Boston Scientific L110 Quick start guide

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 1H MRI (Proton MRI) scanners.
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. 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

1-1
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

1-2 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
INGEVITY MRI Leads
only FINELINE II Leads only
Combination of one
INGEVITY MRI Lead and one
FINELINE II Lead
ESSENTIO MRI Pulse
Generator
PROPONENT MRI
Pulse Generator
ACCOLADE MRI Pulse
Generator
1.5 T or 3 T scanner
allowed.
Normal Operating Mode
or First Level Controlled
Operating Mode.
1.5 T scanner only.
3 T scanner not allowed.
Normal Operating Mode
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.

Introduction to MR Conditional Pacing
System Configuration for 1.5 T 1-3
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 / Sterox EZ Leads
FINELINE II Sterox Pacing Lead 4456, 4457, 4458, 4459, 4479, 4480 MR Conditional
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 Leads
INGEVITY MRI Pacing Lead (Tined Fixation) 7731, 7732, 7735, 7736 MR Conditional
INGEVITY MRI Pacing Lead (Extendable/
Retractable Fixation)
7740, 7741, 7742 MR Conditional
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 Unsafea
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 Leads
INGEVITY MRI Pacing Lead (Tined Fixation) 7731, 7732, 7735, 7736 MR Conditional
INGEVITY MRI Pacing Lead (Extendable/
Retractable Fixation)
7740, 7741, 7742 MR Conditional
Suture Sleeve for INGEVITY MRI leads 6402 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 Unsafea
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)
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, 1H 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 Mode2must 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 Mode3or for First Level Controlled Operating
Mode4must be observed for the entire active scan session as follows:
• 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)
Actions If Condition is Not Met
Potential Clinical
Consequences
Risk is Highest for
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.
• 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).
• 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
• 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.
• Program the pulse
generator to MRI
Protection Mode using the
PRM.
• Arrhythmia induction
• 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
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.
• 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
• Pacing will not occur if
Safety Core is entered.
• 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

Introduction to MR Conditional Pacing
Conditions for Scanning 1-7
Table 1–4. Cardiology Conditions/Patient Conditions (continued)
Condition for Scanning
(Rationale)
Actions If Condition is Not Met
Potential Clinical
Consequences
Risk is Highest for
Pre-existing elevated
temperature is additive with any
scan-induced heating.
result of heating at the
lead/tissue interface
• Pocket discomfort due to
pulse generator 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.
• Check patient records.
• Check by physical exam or
X-ray.
• 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
• Pacing-dependent patients
• Patients prone to sustained
arrhythmias
• Patients with high capture
thresholds
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.
• 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.)
• 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
• 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.
• 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.
• 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
• Pacing-dependent patients
• Patients prone to sustained
arrhythmias
• Patients with high capture
thresholds
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 for
most recent pacing
threshold values or run a
pacing threshold test.
The device will check the most
recently recorded pacing
• Inappropriate pacing,
inhibition of pacing, or
irregular intermittent
capture or pacing, possibly
resulting in pre-syncope or
syncope
• Pacing-dependent patients

1-8 Introduction to MR Conditional Pacing
Conditions for Scanning
Table 1–4. Cardiology Conditions/Patient Conditions (continued)
Condition for Scanning
(Rationale)
Actions If Condition is Not Met
Potential Clinical
Consequences
Risk is Highest for
for patients with a pacing
threshold ≤ 2.0 V plus an
additional 1.0 V to counteract
gradient-induced pace pulse
offsets.
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.
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.
• Check patient records.
• Confirm with physician
responsible for managing
the patient's Pacing
System.
• Check X-rays.
• 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
• Pacing-dependent patients
• Patients prone to sustained
arrhythmias
• Patients with high capture
thresholds
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.
• 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.
• 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
• 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
Potential Clinical
Consequences
Risk is Highest for
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.
• Arrhythmia induction • Pacing-dependent
patients

Introduction to MR Conditional Pacing
Conditions for Scanning 1-9
Table 1–5. Radiology Conditions (continued)
Condition for Scanning (Rationale) Actions If Condition is Not Met
Potential Clinical
Consequences
Risk is Highest for
• RF field of approximately 64 MHz
• Spatial gradient no greater than 50 T/
m (5,000 G/cm)
• Refer to "System
Description" on page 1-
2 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
• Damage to pulse
generator, lead, or
connection
• Physical movement of
pulse generator and/or
leads
• Pocket discomfort due
to pulse generator
heating
• Patients prone to
sustained arrhythmias
• Patients with high
capture thresholds
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 1-
2 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
connection
• Physical movement of
pulse generator and/or
leads
• Pocket discomfort due
to pulse generator
heating
• Pacing-dependent
patients
• Patients prone to
sustained arrhythmias
• Patients with high
capture thresholds
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, 1H 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
• Inappropriate pacing,
inhibition of pacing, or
irregular intermittent
capture or pacing,
• Pacing-dependent
patients
• Patients prone to
sustained arrhythmias
• Patients with high
capture thresholds

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
Risk is Highest for
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).
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
resulting in pre-syncope
or syncope
• Pacing-dependent
patients
• Patients with high
capture thresholds
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, possibly
resulting in pre-syncope
or syncope
• Pacing-dependent
patients
• Patients with high
capture thresholds
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.
• Check technical
specifications of MRI
scanner.
• 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
• Pacing-dependent
patients
• Patients prone to
sustained arrhythmias
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.
• Ensure no local
transmit-only or
transmit/receive coils
are placed directly over
the pacing system.
• Arrhythmia induction
• Clinically significant
pacing threshold
changes and sensing
changes as a result of
• Pacing-dependent
patients
• Patients prone to
sustained arrhythmias

Introduction to MR Conditional Pacing
MRI Protection Mode 1-11
Table 1–5. Radiology Conditions (continued)
Condition for Scanning (Rationale) Actions If Condition is Not Met
Potential Clinical
Consequences
Risk is Highest for
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.
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
• Patients with high
capture thresholds
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.
• 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
• 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).
• 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
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.

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.

Introduction to MR Conditional Pacing
Programming Considerations 1-13
WARNING: Ensure that an external defibrillator and medical personnel skilled in cardio-
pulmonary 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 pacing-
dependence:
• 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 Practices5. 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: 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 Practices6.
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.
Precautions
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.