6515--688_Microwave Ablation System (VA-26-00077651)

Description

This RFI is solely for information and planning purposes and does not constitute a solicitation or obligation on the part of the Government. Per FAR 15.201(e), responses to this notice are not considered offers, shall not be used as a proposal, and cannot be accepted by the Government to form a binding contract. Neither unsolicited proposals nor any other kinds of offers will be considered in response to this notice. No evaluation letters and/or results will be issued to the respondents; however, the Government does reserve the right to contact any respondent and/or respondent reference to obtain additional information. At this time, no solicitation exists; therefore, please do not request a copy of the solicitation. Any resulting procurement action will be the subject of a separate, future announcement. The information is provided for discussion purposes and any potential strategy for this acquisition may change prior to any solicitation release. The acquisition strategy, evaluation methodology, contract type, and any other acquisition decisions are to be determined. Background. The Washington DC VA Medical Center (DC VAMC) requires a new microwave ablation system to be used in the interventional radiology suites. The current ablation system is reaching end of service by 9/31/2026 and has passed its HTM life expectancy (5 years, purchased in 2018). This ablation system is used 2-3 times per week and is essential for providing oncology treatment for kidney, liver, and lung cases. This new system must be compatible with SyngoVia software used at the DC VAMC. Scope of Work. The procurement shall include all parts, materials, labor, software/licenses, resources, and training required to implement and utilize the equipment/system to their fullest capacity. All items must be covered by manufacturer s warranty and procured through a manufacturer-approved distribution channel. Distributers and resellers must be able to document ability to provide items through manufacturer-approved distribution channels upon request. Specifications. 4.1 Equipment Line Item Description Quantity IB-SYS-MAG-SVG-H - IntelliBlate Microwave Ablation System with MyAblation Guide deployed on Syngo.via View & Go, with external computer 1 4.2 Required Features Two fully integrated peristaltic pumps 15.6 inch foldable touchscreen 180° CW/CCW swivels Touchscreen operable with gloved fingers and sterile drape One USB port and one ethernet port Includes tract ablation feature cauterizes needle tract Includes needle lock feature probe migration solution Coolant capacity of 100 mL or greater, sterile water of 0.9% saline MWA generator frequency 2.45 GHz ± 50 MHz Applied part type BF independent channel controls Applied part type BF two remote temperature probe support Output power single channel 0-90 W Output power two channel 0-80 W each Microwave output power accuracy Within 10 seconds of activation of output energy on the touchscreen: Power (tip referenced) <25 W: ± 20% Power (tip references) 25 W: ± 5 W or ± 8% Ximitry Probe Antenna Temperature Measurement 10-60°C (±3°C accuracy) 60-85°C (±6°C accuracy) 85-100°C (±10°C accuracy) Temperature Probe Measurement 10-60°C (±3°C accuracy) 60-85°C (±6°C accuracy) 85-100°C (±10°C accuracy) Weight with cart 95 lbs Dimensions with cart W 24 in D 22 in H 43.4 in (touchscreen closed) H 52.75 in (touchscreen open) Electrical power connection 100 VAC-240 VAC, 50 Hz/60Hz, 900 VA Power cord length 25 ft Specific Tasks. 5.1 Delivery. All equipment shall be delivered to: Washington DC VA Medical Center 50 Irving St NW Washington, DC 20422 ATTN: VHAWAS Equipment Committee Contract VA Purchase Order (PO) number shall be included with delivery information (e.g., packing slip). Note: PO number starts with station code 688 followed by a letter and 5 digits (e.g., 688A12345) Delivery Hours: The Warehouse is open to receive deliveries Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding holidays. Contractor shall coordinate delivery with the on-site Point of Contact (POC) and provide shipment tracking information. Contractor shall verify delivery date and time with the on-site POC at least 3 business days prior to scheduled delivery. Delivery is required within 90 days from award of the contract. 5.2 On Site Procedures. COVID-19 Screening: All persons entering the facility shall be subject to screening for COVID-19 per the current CDC (Center for Disease Control) guidelines. Mask Requirement: All contractors shall wear masks while indoors. Contract personnel are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government Officials. Time spent on site shall be for a period sufficient to complete the work set forth in the statement of work. On site visits shall be scheduled in advance with the designated on-site POC. Contractor shall check in and out with Biomedical Engineering prior to visiting the worksite for each day of work. The VA campus is non-smoking. Contractor personnel are required to comply with this policy. Parking: it is the responsibility of the Contractor to park in the appropriate designated parking areas. Contractor personnel s tool bags are subject to inspection. 5.3 Installation/Implementation. Installation/Implementation will be completed by personnel certified and knowledgeable with the designated equipment/system. Installation shall be completed within the period of performance. Contractor shall be responsible for any Personal Protection Equipment (PPE) required when performing work on site. Contractor shall submit all removable media to be used on a VA system to Biomedical Engineering for scanning with anti-virus software prior to use. In the case turn-in, exchange, repair, or replacement of equipment containing hard drives used by the VA, the hard drives shall be removed from the equipment and remain in possession of the VA (this includes loaned or rented equipment). The contractor shall take all necessary precautions to prevent damage to any government property. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor, unless corrective action is taken. Any damaged material (i.e., trees, shrubs, lawn/turf, curbs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the government, upon approval of the Contracting Officer. 5.4 Training. Contractor shall be responsible for providing training to clinical staff/users. Training is to be scheduled in advance with the designated on-site POC. Education shall be provided prior to and/or at time of installation. Education professional shall be certified to provide instruction on the designated equipment/system. Education curriculum must include: operations and set-up, user maintenance, safety, and user troubleshooting tips. 5.5 Inspection and Acceptance. Contractor shall conduct a joint inspection with the on-site POC upon completion of installation. In the event deficiencies are identified, the contractor shall provide the date when the identified deficiencies will be addressed if not addressed on the date of installation. The Contractor shall conduct a joint inspection with the on-site POC after addressing all deficiencies. All deficiencies identified in the joint inspections shall be corrected by the Contractor prior to Government acceptance of the item. Any disputes shall be resolved by the Contracting Officer. 5.6 Deliverables. The Contractor shall provide the below documentation for the proposed equipment to VHAWASEquipmentRequests@va.gov within 10 business days of work completion: Service report. Warranty information. Electronic copy of the Operators Manual. Electronic copies of the complete technical service manuals, including troubleshooting guides, necessary diagnostic software and equipment information, schematic diagrams, and parts lists. Hours of Operation. DC VAMC s normal business hours are Monday-Friday, 8:00 am to 4:30 pm, excluding observed Federal holidays: New Year s Day Labor Day Martin Luther King s Birthday Columbus Day President s Day Veteran s Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day Any other national holiday as declared by the President of the United States Period of Performance. Delivery within 90 days from contract award. RESPONSES:� Please include descriptive literature demonstrating the product meets or exceeds the brand name product specified above.� Please provide any product solution or configuration so long as they are equivalent to the brand name product. Responses can include any additional product that may be beneficial. These items must be clearly identified by brand name and part number.� PLEASE PROVIDE THE FOLLOWING ADDITIONAL INFORMATION: Full name and address of company DUNS number/ CAGE Code/ SAM UEI Business Size Manufacturer or Distributor� If distributor, provide full name, business size, and address of manufacturer.� Country of Origin designation for all products. Technical Literature that clearly shows product(s) are equivalent. Any additional product solution or configuration that would be beneficial to the functionality of the product line identified. � Authorized Distributor Letter Certified by OEM with a current date.� Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement.