ElectroCore gammaCore Sapphire CV User manual

164000-00137 Rev 1
3Instructions for Use for gammaCore SapphireTM CV4(non-invasive vagus nerve stimulator) authorized for emergency use in the acute treatment of5adult patients with known or suspected COVID-19 who are experiencing exacerbation of6asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not7tolerated or provide insufficient symptom relief as assessed by their healthcare provider, using8non-invasive VNS on either side of the patient’s neck during the COVID-19 pandemic.9
1. EMERGENCY USE AUTHORIZATION............................................................................................................................210
2. INDICATION AND PRODUCT DESCRIPTION ................................................................................................................311
3. GAMMACORE SAPPHIRE CV TREATMENT RECOMMENDATIONS ...........................................................................412
4. COMMON SIDE EFFECTS ASSOCIATED WITH GAMMACORE SAPPHIRE CV………………………………………….513 5. WILL I STILL NEED TO TAKE MEDICATIONS…………………………….……………………………………………..….....514 6. WARNINGS AND PRECAUTIONS………………………………………………………………………………………………..615
7. POTENTIAL RISKS AND COMPLICATIONS ASSOCIATED WITH OTHER VAGUS NERVE STIMULATION16
DEVICES ..........................................................................................................................................................................917
8. DISPLAY SYMBOLS.......................................................................................................................................................1018
9. DEVICE STATUS INDICATORS ....................................................................................................................................1119
10. CHARGING INSTRUCTIONS ........................................................................................................................................1320
11. FUNCTIONS...................................................................................................................................................................1421
12. HOW TO USE GAMMACORE SAPPHIRE CV ..............................................................................................................1522
13. CLEANING .....................................................................................................................................................................2023
14. PRODUCT HANDLING ..................................................................................................................................................2024
15. TROUBLESHOOTING....................................................................................................................................................2125
16. PRODUCT DISPOSAL...................................................................................................................................................2126
17. SYMBOLS AND NOMENCLATURE DESCRIPTION.....................................................................................................2227
18. ORDERING INFORMATION .........................................................................................................................................2328
19. PRODUCT ORDERS AND RETURNS...........................................................................................................................2329
20. DETAILED PRODUCT DESCRIPTION..........................................................................................................................2530
21. ADDITIONAL WARNINGS AND PRECAUTIONS…………………………………………………………………………..…2531
22. CLINICAL STUDIES.......................................................................................................................................................2732
23. ELECTRICAL CLASSIFICATION...................................................................................................................................2833
24. ELECTROMAGNETIC COMPATIBILITY GUIDANCE ...................................................................................................2834
25. CONTACT INFORMATION ............................................................................................................................................3235
36 Caution: Rx Only. US Federal Law restricts this device to sale by or on the order of a licensed healthcare provider.37
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264000-00137 Rev 1
1. EMERGENCY USE AUTHORIZATION
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FDA has issued an Emergency Use Authorization for the emergency use of the gammaCore Sapphire
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CV for acute use at home or in a healthcare setting to treat adult patients with known or suspected
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COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for
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whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by
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their Healthcare Provider, by using non-invasive vagus nerve stimulation (nVNS) on either side of the
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patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic.
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gammaCore Sapphire CV has neither been cleared nor approved for acute use at home or
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in a healthcare setting to treat adult patients with known or suspected COVID-19 who are
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experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom
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approved drug therapies are not tolerated or provide insufficient symptom relief as
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assessed by their healthcare provider, by using non-invasive vagus nerve stimulation
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(nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 (COVID-
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19) pandemic.
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gammaCore Sapphire CV has been authorized for the above emergency use by FDA under
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an Emergency Use Authorization.
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gammaCore Sapphire CV has been authorized only for the duration of the declaration that
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circumstances exist justifying the authorization of the emergency use of medical devices
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under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is
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terminated or revoked.
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364000-00137 Rev 1
2. INDICATION AND PRODUCT DESCRIPTION
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The gammaCore SapphireTM CV (non-invasive vagus nerve stimulator) is intended for acute use at
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home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are
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experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved
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drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare
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provider, by using non-invasive vagus nerve stimulation (nVNS) on either side of the patient’s neck
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during the Coronavirus Disease 2019 (COVID-19) pandemic. The gammaCore Sapphire CV provides a
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mild electrical stimulation to the vagus nerve, which runs through the neck and carries information to
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the central nervous system. Each stimulation with the gammaCore Sapphire CV lasts 2 minutes. The
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patient controls the intensity level.
