Intica Neo 5
Model Intica Neo 5 VR-T | BIOTRONIK SE & Co. KG | ICD
Models with the same MRI conditions
Intica Neo 5 DR-T, Intica Neo 5 VR-T, Intica Neo 5 VR-T DX
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 device system consists of a pacemaker or an ICD with the respective leads and possibly one or more blind plug(s) that are separately labeled MR Conditional and, when combined, constitute an MR Conditional device system.
- Required: Other active or passive devices are permitted if identified as MR Conditional by their manufacturer.
- Required: An MRI exam is permitted only if the product-specific conditions are met for all devices.
- Required: There are no other active or abandoned cardiac devices (e.g., lead extensions, lead adapters or abandoned leads) in the patient's body.
- 3.0 T (EXZ): Required: The patient does not have a fever.
- Required: The lead(s) has/have been implanted for at least six weeks.
- Required: The device system was implanted pectorally.
- Required: The bipolar capture threshold for pacing channels active during the MRI exam is not above 2.0 V at 0.4 ms pulse width.
- Required: The determined lead impedance is between 200 and 1500 Ω.
- Required: The battery status is neither ERI nor EOS.
- Confirm lead compatibility (model and length) with cardiology or the pacemaker clinic.
1Pre-scan checks
- Make sure that your patient, the MRI scanner, as well as the implanted device system meet the conditions for an MRI exam by reading the corresponding chapter.
- Check whether your patient's device system has a scan exclusion zone.
- 3.0 T (EXZ): The patient is at least 1.40 m tall.
- The device is programmed to an MRI mode before the MRI exam.
- The contraindications listed in the respective sections as well as the necessary conditions for an MRI exam have been taken into consideration.
- The patient has been previously examined by a cardiologist and the implanted device is switched to a mode especially suitable for an MRI exam.
- Print out this information and provide it to the radiologist, because without the printout, it is not possible to perform an MRI exam.
- For the MRI AutoDetect function, the value [Expiration date] was checked before the examination by the radiologist.
2MRI scan conditions
1.5 T
| Scanner type | Use of a clinical MRI scanner with a closed bore, cylindrical magnets, and a static magnetic field strength of 1.5 T or 3.0 T. See Combinations of MR Conditional ICDs [Page 9] |
|---|---|
| Gradient slew rate | The slew rate of the MRI scanner's gradient fields must not exceed 200 T/m/s per axis. |
| Whole-body SAR | The mean specific absorption rate (SAR) for the whole body displayed by the MRI scanner must not exceed 2.0 W/kg. |
| Head SAR | The SAR for the head displayed by the MRI scanner must not exceed 3.2 W/kg. |
| Scan region / position conditions | The abbreviation FBS stands for Full-Body Scan and means that no scan exclusion zone applies for such products. |
3.0 T
| Scanner type | Use of a clinical MRI scanner with a closed bore, cylindrical magnets, and a static magnetic field strength of 1.5 T or 3.0 T. See Combinations of MR Conditional ICDs [Page 9] |
|---|---|
| Gradient slew rate | The slew rate of the MRI scanner's gradient fields must not exceed 200 T/m/s per axis. |
| Whole-body SAR | The mean specific absorption rate (SAR) for the whole body displayed by the MRI scanner must not exceed 2.0 W/kg. |
| Head SAR | The SAR for the head displayed by the MRI scanner must not exceed 3.2 W/kg. |
| Scan region / position conditions | • The abbreviation EXZ stands for Exclusion Zone and means that a scan exclusion zone must be observed for such products.• The MRI exam must only be performed with the patient in supine position.• The permissible positioning zone and scan exclusion zone must be observed.• Starting from the feet, the permissible positioning zone for the isocenter of the high-frequency coil is at the greater trochanter level.• Starting from the top of the skull, the permissible positioning zone for the isocenter is at the level of the eyes or the lower edge of the orbital margin.• In practice, this means that the line of the MRI scanner's laser positioning marks must be within this zone. [p. 32]• The overall duration of the examination, i.e., of the imaging sequences displayed by the MRI scanner, must not exceed 30 minutes. However, an MRI exam lasting longer than 30 minutes can be performed if the HF field is switched off for at least 4 minutes after 30 minutes. |
3RF COIL / RF excitation
| RF coil | • For the head and the extremities, local transmitter and receiver coils are approved for use in addition to the local receiver coils.• Only local receiver coils may be used for the thorax. |
|---|
4Monitoring & emergency response
- The MRI mode causes an ICD to be unable to detect dangerous heart rhythms and deliver any therapy shocks.
- An ICD patient must be continuously observed between activation of the MRI program and reactivation of the therapy program, and an external defibrillator must be kept constantly ready.
- Continuous cardiological monitoring of the patient must be ensured until the device system's full functionality is restored in the follow-up examination.
- Emergency equipment for resuscitation must be kept at hand and properly certified staff must be available.
- Continuously monitor the patient's condition during the entire MRI exam using at least one of the following parameters: blood oxygen saturation, blood pressure, or ECG.
- The ECG function integrated in the MRI scanner is often not permitted for patient monitoring. Therefore, only use devices which are permitted for patient monitoring in an MRI environment.
5Post-scan checks
- Subsequent to the MRI exam, ICD patients must immediately undergo cardiological follow-up.
- The patient can stop being continuously monitored and an external defibrillator no longer needs to be kept ready after the reactivation of ICD therapies has been reliably reactivated.
- The MRI AutoDetect function means that the device has a sensor that recognizes the fields of an MRI scanner and automatically switches into the predefined MRI mode. The device automatically switches back into the permanent program one minute after leaving the MRI scanner.
6Other information
- ICD-lead combinations that are not listed should be treated as non MR Conditional.
- The MRI AutoDetect function is active for a maximum of 14 days from the day it is programmed and allows for an indefinite number of MRI exams during this period. The programming expires at 23:59 h of the selected day.
- During the MRI scan, patients may feel a slight pulling sensation or vibration at the implantation site.
- Artifacts and distortion are possible if a device system is within the field of view of an MRI scanner. Image interference is less likely if a device system is outside the field of view.
- If you are planning to perform an MRI exam with an MR Conditional device system from BIOTRONIK, please contact the responsible authorities or BIOTRONIK beforehand to determine whether these products are actually approved as MR Conditional in your country.
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.