S02 - Attachment 1 - Salient Characteristics Worksheet MagPro R30 - rev 3.22.23.docx

Brand Name or Equal Worksheet (“Salient Characteristics”) v 2.0

Brand Name or Equal Item: The Santa Rosa Community Outpatient Clinic is requesting to purchase the Mag Pro R30 which is intended to provide electro-physiological aid to assess, diagnose, and monitor diseases of the central and peripheral nervous system based on use of the Motor Evoked Potentials and provide therapeutic treatment of major depressive disorder (MDD) in adult patients who have failed to improve with anti-depressive medications. The device does not require sedation or anesthesia, as the patient remains awake and alert during the treatment. Devices typically allow for storage of multiple stimulator setups, facilitate external control, and may result in heat tolerance issues when performing intense, focused, and repeated protocols, requiring cooling support.

1) Essential/significant physical, functional, or performance characteristics.

· The TMS Therapy System must be FDA approved.

· The TMS Therapy System must be capable of delivering bi-phasic and bi-phasic waveform stimulation with frequencies of between 01 and 30HZ, with ability to define stimulation frequency with 01 Hz resolution.

· The TMS Therapy System must be FDA certified to provide stimulation using intermittent Theta Burst Stimulation (iTBS) protocols.

· The TMS Therapy System must be FDA certified to provide OCD-specific stimulation protocols.

· The TMS Therapy System must have the capability to measure and display current discharge (di/dt) through the transducer coil circuit with single stimulation, paired plus, and burst stimulation protocols.

· The TMS Therapy System must capture, display and record EMG recordings synchronized with delivery of magnetic stimulation pulses.

· The TMS Therapy System must include a motorized control chair, tilt feature, backrest angle, leg rest angle, and chair height. Must have the ability to position arm for positioning and holding the stimulation (transducer) coil stable relative to the patient during procedures, while supporting the patients head during the stimulation procedure.

· The TMS Therapy System must include embedded software to support double blind delivery of experimental TMS, including the ability to utilize a transducer coil that facilitates delivery of both active TMS, and sham TMS with concurrent electrical stimulation (to mimic the sensation of active TMS).

· The TMS Therapy System must have the ability to use a sham noise generator to mask the acoustic noise produced by the TMS coil (for maintenance of the blind).

· TMS Therapy System must be able to be used with FDA approved robotic TMS coil positioning systems.

· The TMS system must have the ability to restrict unauthorized usage.

· The TMS Therapy System must accommodate the use of both cooled and standard coils in a range of configurations including coils cleared for MDD and OCD treatment and include any relevant associated equipment required for cooling.

2) Complete generic identification – TMS magnetic stimulator

3) Applicable model/make/catalog number – 9016E0721 MagPro R30 Magnetic Simulator

9016E0521 Coil Cool-B70

9016E0537A MagVenture OCD System Pacakage (Cool D-B80 OCD Coil, Dedicated Cooling Unit, Install Training and Support)

9016B0151 Coil Cooler for Cool Coils

9016E0672 Coil C-B70 with marking plate

9016B0712 XH Trolley for Mag Pro

9016B0801 Magventure flow arm

9016B0081 Motorized procedure chair

9016B0253 Head stabilizer system

9016B0601 Textile Caps

9016B0671 Pillow case

9016D0031 Isolation transformer

3) Manufacturer name – MagVenture