Page 1 CEFALY ® CONNECTED A medical device for the treatment of migraine. USER MANUAL...
Page 2 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. The device operation, uses, storage, precautions and warnings are intended to keep you safe, prevent...
Page 3 Email: cs@cefaly.com Email: info@cefaly.us Phone: 1.844.475.7100 Phone: 1.844.475.7100 Rue Louis Plescia, 34 4102 SERAING BELGIUM Outside North America Email: info@cefaly.com www.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...
Page 4: Table Of Contents
1.5. General Warnings and Cautions ....................16 1.6. Side Effects ............................22 1.7. A Note for New Users ........................25 2. About CEFALY Connected 2.1. What’s Included in the CEFALY Connected Package ............26 2.2. Physical Description of CEFALY Connected and Electrode ...........29 2.3. Understanding CEFALY Connected Status ................33...
Page 5 4.1. What is the CeCe Migraine Management App? ..............47 4.2. Downloading CeCe ........................48 4.3. Pairing CeCe and CEFALY Connected for the First Time ..........50 4.4. Using the CeCe App with the CEFALY Connected ............52 4.5. Logging Your CEFALY Treatments with CeCe ..............54 5.
Page 6 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) 6.1. Choose the ACUTE Treatment Program ................59 6.2. Monitoring Your ACUTE Treatment ..................63 6.3.
Page 7 8.4. Accidental Interruptions ......................78 9. Care Information 9.1. Cleaning and Maintenance ......................79 9.2. Operating and Storage Conditions ..................80 9.3. Disposal ..............................80 10. Troubleshooting Problem #01 - The CEFALY Connected emits one long beep when the device button is pressed................................81...
Page 8 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..................87 Problem #06 - My skin is reddened when I remove the electrode.
Page 9 12.1. About the CEFALY Connected Device .................99 12.2. About the Battery ........................103 12.3. USB Power Adaptor ........................103 12.4. Electromagnetic Compatibility ....................104 12.5. Guidance and Manufacturer’s Declaration - Electromagnetic Emission ....104 12.6. Warranty ............................111 13. About CEFALY Technology 14. Glossary 14.1. Terms & Definitions ........................115 14.2.
Page 10 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.
Page 11 Operating and Storage Conditions Use CEFALY Connected Store CEFALY Connected 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 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.
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 Connected has not been demonstrated for patients with medication overuse headache or chronic tension-type headaches.
Page 14: Conventions Used In This Manual
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.
Page 15 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. CAUTION: Alerts the user to the possibility of a problem with CEFALY Connected associated with its use or misuse.
Page 16: 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.
Page 17 • Do not use over, or close to, cancerous lesions or skin abnormalities that could be cancerous. • Use caution or avoid using CEFALY Connected if there has been any loss of feeling in the skin of your forehead or scalp until the normal feeling is resumed.
Page 18 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). 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 19 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 20 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.
Page 21 • This unit will only work with CEFALY approved electrodes and accessories. • Do not use CEFALY Connected in close proximity (less than 3.5 feet) to shortwave or microwave therapy equipment, as it may produce instability in the CEFALY Connected output.
Page 22: Side Effects
• 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 •...
Page 23 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.
Page 24 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 Connected and contact your doctor or the manufacturer CEFALY Technology. The skin rash will gradually disappear within a few days.
Page 25: A Note For New Users
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.
Page 26: About Cefaly Connected
2. About CEFALY Connected 2.1. What’s Included in the CEFALY Connected Package When you receive and open your CEFALY Connected migraine treatment kit, you should find the following items numbered 1-7:...
Page 27 About CEFALY Connected Fig. 1 Contents of the Package...
Page 28 CEFALY Connected to pass through the trigeminal nerve. 3. Resealable Electrode Storage Bag: Use for storage of electrodes between treatments. 4. Quick Start Guide: Learn the features and functions of your CEFALY Connected in an easy-to-digest format to get you started quickly.
Page 29: Physical Description Of Cefaly Connected And Electrode
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.
Page 30 Table 1 - Parts of the CEFALY Connected 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.
Page 31 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.
Page 32 Conductive gel Front Used for effective contact between the electrode and the user. Magnetic contact Rear Used for contact between CEFALY Connected and the zone 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- •...
Page 33: Understanding Cefaly Connected Status
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...
Page 34 Device Operation Action Feedback USB Cable is connected to the Charging Dock and CEFALY Fully Charged Connected is placed on the Solid green glow on the LED indicator. Charging Dock. Connection Waiting for Two chime notes Push Button (without Solid blue glow on the...
