ElectroCore gammaCore Sapphire User manual

1
Instructions for Use for gammaCore Sapphire™
(non-invasive vagus nerve stimulator)
1. INTENDED USE AND PRODUCT DESCRIPTION ............................................................................2
2. WHAT SHOULD I EXPECT?..............................................................................................................3
3. COMMON SIDE EFFECTS ASSOCIATED WITH gammaCore Sapphire..........................................5
4. WILL I STILL NEED TO TAKE MEDICATIONS?................................................................................5
5. WARNINGS AND PRECAUTIONS.....................................................................................................5
6. POTENTIAL RISKS AND COMPLICATIONS ASSOCIATED WITH VAGUS NERVE STIMULATION ..8
7. DISPLAY SYMBOLS ..........................................................................................................................9
8. DEVICE STATUS INDICATORS ......................................................................................................10
9. RELOADING INSTRUCTIONS.........................................................................................................13
10. CHARGING INSTRUCTIONS...........................................................................................................14
11. FUNCTIONS.....................................................................................................................................15
12. HOW TO USE gammaCore Sapphire...............................................................................................16
13. CLEANING........................................................................................................................................22
14. PRODUCT HANDLING.....................................................................................................................22
15. TROUBLESHOOTING......................................................................................................................23
16. PRODUCT DISPOSAL .....................................................................................................................23
17. SYMBOLS AND NOMENCLATURE DESCRIPTION .......................................................................24
18. ORDERING INFORMATION ............................................................................................................25
19. PRODUCT ORDERS AND RETURNS.............................................................................................25
ADDITIONAL INFORMATION FOR HEALTHCARE PROVIDERS ........................................................26
20. PRODUCT DESCRIPTION...............................................................................................................27
21. WARNINGS AND PRECAUTIONS...................................................................................................28
22. CLINICAL STUDIES .........................................................................................................................31
23. ELECTRICAL CLASSIFICATION .....................................................................................................53
24. ELECTROMAGNETIC COMPATIBILITY GUIDANCE......................................................................53
25. CONTACT INFORMATION ..............................................................................................................57
Caution: Heathcare provider authorisation required.

264000-00126 Rev 2
1. INTENDED USE AND PRODUCT DESCRIPTION
gammaCore SapphireTM (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 treatment
and/ or prevention of primary headache (migraine, cluster headache, and hemicrania continua) and
medication overuse headache in 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.
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 intensity level is initially increased above 3. Once the maximum daily number of treatments
has been reached, the device will not deliver any more treatments 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 station to charge the device.
A gammaCore Refill CardTM is used to load the device with days of therapy based on a healthcare
provider's (HCP) prescription.
gammaCore is supplied non-sterile.
Available by healthcare provider authorisation only.
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Device Feature Description / Use
Stimulation
Surfaces
Points of contact with
patient’s skin
Display Indicates device status
(refer to Section 7)
Power Button Turns power ON/OFF
Control Button increases/decreases
stimulation intensity
Cap Covers and protects the
stimulation surfaces
Refill Card Loads device with therapy
Charging Case (Case
with Power Cord)
Charges the device
(refer to Section 10)

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2. WHAT SHOULD I EXPECT?
People respond differently to nVNS.
Preventive Treatment of Cluster Headache
For the preventive treatment of cluster headache, and unless otherwise directed by your HCP, two
self-administered treatments consisting of three consecutive 2-minute stimulations should be applied
daily.
The first daily treatment should be applied within 1 hour of waking. The second daily treatment should
be applied at least 7-10 hours after the first daily treatment. Stimulations may be applied to either side
of the neck.
For the preventive treatment of cluster headache: one treatment is defined as three consecutive
2-minute stimulations.
If the treatment does not provide relief, you should continue taking your usual medications and seek
medical attention, if necessary.
Acute Treatment of Cluster Headache
For the acute treatment of cluster headache, and unless otherwise directed by your healthcare
provider, 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, 3 minutes after the first treatment.
For cluster headache: one treatment is defined as three consecutive 2-minute stimulations lasting 2
minutes.
If the treatment does not provide relief, you should continue taking your usual medications and seek
medical attention, if necessary.
Stimulations may be applied to either side of the neck.
Preventive Treatment of Migraine
For the preventive treatment of cluster headache, and unless otherwise directed by your HCP, three
self-administered treatments consisting of two consecutive 2-minute stimulations should be applied
daily.
The first daily treatment should be applied within 1 hour of waking. The second daily treatment should
be applied mid-day. The third daily treatment should be applied in the evening. Stimulations may be
applied to either side of the neck.
For the preventive treatment of migraine headache: one treatment is defined as two consecutive
2-minute stimulations.
If the treatment does not provide relief, you should continue taking your usual medications and seek
medical attention, if necessary.

