ElectroCore gammaCore Sapphire SLC User manual

164000-00174 Rev 1
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Instructions for Use for gammaCore SapphireTM SLC for Migraine7(non-invasive vagus nerve stimulator)8
1. INDICATIONS AND PRODUCT DESCRIPTION...........................................................................................................292. GAMMACORE TREATMENT RECOMMENDATIONS..................................................................................................310 3. CONTRAINDICATIONS.................................................................................................................................................411 4.
COMMON SIDE EFFECTS ASSOCIATED WITH GAMMACORE ......................................................................4 12 5.
WILL I STILL NEED TO TAKE MEDICATIONS ...………………………………………………………………………4 13 6. WARNINGS AND PRECAUTIONS................................................................................................................................514 7. DISPLAY SYMBOLS......................................................................................................................................................715 8.
DEVICE STATUS INDICATORS ………………………………………………………………………………………...….... 8 16 9. RELOADING INSTRUCTIONS....................................................................................................................................1017 10. DEVICE ERROR CODES……………………………………………………………………………………………………….1118 11. CHARGING INSTRUCTIONS......................................................................................................................................1219 12. FUNCTIONS.................................................................................................................................................................1320 13. HOW TO USE gammaCore Sapphire .........................................................................................................................1421 14. CLEANING...................................................................................................................................................................1822 15. PRODUCT HANDLING................................................................................................................................................1823 16.
TROUBLESHOOTING ......................................................................................................................................19 24 17. PRODUCT DISPOSAL ................................................................................................................................................1925 18. SYMBOLS AND NOMENCLATURE DESCRIPTION..................................................................................................2026 19. PRODUCT ORDERS AND RETURNS........................................................................................................................2127
ADDITIONAL INFORMATION FOR HEALTHCARE PROFESSIONALS................................................................................2228
20. PRODUCT DESCRIPTION..........................................................................................................................................2329 21. ADDITIONAL CONTRAINDICATIONS…………………………………..……………………………………………………2330 22. ADDITIONAL WARNINGS AND PRECAUTIONS ……………………………………..................................................2331 23. CLINICAL STUDIES.....................................................................................................................................................2432 24. ELECTRICAL CLASSIFICATION ................................................................................................................................2433 25. ELECTROMAGNETICCOMPATIBILITY GUIDANCE.................................................................................................2534 26. CONTACT INFORMATION..........................................................................................................................................2935
36 Caution:
Healthcare professional authorisation required. 37
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264000-00174 Rev 1
1. INDICATIONS AND PRODUCT DESCRIPTION
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gammaCore SapphireTM (non-invasive vagus nerve stimulator) is intended to provide non-invasive
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vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for the treatment
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and/or prevention of migraine headache in adults.
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gammaCore provides a mild electrical stimulation to the vagus nerve, which runs through the neck and
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carries information to the central nervous system. Each stimulation with gammaCore lasts 2 minutes.
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The patient controls the intensity level.
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gammaCore delivers up to 30 stimulations in a 24-hour period, starting when the device is
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loaded with therapy using a refill card, and then turned on and the intensity level is increased
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above 3. Once the maximum daily number of stimulations has been reached, the device will not
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deliver any more stimulations until the following 24-hour period. The number of remaining stimulations
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available in a 24-hour period is indicated on the display (refer to Section 8). gammaCore is
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rechargeable and includes a charging case to charge the device. A gammaCore refill card is used to
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load the device with days of therapy based on a healthcare professional’s (HCP) prescription.
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NOTE: Once activated with a refill card, the course of therapy will decrease by one day as every 24
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hours passes. This daily countdown will occur regardless of use, so only activate a refill card when you
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intend to use the full course of therapy.
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NOTE: gammaCore’s 24-hour cycle begins the first time the intensity level is increased past 3.
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NOTE: This is a pre-loaded device that contains three days of therapy intended for training and
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device familiarisation purposes. Three 10-day gammaCoreTM Refill Cards are included to reload
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the device at the end of the period when a refill is required. Please contact Customer Service
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for further assistance (refer to Section 26).
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gammaCore 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
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 11)
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Available by healthcare professional authorisation only.
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364000-00174 Rev 1
2. GAMMACORE TREATMENT RECOMMENDATIONS
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Preventive Treatment of Migraine Headache
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•Three treatments (morning, mid-day, and night) each consisting of two consecutive 2-minute
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stimulations
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Acute Treatment of Migraine Headache
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•One treatment consisting of two consecutive 2-minute stimulations
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•If pain has not decreased 20 minutes after the start of your first treatment, a second treatment
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(consisting of two consecutive 2-minute stimulations) may be administered
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•If you are not pain-free 2 hours after the start of your first treatment, a third treatment (consisting of
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two consecutive 2-minute stimulations) may be administered
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If the therapy does not provide relief, you should continue taking your usual medications and seek
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medical attention, if necessary.
