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

4

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

5
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

6
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

7
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

8
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

9
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.

10

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).



11


This user manual describes the proper use of CEFALY DUAL.

CEFALY DUAL is for paents diagnosed by a physician with migraines per the FDA cleared
indicaons for use.
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.

12
Safety Information
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.


The following are the condions under which CEFALY DUAL should not be used. Usage
under such condions may create unfavorable results and or lead to adverse events.
Notes:
• Episodic migraine is dened as 1-14 headache days per month with associated
migraine symptoms (nausea, photophobia, phonophobia, etc).

13
Do not use CEFALY DUAL if you:
• Have implanted metallic or electronic devices in the head.
• Are suering from pain of unknown origin.
• Have a cardiac pacemaker or implanted or wearable debrillator.

Special convenons have been used throughout this User Manual to highlight important
informaon. Here is a list of the special convenons used.
• Warnings are placed in a box with a light red color in the background.
• Cauons are placed in a box with a light yellow color in the background.
• Notes have been added to provide supplemental informaon to certain instruconal text.
• Some important informaon has been provided as footnotes. The respecve text for
which the footnote has been added contains superscript reference numbers.
Safety Information

14



WARNING:



          

Safety Information

15
WARNINGS
• Do not use CEFALY DUAL while sleeping.
• Do not use CEFALY DUAL in a wet environment, such as in the bath or shower.
• Do not use CEFALY DUAL while driving, operang machinery, or during any acvity
that requires you to be alert and focused. Wait for 1 hour aer each treatment session
before resuming any such acvity.
• Do not use in the presence of electronic monitoring equipment (e.g., cardiac monitors,
electrocardiogram (ECG) alarms).
• The CEFALY DUAL and electrodes are designed for and should be used only in the
forehead region.
• Do not use CEFALY DUAL in the neck region.

Safety Information

16
• While CEFALY DUAL’s design prevents this, do not use CEFALY DUAL close to the
thorax (chest region).
• Use CEFALY DUAL only on normal, intact and clean skin.
• Do not use over open wounds.
• Do not use over skin erupons.
• Do not use over swollen, infected or inamed areas.
• Do not use over, or close to, cancerous lesions or skin abnormalies that could be
cancerous.
• Use cauon or avoid using CEFALY DUAL if there has been any loss of feeling in the
skin of your forehead or scalp unl the normal feeling is resumed.
• Use CEFALY DUAL only with the electrodes and accessories recommended by CEFALY
Technology.
Safety Information

17
• Keep the CEFALY DUAL out of the reach of children.
• Strangulaon risk due to the length of the charging system cable.
• Suocaon risk in case of swallowing the electrode.


All clinical trials regarding the ecacy and safety of the CEFALY DUAL 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.

• You are under 18 years of age.
• You are over 65 years of age.
• You are pregnant or may become pregnant.
Safety Information

18
• You suspect or know that you have heart problems.
• You had a recent head injury.
• You have ever suered a seizure.
• You have never been diagnosed with a migraine by a health professional.
• You have a headache that is dierent from your usual migraines
• You have the worst headache of your life.
• You have fever or a s neck.
• You have a headache that began aer a head injury, exeron, coughing, or bending.
• You experienced your rst headache aer the age of 50 years.
• You have a migraine so severe as to require bed rest.
Safety Information

19
Consult your healthcare provider before using the CEFALY DUAL if you have Medicaon
Overuse Headache, Chronic Tension-Type Headache, or Refractory Migraine, as the
safety and eecveness of the device have not been demonstrated for subjects with
such condions.
If the frequency of your headache is not reduced aer 2 or 3 months of daily use of
Program 2 (prevenon), ask your doctor.
The long-term eects of chronic use of CEFALY DUAL are unknown.
Migraines may indicate that you have a serious medical condion. 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 “Contraindicaons” or “Warnings” apply to you or your condion.
Safety Information

20

• You should ask your doctor before using the CEFALY DUAL device if you have ever
had a seizure. You should ask your doctor before using the CEFALY DUAL device if you
have been diagnosed with epilepsy.
• The CEFALY DUAL device will not cure your migraines.
• The long-term eects of chronic use of the unit are unknown.
• You should use this unit only with the electrodes and accessories recommended by
the manufacturer.
• Do not use CEFALY DUAL in close proximity (less than 3.5 feet) to shortwave or
microwave therapy equipment, as it may produce instability in the CEFALY DUAL
output.
• Use is incompable with the simultaneous use of high-frequency surgical equipment.
• It may be dangerous to connect the CEFALY DUAL with devices not idened in this
user manual.
Safety Information