EnSite™ Velocity™ Cardiac INSTRUCTIONS USE …/media/manuals/product-manual-pdfs/7/7/...On the EnSiteTM Amplifier: ECG or RecordConnect ECG cable connector On the EnSiteTM Amplifier:

1

EnSite™ Velocity™ Cardiac

Mapping System

Model EE3000

INSTRUCTIONS FOR USE

U.S. EDITION

Software Version 5.0

© Copyright 2016St. Jude Medical

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and services marks of St. Jude Medical, Inc. and its related companies.

http://patents.sjm.com

© 2016 St. Jude Medical, Inc. All Rights Reserved.

This software includes a custom version of the AVW Toolkit:

Copyright (c) 1995-2016 Biomedical Imaging Resource, Mayo Clinic/Foundation.

This software includes the DST Digital Segmentation Tool:

Copyright (c) 2004-2016 Biomedical Imaging Resource, Mayo Clinic/Foundation.

Valleylab is a trademark of Covidien AG.

DICOM is a trademark of National Electrical Manufacturers Association

CIDEX and CIDEX OPA are trademarks of Johnson & Johnson Corporation.

SANI-CLOTH is a trademark of Professional Disposables International, Inc.

ARTEN100151580 Rev. A2016-10

You are not here this morning

St. Jude MedicalOne St. Jude Medical DriveSt. Paul, MN55117-9913 USA+1 855 478 5833+1 651 756 5833sjm.com

St. Jude MedicalCoordination Center BVBAThe Corporate Village Da Vincilaan 11 Box F11935 Zaventem Belgium+32 2 774 68 11sjm.com

Australian Sponsor:St. Jude Medical Australia Pty Limited17 Orion Rd.,Lane Cove NSW 2066AUSTRALIA+61 (02) 9936 1200

WARNING: The use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias, may pose an increased risk of adverse events such as cardiac perforation, myocardial infarction, air embolism, and hematoma requiring surgical repair and/or blood transfusion.

2 EnSite™ Velocity™ Cardiac Mapping System Instructions for UseARTEN100151580 Rev. A

Symbol Description

21” Monitor

24” Monitor

Ablation Cable Kit, EPT

Ablation Cable Kit, IBI, T9

Ablation Cable Kit, Stockert

Ablation Cable Kit, JLL

Ablation catheter cable connector

Ablation catheter cable connector

AC Power

Adapter Assembly, ECG/NavX

Amplifier Network Connection

Amp and Chassis

Amplifier

Amplifier Accessory Kit

Amplifier and Display Workstation

Amplifier Cart

Amplifier Kit

Bedrail Mount Kit

Authorized representative in the European community

Auxiliary Reference Cable Connector

Cable Accessory Kit

21” Monitor

24” Monitor

Amp and Chassis

Amplifier

Amplifier Accessory Kit

Amplifier Cart

Amplifier Kit

Cable from RecordConnect to EnSiteTM Amplifier

Cable to Bard-Clearsign recording system

Cable to Bard-Stamp recording system

Cable to GE-Cardiolab recording system

Cable to St. Jude Medical EP-Workmate recording system

Cardiac Mapping System

Catalog Number

Catheter

Catheter Catalog Installation

Catheter Impedance Checker

CIM Certificate

Catheter Input Module (for the recording system in use)

Catheter Input Module Cable Connector




Catheter Interface Module cable connection for catheter inputs 1-56

Symbol Description

CIM

3EnSite™ Velocity™ Cardiac Mapping System Instructions for UseARTEN100151580 Rev. A

Catheter Interface Module cable connection for catheter inputs 57-120

Caution

Warning

Class II equipment

Consult Instructions for Use

Contents

Data Module Connector

Data Network Connection

Date of Manufacture

Defibrillator-proof Type BF applied part

Defibrillator-proof Type CF Applied Part

Dispersive Patch Cable Connector




Symbol Description

Display Workstation

Display Workstation Kit

Dispose of hardware in accordance with local law

Do not reuse

Do not use if package is damaged

DWS Hard Disk Drive

DWS Kit

DWS Velocity v. 2.0

DWS Velocity v. 2.1

DWS Velocity v. 3.0.1.1

ECG cable connector

ECG or RecordConnect ECG Cable Connector

ECG Surface Electrode

ELDI Field Upgrade Kit

EnSiteTM ArrayTM Catheter cable connector

EnSiteTM VelocityTM Cardiac Mapping System Amplifier

Equipotential Cable

Symbol Description

ELDI Field Upgrade Kit

EnSiteTM VelocityTM Amplifier

Equipotential Cable


Equipotential jack

Consult Instructions for Use on Website

ETL Listed Conforms toUL STD 60601-1 IEC STD 60601-1-1Certified toCAN/CSA STD C22.2 NO. 601.1ETL Listed Conforms toAAMI ES 60601-1 Certified toCSA G 22,2 NO. 60601-1

European Customer Service

Federal law (USA) restricts this device to sale by or on the order of a physician.

Follow Instructions For Use

For Use With

Fragile

Fragile

Fuse

GenConnect

GenConnect Cable Connector, to EnSiteTM Amplifier

Hardware

HN

Hospital Network Connection

Symbol Description

European Customer Service

Humidity Limitation

Includes

Input Voltage, Input Frequency andReplacement fuse information

Interface between Biosense Webster - Stockert ablation generator and the EnSiteTM Amplifier

Interface between diagnostic catheters and the EnSiteTM Amplifier

Interface between EnSite™ NavX™ Navigation and Visualization Technology patches / system reference and the EnSiteTM Amplifier

Interface between EnSiteTM VelocityTM Cardiac Mapping System EnSiteTM

ArrayTM catheter / data module and the EnSiteTM Amplifier

Interface between EPT ablation generator and the EnSiteTM Amplifier

Interface between manufacturer-specific generators and the EnSiteTM Amplifier

Interface between manufacturer-specific recording systems and the EnSiteTM Amplifier

Interface between Medtronic Atakr ablation generator and the EnSiteTM Amplifier

Interface between Siemens-Sensis recording system and the EnSiteTM Amplifier

Interface between SJM-T Series (formerly IBI-T Series) ablation generator and the EnSiteTM Amplifier

International Power Kit

International Rail Clamp

Keep Dry

Symbol Description

Intl Power Kit

Intl Rail Clamp


Keep Dry

Kit

Kit, WetLab

Laptop Review Station

Link

Local Monitor Connection

Lot number

Made in U.S.A.

Manufactured By

Model Number

Module

Monitor Arm

Mounting Kit

Multi-electrode Diagnostic Catheter

Non Sterile

Link

Not for direct patient contact

Notified Body CE Mark

On ArrayLink™ cable: ArrayLink™ cable connectororCathLink™, or RecordConnect catheter channels 65 to 128 cable connector

Symbol Description

Laptop Review Station

Made in U.S.A.

MODEL

Monitor Arm

Multi-electrode Diagnostic Catheter

On ArrayLink™ cable: ArrayLink™ Data Module cable connector

On carton: Transport/storage temperature limitation

On CathLink™ or RecordConnect cable: CathLink™ or RecordConnect catheter channels 1 to 64 cable connector

On the EnSiteTM Amplifier: ArrayLink Data Module cable connector

On the EnSiteTM Amplifier: ArrayLink, CathLink, or RecordConnect catheter channels 65 to 128 cable connector

On the EnSiteTM Amplifier: CathLink or RecordConnect catheter channels 1 to 64 cable connector

On the EnSiteTM Amplifier: ECG or RecordConnect ECG cable connector

On the EnSiteTM Amplifier: Fiber optic Cable Connector

On the EnSiteTM Amplifier: GenConnect cable connector

On the EnSiteTM Amplifier: NavLink™ Module cable connector

On GenConnect: GenConnect cable connector

On NavLink™ Module: NavLink™ Module cable connector

Operating Temperature

Power Plug

Power Switch

Symbol Description


Printed Circuit Assembly

Printer

Atmospheric Pressure Limits

Quantity

RecordConnect

Recorder Interconnect Kit, EPMED V5.0

Remote Monitor Connection

Remote Monitor Stand

Research Switch

Research Workstation

RF Filter

RF Filter Trap for Stockert

Serial Number

Small Surface Electrode Kit

Software

Software Installation

Software Upgrade Kit

Standby Power

Status

Symbol Description

Printer

Remote Monitor Stand

Small Surface Electrode Kit

Software Upgrade Kit

Sterilized Using Ethylene Oxide

Surface Electrode Kit

System Reference Patch Connector

Training Media

Universal RecordConnect

US Customer Service

US Power Kit

US Rail Clamp

Use By Date

Utility Upgrade Kit

Weight

Workstation

Workstation Accessory Kit

Workstation Cart

Symbol Description

STERILE EO

Surface Electrode Kit

US Customer Service

US Power Kit

US Rail Clamp

Workstation

Workstation Accessory Kit

Workstation Cart

7

Table of Contents

EnSite™ Velocity™ Cardiac Mapping System Instructions for UseARTEN100151580 Rev. A

Chapter 1. Introduction 11Indications for Use 11System Description 11Key System Features 12System Components 15

EnSite™ Amplifier 15Display Workstation (DWS) 15Components Not Included 16

EnSite™ Cardiac Mapping System Diagram 17Typical EnSite™ Velocity™ Cardiac Mapping System Lab Setup 17 18Signal and Power Connections 18

Warnings and Cautions 19Best Practices and Recommendations 22

Chapter 2. Using the Graphical User Interface 25Operating Modes 25Main Workspace 26Common Controls 27

Menu Bar 27Tool Palette 29Using the Mouse 30Common Interface Elements 32Mapping Control Panel Settings 33Dual View 35Split Screen 36Screen Layout Controls 38Screen Layout Presets 39

System Messages 42Information Message 42Advisory Message 42System Busy Message 42Warning Message 42

Notebook 43Saving an Event 44Saving a Bookmark 44

Presets 45Load a preset 45Save a preset 45

Chapter 3. External Connections 47EnSite™ Amplifier Connections 47NavLink™ Module Connections 48ArrayLink™ Module Connections 48CathLink™ Module Connections 49SJM ECG Cable Connections 49RecordConnect Connections 50GenConnect Connections 51Connecting the EnSite™ Amplifier to the DWS 51

Connecting the Local Monitor to the DWS 51Connecting the Remote Monitor to the DWS 52

Opticis Video Extender 52Avenview Video Extender 54

Using the Remote Monitor Configuration Tool 56Connecting Cables to the EnSite™ Amplifier 57

Color-Coded Connections 57Connecting a System Reference Surface Electrode 58Connecting EnSite™ Surface Electrodes 59

Surface Electrode Description 59Placement Considerations 59Surface Electrode Placement 60

Connecting ECG Surface Electrodes 62Connecting ECG Surface Electrodes When Using a RecordConnect 63Connecting ECG Surface Electrodes When Not Using a RecordConnect 64

Connecting an RF Ablation Catheter and Generator 65Connecting Diagnostic Catheters 66Connecting the EnSite™ Array™ Catheter 67Connecting an Auxiliary Unipolar Reference 68Using a Recording System 69

Connecting Diagnostic Catheters When Using a RecordConnect 70Connecting Diagnostic Catheters When Not Using a RecordConnect 71

Chapter 4. Preparing for a Study 73Preparing for an EnSite™ NavX™ Navigation and Visualization Technology Study 73

EnSite™ NavX™ Navigation and Visualization Technology Study with RecordConnect 73EnSite™ NavX™ Navigation and Visualization Technology Study without RecordConnect 76

Preparing for an EnSite™ Array™ Catheter Study 79EnSite™ Array™ Catheter Study with RecordConnect 79EnSite™ Array™ Catheter Study without RecordConnect 82

Chapter 5. Starting a Study 85Starting the System 85Keyboard and Screen Languages 86

Selecting a Keyboard Language 86Selecting a Screen Language 86

Logging In 87Title Screen 87

Getting Started 88Starting a New Study 91

New Patient 91Existing Patient 92

Past Studies 93

8 Table of Contents EnSite™ Velocity™ Cardiac Mapping System Instructions for UseARTEN100151580 Rev. A

Resuming a Study 93

Chapter 6. Setup 95Checking ECG Signals 95

Verifying ECG Signal Quality 96Validation 96EP Catheter Setup 97

Adding a Catheter to a Study 99Catheter Signal Settings 101Catheter Input Settings 102

Catheter Catalog 102Adding a Catheter to the Catheter Catalog 103Sorting the Catheter Catalog 103Deleting a Catheter from the Catheter Catalog 103

Catheter Presets 103Loading a Catheter Preset 104Saving a Catheter Preset 104Deleting or Renaming a Catheter Preset 104

Sheath Filter Setup 105Description 105Enable and Baseline the Catheter 105

EnSite™ Array™ Catheter Setup 107EnSite™ NavX™ Navigation and Visualization Technology Setup 109Positional Reference Tool 109

Setting Up the Positional Reference Tool 111Positional Reference Catheter Dislodgement 112

Respiration Compensation 114Collecting Respiration Data 114Respiration Rejection 115Respiration Meter 116

EnGuide Alignment 116Saturation Recovery 116Signal Filters 117

Chapter 7. Model 119The EnGuide Navigation System 119

Setting up EnGuide Navigation 119EnGuide Navigation Indicators 121

Modeling 122Model Presets 122Loading a Model Preset 122Saving a New Model Preset 123Deleting or Renaming a Model Preset 123Model Control Panel 124Color Chart and Visibility Selector 125

Collecting Surface Points 125Collect Points 125Edit Points 126

OneModel Tool 127Using the Surface List 128Field Scaling 129

EnSite™ NavX™ Navigation and Visualization Technology Field Scaling (NavX) 129

Digital Image Fusion (DIF) 130Creating a Model to Import 130Importing a Digital Image 130Additional Options for DIF Files 131Viewing a DIF Image for Reference 131DEMRI (Delayed Enhancement MRI) Image Integration 132

Chapter 8. Waveforms 133Using the Waveform Display 133Selecting and Adjusting Waveforms 134Displaying and Filtering Traces 135

Calipers 135How to Create a Caliper 135Using Calipers 135

Chapter 9. Recording and Playing Segments 137Recording Segments 137Automatically Recorded Segments 137Accessing Recorded Segments 138Playing Recorded Segments 138

Chapter 10. Adjusting and Labeling Maps 139Map Settings Properties 141EnGuide Display Settings 142Information Display Settings 143Views and the Orientation Reference 144

Orientation Toolbar 144Creating and Saving Map Views 145Additional Map Controls 146

Labels 147Placing a Map Label 147Selecting and Modifying Labels 148Label Colors 149

Anatomic Markers 149Placing Anatomic Markers 150Selecting and Modifying Anatomic Markers 151

EnGuide Shadows 152Placing EnGuide Shadows 153Selecting and Modifying EnGuide Shadows 154Verifying Catheter Stability 155

Tape Measures 156Placing a Tape Measure 157Selecting and Modifying Tape Measures 158

Chapter 11. Mapping – Noncontact 159Types of Noncontact Maps 159Interpreting Isopotential Maps 160Virtuals 161

Setting Virtual Waveform Parameters 161Placing Virtuals 162Using Global Virtuals 162

Interpreting Isopotential Color 163Using Manual Color Controls 164Using AutoFocus Color Controls 164

Using the Tracking Virtual 166Substrate Mapping 166

Creating a Substrate Map 168Isochronal Mapping 169

Creating an Isochronal Map 170

Chapter 12. Mapping – Contact 171Types of Contact Maps 172

Cardiac Triggered Maps 172Non-Cardiac Triggered Maps 172

Signals Collection 173Reference Signal Source 173Roving Signal Source 173Detection Algorithm 173Additional Signals 174

Considerations 174Non-Cardiac Triggered CFE Maps 174Reentrant Maps 175Propagation Maps 175SparkleMap 175

Mapping Control Panel 176Cardiac Triggered Mapping Settings 176

Table of Contents 9EnSite™ Velocity™ Cardiac Mapping System Instructions for UseARTEN100151580 Rev. A

Non-Cardiac Triggered Mapping Settings 179Collecting Points 180Points Display 183The OneMap Tool 185Creating a Map 186

Setting up a New Map 186Collecting Points 186To Map from a Segment 187

Managing Maps 188Mapping Controls 188

Chapter 13. Therapy 189Lesion Markers 190

Placing Lesion Markersf 191Selecting and Modifying Lesion Markers 192Lesion Control Panel 193

Chapter 14. RealReview 195Reviewing Segments 196Reviewing Bookmarks 196Reviewing Images 196Reviewing Annotations 196

Chapter 15. Reviewing and Editing Past Studies 197Past Studies 197

Reviewing Past Studies 198Editing Past Studies 198

Offline Review 199Offline Review – Model 199Offline Review – Mapping 200Offline Review – Therapy 200Offline Review – Review 200

Managing Patient and Study Records 200Searching for Patient Records 200Modifying Patient Information 200Removing Patient Records 201Modifying Study Records 201Deleting Studies 201

Chapter 16. Ending a Study 203Ending a Study 203

Chapter 17. Capturing, Exporting, and Importing Information 205

Exporting Data to External Devices 205Selecting an Area for Capture 205Saving and Accessing Individual Images 206

Saving an Image 206Accessing an Image 206

Creating Animations 207Creating an MPEG movie 207Creating a JPEG image sequence 207

Data Export 208Waveform Data 208Directory Name 208Export Interval Options 208Exporting 209Presets 209

Archiving Studies 210Archiving Media 211Importing Studies 212

Appendix A. Troubleshooting 215Contacting Technical Support 215

Troubleshooting Tools 215Using SJM™ Connect 216

If You Need SJM™ Technical Support 216Sending Files with SJM™ Connect 217Uploading Logs with SJM™ Connect 218Uploading Studies 218Proxy Configuration 219Notifying SJM 219

Troubleshooting Common Problems 220System Hardware Problems 220Patient Signal Problems 222EnGuide Stability Problems 223Software Interface Problems 224

Appendix B. Care and Service 227Service and Technical Support 227Setting Environmental Information 228

Setting the System Clock 228Setting the Powerline Frequency 228Setting the Owner Information 228

Customer-Performed Maintenance 229EnSite™ Amplifier 229EnSite™ DWS 230

Field Service Representative Performed Maintenance 231Replacement Parts 231Moving the System 232Installing EnSite™ Cardiac Mapping System Software Licenses 232

Preparing to Install 232Retrieve License(s) and Create Media 233Verify the Contents of a License File 236Install Licenses 237Verify Installed Licenses 237Re-Creating Licenses 238Manage Licenses 239Installation Report 239Velocity license has not been installed 239Installing a base license 240

Warranty Policy 240General Notices 240

Appendix C. Technical Specifications 241Specifications 241Electromagnetic Emissions – Declaration 243

Appendix D. EnSite™ Fusion™ Registration Module 247

Indications for Use 247Warnings, Cautions, and Disclaimers 247Introduction 247Performing Registration 248

Importing a DIF Model 248Scaling the EnSite™ NavX™ Navigation and Visualization Technology Navigation Field 249Placing Fiducial Point Pairs 250

Display Options 253The EnSite™ Fusion™ Registration Module Control Panel Display Options 253Map Settings Menu 254

Appendix E. EnSite™ Derexi™ Module 257Indications for Use 257Introduction 257

Minimum System Requirements 257EnSite™ Cardiac Mapping System / EP-WorkMate™ System

10 Table of Contents EnSite™ Velocity™ Cardiac Mapping System Instructions for UseARTEN100151580 Rev. A

Signal Connections 258Connecting to the EnSite™ Cardiac Mapping System 259

HP xw6400 259HP xw6400 or HP Z600 259Connection States 260

Maps and Integration 261Number of Maps / Map Points 261Map Point Analysis 261Mapping Constraints 261

Patient Connections 261Dual System Start-up Procedure using the EnSite™ Derexi™

Module 262Interface Features & Descriptions 263EP-WorkMate™ Recording System Mapping Controls 264

Appendix F. EnSite™ Verismo™ Segmentation Tool Module 265

Indications for Use 265Description 265Contraindications 266Warnings and Precautions 266Operator Requirements 266System Requirements and Considerations 266Overview of Segmentation 266Optimal Characteristics for the EnSite™ Verismo™ Segmentation Tool Image Files 267Loading Files for Segmentation 268

Starting the EnSite™ Verismo™ Segmentation Tool 268Verismo Cleanup 268Loading DICOM Files 268Using DICOM Files from Saved Data 268

Using the Wizard 269Introduction to the Patient Screen 269Selecting a Series for Segmentation 269

Viewing Options 270Subregioning the Series 270Loading the Series for Segmentation 270Using the Segmentation Interface 271

Introduction to the Segmentation Screen 271Menu Bar Summary 272

Using Basic Interface Controls 272Navigating in Slice Views 273Using the Zoom Control 273Using the Pan Control 273Using the Intensity (W/L) Controls 274Rotating the 3D Model 274

Using Templates 274Performing Segmentation 275

Overview of Segmentation Tools 275Additional Controls: Delete, Undo, Cancel 275

Using the Structure List 276Structure Attributes 276Modifying Structures 276

Using the Region Grow Tool 277Using the Chamber Tool 279Using the Vessel Tool 280Using the Separator Tool 281Using the Trace Tool 282

Using Trace in a Slice View 282Using Trace in the 3D View 282

Using the Barrier Tool 283Using the Reassign Tool 284

Reassigning a Structure 284Placing Labels 284Using the Measurement Tools 285

Measuring Distances 286

Measuring Volumes 286Saving and Exporting 287

Key Points About Saving Models 287Saving the Model to the Hard Drive 287Exporting Models to CD or DVD 287

Saving Work in Progress 288Reviewing the Final Model 288

Using the DIF Viewer 288Viewing Segmentation Contours 289

Printing Images 290Troubleshooting 290

Contacting Technical Support 290Troubleshooting Tools 290Troubleshooting Common Problems 290

Appendix G. Glossary 293

Appendix H. Index 303


Introduction
CHAPTER 1
Indications for Use

The EnSite™ Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

■ When used with the EnSite™ Array™ Catheter, the EnSite™ Velocity™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

OR

■ When used with an EnSite™ Velocity™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

System Description

The EnSite™ Velocity™ Cardiac Mapping System (Figure 1 on page 11) is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient’s own cardiac chamber.

Figure 1. The EnSite™ Amplifier and Cart (left), DWS and Cart (right).

12 Chapter 1. Introduction

Key System Features


Key System Features

Catheter Catalog – Catheter-specific information, including catheter diameter, tip electrode size, body electrode size, type, and interelectrode spacing, can be saved to a searchable catalog.

Clipping Plane . The clipping plane helps to increase the understanding and relationship of the model to other related features while reducing visualization obstructions.

Contact Mapping. Maps can be created from conventional EP catheters. Maps can display various information, including: activation timing, peak-to-peak voltage, peak-negative voltage, or complex fractionated electrograms.

■ MultiPoint Mapping Technology – Map points can be added from the active electrode, all electrodes on a specified catheter, or all electrodes in use.

■ Low -V ID – An adjustable Low Voltage Identification (Low -V ID) option allows low-voltage potentials to appear in gray instead of affecting the color pattern. Low - V ID is available for Local Activation Time (LAT) isochronal maps and Complex Fractionated Electrogram (CFE) maps.

Data Storage and Export Capabilities. During an EP study, the monitors display the data and that data can be stored on the DWS hard drive. Once the study is complete, a prompt is displayed to remind the user to back up the study data.

■ Patient records are stored in a database searchable by patient name, patient weight, physician name, date, diagnosis, and study type.

■ Records are copied to CD/DVD, USB, and network drive.

■ Still images, animations, and study data can be exported to a CD/DVD, USB, and network drive, which can then be displayed and reviewed using a non-EnSite™ Velocity™ Cardiac Mapping System computer.

■ The study images can be printed using a color printer.

Delayed Enhancement Magnetic Resonance Imaging. – (DEMRI) See “DEMRI (Delayed Enhancement MRI) Image Integration” on page 132.

DIF Map – Digital Image Fusion Map.

Digital Image Fusion (DIF). Digital images processed by segmentation tools such as the EnSite™ Verismo™ Segmentation Tool can be imported into the EnSite™ Velocity™ Cardiac Mapping System for display.

Field Scaling. – Field Scaling can be configured to automatically scale model, map, and EnGuide catheter locations and facilitates distance measurements.

■ EnSite™ NavX™ Navigation and Visualization Technology (NavX): Known interelectrode spacing used to create the model is used to adjust the dimensions of the navigation field.

First Deflection – Searches for the first spot in the signal (from left to right) where the signal deviates from isoelectric baseline by at least the sensitivity amount.

Fractionation Map – Displays the area of the map where there are clusters of Fractionation and is useful in identifying noisy points or points that require more attention.Indicates the number of CFE detections.

Image and Animation Export (Offline Review only) – Several options allow images and animations to be captured from the system:

■ Image sequences can be exported as either a series of JPEGs or as an mpeg (.mpg) movie.

Last Deflection – Searches for the last spot in the signal (the first spot when scanning from right to left to right) where the signal deviates from isoelectric baseline by at least the sensitivity amount.

Models of Cardiac Chambers. The EnSite™ Velocity™ Cardiac Mapping System can generate a model of one or more of the patient’s cardiac chambers by tracking conventional EP catheter electrodes at various locations on the surface of the endocardium.

Chapter 1. Introduction

Key System Features 13EnSite™ Velocity™ Cardiac Mapping System Instructions for Use

ARTEN100151580 Rev. A

Noncontact Mapping. (EnSite™ Array™ Catheter studies only) When the EnSite™ Velocity™ Cardiac Mapping System is used along with the EnSite™ Array™ Multi-Electrode Catheter, the system can collect, store, and display more than 3000 intracardiac electrograms. Several tools are available to facilitate interpretation:

■ AutoFocus Color Controls allow the system to automatically adjust the color levels of isopotential maps to quickly and clearly identify activation patterns.

■ Isopotential Mapping displays voltages sensed by the EnSite™ Array™ Catheter as three-dimensional maps, which use color to represent a range of electrical potentials across the surface of the heart chamber’s endocardium. These maps contain the electrical potentials at thousands of sites on the endocardial surface. As dynamic cardiac signals are viewed in the waveform display, the same information is animated in the display of the isopotential map.

■ Single-Beat Isochronal Maps of activation time can be projected onto the surface of the anatomic model in review mode.

■ Substrate Mapping (SM) Tool allows voltage patterns from noncontact mapping to be displayed as maps and labeled on the map.

■ Virtual Waveforms are based on simulated electrodes placed on the map display.

Non-fluoroscopic Catheter Navigation. The EnGuide navigation system allows 3D navigation of conventional EP catheters.

Notebook. The notebook allows recorded data and study information to be filed and annotated for future access.

■ Bookmarks can be added to the Notebook to allow the system to return to a specific time in review mode.

■ Events can be added to the Notebook to mark specific times in a study, such as the time of a drug administration.

OneMap. This feature is used to simultaneously create a cardiac chamber model and a contact map.

Point Count Map – Provides a method to visualize areas of high map point density versus low map point density.

Presets. Presets store setting preferences for catheters, models, maps, and layouts.

Propagation Maps. This feature facilitates the playing back of the activation sequence of recorded reentrant maps.

■ Provides controls to turn this feature on/off and features to control the playing through the activation sequence.

■ Loops over the cycle length.

■ Export of propagation sequences are available only in Offline Review.

Reentrant Maps. These maps facilitate the mapping of reentrant arrhythmias and are displayed in a manner similar to activation maps.

Respiration Compensation. (EnSite™ NavX™ Navigation and Visualization Technology studies only.) Respiration Compensation can be configured to dynamically adjust to the motion artifact from patient respiration during an EnSite™ NavX™ Navigation and Visualization Technology study. Respiration Compensation can also be manually recomputed during a study.

■ Respiration Meter – A respiration meter displays the relative level of patient respiration in the map display, based on EnSite™ NavX™ Navigation and Visualization Technology transthoracic impedance. The range is based on the lowest and highest impedance values sampled during Respiration Compensation collection.

■ Respiration Rejection – If a patient’s respiration exceeds the set limits of the respiration levels collected during Data Collection, the system will stop collecting points and stop placing labels and lesions at the Active EnGuide.

RF Filtering. Hardware filters provide cleaner signals during RF ablation.

Saturation Recovery. Saturation Recovery allows the system to quickly recover signals following defibrillation or RF energy ablation. Rapid system recovery allows assessment of post-defibrillation or post-ablation complexes.

Screen Views. The interface can be configured to display different types of information. Various options are available to display waveforms, one or two maps, and split screen.

Sheath Filter – Determines if an electrode is within the sheath (Sheathed) or outside the sheath (Unsheathed).


Key System Features


Signal Recording and Display. The EnSite™ Velocity™ Cardiac Mapping System is designed to collect, record, and display surface ECG and intracardiac electrogram signals provided by ECG electrodes, conventional EP catheters, other EP laboratory equipment, and the EnSite™ Array™ Catheter.

Sort Options – The user can sort the collected map points by the following criteria:

■ Order of Collection

■ LAT

■ Peak to Peak

■ Peak Negative

■ CFE Mean

■ CFE Std. Dev.

■ Fractionation

■ Annotation

■ Cycle Length

■ Point Count

■ Point Status

■ Wave Name

■ Force

Sparkle Map – Live activation map overlaid on the voltage map for easy visualization of voltage pathways on a single map.

Stabilize ABL – The Stabilize ABL feature adjusts the location of the distal electrode, based on the properties of the catheter.

Tape Measures. Tape measures allow measurement between points on the anatomic model of the endocardial surface.Tools to Provide Map Orientation. Several tools are available to enhance map orientation.

TurboMap – Once original mapping has occurred, the user may change mapping criteria and play back through the original dataset at maximum speed to generate a new map at the DWS’s maximum speed. This may be useful if the physician is mapping Sinus Rhythm and intermittent, multiple PVC or VT morphology beats are occurring. This may also be useful if the physician is trying to map multiple, distinct Cycle Length atrial tachycardias.

Waveform Traces. The EnSite™ Velocity™ Cardiac Mapping System has capabilities similar to traditional EP recording systems, including the ability to collect, store, and display surface ECG and intracardiac electrograms as waveform traces.


System Components 15EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


System Components

The EnSite™ Velocity™ Cardiac Mapping System is comprised of two subsystems: the EnSite™ Amplifier and the Display Workstation (DWS).

EnSite™ Amplifier

The EnSite™ Amplifier subsystem consists of the EnSite™ Amplifier, NavLink™ Module, ArrayLink™ Module, CathLink™ Module, SJM ECG Cable, RecordConnect, and GenConnect. The devices accept signals from electrodes attached to the patient and pass these signals to the EnSite™ Amplifier. The EnSite™ Amplifier converts these signals to a digital format and sends them to the DWS for processing.

EnSite™ Amplifier. Accepts signals from the NavLink™ Module, the ArrayLink™ Module, the CathLink™ Module, SJM ECG Cable, RecordConnect, and GenConnect, converts these signals to a digital format, and sends them to the DWS for processing. The Amplifier is connected to the DWS through a fiber-optic cable.

NavLink™ Module. Connects the EnSite™ surface electrodes and the system reference surface electrode to the Amplifier. It also has a connection for an auxiliary unipolar reference electrode.

ArrayLink™ Module. Connects the EnSite™ Array™ catheter to the EnSite™ Amplifier.

CathLink™ Module. Connects diagnostic catheters to the EnSite™ Amplifier.

SJM ECG cable. Connects standard ECG electrodes to the EnSite™ Amplifier.

RecordConnect. Connects a recording system to the EnSite™ Amplifier without the need for jumpers. A different RecordConnect model is required for each make of recording system.

GenConnect. Connects the ablation catheter and dispersive surface electrodes to the EnSite™ Amplifier. It isolates the EnSite™ Velocity™ Cardiac Mapping System location signal from being loaded by the ablation generator, thereby eliminating the need for separate dispersive electrode filters. A different GenConnect model is required for each make of ablation generator.

NOTE: GenConnect is not necessary when using the Ampere™ Generator.

Display Workstation (DWS)

The DWS consists of the workstation (computer), monitors, medical grade isolation transformer, video extender, media converter, and Ethernet switch.

Workstation. The workstation contains the system software displaying data from the EnSite™ Amplifier. Attached to the workstation are a keyboard and mouse for user input.

Monitors. Monitors are used to display patient information. One monitor is placed near the workstation and keyboard for system operation, and an optional second monitor can be placed near the patient table for use by the physician. The monitors display identical information from the same source.

Medical Grade Isolation Transformer. All system components on the DWS cart are connected to line power through the isolation transformer. Only components of the DWS should be connected to this isolation transformer.

Video Extender. This device splits the video signal so that the same information appears on both of the EnSite™ Velocity™ Cardiac Mapping System monitors.

Media Converter. The Media Converter converts optical signals to digital signals. It connects to the hardware via a Fiber Optic Cable and connects to the DWS via an Ethernet cable and a USB cable, which is used for power only.


System Components


Ethernet Switch. The Ethernet Switch allows users to use multiple modules that require Ethernet connections in conjunction with the EnSite™ Velocity™ Cardiac Mapping System.

Components Not Included

The following components are required for EP studies but are not included with the EnSite™ Velocity™ Cardiac Mapping System.

EnSite™ Array™ Catheter. This noncontact multi-electrode catheter collects cardiac electrical information.

Conventional EP Catheters . These catheters are introduced into the cardiac chamber of interest and placed in contact with the chamber wall.

Surface Electrodes – Six surface electrodes are used for the EnSite™ Cardiac Mapping System.

ECG Electrodes. These industry-standard surface electrodes are placed in a standard 12-lead configuration.

System Reference Surface Electrode. A system reference surface electrode is required for all EnSite™ ArrayLink™ Module and EnSite™ NavX™ Navigation and Visualization Technology studies. This surface electrode should be suitable for defibrillation or electrosurgery, such as the Valleylab™ Single Use Patient Return Electrodes (see below).

Figure 2. Valleylab™ Single Use Patient Return Electrode

A system reference surface electrode is included in the EnSite™ Velocity™ Surface Electrode Kit.

Printer. An optional printer is available for printing images and waveforms.

Remote Monitor. The Remote Monitor can be purchased separately. This monitor is typically used in the Patient area of the lab, where the DWS may only be available in the control room.


EnSite™ Cardiac Mapping System Diagram 17EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


EnSite™ Cardiac Mapping System Diagram

Typical EnSite™ Velocity™ Cardiac Mapping System Lab Setup

Figure 3. EnSite™ Velocity™ System fixed installation (preferred installation for new labs).


EnSite™ Cardiac Mapping System Diagram


Signal and Power Connections

EnSite™ Velocity™ Display WorkStation (DWS) Connections

Figure 4. Signal and power connections for an EnSite™ Velocity™ Cardiac Mapping System configuration.

CAUTION: Non-Patient environment system components are not suitable for use within the patient environment where intentional or unintentional contact can occur between a patient and these components or between a patient and other persons touching parts of these components


Warnings and Cautions 19EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Warnings and Cautions

WARNING: A warning contains information for avoiding hazards that represent a significant hazard to the patient or operator. Warnings are also used for hazards that could significantly harm the EnSite™ Velocity™ Cardiac Mapping System.

CAUTION: A caution contains information for avoiding hazards to the system components or improper system performance.

Operator Requirements. The EnSite™ Velocity™ Cardiac Mapping System must be operated by, or under the supervision of, an electrophysiologist trained in the operation of the EnSite™ Velocity™ Cardiac Mapping System and supported by other qualified personnel trained in the field of cardiac EP. It must be used in conjunction with other equipment required for electrophysiology studies such as suggested by the North American Society of Pacing and Electrophysiology1 (a.k.a. Heart Rhythm Society) and the American Heart Association2.

Support Equipment. The EnSite™ Velocity™ Cardiac Mapping System is not intended for use as a primary ECG monitor. During EnSite™ Velocity™ Cardiac Mapping System studies, an ECG monitor that conforms to safety requirements defined in IEC 60601, designated as the primary ECG monitor, must be present.

Connections to non-EnSite™ Velocity™ Cardiac Mapping System equipment. Observe the following:

CAUTION: Sudden impedance changes of the body or catheter electrodes caused by the connection of other devices (e.g., stimulator, defibrillator, and other devices) may create a location shift.

■ Do not modify or make any additional connections to the EnSite™ Velocity™ Cardiac Mapping System, other than those described in this manual.

■ Do not connect the system to multiple portable socket outlets or extension cords.

CAUTION: Do not modify the operating system (OS) or system settings.

WARNING: Installing an un-approved operating system or software on the EnSite™ DWS hard drive may severely affect system performance and device safety.

Patient Safety. Observe the following:

WARNING: For patient safety, any connections that directly connect the patient to the EnSite™ Velocity™ Cardiac Mapping System must be routed through the appropriate module: NavLink, ArrayLink, CathLink, SJM ECG Cable, RecordConnect, or GenConnect.

CAUTION: The EnSite™ Array™ Catheter is intended for single use only. Device integrity will be compromised by any reuse, which may compromise patient safety and system performance.

CAUTION: The EnSite™ Velocity™ Surface Electrode Kit is intended for single use only. Device integrity will be compromised by any reuse, which may compromise patient safety and system performance.

■ Do not touch non-medical equipment and the patient at the same time.

Damaged Cables. Between studies, inspect cables for insulation or connector damage. Replace damaged cables immediately.

Validating the EnSite™ Array™ Catheter. Always have the EnSite™ Array™ Catheter inserted into the patient before validating the catheter in the software.

1. Waldo, AL, et. al, “NASPE Policy Statement: The Minimally Appropriate Electrophysiologic Study for the Initial Assessment of Patients with Documented Sustained Monomorphic Ventricular Tachycardia,” PACE, v. 8, pp 918-922, 1985.

2. Gettes, LS, et. al., “AHA Committee Report: Personnel and Equipment Required for Electrophysiologic Testing,” Circulation, v. 69, pp 1219A-1221A, 1984.


Warnings and Cautions


Validating EnSite™ NavX™ Navigation and Visualization Technology. Before validating EnSite™ NavX™ Navigation and Visualization Technology make sure that all connections have been made between the EnSite Amplifier and DWS. Ensure that the EnSite™ NavLink™ Module is connected to the EnSite™ Amplifier and that all EnSite™ Velocity™ surface electrodes have been connected as described. In particular, make sure that the left leg surface electrode is connected to the EnSite™ NavLink™ Module. Validation should be performed as close as possible to creating the first model, map or 3D point.

External Stimulation. When using stimulus inputs on multiple EP systems, use care not to deliver stimulus through multiple paths.

Software Warning Messages. Caution: Always respond to warning messages as soon as possible. Failure to do so may cause an inability to record data or to communicate properly with the EnSite™ Amplifier.

Navigation. Adhere to the following to ensure accurate navigation:

CAUTION: Make all connections between systems before validating EnSite™ NavX™ Navigation and Visualization Technology. Adding or removing connections after validation may affect navigation quality. Additionally, all patient connections to ancillary equipment (e.g. external defibrillators) should be made prior to validation. Connections between systems refers only to SJM-supplied or approved devices.

CAUTION: When the EnSite™ Amplifier is turned off, it can affect ECG signals viewed on the recording system. When the EnSite™ Amplifier is turned off and a recording system is in use, it is recommended that the cables to the EnSite™ Cardiac Mapping System be disconnected from the EnSite™ Amplifier.

WARNING: Do not use Stabilize ABL in situations where the proximal electrodes on the ablation catheter may be covered by a sheath.

CAUTION: (EnSite™ Array™ Catheter studies) If the EnSite™ Array™ Catheter is repositioned or unintentionally moved, a new model must be created. If a new EnSite™ Array™ Catheter is introduced, a new study must be started.

■ For EnSite™ NavX™ Navigation and Visualization Technology studies, a new study must be started if any of the EnSite™ Velocity™ surface electrodes are repositioned.

■ EnSite™ NavX™ Navigation and Visualization Technology studies intending to use Field Scaling must not have electrodes in a sheath during point collection.

NOTE: Using location information from non-functional electrodes may yield unexpected Field Scaling results. This cannot be reversed. However, the use of Field scaling is optional and can be unapplied if unexpected results are seen.

■ Check for and disable non-functional electrodes or electrodes in a sheath before creating a model. Collecting points from non-functioning electrodes or electrodes in a sheath can result in unexpected field scaling results. See “Field Scaling” on page 129 for details.

WARNING: Sudden impedance changes of the body or catheter electrodes caused by the connection of other devices (e.g., stimulator, defibrillator, and other devices), poor patch adhesion or patient movement may create a location shift. Use conventional EP techniques, such as fluoroscopy or inspection of intracardiac electrogram signals, to confirm catheter location.

WARNING: Overlap of cardioversion patches and surface electrode patches may result in patient skin burns.

Noncontact Mapping. Use appropriate techniques when interpreting data from noncontact maps:

CAUTION: When placing bipolar virtual electrodes near the poles of the map, select latitudinal orientations. Failure to do so may cause the electrograms to be computed improperly, resulting in inaccurate traces.

CAUTION: If the high pass filter is set to low frequencies (< 2Hz), signals may be subject to low-frequency baseline drift.

CAUTION: In the caliper measurements for noncontact isochronal maps and Substrate Mapping, do not use portions of the waveform display that have purple waveforms.

CAUTION: If the EP catheter electrode is not in contact with the endocardium, the comparison between the EnGuide virtual electrogram and the EP catheter electrode may not accurately reflect the relationship between these signals.

CAUTION: Do not disconnect the Array Module from the EnSite™ ArrayLink™ Module or the EnSite™ ArrayLink™ Module from the EnSite™ Amplifier during a study.


Warnings and Cautions 21EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Shutting Down the Workstation. To shut down the workstation, always follow the instructions in “Ending a Study” on page 203.

WARNING: If the workstation is powered off by the user, rather than shutdown by the operating system, data on the hard drive may become corrupted and the EnSite™ Velocity™ Cardiac Mapping System may cease to be operational.

Removable CD/DVD Handling. CD/DVDs must be handled with care. Do not allow CD/DVDs to fall onto a hard surface. Do not place paper labels on the CD/DVD, write directly on the CD/DVD.

