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.