ElectroCore gammaCore-S User manual

1
Instructions for Use for gammaCore®-S
1. INTENDED USE & PRODUCT DESCRIPTION .......................................................... 2
2. WHAT SHOULD I EXPECT?....................................................................................... 2
3. WILL I STILL NEED TO TAKE MEDICATIONS? ......................................................... 3
4. WARNINGS AND PRECAUTIONS.............................................................................. 3
5. POTENTIAL RISKS AND COMPLICATIONS .............................................................. 6
6. DISPLAY SYMBOLS ................................................................................................... 7
7. TROUBLESHOOTING/DEVICE STATUS INDICATORS............................................. 8
8. BUTTON FUNCTIONS...............................................................................................11
9. HOW TO USE gammaCore....................................................................................... 12
10. CLEANING ................................................................................................................ 17
11. PRODUCT HANDLING ............................................................................................. 17
12. PRODUCT DISPOSAL.............................................................................................. 17
13. SYMBOLS AND NOMENCLATURE DESCRIPTION ................................................ 18
14. ORDERING INFORMATION ..................................................................................... 19
15. PRODUCT ORDERS AND RETURNS...................................................................... 19
ADDITIONAL INFORMATION FOR HEALTHCARE PROVIDERS.................................... 20
16. PRODUCT DESCRIPTION ....................................................................................... 21
17. WARNINGS AND PRECAUTIONS............................................................................ 22
18. POTENTIAL ADVERSE REACTIONS....................................................................... 25
19. CLINICAL STUDIES .................................................................................................. 26
20. CONTACT INFORMATION........................................................................................ 47
Caution: Rx Only. US Federal Law restricts this device to sale by or on the
order of a licensed healthcare provider.

264000-00120 Rev 3
1. INTENDED USE AND PRODUCT DESCRIPTION
gammaCore-S (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus
nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for the acute treatment of
pain associated with episodic cluster headache and migraine headache in adult patients.
FDA review is based on a clinical comparison of probable risks and benets to health and FDA has
determined probable benet to health based on clinical evidence submitted to FDA and patient
preference information.
gammaCore provides a mild electrical stimulation of the vagus nerve, which runs through the neck
and carries information to the central nervous system. Each stimulation with gammaCore lasts two
minutes (120 seconds). The patient controls the stimulation intensity. After the rst time gammaCore is
powered on, the device will operate for 31 consecutive days.
gammaCore is supplied non-sterile.
The safety and effectiveness of this device is based on a comparison of its low risks and
probable benet to health. The FDA has determined probable benet to health based
on the patient’s stated preference for the device.
For prescription use only.
2. WHAT SHOULD I EXPECT?
People respond differently to nVNS.
Acute treatment of episodic cluster headache
Based on the clinical trials conducted with gammaCore, and unless otherwise directed by your
healthcare provider (HCP), 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, you may administer an additional treatment, consisting
of three consecutive 2-minute stimulations, three minutes after the rst treatment. Treatments may be
applied to either side of the neck.
Device Feature Description / Use
Stimulation Surfaces Points of contact with
patient’s skin
Light Indicates device status
(refer to Section 7)
Display Indicates device status
(refer to Section 7)
Control buttons
Turn power ON/OFF
INCREASE/DECREASE
stimulation intensity
Caps Cover and protect the
stimulation surfaces

364000-00120 Rev 3
You may administer gammaCore for up to 4 attacks (or 8 separate treatments) per day (for a total of
24 stimulations per day). The length of each stimulation (120 seconds) provides a sufcient
amount of time for correct positioning of gammaCore and for setting the appropriate stimulation strength.
For episodic cluster headache: One treatment is dened as three consecutive 2-minute stimulations
lasting 120 seconds (2 minutes).
If the treatment does not provide relief, you should continue taking your usual medications and seek
medical attention if necessary.
Acute treatment of migraine headache
Based on the clinical trial conducted with gammaCore for the acute treatment of migraine, and
unless otherwise directed by your HCP, each 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 your rst treatment, you may administer
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).
If you are not pain-free two hours after the start of your rst treatment, you may administer 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).
For migraine headache: One treatment is dened as two consecutive 2-minute stimulations lasting 120
seconds (2 minutes).
If the treatment does not provide relief, you should continue taking your usual medications and seek
medical attention if necessary.
3. WILL I STILL NEED TO TAKE MEDICATIONS?
You and your HCP should discuss your ongoing treatment routine, including the use of any additional
therapies and/or medications. It is important to always follow your HCP’s recommendations about
your medications. gammaCore can be used adjunctively with existing medications for the acute
treatment of pain associated with episodic cluster headache or migraine headache.
4. WARNINGS AND PRECAUTIONS
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.

