36A79719Q0008-056.pdf

Qty Description

1 3DIMENSIONS MAMMOGRAPHY SYSTEM 3D US

1 3DIMENSIONS HIGH-RESOLUTION DETECTOR

1 3DM ERGONOMIC UPGRADE

1 SELENIA DIMENSIONS BTO ENABLED

1 ADVANCED WORKFLOW MANAGER SYSTEM,

RACK MOUNT COMPUTER CONFIGURATION

1 DIMENSIONS NEEDLE LOCALIZATION KIT

3 RACK, PADDLE STORAGE

1 IMAGECHECKER CAD (10.0) LICENSE FOR ONE

FFDM

1 CENOVA 2D TOWER SYSTEM

SHIP TO:

WAREHOUSE B80811

V.A. Medical Center

50 IRVING STREET NW

WASHINGTON, DC 20422

P.O.# 688-B80811

Qty Description

1 CAD TRAINING, INITIAL, 1 DAY, 1 SITE, MAX 10

RADS

1 CLINICAL APPS INITIAL TRAINING

1 MEDICAL PHYSICIST, INITIAL TRAINING, 8

HOURS (5 HOURS LIVE - 3 HOURS ONLINE

TRAINING), 1 SITE, MAXIMUM 2 PHYSICISTS

1 RADIOLOGISTS 3D INITIAL TRAINING 8 HOURS

VIRTUAL TRAINING, 14 RADIOLOGISTS, 90 DAY

ACCESS PERIOD

1 C-VIEW SOFTWARE LICENSE

1 INTELLIGENT 2D IMAGING LICENSE UPGRADE

FROM C-VIEW (3DM ONLY)

1 KIT, FMI, ADDITIONAL LICENSE KEY FOR

DIMENSIONS AFFIRM READY SYSTEMS

1 FMI KIT, DIMENSIONS 1.7 TOMO BIOPSY

1 SECURVIEW DX/RT WORKSTATION UPGRADE

COMPUTER (WINDOWS 7 64-BIT), W/ SERVICE

CONTRACT

Long Description

3Dimensions™ mammography system for 3D™ screening and diagnostic mammography with 2D capabilities. Upgradeable to interventional imaging. 3Dimensions™ is a high-resolution capable system.

Includes: X-ray Gantry: •Generator: Fully integrated constant potential, high frequency, inverter type •X-ray Tube: Tungsten, bi-angular, high speed, high heat capacity •X-ray Filters: Rhodium, silver, aluminum •Anti-scatter Grid: Auto-retracting linear grid •Dual-function gantry footswitches (2) with Genius™ 3D Mammography™ artwork on gantry foot cover Adjustable-height Acquisition Workstation:

•CPU: Multi-Core Intel-based CPU, 16 GB RAM min., 2 TB disk min., DVD +/- R/W, Win 7/64 •NVIDIA GPU •User Interface Display: 1.2 MP color LCD touchscreen display •Image Review Display: 21.3” 3 MP, medical-grade color, DICOM monitor with double-jointed articulating arm •Full X-ray shield, X-ray exposure footswitch, pull-out keyboard drawer, keyboard and mouse •Uninterruptible Power Supply (UPS) 3Dimensions™ System Software: •User access control, patient and study selection, imaging procedure selection and definition, X-ray parameter control, image review and acceptance/rejection, quality control. •Software Licenses: 3Dimensions™ System, Diagnostic Imaging, Dynamic Tube Head Motion, Tomosynthesis Imaging, Advanced Connectivity, Bi-directional Communication (Notices), SmartCurve™ Breast Stabilization System Connectivity: •DICOM: Modality work list, storage, storage commitment, query/retrieve, print •IHE Profiles: Scheduled workflow, patient information reconciliation, mammography image •Advanced Connectivity: Ability for the system to participate in DICOM Modality Performed Procedure Step (MPPS) transactions and to output DICOM Radiation Dose Structured Report (RDSR) objects to third-party dose aggregation and reporting systems. The MPPS and RDSR capabilities can be enabled and disabled independently. Accessories: •Small 18 x 24 cm SmartCurve System and large 24 x 29 cm SmartCurve System •Screening Paddles (3): Frameless, 24 x 29 cm, 18 x 24 cm, small breast •Diagnostic Paddles (5): Spot contact, spot contact 10 cm, spot contact 7.5 cm, 10 cm magnification, 7.5 cm spot magnification •Spot Contact Paddle (1): 7.5 cm for use during QC testing only •Other: Magnification stand with platform, flat field phantom and case, ACR tomosynthesis geometry calibration phantom, Dimensions interconnect cable kit •Shields: 2D fixed face shield and sliding 3DMammography™ face shield •MammoPad® Breast Cushion trial box Platinum Marketplace: The Hologic® Platinum Marketplace provides access to free and for purchase promotional and educational material designed to help drive demand for the Hologic products that your site offers. From customizable features to options for digital download or professional printing, choose what works best for your practice.

