CEFALY DUAL ENHANCED User manual

USER MANUAL
CEFALY®
DUAL ENHANCED
A medical device for the treatment
of migraines.

CEFALY®DUAL Enhanced is a FDA-cleared medical device for the treatment of migraine.
CEFALY DUAL Enhanced 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.

for use.
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 Enhanced has not been
demonstrated for paents with medicaon overuse headache or chronic tension-type headaches.
NON-INVASIVE
COMFORTABLE
DRUG-FREE
PORTABLE
WEARABLE
CEFALY ®
DUAL ENHANCED

Copyright © 2021 CEFALY Technology, 4102 Seraing -
Belgium ref. 34201 - Version 01 - EN 03 - 2021.03.11
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


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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 Enhanced 25
2.1. What’s Included in the CEFALY DUAL Enhanced Package ....................................25
2.2. Physical Descripon of CEFALY DUAL Enhanced and Electrode ........................28
2.3. Understanding CEFALY DUAL Enhanced Status ......................................................32
2.4. Best Pracces and Recommendaons ........................................................................36

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3. Seng Up CEFALY DUAL Enhanced 38
3.1. Open the CEFALY DUAL Enhanced Package ............................................................38
3.2. Charge the Baery............................................................................................................ 39
4. Preparing for Migraine Treatment 41
4.1. Clean Your Skin ..................................................................................................................42
4.2. Open the Electrode ..........................................................................................................43
4.3. Posion the Electrode on Your Skin.............................................................................44
4.4. Aach CEFALY DUAL Enhanced to the Electrode ...................................................45
5. Delivering Acute Migraine Treatment (Program 1 - ACUTE) 46
5.1. Choose the ACUTE Treatment Program......................................................................46
5.2. Monitoring Your ACUTE Treatment.............................................................................50
5.3. What to Expect During Your ACUTE Treatment.........................................................50
5.4. Ending Your ACUTE Treatment ..................................................................................... 52

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6. Delivering Preventave Migraine Treatment (Program 2 - PREVENT) 53
6.1. Choose the PREVENT Treatment Program ................................................................53
6.2. Monitoring Your PREVENT Treatment........................................................................ 55
6.3. What to Expect During Your PREVENT Treatment.................................................... 55
6.4. Ending Your PREVENT Treatment ................................................................................57
7. Controlling Your Treatment (ACUTE or PREVENT) 58
8. Care Informaon 64
8.1. Cleaning and Maintenance..............................................................................................64
8.2. Operang and Storage Condions ...............................................................................65
8.3. Disposal ............................................................................................................................... 65
9. Troubleshoong 66
Problem #01 - The CEFALY DUAL Enhanced emits one long beep when the device
buon is pressed. ..........................................................................................................................66

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Problem #02 - The CEFALY DUAL Enhanced turned o during my session................. 67
Problem #03 - I cannot feel any smulaon..........................................................................68
Problem #04 - The intensity feels too high............................................................................ 71
Problem #05 - The intensity feels too low. ............................................................................ 72
Problem #06 - My skin is reddened when I remove the electrode.................................. 73
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................................................................................................................................. 74
Problem #08 - The CEFALY DUAL Enhanced does not power on. .................................. 75
10. Self-Care for Migraines 77
10.1. How Do I Dierenate Headache from Migraine?..............................................77
10.2. What Should I Do to Avoid Migraine Aacks?........................................................80
11. Technical Informaon 83

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11.1. About the CEFALY DUAL Enhanced Device ............................................................83
11.2. About the Baery ........................................................................................................... 87
11.3. USB Power Adaptor .......................................................................................................87
11.4. Electromagnec Compability....................................................................................88
11.5. Guidance and Manufacturer's Declaraon- Electromagnec Emission...........88
11.6. Warranty ........................................................................................................................... 95
12. About CEFALY Technology 98
13. Glossary 99
13.1. Terms & Denions........................................................................................................99
13.2. Symbols ...........................................................................................................................101

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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 77 of this manual on how to dierenate migraine from other types of headaches.

Read this user manual thoroughly before using CEFALY DUAL Enhanced.

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Use CEFALY DUAL Enhanced
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 Enhanced
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).

1-844-475-7100.