Savi Dual User manual

SAVI Dual™ Migraine Therapy Instructions for Use 1
SAVI Dual™
Migraine Therapy
Instructions for Use
SAVI Dual™ Patient Manual
Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician.

SAVI Dual™ Migraine Therapy Instructions for Use 2
Table of Contents
Before You Begin ....................................................................................................................................................................... 3
Intended Use ............................................................................................................................................................... 4
Warnings and Precautions .......................................................................................................................................... 4
Contraindications ........................................................................................................................................................ 6
Clinical Trial and Adverse Reactions............................................................................................................................ 7
Your SAVI Dual™ .......................................................................................................................................................... 8
Getting to Know Your Device........................................................................................................................................... 9
Using Your SAVI Dual™ ............................................................................................................................................................ 11
Setting Up the Device................................................................................................................................................ 11
Recommended Treatment ........................................................................................................................................ 11
Preparing for Treatment ........................................................................................................................................... 12
Positioning the Device............................................................................................................................................... 14
Delivering the Treatment .......................................................................................................................................... 15
Renewing Your SAVI Dual Prescription by Cellular Network..................................................................................... 15
Additional Information ............................................................................................................................................................ 16
Traveling with your SAVI Dual ................................................................................................................................................. 17
Caring For Your SAVI Dual........................................................................................................................................................ 17
Understanding System Display Messages ............................................................................................................................... 18
Troubleshooting ...................................................................................................................................................................... 19
Service ....................................................................................................................................................................... 20
Return Goods Policy .................................................................................................................................................. 21
Technical Specifications........................................................................................................................................................... 21
Operating Environment............................................................................................................................................. 21
Storage Environment................................................................................................................................................. 22
Industry Standard Classification................................................................................................................................ 22
REACH and Warning Statement ................................................................................................................................ 22
EMC Compliance and Warning Statement................................................................................................................ 23
EMC Guidance ......................................................................................................................................................................... 23
Wireless Connection................................................................................................................................................................ 26
Wireless Connection Troubleshooting .................................................................................................................................... 26
Glossary of Abbreviations........................................................................................................................................................ 27
Medical Device Reporting........................................................................................................................................................ 28
Warranty and Limitation of Liability........................................................................................................................................ 28
Customer Care Contact Information ....................................................................................................................................... 28

SAVI Dual™ Migraine Therapy Instructions for Use 3
Before You Begin
Thank you for choosing SAVI Dual™ Migraine Therapy from eNeura. Please call eNeura Customer Care if you do
not understand something in this manual.
eNeura and your doctor are committed to helping you manage your migraine pain. The SAVI Dual™ is a new, safe,
non-drug therapy to treat migraine at the first sign of pain.
Please read this entire manual before using the device.Learn the contraindications, cautions, warnings and notes
about the use of the device.As the manufacturer, eNeura cannot and does not intend to give medical advice.
Contact your doctor for all medical advice.This manual should be kept near the device and be available at all
times.
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 Customer Care at the following:
Manufactured by: eNeura Inc.
101 W. Dickman Street, Ste 900
Baltimore, MD 21230 USA
eNeura Inc.
Corporate Headquarters
101 W. Dickman Street, Ste 900
Baltimore, MD 21230 USA
Tel: [phone]
Toll free (USA only): +1 833.499.9300
Fax: [phone]
www.eNeura.com
[e-mail]
[e-mail]
eNeura (UK) Ltd.
6th Floor
One London Wall London EC2Y 5EB
United Kingdom
www.eNeura.co.uk
Tel. [phone]
Fax: [phone]
[e-mail]
Authorized Representative
Emergo Europe
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
Tel: [phone]
Fax: [phone]
www.emergoeurope.eu
Australia Sponsor
Emergo Australia
Level 20, Tower II, Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia
www.emergogroup.com

