sTMS mini Instructions for Use sTMS mini Patient Manual Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician.
Table of Contents Before You Begin ......................................................................................................................................................... 3 Intended Use ................................................................................................................................................. 4 Warnings and Precautions ............................................................................................................................
Before You Begin Thank you for choosing the eNeura sTMS mini, the portable single-pulse Transcranial Magnetic Stimulation (sTMS) device. This manual provides the Information you need to use the sTMS mini. You will see cautions, warnings, and helpful information placed near the related steps. Call Customer Care if you don’t understand something in this manual. eNeura and your doctor are committed to helping you manage your migraine pain.
Intended Use The sTMS mini (The System) is indicated for the acute and prophylactic treatment of migraine headache. The System is designed for self-treatment and delivers a non-invasive, brief, single pulse of magnetic energy to the back of the head. This creates a brief electrical current in the brain intended to stop or reduce the effects of migraine headaches. This type of stimulation is called single-pulse Transcranial Magnetic Stimulation or sTMS.
WARNING: The sTMS mini should be used under the continued supervision of a physician. The System has been prescribed by your physician only for you. Inspect the System for any signs of damage before use. Do not use it if it is cracked or wet. If you suspect damage to the device, call eNeura at: +1 855.366.8355 option 1 for assistance. Do not operate the System in or near an area where explosive gases are being used or have been used. Do not operate near gasoline or natural gas.
Contraindications WARNING: Failure to follow the restrictions listed below could result in serious injury or death. The sTMS mini creates a very strong single-pulse magnetic field. The System has been prescribed by your doctor for your use only. The System may not be used in patients who have metals, conductive materials, or metal-containing implants in their head, neck or upper body. Metals and conductive materials can be affected by a magnetic field.
WARNING: The System should not be used while driving, operating machinery or during any activity in which involuntary muscle contractions may put the user at risk of injury. Stay at least 2 feet (0.6 meter) from others when using the System. The System could be harmful to anyone with an electronic implant such as a pacemaker. Anyone with a hearing aid or cochlear implant may hear an audible click.
Clinical Trial and Adverse Reactions eNeura completed a clinical study in Headache Centers in the United States designed to support safety and effectiveness for use of the Spring TMS device for the acute treatment and prophylaxis of migraine headache. Baseline medication and symptoms were recorded for 28 days via patient diary. Subjects were instructed to use the SpringTMS device daily (morning and evening) and for the acute treatment of attacks for three months with no change in preventive medication.
Your sTMS mini The complete sTMS mini includes this manual and the following items: The battery-powered, rechargeable device Prescription card with SIM (Subscriber Identity Module) Rx card (SIM Rx card is optional - your prescription may be installed via remote activation) NOTE: Your first prescription is preinstalled at the factory. Battery Charger 12V DC 1.5A 18 watts (reorder no.
Getting to Know Your Device B A D E C G F H I J A. Power Button off. – In the center of the panel on the top of the System. Press the power button to turn the device on and B. Power Indicator LED light on the top of the System inside the Power button. Static white illumination shows the device is on and ready. Pulsing blue illumination indicates device is connecting to the cellular network to transfer data. C. Treatment Progress Indicator for treatment.
Battery Charger (Power Supply) and Micro SIM Rx card Ports K L M N Door side of device, with door open K. Lock ON/OFF Switch –Located behind accessory port door, on the left. Slide the switch to the left or right to unlock or lock the device L. Volume ON/OFF Switch – Located behind accessory port door, on the right. Slide the left or right to turn the sound on or off M. Battery Charger Port – Located behind accessory port door, in the center.
Using Your Device Precaution: Prior to use of the System, this manual must be completely read and understood. Improper use may cause personal injury and damage to the System and may void the warranty. You, as the user of the System, must become familiar with the functions and features of the device prior to use. Setting Up the Device Be prepared to treat your migraine when needed. Set up your sTMS mini as soon as it arrives and keep your device charged and ready to treat. NOTE: Use only as directed.
Read the instructions below prior to operating the device. Then, follow the entire procedure as described below. Consult your physician for additional treatment information. NOTE: Become familiar with the System and how to use it before you experience a migraine. Preparing for Treatment Consult your doctor about your specific condition and the best timing of your sTMS treatment.
WARNING: Remove any personal medical devices such as insulin pumps or other medical pumps and bone growth stimulators. Press the power button Watch the LED track light progress around the power button: It takes 30-60 seconds to prepare the System for treatment. As the device prepares for treatment, each segment will light up to indicate progress.
Precaution: Keep the sTMS mini away from metal or conductive objects, medical devices and magnetic media when it is powered on. When activated, the System emits a strong magnetic pulse and may interfere with other metal, electronic or magnetic products within 2 feet (0.6 meter). A person with a hearing aid or cochlear implant may hear a click when the System is activated.
WARNING: Transcranial magnetic stimulation should only be applied to the back of the head as described in the “Positioning the Device” section of this manual. Do not stimulate over the front of the neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur. Contractions may be strong enough to close the airway or cause difficulty breathing. Do not stimulate over the side of the neck.
Renewing Your Prescription by Remote Activation NOTE: The System is intended for use under the care of a doctor. For more information on renewing your prescription, please contact eNeura Customer Care. An active prescription is required. NOTE: The System only delivers sTMS treatments if the programmed prescription has not expired. The device will display an ORANGE warning light when prescription is about to expire: promptly. Renew your prescription Contact Customer Care to request a refill.
