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 rib 4 (below armpit level)
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
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 rib 4 (below armpit level).
 MR Conditional |
Yes |
|---|---|
| Static Magnet Strength | 1.5T or 3T |
| Scanner Type | Horizontal field, cylindrical closed-bore |
| Operating Model | Normal Operating Mode |
| Exclusion Zone | C7-T8 |
| Max Spatial Gradient | ≤3000 Gauss/cm |
| Max Skew 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 (Models 1000 and 1000-D only) |
| Exposure Time | Transmit head of 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 labeling prior to performing an MRI scan.
For MRI Safety information, refer to MRI Instructions For Use.
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