1260-- Aesculap Bipolar Generator

Combined Synopsis-Solicitation for Commercial Products and Commercial Services Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format Revolutionary FAR Overhaul (RFO) in Federal Acquisition Regulation (FAR) subpart 12.202, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, 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 solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2026-01 dated March 13, 2026. This solicitation is unrestricted for two (2) new bipolar generator systems. The associated North American Industrial Classification System (NAICS) code for this procurement is 334510, with a small business size standard of 1,250 employees. The FSC/PSC is 1260. The NCO 5 Louis A. Johnson VA Medical Center 1 Medical Center Drive Clarksburg, WV 26301 is seeking to purchase an Aesculap Bipolar Generator GN160. All interested companies shall provide brand name or equal quotations for the following: Supplies/Services Line Item Description Quantity Unit of Measure Unit Price Total Price 1 GN160: HF UNIT GN160 2 EA 2 US735: US POWER CORD 305CM 2 EA 3 GN161: FOOT CONTROL FOR GN060 AND GN160 2 EA 4 US349SP: DUAL BIPOLAR CORD STER 365CM 10/BX 2 BX Statement of Work (SOW) Ref: 1. Introduction: This requirement is for the procurement, delivery, setup and acceptance support, training, warranty, and related documentation for two (2) new bipolar generator systems to replace the Synergy MALIS Precision generators currently used by the Surgical Services Department at the Louis A. Johnson VA Medical Center (LAJVAMC), 1 Medical Center Drive, Clarksburg, West Virginia 26301. The required configuration is based on the Aesculap GN160 bipolar generator and the contract line items. 2. Scope of Work: The Contractor shall furnish new, unused, current-production equipment in the OEM's original packaging. The Contractor shall provide both generators, all specified accessories, and every ancillary item required for complete, safe, and clinically intended operation. The Contractor shall package, handle, transport, deliver, and support acceptance of the systems; provide one (1) day of on-site end-user training; provide operating, service, cleaning, sterilization, and warranty documentation; and provide warranty repair and preventive maintenance support. All equipment shall be delivered free from damage and ready for Government inspection and functional verification. Delivery shall be FOB Destination and completed no later than 90 days after receipt of order (ARO). The Contractor shall provide shipment tracking information to the Contracting Officer's Representative (COR). 3. Requirements: A. Equipment and Quantities The Contractor shall provide the following configuration: (1) Two (2) Aesculap GN160 high-frequency bipolar generator units. (2) Two (2) Aesculap US735 United States power cords, 305 cm, one for each generator. (3) Two (2) Aesculap GN161 single-pedal foot controls, one for each generator. (4) Two (2) boxes of Aesculap US349SP sterile disposable dual bipolar cords (forceps plugs), 365 cm, ten (10) cords per box, one box for each generator. (5) All OEM-standard hardware, connectors, cables, and ancillary components required for full operation. Proposed equivalent equipment, when permitted by the solicitation, shall meet or exceed every requirement and shall be fully compatible with all required accessories. B. Technical and Safety Characteristics Each generator shall meet or exceed the following minimum characteristics: (1) Dual-voltage operation at 100-120 V or 220-240 V, 50/60 Hz. (2) Maximum dimensions of 305 mm x 135 mm x 325 mm (length x width x height) and a maximum weight of 6 kg. (3) CE marking and compliance with applicable IEC standards for electromagnetic compatibility, electrical safety, and patient protection. (4) Microprocessor-controlled, AC impedance-adaptive operation that actively reduces power as needed to reduce tissue carbonization and forceps sticking during coagulation. (5) Optimized non-stick bipolar performance using real-time monitoring and adjustment of coagulation parameters to reduce sparking and hot spots. (6) Real-time current and flow measurement. (7) A micro power range of 0.1 to 9.9 watts, adjustable in 0.1-watt increments, and a macro power range of 1 to 50 watts, adjustable in 1-watt increments. (8) Two selectable operating modes: STANDARD, the default mode for rapid coagulation across the full range while limiting voltage based on measured tissue resistance; and FORCED, which uses a different impedance curve for more aggressive coagulation when clinically required. (9) Power settings from 1 to 60 DOSIS units, equivalent to 10 to 170 mA, with a rotary control that can toggle between DOSIS and MALIS scales. (10) A clear front-panel digital display for mode and setting readout, a rotary push-button control for power and operating settings, and single-pedal activation through the GN161 foot control. C. Manuals and Processing Information The Contractor shall provide two (2) complete sets of the operating and service manuals. The Contractor shall also provide the applicable Instructions for Use (IFU), including cleaning and sterilization instructions, so the Government can determine whether the facility can properly process the equipment and accessories. Documentation may be supplied in hard-copy or searchable electronic format unless the OEM requires a specific format. D. Delivery, Work Hours, and Coordination Normal work and delivery hours are Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding Federal holidays observed by the Government and any other day declared a national holiday by the President of the United States. Work outside these hours requires advance coordination with the COR. The LAJVAMC warehouse receives deliveries during the same hours. The Contractor shall coordinate delivery, setup, training, and any on-site service with the COR and Biomedical Engineering. E. Training The Contractor shall provide one (1) full day of on-site training for designated end users. Training shall cover the function and use of the system, controls and displays, STANDARD and FORCED modes, DOSIS/MALIS settings, foot-control operation, safe startup and shutdown, and the process for obtaining warranty support. The Contractor shall provide any training materials used and document completion of the training. F. Warranty and Service Support (1) Each system shall include a one-year warranty beginning upon full installation and Government acceptance. (2) Warranty support shall include system repair and preventive maintenance and shall cover all parts, materials, labor, and travel required to complete covered work. (3) The Contractor shall provide a telephone support number for warranty requests and shall respond to each request within two (2) days. (4) Contractor personnel performing on-site warranty or maintenance work shall comply with the on-site procedures in this SOW. (5) Within five (5) working days after completing any service, the Contractor shall provide the COR with a service report with test data. (6) Each service report shall identify the equipment, describe all work performed and issues found, state the equipment's operational status, identify the technician(s) or engineer(s) performing the work, and state the date of service. 