The Nexalin Adi Device; Intended Use; Contraindications; Warnings And Limitations - NEXALIN ADI Operating Instructions Manual

The Nexalin® ADI Device is a FDA-cleared transcranial electrical stimulation (TES) or cranial electrotherapy
stimulation (CES) device manufactured by Nexalin Technology, Inc. It delivers a safe and effective electrical
stimulation to the patient that provides relief from the symptoms associated with anxiety, depression, and
insomnia.
The proper use of the Nexalin ADI Device includes the application of three external electrodes. One electrode
is placed on the patient's forehead and one is placed behind each ear over the mastoid area. These three
electrodes are specifically placed to enhance the performance of the Nexalin ADI Device. When the device is
activated, a mild current travels between the forehead electrode and each mastoid electrode. The level of
current and the duration of the Nexalin ADI Therapy session are preset to default parameters and cannot be
changed.
The Nexalin ADI Device includes several features that are designed to protect the patient during a Nexalin ADI
Therapy session. When followed properly, these operating Instructions will help to ensure that a safe and
effective treatment is administered.

Intended Use

The Nexalin ADI Device is classified as cranial electrotherapy stimulation (CES) device. Its intended use is for
relief from the symptoms associated with anxiety, depression, and insomnia.
The Nexalin ADI Device is intended for use by or on the order of a licensed healthcare practitioner. Only a
Nexalin Certified Technician (NCT) is qualified to operate and administer a Nexalin ADI Therapy Treatment
session.

Contraindications

Use of the Nexalin ADI Device is strictly prohibited if the patient has any of the following conditions:
History of seizures, epilepsy, hydrocephalus, or tumors of the central nervous system.
Acute brain injuries and infections.
Break in skin integrity at the areas of electrode placement.
Skin sensitivity to electrode gels or adhesives.
Presence of implanted electronic stimulators.
Pregnant or may be pregnant.
Children, ages 12 and under.

Warnings and Limitations

Use of the Nexalin ADI Device may have an increased or decreased effectiveness if the patient has any of the
following conditions:
Acute psychiatric disorders (not depression).
Presence of the pronounced habituation of morphine-like substances. Use of psychoactive drugs.
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The Nexalin® ADI Device
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