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
a
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 System
1
(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.
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