ElectroCore gammaCore Sapphire SLC User manual

164000-00154 Rev 2 EN
Instructions for Use for gammaCore SapphireTM SLC
(non-invasive vagus nerve stimulator)
1. INDICATIONS AND PRODUCT DESCRIPTION ............................................................... 2
2. GAMMACORE TREATMENT RECOMMENDATIONS ..................................................... 3
3. CONTRAINDICATIONS ................................................................................................. 4
4. COMMON SIDE EFFECTS ASSOCIATED WITH GAMMACORE ...................................... 4
5. WARNINGS AND PRECAUTIONS ................................................................................. 5
6. WILL I STILL NEED TO TAKE MEDICATIONS? ............................................................... 7
7. ADDITIONAL INFORMATION FOR HEALTHCARE PROVIDERS ...................................... 7
8. DISPLAY SYMBOLS ...................................................................................................... 8
9. DEVICE STATUS INDICATORS ....................................................................................... 9
10. CHARGING INSTRUCTIONS ....................................................................................... 11
11. FUNCTIONS............................................................................................................... 12
12. HOW TO USE GAMMACORE SAPPHIRE .................................................................... 13
13. RELOADING INSTRUCTIONS...................................................................................... 17
14. DEVICE ERROR CODES .............................................................................................. 18
15. CLEANING ................................................................................................................. 19
16. PRODUCT HANDLING ............................................................................................... 19
17. TROUBLESHOOTING ................................................................................................. 20
18. PRODUCT DISPOSAL ................................................................................................. 20
19. SYMBOLS AND NOMENCLATURE DESCRIPTION ....................................................... 21
20. PRODUCT ORDERS AND RETURNS............................................................................ 22
21. CLINICAL STUDIES..................................................................................................... 22
22. ELECTRICAL CLASSIFICATION .................................................................................... 22
23. ELECTROMAGNETIC COMPATIBILITY GUIDANCE ...................................................... 22
24. CONTACT INFORMATION .......................................................................................... 23
CAUTION: HEALTHCARE PROVIDER (HCP) AUTHORIZATION REQUIRED.

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1. INDICATIONS AND PRODUCT DESCRIPTION
gammaCore Sapphire™ (non-invasive vagus nerve stimulator, gammaCore) is intended to provide
non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for:
•Preventive treatment of cluster headache in adults
•Acute treatment of cluster headache in adults
•Preventive treatment of migraine headache in adolescents (age 12 and older) and adults
•Acute treatment of migraine headache in adolescents (age 12 and older) and adults
gammaCore™ provides a mild electrical stimulation to the vagus nerve, which runs through the neck
and carries information to the central nervous system. Each stimulation with gammaCore lasts 2
minutes. After 2 minutes, the device automatically stops delivering the stimulation and turns itself off.
The patient controls the intensity level.
gammaCore delivers up to 30 stimulations in a 24-hour period, starting when the device is
turned on and the intensity level is increased above 3. Once the maximum daily number of
stimulations has been reached, the device will not deliver any more stimulations until the following 24-
hour period. The number of remaining stimulations available in a 24-hour period is indicated on the
display (refer to Section 8). gammaCore is rechargeable and includes a charging case to charge the
device. A gammaCore refill card is used to load the device with days of therapy based on a healthcare
provider (HCP) authorization.
NOTE: Once activated with a refill card, the course of therapy will decrease by one day as every 24-
hour period passes. This daily countdown will occur regardless of use, so only activate a refill card
when you intend to use the full course of therapy.
gammaCore is supplied non-sterile.
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
stimulation intensity
Cap
Covers and protects the
stimulation surfaces
Refill Card
Loads device with therapy
when a refill is required
(refer to Section 13)
Charging Case
(Case with Power Cord)
Charges the device
(refer to Section 10)

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2. GAMMACORE TREATMENT RECOMMENDATIONS
PREVENTIVE TREATMENT
Daily: Morning and Night
A treatment consisting of 2, two-minute stimulations on the same side of the neck at morning and night*
*Additional treatments may be recommended by a Healthcare Provider (HCP) for Cluster Headache
and other Trigeminal Autonomic Cephalalgias.
ACUTE TREATMENT
At the earliest sign of pain:
A treatment consisting of 2, two-minute stimulations on the same side of the neck as needed; repeat
treatment if pain persists.
*The use of more than 24 stimulations per day has not been evaluated in controlled clinical trials.
Do not use more than 24 stimulations in a 24-hour period.
TREATMENT 1
TREATMENT 2
MORNING
NIGHT
2
TWO-MINUTE
STIMULATIONS
2
TWO-MINUTE
STIMULATIONS
TREATMENT
2
TWO-MINUTE
STIMULATIONS
AT THE START OF PAIN