SAVI Dual™ Migraine Therapy Instructions for Use 4
Intended Use
The SAVI Dual™ Migraine Therapy device (The System) is indicated for the acute and prophylactic treatment of
migraine headache in adolescents (age 12 and older) and adults.
The System is designed for self-treatment and delivers a non-invasive, brief, single pulse of magnetic energy to the
back of the head.This creates a brief electrical current in the brain intended to stop or reduce the effects of
migraine headaches.
The System is a drug-free treatment option that can be used in the home or away from home based on your
doctor’s instructions.After treatment, there are no restrictions.You can resume your normal activities.
WARNING: This device should be used under the supervision of a physician.
Keep the SAVI Dual out of the reach of children.
Safety and effectiveness have not been established in pregnant women and children
under the age of 12.
The long-term effects of single-pulse transcranial magnetic stimulation are unknown.
Warnings and Precautions
The words WARNING, Precaution and NOTE have special meanings in this manual. Read them throughout the
manual to ensure the safe and effective use of your SAVI.
WARNING: A WARNING tells you that the personal safety of the patient may be involved.
Ignoring a WARNING could result in injury to the patient. WARNINGS in the manual are shown in
an orange box.
Precaution: A Precaution means that exact steps must be followed to prevent damage to the
product.Precautions in the manual are shown in a purple box.
NOTE: ANOTE gives special information to ease product use or to explain important
information. NOTES in the manual are shown in a dashed box.

SAVI Dual™ Migraine Therapy Instructions for Use 5
WARNING: The SAVI Dual should be used under the continued supervision of a
physician.The System has been prescribed by your physician only for you.
Inspect the System for any signs of damage before use. Do not use it if it is cracked
or wet.If you suspect damage to the device, call eNeura at: +1 833.499.9300 option
1 for assistance.
Do not operate the System in or near an area where explosive gases are being used
or have been used. Do not operate near gasoline or natural gas.
Do not operate the System in or near the presence of a FLAMMABLE ANESTHETIC
MIXTURE WITH AIR or WITH OXYGEN or NITROUS OXIDE.
Risk of electrical shock. Do not open the System. There are no parts that can be
serviced or replaced by the user. High voltage may be present.
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.
Do not use the System if the cause of your headache is illness, underlying pathology,
trauma or overuse of medication.See your physician if you are uncertain.
Do not use the System if you have suspected or diagnosed epilepsy or a personal or
family history of seizures. Consult your physician before using the System if a family
member has epilepsy or seizures or if you have had seizures, a head trauma or head
injury or take any medication such as tricyclic antidepressants, neuroleptic agents, or
other drugs that lower the seizure threshold.
Do not use the System if you have a history of stroke.
The System has not been demonstrated as safe or effective when treating cluster
headache.
Do not use the System if you use a wearable cardioverter defibrillator (WCD).
The long-term effects of chronic magnetic stimulation are unknown.
Transcranial magnetic stimulation should only be applied to the back of the head as
described in the “Using Your Device” section of this manual.
Do not stimulate over the front of the neck or mouth.Severe spasm of the laryngeal
and pharyngeal muscles may occur, and the contractions may be strong enough to
close the airway or cause difficulty in breathing.
Do not stimulate over the upper side of the neck.Stimulation of the carotid sinus
nerves, particularly in patients with a known sensitivity to the carotid sinus reflex,
could result in a sudden drop in blood pressure, slowing of the heart or loss of
consciousness.
Do not stimulate the chest or back. The induction of electrical current into the heart
may cause cardiac arrhythmias.

