CEFALY CONNECTED A medical device for the treatment of migraine.
CEFALY CONNECTED ® NON-INVASIVE PORTABLE COMFORTABLE WEARABLE DRUG-FREE CEFALY Connected is indicated to be used for: • The acute treatment of migraine with or without aura in patients 18 years of age or older. • The preventative treatment of migraine in patients 18 years of age or older. CEFALY Connected is for patients diagnosed by a physician with migraine per the indications for use. IMPORTANT: Please read this manual prior to operation and use of the CEFALY Connected.
For assistance, please contact us as follows: In the United States Email: info@cefaly.us Phone: 1.844.475.7100 In Canada Email: cs@cefaly.com Phone: 1.844.475.7100 Outside North America Email: info@cefaly.com Phone: +32 4 367 67 22 To view this user manual in Español, please visit cefaly.com/start Copyright © 2022 CEFALY Technology, 4102 Seraing Belgium Rue Louis Plescia, 34 4102 SERAING BELGIUM www.cefaly.
Table Of Contents 1. Safety Information 12 1.1. Purpose ...............................................................................................................................................12 1.2. Indications for Use .........................................................................................................................12 1.3. Contraindications............................................................................................................................13 1.4.
2.4. Best Practices and Recommendations ...................................................................................39 2.5. Electrode Care .................................................................................................................................41 3. Setting Up CEFALY Connected 43 3.1. Open the CEFALY Connected Package ..................................................................................43 3.2. Charge the Battery...................................................
5.2. Open the Electrode.........................................................................................................................56 5.3. Position the Electrode on Your Skin.........................................................................................57 5.4. Attach CEFALY Connected to the Electrode........................................................................58 6. Delivering Acute Migraine Treatment (Program 1 – ACUTE) 59 6.1. Choose the ACUTE Treatment Program..........
8. Controlling Your Treatment (ACUTE or PREVENT) 74 8.1. Stabilizing Intensity During First 14 Minutes......................................................................74 8.2. Manually Increasing the Intensity During First 14 Minutes..........................................75 8.3. Stopping Your Session Early........................................................................................................77 8.4. Accidental Interruptions............................................................
Problem #02 - The CEFALY Connected turned off during my session...............................82 Problem #03 - I cannot feel any stimulation..................................................................................83 Problem #04 - The treatment intensity feels too high and is painful..................................86 Problem #05 - The intensity feels too low......................................................................................
12.1. About the CEFALY Connected Device..................................................................................99 12.2. About the Battery.........................................................................................................................103 12.3. USB Power Adaptor ....................................................................................................................103 12.4. Electromagnetic Compatibility.............................................................
Critical CEFALY Connected Facts Read this user manual thoroughly before using CEFALY Connected. Uses • Helps relieve acute migraine pain. • Helps in reducing the number of monthly migraine days. Who Should Use CEFALY Connected • The acute treatment of migraine with or without aura in patients 18 years of age or older. • The preventative treatment of migraine in patients 18 years of age or older. See page 93 of this manual on how to differentiate migraine from other types of headaches.
Operating and Storage Conditions Use CEFALY Connected Store CEFALY Connected 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). 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 (500 hPa to 1060 hPa). If further assistance is required, contact Customer Service (see page 3).
1. Safety Information 1.1. Purpose This user manual describes the proper use of CEFALY Connected. 1.2. Indications for Use CEFALY Connected is for patients diagnosed by a physician with migraine. CEFALY Connected is indicated for: • The acute treatment of migraine with or without aura in patients 18 years of age or older. • The preventative treatment of migraine in patients 18 years of age or older.
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 Connected has not been demonstrated for patients with medication overuse headache or chronic tension-type headaches. 1.3. Contraindications Contraindications The following are the conditions under which CEFALY Connected should not be used. Usage under such conditions may create unfavorable results and/or lead to adverse events.
Safety Information Do not use CEFALY Connected 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. Here is a list of the special conventions used. • Warnings are placed in a box with a light red color in the background.
Safety Information WARNING: Read all the cautions and warnings included in the manual before using CEFALY Connected because they are intended to keep you safe, prevent injury and avoid a situation that could result in damage to the device. WARNING: Alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of CEFALY Connected. Standard warnings relate to significant harm to the user and not to CEFALY Connected.
1.5. General Warnings and Cautions WARNINGS • Do not use CEFALY Connected while sleeping. • Do not use CEFALY Connected in a wet environment, such as in the bath or shower. • Do not use CEFALY Connected 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. • Do not use in the presence of electronic monitoring equipment (e.g., cardiac monitors, electrocardiogram (ECG) alarms).
