CEFALY Dual User manual

USER MANUAL

CEFALY® DUAL is the rst FDA-cleared medical device of its kind for the treatment of migraine.
CEFALY DUAL is indicated to be used for:
• The acute treatment of migraine with or without aura in paents 18 years of age or older.
• The preventave treatment of episodic migraine in paents 18 years of age or older.

Migraine may indicate that you have a serious medical condion and you should have them evaluated
by a physician. The safety and eecveness of the CEFALY DUAL has not been demonstrated for
paents with medicaon overuse headache or chronic tension-type headaches.
NON-INVASIVE
COMFORTABLE
DRUG-FREE
PORTABLE
WEARABLE

Copyright © 2020 CEFALY Technology, 4102 Seraing - Belgium
ref. 34103 - Version 03 - EN 03 - 2020.03.11
For assistance, please contact us as follows:
Website: www.cefaly.com
Email: [e-mail]
Phone: [phone]
To view this user manual in Español, please visit
cefaly.com/start
Rue Louis Plescia, 34
4102 SERAING
BELGIUM

0459

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1. Safety Informaon 11
1.1. Purpose ................................................................................................................................ 11
1.2. Indicaons for Use............................................................................................................ 11
1.3. Contraindicaons..............................................................................................................12
1.4. Convenons Used in this Manual .................................................................................13
1.5. General Warnings and Cauons.................................................................................... 15
1.6. Side Eects .........................................................................................................................21
2. About CEFALY DUAL 25
2.1. What’s Included in the CEFALY DUAL Package.......................................................25
2.2. Physical Descripon of CEFALY DUAL and Electrode ............................................28
2.3. Understanding CEFALY DUAL Status .......................................................................... 32
2.4. Best Pracces and Recommendaons ........................................................................36

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3. Seng Up CEFALY DUAL 38
3.1. Open the CEFALY DUAL Package ................................................................................38
3.2. Charge the Baery............................................................................................................ 39
4. Preparing for Migraine Treatment 41
4.1. Clean Your Skin .................................................................................................................. 41
4.2. Open the Electrode .......................................................................................................... 42
4.3. Posion the Electrode on Your Skin.............................................................................43
4.4. Aach CEFALY DUAL to the Electrode .......................................................................44
5. Delivering Acute Migraine Treatment (Program 1 - ACUTE) 45
5.1. Choose the ACUTE Treatment Program...................................................................... 45
5.2. Monitoring Your ACUTE Treatment ............................................................................. 49
5.3. What to Expect During Your ACUTE Treatment......................................................... 49
5.4. Ending Your ACUTE Treatment ..................................................................................... 51

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6. Delivering Preventave Migraine Treatment (Program 2 - PREVENT) 52
6.1. Choose the PREVENT Treatment Program ................................................................ 52
6.2. Monitoring Your PREVENT Treatment........................................................................54
6.3. What to Expect During Your PREVENT Treatment....................................................54
6.4. Ending Your PREVENT Treatment ................................................................................56
7. Controlling Your Treatment (ACUTE or PREVENT) 57
8. Care Informaon 63
8.1. Cleaning and Maintenance..............................................................................................63
8.2. Operang and Storage Condions...............................................................................64
8.3. Disposal ...............................................................................................................................64
9. Troubleshoong 65
Problem #01 - The CEFALY DUAL emits one long beep when the device buon is
pressed.............................................................................................................................................65

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Problem #02 - The CEFALY DUAL turned o during my session.....................................66
Problem #03 - I cannot feel any smulaon.......................................................................... 67
Problem #04 - The intensity feels too high............................................................................ 70
Problem #05 - The intensity feels too low. ............................................................................ 71
Problem #06 - My skin is reddened when I remove the electrode.................................. 72
Problem #07 - I experience painful headaches, nausea, tooth pain, nnitus (noise or
ringing in the ears), or hyperlacrimaon (overproducon of tears) that persist aer a
session is over................................................................................................................................. 73
Problem #08 - The CEFALY DUAL does not power on....................................................... 74
10. Self-Care for Migraines 76
10.1. How Do I Dierenate Headache from Migraine?.............................................. 76
10.2. What Should I Do to Avoid Migraine Aacks?........................................................ 79
11. Technical Informaon 82

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11.1. About the CEFALY DUAL Device................................................................................82
12.2. About the Baery...........................................................................................................86
11.3. Electromagnec Compability....................................................................................86
11.4. Guidance and Manufacturer's Declaraon- Electromagnec Emission........... 87
11.5. Warranty ...........................................................................................................................88
12. About CEFALY Technology 91
13. Glossary 92
13.1. Terms & Denions........................................................................................................ 92
13.2. Symbols .............................................................................................................................94

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Uses
• Helps relieve migraine pain.
• Helps in reducing the number of monthly migraine days.

• The acute treatment of migraine with or without aura in paents 18 years of age or
older.
• The preventave treatment of episodic migraine in paents 18 years of age or older.
See page 68 of this manual on how to dierenate migraine from other types of headaches.

Read this user manual thoroughly before using CEFALY DUAL.

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Use CEFALY DUAL
At room temperature between 50°F and
95°F (10°C and 35°C) in a dry environment
(relave humidity between 30% to 75%)
and at normal atmospheric pressures (700
hPa to 1060 hPa).
Store CEFALY DUAL
At temperatures between 23°F and 95°F
(-5°C to 35°C) in a dry environment
(relave humidity 45% to 75%) and at
normal atmospheric pressure (500hPa to
1060hPa).
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