SAVI Dual™ Migraine Therapy Instructions for Use 5
WARNING: The SAVI Dual should be used under the continued supervision of a
physician. The System has been prescribed by your physician only for you.
Inspect the System for any signs of damage before use. Do not use it if it is cracked
or wet. If you suspect damage to the device, call eNeura at: +1 833.499.9300 option
1 for assistance.
Do not operate the System in or near an area where explosive gases are being used
or have been used. Do not operate near gasoline or natural gas.
Do not operate the System in or near the presence of a FLAMMABLE ANESTHETIC
MIXTURE WITH AIR or WITH OXYGEN or NITROUS OXIDE.
Risk of electrical shock. Do not open the System. There are no parts that can be
serviced or replaced by the user. High voltage may be present.
Risk of electrical shock. Do not allow the System or power cords to get wet. Quickly
wipe up spills on or near the SAVI Dual. Do not use the System in or near water. For
example, do not use while in the bathtub or shower, in the rain, or while standing in
water or on a wet surface.
Do not use the System if the cause of your headache is illness, underlying pathology,
trauma or overuse of medication. See your physician if you are uncertain.
Do not use the System if you have suspected or diagnosed epilepsy or a personal or
family history of seizures. Consult your physician before using the System if a family
member has epilepsy or seizures or if you have had seizures, a head trauma or head
injury or take any medication such as tricyclic antidepressants, neuroleptic agents, or
other drugs that lower the seizure threshold.
Do not use the System if you have a history of stroke.
The System has not been demonstrated as safe or effective when treating cluster
headache.
Do not use the System if you use a wearable cardioverter defibrillator (WCD).
The long-term effects of chronic magnetic stimulation are unknown.
Transcranial magnetic stimulation should only be applied to the back of the head as
described in the “Using Your Device” section of this manual.
Do not stimulate over the front of the neck or mouth. Severe spasm of the laryngeal
and pharyngeal muscles may occur, and the contractions may be strong enough to
close the airway or cause difficulty in breathing.
Do not stimulate over the upper side of the neck. Stimulation of the carotid sinus
nerves, particularly in patients with a known sensitivity to the carotid sinus reflex,
could result in a sudden drop in blood pressure, slowing of the heart or loss of
consciousness.
Do not stimulate the chest or back. The induction of electrical current into the heart
may cause cardiac arrhythmias.
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