Boston Scientific L211, L231, L310, L311, L331 Technical Manual

MRI TECHNICAL GUIDE

IMAGEREADY™MR
CONDITIONAL PACING
SYSTEM

REF L110, L111, L131, L210, L211, L231, L310, L311, L331, 4456, 4457,
4458, 4459, 4469, 4470, 4471, 4472, 4473, 4474, 4479, 4480, 6220,
6221, 6402, 7145, 7731, 7732, 7735, 7736, 7740, 7741, 7742

ABOUT THIS MANUAL

This manual is intended for use by physicians and other health care professionals (HCPs)
involved in managing patients with an ImageReady MR Conditional Pacing System, as well as
radiologists and other HCPs involved in performing magnetic resonance imaging (MRI) scans on
such patients.

NOTE: For the purposes of this Technical Guide, MRI is used as a general term and
encompasses all MR-based clinical imaging activities. In addition, information in this guide
applies only to

Read this manual in its entirety before scanning patients who are implanted with an ImageReady
MR Conditional Pacing System.

This manual contains:

• Information about ImageReady MR Conditional Pacing Systems

• Information about ImageReady Pacing System patients who can and cannot undergo an MRI
scan and the Conditions of Use that must be met in order for an MRI scan to be performed

• Instructions for carrying out an MRI scan on ImageReady Pacing System patients

How to use this manual:

1

H MRI (Proton MRI) scanners.

1. Refer to the patient’s records to locate model numbers for all components of the patient’s

implanted system.

2. Refer to "System Configuration for 1.5 T" on page 1-3 and "System Configuration for 3 T" on

page 1-3 to determine if all components of the patient’s implanted system are found within
the tables. If any of the components cannot be found within the tables, the system is not an
ImageReady MR Conditional Pacing System.

NOTE: Multiple Boston Scientific ImageReady MRI Technical Guides are available based
on therapy type, for example, a pacing system versus a defibrillation system. If a particular
pulse generator model is not represented in this manual, refer to the other Boston Scientific
ImageReady MRI Technical Guides. If a particular model is not represented in any Boston
Scientific ImageReady MRI Technical Guide, the patient’s implanted system is not an
ImageReady MR Conditional system.

Refer to the Physician’s Technical Manual, Reference Guide, Leads Manual, Clinician Manual, or
Programmer Operator’s Manual for detailed information about non-MRI aspects of implantation,
features, programming, and use of the components of the Pacing System.

The following are trademarks of Boston Scientific Corporation or its affiliates:

ACCOLADE, ESSENTIO, FINELINE, IMAGEREADY, INGEVITY, LATITUDE, PaceSafe,

PROPONENT, ZOOM, ZOOMVIEW.

TABLE OF CONTENTS

INTRODUCTION TO MR CONDITIONAL PACING ..............................................................1-1

CHAPTER 1

System Description ............................................................................................................1-2

Valid Combinations of Pulse Generators and Leads to Use in 1.5 Tesla and 3 Tesla

Environments ..............................................................................................................1-2

System Configuration for 1.5 T ......................................................................................1-3

System Configuration for 3 T .........................................................................................1-3

MRI Conditions of Use........................................................................................................1-4

Cardiology ...................................................................................................................1-4

Radiology ....................................................................................................................1-4

Conditions for Scanning......................................................................................................1-5

MRI Protection Mode........................................................................................................ 1-11

MRI Basic Concepts......................................................................................................... 1-11

X-ray or Fluoroscopic Identification.................................................................................... 1-12

MR Conditional Pacing System Warnings and Precautions.................................................. 1-12

General .....................................................................................................................1-12

Programming Considerations ...................................................................................... 1-13

Safety Mode .............................................................................................................. 1-13

MRI Site Zone III Exclusions ....................................................................................... 1-14

Precautions ...............................................................................................................1-14

Potential Adverse Events.................................................................................................. 1-14

MRI SCAN PROCEDURE PROTOCOL...............................................................................2-1

CHAPTER 2

Patient Flow.......................................................................................................................2-2

MRI Protection Mode General Information............................................................................2-2

Pre-Scan Activities .............................................................................................................2-4

1. Programming the Pulse Generator for a Scan .............................................................2-5

2. Confirming MRI Scanner Settings and Configuration ................................................. 2-13

3. Preparing the Patient for the Scan ........................................................................... 2-13

During the Scan ............................................................................................................... 2-14

After the Scan.................................................................................................................. 2-14

CARDIOLOGY CHECKLIST FOR THE IMAGEREADY PACING SYSTEM .......................... A-1

APPENDIX A

RADIOLOGY CHECKLIST FOR THE IMAGEREADY PACING SYSTEM ............................. B-1

APPENDIX B

IMAGEREADY PACING SYSTEM COMPONENTS FOR 1.5 T AND 3 T............................... C-1

APPENDIX C

SYMBOLS ON PACKAGING............................................................................................. D-1

APPENDIX D

INTRODUCTION TO MR CONDITIONAL PACING

CHAPTER 1

This chapter contains the following topics:

• “System Description” on page 1-2

• “MRI Conditions of Use” on page 1-4

• “Conditions for Scanning” on page 1-5

• “MRI Protection Mode” on page 1-11

• “MRI Basic Concepts” on page 1-11

• “X-ray or Fluoroscopic Identification” on page 1-12

• “MR Conditional Pacing System Warnings and Precautions” on page 1-12

• “Potential Adverse Events” on page 1-14

1-1

1-2

Introduction to MR Conditional Pacing

System Description

SYSTEM DESCRIPTION

An ImageReady MR Conditional Pacing System consists of specific Boston Scientific model
components including pulse generators, leads, accessories, the Programmer/Recorder/Monitor
(PRM), and the PRM Software Application. For the model numbers of MR Conditional Pacing
System components, see Table 1–2 System Configuration for 1.5 T on page 1-3 and Table 1–3
System Configuration for 3 T on page 1-3.

The ImageReady MR Conditional Pacing Systems were created specifically as a system for use
with MRI scans performed under the Conditions of Use described in this Technical Guide. The
pulse generator design has minimized use of ferromagnetic materials, which can interact with the
fields generated during a typical MRI scan, and the circuits have been designed to tolerate
voltages that may be induced during scans. Any part of the body may be imaged. Boston
Scientific MR Conditional pulse generators and leads, when used together, have mitigated risks
associated with MRI scans as compared to conventional pulse generators and leads. The
implanted system, as opposed to its constituent parts, is determined to have the status of MR
Conditional as described in ASTM F2503:2008. Additionally, an MRI Protection Mode has been
created for use during the scan. MRI Protection Mode modifies the behavior of the pulse
generator and has been designed to accommodate the MRI scanner electromagnetic
environment. A Time-out feature can be programmed to allow automatic exit from MRI Protection
Mode after a set number of hours chosen by the user. These features have been tested to verify
the effectiveness of the designs. Other MRI-related risks are further reduced by adherence to the
conditions for scanning specified in this Technical Guide.

For additional information, see the Boston Scientific Website at http://www.bostonscientific.com/
imageready.

Only specific combinations of pulse generators and leads constitute an ImageReady Pacing
System. Consult the following tables to distinguish between combinations that are valid for use
with only 1.5 T scanners and combinations that are valid for use with both 1.5 T and 3 T

scanners.

Valid Combinations of Pulse Generators and Leads to Use in 1.5 Tesla and 3 Tesla Environments

Table 1–1. Valid Combinations of Pulse Generators and Leads to Use in 1.5 T and 3 T Environments

Combination of one

INGEVITY MRI Lead and one

FINELINE II Lead

1.5 T scanner only.
3 T scanner not allowed.

Normal Operating Mode only.

ESSENTIO MRI Pulse
Generator
PROPONENT MRI
Pulse Generator
ACCOLADE MRI Pulse
Generator

INGEVITY MRI Leads

only

1.5 T or 3 T scanner
allowed.

Normal Operating Mode
or First Level Controlled
Operating Mode.

FINELINE II Leads only

1.5 T scanner only.
3 T scanner not allowed.

Normal Operating Mode
only.

• Refer to Table 1–2 System Configuration for 1.5 T on page 1-3 and Table 1–3 System
Configuration for 3 T on page 1-3 for a complete list of the model numbers of MR Conditional
Pacing System components.

• Refer to "MRI Conditions of Use" on page 1-4 for the entire set of MRI Conditions of Use.

WARNING: Only the combination of INGEVITY MRI lead(s) with an ESSENTIO MRI,
PROPONENT MRI, or ACCOLADE MRI pulse generator is valid to use with either 1.5 T or 3 T
scanners. All other allowable combinations of Boston Scientific MR Conditional system
components must use only 1.5 T scanners.

NOTE: 3 T MRI scanners should be operated in Circularly Polarized mode or Dual Channel
Multi-Transmission mode since ImageReady Pacing Systems have been evaluated against 3 T
MRI scanners during Circularly Polarized and Dual Channel Multi-Transmission RF operation
modes. Multi-Transmission RF operation with greater than two transmit channels has not been
evaluated.

System Configuration for 1.5 T

Table 1–2. System Configuration for 1.5 T

Component Model Number(s) MR Status

Pulse Generators

ESSENTIO MRI Pulse Generator L110, L111, L131 MR Conditional

PROPONENT MRI Pulse Generator L210, L211, L231 MR Conditional

ACCOLADE MRI Pulse Generator L310, L311, L331 MR Conditional

Leads and Accessories

FINELINE II Sterox Pacing Lead 4456, 4457, 4458, 4459, 4479, 4480 MR Conditional

Introduction to MR Conditional Pacing

System Configuration for 1.5 T

FINELINE II Sterox / Sterox EZ Leads

1-3

FINELINE II Sterox EZ Pacing Lead 4469, 4470, 4471, 4472, 4473, 4474 MR Conditional

Suture Sleeve for FINELINE II leads 6220, 6221 MR Conditional

IS-1 Lead Port Plug 7145 MR Conditional

INGEVITY MRI Pacing Lead (Tined Fixation) 7731, 7732, 7735, 7736 MR Conditional

INGEVITY MRI Pacing Lead (Extendable/
Retractable Fixation)

Suture Sleeve for INGEVITY MRI leads 6402 MR Conditional

IS-1 Lead Port Plug 7145 MR Conditional

ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) and PRM Software Application

ZOOM LATITUDE PRM 3120 MR Unsafe

ZOOM LATITUDE PRM Software App. 2869 N/A

a. See PRM is MR Unsafe Warning regarding the PRM.

System Configuration for 3 T

Table 1–3. System Configuration for 3 T

Component Model Number(s) MR Status

Pulse Generators

ESSENTIO MRI Pulse Generator L110, L111, L131 MR Conditional

PROPONENT MRI Pulse Generator L210, L211, L231 MR Conditional

ACCOLADE MRI Pulse Generator L310, L311, L331 MR Conditional

Leads and Accessories

INGEVITY MRI Pacing Lead (Tined Fixation) 7731, 7732, 7735, 7736 MR Conditional

INGEVITY MRI Leads

7740, 7741, 7742 MR Conditional

a

INGEVITY MRI Leads

INGEVITY MRI Pacing Lead (Extendable/
Retractable Fixation)

Suture Sleeve for INGEVITY MRI leads 6402 MR Conditional

7740, 7741, 7742 MR Conditional

1-4

Introduction to MR Conditional Pacing

MRI Conditions of Use

Table 1–3. System Configuration for 3 T (continued)

Component Model Number(s) MR Status

IS-1 Lead Port Plug 7145 MR Conditional

ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) and PRM Software Application

ZOOM LATITUDE PRM 3120 MR Unsafe

ZOOM LATITUDE PRM Software App. 2869 N/A

a. See PRM is MR Unsafe Warning regarding the PRM.