Surface Electrodes. Use care in applying and removing surface electrodes (ECG, system reference, EnSite™ Velocity™ surface electrodes):

CAUTION: Ensure that surface electrodes and associated connectors do not contact one another, electrical ground, or metallic objects.

CAUTION: Do not attempt to connect the system reference surface electrode for the EnSite™ Velocity™ Cardiac Mapping System to other equipment, such as ablation systems.

CAUTION: The system reference surface electrode must be the first patient electrode connected to the EnSite™ Amplifier at the beginning of a study, and the last patient electrode to be disconnected at the end of the study.

CAUTION: When removing the system reference surface electrode from the patient’s abdomen, disconnect the patch from the patient before disconnecting its jack from the EnSite™ NavLink™ Module.

CAUTION: Do not warm the ECG surface electrodes before they are positioned on the patient.

CAUTION: Do not warm the EnSite™ Velocity™ surface electrodes before they are positioned on the patient.

CAUTION: Do not warm the system reference surface electrode before it is positioned on the patient.

WARNING: Do not use surface electrodes if the package seal is broken, the conductive adhesive is dry, or the “use by” date has passed.

WARNING: Before applying the EnSite™ Velocity™ surface electrodes, ensure that the application sites are hair-free, clean, and dry. Dryness is particularly important if the preparation agent is flammable or a potential skin irritant.

WARNING: Before applying the System Reference surface electrode, ensure that the application site is hair-free, clean, and dry. Dryness is particularly important if the preparation agent is flammable or a potential skin irritant.

Liquids . System components are susceptible to damage from liquids. Keep liquids away from this equipment.

Sterilization and Cleaning. Keep this in mind:

CAUTION: Do not clean the system components with disinfectants that contain surfactants.

CAUTION: Do not clean system components with bleach.

CAUTION: Do not apply cleaners while the system is warm to the touch.

CAUTION: Do not sterilize system components.

CAUTION: Do not sterilize EnSite™ Velocity™ Cardiac Mapping System interconnect cables.

CAUTION: Do not immerse system components in liquid.

CAUTION: Do not use aerosol sprays near the equipment as these sprays can damage circuitry.

CAUTION: Do not leave cable connectors where they can be damaged, particularly on the floor, where they can easily be stepped on and damaged.

CAUTION: Pull connections apart by gripping the connector. Do not pull them apart by tugging on the cable as this can damage the connecting cable. Never force a connection or a disconnection.


Best Practices and Recommendations


Hardware Disposal. The EnSite™ Velocity™ Cardiac Mapping System contains electronic printed circuit board assemblies that may contain lead-based solder. Disposal of the equipment must be in accordance with local laws.


Operating Environment. Ensure that the following requirements are maintained:

■ To protect the privacy and security of sensitive information, including protected health information (PHI), the system should be located in a secured environment.

■ All system connections are in place, securely fastened, and functional.

■ Proper grounding and patient isolation standards are maintained.

■ Cables from catheters connected directly to the patient are placed to avoid inadvertent damage or unintentional movement.

■ Proper support equipment (e.g., defibrillation unit, ECG monitor, etc.) is on site for immediate response to patient distress.

■ Proper ventilation is present. The system components are not suitable for use in the presence of flammable gases, including flammable anesthetic mixtures.

NOTE: Refer to “Technical Specifications” on page 241 for specific environmental electromagnetic specifications and recommendations.

NOTE: Activate security settings, individual user logins, and passwords per the Administrators Guide For the EnSite™ Cardiac Mapping System.

Power Sources. Adhere to the following requirements for power sources:

■ Use properly grounded power outlets with appropriate circuit breaker ratings:

– Workstation and monitors: at least 8.0A at 110V , at least 4.0A at 230V .

– EnSite™ Amplifier: at least 4.0A at 110V , at least 2.0A at 230V .

■ The EnSite™ Amplifier should be turned on and allowed to run for at least 30 minutes before beginning a study.


Best Practices and Recommendations 23EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Compatible Components. The EnSite™ Velocity™ Cardiac Mapping System has been tested to meet the safety requirements of IEC 60601-1 (refer to Table 35 on page 242). Use of components other than those specified by St. Jude Medical cannot be guaranteed to perform as intended. These components have been tested to meet safety requirements:

■ EnSite™ Velocity™ Display WorkStation (DWS)

■ EnSite™ Amplifier

■ Hospital grade power cord

■ RecordConnect

■ GenConnect

■ CathLink™ Module

■ ArrayLink™ Module

■ NavLink™ Module

■ SJM ECG Cable

■ EnSite™ Array™ Catheter

■ Fiber optic cable

■ EP WorkMate™ System 4.3.x

■ WorkMate Claris™ System 1.x

■ GE CardioLab

■ Bard ClearSign

■ Siemens AXIOM Sensis XP

■ EnSite™ Velocity™ Surface Electrode Kit

Compatible ModulesThe EnSite™ Velocity™ Cardiac Mapping System is compatible with the following software modules:

■ AutoMark Module

■ EnSite™ AutoMap Module

■ EnSite™ Contact Force Module





Using the Graphical User Interface

CHAPTER 2

Operating Modes

The EnSite™ Velocity™ Cardiac Mapping System can operate in two modes: Realtime and Offline Review. The operating mode determines which system functions are available.

■ Realtime mode allows data to be gathered, displayed, and recorded simultaneously while a patient is being studied. Patient connections to the EnSite™ Velocity™ Cardiac Mapping System Amplifier are required, and the EnSite Amplifier must be powered on.

■ Offline Review mode allows data from a previous study to be viewed and edited. The EnSite Amplifier does not need to be connected or powered on.

The functions available in Offline Review mode are more limited than those available in Realtime mode. Table 1 on page 25 describes the functions that are available in Realtime mode and Offline Review mode.

Table 1. Functions available in Realtime mode and Offline Review mode.

Task Realtime Offline Review

Setup All • Shows a historical view of the study setup. • If viewing a segment or bookmark, shows the setup at the time

of capture. • If viewing the static items (Model View, Images, or

Animations), shows the final state of the setup.• Review the ECG signals and adjust the controls.• Shows the catheters and traces used during the study.• Select which catheters are visible.

Model All • Change surface colors, names, and visibility. • Surface editing functions are not available.

Mapping Primary & Secondary View: Left Primary pane shows the realtime study. Right Secondary pane shows either Realtime or Review. (When Split Screen is active.)

• Open maps.• Review map points.• Collect points from the recorded catheter signal.

Therapy All • Review therapy data.• Modify lesions.

Real Review

• In Realtime mode, the Real Review task allows recorded data from the study to be viewed.

• Primary & Secondary View: Left Primary pane shows the realtime study. Right Secondary pane also shows the realtime study. You can switch between realtime and recorded information.

• In Offline Review mode, the Review task allows recorded data from a past study to be viewed and edited.

• Primary & Secondary View: Left pane shows recorded data from the past study selected in the Title screen. Right pane shows a different view of the recorded data from the same past study.

Status Bar Blue Brown

26 Chapter 2. Using the Graphical User Interface

Main Workspace


Main Workspace

Figure 5. The main workspace (the EnSite™ NavX™ Navigation and Visualization Technology Model workflow is shown here).

Table 2. Horizontal Split Screen Mode Elements

Callout Item Description

A Menu Bar Provides access to system-level controls. For more information, refer to “Menu Bar” on page 27.

B Task Bar Provides access to the five workflow tasks: Setup, Model, Mapping, Therapy, and RealReview (Note, when in Offline Review mode, the RealReview task button reads just Review). When selecting a task, the right-hand control panel changes to provide controls and settings relevant to the task. Each task may have sub-tasks.

C Subtask Bar Most workflow tasks have subtasks. For example, the Setup task has ECG, Catheter, and either EnSite™ NavX™ Navigation and Visualization Technology or Array™ Catheter subtasks. In Figure 5 the Model subtasks shown are Model, DIF and Fusion (with EnSite™ NavX™ Navigation and Visualization Technology). When a subtask icon is selected, the control panel changes.

D Active EnGuide Select the Active EnGuide.

E Active Electrode Select the Active Electrode on the Active EnGuide.

F Tool Bar Provides access to settings for the selected tool.

G Split Screen View Switches between single and split screen views. Display two maps, each generated with a different set of mapping points. The primary display contains the live map, while the secondary can display the same map, a second live map generated with different mapping points, or a Review map. See “Split Screen” on page 36 for more information.

H Single/Dual View Toggles between single and dual map views. Refer to “Dual View” on page 35 for more information.

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Chapter 2. Using the Graphical User Interface

Common Controls 27EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


NOTE: Primary Monitor: a 24-inch wide-screen monitor (1920x1028 resolution) should always be used as the primary monitor. The DWS will automatically configure this monitor to display the system’s full screen view.

Remote Monitor. The remote monitor is available as either a 21-inch monitor (1600x1200, 4:3 aspect ratio), 24-inch wide-screen monitor (1920x1200, 16:10 aspect ratio), or 23-inch monitor (1920x1080, 16:9 aspect ratio).

The EnSite™ Velocity™ Cardiac Mapping System uses a video extender to transmit a video signal from the DWS to the remote monitor over a fiber-optic cable. Refer to “Connecting the Remote Monitor to the DWS” on page 52 about how to connect the remote monitor to the DWS.

Common Controls

Menu Bar

The menu bar provides access to system-level controls. All active menu bar and menu options for the current operating mode are displayed in white lettering. Options not available for the current operating mode are shown in gray lettering. Selecting a menu will display a column of additional options. Menu options followed by three periods “...” will display a window when selected.

The menu bar can also be accessed using the keyboard. Notice that each of the menu names in the menu bar has one letter underlined. Hold the <Alt> key and press the key that corresponds to the underlined letter. For example, hold <Alt> and press <F> to access the File menu.

NOTE: The underlined letters in the menu bar will be different, dependent on the translated language.

I Orientation Reference

Shows the orientation of the map/model DIF.

J Orientation Toolbar Provides one-click orientation of the map/model DIF.

K Control Panel Each task or subtask has its own control panel that displays the controls applicable to the task.

L Tool Palette The tools that are available depend on the task that is enabled and the state of the procedure. Only one tool can be selected at a time from the palette. For more information, refer to “Tool Palette” on page 29.

M Model/Map Display The area where catheters, three-dimensional models, and/or maps are displayed.

N Waveform Display The waveform display area.

O Status Bar The status bar contains icons that indicate the status of various system components, as well as system information.

P Bedside View Depending on the system setup, this control adjusts the bedside monitor display, so that different parts of the workspace may be brought into view. This control will be present only if a remote monitor with a display of 1600 x 1200 (21inch) or less is part of the system setup.An abbreviated view of the EnSite™ Velocity™ Cardiac Mapping System displays because the lower resolution of the 21-inch bedside monitor can display only a portion of the higher resolution primary monitor.• By default, the left portion of the primary monitor containing the model/mapping workspace displays on the bedside

monitor.• The Bedside View button enables you to toggle the bedside monitor to display the left side (model/mapping) or the

right side (control panel) of the primary monitor screen.• The Bedside View button can only be controlled in the lab or control room where the lab technician has access to

the mouse.

Q Control Panel Show/Hide Control Panel Toggle.



Figure 6. The menu bar.


Common Controls


The menu bar contents are described in Table 3 on page 28.

Table 3. Menu bar description.

Menu Submenu Function

File Study/Patient Information Displays the Study and Patient Information screen.

Save Bookmark... <Ctrl> + <B> Create and save a bookmark to the notebook. (Review mode only.)

Save Image... <Ctrl> + <Print> Capture and save still images.

Save Event... <Ctrl> + <E> Create and save a timestamped comment to the Notebook.

Save Animation... Capture and save either MPEG movies or a series of JPEG images

Load DIF Import a three-dimensional model created from digital images collected from Spiral CT or MRI for display in the EnSite™ Velocity™ Cardiac Mapping System for display. See “Digital Image Fusion (DIF)” on page 130 for more details.

Eject External Media Eject the CD/DVD.

Resume Study Initiates the continuation of a previous study. Available in Offline review mode only.

End Study <Ctrl> + <Q> End the current study and Logout.

Amplifier Settings... Access EnSite™ Amplifier controls:• Saturation Recovery• Power Line• RecordConnect• References

Log... Access the EnSite™ Amplifier log.

Reconnect Initiate communication between the DWS and EnSite™ Amplifier. (Realtime mode only.)

Reset Amplifier Reset and test the EnSite™ Amplifier.

Validate... Initiate the use of the EnSite™ Array™ Catheter or EnSite™ NavX™ Navigation and Visualization Technology surface electrodes. (Realtime mode only.)

HotKeys Synchronize Split Screen <F3> Synchronizes the two screens so that both models pan, zoom, rotate, spin, and change perspective together.

Record <F4> Record/Stop recording.

EnGuide Enabled <Shift> + <F5> Turn on/off the EnGuide navigation system.

Add Lesion at EnGuide <F6> Add a lesion at the Active Electrode.

Add 3D Lesion at EnGuide <Shift> + <F6> Add a 3D lesion at the Active Electrode.

Saturation recovery <F8> Initiate saturation recovery.

Freeze and Save <F11> Freeze and save a mapping point.

Cancel <F12> Discard the collect point.

Step Forward <right arrow> Moves the cursor to the right (forward)

Step Backward <left arrow> Moves the cursor to the left (backward)

Help Quick Help Display a list of quick actions and shortcuts.

About Display hardware and software version information, copyright information, notable features, and known issues.




Tool Palette

The tool palette is shown in Figure 7. The available tools depends on the active task. The properties for a selected tool display in the toolbar.

Table 4. Tool Palette


A Layout Preset Recall setting preferences for layout presets (see “Screen Layout Presets” on page 39).

B Magnifying Glass

Centers the model back into view, if it is beyond the borders of the screen.

C Rotate/Pan The Rotate/Pan (hand) tool is used to rotate the model or map.

D Arrow Used for selection.

E Label Used to annotate a model or map. For more information, refer to “Labels” on page 147.NOTE: The labels have no intrinsic meaning to the EnSite™ Velocity™ Cardiac Mapping System. Users can assign their own meaning to labels.

F Anatomic Marker

Used to create anatomic markers. For more information, refer to “Anatomic Markers” on page 149.