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For a detailed treatment guide, please refer to Section 13.9
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3. CONTRAINDICATIONS
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Contraindications include but are not limited to:
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•Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or
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any implanted electronic device
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•Patients with metallic device such as a stent, bone plate or bone screw implanted at or near their
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neck
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•Patients who are using another device at the same time (e.g., TENS Unit, muscle stimulator) or
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any portable electronic device (e.g., mobile phone)
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Patients should not use gammaCore:
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•While driving, operating machinery, or during any activity that may put patient at risk of injury
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•Near microwave machines, magnetic resonance imaging, radio frequency surgical, or computer-
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aided tomography machines
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•In an explosive atmosphere or in the presence of flammable gas mixtures
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•If patient has an open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s)
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on the neck at the treatment location
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•If patient has wet skin, is in the water, or just stepped out of the water (eg, shower, bath, pool)
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4. COMMON SIDE EFFECTS ASSOCIATED WITH GAMMACORE
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The most common side effects (reported in more than 1% of patients who participated in
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gammaCore studies) include:
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•Application site discomfort
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•Application site irritation/redness
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•Local pain, face/head/neck area (including toothache)
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•Muscle twitching and/or contractions, face/head/neck area (including facial droop and/or lip pull)
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•Headache/migraine
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•Dizziness
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•Tingling, pricking, or a feeling of “pins and needles” on the skin where the device is applied
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(paresthesia/dysesthesia)
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These side effects typically resolve immediately after the stimulation is complete.
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5. WILL I STILL NEED TO TAKE MEDICATIONS?
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People respond differently to gammaCore. You and your healthcare professional (HCP) should discuss
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your ongoing treatment routine, including the use of any additional therapies and/or medications. It is
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important to always follow your HCP’s recommendations about your medications. gammaCore can be
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used with existing medications for the preventive treatment of migraine headache and the acute
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treatment of migraine headache.
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564000-00174 Rev 1
6. WARNINGS AND PRECAUTIONS
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Warnings
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• The long-term effects of the chronic use of gammaCore have not been evaluated.
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• Safety and efficacy of gammaCore have not been evaluated in the following
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patients, or situations:
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• Patients with uncontrolled hypertension, hypotension, bradycardia, or tachycardia
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• Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular
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disease, including congestive heart failure, known severe coronary artery disease, or
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recent myocardial infarction (within 5 years)
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• Patients with a history of abnormal baseline ECG, prolonged QT interval or arrhythmia
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• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
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• Pediatric patients
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• Pregnant women
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• Patients with active cancer or cancer in remission
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• Patients with an abnormal cervical anatomy
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• Patients with a history of brain tumor, aneurysm, bleed or head trauma
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• Patients with a history of syncope or seizures
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• Contact your HCP if your symptoms continue or worsen.
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• Treatment is intended to be given (administered) as directed by an HCP. Your HCP or
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Customer Service must train you in the proper use of gammaCore.
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Precautions
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Before Use:
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• You must carefully read the gammaCore Instructions for Use.
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• Only use gammaCore as described in the Instructions for Use, or as otherwise directed
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by the HCP.
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• The use of more than 24 stimulations per day has not been evaluated in controlled
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clinical trials. Do not use more than 24 stimulations in a 24-hour period.
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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.

664000-00174 Rev 1
• Only use an electroCore-approved gel with gammaCore. Please contact Customer
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Service for an electroCore-approved gel that works with the device
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• Do not share gammaCore with another person.
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• gammaCore should not be applied across or through the head, directly on the eyes,
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covering the mouth, on the chest or the upper back, or over the heart.
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• Remove jewelry that may touch the treatment location (necklaces, earrings, etc.).
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• Carefully examine the device for any signs of damage or defects
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Do not use gammaCore if:
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• The stimulation surfaces are broken or cracked.
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• The casing is cracked, dented, or appears to be damaged.
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• An "E" with a numeric code is displayed on the screen when the device is turned on.
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This means that there is an error (refer to Section 10).
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• It has passed its expiration date. The expiration date is indicated on the device packaging.