SAVI Dual™ Migraine Therapy Instructions for Use 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 has been prescribed by your doctor
for your use only. The System may not be used in patients who have metals, conductive materials, or metal-
containing implants in their head, neck or upper body. Metals and conductive materials can be affected by a
magnetic field. You should discuss this with your doctor before use.
Do not use the System if you have a cardiac pacemaker, vagus stimulator (VNS) or other implanted
neurostimulator, implanted cardioverter defibrillator (ICD) or any implanted medical device that stimulates the
body or uses any signal from the body.
Talk to your doctor before using the System if you receive an implant. Patients with implants affected by a
magnetic field should not use the System.Examples of such implants include:
•Aneurysm clips or coils
•Radioactive seeds
•Cochlear implants
•Metallic artificial heart valves
•Cerebral spinal fluid shunts
•Stents
•Bullets or pellets lodged in the head or upper body
•Filters
•Metal plates, screws, staples or sutures in skull,
neck, shoulders, arms or hands
•Magnetically programmable shunt
valves
•Facial tattoos with metallic ink
•Electrodes
Dental implants, fillings or other dental appliances are okay and are not affected by the device.
NOTE: If you have an implanted medical device but are not sure if it has metals or
conductive materials, please talk to your doctor before using the SAVI Dual™.
WARNING: The System should not be used while driving, operating machinery or during
any activity in which involuntary muscle contractions may put the user at risk of
injury.
Stay at least 2 feet (0.6 meter)from others when using the System.The System could
be harmful to anyone with an electronic implant such as a pacemaker. Anyone with
a hearing aid or cochlear implant may hear an audible click.
The device could be disrupted by RF-emitting equipment including: wireless home
network devices, mobile phones, cordless telephones and their base stations and
walkie-talkies. See “EMC Compliance and Warning Statement” section for additional
information on preventing unwanted interference.

SAVI Dual™ Migraine Therapy Instructions for Use 7
•Precaution: Keep the System away from other electronic devices that depend-on
(receive) or radiate (transmit) radio frequency energy, when it is powered on.
•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.
•Keep credit cards, audio/video tapes, computers, computer disks, flash memory
sticks, cell phones, personal digital assistants (PDAs), MP3 players, headphones,
digital cameras, portable glucose meters and other electronic devices or electronic
storage media more than 2 feet (0.6 meter)away from the System when it is in use.
•Keep any loose metal objects such as eyeglasses, keys, coins, jewelry, watches and
hair clips more than 2 feet (0.6 meter)away from the System when it is in use.
•Keep wearable medical devices such as insulin pumps, medicinal pumps, monitors,
bone grow stimulators and Transcutaneous Electrical Nerve Stimulator (TENS) devices
more than 2 feet (0.6 meter)away from the System when it is in use.
•Safety and effectiveness have not been established in pregnant women and children
under the age of 12.
•Caution should be used for patients with suspected or diagnosed heart problems.
•The System is only intended to be serviced or maintained by the manufacturer. Do
not attempt to open the device.The warranty may be invalidated. If the device is
opened, contact eNeura at: +1 833.499.9300 option 1.
•Keep the System out of the reach of children.
•Side effects can include minor dizziness, nausea, vomiting, application site tenderness,
muscle spasm, headache and migraine.
•Special precautions regarding Electromagnetic Compatibility (EMC) are required when
installing and using the 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.
Clinical Trial and Adverse Reactions
eNeura completed a clinical study in Headache Centers in the United States designed to support safety and
effectiveness of the device for the acute treatment and prophylaxis of migraine headache. Baseline medication
and symptoms were recorded for 28 days via patient diary. Subjects were instructed to use the device daily
(morning and evening) and for the acute treatment of attacks for three months with no change in preventive
medication. Study results showed statistically significant reduction in migraine headache days of 2.8 days from a
baseline mean of 9.1 days. Forty-six percent of the patients saw at least a 50% reduction in headache days
(responder rate). Reduction in acute medication was 2.9 days. A statistically significant improvement in quality of
life was reported. 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. 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.*
For further information about the clinical trial and any adverse reaction, please contact eNeura at 1-833-499-9300,
option 1 or consult your prescribing physician.
*Macedo A, Banos JE, Farre M. Placebo response in the prophylaxis of migraine: a meta-analysis. Eur J Pain 2008;
12;68-75

SAVI Dual™ Migraine Therapy Instructions for Use 8
Your 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 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.DWG-0505)
NOTE: Do not discard the box or packing materials.
They will be required if you need to return this
product.

