Eneura Savi Smart Igraine Relief Device Sporting Sleek User Guide

Welcome to the future of migraine care
SAVI™ Smart neuromodulation technology
Quick Start Patient Guide
SAVI by

FDA Cleared for the acute and preventive treatment of migraine in adults and children (12 and older)
“I am just ecstatic about my results. This technology is truly life-changing for me…The Customer Care and Nursing Support have been outstanding and made getting started so easy.”
—53-year-old female
SAVI Smart neuromodulation technology + your personal support team

Clinical Education Specialists (Registered Nurses)

• Provide guidance on using SAVI
• Help you use your SAVI Online Migraine Diary
• Support you in monitoring your progress
• Assist you in communicating with your prescriber

Customer Care is available to help you with any questions about:

• Caring for your SAVI
• Prescription renewals and deliveries
• Traveling with your SAVI
• Caring for your SAVI

What’s in the box?

This package contains everything you need to get started with your SAVI—a safe, clinically proven migraine treatment.

Your SAVI
Battery-powered, rechargeable device

SAVI Patient Quick Guide
For the complete guide to the SAVI, please visit our website at www.eneura.com

Battery charger (AC adapter)
For recharging your SAVI battery
We recommend you charge your device daily.

Carrying bag
For carrying your SAVI with you everywhere you want to go.

Get to know your SAVI™

The buttons and displays on the device are easy to understand.
For migraine management made easy, your SAVI includes Smart Technology to automatically download treatment history and prescription renewals.

Symbol Key

Prescription status indicator
Located on the far left of the top panel. Confirms that a valid prescription is active. Shows the status of the prescription programmed on the device.
Please see page 12 of this patient guide for details.
Contact eNeura® customer care
Action required. Call eNeura customer care for assistance:
US: 1-833-499-9300 option 1
UK: +44 020 3014 8939, option 1
Temperature warning
The temperature of the device is not in the range for safe use.
The temperature range for use is between 16º C (60º F) and 40º C (104º F).
Power button
Located in the center of the top panel. Press the Power button to turn the device on and off. When the Power button shines white, the device is on and ready. When the power button shines blue, it is connecting to the cell network.
Treatment progress indicator
LED lights around the Power button show status as the device prepares for treatment. When the oval around the Power button is fully illuminated, the device is ready to use.
Lock indicator
Located directly to the right of the Power button. The indicator is visible when the device is turned on and the security lock switch is enabled. The security lock switch is located on the back of the device.
AC adapter
Located to the right of the Power button.
The indicator lights up when the AC adapter (battery charger) is connected to the SAVI.
Battery capacity
Located to the far right of the Power button. Indicates how much power is left in the battery and whether or not there is enough to allow for treatment. All 4 bars will illuminate
when the device is fully charged. As the power level lessens, the number of illuminated bars will decrease.
Treatment buttons
Located on the right and left edges of the top panel. Press one or both buttons to deliver treatment.

How to track your treatment progress

SAVI Smart Technology automatically tracks your treatment history, no apps are required!

Getting started with the SAVI™ Online Migraine Diary
You will receive an email to set up your Online Migraine Diary.
Why keep an online diary? It gives you the power to manage your migraine, track your treatment progress, and secure insurance coverage.
We’ve made it easy and secure.

• Opt-in for automated daily text or email reminders
• HIPAA compliant Health Cloud
• No personal health information transmitted

Access your My eNeura Diary at mystmsdiary.eneura.com/patient/s/login/
How to set up and start your diary

1. Click on the link in the email you receive from My eNeura Diary
2. Follow the prompts to create your password
3. Save link on login for easy future access
4. Open your diary
5. Enter your migraine history

How to use your diary

1. Click the link from text or email
2. Rate your day
3. Enter any meds used that day
4. SAVI automatically downloads your treatment history for the day