MRI CONDITIONS OF USE

The following Conditions of Use must be met in order for a patient with an ImageReady Pacing
System to undergo an MRI scan. Adherence to the Conditions of Use must be verified prior to
each scan to ensure that the most up-to-date information has been used to assess the patient’s
eligibility and readiness for an MR Conditional scan.

Cardiology

1. Patient is implanted with an ImageReady MR Conditional Pacing System1(see "System

Description" on page 1-2)

a

WARNING: Only the combination of INGEVITY MRI lead(s) with an ESSENTIO MRI,
PROPONENT MRI, or ACCOLADE MRI pulse generator is valid to use with either 1.5 T or 3
T scanners. All other allowable combinations of Boston Scientific MR Conditional system
components must use only 1.5 T scanners.

2. Pulse generator in MRI Protection Mode during scan

3. Bipolar pacing operation or pacing off

4. Patient does not have elevated body temperature or compromised thermoregulation at time

of scan

5. Pulse generator implant location restricted to left or right pectoral region

6. At least six (6) weeks have elapsed since implantation and/or any lead revision or surgical

modification of the MR Conditional Pacing System

7. No cardiac-related implanted devices, components, or accessories present other than an

ImageReady MR Conditional Pacing System (see "System Description" on page 1-2)

8. Pacing threshold ≤ 2.0 V in pace-dependent patients

9. No abandoned leads or pulse generators

10. No evidence of a fractured lead or compromised pulse generator-lead system integrity

Radiology

1. MRI magnet strength of 1.5 T or 3 T

a. MRI magnet strength of 1.5 T (See Table 1–2 System Configuration for 1.5 T on page 1-3

to determine which pulse generators and leads are valid for use with 1.5 T magnets.)

1. Defined as a Boston Scientific MR Conditional pulse generator and lead(s), with all ports occupied by a lead or port

plug.

Introduction to MR Conditional Pacing

Conditions for Scanning

1-5

• Radio frequency (RF) field of approximately 64 MHz

• Spatial gradient no greater than 50 T/m (5,000 G/cm)

b. MRI magnet strength of 3 T (See Table 1–3 System Configuration for 3 T on page 1-3 to

determine which pulse generators and leads are valid for use with 3 T magnets.)

• RF field of approximately 128 MHz

• Spatial gradient no greater than 50 T/m (5,000 G/cm)

WARNING: Only the combination of INGEVITY MRI lead(s) with an ESSENTIO MRI,
PROPONENT MRI, or ACCOLADE MRI pulse generator is valid to use with either 1.5 T or 3
T scanners. All other allowable combinations of Boston Scientific MR Conditional system
components must use only 1.5 T scanners.

2. Horizontal,

1

H proton, closed bore scanners only

3. Specific Absorption Rate (SAR) limits:

a. For an ImageReady Pacing System with FINELINE II leads only or with one FINELINE II

lead and one INGEVITY MRI lead (see "Valid Combinations of Pulse Generators and
Leads to Use in 1.5 Tesla and 3 Tesla Environments" on page 1-2), SAR limits for Normal
Operating Mode

2

must be observed for the entire active scan session as follows:

• Whole body averaged, ≤ 2.0 watts/kilogram (W/kg)

• Head, ≤ 3.2 W/kg

b. For an ImageReady Pacing System with INGEVITY MRI leads (see "Valid Combinations

of Pulse Generators and Leads to Use in 1.5 Tesla and 3 Tesla Environments" on page
1-2), SAR limits for Normal Operating Mode

4

Mode

must be observed for the entire active scan session as follows:

3

or for First Level Controlled Operating

• Whole body averaged, ≤ 4.0 W/kg

• Head, ≤ 3.2 W/kg

4. Gradient Field limits: Maximum specified gradient slew rate ≤ 200 T/m/s per axis

5. No local transmit-only coils or local transmit/receive coils placed directly over the pacing
system; the use of receive-only coils is not restricted

6. Patient in supine or prone position only

7. The patient must be monitored during the MRI scan by pulse oximetry and/or
electrocardiography (ECG)

Refer to Table 1–4 Cardiology Conditions/Patient Conditions on page 1-6 and Table 1–5
Radiology Conditions on page 1-8 for additional information about the Conditions of Use.

CONDITIONS FOR SCANNING

Table 1–4 Cardiology Conditions/Patient Conditions on page 1-6 summarizes the Cardiology
Conditions/Patient-related Conditions of Use that must be met in order for an MR Conditional

2. As defined in IEC 60601-2-33, 201.3.224, 3rd Edition.

3. As defined in IEC 60601-2-33, 201.3.224, 3rd Edition.

4. As defined in IEC 60601-2-33, 201.3.208, 3rd Edition.

1-6

Introduction to MR Conditional Pacing

Conditions for Scanning

scan to be performed. For each condition or requirement, actions to determine eligibility, the
potential clinical consequences of failing to meet the condition(s), and the patient population most
impacted by failure to meet the condition(s) are listed.

Table 1–4. Cardiology Conditions/Patient Conditions

Condition for Scanning

(Rationale)

1. Patient is implanted with an
ImageReady MR Conditional
Pacing System (defined as a
Boston Scientific MR
Conditional pulse generator and
lead(s), with all ports occupied
by a lead or port plug).

For model numbers of MR
Conditional components, and to
identify an appropriate
combination, refer to "System
Description" on page 1-2 in this
Guide, http://www.
bostonscientific.com/
imageready, or Boston
Scientific Technical Services.

Actions If Condition is Not Met

• Check patient records.

• Interrogate device. (Pulse
generator model number is
provided on PRM screen
and MRI Protection
Settings Report.)

• Check patient ID card.

• Check model numbers in
"System Description" on
page 1-2 of this Guide, at

http://www.bostonscientific.
com/imageready, or by

contacting Boston
Scientific Technical
Services.

• Confirm with physician
responsible for managing
the patient’s Pacing
System.

• Check X-ray or
fluoroscopic images of
pulse generator to assist
identification (see "X-ray or
Fluoroscopic Identification"
on page 1-12).

Potential Clinical
Consequences

• Arrhythmia induction

• Clinically significant pacing
threshold changes and
sensing changes as a
result of heating at the
lead/tissue interface

• Damage to pulse generator
and/or lead

• Erratic pulse generator
behavior

• Inappropriate pacing,
inhibition of pacing, or
irregular intermittent
capture or pacing, possibly
resulting in pre-syncope or
syncope

• Physical movement of
pulse generator and/or
leads

• Pocket discomfort due to
pulse generator heating

Risk is Highest for

• Pacing-dependent patients

• Patients prone to sustained
arrhythmias

• Patients with high capture
thresholds

The appropriate Boston Scientific MR Conditional pulse generator and Boston Scientific MR Conditional lead(s) must be used together to
obtain the intended risk reduction needed for MR Conditional scans.

Another manufacturer's MR Conditional pulse generator combined with a Boston Scientific MR Conditional lead (or vice versa) do not
constitute an MR Conditional System, because the components were not designed to work together in the MRI environment.

WARNING: Only the combination of INGEVITY MRI lead(s) with an ESSENTIO MRI, PROPONENT MRI, or ACCOLADE MRI pulse

generator is valid to use with either 1.5 T or 3 T scanners. All other allowable combinations of Boston Scientific MR Conditional system

components must use only 1.5 T scanners.

2. Pulse generator in MRI
Protection Mode during scan.

Effects of RF or gradient fields
create the potential for
oversensing, and/or induced
voltages in the pulse generator.
MRI Protection Mode is
designed to mitigate these
effects.

3. Bipolar pacing operation or
pacing off.

Unipolar lead configurations
increase the risk of induced
voltages in the lead system.
Bipolar ventricular pacing
operation is required to support
Safety Core operation, if Safety
Core is entered from MRI
Protection Mode.

• Program the pulse
generator to MRI
Protection Mode using the
PRM.

• Confirm that pacing lead
configuration is bipolar. If
unipolar, program to
bipolar.

Unipolar configuration of
the lead used for pacing in
MRI Protection Mode will
prevent entry into MRI
Protection Mode.

• Arrhythmia induction

• Inappropriate pacing,
inhibition of pacing, or
irregular intermittent
capture or pacing, possibly
resulting in pre-syncope or
syncope

• Arrhythmia induction

• Inappropriate pacing,
inhibition of pacing, or
irregular intermittent
capture or pacing, possibly
resulting in pre-syncope or
syncope

• Pacing will not occur if
Safety Core is entered.

• Pacing-dependent patients

• Patients prone to sustained
arrhythmias

• Pacing-dependent patients

• Patients prone to sustained
arrhythmias

4. Patient does not have an
elevated body temperature or
compromised thermoregulation
at time of MRI scan.

• Check patient’s
temperature prior to scan.

• Clinically significant pacing
threshold changes and
sensing changes as a

• Patients with high capture
thresholds

Table 1–4. Cardiology Conditions/Patient Conditions (continued)

Introduction to MR Conditional Pacing

Conditions for Scanning

1-7

Condition for Scanning

(Rationale)

Pre-existing elevated
temperature is additive with any
scan-induced heating.

5. Pulse generator implant
location restricted to left or right
pectoral region.

Lead trajectories associated
with non-pectoral implant
locations pose risks for heating,
inappropriate stimulation, and
arrhythmia induction.

6. At least six weeks have
elapsed since implantation and/
or any lead revision or surgical
modification of the MR
Conditional Pacing System.

A six-week period of healing
allows for formation of scar
tissue and capsule maturation,
which reduce the impact of
heating, vibration, and
movement potentially caused
by the magnetic fields of the
MRI scanner.

Actions If Condition is Not Met

• Check patient records.

• Check by physical exam or
X-ray.

• Check patient records and/
or patient ID card.

• Check PRM data for the
user-entered Implant Date,
if available.

Upon user request to enter MRI
Protection Mode, the PRM
provides an attention message
if the calculated time since exit
from Storage Mode is less than
or equal to six weeks. (Check

that the PRM is set with the
correct time and date to ensure
accuracy.)

Potential Clinical
Consequences

result of heating at the
lead/tissue interface

• Pocket discomfort due to
pulse generator heating

• Arrhythmia induction

• Clinically significant pacing
threshold changes and
sensing changes as a
result of heating at the
lead/tissue interface

• Inappropriate pacing,
inhibition of pacing, or
irregular intermittent
capture or pacing, possibly
resulting in pre-syncope or
syncope

• Physical movement of
pulse generator in pocket

• Pocket discomfort due to
pulse generator heating

• Arrhythmia induction

• Clinically significant pacing
threshold changes and
sensing changes as a
result of heating at the
lead/tissue interface

• Increased rate of lead
dislodgement due to
incomplete capsule
maturation

• Physical movement of
pulse generator in pocket

Risk is Highest for

• Pacing-dependent patients

• Patients prone to sustained
arrhythmias

• Patients with high capture
thresholds

• Patients prone to sustained
arrhythmias

• Patients with high capture
thresholds

7. No cardiac-related implanted
devices, components, or
accessories present other than
an ImageReady MR Conditional
Pacing System (see "System
Description" on page 1-2).

The presence of other cardiac
implants or accessories such as

lead adaptors, extenders, or
abandoned leads or pulse
generators may significantly

reduce the effectiveness of an
ImageReady MR Conditional
Pacing System in reducing risks
of MRI scanning.

8. Pacing threshold ≤ 2.0 V in
pace-dependent patients.

Pulse generator pulse
amplitude in MRI Protection
Mode is set to 5.0 V, providing a
minimum two-fold safety margin

• Check patient records.

• Confirm with physician
responsible for managing
the patient’s Pacing
System.

• Check X-rays.

• Check model numbers in
this Guide ("System
Description" on page 1-2)
or at http://www.

bostonscientific.com/
imageready.

