CEFALY Dual User Manual
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CEFALY Dual User Manual

Medical device of its kind for the treatment of migraine.
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Summary of Contents for CEFALY Dual

  • Page 1 USER MANUAL...
  • Page 2 • The preventative treatment of episodic migraine in patients 18 years of age or older. CEFALY DUAL is for patients diagnosed by a physician with migraine per the indications for use. Migraine may indicate that you have a serious medical condition and you should have them evaluated by a physician.
  • Page 3 Email: info@cefaly.us Rue Louis Plescia, 34 4102 SERAING BELGIUM Phone: 1-844-475-7100 www.cefaly.com To view this user manual in Español, please visit cefaly.com/start Copyright © 2020 CEFALY Technology, 4102 Seraing - Belgium ref. 34103 - Version 03 - EN 03 - 2020.03.11...

  • Page 4: Table Of Contents

    1.5. General Warnings and Cautions ..................15 1.6. Side Effects ......................... 21 2. About CEFALY DUAL 2.1. What’s Included in the CEFALY DUAL Package ............25 2.2. Physical Description of CEFALY DUAL and Electrode ..........28 2.3. Understanding CEFALY DUAL Status ................32...
  • Page 5 4.1. Clean Your Skin ........................41 4.2. Open the Electrode ......................42 4.3. Position the Electrode on Your Skin ................43 4.4. Attach CEFALY DUAL to the Electrode ...............44 5. Delivering Acute Migraine Treatment (Program 1 - ACUTE) 5.1. Choose the ACUTE Treatment Program..............45 5.2.
  • Page 6 7. Controlling Your Treatment (ACUTE or PREVENT) 8. Care Information 8.1. Cleaning and Maintenance ....................63 8.2. Operating and Storage Conditions ................64 8.3. Disposal ..........................64 9. Troubleshooting Problem #01 - The CEFALY DUAL emits one long beep when the device button is pressed............................. 65...
  • Page 7 Problem #02 - The CEFALY DUAL turned off during my session........66 Problem #03 - I cannot feel any stimulation................67 Problem #04 - The intensity feels too high................70 Problem #05 - The intensity feels too low................71 Problem #06 - My skin is reddened when I remove the electrode.
  • Page 8 11.1. About the CEFALY DUAL Device ................82 12.2. About the Battery ......................86 11.3. Electromagnetic Compatibility ..................86 11.4. Guidance and Manufacturer's Declaration- Electromagnetic Emission ... 87 11.5. Warranty ...........................88 12. About CEFALY Technology 13. Glossary 13.1. Terms & Definitions ......................92 13.2. Symbols ..........................94...
  • Page 9 Critical CEFALY DUAL Facts Read this user manual thoroughly before using CEFALY DUAL. Uses • Helps relieve migraine pain. • Helps in reducing the number of monthly migraine days. Who Should Use CEFALY DUAL • The acute treatment of migraine with or without aura in patients 18 years of age or older.
  • Page 10 (relative humidity between 30% to 75%) (relative humidity 45% to 75%) and at and at normal atmospheric pressures (700 normal atmospheric pressure (500hPa to hPa to 1060 hPa). 1060hPa). If further assistance is required, contact Customer Service at cs@cefaly.com or 1-844-475-7100.

  • Page 11: Safety Information

    This user manual describes the proper use of CEFALY DUAL. 1.2. Indications for Use CEFALY DUAL is for patients diagnosed by a physician with migraines per the FDA cleared indications for use. CEFALY DUAL is the first FDA-cleared medical device of its kind for the treatment of migraine.

  • Page 12: Contraindications

    Migraine may indicate that you have a serious medical condition and you should have them evaluated by a physician. The safety and effectiveness of the CEFALY DUAL has not been demonstrated for patients with medication overuse headache or chronic tension- type headaches.

