6515--Bipolar ESU

REQUEST FOR INFORMATION This RFI is being sent 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. The Department of Veteran Affairs, located at LOUIS A. JOHNSON VA Medical Center located at 1 MEDICAL CENTER DRIVE, CLARKSBURG WV 26301 is seeking an Aesculap Bipolar Generator GN160 The associated North American Industrial Classification System (NAICS) code for this procurement is 334510- Electromedical and Electrotherapeutic Apparatus Manufacturing, size standard is 1250 employees. Salient Characteristics: Technical Requirements The procurement is for a quantity of two (2) bipolar generators and necessary accessories. Dual voltage operation: 100 120 V or 220 240 V, 50/60 Hz Compact and portable: 305 × 135 × 325 mm, weight approximately 6 kg CE-marked and compliant with IEC standards for electromagnetic safety and patient protection Accessories shall include: Two (2) foot switches, one (1) for each generator. Two (2) power cords, one (1) for each generator. Two (2) boxes of disposable bipolar forceps plugs, one (1) for each generator The generators shall have real time current and flow measurement. The generators shall have a micro power range of 0.1 to 9.9 watts, adjustable in 0.1W increments. The generators shall have a macro power range of 1 to 50 watts, adjustable in 1W increments. Contractor shall provide two copies of the operating and service manuals. Cleaning/Sterilization Requirements. The Contractor shall provide cleaning/sterilization instructions (Instructions for Use IFU) for the Government to determine the ability of the facility to properly process the equipment. Technology & Safety Microprocessor-controlled, AC impedance adaptive system that actively reduces power to prevent tissue carbonization and forceps sticking during coagulation Optimized Non Stick Bipolar performance: real-time monitoring adjusts coagulation parameters to avoid sparking and hot-spots, enhancing safety and efficiency Operating Modes & Power Output Two selectable modes: 1.STANDARD (default): delivers rapid coagulation across the full range while limiting voltage based on measured tissue resistance FORCED: offers a different impedance curve for more aggressive coagulation when needed Power settings range from 1 60 DOSIS (dose units), equivalent to 10 170 mA, adjusted via a rotary control that can be toggled between DOSIS and MALIS scales User Interface & Controls Front panel includes a clear digital display for mode and setting readout (DOSIS/MALIS). Rotary knob with push-button: adjusts power level and toggles operational settings Features a single-pedal footswitch (either round GN161 or squared GK226) for activation Delivery Requirements Delivery is required 90 days from award of the contract. Contractor is to provide the COR with shipment tracking information. Training Requirements Contract shall include training for the end-users in the operation of the system. Training shall be on the function and use of the device Training shall be on-site for one day. Warranty Information The equipment shall have a warranty of 1 year from the full installation/acceptance of the equipment. Warranty support shall include repair of the system Warranty support shall include preventative maintenance of the system. Warranty support shall include all parts, materials, labor, and travel to complete the repair or maintenance. Requests for warranty support shall be made to the telephone support number provided by the Contractor. Warranty support requests shall be responded to within 2 days. Contractor shall provide a copy of the service report, complete with test data, to the contract COR within five working days after completion of any services. Service reports shall include identifying information about the equipment, all services provided during the service visit, any issues found during the visit, the technician/engineer s names of the personnel performing work, and the date service was provided. Responses: 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. Responses to this Sources Sought Notice shall include the following: Does vendor offer an annual service plan, Yes or No? If Yes: What does the plan cover? Does plan cover software updates only? Does the plan cover parts repair or replacement only? Does the plan cover both software and parts? Vendor are requested to provide documentation that shows information on their service plan. Is the service provided by the OEM or a subcontractor? Full name and address of company DUNS number/ CAGE Code/ SAM UIE Business Size Manufacturer or Distributor If distributor provide 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. Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement.