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Boston Scientific RHYTHMIA HDx User Manual

Boston Scientific RHYTHMIA HDx
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Mapping System
Software Instructions for Use .......................2
Instrucciones de uso del software ........... 106
Mode d’emploi du logiciel .......................221
Gebrauchsanweisung der Software ........338
Istruzioni per l’uso del software ..............453
Gebruiksaanwijzing software ..................566
Instruções de Utilização do Software .....680
RHYTHMIA HDx

Table of Contents

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Boston Scientific RHYTHMIA HDx Specifications

General IconGeneral
BrandBoston Scientific
ModelRHYTHMIA HDx
CategoryMedical Equipment
LanguageEnglish

Summary

1. DEVICE DESCRIPTION

1.1 Contents

Lists system components including Signal Station, System Software, Workstation, and Accessories.

1.1.5 Intended Applied Parts

Lists single-use parts intended for system use but not included, like EP catheters and patch kits.

1.2 Operating Principle

Explains the system's 3D mapping and navigation using continuous mapping and catheter localization.

1.3 User Information

States system operation is restricted to licensed medical practitioners and mapping specialists.

2. INTENDED USE

3. INDICATIONS FOR USE

4. CLINICAL BENEFITS STATEMENT

5. CONTRAINDICATIONS

6. WARNINGS

7. CAUTIONS

7.1 General

Advises frequent back-up routines to prevent data loss and careful handling of components.

7.2 During the Procedure

Details precautions during procedures, like verifying connections, using imported shells as reference, and handling CIEDs.

8. POTENTIAL ADVERSE EVENTS

8.1 Arrhythmias

Patients are at risk of arrhythmias due to programmed stimulation and catheter manipulation during EP procedures.

8.2 Misinterpretation of Data

Poor localization or force measurements can lead to misinterpretation and patient injury.

8.3 Electrical Hazards

Notes the potential risk of electrical shock to users, patients, and service representatives.

9. HOW SUPPLIED

10. MAJOR OPERATING MODES

10.1 Study Log In

Describes accessing the Startup screen and its tabs for selecting modes.

10.2 Overview

Explains the distinct screens, features, and functions of the three system operation modes.

10.3 Live Mode

Used to set up studies, create, display, review, and edit real-time maps and data.

10.3 Live Mode

10.3.1 Setup Screen

Used to prepare for a mapping study by defining, adding, or configuring catheters, electrodes, and signals.

B. Signal Station Status and Connections

Explains the auto-detect feature displaying SiS port status for connected peripherals and warning conditions.

C. Catheter List and Control Settings

Enables users to manage catheters and configure unipolar/bipolar channel settings.

Filters

Allows selection of low-pass/high-pass filters and line noise rejection for unipolar/bipolar channels.

Defining Catheter Channels

Details how to display catheter channels, determine physical connections, and set labels.

Adding and Removing Catheters

Describes how users can add or remove catheters as needed from the system.

D. Sweep Graph

Refers to Figure 19 for details on the Sweep Graph.

E. Patient Alignment and Reference Interface

Facilitates patient alignment to the magnetic field and selection of reference signals.

Setup and reference signal verification

Details system verification of connection signal and quality after patient alignment.

F. Signal(s) of Selected Catheter(s)

Facilitates review of bipolar or unipolar signals for user-selected catheters.

10.3.2 Multiple Monitor Configuration

Allows users to set up primary and secondary windows for study use, supporting up to four monitors.

The secondary window supports the following user interface elements

Lists UI elements available for secondary windows, including graphs and views.

10.3.3 Preparing IntellaMap Orion Family of Catheters for Use

10.3.4 Map Tab

Annotating and Editing Maps Toolbar

Toolbar for configuring mapping settings and starting mapping (Figure 10).

Beat Metrics Panel

Panel to review and edit beat acceptance criteria for mapping modes.

10.3.4.1 System Reference Electrode

Explains the necessity of the reference electrode for impedance location technology.

10.3.4.2 System Status Messages

Describes system messages and localization generator status icons appearing on Live Mode screens.

Localization Generator Disable or Enable Feature

Details how to manually disable/enable the localization generator for specific situations like CIED interference.

10.3.4.3 Stimulation

Explains cardiac tissue stimulation, channel routing, and warnings related to pacing signals.

10.3.4.4 3D View

Describes the display of 3D maps and catheter locations in Live or Review Mode.

Color Bar

Explains the use of the color bar as a legend for map color and electrogram values.

3D Orientation Manipulation

Details using the 3D orientation toolbar and mouse controls for map visualization.

Lock Map Visibility

Describes preserving map visibility in 3D View by clicking a padlock icon.

Map Information

Information displayed at the bottom of 3D view, including volume, time, and accepted beats.

Clipping Plane

Feature to see internal features of a mapped structure by creating a cross-section view.