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During Treatment:
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Discontinue treatment if you experience:
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• Light-headedness, dizziness, or chest pain
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• Excessive skin irritation
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If the device seems to malfunction, discontinue use immediately, continue taking usual
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medications and seek medical care as needed. When possible, contact Customer Service for
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assistance with your device; Customer Service cannot provide medical assistance.
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Caring for Your Device:
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• Turn off gammaCore when it is not being used. If the device is not turned off, the battery
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may become depleted, and the device may not deliver treatment when needed. If the
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battery becomes depleted, place in the charging station to recharge.
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• Keep gammaCore away from water or other liquids, including cleaning liquids.
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• Moisture may damage the device. Keep gammaCore away from items such as
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nebulizers and steam kettles.
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• 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
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(32°F to 100°F). Exposure to such conditions may cause the device to malfunction.
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• Do not attempt to replace the device battery. If the device is not working, contact
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Customer Service.
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• Do not open or take apart the case or attempt to repair or modify the device. There are
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no user- serviceable parts. If the device is not working, contact Customer Service.
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• Do not intentionally damage, burn, or puncture the device.
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• Wireless communications equipment, such as wireless home network devices, mobile
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phones,cordless telephones and their base stations, and walkie-talkies, can affect this
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equipment. Keep gammaCore at least 3.3 m (10.8 ft) away from these items while in use.
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7. DISPLAY SYMBOLS
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Icon Description
Icon
Example
Display
Description
Stimulations
Remaining
6 stimulations remaining
within a 24-hour period
Intensity Level
Intensity level
is at 23
Days Remaining
Flashing display indicates
remaining days of therapy*
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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*When the device is first loaded with a refill card, the display will show days of therapy remaining. The information in
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this section is based on references only and may not represent the exact number as shown on your device.
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8. DEVICE STATUS INDICATORS
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gammaCore has a visual indicator (display) and an auditory signal (beep) to indicate device status.
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Status
Display
Sound
User Action
Start Up /
Ready for Use
1. Days Remaining*
2. Stimulations Remaining
1 beep after
power ON
Follow “How to Use”
Instructions
(refer to Section 13)
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 13)
Stimulation
Complete
Last Intensity Level Used
Will Show
THEN THE DISPLAY WILL
SWITCH BETWEEN
1. Days Remaining*
2. Stimulations Remaining
2 short beeps
NONE:
Device turns off
automatically
*The information in this section is based on references only and may not represent the exact number as shown on
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your device.
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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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9. RELOADING INSTRUCTIONS
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1. Once you have received your gammaCoreTM Refill Card, you
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can now load your device.
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2. Turn gammaCore on by pressing the power button.
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Have your refill card ready.
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3. Once gammaCore is turned on, place the device on a hard
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surface with the display screen facing up. Place the refill
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card across the device so you can see the display (as shown
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in the diagram).
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4. Leave the refill card on the device for a minimum of 10
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seconds. (Do not move the refill card as it may disrupt the
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loading process).
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5. gammaCore will display “rd” and the icon (refer to
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Section 7 for displayed details) while gammaCore is reading
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the refill card.
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6. gammaCore will beep twice when therapy has been
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loaded. The reading and loading process may take a
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minimum of 10 seconds.
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7. The number of days loaded onto your gammaCore will be
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displayed (Refer to Section 7 for display details). The device
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is now ready to be used for treatment.
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NOTE: If a “C”(warning) or “H” (error) with a numeric code is
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displayed, an error has occurred during the reloading process.
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Turn the device off, then back on and try to reload a second
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time. If the error continues, contact Customer Service.
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NOTE: If 5 card reloading “H” errors occur during a 24-hour
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period, “H2” will be displayed. Wait 24 hours and retry or
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contact Customer Service.
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NOTE: If 10 card loading attempts are made during a 24-hour
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period, “H1” will be displayed. Wait 24 hours and retry or
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contact Customer Service.
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10. DEVICE ERROR CODES
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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.
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NOTE: If you see a code displayed that is not listed above or if the error has a different numeric code,
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contact Customer Service (refer to Section 26).
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11. CHARGING INSTRUCTIONS
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1. Plug the power cord of the charging case into a power outlet.
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Only use the provided power cord with the charging case.
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2. Place the device into the charging case with the power
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button facing up. The device should fit into the charging case
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with ease. Do not force the device into the charging case.
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NOTE: The cap is designed to position gammaCore correctly in
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the charging case. If the device is misaligned, “Un” is
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displayed. Remove the device and try placing gammaCore in
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the charging case again.
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3. The device display will show “Ch” with the battery
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charge indicator bars flashing and increasing.
