6515--THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A REQUEST FOR INFORMATION ONLY. FujiFilm Sonosite Edge II Ultrasound Systems for the Philadelphia VAMC

THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A REQUEST FOR INFORMATION ONLY. This Request for Information (RFI) is intended for information and planning purposes only at this time; and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs. Because this is a Request for Information announcement, no evaluation letters and/or results will be issued to the respondents. No solicitation exists. Therefore, do not request a copy of a solicitation. The Department of Veterans Affairs (VA), VISN 4, Network Contracting Office 4 (NCO 4), is seeking information and potential qualified sources capable of meeting the following minimum requirements and salient characteristics below for a brand name or equal ) Fujifilm Sonosite Edge II Ultrasound Systems CPL Michael J. Crescenz Veterans Affairs Medical Center Statement of Need Date May 20, 2022 Client Philadelphia VAMC Job Name FujiFilm Sonosite Edge II Requested by Molecular Imaging & Interventional Radiology Service Summary CMCVAMC has a new brand name requirement for two (2) FujiFilm Sonosite Edge II Ultrasound Systems that will be used in the Molecular Imaging and Interventional Radiology (MIIR)Service. This Ultrasound system will allow the MIIR staff the ability to provide rapid intravenous access that is critical to patient care. Many patients that are treated in the MIIR Service have difficult peripheral intravenous access for a variety of reasons. The ultrasound system is essential to find veins that are not easily found with standard intravenous catheter placement techniques. Objectives/Requirements The SonoSite PX Ultrasound system allows for placement of peripheral intravenous catheters in veins that would not be accessible without the ultrasound machine. It will allow clinicians and skilled nurses to find veins that are invisible on the surface of the skin by providing a clear image of the needle successfully entering the vein. While there are other ultrasound machines out there, the image clarity that the SonoSite PX system provides will enable staff to place IVs and Catheters successfully time after time without multiple attempts. This improves efficiency in our extremely busy ED, improves patient safety, and patient satisfaction. Equipment Descriptions: Item # Description/Part Number* Qty 1 FujiFilm Sonosite Edge II 2 Product Installation The vendor shall be responsible for determination of and compliance with federal and state or local code requirements, design data, and other factors necessary to design and stall the items at the desired location. The system will not require any new construction, space, or special wiring. Training of Operating Personnel Sonosite Institute for Point-of-Care Ultrasound: Included in the price quoted is exclusive access to over 100 hours of education including courses, videos, webinars, quizzes, certificates, and additional resources that the user should be able to access through their desktop computer, tablet, or phone. Place of Delivery The product will be delivered to the Warehouse onsite at the following address: Philadelphia VA Medical Center 3900 Woodland Avenue Philadelphia, PA 19104 Acceptance Procedures Prior to acceptance of the goods or services provided under this contract, inspection and testing will be performed by the Government in accordance with this clause. Upon delivery the equipment shall be turned over to the hospital for use. The contractor shall furnish, upon delivery, a written notice of readiness for inspection for the Contracting Officer and requesting service. VA Patient Privacy and Network Infrastructure None of the equipment listed within this procurement package will access the VA Network or store any sensitive patient information. Any contractors that will come on site for install will not need access to the VA Network. All contractors must comply with VA regulation and complete the following training: VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access or use to VA Sensitive Information. Reference Handbook 6500.6 Appendix A Checklist for Information