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.