It only takes a few seconds to update your diary every day– track your progress and share it with your doctor.
“This is the first headache diary that does the work for me. I love seeing the improvement, and my doctor does, too!”
—46-year-old female
“For the first time in years, I have headache-free days.”
—48-year-old female
Lock ON/OFF switch
Located behind the accessory port door, on the left. Slide the switch to the left or right to unlock or lock the device.
Battery charger port
Located behind the accessory port door, in the center. Recharge the batteries by plugging the AC battery charger into this port. We recommend you charge your SAVI™ nightly like you charge your cell phone.
Volume ON/OFF switch
Located behind the accessory port door, on the right. Slide left or right to turn the sound on or off.
Micro SIM Rx card port
Located on the back of the SAVI at the bottom of the accessory door.
Insert the micro-SIM Rx card into this port (SIM may be needed in areas where cellular network access is limited.)

How to use your SAVI™

You and your healthcare provider can develop a treatment plan that works for you. Your prescription includes plenty of pulses for daily preventive treatment and for treating migraine attacks – treat as early and as often as needed.
Sample Treatment Plan:
Daily preventive treatment: 4 pulses twice daily
Acute Treatment: 3 pulses at the first sign of the migraine attack – the earlier, the better. If needed, treat again every 15-30  minutes until the migraine attack subsides.
Delivering a treatment is easy and takes less than a minute.

1. POWER
   • Press the center button to turn on your device
   • When the oval racetrack around the power button is fully illuminated, the device is ready to position and treat.
   
2. POSITION
   • Place your thumbs below the side button at the same angle
   • Lift the SAVI over your head so it cradles the back of your skull
   • Slide your thumbs over the treatment buttons on  the sides when you are ready to deliver a pulse
   
3. PULSE
   • Press one or both treatment buttons to deliver a safe and therapeutic pulse
   • Once you have pressed the button, the treatment is instantaneous and you may remove the device from the back of your head

Repeat as prescribed.
Personalized treatment for migraine attacks puts you in control – treat as early and often as needed.
Watch a demonstration video at eNeura.com

How to renew your prescription

Fifteen days before your prescription expires, the prescription status indicator on your device will display an orange warning light.
If the indicator glows orange,  your prescription will be expiring in less than 15 days.
If the indicator displays a  zero next to it, the prescription has expired and the device has been disabled.
When you see this orange warning light:

• Send a renewal request via your Online Diary, or
• Contact Customer Care to renew your prescription
  Email: [email protected]
  Toll Free: 1-833-499-9300, option 1
• Once you pay the renewal invoice, your new prescription will be sent to your device via the cell network.

Safe usage and contraindications
Your doctor prescribed this device for your use only.
The SAVI™ generates a powerful single-pulse magnetic field as part of delivering therapy.
Treatment is very well tolerated. A small number of patients reported mild lightheadedness and tingling during treatment.

CONTRAINDICATIONS: This device should not be used in patients who have metals, conductive materials, or metal-containing implants in their head, neck, or upper body.
Dental implants, fillings, or other dental appliances are safe and are not affected by the device.
See the Instructions for Use for a complete list of contraindications and warnings at: www.eneura.com/prescribing-resources
Keep out of reach of children.
INDICATIONS:
The SAVI is indicated for the acute and preventive treatment of migraine headaches in adults and children ages 12 or older.

To begin your journey to migraine relief

complete the form on the back of this guide.
Your Clinical Education Specialist is available to assist you.

US Customer Care

Phone: 1-833-499-9300, option 1
Fax: 1-877-264-1818
Email: [email protected]
Hours of operation:
8:00 am to 5:00 pm PST
Monday – Friday
In case of a medical emergency, please call 911 or contact your doctor.
To learn more about eNeura and the SAVI, visit eNeura.com.
“More clarity, less “fuzzy” days, fewer headache days per month.”
—54-year-old female

eNeura Inc. 
101 W. Dickman Street, Ste 900, Baltimore MD 21230
LBL-0195 Rev B

References

• SAVI Dual™ Migraine Therapy from eNeura | Migraine Treatment & Prevention Without Medication
• For Healthcare Professionals | SAVI Dual™ Migraine Therapy from eNeura