Page 35 Device Operation Action Feedback ACUTE Program Press the device button once. Single turquoise Single beep indicates flash throughout the activation of the program. treatment. ACUTE Program Program has been activated and battery charge is too low to (low battery charge) Chime that repeats four times.
Page 36 Device Operation Action Feedback PREVENT Press the device button twice, Program with a slight pause in between Two beeps indicate Two intermittent each press. activation of the purple flashes program. throughout the treatment. PREVENT Program Program has been activated and battery charge is too low to (low battery charge) Chime that repeats four times.
Page 37 Long press device button Intensity of the treatment gradually (for experienced anytime during the first 14 increases until the device button is CEFALY users) minutes of the treatment. 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.
Page 38 Device Operation Action Feedback End Treatment Remove the device from the electrode. Series of successive beeps indicate that the treatment has been stopped/ interrupted. Accidental If the electrode doesn’t fully grip Interruption your skin, is worn out, and/ or Series of successive beeps that repeat is nudged by movement, your four times indicate that the treatment session may be interrupted.
Page 39: 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.
Page 40 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.
Page 41: 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.
Page 42 About CEFALY Connected Good Electrode Electrode with Gel Missing Dried Out Electrode...
Page 43: Setting Up Cefaly Connected
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 4. Quick Start Guide 5. Instruction Manual 6. Charging Dock & USB Cable 7.
Page 44: Charge The Battery
• 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. Then, connect the USB plug to the power adapter (Fig.
Page 45 Setting Up CEFALY Connected Fig. 5 Fig. 6 Fig. 7 See table for feedback from CEFALY Connected during charging and completion of charging.
Page 46 Setting Up CEFALY Connected Action Feedback from the CEFALY Connected Status Press CEFALY Connected Low Battery device button once to see (Device is not connected feedback. If low battery, to Charging Dock for Solid yellow glow in the Series of beeps.
Page 47: Using Cece With The Cefaly Connected
PDF report of such data. Connection to the CeCe Migraine Management mobile app is not required for operation of or treatment with the CEFALY Connected device. CAUTION When the treatment is completed using the CEFALY Connected device, please kill/close the app or turn off the Bluetooth from mobile.
Page 48: Downloading Cece
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 –...
Page 49 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. 9...
Page 50: Pairing Cece And Cefaly Connected For The First Time
• 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).
Page 51 CAUTION Do not share the pairing PIN. This may result in unintended access to your device or the information you share with CEFALY. Fig. 10...
Page 52: Using The Cece App With The Cefaly Connected
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.
Page 53 Using CeCe with the CEFALY Connected Fig. 11 Fig. 12...
Page 54: Logging Your Cefaly Treatments With Cece
See section 7.4 Ending Your PREVENT Treatment for guidance on how to handle the device and electrode at the end of your treatment. • Review sections 6 and 7 for directions on ending your CEFALY treatment.
Page 55: Preparing For Migraine 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.
Page 56: Open The Electrode
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.
Page 57: 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. 15...
Page 58: Attach Cefaly Connected To The Electrode
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. • Hold your CEFALY Connected on the edge, so these magnets are exposed, and bring the device toward your forehead.
Page 59: Delivering Acute Migraine Treatment (Program 1 - Acute)
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.
Page 60 • You will hear a single beep to indicate your ACUTE program selection. • The CEFALY Connected 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 61 Delivering Acute Migraine Treatment See table for feedback from the CEFALY Connected when the ACUTE treatment program is selected. Status Action Feedback from CEFALY Connected ACUTE Press the device button once. Program Single beep indicates activation of the program. Single turquoise flash throughout the treatment.
Page 62 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...
Page 63: Monitoring Your Acute Treatment
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.
Page 64 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.
Page 65 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 •...
Page 66: Ending Your Acute Treatment
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).
Page 67: Delivering Preventative Migraine Treatment (Program 2 - Prevent)
7. Delivering Preventative Migraine Treatment (Program 2 – PREVENT) 7.1. Choose the PREVENT 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 preventative treatment of migraine, select Program 2 the PREVENT Fig.
Page 68 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.
Page 69: Monitoring Your Prevent Treatment
7.2. Monitoring Your PREVENT Treatment • Throughout this 20-minute program, the CEFALY Connected 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...
Page 70: What To Expect During Your Prevent Treatment
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.
Page 71 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.
Page 72: Ending Your Prevent Treatment
Fig. 21 For more information, review section 8.3 Stopping Your Session Early. • You can now remove the CEFALY Connected by pulling it away from the electrode (Fig. 21). Then gently detach the electrode from your skin (Fig. 22). Fig. 22...