Safety Information • Do not use CEFALY Connected close to the thorax (chest region) to avoid the risk of cardiac fibrillation. • Avoid incorrect electrode positioning to prevent serious injury. See Section 5.3. • Use CEFALY Connected only on normal, intact and clean skin. • Do not use over open wounds. • Do not use over skin eruptions. • Do not use over swollen, infected or inflamed areas. • Do not use over, or close to, cancerous lesions or skin abnormalities that could be cancerous.
Safety Information • Keep the CEFALY Connected out of the reach of children. • Strangulation risk due to the length of the charging system cable. • Suffocation risk in case of swallowing the electrode. 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 Connected have been performed on adults (ages 18-65 years old).
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. • You have the worst headache of your life. • You have fever or a stiff neck. • You have a headache that began after a head injury, exertion, coughing, or bending. • You experienced your first headache after the age of 50 years.
Safety Information Consult your healthcare provider before using the CEFALY Connected 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. If the frequency of your headache is not reduced after 2 or 3 months of daily use of Program 2 (prevention), ask your doctor. The long-term effects of chronic use of CEFALY Connected are unknown.
CAUTION • If you have experienced a seizure or are diagnosed with epilepsy, we recommend that you discuss CEFALY Connected with your healthcare provider prior to use. • If you have a history of herpetic infections/Shingles, please discuss with your healthcare provider prior to use. • CEFALY Connected treatments are not a cure for migraine headaches. • This unit will only work with CEFALY approved electrodes and accessories. • Do not use CEFALY Connected in close proximity (less than 3.
Safety Information • Only individuals authorized by the manufacturer can repair this equipment. • The CEFALY Connected 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. • The CEFALY Connected should only be charged with the charging dock included in the kit. • To minimize the risk of unexpected electric shock, avoid using CEFALY Connected at the same time as other active electronic medical devices.
Safety Information Common • Sleepiness The main side effect is a tendency towards sleepiness. This means that CEFALY Connected 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 Connected session. • Headache After a Session Approximately 0.5% of subjects reported a headache after a session of preventative treatment (Program 2 - PREVENT Treatment).
Safety Information appear blotchy. This effect is caused by activation of the skin blood circulation. This redness may persist for several minutes. Usually it disappears within 15 minutes. Approximately 0.2% of subjects reported reversible forehead skin redness. • Nausea Rare occurrence of nausea during a session of acute treatment (Program 1 - ACUTE Treatment) has been reported in the clinical trials. Rare • Forehead Skin Allergy In rare cases an allergy to the electrode gel can arise.
Safety Information CAUTION If any side effects persist for more than a few weeks, stop use of CEFALY Connected and see your healthcare provider. 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 and CEFALY treatments should never be permitted to become painful.
2. About CEFALY Connected 2.1.
About CEFALY Connected Fig.
About CEFALY Connected 1. CEFALY Connected: The CEFALY Connected 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. 2.
About CEFALY Connected 7. Storage Case: Use for storage of CEFALY Connected, electrodes, charging dock, and USB cable. 2.2. Physical Description of CEFALY Connected and Electrode CEFALY Connected comes with three electrodes, charging dock, and USB cable. The charging dock and USB cable are only used for charging the CEFALY Connected. CEFALY Connected CEFALY Connected is a single device with two program settings (ACUTE and PREVENT) that help users to overcome migraine pain. Fig.
About CEFALY Connected Table 1 - Parts of the CEFALY Connected 30 Part Location Functionality Device button Front Used to turn on CEFALY Connected and activate the treatment programs (ACUTE and PREVENT). LED indicator light Front Used to indicate the status of the CEFALY Connected to user. Magnetic Contacts Rear Used to connect CEFALY Connected to the electrode that transmits the stimulations to the user.
About CEFALY Connected Electrode The CEFALY Connected electrode is 3.7 in. (9.4 cm) long and 0.78 in. (2 cm) high, and comes in a Resealable Storage Bag. It acts as the interface between the CEFALY Connected and the skin. The electrode has two contact zones that connect with the CEFALY Connected through magnets. Magnetic contact zone Conductive gel Fig.
About CEFALY Connected Table 2 - Parts of the Electrode Part Location Functionality Conductive gel Front Used for effective contact between the electrode and the user. Magnetic contact zone Rear Used for contact between CEFALY Connected and the electrode. Notes: • Use electrodes before the “Use-By-Date” printed on the electrode packaging. • Do not use the same electrode on multiple people. For important reasons of hy- giene, each user must have his or her own electrode.
