Table of Contents
Advertisement
Advertisement
Table of Contents
Related Manuals for Boston Scientific L110
Summary of Contents for Boston Scientific L110
- Page 1 MRI TECHNICAL GUIDE ™ IMAGEREADY 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...
- Page 3 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...
-
Page 5: Table Of Contents
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... -
Page 7: Introduction To Mr Conditional Pacing
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 •... -
Page 8: System Description
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... -
Page 9: System Configuration For 1.5 T
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... -
Page 10: Mri Conditions Of Use
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.) Defined as a Boston Scientific MR Conditional pulse generator and lead(s), with all ports occupied by a lead or port plug. -
Page 11: Conditions For Scanning
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. - Page 12 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.
- Page 13 Introduction to MR Conditional Pacing Conditions for Scanning Table 1–4. Cardiology Conditions/Patient Conditions (continued) Condition for Scanning Actions If Condition is Not Met (Rationale) Potential Clinical Risk is Highest for Consequences result of heating at the Pre-existing elevated lead/tissue interface temperature is additive with any scan-induced heating.
- Page 14 Introduction to MR Conditional Pacing Conditions for Scanning Table 1–4. Cardiology Conditions/Patient Conditions (continued) Condition for Scanning Actions If Condition is Not Met (Rationale) Potential Clinical Risk is Highest for Consequences for patients with a pacing threshold testing results for threshold ≤...
- Page 15 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.
- Page 16 1-10 Introduction to MR Conditional Pacing Conditions for Scanning Table 1–5. Radiology Conditions (continued) Condition for Scanning (Rationale) Actions If Condition is Not Met Potential Clinical Risk is Highest for Consequences possibly resulting in pre-syncope or syncope • Damage to pulse generator, lead, or connection •...
-
Page 17: Mri Protection Mode
Introduction to MR Conditional Pacing 1-11 MRI Protection Mode Table 1–5. Radiology Conditions (continued) Condition for Scanning (Rationale) Actions If Condition is Not Met Potential Clinical Risk is Highest for Consequences There are no restrictions for positioning heating at the lead/ •... -
Page 18: X-Ray Or Fluoroscopic Identification
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. -
Page 19: Programming Considerations
Introduction to MR Conditional Pacing 1-13 Programming Considerations WARNING: Ensure that an external defibrillator and medical personnel skilled in cardio- pulmonary resuscitation (CPR) are present during the MRI scan should the patient require external rescue. WARNING: MRI scanning after Explant status has been reached may lead to premature battery depletion, a shortened device replacement window, or sudden loss of pacing. -
Page 20: Mri Site Zone Iii Exclusions
1-14 Introduction to MR Conditional Pacing MRI Site Zone III Exclusions • if the Pacing Mode under MRI Protection Mode settings is programmed to Off; the pulse generator will continue permanently with the Pacing Mode programmed to Off, and the patient will not receive pacing therapy until the pulse generator is replaced MRI Site Zone III Exclusions WARNING: The Programmer/Recorder/Monitor (PRM) is MR Unsafe and must remain outside... - Page 21 Introduction to MR Conditional Pacing 1-15 Potential Adverse Events • Patient discomfort due to slight movement or heating of the device • Side effects of MRI Protection Mode pacing at elevated fixed rate and increased output including reduced exercise capacity, acceleration of heart failure, and competitive pacing/ arrhythmia induction •...
- Page 22 1-16 Introduction to MR Conditional Pacing Potential Adverse Events...
-
Page 23: Mri Scan Procedure Protocol
MRI SCAN PROCEDURE PROTOCOL CHAPTER 2 This chapter contains the following topics: • “Patient Flow” on page 2-2 • “MRI Protection Mode General Information” on page 2-2 • “Pre-Scan Activities” on page 2-4 • “During the Scan” on page 2-14 •... -
Page 24: Patient Flow
MRI Scan Procedure Protocol Patient Flow Before proceeding with this MRI scan procedure protocol, verify that the patient and the MRI scanner meet the MRI Conditions of Use ("MRI Conditions of Use" on page 1-4). This verification must be performed 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. - Page 25 MRI Scan Procedure Protocol MRI Protection Mode General Information • Pacing mode options include asynchronous pacing or no pacing (DOO, AOO, VOO, or Off). Off should only be used if the patient is judged to be clinically capable of receiving no pacing during the time the pulse generator will be in MRI Protection Mode, including during the scan.