  • Page 13: Conventions Used In This Manual

    Safety Information Do not use CEFALY DUAL if you: • Have implanted metallic or electronic devices in the head. • Are suffering from pain of unknown origin. • Have a cardiac pacemaker or implanted or wearable defibrillator. 1.4. Conventions Used in this Manual Special conventions have been used throughout this User Manual to highlight important information.
  • Page 14 It is important that you read all the precautions and warnings included in the manual before using CEFALY DUAL because they are intended to keep you safe, prevent injury and avoid a situation that could result in damage to the device.

  • Page 15: General Warnings And Cautions

    WARNINGS • Do not use CEFALY DUAL while sleeping. • Do not use CEFALY DUAL in a wet environment, such as in the bath or shower. • Do not use CEFALY DUAL while driving, operating machinery, or during any activity that requires you to be alert and focused.
  • Page 16 • Do not use over, or close to, cancerous lesions or skin abnormalities that could be cancerous. • Use caution or avoid using CEFALY DUAL if there has been any loss of feeling in the skin of your forehead or scalp until the normal feeling is resumed.
  • Page 17 If you have known allergies to acrylates, contact CEFALY Technology for hypoallergenic electrode alternatives. All clinical trials regarding the efficacy and safety of the CEFALY DUAL 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.
  • Page 18 Safety Information • 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 •...
  • Page 19 Safety Information Consult your healthcare provider before using the CEFALY DUAL if you have Medication Overuse Headache, Chronic Tension-Type Headache, or Refractory Migraine, as the safety and effectiveness of the device have not been demonstrated for subjects with such conditions.
  • Page 20 Safety Information CAUTION • You should ask your doctor before using the CEFALY DUAL device if you have ever had a seizure. You should ask your doctor before using the CEFALY DUAL device if you have been diagnosed with epilepsy.

  • Page 21: Side Effects

    Safety Information • Do not modify this equipment without written authorization from the manufacturer. • The CEFALY DUAL contains a rechargeable lithium battery. Do not try to tamper with/ misuse the battery as it could result in a fire/explosion/dangerous gas leak.
  • Page 22 Common ● Sleepiness The main side effect is a tendency towards sleepiness. This means that CEFALY DUAL 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 session.
  • Page 23 In rare cases an allergy to the electrode gel can arise. A temporary rash develops on the forehead. If this should occur, stop using CEFALY DUAL and contact your doctor or the manufacturer CEFALY Technology. The skin rash will gradually disappear within a few days.
  • Page 24 Safety Information CAUTION If any side effects persist for more than a few weeks, stop use of CEFALY DUAL and see your healthcare provider.

  • Page 25: About Cefaly Dual

    2. About CEFALY DUAL 2.1. What’s Included in the CEFALY DUAL Package When you receive and open your CEFALY DUAL migraine treatment kit, you should find one of each of the following items numbered 1-5:...
  • Page 26 About CEFALY DUAL Fig. 1 Contents of the Package...
  • Page 27 About CEFALY DUAL 1. CEFALY DUAL: The CEFALY DUAL generates the treatment signal that is sent to stimulate and desensitize the trigeminal nerve. It includes a device button that is used to activate treatment sessions and manage treatment intensity, and an indicator light that is used for treatment monitoring and as a battery charge indicator.

  • Page 28: Physical Description Of Cefaly Dual And Electrode

    CEFALY DUAL comes with two accessories, the electrode and the power adapter and cable. The power adapter and cable are only used for charging CEFALY DUAL. CEFALY DUAL CEFALY DUAL is a single device with two program settings (ACUTE and PREVENT) that help users to overcome migraine pain. Green indicator light...
  • Page 29 Used to turn on CEFALY DUAL and activate the treatment programs (ACUTE and PREVENT). Green indicator Front Used to indicate the status of the CEFALY DUAL to light user. USB charging port Rear Used for connecting the charger to charge CEFALY DUAL.
  • Page 30 About CEFALY DUAL Electrode The CEFALY DUAL electrode is 3.7 in. long and 0.78 in. high, and comes in a silver packet. It acts as the interface between the CEFALY DUAL and the skin. The electrode has two contact zones that connect with the CEFALY DUAL through magnets.
  • Page 31 Conductive gel Front Used for effective contact between the electrode and the user. Magnetic contact Rear Used for contact between CEFALY DUAL and the zone electrode. Notes: Use electrodes before the “Use-By Date”printed on the silver packet. • Do not use the same electrode on multiple people. For important reasons of •...