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4.The device will show “dn” when fully charged.
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NOTE: It only takes a few minutes until there is enough charge
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to deliver 2-3 stimulations.
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NOTE: Charge your device before first use. It typically takes 4
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to 5 hours for a full charge. High temperatures may increase
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the charging time. Monitor battery life and charge as needed to
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maintain an adequate number of stimulations on gammaCore
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(refer to Section 8 for feedback on the device status indicators).
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12. FUNCTIONS
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Power Button
Increase Intensity Level
Decrease Intensity Level
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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13. HOW TO USE gammaCore Sapphire™
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Set Up
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13.1 Remove any jewelry that may touch the treatment
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location.
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13.2 Find a comfortable position. (A place where you can
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see your neck in a mirror may be helpful.)
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13.3 Locate the treatment location by finding the pulse on
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the side of the neck. The vagus nerve is in the same
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area. Make sure the treatment location is clean and
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dry.
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The stimulation surfaces of the
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device will line up with the following
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landmarks:
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• Over the pulse (orange); this is the
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treatment location
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• In front of the large muscle at the
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side of the neck (yellow)
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• Just below the lower jaw (grey)
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• Lined up next to the windpipe
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(green)
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13.4 Remove the cap.
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13.5 Apply a small (pea-size) amount of gel to both of the
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stimulation surfaces. Not applying the gel as described
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may cause the stimulation to be uncomfortable or less
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effective.
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CAUTION: Only use an electroCore-approved gel with
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gammaCore. Please contact Customer Service for an
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electroCore-approved gel that works with the device (refer to
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Section 26).
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Delivering Treatment
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13.6 Turn gammaCore on by pressing the power
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button. When the device is ready for use,
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the device will beep once. The number of
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stimulations available for that 24-hour period
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and days remaining will be displayed.
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13.7 Position the device on the side of the neck
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over the treatment location. Use mild to
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moderate pressure so the device makes good
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contact with the skin; however, do not apply
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excessive pressure to the neck. Make sure
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that both stimulation surfaces are in contact
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with the skin during the stimulation. Checking
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in a mirror may help until you become familiar
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with the device and its correct positioning.
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13.8 Increase the intensity level to the maximum level you can tolerate by repeatedly pressing the top
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area of the control button. You may experience a lip pull. Once you have found your maximum
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level, hold gammaCore in place for the remainder of the 2-minute stimulation. The device will
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beep every time the control button is pushed, and the display will indicate a numerical value
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between 1 and 40, which signifies the intensity level. You will likely feel muscle contractions at
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the treatment location. These muscle contractions are normal and should stop after the
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stimulation is complete. The appropriate intensity level is different for every person and may vary
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from stimulation to stimulation.
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NOTE: Neck muscle contractions during the stimulation that are not painful are normal and
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not a reason to stop the stimulation. If muscle contractions are too strong or uncomfortable, try:
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•Lowering the intensity level by pressing the bottom area of the control button.
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•Repositioning gammaCore on the neck over the pulse and slowly increasing the
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intensity level again by pressing the top area of the control button.
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If the stimulation is still intolerable, remove gammaCore from the neck and turn the device off by
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pressing and holding the power button and discontinue the stimulation.
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NOTE: The length of each stimulation, 2-minutes, provides enough time for correct positioning of
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gammaCore and for setting the appropriate intensity level.
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NOTE: The device has a limited number of stimulations it can deliver in a 24-hour period.
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64000-00174 Rev 1
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13.9. Treatment Guide
Preventive treatment of migraine headache
•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 4-6 hours after the first daily treatment. The third daily treatment should be
applied at night.
•Stimulations should be applied on the same side of the neck.
Acute treatment of migraine headache
•Each self-administered treatment should consist of two consecutive 2-minute stimulations at the
onset of pain or symptoms.
•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.
•Stimulations should be applied on the same side of the neck.
13.10 At the end of each stimulation, the devicewill display the last intensity level that was used2 for approximately 7 seconds, then revert to3 display the number of stimulations and days4 remaining. You may then place the device back5 on the treatment site for another stimulation.6 Additional gel may be applied between each7 stimulation.8
9 NOTE: After 2 minutes, the device will beep10 twice, and the stimulation will automatically stop.11
12 NOTE: The days and stimulations remaining can13 be viewed by turning gammaCore on. However,14 do not turn the intensity level higher than three15 (3) until preparing for a stimulation. The device16 counts each time the intensity level is higher17 than three (3) as a stimulation. gammaCore18 delivers a limited number of stimulations in a 24-19 hour period.20
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64000-00174 Rev 1
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13.11 Clean gammaCore by wiping the leftover gel off the stimulation surfaces with a soft, dry cloth
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(refer to Section 14).