. Included Service: Installation by Hologic certified technicians. Warranty: Standard one-year parts and labor warranty; two-year prorated manufacturer's warranty on X-ray tube. Warranty service coverage is Monday-Friday from 8:00 am to 5:00 pm local time. Conditions: •Required but independently sold software features are not included gratis under Hologic Warranty, or Hologic Service Contracts that include software upgrades, and must be ordered separately •Required system software updates that are included under Hologic Warranty, or Hologic Service Contracts will be provided at no charge SecurView® Workstation Recommendations: If using SecurView workstations, please contact your Hologic representative to confirm that your workstations meet the minimum software and hardware requirements to support the 3Dimensions™ configuration.

Hologic 3D Mammography™ high-resolution digital image receptor for 3Dimensions™ mammography systems or to upgrade existing Selenia® Dimensions® systems. Includes: Digital Image Receptor •Amorphous selenium, TFT •Structure: Single 24 x 29 cm plate •Image Matrix Sizes: 2560 x 3328 (18 x 24 cm); 3328 x 4096 (24 x 29 cm) •Pixel Size: 0.070 mm •Limiting Spatial Resolution: 7.1 lp/mm

Provides an integrated ergonomic package for the 3Dimensions™ system. Includes: •Fingerprint reader for quick biometric login of the technologist, manager or other site personnel •Powered memory height adjust •Bar code scanner Note: •Kit only available for 3Dimensions systems

This configuration enables output of tomosynthesis slices in DICOM Breast Tomosynthesis Image Object form. Use of this configuration will first require an integrated planning team, including your IT department, Hologic and other vendors, to work together to ensure that your enterprise is ready for use of the tomosynthesis data in DICOM Breast Tomosynthesis Image Object form. The completion of critical feasibility questions included in Hologic’s Enterprise Survey will guide the team through understanding any infrastructure requirements and changes necessary. Note: While a preliminary check by your Hologic representatives may have allowed the ability to quote this output configuration, completion of the Enterprise Survey is required before Dimensions Tomosynthesis system or option is enabled.

Software and hardware upgrades may be required. Hologic makes no guarantees of software and hardware performance for products not associated to Hologic. By signing this quote, the customer agrees that the completion of purchase of the accompanying Hologic products shall not be contingent on the implementation of this no-charge configuration. Requires: - Completion of Hologic Enterprise Survey by site personnel in conjunction with Hologic representatives - PACS system including Deep Archive capable of storing / retrieving DICOM Breast Tomosynthesis Image Objects and with suitable storage capacity - Softcopy review workstation capable of displaying DICOM Breast Tomosynthesis Image Objects

The Advanced Workflow Manager (AWM) eases data flow in busy breast imaging departments by integrating 3Dimensions™ and Selenia® Dimensions® systems into a single, patient-focused working environment that provides instant access to current studies, rapid sharing of prior studies and synchronized notices between Hologic systems. The AWM supports up to 15 systems, depending on study volume, site workflow and site network performance. Includes: •Powerful server-grade computer system •Computer server class hardware •5U Rack-mount computer (Note: For tower computer, order AWM-SYS-0100 instead) •CPU: High-end Quad-Core Intel Xeon processor •Memory: 12GB high speed RAM min. •Storage: Serial SCSI, RAID-5, 4 TB min. •Network Interface: 10/100/1000 Base T Ethernet •Operating System: Microsoft Windows server 2008 R2 •User Interface: 2.0 Megapixel color LCD display, mouse and keyboard (for powering on/off) •Advanced Workflow Manager (AWM) software •Port licenses for connection to two (2) 3Dimensions™ or Selenia Dimensions acquisition modalities •Additional port licenses are available (AWM-LIC-0001 sold separately) Requirements: •Network performance: 100 Base- T Ethernet or faster •Minimum of two (2) 3Dimensions™ or Selenia Dimensions systems •Dimensions software must be version 1.5 or later and must match AWM software revision •One (1) AWM port license per system •To participate in Notice Synchronization: •Each Dimensions system must have a Notices license •Each SecurView® DX workstation or cluster with software version 7.2 or later •Facility must provide a method of transmitting prior studies to the AWM, e.g. pre-fetch via SecurXchange® (or other DICOM) router or manual retrieval from PACS

Optional needle localization kit for needle localization procedures for 3Dimensions™ systems. Includes:

•Crosshair paddle •Magnification crosshair paddle •10 cm localization rectangular opening paddle •10 cm rectangular localization magnification paddle

