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About CEFALY

What is CEFALY?

CEFALY is the first FDA-cleared device of its kind for the treatment of migraine headaches. It is a non-invasive, drug-free approach to help relieve migraine pain and decrease the number of migraine days. In technical terms, it is an external Trigeminal nerve stimulator, which is a non-invasive device placed on the head to stimulate and desensitize the Trigeminal nerve.

Who is CEFALY for?

CEFALY DUAL/ CEFALY DUAL Enhanced is indicated to be used for:

  1. The acute treatment of migraine with or without aura in patients 18 years of age or older.
  2. The preventative treatment of episodic migraine in patients 18 years of age or older.

Who should NOT use CEFALY DUAL?

Do not use CEFALY DUAL/ DUAL Enhanced if you:

  1. Have implanted metallic or electronic devices in the head
  2. Are suffering from pain of unknown origin or
  3. Have a cardiac pacemaker or an implanted or wearable defibrillator.

Can pregnant women use it?

If you are, could be, or may possibly become pregnant, you should ask your doctor before using CEFALY.

Is CEFALY for people of all ages?

All clinical trials regarding the efficacy and safety of the CEFALY DUAL/ DUAL Enhanced have been performed on adults (ages 18-65 years old). There are currently no trial results or data specific to use in individuals under the age of 18 or over the age of 65.

Consult a doctor before use if:

  • You are under 18 years of age.
  • You are over 65 years of age.
  • You are pregnant or may become pregnant.
  • You suspect or know that you have heart problems.
  • You had a recent head injury.
  • You have ever suffered a seizure.
  • You have never been diagnosed with a migraine by a health professional.
  • You have a headache that is different from your usual migraines.
  • You have the worst headache of your life.
  • You have fever or a stiff neck.
  • You have a headache that began after a head injury, exertion, coughing, or bending.
  • You experienced your first headache after the age of 50 years.
  • You have a migraine so severe as to require bed rest.

Are there side effects to using CEFALY?

CEFALY DUAL/DUAL Enhanced has few side effects, which have been demonstrated to be minor and fully reversible with cessation of device usage, through clinical trials.

If you experience any serious side effects, or if any side effects persist for more than a few weeks, stop use of CEFALY DUAL/DUAL Enhanced and consult your healthcare provider or seek immediate medical attention.

Common

  • Sleepiness - The main side effect is a tendency towards sleepiness. This means that CEFALY/DUAL Enhanced cannot be used when driving, or when operating machinery, or during any activity that can put you at risk of injury. Approximately 0.5% of subjects reported sleepiness during the CEFALY/DUAL Enhanced session.
  • Headache After a Session - Approximately 0.5% of subjects reported a headache after a session of preventative treatment (Program 2 - PREVENT Treatment)

Uncommon

  • Forehead Skin Redness - At the end of the session, the skin on the forehead under the electrode may occassionally appear blotchy. This effect is caused by activation of the skin blood circulation. This redness may persist for several minutes. Usually it disappears within 15 minutes. Approximately 0.2% of subjects reported reversible forehead skin redness.
  • Nausea - Rare occurrence of nausea during a session of acute treatment (Program 1 - ACUTE Treatment) has been reported in the clinical trials.

Rare

  • Forehead Skin Allergy - In rare cases an allergy to the electrode gel can arise. A temporay rash develops on the forehead. If this should occur, stop using CEFALY DUAL/DUAL Enhanced and contact your doctor or the manufacturer CEFALY Technology. The skin rash will gradually disappear within a few days. The use of an anti-inflammatory cream can accelerate the disappearance of the rash. Less than 1 out of 1000 subjects reported a skin allergic reaction.

I have allodynia. Can I use CEFALY treatments?

Allodynia is a symptom consisting of increased sensitivity to touch. People with allodynia may perceive painful sensations from objects or items that do not typically cause pain. Allodynia can affect your tolerance to nerve stimulation treatments.

If you experience allodynia, you should discuss these symptoms with your healthcare provider before starting CEFALY treatments. We recommend people with allodynia become familiar with the intensity stabilization function before using the CEFALY device.

