ProMRI Cardiac Pacemaker Systems (Biotronik): Full Body MRI at 1.5-T/64-MHz

The ProMRI Cardiac Pacemaker Systems: Full Body MRI at 1.5-T/64-MHz (Biotronik) are MR Conditional and, as such, are designed to allow patients to be safely undergo MRI when used according to the specified conditions for use.

The information applies to the following:

Pulse Generators - Eluna 8 DR-T, Eluna 8 SR-T, Epyra 8 DR-T, Epyra 8 SR-T, Epyra 6 DR-T, Epyra 6 DR-T, Etrinsa 8 DR-T, Etrinsa 6 DR-T, Entovis DR-T*, Entovis SR-T*, Ecuro DR-T*, Ecuro SR-T*, Evia DR-T*, Evia SR-T*, Estella DR-T*, Estella SR-T* (*From serial number 66237095 onwards)

Leads – RA/RV leads, Safio S (53-cm or 60-cm)

Testing has demonstrated that patients with these devices can safely undergo MR procedures according to the instructions in the manual. Download instructions for use from www.biotronik.com

Important note to MR Healthcare Professionals: Different MRI guidelines may exist for different countries. As such, use the appropriate information for your country.

MR healthcare professionals are advised to contact the respective manufacturer in order to obtain the latest safety information to ensure patient safety relative to the use of an MR procedure.

REFERENCE

http://www.biotronikusa.com/manuals/index.cfm