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3. CONTRAINDICATIONS
Contraindications include but are not limited to:
•Patients with an active implantable medical device, such as a pacemaker, hearing aid
implant, or any implanted electronic device
•Patients who are using another device at the same time (e.g., TENS Unit, muscle stimulator)
or any portable electronic device (e.g., mobile phone)
Patients should not use gammaCore:
•While driving, operating machinery, or during any activity that may put patient at risk of injury
•Near microwave machines, magnetic resonance imaging, radio frequency surgical, or
computer-aided tomography machines
•In an explosive atmosphere or in the presence of flammable gas mixtures
•If patient has an open wound, rash, infection, swelling, cut, sore, drug patch, or surgical
scar(s) on the neck at the treatment location
•If patient has wet skin, is in the water, or just stepped out of the water (e.g., shower, bath,
pool)
4. COMMON SIDE EFFECTS ASSOCIATED WITH GAMMACORE
The most common side effects (occurring in less than 2% of patients) include the following:
•Application site discomfort
•Application site irritation/redness
•Local pain, face/head/neck area (including toothache)
•Muscle twitching and/or contractions, face/head/neck area (including facial droop and/or lip
pull)
•Headache/migraine
•Dizziness
•Tingling, pricking, or a feeling of “pins and needles” on the skin where the device is applied
(paresthesia/dysesthesia)
These side effects typically resolve immediately after the stimulation is complete.
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5. WARNINGS AND PRECAUTIONS
Warnings
• The long-term effects of the chronic use of gammaCore have not been evaluated.
• Safety and efficacy of gammaCore has not been evaluated and therefore is NOT
indicated for:
o Adolescents with congenital cardiac issues
• Safety and efficacy of gammaCore have not been evaluated in the following patients:
o Patients with uncontrolled hypertension, hypotension, bradycardia, or tachycardia
o Patients with a history of baseline cardiac disease or atherosclerotic
cardiovascular disease, including congestive heart failure, known severe coronary
artery disease, or recent myocardial infarction (within 5 years)
o Patients with a metallic device such as a stent, bone plate or bone screw
implanted at or near their neck
o Patients with a history of abnormal baseline ECG, prolonged QT interval or
arrhythmia
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 an abnormal cervical anatomy
o Patients with a history of brain tumor, aneurysm, bleed, or head trauma
o Patients with a history of syncope or seizures
• Contact your HCP if your symptoms continue or worsen
• Treatment is intended to be given (administered) as directed by an HCP.Your HCP or
Customer Service must train you in the proper use of gammaCore
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.

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Precautions
• The long-term safety and effectiveness of gammaCore have not been demonstrated in
adolescents 12-17 years of age. Due to hormonal and cognitive development changes in
adolescents, this population should be closely monitored while using the device. The use of
the device in this population is based on extrapolated data from a clinical study in adults.
Before Use:
• Only use gammaCore as described in the Instructions for Use, or as otherwise directed
by the HCP
• The use of more than 24 stimulations per day has not been evaluated in controlled
clinical trials. Do not use more than 24 stimulations in a 24-hour period
• Only use an electroCore-approved gel with gammaCore. Please contact Customer
Service for an electroCore-approved gel that works with the device
• Do not share gammaCore with another person
• gammaCore should not be applied across or through the head, directly on the eyes,
covering the mouth, on the chest or the upper back, or over the heart
• Remove jewelry that may touch the treatment location (necklaces, earrings, etc.)
• Carefully examine the device for any signs of damage or defects
Do not use gammaCore if:
• The stimulation surfaces are broken or cracked
• The casing is cracked, dented, or appears to be damaged
• An “E” with a numeric code is displayed on the screen when the device is turned on. This
means that there is an error (refer to Section 14)
• 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, discontinue use immediately, continue taking usual medications
and seek medical care as needed. When possible, contact Customer Service for assistance with your
device; 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 items such as nebulizers
and steam kettles
•Store gammaCore in a safe location out of reach of children

