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MRI Safety

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)

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

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).

Group B - Requires local transmit-receive coil. Availability may vary.
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 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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