Page 1 CEFALY ® Enhanced A medical device for the treatment of migraine. USER MANUAL...
Page 3 • The preventative treatment of episodic migraine in patients 18 years of age or older. CEFALY Enhanced 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 4 Outside North America BELGIUM Email: info@cefaly.com Phone: +32 4 367 67 22 www.cefaly.com Need help getting started? Visit our website at www.cefaly.com/start to schedule a free CEFALY Coach Session for personal one-on-one assistance! Copyright © 2023 CEFALY Technology, 4102 Seraing Belgium...
Page 5: Table Of Contents
1.7. A Note for New Users ......................28 2. About CEFALY Enhanced 2.1. What’s Included in the CEFALY Enhanced Package ..........29 2.2. Physical Description of CEFALY Enhanced and Electrode ........32 2.3. Understanding CEFALY Enhanced Status ..............36 2.4. Best Practices and Recommendations ................40 2.5.
Page 6 4.1. Clean Your Skin ........................48 4.2. Open the Electrode ......................49 4.3. Position the Electrode on Your Skin ................50 4.4. Attach CEFALY Enhanced to the Electrode ..............51 5. Delivering Acute Migraine Treatment (Program 1 - ACUTE) 5.1. Choose the ACUTE Treatment Program..............52 5.2.
Page 7 7.4. Accidental Interruptions ....................70 8. Care Information 8.1. Cleaning and Maintenance ....................71 8.2. Operating and Storage Conditions ................72 8.3. Disposal ..........................72 9. Troubleshooting Problem #01 - The CEFALY Enhanced emits one long beep when the device button is EN/EU...
Page 8 ............................73 Problem #02 - The CEFALY Enhanced turned off during my session......74 Problem #03 - I cannot feel any stimulation................75 Problem #04 - The intensity feels too high and is painful..........78 Problem #05 - The intensity feels too low................79 Problem #06 - My skin is reddened when I remove the electrode.
Page 9 10.2. What Should I Do to Avoid Migraine Attacks? ............88 11. Technical Information 11.1. About the CEFALY Enhanced Device ................. 91 11.2. About the Battery ......................95 11.3. USB Power Adaptor ....................... 95 11.4. Electromagnetic Compatibility ..................96 11.5. Guidance and Manufacturer's Declaration - Electromagnetic Emission ..96 11.6.
Page 10 Critical CEFALY Enhanced Facts Read this user manual thoroughly before using CEFALY Enhanced. Uses • Helps relieve migraine pain. • Helps in reducing the number of monthly migraine days. Who Should Use CEFALY Enhanced • The acute treatment of migraine with or without aura in patients 18 years of age or older.
Page 11 Operating and Storage Conditions Use CEFALY Enhanced Store CEFALY Enhanced At room temperature between 50° F At temperatures between 23° F and 95° and 95° F (10° C and 35° C) in a dry F (-5° C to 35° C) in a dry environment...
Page 12: Safety Information
This user manual describes the proper use of CEFALY Enhanced. 1.2. Indications for Use CEFALY Enhanced is for patients diagnosed by a physician with migraine per the indications for use. CEFALY Enhanced is a medical device for the treatment of migraine.
Page 13: Contraindications
Safety Information 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 Enhanced has not been demonstrated for patients with medication overuse headache or chronic tension-type headaches.
Page 14 • Have an allergy to acrylate. • Have cutaneous hypersensitivity: +/- 5% of people present a hypersensitivity of the forehead skin and do not tolerate the sensation induced by the CEFALY Enhanced. • Have trigeminal neuralgia. • Have ophthalmic shingles.
Page 15: Conventions Used In This Manual
Safety Information 1.4. Conventions Used in this Manual Special conventions have been used throughout this User Manual to highlight important information. Here is a list of the special conventions used. • Warnings are placed in a box with a light red color in the background. •...
Page 16 Standard warnings relate to significant harm to the user and not to CEFALY Enhanced. CAUTION: Alerts the user to the possibility of a problem with CEFALY Enhanced associated with its use or misuse. Such problems include CEFALY Enhanced malfunction, failure, damage to CEFALY Enhanced or damage to other property.
