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Instructions for Use for gammaCore Sapphire
(non-invasive vagus nerve stimulator) authorized for emergency use in the acute treatment of
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, using
non-invasive VNS on either side of the patient's neck during the COVID-19 pandemic.
1. EMERGENCY USE AUTHORIZATION ............................................................................................................................ 2
2. INDICATION AND PRODUCT DESCRIPTION ................................................................................................................ 3
3. GAMMACORE SAPPHIRE CV TREATMENT RECOMMENDATIONS ........................................................................... 4
4. COMMON SIDE EFFECTS ASSOCIATED WITH GAMMACORE SAPPHIRE CV.................................................5
5. WILL I STILL NEED TO TAKE MEDICATIONS...............................................................................................5
6. WARNINGS AND PRECAUTIONS..............................................................................................................6
DEVICES .......................................................................................................................................................................... 9
8. DISPLAY SYMBOLS ....................................................................................................................................................... 10
9. DEVICE STATUS INDICATORS .................................................................................................................................... 11
10. CHARGING INSTRUCTIONS ........................................................................................................................................ 13
11. FUNCTIONS ................................................................................................................................................................... 14
12. HOW TO USE GAMMACORE SAPPHIRE CV .............................................................................................................. 15
13. CLEANING ..................................................................................................................................................................... 20
14. PRODUCT HANDLING .................................................................................................................................................. 20
15. TROUBLESHOOTING .................................................................................................................................................... 21
16. PRODUCT DISPOSAL ................................................................................................................................................... 21
17. SYMBOLS AND NOMENCLATURE DESCRIPTION ..................................................................................................... 22
18. ORDERING INFORMATION ......................................................................................................................................... 23
19. PRODUCT ORDERS AND RETURNS ........................................................................................................................... 23
20. DETAILED PRODUCT DESCRIPTION .......................................................................................................................... 25
21. ADDITIONAL WARNINGS AND PRECAUTIONS.........................................................................................25
22. CLINICAL STUDIES ....................................................................................................................................................... 27
23. ELECTRICAL CLASSIFICATION ................................................................................................................................... 28
24. ELECTROMAGNETIC COMPATIBILITY GUIDANCE ................................................................................................... 28
25. CONTACT INFORMATION ............................................................................................................................................ 32
Caution: Rx Only. US Federal Law restricts this device to sale by or on the order of a licensed healthcare provider.
TM
CV
1
64000-00137 Rev 1
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Table of Contents
Related Manuals for ElectroCore gammaCore Sapphire CV
Summary of Contents for ElectroCore gammaCore Sapphire CV
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Page 1: Table Of Contents
1. EMERGENCY USE AUTHORIZATION ..........................2 2. INDICATION AND PRODUCT DESCRIPTION ........................ 3 3. GAMMACORE SAPPHIRE CV TREATMENT RECOMMENDATIONS ................4 4. COMMON SIDE EFFECTS ASSOCIATED WITH GAMMACORE SAPPHIRE CV………………………………………….5 5. WILL I STILL NEED TO TAKE MEDICATIONS…………………………….……………………………………………..…..5 6. WARNINGS AND PRECAUTIONS………………………………………………………………………………………………..6 7. -
Page 2: Emergency Use Authorization
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. gammaCore Sapphire CV has neither been cleared nor approved for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are... -
Page 3: Indication And Product Description
Each stimulation with the gammaCore Sapphire CV lasts 2 minutes. The patient controls the intensity level. The gammaCore Sapphire CV delivers up to 30 stimulations in a 24-hour period, starting when the device is turned on and the intensity level is increased above 3. Once the maximum daily number of stimulations has been reached, the device will not deliver any more stimulations until the following 24- hour period. -
Page 4: Gammacore Sapphire Cv Treatment Recommendations
3. GAMMACORE SAPPHIRE CV TREATMENT RECOMMENDATIONS • The gammaCore Sapphire CV is intended for acute use at home or in healthcare settings 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, using non-invasive vagus nerve stimulation (nVNS) on either side of the patient’s... -
Page 5: Common Side Effects Associated With Gammacore Sapphire Cv
These side effects typically resolve immediately after the stimulation is complete. 5. WILL I STILL NEED TO TAKE MEDICATIONS? People respond differently to gammaCore Sapphire CV. 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. -
Page 6: Warnings And Precautions
Warnings • The gammaCore Sapphire CV has neither been cleared nor approved 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... - Page 7 Caring for Your gammaCore Sapphire CV: • Turn off gammaCore Sapphire CV when it is not being used. If gammaCore Sapphire CV is not turned off, the battery may become depleted and the device may not deliver treatment when needed.
- Page 8 • Wireless communications equipment, such as wireless home network devices, mobile phones, walkie-talkies, cordless telephones and their base stations can affect gammaCore Sapphire CV. Keep gammaCore Sapphire CV at least 3.3 m (10.8 ft) away from these items while in use (refer to Section 24 for additional information).
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Page 9: Potential Risks And Complications Associated With Other Vagus Nerve Stimulation Devices
• Shortness of breath (dyspnea) • Tingling, pricking, or a feeling of “pins and needles” (paresthesia/dysesthesia) Please refer to Section 4 for common side effects associated with gammaCore Sapphire CV use. Note: The remainder of this page was intentionally left blank. -
Page 10: Display Symbols
8. DISPLAY SYMBOLS Example Icon Description Icon Description Display Stimulations 6 stimulations remaining Remaining within a 24-hour period Intensity level Intensity Level is at 23 9 months of therapy Months Remaining remaining 30 days of therapy remaining* Days Remaining *The display will begin flashing when there are 31 or fewer days remaining. -
Page 11: Device Status Indicators
9. DEVICE STATUS INDICATORS gammaCore Sapphire CV has a visual indicator (display) and an auditory signal (beep) to indicate device status. Status Display Sound User Action 1. Months/Days Remaining 2. Stimulations Remaining Follow “How to Use” 1 beep after Start Up /... - Page 12 Placed in correctly in Charging Case charging case Card error or Remove card from front wrong card None of device; not a version reloadable device *If error is not resolved, contact electroCore Customer Service (refer to Section 25). 64000-00137 Rev 1...