Security in the initiation phase of acquisitions. The system does not transmit or maintain electronic Protected Health Information. A Manufacture Disclosure Statement for Medical Device Security (MDS2) form in not applicable. A VA Directive 6550 Pre-Procurement Assessment form is included. Recalls The Vendor shall immediately notify all affected VA Medical Centers and designated POC in the event of a device recall, removal, required adjustment, or required modification that is suggested or mandated by the Vendor, distributer, manufacturer, or any regulatory or government agency. The following information shall be included in this notification: A complete item description and identification (to include lot and serial numbers where applicable); Administrative identification data including order numbers and order date; Reasons for recall, removal, adjustment, or modification; and Instructions for appropriate corrective action Defective Items/Warranty Contractor shall list open-market defective items protections and warranties available for the medical equipment being purchased. Specifications System Specifications 1. Dimensions: 12.8 x 12.1 x 2.5 / 32.6 cm x 30.7 cm x 6.4 cm (L x W x H) 2. 9.21 lbs / 4.1.8 kg with battery, 8.37 lbs / 3.80 kg without battery 3. Monitor: 12.1 / 30.7 cm diagonal LCD (NTSC or PAL) with chemically etched glass layer 4. Monitor Viewing Angle: 85 degrees up/down/left/right 5. System Boot up: < 25 seconds from power-on to scanning 6. Image Size: 185 mm x 138 mm 7. Screen Size: 12.1 (246 mm x 138 mm) 8. Screen Resolution: 800 x 600 9. Architecture: All digital broadband 10. Gray Scale: 256 shades 11. Dynamic Range: Up to 165 dB 12. HIPAA Compliance: Comprehensive tool set 13. The system shall withstand a drop from a height of 3 feet/91.4 cm. The system shall be safe and function normally after these drops. 14. Clinical display brightness: max 450 cd/m2, default (level 8) at 350 cd/m Warranty & Service 1. Five-year standard warranty on the system. 2. Five-year standard warranty on rP19x, rC60xi, ICTx, L38xi, L25x, HFL50x, HFL38xi, HSL25x, P10x, C35x and C11x transducers. 3. One-year standard warranty on battery and accessories carrying the manufacturer s label excluding the system. 4. Next business day loaner or replacement where available (Next-day shipping not available in all geographical locations) Transducer Specifications Transducers will withstand a drop from a height of 3 feet/ 91.4 cm and remain functional and safe after these drops. Image Modes 1. 2D/B-mode a. Broadband Imaging b. Tissue Harmonic Imaging (THI) c. Steep needle profiling (SNP) 2. Velocity Color Doppler (CVD) 3. Color Power Doppler (CPD) 4. Pulsed Wave Doppler (PW) 5. Pulsed Wave Tissue Doppler (TDI) 6. Continuous Wave Doppler (CW) 7. ECG 8. M-Mode (Distance and time measurements, heart rate calculations Steep Needle Profiling Available on these transducers and exams: 1. HFL50x: Breast, MSK, Nerve, Small Parts 2. L38xi: Nerve 3. L25x: Nerve, Venous, Arterial, MSK 4. HSL25x: Nerve, Venous, Arterial, MSK 5. HFL38xi: Breast, MSK, Nerve, Small Parts, Arterial, Venous 6. rC60xi: MSK, Nerve 7. C35x: Nerve, MSK, Spine B-Mode Imaging 1. B-mode Controls: a. Depth b. 2D Mode (Near, Far, and Overall Gain) c. Autogain d. 2D Mode THI e. 2D optimization (Res, Gen, Pen) f. SonoMB on/off g. Dynamic Range (7) h. Image Orientation (U/R, U/L, D/L, D/R 2. Screen depth: 1.5 35cm 3. Support acquisition frame rate up to 150Hz. 4. B-mode Imaging features a. Tissue harmonic imaging (THI): transmit at a low frequency and receive at a higher harmonic frequency to reduce clutter, improve lateral resolution and enhance tissue contrast. b. SonoHD2: image processing algorithm that provides better border definition, tissue contrast, texture pattern and speckle reduction. c. SonoMB: multi-beam technology to effectively reduce speckle artifact, enhance tissue contrast, and improve border connectivity. d. ColorHD: color Doppler imaging algorithm which increases color performance, sensitivity and frame rates offering more diagnostic information. 