CEFALY DUAL ENHANCED User Manual
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CEFALY DUAL ENHANCED User Manual

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CEFALY
®
DUAL ENHANCED
A medical device for the treatment
of migraines.
USER MANUAL

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Summary of Contents for CEFALY DUAL ENHANCED

  • Page 1 CEFALY ® DUAL ENHANCED A medical device for the treatment of migraines. USER MANUAL...
  • Page 2 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 Enhanced has not been demonstrated for patients with medication overuse headache or chronic tension-type headaches.
  • Page 3 Email: info@cefaly.us Rue Louis Plescia, 34 4102 SERAING Phone: 1-844-475-7100 BELGIUM www.cefaly.com To view this user manual in Español, please visit cefaly.com/start Copyright © 2021 CEFALY Technology, 4102 Seraing - Belgium ref. 34201 - Version 01 - EN 03 - 2021.03.11...

  • Page 4: Table Of Contents

    1.5. General Warnings and Cautions ..................15 1.6. Side Effects ......................... 21 2. About CEFALY DUAL Enhanced 2.1. What’s Included in the CEFALY DUAL Enhanced Package ........25 2.2. Physical Description of CEFALY DUAL Enhanced and Electrode ......28 2.3. Understanding CEFALY DUAL Enhanced Status ............32...
  • Page 5 4.1. Clean Your Skin ........................42 4.2. Open the Electrode ......................43 4.3. Position the Electrode on Your Skin ................44 4.4. Attach CEFALY DUAL Enhanced to the Electrode ........... 45 5. Delivering Acute Migraine Treatment (Program 1 - ACUTE) 5.1. Choose the ACUTE Treatment Program..............46 5.2.
  • Page 6 7. Controlling Your Treatment (ACUTE or PREVENT) 8. Care Information 8.1. Cleaning and Maintenance ....................64 8.2. Operating and Storage Conditions ................65 8.3. Disposal ..........................65 9. Troubleshooting Problem #01 - The CEFALY DUAL Enhanced emits one long beep when the device button is pressed...........................66...
  • Page 7 Problem #02 - The CEFALY DUAL Enhanced turned off during my session....67 Problem #03 - I cannot feel any stimulation................68 Problem #04 - The intensity feels too high................71 Problem #05 - The intensity feels too low................72 Problem #06 - My skin is reddened when I remove the electrode.
  • Page 8 11.1. About the CEFALY DUAL Enhanced Device ............83 11.2. About the Battery ......................87 11.3. USB Power Adaptor ....................... 87 11.4. Electromagnetic Compatibility ..................88 11.5. Guidance and Manufacturer's Declaration- Electromagnetic Emission ...88 11.6. Warranty ........................... 95 12. About CEFALY Technology 13.
  • Page 9 Critical CEFALY DUAL Enhanced Facts Read this user manual thoroughly before using CEFALY DUAL Enhanced. Uses • Helps relieve migraine pain. • Helps in reducing the number of monthly migraine days. Who Should Use CEFALY DUAL Enhanced • 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 info@cefaly.us or 1-844-475-7100.

  • Page 11: Safety Information

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

  • Page 12: Contraindications

    Episodic migraine is defined as 1-14 headache days per month with associated • migraine symptoms (nausea, photophobia, phonophobia, etc). 1.3. Contraindications Contraindications The following are the conditions under which CEFALY DUAL Enhanced should not be used. Usage under such conditions may create unfavorable results and or lead to adverse events.

  • Page 13: Conventions Used In This Manual

    Safety Information Do not use CEFALY DUAL Enhanced 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 WARNING: Alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of CEFALY DUAL Enhanced. Standard warnings relate to significant harm to the user and not to CEFALY DUAL Enhanced.

  • Page 15: General Warnings And Cautions

    WARNINGS • Do not use CEFALY DUAL Enhanced while sleeping. • Do not use CEFALY DUAL Enhanced in a wet environment, such as in the bath or shower. • Do not use CEFALY DUAL Enhanced 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 Enhanced 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 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.
  • 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 Enhanced 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 • You should use this unit only with the electrodes and accessories recommended by the manufacturer. • Do not use CEFALY DUAL Enhanced in close proximity (less than 3.5 feet) to shortwave or microwave therapy equipment, as it may produce instability in the CEFALY DUAL Enhanced output.

  • Page 21: Side Effects

    • Do not modify this equipment without written authorization from the manufacturer. • Only individuals authorized by the manufacturer can repair this equipment. • The CEFALY DUAL Enhanced 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 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.
  • 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 Enhanced 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 Enhanced and see your healthcare provider.

