VALITUDE X4
Model U128 | Boston Scientific Corporation | CRT-P
Models with the same MRI conditions
U128
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 Pacing 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 lead revision or surgical modification of the MR Conditional Pacing System
- Required: No evidence of a fractured lead or compromised pulse generator-lead system integrity
- Required: Pulse generator implant location restricted to left or right pectoral region
- Required: Patient does not have elevated body temperature or compromised thermoregulation at time of scan
- Do not perform an MRI scan on a patient whose device has entered Safety Mode. Safety Mode pacing is VVI unipolar, which, in the MRI environment, subjects the patient to increased risk of arrhythmia induction, inappropriate pacing, inhibition of pacing, or irregular intermittent capture or pacing.
- Confirm lead compatibility with cardiology or the pacemaker clinic.
1Pre-scan checks
- Adherence to the Conditions of Use must be verified prior to each scan to ensure that the most up-to-date information has been used to assess the patient’s eligibility and readiness for an MR Conditional scan.
- Ensure Cardiology has cleared the patient for scanning eligibility based on the Cardiology MRI Conditions of Use
- Ensure that the HCPs involved in performing the MRI scan have received the model numbers of the pulse generator and lead(s) implanted in the patient.
- Refer to the MRI Protection Settings Report to confirm that the patient’s device is in MRI Protection Mode.
- If the Time-out feature is used, the report includes the exact time and date when MRI Protection Mode will expire. Verify that adequate time remains to complete the scan.
- WARNING: When the Time-out parameter is programmed to a value other than Off, the patient must be out of the scanner before the time programmed elapses. Otherwise, the patient will no longer meet Conditions of Use
2MRI scan conditions
1.5 T
| Scanner type | Horizontal, 1H proton, closed bore scanners only |
|---|---|
| Spatial gradient | Spatial gradient no greater than 50 T/m (5,000 G/cm) |
| Gradient slew rate | Gradient Field limits: Maximum specified gradient slew rate ≤ 200 T/m/s per axis |
| Operating mode | For all ImageReady Pacing Systems, SAR limits for Normal Operating Mode must be observed for the entire active scan session |
| 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.• There are no restrictions for positioning the pacing system within the integrated body coil of the MRI scanner.• Patient in supine or prone position only |
3.0 T
| Scanner type | Horizontal, 1H proton, closed bore scanners only |
|---|---|
| Spatial gradient | Spatial gradient no greater than 50 T/m (5,000 G/cm) |
| Gradient slew rate | Gradient Field limits: Maximum specified gradient slew rate ≤ 200 T/m/s per axis |
| Operating mode | For all ImageReady Pacing Systems, SAR limits for Normal Operating Mode must be observed for the entire active scan session |
| 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.• There are no restrictions for positioning the pacing system within the integrated body coil of the MRI scanner.• Patient in supine or prone position only |
3RF COIL / RF excitation
| RF coil | • The use of 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 pacing system. |
|---|
4Monitoring & emergency response
- The patient must be monitored during the MRI scan by pulse oximetry and/or electrocardiography (ECG)
- Ensure the patient is monitored by pulse oximetry and/or electrocardiography (ECG), with backup therapy available.
- WARNING: Ensure that an external defibrillator and medical personnel skilled in cardio-pulmonary resuscitation (CPR) are present during the MRI scan should the patient require external rescue.
5Post-scan checks
- Ensure the pulse generator is returned to pre-MRI operation, either automatically if the Time-out parameter was set, or manually using the Programmer.
- Do not leave the pulse generator in MRI Protection Mode any longer than necessary following the scan.
- WARNING: Exit MRI Protection Mode after MRI scanning is completed. If the MRI Protection Time-out value of Off is selected, the pulse generator will remain permanently in the MRI Protection Mode until it is programmed otherwise. Prolonged use of the MRI Protection Mode (such as may occur when the Time-out feature is programmed to Off) may increase the rate of battery depletion. In addition, prolonged exposure of a patient to the XOO mode chosen may be deleterious to the patient’s health.
6Other information
- Only a Boston Scientific MR Conditional pulse generator and lead(s), with all ports occupied by a lead or port plug, constitute an ImageReady MR Conditional Pacing System. Another manufacturer’s MR Conditional pulse generator combined with a Boston Scientific MR Conditional lead (or vice versa) does not constitute an MR Conditional System.
- Set MRI Protection Time-out (nominally set to 24 hours, programmable values of Off, 3, 6, 9, 12, 24, and 48 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 on MR Safe 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 packaged with pulse generators and leads, including the torque wrench and stylet wires, 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 MR Conditional Pacing System.
- Image distortion must be considered when planning an MRI scan and when interpreting MRI images in proximity to the pulse generator and/or leads. Artifacts may include moderate spatial distortion beyond the boundaries of the visible artifact.
- In non-clinical 1.5 T and 3 T testing, the maximum image artifact associated with any ImageReady Pacing System pulse generator extended approximately 7.9 cm radially from the device when testing with spin-echo sequencing in a 3 T MRI system and the maximum image artifact associated with any ImageReady Pacing System lead extended 0.9 cm when testing with gradient-echo sequencing in a 3 T MRI system.
- The system response to conditions other than those listed above for the radiology conditions has not been evaluated.
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.