SJM-EDTR-0216-0024 | Item approved for global use.

SJM MRI ACTIVATOR™

HANDHELD DEVICEModel: EX4000

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SJM-EDTR-0216-0024 | Item approved for global use. 2

The SJM MRI Activator™ handheld device must be enabled prior to use using the Merlin™ Patient Care System (PCS).

SETUP SJM MRI ACTIVATOR™ HANDHELD DEVICE

SJM-EDTR-0216-0024 | Item approved for global use. 3

MRI PATIENT WORKFLOW WITH SJM MRI ACTIVATOR™ HANDHELD DEVICE

Saves time, effort,

and inconvenience

3

Patient needs an MRI

scan

Patient has MRI scan

MR

Patient goes homePatient goes to

cardiology center for

device check

SJM-EDTR-0216-0024 | Item approved for global use.

Implant Considerations

Implant the Assurity MRI™ pacemaker no deeper than 4 cm to ensure reliablecommunication with the SJM MRI Activator™ device.

SJM MRI Activator™ Device Compatibility

The SJM MRI Activator™ device is not paired with a specific device and can be used for all Assurity MRI™ pacemakers that have the SJM MRI Activator™ device enabled.

Battery Life/Replacement

3-year battery life from manufacturing date. Activators are powered with a non-standard, non-rechargeable battery,

and must be returned to St. Jude Medical for replacement.

SJM MRI ACTIVATOR™ HANDHELD DEVICE

≤4 cm

3 years

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SJM-EDTR-0216-0024 | Item approved for global use. 5

BUTTONS AND LED INDICATOR LIGHTS

MRI Settings Status

Request Button

Disable MRI Settings Button

Green LED indicator lights

Enable MR Settings Button

Red LED indicator lights

MRDo not use

in MRI

scan room

SJM-EDTR-0216-0024 | Item approved for global use. 6

Color of LED Can the patient be put in MRI scanner? Cause

Green Yes The pacemaker is in MRI Settings

Red No

SJM MRI Activator™ device has not been enabled

Lead impedance readings may be out of programmed ranges so the pacemaker remains in permanent settings

Notify the device clinic, physician, orSt. Jude Medical representative

No Lights

+

Two-tone Beep

No

The SJM MRI Activator™ device is unable to communicate with the pacemaker

Reposition the SJM MRI Activator™ device and press the button again

Notify the device clinic, physician or St. Jude Medical representative if the communication cannot be resolved

LED INDICATOR LIGHTS

SJM-EDTR-0216-0024 | Item approved for global use.

OVERVIEW

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SJM-EDTR-0216-0024 | Item approved for global use.

Step One: Verify that the patient has a St. Jude Medical

MRI Conditional pacing system.

Step Two: Position the SJM MRI Activator™ device over the implanted pacemaker.

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SJM MRI ACTIVATOR™ DEVICE – STEPS TO SCAN PATIENTS

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SJM-EDTR-0216-0024 | Item approved for global use.

STEP 3: PRESS THE BUTTON TO ACTIVATE MRI SETTINGS

If green SJM MRI Activator™ device LED illuminates continuously for 5s

MRI settings are ON

Safe to scan the patient

If red SJM MRI Activator™ device LED illuminates continuously for 5s

DO NOT scan the patient

MRI settings are OFF

3

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SJM-EDTR-0216-0024 | Item approved for global use.

STEP 4: PRESS THE BUTTON TO DISABLE MRI MODE

If red SJM MRI Activator™ device LED illuminates continuously for 5s

MRI settings are OFF

Safe to discharge patient

If green SJM MRI Activator™ device LED illuminates continuously for 5s

DO NOT discharge the patient

MRI settings are ON

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SJM-EDTR-0216-0024 | Item approved for global use.

BUTTON

Use the MR Status button on the

SJM MRI Activator™ device at any

time to check whether the MRI

settings are on or off.

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SJM-EDTR-0216-0024 | Item approved for global use.

NO COMMUNICATION WITH DEVICE

If the SJM MRI Activator™ device makes a two-tone beep, one of the following conditions may apply:

It cannot communicate with the Assurity MRI™ pacemaker; reposition the SJM MRI Activator™ device.

The pacemaker is not MRI conditional; contact the physician (on the ID card) or St. Jude Medical Technical Support.

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SJM-EDTR-0216-0024 | Item approved for global use.

Before the SJM MRI Activator™ device can be used, it must be enabled using the

Merlin™ Patient Care System

The SJM MRI Activator™ device is device agnostic, meaning it can be used to enable

MRI settings in any Assurity MRI™ pacemaker that has the MRI Activator enabled in the device

settings

When the activator has been enabled, a clinician has already verified MRI settings that

are appropriate for the patient.

The activator can be used prior to the scan to enable the MRI settings stored within the device

and then again after the MRI scan to return the device to the original parameter set.

SUMMARY

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SJM-EDTR-0216-0024 | Item approved for global use.

Rx Only

Brief Summary: Prior to using these devices, please review the Instructions for Use 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. © 2016 St. Jude Medical, Inc. All Rights Reserved.

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