SAVI Dual™ Migraine Therapy Instructions for Use 6
Contraindications
WARNING: Failure to follow the restrictions listed below could result in serious injury
or death.
The SAVI Dual™ creates a very strong single-pulse magnetic field. The System has been prescribed by your doctor
for your use only. The System may not be used in patients who have metals, conductive materials, or metal-
containing implants in their head, neck or upper body. Metals and conductive materials can be affected by a
magnetic field. You should discuss this with your doctor before use.
Do not use the System if you have a cardiac pacemaker, vagus stimulator (VNS) or other implanted
neurostimulator, implanted cardioverter defibrillator (ICD) or any implanted medical device that stimulates the
body or uses any signal from the body.
Talk to your doctor before using the System if you receive an implant. Patients with implants affected by a
magnetic field should not use the System. Examples of such implants include:
• Aneurysm clips or coils
• Metallic artificial heart valves
• Cerebral spinal fluid shunts
• Bullets or pellets lodged in the head or upper body
• Metal plates, screws, staples or sutures in skull,
neck, shoulders, arms or hands
• Magnetically programmable shunt
valves
• Facial tattoos with metallic ink
Dental implants, fillings or other dental appliances are okay and are not affected by the device.
NOTE: If you have an implanted medical device but are not sure if it has metals or
conductive materials, please talk to your doctor before using the SAVI Dual™.
WARNING: The System should not be used while driving, operating machinery or during
any activity in which involuntary muscle contractions may put the user at risk of
injury.
Stay at least 2 feet (0.6 meter) from others when using the System. The System could
be harmful to anyone with an electronic implant such as a pacemaker. Anyone with
a hearing aid or cochlear implant may hear an audible click.
The device could be disrupted by RF-emitting equipment including: wireless home
network devices, mobile phones, cordless telephones and their base stations and
walkie-talkies. See “EMC Compliance and Warning Statement” section for additional
information on preventing unwanted interference.
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