TEO
Model TEO SR | MicroPort CRM S.r.l. | Pacemaker
Models with the same MRI conditions
TEO DR, TEO SR
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: The implanted system (pacemaker and leads) consists of a MR Conditional Device and MR Conditional lead(s) listed in "Overview of the MR conditional products" section.
- Required: There are no other active or abandoned cardiac implants (e.g., lead extensions, lead adapters or abandoned leads) in the patient's body.
- Required: No other active or passive implants are permitted if they are not identified as MRI conditional by the manufacturer.
- Required: The MR Conditional Device and leads have been implanted for more than 6 weeks.
- Required: The MR Conditional Device is implanted in the left or right pectoral region.
- Other implantation sites, in particular abdominal implantations, have not been tested and are contraindicated for MRI.
- Required: Patient does not have fever or a compromised thermoregulation at time of scan.
- Confirm lead compatibility with cardiology or the pacemaker clinic.
1Pre-scan checks
- The MR Conditional Device is programmed to enable the MRI Mode during MRI examination (MRI Mode can be programmed to Manual or to Automatic).
- The MRI Mode Monitoring Period is long enough for the MRI scan to be performed in the defined time window.
2MRI scan conditions
1.5 T
| Scanner type | Magnetic resonance imaging of the hydrogen proton nucleus using a static magnetic field of 1.5T or 3T and, as a consequence, an excitation radiofrequency close to 64 MHz or 128 MHz. Horizontal cylindrical bore magnet, clinical MRI. For static magnetic field of 1.5T and 3T, whole Body Transmit Coil operating on Circularly Polarized (CP) RF excitation. |
|---|---|
| Spatial gradient | Maximum spatial gradient of 20 T/m. |
| Gradient slew rate | Maximum gradient slew rate of 200T/m/s per axis. |
| Operating mode | This can be easily achieved by selecting the Normal Mode in the MRI scanning parameters. |
| Whole-body SAR | Whole body averaged specific absorption rate (SAR) as reported by the MRI equipment is 2.0 W/kg or less |
| Head SAR | 3.2 W/kg or less for head scanning |
| Scan region / position conditions | • The MR Conditional Devices enable a Full-Body MRI scan under the following conditions.• Patient lies in the supine or prone position.• No limitations on scan duration or wait time between scans. |
3.0 T
| Scanner type | Magnetic resonance imaging of the hydrogen proton nucleus using a static magnetic field of 1.5T or 3T and, as a consequence, an excitation radiofrequency close to 64 MHz or 128 MHz. Horizontal cylindrical bore magnet, clinical MRI. For static magnetic field of 1.5T and 3T, whole Body Transmit Coil operating on Circularly Polarized (CP) RF excitation. |
|---|---|
| Spatial gradient | Maximum spatial gradient of 20 T/m. |
| Gradient slew rate | Maximum gradient slew rate of 200T/m/s per axis. |
| Operating mode | This can be easily achieved by selecting the Normal Mode in the MRI scanning parameters. |
| Whole-body SAR | Whole body averaged specific absorption rate (SAR) as reported by the MRI equipment is 2.0 W/kg or less |
| Head SAR | 3.2 W/kg or less for head scanning |
| Scan region / position conditions | • The MR Conditional Devices enable a Full-Body MRI scan under the following conditions.• Patient lies in the supine or prone position.• No limitations on scan duration or wait time between scans. |
3RF COIL / RF excitation
| RF coil | • There are no restriction for receive-only local coils• Transmit-only and transmit-receive local coils must not be used. |
|---|
4Monitoring & emergency response
- Proper patient monitoring is provided during the MRI scan (use electrocardiography or pulse oxymetry or non-invasive blood pressure measurements).
- Visual monitoring of the patient and verbal communication are mandatory during the MRI scan.
- An external defibrillator must be available during the MRI scan.
- If the patient’s hemodynamic function is compromised during MRI scanning, discontinue the MRI scan, remove the patient from the MRI room and take the proper measures to restore the patient’s hemodynamic function.
5Post-scan checks
- When MRI Mode is programmed to Auto, asynchronous pacing or absence of pacing programmed as MRI parameters automatically reverts to the initial configuration approximately five minutes after the MR Conditional Device ceases to measure a magnetic field. It is preferable to keep the patient in a controlled medical environment until this mode switch has happened.
- When MRI Mode is programmed to Manual, the MR Conditional Device automatically returns to the initial configuration at the end of the MRI Monitoring Period. However it is recommended to manually disable MRI Mode, in the programmer parameters screen by selecting value “OFF” for MRI mode, in order to avoid keeping the patient in asynchronous pacing or absence of pacing for an extended period of time.
6Other information
- The Programmer is MR Unsafe and should never be taken inside the MRI room.
- Any combination of the MR Conditional Devices with pacing leads other than the ones listed above may result in a hazard to the patient during MRI scanning.
- Please note that the non-MRI lead is identical to the MRI lead (X-fine, Vega, Beflex). When used with “MRI conditional pacemakers”, the previously implanted “non-MRI” lead does not need to be explanted. It will become part of the new MRI conditional system in combination with an MRI conditional pacemaker.
- The MicroPort CRM MRI conditional systems are still MRI conditional when mounting a Third Party off-the-shelf plug, provided that the plug fulfills the following conditions: The plug is a CE marked IS-1 plug / The plug is listed as part of an MRI conditional system for both 1.5T and 3T MR applications.
- Residual potential interactions may still occur and the patient may feel physical sensations such as warm sensation, slight pulling or vibration at the implantation site which can lead to patient discomfort.
- If the device or lead(s) are within or near the field-of-view of the MRI image, quality may be degraded by ferromagnetic artifacts caused by the MR Conditional system.
- In case the patient has to go back into the MRI equipment, the MRI mode will be applied as long as the MRI Mode Monitoring Period is not over and a magnetic field is detected.
- When programmed to MRI Mode, if the MRI Monitoring Period expires while the patient is still in the MRI environment, MRI mode is maintained until the magnetic field is no longer sensed. Then, the pacemaker will wait for a few minutes before resuming normal programming mode.
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.