SAVI Dual™ Migraine Therapy Instructions for Use 9
Getting to Know Your Device
A. Power Button In the center of the panel on the top of the System.Press the power button to turn
the device on and off.
B. Power Indicator LED light on the top of the System inside the Power button. Static white illumination
shows the device is on and ready.Pulsing blue illumination indicates device is connecting to the cellular network
to transfer data or upload prescription data.
C. Treatment Progress Indicator LED light around the power button on the top of the System, shows
status as it prepares for treatment.
D. Prescription Status Indicator 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; static orange with orange Power Button indicates Rx has expired.
E. Contact eNeura Customer Care Action required. Call Customer Care.
F. Temperature warning The device temperature is not in range for safe use.
G. Lock Indicator On the right of the Power button.Indicator is visible when device is turned on if the security
lock switch is enabled.
H. AC Adapter On the right of the Power button. Indicator is lit when the AC adapter is connected to the
device.
I. Battery Capacity On right side on the top of the System. Indicates whether or not battery power is
enough to allow treatment. White illumination indicates battery power is available; orange illumination indicates
battery power will soon be or has been exhausted.
J. Treatment Buttons 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.
A
B
C
F
G
H
I
J
D
E

SAVI Dual™ Migraine Therapy Instructions for Use 10
Battery Charger (Power Supply) and Micro-SIM Rx card Ports
K. Lock ON/OFF Switch –Located behind accessory port door, on the left. Slide the switch to the left or right to
unlock or lock the device.
L. Volume ON/OFF Switch – Located behind accessory port door, on the right. Slide the left or right to turn the
sound on or off
M. Battery Charger Port – Located behind accessory port door, in the center. Recharge the batteries by plugging
the AC battery charger, DWG-0505, into this port.
AC battery charger 12V DC
1.5A 18 watts
(reorder no.DWG-0505)
Plug that connects to
the System
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.
•Precaution: Use only eNeura-supplied accessories with your System: Battery charger
(reorder no. DWG-0505) and micro-SIM Rx card.
M
N
L
K
Door side of device, with door open

SAVI Dual™ Migraine Therapy Instructions for Use 11
Using Your SAVI Dual™
•Precaution: Prior to use of the System, this manual must be completely read and
understood.Improper use may cause personal injury and damage to the System and
may void the warranty.
•You, as the user of the System, must become familiar with the functions and features
of the device prior to use.
Setting Up the Device
Be prepared to treat your migraine when needed.Set up your SAVI Dual™ as soon as it arrives and keep your
device charged and ready to treat.
NOTE: Use only as directed.The device should only be used per the instructions of
your physician who prescribed the System.
Remove the System and the battery charger from the box.
NOTE: Do not discard box or packing materials. They will be required if you need to
return this product.
Your device should arrive ready to use. If it is not ready, plug the battery charger into a standard wall outlet.
Connect the other end of the battery charger to the port on the device. Charge the battery for about 4 to 6
hours.
Treatment delivery is not available during battery charging.
If the device is on while charging, the AC adapter symbol and the battery capacity symbol will be lit.
Unplug the battery charger when the device is fully charged. A fully charged battery should deliver at least 12
treatments.
Keep the accessory door closed when not in use.
Store the device and its battery charger in a cool, dry place, away from excessive dust and direct sunlight.
•Precaution: Only use the battery charger (DWG-0505) included with the SAVI Dual.
Contact eNeura if you have any questions.
Recommended Treatment
The treatment with the SAVI Dual should be performed per the instructions of your prescribing physician.
Prevention
Treat with 4 pulses each morning and evening
Acute
4 sequential pulses at the earliest indication of an attack
After a brief pause, if you do not experience symptom relief, you can treat again as needed.
Read the instructions below prior to operating the device. Then, follow the entire procedure as described below.
Consult your physician for additional treatment information.
NOTE: Become familiar with the System and how to use it before you experience a migraine.