Can I use my CEFALY device on areas besides my forehead?

CEFALY is only designed for the forehead. Do not use the device on your neck, chest, or any other part of your body.

What if I have a skin issue, such as a wound on my forehead?

Do not use CEFALY on open wounds, over swollen, infected or inflamed areas or any skin erruptions. Do not apply over or close to, cancerous lesions (skin abnormalities that could be cancer).

Can I us CEFALY near electronic monitoring equipment?

Do not use in the presence of electronic monitoring equipment (e.g., cardiac monitors, electrocardiogram (ECG) alarms).

Can the CEFALY device get wet?

Do not get device wet (such as use in bath or shower)

Can I use my CEFALY device while sleeping?

While drowsiness may occur, we do not recommend that you use your device while sleeping.

Can I drive while using CEFALY?

Do not use while driving or operating machinery. Do not use during any activity that can put you at risk of injury

Can I travel/fly with CEFALY?

At the airport, your CEFALY device can go through the x-ray machine and also baggage check. Many customers fly with their CEFALY and some even treat with CEFALY in flight. Safe travels!

How Does CEFALY Work?

How does CEFALY work?

The Trigeminal nerve, an important nerve involved in migraine pain, is located under the skin of your forehead. The CEFALY device has been designed to stimulate the nerve endings of this branch via an electrode positioned on the forehead between the eyebrows. Once the electrode has been placed on your forehead, the device magnetically secures to the electrode, establishes a connection, and begins to send tiny electrical impulses through the top branch into the Trigeminal nerve

I've just ordered my CEFALY - how do I get started?

Visit our Get Started page here for a quick start guide, helpful videos, tips and blog articles.

Am I supposed to use the PREVENT treatment program every day?

The PREVENT treatment program is meant for daily preventative treatment and is activated by pressing your device button twice (with the DUAL Enhanced, ensure you press with a slight pause in between each press).

When using the PREVENT migraine treatment program, you will observe the following:

  • You will hear two beeps to indicate your PREVENT program selection.
  • For the CEFALY DUAL, the green indicator light flashes twice throughout the PREVENT program. It may take several seconds for flashing to begin.
  • For the CEFALY DUAL Enhanced, there will be two intermittent purple flashes of light to indicate the PREVENT treatment mode. It may take several seconds for flashing to begin.

For best results, the 20-minute PREVENT treatment should be used daily.

How long does an ACUTE session last?

The 60-minute ACUTE treatment program is intended for treatment during a migraine attack or at the onset of a migraine and is activated by pressing your device button once.

This is a 60-minute program designed to treat migraine attacks when they begin, to stop or relieve your migraine pain. When using the ACUTE migraine treatment program, you will observe the following:

  • You will hear a single beep to indicate your ACUTE program selection.
  • The CEFALY DUAL, a green indicator light will flash once throughout the program to indicate ACUTE treatment mode. It may take several seconds for flashing to begin.
  • For the CEFALY DUAL Enhanced, there will be one intermittent turquoise flash of light to indicate ACUTE treatment mode. It may take several seconds for flashing to begin.

For best results, start ACUTE therapy at the earliest indication of a migraine headache. If you have migraines with Aura, you can start ACUTE treatment when the Aura first presents.

What does it feel like to use CEFALY?

The initial sensations produced by CEFALY may be unusual, but most people become accustomed to the stimulation after a few sessions. When starting an ACUTE or PREVENT treatment session, the stimulation intensity gradually increases over the first 14 minutes. When the session first starts, most patients may not feel anything. As the stimulation increases, for the first 14 minutes of treatment, some patients may experience tingling (“pins and needles”) sensation, numbness or even slight worsening of their headache for a few minutes.

Some patients may be more sensitive to stimulation than others. Keep in mind that the stimulation should never become painful. All users should expect to use the full duration of the treatment session they select; therefore it is important to select an intensity that is comfortable enough to tolerate for the entire duration of the treatment. If you experience local discomfort of the forehead with the stimulation, press the device button once during a session to stabilize the intensity for the remainder of the session. For more information, see Controlling the Intensity video here.

What if the intensity is too strong for me?

