SAM #75F40126Q00277

FDA Solicitation for Electrosurgical Unit (ESU) and Accessories

The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), is seeking to procure a commercial Electrosurgical Unit (ESU) and all required accessories for laboratory and test method development purposes. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Devices and Radiological Health (CDRH) - Office of Science and Engineering Laboratories - White Oak Building 62, Room 1131 - Products and Quantities: - Electrosurgical Unit (ESU): 1 unit - Touchscreen user interface - Real-time tissue impedance monitoring (434,000 times per second) - Output frequency: 400-500 kHz - Supports monopolar CUT (Pure and Blend), monopolar COAG (Fulgurate, Spray, Soft), bipolar coagulation, and vessel sealing modes - Monopolar Electrode and Holster with Switch: 1 unit - Patient Return Electrode: 1 unit - Bipolar Forceps, Cord, and Footswitch: 1 unit - Vessel Sealer with Switch: 1 unit - User Manuals and Technical Documentation: 1 set - Installation services: 1 service - Manufacturer Warranty and Technical Support (Minimum One Year): 1 service - Unique/Notable Requirements: - Equipment must be new, unused, and fully operational upon installation - Delivery and installation required within 30 calendar days after contract award - Minimum one-year manufacturer's warranty and technical support - All accessories must be compatible with the ESU and its operating modes - User and technical documentation, including warranty and service contact information, must be provided - OEMs and Vendors: - No specific OEMs or brands are named; opportunity is open to any manufacturer meeting the technical requirements - Technical requirements are detailed and must be strictly met for laboratory and verification activities.

Description

The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), requires the purchase, delivery, warranty, and acceptance of one (1) commercial Electrosurgical Unit (ESU) and all required accessories. The ESU will be used to generate electromagnetic disturbance signals that emulate real-world exposure conditions in support of laboratory experiments, test method development, and verification activities. The system shall include a touchscreen user interface, real-time tissue impedance monitoring, output frequency between 400 kHz and 500 kHz, and support monopolar, bipolar, and vessel-sealing operating modes. The acquisition includes all accessories necessary for full operation, user and technical documentation, a minimum one-year manufacturer's warranty, and delivery within 30 calendar days after contract award. The equipment shall be new, unused, and fully operational upon completion of required installation and shall meet all technical and functional requirements specified in the Requirements Document.

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