SAVI Dual™ Migraine Therapy Instructions for Use 12
Preparing for Treatment
Consult your doctor about your specific condition and the best timing of your SAVI Dual treatment.
•Precaution: Keep the System away from other electronic devices that depend-on
(receive) or radiate (transmit) radio frequency energy, when it is powered on.
•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.
•The System emits a strong magnetic pulse that may interfere with the operation of
common home electronic devices such as radios, televisions, wireless network
routers, mobile phones, cordless telephones and their base stations and walkie-
talkies, if they are not installed and used in accordance with the manufacturer’s
instructions. There is no guarantee that interference will not occur in a particular
installation.If the System causes interference with other devices, try to correct the
matter by:
oReorienting or relocating the device receiving the interference.
oIncrease the separation distance between the System and the device.
oConnect the System to an AC outlet on a circuit different from that to which
the other device is connected.
Use the System in a comfortable, seated position. Remove the System from its storage location.
WARNING: Inspect the System for any signs of damage before use.Do not use if it is
cracked or wet.If you suspect damage to the device, call eNeura at +1 833.499.9300
option 1 for assistance.
The System needs to be in direct contact with the back of your head to work properly.Before treatment, remove
any hat, head covering, or hairpiece that covers the back of your head and undo any braids, ponytails or buns.
WARNING: Remove any personal medical devices such as insulin pumps or other
medical pumps and bone growth stimulators.
Press the power button
Watch the LED track light progress around the power button:
It takes 30-60 seconds to prepare the System for treatment.
As the device prepares for treatment, each segment will light up to indicate progress.
When the system is ready, the device lights up all 6 segments and sounds an audio tone:
Once the System is ready, you have 45 seconds to position the device and deliver treatment.

SAVI Dual™ Migraine Therapy Instructions for Use 13
WARNING: 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.
Do not use the System if you use a wearable cardioverter defibrillator (WCD).
The System should not be used while driving, operating machinery or during any
activity in which involuntary muscle contractions may put you at risk of injury.
Risk of electrical shock: Do not allow the System or power cords to get wet. Quickly
wipe up spills on or near the device. Do not use the device 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.
Do not operate the System in or near an area where explosive gases are being used
or have been used. Do not operate near diesel fuel, gasoline or natural gas.
Do not operate the System in or near the presence of a FLAMMABLE ANESTHETIC
MIXTURE WITH AIR or with OXYGEN or NITROUS OXIDE.
Do not use the System if the cause of your headache is illness, trauma or excess
medication. Consult your doctor if you are unsure.
Do not use the System if you have suspected or diagnosed epilepsy. Consult your
doctor before using the System if a family member has epilepsy. Consult your doctor
if you have had a head trauma, head injury or take any medication such as tricyclic
antidepressants, neuroleptic agents or other drugs that lower the seizure threshold.
Do not use the System if you have a history of stroke.
Caution should be used for patients with suspected or diagnosed heart problems.
•Precaution: Keep the SAVI Dual away from metal or conductive objects, medical
devices and magnetic media when it is powered on.
•When activated, the System emits a strong magnetic pulse and may interfere with
other metal, electronic or magnetic products within 2 feet (0.6 meter). A person with
a hearing aid or cochlear implant may hear a click when the System is activated.
•The operation of the SAVI Dual System may be impaired when operated near home
devices such as wireless network routers, mobile phones, cordless tele- phones 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 being used.
oMove credit cards, audio/video tapes, computers, computer disks, flash
memory sticks, cell phones, personal digital assistants (PDAs), MP3 players,
headphones, digital cameras, portable glucose meters and other electronic
devices or electronic storage media more than 2 feet (0.6 meter) away from
the System.
•Remove all metal objects from your head, face, neck, arms and hands.Remove
eyeglasses, hearing aids, removable metallic orthodontic appliances, hair clips and
earphones and move them more than 2 feet (0.6 meter) away from the System.
•Remove any loose metal objects from your shirt pockets such as keys, coins, clips,
pens and mechanical pencils and move them more than 2 feet (0.6 meter) away from
the System.

SAVI Dual™ Migraine Therapy Instructions for Use 14
Positioning the Device
With the SAVI Dual in front of you: The treatment buttons should be facing up and the accessory door should
be facing away from you. Place your hands on the sides of the device with your thumbs on the treatment
buttons.
Lift the System over your head. The device should be placed so that it comfortably and naturally cradles the
base of your skull.Hold it firmly against your head.
The curved surface positions the device to fit comfortably against the head and optimize pulse delivery.
WARNING: Transcranial magnetic stimulation should only be applied to the back of
the head as described in the “Positioning the Device” section of this manual.
Do not stimulate over the front of the neck or mouth.Severe spasm of the laryngeal
and pharyngeal muscles may occur.Contractions may be strong enough to close the
airway or cause difficulty breathing.
Do not stimulate over the side of the neck.Stimulation of the carotid sinus nerves,
particularly in patients with a known sensitivity to the carotid sinus reflex, could
result in a sudden drop in blood pressure, slowing of the heart or loss of
consciousness.
Do not stimulate the chest or back.Electrical current into the heart may cause
cardiac arrhythmias.
NOTE: If the device detects an error when it is on, a symbol is displayed. See the
“Understanding System Display Messages” and “Troubleshooting” sections of this manual.
NOTE: The System is a handheld device that comes in direct contact with skin.The housing
of the device is made of polycarbonate, a plastic common in consumer medical products,
and poses no handling risk.

