636-B84043_-_Specifications_Radiology_Ultrasound_-_Iowa_City_-_REVISED.pdf

Functional Requirements for Breast Imaging Radiology Ultrasound

For Iowa City VA Healthcare System (Station 636A8)

636-B84043

This radiology ultrasound will be used for the following clinical applications: Targeted breast ultrasound, handheld whole breast ultrasound, ultrasound guided breast biopsy, and include the ability to perform general purpose, abdominal, small parts, interventional procedures, pelvic, and vascular if needed.

Technical Requirements:

1. Capable of processing multiple data streams simultaneously built for 2D, 3D, and MPR

2. Allows for visual mapping of screened anatomy for documenting full coverage of the breast during image acquisition when performing a handheld whole breast ultrasound screening exam

a. Auto-annotation during image acquisition

b. Key image bookmarking

3. All imaging modes available on a single transducer

a. 2D

b. 3D (freehand)

c. Navigation Software

d. Image Fusion Software

e. Harmonic Imaging

4. Doppler display

a. Frequency

b. Velocity

c. Power – Microvasular/Directional

d. Duplex

e. Triplex

f. Steering for color Doppler is required to be 3 degree increments or less

5. Panoramic mode – less stitching is preferred

6. Ability to query/retrieve previously acquired images that have been archived on our Acuo

Vendor Neutral Archive (VNA) and/or our Visage PACS system. This is intended to be used to compare prior studies (not associated with fusion and navigation). This is preferred but not required.

7. Ability to query/retrieve previous CT and MR images from our Acuo Vender Neutral Archive

(VNA) and/or our Visage PACS system to be used with fusion and navigation.

8. Monitor

a. Size – minimum 20 inches

b. Active screen size – minimum 14 inches – larger size is preferred

c. Split screen – minimum of 2

d. Rotation of the monitor – minimum 180 degrees (preferred 345 degrees)

e. Tilting – minimum 25 degrees

9. Control panel

a. Physical keyboard – it is preferred that the keyboard can be moved/hidden out of the way

b. Touchscreen

i. Keyboard ability on touchscreen is preferred

ii. Image display on touchscreen is preferred

c. Rotation of the control panel – minimum 345 degrees

10. One button image optimization

11. One button optimization of Doppler

12. Programmable protocols

13. 4 active transducer ports

14. Elastography- both strain and shear wave

15. Ease of maneuverability (ergonomics)

a. Monitor rotation - minimum 180 degrees (preferred 345 degrees)

b. Control panel rotation – minimum 180 degrees (preferred 345 degrees)

c. Tilting – minimum 25 degrees

d. Monitor moves up and down

i. Preferred range of height 42 to 70 inches from floor

e. Control panel moves up and down

i. Preferred range of height from 30 to 40 inches from the floor

f. Size of equipment

i. Width – maximum of 25 inches

ii. Depth – maximum of 45 inches

g. Weight of unit – maximum 280 lbs (preferred 250 lbs maximum)

16. Ability to enter a standby mode or sleep mode is preferred

a. State bootup time in seconds/minutes

b. State if the system can enter standby mode or sleep mode

17. Image storage – minimum 1 TB

18. Support operating system (e.g. Windows 7, Windows 10, Linux, etc)

19. License for DICOM SR

20. Wireless

a. Compatible with 802.11b/g/n

b. FIPS 140-2 compliant

Transducers/Probe Type

Weight of each transducer – maximum of 4 lbs – lightest transducers are preferred

1. Linear array high frequency range

2. Linear array lower frequency range

3. Convex/curved for abdominal and interventional

4. Phased array

5. Multi-frequency

6. Endo cavity (vaginal)

7. Endo cavity (rectal)

8. Transducers – Navigation/Fusion biopsy guide

9. Intraoperative (i.e. hockey stick)

10. Transducers – Mechanical 3D

11. Single crystal technology

Each vendor is to respond with transducers that meet the criteria listed above. Please include all other transducers offered by your company in the optional section on the quotes.

Analysis Packages:

1. Procedural

2. Abdominal

3. Pelvic

4. Small Parts

5. Urology

6. Vascular – measurement and analysis of vessels

7. OB

8. Breast

Each vendor is to respond with analysis packages that meet the criteria listed above. Please include all other analysis packages offered by your company in the optional section on the quotes.