For model numbers of MR
Conditional components, and to
identify an appropriate
combination, refer to "System
Description" on page 1-2 in this
Guide, http://www.
bostonscientific.com/
imageready, or Boston
Scientific Technical Services.

• Check patient records for
most recent pacing
threshold values or run a
pacing threshold test.

The device will check the most
recently recorded pacing

• Arrhythmia induction

• Clinically significant pacing
threshold changes and
sensing changes as a
result of heating at the
lead/tissue interface

• Damage to pulse
generator, lead, or
connection

• Physical movement of
pulse generator and/or
leads

• Pocket discomfort due to
pulse generator heating

• Inappropriate pacing,
inhibition of pacing, or
irregular intermittent
capture or pacing, possibly
resulting in pre-syncope or
syncope

• Pacing-dependent patients

• Patients prone to sustained
arrhythmias

• Patients with high capture
thresholds

• Pacing-dependent patients

1-8

Table 1–4. Cardiology Conditions/Patient Conditions (continued)

Introduction to MR Conditional Pacing

Conditions for Scanning

Condition for Scanning

(Rationale)

for patients with a pacing
threshold ≤ 2.0 V plus an
additional 1.0 V to counteract
gradient-induced pace pulse
offsets.

9. No abandoned leads or pulse
generators.

The presence of abandoned
leads or pulse generators may
significantly reduce the
effectiveness of the
ImageReady MR Conditional
Pacing System in reducing risks
of MRI scanning.

10. No evidence of a fractured
lead or compromised pulse
generator-lead system integrity.

Lead impedance values within
the programmed normal range.
No record or evidence of
damage to pulse generator seal
plug and front lead sealing
rings.

Abnormal lead impedance
values may indicate a short or
open circuit in the lead system.
This could result in abnormal
conductive trajectories and
induced voltages. Broken
conductors in the lead system
could result in increased
potential for heating at the lead
tip. A damaged seal plug or
front lead sealing ring could
promote an alternate current
flow path during MRI scanning.

Actions If Condition is Not Met

threshold testing results for
each chamber when MRI
Protection Mode is
programmed and provides an
attention message on the PRM
screen if > 2.0 V.

• Check patient records.

• Confirm with physician
responsible for managing
the patient's Pacing
System.

• Check X-rays.

• Check patient records for
most recent lead
impedance values.

• Review Daily
Measurements on the
Leads Status Summary
Screen to verify stability
over time of pace
impedance, pace
threshold, and intrinsic
amplitude values.

• Check patient records from
implant procedure.

• Check patient records for a
history of noise on EGMs.

The device measures lead
impedances upon user request
to enter MRI Protection Mode
and provides an attention
message on the PRM screen if
the values are out of the
programmed normal range.

A history of noise on EGMs
could be indicative of a
damaged seal plug or front lead
sealing rings.

Potential Clinical
Consequences

• Arrhythmia induction

• Clinically significant pacing
threshold changes and
sensing changes as a
result of heating at the
lead/tissue interface

• Damage to pulse
generator, lead, or
connection

• Pocket discomfort due to
pulse generator heating

• Arrhythmia induction

• Clinically significant pacing
threshold changes and
sensing changes as a
result of heating at the
lead/tissue interface

• Inappropriate pacing,
inhibition of pacing, or
irregular intermittent
capture or pacing, possibly
resulting in pre-syncope or
syncope

Risk is Highest for

• Pacing-dependent patients

• Patients prone to sustained
arrhythmias

• Patients with high capture
thresholds

• Pacing-dependent patients

• Patients prone to sustained
arrhythmias

• Patients with high capture
thresholds

Table 1–5 Radiology Conditions on page 1-8 summarizes the Radiology-related Conditions of
Use that must be met in order for an MR Conditional MRI scan to be performed. For each
condition or requirement, actions to determine eligibility, the potential clinical consequences of
failing to meet the condition(s), and the patient population most impacted by failure to meet the
condition(s) are listed.

Table 1–5. Radiology Conditions

Condition for Scanning (Rationale) Actions If Condition is Not Met

1. MRI magnet strength of 1.5 T or 3 T (see a and b below).

1a.
MRI magnet strength of 1.5 T:

• Check technical
specifications of MRI
scanner.

Potential Clinical
Consequences

• Arrhythmia induction • Pacing-dependent

Risk is Highest for

patients

Introduction to MR Conditional Pacing

Conditions for Scanning

Table 1–5. Radiology Conditions (continued)

Condition for Scanning (Rationale) Actions If Condition is Not Met

Potential Clinical

Risk is Highest for

Consequences

1-9

• RF field of approximately 64 MHz

• Spatial gradient no greater than 50 T/
m (5,000 G/cm)

• Refer to "System
Description" on page 1­2 to determine which
components are valid
for use with 1.5 T
magnets.

• Clinically significant
pacing threshold
changes and sensing
changes as a result of
heating at the lead/
tissue interface

• Patients prone to
sustained arrhythmias

• Patients with high
capture thresholds

• Damage to pulse
generator, lead, or
connection

• Physical movement of
pulse generator and/or
leads

• Pocket discomfort due
to pulse generator
heating

The ImageReady Pacing Systems mitigate hazards associated with 1.5 T or 3 T MRI scanning. System response to other magnet
strengths has not been evaluated. Refer to "System Description" on page 1-2 to determine which components are valid for use with 1.5 T
scanners.

System response to spatial gradients greater than 50 T/m (5,000 G/cm) has not been evaluated.

WARNING: Only the combination of INGEVITY MRI lead(s) with an ESSENTIO MRI, PROPONENT MRI, or ACCOLADE MRI pulse

generator is valid to use with either 1.5 T or 3 T scanners. All other allowable combinations of Boston Scientific MR Conditional system

components must use only 1.5 T scanners.

1b.
MRI magnet strength of 3 T:

• RF field of approximately 128 MHz

• Spatial gradient no greater than 50 T/
m (5,000 G/cm)

• Check technical
specifications of MRI
scanner.

• Refer to "System
Description" on page 1­2 to determine which
components are valid
for use with 3 T
magnets.

• Arrhythmia induction

• Clinically significant
pacing threshold
changes and sensing
changes as a result of
heating at the lead/
tissue interface

• Damage to pulse
generator, lead, or

• Pacing-dependent
patients

• Patients prone to
sustained arrhythmias

• Patients with high
capture thresholds

connection

• Physical movement of
pulse generator and/or
leads

• Pocket discomfort due
to pulse generator
heating

The ImageReady Pacing Systems mitigate hazards associated with 1.5 T or 3 T MRI scanning. System response to other magnet
strengths has not been evaluated. Refer to "System Description" on page 1-2 to determine which components are valid for use with 3 T
scanners.

System response to spatial gradients greater than 50 T/m (5,000 G/cm) has not been evaluated.

WARNING: Only the combination of INGEVITY MRI lead(s) with an ESSENTIO MRI, PROPONENT MRI, or ACCOLADE MRI pulse

generator is valid to use with either 1.5 T or 3 T scanners. All other allowable combinations of Boston Scientific MR Conditional system

components must use only 1.5 T scanners.

2. Horizontal,

1

H proton, closed bore

scanners only.

The ImageReady Pacing Systems
mitigate hazards associated with
horizontal closed bore scanners.

• Check technical
specifications of MRI
scanner.

• Arrhythmia induction

• Clinically significant
pacing threshold
changes and sensing
changes as a result of
heating at the lead/
tissue interface

• Pacing-dependent
patients

• Patients prone to
sustained arrhythmias

• Patients with high
capture thresholds

• Inappropriate pacing,
inhibition of pacing, or
irregular intermittent
capture or pacing,

1-10

Introduction to MR Conditional Pacing

Conditions for Scanning

Table 1–5. Radiology Conditions (continued)

Condition for Scanning (Rationale) Actions If Condition is Not Met

Potential Clinical
Consequences

possibly resulting in
pre-syncope or syncope

• Damage to pulse
generator, lead, or
connection

• Physical movement of
pulse generator and/or
leads

• Pocket discomfort due
to pulse generator
heating

3. Specific Absorption Rate (SAR) limits (see a and b below).

Risk is Highest for

3a.
SAR limits for Normal Operating Mode
must be observed for the entire active
scan session with an ImageReady Pacing
System with FINELINE II leads only or
with a combination of one INGEVITY lead
and one FINELINE II lead.

• Whole body averaged, ≤ 2.0 W/kg

• Head, ≤ 3.2 W/kg

• Ensure MRI scanner is
operated in Normal
Operating Mode (NOT
in First Level Controlled
Operating Mode).

• Clinically significant
pacing threshold
changes and sensing
changes as a result of
heating at the lead/
tissue interface

• Inappropriate pacing,
inhibition of pacing, or
irregular intermittent
pacing, possibly

• Pacing-dependent
patients

• Patients with high
capture thresholds

resulting in pre-syncope
or syncope

An ImageReady Pacing System with FINELINE II leads only or with a combination of one INGEVITY lead and one FINELINE II lead
mitigates hazards associated with Normal Operating Mode. System response to other scanner settings has not been evaluated.

3b.
SAR limits for Normal Operating Mode or
First Level Controlled Operating Mode
must be observed for the entire active
scan session with an ImageReady Pacing
System with INGEVITY MRI leads only.

• Whole body averaged, ≤ 4.0 W/kg

• Head, ≤ 3.2 W/kg

• Ensure MRI scanner is
operated in Normal
Operating Mode or First
Level Controlled
Operating Mode.

• Clinically significant
pacing threshold
changes and sensing
changes as a result of
heating at the lead/
tissue interface

• Inappropriate pacing,
inhibition of pacing, or
irregular intermittent

• Pacing-dependent
patients

• Patients with high
capture thresholds

pacing, possibly
resulting in pre-syncope
or syncope

An ImageReady Pacing System with INGEVITY MRI leads mitigates hazards associated with Normal Operating Mode or First Level
Controlled Operating Mode. System response to other scanner settings has not been evaluated.

4. Gradient Field limits: Maximum
specified gradient slew rate ≤ 200 T/m/s
per axis.

System response to gradient slew rates
higher than 200 T/m/s per axis has not
been evaluated.

5. No local transmit-only coils or local
transmit/receive coils placed directly over
the pacing system; the use of receive-only
coils is not restricted.

• Check technical
specifications of MRI
scanner.

• Ensure no local
transmit-only or
transmit/receive coils
are placed directly over
the pacing system.

• Arrhythmia induction

• Inappropriate pacing,
inhibition of pacing, or
irregular intermittent
capture or pacing,
possibly resulting in
pre-syncope or syncope

• Damage to pulse
generator, lead, or
connection

• Pocket discomfort due
to pulse generator
heating

• Arrhythmia induction

• Clinically significant
pacing threshold
changes and sensing
changes as a result of

• Pacing-dependent
patients

• Patients prone to
sustained arrhythmias

• Pacing-dependent
patients

• Patients prone to
sustained arrhythmias

Introduction to MR Conditional Pacing

Table 1–5. Radiology Conditions (continued)

Condition for Scanning (Rationale) Actions If Condition is Not Met

Potential Clinical
Consequences

MRI Protection Mode

Risk is Highest for

1-11

There are no restrictions for positioning
the pacing system within the integrated
body coil of the MRI scanner. System
response to local transmit-only or
transmit/receive coils placed directly over
the pacing system has not been
evaluated.

6. The patient must be in a supine or
prone position during the scan.

An ImageReady Pacing System mitigates
hazards associated with a patient position
of supine or prone. System response to
other patient positions has not been
evaluated.

