Advisa MRI Pacing System Conditions for Use

A complete SureScan pacing system, including the Advisa DR MRI SureScan IPG and two SureScan leads, is required for use in the MRI environment. Any other combination may result in a hazard to the patient during an MRI scan. The SureScan feature must be programmed to On prior to scanning a patient according to the specified conditions for use.

Cardiology requirements:

  • Patients and their implanted systems must be screened to meet the following requirements:
    • No previously implanted (active or abandoned) medical devices, leads, lead extenders, or lead adaptors
    • No broken leads or leads with intermittent electrical contact as confirmed by lead impedance history
    • A SureScan pacing system that has been implanted for a minimum of 6 weeks
    • A SureScan pacing system implanted in the left or right pectoral region
    • Pace polarity parameters set to Bipolar for programming MRI SureScan to On
    • Pacing capture thresholds of ≤ 2.0 volts (V) at a pulse width of 0.4 milliseconds (ms)
    • A lead impedance value of ≥ 200 ohms (Ω) and ≤ 1,500 Ω
    • No diaphragmatic stimulation at a pacing output of 5.0 V, and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when the MRI SureScan is on

Radiology requirements:

  • Horizontal, cylindrical bore magnet, clinical MRI systems with a static magnetic field of 1.5 Tesla (T) must be used
  • Gradient systems with maximum gradient slew rate performance per axis of ≤ 200 Teslas per meter per second (T/m/s) must be used
  • The scanner must be operated in Normal Operating Mode:
    • The whole body averaged specific absorption rate (SAR) must be ≤ 2.0 watts per kilogram (W/kg)
    • The head SAR must be < 3.2 W/kg
  • The patient must be positioned within the bore such that the isocenter (center of the MRI bore) is superior to the C1 vertebra or inferior to the T12 vertebra
  • During the MRI procedure, the patient must be continuously monitored, including visual and verbal contact with the patient, and monitoring heart rate using instrumentation such as pluse oximetry (plethysmography) or electrocardiography. An external defibrillator must be available nearby during the MRI procedure.

Training requirements:

  • A health professional who has completed cardiology SureScan training must be present during the programming of the SureScan feature
  • A health professional who has completed radiology SureScan training must be present during the MRI scan

Revo MRI® SureScan® Pacing System Conditions for Use

A complete SureScan pacing system including a Revo MRI SureScan IPG and two CapSureFix® MRI SureScan leads is required for use in the MRI environment. Any other combination may result in a hazard to the patient during an MRI scan. The SureScan feature must be programmed to On prior to scanning a patient according to the specified conditions for use.

Cardiology requirements:

  • Patients and their implanted systems must be screened to meet the following requirements:
    • no previously implanted (active or abandoned) medical devices, leads, lead extenders, or lead adaptors
    • no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history
    • a SureScan pacing system that has been implanted for a minimum of 6 weeks
    • a SureScan pacing system implanted in the left or right pectoral region
    • pacing capture thresholds of ≤ 2.0 volts (V) at a pulse width of 0.4 milliseconds (ms)
    • a lead impedance value of ≥ 200 ohms (Ω) and ≤ 1,500 Ω
    • no diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is On

Radiology requirements:

  • Horizontal cylindrical bore magnet, clinical MRI systems with a static magnetic field of 1.5 Tesla (T) must be used
  • Gradient systems with maximum gradient slew rate performance per axis of ≤ 200 Teslas per meter per second (T/m/s)
    must be used
  • The scanner must be operated in Normal Operating Mode:
    • the whole body averaged specific absorption rate (SAR) must be ≤ 2.0 watts per kilogram (W/kg)
    • the head SAR must be < 3.2 W/kg
  • The patient must be positioned within the bore such that the isocenter (center of the MRI bore) is superior to the C1 vertebra or inferior to the T12 vertebra
  • During the MRI procedure, patient must be continuously monitored, including the following methods: visual and verbal contact with the patient, electrocardiography, and pulse oximetry. An external defibrillator must be available nearby during the MRI procedure.

Training requirements:

  • A health professional who has completed cardiology SureScan training must be present during the programming of the
    SureScan feature
  • A health professional who has completed radiology SureScan training must be present during the MRI scan