  • Page 32: Understanding Cefaly Dual Status

    About CEFALY DUAL 2.3. Understanding CEFALY DUAL Status The CEFALY DUAL makes use of alarms and LED flashes as feedback to the user for various operations on the device. See table for details. Table 3 - Alarms and Indicators to Show the Status of the CEFALY DUAL...
  • Page 33 Device Action Feedback Operation ACUTE Press the device button once. Program Single beep indicates activation of the program. Single flash throughout the treatment. PREVENT Press the device button twice. Program Two beeps indicate activation of the program. Two intermittent flashes throughout the treatment.
  • Page 34 About CEFALY DUAL Device Action Feedback Operation Increase Long press device button after Intensity of the treatment slowly Intensity the first 10 seconds of the increases until the device button is treatment. released. Stabilize During the first 14 minutes of...
  • Page 35 Device Action Feedback Operation Restart Press the device button once Treatment during the last 45 seconds of the Single beep indicates that the Session treatment when the treatment is treatment session has been During Last ending. restarted. 45 Seconds Of Treatment Remove the device from the Treatment electrode.

  • Page 36: Best Practices And Recommendations

    Read the following sections (i.e. Setting up CEFALY DUAL, Preparing for Migraine Treatment, Delivering Migraine Treatment, and Care Information) thoroughly before operating the CEFALY DUAL. Refer to page 8 for the Critical CEFALY DUAL Facts. Cleanse your skin before every treatment session. This will ensure the electrode attaches securely to the skin.
  • Page 37 About CEFALY DUAL The magnetic contacts of the CEFALY DUAL should be kept clean. If those contacts should become dirty, clean them with a soft duster and an alcohol-based cleaning product. Handle your cable carefully to avoid tangles. Keep the connectors at the ends of the cables clean.

  • Page 38: Setting Up Cefaly Dual

    3. Setting Up CEFALY DUAL 3.1. Open the CEFALY DUAL Package Open the package and remove the components (see Fig. 4), including: 1. CEFALY DUAL 2. Electrode 3. Instruction Manual 4. Power Adapter and Cable 5. Storage Case Fig. 4 Contents of the Package...

  • Page 39: Charge The Battery

    3 hours to complete). • As shown in Fig. 5, connect the micro-USB plug to the back side of your CEFALY DUAL. Then, connect the USB plug to the power adapter (Fig. 6) and plug the adapter into a power source.
  • Page 40 Setting Up CEFALY DUAL See table for feedback from CEFALY DUAL during charging and completion of charging. Status Action Feedback from the CEFALY DUAL Charging Charging cable is connected to CEFALY DUAL. Intermittent flashing of the LED indicator. Fully Charged Charging cable is connected to CEFALY DUAL.

  • Page 41: Preparing For Migraine Treatment

    • The use of makeup-removing products is NOT recommended as a substitute for soap and water. Fig. 8 WARNING Do not use CEFALY DUAL in or around the neck or chest. It should only be applied to normal, intact, clean skin on the forehead.

  • Page 42: Open The Electrode

    Prepairing for Migraine Treatment 4.2. Open the Electrode • Open the electrode packet and slide out the plastic sleeve and peel the electrode from the clear plastic sleeve (Fig. 9). • Save both the packet and sleeve for later use and storage of your electrode.

  • Page 43: Position The Electrode On Your Skin

    Prepairing for Migraine Treatment 4.3. Position the Electrode on Your Skin • Use a mirror to place the electrode on your forehead with the pointed edge down and in line with the bottom of your forehead as shown in Fig. 10. •...

  • Page 44: Attach Cefaly Dual To The Electrode

    Prepairing for Migraine Treatment 4.4. Attach CEFALY DUAL to the Electrode • On the back of your CEFALY DUAL there are two magnets that allow the device to securely attach to the electrode. • Hold your CEFALY DUAL so these magnets are exposed and bring it toward your forehead.

