St. Jude Medical MRI User Manual

MRI-Ready Systems Manual

MRI Procedure Information for the St. Jude Medical™ MR Conditional System

™ Indicates a trademark of the Abbott group of companies.

‡ Indicates a third

©

St.

Pat.

-party trademark, which is property of its respective owner.

2020 Abbott. All Rights Reserved.

Jude Medical is a wholly-owned subsidiary of Abbott.

http://www.abbott.com/patents

i

Contents

Introduction ............................................................................................................................................................. 1

Symbols ................................................................................................................................................................... 1

St. Jude Medical™ MRI Safety Information ............................................................................................................... 1

3T MRI Scan Parameters for St. Jude Medical™ MR Conditional Systems ................................................................. 2

3T MR Conditional Systems Device/Lead Combinations ............................................................................................................. 3

1.5T MRI Scan Parameters for St. Jude Medical™ MR Conditional Systems .............................................................. 4

1.5T MR Conditional Systems Device/Lead Combinations .......................................................................................................... 5

Instructions for Cardiac Physicians and Clinicians ..................................................................................................... 7

I. Confirm that the Patient has an MR Conditional System .......................................................................................................... 7

II. Confirm that No Adverse Conditions to MRI Scanning are Present.......................................................................................... 7

III. Review the Potential Adverse Events ..................................................................................................................................... 8

IV. Generate a Report of the Patient's Permanently Programmed Parameters ............................................................................. 8

V. Select and Save MRI Settings ................................................................................................................................................ 9

VI. Review the MRI Checklist and Program MRI Settings .......................................................................................................... 12

VII. Disable MRI Settings ......................................................................................................................................................... 13

Instructions for Radiologists and MRI Technologists ................................................................................................ 15

I. Confirm that the Patient has an MR Conditional System ........................................................................................................ 15

II. Confirm that No Adverse Conditions to MRI Scanning are Present........................................................................................ 15

III. Review the Potential Interactions ........................................................................................................................................ 15

IV. Select the Correct Scan Parameters .................................................................................................................................... 16

V. Check MRI Settings Status .................................................................................................................................................. 16

VI. Perform the Scan and Monitor the Patient .......................................................................................................................... 18

VII. Disable MRI Settings ......................................................................................................................................................... 18

Technical Support .................................................................................................................................................. 18

1

Symbol

Description

Introduction

This manual explains the procedures and precautions that must be followed when scanning a patient who is implanted with
a St. Jude Medical™ MR Conditional system.

It is important to read the information in this manual before conducting an MRI scan on a patient with an implanted
St. Jude Medical MR Conditional system. Contact Technical Support (page 18) if you have any questions.

Refer to the Merlin™ Patient Care System (PCS) on-screen help or to the appropriate device or lead user's manual for non-MRI
related information.

The St. Jude Medical MR Conditional system includes a St. Jude Medical MR Conditional device connected to one or more
St. Jude Medical MR Conditional leads. For a list of the device/lead combinations that have been tested, refer to the St. Jude Medical
MR Conditional Systems Device/Lead Combination tables (3T MRI tables (page 3) or 1.5T MRI tables (page 5)). The system remains
MR Conditional when a St. Jude Medical port plug is placed in an unused port of the device header.

Testing has demonstrated that the St. Jude Medical MR Conditional system is conditionally safe for use in the MRI environment
when used according to the instructions in this manual.

Enable MRI Settings to turn on a mode of operation that allows a patient with an MR Conditional system to be safely scanned by an
MRI scanner when used according to the instructions in this manual.

CAUTION: Not all of the products listed as MR Conditional are approved for MR Conditional use in all countries or
regions. Before performing an MRI scan on patients implanted with any of these devices, contact St. Jude Medical or
consult your regulatory authorities to determine if the products have been certified as MR Conditional.

Symbols

Table 1. MR Conditional symbols

Device with demonstrated safety in the MR environment within defined conditions including conditions for the
static magnetic field, the time-varying gradient magnetic fields and the radiofrequency fields.

St. Jude Medical™ MRI Safety Information

Personnel planning or performing an MRI scan of a patient with an MR Conditional system must follow the procedures and
restrictions outlined in this manual.

Failure to follow the procedures outlined here may result in serious harm to the device and the patient.

NOTE: All St. Jude Medical™ MR Conditional systems can be scanned using 1.5 Tesla (1.5T) MRI scanners and some MR
Conditional systems can also be scanned using 3.0 Tesla (3T) MRI scanners. Refer to the sections below to identify the MRI
scanner type and scan parameters for the MR Conditional device/lead combinations.

2

Scan Parameters

Setting

3T MRI Scan Parameters for St. Jude Medical™ MR Conditional Systems

When performing a 3T MRI scan on a patient with a St. Jude Medical™ MR Conditional system, the following scan parameters must
be followed.

Table 2. 3T MRI scan parameters

Scanner Type Cylindrical-bore magnet, horizontal field orientation

Magnet Strength 3 Tesla/128 MHz excitation frequency (hydrogen atom only)

Spatial Field Gradient

RF Power (SAR)

Gradient Slew Rate

Scan Regions See the device/lead combination tables below (page 3).

The above scan parameters are applicable for use with Full-body RF transmit coil with any receive coil.

CAUTION: For 3T MRI system RF excitation, ensure your scanner is operating as circularly polarized (CP) or quadrature
(QD).