About CEFALY Connected 2.3. Understanding CEFALY Connected Status The CEFALY Connected 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 Connected Device Operation Action Low Battery Press CEFALY Connected device button once to see feedback. If low battery, connect to the Charging Dock for recharge.
Device Operation Action Fully Charged USB Cable is connected to the Charging Dock and CEFALY Connected is placed on the Charging Dock. Feedback Solid green glow on the LED indicator. Connection Waiting for Bluetooth Connection, Device Connected, Device Disconnected Push Button (without electrode). Light will flash for 30 seconds while pairing. If unsuccessful, the light will turn off. Two chime notes indicates Bluetooth pairing successful.
Device Operation Action ACUTE Program Press the device button once. Feedback Single beep indicates activation of the program. ACUTE Program (low battery charge) Program has been activated and battery charge is too low to complete one treatment. Single turquoise flash throughout the treatment. Chime that repeats four times.
Device Operation Action PREVENT Program Press the device button twice, with a slight pause in between each press. PREVENT Program Program has been activated and battery charge is too low to complete one treatment. (low battery charge) Stabilize Intensity 36 During the first 14 minutes of treatment when the intensity is increasing, press the device button once to stabilize the intensity. Feedback Two beeps indicate activation of the program.
Device Operation Action Feedback Increase Intensity (for experienced CEFALY users) Long press device button anytime during the first 14 minutes of the treatment. Intensity of the treatment gradually increases until the device button is released. Series of beeps will be heard when button is pressed. Intensity is 10 mA When the treatment intensity reaches a 10 mA output current. Increase to Maximum Intensity Long press device button for 30 seconds anytime during the first 14 minutes of the treatment.
Device Operation Action End Treatment Remove the device from the electrode. Accidental Interruption 38 If the electrode doesn’t fully grip your skin, is worn out, and/ or is nudged by movement, your session may be interrupted. Feedback Series of successive beeps indicate that the treatment has been stopped/ interrupted. Series of successive beeps that repeat four times indicate that the treatment has been stopped/interrupted.
About CEFALY Connected 2.4. Best Practices and Recommendations Read the following sections thoroughly before operating the CEFALY Connected: Setting up CEFALY Connected, Preparing for Migraine Treatment, Delivering Migraine Treatment, and Care Information. Refer to page 10 for the Critical CEFALY Connected Facts. Cleanse and dry your skin before every treatment session. This will ensure the electrode attaches securely to the skin.
About CEFALY Connected The magnetic contacts of the CEFALY Connected 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. To ensure optimal use of your electrode for future sessions, place it back on the plastic backing and put in the Resealable Electrode Storage Bag.
About CEFALY Connected 2.5. Electrode Care A visual inspection and quick stickiness check helps determine if it is time for a new electrode. If you experience any of the following with your current electrode, you should dispose of it and use a new one: • Your electrode is not sticky to the touch or looks dried out. • The two pads of the electrode are not fully covered with gel.
About CEFALY Connected Good Electrode Electrode with Gel Missing Dried Out Electrode 42
3. Setting Up CEFALY Connected 3.1. Open the CEFALY Connected Package Open the package and remove the components (see Fig. 4), including: 1. CEFALY Connected 2. Electrode(s) 3. Resealable Electrode Storage Bag 4. Quick Start Guide 5. Instruction Manual 6. Charging Dock & USB Cable 7. Storage Case Fig.
Setting Up CEFALY Connected 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 Connected treatment session, fully charge the battery (this typically takes 4 hours to complete). • As shown in Fig. 5, connect the micro-USB plug to the charging dock and place your CEFALY Connected 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.
Setting Up CEFALY Connected Fig. 5 Fig. 6 Fig. 7 See table for feedback from CEFALY Connected during charging and completion of charging.
Setting Up CEFALY Connected Status Action Low Battery Press CEFALY Connected device button once to see feedback. If low battery, connect to the Charging Dock for recharge. (Device is not connected to Charging Dock for recharge or an electrode for treatment.) Charging Fully Charged 46 USB Cable is connected to the Charging Dock and CEFALY Connected is placed on the Charging Dock. USB Cable is connected to the Charging Dock and CEFALY Connected is placed on the Charging Dock.
4. Using CeCe with the CEFALY Connected 4.1 What is the CeCe Migraine Management App? The CeCe Migraine Management app provides CEFALY users and non-CEFALY users with an outlet to log their migraine triggers and symptoms, helping them recognize trends over time. The CEFALY Connected communicates via a Bluetooth link to the CeCe Migraine Management mobile app on a user’s mobile device.
