36C25719Q1017-000.docx

FedBizOpps Combined Synopsis/Solicitation Notice

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* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 MagPro X100 system 78229 36C25719Q1017 07-12-2019 N 339112 Department of Veterans Affairs VISN17 Network Contracting Activity 7400 Merton Minter Blvd. (10N17/90C) San Antonio TX 78229 Contract Specialist: Dr. Vinicky Ann Ervin Ph.D.

All interested parties shall only contact Dr. Ervin via email only on July 12, 2019 no later than 4 PM CST.

COE for Research 4800 Memorial Dr. (151C) Waco, TX 76711

USA

vinicky.ervin@va.gov Buisness

MagPro X100 Magnetic Stimulator 230V Systems

LOCAL STOCK NUMBER: 9016E0711

On-site installation and training included in pricing. Extended Warranty Platinum LOCAL STOCK NUMBER: PW

Shipping and insurance

The Department of Veterans Affairs is seeking both manufacturers and/or distributors of the exact match or functionally equivalent equipment/ services to the following listed above.

Statement of Salient Characteristics MagPro X100 TMS Research System The VA requires a repetitive TMS system that meets the requirements as defined below. The vendor shall provide all products and services necessary to complete the tasks outlined. The vendor shall perform all activities to assemble the system equipment to ensure a fully functional system, to include any support systems as applicable. Two rTMS stimulator systems shall be capable of stimulating at a maximum strength of no less than 32 kT/s near the coil surface. The systems must have a documented lineage of “substantial equivalence” to the medical device with 510(k) number K061053. Biphasic pulse width shall be no more than 290 microseconds. Each stimulator shall have an active cooling system such as water cooling or refrigeration making it capable of delivering no less than 20,000 pulses before warm-up at ambient temperature (20 degrees Celsius), when running a protocol with pulses at full dB/dt, pulse trains at 10Hz, 40 pulses per train, 26-second inter-train interval. A system for head fixation shall ensure that coil placement relative to head position remains constant throughout a treatment session – this system should provide adequate resistance to prevent head motion on the millimeter scale, rather than merely providing sensory feedback when such motion occurs. An example of an inadequate head fixation system would be stringing adhesive tape across the patient’s forehead. An internal tracking system shall notify the user of coil use over time, and a replacement plan shall cover the cost of replacement coils including shipping after coils have reached their expected end of reliable stimulation. Both systems shall be capable of neuronavigational, providing native support for DICOM and NifTI file formats. Neuron avigation software shall support the visualization of previously recorded functional MRI data in real time. Both systems shall be capable of delivering sham treatment in the form of electrical stimulation to the skin synchronous with the sound of magnetic pulses in placebo-controlled trials, and these electrodes shall emanate from the stimulator coil itself, while no magnetic fields are permitted to stimulate CNS nerve cells in the sham condition. One system shall include a robotic coil placement apparatus which, in conjunction with the included neuronavigational system, allows for the automatic placement of the coil in user-defined locations in a corresponding 3-dimensional model of the patient’s scalp based on previously acquired MRI data. This robotic system shall include a sensor that prevents the transmission of force more than ten Newtons to the patient’s scalp at any time.

Part # Qty 9016E0711 2 MagPro® X100 Magnetic Stimulator, 230V 9016D0031 2 Isolation Transformer rTMS System 9016B0383 2 Trolley for MagPro (includes coil holder accessories) 9016E0482 2 Coil C-B60 - flat figure of eight coil with built-in power control 9016E0151 1 Coil Cool B65CO - (Axilum TMS-Cobot Edition of the active cooled coil) 9016E0161 1 Coil Cool B65 A/P CO (Axilum TMS-Cobot Edition of the active/sham coil) 9016E0491 1 Coil Cool B65 - dynamic cooled butterfly coil 9016E0501 1 Coil Cool B65 A/P combined active & sham coil 9016S0161 2 Research Software for MagPro R30 / X100 for double blind studies - USB less 9016B0151 2 Coil Cooler for Cool Coils 9016B0171 2 Super Flex Arm for Coil Positioning - long 9016B0081 2 Motorized Procedure Chair with neck rest and cloth cover 9016B0252 2 Head Stabilizer System (Special Vacuum Pillow and Evacuation Pump) 9016B0601 2 Textile Caps - XSmall, Small, Medium, Large, Extra Large-10 pcs.each bundle Sub-Total for two MagPro systems (1) 7611L1710 2 LocaliteTMS Navigator for Research-Spectra (MRI Based Neuro Navigation System) Includes, NDI Polaris Spectra (large format) Infrared Tracking camera, Camera stand, Instruments: Registration Pointer, Calibration Plate, Adhesive Head Reference, 2 Coil Geometry Trackers with MagVenture coil ring brackets to fit the incl. coil handles Localite TMS Navigator software with remote control for MagPro stimulator, High perf.

PC with large format monitor (24"), Three function footswitch, trigger box, and all functional data overlay capabilities (MR- based, MR-Less, MEP+Brainmapping, fMRI, EEG) Sub-Total for two Localite systems (2) 9016ECOB01 1 Axilum Robotics TMS-Cobot TS MV (1) Configuration includes:

Axilum Robotics Optical tracking system for TMS-Cobot TS MV (1) (2) TMS-Cobot Coil adaptation kit for MagVenture Cool B65 CO coil (3) TMS-Cobot Coil adaptation kit for MagVenture Cool B65A/P CO coil (3) Training Onsite installation and training Included