SAVI Dual™ Migraine Therapy Instructions for Use 15
Delivering the Treatment
NOTE: Two hands are needed to stabilize the device, but only one treatment button
needs to be activated to deliver treatment.
NOTE: The device shuts itself off if treatment is not delivered within 45 seconds.Press
the power button to turn the device back on and restart the treatment procedure.
Once the device is in place and your thumbs are on the treatment switches, press one or both switches and
hold for at least 2 seconds.
The device emits a soft, audible click as the treatment is delivered.
After you have successfully delivered the first pulse, remove the device from your head.
The LED light on the POWER button softly pulses to show that treatment is completed. The device is now
ready for another pulse. You may select to treat again by pressing the power button.
Repeat the subsequent procedures from page 15, Positioning the Device.
After delivering the final pulse and 30 seconds of inactivity, the device will attempt to connect to a cellular
network, transfer treatment history to your SAVI Smart Diary™ and will then power off.
While the power button is lit BLUE place the device on a flat surface at least 8 inches (20 cm) away from you,
other people and electronic equipment.
Delivery of several pulses in a row may cause the device’s surface temperature to exceed 105.8°F (41°C). The
surface may get as warm as 118.4°F (48°C). Let the device cool for 15 minutes. Try again.
Renewing Your SAVI Dual Prescription by Cellular Network
NOTE: The System is intended for use under the care of a doctor. For more
information on renewing your prescription, please contact eNeura Customer Care.
An active prescription is required.
NOTE: The System only delivers treatment if the programmed prescription has not
expired.
The device will display an ORANGE warning light when your prescription is about to expire:Renew your
prescription promptly.
Contact Customer Care to request a refill if you are not enrolled in the SAVI Dual monthly subscription
program.
Upon receipt of payment, eNeura Customer Care will initiate reactivation of your device via the cellular
network.
Ensure the System lock switch is in the OFF position and the AC adapter is NOT connected to your device.
Press the Power Button on your device. After approximately 30 seconds, pulsing blue illumination on the
Power Button indicates the device is connecting to the cellular network to transfer treatment history to
your SAVI Smart Diary or download a new prescription.
After the device has successfully connected to a network, the new Rx data will transfer, and the ORANGE Rx
warning light will become white again. You may resume use.
Contact eNeura Customer Care if you are in a low or no-cell service area or if your device does not connect to
the network. A micro-SIM card can be provided to renew your prescription.

SAVI Dual™ Migraine Therapy Instructions for Use 16
Additional Information
Battery Capacity Indicator
Your SAVI Dual has rechargeable batteries.The battery capacity indicator on your device shows how much charge
is remaining in the battery.eNeura recommends that you keep your device’s battery charged so that it is always
ready when you need it. Typically, a fully charged battery can deliver 18 treatments. Your battery pack life is
roughly a minimum of 100 charge cycles.
Recharging the Battery
To recharge your battery, push the round plug on the battery charger into the battery charger port on the
back of the device.Plug the battery charger into a standard wall outlet.
The AC adapter must be disconnected to allow the device to connect to a cellular network. Wait for the device
to shut itself off before connecting the AC adapter.
The AC adapter, power button and battery power indicator symbols will be lit for approximately 10 seconds
when the AC adapter is connected to the device. After 10 seconds, the lights will shut off while the AC adapter
continues to charge the battery pack.
Treatment while recharging is disabled for safety. To use the device for treatment, unplug the battery charger
and proceed with your treatment.
WARNING: The battery charger cable may present a strangulation or trip hazard if
the System is left unattended around infants and small children. Recharge the
System’s battery in a safe location, away from foot traffic and children.Store the
battery charger in a safe place when not in use.
Locking the System/Airplane Mode
The System lock switch is located beneath the Accessory door.
The System lock may be controlled by sliding the switch to the desired position
(ON or OFF).
When the System is locked, the device will prevent others from using it by disabling treatment
functionality.
The System lock switch must be OFF to allow the device to connect to a cellular network. Wait
for the device to shut itself off before you lock it.
Activating the System lock switch places the device in Airplane Mode. Place the System in
Airplane Mode whenever you are in a location where use of cellular devices is discouraged or forbidden.

SAVI Dual™ Migraine Therapy Instructions for Use 17
Adjusting the Audible Tone
The System sounds an audible tone when the device is ready to deliver a treatment.
The switch to control the audible tone is located beneath the Accessory door.
Slide the switch to the desired position (ON or OFF).
Traveling with your SAVI Dual
Your SAVI Dual may travel with you.Place the device in Airplane Mode as explained on page 16 (see “Locking
the System/Airplane Mode”) and pack it securely to avoid damage during travel. Before using the unit after
traveling, check it for any damage to ensure it appears to be working correctly before you use it.
Whenever possible, pack your SAVI Dual in a carry-on rather than in checked luggage.
At security, remove your SAVI Dual 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.
oSecurity may wipe down the device with a chemically sensitive wipe, which is a standard security
procedure and will not harm the device.
For international travel, use the correct universal travel power adapter. A power converter is not needed.
Only use the AC adapter that was provided with the System.
Caring For Your SAVI Dual
Inspect your device regularly
Before using your SAVI Dual always check to make sure your device is in good working order.If you notice
damage to the exterior of the device or rattling when you shake the device DO NOT USE the device and
contact your eNeura representative for a replacement.
Rechargeable Battery
The rechargeable battery in the SAVI Dual is in a sealed compartment and may only be replaced by a trained
service technician. If the battery fails to recharge, please contact Customer Care to arrange for a device
exchange.
Cleaning Procedure
eNeura recommends cleaning the SAVI Dual every three months, similar to the way you would clean a
telephone handset.It may be necessary to clean the System more often if it becomes dirty or sticky.It may
be cleaned as many times as needed.
Only the external surfaces of the System may be cleaned.Wipe dust and lint away with a dry cloth. Take care
not to drip or spray liquid directly onto your device or get liquid into any of the ports, the buttons or the
display.Dampen a soft cloth in water premixed with a mild detergent or an alcohol- based, hospital-grade,
hand-disinfecting solution.Wring out any excess liquid, and then wipe the device.Immediately dry the device
with a soft dry cloth to make sure that no liquid remains on the surface.
Do not use any spray cleaners because fluid should not enter openings. Do not use detergents or other
cleaning solutions to clean the display.
•Precaution: Disconnect the SAVI Dual from the battery charger prior to cleaning.
NEVER immerse the System.Do NOT drip or splash any liquid on the device. Contact
eNeura Customer Care if the device gets wet.Do not attempt to sterilize the System.

SAVI Dual™ Migraine Therapy Instructions for Use 18
Understanding System Display Messages
If your device displays one of the following images, please take the steps listed to clear the message.
White Battery symbol with 4 bars indicates the charge is full
Orange Battery symbol indicates the battery charge is low
The rechargeable battery charge is low. There is only enough power to deliver approximately 10
treatments so charge the battery at your earliest convenience.
Charge the battery for at least 15 minutes. To fully charge the battery, allow the device to charge for
about 4 hours.
If the problem persists, check that only the eNeura battery charger (DWG-0505) is in use. Check that the
battery icon on the display is lit to show it is charging.
If the problem persists, contact eNeura Customer Care for help.
Rx symbol (WHITE) indicates an active prescription
If the Rx symbol is white, the installed prescription is valid and active.
Rx symbol (ORANGE) indicates the prescription expires in less than 15 days
If the Rx symbol is orange, please contact eNeura Customer Care to order a new prescription refill. An
active prescription is required.
Rx symbol (ORANGE and pulsing) indicates an invalid micro-SIM card has been installed
If you have a micro-SIM Rx card installed in the device and the Rx symbol is orange and pusling, the SIM
cannot be read by your device and may be invalid.
Turn off the device, remove and reinstall the micro-SIM Rx card.
If the issue persists, contact eNeura Customer Care for assistance.
Rx0 symbol (ORANGE) indicates your prescription expired
The prescription installed in the device has expired and can no longer be used.Each prescription is valid
for a specific date range based on the prescription issued by your doctor.
If you need a new prescription, contact eNeura Customer Care to order a refill. An active prescription is
required.eNeura can contact your physician if a renewal prescription is required. eNeura can contact
your physician if a renewal prescription is required.
Security Lock Enabled
The security lock is enabled, and the device is non-operable. To unlock the device and make the device
operable, slide the lock switch to the “off” position. The lock switch is located behind the accessory-port
door.
When enabled, the security lock places the System into Airplane Mode and will prevent cellular
transmissions from the device.