Using CeCe with the CEFALY Connected 4.2 Downloading CeCe In order to get the maximum benefit from the CeCe app, you’ll need to be familiar with how your CEFALY Connected works. We recommend you read through this entire user manual before using the CeCe app. • Verify that your mobile device’s operating system is compatible with the CeCe Migraine Management app – iOS 12 and above, or Android 8.1 and above.
Using CeCe with the CEFALY Connected • You will receive an email notification to verify your account. Then, you may sign into your account (Figure 9) using your chosen email and password. Fig. 8 Fig.
Using CeCe with the CEFALY Connected 4.3 Pairing CeCe and CEFALY Connected for the First Time • Ensure your CEFALY Connected is fully charged. See section 3.2 Charge the Battery for more details on charging. • Enable Bluetooth on your mobile device, then open the CeCe app on your mobile device. • Your CEFALY Connected must be in range to connect (the device has been tested at a maximum range of 12 meters (40 feet) between the mobile device and the CEFALY Connected).
Using CeCe with the CEFALY Connected • You will be notified when the CEFALY Connected is successfully paired and connected to the app. See Figure 10. • To optimize battery life, the CEFALY Connected should be disconnected from the app by closing the app on the mobile device when not in use. CAUTION Do not share the pairing PIN. This may result in unintended access to your device or the information you share with CEFALY. Fig.
Using CeCe with the CEFALY Connected 4.4 Using the CeCe App with the CEFALY Connected Please read through this entire user manual before using the CeCe app. You’ll need to be familiar with how your CEFALY Connected works in order to get the maximum benefit from the CeCe app. • To use the CeCe app to track your CEFALY treatments, connect the device and app as described in section 4.3. • Once connected, prepare for treatment as described in section 5 Preparing for Migraine Treatment.
Using CeCe with the CEFALY Connected Fig. 11 Fig.
Using CeCe with the CEFALY Connected 4.5 Logging Your CEFALY Treatments with CeCe • Upon completion of an ACUTE treatment, you must end the migraine log to save your treatment session in the app. Tap the large red button on the home screen that reads “Stop ongoing migraine.” Your ACUTE treatment session will automatically be logged in the app. See section 6.4 Ending Your ACUTE Treatment for guidance on how to handle the device and electrode at the end of your treatment.
5. Preparing for Migraine Treatment 5.1. Clean Your Skin • It is important to cleanse your skin before every CEFALY Connected session. This will help ensure the electrode attaches securely to your forehead. CAUTION Do not apply the electrode to wet or moist skin. Fig. 13 • Use soap and water to wash between and above your eyebrows (Fig. 13). Afterward, be sure to dry your skin thoroughly.
Preparing for Migraine Treatment WARNING Do not use CEFALY Connected in or around the neck or chest. It should only be applied to normal, intact, clean skin on the forehead. 5.2. Open the Electrode • Open the Resealable Electrode Storage Bag, slide out the electrode, then peel it from the clear plastic backing (Fig. 14). Fig. 14 56 • Save the plastic backing for later use to store your electrode in the Resealable Electrode Storage Bag.
Preparing for Migraine Treatment 5.3. Position the Electrode on Your Skin • Use a mirror to help place the electrode on your forehead. Place the electrode so the curved area is between your eyebrows and wings are just above the eyebrows as seen in Fig. 15. • Once in place, run your fingers along the electrode several times to check that it’s flat and firm against your skin. WARNING Incorrect application and placement of the electrode may lead to serious injury.
Preparing for Migraine Treatment 5.4. Attach CEFALY Connected to the Electrode • On the back of your CEFALY Connected there are two magnets that allow the device to securely attach to the electrode. Fig. 16 58 • Hold your CEFALY Connected on the edge, so these magnets are exposed, and bring the device toward your forehead. Take care to avoid accidentally pressing the button on the front of the device.
6. Delivering Acute Migraine Treatment (Program 1 – ACUTE) 6.1. Choose the ACUTE Treatment Program Once your CEFALY Connected 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.
Delivering Acute Migraine Treatment This is a 60-minute program designed to treat migraine attacks when they begin, to stop or relieve your migraine pain. For best results, use this therapy at the beginning of an acute migraine attack. When using the ACUTE migraine treatment program, you will observe the following: • You will hear a single beep to indicate your ACUTE program selection.
Delivering Acute Migraine Treatment See table for feedback from the CEFALY Connected when the ACUTE treatment program is selected. Status Action ACUTE Program Press the device button once. Feedback from CEFALY Connected Single beep indicates activation of the program. Single turquoise flash throughout the treatment. Notes: • For best results, the ACUTE program should be used for its full 60-minute session.