Multiple leads can be connected to an MR Conditional device. Confirm that each individual lead meets MRI conditions
for use.

Not all lead lengths are MR Conditional. The device/lead combination tables below list the MR Conditional lead lengths.

¢30 T/m (3000 G/cm)

The RF Power (SAR) requirements will be met if the scanner is in the specified
operating mode. See the device/lead combination tables below (page 3).

¢200 T/m/s per axis

3

Device model

Lead model (lengths)

RF Power (SAR)

Scan region

Assurity MRI

Endurity MRI
Tendril™ STS

IsoFlex™

Device model

Lead model (lengths)

RF Power (SAR)

Scan region

Zenex MRI

Zenus MRI
Tendril™ STS

IsoFlex™

3T MR Conditional Systems Device/Lead Combinations

Pacemakers

Table 3. 3T MR Conditional System device/lead combinations for Assurity MRI™ and Endurity MRI™ pacemakers

PM1272
PM2272

PM1172

2088TC (46 cm, 52 cm, 58 cm)

1944 (46 cm, 52 cm)
1948 (52 cm, 58 cm)

Normal Operating Mode

Full-body

• RF excitation:
Circularly polarized or quadrature

PM2172

Table 4. 3T MR Conditional System device/lead combinations for Zenex MRI™ and Zenus MRI™ pacemakers

PM1282
PM2282

PM1182
PM2182

2088TC (46 cm, 52 cm, 58 cm)

1944 (46 cm, 52 cm)
1948 (52 cm, 58 cm)

Normal Operating Mode

• RF excitation:
Circularly polarized or quadrature

Full-body

4

Scan Parameters

Setting

Magnet Strength

1.5 Tesla/64 MHz excitation frequency (hydrogen atom only).

1.5T MRI Scan Parameters for St. Jude Medical™ MR Conditional Systems

When performing a 1.5T MRI scan on a patient with a St. Jude Medical™ MR Conditional system, the following scan parameters
must be followed.

Table 5. 1.5T MRI scan parameters

Scanner Type Cylindrical-bore magnet, horizontal field orientation

Spatial Field Gradient

RF Power (SAR)

¢ 30 T/m (3000 G/cm)

Varies for each device/lead combination. The RF Power (SAR) requirements will be met if
the scanner is in the specified operating mode. See the device/lead combination tables
below (page 5).

Gradient Slew Rate

Scan Regions

¢ 200 T/m/s per axis

Varies for each device/lead combination. See the device/lead combination tables below
(page 5).

The above scan parameters are applicable for use with the following RF coil types:

1. Full-body RF transmit coil with any receive coil

2. Local RF transmit-receive coil in Normal Operating Mode

- RF transmit-receive head coil (quadrature only)

- RF transmit- receive lower extremity coil (quadrature only)

- RF transmit-receive upper extremity coil (quadrature only)

WARNING: Do not place local RF transmit coils directly over the device because this has not been tested.

CAUTION: Multiple leads can be connected to an MR Conditional device. Confirm that each individual lead meets MRI
conditions for use. If the implantable system is comprised of a combination of leads that have different scan
parameters, use the most restrictive of each scan parameter to determine the overall set of scan parameters applicable
for the total system.

Not all lead lengths are MR Conditional. The device/lead combination tables below (page 5) list the MR Conditional lead
lengths.

5

Device model

Lead model (lengths)

RF Power (SAR)

Scan region

Assurity MRI

Endurity MRI

Tendril MRI™

IsoFlex™

1948 (52 cm, 58 cm)

Tendril™ STS

Endurity

Endurity Core

Tendril MRI

IsoFlex

1948 (52 cm, 58 cm)

Tendril STS

Device model

Lead model (lengths)

RF Power (SAR)

Scan region

Zenex MRI

Zenus MRI

Tendril MRI™

IsoFlex™
Tendril™ STS

Device model

Lead model (lengths)

RF Power (SAR)

Scan region

Quadra Allure

Quadra Allure MP

Quartet™

Tendril™ STS

IsoFlex™

1.5T MR Conditional Systems Device/Lead Combinations

Pacemakers

Table 6. 1.5T MR Conditional System device/lead combinations for Assurity MRI™, Endurity MRI™, Endurity™, and Endurity™

Core Pacemakers

PM1272
PM2272

PM1172
PM2172

LPA1200M (46 cm, 52 cm,
58 cm)

1944 (46 cm, 52 cm)

First-Level Controlled
Operating Mode

Normal Operating Mode

Full-body

2088TC (46 cm, 52 cm, 58 cm)

PM1162
PM2162

PM1140
PM1152
PM2140
PM2152

LPA1200M (46 cm, 52 cm,
58 cm)

1944 (46 cm, 52 cm)

2088TC (46 cm, 52 cm, 58 cm)

Table 7. 1.5T MR Conditional System device/lead combinations for Zenex MRI™ and Zenus MRI™ pacemakers

PM1282
PM2282

PM1182
PM2182

LPA1200M (46 cm, 52 cm,
58 cm)

1944 (46 cm, 52 cm)
1948 (52 cm, 58 cm)

First-Level Controlled
Operating Mode

Normal Operating Mode

Full-body

2088TC (46 cm, 52 cm, 58 cm)

CRT-Ps

Table 8. 1.5T MR Conditional System device/lead combinations for Quadra Allure™ and Quadra Allure MP™ CRT-Ps

