Savi Dual Instructions For Use Manual

Migraine therapy

Hide thumbs

Table Of Contents

Table of Contents

Quick Links

Download this manual

S A V I D u a l ™

Migraine Therapy

Instructions for Use

SAVI Dual™ Patient Manual

Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician.

SAVI Dual™ Migraine Therapy Instructions for Use

Table of Contents

Troubleshooting

Need help?

Do you have a question about the Dual and is the answer not in the manual?

Questions and answers

Summary of Contents for Savi Dual

Page 1 S A V I D u a l ™ Migraine Therapy Instructions for Use SAVI Dual™ Patient Manual Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician. SAVI Dual™ Migraine Therapy Instructions for Use...
Page 2: Table Of Contents
Preparing for Treatment ............................12 Positioning the Device ............................... 14 Delivering the Treatment ............................15 Renewing Your SAVI Dual Prescription by Cellular Network ..................15 Additional Information ................................16 Traveling with your SAVI Dual ..............................17 Caring For Your SAVI Dual ................................ 17 Understanding System Display Messages ..........................
Page 3: Before You Begin
Thank you for choosing SAVI Dual™ Migraine Therapy from eNeura. Please call eNeura 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 Dual™ is a new, safe, non-drug therapy to treat migraine at the first sign of pain.
Page 4: Intended Use
Intended Use The SAVI Dual™ Migraine Therapy device (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.
Page 5  Risk of electrical shock. Do not allow the System or power cords to get wet. Quickly wipe up spills on or near the SAVI Dual. Do not use the System in or near water. For example, do not use while in the bathtub or shower, in the rain, or while standing in water or on a wet surface.
Page 6: Contraindications
 WARNING: Failure to follow the restrictions listed below could result in serious injury or death. The SAVI Dual™ 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.
Page 7: Clinical Trial And Adverse Reactions
• 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 Dual device at least 2 feet (0.6 meter) from these devices when it is powered on and in use.
Page 8: Your Savi Dual
Your SAVI Dual™ The complete SAVI Dual™ includes the SAVI Dual Patient Quick Guide, part number LBL-0195, and the following items: The battery-powered, rechargeable device Carrying bag for SAVI Dual and its AC adapter battery charger Note: The carrying bag is part of the packaging for shipping the device.
Page 9: Getting To Know Your Device
Treatment Buttons On the right and left edge of the panel on the top of the device. Press one or both buttons to deliver a treatment. Read “Understanding System Display Messages” for more information. SAVI Dual™ Migraine Therapy Instructions for Use...
Page 10 N. Micro-SIM Rx card port – Located on the back of the System beneath the Accessory Door. Insert the micro-SIM RX card into this port. A micro-SIM card is only required if SAVI Dual Prescription is NOT renewed by wireless cellular network.
Page 11: Using Your Savi Dual
Setting Up the Device Be prepared to treat your migraine when needed. Set up your SAVI Dual™ as soon as it arrives and keep your device charged and ready to treat. NOTE: Use only as directed. The device should only be used per the instructions of your physician who prescribed the System.
Page 12: Preparing For Treatment
Preparing for Treatment Consult your doctor about your specific condition and the best timing of your SAVI Dual 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.
Page 13  WARNING: Stay at least 2 feet (0.6 meter) from others when using the SAVI Dual. 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.
Page 14: Positioning The Device
Positioning the Device  With the SAVI Dual 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.
Page 15: Delivering The Treatment
Renew your prescription promptly.  Contact Customer Care to request a refill if you are not enrolled in the SAVI Dual monthly subscription program.  Upon receipt of payment, eNeura Customer Care will initiate reactivation of your device via the cellular network.
Page 16: Additional Information
Additional Information Battery Capacity Indicator Your SAVI Dual 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.
Page 17: Traveling With Your Savi Dual
Traveling with your SAVI Dual  Your SAVI Dual may travel with you. Place the device in Airplane Mode as explained on page 16 (see “Locking the System/Airplane Mode”) and pack it securely to avoid damage during travel. Before using the unit after traveling, check it for any damage to ensure it appears to be working correctly before you use it.
Page 18: Understanding System Display Messages
“off” position. The lock switch is located behind the accessory-port door.  When enabled, the security lock places the System into Airplane Mode and will prevent cellular transmissions from the device. SAVI Dual™ Migraine Therapy Instructions for Use...
Page 19: Troubleshooting
 This symbol appears when the device is connecting to a cellular network to upload treatment history to your SAVI Smart Diary™ or download a new Rx. The device will automatically shut down after it has completed the connection. ...
Page 20: Service
• Precaution: Do NOT actively heat or cool your SAVI Dual in any way. Service  For questions about your SAVI Dual, please call or email Customer Care at eNeura.  Please have your device available when calling eNeura Customer Care.
Page 21: Return Goods Policy
700 hPa to 1013 hPA; operating altitude of less than or equal to 3000m.  The SAVI Dual is not affected by exposure to dust or lint normally found in household and office environments.  The SAVI Dual and its accessories may be exposed to sunlight for a few days duration, but prolonged or repeated exposure to direct sunlight is not recommended.
Page 22: Storage Environment
Storage Environment  The SAVI Dual 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.
Page 23: Emc Compliance And Warning Statement
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the SAVI Dual, including cables specified by the manufacturer. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Page 24 During the immunity testing below, the DWG-0600 (SAVI Dual™) will continue to operate within specification, by delivering a brief, single pulse of magnetic energy (not above 0.95T) which creates a brief electrical current in the brain intended to stop or reduce the effects of migraine headaches.
Page 25 Pulse, 217 Hz, 50% DC 2450 5240, 5500, 5785 The device and the method of use that comprise the eNeura SAVI Dual  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.
Page 26: Wireless Connection
Wireless Connection The SAVI Dual™ Migraine Therapy device contains a wireless module that is used to download an active prescription and transfer data to the patient diary system. The cellular connection allows for device data upload and device activation download.
Page 27: Glossary Of Abbreviations
Contact eNeura Customer Care radiation Smart Card status Ready for Treatment Power button On/Off Treatment not allowed Preparing for Treatment Connecting to cellular network AC Adapter connected Lock switch enabled Medical Device Rechargeable Battery capacity level SAVI Dual™ Migraine Therapy Instructions for Use...
Page 28: Medical Device Reporting
Level 20, Tower II, Darling Park eNeura (UK) Ltd. 201 Sussex Street 6th Floor Sydney, NSW 2000 One London Wall London EC2Y 5EB Australia United Kingdom www.emergogroup.com Tel. +44 (0) 20.3356 4889 Fax: +44 (0) 20.7785.8152 www.eNeura.co.uk customercare@eneura.co.uk SAVI Dual™ Migraine Therapy Instructions for Use...
Page 29 SAVI Smart Diary™ are trademarks of Aruene Corporation  The device and the method of use that comprise the eNeura SAVI Dual 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;...