Statement Of Work TMS Upgrade Horizon Lite with Stimguide.docx

TMS UNIT PWS/SALIENT

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

a) TMS medical device system must be able to deliver repeatable, reliable pulse frequency, pulse train, and time between pulse trains. There must be no difference in power/strength of pulse delivery from first to last pulse. Power - 120% of motor threshold as separately determined for each patient prior to treatment sessions. MUST be iTBS (intermittent Theta Burst) protocol capable.

b) TMS medical device system must have a cooling system that prevents the coil from overheating. An air-cooled unit is required instead of water cooled to prevent the water-cooling system from freezing in cold weather in the event of an environmental failure (which occurred twice in our building). We must prevent the TMS unit from being unusable in the cold climate of our VISN.

c) TMS medical device system must have a method of accurately repositioning and maintaining the coil on the patient’s head from one treatment to the next to ensure repeatable treatment location. The coil must be gravity free. The TMS device must have neuro-navigation capabilities that are integrated with the TMS device package.

d) TMS medical device system must have an adjustable chair for patients to allow correct positioning during TMS treatment. The TMS device and chair must come as a unit.

e) TMS medical device system must be a figure of 8 coil configuration due to lower risk of seizure.

f) TMS medical device system must provide a properly grounded (shock proof) medical device.

g) TMS medical device system must be delivered and setup/installed by medical devices by manufacturers’ certified technicians.

h) TMS medical device system must ensure all medical devices will be calibrated when initially installed and recalibrated according to manufacturer's specifications on a regular schedule by certified personnel to ensure patient safety (magnetic field strength should be defined and measurable).

i) TMS medical device system must operate in normal room temperature environment (59°- 86°F).

j) TMS medical device system must have technology supported customer service.

k) TMS medical device system must provide device training and certificate of training for medical staff for initial installation.

2) Compatibility – Is this item required to be technically compatible with existing equipment? If so, how? Yes. Must be compatible with MagStim. MagStim components must be used to upgrade our current MagStim Horizon Lite to MagStim Horizon Performance with Stim Guide.

3) Dimensions - If dimensions are critical, list below? TMS medical device must fit on and move through a standard ADA wheelchair door.

4) Weight- If weight is critical, list below: Not critical

5) Industry Standard – Is this particular item required to meet specific Industry Standards or Requirements? Yes. Meets all standards for standard medical equipment (FDA approved for clinical treatment).

6) Purpose – How will this item be utilized? This device will conduct transcranial magnetic stimulation (TMS) with iTBS protocol and neuronavigation capabilities to treat treatment resistant major depression.

7) Governing Body or Organization – Not Required.

8) Complete generic identification – Not Required.

9) Applicable model/make/catalog number – MagStim Horizon Performance with StimGuide with 2-year warranty, Onsite Installation & Training. See attached quote

10) Manufacturer name - If requesting specific manufacturer. MagStim Horizon Performance with StimGuide with 2-year warranty, Onsite Installation & Training.

11) The C&A requirements do not apply; a Security Accreditation Package is not required