Startup and Shutdown The About screen appears 2 On the About screen click More Information UDI information is displayed on the subsequent screen HOLOGIC System
12. Information Cenova Server Software Build System Serial Number Hologic Connect Serial Number Hologic Connect Build Hologic Connect Agent Dongle Serial Number Processing 2D Processing Version 2D Mass Operating Point 2D Calc Operating Point 3D Processing Version 3D Calc Operating Point Connectivity Hostname IP Address Input AE Title and Port Output AE Title UDI Information ImageChecker CAD 10 0 24 0 7 Not configured 00 0C 29 CF B2 2C 3 4 0 1 1357 10 0 10 0 Cenova 192 168 84 134 CENOVA SCP 7100 CENOVA SCU 01 15420045500037 21 13572014050903223420200000017 Control Panel Log Out Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 17 Chapter 3 System Operation 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 e Browse and sort cases e Search for a study using data such as patient information date processed etc e Export Biomarker results e Delete cases e Review details for a study When you select the Case Manager option from the Cenova control panel a screen similar to the following appears HOLOGIC Control Panel u Log Out Home Case r mr About Administration Patient name Patient ID Accession s Case Status meren Output status Rece System Control n EE 6 05000395 05000395 04999
13. Note that exceeding these guidelines with a single server can affect system response times Each Cenova software application reguires one software license for each input device For example if there are four FFDM devices then the Cenova server must be configured with four software licenses for each desired Cenova software application The Cenova server can also process images sent from any number of PACS devices as long as the images originated from one of the licensed input devices For assistance with license configurations contact your Hologic Account Manager Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 2 2 Results from Cenova 2 2 Results from Cenova Cenova sends its results to diagnostic review workstations such as Hologic SecurView DX and PACS devices Depending upon the application Cenova can transmit results in one or more forms The table below shows output formats for each application Application CADSR SC Image RTSS Printer MG Image ImageChecker CAD v v v v Hologic Imaging Biomarkers v v DigitalNow HD v e CAD SR The Mammography CAD SR format is the DICOM standard used for ImageChecker CAD and or Hologic Imaging Biomarker results e SC Image Mammography CAD SC Secondary Capture provides the case processed views normally the four screening views with ImageChecker CAD or Hologic Imaging Biomarkers For ImageChecker CAD and Hologic Imaging Biomarkers this format is for wor
14. PLETED 1071820 a 09009371 05000371 84975 PROCESSED SUCCESS COMPLETED voriaraq a m u 123456789 10 gt gt Pageske 2 gt 7074 toms in 283 page Select All f Export Biomarkers Refresh By default the cases appear in reverse chronological order newest first The records are arranged in rows and columns Each row shows one case Click Hide Navigation Panel to expand the Case Manager viewing window 18 Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 3 5 Using Case Manager gt 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 a study Clear Filters 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 studies with values containing the characters you typed To remove the filter click the Filter Icon i and click NoFilter in the drop down list Patient Name Patient ID Loretta 7 y NoFilt Lords Loretta 1 DEFN N Contains For some columns you can exclude a search criterion by using the Not box Algorithm M not M d DigitalNowHD MAMMO
15. PROCESSED SUCCESS COMPLETED 10 1 Solt Test 3 05000304 05000304 84998 PROCESSED SUCCESS COMPLETED 1001 System Settings 05000393 05000393 84907 PROCESSED SUCCESS COMPLETED 1011820 Connecty J 05000392 05000392 84990 PROCESSED SUCCESS COMPLETED 10872 a 06000301 05000391 84995 PROCESSED SUCCESS COMPLETED 10 18 econ lal 05000390 05000390 84994 PROCESSED SUCCESS COMPLETED 10n Licensing 05000389 05000389 84993 PROCESSED S ss COMPLETED 1018 2 Hologic Connect W 05000388 05000388 84992 PROCESSED SUCCESS COMPLETED pine She Details 3 05090387 05000387 84991 PROCESSED success COMPLETED 10 1 3 05000305 05000300 84990 PROCESSED success COMPLETED 1018720 Controt a 05000305 05000305 64909 PROCESSED SUCCESS COMPLETED 10 a 05000384 05000384 84988 PROCESSED success COMPLETED yne 02000383 05000383 84987 PROCESSED SUCCESS COMPLETED 1011820 3 05000382 05000382 84980 PROCESSED SUCCESS COMPLETED 1001 05000381 05000381 24985 PROCESSED ss COMPLETED 10r1872g a 05000380 05000380 84984 PROCESSED COMPLETED 10118720 3 05000379 05000379 84983 PROCESSED COMPLETED 1011820 a 05000378 05000378 84982 PROCESSED COMPLETED toriareg 5 05000377 05000377 84981 PROCESSED COMPLETED 10118720 5a 05000376 05000370 94900 PROCESSED COMPLETED 1018720 Ia 05000375 05000375 84979 PROCESSED COMPLETED 1018 20 05000374 05000374 84978 PROCESSED COMPLETED 1018020 a 05000373 05000373 84977 PROCESSED COMPLETED 10 1820 05000372 05000372 84976 PROCESSED COM