Pull the Micro SIM Rx card out with your fingers. This expired Micro SIM Rx card is of no value. Dispose as eWaste or recycle by appropriate methods. WARNING: The Micro SIM Rx card may be swallowed and present a choking hazard for infants or small children if it is ejected from the SIM card port and left loose and unattended. Remove your new Micro SIM Rx card (the cut-out portion) from the prescription card by pressing down firmly on the Micro SIM Rx card.
your treatment. WARNING: The battery charger cable may present a strangulation or trip hazard if the System is left unattended around infants and small children. Recharge the System’s battery in a safe location, away from foot traffic and children. Store the battery charger in a safe place when not in use.
Locking the System The System lock switch is located beneath the Accessory door. The System lock may be controlled by sliding the switch to the desired position (ON or OFF). When the System is locked, the device will prevent others from using it by disabling treatment functionality. Activating the System lock switch places the device in Airplane Mode. Place the System in Airplane Mode whenever you are in a location where use of cellular devices is discouraged or forbidden.
Precaution: Disconnect the sTMS mini from the battery charger prior to cleaning. NEVER immerse the System. Do NOT drip or splash any liquid on the device. Contact eNeura if the device gets wet. Do not attempt to sterilize the System.
Understanding System Display Messages If your device displays one of the following images, please take the steps listed to clear the message. Battery charge is full Battery charge is low The rechargeable battery charge is low. There is only enough power to deliver approximately 10 treatments so charge the battery at your earliest convenience. Charge the battery for at least 15 minutes. To fully charge the battery, allow the device to charge for about 4 hours.
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Device temperature not in operating range The device does not operate when its temperature is below 16°C (60°F) or above 40°C (104°F). Move the device to a more temperate environment, such as inside your home or office, and wait 15 minutes. Try again. Precaution: Do NOT actively heat or cool your sTMS mini in any way. Contact eNeura Customer Care If this symbol appears with the Prescription low or expired symbol, contact Customer Care (+1-408-2456400, option 1) to renew or refill your prescription.
environment and wait 15 minutes before trying again. Precaution: Do NOT actively heat or cool your sTMS mini in any way. Service For questions about your sTMS mini, please call or email Customer Care at eNeura. Please have your device available when calling eNeura Customer Care. When the System is no longer usable, return it to eNeura or your local Representative. Do not dispose of the device. For questions, contact eNeura or your local Representative for assistance.
Operating Environment The sTMS mini is a battery-operated device. The sTMS mini requires a regular home or office electrical outlet for proper battery recharging. The sTMS mini operates best in typical household and office environments where the temperature is 15°C to 40°C (60°F to 104°F); relative humidity range of 10% to 90%, non-condensing; an atmospheric pressure range of 700 hPa to 1013 hPA; operating altitude of less than or equal to 3000m.
REACH and Warning Statement Thresholds and Substances of Very High Concern (SVHCs) are defined in Article 7 and 57 of Regulation (EC) No 1907/2006 (REACH Regulation). This article contains a substance on the Candidate List in a concentration above 0.
EMC Guidance In accordance with Clause 4.3 of IEC 60601-1, the Essential Performance of the sTMS Mini is to not deliver a pulse above 0.95T. EMC interference from other equipment may disrupt normal operation of the sTMS Mini and may impede the delivery of the 0.9T magnetic pulse to the patient’s head.
Guidance and Manufacturer’s Declaration – Immunity The DWG-0600 is intended for use in the electromagnetic environment specified below. The customer or user of the DWG-0600 should ensure that it is used in such an environment.
EMC Guidance (continued) Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The DWG-0600 is intended for use in the electromagnetic environment specified below. The customer or user of the DWG-0600 should ensure that it is used in such an environment.
Immunity to RF Wireless Communications Equipment Test Frequency (MHz) Band a) 385 380 - 390 TETRA 400 450 430 - 470 GMRS 460, FRS 460 710 745 780 704 - 787 LTE Band 13, 17 800 - 960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 Pulse modulation 18 Hz 1700 - 1990 GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS 2450 5240 5500 5785 810 870 930 1720 1845 1970 Maximum Power (W) Distance (m) Immunity Test Level (V/m) 1.8 0.
Recommended separation distances between portable and mobile RF communications equipment and the sTMS Mini The sTMS Mini is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Glossary of Abbreviations CE Mark Intertek ETL EMC IEC SN TMS CE mark certifies that a product has met EU consumer safety, health or environmental requirements. Intertek Mark certification marks indicate that this product has been tested to a U.S. standard and it meets the requirements of an applicable ETL standard or another recognized document used as a basis for certification.
AC Adapter connected Rechargeable Battery capacity level Medical Device Reporting Any potential adverse incident involving eNeura products should be reported immediately by calling your local Representative or Customer Care at eNeura. Users and physicians may also report adverse events to FDA through MedWatch at 1-800-332-1088 or at https://www.fda.gov/safety/medwatch. Warranty and Limitation of Liability eNeura Inc.
sTMS mini © 2018 eNeura Inc. eNeura® and sTMS mini are trademarks of eNeura Inc. The device and the method of use that comprise the eNeura sTMS mini are protected by U.S. Patents 6,402,678, 7,294,101, 7,494,458 and 7,601,116; by European Patents 1 307 260 B1 and 1 977 787 B1; and by Canadian Patent 2423840. Additional patents are pending.
