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64000-00137 Rev 1
2. INDICATION AND PRODUCT DESCRIPTION
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The gammaCore Sapphire
TM
CV (non-invasive vagus nerve stimulator) is intended for acute use at
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home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are
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experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved
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drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare
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provider, by using non-invasive vagus nerve s
timulation (nVNS) on either side of the patient’s neck
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during the Coronavirus Disease 2019 (COVID-19) pandemic. The gammaCore Sapphire CV provides a
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mild electrical stimulation to the vagus nerve, which runs through the neck and carries information to
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the central nervous system. Each stimulation with the gammaCore Sapphire CV lasts 2 minutes. The
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patient controls the intensity level.
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The gammaCore Sapphire CV delivers up to 30 stimulations in a 24-hour period, starting when the
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device is turned on and the intensity level is increased above 3
.
Once the maximum daily number of
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stimulations has been reached, the device will not deliver any more stimulations until the following 24-
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hour period. The number of remaining stimulations available in a 24-hour period is indicated on the
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display (refer to Section 8). gammaCore Sapphire CV is rechargeable and includes a charging case
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to charge the device. The use of more than 24 stimulations per day has not been evaluated in
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controlled clinical trials.
Do not use gammaCore Sapphire CV
more than 24 stimulations in a 24-
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hour period.
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NOTE:
The gammaCore
Sapphire CV’s 24-hour cycle begins the first time the intensity level is
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increased past 3.
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gammaCore Sapphire CV is supplied non-sterile.
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Device Feature
Description / Use
Stimulation Surfaces
Points of contact with
patient’s skin
Display
Indicates device status
(refer to Section 8)
Power Button
Turns power ON/OFF
Control Button
Increase/decrease
intensity level
Cap
Covers and protects the
stimulation surfaces
Charging Case (Case
with Power Cord)
Charges the device
(refer to Section 1
0
)
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For prescription use only.
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