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


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 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

5
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

6
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

7
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

8
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

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 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.

10

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.

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

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

15
WARNINGS
• Do not use CEFALY DUAL Enhanced while sleeping.
• Do not use CEFALY DUAL Enhanced in a wet environment, such as in the bath or
shower.
• Do not use CEFALY DUAL Enhanced 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 Enhanced and electrodes are designed for and should be used only
in the forehead region.
• Do not use CEFALY DUAL Enhanced in the neck region.

Safety Information

16
• While CEFALY DUAL Enhanced’s design prevents this, do not use CEFALY DUAL
Enhanced close to the thorax (chest region).
• Use CEFALY DUAL Enhanced 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 Enhanced 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 Enhanced only with the electrodes and accessories recommended
by CEFALY Technology.
Safety Information

17
• Keep the CEFALY DUAL Enhanced 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 Enhanced 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 Enhanced 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 Enhanced 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 Enhanced device if you
have ever had a seizure. You should ask your doctor before using the CEFALY DUAL
Enhanced device if you have been diagnosed with epilepsy.
• The CEFALY DUAL Enhanced 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 Enhanced in close proximity (less than 3.5 feet) to shortwave
or microwave therapy equipment, as it may produce instability in the CEFALY DUAL
Enhanced output.
• Use is incompable with the simultaneous use of high-frequency surgical equipment.
• It may be dangerous to connect the CEFALY DUAL Enhanced with devices not
idened in this user manual.
Safety Information