The sensations experienced while using the CEFALY DUAL/DUAL Enhanced are novel to most people and can take some adjustment. To make treatment more enjoyable, we recommend you increase the intensity in small increments of time, over the course of a few weeks. If you feel the intensity is too strong for you, simply press the device button once during a session to stabilize the pulses at a tolerable level for the remainder of the session.

How do I rapidly increase the treatment intensity?

Rapidly increasing the treatment intensity or “ramping” is recommended only for experienced CEFALY users who are accustomed to the higher stimulation intensities of treatment.

Ramping can be accomplished by pressing and holding the device button anytime during the first 14 minutes of a session. This can be repeated until the maximum intensity has been reached. If you wish to increase the intensity, you can press and hold the button until the intensity reaches your desired strength. When you release the button, the intensity will stabilize and remain constant. Should you press and hold the button again, the intensity will increase again. The maximum intensity is reached after pressing and holding the button for 30 consecutive seconds. Click here to watch a video that shows how to adjust the intensity for the DUAL. Click here to watch a video that shows how to adjust the intensity for the DUAL Enhanced.

Can I reuse my electrodes?

With proper care, one regular electrode can be reused. The number of uses varies based on skin prep, proper storage and activity level while using the device.

Cleanse and dry your skin before every CEFALY treatment. This will help ensure the electrode attaches securely to your forehead. Use soap and water to wash between and above your eyebrows, and then dry thoroughly. The use of makeup removing products, moisturizing facial cleansers, and alcohol/alcohol wipes are NOT recommended as a substitute for soap and water. Use of any of these products may reduce the lifespan of the electrodes.

Once the session ends, the electrode should be placed back onto its clear plastic backing sheet and stored inside the Resealable Electrode Storage Bag.

Do not leave the electrode exposed and unpackaged, especially in a dry place. It will dehydrate and will no longer function as designed.

With proper care, one regular electrode can be reused with proper use and care. The number of uses varies based on skin prep, consistent storage and activity level while using the device.

Tip from other users: Do not leave the electrode exposed and unpackaged, especially in a dry place. It will dehydrate and will no longer function as designed. If cared for properly, a few drops of tap water on the electrode gel can gently rehydrate it and help prolong its usage.

How do I manage my electrode subscription account?

Sign into your account to manage your subscription. Go to “Manage Subscription” to push your next shipment date or cancel at any time.

How long will my battery last?

A fully charged battery will last for about 2-3 hours of treatment, depending on the program and intensity used.

How do I know when CEFALY needs to be charged?

If the CEFALY DUAL emits a long beep when you press the button, this means the battery charge is too low.

If the CEFALY DUAL Enhanced emits a long beep, or shows a yellow LED color, this means the battery charge is too low.

Can I use CEFALY with Botox?

There is no contraindication for using CEFALY with Botox injections. If you are interested in CEFALY treatments and Botox injections, we recommend that you discuss both therapies with your healthcare provider.

If you already receive Botox injections for chronic migraine, we recommend waiting 48-72 hours after an injection before placing a CEFALY electrode and starting CEFALY treatments.

 

If you are new to both CEFALY and Botox treatments, we recommend starting one therapy at a time and waiting at least three months before beginning the other treatment.

Ordering / Financing

Do I need a prescription?

CEFALY DUAL/ CEFALY DUAL Enhanced was recently cleared by the FDA for over-the-counter (OTC) use in the U.S. Globally, CEFALY DUAL is available over-the-counter to individuals that have been diagnosed by a physician with migraine.

Is it covered by health insurance?

CEFALY is not covered by insurance. Overcoming migraine treatment insurance barriers is a significant topic of focus at the moment for the Coalition of Headache and Migraine Patients (CHAMP). More information on this can be found on CHAMP’s website at https://headachemigraine.org/migraine-treatment-help/

In addition, we recommend individuals interested in trying CEFALY explore payment through their HSA/FSA account as CEFALY is an approved expense.

If you are a Veteran, CEFALY is covered through the VA health care system. Please visit your VA healthcare provider for more information.

Can I use my HSA or FSA account?

