CEFALY Enhanced Migraine Relief Device

Indications, Contraindications, Precautions & Warnings

CEFALY® Enhanced is the first FDA / TGA cleared medical device of its kind for treatment of migraine.

CEFALY Enhanced 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 episodic migraine in patients 18 years of age or older.

CEFALY Enhanced is for patients diagnosed by a physician with migraine per the indications for use.

Do not use if you:

• Have implanted metallic or electronic devices in the head.
• Are suffering from pain of unknown origin.
• Have a cardiac pacemaker or an implanted or wearable defibrillator.

Consult a doctor before use if:

• You are under 18 years of age.
• You are over 65 years of age.
• You are pregnant or may become pregnant.
• You suspect or know that you have heart problems.
• You had a recent head injury.
• You have ever suffered a seizure.
• You have never been diagnosed with a migraine by a health professional.
• You have a headache that is different from your usual migraines.
• You have the worst headache of your life.
• You have fever or a stiff neck.
• You have a headache that began after a head injury, exertion, coughing, or bending.
• You experienced your first headache after the age of 50 years.
• You have a migraine so severe as to require bed rest.

Warnings

• Do not use CEFALY Enhanced while sleeping.
• Do not use CEFALY Enhanced in a wet environment, such as in the bath or shower.
• Do not use CEFALY Enhanced while driving, operating machinery, or during any activity that requires you to be alert and focused. Wait for 1 hour after each treatment session before resuming any such activity.
• Do not use in the presence of electronic monitoring equipment (e.g., cardiac monitors, electrocardiogram (ECG) alarms).
• The CEFALY Enhanced and electrodes are designed for and should be used only in the forehead region.
  • Do not use CEFALY Enhanced in the neck region.
  • While CEFALY Enhanced’s design prevents this, do not use CEFALY Enhanced close to the thorax (chest region).
• Use CEFALY Enhanced only on normal, intact and clean skin.
  • Do not use over open wounds.
  • Do not use over skin eruptions.
  • Do not use over swollen, infected or inflamed areas.
  • Do not use over, or close to, cancerous lesions or skin abnormalities that could be cancerous.
• Use caution or avoid using CEFALY Enhanced if there has been any loss of feeling in the skin of your forehead or scalp until the normal feeling is resumed.
• Use CEFALY Enhanced only with the electrodes and accessories recommended by CEFALY Technology.
• Keep the CEFALY Enhanced out of the reach of children.
• Strangulation risk due to the length of the charging system cable.
• Suffocation risk in case of swallowing the electrode.
• If you have known allergies to acrylates, contact CEFALY TEchnology for hypoallergenic electrode alternatives.

Consult your healthcare provider before using the CEFALY Enhanced if you have Medication Overuse Headache, Chronic Tension-Type Headache, or Refractory Migraine, as the safety and effectiveness of the device have not been demonstrated for subjects with such conditions.

If the frequency of your headache is not reduced after 2 or 3 months of daily use of Program 2 (prevention), ask your doctor.

The long-term effects of chronic use of CEFALY Enhanced are unknown.

Migraines may indicate that you have a serious medical condition. 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 Contraindications or Warnings apply to you or your condition.