CARDIOVASCULAR
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SJM™ Confirm™ Implantable Cardiac Monitor (ICM)

PRODUCT HIGHLIGHTS

  • Manual and auto activated triggers for EGM storage
  • Programmable data storage options to maximize episode capture
  • 3-year implant life
  • 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 Abbott’s MR Conditional SJM Confirm™ ICM produced a temperature rise of less than 3C 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).1
  • MR Conditional — Please refer to the Confirm™ ICM User’s Manual.

ORDERING INFORMATION


Reorder Number Description
DM2100 SJM Confirm ICM Model DM2100
DM2102 SJM Confirm™ ICM Model DM2102 (AF Detection)
DM2100A Patient Activator Model DM2100A
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SJM™ Confirm™ Implantable Cardiac Monitor (ICM)
1Abbott. Data on File. Report No. 60044017 Rev. B.

Rx Only

Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

 

SJM-CAG-0915-0035r(1)

Last Updated: January 02, 2019

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