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64000-00137 Rev 1 

 
 

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Instructions for Use for gammaCore Sapphire

TM

 CV 

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(non-invasive vagus nerve stimulator) authorized for emergency use in the acute treatment of 

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adult patients with known or suspected COVID-19 who are experiencing exacerbation of 

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asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not 

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tolerated or provide insufficient symptom relief as assessed by their healthcare provider, using 

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non-invasive VNS on either side 

of the patient’s neck during the COVID-19 pandemic. 

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1. EMERGENCY USE AUTHORIZATION ............................................................................................................................ 2 

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2. INDICATION AND PRODUCT DESCRIPTION ................................................................................................................ 3 

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3. GAMMACORE SAPPHIRE CV TREATMENT RECOMMENDATIONS ........................................................................... 4 

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4. COMMON SIDE EFFECTS ASSOCIATED WITH GAMMACORE SAPPHI

RE CV………………………………………….5 

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. WILL I STILL NEED TO TAKE MEDICATIONS…………………………….……………………………………………..….....5 

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6. WARNINGS AND PRECAUTIONS

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7. POTENTIAL RISKS AND COMPLICATIONS ASSOCIATED WITH OTHER VAGUS NERVE STIMULATION 

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    DEVICES .......................................................................................................................................................................... 9 

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8. DISPLAY SYMBOLS ....................................................................................................................................................... 10 

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9. DEVICE STATUS INDICATORS .................................................................................................................................... 11 

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10. CHARGING INSTRUCTIONS ........................................................................................................................................ 13 

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11. FUNCTIONS ................................................................................................................................................................... 14 

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12. HOW TO USE GAMMACORE SAPPHIRE CV .............................................................................................................. 15 

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13. CLEANING ..................................................................................................................................................................... 20 

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14. PRODUCT HANDLING .................................................................................................................................................. 20 

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15. TROUBLESHOOTING .................................................................................................................................................... 21 

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16. PRODUCT DISPOSAL ................................................................................................................................................... 21 

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17. SYMBOLS AND NOMENCLATURE DESCRIPTION ..................................................................................................... 22 

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18. ORDERING INFORMATION  ......................................................................................................................................... 23 

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19. PRODUCT ORDERS AND RETURNS ........................................................................................................................... 23 

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20. DETAILED PRODUCT DESCRIPTION .......................................................................................................................... 25 

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21. ADDITIONAL WARNINGS AND PRECAUTIONS

…………………………………………………………………………..…25 

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22. CLINICAL STUDIES ....................................................................................................................................................... 27 

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23. ELECTRICAL CLASSIFICATION ................................................................................................................................... 28 

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24. ELECTROMAGNETIC COMPATIBILITY GUIDANCE ................................................................................................... 28 

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25. CONTACT INFORMATION ............................................................................................................................................ 32

 

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Caution: Rx Only. US Federal Law restricts this device to sale by or on the order of a licensed healthcare provider.

 

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Содержание gammaCore Sapphire CV

Страница 1: ...E EFFECTS ASSOCIATED WITH GAMMACORE SAPPHIRE CV 5 5 WILL I STILL NEED TO TAKE MEDICATIONS 5 6 WARNINGS AND PRECAUTIONS 6 7 POTENTIAL RISKS AND COMPLICATIONS ASSOCIATED WITH OTHER VAGUS NERVE STIMULATION 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 TROUBLESHOOT...

Страница 2: ... 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 Coro...

Страница 3: ...riod 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 The number of remaining stimulations available in a 24 hour period is indicated on the display refer to Section 8 gammaCore Sapphire CV is rechargeable and includes...

Страница 4: ...eir healthcare provider using non invasive vagus nerve stimulation nVNS on either side of the patient s neck during the Coronavirus Disease 2019 COVID 19 pandemic One treatment consisting of two consecutive 2 minute stimulations If the therapy does not provide relief seek medical attention by consulting your Healthcare Provider The use of more than 24 stimulations per day has not been evaluated in...

Страница 5: ... pull Headache migraine Dizziness Tingling pricking or a feeling of pins and needles on the skin where the device is applied paresthesia dysesthesia These side effects typically resolve immediately after the stimulation is complete 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...

Страница 6: ...ed at or near your neck o Patients with an open wound rash infection swelling cut sore drug patch or surgical scar s on their neck at the treatment location Patients should not use the gammaCore Sapphire CV o While they are driving operating machinery or during any activity that may put the patient at risk of injury o If they have any planned surgeries that may involve implants The patient should ...

Страница 7: ...r Use Remove jewelry that may touch the treatment location necklaces earrings etc Carefully examine the device for any signs of damage or defects if present contact your HCP and when possible contact electroCore Customer Service using the information provided in Section 25 Do not use gammaCore Sapphire CV if The stimulation surfaces are broken or cracked The casing is cracked dented or appears to ...

Страница 8: ...t open or take apart the case or attempt to repair or modify the device There are no user serviceable parts Do not intentionally damage burn or puncture the device 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 fro...

Страница 9: ... Headache Muscle twitching and or contractions of head neck face Gastrointestinal discomfort Hoarseness or change in voice Irregular heartbeat arrhythmia Light headedness dizziness Metallic taste Coughing Nausea 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 ...

