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: A NOTE gives special information to ease product use or to explain important
information. NOTES in the manual are shown in a dashed box.
To Next Page
Loading...