G Tape Measure Used to create tape measures. For more information, refer to “Tape Measures” on page 156.

H Lesion Used to create lesions. For more information, refer to “Lesion Markers” on page 190.

I Virtuals (EnSite™ Array™ Catheter studies only) Used to place virtual electrodes on noncontact maps. For more information, refer to “Virtuals” on page 161.

J EnGuide Shadow

Used to place a shadow on the selected EnGuide. For more information, refer to “EnGuide Shadows” on page 152.

K Add a Caliper Add a timing caliper.

L Cleanup Display

Toggle: Show/Hide meters and controls in the Model/Map display area.

M Meter Displays

Clicking this icon displays a list of checkboxes that control the display of:• Velocity Meter (EnSite™ NavX™ Navigation and Visualization Technology only)• Velocity Filter (EnSite™ NavX™ Navigation and Visualization Technology only)• Respiration Meter (EnSite™ NavX™ Navigation and Visualization Technology)• Voltage Caliper• Tracking Virtual (ArrayLink™ Module only, RealReview)• Electrode Spacing (EnSite™ NavX™ Navigation and Visualization Technology only)• Proximity to Surface (realtime only)• Velocity Lockout Slider (EnSite™ NavX™ Navigation and Visualization Technology only)• Collect Respiration Data (EnSite™ NavX™ Navigation and Visualization Technology only).For more information, refer to “Information Display Settings” on page 143.NOTE: In an EnSite™ Array™ Catheter study, Velocity Filters, Meter Threshold, and Lockout Settings are not available.

N EnGuide Displays

Displays a list of checkboxes that control the EnGuide Display options, including Show EnGuides, Electrode Numbers, Active EnGuide Silhouette, Stabilize ABL, and a slider control for EnGuide Responsiveness. For more information, refer to “EnGuide Display Settings” on page 142.

O Display Settings

Map Settings Properties (see “Map Settings Properties” on page 141)

P Waveform Display

Filters/Waves properties used to control the filter settings for the waveforms and the settings used for manipulating the displayed waveforms.

Q Detection Settings

Configure signal detection settings (see “Signals Collection” on page 173).

Figure 7. Tool palette.

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Common Controls


Selecting Map Tags on the Model or Map

Map Tags include labels, anatomic markers, tape measures, lesion markers, and EnGuide shadows.

To select Map Tags in the Tool Palette:

■ To select a Map Tag, click on the tool in the Tool Palette, hold down <Shift>, and then click on the Map Tag’s name.

■ To select multiple Map Tags of the same type, click on the tool in the Tool Palette, hold down <Ctrl>, and then click on the each Map Tag. Alternatively, click on the tool in the Tool Palette, hold down <Shift> or <Ctrl>, hold down the left mouse button, and drag a box around the Map Tags.

■ To deselect a Map Tag, hold down <Shift> and click away from the Map Tag’s name.

NOTE: When a Map Tag is selected, the color of its name changes to white or red in the model/map display area.

NOTE: Multiple Map Tags can only be selected if they are of the same type (such as labels, anatomic markers, tape measures lesion markers, and EnGuide shadows).

To select Map Tags in a list:

■ To select a single Map Tag in the list, click on the Map Tag in the list.

■ To select multiple Map Tags in the list, hold down <Ctrl> and click on each Map Tag.

■ To select multiple consecutive Map Tags in the list, hold down <Shift>, click on a Map Tag, and then click on another Map Tag. Alternatively, click on a Map Tag and drag to select additional consecutive Map Tags.

NOTE: When a Map Tag is selected, the color of its name changes to white in the model/map display area.

Using the Mouse

Basic Mouse Actions

The following terms are used to describe ways to use the mouse:

■ Click – Move the mouse pointer over a specified feature and press the left mouse button once and release.

■ Right-click – Move the mouse pointer over a specified feature and press the right mouse button once and release to display a context-sensitive menu.

■ Double click – Move the mouse pointer over a specified feature and quickly press and release the left mouse button twice.

■ Drag – Press and hold a mouse button, move the mouse, and release the button.

■ Select – “Select” is a generic term for selecting a specified feature by using the mouse. “Select” could refer to a single click on an object, such as an on-screen button, choosing text from a list of options, or it could refer to clicking on an item in the menu bar, highlighting a selection in the menu and clicking again.




Rotating, Panning, and Zooming

Use the mouse to rotate, pan, and zoom a model/map:

■ To rotate the model/map in any direction, use the middle mouse button to click and drag in any direction. Alternatively, select the Hand tool on the Tool Palette and then left click and drag in any direction.

■ To rotate the model/map clockwise or counterclockwise, hold down <Ctrl> or <Alt> and middle-click and drag clockwise or counterclockwise. Alternatively, select the Hand tool on the Tool Palette, hold down <Ctrl> and click and drag clockwise or counterclockwise.

■ To pan (move vertically and horizontally) the model/map, hold <Shift>, middle-click, and drag. Alternatively, select the Hand tool on the Tool Palette, hold down <Shift>, and then click and drag. In Dual View, panning works independently for each model/map.

■ To zoom the model/map in and out at the mouse pointer position, hold down <Shift> and rotate the mouse middle wheel or select the menu item in the Map Settings menu. In Dual View, zooming works independently for each model/map, unless synced/F3 is active.

Use keyboard keys

■ “A” and “D” rotate the view about the torso’s vertical axis.

■ “W” and “S” tip the view forward and backward about the torso’s horizontal axis (through its left and right sides).

Selecting and Adjusting Waveforms

Use the mouse to select and adjust waveforms:

NOTE: This does not apply to waveforms while in the Mapping task.

■ To add a temporary isoelectric line, left-click and hold on the waveform.

■ To add a permanent isoelectric line to a waveform, select the waveform, hold down <Shift> and left-click on the waveform.

■ To move a waveform, left-click on the waveform and drag up or down.

■ To remove a waveform from the waveform display, left-click on the waveform and drag it off the left edge of the screen.

■ Waveforms of a specific signal type are ganged so the amplitude for all will be adjusted. To adjust the amplitude of all waveforms, middle-click on the waveform and drag up or down to increase or decrease the amplitude.

■ To adjust the amplitude of a single waveform, hold down <Shift> then middle-click and drag the waveform up or down.


Common Controls


Common Interface Elements

The interface is controlled by using the mouse and keyboard to manipulate the information that appears on the display. Figure 8 on page 32 shows examples of the types of controls that are common throughout the interface.

A. Button. Click a button to initiate the action described by the button’s label. Buttons are referred to in the text with the button’s label in brackets, such as “Click [OK] to continue.” Some labels on buttons will change to reflect the buttons role in a process. For example, in the Mapping control panel, clicking the propagation map [Play] button changes the button to [Stop]. When the [Stop] button is clicked, it changes to [Play]. The following buttons commonly appear at the bottom of windows:

■ [OK] – When clicked, all the settings in the window are accepted, the required actions are performed, and the window closes.

■ [Apply] – When clicked, all the settings in the window are accepted, the required actions are performed, and the window remains open.

■ [Cancel] – When clicked, settings that have not been applied are ignored, and the window closes, without implementing changes.

■ [Close] – This button appears in windows with controls that take effect as soon as they are selected. When clicked, the window closes.

B. Checkbox. The item is selected when either a white check mark ✓ or ✕ is shown in the box. When the box is empty, the item is not selected. Click the checkbox to select or unselect the item.

C. Drop-down menu. Click the down arrow to display a list of choices.

D. Tab. Click on a tab to display the appropriate panel (i.e., Settings, Points).

E. Slider. Click and drag the bar to change the value. In some cases, the value is displayed to the right of the slider.

F. Radio Button. Click to select only one in a series of radio buttons.

Interface Text. Interface text is shown in this document as a bold sans-serif font.

Lists. Lists display information that can be selected by clicking with the mouse. If a list contains more information than will fit in the list, scrollbars appear on the right or bottom edge of the list. Click and drag the scrollbars to move the information in the list.

■ Select contiguous multiple items from a list by clicking and dragging in the list or by clicking one item, pressing <Shift>, and then clicking another item to select all items in between.

■ Select multiple individual items from a list by hold down <Shift> while clicking on items in the list.

Text areas. Text areas are for typing text using the keyboard. To use a text area, click on the text area to display a cursor. Then, use the keyboard to type information into the text area.

NOTE: In the Toolbar area only, when typing in new names (e.g., labels, markers, shadows), the area behind the text turns a pale yellow color. This is a reminder that the text entry is not complete until <Enter> has been pressed.

Keyboard keys. Keys on the keyboard are represented by the text that appears on the key in angled brackets, such as <Shift>.

Figure 8. Common Controls.

A

B C

DE

E

E

EF

B




Mapping Control Panel Settings

NOTE: Refer to chapters “Mapping – Contact” on page 171 and “Mapping – Noncontact” on page 159 for information about map types.

When the Mapping task is selected, the Mapping Settings appear in the control panel on the right side of the main workspace. You can save these settings as “Presets” when you anticipate using a particular setting often for future setups.

When Split Screen is active, the settings apply to the display that has focus, which is highlighted with a yellow border.

A. Active map name: Name of the map that has focus (yellow border). Double-click the name to rename the map.

B. (Cardiac Triggered map settings)

■ Unipole/Bipole display. Only available if peak-to-peak or peak negative voltage maps are selected.

■ Cardiac Triggered Reference ( (on) for LAT)

■ Current Map (LAT, Peak-to-Peak, Peak-Negative, CFE Mean, CFE Std. Dev)

■ Project Map to: Select the surface group you want to project the map to.

NOTE: At least one LAT point must be mapped and saved in order for Peak-to-Peak, Peak-Negative, and CFE Mean options to become available.

C. Settings

– Low-V ID slider

– Map Display (Standard LAT, Reentrant Map, Propagation Map, [Play])

■ Map Display (Standard LAT, Reentrant Map, Propagation Map)

D. Map Appearance slider controls (Interior Projection, Exterior Projection, Interpolation)

■ Use Last Duplicate

■ Use Best Duplicate

■ Points/Labels (Show Selected Points Only, 3D Points, 3D Labels, 3D Annotations, Surface Points, 3D Annotations, Flash New Points)

■ Appearance (Auto Color, Show HR/CL)

Complex Fractionated Electrograms (CFE) map settings

B. (Non Cardiac Triggered map settings)

■ Cardiac Triggered Reference ( (off) for CFE)

– Current Map (CFE Mean, CFE Std Dev)

C. Settings

– Low-V ID slider

– Fractionation Threshold checkbox

– Width slider

– Refractory slider

– Segment Length slider

Figure 9. Mapping control panel for non-cardiac triggered map

settings.

AB

C

D


Common Controls


D. Map Appearance slider controls (Interior Projection, Exterior Projection, Interpolation)

– Use Last Duplicate/Use Best Duplicate radio buttons

■ Points/Labels (Show Selected Points Only, 3D Points, 3D Labels, 3D Annotations, Surface Points, Flash New Points)

■ Appearance (Auto Color, Show Mapping Metrics)




Dual View

Dual View allows you to display two views of the same map. Using Dual View with Split Screen mode you can display two views of the same map in either the primary or secondary display, or in both displays.

In Dual View, the active view is highlighted by green corners. To make the other view active, click once on the black background of the non-highlighted view.

The following features are available only for the highlighted, active view:

■ Using the mouse to rotate the model

■ Adjusting the clipping plane

■ Adjusting the view scale

■ Saving or loading a Map View

Using the mouse to delete surface points or place map labels, lesion markers, anatomic markers, tape measures, or virtual electrodes can only be done in the highlighted view; however, the result of these actions appear in both views.

Table 5. Dual View Mode

Callout Description

A Primary View

B Secondary View

C Active View (framed with green brackets)

Figure 10. Dual View Mode

A BC


Common Controls


Split Screen

(Available in all tasks except Setup.)

Split Screen mode allows you to display combinations of Realtime and Review maps, generated with the same or different mapping points. You can:

■ Display the same map side-by-side in Realtime and Review workflows

■ Display two different maps, each generated with the same or different mapping points

■ Display one Realtime map (primary display) and one Realtime or Review map (secondary display)

NOTE: To visualize different screen arrangements, try a different screen layout preset (see “Screen Layout Presets” on page 39).

Manipulating the Windows:

■ The primary map displays on the left and the secondary map displays on the right

■ A yellow border highlights the active display

■ The Control Panel information and controls relate to the active display (the active map name displays at the Control Panel top)

■ Click within the inactive display to make it active

■ Change the size of the displays by dragging the adjustment bar (C) left or right.

Figure 11. Split Screen

A B

C

D

FE

G

H

I




Window Elements


Callout Description

A Primary Display: Click in this display to make it active.

B Secondary Display: Click in this display to make it active.

C Adjustment Bar: Click and drag to resize the display areas.

D Yellow highlight around the active display. The Control Panel works with the active display and shows the active map name (E).

E Name of the active map.

F Toggle between single and split screen mode

G Toggle on or off unipolar map. Available only for Peak-to-Peak and Peak-Negative.

H Mapping waveform display.

I Realtime/Review: Switch between Realtime or Review mode.

Hotkey Hotkey F3 Synchronizes the two screens so that both models rotate and zoom together


Common Controls


Screen Layout Controls

After beginning a study and completing the Setup task, a default window layout displays, including a map display and several configurable blank windows (see Figure 12). You can customize the window contents as follows:

Choose from available content

■ Click the button in the desired empty window to place that content in the window (Figure 12: A).

■ When the content is placed, the button is removed. You can still select different content using the right-click menu of that window.

■ Only one type of content can exist within each display group.

■ If you choose content that exists in a different window, that content is swapped into the selected window.

Split existing windows

The two Split Screen buttons (Figure 12: B) open a second horizontal or vertical display group to the right of the original displays. The layout and content choices will be copied from original displays into the second display group.

NOTE: You can only have one Realtime Waveforms display at a time, even when in Split Screen mode. The second Waveforms display will revert to a blank window showing that the Waveforms content has been selected, and it will fill the window when it can (if the display group is changed to show review data, or the Waveforms display from the other realtime display group is closed).

Close extra windows

■ Click the “X” at the upper-right corner of the window (Figure 12: C) to close the window.

