CARDIOVASCULAR
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SJM MRI Activator™

Handheld Device

SJM Handheld MRI Activator

PRODUCT HIGHLIGHTS

  • The SJM MRI Activator™ handheld device, model EX4000, is an external device that uses radio waves to communicate with a St. Jude Medical™ MRI conditional implanted pulse generator1
  • The SJM MRI Activator device streamlines MRI patient workflow by allowing previously stored MRI settings to be easily:
     - Enabled before an MRI scan2
     - Disabled after an MRI scan2
     - Verified at any time

ORDERING INFORMATION

Contents: SJM MRI Activator device


Reorder Number Description
EX4000 SJM MRI Activator™ EX4000
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1. The SJM MRI Activator handheld device is only designed for use with MRI Ready Pacing Systems from St. Jude Medical.


2. The SJM MRI Activator device is designed to enable/disable pre-programmed MRI mode quickly and easily pre- and post-scan; do not take the SJM MRI Activator device into the MRI magnet/scanner room.


Rx Only

 

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies. © 2017 St. Jude Medical, Inc. All Rights Reserved.

 

Intended Use: The SJM MRI Activator™ handheld device is used to evaluate the status of, and to enable and disable, the previously stored MRI settings. The activator is intended for use with St. Jude Medical™ MR Conditional pulse generators.

 

Contraindications: There are no contraindications.

 

Warnings and Precautions: Electromagnetic interference. The activator is not magnetic and has no moving parts. However, you should avoid equipment which generates a strong electromagnetic interference (EMI). EMI could interfere with communication between the activator and the implanted St. Jude Medical™ MR Conditional pulse generator. Moving away from the source of EMI or turning it off will usually allow the activator to return to its normal mode of operation. Communication equipment. Communication equipment such as microwave transmitters or high-power amateur transmitters may generate enough EMI to interfere with the performance of the activator if you are too close to the source of EMI. Wireless communication devices. Wireless communication devices such as computers that operate on a wireless network, handheld personal computers (PDA), cellular phones, and even cordless telephones may generate enough EMI to interfere with the performance of the activator if it is used too close to the source of EMI. Hospital and Medical equipment. A variety of standard hospital and medical equipment may generate enough EMI to interfere with the performance of the activator. These include, but are not limited to: blood pressure monitors, ECG equipment, external defibrillation equipment, x-ray machines. Office equipment. A variety of standard office equipment may generate enough EMI to interfere with the performance of the activator. These include, but are not limited to: desktop or laptop computers, fax machines, phone systems. Industrial equipment. A variety of industrial equipment may generate enough EMI to interfere with the performance of your activator. These include, but are not limited to: arc welders; induction furnaces; very large or defective electric motors; and internal combustion engines with poorly shielded ignition systems.

SJM-ACCT-0115-0017b(2)

Last Updated: January 02, 2019

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