• Ensure patient is in the
correct position during
scan.

heating at the lead/
tissue interface

• Erratic pulse generator
behavior

• Inappropriate pacing,
inhibition of pacing, or
irregular intermittent
capture or pacing,
possibly resulting in
pre-syncope or syncope

• Pocket discomfort due
to pulse generator
heating

• Arrhythmia induction

• Clinically significant
pacing threshold
changes and sensing
changes as a result of
heating at the lead/
tissue interface

• Inappropriate pacing,
inhibition of pacing, or
irregular intermittent
capture or pacing,
possibly resulting in
pre-syncope or syncope

• Physical movement of
pulse generator and/or
leads

• Pocket discomfort due
to pulse generator
heating

• Patients with high
capture thresholds

• Pacing-dependent
patients

• Patients prone to
sustained arrhythmias

• Patients with high
capture thresholds

7. The patient must be monitored during
the MRI scan by pulse oximetry and/or
electrocardiography (ECG).

MRI PROTECTION MODE

In preparation for an MRI scan, the pulse generator must be programmed into MRI Protection
Mode using the programmer. MRI Protection Mode modifies certain pulse generator functions in
order to mitigate risks associated with exposing the ImageReady MR Conditional System to the
MRI environment. For a list of features and functions that are suspended in MRI Protection
Mode, see "MRI Protection Mode General Information" on page 2-2.

MRI BASIC CONCEPTS

MRI is a diagnostic tool that uses three types of magnetic and electromagnetic fields to image
soft tissue in the body:

• A static magnetic field generated by a superconducting electromagnet coil, 1.5 T or 3 T in
strength.

• Gradient magnetic fields of much lower intensity, but with high rates of change over time.
Three sets of gradient coils are used to create the gradient fields.

• Ensure patient is being
monitored during scan.

• Lack of patient
monitoring could result
in failure to detect
potentially dangerous
changes in the patient’s
cardiac or
hemodynamic function.

• All patients

1-12

Introduction to MR Conditional Pacing

X-ray or Fluoroscopic Identification

• A pulsed radio frequency (RF) field produced by transmission RF coils (approximately 64
MHz for 1.5 T and 128 MHz for 3 T).

These fields may create physical forces or electrical currents that can affect the functioning of
active implantable medical devices (AIMDs) such as pulse generators and leads. Therefore,
only patients implanted with an MR Conditional system are eligible to be scanned. Furthermore,
by complying with the MRI Conditions of Use, outlined in this Technical Guide ("MRI Conditions
of Use" on page 1-4), ImageReady MR Conditional System patients can undergo MRI scans with
risks mitigated to the best current standard of care.

X-RAY OR FLUOROSCOPIC IDENTIFICATION

The primary means of identification of the implanted device and lead(s) should be the patient's
medical files. To provide additional means of identification of the device, images of the pulse
generators as visible under X-ray or fluoroscopy are shown in Table 1–6 Pulse Generator Images
on page 1-12.

Table 1–6. Pulse Generator Images

Pulse Generator Images

Pulse Generators X-Ray Identifier Approximate Location on Device (1)

ESSENTIO MRI
PROPONENT MRI
ACCOLADE MRI

MR CONDITIONAL PACING SYSTEM WARNINGS AND PRECAUTIONS

General

WARNING: Unless all of the MRI Conditions of Use ("MRI Conditions of Use" on page 1-4) are

met, MRI scanning of the patient does not meet MR Conditional requirements for the implanted
system, and significant harm to or death of the patient and/or damage to the implanted system
may result.

For potential adverse events applicable when the Conditions of Use are met or not met, see
"Potential Adverse Events" on page 1-14.

NOTE: Table 1–4 Cardiology Conditions/Patient Conditions on page 1-6 and Table 1–5
Radiology Conditions on page 1-8 provide information on the nature of the increased risk(s)
associated with the failure to meet each Condition of Use. This information is intended to assist in
performing a risk/benefit analysis to decide whether or not to scan a patient who does not meet
all the stated criteria for MR Conditional status. Alternatives including other imaging methods
may also be considered.

WARNING: Only the combination of INGEVITY MRI lead(s) with an ESSENTIO MRI,
PROPONENT MRI, or ACCOLADE MRI pulse generator is valid to use with either 1.5 T or 3 T
scanners. All other allowable combinations of Boston Scientific MR Conditional system
components must use only 1.5 T scanners.

WARNING: Ensure that an external defibrillator and medical personnel skilled in cardio­pulmonary resuscitation (CPR) are present during the MRI scan should the patient require
external rescue.

WARNING: MRI scanning after Explant status has been reached may lead to premature
battery depletion, a shortened device replacement window, or sudden loss of pacing. After
performing an MRI scan on a device that has reached Explant status, verify pulse generator
function and schedule device replacement.

WARNING: When the Time-out parameter is programmed to a value other than Off, the patient
must be out of the scanner before the time programmed elapses. Otherwise, the patient will no
longer meet Conditions of Use ("MRI Conditions of Use" on page 1-4).

Programming Considerations

WARNING: If the MRI Protection Time-out value of Off is combined with a Pacing Mode of Off,

the patient will not receive pacing until the pulse generator is programmed out of MRI Protection
Mode and back to normal operation. It is recommended to have the Programmer/Recorder/
Monitor (PRM) near the MRI room in case the patient develops the urgent need for pacing.
Patients with the following conditions may have increased risk of developing transient pacing­dependence:

Introduction to MR Conditional Pacing

Programming Considerations

1-13

• A history of syncope related to bradyarrhythmia

• A history of syncope of unknown etiology

• Sinus pauses (Pause > 2 s), AV block permanently or intermittently

• At risk for intermittent AV block (for example, those with progressive AV block, or a history of
unexplained syncope)

• At risk for trifascicular block (alternating bundle branch block or PR interval > 200 ms with
LBBB or other bifascicular block)

WARNING: Use caution when programming the MRI Protection Mode pacing amplitude for
pacing-dependent patients who have high pacing thresholds (> 2.0 V). Programming pacing
amplitude below 5.0 V is provided as an option in case of extracardiac stimulation (for example,
diaphragmatic stimulation for RV pacing). If pacing amplitude is programmed below 5.0 V, an
appropriate safety margin (2X the pacing threshold + 1.0 V) should be maintained. An inadequate
safety margin may result in loss of capture.

WARNING: Exit MRI Protection Mode after MRI scanning is completed. If the MRI Protection
Time-out value of Off is selected, the pulse generator will remain permanently in the MRI
Protection Mode until it is programmed otherwise. Prolonged use of the MRI Protection Mode
(such as may occur when the Time-out feature is programmed to Off) may increase the rate of
battery depletion. In addition, prolonged exposure of a patient to the XOO mode chosen may be
deleterious to the patient’s health.

Safety Mode

WARNING: Do not perform an MRI scan on a patient whose device has entered Safety Mode.

Safety Mode pacing is VVI unipolar, which, in the MRI environment, subjects the patient to
increased risk of arrhythmia induction, inappropriate pacing, inhibition of pacing, or irregular
intermittent capture or pacing.

WARNING: If the pulse generator enters Safety Mode from MRI Protection Mode, backup
pacing will not occur in the following scenarios:

• if a functional bipolar ventricular pacing lead is not present

1-14

Introduction to MR Conditional Pacing

MRI Site Zone III Exclusions

• if the Pacing Mode under MRI Protection Mode settings is programmed to Off; the pulse
generator will continue permanently with the Pacing Mode programmed to Off, and the
patient will not receive pacing therapy until the pulse generator is replaced

MRI Site Zone III Exclusions

WARNING: The Programmer/Recorder/Monitor (PRM) is MR Unsafe and must remain outside

the MRI site Zone III (and higher) as defined by the American College of Radiology Guidance
Document for Safe MR Practices
MRI scanner room, the control room, or the MRI site Zone III or IV areas.

5

. Under no circumstances should the PRM be brought into the

Precautions

WARNING: Implant of the system cannot be performed in an MRI site Zone III (and higher) as

defined by the American College of Radiology Guidance Document for Safe MR Practices

6

.
Some of the accessories packaged with pulse generators and leads, including the torque wrench
and stylet wires, are not MR Conditional and should not be brought into the MRI scanner room,
the control room, or the MRI site Zone III or IV areas.

CAUTION: The physician choosing MRI Protection Mode parameter values will need to
exercise professional judgment to determine an individual patient’s ability to tolerate the pacing
parameters required for MR Conditional scanning, in conjunction with the physical conditions
required during a scan (for example, prolonged time in a supine position).

CAUTION: If the MR Conditional Pacing System enters Safety Core Operation during MRI
Protection Mode and the pacing mode was set to a value other than Off, MRI Protection Mode
pacing will be automatically switched to VOO mode, RV bipolar configuration (sensing and
pacing), 5.0 V pace pulse amplitude, 1.0 ms pulse width, and 72.5 min

-1

pacing rate as the safety

mode.

CAUTION: The presence of the implanted Pacing System may cause MRI image artifacts (see
"3. Preparing the Patient for the Scan" on page 2-13).

NOTE: All normal risks associated with an MRI procedure apply to MRI scans with the MR
Conditional Pacing System. Consult MRI scanner documentation for a complete list of risks
associated with MRI scanning.

NOTE: Other implanted devices or patient conditions may cause a patient to be ineligible for an
MRI scan, independent of the status of the patient’s ImageReady MR Conditional Pacing
System.

POTENTIAL ADVERSE EVENTS

Potential adverse events differ depending on whether the MRI Conditions of Use ("MRI
Conditions of Use" on page 1-4) are met. For a complete list of potential adverse events, refer to
the Physician's Technical Manual for the pulse generator.

MRI scanning of patients when the Conditions of Use are met could result in the following
potential adverse events:

• Arrhythmia induction

• Bradycardia

• Patient death

5. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.

6. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.

Introduction to MR Conditional Pacing

Potential Adverse Events

1-15

• Patient discomfort due to slight movement or heating of the device

• Side effects of MRI Protection Mode pacing at elevated fixed rate and increased output
including reduced exercise capacity, acceleration of heart failure, and competitive pacing/
arrhythmia induction

• Syncope

MRI scanning of patients when the Conditions of Use are NOT met could result in the following
potential adverse events:

• Arrhythmia induction

• Bradycardia

• Damage to the pulse generator and/or leads

• Erratic pulse generator behavior

• Inappropriate pacing, inhibition of pacing, failure to pace

• Increased rate of lead dislodgement (within six weeks of implant or revision of system)

• Irregular or intermittent capture or pacing

• Pacing threshold changes

• Patient death

• Patient discomfort due to movement or heating of the device

• Physical movement of pulse generator and/or leads

• Sensing changes

• Syncope

1-16

Introduction to MR Conditional Pacing

Potential Adverse Events

MRI SCAN PROCEDURE PROTOCOL

CHAPTER 2

This chapter contains the following topics:

• “Patient Flow” on page 2-2

• “MRI Protection Mode General Information” on page 2-2

• “Pre-Scan Activities” on page 2-4

• “During the Scan” on page 2-14

• “After the Scan” on page 2-14

2-1

2-2

MRI Scan Procedure Protocol

Patient Flow

Before proceeding with this MRI scan procedure protocol, verify that the patient and the MRI
scanner meet the MRI Conditions of Use ("MRI Conditions of Use" on page 1-4). This verification
must be performed prior to each scan to ensure that the most up-to-date information has been
used to assess the patient’s eligibility and readiness for an MR Conditional scan.

WARNING: Unless all of the MRI Conditions of Use ("MRI Conditions of Use" on page 1-4) are
met, MRI scanning of the patient does not meet MR Conditional requirements for the implanted
system, and significant harm to or death of the patient and/or damage to the implanted system
may result.

For potential adverse events applicable when the Conditions of Use are met or not met, see
"Potential Adverse Events" on page 1-14.