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Acute Treatment of Migraine
For the acute treatment of migraine, and unless otherwise directed by your HCP, each self-
administered treatment should consist of two 2-minute stimulations applied at the onset of pain
or symptoms. Stimulations may be applied to either side ofthe neck.
If the pain has not decreased 20 minutes after the start of your first treatment, you may administer
an additional treatment consisting of two 2-minute stimulations.
If you are not pain-free 2 hours after the start of your first treatment, you may administer a third
treatment consisting of two 2-minute stimulations.
For migraine headache: one treatment is defined as two consecutive 2-minute stimulations.
If the treatment does not provide relief, you should continue taking your usual medications and seek
medical attention, if necessary.
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564000-00126 Rev 2
3. COMMON SIDE EFFECTS ASSOCIATED WITH gammaCore
The most common side effects (reported in more than 1% of patients who participated in
gammaCore studies) include:
• 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.
4. 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.
5. 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.

664000-00126 Rev 2
Warnings
• The long-term effects of the chronic use of gammaCore (nVNS) have not been evaluated.
• Safety and efficacy of gammaCore have not been evaluated in the following patients, and
therefore 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 (vagotomy)
o Pediatric patients
o Pregnant women
o Patients with active cancer or cancer in remission
o Patients with clinically significant 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, 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 (eg, second- or third-degree heart block,
atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or
clinically significant 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 emitting equipment, magnetic resonance imaging, radio frequency surgical or
computer-aided tomography machines
o In an explosive atmosphere or in the presence of flammable 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 (eg, shower, bath, pool)
o If you are using another device at the same time (eg, TENS Unit, muscle stimulator) or any
portable electronic device (eg, mobile phone)
• Contact your HCP if your symptoms continue or worsen.
• Treatment is intended to be given (administered) as directed by an HCP. Your HCP or electroCore
Customer Service must train you in the proper use of gammaCore.

764000-00126 Rev 2
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 clarification of the Instructions for Use.
• Only use gammaCore as described in these Instructions for Use, or as otherwise directed by your
HCP.
• 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.
• “E7” is displayed on the screen when the device is turned on. “E7” 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, discontinue use, 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:
• Turn off gammaCore when it is not being used. If the device is not turned off, the battery may
become depleted, and the device may not deliver treatment when needed. If the battery becomes
depleted, place in the charging station to recharge.
• 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.
• 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 fireplaces
and heaters.
• Do not attempt to replace the device battery. If the device is not working, contact electroCore
Customer Service.

864000-00126 Rev 2
• Do not open or take apart the case or attempt to repair or modify the device. There are no user-
servicable 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 m (10.8 ft) away from these items while in use.
6. POTENTIAL RISKS AND COMPLICATIONS ASSOCIATED WITH
VAGUS NERVE STIMULATION
The following risks and complications have been associated with other VNS devices and may
potentially occur with gammaCore.
• Coughing
• Gastrointestinal discomfort
• Headache
• Hoarseness or change in voice
• Irregular heart beat (arrhythmia)
• Light-headedness/dizziness
• Metallic Taste
• Muscle twitching and/or contractions of head/neck/face
• Nausea
• Pain
• Shortness of breath (dyspnea)
• Skin irritation
• Tingling, pricking, or a feeling of “pins and needles” (paresthesia/dysesthesia)
Please refer to Section 3 for common side effects associated with gammaCore use.
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964000-00126 Rev 2
7. DISPLAY SYMBOLS
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Icon Description Icon Example Display Description
Treatments Remaining 6 treatments remaining
within a 24-hour period
Intensity Level Intensity level
is at 23
Days Remaining
30 days remaining until
device will not deliver
stimulations
Intensity Level
at Last Use
Last delivered intensity
level was 23
Battery Battery is charging
Reload Refill card is
being read

