Information to be provided in case of contact
with magnetic resonance imaging (MRI) equipment
Non-clinical tests have shown that X.NOV implants are conditionally compatible with MRI. Patients with this device can be safely examined with an MRI scanner under the following conditions:
- Tunnel cylindrique
- Champ magnétique statique horizontal de 1,5 Tesla ou 3 Tesla
- Spatial gradient of static magnetic field less than or equal to 14.2 T/m and 1420 Gauss/cm
- Radio frequency (RF) field exposure :
- Circular polarisation (CP)
- Whole body transmit antenna only
- Any type of receiving antenna
- Average whole-body SAR (specific absorption rate) limited to normal operating mode (WB-SAR ≤2W/kg including FPO:B)
- Acquisition of up to 9 minutes of continuous RF (multiple successive sequences/scans or one without interruption).
- During non-clinical testing, the device produced a maximum temperature rise of 10.5 ± 0.3 ° C at 1.5 T for a measured WB-SAR of 2.02 ± 0.21 W/kg and a maximum temperature rise of 3.9 ± 0.2 ° C at 3 T for a measured WB-SAR of 2.25 ± 0.23 W/kg both after 15 minutes of continuous scanning
MRI image quality may be compromised if the target imaging area is in the exact same area as the implant.