Normal Operating Mode

Full-body

PM3542

PM3562

1456Q (86 cm)
1457Q (86 cm)
1458Q (86 cm)
1458QL (86 cm)

2088TC (46 cm, 52 cm, 58 cm)

1944 (46 cm, 52 cm)
1948 (52 cm, 58 cm)

6

Device model

Lead model (lengths)

RF Power (SAR)

Scan region

Ellipse

Durata™

Optisure™
Tendril MRI™

Tendril™ STS

IsoFlex™

Device model

Lead model (lengths)

RF Power (SAR)

Scan region

Fortify Assura

Durata™

Optisure™
Tendril MRI™

Tendril™ STS

IsoFlex™

Device model

Lead model (lengths)

RF Power (SAR)

Scan region

Quadra Assura

Quadra Assura MP

Quartet™

Durata™

Optisure™
Tendril™ STS

IsoFlex™

ICDs

Table 9. 1.5T MR Conditional System device/lead combinations for Ellipse™ ICDs

CD1377-36Q
CD1377-36QC
CD2377-36Q
CD2377-36QC

7120Q (58 cm, 65 cm)
7122Q (58 cm, 65 cm)

LDA220Q (58 cm, 65 cm)

Normal Operating Mode Full-body

LDA210Q (58 cm, 65 cm)

LPA1200M (46 cm, 52 cm, 58 cm)

2088TC (46 cm, 52 cm)

1944 (46 cm, 52 cm)

Table 10. 1.5T MR Conditional System device/lead combinations for Fortify Assura™ ICDs

CD1359-40Q
CD1359-40QC
CD2359-40Q
CD2359-40QC

7120Q (58 cm, 65 cm)
7122Q (58 cm, 65 cm)

LDA220Q (58 cm, 65 cm)

Normal Operating Mode Full-body

LDA210Q (58 cm, 65 cm)

LPA1200M (46 cm, 52 cm, 58 cm)

2088TC (46 cm, 52 cm)

1944 (46 cm, 52 cm)

CRT-Ds

Table 11. 1.5T MR Conditional System device/lead combinations for Quadra Assura™ and Quadra Assura MP™ CRT-Ds

CD3367-40Q
CD3367-40QC

CD3371-40Q
CD3371-40QC

1456Q (86 cm)
1457Q (86 cm)
1458Q (86 cm)
1458QL (86 cm)

Normal Operating Mode Full-body

7120Q (58 cm, 65 cm)
7122Q (58 cm, 65 cm)

LDA210Q (58 cm, 65 cm)
LDA220Q (58 cm, 65 cm)

2088TC (46 cm, 52 cm)

1944 (46 cm, 52 cm)

7

Instructions for Cardiac Physicians and Clinicians

NOTE: Radiologists and MRI technologists should see Instructions for Radiologists and MRI Technologists (page 15).

The role of cardiac physicians and clinicians in preparing a patient for an MRI scan is to:

 Confirm that the Patient has an MR Conditional System (page 7)

 Confirm that No Adverse Conditions to MRI Scanning are Present (page 7)

 Review the Potential Adverse Events (page 8)

 Generate a Report of the Patient's Permanently Programmed Parameters (page 8)

 Select and Save MRI Settings (page 9)

 Review the MRI Checklist and Program MRI Settings (page 12)

 Disable MRI Settings (page 13)

I. Confirm that the Patient has an MR Conditional System

1. Review the patient’s ID card or Parameter report (generated by the Merlin™ PCS) to obtain the model numbers for both the
implanted lead or leads, and device.

2. Check the model numbers against the St. Jude Medical™ MR Conditional Systems Device/Lead Combination tables (3T MRI
tables (page 3) or 1.5T MRI tables (page 5)).

NOTE: Multiple leads can be connected to an MR Conditional device. Not all lead lengths are MR Conditional. Check the lead
lengths listed in the device/lead combination tables for MR Conditional lead lengths. Lead lengths not listed are untested.

Patients can be considered safe for an MRI scan only if the implanted system consists of a St. Jude Medical MR Conditional
device connected to the appropriate St. Jude Medical MR Conditional lead or leads.

II. Confirm that No Adverse Conditions to MRI Scanning are Present

If any conditions exist that could make MRI scanning unsafe, do not scan the patient. Such conditions include:
 Patient has elevated body temperature or compromised thermoregulation at time of scan, and if system includes any 1944,

1948, or 2088TC leads; or an Ellipse™ ICD, Fortify Assura™ ICD, Quadra Allure™ CRT-P, Quadra Allure MP™ CRT-P, Quadra
Assura™ CRT-D, or Quadra Assura MP™ CRT-D

 The device is at End-of-Life

 A combination of one or more leads and a device that is not listed as MR Conditional in the St. Jude Medical™ MR Conditional

Systems Device/Lead Combination tables (3T MRI tables (page 3) or 1.5T MRI tables (page 5)).