NOTE: Table 1–4 Cardiology Conditions/Patient Conditions on page 1-6 and Table 1–5
Radiology Conditions on page 1-8 provide information on the nature of the increased risk(s)
associated with the failure to meet each Condition of Use. This information is intended to assist in
performing a risk/benefit analysis to decide whether or not to scan a patient who does not meet
all the stated criteria for MR Conditional status. Alternatives including other imaging methods
may also be considered.

PATIENT FLOW

A sample patient flow sequence for an ImageReady Pacing System patient who needs an MRI
scan is described below. For a more detailed description of the programming and scanning
procedure, see this chapter.

1. MRI recommended to patient by specialist (for example, orthopedist or oncologist).

2. Patient or specialist or radiologist contacts the electrophysiologist/cardiologist who manages
the patient’s MR Conditional Pacing System.

3. Electrophysiologist/cardiologist determines patient eligibility for scan per the information in
this Technical Guide.

4. If the patient is eligible, the PRM is used to put the pulse generator in MRI Protection Mode
as close in time to the scan as reasonable. The MRI Protection Settings Report is printed,
placed in the patient's file, and provided to radiology personnel. The report documents MRI
Protection Mode settings and details. If the Time-out feature is used, the report includes the
exact time and date when MRI Protection Mode will expire.

5. The model number of each lead implanted in the patient is identified, and this information is
communicated to the HCPs involved in performing the MRI scan.

6. The radiologist checks the patient file and/or printed report. If the Time-out feature is used,
the radiologist verifies that adequate time remains to complete the scan.

7. Patient undergoes scan according to the conditions of use described in this Technical Guide.

8. After the scan, manually exit MRI Protection Mode using the PRM to return the pulse
generator to pre-MRI operation. Perform follow-up testing of the implanted system.

MRI PROTECTION MODE GENERAL INFORMATION

Prior to the patient undergoing an MRI scan, an ImageReady MR Conditional Pacing System
must be programmed to the MRI Protection Mode using the PRM (see Table 2–1 MRI Protection
Parameters on page 2-4). In MRI Protection Mode:

MRI Protection Mode General Information

MRI Scan Procedure Protocol

2-3

• Pacing mode options include asynchronous pacing or no pacing (DOO, AOO, VOO, or Off).
Off should only be used if the patient is judged to be clinically capable of receiving no pacing
during the time the pulse generator will be in MRI Protection Mode, including during the scan.

The programmed pacing mode prior to entry into MRI Protection Mode determines the default
MRI Protection pacing mode. For example, if MRI Protection Mode is entered from DDD(R),
the pacing mode will be DOO. Any of the other pacing mode options may then be selected.

WARNING: The Programmer/Recorder/Monitor (PRM) is MR Unsafe and must remain
outside the MRI site Zone III (and higher) as defined by the American College of Radiology
Guidance Document for Safe MR Practices

1

. Under no circumstances should the PRM be

brought into the MRI scanner room, the control room, or the MRI site Zone III or IV areas.

WARNING: If the pulse generator enters Safety Mode from MRI Protection Mode, backup
pacing will not occur in the following scenarios:

– if a functional bipolar ventricular pacing lead is not present

– if the Pacing Mode under MRI Protection Mode settings is programmed to Off; the pulse

generator will continue permanently with the Pacing Mode programmed to Off, and the
patient will not receive pacing therapy until the pulse generator is replaced

• The Lower Rate Limit is nominally set to 20 min

-1

above the starting LRL, and is

programmable in normal increments. For both the nominal setting based on the LRL and the

-1

programmable setting, the maximum value is 100 min

.

• Atrial pulse amplitude and ventricular pulse amplitude are nominally set to 5.0 V and are
programmable in normal increments between 2.0 V and 5.0 V.

WARNING: Use caution when programming the MRI Protection Mode pacing amplitude for
pacing-dependent patients who have high pacing thresholds (> 2.0 V). Programming pacing
amplitude below 5.0 V is provided as an option in case of extracardiac stimulation (for
example, diaphragmatic stimulation for RV pacing). If pacing amplitude is programmed below

5.0 V, an appropriate safety margin (2X the pacing threshold + 1.0 V) should be maintained.
An inadequate safety margin may result in loss of capture.

• AV Delay is fixed at 100 ms

• Pulse width is fixed at 1.0 ms for both chambers

• A Time-out feature is nominally set to 24 hours, with programmable values of Off, 12, 24, and
48 hours

WARNING: Exit MRI Protection Mode after MRI scanning is completed. If the MRI
Protection Time-out value of Off is selected, the pulse generator will remain permanently in
the MRI Protection Mode until it is programmed otherwise. Prolonged use of the MRI
Protection Mode (such as may occur when the Time-out feature is programmed to Off) may
increase the rate of battery depletion. In addition, prolonged exposure of a patient to the XOO
mode chosen may be deleterious to the patient’s health.

NOTE: Twenty-four hours in MRI Protection Mode (with pacing on) reduces pulse
generator longevity by approximately 5 days.

CAUTION: The physician choosing MRI Protection Mode parameter values will need to
exercise professional judgment to determine an individual patient’s ability to tolerate the
pacing parameters required for MR Conditional scanning, in conjunction with the physical
conditions required during a scan (for example, prolonged time in a supine position).

1. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.

2-4

MRI Scan Procedure Protocol

Pre-Scan Activities

The following features and functions are suspended in MRI Protection Mode:

• PaceSafe RV automatic capture

• PaceSafe RA automatic threshold

• Cardiac sensing

• Daily diagnostics (lead impedance, intrinsic amplitude, pace threshold)

• Motion and respiratory sensors

• Magnet detection

• RF telemetry

• Battery voltage monitoring

The following device conditions will preclude the user from having the option to enter MRI
Protection Mode (see the Reference Guide for the pulse generator for additional information
about these conditions):

• Battery capacity status is Depleted

• Pulse generator is in Storage Mode

• Pulse generator is in Electrocautery Mode

• Pulse generator is in Safety Core operation (Safety Mode)

• Diagnostic test is in progress

• EP test is in progress

WARNING: MRI scanning after Explant status has been reached may lead to premature
battery depletion, a shortened device replacement window, or sudden loss of pacing. After
performing an MRI scan on a device that has reached Explant status, verify pulse generator
function and schedule device replacement.

WARNING: Do not perform an MRI scan on a patient whose device has entered Safety Mode.
Safety Mode pacing is VVI unipolar, which, in the MRI environment, subjects the patient to
increased risk of arrhythmia induction, inappropriate pacing, inhibition of pacing, or irregular
intermittent capture or pacing.

Table 2–1. MRI Protection Parameters

Parameter Programmable Values Nominal

MRI Brady Mode Off; VOO; AOO; DOO DOO for DDD(R), DDI(R), or DOO normal

MRI Lower Rate Limit (LRL) ( min

MRI Atrial Amplitude (V) 2.0; 2.1; …; 3.5; 4.0; …; 5.0 5.0 (Tolerance ± 15% or ± 100 mV,

MRI Ventricular Amplitude (V) 2.0; 2.1; …; 3.5; 4.0; …; 5.0 5.0 (Tolerance ± 15% or ± 100 mV,

-1

) 30; 35; ...; 100 20 min

Brady modes;
VOO for VDD(R), VVI(R), or VOO normal
Brady modes;
AOO for AAI(R) or AOO normal Brady
Mode;
Off for Normal Brady Mode Off

-1

above the normal mode LRL

whichever is greater)

whichever is greater)

a

a

MRI Protection Time-out (hours) Off; 12; 24; 48 24

a. During the transition into the MRI Protection Mode, it may take up to 6 cardiac pacing cycles for the pace amplitude to meet the specified tolerance range.

PRE-SCAN ACTIVITIES

Three activities are required before the MRI scan takes place:

1. Prepare the pulse generator for the scan by programming into MRI Protection Mode ("1.
Programming the Pulse Generator for a Scan" on page 2-5)

2. Confirm the MRI scanner settings and configurations ("2. Confirming MRI Scanner Settings
and Configuration" on page 2-13)

3. Prepare the patient for the scan ("3. Preparing the Patient for the Scan" on page 2-13)

1. Programming the Pulse Generator for a Scan

Use the PRM to program pulse generator entry into MRI Protection Mode.

NOTE: Maintain access to the programmer wand, as RF telemetry becomes unavailable
during the process of entering MRI Protection Mode.

From the Main screen, use the Device Mode button to enable MRI Protection Mode.

The user chooses whether to Cancel Changes or Apply Changes to proceed with entry into MRI
Protection Mode (Figure 2–1 Change Device Mode dialog on page 2-5).

1. Programming the Pulse Generator for a Scan

MRI Scan Procedure Protocol

2-5

Figure 2–1. Change Device Mode dialog

Certain conditions in the pulse generator and/or system will cause a user request to enter MRI
Protection Mode to be rejected. These include:

• A ventricular episode as detected and recognized by the pulse generator is in progress

• Magnet presence is detected by magnet sensor

• Pulse generator is in STAT PACE mode

• Unipolar pacing configuration in chamber(s) where pacing will occur in MRI Protection Mode

If one or more of these conditions are present, a dialog box will appear describing the condition,
and MRI Protection Mode cannot be entered. For example, see Figure 2–2 Episode in progress
attention message on page 2-6.

2-6

MRI Scan Procedure Protocol

1. Programming the Pulse Generator for a Scan

Figure 2–2. Episode in progress attention message

In addition to the above-listed conditions that prevent entry into MRI Protection Mode, two other
conditions of use are assessed by the PRM upon a request to enter MRI Protection Mode: lead
impedance and time since implant.

• Lead Impedance

A user request to enter the MRI Protection Mode triggers a lead impedance test in all
chambers. If the lead impedance values obtained from this testing are outside the
programmed normal range, the PRM provides a dialog box recommending a review of the
associated risks if the user chooses to proceed (see Table 1–4 Cardiology Conditions/Patient
Conditions on page 1-6). The dialog provides the option of activating MRI Protection Mode in
the presence of these conditions, or cancelling entry into MRI Protection Mode. The dialog
box that appears in the case of an out-of-range lead impedance value is shown in Figure 2–3
Lead impedance out of range attention message on page 2-6.

Figure 2–3. Lead impedance out of range attention message

• Time Since Implant

The PRM also determines the time since implant, calculated based on the date at which the
pulse generator was taken out of Storage Mode.

NOTE: If the PRM clock is not set to the correct time and date, this determination may not
be accurate.

If the calculated time since exit from Storage Mode is less than 6 weeks, the PRM provides a
dialog box recommending a review of the associated risks if the user chooses to proceed
(see Table 1–4 Cardiology Conditions/Patient Conditions on page 1-6). The dialog provides
the option of activating MRI Protection Mode in the presence of these conditions, or
cancelling entry into MRI Protection Mode.

Upon continuing with entry into MRI Protection Mode, the MRI Protection Checklist screen is
displayed (Figure 2–4 MRI Protection Checklist on page 2-7). The Checklist summarizes the
conditions that must be met at the time of scanning in order for a patient to be eligible for an MR

1. Programming the Pulse Generator for a Scan

MRI Scan Procedure Protocol

2-7

Conditional scan. Re-verification is required before every scan to guard against the possibility
that changes in the system or patient occurred subsequent to the original pulse generator/system
implant. These conditions are described in greater detail in Table 1–4 Cardiology Conditions/
Patient Conditions on page 1-6 and Table 1–5 Radiology Conditions on page 1-8.

Figure 2–4. MRI Protection Checklist

If the Conditions of Use as described in this manual are not met, the Cancel button is selected to
return to normal system operation, and the patient does not undergo an MRI scan.

If the Conditions of Use are met, or if the Conditions of Use are not met, but the user elects to
continue with MRI Protection Mode after reviewing the risks of proceeding (see Table 1–4
Cardiology Conditions/Patient Conditions on page 1-6 and Table 1–5 Radiology Conditions on
page 1-8 for additional information about risks), the Continue with MRI Protection button is
selected. As a result, the Program MRI Protection screen appears (Figure 2–5 Program MRI
Protection dialog on page 2-9).

Use the dialog boxes to set the:

• Pacing mode (DOO, VOO, AOO, Off)

• Lower rate limit (nominally set to 20 min

increments to a maximum value 100 min

-1

above normal mode LRL, programmable in normal

-1

)

NOTE: Because MRI Protection Mode pacing is asynchronous, when setting the lower rate
limit, consider the patient’s intrinsic rate to avoid competitive pacing.

• Atrial amplitude (nominally set to 5.0 V, programmable in normal increments from 2.0 V to 5.0

V)

• Ventricular amplitude (nominally set to 5.0 V, programmable in normal increments from 2.0 V

to 5.0 V)

2-8

MRI Scan Procedure Protocol

1. Programming the Pulse Generator for a Scan

WARNING: Use caution when programming the MRI Protection Mode pacing amplitude for

pacing-dependent patients who have high pacing thresholds (> 2.0 V). Programming pacing
amplitude below 5.0 V is provided as an option in case of extracardiac stimulation (for
example, diaphragmatic stimulation for RV pacing). If pacing amplitude is programmed below

5.0 V, an appropriate safety margin (2X the pacing threshold + 1.0 V) should be maintained.
An inadequate safety margin may result in loss of capture.

• MRI Protection Time-out (nominally set to 24 hours, programmable values of Off, 12, 24, and
48 hours)

The MRI Protection Mode Time-out function allows the user to choose the length of time the
pulse generator remains in MRI Protection Mode. Check that the programmer clock is set to the
correct time and date to ensure the accuracy of the projected expiration time (displayed on the
screen and on the printed MRI Protection Settings Report). When the programmed time has
elapsed, the pulse generator automatically exits MRI Protection Mode and returns to the
previously programmed settings.

WARNING: When the Time-out parameter is programmed to a value other than Off, the patient
must be out of the scanner before the time programmed elapses. Otherwise, the patient will no
longer meet Conditions of Use ("MRI Conditions of Use" on page 1-4).

NOTE: Any subsequent interrogation by a PRM while the device is still in MRI Protection Mode
will reset the Time-out feature to the start of the initially selected time period.

WARNING: If the MRI Protection Time-out value of Off is combined with a Pacing Mode of Off,
the patient will not receive pacing until the pulse generator is programmed out of MRI Protection
Mode and back to normal operation. It is recommended to have the Programmer/Recorder/
Monitor (PRM) near the MRI room in case the patient develops the urgent need for pacing.
Patients with the following conditions may have increased risk of developing transient pacing­dependence:

• A history of syncope related to bradyarrhythmia

• A history of syncope of unknown etiology

• Sinus pauses (Pause > 2 s), AV block permanently or intermittently

• At risk for intermittent AV block (for example, those with progressive AV block, or a history of
unexplained syncope)

• At risk for trifascicular block (alternating bundle branch block or PR interval > 200 ms with
LBBB or other bifascicular block)

WARNING: If the pulse generator enters Safety Mode from MRI Protection Mode, backup
pacing will not occur in the following scenarios:

• if a functional bipolar ventricular pacing lead is not present

• if the Pacing Mode under MRI Protection Mode settings is programmed to Off; the pulse
generator will continue permanently with the Pacing Mode programmed to Off, and the
patient will not receive pacing therapy until the pulse generator is replaced

WARNING: Exit MRI Protection Mode after MRI scanning is completed. If the MRI Protection
Time-out value of Off is selected, the pulse generator will remain permanently in the MRI
Protection Mode until it is programmed otherwise. Prolonged use of the MRI Protection Mode
(such as may occur when the Time-out feature is programmed to Off) may increase the rate of
battery depletion. In addition, prolonged exposure of a patient to the XOO mode chosen may be
deleterious to the patient’s health.

1. Programming the Pulse Generator for a Scan

MRI Scan Procedure Protocol

2-9

CAUTION: The physician choosing MRI Protection Mode parameter values will need to

exercise professional judgment to determine an individual patient’s ability to tolerate the pacing
parameters required for MR Conditional scanning, in conjunction with the physical conditions
required during a scan (for example, prolonged time in a supine position).

CAUTION: If the MR Conditional Pacing System enters Safety Core Operation during MRI
Protection Mode and the pacing mode was set to a value other than Off, MRI Protection Mode
pacing will be automatically switched to VOO mode, RV bipolar configuration (sensing and
pacing), 5.0 V pace pulse amplitude, 1.0 ms pulse width, and 72.5 min

-1

pacing rate as the safety

mode.

Figure 2–5. Program MRI Protection dialog

NOTE: Use of the wand is necessary to complete entry into MRI Protection Mode. Keep the
wand in place until receiving confirmation that MRI Protection Mode is programmed. Wanded
communication is also required for manual cancellation of MRI Protection Mode (see Manual Exit
from MRI Protection Mode in "After the Scan" on page 2-14).

After the values are chosen, the Program MRI Protection button is selected. Selection of the
Program MRI Protection button triggers two additional tests: Previous Pacing Threshold and
Pacing Lead Configuration. If the results indicate that the Previous Pacing Threshold is less than
or equal to 2.0 V and the Pacing Lead Configuration is bipolar, the device enters MRI Protection
Mode and the MRI Protection Mode Programmed screen (Figure 2–7 MRI Protection Mode
Programmed dialog on page 2-10) appears. The two tests are described below.

Previous Pacing Threshold

The most recently recorded pacing threshold test results (whether from a commanded or
automatic test) are used by the programmer to determine if pacing thresholds are less than or
equal to 2.0 V, a Condition of Use applicable to pace-dependent patients. Thresholds greater
than 2.0 V may result in an insufficient safety margin and failure to capture in MRI Protection
Mode (see Table 1–4 Cardiology Conditions/Patient Conditions on page 1-6). If the threshold is
greater than 2.0 V, an attention message appears on the PRM screen advising the user to review
the risks of proceeding (Figure 2–6 Pacing threshold greater than 2.0 V attention message on
page 2-10). Running these tests prior to programming the device to MRI Protection Mode will
ensure that the most up-to-date information is used to determine whether this Condition of Use is
satisfied.

NOTE: Threshold values available for leads that are not enabled for Daily Measurements will
only be as current as the date of the last commanded test. Lack of a pace threshold attention
message when MRI Protection Mode is programmed does not mean that all leads have threshold
values of 2.0 V or lower.

2-10

MRI Scan Procedure Protocol

1. Programming the Pulse Generator for a Scan

WARNING: Use caution when programming the MRI Protection Mode pacing amplitude for

pacing-dependent patients who have high pacing thresholds (> 2.0 V). Programming pacing
amplitude below 5.0 V is provided as an option in case of extracardiac stimulation (for example,
diaphragmatic stimulation for RV pacing). If pacing amplitude is programmed below 5.0 V, an
appropriate safety margin (2X the pacing threshold + 1.0 V) should be maintained. An inadequate
safety margin may result in loss of capture.

Figure 2–6. Pacing threshold greater than 2.0 V attention message

Pacing Lead Configuration

Upon programming parameters for MRI Protection Mode, the device also checks the pacing lead
configuration to confirm that it is bipolar in chambers where pacing will occur in MRI Protection
Mode. If the lead(s) to be used for pacing while in MRI Protection Mode are programmed to a
unipolar pacing configuration, entry into MRI Protection Mode is denied, since the device does
not meet the Condition of Use related to bipolar pacing (see Table 1–4 Cardiology Conditions/
Patient Conditions on page 1-6). In order to proceed, program any lead that will be used to pace
in the MRI Protection Mode to bipolar or choose a pacing mode of Off.

If threshold tests are within range and the pacing configuration is bipolar in chambers where
pacing will occur in MRI Protection Mode, or if the user elects to continue with MRI Protection
Mode after reviewing the risks of proceeding in the presence of pacing thresholds greater than

2.0 V, the following screen appears, indicating that the device has successfully been

programmed into MRI Protection Mode at the settings indicated (Figure 2–7 MRI Protection
Mode Programmed dialog on page 2-10).

Figure 2–7. MRI Protection Mode Programmed dialog

1. Programming the Pulse Generator for a Scan

MRI Scan Procedure Protocol

2-11

To exit MRI Protection Mode manually, select the Cancel MRI Protection button (see Manual Exit
from MRI Protection Mode in "After the Scan" on page 2-14). If necessary, STAT PACE or
DIVERT THERAPY can also be used to exit MRI Protection Mode and return the pulse generator
to previously programmed settings (DIVERT THERAPY) or initiate STAT PACE pacing
parameters (see the pulse generator Reference Guide for more information about STAT PACE).

Once MRI Protection Mode has successfully been programmed, print a copy of the MRI
Protection Settings Report by selecting the Print Settings button on the MRI Protection Mode
Programmed screen. The report lists the settings in operation during MRI Protection Mode. If the
Time-out feature is used, the report includes the time and date when MRI Protection Mode will
expire, returning the pulse generator to the pre-MRI Protection Mode settings.

The printed report can be placed in the patient's file and used by radiology personnel, for
example, to confirm that sufficient time remains to complete the MRI scan. A sample Settings
Report and checklist printout is shown in Figure 2–8 Sample settings report and checklist printout
on page 2-12.

Ensure that the HCPs involved in performing the MRI scan have received the model numbers of
the pulse generator and lead(s) implanted in the patient.

WARNING: When the Time-out parameter is programmed to a value other than Off, the patient
must be out of the scanner before the time programmed elapses. Otherwise, the patient will no
longer meet Conditions of Use ("MRI Conditions of Use" on page 1-4).

2-12

MRI Scan Procedure Protocol

1. Programming the Pulse Generator for a Scan

[1] If MRI Protection Time-out is displayed as “Off”, the pulse generator remains in MRI Protection Mode until manually reprogrammed; [2]
Twenty-four hour time format is used; [3] Column indicates date measurement was taken

Figure 2–8. Sample settings report and checklist printout

The End Session button will end the current programmer session with the pulse generator
remaining in MRI Protection Mode (Figure 2–9 End Session Confirmation dialog on page 2-13).

2. Confirming MRI Scanner Settings and Configuration

Figure 2–9. End Session Confirmation dialog

2. Confirming MRI Scanner Settings and Configuration

Ensure that the MRI scanner equipment meets the "MRI Conditions of Use" on page 1-4. Refer to
Table 2–2 Valid Combinations of Pulse Generators and Leads to Use in 1.5 T and 3 T
Environments on page 2-13 for component combinations.

MRI Scan Procedure Protocol

2-13

Valid Combinations of Pulse Generators and Leads to Use in 1.5 T and 3 T Environments

Table 2–2. Valid Combinations of Pulse Generators and Leads to Use in 1.5 T and 3 T Environments

Combination of one

INGEVITY MRI Lead and one

FINELINE II Lead

1.5 T scanner only.
3 T scanner not allowed.

Normal Operating Mode only.

ESSENTIO MRI Pulse
Generator
PROPONENT MRI
Pulse Generator
ACCOLADE MRI Pulse
Generator

INGEVITY MRI Leads

only

1.5 T or 3 T scanner
allowed.

Normal Operating Mode
or First Level Controlled
Operating Mode.

FINELINE II Leads only

1.5 T scanner only.
3 T scanner not allowed.

Normal Operating Mode
only.

• Refer to Table 1–2 System Configuration for 1.5 T on page 1-3 and Table 1–3 System
Configuration for 3 T on page 1-3 for a complete list of the model numbers of MR Conditional
Pacing System components.