16. eeaeesaeecseecaecaecaeceaeceseceseeeseeseneeeneesaes 8 2 3 2 ImageChecker CAD with DICOM 6000 Data FlOw e ue eennennnnnnnrn cnseteeesensetaeens 10 2 3 3 Hologic Imaging Biomarkers Data FIOW sscessseesseceteceeceeceeeeeseeseeeseneesaeesaeessaesaaees 11 23 4 DigitalNow HD Data FlOW 2 cee scccseee octal cccceuttecnvdta cectavene vedneeecdesvadeemdsascoustondevetneccest 12 Chapter 3 System Operation anwucnianwicnnidnwilanwanudnaniandeiun 13 Sele Chimical Workowe ea FI GT es MH GU LD AA NA 13 3 2 Sending Imagesito the Server und an a a a T a a CG A A TiS 14 3 32 S rver Startup and Shutdownte ieu y edi L A FY aioe GW E a 15 3 3 1 Shutting Down the Server sssssssersssssiserssrrsrrsressesrrsstsressrestsstesttstrssestessresessresestrssesees 15 33 2 Starting U p theiSenVetise inii e R E i A AAE taney 16 3 3 3 Restarting the Serve assented isch ea diseeteds Genoese EYN FYD FOD 16 3 4 Accessing Unique Device Identifier UDI Information cee ceeceeeeeeeeeeeeeeneeeeesnseeaecnaeenseeeseeees 17 3 54 Using Case Mama ger yri ori dud ceca Y ddd seg O 0 FODA IR ceeds nd Leads tad oe FYNO cand DEFRA LD CBT Gio Ses 18 hw 21 Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 iii iv Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 Chapter 1 Introduction 1 1 Overview 1 2
17. er 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 properly grounded and provides voltage and current within the specifications of the server To connect primary power to the server 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 any concerns about lifting or positioning the server request assistance Before cleaning the server always shut down the server 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 CAUTION This product contains no user serviceable parts To prevent damage to the server 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 Cenova server Only trained personnel authorized by Hologic are qualified to install or repair the server Disconnect power cord before moving or servicing Install the server behind the institution firewall for network security and antivirus protection Hologic provides no computer virus protection or network security for the server If antivirus s
18. kstations that do not support Mammography CAD SR e RTSS The Radiotherapy Structure Set format was developed specifically to display ImageChecker CAD results on certain GE review workstations e Printer This format provides ImageChecker CAD results for the case processed views normally the four screening views e MG Image This format DICOM Digital Mammography X Ray Image For Presentation provides DigitalNow HD images For workstations and PACS devices that do not support ImageChecker CAD Mammography CAD SR objects but do support DICOM 6000 overlays Hologic s DICOM 6000 Interface solution can be used to convert the ImageChecker CAD results see 2 3 2 ImageChecker CAD with DICOM 6000 Data Flow For more information contact your Hologic Account Manager A Note DICOM 6000 version 1 1 7 is reguired to support CAD on C View 2D image results as DICOM 6000 overlay Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 7 Chapter 2 System Description 2 3 Data Flows This section describes how information flows among the various devices for the Cenova applications as listed below gt 2 3 1 ImageChecker CAD Data Flow 2 3 2 ImageChecker CAD with DICOM 6000 Data Flow gt 2 3 3 Hologic Imaging Biomarkers Data Flow gt 2 3 4 DigitalNow HD Data Flow Note that mammography systems may have different configurations depending upon the devices installed at your site 2 3 1 ImageChecker CAD
19. l rights reserved Pateres hp hologc com patents Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 15 Chapter 3 System Operation 4 Shutdown Click System Control to display the following screen HOLOGIC Control Panel r ETT D Home Power togo About prene Y a Y uu adr ec NvS Administration Shutdown Restart System Control Services Case Manager Saif Test ocom Processing System Settings Suning Connectivity Stopped _ e DICOU Stop Stop Licensing Hologic Connect Site Detats Control Click Shutdown The server prompts Are you sure Click OK to switch the server off A Note Physical access to the server is required to restore power from a shutdown If the server is in a remote location use Restart 3 3 2 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 Cenova software starts up automatically and the server should be ready for use within 3 5 minutes 3 3 3 Restarting the Server You might need to restart the 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 gt To restart the server 1
20. lt in damage to the system A 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 Before using the system read the following warnings and precautions System Operation ZX WARNING Observe the following instructions that if not followed can result in a hazardous condition e__ The server is intended for use only by personnel who have read this manual and received training on how to use the server Hologic does not accept responsibility for injury or damage associated with improper or unsafe system operation e Use the server only outside the patient environment The server is rated for use only in an office environment e 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 liguid do not operate the device contact your service representative A CAUTION 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 A Important Observe the following instructions provided either to ensure correct results and optimal performance or to clarify limitations of the device e For proper system operation the technical q