Page 17: General Warnings And Cautions
WARNINGS • Do not use CEFALY Enhanced while sleeping. • Do not use CEFALY Enhanced in a wet environment, such as in the bath or shower. • Do not use CEFALY Enhanced while driving, operating machinery, or during any activity that requires you to be alert and focused. Wait for 1 hour after each treatment session before resuming any such activity.
Page 18 • Do not use over, or close to, cancerous lesions or skin abnormalities that could be cancerous. • Use caution or avoid using CEFALY Enhanced if there has been any loss of feeling in the skin of your forehead or scalp until the normal feeling is resumed.
Page 19 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 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 20 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 21 Safety Information Consult your healthcare provider before using the CEFALY 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 22 • You should use this unit only with the electrodes and accessories recommended by the manufacturer. • Do not use CEFALY Enhanced in close proximity (less than 3.5 feet) to shortwave or microwave therapy equipment, as it may produce instability in the CEFALY Enhanced output.
Page 23 Safety Information • It may be dangerous to connect the CEFALY Enhanced with devices not identified in this user manual. • Do not modify this equipment without written authorization from the manufacturer. • Only individuals authorized by the manufacturer can repair this equipment.
Page 24: Side Effects
Safety Information 1.6. Side Effects CEFALY Enhanced has few side effects, which have been demonstrated to be minor and fully reversible with cessation of device use, 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 Enhanced and consult your healthcare provider or seek immediate medical attention.
Page 25 (Program 2 - PREVENT Treatment). ● Pain During the Session Some people may perceive the sensation produced by the CEFALY Enhanced during the session as painful. In the first 14 minutes of a session, briefly press the device button to set the stimulation at a level you can comfortably tolerate.
Page 26 Some subjects, especially in the early stages of use, tend to unconsciously contract their neck muscles during a session. This can cause pain in the neck. We recommend using CEFALY while sitting or reclining, with the head tilted back and resting on a pillow. EN/EU...
Page 27 ● Tooth Pain In very rare cases, some patients have reported transitory tooth pain during a session. CAUTION If any side effects persist for more than a few weeks, stop use of CEFALY Enhanced and see your healthcare provider. EN/EU...
Page 28: A Note For New Users
Safety Information 1.7. A Note for New Users In clinical studies, CEFALY demonstrated efficacy and safety for acute and preventative treatment of episodic migraines at the highest intensity levels. • Individual tolerance for CEFALY stimulation intensity may vary. CEFALY treatments should never feel painful.
Page 29: About Cefaly Enhanced
2. About CEFALY Enhanced About CEFALY DUAL Enhanced 2.1. What’s Included in the CEFALY Enhanced Package When you receive and open your CEFALY Enhanced migraine treatment kit, you should find the following items numbered 1-7: EN/EU...
Page 30 About CEFALY Enhanced Fig. 1 Contents of the Package EN/EU...
Page 31 3. Resealable Electrode Storage Bag: Use for storage of opened electrodes between treatments. 4. Quick Start Guide: Learn the features and functions of your CEFALY Enhanced in an easy-to-digest format to get you started quickly. 5. Instruction Manual: The manual includes instructions to help you set up and use your CEFALY Enhanced.
Page 32: Physical Description Of Cefaly Enhanced And Electrode
About CEFALY Enhanced 6. Charging Dock and USB Cable: These are used to recharge the CEFALY Enhanced battery. 7. Storage Case: Use for storage of CEFALY Enhanced, electrodes, charging dock, and USB cable. 2.2. Physical Description of CEFALY Enhanced and Electrode CEFALY Enhanced comes with an electrode, charging dock, and USB cable.
Page 33 Table 1 - Parts of the CEFALY Enhanced Part Location Functionality Device button Front Used to turn on CEFALY Enhanced and activate the treatment programs (ACUTE and PREVENT). LED indicator light Front Used to indicate the status of the CEFALY Enhanced to user.
