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USER MANUAL

 CEFALY

®

CONNECTED

A medical device for the 

treatment of migraine.

Summary of Contents for Connected C1

Page 1: ...USER MANUAL CEFALY CONNECTED A medical device for the treatment of migraine...

Page 2: ...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 The devi...

Page 3: ...ng Belgium For assistance please contact us as follows To view this user manual in Espa ol please visit cefaly com start In the United States Email info cefaly us Phone 1 844 475 7100 Outside North Am...

Page 4: ...d in this Manual 14 1 5 General Warnings and Cautions 16 1 6 Side Effects 22 1 7 A Note for New Users 25 2 About CEFALY Connected 26 2 1 What s Included in the CEFALY Connected Package 26 2 2 Physical...

Page 5: ...the Battery 44 4 Using CeCe with the CEFALY Connected 47 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...

Page 6: ...ACUTE Treatment Program 59 6 2 Monitoring Your ACUTE Treatment 63 6 3 What to Expect During Your ACUTE Treatment 63 6 4 Ending Your ACUTE Treatment 66 7 Delivering Preventative Migraine Treatment Prog...

Page 7: ...the Intensity During First 14 Minutes 75 8 3 Stopping Your Session Early 77 8 4 Accidental Interruptions 78 9 Care Information 79 9 1 Cleaning and Maintenance 79 9 2 Operating and Storage Conditions 8...

Page 8: ...s reddened when I remove the electrode 88 Problem 07 I experience painful headaches nausea tooth pain tinnitus noise or ringing in the ears or hyperlacrimation overproduction of tears that persist aft...

Page 9: ...dance and Manufacturer s Declaration Electromagnetic Emission 104 12 6 Warranty 111 13 About CEFALY Technology 114 14 Glossary 115 14 1 Terms Definitions 115 14 2 Symbols 117 15 Compliance Statement 1...

Page 10: ...reatment 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 differen...

Page 11: ...elative humidity between 30 to 75 and at normal atmospheric pressures 700 hPa to 1060 hPa Store CEFALY Connected At temperatures between 23 F and 95 F 5 C to 35 C in a dry environment relative humidit...

Page 12: ...onnected 1 2 Indications for Use CEFALY Connected is for patients diagnosed by a physician with migraine CEFALY Connected is indicated for Theacutetreatmentofmigrainewithorwithoutaurainpatients18years...

Page 13: ...ffectiveness 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...

Page 14: ...s 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...

Page 15: ...he 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 Conne...

Page 16: ...ty 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 mo...

Page 17: ...r 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 Use caution...

Page 18: ...gy 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 tri...

Page 19: ...alth 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 in...

Page 20: ...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 Migraines may in...

Page 21: ...graine headaches 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...

Page 22: ...cal attention 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...

Page 23: ...ou 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...

Page 24: ...Treatment has been reported in the clinical trials Rare Forehead Skin Allergy In rare cases an allergy to the electrode gel can arise A temporary rash develops on the forehead If this should occur st...

Page 25: ...at the highest intensity levels Individual tolerance for CEFALY stimulation intensity may vary and CEFALY treatments should never be permitted to become painful New users are encouraged to stabilize t...

Page 26: ...26 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: ...27 Fig 1 Contents of the Package About CEFALY Connected...

Page 28: ...ctrodeadherestotheskinontheforeheadandallowsthetreatment signal from the CEFALY Connected to pass through the trigeminal nerve 3 Resealable Electrode Storage Bag Use for storage of electrodes between...

Page 29: ...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 d...

Page 30: ...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 transmit...

Page 31: ...4cm longand0 78in 2cm high andcomes 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 Conn...

Page 32: ...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...

Page 33: ...to Charging Dock for recharge or an electrode for treatment Press CEFALY Connected device button once to see feedback If low battery connect to the Charging Dock for recharge Series of beeps Solid yel...

Page 34: ...dicator 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 Connec...

Page 35: ...device button once Single beep indicates activation of the program Single turquoise flash throughout the treatment ACUTE Program low battery charge Program has been activated and battery charge is too...