In the U.S., expenses for CEFALY are HSA/FSA Approved. Your purchase may be reimbursed through your Health Savings Account (HSA) or Health Flexible Savings Account (FSA). Please consult your HSA or FSA administrator for more information.

What if I’m a Veteran?

In the US, CEFALY is covered through the VA health care system. Please visit our For Veterans page or visit your VA health care provider for more information.

Is CEFALY covered by a warranty?

Your CEFALY DUAL/ CEFALY DUAL Enhanced is protected by a three (3) year limited warranty from the original date of purchase when purchased directly from www.cefaly.com, or from an authorized retailer AND you have registered your device on cefaly.com.

This limited warranty ensures your CEFALY DUAL/ CEFALY DUAL Enhanced is free of defects in manufacture and workmanship if used in accordance with the instructions provided. Electrodes, charging cables, and other accessories are excluded from this warranty. Please keep your invoice or sales receipt as your Proof of Purchase date.

This limited warranty does not cover damage caused by misuse or abuse; contact with any liquids; accident; loss of device; the attachment of any unauthorized accessory; alteration to the product; improper installation; unauthorized repairs or modifications; improper use of electrical/power supply; dropped product; malfunction or damage of an operating part from a failure to provide manufacturer’s recommended maintenance and storage; transportation damage; theft; neglect; vandalism; environmental conditions; loss of use during the period the product is at a repair facility or otherwise awaiting parts or repair; or any other conditions whatsoever that are beyond the control of CEFALY Technology. Learn more about our warranty.

Is there a money-back guarantee?

We stand behind the quality of CEFALY products, and hope you are happy with the device. CEFALY Technology offers a satisfaction guarantee on the CEFALY device. If you are not satisfied with the product, you may return it within 90 calendar days of your product delivery date for a refund. If you are considering a return because you are unhappy with the results, please understand that everyone responds to treatment differently. It may take a few weeks of consistent use, following the directions for use detailed in the user manual before you feel an improvement. If you have any questions, CEFALY’s Customer Service team is happy to help. Learn more about our Return Policy.

What financing options are available?

If you prefer to pay over time, we offer two ways to finance your purchase in the US. We offer PayPal Credit for purchases of $99 or more, as well as 3-, 6- and 12-month financing options through Affirm. With Affirm, a down payment may be required. Subject to eligibility check and approval. Payment options depend on your purchase amount. Estimated payment amount excludes taxes and shipping fees. Actual terms may vary. Affirm loans are made by Cross Riverbank, Member FDIC. Visit affirm.com/help for more info.

Please note that neither PayPal Credit nor Affirm can be used for orders that include an electrode subscription. If you prefer to finance your CEFALY DUAL device but also want to order an electrode subscription, please create a separate order transaction for your subscription using a credit card as payment method.

 

What payment options does CEFALY accept?

Globally, we accept credit cards (Visa, Mastercard, or American Express) in addition to PayPal, Apple Pay, Microsoft Pay and Google Pay. In the U.S., we also offer payment options through Affirm and PayPal Credit.

In the Netherlands, we also accept iDEAL.

 

 

How long will it take to receive my order?

In the US and Canada, the average delivery time is one week for both devices and electrodes. For Europe, devices arrive in about 2 weeks, electrodes are shipped via Belgium Post and the transit time varies greatly by country. As a general rule, electrodes arrive for Belgium and countries bordering Belgium in 1-2 weeks, other European countries arrive in 2 – 4 weeks.

Why am I being charged an international fee?

CEFALY Technology is a Belgian company and as such, some US credit card companies may charge you an international or foreign exchange fee. This fee is collected by your bank, not CEFALY Technology.

If I’m not home, how can I receive my order?

In the U.S. CEFALY devices and electrodes are shipped via FedEx. In Canada, devices are shipped via UPS and electrodes are delivered by Canada Post. In the EU, we ship devices via FedEx or DHL, and electrodes are shipped via Belgium Post. Regardless of the courier, we recommend choosing a delivery address where you know someone will be available to receive your order.

How can I return a CEFALY device not purchased on cefaly.com?

