Manuals Link

MAGNETIC RESONANCE IMAGING (MRI) ______

Caution: Magnetic resonance imaging (MRI) should not be
performed with a magnetic resonance body coil in the transmit
mode. The heat induced in the Lead by an MRI body scan can cause
injury.

If an MRI should be done, use only a transmit and receive type of
head coil. Magnetic and RF fields produced by MRI may change the
Pulse Generator settings (change to reset parameters) or activate the
device. Stimulation has been shown to cause the adverse events
reported in the ¡°Adverse Events¡± section in the indication-specific
parts of the multi-part physician manuals. MRI compatibility was
demonstrated using a 1.5T General Electric Signa Imager with a
Model 100 only. The Model 102 and Model 102R are functionally
equivalent to the Model 100. Testing on this imager as performed on
a phantom1 indicated that the following Pulse Generator and MRI
procedures can be used safely without adverse events:

�� Pulse Generator output programmed to 0 mA for the MRI
procedure, and afterward, retested by performing the System
Diagnostics (Lead Test) and reprogrammed to the original
settings
�� Head coil type: transmit and receive only
�� Static magnetic field strength: ¡Â2.0 tesla
�� Specific absorption rate (SAR): <1.3 W/kg for a 154.5-lb (70-
kg) patient
�� Time-varying intensity: <10 tesla/sec

Use caution when other MRI systems are used, since adverse events may
occur because of different magnetic field distributions. Consider other
imaging modalities when appropriate.

Caution: Procedures in which the RF is transmitted by a body coil
should not be done on a patient who has the VNS Therapy¢â
System. Thus, protocols must not be used that utilize local coils that
are RF-receive only, with RF-transmit performed by the body coil.
Note that some RF head coils are receive-only, and that most other
local coils, such as knee and spinal coils, are also RF receive-only.
These coils must not be used in patients with the VNS Therapy
System.

MANUALS

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