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Page 13: Charging Instructions
Monitor battery life and charge as needed to maintain an adequate number of stimulations on gammaCore Sapphire CV (refer to Section 9 for feedback on the device status indicators). Note: The remainder of this page was intentionally left blank. -
Page 14: Functions
11. FUNCTIONS Power Button Increase Intensity Level Decrease Intensity Level Press the power button to turn device ON Press the upper area of Press the lower area of the control button the control button Hold the power button to turn the device OFF Note: The remainder of this page was intentionally left blank. -
Page 15: How To Use Gammacore Sapphire Cv
12. HOW TO USE GAMMACORE SAPPHIRE CV Set Up 12.1 Remove any jewelry that may touch the treatment location. 12.2 Find a comfortable sitting position. (A place where you can see your neck in a mirror may be helpful.) 12.3 Locate the treatment location by finding the pulse on the side of the neck. - Page 16 CAUTION: Only use an electroCore-approved gel with gammaCore Sapphire CV. Please contact electroCore Customer Service for an electroCore-approved gel that works with the device (refer to Section 25). 64000-00137 Rev 1...
- Page 17 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 Sapphire CV on again until preparing for the next treatment. The device has a limited number of stimulations it can deliver.
- Page 18 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.
- Page 19 24-hour period. 12.11 Clean gammaCore Sapphire CV by wiping the leftover gel off the stimulation surfaces with a soft, dry cloth (refer to Section 13). 12.12 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.
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Page 20: Cleaning
Load Impedance: 450 to 550 Ohms • gammaCore Sapphire CV produces an electrical signal consisting of five 5,000-Hz pulses, repeating at a rate of 25 Hz. The waveform of the gammaCore Sapphire CV pulse is approximately a sine wave. Operating Conditions – Charging Case •... -
Page 21: Troubleshooting
• Restart gammaCore Sapphire CV. Turn gammaCore Sapphire CV off and on again. gammaCore Sapphire CV does not charge • If “Un” is displayed, remove gammaCore Sapphire CV and place back in charging case. If “Un” continues to be displayed, move device around in the charging case. -
Page 22: Symbols And Nomenclature Description
17. SYMBOLS AND NOMENCLATURE DESCRIPTION 64000-00137 Rev 1... -
Page 23: Ordering Information
Customer Service. When the COVID-19 public health emergency has been terminated, electroCore will attempt to inform recipients of gammaCore Sapphire CV to facilitate the return or disposal of the gammaCore Sapphire Refer to Section 25 for electroCore Customer Service Contact Information. - Page 24 ADDITIONAL INFORMATION FOR HEALTHCARE PROVIDERS 64000-00137 Rev 1 64000-00137 Rev 1...
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Page 25: Detailed Product Description
Sapphire CV produces a low-voltage electric signal consisting of five 5,000-Hz pulses that are repeated at a rate of 25 Hz. The waveform of the gammaCore Sapphire CV pulse is approximately a sine wave with a peak voltage limited to 24 Volts when placed on the skin and a maximum output current of 60mA. - Page 26 Precautions • Prior to using or prescribing gammaCore Sapphire CV, the HCP should read and understand all instructions and labeling. • gammaCore Sapphire CV is not to be used outside of its intended use. Consider all warnings and precautions. Note: The remainder of this page was intentionally left blank.
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Page 27: Clinical Studies
22. CLINICAL STUDIES A summary of the studies that assessed nVNS in patients with asthma is provided in Table 1: Table 1. Summary of nVNS trials relevant to COVID-19 Study Design Findings relevant to COVID-19 nVNS for the treatment Prospective, 90 minutes after acute nVNS treatment, of acute asthma multicenter,... -
Page 28: Electrical Classification
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions gammaCore Sapphire CV is intended for use in the electromagnetic environment specified below. The customer or the user of gammaCore Sapphire CV should assure that it is used in such an environment. Electromagnetic... - Page 29 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and gammaCore Sapphire CV The customer or the user of gammaCore Sapphire CV can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and gammaCore Sapphire CV, as recommended below, according to the maximum output power of the communications equipment.
- Page 30 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity gammaCore Sapphire CV is intended for use in the electromagnetic environment specified below. The customer or the user of gammaCore Sapphire CV should assure that it is used in such an environment. Immunity...
- Page 31 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity gammaCore Sapphire CV is intended for use in the electromagnetic environment specified below. The customer or the user of gammaCore Sapphire CV should ensure that it is used in such an environment. Electromagnetic...
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Page 32: Contact Information
For patent information, please visit electroCore.com electroCore software or firmware, or any updates or later versions thereof, included in or provided for use with any electroCore product is provided subject to a revocable non-exclusive license solely for use with such electroCore product to operate such product for its intended use, and not for any other use, and may not be copied, altered, removed, modified, reprogrammed, or de-compiled or used for any other purpose. - Page 33 (b) repairs or modifications performed other than by electroCore or an electroCore authorized repair facility; (c) use of the device in any manner other than for which it is intended; or (d) any special, indirect and/or consequential damages of any kind and however caused arising from the sale or use of the product.
- Page 34 Inc. 150 Allen Road, Suite 201 Basking Ridge, NJ 07920 United States 1 (888) 903-CORE (2673) www.electrocore.com...
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