  • Page 45: Delivering Acute Migraine Treatment (Program 1 - Acute)

    5. Delivering Acute Migraine Treatment (Program 1 – ACUTE) 5.1. Choose the ACUTE Treatment Program Once your CEFALY DUAL is securely attached to the electrode on your forehead, you’re ready to select your treatment program. For the acute treatment of migraine with or without aura, select Program 1 the ACUTE Treatment Program.
  • Page 46 • You will hear a single beep to indicate your ACUTE program selection. • The CEFALY DUAL green indicator light will flash once throughout the program to aid in treatment monitoring. It may take several seconds for flashing to begin.
  • Page 47 Delivering Acute Migraine Treatment See table for feedback from the CEFALY DUAL when the ACUTE treatment program is selected. Status Action Feedback from CEFALY DUAL ACUTE Press the device button once. Program Single beep indicates activation of the program. Single flash throughout the treatment.
  • Page 48 Delivering Acute Migraine Treatment CAUTION The acute treatment session for CEFALY DUAL (Program 1 - ACUTE Treatment) can be used the same day for a second 60-minute session if the migraine pain is not relieved within two hours or if another migraine attack occurs; however, the effectiveness of the second 60-minute session...

  • Page 49: Monitoring Your Acute Treatment

    Delivering Acute Migraine Treatment 5.2. Monitoring Your ACUTE Treatment • Throughout this 60-minute program, the CEFALY DUAL light will flash once repeatedly to indicate the program is active. • This flash of the indicator light will aid in treatment monitoring. It may take several seconds for flashing to begin.
  • Page 50 Notes: For the best results, you should aim to use CEFALY DUAL at the highest intensity • level. Gradually increase the intensity with each treatment for your skin to get...

  • Page 51: Ending Your Acute Treatment

    CEFALY DUAL and it will automatically shut off. • You can now remove the CEFALY DUAL by pulling it away from the electrode (Fig. 13). Then gently detach the electrode from your skin (Fig. 14).

  • Page 52: Delivering Preventative Migraine Treatment (Program 2 - Prevent)

    PREVENT migraine treatment program, you will observe the following: • You will hear two beeps to indicate your PREVENT program selection. • The CEFALY DUAL green indicator light flashes twice throughout the program to aid in treatment monitoring. It may take several seconds for flashing to begin.
  • Page 53 Delivering Preventative Migraine Treatment See table for feedback from the CEFALY DUAL when the PREVENT treatment program is selected. Status Action Feedback from CEFALY DUAL PREVENT Press the device button twice. Program Two beeps indicate activation of the program. Two intermittent flashes throughout the treatment.

  • Page 54: Monitoring Your Prevent Treatment

    6.2. Monitoring Your PREVENT Treatment • Throughout this 20-minute program, the CEFALY DUAL light will flash twice repeatedly to indicate the program is active. • This flash of the indicator light will aid in treatment monitoring. It may take several seconds for flashing to begin for the remainder of the session.
  • Page 55 Notes: For the best results, you should aim to use CEFALY DUAL at the highest intensity • level. Gradually increase the intensity with each treatment for your skin to get...

  • Page 56: Ending Your Prevent Treatment

    CEFALY DUAL and it will automatically shut off. • You can now remove the CEFALY DUAL by pulling it away from the electrode (Fig. 15). Then gently detach the electrode from your skin (Fig. 16).