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•Avoid exposure to extreme hot or cold temperatures outside the range of 0°C to 38°C (32°F
to 100°F). Exposure to such conditions may cause the device to malfunction
•Do not attempt to replace the device battery. If the device is not working, contact 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 Customer Service
•As the device contains a lithium-ion battery, 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 m (10.8 ft) away from these items while in use
If the device is not working, contact Customer Service (refer to Section 24).
6. WILL I STILL NEED TO TAKE MEDICATIONS?
You and your healthcare provider (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 with existing medications as there
have been no reported device-drug interactions.
7. ADDITIONAL INFORMATION FOR HEALTHCARE PROVIDERS
gammaCore Sapphire™ (non-invasive vagus nerve stimulator) is a hand-held, rechargeable, portable
device consisting of a rechargeable battery, signal-generating and -amplifying electronics, and a control
button for the patient to control the signal amplitude. It is intended for single patient use and can deliver
multiple stimulations a day. The device provides visible (display) and audible (beep) feedback on the
device and stimulation status. A pair of stainless-steel surfaces, which are the skin contact surfaces
(“stimulation surfaces”), allow the delivery of a proprietary electrical signal. The patient applies
electroCore-approved gel to the stimulation surfaces to maintain an uninterrupted conductive path from
the stimulation surfaces to the skin on the neck. Tubes of electroCore-approved gel are provided with
each unit and refill kit for this purpose. The stimulation surfaces are capped when not in use.
gammaCore produces a low-voltage electric signal consisting of five 5,000-Hz pulses that are repeated at
a rate of 25 Hz. The waveform of the gammaCore pulse is approximately a sine wave with a peak voltage
limited to 24 Volts when placed on the skin and a maximum output current of 60mA.
The HCP must brief the patient on the following items:
•The HCP must inform the patient using gammaCore to notify them of any changes in health
status. The HCP must re-evaluate the patient’s suitability for treatment using gammaCore
based on the patient’s new health information.
•The HCP should train patients in the proper use of gammaCore, inform them of all potential
risks and complications of treatment, and provide accompanying device labeling.

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8. DISPLAY SYMBOLS
Icon Description Icon Example
Display
Description
Stimulations
Remaining
6 stimulations remaining
within a 24-hour period
Intensity Level
Intensity level
is at 23
Months Remaining
3 months of therapy
remaining*
Days Remaining
30 days of therapy
remaining*
The display will begin
flashing when there are 31
days remaining.
Intensity Level
at Last Use
Last delivered intensity
level was 23
Battery Battery is charging
Reload
Refill card is being read
*When the device is first loaded with a refill card, the display will show months of therapy remaining. The display will show the number of
months of treatment left until day 31, where it will begin counting down the number of days remaining.

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9. DEVICE STATUS INDICATORS
gammaCore has a visual indicator (display) and an auditory signal (beep) to indicate device status.
Status Display Sound User Action
Start Up /
Ready for Use
1. Months/Days Remaining
2. Stimulations Remaining
1 beep after
power ON
Follow “How to Use”
Instructions
(refer to Section 12)
Device in Use
Intensity Level
(min 1 – max 40)
Short beep each
time intensity is
increased/
decreased
Follow “How to Use”
Instructions
(refer to Section 12)
Stimulation
Complete
Last Intensity Level Used
Will Show
THEN THE DISPLAY WILL
SWITCH BETWEEN
1. Months/Days Remaining
2. Stimulations Remaining
2 short beeps
NONE:
Device turns off
automatically
*If error is not resolved, contact Customer Service (refer to Section 24).
2 seconds
2 seconds

