eNeura LBL-0195-Rev-B-SAVI SAVI Samrt Igraine Relief Device Sporting Sleek User Guide
- June 4, 2024
- eNeura
Table of Contents
SAVI™ Smart
neuromodulation
technology
Welcome to the future of migraine care
SAVI bye eNeura
Quick Start Patient Guide
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
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.
**** The power
button will blink blue during updates and will shut off automatically when
complete.
Symbol Key
The prescription status indicator is 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. Whenthe oval around the Power button is fully illuminated, and 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
- Click on the link in the email you receive from My eNeura Diary
- Follow the prompts to create your password
- Save the link on login for easy future access
- Open your diary
- Enter your migraine history
How to use your diary
- Click a link from text or email
- Rate your day
- Enter any meds used that day
- SAVI automatically downloads your
- treatment history for the day
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
It only takes a few seconds to update your diary every day– track your
progress and share it with your doctor.
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.)
Your device will ship in “Lock On” mode. Slide the switch to the left to
unlock the device.
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.
-
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.
-
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
-
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 with 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: customercare@eneura.com
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: customercare@eneura.com
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.
More clarity, fewer “fuzzy” days, fewer headache days per month.
—54-year-old female
To learn more about eNeura and the SAVI, visit
eNeura.com.
Clinical Education Specialist name: Phone number:———————— Diary access
Username:————————— Password:———————
Best way to contact:—————————–
Headache history # of headache days per month:——————— Medications
Preventive:————————— Acute:————————
sTMS prescription Preventive:————————- Acute:————————– Best time to
contact:—————-
Baseline # of headache days per month
On average how many days per month do you have: (the total days should be 30)
Describe what success with your SAVI looks like to you
(for example: attending sporting events or concerts, not missing work or
school, etc.)
No pain——————————–
Mild headache – Normal Function——————————
Moderate Pain – Reduced Function———————–
Severe Pain – No Function——————————
Next Clinical Education
Specialist appointment:
Date:——————
Time:———————-
Renew your prescription before it expires
Prescription expiration date:
If your Prescription Status Indicator on your SAVI turns orange, your
prescription expires in less than 15 days. Please contact Customer Care to
order a new prescription card.
eNeura Inc. | 101 W. Dickman Street, Ste 900, Baltimore MD 21230 | LBL-0195
Rev B