Page 34 About CEFALY Enhanced Electrode The CEFALY Enhanced electrode is 3.7 in. (9.4 cm) long and 0.78 in. (2 cm) high, and comes in a silver packet. It acts as the interface between the CEFALY Enhanced and the skin. The electrode has two contact zones that connect with the CEFALY Enhanced through magnets.
Page 35 Conductive gel Front Used for effective contact between the electrode and the user. Magnetic contact Rear Used for contact between CEFALY Enhanced 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 hygienic reasons, each •...
Page 36: Understanding Cefaly Enhanced Status
About CEFALY Enhanced 2.3. Understanding CEFALY Enhanced Status The CEFALY 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 Enhanced...
Page 37 Action Feedback Fully Charged USB Cable is connected to the Charging Dock and CEFALY Solid green glow on the LED indicator. Enhanced is placed on the Charging Dock. ACUTE Program Press the device button once. Single turquoise Single beep indicates activation flash throughout the treatment.
Page 38 About CEFALY Enhanced Device Operation Action Feedback PREVENT Program Program has been activated and battery charge is too low to (low battery charge) Melody that repeats four times. complete one treatment. Increase Intensity Long press device button Intensity of the treatment slowly...
Page 39 About CEFALY Enhanced Device Operation Action Feedback Increase to Long press device button for 30 Maximum Intensity seconds anytime during the first Series of rapid beeps to indicate that the 14 minutes of the treatment. device has reached maximum intensity.
Page 40: Best Practices And Recommendations
Read the following sections thoroughly before operating the CEFALY Enhanced: Setting up CEFALY Enhanced, Preparing for Migraine Treatment, Delivering Migraine Treatment, and Care Information. Refer to the beginning of this manual for the Critical CEFALY Enhanced Facts. Cleanse your forehead with soap and water before every treatment session. This will ensure the electrode attaches securely to the skin.
Page 41 About CEFALY Enhanced The magnetic contacts of the CEFALY 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 42: Electrode Care
• With the device on the electrode, the electrode slips or separates in any way from your forehead. If you are not able to verify the above, you should use a new electrode. If you have any questions about reusing your electrode, please contact CEFALY for assistance. EN/EU...
Page 43 About CEFALY Enhanced Good Electrode Electrode with Gel Missing Dried Out Electrode EN/EU...
Page 44: Setting Up Cefaly Enhanced
3. Setting Up CEFALY Enhanced Setting Up CEFALY DUAL Enhanced 3.1. Open the CEFALY Enhanced Package Open the package and remove the components (see Fig. 4), including: 1. CEFALY Enhanced 2. Electrode(s) 3. Resealable Electrode Storage Bag 4. Quick Start Guide 5.
Page 45: Charge The Battery
• As shown in Fig. 5, connect the micro-USB plug to the charging dock and place your CEFALY Enhanced onto the top side of the charging dock. The silicon pad should be facing down, and the silver ring with the gold pin should be facing up. Then, connect the USB plug to the power adaptor (Fig.
Page 46 Setting Up CEFALY Enhanced Fig. 5 Fig. 6 Fig. 7 EN/EU...
Page 47 Setting Up CEFALY Enhanced Action Feedback from the CEFALY Enhanced Status Press CEFALY Enhanced Low Battery device button once to see (Device is not connected feedback. If low battery, to Charging Dock for Solid yellow glow in Series of beeps.
Page 48: Preparing For Migraine Treatment
• The use of makeup-removing products is NOT recommended as a substitute for soap and water. WARNING Do not use CEFALY Enhanced in or around the neck or chest. It should only be applied to normal, intact, clean skin on the forehead. EN/EU...
Page 49: Open The Electrode
Preparing 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 50: Position The Electrode On Your Skin
WARNING Incorrect application and placement of the electrode may lead to serious injury. Contact CEFALY for assistance in questions related to the placement of the electrode before using the device. Fig. 10 EN/EU...
