SAVI™ Instructions for Use SAVI 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 SAVI™ from eNeura. Please call Customer Care if you do not understand something in this manual. eNeura and your doctor are committed to helping you manage your migraine pain. The SAVI is a new, safe, non-drug therapy to treat migraine at the first sign of pain. Please read this entire manual before using the SAVI. Learn the contraindications, cautions, warnings and notes about the use of the device.
Intended Use The SAVI (The System) is indicated for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults. 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.
WARNING: The SAVI 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 SAVI 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. You should discuss this with your doctor before use.
Precaution: Keep the System away from other electronic devices that depend-on (receive) or radiate (transmit) radio frequency energy, when it is powered on. The operation of the System may be impaired when operated near home devices such as wireless network routers, mobile phones, cordless telephones and their base stations and walkie-talkies. Keep the SAVI device at least 2 feet (0.6 meter) from these devices when it is powered on and in use.
Your SAVI The complete SAVI includes this manual and the following items: The battery-powered, rechargeable device Carrying bag for SAVI and its AC adapter battery charger Note: The carrying bag is part of the packaging for shipping the SAVI device. Please place the device into the bag prior to boxing the device for return/exchange.. Battery Charger 12V DC 1.5A 18 watts (reorder no. DWG-0505) NOTE: Do not discard the box or packing materials. They will be required if you need to return this product.
Getting to Know Your Device B A D E C G F H I J – In the center of the panel on the top of the System. Press the power button to turn the device on and A. Power Button off. 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 SAVI 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 SAVI as soon as it arrives and keep your device charged and ready to treat. NOTE: Use only as directed.
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. Precaution: Keep the System away from other electronic devices that depend-on (receive) or radiate (transmit) radio frequency energy, when it is powered on.
WARNING: Stay at least 2 feet (0.6 meter) from others when using the SAVI. This device could be harmful to anyone with an electronic implant such as a pacemaker. Remove any personal medical devices such as insulin pumps, other medicinal pumps, bone growth stimulators, Transcutaneous Electrical Nerve Stimulator (TENS) devices and hearing aids. Do not use the System if you use a wearable cardioverter defibrillator (WCD).
Positioning the Device With the SAVI in front of you: The treatment buttons should be facing up and the accessory door should be facing away from you. Place your hands on the sides of the device with your thumbs on the treatment buttons. Lift the System over your head. The device should be placed so that it comfortably and naturally cradles the base of your skull. Hold it firmly against your head. The curved surface positions the device to fit comfortably against the head and optimize pulse delivery.
Delivering the Treatment NOTE: Two hands are needed to stabilize the device, but only one treatment button needs to be activated to deliver treatment. NOTE: The device shuts itself off if treatment is not delivered within 45 seconds. Press the power button to turn the device back on and restart the treatment procedure. Once the device is in place and your thumbs are on the treatment switches, press one or both switches and hold for at least 2 seconds.
Replacing the Micro SIM Rx card Open the accessory door on the back of the device. Push on the edge of the Micro SIM Rx card. It pops out about 3 mm (1/8 inch). Pull the Micro SIM Rx card out with your fingers. This expired Micro SIM Rx card is of no value. Dispose as e-waste 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.
Additional Information Battery Capacity Indicator Your SAVI has rechargeable batteries. The battery capacity indicator on your device shows how much charge is remaining in the battery. eNeura recommends that you keep your device’s battery charged so that it is always ready when you need it. Typically, a fully charged battery can deliver 18 treatments. Your battery pack life is roughly a minimum of 100 charge cycles.
Sound OFF Adjusting the Audible Tone The System sounds an audible tone when the device is ready to deliver a treatment. The switch to control the audible tone is located beneath the Accessory door. Slide the switch to the desired position (ON or OFF). Traveling with your SAVI Your SAVI may travel with you. Place the device in Airplane Mode as explained on page 18 (see “Locking the System/Airplane Mode”) and pack it securely to avoid damage during travel.
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.
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 SAVI in any way. Contact eNeura Customer Care If this symbol appears with the Prescription low or expired symbol, contact Customer Care (+1-408-245-6400, option 1) to renew or refill your prescription.
The device is charging correctly, but I can’t make it deliver a treatment. Check the power button indicator to confirm the device is ready for treatment. Check the lock switch to make certain it is not locked. Disconnect the battery charger if it is connected to the device. The Micro SIM Rx card may not be installed or may have expired. Check the card if required. indicator and install a current Micro SIM Rx The device may be too warm or too cold. Check the indicator.
Return Goods Policy Contact eNeura or your local Representative for information on product returns and return authorization. Contact information is available at the beginning of this manual and on the last page. NOTE: Do not discard the box or packing materials. They will be required if you need to return this product. Technical Specifications Weight: 3.2 lb. (1.4 kg) Size: 8.8 in long x 5.1 in wide x 2.7 in deep (22.4 cm long x 13 cm wide x 6.
Storage Environment The SAVI may be stored at -40°C to 60°C (-40°F to 140°F) with a relative humidity of up to 90% non-condensing and an atmospheric pressure range of 700 hPa to 1060 hPa and storage altitude of less than or equal to 3000m. Keep your SAVI dry during operation, storage and transport. When not in use, store the sTMS to protect it from household dust and lint, accidental spills or exposure to the elements (rain, dust, insects, vermin, prolonged direct sunlight, etc.).
EMC Compliance and Warning Statement This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
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) 385 Band a) Service a) Modulation b) (MHz) Maximum Power (W) Distance (m) Immunity Test Level (V/m) 1.8 0.3 27 2 0.3 28 0.2 0.3 9 2 0.3 28 2 0.3 28 2 0.3 28 0.2 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 Intertek ETL EMC IEC SN TMS 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.
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.
SAVI™ © 2020 eNeura Inc. eNeura® and SAVI are trademarks of eNeura Inc. The device and the method of use that comprise the eNeura SAVI 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.