 Broken or intermittently functioning St. Jude Medical MR Conditional leads

 Lead impedance measurements not within the programmed lead impedance limits

 Additional hardware including lead extenders, lead adapters, or abandoned leads

 A St. Jude Medical MR Conditional system implanted in sites other than the left and right pectoral region (see figure below)

 Patients with unstable capture thresholds

 Patients with capture threshold values of > 2.5 V at a pulse width of 0.5 ms for RA and RV leads

 Patients with capture threshold values of > 2.0 V at a pulse width of 0.5 ms for the LV lead

 Complaints of diaphragmatic stimulation at a pacing output of 5.0V or 7.5V and at a pulse width of 1.0 ms in patients whose

device will be programmed to an asynchronous pacing mode when MRI Settings are enabled

 For ICDs and CRT-Ds: capacitor has not been prepared for the MRI scan (see VI. Review the MRI Checklist and Program MRI

Settings (page 12))

NOTE: Lead fractures or other damage to the leads may cause changes in the electrical properties of the St. Jude Medical™
MR Conditional system that make the system unsafe for an MRI scan. Patients with damaged leads may be harmed if an MRI
scan is performed.

8

Device Family

Diagnostics

Pacemakers

Figure 1. Correct locations for device implant

1. Right-pectoral region

2. Left-pectoral region

III. Review the Potential Adverse Events

The St. Jude Medical™ MR Conditional system has been designed to minimize the potential adverse events that may cause patient
harm. The following potential adverse events may occur in the MRI environment:

 Lead electrode heating and tissue damage resulting in loss of sensing or capture or both

 Device heating resulting in tissue damage in the implant pocket or patient discomfort or both

 Induced currents on leads resulting in continuous capture, VT/VF, hemodynamic collapse, or all three

 Damage to the device or leads causing the system to fail to detect or treat irregular heartbeats or causing the system to treat the

patient's condition incorrectly

 Damage to the functionality or mechanical integrity of the device resulting in the inability to communicate with the device

 Movement or vibration of the device or leads

 Lead dislodgement

 Competitive pacing and potential for VT/VF induction if asynchronous pacing is programmed when MRI Settings are enabled

 Syncope due to loss of pacing if no pacing support is programmed with MRI Settings

 For ICDs and CRT-Ds: Death due to untreated spontaneous arrhythmia because Tachy therapy is disabled when MRI Settings

are programmed.

Potential interactions between the MRI scanner and the system include:
 The magnetic material of an implanted system may exert force, vibration, and torque effects due to the static magnetic field and

gradient magnetic fields produced by an MRI scanner. These effects have been shown to be minimal in St. Jude
Medical™ MR Conditional systems. Patients may feel a mild tugging or vibration sensation at the site of the device implant
while in or near the MRI scanner.

 The gradient magnetic and RF fields produced by an MRI scanner could potentially interact with the MR Conditional system

and cause unintended stimulation of the heart. When all conditions outlined in this manual are met, the voltages and pulse
widths induced on the leads of the St Jude Medical MR Conditional System are limited so that the potential for capturing the
heart is minimized.

 The RF fields generated by an MRI scanner could induce voltages onto an implanted lead system that may cause heating at the

lead electrodes. This heating could damage the tissue surrounding the electrodes and compromise pacing and sensing
thresholds at that site. When all conditions outlined in this manual are met, St. Jude Medical MR Conditional leads have been
tested and shown to limit heating at the electrodes and to minimize thermal damage of the surrounding cardiac tissue.

IV. Generate a Report of the Patient's Permanently Programmed Parameters

CAUTION: Do not bring the Merlin™ Patient Care System (PCS) Model 3650 or the SJM MRI Activator™ handheld
device Model EX4000 into Zone IV (MRI scanner magnet room), as defined by the American College of Radiology. Each
device is MR Unsafe.

1. Interrogate the device with the Merlin™ PCS.

2. If needed, perform capture, sense, and lead impedance tests.

3. From the FastPath™ Summary screen, select the Print button to print the Diagnostics and any other relevant reports.

The Merlin PCS will print to the default printer (internal printer, external printer or PDF).

NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. Refer to the table below for the
behavior of each system.

Table 12. Diagnostic Data during MRI Settings

Assurity MRI™ pacemakers Suspended with MRI Settings

9

Device Family

Diagnostics

CRT-Ps

ICDs

CRT-Ds

Parameter

Setting

Parameter

Setting

Parameter

Setting

MRI Mode

Pacing Off

MRI Base Rate

n/a

MRI Paced AV Delay

n/a

Table 12. Diagnostic Data during MRI Settings

Endurity™ pacemakers Suspended with MRI Settings

Endurity™ Core pacemakers Suspended with MRI Settings

Endurity MRI™ pacemakers Suspended with MRI Settings

Zenex MRI™ pacemakers Suspended with MRI Settings

Zenus MRI™ pacemakers Suspended with MRI Settings

Quadra Allure™ CRT-Ps Suspended with MRI Settings

Quadra Allure MP™ CRT-Ps Suspended with MRI Settings

Ellipse™ ICDs Cleared from memory when MRI Settings are programmed

Fortify Assura™ ICDs Cleared from memory when MRI Settings are programmed

Quadra Assura™ CRT-Ds Cleared from memory when MRI Settings are programmed

Quadra Assura MP™ CRT-Ds Cleared from memory when MRI Settings are programmed

For any device, it is recommended that the clinician perform a complete follow-up prior to the MRI procedure to save all diagnostic
data.

V. Select and Save MRI Settings

NOTE: The Merlin™ PCS must be operating with software version 23.1.2 or greater to interrogate an MR Conditional device.

The MRI parameter settings are selected at the physician's discretion.

The default MRI parameter settings are automatically stored in the St. Jude Medical™ MR Conditional device.

