EMBLEM MRI S-ICD
Model A219 | Boston Scientific Corporation | S-ICD
Models with the same MRI conditions
A219
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 →
MR Conditional
Important alert
- Required: Patient is implanted with an ImageReady MR Conditional S-ICD System.
- Required: No other active or abandoned implanted devices, components, or accessories present such as lead adaptors, extenders, leads, or pulse generators.
- Required: At least six (6) weeks have elapsed since implantation and/or any electrode revision or surgical modification of the ImageReady S-ICD System.
- Required: No evidence of a fractured electrode or compromised pulse generator-electrode system integrity.
- Required: Patient does not have elevated body temperature or compromised thermoregulation at time of scan.
- Confirm electrode compatibility with cardiology or the pacemaker clinic.
1Pre-scan checks
- Ensure Cardiology has cleared the patient for scanning eligibility based on the Cardiology MRI Conditions of Use.
- As close to the start of the scan as possible, the patient’s pulse generator is programmed into MRI Protection Mode and continuous monitoring of the patient begins.
- Refer to the MRI Protection Settings Report to confirm that the patient’s device is in MRI Protection Mode.
- The report includes the exact time and date when MRI Protection Mode will expire via the Time-out feature. Verify that adequate time remains to complete the scan.
- The patient must be out of the scanner before the programmed Time-out period elapses. Otherwise, the patient will no longer meet Conditions of Use.
- WARNING: Ensure the device is in MRI Protection Mode before entering the scanner and that the patient is out of the scanner before the programmed Time-out period elapses. This will ensure that inappropriate therapy and potential unintended arrhythmia induction do not occur while undergoing an MRI scan.
- Ensure that the HCPs involved in performing the MRI scan have received the identification of the pulse generator and electrode(s) implanted in the patient.
2MRI scan conditions
1.5 T
| Scanner type | MRI equipment specification: Horizontal, 1H proton, closed bore scanners only RF field: Approximately 64 MHz |
|---|---|
| Spatial gradient | Maximum spatial gradient: 30 T/m (3,000 G/cm) |
| Gradient slew rate | Maximum specified gradient slew rate: ≤ 200 T/m/s per axis |
| Operating mode | Specific Absorption Rate (SAR) limits for the entire active scan: Normal Operating Mode |
| Whole-body SAR | Whole body averaged, ≤ 2.0 watts/kilogram (W/kg) |
| Head SAR | Head, ≤ 3.2 W/kg |
| Scan region / position conditions | • Any part of the body may be imaged.• Patient in supine or prone position only |
3RF COIL / RF excitation
| RF coil | • The use of local receive-only coils is not restricted.• Local transmit-only coils or local transmit/receive coils may be used, but should not be placed directly over the ImageReady S-ICD System. |
|---|
4Monitoring & emergency response
- During MRI Protection Mode, the patient will not receive Tachycardia therapy. Therefore, the patient must be continuously monitored for the entire duration in which the system is in MRI Protection Mode, including during the scan. Continuous monitoring includes maintaining normal voice and visual contact, as well as monitoring pulse oximetry and ECG for the entire duration that the pulse generator is in MRI Protection Mode.
- Patient must be continuously monitored by pulse oximetry and electrocardiography (ECG) for the entire duration in which the pulse generator is in MRI Protection Mode. Ensure backup therapy is available (external rescue).
- Normal voice and visual contact, as well as pulse oximetry and ECG, must be monitored for the duration of the scan.
- Ensure that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation (CPR) are present as long as the pulse generator is in MRI Protection Mode, including during the scan, should the patient require external rescue.
5Post-scan checks
- Ensure the pulse generator is returned to pre-MRI operation, either automatically via the Time-out feature, or manually using the programmer.
- Continue patient monitoring until the pulse generator is returned to pre-MRI operation.
- Do not leave the pulse generator in MRI Protection Mode any longer than necessary following the scan.
6Other information
- A Time-out feature is nominally set to 6 hours, with programmable values of 6, 9, 12, and 24 hours
- The Programmer is MR Unsafe and must remain outside the MRI site Zone III (and higher) as defined by the American College of Radiology Guidance Document for Safe MR Practices. Under no circumstances should the programmer be brought into the MRI scanner room, the control room, or the MRI site Zone III or IV areas.
- Some of the accessories used with pulse generators and electrodes, including the torque wrench and electrode implant tools, are not MR Conditional and should not be brought into the MRI scanner room, the control room, or the MRI site Zone III or IV areas.
- Other implanted devices or patient conditions may cause a patient to be ineligible for an MRI scan, independent of the status of the patient’s ImageReady S-ICD System.
- CAUTION: MR scanning when other active implants such as lead adaptors, extenders, leads or pulse generators are present may increase MRI-related risks. If MR scanning is required, refer to product labeling to ensure that the MR conditions of use are met for all implanted products.
- Image distortion must be considered when planning an MRI scan, and when interpreting MRI images of fields containing the pulse generator and/or electrode. Pulse generator artifacts extend beyond the margin of the device in all directions. Artifacts may also be present around the electrode.
- Some artifacts include moderate spatial distortion beyond the boundaries of the visible pulse generator artifact. Gradient Recalled Echo artifacts are generally larger and more prone to have accompanying spatial distortion than Spin Echo artifacts.
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.