Page 36: ...nt PREVENT Program low battery charge Program has been activated and battery charge is too low to complete one treatment Chime that repeats four times Stabilize Intensity During the first 14 minutes o...

Page 37: ...eased Series of beeps will be heard when button is pressed Intensity is 10 mA When the treatment intensity reaches a 10 mA output current Series of three successive beeps Increase to Maximum Intensity...

Page 38: ...as been stopped interrupted Accidental Interruption If the electrode doesn t fully grip your skin is worn out and or is nudged by movement your session may be interrupted Series of successive beeps th...

Page 39: ...eatment and Care Information Refer to page 10 for the Critical CEFALY Connected Facts Cleanseanddryyourskinbeforeeverytreatmentsession Thiswillensuretheelectrode attaches securely to the skin CEFALY C...

Page 40: ...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 Electrod...

Page 41: ...he two pads of the electrode are not fully covered with gel Afterwashingyourforeheadwithsoapandwater anddryingitthoroughly theelectrode does not stick uniformly to your forehead and peels at the ends...

Page 42: ...42 Dried Out Electrode Electrode with Gel Missing Good Electrode About CEFALY Connected...

Page 43: ...ected 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 Doc...

Page 44: ...de 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 6 and plug the adapter into a...

Page 45: ...45 Fig 5 Fig 6 Fig 7 See table for feedback from CEFALY Connected during charging and completion of charging Setting Up CEFALY Connected...

Page 46: ...yellow glow in the LED indicator Charging USB Cable is connected to the Charging Dock and CEFALY Connected is placed on the Charging Dock Low battery charging Slow intermittent green flashes on the L...

Page 47: ...r s mobile device The mobile app displays the device status provides indications such astheselectedtreatmentprogram batterylevel treatmentduration andintensitylevel andallows users to download a PDF r...

Page 48: ...ith the CeCe Migraine Management app iOS 12 and above or Android 8 1 and above Download the free CeCe Migraine Management app to your mobile device from the App Store or Google Play depending on your...

Page 49: ...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: ...ange of 12 meters 40 feet between the mobile device and the CEFALY Connected Click the button on your CEFALY Connected A dark blue flashing LED will appear On the app tap Scan to search for your CEFAL...

Page 51: ...d 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 Fig 10 CAUTION Do not sha...

Page 52: ...p as described in section 4 3 Once connected prepare for treatment as described in section 5 Preparing for Migraine Treatment Begin an ACUTE or PREVENT session as described in sections 6 and 7 respect...

Page 53: ...53 Using CeCe with the CEFALY Connected Fig 11 Fig 12...

Page 54: ...d 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 Upon completion of a PREVENT session follow the on screen i...

Page 55: ...electrode attaches securely to your forehead Use soap and water to wash between and above your eyebrows Fig 13 Afterward be sure to dry your skin thoroughly The use of makeup removing products moistu...

Page 56: ...he clear plastic backing Fig 14 Save the plastic backing for later use to store your electrode in the Resealable Electrode Storage Bag Fig 14 Preparing for Migraine Treatment WARNING Do not use CEFALY...

Page 57: ...ust 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 Preparing for Migraine Treatment WARNING In...

Page 58: ...the electrode 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 dev...

Page 59: ...orehead 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 Fig 17 Selecting the ACUTE Treatment Program...

Page 60: ...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...

Page 61: ...s the device button once Single beep indicates activation of the program Single turquoise flash throughout the treatment See table for feedback from the CEFALY Connected when the ACUTE treatment progr...

Page 62: ...E 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...

Page 63: ...flashing to begin 6 3 What to Expect During Your ACUTE Treatment For the first few minutes of your ACUTE treatment session the sensation is light and it s possible you may not feel anything The stimu...

Page 64: ...60 minute treatment During the first 14 minutes the stimulation intensity may become slightly uncomfortable however it should not be painful You may stabilize the device intensity within the first 14...

Page 65: ...ntensity 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 Av...

