Endurity
Model PM2162 | Abbott Medical | Pacemaker
Models with the same MRI conditions
PM1162, PM2162
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
- Do not scan: A combination of one or more leads and a device that is not listed as MR Conditional in the device/lead combination tables.
- Do not scan: Additional cardiac hardware including lead extenders, lead adapters, or abandoned leads
- Do not scan: Broken or intermittently functioning Abbott Medical MR Conditional leads
- Do not scan: A device implanted in a location other than the left or right pectoral region
- Do not scan: Patient has elevated body temperature or compromised thermoregulation at time of scan
- Do not scan: Any patient position in scanner other than supine or prone, with patient's arms at his or her sides
- Confirm lead compatibility (model and length) with cardiology or the pacemaker clinic.
1Pre-scan checks
- Review the patient's ID card or the MRI Summary Report (generated by the Merlin™ PCS or Merlin™ 2 PCS) including information from the device management physician or clinician for confirmation of an MR Conditional system.
- Check the model numbers for both the implanted lead or leads and device against the Abbott Medical MR Conditional Device/Lead Combination tables.
- Multiple leads can be connected to an MR Conditional device. Not all lead lengths are MR Conditional. Confirm that each individual lead meets MRI conditions for use.
- If the implantable system is comprised of a combination of leads that have different scan parameters, use the most restrictive of each scan parameter to determine the overall set of scan conditions applicable for the total system.
- Refer to the MRI Summary Report generated by the Merlin™ PCS or Merlin™ 2 PCS. Confirm these settings with the device management physician or clinician.
- Device programming is required for safe scanning: MRI Settings must be enabled before start of scan.
- Place the SJM MRI Activator handheld device over the implanted pulse generator. Press the MR Status button. MRI Settings Enabled. The green LEDs (on the right side of the SJM MRI Activator handheld device) illuminate continuously for 5 seconds. Refer to the MRI Summary Report generated by the Merlin™ PCS or Merlin™ 2 PCS.
- MRI Settings Disabled. The red LEDs (on the left side of the SJM MRI Activator handheld device) illuminate continuously for 5 seconds. When MRI Settings could not be enabled, the red LEDs illuminate continuously for 5 seconds to indicate that an error occurred while enabling MRI Settings in the implanted MR Conditional pacing system, or that the implanted pacing system did not satisfy the conditions for an MRI scan. In this case, the patient should NOT proceed with the MRI scan. Contact the referring physician for further instruction.
2MRI scan conditions
1.5 T
| Scanner type | Cylindrical-bore magnet, horizontal field orientation |
|---|---|
| Spatial gradient | Maximum Spatial Field Gradient: 30 T/m (3000 Gauss/cm) |
| Gradient slew rate | Maximum Gradient Slew Rate per axis: 200 T/m/s |
| Operating mode | Normal Operating Mode |
| Scan region / position conditions | • Scan region: Full-body• Patient Position in Scanner: Supine or pronepatient's arms must be at his or her sides. |
3RF COIL / RF excitation
| RF coil | • Integrated Whole Body RF Transmit coil -or- Detachable RF Transmit-Receive coils (Head, Lower Extremity, or Upper Extremity) with RF excitation: Circularly polarized (CP)• RF Receive Coil Type: Any receive coil may be used. |
|---|
4Monitoring & emergency response
- Proper patient monitoring must be provided during the MRI scan. This includes continuous monitoring of the patient's hemodynamic function.
- Since the MR environment may interfere with the patient monitoring system, it is recommended that more than one of the following systems be used: electrocardiography, pulse oximetry, or noninvasive blood pressure measurements.
- If the patient's hemodynamic function is compromised during the MRI scan, discontinue the MRI scan and take the proper measures to restore the patient's hemodynamic function.
- Verbal communication with the patient during the MRI scan is recommended.
- Keep an external defibrillator available during the MRI scan.
5Post-scan checks
- Be sure to disable MRI Settings as soon as the MRI scan is complete.
- If you are using the SJM MRI Activator™ handheld device, place the SJM MRI Activator handheld device over the implanted device: Press the MRI Settings Off button.
- If you are not using the SJM MRI Activator handheld device, MRI Settings must be disabled by the patient's device management physician or clinician using the Merlin™ PCS or Merlin™ 2 PCS.
6Other information
- Scanning patients who have other MR Conditional devices that are not implanted in cardiac tissue is acceptable provided all MR Conditional requirements for each implanted device are met.
- Scanning patients who have other MR Conditional devices implanted in cardiac tissue that are at least 2 cm from the lead electrodes is acceptable provided all MR Conditional requirements for each implanted device are met.
- Do not bring any external control devices, such as the Merlin™ Patient Care System (PCS) Model 3650 or Merlin™ 2 Patient Care System (PCS) Model MER3700, or SJM MRI Activator™ handheld device Model EX4000, into the scanner magnet room (Zone IV). These devices are considered MR Unsafe.
- The system remains MR Conditional when an Abbott Medical port plug is placed in an unused port of the device header.
- The presence of this device may produce an image artifact. Some manipulation of scan parameters may be required to compensate for the artifact.
- Patients may feel a mild tugging or vibration sensation at the site of the device implant while in or near the MRI scanner.
- For UltiPace and Tendril STS leads used in the left bundle branch area, MRI safety has been evaluated only with Assurity MRI™, Endurity MRI™, Zenex MRI™, Zenus MRI™, Endurity™ and Endurity™ Core pacemakers.
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.