Figure 12. Default Window Layout

B

A

A

A

B

B

C

C

C




Screen Layout Presets

■ The system provides basic display configuration presets that are accessed from the Layout Presets menu. These built-in presets contain a map display and several blank windows to populate as desired.

■ You can also save a custom preset, as well as rename and delete the custom presets

NOTE: A Layout Preset contains the configuration for a single display group. When saving a Layout Preset in Split Screen mode, the preset will contain only the information for the focused display group (outlined with the yellow focus box). When loading a Layout Preset, it will load only into the focused display group.

Figure 13. Screen Layout Presets (Closeup View)

A

B

CD

D


Common Controls


Display Options

The following options are available from the right-click menu in the respective window:

■ Size, location, and content type of each window

■ Stack Waveform Display

– Font Size

– Sweep Speed

– Wave Thickness

■ Acquisition Waveform Display

– Font Size

– High/Low Lines setting (“Show All”, “Show Distal”, or “Hide All”)

– Sweep Speed

– Wave Thickness

■ Map Display

– Active EnGuide Silhouette (Off, Normal, Enhanced)

– CL/Metric display

– Visibility

– Flash for new points on/off

– Electrode spacing visibility

– Font Size

– Proximity Indicator

– Visibility

– Fixed on/off

– Proximity to Surface visibility (text display)

– Respiration Meter visibility

– Tracking Virtual visibility

– Velocity Meter visibility

– Voltage Caliper visibility

Load a Screen Layout Preset

1. Click the Screen Layout Preset button (Figure 13A).

2. Click a pre-defined blank layout, or a saved preset name (if available) (Figure 13 B).

■ The selected screen layout loads.




3. Add or change content in the window:

■ Click a content button (D), in a blank window, or;

■ Right-click in the window and select the desired content from the Window menu selection (Figure 14).

Figure 14. Window Content Right-Click Menu

Save a Custom Preset

1. Configure the screen layout as desired, using the “Screen Layout Controls” on page 38.


3. Select Save Preset option.

4. Enter the name and click OK.

Manage a Custom Preset

This option allows you to rename a preset, as well as add notes or delete the preset.


2. Select the Manage Presets option.

3. Highlight the preset name, and click Rename, Delete, or enter text into the Notes field.

4. Click Close when finished.


System Messages


System Messages

System messages appear near the status tray or on the desktop. The appearance and behavior of each message depends on the severity of the situation. System messages are logged to the system for troubleshooting purposes. There are four types of messages, as shown below.

Information Message

Information messages are non-critical messages that appear temporarily in a blue window above the status tray. They persist for 3 seconds and then fade away. (Figure 15).

NOTE: Access a list of Information and Advisory messages displayed during the study by clicking on the Message Log icon in the status tray in the lower right portion of the screen of Realtime and live studies only.

Advisory Message

Advisory messages appear above the status tray and persist until the user closes the message (Figure 16).

NOTE: Access a list of Information and Advisory messages displayed during the study by clicking on the Message Log icon in the status tray in the lower right portion of the screen of Realtime and live studies only.

System Busy Message

System Busy Messages display when the system is collecting data; during this time the system will be non-responsive to user actions.

Warning Message

Warning messages alert the user of an action that is going to occur and asks the user to verify the action. The message must be acted upon before any other action can be taken on the system.

NOTE: Some warning messages can be disabled by checking the “Do not show this message again” box; once this box is checked and the user clicks OK, the message will no longer display for the remainder of the study session.

Figure 15. Information message.

Figure 16. Advisory message.

Figure 17. System Busy message.

Figure 18. Warning message.


Notebook 43EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Notebook

The Notebook feature is accessible in Realtime and Review.

The section labeled “A” shows study information stored in the Notebook, which can be presented in Order by Type or Order by Time. The section labeled “B” shows labels names and visibility status.

The Notebook contains study information that was saved during a study. This information includes the following:

NOTE: Click on Order by Type / Order by Time to switch from one to the other.

▼ Order by Type

■ Animation

■ Bookmark

■ Mapping

■ Image Sequence

■ Segment

■ Stop Time

■ Auto Segment (System automatically adds)

■ Comment

■ Image

■ Model

■ StartTime

Order by Time

For example:

– Autosegments (#)

– Events (#)

– Segments (#)

– Images (#)

– Bookmarks (#)

– Mapping (#)

– and others....

The Notebook is used to review segments and other events saved during a study. Events are designated under Description and are logged along with the associated Time that the event took place.

Figure 19. The Notebook control panel.

A

B


Notebook


Saving an Event

(Realtime mode and RealReview mode only)

An event can be added to the Notebook to mark important activities (e.g. drug administration). An event is always stamped with the current Realtime clock (not the time cursor, in RealReview mode.)

NOTE: The key sequence for saving an event is <Ctrl> + <E>. The time is stamped when the key sequence is executed.

1. From the menu bar, select File > Save Event. The Save Event window will appear (Figure 20 on page 44).

2. Type the text of the annotation in the text area, and then click [Save].

Saving a Bookmark

(RealReview mode and Offline Review mode only)

Bookmarks create Notebook entries that allow the system to return to a specific time.

NOTE: The key sequence for saving a bookmark is <Ctrl> + <B>. The time is stamped when the key sequence is executed.

1. If the segment is playing, pause it by clicking [ll].

2. From the menu bar, select File > Save Bookmark. The Save Bookmark window will appear.

3. Type the annotation for the bookmark in the text area, and then click [Save].

Figure 20. The Save Event window.


Presets 45EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Presets

Presets can be used in the Setup (Catheters), Model (Surfaces), and Mapping (Controls) tasks to load a predefined set of:

■ EP catheters

■ Model surfaces

■ Mapping controls

■ Screen layouts

Although there are some differences in the use of presets in these three areas, the basic ideas in their use are the same. See Figure 21 on page 45 for examples of model presets.

Load a preset

Open the Preset menu and select a preset from the list. The menu lists all of the available presets, which include not only the active physician but all physicians.

Save a preset

To save the current settings as a preset, open the Preset menu in the upper-right corner of the control panel, select Save Preset, type a name for the preset, in the Name text area then click [OK].

Rename or delete the current physician’s presets

■ Open the Preset menu and select Manage Presets.

■ To rename a preset, select the preset in the list then click the [Rename] button (or double-click on the current preset name) and type a new name in the [Name] text area.

■ Alternatively, double-click on the name in the list and type a new name. A note can also be written in the Note text area.

■ To delete a preset, select a preset in the list then click [Delete]. When renaming or deleting are complete, click [Close].

Figure 21. Using presets.


Presets



External Connections
CHAPTER 3
WARNING: For patient safety, any connections that directly connect the patient to the EnSite™ Velocity™ Cardiac Mapping System must go through the NavLink™ Module, the ArrayLink™ Module, the CathLink™ Module, SJM ECG Cable, RecordConnect, and GenConnect.

EnSite™ Amplifier Connections

Figure 22. EnSite™ Amplifier connections.

Description

The EnSite™ Amplifier accepts signals from the NavLink™ Module, the ArrayLink™ Module, the CathLink™ Module, SJM ECG Cable, RecordConnect, and GenConnect, converts these signals to digital format, and sends them to the workstation for processing. The EnSite™ Amplifier is connected to the workstation through a fiber-optic cable.

A. Status lights.

B. GenConnect connector.

C. EnSite™ NavLink™ Module connector.

D. EnSite™ CathLink™ Module OR RecordConnect connector.

E. SJM ECG Cable OR RecordConnect ECG cable connector.

F. ArrayLink™ Data Module connector.

G. EnSite™ ArrayLink™ Module, EnSite™ CathLink™ Module, or RecordConnect connector.

H. Fiber-optic cable connectors.Note: The physical location of the F.O. cable connections, on the front panel of the EnSite™ Amplifier, may be located on the right side of the panel (as shown) or may be located on the left side of the panel, depending on the hardware configuration installed.

I. Power switch.

J. AC power module with fuse holder.

K. Equipotential ground.

The connections shown in this chapter should only be made after a successful EnSite™ Velocity™ Cardiac Mapping System installation by qualified SJM personnel.

• See Note: for letter “H”

48 Chapter 3. External Connections

NavLink™ Module Connections


NavLink™ Module Connections

Figure 23. NavLink™ Module connections.

ArrayLink™ Module Connections

Figure 24. ArrayLink™ Module connections.

Description

The NavLink™ Module is used to connect EnSite™ Velocity™ surface electrodes and the system reference surface electrode to the EnSite™ Amplifier. The NavLink™ Module is required for both EnSite™ NavX™ Navigation and Visualization Technology and EnSite™ Array™ Catheter studies because it has the system reference surface electrode connector. It also has a connection for an auxiliary unipolar reference electrode.

A. System reference surface electrode connector.

B. EnSite™ Velocity™ surface electrode connectors.

C. EnSite™ Velocity™ left leg surface electrode with integrated Data chip connector.

D. Auxiliary unipolar reference connector.

E. NavLink™ Module Cable to EnSite™ Amplifier.

Description

The ArrayLink™ Module is used to connect the EnSite™ Array™ Catheter and Data Module to the EnSite™ Amplifier.

A. Data Module connector from EnSite™ Array™ Catheter cable.

B. EnSite™ Array™ Catheter cable connector.

C. Cable to EnSite™ Amplifier.

Chapter 3. External Connections

CathLink™ Module Connections 49EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


CathLink™ Module Connections

Figure 25. CathLink™ Module connections.

SJM ECG Cable Connections

Figure 26. SJM ECG Cable connections.

Description

The CathLink™ Module is used to connect diagnostic catheters to the EnSite™ Amplifier. The CathLink Module cannot be used if a RecordConnect is used.

A. Catheter connectors.

B. Cable to EnSite™ Amplifier.

A

C

B

Description

The SJM ECG Cable is used to connect standard ECG electrodes to the EnSite™ Amplifier. Except for Bard Recording Systems, the ECG cable cannot be used if a Record Connect is used.

A. Chest & Limb leads.

B. ECG patch snap connectors.

C. EnSite™ Amplifier Connection.


RecordConnect Connections


RecordConnect Connections

Figure 27. RecordConnect connections.

Description

RecordConnect is used to connect a recording system to the EnSite™ Amplifier. When RecordConnect is used, the CathLink™ Module and the SJM ECG Cable are normally not used.

A different RecordConnect model is required for each make of recording system. The RecordConnect for a particular make of recording system is fitted with the correct number and type of connectors.

A. Cables to the EnSite™ Amplifier.

B. CIM cable connectors. The number and type of connectors depends on the make of the recording system.

C. ECG cable connector.

D. Cables to the recording system. The number of cables and type of connectors on the cables depends on the make of the recording system.


GenConnect Connections 51EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


GenConnect Connections

Figure 28. GenConnect connections.

Connecting the EnSite™ Amplifier to the DWS

Use the fiber optic cable to connect the DWS to the EnSite™ Amplifier. Take one end of the fiber-optic cable and align the tabbed edge of the connector on the cable to the slotted edge of the connector on either port of the EnSite™ Amplifier, and press it into place. Take the other end of the fiber optic cable and connect it to the Media Converter in the same manner.

If, for any reason, the DWS and EnSite™ Amplifier must be disconnected, be sure to disconnect the fiber optic cable from the EnSite™ Amplifier and the Media Converter and store it in a safe place.

Connecting the Local Monitor to the DWS

The local monitor is connected to the DWS using a digital video connector cable Connect one end of the cable to the digital video connector on the back of the DWS, and connect the other end to the connector on the rear of the monitor. Hand-tighten the connector thumb screws at each end.

Description

GenConnect is used to connect the ablation catheter and dispersive surface electrodes to the EnSite™ Amplifier. It isolates the EnSite™ Velocity™ Cardiac Mapping System location signal from the ablation generator.

A different GenConnect model is required for each make of ablation system. The GenConnect for a particular make of ablation system is fitted with the correct type of connectors and is supplied with interconnect cables with the correct connectors for connecting to the ablation system. All GenConnect models use the same interconnect cable to connect GenConnect to the EnSite™ Amplifier.NOTE: A GenConnect is not needed when using an Ampere™ RF generator.

A. Dispersive patches IN connectors. The type of connector depends on the make of the ablation system.

B. Ablation catheter IN connector. The type of connector depends on the make of the ablation catheter.

C. Ablation catheter OUT connector.

D. Dispersive patches OUT connector.

E. Cable to the EnSite™ Amplifier.


Connecting the Remote Monitor to the DWS



The remote monitor is connected to the DWS by means of a video extender. Two type of video extenders available: Opticis and Avenview. The procedure used to connect the remote monitor to the DWS depends on the video extender being used. Refer to one of these procedures:

■ “Opticis Video Extender” on page 52.

■ “Avenview Video Extender” on page 54.

Opticis Video Extender

The Opticis video extender consists of two components: one is labeled MONITOR(Rx) and connects to the remote monitor; the other is labeled COMPUTER(Tx) and connects to the DWS. Each component is powered by its own 5V DC power adapter. The two components are connected to each other by means of an LC connector fiber optic cable.

Follow these steps to connect the remote monitor to the DWS.

1. Connect the MONITOR(Rx) video extender to the remote monitor (see Figure 29 on page 52):

a. Connect one end of the fiber optic cable to the MONITOR(Rx) video extender, and the other end to the COMPUTER(Tx) video extender.

b. Plug the 5VDC Power Adapter into a power source and then into the video extender. The blue LED will illuminate.

c. Connect the MONITOR(Rx) video extender to the remote monitor’s DVI input connector. (See Figure 29.)

Table 7. Remote Monitor Connections

A DVI Input

B Video Extender — MONITOR (Rx)

C Fiber Optic Cable

D 5V DC Power Cable Figure 29. Remote Monitor Connections.


Connecting the Remote Monitor to the DWS 53EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


2. Connect the COMPUTER(Tx) video extender to the workstation:

a. Plug the 5VDC Power Adapter into a power source and then into the video extender. The blue LED (C) will blink twice, then remain lit.

– Connect the DVI converter cable to the COMPUTER(Tx) video extender, then connect the DVI converter cable (E) to the display port on the workstation (F).

