64000-00137 Rev 1
25
20. DETAILED PRODUCT DESCRIPTION
161
gammaCore Sapphire
TM
CV (non-invasive vagus nerve stimulator) is a multi-use, hand-held,
162
rechargeable, portable device consisting of a rechargeable battery, signal-generating and -amplifying
163
electronics, and a control button for the patient to control the signal amplitude. The device provides
164
visible (display) and audible (beep) feedback on the device and stimulation status. A pair of stainless-
165
steel
surfaces, which are the skin contact surfaces (“stimulation surfaces”), allow the delivery of a
166
proprietary electrical signal. The patient applies electroCore-approved gel to the stimulation surfaces
167
to maintain an uninterrupted conductive path from the stimulation surfaces to the skin on the neck.
168
Tubes of electroCore-approved gel are provided with each unit and refill kit for this purpose. The
169
stimulation surfaces are capped when not in use.
170
gammaCore Sapphire CV produces a low-voltage electric signal consisting of five 5,000-Hz pulses that
171
are repeated at a rate of 25 Hz. The waveform of the gammaCore Sapphire CV pulse is approximately a
172
sine wave with a peak voltage limited to 24 Volts when placed on the skin and a maximum output
173
current of 60mA.
174
The signal is transmitted through the skin of the neck to vagus nerve. Each stimulation last 2 minutes
175
allowing the patient to properly position the device, adjust the intensity level, and deliver the dose. After 2
176
minutes, the device automatically stops delivering the stimulation and turns itself off. Each gammaCore
177
Sapphire CV allows for multiple treatments (Refer to Section 12).
178
179
gammaCore Sapphire CV delivers up to 30 stimulations within a 24-hour period (refer to Section 12).
180
Once the maximum daily number of treatments has been reached, the device will not deliver any
181
more stimulations until the following 24-hour period. A charging case is included to charge
182
gammaCore Sapphire CV.
183
184
21. ADDITIONAL WARNINGS AND PRECAUTIONS
185
186
Warnings
187
• Please refer to Section 6 for a complete list of warnings.
188
189
190
Warnings indicate instructions, which, if not followed, may result
in serious injury or death to the device user or to the patient.
Precautions indicate instructions, which, if not followed, may
result in damage to the equipment or degradation in the quality
of treatment.