The Food and Drug Administration (FDA) is seeking Full and Open Competition for vendors that can provide quotes/proposals. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant of firm fixed price purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-24. NAICS Code 423490 Project Title: MRI Gradient Field Simulator Background: The Division of Physics, Office of Science and Engineering Laboratories Center for Devices and Radiological Health, FDA requires a Magnetic Resonance Imaging (MRI) Gradient Field Simulator. This system is required for testing implanted medical devices in strong magnetic field similar to those in clinical magnetic resonance imaging (MRI) systems. These fields can cause serious injuries in patients with implanted medical devices undergoing MRI examinations. Required Technical Specifications: The Gradient Field Simulator shall meet the following specifications. QTY 1 Magnetic field generation: 1. The slew rate (dB/dt) of the B field (flux density) shall be variable with a maximum of 30 Tesla/second. The slewing duration will be variable, ranging from 0.25 to 1 msec. 2. The spatial variation of B shall be less or equal to 10% over a cylindrical volume with a diameter of 42 cm and a length of 30 cm. 3. Pulse widths of the magnetic field in the cylindrical volume shall be adjustable from 0.25 to 2 msec. 4. Operating Duty cycle: maximum of 5 pulses/second for 5 minutes interleaved with 5 minute cool-down time Electronics: 1. Pulse generator/amplifier output shall be sufficient to drive the coil to achieve the magnetic field specifications. 2. Power input shall be 3 phase 208 VAC 3. The electronics system shall be air cooled including magnetic field generating amplifier(s) 4. A programmable control interface will be incorporated in the system to allow the user to provide the shape, slew rate, amplitude, and duration of each individual pulse as well as pulse repetition rate and duration of the pulse train. 5. Operation of the Gradient Field Simulator will be performed via a control interface to a personal computer and via manual controls on the system. Commands from a control interface will be sent from a computer via GPIB and USB interfaces. A personal computer with software that is resident on it will be provided with the system. 6. The control interface will allow computer controlled operation and storage of user-defined standard operating settings including pulse sequences. 7. A temperature monitoring system shall provide protection of the system components in the event of excessive power or high duty cycle operation. Mechanical: 1. Weight of entire system: 80 kilograms or less 2. Inside diameter of coil: 50 cm 3. Outside dimensions of coil: less than 90 cm diameter by 150 cm long Installation: 1. The manufacturer will provide detailed, written installation and calibration instructions. Computer files of this material will also be provided. Documentation: 1. The manufacturer will provided detailed, written description of the system including schematics for their custom designed electronic circuitry. Computer files of this material will also be provided. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to
[email protected], no later than March 30, 2009 3:00pm EST. QUOTATIONS DUE: All quotations are due, via fax to: (301) 827-7101 or email to:
[email protected], no later than 3:00pm, EST on Wenesday, April 8, 2009. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to
[email protected], No phone calls will be accepted.