Clipping Plane

Explains how to access and adjust the clipping plane using drag controls or a pop-up menu.

10.3.4.5 ECG and Intracardiac Signal Display Functions

Details collecting and displaying ECG and intracardiac signals on Sweep Graph and Beat Graph.

Beat Graph

Shows multiple ECG/intracardiac electrograms for examining and comparing beats.

Beat Review Graph

Includes a beat graph color bar to help understand activation time maps and annotate beats.

Study Log

Used to search, view, edit, add, or remove recorded events and tags.

Slow/Fast Graph

Synchronized graphs for reviewing study log data, available only for data review.

The Slow Graph (left side of Figure 20)

Describes the Slow Graph for viewing data at slow sweep speeds, toggling signals, and configuring traces.

10.3.4.6 AutoTag Parameter Panes

Displays tag drop progress bars and coloring parameters associated with active AutoTag groups.

10.3.5 Ablation Tab

10.3.6 3D Mapping Overview

10.3.6.1 Map Setup

Expands the Map Initiation Tool to select mapping catheter, enter map name, and select chamber of interest.

Map Type

Details map types: Anatomy Only, Activation or Voltage, and FrAP.

Templates

Describes three template types for initializing trigger settings: Detected, Previous, and Snapshot.

Catheter Selection Panel

Used to select catheters visible on the 3D view and change certain catheter parameters.

10.3.6.2 Mapping Window

Displays the portion of cardiac cycle analyzed for activation time and voltage, and how to adjust it.

10.3.6.3 Beat Detection and Timing Reference Channel

Explains beat detection and designation of the timing reference channel for consistent analysis.

10.3.6.4 Anatomical Maps

Explains how anatomical maps are created by aggregating catheter locations and options for including/excluding data.

10.3.6.5 Electroanatomical Maps

Describes electroanatomical maps based on anatomical map, electrode location, and electrical activity.

Activation Time Map

Includes sequence of tissue electrical activation, determining activation time, and manual annotation.

The Beat Review Graph displays a color bar

Explains how the Beat Review Graph color bar synchronizes with activation time maps for interpretation.

Voltage Maps

Used to identify low voltage areas (scar) by displaying peak-to-peak voltage.

Fractionation Maps

Used to identify areas with high electrogram fractionation based on number of activations.

10.3.6.6 Electroanatomical Mapping Modes

Covers manual beat acquisition and continuous mapping for data collection.

Manual Beat Acquisition (beat-by-beat) Mapping

Describes manually adding beats to a map by freezing the Beat Graph and reviewing electrograms.

Continuous Mapping

Allows rapid map completion by continuously acquiring beats as catheter moves, using beat acceptance criteria.

10.3.7 Mapping with Catheters other than IntellaMap Orion Family of Catheters

Non-Orion Map Data Interpolation

Explains interpolating anatomical data to smooth meshes and fill gaps in sparse maps.

Non-Orion Map Editing

Describes the anatomy editing tool for selecting regions and modifying interpolation levels.

Non-Orion Map Visualization

Explains visualizing acquired vs. interpolated data, with acquired data as opaque and interpolated as transparent.

10.3.8 Map Tagging and Editing

10.3.8.1 Map Cloning

Allows cloning of Activation Time, Voltage, and Anatomical Maps to create exact duplicates.

10.3.8.2 Tools for Annotating and Editing Maps

Lists tools for annotating and editing maps in Live Mode, shown in Figure 36.

Tagging Window

Tool to create and manage manual and AutoTag groups, organize tags, and preview.

Anatomy Tagging

Invokes anatomy tagging mode to drop anatomy tags on the 3D view surface.

Create and Edit Cutouts

Tool to cut out and remove selected anatomy, like veins or valves.

Move/Rotate

Aligns imported anatomical shells to patient orientation or previously created 3D map.

Screenshots/Video

Selects desired image capture method for full screen or partial image/video.

Roving Probe

Activates the roving probe to place or move it to desired map locations.

Area Measurement

Tool to measure distance between tags or surface area of a region on the 3D map.

10.3.8.3 Live Study Review

Function in Live Mode to review maps and data, including electrograms and tags.

10.3.8.4 Tagging

Lists four tagging options: Manual, Anatomy, Trace, and Automatic (AutoTag).

Tag Setup and Management

Details managing tags using the tagging window, creating tag groups, and setting active groups.

Tag Group Folders

Explains organizing tag groups into folders for better management within the tagging window.

Tagging Tools

Discusses tagging location selection and tag projection appearance (sphere vs. disc).

Tagging Location

Defines selecting the center or tip of the distal electrode for accurate tagging.

Tag Projection

Explains how tag appearance depends on proximity to the anatomical surface and projection settings.