Page 51: Attach Cefaly Enhanced To The Electrode
Preparing for Migraine Treatment 4.4. Attach CEFALY Enhanced to the Electrode • On the back of your CEFALY Enhanced there are two magnets that allow the device to securely attach to the electrode. • Hold your CEFALY Enhanced on the edge, so these magnets are exposed, and bring the device toward your forehead.
Page 52: Delivering Acute Migraine Treatment (Program 1 - Acute)
Delivering Acute Migraine Treatment 5.1. Choose the ACUTE Treatment Program Once your CEFALY 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 53 • You will hear a single beep to indicate your ACUTE program selection. • The CEFALY 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 begin.
Page 54 Delivering Acute Migraine Treatment See table for feedback from the CEFALY Enhanced when the ACUTE treatment program is selected. Status Action Feedback from CEFALY Enhanced ACUTE Press the device button once. Program Single beep indicates activation of the program. Single turquoise flash throughout the treatment.
Page 55 Delivering Acute Migraine Treatment CAUTION The acute treatment session for CEFALY 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 session has not been established.
Page 56: Monitoring Your Acute Treatment
Delivering Acute Migraine Treatment 5.2. Monitoring Your ACUTE Treatment • Throughout this 60-minute program, the CEFALY 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 57 Delivering Acute Migraine Treatment a 10 mA output current. After 14 minutes, the stimulation intensity will plateau for the remainder of your session. Users should start at an intensity where they feel a strong vibration or stimulation sensation that is not painful. You may stabilize the device intensity by pressing the device button once during the first 14 minutes of a session.
Page 58 Delivering Acute Migraine Treatment Notes: For the best results, you should aim to use CEFALY Enhanced at the highest • intensity level. Gradually increase the intensity with each treatment for your skin to get used to the stimulation. • New users are encouraged to stabilize the treatment intensity at any point during the first 14 minutes, before they experience painful sensations.
Page 59: Ending Your Acute Treatment
Fig. 13 • You can now remove the CEFALY Enhanced by pulling it away from the electrode (Fig. 13). Then gently detach the electrode from your skin (Fig. 14). • To ensure optimal use of your electrode for future sessions, place it back on the plastic backing and store inside the Resealable Electrode Storage Bag.
Page 60: 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 Enhanced LED indicator will have two intermittent purple flashes throughout the program to aid in treatment monitoring. It may take several seconds for flashing to begin.
Page 61 Delivering Preventative Migraine Treatment See table for feedback from the CEFALY Enhanced when the PREVENT treatment program is selected. Status Action Feedback from CEFALY Enhanced PREVENT Press the device button twice, Program with a slight pause in between Two beeps indicate activation of each press.
Page 62: Monitoring Your Prevent Treatment
6.2. Monitoring Your PREVENT Treatment • Throughout this 20-minute program, the CEFALY 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 63 Delivering Preventative Migraine Treatment your eyes. You may even begin to feel like your hair is standing on end or your eyebrows are twitching, but this is only a sensation. Important: During the first 14 minutes of the PREVENT treatment session, the intensity will gradually increase.
Page 64 Delivering Preventative Migraine Treatment Notes: For the best results, you should aim to use CEFALY Enhanced at the highest • intensity level. Gradually increase the intensity with each treatment for your skin to get used to the stimulation. • New users are encouraged to stabilize the treatment intensity at any point during the first 14 minutes, before they experience painful sensations.
Page 65: Ending Your Prevent Treatment
• At the end of your PREVENT treatment session, you will stop feeling sensations from your CEFALY Enhanced and it will automatically shut off. • You can now remove the CEFALY Enhanced by pulling it away from the electrode (Fig. 16). Then gently Fig. 16 detach the electrode from your skin (Fig.
Page 66: Controlling Your Treatment (Acute Or Prevent)
14 minutes until they become accustomed to the treatment. Over time, consider allowing stimulation intensities to increase based on individual tolerance of the stimulation. • You will hear a single beep as confirmation. See table for feedback from CEFALY Enhanced. Status...
Page 67: Manually Increasing The Intensity During The First 14 Minutes
• 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 Enhanced. EN/EU...
