Frequently Asked Questions and Troubleshooting

gammaCore™ is intended for the prevention and/or treatment of primary headache disorders. The below list of indications have been cleared by either the US FDA, TGA, Health Canada, UK CA or European CE Mark. Please read the important safety information before use.

• The preventive treatment of migraine headache in adolescents (age 12 and older) and adults.
• The acute treatment of pain associated with migraine headache in adolescents (age 12 and older) and adults.
• The preventive treatment of cluster headache in adults.
• The acute treatment of pain associated with cluster headache in adults.
• Treatment of hemicrania continua in adults.
• Treatment of paroxysmal hemicrania in adults.
• Medication overuse headache in adults.

gammaCore™ works by safely and gently stimulating the vagus nerve from outside the body. 3 simple, straightforward steps for correct use:

1. Prepare: Find the correct treatment location and positioning on the neck to activate the vagus nerve.
2. Start: Apply the supplied gel to each of the stimulation surfaces of the device, turn it on, and position it on the neck.
3. Deliver: Adjust the stimulation intensity to the right level.

Please refer to the Important Safety Information and gammaCore™ Instructions for Use.

When using gammaCore™, you should feel a tingling sensation on the neck where the device is held. You may feel a downward pulling on your lip - this is the most common muscle contraction seen with gammaCore™ use and indicates you’re in the correct treatment position. The user controls the intensity level and can increase or decrease at any time during the treatment. Treatment should never be painful.

NOTE: Neck muscle contractions during the stimulation that are not painful are normal and not a reason to stop the stimulation. If muscle contractions are too strong or uncomfortable, try:

• Lowering the intensity level by pressing the bottom area of the control button
• Repositioning gammaCore on the neck over the pulse and slowly increasing the intensity level again by pressing the top area of the control button.

The usual treatment consists of 2 two-minute stimulations on the same side of the neck, twice per day (morning and night). Depending on the type of headache you are treating, initial treatments can last anywhere from 4 to 6 minutes. If needed, treatments can be repeated if additional attacks occur and can be used for multiple attacks per day. Additional treatments may be recommended by your Healthcare Provider. Click here to learn more about treatment timing.

We recommend using the highest intensity level comfortably tolerated. This number is different for everyone, users typically feel optimal intensity between 15 and 25. For best results, raise the intensity to a level where you feel a slight “lip pull” sensation.

The device will beep every time the control button is pushed, and the display will indicate a numerical value between 1 and 40, which signifies the intensity level. You will likely feel 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.

You and your healthcare provider should discuss your ongoing treatment routine, including the use of any additional therapies and/or medications. It is important to always follow your healthcare provider’s recommendations about your medications. gammaCore can be used with existing medications as there have been no reported device-medication interactions.

The gammaCore™ device comes preloaded with either 3 months (93 days) or 36 months of consecutive treatment days. Each day the device allows up to 30  stimulations (recommended to not exceed 24 simulations within a 24hr period), so you can treat multiple attacks if needed. 

Refill kits are available for the starter kit device of 93 days of consecutive treatment and can be purchased from Byond Healthcare as a refill card to be loaded onto your device. 

NOTE: The remaining months/days and stimulations can be viewed by turning gammaCore™ on. However, do not turn the intensity level higher than three (3) until preparing for a stimulation. Each time the intensity level is higher than three (3), the device counts as a stimulation. gammaCore™ delivers a limited number of stimulations in a 24-hour period.

gammaCore™ is a safe and well-tolerated treatment. Most side effects are mild, occur while using the device, and disappear soon after each treatment. In clinical studies, <5% of participants experienced mild side effects, included but nothing limited to:

• Application site discomfort, irritation, and redness
• Muscle twitching and/or contractions
• Local pain, face/head/neck area (including toothache)
• Headache
• Dizziness
• Tingling, pricking, or a feeling of “pins and needles” on the skin where the device is applied

Discontinue treatment if you experience:

• Light-headedness, dizziness, or chest pain during treatment
• Excessive skin irritation

If the device seems to malfunction, discontinue use immediately, continue taking usual medications, and seek medical care as needed. When possible, contact info@byondhealthcare for assistance with your device. Byond Healthcare cannot provide medical assistance.

 

It is safe to travel with gammaCore™; as the device contains a lithium battery, we recommend storing gammaCore™ in your carry-on luggage to assure it is not exposed to extreme conditions. One tube of conductive gel is within the AVSEC (as well as the TSA) liquid carry on regulation.

You can download your gammaCore™ quickstart guide here. The instruction for use is supplied with your device and enclosed in the outer carton of the device.   

