AtriClip FLEX Device

MRI SAFETY INFORMATION:

MR CONDITIONAL

The LAA Exclusion System Clip is MR Conditional. A patient with the LAA Exclusion System Clip may be safely scanned under the following conditions. Failure to follow these conditions may result in injury to the patient:

• Nominal Values of Static Magnetic Field: 1.5-Tesla or 3.0-Tesla
• Maximum Spatial Field Gradient: 40 T/m (4,000 gauss/cm)
• Type of RF Excitation: Circularly Polarized (CP) (i.e., Quadrature Transmission)
• Transmit RF Coil Information: There are no transmit RF coil restrictions.
• Operating Mode of MR System: Normal Operating Mode
• Maximum Whole Body Averaged SAR: 2-W/kg (Normal Operating Mode)
• Limits on Scan Duration: Whole body averaged SAR of 2-W/kg for 60 minutes of continuous RF exposure (i.e., per pulse sequence or back-to-back sequences/series without breaks)
• MR Image Artifact: The presence of this implant produces an imaging artifact. Therefore, carefully select pulse sequence parameters if the implant is located in the area of interest.