CEFALY Connected C1 User manual

USER MANUAL
CEFALY®
CONNECTED
A medical device for the
treatment of migraine.

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. The
device operation, uses, storage, precautions and warnings are intended to keep you safe, prevent
injury and avoid device malfunction or damage.
NON-INVASIVE
COMFORTABLE
DRUG-FREE
PORTABLE
WEARABLE
CEFALY ®
CONNECTED

Rue Louis Plescia, 34
4102 SER AING
BELGIUM
www.cefaly.com
Copyright © 2022
CEFALY Technology, 4102 Seraing Belgium
For assistance, please contact us as follows:
To view this user manual in Español, please visit
cefaly.com/start
In the United States
Email:[e-mail]
Phone:1.844.475.7100
Outside North America
Email:[e-mail]
Phone: [phone]
In Canada
Email:[email protected]
Phone:1.844.475.7100

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1. Safety Information 12
1.1. Purpose ..............................................................................................................................................12
1.2. Indications for Use .........................................................................................................................12
1.3. Contraindications ...........................................................................................................................13
1.4. Conventions Used 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 Description of CEFALY Connected and Electrode...........................................29
2.3. Understanding CEFALY Connected Status ..........................................................................33
Table Of Contents

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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.........................................................................................................................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 the CeCe App with the CEFALY Connected ............................................................52
4.5. Logging Your CEFALY Treatments with CeCe.....................................................................54
5. Preparing for Migraine Treatment 55
5.1. Clean Your Skin................................................................................................................................55

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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...............................................................................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 (Program 2 – PREVENT) 67
7.1. Choose the PREVENT Treatment Program .........................................................................67
7.2. Monitoring Your PREVENT Treatment..................................................................................69
7.3. What to Expect During Your PREVENT Treatment..........................................................70
7.4. Ending Your PREVENT Treatment...........................................................................................72

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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..............................................................................................................78
9. Care Information 79
9.1. Cleaning and Maintenance .........................................................................................................79
9.2. Operating and Storage Conditions ..........................................................................................80
9.3. Disposal ..............................................................................................................................................80
10. Troubleshooting 81
Problem #01 - The CEFALY Connected emits one long beep when the device button is
pressed. .......................................................................................................................................................81

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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......................................88
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. .........................................................................................................................................89
Problem #08 - The CEFALY Connected does not power on...................................................91
11. Self-Care for Migraines 93
11.1. How Do I Differentiate Headache from Migraine? ........................................................93
11.2. What Should I Do to Avoid Migraine Attacks? ................................................................96
12. Technical Information 99

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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 114
14. Glossary 115
14.1. Terms & Denitions.....................................................................................................................115
14.2. Symbols............................................................................................................................................117
15. Compliance Statement 121
15.1. FCC - Regulatory Compliance Statement..........................................................................121
15.2. ISED Canada - Regulatory Compliance Statement ........................................................123
15.3. FCC & IC Radiation Exposure Statement...........................................................................124

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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.
Critical CEFALY Connected Facts
Read this user manual thoroughly before using CEFALY Connected.

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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).
Store CEFALY Connected
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).

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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.

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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.

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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 debrillator.
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.
• Cautions are placed in a box with a light yellow color in the background.
• Notes have been added to provide supplemental information to certain instructional text.
Safety Information

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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 signicant 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. Such problems include CEFALY
Connected malfunction, failure, damage to CEFALY Connected or damage to
other property.
Safety Information

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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).
• The CEFALY Connected and electrodes are designed for and should be used only in the
forehead region.
• Do not use CEFALY Connected in the neck region.
1.5. General Warnings and Cautions

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• Do not use CEFALY Connected close to the thorax (chest region) to avoid the risk of
cardiac brillation.
• 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 inamed areas.
• 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.
• Use CEFALY Connected only with the electrodes and accessories recommended by
CEFALY Technology.
Safety Information

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• 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 efcacy and safety of the CEFALY Connected have been
performed on adults (ages 18-65 years old). There are currently no trial results or data
specic to use in individuals under the age of 18 or over the age of 65.
Ask a doctor before use if you:
• You are under 18 years of age.
• You are over 65 years of age.
• You are pregnant or may become pregnant.
Safety Information

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• 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 rst headache after the age of 50 years.
• You have a migraine so severe as to require bed rest.
Safety Information

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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.
Migraines may indicate that you have a serious medical condition. You should have them
checked by a doctor.
You should check with your doctor if you do not understand or if you are not sure whether
any of the above “Contraindications” or “Warnings” apply to you or your condition.
Safety Information