Table 13. Default MRI Settings for Pacemakers

MRI Mode (dual-chamber devices) DOO

MRI Mode (single-chamber devices) VOO or AOO (as applicable)

MRI Base Rate

MRI Paced AV Delay 120 ms

MRI Pulse Amplitude 5.0 V

MRI Pulse Width 1.0 ms

MRI Pulse Configuration Bipolar

Table 14. Default MRI Settings for CRT-Ps

MRI Mode DOO

MRI Base Rate

MRI Paced AV Delay 120 ms

MRI Pulse Amplitude 5.0 V

MRI Pulse Width 1.0 ms

MRI Pulse Configuration Bipolar

MRI V Pacing Chamber RV Only

85 min§

85 min§

Table 15. Default MRI Settings for ICDs

MRI Pulse Amplitude n/a

MRI Pulse Width n/a

10

Parameter

Setting

Parameter

Setting

Table 15. Default MRI Settings for ICDs

MRI Pulse Configuration n/a

Tachy Therapy Disabled

Table 16. Default MRI Settings for CRT-Ds

MRI Mode DOO

MRI Base Rate

MRI Paced AV Delay 120 ms

MRI Pulse Amplitude 5.0 V

MRI Pulse Width 1.0 ms

MRI Pulse Configuration Bipolar

MRI V Pacing Chamber RV Only

Tachy Therapy Disabled

If you change MRI Settings from the default values, you must save the modified MRI Settings in the device as described below.

Refer to the Merlin™ PCS on-screen help for information on selecting, testing, and saving the MRI parameter settings.

1. After you interrogate the device with the Merlin PCS, select the Parameters button on the right to open the Parameters window.
Then, select the MRI Settings tab. This opens the MRI Settings window.

2. From this window, you can modify the default values of the MRI parameters that are in effect when MRI Settings are enabled.

3. For ICDs and CRT-Ds, select the appropriate HV lead type implanted in the patient

- For patients implanted with dual coil defibrillation lead, select Dual Coil value

- For patients implanted with single coil defibrillation lead, select the Single Coil value

NOTE: Selecting the correct HV lead type ensures appropriate testing during MRI setup.

4. You can temporarily test the settings if you select the Test MRI Settings button. Use this function to evaluate the patient's
hemodynamic status with the proposed MRI parameter settings.

5. Select the Cancel Test button to return to permanently programmed settings.

6. Select the Save MRI Settings button to save any changed parameters.

NOTE: MRI Pacing Chamber defaults to RV only in CRT devices. Left Ventricular pacing will be turned off when MRI Settings
are programmed

7. If you plan to use the SJM MRI Activator™ handheld device to implement MRI Settings, you must review the MRI Activator
Checklist and enable the pulse generator to communicate with the handheld device. See Enabling the Device to Communicate
with the SJM MRI Activator handheld device (page 10).

NOTE: Only certain devices can be programmed by the SJM MRI Activator handheld device. For a list of these devices, see the
table below.

Before the use of the SJM MRI Activator handheld device can be enabled, in-range bipolar pacing lead impedance
measurements from the current programming session are required.

8. When you are satisfied with MRI Settings, select the Setup for MRI Now button to run the system integrity tests required for MRI
setup.

CAUTION:

 Regardless of the programmed permanent pacing mode, sensed events are ignored by the device when MRI

Settings are enabled. Determine whether or not pacing support is needed during the MRI scan. When pacing
support is needed, set the MRI Mode to an available asynchronous pacing mode (DOO, AOO, or VOO). When
pacing support is not needed, set the MRI Mode to Pacing Off.

 Some patients may be susceptible to cardiac arrhythmia induced by competitive pacing when an

asynchronous MRI Mode is selected. For these patients, it is important to select an appropriate MRI pacing
rate to avoid competitive pacing and then minimize the duration of the asynchronous pacing operation.

 In MR Conditional ICDs and CRT-Ds, tachycardia therapy is disabled when MRI Settings are programmed.

85 min§

Enabling the Device to Communicate with the SJM MRI Activator™ handheld device

To use the SJM MRI Activator™ handheld device, you must first enable the pulse generator to communicate with the handheld
device. This is done through the MRI Settings window on the Merlin™ PCS.

11

Model Name and Number

Operates with the SJM MRI Activator handheld device
Model EX4000

Pacemakers

Assurity MRI™ pacemakers

Endurity MRI™ pacemakers

Endurity™ pacemakers

Endurity™ Core pacemakers

Zenex MRI™ pacemakers

Zenus MRI™ pacemakers
CRT-Ps

Quadra Allure™ CRT-Ps

Quadra Allure MP™ CRT-Ps
ICDs

Ellipse™ ICDs

Fortify Assura™ ICDs
CRT-Ds

Quadra Assura™ CRT-Ds

Quadra Assura MP™ CRT-Ds

NOTE: If you plan to use the SJM MRI Activator handheld device to implement MRI Settings, program V. AutoCapture 'On' prior
to enabling MRI Settings. The AutoCapture feature will provide a safety margin against increased pacing capture thresholds that
may occur post-MRI due to lead tip heating. Before communication between the SJM MRI Activator handheld device and the
pulse generator can be enabled, you must obtain in-range bipolar pacing lead impedance measurements from the current
programming session.

