Related Manuals for eNeura SAVI
Summary of Contents for eNeura SAVI
- Page 1 SAVI™ Instructions for Use SAVI Prescriber’s Manual Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician.
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Page 2: Table Of Contents
Clinical Trial and Adverse Reactions ......................8 SAVI ................................11 Getting to Know the device ............................12 Using the SAVI ................................14 Setting Up the SAVI ............................. 14 Recommended Treatment .......................... 15 Preparing for Treatment ..........................15 Positioning the Device ..........................17 Delivering the Treatment .......................... -
Page 3: Before You Begin
If there are any questions about the use of the eNeura SAVI, please contact Customer Care or your local representative at the following: Manufactured by: eNeura Inc. -
Page 4: Intended Use
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 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. 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 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 him or her. 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 System. Portable and mobile communications devices can affect proper operation of the System. See “EMC Compliance and Warning Statement” section of the Instructions for Use for more information. • Advise your patient that the eNeura SAVI should be installed and put into service according to the EMC information provided in this Physician Manual. •...
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Page 8: Clinical Trial And Adverse Reactions
Six patients reported using prophylactic medications at baseline (2.8%), of these, 5 were using topiramate and propranolol. 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. - Page 9 Primary End Point: Study results showed statistically significant reduction in migraine headache days of 2.8 days (from a baseline mean of 9.1 days) (FAS), P<0.0001; 2.8 days (from a baseline mean of 8.9 days) (CC) P<0.0001, and 3.0 days (from a baseline mean of 9.1 days) (PP) P<0.0001.
- Page 10 (PP) 40 (0, 91.43) 20 (-48.57, 56.54 (24.30) 14.84 (26.47) MSQOL RP (9.39, 20.29) 5.41 <0.0001 (PP) 60 (0, 100) 10 (-50, 100) 44.26 (27.89) 19.43 (29.22) MSQOL EF (13.41, 25.44) 6.41 <0.0001 (PP) 40 (0, 100) 20 (-40, 100) Fourth secondary endpoint: The reduction from baseline in the days with headache for more than 4 hours with any pain intensity.
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Page 11: Savi
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. -
Page 12: Getting To Know The Device
Located on left side on the top of the System. Confirms a valid prescription is available and shows the status of the prescription: White illumination indicates Rx is active; static orange indicates Rx will expire soon; orange with orange Power Button indicates Rx has expires. Contact eNeura Customer Care Action required. Call Customer Care. Temperature warning The device temperature is not in range for safe use. - Page 13 – Located on the back of the System beneath the Accessory Door. Insert the micro SIM RX card into this port. • Precaution: Use only eNeura-supplied accessories with the SAVI: Battery charger (reorder no. DWG-0505) and Micro SIM Rx card.
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Page 14: Using The Savi
Setting Up the SAVI Instruct the patient to be prepared to treat his or her migraine when needed. Instruct the patient to set up the SAVI as soon as it arrives and keep the device charged and ready to treat. -
Page 15: Recommended Treatment
Recommended Treatment The treatment with the SAVI should be performed per your instructions as the prescribing physician. Read the instructions below prior to operating the device. When discussing the treatment with the patient, emphasize the importance of following your instructions, the instructions in the Patient Manual and adhering to the prescribed treatment regimen. Review the instructions below with your patient. - Page 16 Once the System is ready, you have 45 seconds to position the device and deliver treatment. WARNING: Instruct your patient to 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.
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Page 17: Positioning The Device
Positioning the Device With the SAVI 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
NOTE: The System is intended for use under your care of the patient. For more information on renewing a patient’s prescription, please contact eNeura Customer Care. An active prescription is required. NOTE: The System only delivers sTMS treatments if the Micro SIM Rx card has been properly inserted and has not... -
Page 19: Renewing A Prescription By Optional Micro Sim Rx Card
The Micro SIM Rx card from the prescription card must be installed to activate the device to deliver sTMS treatments. The device will display an ORANGE warning light when your Micro SIM Rx card is about to expire: Renew your prescription promptly. -
Page 20: Replacing The Micro Sim Rx Card
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. ... -
Page 21: Additional Information
Battery Capacity Indicator The SAVI 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. Typically, a fully charged battery can deliver 18 treatments. -
Page 22: Traveling With The Savi
Whenever possible, pack your SAVI in a carry-on rather than in checked luggage. At security, remove your SAVI from your 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 23: Understanding System Display Messages
If the problem persists, contact eNeura or your local Agent for help. Prescription expires in less than 15 days If the RX symbol is orange, please contact eNeura or the local Representative to order a new prescription card. An active prescription is required. -
Page 24: 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 25: 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 or the local Representative for assistance. -
Page 26: Operating Environment
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. -
Page 27: Reach And Warning Statement
EMC Guidance In accordance with Clause 4.3 of IEC 60601-1, the Essential Performance of the SAVI is to not deliver a pulse above 0.95T. EMC interference from other equipment may disrupt normal operation of the SAVI and may impede the delivery of the 0.9T magnetic pulse to the patient’s head. - Page 28 Guidance and Manufacturer’s Declaration - Emissions 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. Emissions Test Compliance Electromagnetic Environment – Guidance The DWG-0600 uses RF energy only for its internal function.
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Page 29: Emc Guidance (Continued)
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 Test IEC 60601 Test Level Compliance Electromagnetic Environment –... - Page 30 Immunity to RF Wireless Communications Equipment Test Band Maximum Distance Immunity Test Frequency Service Modulation Power Level (MHz) (MHz) (V/m) Pulse modulation 380 - 390 TETRA 400 18 Hz GMRS 460, 430 - 470 ± 5 kHz deviation FRS 460 1 kHz sine LTE Band 13, Pulse modulation...
- Page 31 NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 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;...
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Page 32: Glossary Of Abbreviations
Authorized representative Temperature limitation in European Community EMC non-ionizing Humidity limitation radiation Smart Card status Contact eNeura Customer Care Power button On/Off Ready for Treatment Preparing for Treatment Treatment not allowed Lock switch enabled Connecting to cellular network Rechargeable Battery capacity level... -
Page 33: 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 34 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.
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