Before an MRI scan, determine the patient's body temperature. Exceeding the active scan time limit increases the risk of excessive heating and serious patient injury.įever. The total active scan time must be limited to 30 minutes per session with a wait time of 30 minutes between sessions. Do not scan with other transmit coil designs (for example, linear, phased-array, or saddle) as serious patient injury could occur.Īctive scan time. Only use circularly polarized transmit coil designs. Exceeding the SAR or B1+rms limits may cause excessive heating of implanted components, which could result in serious patient injury. Ensure the scanner displays the SAR or B1+rms value prior to starting the scan. For scans requiring maximum SAR <2 W/kg or specific maximum B1+rms value, personnel knowledgeable in MR safety should be involved to optimally plan the scan and actively monitor SAR or B1+rms levels during the scan. These modes allow higher levels of RF energy and may cause excessive heating of implanted components, which could result in serious patient injury. Do not conduct MRI scans in first-level controlled or second-level controlled operating mode. Use of these positions could cause device damage and excessive heating of implanted components, which could result in serious patient injury. Do not scan with the patient in any prone positions or “superman” positions (where the patient's arm is raised above his or her head). Do not scan with other MRI systems, such as 1.0T and 3.0T machines or vertical field orientation machines, as device damage, excessive heating of implanted components, and serious patient injury could occur. Only use 1.5T cylindrical-bore magnet, horizontal field orientation MRI systems. Frequencies other than 64 MHz could cause device damage, excessive heating, and serious patient injury. Do not conduct MRI scans with nonproton scanning frequencies (such as 13C, 23Na, or 31P). If you are unclear what implants are present, perform an X‑ray to determine the implant type and location. Do not conduct an MRI scan if any conditions or implants prohibit it, as serious patient injury could occur. Of all medical device implants, the most restrictive MRI exposure requirements must be used. Prior to an MRI examination, determine whether the patient has multiple medical device implants, either active medical device implants (such as deep brain stimulation systems, implantable cardiac defibrillators, pacemakers) or passive medical device implants (such as spinal hardware, stents). MRI scans may result in excessive heating of the lead electrodes and serious patient injury. Do not perform an MRI scan on patients who have multiple MR Conditional neurostimulation systems for pain (multiple IPGs for pain). Do not perform an MRI scan on patients who have an external neurostimulation trial system or any components that are not fully implanted. The MRI scan may result in excessive heating of the system and serious patient injury. Do not perform an MRI scan on patients who have any portion of their implanted system exposed due to skin erosion. This can be confirmed with X-ray imaging of the neck, head, and extremity regions or by referring to the patient records. Head or extremity MRI scans can be conducted safely using a Detachable Head or Extremity RF transmit-receive coil when no parts of the implanted neurostimulation system are within the transmit-receive coil according to the conditions specified for each system in the MRI labeling. MRI scans of implants that are not located in approved locations can possibly result in increased unintended stimulation, excessive heating at the lead electrodes, and serious patient injury. Lead tips can be located at different spinal epidural levels. Two leads should travel in close proximity to one another from the IPG to the spine. The MR Conditional leads must be implanted in the epidural space and routed subcutaneously to the IPG pocket. Location of implanted system. To meet the MR Conditional requirements, components must be implanted according to the approved locations specified by the MRI labeling. MRI scans of nonfunctional leads may result in excessive heating occurring at the location of the implanted lead electrodes and serious patient injury. There may be a problem with the implanted lead(s).” message displays when attempting to enter MRI mode on the patient controller. Do not perform an MRI scan on patients when the “MRI is Not Advised. Do not perform an MRI scan on patients who have an incomplete neurostimulation system, where a lead is present without the IPG or disconnected from the system. Serious patient injury could occur.Ībandoned devices. Do not perform an MRI scan on patients who have any components of a neurostimulation system that are unapproved for use in an MR environment. The following warnings, precautions, and potential adverse events apply when performing MRI scans on Abbott MR Conditional SCS/DRG systems.
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