• Refer to "MRI Conditions of Use" on page 1-4 for the entire set of MRI Conditions of Use.

WARNING: Only the combination of INGEVITY MRI lead(s) with an ESSENTIO MRI,
PROPONENT MRI, or ACCOLADE MRI pulse generator is valid to use with either 1.5 T or 3 T
scanners. All other allowable combinations of Boston Scientific MR Conditional system
components must use only 1.5 T scanners.

NOTE: 3 T MRI scanners should be operated in Circularly Polarized mode or Dual Channel
Multi-Transmission mode since ImageReady Pacing Systems have been evaluated against 3 T
MRI scanners during Circularly Polarized and Dual Channel Multi-Transmission RF operation
modes. Multi-Transmission RF operation with greater than two transmit channels has not been
evaluated.

3. Preparing the Patient for the Scan

The patient must not have an elevated temperature or compromised thermoregulation. Patient
position within the bore must be prone or supine, and the appropriate monitoring system must be
put in place (pulse oximetry and/or ECG). See "MRI Conditions of Use" on page 1-4.

If the MRI Protection Mode Time-out feature is being used, be sure to note the time at which the
pulse generator is scheduled to exit MRI Protection Mode. Refer to Figure 2–8 Sample settings
report and checklist printout on page 2-12.

2-14

MRI Scan Procedure Protocol

During the Scan

NOTE: If the time remaining is not sufficient for the patient to undergo the MRI scan, re­interrogation of the device will reset the Time-out value to the start of the originally programmed
timer setting.

WARNING: When the Time-out parameter is programmed to a value other than Off, the patient
must be out of the scanner before the time programmed elapses. Otherwise, the patient will no
longer meet Conditions of Use ("MRI Conditions of Use" on page 1-4).

Image distortion must be considered when planning an MRI scan, and when interpreting MRI
images of fields containing the pulse generator and/or leads. Pulse generator artifacts extend
beyond the margin of the device in all directions. Only minor artifacts are present around the
pacing lead. Some artifacts include moderate spatial distortion beyond the boundaries of the
visible pulse generator artifact. Gradient Recalled Echo artifacts are generally larger and more
prone to have accompanying spatial distortion than Spin Echo artifacts.

DURING THE SCAN

Patient Monitoring

Normal voice and visual contact, as well as pulse oximetry and/or ECG, must be monitored for
the duration of the scan.

WARNING: Ensure that an external defibrillator and medical personnel skilled in cardio­pulmonary resuscitation (CPR) are present during the MRI scan should the patient require
external rescue.

WARNING: If the MRI Protection Time-out value of Off is combined with a Pacing Mode of Off,
the patient will not receive pacing until the pulse generator is programmed out of MRI Protection
Mode and back to normal operation. It is recommended to have the Programmer/Recorder/
Monitor (PRM) near the MRI room in case the patient develops the urgent need for pacing.
Patients with the following conditions may have increased risk of developing transient pacing­dependence:

• A history of syncope related to bradyarrhythmia

• A history of syncope of unknown etiology

• Sinus pauses (Pause > 2 s), AV block permanently or intermittently

• At risk for intermittent AV block (for example, those with progressive AV block, or a history of
unexplained syncope)

• At risk for trifascicular block (alternating bundle branch block or PR interval > 200 ms with
LBBB or other bifascicular block)

WARNING: The Programmer/Recorder/Monitor (PRM) is MR Unsafe and must remain outside
the MRI site Zone III (and higher) as defined by the American College of Radiology Guidance
Document for Safe MR Practices

2

. Under no circumstances should the PRM be brought into the

MRI scanner room, the control room, or the MRI site Zone III or IV areas.

AFTER THE SCAN

WARNING: Exit MRI Protection Mode after MRI scanning is completed. If the MRI Protection

Time-out value of Off is selected, the pulse generator will remain permanently in the MRI
Protection Mode until it is programmed otherwise. Prolonged use of the MRI Protection Mode
(such as may occur when the Time-out feature is programmed to Off) may increase the rate of

2. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.

MRI Scan Procedure Protocol

After the Scan

2-15

battery depletion. In addition, prolonged exposure of a patient to the XOO mode chosen may be
deleterious to the patient’s health.

Manually exit MRI Protection Mode using the PRM after the scan (see Manual Exit from MRI
Protection Mode). After exit from MRI Protection Mode, check system integrity by running lead
impedance, pacing threshold, and intrinsic amplitude tests.

Upon exit from MRI Protection Mode, all parameters are immediately restored to pre-MRI
Protection Mode values with two exceptions. If PaceSafe Automatic Capture (RVAC) was
programmed on, this feature enters suspension upon entry of the device into MRI Protection
Mode. Upon exit from MRI Protection Mode, RV pace amplitude is set to two times the last
capture threshold determined by the RVAC feature before it entered suspension (output limited to
between 3.5 V and 5.0 V). After the next scheduled autothreshold test runs (within the next 21
hours) and is successful, the RV pace amplitude is set to the new capture threshold plus 0.5 V.
This behavior was designed to provide a safety margin against loss of capture during the
transient period between MRI completion and full body recovery from effects of the scanner
electromagnetic fields.

For details about the PaceSafe Automatic Capture feature, see the Reference Guide for the
pulse generator.

Restoration of function of the Minute Ventilation sensor is also delayed upon exit from MRI
Protection Mode. If MV is programmed to On or Passive at the time of entry into MRI Protection
Mode, upon exit from the mode, an automatic six-hour calibration of the sensor will begin. MV­driven rate response is not available during this calibration period. If MV-driven rate response is
desired sooner, a manual calibration can be performed. Manual calibration is completed in five
minutes or less. For additional information about MV calibration, see the Reference Guide for the
pulse generator.

Time-out (automatic) Exit from MRI Protection Mode

If the MRI Protection Mode Time-out parameter was programmed to a value other than Off, the
pulse generator will exit MRI Protection Mode automatically after the selected number of hours,
and the system will return to previously programmed settings (for details about the resumption of
PaceSafe Automatic Capture and Minute Ventilation, see "After the Scan" on page 2-14).

Manual Exit from MRI Protection Mode

Manually exit MRI Protection Mode using the PRM after the scan.

Do not leave the pulse generator in MRI Protection Mode any longer than necessary following the
scan. MRI Protection Mode pacing is performed at a fixed, elevated rate. Some patients may
experience side effects during protracted pacing in this mode, including decreased exercise
capacity, acceleration of heart failure, and proarrhythmia.

• Interrogate the pulse generator using the wand (RF telemetry is disabled in MRI Protection
Mode)

• Select the Cancel MRI Protection Mode button from the MRI Protection Mode Programmed
screen (Figure 2–10 MRI Protection Mode Programmed (Cancel MRI Protection) on page 2-

16)

2-16

MRI Scan Procedure Protocol

After the Scan

Figure 2–10. MRI Protection Mode Programmed (Cancel MRI Protection)

Following user-initiated cancellation of MRI Protection Mode, the PRM will automatically navigate
to the Lead Tests screen and prompt the user to perform the following lead tests (Figure 2–11
MRI Protection Cancelled dialog on page 2-16):

• Lead impedance

• Pacing threshold

• Intrinsic amplitude

These tests may be performed subsequent to automatic (Time-out) exit from MRI Protection
Mode as well.

Figure 2–11. MRI Protection Cancelled dialog

On exit from MRI Protection Mode, a summary report of the MRI is stored as an MRI episode and
can be printed as an episode report using the PRM printer. The MRI Protection episode can also
be accessed and viewed via the Arrhythmia Logbook. A sample stored event detail printout is
shown in Figure 2–12 Sample stored event detail printout on page 2-17.

The MRI episode can also be viewed on the Arrhythmia Logbook via remote patient monitoring (if
available).

Figure 2–12. Sample stored event detail printout

MRI Scan Procedure Protocol

After the Scan

2-17

2-18

MRI Scan Procedure Protocol

After the Scan

A-1

CARDIOLOGY CHECKLIST FOR THE IMAGEREADY PACING SYSTEM

APPENDIX A

This appendix is provided for convenience. Refer to the remainder of this Technical Guide for the
full list of Warnings and Precautions and complete instructions for using the ImageReady Pacing
System.

Conditions of Use – Cardiology Scanning Procedure

The following Conditions of Use must be met in order for
a patient with an ImageReady Pacing System to undergo
an MRI scan

Patient is implanted with an ImageReady MR
Conditional Pacing System (see "ImageReady Pacing
System Components for 1.5 T and 3 T" on page C-1)

Pulse generator in MRI Protection Mode during scan

Bipolar pacing operation or pacing off

Patient does not have elevated body temperature
or compromised thermoregulation at time of scan

Pulse generator implant location restricted to left or
right pectoral region

At least six (6) weeks have elapsed since
implantation and/or any lead revision or surgical
modification of the MR Conditional Pacing System

No cardiac-related implanted devices, components, or
accessories present other than an ImageReady MR
Conditional Pacing System

Pacing threshold ≤ 2.0 V in pace-dependent patients

No abandoned leads or pulse generators

No evidence of a fractured lead or compromised pulse
generator-lead system integrity

Pre-scan

1. Ensure patient meets all Cardiology Conditions of Use
for MRI scanning (see left column).

2. Ensure that the HCPs involved in performing the MRI
scan have received the model numbers of the pulse
generator and lead(s) implanted in the patient.

3. As close to the start of the scan as possible, program
the pulse generator into MRI Protection Mode.

4. Print the MRI Protection Settings Report, place it in the
patient’s file, and provide to radiology personnel.

• The report documents MRI Protection Mode settings
and details. If the Time-out feature is used, the report
includes the exact time and date when MRI
Protection Mode will expire

During Scan

5. Ensure the patient is continuously monitored by pulse

oximetry and electrocardiography (ECG), with backup
therapy available (external rescue), while the device is in
MRI Protection Mode.

After Scan

6. Manually exit MRI Protection Mode using the PRM to

return the pulse generator to pre-MRI operation. Perform
follow-up testing of the implanted system.

WARNING: Unless all of the MRI Conditions of Use are met, MRI scanning of the patient does
not meet MR Conditional requirements for the implanted system, and significant harm to or death
of the patient and/or damage to the implanted system may result.

WARNING: Only the combination of INGEVITY MRI lead(s) with an ESSENTIO MRI,
PROPONENT MRI, or ACCOLADE MRI pulse generator is valid to use with either 1.5 T or 3 T
scanners. All other allowable combinations of Boston Scientific MR Conditional system
components must use only 1.5 T scanners.

WARNING: The Programmer/Recorder/Monitor (PRM) is MR Unsafe and must remain outside
the MRI site Zone III (and higher) as defined by the American College of Radiology Guidance
Document for Safe MR Practices

1

. Under no circumstances should the PRM be brought into the

MRI scanner room, the control room, or the MRI site Zone III or IV areas.

1. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.

A-2

CARDIOLOGY CHECKLIST FOR THE IMAGEREADY PACING SYSTEM

RADIOLOGY CHECKLIST FOR THE IMAGEREADY PACING SYSTEM

APPENDIX B

This appendix is provided for convenience. Refer to the remainder of this Technical Guide for the
full list of Warnings and Precautions and complete instructions for using the ImageReady Pacing
System.

Conditions of Use – Radiology Scanning Procedure

B-1

The following Conditions of Use must be met in order for
a patient with an ImageReady Pacing System to undergo
an MRI scan.

