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                                            Safety Information Article
                      Information on this page is limited by the terms of our Disclaimer.  Please Read!

       St. Jude Medical (SJM) Confirm, Implantable Cardiac Monitor (OUTSIDE THE UNITED STATES) 

SJM Confirm, Implantable Cardiac Monitor, Models DM2100, DM2102
Implantable Cardiac Monitor, St. Jude Medical


NOTE: The MRI labeling is different in the United States versus Outside of the United States.

The St. Jude Medical (SJM) Confirm Implantable Cardiac Monitor (ICM) (St. Jude Medical, Sylmar, CA) is designed to monitor and store ECG data and to communicate with the St. Jude Medical, Merlin Patient Care System and the SJM Confirm external patient activator. The SJM Confirm ICM is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:
-Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
-Patients who experience transient symptoms that may suggest a cardiac arrhythmia

MR Conditional
The SJM Confirm ICM can be scanned in patients under the following conditions:
-Closed bore, cylindrical magnet
-Static magnetic field strength of 1.5 Tesla (T) only
-Maximum gradient slew rate 200 T/m/s per axis
-Whole body Specific Absorption Rate (SAR) less than or equal to 4.0 W/kg
-The uninterrupted duration of active scanning (when radio frequency (RF) and gradients are on) over the chest during MRI must not exceed 60 minutes
-Confirmation of absence of other contraindicated implantable devices and/or leads, including abandoned leads, lead extenders and lead adaptors

In non-clinical testing, the St. Jude Medical MR Conditional SJM Confirm ICM produced a temperature rise of less than 3 degrees C at a maximum MR system-reported whole body averaged specific absorption rate (SAR) of 3.9 W/kg as displayed on the MR scanner console for 60 minutes of MR scanning in a 1.5-T closed bore MR scanner (manufacturer Philips, model Intera 1.5, Software version: 9.5.2).

If you have any questions on this topic, please contact St. Jude Medical Technical Services.

[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

www.SJMprofessional.com/MRI



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