464000-00120 Rev 3
Warnings
• The safety and effectiveness of gammaCore (nVNS) have not been established in the acute
treatment of chronic cluster headache.
• This device has not been shown to be effective for the prophylactic treatment of migraine
headache, chronic cluster headache, or episodic cluster headache.
• The long-term effects of the chronic use of the device have not been evaluated.
• Safety and efcacy of gammaCore have not been evaluated in the following patients, and
therefore it is NOT indicated for:
o Patients with an active implantable medical device, such as a pacemaker, hearing aid implant,
or any implanted electronic device
o Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
o Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
o Pediatric patients
o Pregnant women
o Patients with active cancer or cancer in remission
o Patients with clinically signicant hypertension, hypotension, bradycardia, or tachycardia
o Patients with an abnormal cervical anatomy
o Patients with a history of brain tumor
o Patients with aneurysms
o Patients with “bleed or head trauma”
o Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease,
including congestive heart failure (CHF), known severe coronary artery disease or recent
myocardial infarction (within 5 years).
o Patients with a history of a prolonged QT interval or arrhythmia
o Patients with a history of an abnormal baseline ECG (e.g. second and third degree heart
block, atrial brillation, atrial utter, recent history of ventricular tachycardia or ventricular
brillation, or clinically signicant premature ventricular contraction)
o Patients with uncontrolled hypertension
o Patients with a history of seizures
• Do not use gammaCore:
o While driving, operating machinery, or during any activity that may put you at risk of injury.
o If you have a metallic device such as a stent, bone plate, or bone screw implanted at or near
your neck. You must inform your HCP of any planned surgeries that may involve implants.
o Near Microwave rays, MR, X-Ray, RF surgical, or CAT machines. gammaCore is not
compatible for use in an MR eld.
o In an explosive atmosphere or in the presence of ammable gas mixtures.
o If you have an open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s)
on your neck at the treatment location.
o If you have wet skin, are in the water, or just stepped out of the water (e.g., shower, bath, pool).
o If you are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any
portable electronic device (e.g., mobile phone).

564000-00120 Rev 3
• Contact your HCP if your symptoms continue or worsen.
• Treatment is intended to be given (administered) by a clinician in a healthcare facility or as
directed by an HCP. Your HCP or electroCore Customer Service must train you in the proper use
of gammaCore.
Precautions
Before Use:
• You must read the gammaCore Instructions for Use before using gammaCore. However, reading
the Instructions for Use may not be enough to fully explain the safe and effective use of the
device. Ask your HCP or electroCore Customer Service if you have any questions about how to
use the device or require any further clarication of the Instructions for Use.
• Only use gammaCore as described in these Instructions for Use or as otherwise directed by your
HCP. The use of gammaCore for up to 4 attcks (or 8 separate treatments) per day (for a total of
24 stimulations per day) for the acute treatment of episodic cluster headache and more than 3
gammaCore treatments per day (for a total of 6 stimulations per day) for the acute treatment of
migraine headache has not been evaluated.
• Only use an electroCore-approved gel with gammaCore. Please contact electroCore Customer
Service for an electroCore-approved gel that works with the device.
• Remove jewelry that may touch the treatment location (necklaces, earrings, etc.) before treating
with gammaCore.
• Always carefully examine the device for any signs of damage or defects before use.
• Do not share your gammaCore with another person.
Do not use gammaCore if:
• The stimulation surfaces are broken or cracked.
• The casing is cracked, dented, or appears to be damaged.
• The light is ashing green and “Err” is shown on the display when the device is turned on.
Flashing green means that there is an error (refer to Section 7).
• It has passed its expiration date. The expiration date is indicated on the device packaging.
During Treatment:
Discontinue treatment if you experience:
• Light-headedness, dizziness, or chest pain
• Excessive skin irritation
If the device seems to malfunction, continue taking usual medications and seek medical care as
needed. When possible, contact electroCore Customer Service for assistance with your device;
electroCore Customer Service cannot provide medical assistance.
Caring for Your Device:
• Keep gammaCore away from water or other liquids, including cleaning liquids.
• Moisture may damage the device. Keep gammaCore away from things like nebulizers and
steam kettles.
• Store gammaCore in a safe location out of reach of children.

