Indication for Use and Important Safety Information

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.

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 that operate below 150kHz
• in the presence of the following sources of radio frequency (RF) energy:
  • Magnetic Resonance Imaging (MRI)
  • Diathermy
  • Cell phones
  • Computed Tomography (CT)
  • Microwave or shortwave
  • Metal detectors
  • Radiofrequency Identification (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)

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:

• Headache
• Lightheadedness
• Trouble sleeping
• Nightmares
• Drowsiness
• Fatigue
• Clenching teeth
• Tooth pain
• Bronchitis
• Rapid heartbeat
• Increased appetite
• Poor appetite
• Stomach ache
• Nausea
• Vomiting
• Frequent urination
• Constipation
• Itching
• Skin rash
• Tingling

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
• not be cleaned while the device is in use
• not be altered or repaired, nor should  any of its components in the eTNS System be altered or repaired, as this may result in personal injury, damage to equipment and voiding the manufacturer’s warranty
• not be dropped, shaken or handled roughly as the Monarch may be damaged , which may result in device malfunction, loss of treatment effect and/or personal injury.
• be stored in a dry environment avoiding excess humidity, temperature, sunlight and dust.
• not be stored near chemicals or gases.

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 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

Long-Term Use: 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 reevaluate the long-term usefulness of the device for the individual patient.

Environmental Specifications

The Monarch eTNS System is only intended to be used in the electromagnetic environment specified in the Instructions for Use. Please refer to the instruction for use for additional information.

A full description of the safety information for the Monarch eTNS System is provided in the device’s Instructions for Use for use manual. Users should review the device’s Instructions for Use manual prior to using the device.