  • Page 25: About Cefaly Dual Enhanced

    2. About CEFALY DUAL Enhanced 2.1. What’s Included in the CEFALY DUAL Enhanced Package When you receive and open your CEFALY DUAL Enhanced migraine treatment kit, you should find the following items numbered 1-6:...
  • Page 26 About CEFALY DUAL Enhanced Fig. 1 Contents of the Package...
  • Page 27 3. Resealable Electrode Storage Bag: Use for storage of opened electrodes between treatments. 4. Instruction Manual: The manual includes instructions to help you set up and use your CEFALY DUAL Enhanced. 5. Charging Dock and USB Cable: These are used to recharge the CEFALY DUAL Enhanced battery.

  • Page 28: Physical Description Of Cefaly Dual Enhanced And Electrode

    2.2.Physical Description of CEFALY DUAL Enhanced and Electrode CEFALY DUAL Enhanced comes with an electrode, charging dock, and USB cable. The charging dock and USB cable are only used for charging the CEFALY DUAL Enhanced. CEFALY DUAL Enhanced CEFALY DUAL Enhanced is a single...
  • Page 29 About CEFALY DUAL Enhanced Table 1 - Parts of the CEFALY DUAL Enhanced Part Location Functionality Device button Front Used to turn on CEFALY DUAL Enhanced and activate the treatment programs (ACUTE and PREVENT). LED indicator light Front Used to indicate the status of the CEFALY DUAL Enhanced to user.
  • Page 30 About CEFALY DUAL Enhanced Electrode The CEFALY DUAL Enhanced 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 Enhanced and the skin. The electrode has two contact zones that connect with the CEFALY DUAL Enhanced 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 Enhanced zone and the electrode. Notes: Use electrodes before the “Use-By Date” printed on the silver packet. •...

  • Page 32: Understanding Cefaly Dual Enhanced Status

    About CEFALY DUAL Enhanced 2.3. Understanding CEFALY DUAL Enhanced Status The CEFALY DUAL Enhanced 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 Enhanced...
  • Page 33 Action Feedback Fully Charged USB Cable is connected to the Charging Dock and CEFALY Solid green glow on the LED indicator. DUAL Enhanced is placed on the Charging Dock. ACUTE Program Press the device button once. Single turquoise Single beep...
  • Page 34 Device Operation Action Feedback PREVENT Program Program has been activated and battery charge is too low to (low battery charge) complete one treatment. Melody that repeats four times. Increase Intensity Long press device button after Intensity of the treatment slowly the first 10 seconds of the increases until the device button is treatment.
  • Page 35 Device Operation Action Feedback Maximum Intensity Long press device button for 30 seconds after the first 10 Series of rapid beeps to indicate that the seconds of the treatment. device has reached maximum intensity. Restart Treatment Press the device button once Session During during the last 45 seconds Single beep indicates that the treatment...

  • Page 36: Best Practices And Recommendations

    Read the following sections (i.e. Setting up CEFALY DUAL Enhanced, Preparing for Migraine Treatment, Delivering Migraine Treatment, and Care Information) thoroughly before operating the CEFALY DUAL Enhanced. Refer to page 8 for the Critical CEFALY DUAL Enhanced Facts. Cleanse your skin before every treatment session. This will ensure the electrode attaches securely to the skin.
  • Page 37 About CEFALY DUAL Enhanced The magnetic contacts of the CEFALY DUAL Enhanced 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 Enhanced

    3. Setting Up CEFALY DUAL Enhanced 3.1. Open the CEFALY DUAL Enhanced Package Open the package and remove the components (see Fig. 4), including: 1. CEFALY DUAL Enhanced 2. Electrode(s) 3. Resealable Electrode Storage 4. Instruction Manual 5. Charging Dock & USB Cable 6.

  • Page 39: Charge The Battery

    Confirm your package contains all of the listed components and proceed to the next step. 3.2. Charge the Battery • Prior to your first CEFALY DUAL Enhanced treatment session, fully charge the battery (this typically takes 4 hours to complete).
  • Page 40 Setting Up CEFALY DUAL Enhanced Fig. 5 Fig. 6 Fig. 7 See table for feedback from CEFALY DUAL Enhanced during charging and completion of charging.

  • Page 41: Preparing For Migraine Treatment

    Setting Up CEFALY DUAL Enhanced Action Feedback from the CEFALY DUAL Enhanced Status Press CEFALY DUAL Low Battery Enhanced device button (Device is not connected once to see feedback. If to Charging Dock for Solid yellow glow in Series of beeps.

  • Page 42: Clean Your Skin

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

  • Page 43: 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 44: 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 45: Attach Cefaly Dual Enhanced To The Electrode

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

  • Page 46: 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 Enhanced 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 47 • You will hear a single beep to indicate your ACUTE program selection. • The CEFALY DUAL Enhanced LED indicator will have a single turquoise flash throughout the program to aid in treatment monitoring. It may take several seconds for flashing to...
  • Page 48 Delivering Acute Migraine Treatment See table for feedback from the CEFALY DUAL Enhanced when the ACUTE treatment program is selected. Status Action Feedback from CEFALY DUAL Enhanced ACUTE Press the device button once. Program Single beep indicates activation of the program.
  • Page 49 Delivering Acute Migraine Treatment CAUTION The acute treatment session for CEFALY DUAL Enhanced (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...