4. Tasks: A. Procurement and Delivery The Contractor shall procure the required equipment and accessories; verify quantities and part numbers before shipment; ensure the items are properly packaged and undamaged; provide tracking information to the COR; and deliver the complete order to the LAJVAMC within 90 days ARO. B. Setup, Inspection, and Functional Verification The Contractor shall coordinate setup or installation support required by the OEM. End users, Biomedical Engineering, and/or the COR will inspect the shipment and perform functional verification to confirm that both systems are complete, safe, and fully operational. The Contractor shall promptly correct shortages, shipping damage, defects, incompatibilities, or other nonconformities at no additional cost to the Government. Quality concerns will be communicated through the Contracting Officer to the Contractor's point of contact for resolution. Government acceptance documentation will be completed in Government systems. C. Training The Contractor shall schedule and conduct the required one-day on-site training after delivery and before or in conjunction with final acceptance, as coordinated with the COR. D. Warranty, Maintenance, and Reporting The Contractor shall activate and administer the warranty; provide repair and preventive maintenance support; meet the response and reporting timeframes stated above; and maintain complete service documentation throughout the warranty period. E. On-Site, Safety, Security, Property, and Records Compliance Contractor personnel arriving for on-site work shall report to Biomedical Engineering; sign the department's vendor log in and out; provide all required information; permit inspection of tool bags upon arrival and departure; wear visible identification and clearly identify themselves as contractor personnel; comply with parking requirements and the VA's non-smoking policy; and, before departure, report equipment issues and operational status to Biomedical Engineering. Contractor personnel shall follow all applicable Occupational Safety and Health Administration requirements and LAJVAMC infection-control, safety, and security procedures. The Contractor shall prevent damage to Government property, immediately report any damage, and repair or replace damaged property with like material at no additional cost to the Government, subject to Contracting Officer approval. Contractor personnel who create, receive, maintain, or otherwise handle Federal records shall comply with applicable Federal records laws, National Archives and Records Administration regulations, VA policies, Privacy Act and Freedom of Information Act safeguards, and Government requirements for protecting sensitive, proprietary, classified, and controlled unclassified information. The Contractor shall prevent unauthorized disclosure, removal, alteration, or destruction; return records and data when no longer needed or as directed; obtain Contracting Officer approval before subcontracting work that requires disclosure of protected records; use Government information technology only as authorized; and complete required VA records-management training. The Government owns all data, records, and deliverables produced under the contract, and the Contractor shall not retain, use, sell, or disseminate protected copies except as authorized by the contract. 5. Deliverables (a) Two complete GN160 bipolar generator systems and all contract line-item accessories. (b) Shipment tracking information provided to the COR before delivery. (c) Two complete sets of the operating and service manuals, applicable IFUs and cleaning/sterilization instructions, warranty information, and the warranty-support telephone number. (d) Setup or installation support and documentation of successful inspection and functional verification. (e) One day of on-site end-user training, including any training materials used and documentation of completion. (f) Warranty and preventive maintenance support, including timely service reports with test data for all covered service events. 6. Acceptance Criteria (a) All required equipment and accessories are delivered within 90 days ARO, in the correct quantities, in original OEM packaging, and free from shipping damage. (b) Each generator and accessory meets or exceeds the contract line-item requirements and salient technical and safety characteristics. (c) Biomedical Engineering, end users, and/or the COR successfully complete inspection and functional verification, and the systems are fully operational. (d) All required manuals, IFUs, processing instructions, warranty documentation, and contact information are complete and accepted by the Government. (e) The required one-day on-site training is completed and documented. (f) The one-year warranty is activated as of full installation and Government acceptance, and all deficiencies identified before acceptance are corrected at no additional cost to the Government. The purchase order period of performance is within 90 days ARO. Delivery shall be provided no later than 90 days after receipt of order (ARO). It is FOB Destination Place of Performance/Place of Delivery Address: 1 Medical Center Dr Clarksburg, WV Postal Code: 26301 Country: UNITED STATES The full text of FAR provisions or clauses may be accessed electronically at https://www.acquisition.gov/browse/index/far. The following solicitation provisions and clause apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Products and Commercial Services The response must include descriptive literature demonstrating the product meets or exceeds the salient characteristics specified above. The Government's intent is to include all ancillary items to ensure the equipment can function as designed by the Original Equipment Manufacturer (OEM) and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the salient characteristics. Additionally, responses can include any additional product that may be beneficial. These items must be clearly identified by brand name and part number. Manufacturer or Distributor If distributor provides full name, business size and address of manufacturer. Country of Origin designation for all products MUST COMPLETE THIS SECTION Technical Literature that clearly shows product(s) meet the identified salient characteristics and page numbers where each salient characteristic is met. Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified. Authorized Distributor Letter Certified by OEM with a current date. Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of RFO FAR 12. FAR 52.212-2 Evaluation-Commercial Products and Commercial Services: In accordance with RFO FAR 12.201-1 and FAR 12.201-2 when appropriate, the contracting officer may (1) Insert the provision at 52.212-2, Evaluation-Commercial Products and Commercial Services, in solicitations for commercial products or commercial services. The following are the decision factors: Technical, Warranty/extended , Price, Past Performance Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://sam.gov/. FAR 52.212-4, Contract Terms and Conditions Commercial Products and Commercial Services NOV 2023 To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoters shall list exception(s) and rationale for the exception(s), if any. Submission of your response shall be received not later than 0900AM on June 19th 2026 at charles.cameron3@va.gov. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). FAR 52.222-90 Addressing DEI Discrimination by Federal Contractors APR 2026 (a) Definitions. As used in this clause Program participation means membership or participation in, or access or admission to: training, mentoring, or leadership development programs; educational opportunities; clubs; associations; or similar opportunities that are sponsored or established by the contractor or subcontractor. Racially discriminatory diversity, equity, and inclusion (DEI) activities means disparate treatment based on race or ethnicity in the recruitment, employment (e.g., hiring, promotions), contracting (e.g., vendor agreements), program participation, or allocation or deployment of an entity's resources. (b) In connection with the performance of work under this contract, the Contractor agrees as follows: (1) The Contractor will not engage in any racially discriminatory DEI activities; (2) The Contractor will furnish all information and reports, including providing access to books, records, and accounts, as required by the Contracting Officer, for purposes of ascertaining compliance with this clause; (3) In the event of the Contractor's or a subcontractor's noncompliance with this clause, this contract may be canceled, terminated, or suspended in whole or in part, and the Contractor or subcontractor may be declared ineligible for further Government contracts; (4) The Contractor will report any subcontractor's known or reasonably knowable conduct that may violate this clause to the Contracting Officer and take any appropriate remedial actions directed by the Contracting Officer; and (5) The Contractor will inform the Contracting Officer if a subcontractor sues the Contractor and the suit puts at issue, in any way, the validity of this clause. (6) The Contractor recognizes that compliance with the requirements of this clause are material to the Government's payment decisions for purposes of 31 U.S.C. 3729(b)(4). (c) The Contractor must include the substance of this clause, including this paragraph (c), in subcontracts at any tier, including those for commercial products and commercial services, except those where the place of delivery or performance is outside the United States. 52.226-8 ENCOURAGING CONTRACTOR POLICIES TO BAN TEXT MESSAGING WHILE DRIVING (MAY 2024) (a) Definitions. As used in this clause "Driving" (1) Means operating a motor vehicle on an active roadway with the motor running, including while temporarily stationary because of traffic, a traffic light, stop sign, or otherwise. (2) Does not include operating a motor vehicle with or without the motor running when one has pulled over to the side of, or off, an active roadway and has halted in a location where one can safely remain stationary. "Text messaging" means reading from or entering data into any handheld or other electronic device, including for the purpose of short message service texting, e-mailing, instant messaging, obtaining navigational information, or engaging in any other form of electronic data retrieval or electronic data communication. The term does not include glancing at or listening to a navigational device that is secured in a commercially designed holder affixed to the vehicle, provided that the destination and route are programmed into the device either before driving or while stopped in a location off the roadway where it is safe and legal to park. (b) This clause implements Executive Order 13513, Federal Leadership on Reducing Text Messaging while Driving, dated October 1, 2009. (c) The Contractor is encouraged to (1) Adopt and enforce policies that ban text messaging while driving (i) Company-owned or -rented vehicles or Government-owned vehicles; or (ii) Privately-owned vehicles when on official Government business or when performing any work for or on behalf of the Government. (2) Conduct initiatives in a manner commensurate with the size of the business, such as (i) Establishment of new rules and programs or re-evaluation of existing programs to prohibit text messaging while driving; and (ii) Education, awareness, and other outreach to employees about the safety risks associated with texting while driving. (d) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (d), in all subcontracts that exceed the micro-purchase threshold, as defined in Federal Acquisition Regulation 2.101 on the date of subcontract award. Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. Point of Contact Charles Cameron charles.cameron3@va.gov Alison Klein Alison.klein@va.gov