MRI Safety - Group B
Scan Conditions
Applies to all Pulse™ Model 102, Pulse Duo™ Model 102R, DemiPulse Duo™ Model 104
AND DemiPulse™ Model 103, AspireHC™ 105, ApsireSR™ Model 106, SenTiva™ Model 1000, SenTiva DUO™ Model 1000-D implanted lower than anterior rib 4 (below armpit level)
The following scan conditions apply for a cylindrical closed-bore 1.5T or 3.0T scanner.1
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 labelling; however, the patient may feel sensations of warmth or vibration at the implant site during the MRI scan.1
Scan conditions1
Applies to all Model 100C, Model 101, Pulse™ Model 102, Pulse Duo™ Model 102R, DemiPulse Duo™ Model 104 and DemiPulse™ Model 103, AspireHC™ 105, ApsireSR™ Model 106, SenTiva™ Model 1000, SenTiva DUO™ Model 1000-D implanted lower than anterior rib 4 (below armpit level).
MR Conditional |
Yes |
|---|---|
| Static Magnetic Field Strength | 1.5T or 3T |
| Scanner Type | Horizontal field, cylindrical closed-bore clinical system for hydrogen proton imaging
|
| Operating Mode | Normal Operating Mode |
| Exclusion Zone | C7-T8 |
| Spatial Field Gradient | ≤3000 Gauss/cm |
| Max Slew Rate | 200 T/m/s |
| RF Coil | Transmit-receive head or extremity coils |
| Max SAR | Transmit-receive head coil: 3.2 W/kg |
| System Programming | Stimulation OFF Sensing OFF*
*for select models with AutoStim mode Optional device features OFF (Model 1000 and Model 1000-D only) |
| Exposure Time | Transmit-receive head or extremity coil: No restrictions |
| Additional Restrictions | None |
NOTE: MRI scans using a body coil have not been approved in all geographies.
Always review the most current labelling prior to performing an MRI scan.1
For MRI Safety information, refer to MRI Instructions For Use.
References
1. VNS Therapy™ System MRI Guidelines, October 2023, LivaNova.