Summary of Contents for Monarch NeuroSigma
- Page 1 ® ® User Manual Caution: Federal law restricts this device to sale by or on the order of a physician...
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Page 2: Table Of Contents
Monarch eTNS System ® ® CONTENTS Labeling Definitions and Symbol Descriptions Contraindications, Warnings and Precautions III. Indications For Use Trigeminal Nerve Stimulation Therapy General Description Monarch Key Functions ® VII. Operating Procedures Before Treatment Treatment Course of Treatment After Treatment... - Page 3 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 Environmental Specifications Manufacturer’s Declaration – Electromagnetic Emissions Manufacturer’s Declaration – Electromagnetic Immunity...
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Page 4: Labeling Definitions And Symbol Descriptions
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... - Page 5 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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Page 6: Contraindications, Warnings And Precautions
- 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) - Page 7 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...
- Page 8 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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Page 9: Indications For Use
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. -
Page 10: General Description
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) LCD Screen... - Page 11 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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Page 12: Monarch Key Functions
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. - Page 13 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.
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Page 14: Operating Procedures
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. - Page 15 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.
- Page 16 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.
- Page 17 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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Page 18: Treatment
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. -
Page 19: Course Of Treatment
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. - Page 20 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.
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Page 21: After Treatment
If you wake up and the Monarch is powered off, first make sure all the connections are intact. Then, press the ON/OFF key. If the Monarch does not turn on, remove the battery and insert a fully-charged battery. -
Page 22: Maintenance And Cleaning
VIII. Maintenance and Cleaning Cleaning Instructions The Monarch can be cleaned with a cloth dampened with either water or a mild cleaning solution. Do not apply water or cleansers directly to any part of the Monarch eTNS System. Completely dry any component with a non-abrasive cloth before initiating treatment. - Page 23 VIII. Maintenance and Cleaning (continued) Cautions The Monarch eTNS System generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in any particular installation.
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Page 24: Environmental Specifications
Portable and mobile RF communications devices may affect medical electronic devices. Do not place the Monarch next to or on top of another device when using it. If it has to be placed next to or on top of another device, check that this instrument and the device function properly before use. -
Page 25: Manufacturer's Declaration - Electromagnetic Immunity
IX. Environmental Specifications (continued) Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Part 1 Immunity Test IEC 60601-1-2 test level Compliance level Electromagnetic environment - guidance Electromagnetic + 6 kV contact Floors should be wood, concrete or ceramic tile. discharge (ESD) + 8 kV air If floors are covered with synthetic material, IEC 61000-4-2... - Page 26 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,amature radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Monarch is used exceeds the applicable RF compliance level above, the Monarch should be observed to verify normal operation.
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Page 27: Recommended Separation Distance
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and The Monarch eTNS System The Monarch is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Monarch can help prevent... -
Page 28: Electrical Specifications
69 mm (Width) x 115 mm (Length) x 27 mm (Depth) Weight: 145 g (without battery) Display: Tested durability: Service life (Monarch main unit): 5 years *Components (e.g., electric patches) are consumables Error functions: Battery error and open error only... -
Page 29: Electrical Stimulation
XI. Electrical Stimulation Parameters Specification Intensity I (mA) 0 - 10 mA Step (increment) 0.2 mA Time 1, 4, 6, 8, 10, 12, 16 hour and continuous Lock Mode Locks all buttons except itself (Lock button). Press for two seconds to unlock. Input code (password) Restricts use for intended patient XII. -
Page 30: Clinical Data
The pilot study was an 8-week, single arm, open label trial designed to assess the safety, tolerability, and initial efficacy of the Monarch eTNS. The subjects were aged 7 - 14 years old and were diagnosed with ADHD based on DSM-IV criteria. - Page 31 XIII. Clinical Data (continued) Pivotal Study The pivotal study was a prospective, double-blind, randomized controlled trial of the Monarch eTNS as monotherapy for pediatric ADHD, with 4 weeks of treatment. The study enrolled 62 children (32 active; 30 sham) who had been diagnosed with moderated to severe ADHD.
- Page 32 XIII. Clinical Data (continued) Pivotal Study (continued) The trial met its primary efficacy endpoint. At the end of Week 4, the average ADHD-RS score in the active group decreased from 34.1 points at baseline to 23.4 points, versus a decrease from 33.7 to 27.5 points in the sham group.
- Page 33 XIII. Clinical Data (continued) eTNS was well-tolerated in all 62 subjects and there were no serious adverse events (SAEs) associated with use of the device. Commonly reported side effects among all pivotal study subjects included trouble sleeping, hyperactiveness, drowsiness, and stuffy nose, but there was no statistically significant difference between the active and sham groups for these events.
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Page 34: Warranty
The warranty does not apply to devices whose cases and/or screens are crushed, cracked, broken, or buckled. During the warranty period, at the sole discretion of NeuroSigma, the Monarch device will either be repaired free of charge by an approved service provider or replaced. - Page 35 Level 20, Tower II, Darling Park 201 Sussex Street, Sydney NSW 2000, Australia Monarch and eTNS are trademarks of NeuroSigma, Inc. Patent pending. © Copyright 2013 & 2016 NeuroSigma, Inc., Los Angeles, CA, USA. All rights reserved. 760-0003-003 Rev A, 07/2019...
- Page 36 NeuroSigma , Inc. ® ® 10960 Wilshire Boulevard Suite 1910 Los Angeles, California 90024 USA...
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