21. ntation images and Raw C View images Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 1 Chapter 1 Introduction 1 2 Using This Manual This manual is organized as follows Chapter 1 Introduction provides background information on the Cenova server and the manuals Chapter 2 System Description provides a summary of image specifications and data formats passed between the Cenova server and other devices that may be installed at your site Chapter 3 System Operation provides information about managing clinical workflow shutting down and powering up the server accessing UDI information and using the Cenova Case Manager 1 3 Resources Available In addition to this manual the following resources are available to assist you when working with the Cenova server Hologic Member Center This website provides guick access to electronic pdf versions of manuals and training materials for Hologic products The Member Center is available at no charge to our customers under warranty or Hologic service contract You can find the Member Center under the Medical Professionals tab in the Hologic website Training The Hologic Member Center provides online training materials for Cenova applications The Hologic Applications team is available to train your staff should you feel they need additional training To purchase additional onsite training contact your Hologic Account Manager Manuals Hologic pro
22. oftware is required visit the Hologic website for information on Hologic s cybersecurity program and antivirus software installation guidance 4 Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 Chapter 2 System Description gt 2 1 Inputs to Cenova 2 2 Results from Cenova gt 2 3 Data Flows This chapter describes the flow of data passed between Cenova and other devices that may be installed at your site 2 1 Inputs to Cenova gt 2 1 1 Input Devices gt 2 1 2 Image Formats gt 2 1 3 Input Ports and Application Licenses 2 1 1 Input Devices The server supports inputs from the types of devices listed below Certain in country restrictions may apply e Full Field Digital Mammography Systems Cenova processes two dimensional digital mammography images originating from Full Field Digital Mammography FFDM image acquisition systems Cenova supports inputs from FFDM devices manufactured by Hologic Inc Bedford MA GE Healthcare Waukesha WI and Siemens AG Munich Germany e Digital Breast Tomosynthesis Systems Cenova processes C View 2D images originating from Hologic Selenia Dimensions systems e Film Digitizing Systems For film mammograms Cenova processes DigitalNow images originating from any of Hologic s film scanning systems In addition images produced by any of these systems may be sent to Cenova from a Picture Archiving and Communication System PACS For more inf
23. or more information about the Hologic DICOM 6000 interface option contact your Hologic Account Manager Image Acquisition System s 1 2 3 4 The FFDM device sends For Processing images to the Cenova server and For Presentation images to the diagnostic review workstation s PACS and DICOM 6000 Interface Cenova Server 5 The Cenova server sends CAD results in DICOM Mammography CAD SR format to the DICOM 6000 Interface No images need be forwarded DICOM 6000 Interface 6 The DICOM 6000 Interface sends the images with DICOM 6000 CAD results overlays to the diagnostic workstation for review and to the PACS for storage Diagnostic Review Workstation s and PACS 3 6 The review workstation receives the For Presentation images and the For Presentation images with DICOM 6000 CAD results overlays which then can be reviewed by the radiologist 7 If results are stored on a PACS then they can be retrieved and sent to the review workstation at any time 7 For Presentation Images and For Presentation Images with DICOM 6000 Overlays 3 For Presentation Images 7 Diagnostic Workstation s gt 2 For Presentation images me if archived F 6 For Presentation Images with DICOM 6000 Overlays 1 For Processing Images 5 Mammography Image Acquisition CAD SR Objects System s Note Elements shown in italic type and or dashed Cenova DICOM 6000 lines are optional 4
24. ormation about supported input devices see the manual for the specific software application Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 5 Chapter 2 System Description 6 2 1 2 2 1 3 Image Formats The Cenova server processes digital mammography image objects that conform to the DICOM standard The server processes the following types of DICOM image objects e Image objects sent to Cenova by an FFDM system following a conventional mammography examination known as For Processing images also referred to as raw 2D images e Image objects sent to Cenova by Hologic DBT systems known as Raw C View images e Image objects sent to Cenova by any of the Hologic film digitizing systems known as For Presentation images Some DICOM image objects are not processed by the software depending upon the application and mammography view shown in the image For more information on image formats see the diagrams in 2 3 Data Flows Input Ports and Application Licenses Each device that produces digital mammography image files maps to an input port on the Cenova server The DICOM header for each image object includes an identifier e g a serial number that indicates the device from which the image originated For each Cenova server sites can support e Up to four licenses for any or all of the 2D software applications plus a single license for DigitalNow HD or e A single license for DigitalNow HD
25. re 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 Time Out Interval E 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 image acquisition system together at the close of the study and in rapid succession A Note 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 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 and to the desired final destinations For more about the data flow among the various devices see 2 3 Data Flows Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 3 3 Server Startup and Shutdown 3 3 Server Startup and Shutdown The Cenova server does not require regular maintenance The only procedures you might need to perform are gt 3 3 1 Shutting Down the Server gt 3 3 2 Star
