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.