-
Page 26: Pre-Scan Activities
MRI Scan Procedure Protocol Pre-Scan Activities The following features and functions are suspended in MRI Protection Mode: • PaceSafe RV automatic capture • PaceSafe RA automatic threshold • Cardiac sensing • Daily diagnostics (lead impedance, intrinsic amplitude, pace threshold) • Motion and respiratory sensors •... -
Page 27: Programming The Pulse Generator For A Scan
MRI Scan Procedure Protocol 1. Programming the Pulse Generator for a Scan 2. Confirm the MRI scanner settings and configurations ("2. Confirming MRI Scanner Settings and Configuration" on page 2-13) 3. Prepare the patient for the scan ("3. Preparing the Patient for the Scan" on page 2-13) 1. - Page 28 MRI Scan Procedure Protocol 1. Programming the Pulse Generator for a Scan Figure 2–2. Episode in progress attention message In addition to the above-listed conditions that prevent entry into MRI Protection Mode, two other conditions of use are assessed by the PRM upon a request to enter MRI Protection Mode: lead impedance and time since implant.
- Page 29 MRI Scan Procedure Protocol 1. Programming the Pulse Generator for a Scan Conditional scan. Re-verification is required before every scan to guard against the possibility that changes in the system or patient occurred subsequent to the original pulse generator/system implant. These conditions are described in greater detail in Table 1–4 Cardiology Conditions/ Patient Conditions on page 1-6 and Table 1–5 Radiology Conditions on page 1-8.
- Page 30 MRI Scan Procedure Protocol 1. Programming the Pulse Generator for a Scan WARNING: Use caution when programming the MRI Protection Mode pacing amplitude for pacing-dependent patients who have high pacing thresholds (> 2.0 V). Programming pacing amplitude below 5.0 V is provided as an option in case of extracardiac stimulation (for example, diaphragmatic stimulation for RV pacing).
- Page 31 MRI Scan Procedure Protocol 1. Programming the Pulse Generator for a Scan CAUTION: The physician choosing MRI Protection Mode parameter values will need to exercise professional judgment to determine an individual patient’s ability to tolerate the pacing parameters required for MR Conditional scanning, in conjunction with the physical conditions required during a scan (for example, prolonged time in a supine position).
- Page 32 2-10 MRI Scan Procedure Protocol 1. Programming the Pulse Generator for a Scan WARNING: Use caution when programming the MRI Protection Mode pacing amplitude for pacing-dependent patients who have high pacing thresholds (> 2.0 V). Programming pacing amplitude below 5.0 V is provided as an option in case of extracardiac stimulation (for example, diaphragmatic stimulation for RV pacing).
- Page 33 MRI Scan Procedure Protocol 2-11 1. Programming the Pulse Generator for a Scan To exit MRI Protection Mode manually, select the Cancel MRI Protection button (see Manual Exit from MRI Protection Mode in "After the Scan" on page 2-14). If necessary, STAT PACE or DIVERT THERAPY can also be used to exit MRI Protection Mode and return the pulse generator to previously programmed settings (DIVERT THERAPY) or initiate STAT PACE pacing parameters (see the pulse generator Reference Guide for more information about STAT PACE).
- Page 34 2-12 MRI Scan Procedure Protocol 1. Programming the Pulse Generator for a Scan [1] If MRI Protection Time-out is displayed as “Off”, the pulse generator remains in MRI Protection Mode until manually reprogrammed; [2] Twenty-four hour time format is used; [3] Column indicates date measurement was taken Figure 2–8.
-
Page 35: Confirming Mri Scanner Settings And Configuration
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. -
Page 36: During The Scan
2-14 MRI Scan Procedure Protocol During the Scan NOTE: If the time remaining is not sufficient for the patient to undergo the MRI scan, re- interrogation of the device will reset the Time-out value to the start of the originally programmed timer setting. - Page 37 MRI Scan Procedure Protocol 2-15 After the Scan battery depletion. In addition, prolonged exposure of a patient to the XOO mode chosen may be deleterious to the patient’s health. Manually exit MRI Protection Mode using the PRM after the scan (see Manual Exit from MRI Protection Mode).
