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PATIENTS

Download here a blank template of the implant card

Download here the leaflet of the implant card

According to Article 18 of EU Regulation 2017/745, the manufacturer shall provide the following information to patients and/or healthcare professionals.

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.

Information on the expected lifetime of the device and any follow-up required

Expected lifetime

The expected life of your implant is shown in the table below. To read the table, use the name of your implant on your implant card labels. Then read the relevant row to find out how long it will last.
Do the same for each on your labels. 
Please note: The expected lifespan may be shorter due to surgical factors and/or your lifestyle (diet, sport, ...).


durée de vie

Post-operator search

After your surgery, it is important to follow these rules:
  • Keep your weight under control
  • Maintain the implant with regular visits to your doctor
  • Maintain care and rehabilitation prescriptions
  • Consult your surgeon if you experience pain, loss of mobility or side effects

Information to ensure safe use of the device by the patient

Composition of materials

The material composition of your implant is shown in the table below. To read the table, use the logos on your implant card labels. Then read the relevant row to find out what it is made of.
Do the same for each of your labels.