For devices not purchased on cefaly.com, please contact the company you bought it from for their return policy and procedure. We can assist you with your three-year limited warranty if you have registered your device.

CUSTOMER SUPPORT

I'm in the US. Who do I contact with questions about my order?

In the US, you can call us at 1.844.475.7100 9:00 AM to 10:00 PM ET, Monday – Friday, and 10:00 AM to 4:00 PM ET, Saturday - Sunday. You can also email us anytime at info@cefaly.us

I'm in Canada. Who do I contact with questions about my order?

In Canada, you can call us at 1.844.475.7100 9:00 AM to 10:00 PM ET, Monday – Friday, and 10:00 AM to 4:00 PM ET, Saturday - Sunday. You can also email us anytime at cs@cefaly.com

I'm outside of North America. Who do I contact with questions about my order?

Outside of North America, you can call us at +32 4 367 67 22 8:30 PM to 12:30 PM and 1:30 PM to 5:30 PM CEST, Monday – Thursday; on Friday, 8:30 AM to 12:30 PM and 1:30 PM to 3:30 PM CEST. You can also email us anytime at info@cefaly.com

Who do I contact for medical or treatment related questions?

Please contact Medical Affairs by email. If you reside in North America, please contact NAmedical.cefaly.us. For those who live outside North America, please contact GLmedical@cefaly.com

What other resources do you have to help me use my CEFALY effectively?

To get set up with your new CEFALY device, visit our Get Started page. You'll find resources to help you get started using your CEFALY device, including videos showing how to use your device, a quick start guide, helpful articles and Frequently Asked Questions. You can also read about others' journey with migraine and learn new tips in our blog, and we'd love for you to join our social media community.

What if I have specific issues or medical questions about the CEFALY device?

If you have specific issues or questions about CEFALY, please contact CEFALY Medical Affairs at NAmedical@cefaly.us in North America, and GLmedical@cefaly.com outside of North America.

How do I clean my device?

Thoroughly clean all sides of your device, power adapter (for DUAL devices and earlier), charging dock (for DUAL Enhanced and later) and cable with a soft duster and an alcohol-based cleaning product. DO NOT put your CEFALY device or components in water.

TROUBLESHOOTING

The CEFALY DUAL emits one long beep when the device is pressed. OR The CEFALY DUAL Enhanced emits one long beep and a yellow LED when the device is pressed.

This means the battery is empty. Please charge your device for 4+ hours for a full charge. 

The CEFALY DUAL turned off during my session.

Possible Cause:

  • Your electrode is not sticking well to your forehead
  • Your Cefaly Dual is not properly secured to the electrode
  • The battery charge is too low

Solution:

  • Cleanse your skin again with soap and water, and pat dry. Then reposition the electrode, attach the CEFALY DUAL/ DUAL Enhanced and try powering it on again. When placing the electrode on your forehead, take your index finger and run it across the expanse of the electrode, applying light pressure to ensure it is adhered uniformly to the skin. Ensure the edges are sealed, so there are no air pockets or bubbles. You want to the electrodes to be flat and firm against your forehead skin.
  • Use a mirror to make sure your CEFALY DUAL/ CEFALY DUAL Enhanced is properly positioned on the electrode. The magnetic contacts on the CEFALY DUAL/ CEFALY DUAL Enhanced must be properly secured by the corresponding magnetic contact zone on the electrode for the CEFALY DUAL/ CEFALY DUAL Enhanced to work properly. If the electrode is not positioned correctly and is not flat against your forehead, the contacts may not connect properly.
  • Recharge the battery for 4+ hours.

I cannot feel any stimulation.

Possible Cause:

  • Your electrode is not sticking well to your forehead.
  • Your CEFALY DUAL/ CEFALY DUAL Enhanced is not properly secured to the electrode.
  • Once accustomed to the sensations experienced while using the CEFALY DUAL/ CEFALY DUAL Enhanced you may feel desensitized to its lower-strength pulses at the beginning of a session.
  • You accidentally pressed the device button to stabilize your treatment at a low intensity level, prohibiting it from increasing.