Measuring the Distance between Tags

Describes using the Measurement Tool to measure distances between tags on a 3D map.

Measuring the Distance between Tags and Catheter Tip

Explains the Tip to Closest Tag Distance tool for measuring proximity.

Tag Visibility

Details hiding tag groups or individual tags using eye icons in the Tagging Window or study log.

Starring Tags

Allows converting tags to star shapes for marking locations of interest.

Manual Tag Preview

Describes displaying a preview ring on anatomy to identify where manual tags would appear.

Manual Tags

Facilitates manual tagging of catheter location with respiration feedback in the tagging window.

Anatomy Tags

Describes placing anatomy tags by invoking anatomy tagging mode and clicking on the anatomical surface.

Trace Tags

Allows tagging from unipolar/bipolar traces by double-clicking on a trace in Beat Graph.

Automatic Tags (AutoTag)

Tags placed automatically based on user-defined criteria, colored by parameters.

AutoTag Presets

Collection of user-defined tag drop and coloring criteria to determine AutoTag placement and color.

AutoTag Groups

How to set up and activate an AutoTag group, associating it with a tag group.

AutoTag Drop Parameters

Conditions for AutoTag placement: active group, tracked catheter, and no data gaps.

AutoTag Coloring Parameters

Explains how AutoTags are colored based on five parameters and how coloring updates in real-time.

Like manual tags, the color palette for an AutoTag

Describes user-selectable color palettes for AutoTags and how coloring is determined by thresholds.

Reprocessing an AutoTag Group

Allows reprocessing an active AutoTag group by assigning a different preset.

AutoTag Error States

Explains errors affecting tag drop/coloring parameters and how they are indicated.

Reviewing Tags

Describes how new tags are added as study log entries and are searchable.

10.3.8.5 Editing Anatomy

Covers adjusting mesh tightness and visualization options for newly acquired data.

Editing the Anatomical Shell

Details the two types of anatomy editing: surface editing and volume editing.

Quick Access to Anatomy Editing

Describes using the F5 key as a shortcut for the Scissors Tool.

Undoing or Redoing Anatomy Edits

Explains the undo/redo functionality for anatomy selections or deletions.

10.3.9 Catheter Location Tracking

10.3.9.1 Magnetic Location Technology

Uses magnetic fields from a generator to determine catheter position.

10.3.9.2 Impedance Location Technology

Tracks catheters without magnetic sensors using small currents and voltage measurements.

10.3.9.3 Impedance Field Map

Creates an impedance field map to enhance impedance tracking accuracy by coupling with magnetic location.

10.3.9.4 Tracking Related Indicators

Discusses visual indicators for tracking quality affected by factors like electrode connections and motion.

Tracking Quality Indicator

Provides a quality indicator for each magnetically tracked catheter, including features and indicators.

Drift Adjustment

Automatic adjustment for impedance measurement degradation due to factors like motion or irrigation.

Catheter Motion

Minimizes on-screen effects of motion using a software-applied motion filter.

Catheter Stabilization

Corrects Non-Orion catheter rendering for motion, basing visualization on motion-corrected position.

10.3.9.5 Troubleshooting for Location Accuracy

Provides steps for poor location accuracy, including verifying connections and resetting field maps.

Observing Trends in Tracking Quality

Helps target troubleshooting by observing visual trends in tracking quality graphs.

10.3.9.6 Location References

Explains the two location references: magnetic (back patch) and impedance (system reference electrode).

Catheter Proximity Visualization

Provides qualitative understanding of catheter location relative to a 3D anatomical shell.

Mapping Catheter Proximity

Represented by an outline or halo showing the area updated if data is added to the map.

Ablation Catheter Proximity

Represented by a ring, proportional to distance, with different display inside/outside shell.

Catheter Visualization, Tracing, and Location Feedback

Describes visibility of internal/external catheter images and warnings when localization generator is disabled.

10.3.10 DirectSense

10.3.10.1 User Interface Elements

Details the four DirectSense UI elements: impedance graph, power bar, tip visualization, and value widget.

Local Impedance vs. Time Graph (DirectSense Graph)

Shows raw and moving average local impedance data over time, with calibration mechanism.

Power Bar and Catheter Tip Visualization

Explains the power bar graphic and its visualization at the catheter tip.

Local Impedance Value Widget (DirectSense value widget)

Displays filtered impedance value in user-selectable modes.

10.3.10.2 Local Impedance During Ablation

10.3.11 Ablation Generator Data Display

10.3.12 Force Sensing

10.3.12.1 Force Preconditioning

Explains the warm-up process for IntellaNav StablePoint catheters before force data can be displayed.

Warm-up Force Catheter

Details the warm-up process in the Force value widget, including conditions and progress.

Zero Force Catheter

Explains the process of zeroing the force catheter after warm-up for accurate readings.