26. red to send the For Presentation DigitalNow HD images to one or more review workstation s The radiologist can then review the images 5 Depending upon the needs of the site the PACS can also be configured to send previously archived DigitalNow images to the Cenova server Note Data flow shown in italic type and or dashed DigitalNow Images lt 2 lines is optional optional 4 gt l 4 DigitalNow HD Images PACS Hologic Film A Scannng System 2 DigitalNow HD 5 Previously Archived For Presentation Images DigitalNow Images optional gt 1 DigitalNow 3 DigitalNow HD For Presentation Images Images optional pe 7 leg sy SecurView DX or other diagnostic Films Cenova workstation DigitalNow HD Data Flow 12 Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 3 1 Clinical Workflow Chapter 3 v v v Y yV System Operation 3 1 Clinical Workflow 3 2 Sending Images to the Server 3 3 Server Startup and Shutdown 3 4 Accessing Unique Device Identifier UDI Information 3 5 Using Case Manager Once configured little direct interaction with the Cenova server is necessary Any interaction with the server is through a web browser and a user friendly interface 3 1 Clinical Workflow To view results produced by the Cenova server with the patient s mammography images follow the guidelines of your
27. ting Up the Server 3 3 3 Restarting the Server turning off and on again For these procedures you need to know the IP address for the computer You can get the IP address from the Cenova System Settings Connectivity screen Write that number here Cenova Server IP Address _ 3 3 1 Shutting Down the Server You might need to shut down the Cenova server if you are going to move the computer or if you know the power is going out for a period of time A Important 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 gt 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 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 At the log in screen enter the user name siteadmin and password The About screen should appear as shown below System Control Case Manager Set Test Access Control H Reg drn Image Analytics Server Connectivity Customer Support Monday Friday 6 00 AM amp 00 PM PT GMT 8 00 DICOM Toll Free 1 806 CHECKED 1 986 243 263340 Phone 1 408 352 01009 Emak sctechspeonsthologic com Fax 1408 352 01459 More information Server Sotware Bald 2202 Cenova Copyright 20082013 Hologic Inc A
28. uality of the images e g contrast should be acceptable to the interpreting radiologist and meet the requirements of the Mammography Quality Standards Act MQSA or the appropriate national standards e 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 Cenova mammography applications in clinical protocols e 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 Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 3 Chapter 1 Introduction 1 4 2 LN Installation and Maintenance A WARNING Observe the following instructions that if not followed can result in a hazardous condition The symbol next to the pow
29. vides the following manuals for the Cenova server and its applications Cenova Image Analytics Server User Guide Understanding ImageChecker CAD User Guide Understanding Ouantra User Guide Understanding DigitalNow HD User Guide Cenova Image Analytics Server Installation amp Service Manual Cenova Image Analytics Server Release Notes Cenova Image Analytics Server DICOM Conformance Statement Cenova Image Analytics Server Cybersecurity Product Report You can obtain additional copies of printed manuals through your Hologic Account Manager You can find the DICOM Conformance Statement and Cybersecurity Product Report under the Product Support tab on the Hologic website Technical Support and Service For support in North America contact Toll Free 41 866 243 2533 41 866 CHECKED Email sctechsupport hologic com 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 2 Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 1 4 Server Warnings and Precautions 1 4 Server Warnings and Precautions A 1 4 1 This manual uses the following conventions to provide technical and safety information of special interest A WARNING An instruction that if not followed can result in a hazardous condition CAUTION An instruction that if not followed can resu
30. workstation vendor Radiologists typically review mammography images using a protocol similar to the sequence shown in the following table For this step The radiologist Preliminary Review Reviews the mammography images to get a preliminary sense of the patient s status DigitalNow HD Compares prior digitized film images to the new mammography images Hologic Imaging Reviews and notes the Biomarker findings Biomarkers Preliminary Assessment Examines the mammography images in detail and forms a primary diagnosis Computer Aided Views CAD marks and evaluates related ImageChecker data to Detection determine if other areas on the images warrant further review Final Assessment Makes a final assessment and creates a report Cenova Image Analytics Server 2 4 User Guide MAN 03998 Rev 001 13 Chapter 3 System Operation 3 2 Sending Images to the Server 14 The server accepts the images automatically as they are sent from the image acguisition system film scanner or archiving device The Cenova server groups successive images with the same DICOM study instance UID unigue 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 contact Hologic Technical Support Server Assigns Images Received Befo
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