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8. 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
Days Remaining
Stimulations Remaining
1 short 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
1. Number of Days Remaining
2. Number of Stimulations
Remaining in a 24-Hour Period
3. Last Intensity Level Used
2 short beeps
NONE:
Device turns off
automatically
Error Repeated long
beeps
Device turns off
automatically after
10 seconds
Restart device
(Turn off and on again)*
*If error is not resolved, contact electroCore Customer Service.

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Status Display Sound User Action
No
Stimulations
Remaining
Repeated long
beeps
Device turns off
automatically
Maximum number of
treatments reached
within 24 hours. Wait until
next 24-hour period
Expired/No
Days Left
Repeated long
beeps
Device turns off
automatically
Reload with refill card*
Low Battery Repeated long
beeps Place in charging station
Dead Battery None None Place in charging station
Charging
Battery Charge Indicator Bars
Flash and Increase
None Allow device to fully charge
Charging
Complete None
Remove device from
charging station
Device is ready to use
Device Not
Fully Seated in
Charging
Station
None Ensure device is fully seated
in charging station
Charging
Error
Repeated long
beeps
Remove device from
charging station
and place back in*
Unplug charging base
power adapter
from the outlet and
plug in again*
*If error is not resolved, contact electroCore Customer Service.

12 64000-00126 Rev 2
*If error is not resolved, contact electroCore Customer Service.
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Status Display Sound User Action
Reloading
Error None
Restart device
(turn off and on again)*
If error is not resolved,
contact electroCore
Customer Service*
Card Error None
Wait 24 hours and
restart device
(turn off and on again)*

13 64000-00126 Rev 2
9. RELOADING INSTRUCTIONS
1. Turn gammaCore on by pressing the power button.
Have your refill card ready.
2. Once the device is turned on, immediately place the
refill card across the device so you can see the display
(as shown in the diagram).
3. gammaCore will display “rd” and the refill icon when
gammaCore is reading the refill card.
4. gammaCore will beep twice when the device has
been loaded with days. The device is now ready to be
used for treatment.
NOTE: If “bd” is displayed, an error has occurred during
the reloading process. Turn device off and try again.
NOTE: If 5 consecutive reload errors occur, “Ec” will be
displayed. Wait 24 hours and retry, or contact electroCore
Customer Service.
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14 64000-00126 Rev 2
10. CHARGING INSTRUCTIONS
1. Plug the power cord of the KEEP STATION into a
power outlet. Only use the provided power cord with
the charging case.
2. With the power button facing up, place the device
into the charging case. The device should fit into the
charging case with ease. Do not force the device into
the charging case.
3. The device display will show “Ch” with the battery
charge indicator bars flashing and increasing.
4. When the device is finished charging, the display
will show “dn”. The device is ready to be used for
treatment.
5. If “Un” is displayed on the device, remove the device
and place in charging case again.
6. If “Er” is displayed on the device, unplug the power
cord from the outlet and plug in again. If “Er” remains
on the device’s display, please contact electroCore
Customer Service.
NOTE: Charge your device before first use. Allow 6 to 7
hours for a full charge. High temperatures may increase
the charging time. If the device has no charge, it takes
only a few minutes to charge an additional two to three
treatments. Monitor battery life and charge as needed
to maintain adequate number of treatments on device
(refer to Section 8 for feedback on device and treatment
status).
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11. FUNCTIONS
Power Button Increase Intensity Decrease Intensity
Press the power button to
turn device ON
Hold the power button to
turn the device OFF
Press the upper area of
the control button
Press the lower area of
the control button

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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 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)
12. HOW TO USE gammaCore SapphireTM
Jaw
Muscle
Windpipe
Treatment
Location
(Pulse)
Set Up

17 64000-00126 Rev 2
4. Remove the cap.
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 25).

