ElectroCore gammaCore Sapphire SLC Instructions Manual
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- Instructions for use manual (48 pages)
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Instructions for Use for gammaCore Sapphire
(non-invasive vagus nerve stimulator)
1.
INDICATIONS AND PRODUCT DESCRIPTION ........................................................................................................... 2
2.
GAMMACORE TREATMENT RECOMMENDATIONS .................................................................................................. 3
3.
CONTRAINDICATIONS ................................................................................................................................................. 4
4.
COMMON SIDE EFFECTS ASSOCIATED WITH GAMMACORE ...................................................................... 4
5.
WILL I STILL NEED TO TAKE MEDICATIONS ....................................................................................4
6.
WARNINGS AND PRECAUTIONS ................................................................................................................................ 5
7.
DISPLAY SYMBOLS ...................................................................................................................................................... 7
DEVICE STATUS INDICATORS .............................................................................................................8
8.
9.
RELOADING INSTRUCTIONS .................................................................................................................................. ..10
DEVICE ERROR CODES......................................................................................................................11
10.
11.
CHARGING INSTRUCTIONS ...................................................................................................................................... 12
12.
FUNCTIONS ................................................................................................................................................................. 13
13.
HOW TO USE gammaCore Sapphire ......................................................................................................................... 14
14.
CLEANING ................................................................................................................................................................... 18
15.
PRODUCT HANDLING ................................................................................................................................................ 18
16.
TROUBLESHOOTING ...................................................................................................................................... 19
17.
PRODUCT DISPOSAL ................................................................................................................................................ 19
18.
SYMBOLS AND NOMENCLATURE DESCRIPTION .................................................................................................. 20
19.
PRODUCT ORDERS AND RETURNS ........................................................................................................................ 21
ADDITIONAL INFORMATION FOR HEALTHCARE PROFESSIONALS ................................................................................ 22
20.
PRODUCT DESCRIPTION .......................................................................................................................................... 23
ADDITIONAL CONTRAINDICATIONS.....................................................................................................23
21.
ADDITIONAL WARNINGS A ND P RECAUTIONS .......................................... .................................................. 23
22.
23.
CLINICAL STUDIES ..................................................................................................................................................... 24
24.
ELECTRICAL CLASSIFICATION ................................................................................................................................ 24
25.
ELECTROMAGNETIC COMPATIBILITY GUIDANCE ................................................................................................. 25
26.
CONTACT INFORMATION .......................................................................................................................................... 29
Caution:
Healthcare professional authorisation required.
1
SLC for Migraine
TM
64000-00174 Rev 1
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Table of Contents
Related Manuals for ElectroCore gammaCore Sapphire SLC
Summary of Contents for ElectroCore gammaCore Sapphire SLC
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Page 1: Table Of Contents
Instructions for Use for gammaCore Sapphire SLC for Migraine (non-invasive vagus nerve stimulator) INDICATIONS AND PRODUCT DESCRIPTION ......................2 GAMMACORE TREATMENT RECOMMENDATIONS ....................3 CONTRAINDICATIONS ..............................4 COMMON SIDE EFFECTS ASSOCIATED WITH GAMMACORE ..............4 WILL I STILL NEED TO TAKE MEDICATIONS ...………………………………………………………………………4 WARNINGS AND PRECAUTIONS .......................... -
Page 2: Indications And Product Description
1. INDICATIONS AND PRODUCT DESCRIPTION gammaCore Sapphire (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for the treatment and/or prevention of migraine headache in adults. gammaCore provides a mild electrical stimulation to the vagus nerve, which runs through the neck and carries information to the central nervous system. -
Page 3: Gammacore Treatment Recommendations
2. GAMMACORE TREATMENT RECOMMENDATIONS Preventive Treatment of Migraine Headache • Three treatments (morning, mid-day, and night) each consisting of two consecutive 2-minute stimulations Acute Treatment of Migraine Headache • One treatment consisting of two consecutive 2-minute stimulations • If pain has not decreased 20 minutes after the start of your first treatment, a second treatment (consisting of two consecutive 2-minute stimulations) may be administered •... -
Page 4: Contraindications
3. CONTRAINDICATIONS Contraindications include but are not limited to: • Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device • Patients with metallic device such as a stent, bone plate or bone screw implanted at or near their neck •... -
Page 5: Warnings And Precautions
WARNINGS AND PRECAUTIONS Warnings indicate instructions, which, if not followed, may result in serious injury or death to the device user or to the patient. Precautions indicate instructions, which, if not followed, may result in damage to the equipment or degradation in the quality of treatment. - Page 6 • Only use an electroCore-approved gel with gammaCore. Please contact Customer Service for an electroCore-approved gel that works with the device • Do not share gammaCore with another person. • gammaCore should not be applied across or through the head, directly on the eyes, covering the mouth, on the chest or the upper back, or over the heart.
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Page 7: Display Symbols
7. 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 Flashing display indicates Days Remaining remaining days of therapy* Intensity Level Last delivered intensity at Last Use level was 23 Battery Battery is charging... -
Page 8: Device Status Indicators
8. DEVICE STATUS INDICATORS gammaCore has a visual indicator (display) and an auditory signal (beep) to indicate device status. Status Display Sound User Action 1. Days Remaining* 2. Stimulations Remaining Follow “How to Use” 1 beep after Start Up / power ON Instructions Ready for Use... - Page 9 Status Display Sound User Action gammaCore turns off Maximum number automatically of stimulations None reached within 24 Wait until next 24-hour hours. period gammaCore turns off Expired/No automatically None Days Left Reload with refill card Repeated Low Battery Place in charging case long beeps Dead Battery None...