3. Start the workstation. The same video should display on both the Primary Monitor and on the Remote Monitor.

4. Follow the steps in “Using the Remote Monitor Configuration Tool” on page 56 to configure the remote monitor.

NOTE: Avoid wear and tear on the fiber optic video cable connections by only handling the (Opticis) video extenders by the black chassis. Avoid repeatedly disconnecting and re-connecting the fiber optic video cable connectors.

Table 8.

Figure 30. Workstation Remote Monitor Connections.

A 5V DC Power Cable

B Fiber Optic Cable

C Blue LED

D Opticis Video Extender

E DVI Converter Cable• Plug into the Display Port labeled “REM”, next to the arrow symbol

F Display Port

Figure 30. Opticis Video Extender and Workstation Remote Monitor Connection.

F

BA

DC

E




Avenview Video Extender

The Avenview video extender consists of two components: one is labeled MONITOR and connects to the remote monitor; the other is labeled COMPUTER and connects to the DWS. The two components are connected to each other by means of a fiber optic cable.

The Avenview COMPUTER video extender must be configured for use with the remote monitor before first use. Whenever the model of the remote monitor is changed, the Avenview COMPUTER video extender must be reconfigured.

Follow these steps to connect the remote monitor to the DWS:

1. Configure the COMPUTER video extender:

a. Power on the Remote Monitor.

b. Connect the COMPUTER video extender to the Remote Monitor’s DVI input.

c. Plug the 5VDC Power Adapter into the COMPUTER video extender. (See Figure 31).

d. Observe the red LED on the Video Extender. It should turn on immediately after the 5VDC Power Adapter is connected, turn off momentarily, then turn back on. This sequence indicates that the Video Extender has read the data that it needs from the Remote Monitor to allow the Workstation to correctly identify the Remote Monitor’s characteristics.

e. Disconnect the 5VDC Power Adapter from the COMPUTER video extender, and then remove the video extender from the Remote Monitor.

2. Connect the MONITOR video extender to the remote monitor (see Figure 32):

a. Plug the 5VDC Power Adapter into a power source and then into the video extender.

b. Connect the video extender to the remote monitor’s DVI input connector.

3. Connect the DVI converter cable to the COMPUTER video extender, then connect the DVI converter cable (D) to the workstation display port (E). (See Figure 33 on page 55.)

4. Connect one end of the fiber optic cable to the MONITOR video extender, and the other end to the COMPUTER video extender.

Table 9.

Figure 31. Configuring the COMPUTER Video Extender.

A DVI Input

B Video Extender — COMPUTER

C Red LED

D 5V DC Power Cable

E Fiber Optic Cable

Table 10.

Figure 32. Remote Monitor Connections.

A DVI Input

B Video Extender — MONITOR

C Red LED

D 5V DC Power Cable

E Fiber Optic Cable

A

D

B

E

C

Figure 31. Configuring the COMPUTER Video Extender.

Figure 32. Remote Monitor Connections.


Connecting the Remote Monitor to the DWS 55EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


5. Be sure to connect the same color to each connection (either both black or both red).

6. Restart the Workstation. The same video should display on both the Primary Monitor and on the Remote Monitor.

NOTE: If the Remote monitor fails to display properly after the reboot, refer to “Using the Remote Monitor Configuration Tool” on page 56.

Table 11.

Figure 33 Workstation Remote Monitor Connections.

A 5V DC Power Cable

B Fiber Optic Cable

C Avenview Video Extender

D DVI Converter Cable• Plug into the Display Port labeled “REM”, next to the arrow symbol

E Display Port

Figure 33. Avenview Video Extender and Workstation Remote Monitor Connection.

E

B

C

D

A


Using the Remote Monitor Configuration Tool


Using the Remote Monitor Configuration Tool

Follow these steps to configure the Remote Monitor:

1. Login as the EnSite™ Velocity™ Cardiac Mapping System user.

2. Click the [Services] button.

3. On the Services tab, click the [Configure Remote Monitor button].

4. Select the remote monitor from the {Select a Monitor] drop-down menu, and click [OK].

NOTE: Click [Reset to Default (Auto-select)] to return the system to the state where it will attempt to function with whichever monitor is connected.

5. Click [Reboot Now] to complete the setup.

NOTE: All changes will be discarded if the user does not select [OK] before exiting. Changes will not take effect until the DWS is rebooted.

NOTE: All monitors and video extenders should be connected prior to booting or re-booting the DWS.

NOTE: The DWS detects monitors and video extenders that are connected to it during the boot process. Any monitors or video extenders that are not connected during the boot process will not have their video signals enabled by the DWS (i.e. you will not see anything on the monitor.)


Connecting Cables to the EnSite™ Amplifier 57EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Connecting Cables to the EnSite™ Amplifier

The NavLink™ Module, ArrayLink™ Module, CathLink™ Module, SJM ECG Cable, RecordConnect, and GenConnect are connected to the EnSite™ Amplifier using locking ring connectors.

Figure 34. Connecting a cable to and disconnecting a cable from the EnSite™ Amplifier.

■ To connect a cable to the EnSite™ Amplifier (Figure 34 above), align the dot on the cable connector with the arrow on the EnSite™ Amplifier connector and push the cable connector onto the EnSite™ Amplifier connector until a click is heard.

■ To disconnect a cable from the EnSite™ Amplifier (Figure 34 above), turn the locking ring on the cable connector counterclockwise and pull the cable connector off of the EnSite™ Amplifier connector.

Color-Coded Connections

The cable connectors and the EnSite™ Amplifier connections are color coded and labeled with identical icons on each, for easy identification. The icons and color codes are described in Table 12 below.

Table 12. EnSite Amplifier cable connector icons and colors.

Figure 35. The EnSite™ Amplifier Panel Connectors

Icon Connector Color Function

Black GenConnect

Green NavLink™ Module

Yellow CathLink™ or RecordConnect catheter

Blue ECG or RecordConnect ECG

White ArrayLink™ Data Module

Yellow ArrayLink™ Module, CathLink™ Module, or RecordConnect Catheter


Connecting a System Reference Surface Electrode


Connecting a System Reference Surface Electrode

A system reference surface electrode is required for proper system operation for EnSite™ Array™ and EnSite™ NavX™ Navigation and Visualization Technology studies. The system reference surface electrode connects to the NavLink™ Module. Therefore, EnSite™ Array™ studies require both the ArrayLink™ Module and the NavLink™ Module.

NOTE: The EnSite™ Velocity™ Surface Electrode Kit contains a system reference surface electrode.

CAUTION: Do not warm the system reference surface electrode prior to application to the patient.

CAUTION: The system reference surface electrode must be the first patient electrode connected to the EnSite™ Amplifier at the beginning of a study, and the last patient electrode to be disconnected at the end of the study.

CAUTION: Do not attempt to connect the system reference surface electrode for the EnSite™ Velocity™ Cardiac Mapping System to other equipment, such as ablation systems.

WARNING: Do not use surface electrodes if the package seal is broken, the conductive adhesive is dry, or the “use by” date has passed.

WARNING: Before applying the system reference surface electrode, ensure that the application site is hair-free, clean, and dry. Dryness is particularly important if the preparation agent is flammable or a potential skin irritant.

The numbered steps in the following procedure correspond to the numbered callouts in Figure 36 on page 58.

1. Place the system reference surface electrode on the patient’s abdomen (Figure 36 on page 58).

2. Connect the system reference surface electrode lead to the Sys-Ref connector on the NavLink™ Module.

3. Connect the NavLink™ Module cable to the green NavLink™ Module connector on the EnSite™ Amplifier.

Figure 36. Connecting the system reference surface electrode.


Connecting EnSite™ Surface Electrodes 59EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Connecting EnSite™ Surface Electrodes

Surface Electrode Description

■ The shape of the electrode may vary depending on which kit you have; all electrode shapes are functionally equivalent.

■ The electrodes are color-coded and have a placement diagram printed on the surface.

Placement Considerations

When placing the EnSite™ surface electrodes on the patient, it is important to place them in the correct position, not only in relationship to each other, but also in relationship to other surface electrodes placed for other purposes (see Figure 37).

Skin preparation

Good skin preparation is essential to all electrophysiology studies. Adhering to the steps below helps minimize the noise related to surface patch placement during EnSite Velocity System procedures.

1. Trim excess hair from all locations where surface electrodes and patches will be used.

2. Prepare the skin surface where ECG and surface electrodes will be placed using the following technique:

a. Gently abrade the skin using a gauze pad or like material, or using a gel prep (such as Omni Prep) that contains small particles of gritty material. Make sure that all the gel material is removed from the skin.

b. Clean the surface with soap and water after the skin has been abraded.

NOTE: Avoid cleaning with isopropyl alcohol unless the skin is excessively oily or covered with lotion.

c. Ensure that the skin is completely dry and that all alcohol has evaporated before placing any surface patches.

NOTE: Press firmly on the center of the surface electrodes with a circular motion to ensure proper contact.

Anterior (Chest) and Posterior (Back) Electrodes

The precordial lead V2 placement at the 4th intercostal space and the left sternal border guides the placement of the anterior surface electrode. If both are placed correctly, the anterior surface electrode will be offset slightly to the left of the patient’s sternum. It is important that the posterior surface electrode be placed directly opposite of the anterior surface electrode. As a result, it should be offset slightly to the left of the patient’s spine. This placement will help maintain appropriate AP orientation. Placing the posterior surface electrode right or left of midline will skew the AP orientation.

Right and Left Electrodes

The right and left side surface electrodes must also be directly across from each other and orthogonal to the AP surface electrode arrangement. Any other placement may skew side-to-side orientation.

Neck and Left Leg Electrodes

The neck surface electrode and left leg surface electrode should be vertically aligned to maintain an orthogonal relationship to the other four surface electrodes. The neck surface electrode can easily be placed midline. Placement of the left leg surface electrode on the inner thigh is recommended to achieve as near of a midline location as possible. Any other placement may skew the vertical axis.

NOTE: None of the surface electrodes should overlap each other or overlap any other surface electrodes used for other purposes. Edge-to-edge contact with ECG surface electrodes should not create interference. Avoid direct contact of any surface electrode with an RF return patch.

NOTE: The rectangular version front surface electrode has cutouts to allow ECG surface electrode positioning. The V2 ECG surface electrode should be placed before the front surface electrode is placed. Refer to “Connecting ECG Surface Electrodes” on page 62 for more information.


Connecting EnSite™ Surface Electrodes


NOTE: The left leg surface electrode contains an integrated Data Module chip.

WARNING: Before applying the surface electrodes, ensure that the application sites are hair-free, clean, and dry. Dryness is particularly important if the preparation agent is flammable or a potential skin irritant.


CAUTION: Do not warm the surface electrodes before they are positioned on the patient.

Surface Electrode Placement

“X” indicates the location of the surface electrode.

Figure 37. Placement of Surface Electrodes.

Caudal Views of Thorax

Correct Placement

Incorrect Placement


Connecting EnSite™ Surface Electrodes 61EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Surface Electrode Placement Order

The numbered steps in the following procedure correspond to the numbered callouts in Figure 38.

1. Position the ECG surface electrodes on the patient. Proper placement of the C2 ECG surface electrode is important. For more information about placing ECG electrodes, refer to “Connecting ECG Surface Electrodes” on page 62.

2. Place each surface electrode on the patient as per the illustration printed on the back of the surface electrode. Proper surface electrode placement is important. See Figure 37 on page 60 for proper placement. The orientation of the surface electrode leads is not important.

3. Connect each surface electrode lead to its matching color-coded connector on the NavLink™ Module.

4. Connect the NavLink™ Module cable to the green NavLink™ Module connector on the EnSite™ Amplifier.

NOTE: Do not add or remove any surface patches of any type after validating the data module.

Figure 38. surface electrode placement order. The dashed lines indicate electrode fields.


Connecting ECG Surface Electrodes



(EnSite™ Array™ Catheter and EnSite™ NavX™ Navigation and Visualization Technology studies)

When a RecordConnect is used, ECG surface electrodes are connected to the recording system manufacturer’s ECG cable and the ECG cable is connected to the RecordConnect. When a RecordConnect is not used, ECG surface electrodes are normally connected to the SJM ECG Cable and the SJM ECG Cable is connected to the EnSite™ Amplifier.

NOTE: For EnSite™ NavX™ Navigation and Visualization Technology studies, a set of ten ECG surface electrodes is included in the EnSite™ Velocity™Surface Electrode Kit. Place ECG surface electrodes within the front EnSite™ Velocity™surface electrode (Figure 39 on page 62). Placing the ECG surface electrodes on the patient in the following order may prove to be the most efficient:

1. Place the C2 ECG surface electrode at the 4th intercostal space, left sternal edge.3

2. Place the front surface electrode.

3. Place the remaining ECG surface electrodes.


CAUTION: Do not warm the ECG surface electrodes before they are positioned on the patient.

Figure 39. ECG Surface Electrode Placement .

3. “Guidelines For Recording A 12 Lead Electrocardiogram (ECG),” South Durham Health Care NHS Trust.


Connecting ECG Surface Electrodes 63EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Connecting ECG Surface Electrodes When Using a RecordConnect

The numbered steps in this procedure correspond to the numbered callouts in Figure 40.

1. Connect the standard ECG surface electrodes to the patient in the typical 12-lead configuration.

2. Connect the ECG surface electrodes to the recording manufacturer’s ECG cable.

3. Connect the recording manufacturer’s ECG cable to the ECG connector on the RecordConnect.

4. Connect the ECG interconnect on the RecordConnect to the recording system.

5. Connect the ECG cable on the RecordConnect to the blue connector on the EnSite™ Amplifier.

Figure 40. ECG surface electrode connections when using a RecordConnect.




Connecting ECG Surface Electrodes When Not Using a RecordConnect

The numbered steps in this procedure correspond to the numbered callouts in Figure 41.

1. Connect the standard ECG surface electrodes to the patient in the typical 12-lead configuration.

2. Labels identify the proper connections for each surface electrode: RL – right leg, LL – left leg, RA – right arm, LA – left arm, V1: right-most chest surface electrode, through V6: left-most chest surface electrode.

Connect the SJM ECG Cable to the blue ECG connector on the EnSite™ Amplifier.

Figure 41. ECG surface electrode connections when not using a RecordConnect.


