CEFALY Technology Dual User manual

DUAL

Copyright © 2019 CEFALY Technology, 4102 Seraing - Belgium
Texte original français :
Département Médical CEFALY Technology
(Seraing, Belgique)
Revue et validation :
Département R&D CEFALY Technology
(Seraing, Belgique)
ref. 34074 - Version 03 - EN/US 03 - 16.07.2019

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TABLE OF CONTENTS
INDICATIONS FOR USE 6
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND ADVERSE REACTIONS 7
1. Contraindications 7
2. Warnings 7
3. Precautions 8
4. Adverse reactions 9
DESCRIPTION OF THE CEFALY®DUAL AND ACCESSORIES 10
1. Set Cefaly®Dual 10
2. Cefaly®Dual device 10
3. Cefaly®electrode 11
DIRECTIONS FOR USE 12
1. Practical use 12
Preparing the session 12
1. Cleansing and degreasing the skin 12
2. Removing an electrode 13
3. Positioning the electrode 13
4. Positioning the Cefaly®Dual device 14
Selecting and starting the program 15
1. Program 1: Acute treatment 15
2. Program 2: Prevention 15

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During the session 16
1. Conducting the session 16
2. Controlling the intensity 16
3. Interrupting the session 17
4. Accidental interruption: defective electrode 17
After the session 18
1. Removing the device 18
2. Detaching and stowing the electrode 18
2. Sensations 19
3. Frequency and timing of sessions 20
Treating attacks 20
Preventive treatment 20
PRACTICAL INFORMATION 21
1. Electrodes 21
2. Operating conditions 21
3. Storage conditions 21
4. Charging the battery 22
5. Cleaning your unit and device maintenance 23
6. Guarantee 23
TROUBLESHOOTING 24
TECHNICAL INFORMATION 25

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INDICATIONS FOR USE
The Cefaly®Dual device is indicated for:
The acute treatment of migraine with or without
aura in patients 18 years of age or older.
The prophylactic treatment of episodic migraine in
patients 18 years of age or older.
Caution: Federal law restricts this device to sale by
or on the order of a physician.

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INDICATIONS FOR USE
CONTRAINDICATIONS, WARNINGS,
PRECAUTIONS AND ADVERSE REACTIONS
1. CONTRAINDICATIONS
1. Subjects with implanted metallic or electronic
device in the head.
2. Subjects suffering from pain of unknown origin.
3. Subjects who have a cardiac pacemaker or
implanted or wearable debrillator. This may cause
interference with pacing, electric shock, or death.
2. WARNINGS
1. Use the Cefaly®Dual device and Cefaly®electrode
only on the forehead.
2. Do not apply on the neck.
3. Do not apply on the chest.
4. Do not apply over open wounds. Do not apply over
swollen, infected or inamed areas. Do not apply
over skin eruptions.
5. Do not apply over, or close to, cancerous lesions
(skin abnormalities that could be cancer).
6. Do not use in the presence of electronic monitoring
equipment (e.g., cardiac monitors, electrocardio-
gram (ECG) alarms).
7. Do not use in the bath or shower.
8. Do not use while sleeping.
9. Do not use while driving. Do not use while operating
machinery. Do not use during any activity that can
put you at risk of injury.
10. Apply stimulation only to normal, intact, clean skin.
11. The long-term effects of using the Cefaly®Dual are
unknown.
12. Migraines may indicate that you have a serious
medical condition. You should have them checked
by a doctor.
13. If the frequency of your headache is not reduced
after 2 or 3 months of daily use of Program 2 (pre-
vention), ask your doctor.

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14. 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.
3. PRECAUTIONS
1. You should ask a doctor before using the Cefaly®
Dual device if you are, could be or could become
pregnant.
2. You should ask your doctor before using the Cefaly®
Dual device if you suspect or know that you have
problems with your heart.
3. 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.
4. If you have had a recent head injury, you should
not use the Cefaly®Dual device until you have fully
recovered.
5. You should use caution if there has been any loss of
feeling in the skin of your forehead or scalp.
6. The safety and effectiveness of the Cefaly®Dual
device has not been demonstrated for subjects with
medication overuse headache, chronic tension-type
headache, and refractory migraine.
7. The Cefaly®Dual device will not cure your migraines.
8. The long-term effects of chronic use of the unit are
unknown.
9. You should use this unit only with the electrodes and
accessories recommended by the manufacturer.

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4. ADVERSE REACTIONS
Sleepiness
The main side effect is a tendency towards sleepiness.
This means that Cefaly®Dual cannot be used when
driving, or when operating machinery, or during any
activity that can put you at risk of injury. Approximately
0.5% of subjects reported sleepiness during the Cefaly®
Dual session.
Forehead skin redness
At the end of the session, the skin on the forehead
under the electrode may occasionally appear blotchy.
This effect is caused by activation of the skin blood
circulation. This redness may persist for several
minutes. Usually it disappears within 15 minutes.
Approximately 0.2% of subjects reported reversible
forehead skin redness.
Forehead skin allergy
In rare cases an allergy to the electrode gel can arise.
A temporary rash develops on the forehead. If this
should occur, stop using Cefaly®Dual and contact your
doctor or the manufacturer CEFALY Technology. The
skin rash will gradually disappear within a few days.
The use of an anti-inammatory cream can accelerate
the disappearance of the rash. Less than 1 out of 1000
subjects reported a skin allergic reaction.
Nausea
Rare occurrence of nausea during a session of acute
treatment (Program 1) has been reported in the clinical
trials.
Headache after a session
Approximately 0.5% of subjects reported a headache
after a session of preventive treatment (Program 2).
Tooth pain
In very rare cases, some patients have reported transi-
tory tooth pain during a session.

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DESCRIPTION OF THE CEFALY®DUAL AND ACCESSORIES
1. SET CEFALY® DUAL
The set Cefaly®Dual has the following elements:
1 Storage case
1 Instruction manual
1 Cefaly®electrode
1 Cefaly®Dual device
1 Power adapter
1 Cable
2. CEFALY®DUAL DEVICE
Cefaly®Dual device is in PC plastic having the following
characteristics:
Silver color painted
Dimensions: 55 mm x 40 mm x 15 mm
Weight: 12 g
Front side: The front side has a single button to switch
on the device, select the stimulation program and ad-
just the intensity.
Rear side: The backside has two magnets for the
connection with the electrode and a connector for char-
ging the battery.