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4. SAFETY
4.1. CONDITIONS FOR USE
4.1.1. INDICATION FOR USE
The Nerivio
™ is indicated for acute treatment of migraine with or without aura in patients
18 years of age or older who do not have chronic migraine. It is a prescription use, self-
administered device for use in the home environment at the onset of migraine headache
or aura.
4.1.2. CONTRAINDICATIONS
I.
The device should not be used by people with congestive heart failure (CHF),
severe cardiac or cerebrovascular disease.
II.
The device should not be used by people with uncontrolled epilepsy
III.
The device should not be used by people with an active implantable medical
device, such as a pacemaker, hearing aid implant, or any implanted electronic
device. Such use could cause electric shock, electrical interference or serious
injuries or medical conditions.
4.2. WARNINGS, PRECAUTIONS AND ADVERSE EVENTS
The following icons are used throughout this user manual:
Warning: Indicates a potentially hazardous situation which, if not avoided, could
result in serious injury or death.
Precaution: Indicates a potentially hazardous situation which, if not avoided,
may result in minor or moderate injury to the user or patient or damage to the
equipment or other property.
Note: indicates important information regarding the use of the system
Warnings
Do not attempt to perform any procedure before carefully reading all the
instructions
Do not use the device on the heart, chest, neck, head or any other body location
other than the upper arm, because this could cause severe muscle spasms
resulting in closure of your airway, difficulty in breathing, or adverse effects on
heart rhythm or blood pressure