Before use:

• Check warnings and contraindications.
• You must read the Parasym™ instructions before using the device. However, reading the instructions for use may not be enough to fully explain the safe and effective use of the device. Please ask your healthcare provider or contact Byond Healthcare or Parasym™ support if you have any questions about how to use the device or require any further clarification of these instructions.
• Only use Parasym™ as described in the instructions for use or as otherwise directed by your healthcare provider.
• Remove all jewelry that may interfere with the electrode location (earrings etc.) before using Parasym™.
• Always carefully examine the device for any signs of damage or defects before use.
• Do not strip the batteries’ outer seal when inserting (for risk of short-circuiting), this can be avoided by taking care when inserting.
• Do not share your Parasym™ device with another person.

• Patients with an active implantable medical device, such as a cardiac pacemaker, hearing aid implant, or any implanted metallic or electronic device.
• Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure (CHF), severe coronary artery disease or recent myocardial infarction (within 5 years).
• Patients with diagnosed bradycardia.
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy).
• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis).
• Patients whose pain syndromes are undiagnosed.
• Paediatric patients.
• Pregnant women.

Read these instructions carefully to ensure proper use of the Parasym™ device:

• Do not inhale or swallow small parts.
• Do not wrap the lead wire around the neck.
• Do not apply stimulation in the bath or shower or while sleeping.
• Do not get the Parasym™ device wet.
• Do not apply stimulation while drilling, operating machinery, or during any activity in which electrical stimulation can put the patient at risk of injury.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins).
• Do not apply stimulation over, or in proximity to, cancerous lesions.
• Do not apply stimulation over the patient’s neck or mouth because this could cause severe muscle spasms resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.
• Do not apply stimulation across the patient’s chest, because the introduction of electrical current into the chest may cause rhythm disturbances to the patient’s heart, which could be lethal.
• Do not apply electrodes near the thorax because the introduction of electrical current may increase the risk of cardiac fibrillation.
• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the front of the neck, (especially the carotid sinus), or from electrodes placed on the chest and the upper back or crossing over the heart.
• Use this device only with the electrodes and accessories recommended by the manufacturer as using others may be unsafe.
• Potential hazard from simultaneous connection of a patient to a high frequency surgical equipment and the device that may result in burns and possible damage to the device.
• Operation in close proximity (e.g. 1 m) to a shortwave or microwave therapy equipment may produce instability in the stimulator output.
• The long-term effects of the chronic use of the device have not been evaluated. Contact your healthcare provider if your symptoms worsen.
• Electronic monitoring equipment such as EKG alarms may not operate properly when the Parasym™ device is in close proximity while being used.

Parasym™ works by stimulating the auricular branch of the vagus nerve with targeted micro pulses of electrical current through a specially designed electrode that connects to the tragus of the outer ear. Through the Parasym™ device, it is possible to achieve safe and effective non-invasive vagus nerve stimulation.

60-90 minutes* daily (*recommended).

• This can be achieved by pressing the timer button to “60-90 min”. The device will automatically shut down after 60 minutes.
• Please find a convenient time each day, using the treatment at the same time each day, for consistency.
• Daily treatment sessions with the Parasym™ device may be used as often as necessary but for most people it is best to treat between once a day and twice a week. Results usually improve and last longer with additional treatments.

 

It is common for sensory thresholds to change throughout sessions as well as between sessions. This is because the variables that affect conductivity which causes the perception of the stimulation and establishes a sensory level, can vary depending on the time of day, skin conductivity and stress levels etc.

You should be able to feel a mild tingling or pulsing sensation at your tragus* although it is common to become used to this sensation.

*Note: The tragus is a sensitive area on the inner side of the external ear.

It is important not to over-stimulate the area with too high an intensity level or for an extended period.

You and your healthcare provider should discuss your ongoing treatment routine, including the use of any additional therapies and/or medications. It is important to always follow your healthcare provider’s recommendations about your medications.

The metal used on the electrode is a gold-plated copper.

If the device does not appear to be operating as expected, please refer below to determine the cause. Should none of these measures correct the problem, please contact us.

This product is warranted to be free from manufacturing defects for 2 years from date of purchase for the Parasym device and 3 months for the Parasym electrode; Parasym electrodes are considered consumables and with regular use can require replacement. Optimal design and functioning of electrodes requires a balance of technical requirements, this includes the balance of biocompatible and conductive materials which can decrease over time with use.

This warranty is void if the product is modified or altered, is subject to misuse or abuse; damaged in transit; lack of responsible care; is dropped; if an incorrect battery has been fitted; if the unit has been immersed in water; if damage occurs by reason of failure to follow the written instructions in the IFU booklet received; or if product repairs are carried out without authority from Parasym Ltd.