  • Page 57: Controlling Your Treatment (Acute Or Prevent)

    14 minutes, you may press your device button once to stabilize the intensity level for the remainder of the treatment session. • You will hear a single beep as confirmation. See table for feedback from CEFALY DUAL. Status...
  • Page 58 • You can manually increase the intensity any time within the first 14 minutes of the cycle. • The intensity of the stimulation reaches its maximum level at the end of the first 14 minutes. See table for feedback from CEFALY DUAL.
  • Page 59 Controlling Your Treatment Status Action Feedback from CEFALY DUAL Increase Long press device button after Intensity of the treatment slowly Intensity the first 10 seconds of the increases until the device button is treatment. released. Maximum Long press device button for...
  • Page 60 Of Treatment Stopping Your Session Early • If at any point you need to stop your treatment session, simply remove your CEFALY DUAL from the electrode and your session will end. • You will hear a series of beeps indicating that your device has been disconnected and...
  • Page 61 Accidental Interruptions The electronics involved in CEFALY DUAL constantly check that your device is in contact with the electrode. If the electrode doesn’t fully grip your skin, is worn out, and/or is nudged by movement, your session may be interrupted. In this case, a series of successive beeps will indicate the device has been disconnected.
  • Page 62 Controlling Your Treatment Status Action Feedback from CEFALY DUAL Accidental If the electrode doesn’t fully Interruption grip your skin, is worn out, and/ Series of successive beeps indicate or is nudged by movement, your that the treatment has been session may be interrupted.

  • Page 63: Care Information

    8. Care Information 8.1. Cleaning and Maintenance The magnetic contacts of the CEFALY DUAL should be kept clean. If those contacts should become dirty, clean them with a soft duster and an alcohol-based cleaning product. It is not necessary to disinfect or sterilize the CEFALY DUAL between uses and/or between users.

  • Page 64: Operating And Storage Conditions

    Store the CEFALY DUAL at temperatures between 23°F and 95°F (-5°C to 35°C) in a dry environment (relative humidity 45% to 75%) and at normal atmospheric pressure (500hPa to 1060hPa) 8.3. Disposal When your CEFALY DUAL reaches the end of its service life, dispose of it and its battery in accordance with your local regulations.

  • Page 65: Troubleshooting

    When a problem occurs, troubleshooting will help you to determine if the problem is with the CEFALY DUAL or your use. Check the troubleshooting table for a solution if a problem should arise with your CEFALY DUAL. If further assistance is required, contact Customer Service at cs@cefaly.com or 1-844-475-7100.

  • Page 66: Problem #02 - The Cefaly Dual Turned Off During My Session

    You want the electrode to be flat and firm against your forehead skin. • Use a mirror to make sure your CEFALY DUAL is properly positioned on the electrode. The magnetic contacts on the CEFALY DUAL must be properly secured...

  • Page 67: Problem #03 - I Cannot Feel Any Stimulation

    • Your electrode is not sticking well to your forehead. • Your CEFALY DUAL is not properly secured to the electrode. • Once accustomed to the sensations experienced while using the CEFALY DUAL you may feel desensitized to its lower-strength pulses at the beginning of a session.
  • Page 68 You want the electrode to be flat and firm against your forehead skin. • Use a mirror to make sure your CEFALY DUAL is properly positioned on the electrode. The magnetic contacts on the CEFALY DUAL must be properly secured by the corresponding magnetic contact zone on the electrode for the CEFALY DUAL to work properly.
  • Page 69 You want the electrode to be flat and firm against your forehead skin. • Wait 2-3 minutes while using CEFALY DUAL for the intensity to increase. It’s possible you are becoming used to the sensation.

  • Page 70: Problem #04 - The Intensity Feels Too High

    If this is not your first time using your CEFALY DUAL and it is not powering on, charging for 5 minutes should allow it to turn on and get you through a full session.

  • Page 71: Problem #05 - The Intensity Feels Too Low

    Problem #05 - The intensity feels too low. Possible Cause: • Once you’re accustomed to the sensations experienced while using the CEFALY DUAL you may feel desensitized to its lower-strength pulses at the beginning of a session. Solution: • 10 seconds after you’ve selected your session, you may press and hold the device button to quickly ramp up the intensity to your desired strength.

  • Page 72: Problem #06 - My Skin Is Reddened When I Remove The Electrode

    If this should happen, stop using the CEFALY DUAL and wash the area with soap and water, gently. The skin rash should gradually disappear within a few days...

