SAM #75F40126Q00277

FDA Solicitation for Electrosurgical Unit (ESU) and Accessories

The U.S. Food and Drug Administration's Center for Devices and Radiological Health is seeking to procure a newly manufactured electrosurgical unit (ESU) for medical use. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Devices and Radiological Health (CDRH) - Office of Science and Engineering Laboratories - Products Requested: - One (1) commercial electrosurgical unit (ESU) with touchscreen display - Real-time tissue impedance monitoring (minimum 434,000 times per second) - Output frequency between 400 kHz and 500 kHz - Operating modes: monopolar CUT (Pure and Blend), monopolar COAG (Fulgurate, Spray, Soft), bipolar coagulation, vessel sealing - Accessories: - Monopolar electrode and holster with switch - Patient return electrode - Bipolar forceps, cord, and footswitch - Vessel sealer with switch - Technical documentation and user manuals - Installation service - Minimum one-year manufacturer's warranty and technical support - Unique/Notable Requirements: - All equipment and accessories must be new, unused, and in full working condition - Delivery required within 30 days after award - Installation at delivery location - Compliance with all applicable safety standards - Warranty period is 12 months from acceptance - No specific OEMs or vendors are named in the solicitation - No part numbers are specified; quantity is one unit

Description

All equipment shall be newly manufactured. It shall not be used, refurbished, reconditioned, remanufactured, or previously used for demonstration. The equipment and all included accessories shall be new, unused, and in full working condition at the time of delivery. 

Salient characteristics and any single-source need 

The salient physical, functional, and performance characteristics the equipment must meet are stated under Minimum technical requirements below: 

Minimum technical requirements 

The equipment shall meet the following minimum requirements. 

Display and user interface 

A touchscreen display for user interaction and parameter control 

Tissue impedance monitoring 

Monitoring of tissue impedance at a minimum rate of 434,000 times per second, providing real-time feedback and energy delivery adjustment 

Output frequency 

Output frequency within the range of 400 kHz to 500 kHz 

Operating modes 

The equipment shall support the following operating modes. 

Monopolar CUT (Pure) 

Monopolar CUT (Blend) 

Monopolar COAG (Fulgurate) 

Monopolar COAG (Spray) 

Monopolar COAG (Soft) 

Bipolar coagulation 

Vessel sealing 

Electrical and safety 

Compliance with all applicable Federal, state, and local safety standards 

Required accessories 

The contractor shall provide all accessories necessary to fully operate the equipment in every operating mode listed above. At minimum the following shall be included. 

Monopolar electrode and holster with switch, compatible with all monopolar modes.  

Patient return electrode for monopolar operation.  

Bipolar forceps, cord, and footswitch for bipolar coagulation.  

Vessel sealer with switch for vessel sealing mode.  

All accessories shall be compatible with the delivered equipment and ready for use upon delivery. 

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