MRI magnet strength of 1.5 T or 3 T (see "ImageReady
Pacing System Components for 1.5 T and 3 T" on page
C-1)

• 1.5 T

• Radio frequency (RF) field of approximately 64
MHz

• Spatial gradient no greater than 50 T/m (5,000
G/cm)

• 3 T

• RF field of approximately 128 MHz

• Spatial gradient no greater than 50 T/m (5,000
G/cm)

Horizontal,1H proton, closed bore scanners only

Specific Absorption Rate (SAR) limits:

• For FINELINE II leads only or for one FINELINE II
lead and one INGEVITY MRI lead, SAR limits for
Normal Operating Mode
entire active scan session as follows:

• Whole body averaged, ≤ 2.0 watts/kilogram (W/

kg)

• Head, ≤ 3.2 W/kg

• For INGEVITY MRI leads only, SAR limits for Normal
Operating Mode
Operating Mode
active scan session as follows:

• Whole body averaged, ≤ 4.0 W/kg

• Head, ≤ 3.2 W/kg

a

must be observed for the

a

or for First Level Controlled

b

must be observed for the entire

Pre-scan

1. Ensure Cardiology has cleared the patient for scanning
eligibility based on the Cardiology MRI Conditions of Use
(see "Cardiology Checklist for the ImageReady Pacing
System" on page A-1) and has provided the model
numbers of the pulse generator and lead(s) implanted in
the patient.

2. Ensure patient meets all Radiology Conditions of Use
for MRI scanning (see left column).

3. Refer to the MRI Protection Settings Report to confirm
that the patient’s device is in MRI Protection Mode. If the
Time-out feature is used, the report includes the exact
time and date when MRI Protection Mode will expire.

Verify that adequate time remains to complete the
scan.

During Scan

4. Ensure the patient is continuously monitored by pulse
oximetry and electrocardiography (ECG), with backup
therapy available (external rescue), while the device is in
MRI Protection Mode.

After Scan

5. Manually exit MRI Protection Mode using the PRM to
return the pulse generator to pre-MRI operation. Perform
follow-up testing of the implanted system.

Gradient Field limits: Maximum specified gradient slew

rate ≤ 200 T/m/s per axis

No local transmit-only coils or local transmit/receive
coils placed directly over the pacing system; the use of
receive-only coils is not restricted

Patient in supine or prone position only

The patient must be monitored during the MRI scan by
pulse oximetry and/or electrocardiography (ECG)

a. As defined in IEC 60601-2-33, 201.3.224, 3rd Edition.
b. As defined in IEC 60601-2-33, 201.3.208, 3rd Edition.

WARNING: Unless all of the MRI Conditions of Use are met, MRI scanning of the patient does
not meet MR Conditional requirements for the implanted system, and significant harm to or death
of the patient and/or damage to the implanted system may result.

WARNING: Only the combination of INGEVITY MRI lead(s) with an ESSENTIO MRI,
PROPONENT MRI, or ACCOLADE MRI pulse generator is valid to use with either 1.5 T or 3 T

B-2

RADIOLOGY CHECKLIST FOR THE IMAGEREADY PACING SYSTEM

scanners. All other allowable combinations of Boston Scientific MR Conditional system
components must use only 1.5 T scanners.

WARNING: The Programmer/Recorder/Monitor (PRM) is MR Unsafe and must remain outside
the MRI site Zone III (and higher) as defined by the American College of Radiology Guidance
Document for Safe MR Practices

1

. Under no circumstances should the PRM be brought into the

MRI scanner room, the control room, or the MRI site Zone III or IV areas.

CAUTION: The presence of the implanted Pacing System may cause MRI image artifacts (see
"3. Preparing the Patient for the Scan" on page 2-13).

NOTE: All normal risks associated with an MRI procedure apply to MRI scans with the MR
Conditional Pacing System. Consult MRI scanner documentation for a complete list of risks
associated with MRI scanning.

NOTE: Other implanted devices or patient conditions may cause a patient to be ineligible for an
MRI scan, independent of the status of the patient’s ImageReady MR Conditional Pacing
System.

NOTE: 3 T MRI scanners should be operated in Circularly Polarized mode or Dual Channel
Multi-Transmission mode since ImageReady Pacing Systems have been evaluated against 3 T
MRI scanners during Circularly Polarized and Dual Channel Multi-Transmission RF operation
modes. Multi-Transmission RF operation with greater than two transmit channels has not been
evaluated.

1. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.

IMAGEREADY PACING SYSTEM COMPONENTS FOR 1.5 T AND 3 T

APPENDIX C

Only specific combinations of pulse generators and leads constitute an ImageReady Pacing
System. Consult the following tables to determine which combinations are valid for use with only

1.5 T scanners and which are valid for use with both 1.5 T and 3 T scanners.

Table C–1. Valid Combinations of Pulse Generators and Leads to Use in 1.5 T and 3 T Environments

INGEVITY MRI Leads

ESSENTIO MRI Pulse
Generator
PROPONENT MRI
Pulse Generator
ACCOLADE MRI Pulse
Generator

Table C–2. ImageReady MR Conditional Pacing System Components for 1.5 T and 3 T

1.5 T or 3 T scanner
allowed.

Normal Operating Mode
or First Level Controlled
Operating Mode.

only

FINELINE II Leads only

1.5 T scanner only.
3 T scanner not allowed.

Normal Operating Mode
only.

Combination of one

INGEVITY MRI Lead and one

FINELINE II Lead

1.5 T scanner only.
3 T scanner not allowed.

Normal Operating Mode only.

C-1

Component Model Number(s) MR Status Valid

Pulse Generators

ESSENTIO MRI L110, L111, L131 MR Conditional

PROPONENT MRI L210, L211, L231 MR Conditional

ACCOLADE MRI L310, L311, L331 MR Conditional

Leads and Accessories

FINELINE II Sterox Pacing Lead 4456, 4457, 4458,

FINELINE II Sterox EZ Pacing Lead 4469, 4470, 4471,

Suture Sleeve for FINELINE II leads 6220, 6221 MR Conditional

INGEVITY MRI Pacing Lead (Tined Fixation) 7731, 7732, 7735,

INGEVITY MRI Pacing Lead (Extendable/
Retractable Fixation)

Suture Sleeve for INGEVITY MRI leads 6402 MR Conditional

IS-1 Lead Port Plug 7145 MR Conditional

ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) and PRM Software Application

ZOOM LATITUDE PRM 3120 MR Unsafe

ZOOM LATITUDE PRM Software App. 2869 N/A

4459, 4479, 4480

4472, 4473, 4474

7736

7740, 7741, 7742 MR Conditional

MR Conditional

MR Conditional

MR Conditional

a

Combinations

For valid

combinations for 1.5

T and 3 T see the
“Valid Combinations
of Pulse Generators

and Leads to Use in

1.5 T and 3 T

Environments” table

above.

a. See PRM is MR Unsafe Warning regarding the PRM.

C-2

IMAGEREADY PACING SYSTEM COMPONENTS FOR 1.5 T and 3 T

SYMBOLS ON PACKAGING

APPENDIX D

The following symbols may be used on packaging and labeling.

Table D–1. Symbols on Packaging

Symbol Description

D-1

MR Conditional

Reference number

D-2

Symbols on Packaging

INDEX

A

Abandoned leads or pulse generators 1-4, 1-7–1-8
ACCOLADE MRI 1-2–1-3, 1-12, 2-13
Active implantable medical devices (AIMDs) 1-11
Arrhythmia Logbook 2-16

B

Battery capacity status 2-4
Bipolar pacing configuration 1-4, 1-6, 2-10

C

Cardiology Checklist A-1
Closed bore 1-5, 1-9, 2-13
Coils 1-11

receive-only 1-5, 1-10
transmit-only 1-5, 1-10
transmit/receive 1-5, 1-10

M

Magnet sensor 2-5
Minute Ventilation 2-15
Models for use with 1.5 T 1-3
Models for use with 3 T 1-3
MR Unsafe 1-3
MRI magnet strength

1.5 T 1-2

1.5 Tesla 1-2–1-4, 1-8, 1-11, 2-13
3 T 1-2

3 Tesla 1-2–1-3, 1-5, 1-8–1-9, 1-11, 2-13
MRI Protection Checklist 2-6–2-7
MRI Protection episode 2-16
MRI Protection Mode 1-4, 1-11, 2-5, 2-15

automatic exit 2-15

conditions preventing entry 2-4–2-5

default pacing mode 2-3

entry into 2-5

manual exit 2-9, 2-11, 2-15

risks when Conditions of Use are not met 2-7, 2-9–

2-10
suspended features and functions 2-4
Time-out feature 1-2, 2-2–2-4, 2-8, 2-11, 2-13, 2-

16

MRI Protection Settings Report 1-6, 2-2, 2-8, 2-11

E

Electrocautery Mode 2-4
ESSENTIO MRI 1-2–1-3, 1-12, 2-13

F

FINELINE II 1-2, 1-5, 1-10
First level controlled operating mode 1-2, 1-5, 1-10,

2-13

Fractured lead 1-4, 1-8

I

Image distortion 2-14
ImageReady MR Conditional Pacing System 1-2, 1-

4, 1-6–1-8
INGEVITY MRI 1-2–1-3, 1-5, 1-10, 1-12, 2-13
Intrinsic amplitude 1-8, 2-4, 2-15–2-16

L

LATITUDE 1-3
Lead impedance 1-8, 2-4, 2-6, 2-15–2-16
Leads

FINELINE II 1-2, 1-5, 1-10
INGEVITY MRI 1-2–1-3, 1-5, 1-10, 1-12, 2-13

N

Normal operating mode 1-2, 1-5, 1-10, 2-13

O

Operating mode

first level controlled 1-2, 1-5, 1-10, 2-13
normal 1-2, 1-5, 1-10, 2-13

P

Pace-dependent patients 1-4, 1-7, 2-9
PaceSafe Automatic Capture 2-15
Pacing threshold 1-4, 1-7, 2-10, 2-15–2-16
Pacing threshold changes 1-6, 1-15
Patient position 1-5, 1-11, 2-13
Previous pacing threshold 2-9
PRM 1-2–1-3
Programmer wand 2-5, 2-9, 2-15
PROPONENT MRI 1-2–1-3, 1-12, 2-13
Pulse generators 1-3

ACCOLADE MRI 1-2–1-3, 1-12, 2-13
ESSENTIO MRI 1-2–1-3, 1-12, 2-13
PROPONENT MRI 1-2–1-3, 1-12, 2-13

Pulse oximetry 1-5, 1-11, 2-13–2-14

Q

Quick Reference Guide C-1

R

Radiology Checklist B-1
Receive-only coils 1-5, 1-10
RF telemetry 2-4–2-5, 2-15

S

Safety Core operation 1-6, 2-4
SAR limits 1-5, 1-10
Six weeks since implant 1-4, 1-7, 1-15
Specific Absorption Rate (SAR) limits 1-5, 1-10
STAT PACE mode 2-5, 2-11
Storage Mode 1-7, 2-4, 2-6
System integrity 2-15

compromised 1-4, 1-8

T

Tesla

1.5 T 1-2–1-4, 1-8, 1-11, 2-13

3 T 1-2–1-3, 1-5, 1-8–1-9, 1-11, 2-13
Time since implant 2-6
Transmit-only coils 1-5, 1-10
Transmit/receive coils 1-5, 1-10

U

Unipolar pacing configuration 2-5, 2-10

V

Valid combinations 1-2, 2-13
Ventricular episode 2-5

Z

ZOOM LATITUDE 1-3

Cardiac Pacemakers Incorporated a wholly owned subsidiary of Guidant Corporation
a wholly owned subsidiary of Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul, MN 55112-5798 USA

www.bostonscientific.com

1.800.CARDIAC (227.3422)

+1.651.582.4000

©

2017 Boston Scientific Corporation or its affiliates.

All rights reserved.

359486-005 EN Canada 2017-08

*359486-005*