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.
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