  • Page 73: Problem #07 - 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

    Troubleshooting If your condition does not improve, stop using the CEFALY DUAL and speak with your healthcare provider. Before using your CEFALY DUAL after such an event, contact CEFALY Technology to ask about the alternate hypoallergenic electrodes. Problem #07 - 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.

  • Page 74: Problem #08 - The Cefaly Dual Does Not Power On

    • Use the micro-USB cable and the adapter to connect your CEFALY DUAL to a power source for 3+ hours. If this is your first time using the CEFALY DUAL it must be fully charged. Once fully charged, the indicator light will remain turned on. If...
  • Page 75 You want the electrode to be flat and firm against your forehead skin. • Use a mirror to make sure your CEFALY DUAL is properly positioned on the electrode. The magnetic contacts on the CEFALY DUAL must be properly secured by the corresponding magnetic contact zone on the electrode for the CEFALY DUAL to work properly.

  • Page 76: Self-Care For Migraines

    10. Self-Care for Migraines 10.1. How Do I Differentiate Headache from Migraine? Migraine headache is a disorder that should be diagnosed by a physician. • The key symptoms of migraine headaches are duration, characteristics of pain, and associated symptoms. • Migraines generally last from about 4 to 72 hours and are typically located on one side of the head.
  • Page 77 Self-Care for Migraines Non-Migraine Headaches • Each specific type of non-migraine headache has unique characteristics. • The most common non-migraine headache that people experience is the tension-type headache (TTH). TTH has pain on both sides of the head and a constant pain often described as someone ‘squeezing’...
  • Page 78 HOW DO I KNOW I HAVE MIGRAINES? MIGRAINE HEADACHE NON-MIGRAINE HEADACHE Headache pain with Headache pain is not associated associated symptons with other symptoms GENERAL CHARACTERISTICS GENERAL CHARACTERISTICS Duration of 4-72 hours Duration of 30 mins to 7 days ‚ ‚...

  • Page 79: What Should I Do To Avoid Migraine Attacks

    Self-Care for Migraines 10.2. What Should I Do to Avoid Migraine Attacks? Migraine Triggers Triggers are environmental conditions, foods, and/or activities that may precipitate a migraine. One of the most common triggers is stress. Coping with stress can be as simple as having a friend to talk with regularly, seeing a therapist, or scheduling regular, moderate exercise.
  • Page 80 Self-Care for Migraines The following are some commonly reported migraine triggers: • Stress • Fasting/hunger • Significant changes in weather • Dehydration • Changes in sleep routine • Artificial sweeteners • Medication overuse • Hormonal changes (menses, hormone replacement therapy, etc.) •...
  • Page 81 Self-Care for Migraines Daily Practices to Help Avoid Migraine Attacks Research shows there are some daily habits and non-pharmacological treatments that help reduce the burden of migraine. Daily Helpful Habits: • Meditation and mindfulness practices • Keeping a migraine diary •...

  • Page 82: Technical Information

    11. Technical Information 11.1. About the CEFALY DUAL Device Maximum output current: 16 mA (milliamps) Pulse width: 250 μs (microseconds) Maximum phase charge: 5 μC (microcoulombs) Maximum rise time of an impulse: 5 microseconds at 50% of the maximum Number of programs: 2...
  • Page 83 Technical Information Table 4 - Program Parameters Parameters ACUTE PREVENT Pulse Frequency 100 Hz 60 Hz Pulse Width 250 μs 250 μs Pulse Duration 500 μs 500 μs Maximum Intensity 16 mA 16 mA Ramp Up Time 14 minutes 14 minutes Steady Time 46 minutes 6 minutes...
  • Page 84 Any electrode for which the current density is above 2mA/ cm2 requires special attention from the operator. Device Temperature Specifications When the CEFALY DUAL is operated at an ambient temperature of 95°F the temperature of the electrode will stay below 104°F.
  • Page 85 Technical Information Table 5 - IP22: Degree of protection against harmful ingress of particulate matter and water. Ingress Protection Rating: Degree of protection IP22 against harmful ingress of particulate matter and water Solids Protection Level protected against particulate matter above 12.5 mm Liquids Protection Level Protected against dripping water when tilted...