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The gammaCore Sapphire CV delivers up to 30 stimulations in a 24-hour period, starting when the
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device is turned on and the intensity level is increased above 3.Once the maximum daily number of
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stimulations has been reached, the device will not deliver any more stimulations until the following 24-
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hour period. The number of remaining stimulations available in a 24-hour period is indicated on the
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display (refer to Section 8). gammaCore Sapphire CV is rechargeable and includes a charging case
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to charge the device. The use of more than 24 stimulations per day has not been evaluated in
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controlled clinical trials. Do not use gammaCore Sapphire CV more than 24 stimulations in a 24-
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hour period.
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NOTE: The gammaCore Sapphire CV’s 24-hour cycle begins the first time the intensity level is
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increased past 3.
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gammaCore Sapphire CV is supplied non-sterile.
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Device Feature
Description / Use
Stimulation Surfaces
Points of contact with
patient’s skin
Display
Indicates device status
(refer to Section 8)
Power Button
Turns power ON/OFF
Control Button
Increase/decrease
intensity level
Cap
Covers and protects the
stimulation surfaces
Charging Case (Case
with Power Cord)
Charges the device
(refer to Section 10)
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For prescription use only.
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464000-00137 Rev 1
3. GAMMACORE SAPPHIRE CV TREATMENT RECOMMENDATIONS
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•The gammaCore Sapphire CV is intended for acute use at home or in healthcare settings to
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treat adult patients with known or suspected COVID-19 who are experiencing exacerbation
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of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are
101
not tolerated or provide insufficient symptom relief as assessed by their healthcare
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provider, using non-invasive vagus nerve stimulation (nVNS) on either side of the patient’s
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neck during the Coronavirus Disease 2019 (COVID-19) pandemic.
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•One treatment consisting of two consecutive 2-minute stimulations.
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•If the therapy does not provide relief, seek medical attention by consulting your Healthcare
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Provider.
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•The use of more than 24 stimulations per day has not been evaluated in controlled clinical trials.
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Do not use more than 24 stimulations in a 24-hour period.
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For a detailed treatment guide, please refer to Section 12.9
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4. COMMON SIDE EFFECTS ASSOCIATED WITH GAMMACORE SAPPHIRE CV
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The most common side effects (reported in patients who participated in gammaCore Sapphire
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CV 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 Sapphire CV. You and your HCP should discuss your
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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.
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664000-00137 Rev 1
6. WARNINGS AND PRECAUTIONS
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Warnings
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•The gammaCore Sapphire CV has neither been cleared nor approved for acute use at home
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or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are
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experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom
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approved drug therapies are not tolerated or provide insufficient symptom relief as assessed
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by their healthcare provider, by using non-invasive vagus nerve stimulation (nVNS) on either
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side of the patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic.
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•The safety and efficacy of gammaCore Sapphire CV has not been formally evaluated in any
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patients with COVID-19
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•The gammaCore Sapphire CV is contraindicated for:
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oPatients 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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oPatients with a metallic device, such as a stent, bone plate, or bone screw, implanted at or near
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your neck
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oPatients with an open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s)
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on their neck at the treatment location
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•Patients should not use the gammaCore Sapphire CV:
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oWhile they are driving, operating machinery, or during any activity that may put the patient at risk
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of injury
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oIf they have any planned surgeries that may involve implants. The patient should advise their
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HCP accordingly
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oNear microwave machines, magnetic resonance imaging, radio frequency surgical, or computer-
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aided tomography machine
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oIn an explosive atmosphere or in the presence of flammable gas mixtures
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oIf the patient has wet skin, is in water, or just stepped out of the water (e.g. shower, bath, pool)
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oIf the patient is using another device at the same time (e.g. TENS Unit, muscle stimulator) or any
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portable electronic device
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Contact your HCP if your symptoms continue or worsen.
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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.

764000-00137 Rev 1
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Treatment is intended to be given (administered) as directed by an HCP. Your HCP must train
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you on the proper use of gammaCore Sapphire CV.
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Precautions
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•Only use gammaCore Sapphire CV as described in these Instructions for Use, or as otherwise
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directed by your HCP.
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•The use of more than 24 stimulations per day has not been evaluated in controlled clinical trials. Do
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not use more than 24 stimulations in a 24-hour period.
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•Only use an electroCore-approved gel with gammaCore Sapphire CV. Please contact electroCore
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Customer Service for an electroCore-approved gel that works with the device.
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•Do not share your gammaCore Sapphire CV with another person.
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•gammaCore Sapphire CV 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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Before Use:
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•Carefully read the gammaCore Sapphire CV Instructions for Use. Ask your HCP or electroCore
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Customer Service if you have any questions about how to use the device or require any further
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clarification on the Instructions for Use.
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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; if present contact your HCP and
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when possible, contact electroCore Customer Service using the information provided in Section 25.
