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
2
5
1
3
7
4
8
6
9

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V. General Description (continued)
Standard accessories and spare parts
Monarch electric patches (Four 7-packs : 28-day supply)
Lead wires (2)
NeuroSigma rechargeable 9-volt batteries (2)
NeuroSigma battery recharging station (1)
NeuroSigma battery recharging station AC adapter (1)
Belt clip (1)
Monarch User Manual (1)
Monarch carrying case (1)
Use only NeuroSigma approved accessories and spare parts. Use of unapproved
accessories may cause personal injury, loss of therapeutic effect, equipment damage
and will void manufacturer’s warranty.

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VI. Monarch Key Functions
SELECT key
Pressing the SELECT key selects output channels in the following sequence:
CH-1 (Channel 1)
CH-2 (Channel 2)
CH-1 & CH-2 (both channels)
The selected channel blinks.
SET key
Pressing the SET key finalizes the selected item and stops the selected item from blinking.
Returns screen to selection mode if ERR is displayed.
Up and Down keys
These keys are for setting or changing the current amplitude (intensity) in 0.2 mA increments.
Keeping the key depressed will cause the current amplitude to increase or decrease with
the key is depressed.
The current amplitude cannot be increased while the Monarch is not providing stimulation (Off Cycle).
will be displayed at the top of the LCD screen during the Off Cycle.

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VI. Monarch Key Functions (continued)
Lock key
Pressing the Lock key locks all the keys except the Lock key itself. will be displayed
at the top of the LCD screen.
To unlock, press the Lock key for two seconds or longer.
ON/OFF key
This key turns the power on and off.

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VII. Operating Procedures
Before Treatment
Set switch on side of battery charging station
to “Li” (lithium).
Plug charging station into an electrical outlet
(AC mains).
Insert battery into charging station.
The LED light will glow red when the battery
is charging.
Charging a battery can take up to one hour.
If the LED light flashes (red or green),
then this battery cannot be charged and
must be disposed according to local law.
The LED light on the charging station,
above the battery will glow green
when fully charged.
Remove battery from the charging station.

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1
2
2
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VII. Operating Procedures (continued)
Insert a fully-charged battery as follows:
Slide the battery cover retainer upwards.
Pull the battery cover open.
Place the battery into the battery case.
Be sure to align the positive and negative terminals
on the battery with the markings inside the case.
The case will not close if the terminals do not match.
Close the battery cover and return the retainer
to its original closed position.
If the low battery symbol appears, replace
with a fully-charged battery.
Use of a partially-charged battery may cause the Monarch to turn off before the treatment
has completed.
If the Monarch will not be used for more than two days, remove the battery.
Use only NeuroSigma approved rechargeable batteries. Using unapproved batteries
(rechargeable or non-rechargeable) may cause loss of therapeutic effect, fire or explosion.
Disposal of batteries should be done according to local law.

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VII. Operating Procedures (continued)
Clean the skin of the forehead
with soap and water
or an alcohol-based cleaning pad.
Completely dry the skin.
Remove electric patch
from the release liner backing.
Using a mirror, center the patch
on the forehead and apply
just above the eyebrows.
Be sure the patch is securely
and completely attached to the skin.

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VII. Operating Procedures (continued)
Connect electric patch wires to the lead wires.
Place wires above and over the ears.
Insert lead wire plug into one of the two
output ports (CH-1 or CH-2) of the Monarch.
Be sure the lead wire is securely
connected in one of the output ports.

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VII. Operating Procedures (continued)
Treatment
Press the ON/OFF key
LCD screen will turn on. will flash three times, followed by .
Press any of the four blue keys: Up, Down, SELECT or SET.
The screen will display .
Enter the password by pressing these keys in the following order: ---.
CH-1, CH-2 and the Timer setting will appear on the screen.
CH-1 will be automatically selected (blinking). Current amplitude will be set at 0.0mA.
You may choose CH-2 by pressing the SELECT key. Be sure the lead wire is connected
to the selected output port.
Press the UP key to increase current amplitude to maximum tolerable level.
Stimulation should not be painful or uncomfortable.
Once the desired current amplitude is set, press the SET key then press the Lock key. The screen
will display at the top and the symbol will be displayed at the bottom left. All the
controls other than the Lock key will be disabled. To unlock, press the Lock key for two seconds
or longer.
You may attach the Monarch to your clothing using the belt clip provided.
When using the Monarch during sleep, the device can be worn, placed under a pillow or on a
bedside table.

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VII. Operating Procedures (continued)
Course of Treatment
At least eight hours of continued use is recommended. Consult your physician for
recommended duration of treatment.
Caregivers should look for skin irritation at the site where the electric patch is placed prior to
and following the use of the device.
Clinical trials suggest that a clinical response to eTNS should be seen within 4 weeks.
Limited long-term data is available. Once a clinical response is achieved, continued therapy
may be necessary. Consult your physician.
In case of skin irritation, stop use and consult your physician.
Do not apply electric patches to broken, inflamed or infected skin.
Do not attempt to clean or reuse electric patches. Dispose after a single use.

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VII. Operating Procedures (continued)
A sudden, electric stimulus, bothersome to some users, may be experienced
under the following conditions:
- When a lead wire is broken.
- When the contact at the following locations is poor:
Between the patch and the skin.
At the connection between the patch wire and the lead wire.
At the connection between the lead wire and the Monarch.
In the instance of a sudden electric stimulus, replace the lead wire and electric patch and
restart treatment at a low current amplitude. If the sudden stimulus continues, stop using the
Monarch and contact your physician immediately.
The message ERR will appear at the top of the LCD screen when the Monarch detects
an interruption in any of the connections within the Monarch eTNS System. This message
will also appear if the user adjusts the current amplitude either without connecting the lead
wires or adjusts the current amplitude on the incorrect output channel.
To clear the ERR message, make sure all the connections between the Monarch unit, the lead
wires, and the patch are secure.
If the ERR message does not clear, try another lead wire and/or output channel until the
message clears.