Delivering Acute Migraine Treatment CAUTION The acute treatment for CEFALY Connected (Program 1 - 60-minute ACUTE session) 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.
Delivering Acute Migraine Treatment 6.2. Monitoring Your ACUTE Treatment • Throughout this 60-minute program, the CEFALY Connected 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. 6.3.
Delivering Acute Migraine Treatment IMPORTANT: During the first 14 minutes of the ACUTE treatment session, the intensity will automatically increase until the device reaches maximum intensity. As the intensity increases to maximum intensity, you may hear 3 successive beeps during your session. This indicates the treatment intensity has reached a 10 mA output current. The intensity will remain at maximum intensity after the first 14 minutes for the remainder of your 60 minute treatment.
Delivering Acute Migraine Treatment Notes: • For the best results, you should aim to use CEFALY Connected at the highest intensity level. Gradually increase the intensity with each treatment for your skin to get used to the stimulation. • The electrode gel is the conductive material that transmits the stimulation impulses. Avoid touching the gel during the treatment session.
Delivering Acute Migraine Treatment 6.4. Ending Your ACUTE Treatment • At the end of the ACUTE 60-minute treatment session, the CEFALY Connected device will play a series of successive beeps then automatically shut off. You may continue to feel sensations over the stimulation area lasting for several minutes after the treatment session is complete. Fig. 18 • You can now remove the CEFALY Connected by pulling it away from the electrode (Fig. 18). Then gently detach the electrode from your skin (Fig. 19).
7. Delivering Preventative Migraine Treatment (Program 2 – PREVENT) 7.1. Choose the PREVENT Treatment Program Fig. 20 Once your CEFALY Connected is securely attached to the electrode on your forehead, you’re ready to select your treatment program. For the preventative treatment of migraine, select Program 2 the PREVENT Treatment Program.
Delivering Preventative Migraine Treatment • The CEFALY Connected 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. See table for feedback from the CEFALY Connected when the PREVENT treatment program is selected. Status Action PREVENT Program Press the device button twice, with a slight pause in between each press. Feedback from CEFALY Connected Two beeps indicate activation of the program.
Delivering Preventative Migraine Treatment Notes: • For new CEFALY users, please review section 8.1 Stabilizing Intensity During First 14 Minutes. • The PREVENT Treatment (Program 2 - 20-minute PREVENT session) should be used daily for 20-minute sessions. More than one 20-minute session per day is not recommended because the safety and effectiveness of Program 2 when used more than once per day has not been studied. 7.2.
Delivering Preventative Migraine Treatment 7.3. What to Expect During Your PREVENT Treatment At the beginning of therapy, you may not feel the stimulation. The initial stimulation intensity can be low for some users. The stimulation intensity will gradually increase and you may feel vibrations or a tingling on your forehead and near 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.
Delivering Preventative Migraine Treatment At the end of the treatment, when you remove the electrode, your skin may appear reddened where the electrode was placed. This redness may last a few minutes and is an indication the device has stimulated blood flow to the area. Note: • For the best results, you should aim to use CEFALY Connected at the highest intensity level. Gradually increase the intensity with each treatment for your skin to get used to the stimulation.
Delivering Preventative Migraine Treatment 7.4. Ending Your PREVENT Treatment • At the end of your PREVENT treatment session, you will stop feeling sensations from your CEFALY Connected and it will automatically shut off. Fig. 21 • If at any point you need to stop your treatment session, simply remove your CEFALY Connected device from the electrode and your session will end. For more information, review section 8.3 Stopping Your Session Early.
Delivering Preventative Migraine Treatment • To ensure optimal use of your electrode for future sessions, place it back on the plastic backing, then store inside the Resealable Electrode Storage Bag. • After successfully completing your treatment, pack your CEFALY Connected and electrode away in the storage case until you are ready for your next treatment.
8. Controlling Your Treatment (ACUTE or PREVENT) 8.1. Stabilizing Intensity During First 14 Minutes • Migraine relief in clinical studies were demonstrated at maximum stimulation intensity, however the tolerance for stimulation intensity may vary among users. New CEFALY users are encouraged to stabilize the device intensity during the first 14 minutes until they become accustomed to the treatment.
Controlling Your Treatment 8.2. Manually Increasing the Intensity During First 14 Minutes At any point during the first 14 minutes of either treatment program, you can manually increase your intensity. • To manually increase intensity, long press your device button until you reach your desired intensity level. When you release the device button, the intensity will stabilize for the remainder of the session. • You can repeat this if you would like to increase the intensity again.
