6515--ADI Finapres Nova

This is a combined synopsis/solicitation for commercial products prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This is a Brand Name or Equal To Request for Quote (RFQ), and the solicitation number is 36C26025Q0535. The Government anticipates awarding a firm-fixed price supply order from this solicitation. This is a solicitation for ADI Finapres Nova autonomic function monitor. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2025-03 Effective January 17, 2025. This solicitation is 100% set-aside for small business. The associated North American Industrial Classification System (NAICS) code for this procurement is 334510, with a small business size standard of 1250 employees, and the PSC is 6515. All interested companies shall provide quotations that are Brand Name or Equal To the following: Equipment Needed: ADI Finapres Nova Autonomic Function Monitor Items: Brand Name or Equal to Finapres Nova Description/Part Number* Qty Price Extended Amount PLC01 PowerLab C 1 PLCI1/LP Instrument Interface (C Series, with LabChart 8 Pro) 1 CWE14-10000 GEMINI Respiratory Gas Analyzer 1 FE141/CS Spirometer (with Front End Interface) 1 MLT1000L Respiratory Flow Head 1000 L 1 MLA1011A Clean-bore Tubing & Tubing Adapter 1 FE285/CS Neuro Amp (with Front End Interface) 1 FMSNP287/3 Finapres Nova Plus NC System (Full Options, 3 Lead ECG) 1 MLT382/L Finger Cuff for Human NIBP Nano (Large) 1 MLT382/M Finger Cuff for Human NIBP Nano (Medium) 1 MLT382/S Finger Cuff for Human NIBP Nano (Small) 1 MLAC23 BNC to 3.5 mm Mono Audio Plug (1/8") Cable (2 m) 4 MLAC30 BNC to BNC Cable (2 m) 2 Training 1 TOTAL - SALIENT CHARACTERISTICS The Portland VA Medical Center is seeking information to determine market capability for The Finapres NOVA Plus, a non-invasive continuous blood pressure monitor that can be expanded with several hardware modules and software applications, compatible with ADInstruments DAQ. The double finger cuff system measures patients 24/7, is patient friendly, and basic configuration displays basic blood pressure values and hemodynamic parameters. This is a non-invasive continuous beat-to-beat pressure monitor with an algorithm that measures finger plethysmography which it then transforms into a systolic and diastolic arterial blood pressure, reflective of being recorded in the brachial artery. It provides a blood pressure waveform output that characterizes variability in arterial circulation pressure and flow. It can also provide thermodilution-calibrated cardiac output values. These complex transformations rely on extensive data sets for validation allowing comparison across other studies and will be relied upon for insight into possible treatment, disease, and intervention progression. The system consists of hardware and software components capable of functionally replacing a multi-pen recorder, storage oscilloscope and a sweep/pulse generator. The software is fully integrated with the hardware and requires little or no programming skill to use. The software provides control and storage of all hardware settings to allow automatic experiment initialization. The hardware has a USB (2.0 or C) interface to allow for system portability. The hardware/software package is capable of being used on a Macintosh (MacOS X v10.8, OS X 10.11) or Microsoft Windows 11, 10, and 8.1 The system must also meet the following international and local safety standards. International: IEC60601-1:1998 General requirements for safety IEC60601-1-1:1992 Safety requirements for medial electrical systems IEC60601-1-2:1993 Electromagnetic compatibility IEC61326:2002 Electrical equipment for measurement, control & laboratory use EMC requirements IEC61010-1ED2.0 Safety requirements for electrical equipment for measurement, control and laboratory use Local: CE Mark EU Safety Directives CSA Mark Class 8750 01 Medical Electrical Equipment Class 8750 81 - Medical Electrical Equipment (Certified to US Standards) UL Mark CAN/CSA-C22.2 No. 601.1 and UL 60601-1. Dimensions (what is the space requirement for the product?): Height 333mm Width 277mm Depth 260mm Weight 5kg Display/Monitor/Screen (If required): Height 65mm Width 50mm Depth 30mm Weight 0.75kg If Yes, Voltage (AC/DC) range 10A, 125V Power Cable Length 3xmin 0,75 mm2 appliance Grounded: The Finapres Nova should only be used with a properly grounded AC receptacle (100V - 240V, 50/60 Hz). Hospital grade line cords in AC-powered systems are preferred. Environmental Considerations: Humidity control range from 5 to 90 % non-condensing Heating/Cooling range from (operation) 0 °C to 35 °C (storage) -20 °C to 70 °C Accessories/Consumables: The finger cuffs are considered consumables and should be replaced after extended use. The HCU should also be replaced every three years. Warranty and Parts/Service Requirements: Minimum Warranty Finapres Medical Systems B.V. issues a 12 month guarantee on the Finapres Nova. Parts/Service/Support options: provide support during normal business hours. Service options for the Nova should