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Boston Scientific L310 - Page 15

Boston Scientific L310
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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,
1
H 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

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