Controlling Your Treatment • 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 Connected Status for more information. Status Increase Intensity Maximum Intensity 76 Action Feedback from CEFALY Connected Long press device button anytime Intensity of the treatment slowly during the first 14 minutes of the increases until the device button is treatment. released.
Controlling Your Treatment 8.3. Stopping Your Session Early • If at any point you need to stop your treatment session, simply remove your CEFALY Connected 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. See table for feedback from CEFALY Connected. Status Action End Treatment Remove the CEFALY Connected from the electrode.
Controlling Your Treatment 8.4. Accidental Interruptions The electronics involved in CEFALY Connected 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. See table for feedback from CEFALY Connected.
9. Care Information 9.1. Cleaning and Maintenance The magnetic contacts of the CEFALY Connected 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 Connected between uses and/or between users. Electrodes Electrodes must be used before the expiration date printed on the outside of the packet. Electrodes may be reused as long as they effectively stick to your forehead.
Care Information Charging Dock: Keep the front surface and connection pin of the charging dock clean. Please ensure the charging dock is disconnected from its power source before cleaning. 9.2. Operating and Storage Conditions Use CEFALY Connected 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). This device is intended for use at altitudes lower than 9842.5 ft (3000 m).
10. Troubleshooting When a problem occurs, troubleshooting will help you to determine if the problem is with the CEFALY Connected or your use. Check the troubleshooting table for a solution if a problem should arise with your CEFALY Connected. If further assistance is required, contact Customer Service (see page 3). Table 4 - Troubleshooting Problem #01 - The CEFALY Connected emits one long beep when the device button is pressed. Possible Cause: • The battery charge is too low.
Troubleshooting Problem #02 - The CEFALY Connected turned off during my session. Possible Cause: • Your electrode is not sticking well to your forehead. • Your CEFALY Connected is not properly secured to the electrode. • The battery charge is too low. Solution: • Cleanse your skin again with soap and water, and pat dry. Then reposition the electrode, attach the CEFALY Connected and try powering it on again.
Troubleshooting CEFALY Connected 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. You want the electrode to be flat and firm against your forehead skin.
Troubleshooting • You accidentally pressed the device button to stabilize your treatment at a low intensity level, prohibiting it from increasing. • Your CEFALY Connected is not turned on. Solution: • Cleanse your skin again with soap and water, and pat dry. Then reposition the electrode, attach the CEFALY Connected and try powering it on again.
Troubleshooting toward each corner, running your fingers several times along the entire surface of the electrode. You want the electrode to be flat and firm against your forehead skin. • Wait 2-3 minutes while using CEFALY Connected for the intensity to increase. It’s possible you are becoming used to the sensation. • Wait until at least 4 minutes into your session, then press and hold the device button to manually ramp up the intensity of the session.
Troubleshooting time using the CEFALY Connected it must be fully charged. Once your CEFALY Connected is fully charged, a green indicator light will remain turned on. Problem #04 - The treatment intensity feels too high and is painful. Possible Cause: • The sensations experienced while using the CEFALY Connected are novel to most people and can take some adjustment. Solution: • IMPORTANT: Please use the stabilization feature of the device when first starting treatments - Refer to section 8.
Troubleshooting • If you experience any zapping or shocking sensation during treatment, stop treatment immediately. Zapping and shocking sensations are not expected during treatment and may result in injury if allowed to continue. Once you stop treatment, ensure that you have thoroughly cleansed the forehead area with soap and water and dry thoroughly. Ensure you use an electrode with a moist and cool gel surface without cracks or dry areas.
Troubleshooting Solution: • You may press and hold the device button anytime during the first 14 minutes of program selection to manually increase intensity to your desired strength. When you release the device button, the intensity will stabilize and remain constant. Should you press and hold the device button again, the intensity will increase again. The maximum intensity is reached after pressing and holding the device button for 30 consecutive seconds.
Troubleshooting Solution: • This redness may last a few minutes or more after your session, and is usually harmless. It indicates the CEFALY Connected has stimulated blood flow to the area. • In rare cases, you may experience an allergy to the acrylate used in the electrode adhesive and a temporary rash may cause. You may experience small blistering, burning, itching, or swelling in the areas where the electrode comes in contact with the skin.
Troubleshooting Possible Cause: • These may indicate that you are experiencing an uncommon side effect of using the CEFALY Connected. • You may be experiencing what is known as a Trigeminal Autonomic Cephalalgia (TAC), which can occur with migraine. Solution: • Some users have reported experiencing painful headaches, nausea, tooth pain, tinnitus or hyperlacrimation during and after CEFALY Connected sessions.
