LUX-Dx
Model M302 | Boston Scientific Corporation | ICM
Models with the same MRI conditions
M301, M302, M312
The MRI conditions shown are based on the manufacturer's official guidelines.
Do not apply them to models not listed above; search for that model separately. Search models →
MR Conditional
Important alert
- Do not conduct an MRI scan if any conditions or implants prohibit it.
1Pre-scan checks
- Patient has a LUX-Dx, LUX-Dx II, or LUX-Dx II+ ICM model number M301, M302, or M312 inserted.
- Adherence to the Conditions of Use must be verified prior to each scan to ensure that the most up-to-date information has been used to assess the patient’s eligibility and readiness for an MR Conditional scan.
- The physician should ensure the patient has no other devices that are known to pose a hazard in an MR environment.
- If the radiology staff has questions about whether the patient should receive an MRI scan, the staff should contact the patient’s cardiologist.
2MRI scan conditions
1.5 T
| Scanner type | Horizontal, 1H proton, closed bore scanners only |
|---|---|
| Spatial gradient | Spatial gradient no greater than 30 T/m (3,000 G/cm) |
| Gradient slew rate | Gradient Field limits: Maximum specified gradient slew rate ≤ 200 T/m/s per axis |
| Operating mode | SAR limits up to First Level Controlled Operating Mode may be applied for the entire active scan session |
| Whole-body SAR | Whole body averaged, ≤ 4.0 W/kg |
| Head SAR | Head, ≤ 3.2 W/kg |
| Scan region / position conditions | • There are no restrictions for positioning the device within the integrated body coil of the MRI scanner.• Patient in supine or prone position only |
3.0 T
| Scanner type | Horizontal, 1H proton, closed bore scanners only |
|---|---|
| Spatial gradient | Spatial gradient no greater than 30 T/m (3,000 G/cm) |
| Gradient slew rate | Gradient Field limits: Maximum specified gradient slew rate ≤ 200 T/m/s per axis |
| Operating mode | SAR limits up to First Level Controlled Operating Mode may be applied for the entire active scan session |
| Whole-body SAR | Whole body averaged, ≤ 4.0 W/kg |
| Head SAR | Head, ≤ 3.2 W/kg |
| Scan region / position conditions | • There are no restrictions for positioning the device within the integrated body coil of the MRI scanner.• Patient in supine or prone position only |
3RF COIL / RF excitation
| RF coil | • The use of receive-only coils is not restricted.• Local transmit-only coils or local transmit/receive coils may be used, but should not be placed directly over the device. |
|---|
4Other information
- Scanning patients who have other MR Conditional devices is acceptable if all the MR Conditional requirements for each of the implanted devices are met.
- The mobile devices and magnet are MR Unsafe and must remain outside the MRI site Zone III (and higher) as defined by the American College of Radiology Guidance Document for Safe MR Practices. Under no circumstances should the mobile device or magnet be brought into the MRI scanner room, the control room, or the MRI site Zone III or IV areas.
- Image artifacts and distortion may extend beyond the boundaries of the device and must be considered when planning an MRI scan as well as in interpreting MRI images in proximity to the device.
- In non-clinical 1.5 T and 3 T testing, the maximum image artifact associated with the device extended approximately 4.5 cm radially from the device when testing with spin-echo sequencing in a 3 T MRI system.
- MRI scanning of patients when the Conditions of Use are met could result in the following potential adverse events: Patient discomfort due to slight movement or heating of the device
- The system response to conditions other than those listed above for the radiology conditions has not been evaluated.
These conditions are based on the source document shown below (revision and date). Before scanning, verify the patient's complete system (device, leads, and any other implants) against the latest manufacturer labeling.