Attachment 1b - Salient Characteristics - Final - RC082 - rTMS.docx

Salient Characteristics Rapid City Package 082: rTMS In no order of importance, the proposed product must (Have / Be / Able to):

· Approved by the US Food and Drug Administration

· Additionally, separate coils cleared for these specific conditions

· Major Depressive Disorder

· Obsessive Compulsive Disorder (OCD)

· Cooled Coils

· Butterfly Coils

· Bi-Phasic Waveform between 01 and 60HZ with burst of 10 – 50Hz @ 01HZ Resolution

· Intermittent Theta Burst Stimulation (iTBS)

· OCD Specific Stimulation Protocols

· Measure and display current discharge and current rate-of-change with single stimulation, paired plus and burst stimulation protocols

· Ability to store, retrieve and load, >50 stimulation protocols without being connected to a computer or network

· Motorized control chair, tilt feature, angled back rest, angled leg rest, and adjustable chair height

· Neck Rest: Vacuum Pillow pump with Vacuum Pillow for neck and head stabilization

· 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

· Ability to send outgoing and accept incoming, trigger signals as well as introduced delays to outgoing and incoming trigger signals to allow users to coordinate functions of connected devices via triggering

· Medical grade, isolation transformer that steps up voltage from 115v to 250v

· 100% output intensity that produces clicking sounds below the OSHA recommended threshold for hearing protection in conditions of prolonged (8 Hour) exposure to loud noise (SPL>=90dB), when measured at distance of 10cm from the surface of the transducer coil