SAVI Dual™ Migraine Therapy Instructions for Use 19
Device temperature not in operating range
The device does not operate when its temperature is below 16°C (60°F) or above 40°C (104°F).Move the
device to a more temperate environment, such as inside your home or office, and wait 15 minutes.Try
again.
•Precaution: Do NOT actively heat or cool your SAVI Dual in any way.
Service needed - Contact eNeura Customer Care
If this symbol appears with the Prescription low or expired symbol, contact Customer Care to renew or
refill your prescription: [phone], option 1
Otherwise, this symbol means service is needed and the device will not deliver treatment. Contact
Customer Care for assistance.
Treatment not allowed (ORANGE power button)
If this symbol appears with the Prescription Expired, Device Locked, Battery Low, Charger Connected or
other symbols, then the device will prohibit treatment until the other system messages are cleared. Clear
these symbols. Restart the device.
Contact eNeura Customer Care for help if ONLY the ORANGE power button is illuminated or if it is
presented with the “Service needed” symbol.
If treatment is not allowed due to a device failure, an expired or invalid prescription, or temperature out
of range condition, then, after 30 seconds of inactivity, the device will attempt to connect to a cellular
network, transfer data and power off. During data transfer, the power button indicator will pulse blue.
Device connecting to a cellular network (BLUE and pulsing power button)
This symbol appears when the device is connecting to a cellular network to upload treatment history to
your SAVI Smart Diary™ or download a new Rx. The device will automatically shut down after it has
completed the connection.
While the power button is lit Blue place the device on a flat surface at least 8 inches (20 cm) away from
you, other people and electronic equipment.
Troubleshooting
None of the device indicator lights are on
The device may not be powered on. Press the power button for at least one second.
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.
If the problem persists, contact eNeura Customer Care for assistance.
WARNING: There are no user serviceable parts inside.Do not attempt to open the
device, as it could expose user to hazardous voltages.Do not try to modify the unit
in any way.

SAVI Dual™ Migraine Therapy Instructions for Use 20
The device is charging correctly, but I can’t make it deliver a treatment.
Check the power button indicator to confirm the device is ready for treatment.
Check the lock switch to make certain it is not locked.
Disconnect the battery charger if it is connected to the device.
An active prescription may not be installed or may have expired. Check the indicator and contact eNeura
Customer Care to order a refill.
The device may be too warm or too cold. Check the indicator. The device does not operate when its
temperature is below 15°C (60°F) or above 40°C (104°F).Move the device to a normal indoor environment
and wait 15 minutes before trying again.
•Precaution: Do NOT actively heat or cool your SAVI Dual in any way.
Service
For questions about your SAVI Dual, please call or email Customer Care at eNeura.
Please have your device available when calling eNeura Customer Care.
When the System is no longer usable, return it to eNeura Customer Care. Do not dispose of the device.For
questions, contact eNeura Customer Care for assistance.
•Precaution: Only authorized service personnel should service or repair components of
the SAVI Dual.There are no user serviceable parts.Improper service, repair or
modifications performed by unauthorized personnel may pose a hazard and void the
warranty. Do not heat, incinerate or dispose of the device.