6515--PRSCT/649- MRI VENTILATOR TRANSPORT

r large business relative to NAICS 339112 with size standards of 1000 employees. This sources sought is neither a request for competitive proposals nor solicitation of offers. This synopsis is to assit the VA in determining sources only and a solicitation is not currently available. Note that if VA s pending market research establishes that two or more VOSB or SDVOSB, who are certified in U.S Small Business Administration site https://www.sba.gov can perform the project, VA will set aside the underlying solicitation per 38 U.S.C. §8127.� Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this Sources Sought Synopsis, a solicitation announcement may be published on SAM, and/or GSA eBuy. Responses to this Sources Sought Synopsis are not considered adequate responses to the solicitation announcement. General Requirements: The Department of Veterans Affairs (VA), VA Prescott Healthcare System, has a need for the HAMILTON-MR1 PACKAGE. The Hamilton-MR1 will be used to provide mechanical ventilation to patients who require respiratory support while undergoing diagnostic or therapeutic procedures in a Magnetic Resonance Imaging environment. The requirement is for brand name or equal to: MR1 Ventilator Transport Please Identify any domestic alternatives (meaning manufactured in the United States) Nomenclature: Transport Ventilator MANUFACTURE AND BRAND NAME PRODUCT INFORMATION Hamilton Medical Inc CLIN Description Qty Unit of Measure 01 #1610100 - Hamilton-MR1 Package 1 EA - Clinical Training 1 - MR1 Reno Service Training Tuition 1 - MR1 O2 Hose 1 - MR1 Adult/Pediatric Configuration 1 - MR1 US Power Cord 1 - MR1 Trolley (with Intelli brake) 1 - Diss Connector 02-Platform C 1 - MR1 02 Cell-Initial Order 1 - MR1 Li-Ion Batteries (2 pieces) 1 - MR1English Language Kit 1 - MR1 USA Customization 1 02 Hamilton C3/C2/C1/T1/MR1 battery calibrator w/cord 1 EA 03 MR1 Trends/Loops Application 1 EA 04 MR1 NIV/NIV-ST Application 1 EA 05 MR1 DuoPAP/APRV Application 1 EA REQUIREMENTS: The Radiology department requests the acquisition of a Mechanical Ventilator for the purpose of providing continuous respiratory support to patients during MRI imaging procedures. The Salient Characteristics must include: MR-Conditional to 50 mT (compatible with 1.5 T & 3 T scanners) TeslaSpy continuously monitors magnetic field and alerts if too close even when off. Portable ICU ventilator weighing ~6.8 kg ( 21 kg with trolley); compact size supports ICU MRI transport with quick-release trolley and auto-lock brakes. Broad patient range: neonatal (tidal down to 2 mL), pediatric, adult. Ventilation modes: full suite volume & pressure-controlled, ASV®, NIV, nCPAP, HFOT, duet modes like PSIMV+, APRV, DuoPAP. Turbine-driven, no external compressed air needed; delivers up to 260 L/min flow. Battery life 8 9 hr (72 Wh, 2× lithium-ion); recharge time ~3 6 hrs. Ventilation Cockpit UI with 8.4 touchscreen showing waveforms, loops, trends, lung mechanics. Safety & monitoring: alarms for pressures, volumes, disconnections, apnea; leak compensation; dynamic lung panels show compliance, resistance, stress/strain FDA 510(k) cleared in 2016 (K153046) for invasive and noninvasive use in MRI, with neonatal capability and enhanced battery runtime Participating Healthcare Facilities: VISN 22 West VA Prescott Healthcare System 500 HW 89N; Prescott, AZ 86313-5001 In response to this announcement, please complete the information below: Company: Address: Contact Name: Phone No: Email: DUNS: Business size information Select all that applies: Small Business Emerging Small Business Small Disadvantaged Business Certified under Section 8(a) of the Small Business Act HubZone Woman Owned Certified Service-Disabled Veteran Owned Small in Vetbiz.gov Certified Veteran Owned Small Business in Vetbiz.gov Large Business Other:____________ All offered items must be listed on vendor FSS contract FSS/ GSA Contract Holder of the requested item(s) Yes No FSS/ GSA Contract Number Effective Date / Expiration Date Country of Origin (COO) Does your company manufacture the requested product(s)? If no, answer the questions below. Yes No Does your company exceed the 500-employee alternative size standard for nonmanufacturers? Yes No Is your company primarily engaged in the retail or wholesale trade and normally sell the type of product(s) being supplied? Yes No Does your company take ownership or possession of the products(s) with its personnel, equipment, or facilities in a manner consistent with industry practice? Yes No Does your company supply the end product(s) of a small business manufacturer or processor made in the US, or obtain a waiver of such requirement? Yes No Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes. Not applicable List: Note* The Non-Manufacturer Rule (NMR) in accordance with 13 CFR § 121.406, September 4, 2019 applies to this acquisition. Additionally, as prescribed on 25.1101(a)(1). FAR 52.225-1 Buy American Supplies and FAR 52.225-2 Buy American Certificate applies to this acquisition. a) For small business set-asides other than construction or service contracts the prime contractor that s supplying products to the government is required to cover at least 50 percent of the cost of manufacturing those products. The non-manufacturer rule is an exception to that requirement. The rule allows a small business to supply products it did not manufacture as long as those products come from another small business. b) A manufacturer is defined as a business that, with its own facilities, performs primary activities in transforming inorganic or organic substances, including the assembly of parts and components, into the end product being acquired. In other words, a manufacturer makes or produces products. Businesses may qualify as a non-manufacturer if it meets the following criteria: · Does not exceed 500 employees · Is primarily engaged in the retail or wholesale trade and normally sells the type of products being supplied · Will supply the end products of a small business manufacturer or processor made in the United States, or obtains a waiver of such requirement See Title 13 Part 121.406 of the Code of Federal Regulations (CFR) for detailed information about the non-manufacturer rule. FAR 52.225-1 Buy American American-Supplies (Oct 2022) (a) Definitions. As used in this clause Commercially available off-the-shelf (COTS) item (1) Means any item of supply (including construction material) that is (i) A commercial product (as defined in paragraph (1) of the definition of commercial product at Federal Acquisition Regulation (FAR) 2.101); (ii) Sold in substantial quantities in the commercial marketplace; and (iii) Offered to the Government, under a contract or subcontract at any tier, without modification, in the same form in which it is sold in the commercial marketplace; and (2) Does not include bulk cargo, as defined in 46 U.S.C. 40102(4), such as agricultural products and petroleum products. Component means an article, material, or supply incorporated directly into an end product. Cost of components means (1) For components purchased by the Contractor, the acquisition cost, including transportation costs to the place of incorporation into the end