10.3.12.2 Force User Interface Elements

Lists the four elements of the Force Sensing UI: graph, tip visualization, value widget, and angle indicator.

Force Graph

Displays raw and filtered force data, with configurable thresholds and time history.

Force Visualization at the Catheter Tip

Depicts the force graphic at the catheter tip, similar to DirectSense visualization.

Force Value Widget and Angle Indicator

Displays numerical force value and angle indicator, with color-coded feedback.

10.3.12.3 Sheath Detection

Describes system detection of force catheter presence within compatible sheaths.

10.3.12.4 Force During Ablation

Explains changes in force UI elements during RF energy delivery, indicating ablation status.

10.3.13 LUMIPOINT Module

LUMIPOINT control panel items include:

Lists items within the LUMIPOINT control panel, such as search tools and settings.

10.3.13.1 LUMIPOINT Tools

Details LUMIPOINT tools accessible via control panel or Beat Review Graph.

ACTIVATION

Highlights map regions activating at a certain time, with desired strictness criteria.

Complex Activation

Highlights regions activating at a certain time and exhibiting multiple activation components.

Split Activation

Highlights regions exhibiting discontinuous activation anywhere within the mapping window.

Presets

Allows saving and recalling activation category settings, with options to save and recall.

SKYLINE

Plots a histogram of normalized surface area active at different times across the mapping window.

Trend Tool

Plots relative activation of electrograms within a user-defined radius around the roving probe.

Group Re-annotation

Allows changing annotation of highlighted electrograms based on user-defined targets.

10.3.13.2 LUMIPOINT Visual Descriptors

Introduces new visuals for LUMIPOINT, describing anatomic area, electrogram area, and time period of interest.

10.3.13.3 Study Reprocessing

Extends LUMIPOINT functionality to review Orion data initially collected without the module.

10.3.14 Image Import

Segmentation

Allows importing pre-acquired DICOM images and segmentation of cardiac chamber using ITK-SNAP.

Pre-segmented Import

Allows importing pre-segmented DICOM and VTK file formats.

10.4 Review Mode

10.4.1 Dynamic Review

Facilitates review of map data and map editing in Live or Review Mode.

10.4.2 Display of Live or Recorded Catheter Locations in 3D View

Selects display of live or recorded catheter locations in the 3D View.

10.4.3 Roving Probe

Tool for evaluating large amounts of map data by positioning a probe to view electrograms.

10.4.4 Showing Earliest Point(s) of Activation

Helps find earliest activation points on unipolar/bipolar Activation Time Maps using the Roving Probe.

10.4.5 Map Editing

Allows editing individual points on a map in dynamic review, such as changing timing or deleting electrograms.

10.5 Study Archiving and Export

10.5.1 MATLAB Export

Allows exporting study data to MATLAB-compatible files in various formats: Basic, Advanced, Ablation.

10.6 Configure Mode

10.6.1 File Shares

Supports wired Ethernet connection for importing/exporting studies via network.

To begin using the network storage point

Details configuring a new file share, including name, path, credentials, and testing connection.

Troubleshooting

10.7 System Settings

11. SOFTWARE TROUBLESHOOTING GUIDE

11. SOFTWARE TROUBLESHOOTING GUIDE (Continued)

Continues troubleshooting guide for software issues, including Signal Station and localization errors.

11. SOFTWARE TROUBLESHOOTING GUIDE (Continued)

Continues troubleshooting guide for software issues, including device errors and cable mismatches.

11. SOFTWARE TROUBLESHOOTING GUIDE (Continued)

Continues troubleshooting guide for software issues related to catheter tracking and electrode problems.

11. SOFTWARE TROUBLESHOOTING GUIDE (Continued)

Continues troubleshooting guide for software issues, including magnetic localization and ablation generator connection problems.

11. SOFTWARE TROUBLESHOOTING GUIDE (Continued)

Continues troubleshooting guide for software issues, including DirectSense saturation and sheath detection errors.

11. SOFTWARE TROUBLESHOOTING GUIDE (Continued)

Continues troubleshooting guide for software issues, including disk space, memory, and CPU synchronization errors.

11. SOFTWARE TROUBLESHOOTING GUIDE (Continued)

Continues troubleshooting guide for software issues, including force connection box and catheter errors.

11. SOFTWARE TROUBLESHOOTING GUIDE (Continued)

Continues troubleshooting guide for software issues, including force catheter errors and sheath detection unavailability.

11. SOFTWARE TROUBLESHOOTING GUIDE (Continued)

Continues troubleshooting guide for software issues, including force data packet drop and catheter incompatibility.

12. WARRANTY

13. CONTACTS

14. SYMBOLS FOUND ON RHYTHMIA HDx™ DEVICES AND LABELING

Lot Number

Serial Number

Legal Manufacturer

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