5. Up to 2 x pan/zoom 6. Support up to three focal zones to improve resolution uniformity 7. Support individual live scanning on either side of the dual imaging display 8. Support seamless dual imaging display as extended field of view Color Imaging: CVD and CPD 1. CVD/CPD Controls/options a. Color Gain b. Color Maps (CVD, CPD, Variance) c. Color Type (CVD, CPD) d. Color Variance (On/Off) e. Color Scale f. Color Optimization (High, Mid, Low) g. Color Wall Filter h. Color Steer Angle i. Adjust Color box size and position 2. Max PRF used is 12500Hz. Transducer Technology 1. DirectClearTM Technology: Increases penetration and resolution. Available on: (rC60xi, rP19x) 2. Armored Cable Technology: Provides further protection against trampling, crushing and twisting using a stainless-steel jacket inside the cable. (Optional on rC60xi, rP19x, L38xi, HFL38xi, L25x and L52x (vet only)) 3. Linear Array, Curved Array, Phased Array, Multiplane TEE and Micro-Convex 4. Center line marker on linear transducer Spectral Doppler Imaging 1. Doppler modes: a. Pulsed wave (PW) b. Tissue Doppler Pulse Wave Doppler (TDI) c. Continuous Wave (CW) d. Transcranial (TCD) e. Orbital (ORB) 2. Doppler controls: a. PW/CW Doppler Gain b. PW Doppler Sample Volume Size c. TDI-PW Doppler Sample Volume Size d. Doppler Invert e. Doppler Trace Type (Peak / Mean) f. Doppler Trace (Above/Below/All) g. Doppler Scale h. Doppler Sweep Speed i. Sweep Speed j. Doppler Baseline k. Doppler Angle Correct l. Doppler wall filter 3. 256 gray levels in the spectral Doppler display 4. Cine review available (Up to 255 frame-by-frame images User Interface and Programmable Controls 1. Clinical Display Information 2. Programmable A and B Keys 3. Low profile keyboard, sealed completely to edge for maximum infection control 4. Image Acquisition Keys: Save, Review, Report, Video Clip Store, Video Clip Edit 5. Display formats for Duplex Imaging: 1/3 and 2/3, ½ and ½, Full 2D, Full Trace 6. Doppler Controls: angle, steer, scale, baseline, sample volume, gain, wall filter and volume Onboard Image and Clip Storage Review 1. 2D Cine Review 20 seconds 2. PW, CW, M Mode Cine Review 16 seconds 3. Internal Flash Memory 16GB 4. Storage support for up to 500 patients 5. Maximum storage in ECG beats mode is 10 heart cycles 6. Prospective and Retrospective Clip Store 7. Auto Clip Export (auto export to USB at end of study) 8. Video clip playback at 1, ½ or ¼ of the captured rate 9. Video Clip Save Lengths: 2, 4, 6, 10, 15, 30 and 60 seconds. 10. Image Format: JPEG, MP4, BMP 11. Export Format: HTML 12. JPEG Compression Options: High, Medium, Low Worksheets 1. EMED Worksheets (FAST, Procedural. Gallbladder, Kidney, AAA, OB) 2. Musculoskeletal Worksheets (Shoulder, Knee, Elbow, Hand/Wrist, Ankle/Foot, Hip Generic Measurements 1. Up to 8 generic measurements at once 2. 2D: Distance, Ellipse, Manual Trace Volume, Bladder Volume, Doppler: Velocity measurements, Pressure Gradient, Elapsed Time, Acceleration, Heart Rate, Resistive Index, Systolic/Diastolic Ratio, 3. Measurements can be traced manually or automatically. 4. Velocity Time Integral, Peak Velocity, Mean Pressure Gradient, Mean Velocity on Peak Trace, Pressure Gradient, Cardiac Output, Peak Systolic Velocity, Time Average Mean, Systolic/Diastolic Ratio, Pulsatility Index, End Diastolic Velocity, Acceleration Time, Resistive Index, Time Average Peak, Gate Depth, Heart Rate. 5. M-mode: All points guided workflow, distance and time measurements, Heart Rate Calculation Packages OB/Gyn/Fertility 1. OB/Gyn/Fertility: Diameter/ellipse measurements, volume, 10 follicle measurements 2. 2D OB Calculation Package Measurements: EFD, EDD, gestational age, LMP, growth charts, user defined tables, multi user selectable authors, ratios, AFI, patient report, humerus, and tibial measurement and charts. 3. HR, Fetal HR, MCA, UMBA, Ovarian Volume, Uterine Volume, Endometrial thickness. 