Revo MRI SureScan

Model RVDR01 | Medtronic, Inc. | Pacemaker

Models with the same MRI conditions

RVDR01

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 →

Important alert

  • Do not scan patients who do not have a complete SureScan pacing system, which includes a SureScan device and two SureScan leads.
  • Do not scan patients with previously implanted (active or abandoned) medical devices, leads, lead extenders, or lead adaptors.
  • Do not scan patients with broken or intermittent leads.
  • Required: A SureScan pacing system that has been implanted for a minimum of 6 weeks.
  • Do not scan patients with a SureScan pacing system implanted in sites other than the left and right pectoral region.
  • Do not scan the patient positioned such that the isocenter (center of the MRI bore) is inferior to the C1 vertebra and superior to the T12 vertebra.
  • Do not scan patients with a lead impedance value of < 200 Ω or > 1500 Ω.
  • Do not scan patients with pacing capture threshold values of > 2.0 V at a pulse width of 0.4 ms.
  • Do not scan patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is on, and who have diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms.
  • Confirm lead compatibility with cardiology or the pacemaker clinic.

1Pre-scan checks

    • A complete SureScan pacing system including a Revo MRI SureScan IPG and two SureScan leads is required for use in the MRI environment.
    • No previously implanted (active or abandoned) medical devices, leads, lead extenders, or lead adaptors.
    • No broken leads or leads with intermittent electrical contact.
    • Check that the SureScan pacing system has been implanted for more than 6 weeks.
    • A SureScan pacing system implanted in the left or right pectoral region.
    • A health professional who has completed radiology SureScan training must be present during the MRI scan.
    • 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.
    • The SureScan feature must be programmed to On prior to scanning a patient according to the specified conditions for use.

    2MRI scan conditions

    1.5 T

    Scanner typehydrogen proton magnetic resonance imaging equipment with a static magnetic field of 1.5 T, operating at a frequency of 64 MHz
    cylindrical bore magnet, clinical MRI systems
    Gradient slew rateGradient systems with maximum gradient slew rate performance per axis of ≤ 200 Teslas per meter per second (T/m/s) must be used.
    Operating modeThe scanner must be operated in Normal Operating Mode
    Whole-body SARThe whole body averaged specific absorption rate (SAR) must be ≤ 2.0 watts per kilogram (W/kg).
    Head SARThe head SAR must be < 3.2 W/kg.
    Scan region / position conditions• 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.• Do not scan the patient positioned such that the isocenter (center of the MRI bore) is inferior to the C1 vertebra and superior to the T12 vertebra (see Figure 1). [p. 8]• Localizer scans – All position localizer scans are allowed. These scans may be used to confirm compliance with the patient positioning criteria as described in Section 6.4 during diagnostic scans. If the localizer scan image indicates that the patient is positioned such that the isocenter (center of the MRI bore) is between C1 and T12, reposition the patient and confirm that the new relationship complies with the patient positioning criteria as described.

    3RF COIL / RF excitation

    RF coilUse of transmit/receive and receive-only coils – As long as the patient positioning and centering criteria are followed, there are no restrictions on the use of local transmit/receive coils for imaging of the head or of the extremities, and there are no restrictions on the placement of receive-only coils.

    4Monitoring & emergency response

      • Visual and verbal contact with the patient.
      • The methods include visual and verbal contact with the patient, electrocardiography, and pulse oximetry (plethysmography).
      • An external defibrillator must be available nearby during the MRI scan.
      • If the patient’s hemodynamic function is compromised during the MRI scan, discontinue the MRI scan, remove the patient from the magnet room, and take the proper measures to restore the patient’s hemodynamic function.

      5Post-scan checks

        • Program MRI SureScan to Off.

        6Other information

        • Horizontal cylindrical bore magnet, clinical MRI systems with a static magnetic field of 1.5 Tesla (T) must be used.
        • Images within the C1 vertebra and the T12 vertebra (for example, the cervical spine, elbow, thoracic spine, and liver) may still be obtained as long as the patient positioning criteria are followed. This may require modification of scan sequences.
        • Image artifacts and distortion resulting from the presence of the device and the leads within the field of view must be considered when selecting the field of view and imaging parameters. These factors must also be considered when interpreting the MRI images. Significant image distortion can result from the presence of the device within the field of view.

        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.

        7Source documents

        Source Title: REVO MRI® SURESCAN® PACING SYSTEM — MRI Technical Manual

        Document No.: M950515A001 A

        Revision / Date: A / 2012-02-13

        Official URL: www.medtronic.com/manualsSearch for document number M950515A001 on this site.