- You can find detailed information about the requirements, conditions and measures for safely conducting an MRI scan in the ProMRI manual .
- The device is programmed to an MRI mode before the MR scan.
Imprint
Company Name: BIOTRONIK SE & Co. KG
Address: Woermannkehre 1, 12359 Berlin, Germany
Tel: + 49 - 30 - 6 89 05 - 0
Fax: + 49 - 30 - 6 84 40 - 60
e-Mail: impressum@biotronik.de
Limited Partnership having its registered place of business in Berlin
Commercial Register No.: Berlin-Charlottenburg HRA 6501 B
General partner: BIOTRONIK MT SE
Commercial Register No.: Berlin-Charlottenburg HRB 118866 B
Managing Directors: Dr. Alexander Uhl (Chairman), Dr. Andreas Hecker, Holger Krumel
Ust ID No.: DE 136651322
Please contact us here if you need assistance.
In general, the use of medical devices is only allowed if they are approved. As the approval process takes a different amount of time in each country, MR conditions and available MR conditional systems may differ from country to country. To make sure that only approved products and conditions will be shown, the country where the scan will take place must be selected. You can find detailed information about the requirements, conditions and measures for safely conducting an MRI scan in the ProMRI System Technical Manual.
Please contact us here if you need assistance.
The serial number and product name can be found on:
None of the entered data will be stored. Neither data such as the serial number, product names or order numbers, nor the result will be stored.
Please contact us here if you need assistance.
The serial number and product name can be found on:
None of the entered data will be stored. Neither data such as the serial number, product names or order numbers, nor the result will be stored.
The field strength is measured in tesla (T). The MR scan with BIOTRONIK systems requires the use of a clinical MRI scanner with a closed bore, cylindrical magnets and a static magnetic field strength of 1.5 T or 3 T.
The isocenter position is an MR condition that describes the permissible scan areas of the patient. Regarding the isocenter position you can find two possible scan conditions:
Full body will be shown for BIOTRONIK products that have been tested under the conditions of an MR scan and are approved as MR conditional without a scan exclusion zone.
Hip and eye will be shown for BIOTRONIK products that have been tested under the conditions of an MR scan and are approved as MR conditional with a scan exclusion zone.
General considerations The permissible positioning zone explained below must always be maintained during MR scans of patients with restricted device systems.
Isocenter 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 eye socket. In practice, this means that the marker line of the MRI scanner's laser positioning marks must be within this zone. However, receiver only coils can also be positioned outside this area.
Field of view An MRI scanner's field of view is the area within which imaging data can be obtained. The scan exclusion zone is determined by the MRI scanner's field of view and the size of the patient.
The slew rate of the MRI scanner's gradient fields is shown in tesla per meter per second per axis (T/m/s per axis). This website shows the maximum for the slew rate value, which must not be exceeded during the scan. Note: A maximum slew rate of 125 T/m/s per axis is valid for Evia, Entovis, Estella and Ecuro models up to and including serial number 66237094.
The mean specific absorption rate (SAR) for the whole body is shown in watts per kilogram (W/kg). This website shows the maximum value for the whole body SAR. It must not be exceeded during the scan.
Caution: Detailed information about ProMRI can be found in the ProMRI System Technical Manual. Please contact your local BIOTRONIK representative.