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Status Display Sound User Action
Maximum number
of stimulations
reached within 24
hours.
None
gammaCore turns off
automatically
Wait until next 24-hour
period
Expired/ No
Days Left
None
gammaCore turns off
automatically
Reload with refill card
Low Battery
Repeated
long beeps Place in charging case
Dead Battery None None Place in charging case
Charging
Battery Charge Indicator
Bars Flash and Increase
None Allow device to
fully charge
Charging
Complete
None
Remove gammaCore
from charging case
gammaCore is
ready to use
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10. CHARGING INSTRUCTIONS
1. Plug the power cord of the charging case into a power
outlet. Only use the provided power cord with the charging
case.
2. Place the device into the charging case with the power
button facing up. The device should fit into the charging
case with ease. Do not force the device into the charging
case.
NOTE: The cap is designed to position gammaCore correctly
in the charging case. If the device is misaligned, “Un” is
displayed. Remove the device and try placing gammaCore in
the charging case again.
3. The device display will show “Ch” with the battery charge
indicator bars flashing and increasing.
4. The device will show “dn” when fully charged.
NOTE: It only takes a few minutes until there is enough
charge to deliver 2-3 stimulations.
NOTE: Charge your device before first use. It typically takes 4
to 5 hours for a full charge. High temperatures may increase
the charging time. Monitor battery life and charge as needed
to maintain an adequate number of stimulations on
gammaCore (refer to Section 9 for feedback on the device
status indicators).
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11. FUNCTIONS
Power Button Increase Intensity Level Decrease Intensity Level
Press power button to turn
device ON
Hold power button to turn
the device OFF
Press upper area of the
control button
Press lower area of the
control button
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12. HOW TO USE GAMMACORE SAPPHIRE
Set Up
1. Remove any jewelry that may touch the treatment
location.
2. Find a comfortable position. (A place where you can
see your neck in a mirror may be helpful.)
3. Locate the treatment location by finding 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.
The stimulation surfaces of the device will
line up with the following landmarks:
• Over the pulse (orange); this is the
treatment location
• In front of the large muscle at the side of
the neck (yellow)
• Just below the lower jaw (grey)
• Lined up next to the windpipe (green)
Jaw
Treatment
Location
(Pulse)
Muscle
Windpipe

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4. Remove the cap.
5. Apply a small (pea-size) amount of gel to both of the
stimulation surfaces. Not applying the gel as described may
cause the stimulation to be uncomfortable or not effective.
CAUTION: Only use an electroCore-approved gel with
gammaCore. Please contact Customer Service for an
electroCore-approved gel that works with the device (refer to
Section 24).

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Delivering Treatment
6. Turn gammaCore on by pressing the power
button. When the device is ready for use, the
device will beep once. The number of
stimulations available for that 24-hour period
and months/days remaining will be displayed.
7. Position the device on the side of the neck over
the treatment location. Use mild to moderate
pressure so both stimulation surfaces make
good contact with the skin; however, do not
apply excessive pressure to the neck
8. Increase the intensity level to the maximum level you can tolerate by repeatedly pressing the top
area of the control button. Once you have found your maximum level, hold gammaCore in place for
the remainder of the 2-minute stimulation. You may experience a lip pull. The device will beep every
time the control button is pushed, and the display will indicate a numerical value between 1 and 40,
which signifies the intensity level.You will likely feel muscle contractions at the treatment location.
These muscle contractions are normal and should stop after the stimulation is complete. The
appropriate intensity level is different for every person and may vary from stimulation to stimulation.
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:
•Lowering the intensity level by pressing the bottom area of the control button
•Repositioning gammaCore on the neck over the pulse and slowly increasing the
intensity level again by pressing the top area of the control button
If the stimulation is still intolerable, remove gammaCore from the neck and turn the device off by
pressing and holding the power button and discontinue the stimulation.
NOTE: The device has a limited number of stimulations it can deliver in a 24-hour period.
NOTE: The length of each stimulation, 2-minutes, provides enough time for correct positioning of
gammaCore and for setting the appropriate intensity level.
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.