- Page 38 2-16 MRI Scan Procedure Protocol After the Scan Figure 2–10. MRI Protection Mode Programmed (Cancel MRI Protection) Following user-initiated cancellation of MRI Protection Mode, the PRM will automatically navigate to the Lead Tests screen and prompt the user to perform the following lead tests (Figure 2–11 MRI Protection Cancelled dialog on page 2-16): •...
- Page 39 MRI Scan Procedure Protocol 2-17 After the Scan Figure 2–12. Sample stored event detail printout...
- Page 40 2-18 MRI Scan Procedure Protocol After the Scan...
-
Page 41: Cardiology Checklist For The Imageready Pacing System
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. - Page 42 CARDIOLOGY CHECKLIST FOR THE IMAGEREADY PACING SYSTEM...
-
Page 43: Radiology Checklist For The Imageready Pacing System
RADIOLOGY CHECKLIST FOR THE IMAGEREADY PACING SYSTEM APPENDIX B 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 –... - Page 44 RADIOLOGY CHECKLIST FOR THE IMAGEREADY PACING SYSTEM 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 .
-
Page 45: Imageready Pacing System Components For 1.5 T And 3 T
Table C–2. ImageReady MR Conditional Pacing System Components for 1.5 T and 3 T Component Model Number(s) MR Status Valid Combinations Pulse Generators ESSENTIO MRI L110, L111, L131 MR Conditional PROPONENT MRI L210, L211, L231 MR Conditional ACCOLADE MRI L310, L311, L331 MR Conditional... - Page 46 IMAGEREADY PACING SYSTEM COMPONENTS FOR 1.5 T and 3 T...
-
Page 47: Symbols On Packaging
SYMBOLS ON PACKAGING APPENDIX D The following symbols may be used on packaging and labeling. Table D–1. Symbols on Packaging Symbol Description MR Conditional Reference number... - Page 48 Symbols on Packaging...
- Page 49 INDEX Abandoned leads or pulse generators 1-4, 1-7–1-8 Magnet sensor 2-5 ACCOLADE MRI 1-2–1-3, 1-12, 2-13 Minute Ventilation 2-15 Active implantable medical devices (AIMDs) 1-11 Models for use with 1.5 T 1-3 Arrhythmia Logbook 2-16 Models for use with 3 T 1-3 MR Unsafe 1-3 MRI magnet strength 1.5 T 1-2...
- Page 50 Quick Reference Guide C-1 Radiology Checklist B-1 Receive-only coils 1-5, 1-10 RF telemetry 2-4–2-5, 2-15 Safety Core operation 1-6, 2-4 SAR limits 1-5, 1-10 Six weeks since implant 1-4, 1-7, 1-15 Specific Absorption Rate (SAR) limits 1-5, 1-10 STAT PACE mode 2-5, 2-11 Storage Mode 1-7, 2-4, 2-6 System integrity 2-15 compromised 1-4, 1-8...
- Page 52 Cardiac Pacemakers Incorporated a wholly owned subsidiary of Guidant Corporation a wholly owned subsidiary of Boston Scientific Corporation 4100 Hamline Avenue North St. Paul, MN 55112-5798 USA www.bostonscientific.com 1.800.CARDIAC (227.3422) +1.651.582.4000 © 2017 Boston Scientific Corporation or its affiliates. All rights reserved.
Need help?
Do you have a question about the L110 and is the answer not in the manual?
Questions and answers
Have complete heart block. Boston Scientific pacemaker L111 implanted 12/ 31 2018.When does battery need replacement? Thanks.
For a Boston Scientific pacemaker model L111, the battery needs replacement when follow-up assessments show accelerated depletion, indicated by a significant decrease in the ‘Approximate Time to Explant’ that exceeds the interval between follow-ups. Follow-ups should occur at least every 12 months until one year of battery life remains, then every 3 months until replacement is indicated. If accelerated depletion is suspected, the device should be replaced and returned within 90 days of explant.
This answer is automatically generated