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13.12 Clean the excess gel off your neck with a cloth or tissue. The gel is not intended to be left on
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the skin and may cause skin irritation for some people.
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13.13 Put the cap back on the device after use.
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14. CLEANING
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•Clean the device after each use by gently wiping the case and the stimulation surfaces with a soft,
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dry cloth to remove leftover gel.
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•Put the cap back on the device after use to protect the stimulation surfaces from dirt, debris, and
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damage.
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PRECAUTIONS:
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•Do not submerge the device in water; it is not water resistant.
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•Do not use soap, hand sanitizer, detergents, or other cleansers when cleaning the device.
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15. PRODUCT HANDLING
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Operating Conditions –gammaCore Sapphire
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•Range: -20°C to 60°C (-40°F to 140°F)
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•Maximum Output: 30V (peak), 60mA (peak)
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•Load Impedance: 450 to 550 Ohms
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•gammaCore produces an electrical signal consisting of five 5,000-Hz pulses, repeating at a rate of
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25 Hz. The waveform of the gammaCore pulse is approximately a sine wave.
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Operating Conditions –Charging Case
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•Range: -20°C to 60°C (-40°F to 140°F)
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•Only use the charging case indoors
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•Do not place any object except gammaCore on the charging surface
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•Maximum Output: 5.5V DC, 5W
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•Input: 100 to 240 VAC, 50 to 60 Hz, 0.4A max
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Storage/Transport Conditions
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•gammaCore should be stored at room temperature away from moisture
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•Range: 0°C to 38°C (32°F to 100°F)
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•Replace cap after each use
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•Store the device in such a way (e.g., drawer or shelf) that the cap remains in place and is not
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accidentally removed.
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Service Life
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•The service life of gammaCore is 3 years after the date the device has been activated.
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•The expiration date of the conductive gel is 5 years after the date of manufacture.
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16. TROUBLESHOOTING
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gammaCore does not turn on
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• gammaCore is not charged. Charge gammaCore by placing the device in the charging case (refer to
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Section 11).
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• Restart gammaCore. Turn gammaCore off and on again.
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gammaCore does not charge
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• If “Un” is displayed, remove gammaCore and place back in charging case. If “Un” continues to be
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displayed, move device around in the charging case.
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• Ensure the AC power cord is plugged into a live power outlet.
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• Ensure AC power cord wire is plugged into the charging case.
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gammaCore has no stimulations left/days left
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• Reload gammaCore with a gammaCore Sapphire Refill Card. If necessary, contact Customer
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Service to order a refill card or if purchased online please log into your account and request your
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next refill kit.
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For further assistance, please contact Customer Service (refer to Section 26).
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17. PRODUCT DISPOSAL
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Regulations require that disposal of electrical and electronic equipment, including
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used and unused medical devices, is handled in a controlled manner. A product that
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may be contaminated after use or that may contain chemicals or elements that may
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present hazards to people or the environment must be disposed of in accordance
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with the applicable government regulations. Contact Customer Service (refer to
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Section 26) if you have questions about the appropriate disposal of this device.
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NOTE: gammaCore contains a lithium battery that cannot be removed by the user.
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NOTE: Please dispose gammaCore as you would a cell phone or other electronic device. Check with
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your local municipality to do this according to your local electronic waste regulations.
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64000-00174 Rev 1
20
18. SYMBOLS AND NOMENCLATURE DESCRIPTION
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Expiration date
Follow operating instructions
Lot number
Manufacturer
Catalog number / Reference number
IP22
Protection from solid foreign objects
≥12.5 mm and ingress of water at 15°
Electric shock hazard
Type BF applied part
Serial number
Storage temperature
Non-sterile
xxyyGzzzz
(package
label)
Date of Manufacture on package label,
where: yy is the year of manufacture, eg,
2521G1001 indicates the year of
manufacture is 2021
WARNING
Failure to follow instructions may
result in serious injury or death to
the patient or user
Non-ionizing electromagnetic radiation
PRECAUTION
Failure to follow instructions may
result in damage to the equipment or
degradation in the quality of treatment
Magnetic resonance unsafe
Refer to instruction manual
Authorized representative
Information or additional
information available
Keep away from sunlight
Separate collection for waste of
electrical and electronic equipment
Do not use if package is damaged
Date of Manufacture
Medical device