Table of Contents
Troubleshooting
Related Manuals for eNeura SAVI Dual
Summary of Contents for eNeura SAVI Dual
- Page 1 SAVI Dual™ Migraine Therapy Instructions for Use Prescriber’s Manual Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician. SAVI Dual Migraine Therapy Prescribers Instructions for Use Manual...
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Page 2: Table Of Contents
Preparing for Treatment ..........................15 Positioning the Device..........................17 Delivering the Treatment ..........................18 Renewing the SAVI Dual Prescription by Cellular Network ................. 18 Additional Information .............................. 19 Traveling with the SAVI Dual ........................20 Caring for the SAVI Dual ..........................20 Understanding System Display Messages ......................... -
Page 3: Before You Begin
This manual must be available for your reference when discussing the device with your patients. eNeura is committed to the service and support of our customers. If there are any questions about the use of the eNeura SAVI Dual, please contact Customer Care or your local representative at the following: Manufactured by: eNeura Inc. -
Page 4: Intended Use
Intended Use The SAVI Dual (The System) is indicated for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults. The System is intended 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.
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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 should be used only under your continued supervision of the patient. Advise the patient that the device has been prescribed only for use by them. - Page 7 • 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.
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Page 8: Clinical Trial And Adverse Reactions
The efficacy of the eNeura device for prophylactic treatment is based on the result of an open label study. In open label studies, bias may affect the result. Additionally, open-label studies may introduce placebo rates of 10-25%. This is consistent with placebo rates reported in Randomized Controlled studies for migraine prevention.*... - Page 9 59.45 (23.51) MSQOL RP (7.85, 17.25) 5.29 <0.0001 (CC) 10.0 (-50, 62.5 (0, 100) 100) 16.40 (29.01) 48.16 (27.94) MSQOL EF (10.99, 21.81) 6.01 <0.0001 (CC) 13.33 (-40, 46.67 (0, 100) 100) SAVI Dual Migraine Therapy Prescribers Instructions for Use Manual...
- Page 10 1.02, 5.92 5 Possibly, 1 Definitely (2.77) Ringing in Ears 7/217 1.31, 6.53 1 Not Related, 6 Possibly (Tinnitus) (3.23) Worsened Headache 5/217 0.75, 5.30 3 Possibly, 2 Not specified Pain (2.30) SAVI Dual Migraine Therapy Prescribers Instructions for Use Manual...
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Page 11: Savi Dual
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 SAVI Dual device. -
Page 12: Getting To Know The Device
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 Prescribers Instructions for Use Manual... - Page 13 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.
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Page 14: Using The Savi Dual
Using the SAVI Dual • Precaution: Instruct your patient that this manual must be completely read and understood prior to use of the SAVI Dual. Improper use may cause personal injury and damage to the System and may void the warranty. -
Page 15: Preparing For Treatment
Preparing for Treatment Consult with your patient about their specific condition and the best timing of treatment with SAVI Dual . • Precaution: Instruct your patient to keep the System away from other electronic devices that depend on (receive) or radiate (transmit) radio frequency energy when it is powered on. - Page 16 WARNING: Instruct your patient to 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.
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Page 17: Positioning The Device
Positioning the Device With the SAVI Dual in front of the patient: The treatment buttons should be facing up and the accessory door should be facing away from the patient. The patient places both hands on the sides of the device with thumbs on the treatment buttons. -
Page 18: Delivering The Treatment
The patient may resume use of the device. Advise your patient to contact eNeura Customer Care if they reside in a low or no-cell service area or if their device does not connect to the cell network. A micro-SIM card can be provided to renew the prescription. -
Page 19: Additional Information
Additional Information Battery Capacity Indicator The SAVI Dual has rechargeable batteries. The battery capacity indicator on the device shows how much charge is remaining in the battery. eNeura recommends that patients keep their device’s battery charged so that it is always ready when needed. -
Page 20: Traveling With The Savi Dual
Whenever possible, pack the SAVI Dual in a carry-on rather than in checked luggage. At security, advise your patient to remove the SAVI Dual from their carry-on, place it in a bin and, before it goes through x-ray, notify TSA or Airport Security that it is a medical device. This will speed up the security- check process. -
Page 21: Understanding System Display Messages
If a micro-SIM Rx card was installed in the patient’s SAVI Dual and the Rx symbol is orange and pulsing, the Micro SIM Rx card installed in the device cannot be read by your patient’s device and may be invalid. -
Page 22: Troubleshooting
The battery may be completely discharged. Plug in the battery charger to charge the battery for at least 15 minutes. Be sure that only the eNeura battery charger (DWG-0505) is being used. When you plug in the battery charger, the display should light. Check that the battery icon on the display is lit to indicate that the battery is charging. -
Page 23: Service
Instruct your patient to have the device’s serial number available when calling eNeura Customer Care. When the System is no longer usable, the patient may return it to eNeura. The patient should not dispose of the device. For questions, contact eNeura Customer Care for assistance. -
Page 24: 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 25: 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 26: 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 27: Emc Guidance (Continued)
EN 61000-3-3 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 28 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.
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Page 29: 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 30: Glossary Of Abbreviations
Smart Card status Ready for Treatment Power button On/Off Treatment not allowed Preparing for Treatment Connecting to cellular network Lock switch enabled AC Adapter connected Rechargeable Battery capacity Medical Device level SAVI Dual Migraine Therapy Prescribers Instructions for Use Manual... -
Page 31: Medical Device Reporting
Warranty and Limitation of Liability eNeura Inc. warrants that the product when delivered is free from defect in materials and workmanship and conforms to the manufacturer’s product specifications. eNeura shall not be liable for any incidental or consequential loss, damage, or expense, directly or indirectly arising from the use of, or inability to use, its product. - Page 32 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;...
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