Page 68 • As you ramp up the intensity, you may hear a series of three successive beeps. This indicates the treatment intensity has reached a 10 mA output current. See section 2.3 Understanding CEFALY Enhanced Status for more information. Status Action...
Page 69: Stopping Your Session Early
Controlling Your Treatment 7.3 Stopping Your Session Early • If at any point you need to stop your treatment session, simply remove your CEFALY 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 70: Accidental Interruptions
Controlling Your Treatment 7.4 Accidental Interruptions The electronics involved in CEFALY 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 71: Care Information
Care Information 8.1. Cleaning and Maintenance The magnetic contacts of the CEFALY 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 Enhanced between uses and/or between users.
Page 72: Operating And Storage Conditions
Please ensure the charging dock is disconnected from its power source before cleaning. 8.2. Operating and Storage Conditions Use CEFALY Enhanced at room temperature between 50° F and 95° F (10° C and 35° C) in a dry environment (relative humidity between 30% to 75%) and at normal atmospheric pressures (700 hPa to 1060 hPa).
Page 73: Troubleshooting
CEFALY Enhanced. If further assistance is required, contact Customer Service (see page 3). Table 7 - Troubleshooting Problem #01 - The CEFALY Enhanced emits one long beep when the device button is pressed. Possible Cause: •...
Page 74: Problem #02 - The Cefaly 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 Enhanced is properly positioned on the electrode. The magnetic contacts on the CEFALY Enhanced must be properly secured...
Page 75: Problem #03 - I Cannot Feel Any Stimulation
Troubleshooting by the corresponding magnetic contact zone on the electrode for the CEFALY 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 and work your way outward toward each corner, running your fingers several times along the entire surface of the electrode.
Page 76 You want the electrode to be flat and firm against your forehead skin. • Use a mirror to make sure your CEFALY Enhanced is properly positioned on the electrode. The magnetic contacts on the CEFALY Enhanced must be properly secured by the corresponding magnetic contact zone on the electrode for the CEFALY Enhanced to work properly.
Page 77 You want the electrode to be flat and firm against your forehead skin. • Wait 2-3 minutes while using CEFALY Enhanced for the intensity to increase. It’s possible you are becoming used to the sensation.
Page 78: Problem #04 - The Intensity Feels Too High And Is Painful
4+ hours. If this is your first time using the CEFALY Enhanced it must be fully charged. Once your CEFALY Enhanced is fully charged, the indicator light will remain turned on.
Page 79: Problem #05 - The Intensity Feels Too Low
CEFALY for further information. Problem #05 - The intensity feels too low. Possible Cause: • Once you’re accustomed to the sensations experienced while using the CEFALY Enhanced you may feel desensitized to its lower-strength pulses at the beginning of a session. EN/EU...
Page 80: Problem #06 - My Skin Is Reddened When I Remove The Electrode
Troubleshooting Solution: • You may press and hold the device button anytime during the first 14 minutes of program selection to manually increase 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.
Page 81 If this should happen, stop using the CEFALY 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.
Page 82: 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
CEFALY Enhanced sessions. If you experience any one or more of these conditions and it (they) persists, both during sessions and while not using CEFALY Enhanced, for more than a few weeks, stop use and consult your healthcare provider.
Page 83: Problem #08 - The Cefaly Enhanced Does Not Power On
• Use the micro-USB cable to connect the Charging Dock, then place the CEFALY Enhanced onto the Charging Dock and let it charge for 4+ hours. If this is your first time using the CEFALY Enhanced it must be fully charged. Once fully charged, the indicator light will have a solid green glow.
Page 84 You want the electrode to be flat and firm against your forehead skin. • Use a mirror to make sure your CEFALY Enhanced is properly positioned on the electrode. The magnetic contacts on the CEFALY Enhanced must be properly secured by the corresponding magnetic contact zone on the electrode for the CEFALY Enhanced to work properly.