Page 73 • 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.
Page 74: 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 Connected. Status...
Page 75: Manually Increasing The Intensity During 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 Connected.
Page 76 • 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 Action...
Page 77: Stopping Your Session Early
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.
Page 78: Accidental Interruptions
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.
Page 79: Care Information
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.
Page 80: Operating And Storage Conditions
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).
Page 81: 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).
Page 82: Problem #02 - The Cefaly Connected 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 Connected is properly positioned on the electrode. The magnetic contacts on the CEFALY Connected must be properly...
Page 83: Problem #03 - I Cannot Feel Any Stimulation
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.
Page 84 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.
Page 85 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.
Page 86: Problem #04 - The Treatment Intensity Feels Too High And Is Painful
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: •...
Page 87: 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 Connected you may feel desensitized to its lower-strength pulses at the beginning of a session.
Page 88: 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 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 89: 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 Connected and speak with your healthcare provider. Before using your CEFALY Connected after such an event, contact CEFALY Technology to ask about the alternate hypoallergenic electrodes.
Page 90 Solution: • Some users have reported experiencing painful headaches, nausea, tooth pain, tinnitus or hyperlacrimation during and after CEFALY Connected sessions. If you continue to experience any one or more of these conditions despite attempts to stabilize treatment intensity or if the symptoms persist for more than a few days after treatment, stop use and consult your healthcare provider.
Page 91: Problem #08 - The Cefaly Connected Does Not Power On
• 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. If this is your first time using the CEFALY Connected it must be fully charged.
Page 92 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.
Page 93: Self-Care For Migraines
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.
Page 94 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 95 HOW DO I KNOW I HAVE MIGRAINES? 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 96: What Should I Do To Avoid Migraine Attacks
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.
Page 97 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 98 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 using tools such as the CeCe Migraine Management App •...
Page 99: Technical Information
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 : 0.15 dBm Maximum phase charge: 5 μC (microcoulombs) Frequency of Bluetooth: 2402-2480 MHz...
Page 100 Technical Information Table 5 - 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 101 Any electrode for which the current density is above 2 mA/ cm requires special attention from the operator. Device Temperature Specifications When the CEFALY Connected is operated at an ambient temperature of 95° F the electrode’s maximum temperature measured in testing is 109.4° F.
Page 102 Technical Information Table 6 - 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 103: About The Battery
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.
Page 104: 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.
Page 105 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 106 Electromagnetic environment - guidance Conducted RF emissions - Not Applicable CISPR 11 Radiated RF emissions - CISPR Group 1 The CEFALY Connected is suitable for use in all Class B establishments including domestic. Harmonic current emissions - Not Applicable IEC 61000-3-2...
Page 107 16 cm (5 inches) to any IMMUNITY to proximity Levels of table below Levels of table below part of CEFALY Connected fields from RF wireless product. Professional communications equipment, and home healthcare IEC 61000-4-3...
Page 108 Technical Information Conducted RF, Professional and home IEC 61000-4-6 0.15 — 80 MHz 0.15 — 80 MHz healthcare Environment. 80% AM at 1kHz 80% AM at 1kHz 6V in ISM and 6V in ISM and amateur amateur radio bands radio bands between between [0.15MHz - 80MHz] [0.15MHz - 80MHz]...
Page 109 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Frequency Band (MHz) Modulation Immunity Applied test level (CEFALY levels allowing to reduce (MHz) test level the minimum separation distance to (V/m) 16 cm instead of 30 cm) 380 - 390...
Page 110 Technical Information Test Frequency Band (MHz) Modulation Immunity Applied test level (CEFALY levels allowing to reduce (MHz) test level the minimum separation distance to (V/m) 16 cm instead of 30 cm) 1720 1700 - 1990 Pulse modulation 217 Hz 1845...
Page 111: Warranty
CEFALY Connected. To be eligible for a refund, the CEFALY Connected 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 112 CEFALY Technology. 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.
Page 113 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 114: About Cefaly Technology
CEFALY Connected 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 Connected 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 115: Glossary
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.
Page 116 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.
Page 117: Symbols
Glossary 14.2. 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 118 Glossary Symbols 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.
Page 119 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 120 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 121: Compliance Statement
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.
Page 122 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.
Page 123: Ised Canada - Regulatory Compliance Statement
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).
Page 124: Fcc & Ic Radiation Exposure Statement
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.
Page 125 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 C1 User Manual

Quick Links

Related Manuals for CEFALY Connected C1

Summary of Contents for CEFALY Connected C1

Table of Contents