Solution:

  • Cleanse your skin again with soap and water, and pat dry. Then reposition the electrode, attach the CEFALY DUAL/ CEFALY DUAL Enhanced and try powering it on again. When placing the electrode on your forehead, take your index finger and run it across the expanse of the electrode, applying light pressure to ensure it is adhered uniformly to the skin. Ensure the edges are sealed, so there are no air pockets or bubbles. You want to the electrodes to be flat and firm against your forehead skin.
  • Use a mirror to make sure your CEFALY DUAL/ CEFALY DUAL Enhanced is properly positioned on the electrode. The magnetic contacts on the CEFALY DUAL/ CEFALY DUAL Enhanced must be properly secured by the corresponding magnetic contact zone on the electrode for the CEFALY DUAL/ CEFALY DUAL Enhanced to work properly. If the electrode is not positioned correctly and is not flat against your forehead, the contacts may not connect properly.
  • Wait 2-3 minutes while using CEFALY DUAL/ CEFALY DUAL Enhanced for the intensity to increase. It's possible you are becoming used to the sensation.
  • Wait until at least 4 minutes into your session, then press and hold the device button to manually ramp up the intensity of the session. When you release the device button, the intensity will stabilize at the new level and remain constant. Should you press and hold the device button again, the intensity will increase again. The maximum intensity is reached after pressing and holding the device button for 30 consecutive seconds. You should increase the intensity to a tolerable level, but you should stop before the sensation becomes intolerable or painful.
  • Push the device button once to start the ACUTE program and twice in a row (for the DUAL Enhanced, push twice, with a slight pause in between each press) to begin the PREVENT program once the electrode and device are properly positioned on your forehead. If the CEFALY DUAL/ CEFALY DUAL Enhanced does not power on, use the micro-USB cable, charging dock (when applicable), and an adapter to charge it for 4+ hours. If this is your first time using the CEFALY DUAL/ CEFALY DUAL Enhanced, it must be fully charged. Once your CEFALY DUAL/ CEFALY DUAL Enhanced is fully charged, the indicator light will remain turned on. If this is not your first time using your CEFALY DUAL/ CEFALY DUAL Enhanced and it is not powering on, charge your device until it is fully charged.

The intensity feels too high.

Possible Cause:

  • The sensations experienced while using the CEFALY DUAL/ CEFALY DUAL Enhanced are novel to most people and can take some time to become acclimated to the stimulation.

Solution:

  • To make treatment more enjoyable, we recommend you increase the intensity in small increments of time, over the course of a few weeks. If you feel the intensity is too strong for you, simply press the device button once during a session to stabilize the pulses at a tolerable level for the remainder of the session.

The intensity feels too low.

Possible Cause:

  • Once you are accustomed to the sensations experienced while using the CEFALY DUAL/ CEFALY DUAL Enhanced you may feel desensitized to its lower-strength pulses at the beginning of a session.

Solution:

  • You may press and hold the device button anytime during the first 14 minutes of program selection to quickly ramp up the intensity to your desired strength. When you release the device button, the intensity will stabilize and remain constant. Should you press and hold the device button again, the intensity will increase again. The maximum intensity is reached after pressing and holding the device button for 30 consecutive seconds. You should increase the intensity to a tolerable level, but you should stop before the sensation becomes intolerable or painful.

My skin is reddened when I remove the electrode

Possible Cause:

  • The skin on the forehead may at times become reddened where the electrode was placed.
  • This may indicate an allergy to the acrylate used in the electrode.

Solution:

  • This redness may last a few minutes or more after your session and is usually harmless. It indicates the CEFALY DUAL/ CEFALY DUAL Enhanced has stimulated blood flow to the area.
  • In rare cases, you may experience an allergy to the acrylate used in the electrode adhesive and a temporary rash may cause. You may experience small blistering, burning, itching, or swelling in the areas where the electrode comes in contact with the skin. If this should happen, stop using the CEFALY DUAL/ CEFALY DUAL Enhanced and wash the area with soap and water, gently. The skin rash should gradually disappear within a few days and can be helped along by applying an anti-inflammatory cream.