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Do not use gammaCore Sapphire CV 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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•It has passed its expiration date. The expiration date is indicated on the device packaging.
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•Error code “C4” is displayed. (refer to Section 9)
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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 gammaCore Sapphire CV seems to malfunction, discontinue use immediately. Contact your HCP
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and seek medical care as needed. When possible, contact electroCore Customer Service for
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assistance with your gammaCore Sapphire CV; electroCore Customer Service cannot provide
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medical assistance.
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Caring for Your gammaCore Sapphire CV:
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•Turn off gammaCore Sapphire CV when it is not being used. If gammaCore Sapphire CV is not
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turned off, the battery may become depleted and the device may not deliver treatment when
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needed.
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•If the battery becomes depleted, place gammaCore Sapphire CV in the charging case to recharge.
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864000-00137 Rev 1
•Moisture may damage the gammaCore Sapphire CV. Keep the device away from items such as
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nebulizers and steam kettles.
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•Store gammaCore Sapphire CV 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
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100°F). Exposure to such conditions may cause the device to malfunction.
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•Do not attempt to replace the device battery.
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•Do not open or take apart the case or attempt to repair or modify the device. There are no user
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serviceable parts.
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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 phones,
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walkie-talkies, cordless telephones and their base stations can affect gammaCore Sapphire CV.
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Keep gammaCore Sapphire CV at least 3.3 m (10.8 ft) away from these items while in use (refer to
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Section 24 for additional information).
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If the device is not working, contact electroCore Customer Service (refer to Section 25).
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964000-00137 Rev 1
7. POTENTIAL RISKS AND COMPLICATIONS ASSOCIATED WITH OTHER VAGUS
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NERVE STIMULATION DEVICES
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The following risks and complications have been associated with other nVNS devices and may
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potentially occur with gammaCore Sapphire CV:
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•Pain
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•Skin irritation
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•Headache
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•Muscle twitching and/or contractions of head/neck/face
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•Gastrointestinal discomfort
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•Hoarseness or change in voice
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•Irregular heartbeat (arrhythmia)
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•Light-headedness/dizziness
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•Metallic taste
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•Coughing
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•Nausea
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•Shortness of breath (dyspnea)
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•Tingling, pricking, or a feeling of “pins and needles” (paresthesia/dysesthesia)
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Please refer to Section 4 for common side effects associated with gammaCore Sapphire CV use.
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8. 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
Months Remaining
9 months of therapy
remaining
Days Remaining
30 days of therapy
remaining*
*The display will begin
flashing when there are 31
or fewer days remaining.
Intensity Level
at Last Use
Last delivered intensity
level was 23
Battery
Battery is charging
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9. DEVICE STATUS INDICATORS
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gammaCore Sapphire CV has a visual indicator (display) and an auditory signal (beep) to indicate device
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status.
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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 electroCore Customer Service (refer to Section 25).
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Status
Display
Sound
User Action
Maximum number
of stimulations
reached within 24
hours.
None
gammaCore Sapphire CV
turns off automatically
Wait until next 24-hour
period
Expired/No
Days Left
None
gammaCore Sapphire CV
turns off automatically
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
Sapphire CV from
charging case
gammaCore Sapphire CV
is ready to use
gammaCore
Sapphire CV
Not Correctly
Placed in
Charging Case
None
Ensure gammaCore
Sapphire CV is placed
correctly in
charging case
Card error or
wrong card
version
None
Remove card from front
of device; not a
reloadable device
*If error is not resolved, contact electroCore Customer Service (refer to Section 25).
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10. CHARGING INSTRUCTIONS
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1. Plug the power cord of the charging case into a power
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outlet. Only use the provided power cord with the charging
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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
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case with ease. Do not force the device into the charging
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case.
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NOTE: The cap is designed to position gammaCore Sapphire
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CV correctly in the charging case. If the device is misaligned,
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“Un” is displayed. Remove the device and try placing
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gammaCore Sapphire CV in 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
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charge to deliver 2-3 stimulations.
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NOTE: Charge your device before first use. It typically takes 6
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to 7 hours for a full charge. High temperatures may increase
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the charging time. Monitor battery life and charge as needed
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to maintain an adequate number of stimulations on
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gammaCore Sapphire CV (refer to Section 9 for feedback on
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the device status indicators).
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11. 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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12. HOW TO USE GAMMACORE SAPPHIRE CV
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Set Up
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12.1 Remove any jewelry that may touch the treatment
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location.
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12.2 Find a comfortable sitting position. (A place where
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you can see your neck in a mirror may be helpful.)
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12.3 Locate the treatment location by finding the pulse
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on the side of the neck. The vagus nerve is in the
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same area. Make sure the treatment location is
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clean and 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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12.4 Remove the cap.