Troubleshooting Problem #08 - The CEFALY Connected does not power on. Possible Cause: • The CEFALY Connected does not have enough charge. • Your electrode is not sticking well to your forehead. • Your CEFALY Connected is not properly secured to the electrode. • Device is not responding when trying to switch ON. Solution: • Use the micro-USB cable to connect the Charging Dock, then place the CEFALY Connected onto the Charging Dock and let it charge for 4+ hours.
Troubleshooting start from the center and work your way outward toward each corner, running your fingers several times along the entire surface of the electrode. You want the electrode to be flat and firm against your forehead skin. • Use a mirror to make sure your CEFALY Connected is properly positioned on the electrode. The magnetic contacts on the CEFALY Connected must be properly secured by the corresponding magnetic contact zone on the electrode for the CEFALY Connected to work properly.
11. Self-Care for Migraines 11.1. 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. • The pain increases and decreases in a pulse-like manner.
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’ the head. • The headaches are not worsened with walking, movement, exercise, etc., and rarely have associated symptoms like nausea.
HOW DO I KNOW I HAVE MIGRAINES? MIGRAINE HEADACHE Headache pain with associated symptoms NON-MIGRAINE HEADACHE Headache pain is not associated with other symptoms GENERAL CHARACTERISTICS Duration of 4-72 hours Pain located on one side of the head (unilateral) Pulsating or throbbing pain Physical activity increases pain and symptoms Pain is associated with: ▫ Nausea/vomiting ▫ Sensitivity to light ▫ Sensitivity to sound GENERAL CHARACTERISTICS Duration of 30 mins to 7 days Pain on both side
Self-Care for Migraines 11.2. 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. Life can be difficult; add suffering with migraines to the mix, and it gets even more challenging.
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.) Alcohol Over-exertion (excessive exercise, etc.
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.
12. Technical Information 12.1. About the CEFALY Connected Device Maximum output current: 16 mA (milliamps) Wireless protocol: BLE 4.2 Pulse width: 250 μs (microseconds) Transmitter power : 0.
Technical Information Table 5 - Program Parameters 100 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 Ramp Down Time 45 seconds 45 seconds Session Duration 60 minutes 20 minutes
Technical Information Device Electrical Specifications For a charge between 200 and 1000 ohms. • Constant amplitude intensity predefined automatically, depending on the program. • Rectangular impulses. • Compensated constant current preventing any galvanic direct component. Any electrode for which the current density is above 2 mA/ cm2 requires special attention from the operator.
Technical Information Table 6 - IP22: Degree of protection against harmful ingress of particulate matter and water. Ingress Protection Rating: Degree of protection against harmful ingress of particulate matter and water IP22 Solids Protection Level 2 protected against particulate matter above 12.5 mm Liquids Protection Level 2 Protected against dripping water when tilted up to 15° from the vertical CAUTION Use is incompatible with the simultaneous use of high-frequency surgical equipment.
Technical Information 12.2. About the Battery Power supply: CEFALY Connected uses a 3.7 V 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. 12.3. USB Power Adaptor • The USB adaptor shall be a class II power supply that is IEC 60601-1 Ed 3.1 2012 certified, with two means of operator protection, input 110 V~240 V, 50/60 Hz, max 0.
Technical Information 12.4. Electromagnetic Compatibility Portable RF communication equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 16 cm (5 inches) to any part of the CEFALY Connected. Otherwise, degradation of the performance of this equipment could result. 12.5. Guidance and Manufacturer’s Declaration - Electromagnetic Emission The CEFALY Connected is intended for use in the electromagnetic environment specified in the table.
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.
Technical Information 106 Emission test Compliance Conducted RF emissions CISPR 11 Not Applicable Radiated RF emissions - CISPR 11 Group 1 Class B Harmonic current emissions IEC 61000-3-2 Not Applicable Voltage changes, voltage fluctuations and flicker EMISSIONS - IEC 61000-3-3 Not Applicable Electromagnetic environment - guidance The CEFALY Connected is suitable for use in all establishments including domestic.
Technical Information Immunity tests IEC 60601-1-2 ed.4 Compliance Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD), IEC 61000-4-2 ±8 kV contact ±15 kV air ±8 kV contact ±15 kV air Professional and home healthcare Environment. The humidity shall be at least 30%. Radiated RF electromagnetic field, IEC 61000-4-3 10 V/m 80 MHz to 2.7 GHz 80% AM at 1 kHz 10 V/m 80 MHz to 2.
