eNeura SAVI User manual

SAVI™Smart
neuromodulation
technology
Take your life back - enjoy pain free, clear blue days
-Stop migraine attacks
-Prevent headache days
-Automatically track your treatment progress
-NO medication side eects
Quick Start Patient Guide
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SAVI by
Welcome to the future of migraine care
FDA Cleared for the acute and preventive treatment
of migraine in adults and children (12 and older)

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
Available to help you with
any questions about:
• Caring for your SAVI
• Prescription renewals
and deliveries
• Traveling with your SAVI
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
2

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
Carrying bag
Battery charger
(AC adapter)
For recharging your SAVI
battery
We recommend you
charge your device
daily.
For carrying your SAVI
with you everywhere you
want to go.
3

Get to know
your SAVI™
The buttons and displays
on the device are easy to
understand.
For migraine managment
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 shutoff
automatically when complete.
!
4

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Symbol Key
Prescription status indicator
Located on the far left of the
top panel. Conrms 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: [phone], 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 o. 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. Indicator is visible
when 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. 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 a treatment.
5

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
How to track your
treatment progress
Access your My eNeura Diary at
mystmsdiary.eneura.com/patient/s/login/
SAVI Smart Technology automatically tracks your
treatment history, no apps required!
6

How to set up and start your diary
It only takes a few seconds
to update your diary every
day– track your progress
and share with your doctor.
This is the rst
headache diary
that does the
work for me. I
love seeing the
improvement,
and my doctor
does, too!
—46-year-old female
3
5
4
2
1
Click on the link in the email you receive from My eNeura Diary
Follow the prompts to create your password
Save link on login for easy future access
Open your diary
Enter your migraine history
How to use your diary
3
4
2
1
Click link from text or email
Rate your day
Enter any meds used that day
SAVI automatically downloads your
treatment history for the day
7

For the rst
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.
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.)
Volume ON/OFF switch
Located behind the accessory port door, on the right. Slide left or right to
turn the sound on or o.
8

SAVI – back of device view
Your device will ship in "Lock On" mode.
Slide the switch to the left to unlock the device.
9

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 rst sign of the migraine
attack - the earlier, the
better. If needed, treat again
every 15-30 minutes until
migraine attack subsides.
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.
1POSITION
• 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
2
Delivering a treatment is easy and takes less than a minute.
10

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
3
Watch a demonstration
video at eNeura.com
Repeat as
prescribed.
Personalized treatment for
migraine attacks puts you
in control - treat as early
and often as needed.
Delivering a treatment is easy and takes less than a minute.
11

Fifteen days before your prescription expires,
the prescription status indicator on your
device will display an orange warning light.
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
cell network.
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.
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How to
renew your
prescription
12
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Safe usage and contraindications
Your doctor prescribed this device for your
use only.
The SAVI™ generates a powerful single-pulse
magnetic eld as part of delivering therapy.
Treatment is very well tolerated. A small
number of patients reported mild light
headedness 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, llings, or other dental
appliances are safe and are not aected 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 headache in
adults and children ages 12 or older.
13

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.
14

To learn more about eNeura and the SAVI, visit eNeura.com.
US Customer Care
Phone: [phone], option 1
Fax: [phone]
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.
15
More clarity, less
"fuzzy" days,
fewer headache
days per month.
—54-year-old female
15

Next Clinical Education
Specialist appointment:
Date:
Time:
Baseline # of headache days per month
On average how many days per month do you
have: (the total days should be 30)
No pain
Mild headache - Normal Function
Moderate Pain - Reduced Function
Severe Pain - No Function
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.
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Clinical Education Specialist name:
Phone number:
Best way to contact:
Diary access
Username:
Password:
Best time to contact:
Describe what success with your SAVI looks like to you
(for example: attending sporting events or concerts, not missing work or school, etc.)
Headache history
# of headache days per month:
sTMS prescription
Preventive:
Acute:
Medications
Preventive:
Acute:
eNeura Inc. | 101 W. Dickman Street, Ste 900, Baltimore MD 21230 | LBL-0195 Rev B