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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 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 the device makes good
contact with the skin; however, do not apply
excessive pressure to the neck.
8. Increase the intensity level by repeatedly
pressing the top area of the control button
to the maximum level you can tolerate. 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 are normal and should stop after the
stimulation is complete. The appropriate
intensity level 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 intensity level by pressing the
bottom area of the control button
c. 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, turn the device
off by pressing and holding the power button and
discontinue the stimulation.
CAUTION: Do not turn gammaCore on again
until preparing for the next treatment. The device
has a limited number of stimulations it can deliver.
9. Delivering treatment
a. Preventive treatment of cluster headache
Two self-administered treatments consisting of
three consecutive 2-minute stimulations should
be applied daily.
The first daily treatment should be applied within
1 hour of waking. The second daily treatment
should be applied at least 7-10 hours after the
first daily treatment.
Stimulations may be applied to either side of
the neck. Please see Figure 1 at the end of this
section for an example of the preventive treatment
of cluster headache.
b. Acute treatment of cluster headache
Each self-administered treatment should consist
of three 2-minute stimulations applied consecu-
tively at the onset of cluster headache pain or
symptoms.
If the cluster headache attack is not aborted, you
may stimulate with an additional three 2-minute
stimulations, 3 minutes after the first treatment.
Stimulations may be applied to either side of the
neck. Please see Figure 2 at the end of this sec-
tion for an example of the treatment of one attack.

19 64000-00126 Rev 2
c. Preventive treatment of migraine
Three self-administered treatments consisting
of two consecutive 2-minute stimulations should
be applied daily.
The first daily treatment should be applied within
1 hour of waking. The second daily treatment
should be applied mid-day. The third daily
treatment should be applied in the evening.
Stimulations may be applied to either side of
the neck. Please see Figure 3 at the end of
this section for an example of the preventive
treatment of migraine.
d. Acute treatment of migraine
Each self-administered treatment should consist
of two consecutive 2-minute stimulations at the
onset of pain. Stimulations may be applied to
either side of the neck.
If the pain has not decreased 20 minutes
after the start of the first treatment, you may
administer an additional treatment consisting
of two consecutive 2-minute stimulations.
If you are not pain free 2 hours after the start
of the first treatment, you may administer a
third treatment consisting of two consecutive
2-minute stimulations.
Please see Figure 4 at the end of this section
for an example of the acute treatment of one
migraine.
NOTE: The length of each stimulation, 2 minutes,
provides a sufficient amount of 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.
10. After each stimulation, remove the device.
After completing the stimulation, the device
will display the number of stimulations and
days remaining and the last intensity level
before automatically turning off.
NOTE: A stimulation stops automatically after 2
minutes. The device will make 2 short beeps and
automatically stop stimulation.
NOTE: The days and stimulations remaining can
be viewed by turning the device 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. The device has
a limited number of stimulations it can deliver in
a 24-hour period.
11. Clean the device by wiping the leftover gel off
the stimulation surfaces with a soft dry cloth
(refer to Section 13).
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 cap back on the device after use.

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*The first treatment consists of three consecutive 2-minute stimulations applied to either
side of the neck within 1 hour of waking. A second treatment of three consecutive 2-minute
stimulations should be applied at least 7-10 hours after the first daily treatment.
*The first treatment consists of three consecutive 2-minute stimulations applied to either side
of the neck at the onset of cluster headache pain or symptoms. If pain is still present 3 minutes
after the first 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.
Figure 2. Acute Treatment of Cluster Headache*
Figure 1. Preventive Treatment of Cluster Headache*