664000-00120 Rev 3
• Exposure to extreme hot or cold temperatures outside the range of 0°C to 38°C (32°F to 100°F)
may cause the device to not work properly. Keep gammaCore away from things like replaces
and heaters.
• Do not attempt to replace the device battery. If the device is not working, contact electroCore
Customer Service.
• Do not open or take apart the case, or attempt to repair or modify the device. There are no user
serviceable parts. If the device is not working, contact electroCore Customer Service.
• Do not intentionally damage, burn, or puncture the device.
• Wireless communications equipment such as wireless home network devices, mobile phones,
cordless telephones and their base stations, and walkie-talkies can affect this equipment. Keep
gammaCore at least 3.3 meters away from these items while in use.
5. POTENTIAL RISKS AND COMPLICATIONS
• Shortness of breath (dyspnea), hoarseness, or change in voice during treatment
• Muscle twitching, discomfort, or pain during stimulation
• Change of taste (dysgeusia)
The above should resolve after treatment is complete.
• Tingling, pricking, or a feeling of “pins and needles” on the skin where the device is applied
(paresthesia or dysaesthesia) lasting beyond the treatment period
• Skin irritation/inammation
• Fainting (syncope), light-headedness, and/or dizziness
• Sweating
• Fatigue, depressed mood
• Tinnitus
• Progression of headache symptoms
• Diarrhea
• Abnormal heart rhythm
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764000-00120 Rev 3
6. DISPLAY SYMBOLS
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Icon Icon Description Example Display Display Description
Stimulations Remaining 9 stimulations remaining
Stimulation Intensity
Stimulation intensity at 20,
V symbol indicates a signal
at stimulation surfaces
Days Remaining
15 days remaining until
device expires and will not
deliver stimulations
Stimulation
Last stimulation intensity
Intensity at Last Use

864000-00120 Rev 3
7. TROUBLESHOOTING / DEVICE STATUS INDICATORS
gammaCore has a visual indicator (light and display) and an auditory signal (beep) to indicate device
status.
Status Light Display Sound User Action
Start Up / Ready
for Use
Green Light On
1. Number of Days
Remaining
2. Number of
Stimulations Remaining
1 short beep after
power ON
Follow
“How to Use”
Instructions
Device in Use
Green Light On
(is not an indicator
that there is a signal
at the stimulation
surfaces)
Stimulation Intensity
(min 1 – max 40)
Short beep each
time (+) or (-) button
is pressed
Follow
“How to Use”
Instructions
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964000-00120 Rev 3
Status Light Display Sound User Action
Stimulation
Complete
None
1. Number of Days
Remaining
2. Number of
Stimulations Remaining
3. Last Stimulation
Intensity
2 short beeps
NONE:
Device turns off
automatically
Error
Flashing Green Light
Repeated long
beeps
Device turns off
automatically after
10 seconds
Turning off and on
again may clear
error*
No Stimulations
Remaining
Flashing Green Light
Repeated long
beeps
Device turns off
automatically
Replace device*
Expired/
No Days Left
Flashing Green Light
Repeated long
beeps
Device turns off
automatically
Replace device*

10 64000-00120 Rev 3
Status Light Display Sound User Action
Low Battery
Flashing Green Light
Repeated long
beeps
Plan to
replace device*
Device Does Not
Turn On
None
None None
Press the (+) and (-)
buttons at the same
time for 10 seconds
and then release.
Wait 5 seconds and
press the top (+)
button again to turn
the device on
Dead Battery
None
None None Replace device*
*Contact electroCore Customer Service if error is not cleared or to order a new device.
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11 64000-00120 Rev 3
8. BUTTON FUNCTIONS
(+) Button (-) Button (+) and (-) Buttons pressed
at the same time
Turns device ON; Increases
stimulation intensity
Decreases stimulation
intensity Turns device OFF
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12 64000-00120 Rev 3
Set Up
1. Remove any jewelry that may touch the
treatment location.
2. Find a comfortable sitting position. (A place
where you can see your neck in a mirror would
be helpful).
3. Locate the treatment location by nding the pulse
on the side of the neck. The vagus nerve is in the
same area. Make sure the treatment location is
clean and dry.
9. HOW TO USE gammaCore
Jaw
Muscle
Windpipe
Treatment
Location (Pulse)
The stimulation
surfaces of the device
will line up with the
following landmarks:
• Over the pulse
(orange)
• In front of the large
muscle at the side of
the neck (yellow)
• Just below the lower
jaw (blue)
• Lined up next to the
windpipe (green)

