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