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64000-00120 Rev 3
16. PRODUCT DESCRIPTION
gammaCore-S (non-invasive vagus nerve stimulator) is a multi-use, hand-held, portable device
consisting of a battery, signal-generating and amplifying electronics, and two buttons for the patient to
control the signal amplitude. The device provides visible (light and display) and audible (beep) feedback
on device and stimulation status. A pair of stainless steel round discs, which are the skin contact
surfaces (“stimulation surfaces”), allows the delivery of a proprietary electrical signal. The patient applies
an electroCore-approved gel to the stimulation surfaces to maintain an uninterrupted conductive path
from the stimulation surfaces to the skin on the neck. electroCore-approved gel is provided with each
unit for this purpose. The stimulation surfaces are capped when not in use.
gammaCore produces a low voltage electric signal consisting of five 5000 Hz pulses that are repeated
at a rate of 25 Hz. The waveform of the electric pulses is approximately a sine wave with a peak
voltage limited to 24 Volts when placed on the skin and a maximum output current of 60 mA.
The signal is transmitted through the skin of the neck to the vagus nerve. gammaCore allows for
the patient to appropriately position and adjust the stimulation intensity as instructed by their HCP.
Each stimulation is designed to be applied for two minutes (120 seconds), after which the device
automatically turns off. Each device allows for multiple stimulations (refer to Section 9).
Unless otherwise directed by the HCP, treatment should be administered as follows:
Acute treatment of episodic cluster headache
Each self-administered treatment should consist of three 2-minute stimulations applied consecutively
at the onset of cluster headache pain or symptoms.
If the cluster headache attack is not aborted, an additional three consecutive 2-minute stimulations
three minutes after the first treatment may be administered.
Treatments may be applied to either side of the neck. gammaCore may be administered for up to
4 attacks (or 8 separate treatments) per day (for a total of up to 24 stimulations per day).
Please see Figure 1 in section 9 for an example of the treatment for one attack.
Acute treatment of migraine headache
Each self-administered treatment should consist of two 2-minute stimulations at the onset of pain. One
stimulation should be applied to the right side of the neck and one stimulation should be applied to the
left side of the neck.
If the pain has not decreased twenty minutes after the start of the first treatment, an additional treatment
consisting of two 2-minute stimulations (one on the right side of the neck, one on the left side of the
neck) may be administered.
If not pain-free two hours after the start of the first treatment, a third treatment consisting of two 2-minute
stimulations (one on the right side of the neck, one on the left side of the neck) may be administered.
Please see Figure 2 in section 9 for an example of the treatment of one migraine headache.
NOTE: The length of each stimulation (120 seconds) provides a sufficient amount of time for correct
positioning of gammaCore and for setting the appropriate stimulation intensity.
NOTE: Make sure that both stimulation surfaces are in contact with the skin during the stimulation.
Checking in a mirror may help until you become familiar with the device and its correct positioning.