Page 66: ...omplete 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 To ensure optimal use of your electrode for future s...

Page 67: ...graines When using the PREVENT migraine treatment program you will observe the following You will hear two beeps to indicate your PREVENT program selection 7 Delivering Preventative Migraine Treatment...

Page 68: ...m Two intermittent purple flashes throughout the treatment Delivering Preventative Migraine Treatment See table for feedback from the CEFALY Connected when the PREVENT treatment program is selected Th...

Page 69: ...conds for flashing to begin for the remainder of the session Delivering Preventative Migraine Treatment Notes For new CEFALY users please review section 8 1 Stabilizing Intensity During First 14 Minut...

Page 70: ...ensity will gradually increase to the maximum intensity As the intensity increases to maximum intensity you may hear 3 successive beeps during your session This indicates the treatment intensity has r...

Page 71: ...bilize the treatment intensity at any point during the first 14 minutes if they experience painful sensations The electrode gel is the conductive material that transmits the stimulation impulses Avoid...

Page 72: ...ected and it will automatically shut off 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 inform...

Page 73: ...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...

Page 74: ...ing the first 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...

Page 75: ...remainder of the session You can repeat this if you would like to increase the intensity again Maximum intensity is reached after long pressing the device button for about 30 seconds You will hear a s...

Page 76: ...ntensity Long press device button for 30 seconds anytime during the first 14 minutes of the treatment Series of rapid beeps to indicate that the device has reached maximum intensity Controlling Your T...

Page 77: ...stopped interrupted 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 s...

Page 78: ...t the treatment has been stopped interrupted Controlling Your Treatment 8 4 Accidental Interruptions The electronics involved in CEFALY Connected constantly check that your device is in contact with t...

Page 79: ...des 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 Electrodes that have been overus...

Page 80: ...elative 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 Store the CEFALY Connected at tempera...

Page 81: ...eshooting table for a solution if a problem should arise with your CEFALY Connected If further assistance is required contact Customer Service see page 3 Problem 01 The CEFALY Connected emits one long...

Page 82: ...CEFALY Connected and try powering it on again 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...

Page 83: ...along the entire surface of the electrode You want the electrode to be flat and firm against your forehead skin Recharge the battery fully for about 4 hours so you may complete a full treatment sessi...

Page 84: ...ing 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 proper...

Page 85: ...stabilize at the new level 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 devic...

Page 86: ...e the stabilization feature of the device when first starting treatments Refer to section 8 1 Stabilizing Intensity During the First 14 Minutes Each user will have a different pain threshold to stimul...

Page 87: ...surface without cracks or dry areas Reapply the electrode ensuring full adhesion to the skin by running your fingers along the entire length of the electrode Ensure there are no air bubbles under the...

Page 88: ...intensity will increase again The maximum intensity is reached after pressing and holding the device button for 30 consecutive seconds You should increase the intensity to a tolerable level but you sh...

Page 89: ...pen stop using the CEFALY Connected 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 cre...

Page 90: ...inful headaches nausea tooth pain tinnitus or hyperlacrimation during and after CEFALY Connected sessions If you continuetoexperienceanyoneormoreoftheseconditionsdespiteattemptstostabilize treatmentin...

Page 91: ...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 CEF...

Page 92: ...d must be properly securedbythecorrespondingmagneticcontactzoneontheelectrodefortheCEFALY Connected to work properly If the electrode is not positioned correctly and is not flat against your forehead...

Page 93: ...ally 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 Associatedwiththepain youmayalsoexperiencenausea vomiting i...

Page 94: ...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...

Page 95: ...l tenderness MIGRAINE HEADACHE Headache pain with associated symptoms GENERAL CHARACTERISTICS Duration of 4 72 hours Pain located on one side of the head unilateral Pulsating or throbbing pain Physica...

Page 96: ...and it gets even more challenging Find some practices and habits that help you cope with stress and better treat your migraines Another commonly reported trigger for migraines is food As to which food...