To enable the pulse generator to communicate with the handheld device:

1. Determine the appropriate MRI Settings as described above.

2. From the MRI Settings window, select the Setup MRI Activator button.

The MRI Activator Checklist window opens.

3. Review each condition on the checklist and check off each one that applies. You will not be able to enable the pulse generator
to communicate with the handheld device until all boxes are checked.

Once you have verified each condition, the Enable MRI Activator button becomes available.

4. Select the Enable MRI Activator button.

The device can now communicate with the handheld device.

Table 17. St. Jude Medical™ MR Conditional devices1 with SJM MRI Activator™ handheld device functionality

PM1272, PM2272

PM1172, PM2172

PM1162, PM2162

PM1140, PM1152, PM2140, PM2152

PM1282, PM2282

PM1182, PM2182

PM3542

PM3562

CD1377-36Q, CD1377-36QC, CD2377-36Q, CD2377-36QC

CD1359-40Q, CD1359-40QC, CD2359-40Q, CD2359-40QC

CD3367-40Q, CD3367-40QC

CD3371-40Q, CD3371-40QC

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

No

No

No

1

Not all device models are available in all countries.

12

VI. Review the MRI Checklist and Program MRI Settings

Figure 2. An example of the MRI Checklist screen for pacemakers on the Merlin™ PCS

Figure 3. An example of MRI Checklist screen for CRT-Ps on the Merlin™ PCS

Figure 4. An example of the MRI Checklist screen for ICDs on the Merlin™ PCS

13

Figure 5. An example of the MRI Checklist screen for CRT-Ds on the Merlin™ PCS

1. After you have selected the appropriate MRI Settings, from the MRI Settings window on the Merlin™ PCS, select the Setup for
MRI Now button.

After the system performs test measurements required for MRI setup, the MRI Checklist window opens.

2. Review each condition on the checklist and check off each one that applies. You will not be able to program MRI Settings until
all checkboxes are checked.

The MRI software provides automatic verification that no device or lead issues are detected that may compromise patient safety
during an MRI scan. Before allowing the user to initiate MRI Settings, the MRI software ensures:

- Pacing lead impedance is within range - If bipolar pacing lead impedance for RA, RV, or LV leads is out of range, the

software prevents MRI Settings from being enabled.

- Defibrillation lead impedance is within range - If the lead impedance for any of the implanted coils on the defibrillation

lead is out of range, the software prevents MRI Settings from being enabled.

- Capacitor maintenance is postponed - For ICDs and CRT-Ds, the software prepares the capacitor to prevent automatic

capacitor maintenance from occurring during an MRI scan.

3. If any of the system integrity tests required for MRI setup is incomplete, Perform Test will be displayed on the test panel in the
MRI Checklist. Click on the panel to manually run the incomplete test before enabling MRI Settings.

4. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings.

MRI Settings: Active window appears. This window confirms the programmed changes. Use this window to print the MRI
Summary report and end the session (recommended) before performing the MRI scan. MRI Settings can also be disabled in
this window.

NOTE: If the programmer Shock button is selected when MRI Settings are enabled, the system will disable MRI Settings and
display the emergency shock dialog box. After an emergency shock, restore MRI Settings before scanning the patient.

5. Select Print MRI Report button to print the report.

6. Select End Session.

The patient is now ready for the MR scan.

CAUTION: An ICD or CRT-D patient must be hemodynamically monitored while MRI Settings are programmed, and an
external defibrillator must be kept continuously ready. Be sure to disable MRI Settings as soon as the MRI scan is
complete.

VII. Disable MRI Settings

CAUTION: Do not bring the Merlin™ Patient Care System (PCS) Model 3650 or the SJM MRI Activator™ handheld
device Model EX4000 into Zone IV (MRI scanner magnet room), as defined by the American College of Radiology. Each
device is MR Unsafe.

Immediately following the MRI procedure, the patient's device management physician or clinician must:

1. Interrogate the device using the Merlin™ PCS or the SJM MRI Activator handheld device.

2. For the SJM MRI Activator handheld device, select the MRI Settings Off button.

3. For the Merlin PCS, disable MRI Settings by selecting the Disable MRI Settings button. This restores the permanently
programmed settings.

a. Confirm the permanently programmed settings are appropriate.

b. To ensure an accurate lead impedance measurement, perform a lead impedance test by selecting Tests > Battery &

Leads > Update leads.

c. Check the pacing capture thresholds after the scan is complete and ensure that the pacing parameters are

programmed adequately for the patient based on the threshold.

Refer to the Merlin PCS on-screen help for information on selecting and programming parameter settings.

14

NOTE: If the device performs an automatic lead impedance measurement during the procedure, the results may be inaccurate.
The magnetic field exerted by the MRI scanner can sometimes result in an inaccurate lead impedance measurement.

15

Instructions for Radiologists and MRI Technologists

NOTE: Cardiac physicians and clinicians should see Instructions for Cardiac Physicians and Clinicians (page 7).

The role of the radiologist or MRI technologist is to:

 Confirm that the Patient has an MR Conditional System (page 15)

 Confirm that No Adverse Conditions to MRI Scanning are Present (page 15)

 Review the Potential Interactions (page 15)

 Select the Correct Scan Parameters (page 16)

 Check MRI Settings Status (page 16)

 Perform the Scan and Monitor the Patient (page 18)

 Disable MRI Settings (page 18)

I. Confirm that the Patient has an MR Conditional System

1. Review the patient’s ID card or the MRI Summary Report (generated by the Merlin™ PCS) to obtain the model numbers for
both the implanted lead or leads and device.