4. Biophysical profile 5. User Defined Measurements 5 6. Twin Measurement Packages (A & B) 7. Obstetrics (Twin A and B) Reports Arterial 1. Diameter/ellipse/trace measurements, volume, volume flow, percent diameter and area reduction, ratio, peak trace, angle correction, patient report, HR, TAP 2. Carotid Calculation Package: Lt/Rt CCA, ICA, ECA, ICA/CCA ratio, vertebr Cardiac 1. Automated Cardiac Output package and patient report including: ventricular, aortic and atrial measurements; ejection fraction, volume measurements, Simpson s rule, continuity equation, pressure half time and cardiac output; IVC Collapse Ratio, LA/RA Volume, TAPSE, PA AT, TV, E, A, PHT, TVI, MV time, Pulmonary Veins, LV Mass, TDI e , TDI a , HR, dP:dT, Qp/Qs 2. Ability to view EF and FS simultaneously 3. LVO (Left Ventricular Opacification Small Parts/MSK 1. Volume, Hip Angle, and d:D Ratio Transcranial Doppler (TCD) Complete TCD package including Time Average Peak (TAP) DICOM Image Management 1. Print, Store, Modality Worklist, Modality Performed Procedure Step (MPPS), Storage Commitment 2. Capable of transferring images by batch or as exam in progress to a DICOM archive 3. Allow saving DICOM configuration via USB for easy replication or restoration. 4. DICOM 3.0 compliant Connectivity and External Data Management 1. 3 USB 2.0 Ports (2 onboard system, 1 on mini-dock) 2. 256 bit AES encryption of data on system 3. Ethernet Port (on mini-dock) 4. ECG Connector (on mini-dock and system) 5. Storage capacity alert if internal storage is less than 10% 6. Barcode auto-query (populates patients demographic from worklist) 7. DVI video out connector (on mini-dock) 8. Composite video output (NTSC/PAL, on mini-dock) 9. Audio output (on mini-dock) 10. RS-232 Transfer (on mini-dock) 11. S-Video, input & output, (on mini-dock) 12. Patient Data Archival Software (PDAS) for Wireless/Wired Image, Report Management (optional feature Wireless Solutions 1. External Wireless Option: 2.4GHz and 5GHz wireless: 802.11 (b, g, and n networking) 2. Security policies: Open, WEP, Shared WEP, Radius, WPA, and WPA2 3. Key management protocols: WEP64, WEP128, and WPA/WPA2 (Personal and Enterprise) 4. Allow location specific connectivity configuration 5. FIPS 140-2 security encryption (US only) Accessories 1. Medical Grade Black and White Printer (Sony UPx-898 B&W printer) 2. Triple Transducer Connect 3. USB Bar Code Reader 4. Footswitch 5. Stand with mini dock, gel holders, and large storage basket 6. AC Cord Retainer 7. PowerPark (External Power Docking Station) 8. ECG Module: 3 lead ECG 9. ECG Slave Cable and Adapter Kit (used to interface with external ECG monitors) 10. Color Printer 11. PowerPack (external battery for increased scan time) 12. Unencrypted USB drive Power Supply 1. System operates via battery or AC Power 2. Input: 100-240 VAC, 50-60 Hz, 2.0 A Max @ 100 VAC 3. Output 1: 15 VDC, 5.0 A Max 4. Output 2: 12 VDC, 2.3 A Max 5. Rechargeable lithium-ion battery 6. Battery life: 3 years Environmental Limits for System, Transducer and Battery 1. Operating a. Temperature range: 10-40°C (50-104°F) b. Humidity range: 15-95% R.H. c. Pressure range: 700 to 1060 hPa (0.7- 1.05 ATM) 2. Shipping and Storage a. Temperature range: -20-60°C (-4 -140°F) b. Humidity range: 15-95% R.H. c. Pressure range: 500 to 1060 hPa (0.5- 1.05 ATM) 3. Shipping and Storage (system and transducer) a. Temperature range: -35-65°C (-31 -149°F) b. Humidity range: 15-95% R.H. c. Pressure range: 500 to 1060 hPa (0.5- 1.05 ATM The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above. Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, DUNS Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 334510 (size standard of 1250 employees). Please answer the following questions: (1) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? (2) Is your company considered small under the NAICS code identified under this RFI? (3) Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? (4) If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). (5) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? 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All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award. If a solicitation is issued, information will be posted on the FedBizOpps (FBO) web site for all qualified interested parties at a later date and interested parties must respond to the solicitation to be considered for award. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by e-mail to Contracting Specialist at contact@example.gov. DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. 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