13 64000-00120 Rev 3
4. Remove the caps from the stimulation surfaces.
5. Apply a small (pea-sized) amount of the gel to
both of the stimulation surfaces. Not applying the
gel as described may cause the stimulation to be
uncomfortable or less effective.
CAUTION: Only use an electroCore-approved gel with
gammaCore. Please contact electroCore Customer
Service for an electroCore-approved gel that works
with the device (Refer to Section 22).
6. Turn gammaCore on by pressing the top (+) button.
When the device is ready for use, the light will turn
green and the device will beep once. The number
of stimulations available and days remaining will be
displayed.

14 64000-00120 Rev 3
Delivering Treatment
7. Position the device on the side of the neck
over the treatment location. Use mild to
moderate pressure so the device makes
good contact with the skin; however, do
not apply excessive pressure to the neck.
8. Increase the stimulation intensity by repeat-
edly pressing (or holding down) the (+) button
to the maximum level you can tolerate. The
device will beep every time the control but-
ton is pushed and the display will indicate a
numerical value between 1 and 40, which
signies the intensity of the stimulation. You
will likely feel muscle contractions at the treat-
ment location. These are normal and should
stop after the stimulation is complete. The
appropriate stimulation intensity is different for
every person.
NOTE: Neck muscle contractions during the
stimulation that are not painful are normal and
not a reason to stop the stimulation. If muscle
contractions are too strong or uncomfortable, try:
a. Removing gammaCore from the neck.
b. Lowering the stimulation intensity by press-
ing the (-) button. Be careful not to turn the
device off, unless intended (this will use up
one of the available stimulations).
c. Repositioning gammaCore on the neck over
the pulse and slowly increasing the stimula-
tion intensity again by pressing the (+) button.
If the stimulation is still intolerable, turn the
device off by pressing the (+) and (-) buttons at
the same time and discontinue the stimulation.
CAUTION: Do not turn gammaCore on again
until preparing for the next treatment. The
device counts each time the stimulation intensity
is higher than three (3) as a stimulation. The
device has a limited number of stimulations it
can deliver.
9. Delivering treatment
a. 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,
you may stimulate with an additional three
consecutive 2-minute stimulations three
minutes after the rst treatment.
Treatments may be applied to either
side of the neck. You may administer gam-
maCore 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 at
the end of this section for an example
of the treatment for one attack.
b. 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.

15 64000-00120 Rev 3
If the pain has not decreased twenty minutes
after the start of your rst treatment, you may
administer an additional treatment consisting of
two 2-minute stmulations (one on the right side of
the neck, one on the left side of the neck).
If you are not pain-free two hours after the start
of your rst treatment, you may administer 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).
Please see Figure 2 at the end of this section
for an example of the treatment of one migraine
headache.
NOTE: The length of each stimulation (120
seconds) provides a sufcient 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.
10. After each stimulation, remove the device
and turn it off by pressing the (+) and (-)
buttons at the same time or wait for the
device to automatically turn off. After
completing the stimulation, the device will
display the number of stimulations and days
remaining and the last stimulation intensity
before automatically turning off.
NOTE: A stimulation stops automatically after 120
seconds. The device will make 2 short beeps and
automatically stop stimulation.
NOTE: The number of days and stimulations
remaining can be viewed by turning the device
on. However, do not turn the stimulation intensity
higher than three (3) until preparing for a stimula-
tion. The device counts each time the stimulation
intensity is higher than three (3). The device has
a limited number of stimulations.
NOTE: Some users who attempt multiple stimula-
tions in a row could experience an issue where the
device will not turn on immediately. gammaCore
has a delay feature to prevent accidental starts
due to an unintentional button press. To resolve,
wait 10 seconds before turning the device on
again and repeat steps 5-9a for the acute treatment
of episodic cluster headache and steps 5-9b for
the acute treatment of migraine headache.
NOTE: If you have trouble turning on the device,
press the (+) and (-) buttons at the same time for
10 seconds and then release. Wait 5 seconds and
press the top (+) button again to turn on the device.
11. Clean the device by wiping the leftover gel
off the stimulation surfaces with a soft dry
cloth (refer to Section 10).
12. Clean the excess gel off your neck with a
cloth or tissue. The gel is not intended to be
left on the skin and may cause skin irritation
for some people.
13. Put the caps back on the device after use.