  • Page 50: Monitoring Your Acute Treatment

    Delivering Acute Migraine Treatment 5.2. Monitoring Your ACUTE Treatment • Throughout this 60-minute program, the CEFALY DUAL Enhanced light will flash a turquoise color 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 51 This redness may last a few minutes and is an indication the device has stimulated blood flow to the area. Notes: For the best results, you should aim to use CEFALY DUAL Enhanced at the highest • intensity level. Gradually increase the intensity with each treatment for your skin...

  • Page 52: Ending Your Acute Treatment

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

  • Page 53: 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 Enhanced LED indicator will have two intermittent purple flashes throughout the program to aid in treatment monitoring. It may take several seconds for...
  • Page 54 Delivering Preventative Migraine Treatment See table for feedback from the CEFALY DUAL Enhanced when the PREVENT treatment program is selected. Status Action Feedback from CEFALY DUAL Enhanced PREVENT Press the device button twice. Program Two beeps indicate activation of the program.

  • Page 55: Monitoring Your Prevent Treatment

    6.2. Monitoring Your PREVENT Treatment • Throughout this 20-minute program, the CEFALY DUAL Enhanced light will flash a purple color 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 56 This redness may last a few minutes and is an indication the device has stimulated blood flow to the area. Notes: For the best results, you should aim to use CEFALY DUAL Enhanced at the • highest intensity level. Gradually increase the intensity with each treatment for...

  • Page 57: Ending Your Prevent Treatment

    CEFALY DUAL Enhanced and it will automatically shut off. • You can now remove the CEFALY DUAL Enhanced by pulling it away from the electrode (Fig. 16). Then gently detach the electrode from your skin (Fig. 17).

  • Page 58: 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 Enhanced.
  • Page 59 • 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 Enhanced.
  • Page 60 Controlling Your Treatment Status Action Feedback from CEFALY DUAL Enhanced 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 61 Controlling Your Treatment Status Action Feedback from CEFALY DUAL 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.
  • Page 62 Controlling Your Treatment Stopping Your Session Early • If at any point you need to stop your treatment session, simply remove your CEFALY DUAL Enhanced from the electrode and your session will end. • You will hear a series of beeps indicating that your device has been disconnected and your treatment interrupted.
  • Page 63 Controlling Your Treatment Accidental Interruptions The electronics involved in CEFALY DUAL Enhanced 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 64: Care Information

    8. Care Information 8.1. Cleaning and Maintenance The magnetic contacts of the CEFALY DUAL Enhanced 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 Enhanced between uses and/or between users.

  • Page 65: Operating And Storage Conditions

    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 Enhanced reaches the end of its service life, dispose of it and its battery in accordance with your local regulations.

  • Page 66: Troubleshooting

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

  • Page 67: Problem #02 - The Cefaly Dual Enhanced 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 Enhanced is properly positioned on the electrode. The magnetic contacts on the CEFALY DUAL Enhanced must be...

  • Page 68: Problem #03 - I Cannot Feel Any Stimulation

    Troubleshooting the 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. To reposition the electrode, start from the center of and work your way outward toward each corner, running your fingers several times along the entire surface of the electrode.
  • Page 69 You want the electrode to be flat and firm against your forehead skin. • Use a mirror to make sure your CEFALY DUAL Enhanced is properly positioned on the electrode. The magnetic contacts on the CEFALY DUAL Enhanced must be properly secured by the corresponding magnetic contact zone on the electrode for the CEFALY DUAL Enhanced to work properly.
  • Page 70 You want the electrode to be flat and firm against your forehead skin. • Wait 2-3 minutes while using CEFALY DUAL Enhanced for the intensity to increase. It’s possible you are becoming used to the sensation.

  • Page 71: Problem #04 - The Intensity Feels Too High

    Troubleshooting first time using the CEFALY DUAL Enhanced it must be fully charged. Once your CEFALY DUAL Enhanced is fully charged, the indicator light will remain turned on. Problem #04 - The intensity feels too high. Possible Cause: • The sensations experienced while using the CEFALY DUAL Enhanced are novel to most people and can take some adjustment.