Page 85: Self-Care For Migraine
10. Self-Care for Migraines 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.
Page 86 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 87 Self-Care for Migraines HOW DO I KNOW I HAVE MIGRAINE? MIGRAINE HEADACHE NON-MIGRAINE HEADACHE Headache pain with Headache pain is not associated associated symptoms with other symptoms GENERAL CHARACTERISTICS GENERAL CHARACTERISTICS Duration of 4-72 hours Duration of 30 mins to 7 days ‚...
Page 88: 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 89 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 90 Self-Care for Migraines Practices to Help Avoid Migraine Attacks Research shows there are some habits and non-pharmacological treatments that help reduce the burden of migraine. Helpful Habits: • Meditation and mindfulness practices • Keeping a migraine diary • Daily personal journaling •...
Page 91: Technical Information
11. Technical Information Technical Information 11.1. About the CEFALY 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 92 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 93 Any electrode for which the current density is above 2 mA/ cm requires special attention from the operator. Device Temperature Specifications When the CEFALY Enhanced is operated at an ambient temperature of 95° F the temperature of the electrode will stay below 104° F. EN/EU...
Page 94 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 95: About The Battery
Technical Information 11.2. About the Battery Power supply: CEFALY Enhanced uses a 3.7v Lithium-Ion Polymer battery that is recharged using the included micro-USB cable and power adapter. Battery shelf life: 450 cycles of complete charge-discharge. Maximum input voltage (micro-USB connection): 5.25 Vdc.
Page 96: Electromagnetic Compatibility
11.5. Guidance and Manufacturer’s Declaration - Electromagnetic Emission The CEFALY Enhanced is intended for use in the electromagnetic environment specified in the table. The customer or the user of the CEFALY Enhanced should ensure that it is used in such an environment.
Page 97 Technical Information WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it may result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Page 98 Electromagnetic environment - guidance Conducted RF emissions - Not Applicable CISPR 11 Radiated RF emissions - Group 1 The CEFALY Enhanced is suitable for use in all CISPR 11 Class B establishments including domestic. Harmonic current emissions - Not Applicable...
Page 99 IEC 61000-4-3 80% AM at 1 kHz 80% AM at 1 kHz should be used no closer to any part of CEFALY IMMUNITY to proximity Levels of table below Levels of table below Enhanced product. fields from RF wireless...
Page 100 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 101 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 EN/EU...
Page 102 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 EN/EU...
Page 103: Warranty
90 days from your delivery date, and you will be refunded the purchase price of the CEFALY Enhanced. To be eligible for a refund, the CEFALY Enhanced and accessories must be in the same condition 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 104 These limited warranties are effective only if the product is purchased from www.cefaly.com or CEFALY US, Inc. and the product is only operated in the country in which the product is purchased. A product that requires modifications or adoption to enable it to operate in any other country than the...
Page 105 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 106: About Cefaly Technology
CEFALY 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 Enhanced magnetically 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 107: Glossary
13. Glossary 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 108 Glossary 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. ACUTE Program - A 60-minute program designed to treat migraine attacks at the onset, to stop or relieve the pain.
Page 109: 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 110 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). Indicates Waste Electrical and Electronic Equipment that can have potentially harmful effects on the environment. WEEE Symbol Incorrect disposal can cause harmful toxins to build up in the air, water, and soil, and can be harmful to humans.
Page 111 Glossary Symbols Title of the Symbol Description of the Symbol Indicates the date after which the electrodes are not to be Use-By Date used. Indicates a medical device that needs to be protected from Keep Dry moisture. Indicates that the device contains recyclable lithium-ion Lithium-ion Battery batteries.
Page 112 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. Ingress Protection Indicates the degree of protection against harmful ingress of IP22 particulate matter and water.
Page 113 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 114 Notes EN/EU...
Page 115 EN/EU...
Page 116 The CEFALY Enhanced device Is A Patented Model And Is Protected By An International Patent. CEFALY® Is A Trademark That Has Been Registered Internationally. The CEFALY Enhanced Is Manufactured In Conformity With ISO 13485 And GMP. The Manufacturer Is ISO 13485 (Medical) Certified.

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