2. Check the model numbers against the St. Jude Medical™ MR Conditional Systems Device/Lead Combination tables (3T MRI
tables (page 3) or 1.5T MRI tables (page 5)).

NOTE: Not all lead lengths are MR Conditional. Check the lead lengths listed in the device/lead combination tables for MR
Conditional lead lengths. Lead lengths not listed are untested.

Patients can be considered safe for an MRI scan only if the implanted system consists of a St. Jude Medical MR Conditional
device connected to the appropriate St. Jude Medical MR Conditional lead or leads.

II. Confirm that No Adverse Conditions to MRI Scanning are Present

If any conditions exist that could make MRI scanning unsafe, do not scan the patient. Such conditions include:
 Patient has elevated body temperature or compromised thermoregulation at time of scan, and if system includes any 1944,

1948, or 2088TC leads; or an Ellipse™ ICD, Fortify Assura™ ICD, Quadra Allure™ CRT-P, Quadra Allure MP™ CRT-P, Quadra
Assura™ CRT-D, or Quadra Assura MP™ CRT-D

 A combination of one or more leads and a device that is not listed as MR Conditional in the device/lead combination tables (3T

MRI tables (page 3) or 1.5T MRI tables (page 5)).

 Broken or intermittently functioning St. Jude Medical™ MR Conditional leads

 Additional hardware including lead extenders, lead adapters, or abandoned leads

 A St. Jude Medical MR Conditional system implanted in sites other than the left and right pectoral region (see figure below)

 Any prone or lateral recumbent patient positions, or positions where the patient's arm is raised above his or her head; these

positions are excluded and have not been tested

NOTE: Lead fractures or other damage to the leads may cause changes in the electrical properties of the St. Jude Medical MR
Conditional system that make the system unsafe for an MRI scan. Patients with damaged leads may be harmed if an MRI scan
is performed.

Figure 6. Correct locations for device implant

1. Right-pectoral region

2. Left-pectoral region

III. Review the Potential Interactions

Potential interactions between the MRI scanner and the system include:
 The magnetic material of an implanted system may exert force, vibration, and torque effects due to the static magnetic field and

gradient magnetic fields produced by an MRI scanner. These effects have been shown to be minimal in St. Jude
Medical™ MR Conditional systems. Patients may feel a mild tugging or vibration sensation at the site of the device implant
while in or near the MRI scanner.

16

Parameter

Setting

 The gradient magnetic and RF fields produced by an MRI scanner could potentially interact with the MR Conditional system

and cause unintended stimulation of the heart. When all conditions outlined in this manual are met, the voltages and pulse
widths induced on the leads of the St Jude Medical MR Conditional System are limited so that the potential for capturing the
heart is minimized.

 The RF fields generated by an MRI scanner could induce voltages onto an implanted lead system that may cause heating at the

lead electrodes. This heating could damage the tissue surrounding the electrodes and compromise pacing and sensing
thresholds at that site. When all conditions outlined in this manual are met, St. Jude Medical MR Conditional leads have been
tested and shown to limit heating at the electrodes and to minimize thermal damage of the surrounding cardiac tissue.

IV. Select the Correct Scan Parameters

1. Refer to the MRI scan parameters table (3T MRI table (page 2) or 1.5T MRI table (page 4) for the applicable scan parameter
settings for approved MR Conditional device/lead combinations.

2. Refer to the section on St. Jude Medical™ MR Conditional Systems Device/Lead Combinations (3T MRI tables (page 3) or 1.5T
MRI tables (page 5)) to identify the settings for RF Power (SAR) and scan regions for specific device/lead combinations.

3. Make sure that you identify the combination of both the device and one or more leads to select the correct settings.

4. If the implantable system is comprised of a combination of leads that have different scan parameters, use the most restrictive of
each scan parameter to determine the overall set of scan conditions applicable for the total system.

V. Check MRI Settings Status

CAUTION: Do not bring the Merlin™ Patient Care System (PCS) Model 3650 or the SJM MRI Activator™ handheld
device Model EX4000 into Zone IV (MRI scanner magnet room), as defined by the American College of Radiology. Each
device is MR Unsafe.

If you do not have an SJM MRI Activator™ handheld device Model EX4000, see, Check MRI Setting Status without the SJM MRI
Activator™ Handheld Device (page 16).

If you do have an SJM MRI Activator™ handheld device Model EX4000 available, see, Check MRI Settings Status with the SJM MRI
Activator™ Handheld Device (page 16).

Check MRI Settings Status without the SJM MRI Activator™ Handheld Device

1. Refer to the MRI Summary Report generated by the Merlin™ PCS.

2. Confirm these settings with the device management physician or clinician.

The currently programmed settings should include:

Table 18. MRI Settings2

Tachy Therapy (ICD and CRT-D patients) Disabled

MRI Mode DOO, VOO, AOO, Pacing Off

MRI Base Rate

MRI Paced AV Delay 25 - 120 ms

MRI Pulse Amplitude 5.0 or 7.5 V

MRI Pulse Width 1.0 ms

MRI Pulse Configuration Bipolar

MRI V Pacing Chamber (CRT-P and CRT-D patients) RV only

Pacemakers and CRT-Ps: 30 - 120 min§

ICDs and CRT-Ds: 30-100 min§

Check MRI Settings Status with the SJM MRI Activator™ Handheld Device

To check the status of MRI Settings:

1. Refer to the table below to determine if the device can communicate with the handheld device.

2. Place the handheld device over the implanted device.

The handheld device should be held against the patient's chest directly over the implanted pulse generator.
For the proper location, see the figure above.