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Page 10: Reloading Instructions
9. RELOADING INSTRUCTIONS 1. Once you have received your gammaCore Refill Card, you can now load your device. 2. Turn gammaCore on by pressing the power button. Have your refill card ready. 3. Once gammaCore is turned on, place the device on a hard surface with the display screen facing up. -
Page 11: Device Error Codes
10. DEVICE ERROR CODES Status Display Sound User Action An example of an error code: Wait 24 hours and Start-Up Error None restart device (Turn off and on again)* Errors may have different numeric codes Too many attempts to reload Repeated Long Wait 24 hours and try the device in 24-... -
Page 12: Charging Instructions
11. CHARGING INSTRUCTIONS 1. Plug the power cord of the charging case into a power outlet. Only use the provided power cord with the charging case. 2. Place the device into the charging case with the power button facing up. The device should fit into the charging case with ease. -
Page 13: Functions
12. 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 14: How To Use Gammacore Sapphire
13. HOW TO USE gammaCore Sapphire™ Set Up 13.1 Remove any jewelry that may touch the treatment location. 13.2 Find a comfortable position. (A place where you can see your neck in a mirror may be helpful.) 13.3 Locate the treatment location by finding the pulse on the side of the neck. - Page 15 Not applying the gel as described may cause the stimulation to be uncomfortable or less effective. CAUTION: Only use an electroCore-approved gel with gammaCore. Please contact Customer Service for an electroCore-approved gel that works with the device (refer to Section 26). 64000-00174 Rev 1...
- Page 16 Delivering Treatment 13.6 Turn gammaCore on by pressing the power button. When the device is ready for use, the device will beep once. The number of stimulations available for that 24-hour period and days remaining will be displayed. 13.7 Position the device on the side of the neck over the treatment location.
- Page 17 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.
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Page 18: Cleaning
13.11 Clean gammaCore by wiping the leftover gel off the stimulation surfaces with a soft, dry cloth (refer to Section 14). 13.12 Clean the excess gel off your neck with a cloth or tissue. The gel is not intended to be left on the skin and may cause skin irritation for some people. -
Page 19: Troubleshooting
16. TROUBLESHOOTING gammaCore does not turn on • gammaCore is not charged. Charge gammaCore by placing the device in the charging case (refer to Section 11). • Restart gammaCore. Turn gammaCore off and on again. gammaCore does not charge • If “Un” is displayed, remove gammaCore and place back in charging case. If “Un” continues to be displayed, move device around in the charging case. -
Page 20: Symbols And Nomenclature Description
18. SYMBOLS AND NOMENCLATURE DESCRIPTION Follow operating instructions Expiration date Manufacturer Lot number IP22 Protection from solid foreign objects Catalog number / Reference number ≥12.5 mm and ingress of water at 15° Type BF applied part Electric shock hazard Storage temperature Serial number Date of Manufacture on package label, xxyyGzzzz... -
Page 21: Product Orders And Returns
Authorisation by your HCP is required. Please refer to the device label and contact Customer Service to place an order for gammaCore, a refill card kit or electroCore-approved gel or if ordered online, please log in to your account and navigate to the purchase options. -
Page 22: Additional Information For Healthcare Professionals
ADDITIONAL INFORMATION FOR HEALTHCARE PROFESSIONALS 64000-00174 Rev 1... -
Page 23: Product Description
Tubes of electroCore-approved gel are provided with each unit and refill kit for this purpose. The stimulation surfaces are capped when not in use. -
Page 24: Clinical Studies
Precautions • Prior to using or prescribing gammaCore, the HCP should read and understand all instructions and labeling. • gammaCore is not to be used outside of its intended use. Consider all Warnings and Precautions. • Please refer to Section 6 for a complete list of Precautions. The HCP must brief the patient on the following items: •... -
Page 25: Electromagnetic Compatibility Guidance
25. ELECTROMAGNETIC COMPATIBILITY GUIDANCE Guidance and Manufacturer’s Declaration - Electromagnetic Emissions gammaCore is intended for use in the electromagnetic environment specified below. The customer or the user of gammaCore should assure that it is used in such an environment. Electromagnetic Emissions Test Compliance Environment –... - Page 26 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and gammaCore The customer or the user of gammaCore can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and gammaCore, as recommended below, according to the maximum output power of the communications equipment.
- Page 27 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity gammaCore is intended for use in the electromagnetic environment specified below. The customer or the user of gammaCore should assure that it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic Test Test Level Level...
- Page 28 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity gammaCore is intended for use in the electromagnetic environment specified below. The customer or the user of gammaCore should ensure that it is used in such an environment. Electromagnetic IEC 60601 Compliance Immunity Test Environment - Test Level Level...
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Page 29: 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 30 NOTES 64000-00174 Rev 1...
- Page 31 NOTES 64000-00174 Rev 1...
- Page 32 Inc. 200 Forge Way, Suite 205 Rockaway, NJ 07866 United States www.electrocore.com 64000-00174 Rev 1...
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