Monarch NeuroSigma User manual

Caution: Federal law restricts this device to sale by or on the order of a physician
User Manual
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Monarch®eTNS® System
CONTENTS
I. Labeling Definitions and Symbol Descriptions 3
II. Contraindications, Warnings and Precautions 5
III. Indications For Use 8
IV. Trigeminal Nerve Stimulation Therapy 8
V. General Description 9
VI. Monarch®Key Functions 11
VII. Operating Procedures 13
Before Treatment 13
Treatment 17
Course of Treatment 18
After Treatment 20

Please read this manual carefully before beginning treatment. It is an essential part
of the Monarch®eTNS®System. This manual should be saved for future reference.
VIII. Maintenance and Cleaning 21
IX. Environmental Specifications 23
Manufacturer’s Declaration – Electromagnetic Emissions 23
Manufacturer’s Declaration – Electromagnetic Immunity 24
Recommended Separation Distance 26
X. Electrical Specifications 27
XI. Electrical Stimulation 28
XII. Environmental Conditions 28
XIII. Clinical Data 29
XIV. Warranty 33

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Caution: Federal law restricts this device to sale by or on the order of a physician.
I. Labeling Definitions and Symbol Descriptions
Caution: Pay special attention to the following details or consult
accompanying documents
Type BF Applied Part
By order of a physician (not applicable in the EU)
Manufacturer
Conformité Européenne (European Conformity). This symbol means
this device fully complies with MDD Directive 93/42/EEC
Temperature limitations
Use by date

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I. Labeling Definitions and Symbol Descriptions (continued)
Authorized representative in the European community
Serial number
Do not reuse
Refer to instruction manual
Operating instructions
Product number
Lot number
Unsafe within the magnetic resonance environment
Recycle product separate from other disposables

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II. Contraindications, Warnings and Precautions
READ ALL INSTRUCTIONS BEFORE USING
Contraindications
The device is contraindicated for use by patients with:
- implanted cardiac and/or neurostimulation systems
- implanted metallic or electronic device in their head
Do not use the Monarch eTNS System:
- in children under the age of 7 years
- in patients with body worn devices (e.g. insulin pumps and t-VNS)
- within 100cm of RFID readers or emitters that operate below 150kHz
- in the presence of the following sources of radio frequency (RF) energy:
• MRI
• Diathermy
• Cell phones
• CT
• Microwave or shortwave
• Metal detectors
• RFID tags
• Electronic article surveillance systems
• TV transmission lines
• High frequency (HF) equipment (e.g. surgical cauterizing tools and welding equipment)
Do not attach the electric patches:
- anywhere on the body other than the forehead
- on the neck
- on the chest
- over a defect in the skull (i.e. post brain surgery or head trauma) or over an open fontanel

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II. Contraindications, Warnings and Precautions (continued)
Adverse Events
eTNS is generally well-tolerated. However, during the eTNS pivotal study, the following events
occurred at a higher rate in the group treated with the eTNS system compared to subjects
treated with the sham (placebo) device. Patients should consult their physician if any of the
following events are observed:
- Bronchitis
- Headache
- Itching
- Lightheadedness
- Nausea
- Poor appetite
- Skin rash
- Stomach ache
- Tooth pain
- Vomiting
- Trouble sleeping
- Nightmares
- Drowsiness
- Fatigue
- Tingling
- Rapid heartbeat
- Constipation
- Frequent urination
- Increased appetite
- Clenching teeth

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II. Contraindications, Warnings and Precautions (continued)
Warnings
Children 7 to 12 years receiving eTNS treatment should be closely supervised by an adult who
has read the user manual and is familiar with the Monarch eTNS System.
The Monarch eTNS System should:
- only be used by the individual for whom it is intended.
- be used with the guidance of a licensed physician.
- be used with caution in patients with heart disease or serious medical disorders.
- be kept out of the reach of infants and children under the age of 7 years.
- be used only as directed and be applied to healthy, clean, intact skin.
- not be used with other electronic therapeutic devices.
- not be applied on the neck or chest.
- not be used in the presence of electric monitoring equipment (e.g. cardiac monitors).
- not be used in the bath or shower.
- not be used while operating machinery.
The Monarch electric patches should not:
- be used in patients with dermatitis or sensitive skin, as they are at higher risk of developing
irritation.
- be used over broken, infected, or inflamed skin.
- be removed carelessly as this may damage the skin.
The Monarch lead wires should not be allowed to wrap around the neck.
The safety of the Monarch is unknown in the following conditions:
- trigeminal neuralgia or injury to the trigeminal nerve
- pregnancy
- concurrent use of hearing aids
The long-term effects of using the Monarch eTNS System are unknown. The effectiveness of
the Monarch for long-term use in the indicated population (i.e. for more than 4 weeks) has not
been systematically evaluated in controlled trials. Therefore, the physician who elects to use
the Monarch for extended periods in patients with ADHD should periodically re-evaluate the
long-term usefulness of the device for the individual patient.

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III. Indications For Use
The Monarch external Trigeminal Nerve Stimulation (eTNS) System is indicated for treatment of
pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7
through 12 years old who are not currently taking prescription ADHD medications.
The device is to be used for patient treatment by prescription only and is intended to be used in
the home under the supervision of a caregiver during periods of sleep.
IV. Trigeminal Nerve Stimulation Therapy
The main role of the trigeminal nerve is to convey sensation information from the face into the
brain. External trigeminal nerve stimulation (eTNS) uses this natural pathway to send therapeutic
signals into the brain. The trigeminal nerve connects directly from the face to the brainstem, and
from there information is sent to other key brain regions thought to be involved in medical
conditions such as ADHD (alternatively called hyperkinetic disorder or HKD). While the exact
mechanism of action of eTNS is not yet known, neuroimaging studies have shown that eTNS
increases activity in brain regions that are known to be important in regulating attention,
emotion, and behavior. These findings are supplemented by basic science studies in animals,
as well as clinical studies in humans. For more information on eTNS, please visit
www.monarch-etns.com.

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V. General Description
The Monarch eTNS System is designed to deliver electrical stimulation to branches of the
trigeminal nerve, located just below the skin above the eyebrows, via a cutaneous electric patch.
Main component
Monarch (external pulse generator)
1. LCD Screen
2. Output Ports (CH1, CH2)
3. Up Key
4. Down Key
5. Lock Key
6. SELECT Key
7 ON/OFF Key
8. SET Key
9. Battery Cover
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