Use Instructions

DRAFT 2/12/2019 SPW 4
Intended Use
The sTMS mini (The System) is indicated for the acute and prophylactic treatment of migraine headache.
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. This type of
stimulation is called single-pulse Transcranial Magnetic Stimulation or sTMS.
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 sTMS mini out of the reach of children.
 Safety and effectiveness have not been established in pregnant women, children under the age of 18
and adults over the age of 65.
 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 sTMS mini.
 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.