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.
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