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9. At the end of each stimulation, the device will
display the last intensity level that was used for
approximately 7 seconds, then revert to display
the number of stimulations and months/days
remaining.You may then place the device back
on the treatment location for another
stimulation. Additional gel may be applied
between each stimulation.
NOTE: After 2 minutes, the device will beep twice,
and the stimulation will automatically stop.
NOTE: The months/days and stimulations
remaining can be viewed by turning gammaCore
on. However, do not turn the intensity level higher
than three (3) until preparing for a stimulation. The
device counts each time the intensity level is
higher than three (3) as a stimulation. gammaCore
delivers a limited number of stimulations in a 24-
hour period.
10. Clean gammaCore by wiping the leftover gel off the stimulation surfaces with a soft, dry cloth
(refer to Section 15).
11. 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.
12. Put the cap back on the device after use.
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13. RELOADING INSTRUCTIONS
1. Once you have received your gammaCore Refill Card, you
can now load your device.
2. Turn gammaCore on by pressing the power button. Have
your refill card ready.
3. Once gammaCore is turned on, place the device on a hard
surface with the display screen facing up. Place the refill
card across the device so you can see the display (as
shown in the diagram).
4. Leave the refill card on the device for a minimum of 10
seconds. (Do not move the refill card as it may disrupt the
loading process).
5. gammaCore will display “rd” and the icon (refer to
Section 8 for displayed details) while gammaCore is
reading the refill card.
6. gammaCore will beep twice when therapy has been
loaded. The reading and loading process may take a
minimum of 10 seconds.
7. The number of months/days loaded onto your gammaCore
will be displayed (Refer to Section 8). The device is now
ready to be used for treatment.
NOTE: If a “C” (warning) or “H” (error) with a numeric code is
displayed, an error has occurred during the reloading process.
Turn the device off, then back on and try to reload a second
time. If the error continues, contact Customer Service.
NOTE: If 5 card reloading “H” errors occur during a 24-hour
period, “H2” will be displayed. Wait 24 hours and retry or
contact Customer Service.
NOTE: If 10 card loading attempts are made during a 24-hour
period, “H1” will be displayed. Wait 24 hours and retry or
contact Customer Service.

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14. DEVICE ERROR CODES
Status Display Sound User Action
Start-Up Error
An example of an error
code:
Errors may have different
numeric codes
None
Wait 24 hours and restart
device
(Turn off and on again)*
Too many
attempts to reload
the device in
24-hour period
Repeated Long
Beeps
Wait 24 hours and try
again*
Too many reload
errors in 24-hour
period
Repeated Long
Beeps
Wait 24 hours and try
again*
Card already used
None Locate unused refill card
and try again*
Wrong Card
Version for this
Device
None
Card has already been
used or wrong version card
for this device*
gammaCore Not
Correctly
Placed in
Charging Case
None
Ensure gammaCore is
placed correctly in
charging case
*If error is not resolved, contact Customer Service.
NOTE: If you see a code displayed that is not listed above or if the error has a different numeric code,
contact Customer Service (refer to Section 24).

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15. 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 cap back on the device after use to protect the stimulation surfaces from dirt, debris, and
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.
16. PRODUCT HANDLING
Operating Conditions – gammaCore Sapphire
• Range: -20°C to 60°C (-40°F to 140°F)
• Maximum Output: 30V (peak), 60mA (peak)
• Load Impedance: 450 to 550 Ohms
• gammaCore produces an electrical signal consisting of five 5,000-Hz pulses, repeating at a rate of 25
Hz. The waveform of the gammaCore pulse is approximately a sine wave.
Operating Conditions – Charging Case
• Range: -20°C to 60°C (-40°F to 140°F)
• Only use the charging case indoors
• Do not place any object except gammaCore on the charging surface
• Maximum Output: 5.5V DC, 5W
• Input: 100 to 240 VAC, 50 to 60 Hz, 0.4A max
Storage/Transport Conditions
• gammaCore should be stored at room temperature away from moisture
• Range: 0°C to 38°C (32°F to 100°F)
• Replace cap after each use
• Store the device in such a way (e.g., drawer or shelf) that the cap remains in place and is not
accidentally removed.
Service Life
• The service life of gammaCore is 3 years after the date the device has been activated.
• The expiration date of the conductive gel is 5 years after the date of manufacture.
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17. TROUBLESHOOTING
gammaCore does not turn on
• gammaCore is not charged. Charge gammaCore by placing the device in the charging case (refer to
Section 10).
• Restart gammaCore by pressing and holding the power button for 3 seconds.
gammaCore does not charge
• If “Un” is displayed, remove gammaCore and place back in charging case. If “Un” continues to be
displayed, move device around in the charging case.
• Ensure the power cord is plugged into a live power outlet and into the charging case. Only use the
provided power cord with the charging case.
gammaCore has no stimulations left/days left
• A gammaCore Refill Card is needed to reload the device (refer to Section 13). Please contact
Customer Service to order a refill card.
For further assistance, please contact Customer Service (refer to Section 24).
18. 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 that may present
hazards to people or the environment must be disposed of in accordance with the
applicable government regulations. Contact Customer Service (refer to Section 24) if
you have questions.
NOTE: gammaCore contains a lithium-ion battery that cannot be removed by the user.
NOTE: Please dispose gammaCore as you would a cell phone or other electronic device. Check with
your local municipality to do this according to your local electronic waste regulations.
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