be available upon request and may incur an additional cost. Cleaning Instructions: Can be cleaned by whipping its surface using a soft, slightly moistened cloth. Cleaning fluid or any liquid should not be sprayed directly onto the device or its units. The finger cuffs could be cleaned after each use by submerging the bladder end in an appropriate cleaning solution. Must be FDA approved. Additional information sought: Warranty Must have minimum 1 year warranty Place of manufacture Please complete the attached Buy American Certificate Delivery 30 days ARO desired 52.211-6 Brand Name or Equal. As prescribed in 11.107(a), insert the following provision: Brand Name or Equal (Aug 1999) (a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government s needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation. (b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must- (1) Meet the salient physical, functional, or performance characteristic specified in this solicitation; (2) Clearly identify the item by- (i) Brand name, if any; and (ii) Make or model number; (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and (4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications. (c) The Contracting Officer will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. (d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation. (End of provision) All deliveries will be coordinated with the POC of the following location: Place of Delivery: Portland VA Medical Center Vancouver Warehouse Bldg. 2 1601 E Fourth Plain Blvd. Vancouver, WA 98661 The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html http://www.va.gov/oal/library/vaar/index.asp The following solicitation provisions apply to this acquisition: System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph (d) of 52.212-3, Offeror Representations and Certifications Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM FAR 52.212-1, Instructions to Offerors Commercial Products ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL 52.204-7 System for Award Management (OCT 2018) 52.204-16 Commercial and Government Entity Code Reporting (AUG 2020) 52.204-20 Predecessor of Offeror (AUG 2020) 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021) 52.204-29 Federal Acquisition Supply Chain Security Act Orders Representation and Disclosures (DEC 2023) 52.211-6 Brand Name or Equal (AUG 1999) 52.212-3 Offeror Representations and Certifications-Commercial Products and Commercial Services (MAY 2024) 52.225-2 Buy American Certificate (Oct 2022) (41 U.S.C. chapter 83) 52.252-1 Provisions Incorporated by Reference (FEB 1998) (a) Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e., replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable. (b) Offeror shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e., replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions. (c) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items. (d) Any award made as a result of this solicitation will be made on an All or Nothing Basis. (e) Offerors are warned against contacting any VA personnel other than the Contracting Officer and Contract Specialist prior to placement of any award made resulting from this RFQ. If such contact occurs and found to be prejudicial to competing contractors, the offeror making such contact may be excluded from award considerations. (f) All proprietary information shall be clearly and properly marked. If the Offeror submits annexes, documentation, attachments, or the like, not specifically required by this solicitation, such will count against the Offeror s page limitations unless otherwise indicated in the specific volume instructions below. (g) All information shall be confined to the appropriate file. The offeror shall confine submissions to essential matters, sufficient to define the quote and provide an adequate basis for evaluation. Offerors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each quote. (End of Addendum to 52.212-1) FAR 52.212-2, Evaluation-Commercial Items : The Government may award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. In accordance with FAR 9.104-2, the special standards of responsibility described below apply to this procurement. Offerors who fail to meet any special standards of responsibility will not be eligible to receive contract award. The following factors shall be used to evaluate offers: Special Standards of Responsibility: (Per FAR 9.104-2) The following special standards of responsibility apply to this procurement: SP1: Offeror must be a manufacturer authorized provider for the items provided. A letter from the manufacturer stating such must be included with any response to this solicitation. 1. Price Adherence to the salient characteristics and meeting the special standard is more important than price. (a) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offeror's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. FAR 52.213-3 Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer if it has not been completed on SAM.gov. Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. All Service-Disabled Veteran Owned Businesses or Veteran Owned Businesses must be registered/certified with the U.S Small Business Administration at Veteran Small Business Certification Veteran Small Business Certification (sba.gov). The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Products (OCT 2018) ADDENDUM to FAR 52.212-4 The following clauses are included as a part of the addendum: http://www.acquisition.gov/far/index.html (FAR) http://www.va.gov/oal/library/vaar/index.asp (VAAR) 52.204-13 System for Award Management Maintenance (OCT 2018) 52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020) 52.252-2 Clauses Incorporated by Reference (FEB 1998) VAAR Clauses: 852.203-70 Commercial Advertising (MAY 2018) 852.211-70 Equipment Operation and Maintenance Manuals (NOV 2018) 852.212-71 Gray Market Items (NOV 2018) 852.232-72 Electronic Submission of Payment Requests (NOV 2018) 852.242-71 Administrative Contracting Officer (OCT 2020) 852.246-71 Rejected Goods (OCT 2018) 852.247-71 Delivery Location (OCT 2018 852.247-72 Marking Deliverables (OCT 2018) 852.247-73 Packing for Domestic Shipment (OCT 2018) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products (JAN 2025) (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services: (1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E. Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)). (2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kapersky Lab Covered Entities (DEC 2023) (Section 1634 of Pub. L. 115-91). (3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021) Section 889(a)(1)(A) of Pub. L. 115-232). (4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015). (5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801). (6) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (7) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78) (19 U.S.C. 3805 note)). (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services: The following subparagraphs of FAR 52.212-5 are applicable and incorporated by reference: 52.203-17 52.204-10 52.204-27 52.209-6 52.219-6 Contractor Employee Whistleblower Rights (NOV 2023) (41 U.S.C. 4712) Reporting Executive Compensation & First Tier Subcontract Awards (JUN 2020) Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117-328) Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded (JAN 2025) (31 U.S.C. 6101 note) Notice of Total Small Business Set-Aside (NOV 2020) (U.S.C.644) 52.219-28 Post Award Small Business Program Representation (JAN 2025) (15 U.S.C 632(a)(2)) 52.222-3 52.222-19 Convict Labor (JUN 2003) (E.O. 11755) Child Labor Cooperation with Authorities and Remedies (JAN 2025) (E.O. 13126) 52.222-36 Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793) 52.222-50 Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627) 52.223-23 52.225-1 Sustainable Products and Services (May 2024) Buy American-Supplies (Oct 2022) (41 U.S.C. chapter 83) 52.225-13 52.226-8 Restrictions on Certain Foreign Purchases (FEB 2021) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury) Encouraging Contractor Policies to Ban Text Messaging While Driving (MAY 2024) 52.232-33 Payment by Electronic Funds Transfer System for Award Management (Jul 2018) (31 U.S.C. 3332) All quoters shall submit according to the following: Quotes must be emailed to contact@example.gov and received no later than 10:00 AM PST on 05/21/2025. Quotes may be submitted on this document or the vendor s own form and must include the completed Buy American Certificate 52.225-2, and if not the manufacturer, an authorized distributor letter. Any offer that does not provide the supporting documentation may be considered non-responsive. Required Supporting Documentation and Information: Buy American Certificate Authorized Distributor Letter if not the manufacturer Certification that equipment meets/exceeds the salient characteristics of the desired brand above Delivery date The Government intends to make award without discussions. For information regarding the solicitation, please contact Maureen Sundstrom at contact@example.gov. A.1 52.225-2 BUY AMERICAN CERTIFICATE (OCT 2022) (a)(1) The Offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a domestic end product and that each domestic end product listed in paragraph (c) of this provision contains a critical component. (2) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select no . (3) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component (see FAR 25.105). (4) The terms commercially available off-the-shelf (COTS) item, critical component, domestic end product, end product, and foreign end product are defined in the clause of this solicitation entitled Buy American Supplies. (b) Foreign End Products: Line item No. Country of origin Exceeds 55% domestic content (yes/no) [List as necessary] (c) Domestic end products containing a critical component: Line item No. [List as necessary] (d) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation. (End of Provision)