Wall-mounted, felt-lined rack for storing system compression paddles. Each rack, sold separately, provides enough storage room for 3-4 compression paddles. Includes: •Paddle storage rack with felt lining •Wall-mounting bracket (installation not included) •Graphic paddle labels Dimensions: •W x H x D: 36 1/4" x 7" x 4" (from the wall) •Minimum Vertical Pitch: 12" to 14” when multiple racks are installed one above another Recommended: •Selenia® Dimension® Avia systems: min. 1 rack •Selenia Dimensions 2D systems: min. 2 racks •Selenia Dimensions 3D™ systems: min. 3 racks •3Dimensions™ systems: min. 3 racks Requirements: •Must be securely attached to the wall •Must be installed by a professional installer

The ImageChecker® Digital computer-added detection (CAD) and Citra™ advanced CAD display software adds one port license to a Cenova™ image analytics server to process images from a single digital mammography system. Includes: •One ImageChecker CAD software license to support: •Hologic software generated 2D images •Hologic and other manufacturers 2D FFDM systems •Citra advanced CAD display license to provide additional information about why ImageChecker CAD marked specific regions: •RightOn™ CAD marks placed right on the region-of-interest to unambiguously flag the location •Malc™ CAD marks placed where the algorithm sees signs of both density and calcifications •PeerView Digital to show exactly the tissue that caused CAD to mark the region •EmphaSize™ variable size CAD marks differentiate CAD marks that have more prominent features •LesionMetrics™ ancillary CAD information to display additional information about the finding Requirements: •A Cenova server at Cenova software version 2.4.3 or later •Specify serial number, manufacturer and model of FFDM system at time of order •For CAD on C-View generated 2D images, a Dimensions® tomosynthesis system with software version 1.8.3 or higher •Please refer to SecurView® DX diagnostic workstation description for minimum requirements Notes: •Advanced Citra CAD features require workstations that conform to proper display of those features. They can be disabled for use with other non-conformant workstations. The customer needs to check with their workstation vendor •This item is for use with 2D Images only. •Verify with the technical team that the number of licenses on a server can be adequately supported. •Order additional licenses for each additional FFDM system. •With respect to the future development path of our products, during the warranty period and during the term of any Hologic Service Agreement, Hologic will provide, at no cost to the Customer, any commercially released software update that (i) improves the ability of any Equipment purchased under the Agreement or software purchased as part of the Equipment to function in accordance with its published specifications and (ii) does not require any new hardware or other hardware modifications. Hardware is not part of Hologic service agreements; if Hardware needs to be replaced, there will be an additional charge. This offer is entirely contingent on whether Hologic receives applicable regulatory approval for the software update, and the software update is subsequently commercially released. There are no guarantees that this will be the case, and, therefore, Hologic makes no commitment and assumes no obligation to the contrary.

The Cenova™ digital mammography processing system hosts image analytics software applications.

Image analytics licenses are sold separately. Includes: •Cenova processing unit server (6U) •Windows 7 operating system •Dynamic resource management and case control •Output transmission re-try mechanism •Flexible output routing to multiple output destinations •License dongle •Hologic Connect™ remote system diagnostics software for post-installation service and applications support; conforms with Verisign security Requirements: •Specify manufacturer and model of FFDM system at time of order •Verify with the technical team that the number of licenses on a server can be adequately supported. Notes:

•This server can be used horizontally and rack-mounted by ordering R2ACC-2001. (R2SYS-2200-1U is a thinner server, ships with a rack mount and is preferred for rack mounting.) •The system is designed to process 2D images only

* One (1) day of Applications Training. Training for up to 10 Rads * Applications must be completed within 24 months of equipment installed. * This training cannot be performed until FFDM certification extension is received for Tomosynthesis. * Please note: Cancellation must be made 6 business days prior to the confirmed and scheduled applications training start date. * * Initial

Included in the purchase price of your 3Dimensions™ or Selenia® Dimensions® system(s); Initial . Technologists: Onsite applications training or other clinical support at one site, maximum of 5 technologists. •Online CEU courses required prior to onsite applications training •Video training available during and post applications training •Onsite portion of purchased applications training or other clinical support must be completed within 24 months of equipment installation. Required FDA training: •FFDM accreditation is required: Apply to the ACR or your State for FFDM certification.

•Once FFDM accredited, contact the MQSA FFDM Certification Extension Program for Tomosynthesis at 301-796-5710. •Sites must obtain ACR or State FFDM accreditation before using the tomosynthesis modality Note: Cancellation must be made 6 business days prior to the confirmed and scheduled applications training start

Included in the purchase price of your 3Dimensions™ or Selenia® Dimensions® system(s); Initial . Medical Physicists: 5 hours of live tomosynthesis training with a

Hologic Field Service Engineer during the installation of the system and access to Hologic’s 3-hour online tomosynthesis training course for medical physicists to fulfill the 8 hour FDA requirement. See course description for more details and requirements. Visit www.hologic.com/training for a complete list of Hologic educational opportunities. Note: Cancellation must be made 6 business days prior to the confirmed and scheduled applications training start date. Fee for cancellation within 6 business days of confirmed

Included in the purchase price of your 3Dimensions™ or Selenia® Dimensions® system(s); Initial . Radiologists: Access to Hologic's virtual tomosynthesis training course for up to 14 radiologists. This program will fulfill the 8-hour FDA training requirement. Upon activation, each radiologist will have 90 days to complete the course. See course description for more details and requirements. Visit www.hologic.com/training www.hologic.com/training for a complete list of Hologic educational opportunities.