3. Press the MR Status button.

- MRI Settings Enabled. The green LEDs (on the right side of the handheld device) illuminate continuously for 5 seconds.

- MRI Settings Disabled. The red LEDs (on the left side of the handheld device) illuminate continuously for 5 seconds.

2

This is the entire range of all possible settings for this parameter.

17

Model Name and Number

Operates with the SJM MRI Activator handheld device
Model EX4000

Pacemakers

Assurity MRI™ pacemakers

Endurity MRI™ pacemakers

Endurity™ pacemakers

Endurity™ Core pacemakers

Zenex MRI™ pacemakers

Zenus MRI™ pacemakers
CRT-Ps

Quadra Allure™ CRT-Ps

Quadra Allure MP™ CRT-Ps
ICDs

Ellipse™ ICDs

Fortify Assura™ ICDs

Figure 7. SJM MRI Activator handheld device

1. MR Status button

2. MRI Settings On button

3. Green LED

4. MRI Settings Off button

5. Red LED

If MRI Settings are not enabled and the patient is ready for the MRI scan, enable the settings with the handheld device.

To enable MRI Settings:

1. Place the handheld device over the implanted pulse generator.

The handheld device should be touching the patient's clothing directly over the implanted pulse generator.

2. Press the MRI Settings On button.

The LEDs may flash before they illuminate continuously.

- MRI Settings Enabled. The green LEDs (on the right side of the handheld device) illuminate continuously for 5 seconds.

- MRI Settings Disabled. The red LEDs (on the left side of the handheld device) illuminate continuously for 5 seconds.

Table 19. St. Jude Medical™ MR Conditional devices3 with SJM MRI Activator™ handheld device functionality

Yes

PM1272, PM2272

Yes

PM1172, PM2172

Yes

PM1162, PM2162

Yes

PM1140, PM1152, PM2140, PM2152

Yes

PM1282, PM2282

Yes

PM1182, PM2182

No

PM3542

No

PM3562

No

CD1377-36Q, CD1377-36QC, CD2377-36Q, CD2377-36QC

No

CD1359-40Q, CD1359-40QC, CD2359-40Q, CD2359-40QC

3

Not all device models are available in all countries.

18

Model Name and Number

Operates with the SJM MRI Activator handheld device
Model EX4000

CRT-Ds

Quadra Assura™ CRT-Ds

Quadra Assura MP™ CRT-Ds

Table 19. St. Jude Medical™ MR Conditional devices3 with SJM MRI Activator™ handheld device functionality

CD3367-40Q, CD3367-40QC

CD3371-40Q, CD3371-40QC

No

No

VI. Perform the Scan and Monitor the Patient

Proper patient monitoring must be provided during the MRI scan. This includes continuous monitoring of the patient's
hemodynamic function. Since the MR environment may interfere with the patient monitoring system, it is recommended that more
than one of the following systems be used: electrocardiography, pulse oximetry, noninvasive blood pressure measurements.
If the patient's hemodynamic function is compromised during the MRI scan, discontinue the MRI scan and take the proper
measures to restore the patient's hemodynamic function.

Verbal communication with the patient during the MRI scan is recommended.

Keep an external defibrillator available during the MRI scan.

CAUTION: In MR Conditional ICDs and CRT-Ds, tachycardia therapy is disabled when MRI Settings are programmed.

CAUTION:

 An ICD or CRT-D patient must be hemodynamically monitored while MRI Settings are programmed, and an

external defibrillator must be kept constantly ready.

 Be sure to disable MRI Settings as soon as the MRI scan is complete.

St. Jude Medical™ MR Conditional leads have demonstrated minimal image distortion for areas surrounding the
implanted leads when the device is out of the field of view. Significant image distortion can result from the presence of the

device within the field of view. Image artifacts and distortion resulting from the presence of the device and the leads within the field
of view must be considered when selecting the field of view and imaging parameters. These factors must also be considered when
interpreting the MRI images.

VII. Disable MRI Settings

1. If you are using the SJM MRI Activator™ handheld device, place the handheld device over the implanted device.

The handheld device should be touching the patient's clothing directly over the implanted device.

2. Press the MRI Settings Off button.

The LEDs may flash before they illuminate continuously.
MRI Settings Disabled. The red LEDs illuminate continuously for 5 seconds.

3. If you are not using the handheld device, MRI Settings must be disabled by the patient's device management physician or
clinician using the Merlin PCS programmer.

Technical Support

St. Jude Medical maintains 24-hour phone lines for technical questions and support:

 1 818 362 6822

 1 800 722 3774 (toll-free within North America)

 + 46 8 474 4147 (Sweden)

 + 61 2 9936 1200 (Australia)

 manuals.sjm.com

For additional assistance, call your local St. Jude Medical representative.

St. Jude Medical

St. Jude Medical

St. Jude Medical Puerto Rico LLC

St. Jude Medical Operations (M) Sdn. Bhd.

sjm.com

2020-06

Cardiac Rhythm
Management Division
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