If your condition does not improve, stop using the CEFALY DUAL/ CEFALY DUAL Enhanced and speak with your healthcare provider. Before using your CEFALY DUAL/ CEFALY DUAL Enhanced after such an event, contact CEFALY Technology to ask about the alternate hypoallergenic electrodes.

I experience painful headaches, nausea, tooth pain, tinnitus (noise or ringing in the ears), or hyperlacrimation (overproduction of tears) that persist after a session is over

Possible Cause:

  • These may indicate that you are experiencing an uncommon side effect of using the CEFALY DUAL/ CEFALY DUAL Enhanced.

Solution:

  • Some users have reported experiencing painful headaches, nausea, tooth pain, tinnitus or hyperlacrimation during and after CEFALY DUAL/ CEFALY DUAL Enhanced sessions. If you experience any one or more of these conditions and it (they) persist, both during sessions and while not using CEFALY DUAL/ CEFALY DUAL Enhanced, for more than a few weeks, stop use and consult your healthcare provider.

While the device is running, it suddenly stops with a repeated sound.

The connection between the device and the skin has been lost. Make sure that the device has not moved from its position. If it has not moved, try again with a new electrode after cleaning the forehead skin.

I am experiencing blurry vision when I use CEFALY Treatments, what should I do?

If you experience blurry vision in one or both eyes during CEFALY treatments, stop the treatment session and contact your healthcare provider. Blurry vision is rarely reported with CEFALY use; however, should you experience these symptoms, do not continue to use the treatment until you contact a healthcare provider regarding your symptoms. All users experiencing blurry vision are also encouraged to contact our medical department for additional information and guidance at NAmedical@cefaly.us in North America, and GLmedical@cefaly.com outside of North America.

The CEFALY DUAL/ DUAL Enhanced does not power on.

Possible Cause:

  • The CEFALY DUAL/ CEFALY DUAL Enhanced does not have enough charge.
  • Your electrode is not adhering well to your forehead.
  • Your CEFALY DUAL/ CEFALY DUAL Enhanced is not properly secured to the electrode.

Solutions:

  • Use the micro-USB cable and an adapter to connect your CEFALY DUAL/ CEFALY DUAL Enhanced to a power source for 4+ hours. If this is your first time using the CEFALY DUAL/ CEFALY DUAL Enhanced it must be fully charged. Once fully charged, the indicator light will remain turned on.
  • Cleanse your skin again with soap and water, and pat dry. Then reposition the electrode, attach the CEFALY DUAL/ CEFALY DUAL Enhanced and try powering it on again. To reposition the electrode, start from the center and work your way outward toward each corner, running your fingers several times along the entire surface of the electrode. You want the electrode to be flat and firm against your forehead skin.
  • Use a mirror to make sure your CEFALY DUAL/ CEFALY DUAL Enhanced is properly positioned on the electrode. The magnetic contacts on the CEFALY DUAL/ CEFALY DUAL Enhanced must be properly secured by the corresponding magnetic contact zone on the electrode for the CEFALY DUAL/ CEFALY DUAL Enhanced to work properly. If the electrode is not positioned correctly and is not flat against your forehead, the contacts may not connect properly.

If I am experiencing a side-effect, what should I do?

CEFALY DUAL clinical trials have shown side effects to be minor and fully reversible, as outlined in our clinical trials. If you are experiencing any of these side effects, discontinue use and contact your healthcare provider or reach out to our Medical Affairs team at NAmedical@cefaly.us in North America, and GLmedical@cefaly.com outside of North America.

Can the sensation of the CEFALY device feel less intense over time?

If you use CEFALY regularly, you may eventually perceive the stimulation from the device to be less intense. This is normal and your device is not defective or malfunctioning.

Over time, our nerves may become accustomed to stimulations that are introduced regularly. Our nerves can and adapt over time which may lead to the perception that the stimulation is largely responsible for the perception that the stimulation becomes less intense over time. For some, this process may take weeks, months, or years and for others the intensity of the stimulation may seem unchanged. If your device has been stored, handled and maintained according to the user manual, rest assured the device is working properly and providing the same intensity of stimulation as when it was initially acquired.

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