SAVI Dual™ Migraine Therapy Instructions for Use 13
WARNING: Stay at least 2 feet (0.6 meter) from others when using the SAVI Dual.
This device could be harmful to anyone with an electronic implant such as a
pacemaker.
Remove any personal medical devices such as insulin pumps, other medicinal pumps,
bone growth stimulators, Transcutaneous Electrical Nerve Stimulator (TENS) devices
and hearing aids.
Do not use the System if you use a wearable cardioverter defibrillator (WCD).
The System should not be used while driving, operating machinery or during any
activity in which involuntary muscle contractions may put you at risk of injury.
Risk of electrical shock: Do not allow the System or power cords to get wet. Quickly
wipe up spills on or near the device. Do not use the device 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 operate the System in or near an area where explosive gases are being used
or have been used. Do not operate near diesel fuel, 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.
Do not use the System if the cause of your headache is illness, trauma or excess
medication. Consult your doctor if you are unsure.
Do not use the System if you have suspected or diagnosed epilepsy. Consult your
doctor before using the System if a family member has epilepsy. Consult your doctor
if you have had a head trauma, 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.
Caution should be used for patients with suspected or diagnosed heart problems.
• Precaution: Keep the SAVI Dual away from metal or conductive objects, medical
devices and magnetic media when it is powered on.
• When activated, the System emits a strong magnetic pulse and may interfere with
other metal, electronic or magnetic products within 2 feet (0.6 meter). A person with
a hearing aid or cochlear implant may hear a click when the System is activated.
• The operation of the SAVI Dual System may be impaired when operated near home
devices such as wireless network routers, mobile phones, cordless tele- phones and
their base stations, and walkie-talkies. Keep the SAVI Dual device at least 2 feet (0.6
meter) from these devices when it is powered on and being used.
o Move credit cards, audio/video tapes, computers, computer disks, flash
memory sticks, cell phones, personal digital assistants (PDAs), MP3 players,
headphones, digital cameras, portable glucose meters and other electronic
devices or electronic storage media more than 2 feet (0.6 meter) away from
the System.
• Remove all metal objects from your head, face, neck, arms and hands. Remove
eyeglasses, hearing aids, removable metallic orthodontic appliances, hair clips and
earphones and move them more than 2 feet (0.6 meter) away from the System.
• Remove any loose metal objects from your shirt pockets such as keys, coins, clips,
pens and mechanical pencils and move them more than 2 feet (0.6 meter) away from
the System.
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