Страница 10: ...maining 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 ...

Страница 11: ...r 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 ...

Страница 12: ... 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 R...

Страница 13: ...he device and try placing gammaCore Sapphire CV in the charging case again 3 The device display will show Ch with the battery charge indicator bars flashing and increasing 4 The device will show dn when fully charged NOTE It only takes a few minutes until there is enough charge to deliver 2 3 stimulations NOTE Charge your device before first use It typically takes 6 to 7 hours for a full charge Hi...

Страница 14: ...y 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 Note The remainder of this page was intentionally left blank ...

Страница 15: ...ul 12 3 Locate the treatment location by finding the pulse on the side of the neck The vagus nerve is in the same area Make sure the treatment location is clean and dry The stimulation surfaces of the device will line up with the following landmarks Over the pulse orange this is the treatment location In front of the large muscle at the side of the neck yellow Just below the lower jaw grey Lined u...

Страница 16: ...tion surfaces Not applying the gel as described may cause the stimulation to be uncomfortable or less effective CAUTION Only use an electroCore approved gel with gammaCore Sapphire CV Please contact electroCore Customer Service for an electroCore approved gel that works with the device refer to Section 25 ...

Страница 17: ...l muscle contractions at the treatment location These muscle contractions are normal and should stop after the stimulation is complete The appropriate intensity level is different for every person and may vary from stimulation to stimulation For the majority of individuals the appropriate level of stimulation will be between 15 25 on the numerical display NOTE Neck muscle contractions during the s...

Страница 18: ...efer 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 Sa...

Страница 19: ... Sapphire CV on However do not turn the intensity level higher than three 3 until preparing for a stimulation The device counts each time the intensity level is higher than three 3 as a stimulation gammaCore Sapphire CV delivers a limited number of stimulations in a 24 hour period 12 11 Clean gammaCore Sapphire CV by wiping the leftover gel off the stimulation surfaces with a soft dry cloth refer ...

Страница 20: ... repeating at a rate of 25 Hz The waveform of the gammaCore Sapphire CV pulse is approximately a sine wave Operating Conditions Charging Case Range 0 C to 38 C 32 F to 100 F Humidity 10 to 90 Barometric Pressure 80 to 101 kPa Altitude Use below 2000 m Only use the charging case indoors Do not place any object except gammaCore Sapphire CV on the charging surface Maximum Output 5 5V DC 5W Input 100 ...

Страница 21: ...ations left days left Contact electroCore Customer Service to order a new device For further assistance please contact electroCore Customer Service refer to Section 25 16 PRODUCT DISPOSAL Regulations require that disposal of electrical and electronic equipment including used and unused medical devices is handled in a controlled manner A product that may be contaminated after use or that may contai...

Страница 22: ...64000 00137 Rev 1 22 17 SYMBOLS AND NOMENCLATURE DESCRIPTION ...

Страница 23: ... device including a non working device when treatment has been completed or when the COVID 19 public health emergency has been terminated should be made to electroCore 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 CV Refer to Section...

Страница 24: ...64000 00137 Rev 1 24 ADDITIONAL INFORMATION FOR HEALTHCARE PROVIDERS 24 64000 00137 Rev 1 ...

Страница 25: ...veform 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 The signal is transmitted through the skin of the neck to vagus nerve Each stimulation last 2 minutes allowing the patient to properly position the device adjust the intensity level and deliver the dose After 2 minutes the devic...

Страница 26: ...ibing 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 ...

Страница 27: ...ment FEV1 improved from baseline by a mean of 73 and mean VAS dyspnea score decreased from 8 at baseline to 1 nVNS for the relief of acute bronchoconstriction due to asthma Prospective multicenter open label study 30 90 minutes after acute nVNS treatment 93 of patients reported improvement in VAS dyspnea score and 86 had improvements in FEV1 Abbreviations COVID 19 coronavirus disease 2019 FEV1 for...

Страница 28: ...CTROMAGNETIC COMPATIBILITY GUIDANCE 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 Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 2 gammaCore...

Страница 29: ... 0 35 P 80 MHz to 800 MHz d 0 35 P 800 MHz to 2 6 GHz d 0 70 P 0 01 0 04 0 04 0 07 0 1 0 11 0 11 0 22 1 0 35 0 35 0 70 10 1 1 1 1 2 2 100 3 5 3 5 7 0 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the t...

Страница 30: ...etermined by an electromagnetic site surveya should be less than the compliance level in each frequency range b interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption a...

Страница 31: ... 2 kV line s to earth 1 kV for power supply lines 2 kV line s to earth Mains power quality should be that of a typical commercial and or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 cycles 5 UT 95 dip in...

Страница 32: ...electrocore com CE2797 2020 electroCore Inc All rights reserved electroCore the electroCore logo gammaCore the gammaCore logo gammaCore Sapphire CV and the gammaCore Sapphire CV logo are trademarks of electroCore Inc 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 prod...

Страница 33: ... electroCore shall not be liable expressly or implied for any damage that might arise or be caused whether by the customer or by any of the users of the product as a result of a misuse mishandling and or improper operation 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...

Страница 34: ...electroCore Inc 150 Allen Road Suite 201 Basking Ridge NJ 07920 United States 1 888 903 CORE 2673 www electrocore com ...

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