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Boston Scientific EMBLEM S-ICD User Manual

Boston Scientific EMBLEM S-ICD
70 pages
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PULSE GENERATOR USER'S MANUAL
EMBLEM™ S-ICD
Subcutaneous Implantable Cardioverter Debrillator
A209
Outdated version. Do not use.
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Table of Contents

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Boston Scientific EMBLEM S-ICD Specifications

General IconGeneral
Device TypeSubcutaneous Implantable Cardioverter Defibrillator (S-ICD)
ManufacturerBoston Scientific
ModelEMBLEM S-ICD
TherapyDefibrillation
Lead TypeSubcutaneous lead
Battery LifeApproximately 5-7 years
ProgrammabilityYes
MRI CompatibilityMRI conditional
IndicationPatients at risk of sudden cardiac arrest due to ventricular tachyarrhythmias
Remote MonitoringCompatible with LATITUDE™ Remote Patient Management system
LongevityApproximately 5-7 years

Summary

Handling and Implantation Procedures

Sterilization, Storage, and Implantation Steps

Implantation Details and Device Programming

Electrode Connection and Replacement

Instructions for connecting the electrode and implanting replacement devices.

Radiation and Electrical Interference Hazards

Follow-up Testing and Device Explantation

Potential Adverse Events - Part 1

Device-Related Adverse Events

Lists events related to device function, connection, and physical integrity.

Patient-Related Adverse Events

Lists events related to patient's physiological response or systemic issues.

Potential Adverse Events - Part 2

Device and Therapy Related Events

Lists events like inappropriate shocks, infections, and device failures.

Psychological and Systemic Events

Covers psychological disorders and systemic issues like emphysema.

Patient Screening Process

Patient Screening - ECG Recording

Evaluating the Surface ECG

Determining an Acceptable Sense Vector

Device Operation Modes

Device Modes: Shelf, Therapy On, Therapy Off

Describes the three operational modes of the device.

Sensing Configuration and Tachyarrhythmia Detection

Optimal Sensing Vector and Gain Selection

Explains automatic selection of sensing vectors and gain settings.

Event Classification and Therapy Zones

Shock Zone and Conditional Shock Zone Setup

Details programmable therapy zones and their criteria.

Analysis in the Conditional Shock Zone

Rate and Morphology Discrimination

Explains analysis of rate and morphology for discriminating arrhythmias.

Charge Confirmation, Therapy Delivery, and Smart Charge

Charge Confirmation Strategy and Therapy Delivery

Details charge confirmation and therapy delivery processes.

Shock Delivery and Pacing Functions

Post-Shock Pacing and Manual Shock Delivery

Describes post-shock pacing and manual/rescue shock commands.

System Diagnostics and Monitoring

Subcutaneous Electrode and Device Integrity Checks

Describes tests for electrode impedance and device integrity.

Battery Performance Monitoring

Details the system for monitoring battery status and depletion.

Storing and Analyzing Episode Data

S-ICD System Magnet Use

Procedure for Suspending Therapy with a Magnet

Step-by-step instructions for suspending therapy using a magnet.

Magnet Response and Pulse Generator Mode

System Components and Initial Implantation

Equipment Check and Preparation

Pulse Generator Interrogation and Device Pocket Creation

Interrogating and Checking the Pulse Generator

Procedures for checking pulse generator sterility and parameters.

Creating the Device Pocket Incision

Details on making the incision for the device pocket.

Subcutaneous Electrode Implantation - Part 1

Surgical Approach and Xiphoid Incision

Describes the surgical approach and the xiphoid incision for electrode implantation.

Tunneling and Electrode Connection to EIT

Details tunneling and connecting the electrode to the EIT.

Subcutaneous Electrode Implantation - Part 2

Suture Sleeve Attachment and Second Incision

Procedures for attaching the suture sleeve and making a second incision.

Fascial Sutures and Tissue Fixation

Guidance on fascial sutures and ensuring adequate tissue fixation.

Subcutaneous Electrode Implantation - Part 3

Pulling EIT and Securing Suture Loop

Steps for pulling the EIT and securing the suture loop.

Anchoring Techniques and Suture Security

Provides guidance on anchoring techniques and ensuring suture security.

Connecting Subcutaneous Electrode to Device - Part 1

Device Mode and Tool Usage Precautions

Emphasizes using Shelf mode and correct tools to prevent damage.

Connector Port Insertion and Seal Plug

Step-by-step instructions for inserting the electrode into the port and dealing with the seal plug.

Connecting Subcutaneous Electrode to Device - Part 2

Inserting Torque Wrench into Setscrew Cavity

Details on inserting the torque wrench into the setscrew cavity.

Connecting Subcutaneous Electrode to Device - Part 3

Connector Block and Setscrew Positioning

Illustrates connector block and setscrew positions and warnings.

Connecting Subcutaneous Electrode to Device - Part 4

Securing Setscrew and Device Anchoring

Instructions for securing the setscrew and anchoring the device to the fascia.

Setting up the S-ICD Programmer

Initial Programmer Setup Process

Outlines the brief initial setup process for the programmer.

Automated Setup Functions

Lists the automated functions performed during programmer setup.

Defibrillation Testing Procedures

Initiating Automatic and Manual Setup

Steps to initiate automatic and manual setup processes.

Induction Test Setup and Execution

Procedures for setting up and conducting an induction test.

Defibrillation Testing and Implantation Form Completion

Test Functions, Outcomes, and Post-Test Evaluation

Describes test functions, outcomes, and post-test evaluation steps.

Post Implant Follow-Up Procedures

Periodic Device Evaluation and Testing

Recommends periodic testing for device performance review.

Device Status Verification and Patient Management

Advises verifying device status and physician discretion in management.

Explantation and Component Return

Pulse Generator Longevity

S-ICD System and Pacemaker Interaction

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