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.

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DESCRIPTION OF THE CEFALY®DUAL AND ACCESSORIES
3. CEFALY®ELECTRODE
Cefaly®Dual works with a unique self-adhesive electrode
applied on the forehead.
Only the Cefaly®electrode is appropriate to work with
the Cefaly® Dual device because of a specic connection
between the device and the electrode.
Cefaly®electrode is 94 mm long and 30 mm high. It
makes the interface between the device and the skin.
It’s a reusable electrode designed to be used 20 times.
The electrode has two contact zones that connect with
the Cefaly®Dual device through magnets.

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1. Cleansing and degreasing the skin
It is essential to cleanse and degrease the skin thoroughly
before the session to ensure a good quality skin-
electrode interface. Use water and soap to cleanse and
degrease the forehead skin.Do not use make-up removal
products because they leave a greasy lm on the skin.
Cleanse the skin on the area between the eyebrows
and forehead (see Figure 1). Pay special attention
to the whole of the area where the electrode will be
placed: the main part of the forehead and between
the eyebrows. This step is essential to ensure that the
electrode grips and that the session is effective.
1. PRACTICAL USE
Preparing the session
Before rst use, please fully charge the device (see p. 22).
DIRECTIONS FOR USE
FIGURE 1

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DIRECTIONS FOR USE
2. Removing an electrode
Remove an electrode from its plastic support, holding
it by one of its two tips (see Figure 2). The quality of
the treatment depends on the quality of the electrodes.
They are designed to be used 20 times, providing that
the skin has been cleansed thoroughly and degreased
before the electrode is applied. Electrodes that have
been overused lose their capacity to transmit electrical
impulses and the treatment is consequently ineffective.
3. Positioning the electrode
Use a mirror to correctly position the electrode (see
Figure 3).
FIGURE 2
FIGURE 3

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The pointed part is placed downwards with the lower
edge placed exactly on the horizontal line that joins
both eyebrows (see Figure 4). Press your ngers
several times along the entire surface of the electrode
so that it grips your skin rmly. The effectiveness of
the treatment depends on the quality of the contact
between the electrode and the skin.
4. Positioning the Cefaly®Dual device
Two magnets allow to x the device on the electrode.
Hold the device and bring the rear side of the device
with the two magnets against the central part of the
electrode. The device is attracted by the two contact
zones of the electrode and gets automatically into po-
sition (see Figure 5).
FIGURE 4 FIGURE 5

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Selecting and starting the program
Press the button (see Figure 6) to select and start the
session. An indicator light above the button will begin to
ash signaling the device is working properly.
1. Program 1: Acute treatment
Press the button once to select and start Program 1. You
will hear a single beep. Program 1 is designed to treat
migraine attacks.
2. Program 2: Prevention
Press the button twice in succession to select and start
Program 2. You will hear two successive beeps. As
Program 2 is designed to prevent migraine it is used
during pain-free periods.
1
2
Press 1 x : Start prg.
Press 2 x : Start prg.
FIGURE 6

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During the session
1. Conducting the session
A session of Program 1 lasts sixty minutes and a session
of Program 2 lasts twenty minutes. It runs automatically
and step by step. During the rst few minutes, the
sensation is very weak, even imperceptible. Nothing or
almost nothing is felt as the impulses are very light.
A vibration or tingling sensation then appears which
increases. When this sensation becomes sufciently
intense, pressing the button once will stabilize it. The
intensity reduces at the end of the sixty (Program 1)
or twenty (Program 2) minutes and the session stops
automatically.
2. Controlling the intensity
The intensity will gradually increase during the rst
14 minutes. When the sensation becomes too intense,
press the button just once to stabilize the intensity. The
session always ends after sixty (Program 1) or twenty
(Program 2) minutes, but the intensity remains at the
same level until it stops. You can as well increase again
the intensity by pressing continuously on the button: as
long as you press on the button the intensity increases,
and it stabilizes as soon as you release the pressure
on the button.
The sensations will feel unusual at rst but you will
soon become accustomed to them after a few sessions,
and consequently be able to work with the maximum
intensity possible (i.e. without restricting the intensity).

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3. Interrupting the session
To stop the session before its end, just remove the
device by pulling it forwards (see Figure 7) and the
session automatically stops. Four series of 3 successive
beeps indicate the disconnection of the device and the
interruption of the session.
4. Accidental interruption: defective electrode
Cefaly®Dual could interrupt the session by itself.
This unintentional spontaneous interruption means
that either the skin has not been fully cleansed or
the electrode has not been placed correctly or is not
intact. It may also mean that the two magnets of the
device need to be cleaned. In this case, four series of
3 successive beeps indicate the disconnection of the
device and the interruption of the session.
FIGURE 7

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After the session
1. Removing the device
The session ends after sixty (Program 1) or twenty
(Program 2) minutes, and the device automatically
switches off. Remove the device by pulling it forwards
(see Figure 8).
2. Detaching and stowing the electrode
Detach the electrode from your skin by holding one
of its tips (see Figure 9). Replace the electrode on its
transparent plastic support sheet. Then store it in its
bag. Do not leave the electrode uncovered in a dry
place to prevent it from becoming dehydrated. Once
the gel loses its moisture, its properties deteriorate and
the electrode ceases to be effective.
FIGURE 9
FIGURE 8

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2. SENSATIONS
The sensations induced by the Cefaly®Dual are unusual
and unexpected.
Cefaly®Dual generates electrical impulses very
gradually. During the rst two minutes, either
nothing is felt or a slight tingling sensation under the
electrode. A lack of sensation for one or two minutes
does not mean that the device is not working; it
simply means that the impulses produced are below
the stimulation threshold of the nerve bers.
Tingling sensations are then felt in the skull, making
you feel as if your hair is standing on end.
The sensation of vibration or massage increases
and spreads very gradually to the whole of the
forehead and the front part of the skull. The Cefaly®
Dual increases the intensity very gradually. After
about fourteen minutes, the intensity stabilizes and
remains constant until the treatment session is over.
The sensation can last for several minutes to several
hours after the session.

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3. FREQUENCY AND TIMING OF SESSIONS
Treating attacks
Program 1 should be used for a 60-minute session
during a migraine attack. The session can be done
anytime during the day or evening. During the session,
simple tasks as reading or watching TV can be done.
Program 1 can be used the same day for a second
60-minute session if the migraine pain is not relieved
within two hours or if another migraine attack occurs;
however, the effectiveness of the second 60-minute
session has not been established.
Preventive treatment
Program 2 should be used daily for 20-minute sessions.
More than one 20-minute session per day is not
recommended because the safety and effectiveness of
Program 2 when used more than once per day has not
been studied. The session can be done anytime during
the day or evening. During the session, simple tasks as
reading or watching TV can be done.