Page 97: ...ation Changes in sleep routine Artificial sweeteners Medication overuse Hormonal changes menses hormone replacement therapy etc Alcohol Over exertion excessive exercise etc Strong noxious odors Altitu...

Page 98: ...migraine Daily Helpful Habits Meditation and mindfulness practices Keeping a migraine diary using tools such as the CeCe Migraine Management App Daily personal journaling Cognitive behavioral therapy...

Page 99: ...of an impulse 5 microseconds at 50 of the maximum Number of programs 2 Device service life 4 years Device Casing PC plastic painted Dimensions 2 6 inch x 1 86 inch x 0 68 inch 66 mm x 47 mm x 17 mm W...

Page 100: ...uency 100 Hz 60 Hz Pulse Width 250 s 250 s Pulse Duration 500 s 500 s 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 sec...

Page 101: ...s 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 Device Temperature Sp...

Page 102: ...nst 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 t...

Page 103: ...m 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 in...

Page 104: ...dance and Manufacturer s Declaration Electromagnetic Emission The CEFALY Connected is intended for use in the electromagnetic environment specified in the table The customer or the user of the CEFALY...

Page 105: ...Use of accessories transducers and cables other than provided by the manufacturer could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result...

Page 106: ...plicable Radiated RF emissions CISPR 11 Group 1 Class B The CEFALY Connected is suitable for use in all establishments including domestic Harmonic current emissions IEC 61000 3 2 Not Applicable Voltag...

Page 107: ...ast 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 7 GHz 80 AM at 1 kHz Portable and mobile RF communications equipment should be used no...

Page 108: ...ectrostatic fast transient burst IEC 61000 4 4 Not Applicable Not Applicable Surge IEC 61000 4 5 Not Applicable Not Applicable Power frequency magnetic field IEC 61000 4 8 30 A m 50 60 Hz 30 A m 50 60...

Page 109: ...istance to 16 cm instead of 30 cm 385 380 390 Pulse modulation 18 Hz 27 54 450 430 470 FM 5 kHz deviation 1 kHz sine 28 54 710 704 787 Pulse modulation 217 Hz 9 18 745 18 780 18 810 800 960 Pulse modu...

Page 110: ...el V m Applied test level CEFALY levels allowing to reduce the minimum separation distance to 16 cm instead of 30 cm 1720 1700 1990 Pulse modulation 217 Hz 28 54 1845 54 1970 54 2450 2400 2570 Pulse m...

Page 111: ...ected kit postmarked within 90 days from your delivery date and you will be refunded the purchase price of the CEFALY Connected To be eligible for a refund the CEFALY Connected and accessories must be...

Page 112: ...ranty does not cover damage caused by misuse or abuse accident the attachment of any unauthorized accessory alteration to the product improper installation unauthorized repairs or modifications improp...

Page 113: ...such product s Customer s sole remedy for any defective product or any other breach of performance shall be the repair or replacement of any defective product furnished by CEFALY Technology IT IS EXP...

Page 114: ...of these nerves has three distinct branches CEFALY Connected has been specifically engineered to modify pain sensation in the trigeminal nerve through its ophthalmic branch which runs under the skin...

Page 115: ...es of light or stars Such experiences are called aura Headache A general term for pain in any region of the head not originating from the skin Indications for use Indications for use for a device incl...

Page 116: ...alfunction 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 PREVENT Program A 20 m...

Page 117: ...al Instructions for Use before using the device Temperature Limit Indicates the temperature limit to which the device can be safely exposed Type BF Applied Parts This symbol on the electrode package m...

Page 118: ...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...

Page 119: ...ection against harmful ingress of particulate matter and water In this case Solid Particle Protection level is 2 fingers or similar objects Liquid Ingress Protection level is 2 dripping water when the...

Page 120: ...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 dev...

Page 121: ...ps 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...

Page 122: ...ful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or telev...

Page 123: ...t Canada s license exempt RSS s Operation is subject to the following two conditions 1 This device may not cause interference 2 This device must accept any interference including interference that may...

Page 124: ...nt 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 an...

Page 125: ...ternationally 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 CEF...

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