Warranty and Service:

1. VPN/Remote Access – The vendor shall provide, at no additional charge, any and all equipment service programs, such as remote diagnostics, during the warranty period. The vendor shall provide post-warranty remote diagnostic service program as an “Add Option” with the offer.

The system shall provide Vendor Remote Diagnostics via VPN. Vendor shall utilize the VA national Site-to-Site VPN, or the vendor shall work with the Office of Cyber and Information

Security and the VAMC Information Security Officer to establish a Client-Based VPN.

2. Service and Operator Manuals – The vendor shall provide the following documentation for the proposed system:

a. Two (2) copies of the operator’s instruction manuals (one electronic and one paper copy)

b. Two (2) copies of the complete technical service manuals including detailed troubleshooting guides, necessary diagnostic software, service keys, schematic diagrams, and parts lists (one electronic and one paper copy)

c. Two (2) copies of a system manager’s (super users) manual outlining back-up procedures, managing privilege group limits, routine tasks, etc.

3. Minimum Warranty – The system and accessories shall be covered under the manufacturer’s warranty, and shall include all parts and labor for one year following acceptance by the VAMC.

This warranty must include PMs as required by the manufacturer. The manufacturer’s factory-trained field service personnel shall perform installation and maintenance during the warranty period.

Training

1. On-site

a. Clinical applications during go-live – minimum of 4 days (8 hours each day)

b. Training should be for both technologists and physicians

c. 1 day of the training should be dedicated to training on fusion and navigation

2. Same clinical applications trainer for all training, who must be cleared through VISN 23 workgroup. It is expected that the same clinical applications trainer be available for all VISN 23 sites. If a vendor has a specialist for handheld whole breast ultrasound, that same specialist should be available.

3. Follow-up

a. Applications training to be provided after technologists have hands-on experience with the system – between 3-4 months following go-live for a minimum of 2 days (8 hours each day) for each site.

b. Applications training to be provided after technologists have hands-on experience with the system – between 6-9 months after go-live for a minimum of 2 days (8 hours each day) for each site.

4. Off-site

a. Technologist Clinical Training for 3 technologists focused on breast ultrasound

i. Tuition and travel (lodging and airfare) is preferred

ii. This training should be scheduled and completed after the system has been installed

b. Biomedical Technical Training for 1 technician

i. Tuition and travel (lodging and airfare) is preferred

ii. Include training for all courses including any prerequisites

iii. Equivalent to what your OEM field service representatives receives

iv. All service manuals, schematics, diagrams, diagnostic software, other special tools and hardware keys equivalent to what their OEM field service reps have available to diagnose, troubleshoot, repair and maintain the equipement

Information and other documentation vendors are to provide:

1. Brochures

2. Technical specification sheets

3. Weigh of the unit (in lbs)

4. Weight of each transducer (in ounces and/or lbs)

5. Height (in inches) from the floor to the handle of the lowest setting

6. Height (in inches) from the floor to the handle of the highest setting

7. Describe in detail the standby mode or sleep mode

8. Version/platform long-range plan

9. DICOM conformance statement

10. FIPS 140-2 certification

11. Completed pre-procurement assessment form (6550)

12. Detailed information about the curriculum and length of the Biomedical

Technical Training.

13. Details on any off-site training offered for sonographers

14. Information about your companies support structure during the warranty period

a. Describe on-line or telephonic applications support and availability

b. Provide a listing of Field Service Engineer locations and availability

c. Listing of part depots

15. Information about your company’s support options following the warranty period

a. Describe on-line or telephonic applications support and availability

16. 2 (two) copies of the products service manual (1 hard copy and one digital copy)

17. References for the clinical applications trainer that will be assigned to

VISN 23.

18. Any information on FDA safety recalls associated with the equipment and/or transducers

Trade-in:

None

Summary:

• This procurement includes one radiology ultrasound unit for the Iowa City Veterans Health Care

System within VISN 23.

• This radiology ultrasound will be used for the following clinical applications: Targeted breast ultrasound, handheld whole breast ultrasound, ultrasound guided breast biopsy, and include the ability to perform general purpose, abdominal, small parts, interventional procedures, pelvic, and vascular if needed.