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12.5 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 Sapphire CV. Please contact electroCore
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Customer Service for an electroCore-approved gel that works
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with the device (refer to Section 25).
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Delivering Treatment
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12.6 Turn gammaCore Sapphire CV on by pressing
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the power button. When the device is ready for
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use, the device will beep once. The number of
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stimulations available for that 24-hour period
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and months/days remaining will be displayed.
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12.7 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.
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12.8 Increase the intensity level by repeatedly pressing the top area of the control button to the
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maximum level you can tolerate. Once you have found your maximum level, hold gammaCore
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Sapphire CV in place for the remainder of the 2-minute stimulation. The device will beep every
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time the control button is pushed, and the display will indicate a numerical value between 1 and
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40, which signifies the intensity level. You will likely feel muscle contractions at the treatment
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location. These muscle contractions are normal and should stop after the stimulation is
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complete. The appropriate intensity level is different for every person and may vary from
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stimulation to stimulation. For the majority of individuals, the appropriate level of stimulation will
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be between 15-25 on the numerical display.
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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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•Removing gammaCore Sapphire CV from the neck.
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•Lowering the intensity level by pressing the bottom area of the control button.
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•Repositioning gammaCore Sapphire CV on the neck over the pulse and slowly
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increasing the intensity level again by pressing the top area of the control button.
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If the stimulation is still intolerable, turn the device off by pressing and holding the power button and
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discontinue the stimulation.
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CAUTION: Do not turn gammaCore Sapphire CV on again until preparing for the next treatment. The
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device has a limited number of stimulations it can deliver.
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12.9. Treatment Guide
The gammaCore Sapphire CV is intended for acute use at home or in a healthcare setting to
treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of
asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not
tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by
using non-invasive vagus nerve stimulation (nVNS) on either side of the patient’s neck during
the Coronavirus Disease 2019 (COVID-19) pandemic.
Each treatment should consist of two consecutive 2-minute stimulations at the onset of respiratory
distress or shortness of breath. Stimulations may be applied to either side of the neck.
Please refer to Section 3 for an example.
The HCP must brief the patient on the following items:
• The HCP must instruct the patient using gammaCore Sapphire CV to notify the HCP of any
change in health status. The HCP must re-evaluate the patient’s suitability for treatment using
gammaCore Sapphire CV based on the patient’s new health information.
• The HCP should train patients in the proper use of gammaCore Sapphire CV, inform them of all
potential risks and complications of treatment, and provide accompanying device labeling.
NOTE: The length of each stimulation, 2-minutes, provides enough time for correct positioning of
gammaCore Sapphire CV 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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12.10 Remove gammaCore Sapphire CV after
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each stimulation. At the end of each
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stimulation, the device will display the
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number of stimulations and months/days
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remaining and the last intensity level
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before automatically turning off.
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NOTE: After 2 minutes, the device will beep
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twice, and the stimulation will automatically stop.
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NOTE: The days and stimulations remaining can
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be viewed by turning gammaCore Sapphire CV
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on. However, do not turn the intensity level
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higher than three (3) until preparing for a
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stimulation. The device counts each time the
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intensity level is higher than three (3) as a
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stimulation. gammaCore Sapphire CV delivers a
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limited number of stimulations in a 24-hour
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period.
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12.11 Clean gammaCore Sapphire CV by wiping the leftover gel off the stimulation surfaces with a
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soft, dry cloth (refer to Section 13).
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12.12 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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12.13 Put the cap back on the device after use.
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13. 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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14. PRODUCT HANDLING
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Operating Conditions –gammaCore Sapphire CV
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•Range: 0°C to 38°C (32°F to 100°F)
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•Humidity: 10% to 90%
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•Barometric Pressure: 80 to 101 kPa
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•Altitude: Use below 2000 m
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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 Sapphire CV produces an electrical signal consisting of five 5,000-Hz pulses, repeating
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at a rate of 25 Hz. The waveform of the gammaCore Sapphire CV pulse is approximately a sine
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wave.
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Operating Conditions –Charging Case
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•Range: 0°C to 38°C (32°F to 100°F)
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•Humidity: 10% to 90%
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•Barometric Pressure: 80 to 101 kPa
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•Altitude: Use below 2000 m
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•Only use the charging case indoors
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•Do not place any object except gammaCore Sapphire CV 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 Sapphire CV 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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•Humidity: 10% to 90%
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•Barometric Pressure: 80 to 101 kPa
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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 Sapphire CV is 3 years after the date of manufacture (refer to
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package label for the expiration date).
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•The service life of the conductive gel is 5 years.
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