  • Page 72: 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 Enhanced 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 73: Problem #06 - My Skin Is Reddened When I Remove The Electrode

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

  • Page 74: 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

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

  • Page 75: Problem #08 - The Cefaly Dual Enhanced Does Not Power On

    • Your CEFALY DUAL Enhanced is not properly secured to the electrode. Solution: • Use the micro-USB cable to connect the Charging Dock, then place the CEFALY DUAL Enhanced onto the Charging Dock and let it charge for 4+ hours. If this is...
  • Page 76 Troubleshooting your first time using the CEFALY DUAL Enhanced it must be fully charged. Once fully charged, the indicator light will have a solid green glow. If your device is already fully charged and you have problems turning on, please contact CEFALY Technology for further assistance.

  • Page 77: 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 78 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 79 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 80: 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 81 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 82 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 83: Technical Information

    11. Technical Information 11.1. About the CEFALY DUAL Enhanced 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...
  • Page 84 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 85 Any electrode for which the current density is above 2mA/ cm requires special attention from the operator. Device Temperature Specifications When the CEFALY DUAL Enhanced is operated at an ambient temperature of 95°F the temperature of the electrode will stay below 104°F.
  • Page 86 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 87: About The Battery

    Technical Information 11.2. About the Battery Power supply: CEFALY DUAL Enhanced uses a 3.7v Lithium-Ion Polymer battery that is recharged using the included micro-USB cable and power adapter. Battery shelf life: 300 cycles of complete charge-discharge. Maximum input voltage (micro-USB connection): 5.25 Vdc.

  • Page 88: Electromagnetic Compatibility

    11.5. Guidance and Manufacturer’s Declaration- Electromagnetic Emission The CEFALY DUAL Enhanced is intended for use in the electromagnetic environment specified in the table. The customer or the user of the CEFALY DUAL Enhanced should ensure that it is used in such an environment.
  • Page 89 Technical Information Electromagnetic Interference In order to regulate the requirements for ElectroMagnetic Compatibility with the aim of preventing unsafe product situations, the EMC IEC 60601-1-2 4th edition standard has been implemented. WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it may result in improper operation.
  • Page 90 Electromagnetic environment - guidance Conducted RF emissions - Not Applicable CISPR 11 Radiated RF emissions - Group 1 The CEFALY DUAL Enhanced is suitable for use CISPR 11 Class B in all establishments including domestic. Harmonic current emissions - Not Applicable...
  • Page 91 IEC 61000-4-3 80% AM at 1kHz 80% AM at 1kHz should be used no closer to any part of CEFALY DUAL IMMUNITY to proximity Levels of table below Levels of table below Enhanced product. fields from RF wireless...
  • Page 92 Technical Information Electrostatic fast transient / Not Applicable Not Applicable burst, IEC 61000-4-4 Surge, IEC 61000-4-5 Not Applicable Not Applicable Power frequency magnetic 30 A/m (50/60 Hz) 30 A/m (50/60 Hz) Power frequency magnetic field IEC 61000-4-8 fields should be at levels characteristic of a typical in all establishments including domestic.
  • Page 93 Technical Information Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Frequency Modulation Immunity test level (MHz) (V/m) Pulse modulation 18 Hz FM, ± 5 kHz deviation 1 kHz sine Pulse modulation 217 Hz Pulse modulation 18 Hz...
  • Page 94 Technical Information Test Frequency Modulation Immunity test level (MHz) (V/m) 1720 Pulse modulation 217 Hz 1845 1970 2450 Pulse modulation 217 Hz 5240 Pulse modulation 217 Hz 5500 5785...

  • Page 95: Warranty

    CEFALY DUAL Enhanced. To be eligible for a refund, the CEFALY DUAL Enhanced and accessories must be in the same condi- tion they were received and in the original packaging. We reserve the right to decline your return if any items have been damaged or modified, or have been in contact with any liquids.
  • Page 96 Technical Information Limited Warranty Your 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 CEFALY US, Inc. This limited warranty ensures your CEFALY DUAL Enhanced is free of defects in manufacture and workmanship if used in accordance with the instructions provided.
  • Page 97 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 98: About Cefaly Technology

    (One trigeminal nerve runs to the right side of the head, while the other runs to the left. Each of these nerves has three distinct branches.) CEFALY DUAL Enhanced 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 Enhanced magnetically secures to an electrode positioned on the forehead between the eyebrows.

  • Page 99: 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 100 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 101: 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 102 Glossary Symbols Title of the Symbol Description of the Symbol Type BF Applied This symbol on the electrode package means type BF applied Parts parts (electrode). WEEE Symbol Indicates Waste Electrical and Electronic Equipment that can have potentially harmful effects on the environment. Incorrect disposal can cause harmful toxins to build up in the air, water, and soil, and can be harmful to humans.
  • Page 103 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 104 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 105 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 108 The CEFALY DUAL Enhanced device Is A Patented Model And Is Protected By An International Patent. CEFALY® Is A Trademark That Has Been Registered Internationally. The CEFALY DUAL Enhanced Is Manufactured In Conformity With Iso 13485 And GMP. The Manufacturer Is ISO 13485 (Medical) Certified.

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