Use Instructions

DRAFT 2/12/2019 SPW 16
 WARNING: Transcranial magnetic stimulation should only be applied to the back of the head
as described in the “Positioning the Device” section of this manual.
 Do not stimulate over the front of the neck or mouth. Severe spasm of the laryngeal and
pharyngeal muscles may occur. Contractions may be strong enough to close the airway or
cause difficulty breathing.
 Do not stimulate over the side of the neck. Stimulation of the carotid sinus nerves, particularly
in patients with a known sensitivity to the carotid sinus reflex, could result in a sudden drop
in blood pressure, slowing of the heart or loss of consciousness.
 Do not stimulate the chest or back. Electrical current into the heart may cause cardiac
arrhythmias.
NOTE: If the device detects an error when it is on, a symbol is displayed. See the
“Understanding System Display Messages” and “Troubleshooting” sections of this manual.
NOTE: The System is a handheld device that comes in direct contact with skin. The housing of
the device is made of polycarbonate, a plastic common in consumer medical products, and
poses no handling risk.
Delivering the Treatment
NOTE: Two hands are needed to stabilize the device, but only one treatment button needs to
be activated to deliver treatment.
NOTE: The device shuts itself off if treatment is not delivered within 45 seconds. Press the
power button to turn the device back on and restart the treatment procedure.
 Once the device is in place and your thumbs are on the treatment switches, press one or both switches and hold for at
least 2 seconds.
 The device emits a soft, audible click as the treatment is delivered.
 After you have successfully delivered the first pulse, remove the device from your head.
 The LED light on the POWER button softly pulses to show that treatment is completed. The device is now ready for
another pulse. You may select to treat again by pressing the power button.
 Repeat the subsequent procedures from page 15, Positioning the Device.
 After delivering the final pulse and 30 seconds of inactivity, the device will attempt to connect to a cellular network,
transfer data and will then power off.
 Delivery of several pulses in a row may cause the device’s surface temperature to exceed 105.8 F (41 C). The surface
may get as warm as 118.4 F (48 C). Let the device cool for 15 minutes. Try again.