  • Page 86: About The Battery

    Portable RF communication equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the CEFALY DUAL. Otherwise, degradation of the performance of this equipment could result.

  • Page 87: Guidance And Manufacturer's Declaration- Electromagnetic Emission

    11.4. Guidance and Manufacturer’s Declaration- Electromagnetic Emission The CEFALY DUAL is intended for use in the electromagnetic environment specified in the table. The customer or the user of the CEFALY DUAL should ensure that it is used in such an environment.

  • Page 88: Warranty

    If you decide CEFALY DUAL is not the right treatment for you, return your CEFALY DUAL kit post- marked within 60 days from your delivery date, and you will be refunded the purchase price of the CEFALY DUAL.
  • Page 89 Technical Information Limited Warranty Your CEFALY DUAL is protected by a three (3) year limited warranty from the original date of pur- chase when purchased directly from www.cefaly.com or CEFALY US, Inc. This limited warranty en- sures your CEFALY DUAL is free of defects in manufacture and workmanship if used in accordance with the instructions provided.
  • Page 90 In no event shall CEFALY Technology’s liability with respect to any of the products furnished by the company exceed the charges paid by the Customer to CEFALY Technology for such product(s).

  • Page 91: About Cefaly Technology

    CEFALY DUAL has been specifically engineered to modify pain sensation in the trigeminal nerve through its ophthalmic branch, which runs under the skin of the forehead. CEFALY DUAL magnetical- ly secures to an electrode positioned on the forehead between the eyebrows. Then, it begins sending tiny electrical impulses to the trigeminal nerve, reducing or eliminating migraine pain.

  • Page 92: Glossary

    13. Glossary 13.1 Terms & Definitions Migraine - Migraine is a medical condition that causes severe, disabling headaches. A migraine headache involves a throbbing pain in the head accompanied by nausea, vomiting, sensitivity to light, and/or sensitivity to sound. Aura - Some people experience temporary sensory disturbances, such as blind spots, zigzag patterns, flashes of light, or stars.
  • Page 93 Glossary user and not to the device. Caution - Alerts the user to the possibility of a problem with the device associated with its use or misuse. Such problems include device malfunction, failure, damage to the device or damage to other property.

  • Page 94: Symbols

    Glossary 13.2. Symbols Symbols Title of the Symbol Description of the Symbol Consult instructions This symbol indicates that the user should refer to the User for use. Manual/Instructions for Use before using the device. Consult instructions This symbol indicates that the user should refer to the User for use.
  • Page 95 Glossary Symbols Title of the Symbol Description of the Symbol CE Mark Indicates conformity to the requirements of the Medical Device Directive (93/42/EEC). 0459 is the number of the notified body (GMED). The CE mark applied also indicates that this equipment complies with the requirements of the ROHS Directive (2011/65/EU) for the Restriction of Hazardous Substances in Electrical and Electronic Equipment.
  • Page 96 Glossary Symbols Title of the Symbol Description of the Symbol Use-By Date Indicates the date after which the medical device is not to be used. Keep Dry Indicates a medical device that needs to be protected from moisture. Lithium-ion Battery Indicates that the device contains recyclable lithium-ion batteries.
  • Page 97 Glossary Symbols Title of the Symbol Description of the Symbol Do not use if the Indicates a medical device that should not be used if the package is damaged package has been damaged or opened. IP22 Ingress Protection Indicates the degree of protection against harmful ingress of particulate matter and water.
  • Page 98 Glossary Symbols Title of the Symbol Description of the Symbol Non-sterile Indicates a medical device that has not been subjected to a sterilization process. STERILE Warning Alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the device.
  • Page 101 The CEFALY DUAL device Is A Patented Model And Is Protected By An International Patent. CEFALY® Is A Trademark That Has Been Registered Internationally. The CEFALY DUAL Is Manufactured In Conformity With Iso 13485 And GMP. The Manufacturer Is ISO 13485 (Medical) Certified. The...

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