Non-clinical testing has demonstrated the Micro Plug Device is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
- Static magnetic field of 1.5 Tesla or 3.0 Tesla
- Maximum spatial field gradient of 3,000-Gauss/cm (30-T/m)
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg (First Level Controlled Operating Mode)
Under the scan conditions defined above, the Micro Plug Device is expected to produce a maximum temperature rise of less than 3°C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the Micro Plug Device extends approximately 6 mm from the Device when imaged with a gradient echo pulse sequence and a 3.0 Tesla MRI system.