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MRI Safety - Implanted Above Rib 4

Scan Conditions

SenTiva Model 1000, SenTiva DUO™ Model 1000-D, AspireSR Model 106, AspireHC Model 105, Demipulse Model 103

MRI Safety - Scan Conditions

The following scan conditions apply for a cylindrical closed-bore 1.5T or 3.0T scanner.

The device has been evaluated for MRI induced risks, including heating, unintended stimulation, force, torque, device malfunction and device vibration and has been determined to be safe under the conditions specified in labeling; however, the patient may feel sensations of warmth or vibration at the implant site during the MRI scan.

Scan conditions - Latest VNS Therapy technology

*Demipulse Model 103, AspireHC Model 105, AspireSR Model 106, SenTiva Model 1000, SenTiva DUO™ Model 1000-D.

MR Conditional
MR Conditional
Yes
Static Magnet Strength 1.5T or 3T
Scanner Type Horizontal field, cylindrical closed-bore
Operating Model Normal Operating Mode
Exclusion Zone Body Coil: C7-L3
Transmit-receive head or extremity coil: C7-T8
Max Spatial Gradient ≤3000 Gauss/cm
Max Skew Rate 200 T/m/s
RF Coil Transmit: Body coil or Transmit-receive head or extremity coils
Receive: No restrictions
Max SAR Transmit head coil: 3.2 W/kg
Transmit body coil: 2.0 W/kg
System Programming Stimulation OFF Sensing OFF*
*for select models with AutoStim mode
Optional device feature OFF (Models 1000 and 1000-D only)
Exposure Time Transmit head of extremity coil: No restrictions
Transmit body coil: ≤15 minutes of active scan time within a 30 minute window
Additional Restrictions Transmit head or extremity coil: none
Transmit body coil: Circularlized Polarized mode only
NOTE: MRI scans using a body coil have not been approved in all geographies.
Always review the most current labeling prior to performing an MRI scan.
For MRI Safety information, refer to MRI Instructions For Use.

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