16 64000-00120 Rev 3
*One treatment consists of three consecutive 2-minute stimulations at the onset of pain; if pain is
still present 3 minutes after the rst treatment, a second treatment of three consecutive 2-minute
stimulations may be applied. You may treat up to 4 attacks per day; however, do not exceed 24
stimulations per day.
*One treatment consists 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 your rst treatment, you
may administer 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). If you are not pain-free two hours after the start
of your rst treatment, you may administer a third treatment consisting of two 2-minute stimula-
tions (one on the right side of the neck, one on the left side of the neck).
Figure 1. Treating an episodic cluster headache*
Figure 2. Treating a migraine headache*
20 min after the
start of Treatment 1
120 min after the
start of Treatment 1

17 64000-00120 Rev 3
10. CLEANING
• Clean the device after each use by gently wiping the case and the stimulation surfaces with a soft,
dry cloth to remove leftover gel.
• Put the caps back on the device after use to protect the stimulation surfaces from dirt, debris, or
damage.
PRECAUTIONS:
• Do not submerge the device in water; it is not water resistant.
• Do not use soap, hand sanitizer, detergents, or other cleansers when cleaning the device.
11. PRODUCT HANDLING
Operating Conditions
• Range: 0° to 38°C (32° to 100° F)
• Humidity: 10% - 90%
• Barometric Pressure: less than 80 kPa
• Altitude: Use below 2000m
• Only use the device indoors.
• Maximum Output: 30V (peak), 60mA (peak)
• Load impedance: 450-550 Ohms
• gammaCore produces an electrical signal consisting of ve 5,000 Hz pulses, repeating at a rate
of 25 Hz. The waveform of the gammaCore pulse is approximately a sine wave.
Storage/Transport Conditions
• gammaCore should be stored at room temperature away from moisture
• Range: 0° to 38°C (32° to 100°F)
• Humidity: 10% - 90%
• Barometric Pressure: less than 80 kPa
• Replace caps after each use.
• Store device in such a way (e.g., drawer or shelf) so that the caps remain in place and are not
inadvertently removed.
Service Life
• The service life of gammaCore is 1.5 years after the date of manufacture (refer to package label
for expiration date).
• The service life of the gel is 1.5 years.
12. PRODUCT DISPOSAL
Regulations require that disposal of electrical and electronic equipment including
used and unused medical devices is handled in a controlled manner. A product that
may be contaminated after use or that may contain chemicals or elements which may
present hazards to people or the environment must be disposed of in accordance
with the applicable government regulations. Contact electroCore Customer Service
if you have questions about the appropriate disposal of this device.
NOTE: gammaCore contains a lithium battery that cannot be removed by the user.

18 64000-00120 Rev 3
13. SYMBOLS AND NOMENCLATURE DESCRIPTION
Follow operating instructions
Manufacturer
Protection from solid foreign objects
≥12.5 mm and ingress of water at 15°
Type BF applied part
Storage temperature
Date of Manufacture on package label,
where: yy is the year of manufacture,
e.g., 2518G1001 indicates the year of
manufacture is 2018
Non-ionizing electromagnetic radiation
Atmospheric pressure range
Relative humidity range
MR unsafe
Authorized representative
Expiration date
Lot number
Catalogue number / Reference number
Electric shock hazard
Serial number
Non-sterile
WARNING
Failure to follow instructions may
result in serious injury or death to
the patient or user
PRECAUTION
Failure to follow instructions may
result in damage to the equipment or
degradation in the quality of treatment
Refer to instruction manual
Information or additional
information available
Separate collection for waste of
electrical and electronic equipment
IP22
xxyyGzzzz
(package
label)

19 64000-00120 Rev 3
14. ORDERING INFORMATION
Authorization by your HCP is required.
Catalog Number Description
10009-40601 gammaCore, 31 Day
40000-00103 Conductive Gel
15. PRODUCT ORDERS AND RETURNS
Returns of a non-working device should be reported to electroCore customer service. For Contact
Information, refer to Section 22.
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20 64000-00120 Rev 3 20 64000-00120 Rev 3
ADDITIONAL INFORMATION FOR HEALTHCARE PROVIDERS