Technical Information Conducted RF, IEC 61000-4-6 108 3V 0.15 — 80 MHz 80% AM at 1kHz 3V 0.15 — 80 MHz 80% AM at 1kHz 6V in ISM and amateur radio bands between [0.15MHz - 80MHz] 6V in ISM and amateur radio bands between [0.
Technical Information Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Frequency (MHz) Band (MHz) 385 380 - 390 450 710 Immunity test level (V/m) (CEFALY levels allowing to reduce the minimum separation distance to 16 cm instead of 30 cm) Pulse modulation 18 Hz 27 54 430 - 470 FM, ± 5 kHz deviation 1 kHz sine 28 54 704 - 787 Pulse modulation 217 Hz 9 18 Pulse modulation 18 Hz 28 745 Modulation 18 780 810 870 930 Applied test level 18 800
Technical Information Test Frequency (MHz) Band (MHz) 1720 1700 - 1990 1845 Modulation Pulse modulation 217 Hz Immunity test level (V/m) (CEFALY levels allowing to reduce the minimum separation distance to 16 cm instead of 30 cm) 28 54 54 1970 54 2450 2400 - 2570 Pulse modulation 217 Hz 28 54 5240 5100 - 5800 Pulse modulation 217 Hz 9 18 5500 5785 110 Applied test level 18 18
Technical Information 12.6. Warranty 90-Day Money-Back Guarantee CEFALY Connected devices purchased directly from www.cefaly.com or CEFALY US, Inc. are covered by a 90-Day Money-Back Guarantee. The guarantee does not include refunds for shipping fees and begins upon the date of your item delivery.
Technical Information Limited Warranty Your CEFALY device is protected by a three (3) year limited warranty from the original date of purchase when purchased directly from www.cefaly.com or an authorized retailer. It is important after purchasing your device that you complete the product registration on www.cefaly.com to receive this coverage. This limited warranty ensures your device is free of defects in manufacture and workmanship if used in accordance with the instructions provided.
Technical Information A product that requires modifications or adoption to enable it to operate in any other country than the country for which it was designed, manufactured, approved and/or authorized, or repair of products damaged by these modifications is not covered under this warranty. 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).
13. About CEFALY Technology CEFALY Technology is a global company that has been transforming people’s approach to migraine treatment since 2008. CEFALY Technology’s mission is to solve the persistent problem of migraine through advanced therapeutic innovations. While the causes of migraine are not completely understood, current research shows that the largest and most complex cranial nerve, the trigeminal nerve, is heavily involved in the sensation of migraine headache pain.
14. Glossary 14.1. 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. Such experiences are called aura.
Glossary Warning - Alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the device. Standard warnings relate to significant harm to the 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.
Glossary 14.2. Symbols Symbols Title of the Symbol Description of the Symbol Consult instructions for use. This symbol indicates that the user should refer to the User Manual/Instructions for Use before using the device. Consult instructions for use. This symbol indicates that the user should refer to the User Manual/Instructions for Use before using the device. Temperature Limit Indicates the temperature limit to which the device can be safely exposed.
Glossary Symbols 118 Title of the Symbol Description of the Symbol Use-By Date Indicates the date after which the electrodes are 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. Manufactured By Indicates the medical device manufacturer. Date of Manufacture Indicates the date when the medical device was manufactured.
Glossary Symbols IP22 Title of the Symbol Description of the Symbol Do not use if the package is damaged Indicates a medical device that should not be used if the package has been damaged or opened. Ingress Protection Indicates the degree of protection against harmful ingress of particulate matter and water.
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. Warning Alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the device. Standard warnings relate to significant harm to the 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.
15. Compliance Statement Connection of the CEFALY Connected device to any other devices through apps that are not authorized by CEFALY Technology could result in previously unidentified risks to the user or third parties. CEFALY Connected should only be connected to a mobile device through the CeCe Migraine Management App.
Compliance Statement Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
Compliance Statement CAUTION Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 15.2. ISED Canada - Regulatory Compliance Statement This device contains license-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s license-exempt RSS(s). Operation is subject to the following two conditions: (1) This device may not cause interference.
Compliance Statement 15.3. FCC & IC Radiation Exposure Statement This equipment complies with FCC and Canada radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
The CEFALY Connected device Is A Patented Model And Is Protected By An International Patent. CEFALY® Is A Trademark That Has Been Registered Internationally. The CEFALY Connected Is Manufactured In Conformity With ISO 13485 And GMP. The Manufacturer Is ISO 13485 (Medical) Certified. CEFALY Connected Is A Class II Medical Device. Copyright © 2022 CEFALY Technology, 4102 Seraing Belgium All Rights Reserved.