Enables creation of C-View™ generated 2D images on Selenia® Dimensions® systems or 3Dimensions™ systems configured with Hologic standard resolution 3D™ imaging. The C-View software license adds the ability to create low dose tomosynthesis studies in Tomo HD (standard tomo + C-View) and Combo HD (standard tomo + FFDM + C-View) imaging modes. Includes: •C-View Generated 2D Imaging software license

Enables creation of Intelligent 2D™ images on 3Dimensions™ systems configured with Clarity HD high-resolution 3D™ imaging. The Intelligent 2D Imaging software license adds the ability to create low-dose tomosynthesis studies in Tomo HD (high-resolution tomo + Intelligent 2D) and Combo HD (high-resolution tomo + FFDM + Intelligent 2D) imaging modes. Intelligent 2D may be used to replace FFDM when used in combination with high-resolution 3D™ imaging. Includes: •Intelligent 2D™ Imaging software license Requirements: •3Dimensions™ or Selenia Dimensions system with software version 1.9 or later •Clarity HD High-resolution 3D™ Imaging license •Supply Selenia Dimensions system serial number at time of purchase •Advanced Workflow Manager software version 1.8.2 or later Note for optional CAD application:

•Cenova™ software version 3.0 or later •ImageChecker ® CAD software version 10.0 or later •Service flag needed to enable CAD for Intelligent 2D processing at this facility Intelligent 2D™ upgrade (part #: 3DM- LIC-I2D-UP) includes license, 12 months of software maintenance, and one-time installation. Installation is for a one-time setup of Intelligent 2D from C-View™. If customer no longer requires the use of Intelligent 2D and would like to go back and configure the system for C-View later, the customer will incur a separate service charge. Part number is only valid for a 3Dimensions™ and not a 3D™ Performance, 6000 or 9000 Selenia® Dimensions® system.

Enables the use of an Affirm® biopsy guidance system on one (1) additional 3Dimensions™ system or Selenia® Dimensions® system for stereotactic procedures using 2D imaging only. For newer SDM systems. Includes: •Affirm Stereotactic Biopsy software license Requirements: •All systems: Software version 1.6.2 or higher •2MP medical grade LCD display •Avia systems: Dynamic Tube Head Motion Software license for biopsy only Recommendations: •3MP medical grade DICOM monitor •Two (2) dual-function gantry footswitches

The Affirm® Tomosynthesis Biopsy software license provides the ability to easily and accurately target lesions with tomosynthesis imaging including lesions that may only be found under tomosynthesis.

This license provides the ability to use Affirm tomosynthesis biopsy software on one (1) 3Dimensions™ system or (1) Selenia® Dimensions® tomosynthesis system that has an Affirm Upright Biopsy license.

Also included is a tomosynthesis biopsy QAS needle. Intended for use on new 3Dimensions™ or Selenia Dimensions system purchases. Includes: •3D™ Biopsy license •3D™ QAS Target Requires:

•3Dimensions 3D™ system or Selenia Dimensions 3D™ system, system with DTHM license for biopsy and 3D imaging •Affirm breast biopsy guidance system •Affirm Stereotactic 2D Biopsy license •2MP medical grade LCD display •Supply the system serial number with your order Recommendation: •3MP medical grade DICOM monitor

The SecurView DX or RT workstation computer upgrade kit allows an existing SecurView DX or RT standalone or client workstation to be upgraded to the latest computer hardware. This kit is for customers who are ARE covered under a Service Contract, and requires trade-in of existing computer. This product is discounted due to the existing service contract that is expected to be renewed; therefore it is sold as is with NO warranty. SPECIFICATIONS: High End, Windows Based System equipped with a Six-Core Processor (2.4 GHz or higher), 16GB High Speed RAM, (3) 2TB SAS drives in RAID 5 array, 10/100/1000 Base T Ethernet Network Interface. REQUIREMENTS: Replaces any SecurView DX or RT standalone or client. SecurView DX systems equipped with older CRT displays and video cards will have to be upgraded to the newer LCD displays and video cards by ordering the appropriate Product ID. NOTE: Price includes trade-in of existing computer. The warranty information in this product description shall supersede any warranty language in the attached terms.