Connecting an RF Ablation Catheter and Generator 65EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Connecting an RF Ablation Catheter and Generator

For optimal navigation, RF ablation should be routed through the EnSite™ Amplifier using a GenConnect specifically designed for the model of ablation generator being used. Contact St. Jude Medical for a list of available GenConnect models.

CAUTION: Do not sterilize the EnSite™ Velocity™ Cardiac Mapping System interconnect cables.

NOTE: The extension cable must be designed for use with both the ablation catheter and the ablation generator. Extension cables often contain thermistor/thermocouple wiring that allow catheters to be compatible with RF generators.

NOTE: The procedure described here and the accompanying diagram (Figure 42) are generic. The specific connections required to connect an ablation system depend on the brand of ablation system being used.

Figure 42. Basic connections when using the GenConnect.

The numbered steps in the following procedure correspond to the numbered callouts in Figure 42.

1. Connect the ablation catheter extension cable to the Ablation Catheter cable connector IN on the GenConnect.

2. Connect the dispersive patches cable to the Dispersive Patches cable connector IN on the GenConnect.

3. Connect one end of the St Jude Medical (SJM™) catheter interconnect cable to the Ablation Catheter cable OUT connector on the GenConnect and the other end to the RF ablation generator.

4. Connect one end of the SJM™ dispersive interconnect cable to the GenConnect Dispersive cable OUT connector on the GenConnect and the other end to the RF ablation generator.

5. Connect one end of the SJM™ interconnect cable to the EnSite™ Amplifier connection on the GenConnect module and the other end to the EnSite™ Amplifier.


Connecting Diagnostic Catheters


Connecting Diagnostic Catheters

When a RecordConnect is used, diagnostic catheters are connected to the recording system manufacturer’s catheter input module (CIM) and the CIM is connected to the RecordConnect. When a RecordConnect is not used, diagnostic catheters are connected using a CathLink™ Module.

CAUTION: Make all connections between systems before validating EnSite™ NavX™ Navigation and Visualization Technology. Adding or removing connections after validation may affect navigation quality.

CAUTION: When the EnSite™ Amplifier is turned off, it can affect ECG signals viewed on the recording system. When the EnSite™ Amplifier is turned off and a recording system is in use, it is recommended that the cables to the EnSite™ Cardiac Mapping System be disconnected from the EnSite™ Amplifier.

NOTE: Catheter polarity and waveform display are controlled in the software. See “EP Catheter Setup” on page 97.”

NOTE: An EnSite™ NavX™ Navigation and Visualization Technology study will support up to 128 diagnostic catheter electrodes through either a RecordConnect or up to two CathLink™ Modules.

NOTE: An EnSite™ Array™ study will support up to 64 diagnostic catheter electrodes through either a RecordConnect or a CathLink™ Module. However, only the first 28 channels are available for locating electrodes.

Figure 43. CathLink™ Module - In an EnSite™ Array™ Catheter Study only the first 28 channels can be used for locating electrodes.


Connecting the EnSite™ Array™ Catheter 67EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Connecting the EnSite™ Array™ Catheter

(EnSite™ Array™ Catheter studies only)

NOTE: The ArrayLink™ Module must be clamped to the table rail and facing the patient.

CAUTION: Do not disconnect the Data Module from the ArrayLink™ Module or the EnSite™ Amplifier during a study.

NOTE: Prepare and introduce the EnSite™ Array™ Catheter as per the product literature provided with the EnSite™ Array™ catheter.


1. Align the EnSite™ Array™ Catheter connector so that the plastic chain connecting the Data Module is facing to the left and gently press the connector into the EnSite™ ArrayLink™ Module connector on the ArrayLink™ Module. The latch on the ArrayLink™ Module will lock the connection in place.

2. Connect the Data Module to the Data Module connector on the ArrayLink™ Module. The Data Module is tethered to the EnSite™ ArrayLink™ Module connector.

3. Connect the large yellow connector on the ArrayLink™ Module to the yellow ArrayLink™ Module connection on the far right side of EnSite™ Amplifier.

4. Connect the small white connector on the ArrayLink™ Module cable to the white Data Module connection on the EnSite™ Amplifier.

Figure 45. An EnSite™ Array™ Catheter connector and Data Module connected to the ArrayLink™ Module.

Figure 44. The ArrayLink™ Module clamping position


Connecting an Auxiliary Unipolar Reference


Connecting an Auxiliary Unipolar Reference

The unipolar reference is the zero potential reference for unipolar diagnostic catheters and EnSite™ Array™ Catheter signals.

■ For EnSite™ Array™ Catheter studies, the default unipolar reference is the most proximal ring electrode (E3) on the EnSite™ Array™ Catheter.

■ For EnSite™ NavX™ Navigation and Visualization Technology studies, the default unipolar reference is the System Reference.

To use an Auxiliary Unipolar Reference:

NOTE: The Auxiliary Unipolar Reference electrode needs to be stationary throughout the study.

1. Place the electrode of the diagnostic catheter to be used as the unipolar reference within the blood pool, but outside of all chambers of interest. Connect the lead of this electrode to the Aux Ref connector on the NavLink™ Module.

2. From the menu bar, select Amplifier > Settings > References, and check the Auxiliary checkbox.

Figure 46. Connecting a diagnostic catheter electrode being used as a unipolar reference.


Using a Recording System 69EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Using a Recording System

There are two methods of using the EnSite™ Velocity™ Cardiac Mapping System with a conventional recording system. The first method offers a convenient means of making patient connections, but is dependent on the type of recording system. The second method offers a universal means of using any recording system, but requires more manual connections. These methods are described here and illustrated in Figure 49 on page 72.

Method 1 uses a recording system RecordConnect, which routes the ECG and EP catheter signals from the patient to both the EnSite™ Amplifier and the recording system, thereby eliminating the need for a second set of ECG surface electrodes and the use of jumper cables to share intracardiac signals.

■ The ECG surface electrode leads are connected to the recording system ECG cable, and the ECG cable is normally connected to the RecordConnect. The RecordConnect routes the ECG signals from the patient to the EnSite™ Amplifier and the recording system.

■ The EP catheters are connected to the recording system CIM, and the CIM is connected to the RecordConnect. The RecordConnect routes the EP catheter signals from the patient to the EnSite™ Amplifier and the recording system.

Method 2 uses a CathLink™ Module catheter input module, an SJM ECG Cable, a second set of ECG surface electrodes, and jumper cables.

■ One set of ECG surface electrode leads is connected to the SJM ECG Cable, and the SJM ECG Cable is connected to the EnSite™ Amplifier. The second set of ECG surface electrode leads is connected to the recording system.

■ The EP catheters are connected to the recording system and jumpered to a CathLink™ Module. The CathLink™ Module routes the EP catheter signals from the recording system to the EnSite™ Amplifier.




Connecting Diagnostic Catheters When Using a RecordConnect

NOTE: The procedure described here and the accompanying diagram (Figure 47 on page 70) are for a generic RecordConnect. The actual connections required to connect a RecordConnect depend on the brand of recording system being used. Contact SJM for a list of available RecordConnect modules.


1. Connect the diagnostic catheter electrode leads to the recording system manufacturer’s CIM.

2. Connect the recording system manufacturer’s CIMs to the CIM input connectors on the RecordConnect.

3. Connect the CIM interconnect cables on the RecordConnect to the recording system.

4. Connect the CIM cables on the RecordConnect to the yellow RecordConnect connectors on the EnSite™ Amplifier.

Connect electrodes to sequentially numbered channels, (1 through 64) on the CIM of the conventional recording system.

Figure 47. Diagnostic catheter connections when using a RecordConnect.


Using a Recording System 71EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Connecting Diagnostic Catheters When Not Using a RecordConnect


1. Connect the diagnostic catheter leads to the CathLink™ Module.

2. Connect the CathLink™ Module cable to the yellow CathLink™ Module connector on the EnSite™ Amplifier.

Figure 48. Diagnostic catheter connections when not using a RecordConnect.




Figure 49. Using a recording system with and without RecordConnect.


Preparing for a Study
CHAPTER 4
Preparing for an EnSite™ NavX™ Navigation and Visualization Technology Study

Refer to “Using a Recording System” on page 69 for more information.

Contact St. Jude Medical for a list of available RecordConnect modules.

EnSite™ NavX™ Navigation and Visualization Technology Study with RecordConnect

An EnSite™ NavX™ Navigation and Visualization Technology study that uses RecordConnect requires the following:

■ EnSite™ Velocity™ surface electrodes

■ System reference surface electrode


■ Diagnostic catheters

■ ECG surface electrodes

■ RecordConnect

■ Ablation catheter and generator

■ Dispersive surface electrodes

■ GenConnect

Figure 50 on page 74 illustrates the basic components and connections required for an EnSite™ NavX™ Navigation and Visualization Technology study that uses RecordConnect.

Table 13 on page 75 describes the basic tasks required in an EnSite™ NavX™ Navigation and Visualization Technology study.

74 Chapter 4. Preparing for a Study

Preparing for an EnSite™ NavX™ Navigation and Visualization


*The physical location of the fiber optic cable connections, on the front panel of the EnSite™ Amplifier, may be located on the right side of the panel (as shown) or may be located on the left side of the panel, depending on the hardware configuration installed.

Figure 50. The basic components and connections for an EnSite™ NavX™ Navigation and Visualization Technology study when a RecordConnect is used.

Chapter 4. Preparing for a Study

Preparing for an EnSite™ NavX™ Navigation and Visualization 75EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Table 13. EnSite™ NavX™ Navigation and Visualization Technology study with RecordConnect.

1. Turn on the EnSite™ Amplifier and allow it to warm up for 30 minutes before beginning a study.

“Starting the System” on page 85

2. Connect the EnSite™ Velocity™ Cardiac Mapping System component cables to the EnSite™ Amplifier.

“Using the Remote Monitor Configuration Tool” on page 56

3. Place the system reference surface electrode on the patient, and then connect the electrode leads to the NavLink™ Module.

“Connecting a System Reference Surface Electrode” on page 58

4. Place the V2 ECG surface electrode on the patient. “Connecting ECG Surface Electrodes” on page 62

5. Place the EnSite™ Velocity™surface electrodes on the patient, and then connect the electrode leads to the NavLink™ Module.

“Connecting EnSite™ Surface Electrodes” on page 59

6. Place the remaining ECG surface electrodes on the patient, and then connect all electrode leads to the recording system’s ECG cable.

“Connecting ECG Surface Electrodes” on page 62

7. Connect the recording system’s ECG cable to the RecordConnect. “Connecting ECG Surface Electrodes When Using a RecordConnect” on page 63

8. Connect EP catheters to the recording system’s CIMs, and then connect the CIMs to the RecordConnect.

“Connecting Diagnostic Catheters When Using a RecordConnect” on page 70

9. Connect the ablation catheter and dispersive patches to the GenConnect, and then connect the GenConnect to the ablation generator and the EnSite™ Velocity™ Cardiac Mapping System.

“Connecting an RF Ablation Catheter and Generator” on page 65

10. Turn on the DWS. “Starting the System” on page 85

11. Log in to the EnSite™ Velocity™ Cardiac Mapping System. “Logging In” on page 87

12. Start a new EnSite™ NavX™ Navigation and Visualization Technology study. “Starting a New Study” on page 91

13. Enter the Setup task. “Setup” on page 95

14. Check ECG signal quality and turn on signal filters if necessary. “Checking ECG Signals” on page 95

15. Perform validation. “Validation” on page 96

16. Add EP catheters to the study. “EP Catheter Setup” on page 97

17. Perform EnSite™ NavX™ Navigation and Visualization Technology setup. “EnSite™ NavX™ Navigation and Visualization Technology Setup” on page 109

18. Create a model. “Model” on page 119

19. Create maps. “Mapping – Contact” on page 171

20. Deliver therapy, if indicated. “Therapy” on page 189

21. End the study. “Ending a Study” on page 203




EnSite™ NavX™ Navigation and Visualization Technology Study without RecordConnect

An EnSite™ NavX™ Navigation and Visualization Technology study that does not use RecordConnect requires the following:

■ EnSite™ Velocity™ surface electrodes




■ Jumper cables for diagnostic catheters

■ CathLink™ Module (one or two, depending on the recording system)

■ ECG surface electrodes (two sets)

■ SJM ECG Cable



■ GenConnect

Figure 51 on page 77 illustrates the basic components and connections required for an EnSite™ NavX™ Navigation and Visualization Technology study that does not use RecordConnect.

Table 14 on page 78 describes the basic tasks required in an EnSite™ NavX™ Navigation and Visualization Technology study.


Preparing for an EnSite™ NavX™ Navigation and Visualization 77EnSite™ Velocity™ Cardiac Mapping System Instructions for Use



Figure 51. The basic components and connections for an EnSite™ NavX™ Navigation and Visualization Technology study when a RecordConnect is not used.




Table 14. EnSite™ NavX™ Navigation and Visualization Technology study without RecordConnect.







Note: Two sets of ECG surface electrodes are required. They are referred to here as Set 1 and Set 2.

4. Place the Set 1 V2 ECG surface electrode on the patient. “Connecting ECG Surface Electrodes” on page 62

5. Place the EnSite™ Velocity™surface electrodes on the patient, and then connect the electrode leads to the NavLink™ Module.

“Connecting EnSite™ Surface Electrodes” on page 59

6. Place the remaining Set 1 ECG surface electrodes on the patient, and then connect all electrode leads to the SJM ECG Cable.

“Connecting ECG Surface Electrodes When Not Using a RecordConnect” on page 64

7. Place the Set 2 ECG surface electrodes on the patient, and then connect all electrode leads to the recording system’s ECG cable.


8. Connect EP catheters to the recording system’s CIMs, as per the recording system’s instructions, and then jumper the EP catheters from the recording system’s CIMs to the CathLink™ Module.

“Connecting Diagnostic Catheters When Not Using a RecordConnect” on page 71





12. Start a new EnSite™ NavX™ Navigation and Visualization Technology study. “Starting a New Study” on page 91

13. Enter the Setup task “Setup” on page 95




17. Perform EnSite™ NavX™ Navigation and Visualization Technology setup. “EnSite™ NavX™ Navigation and Visualization Technology Setup” on page 109


19. Create maps. “Mapping – Contact” on page 171




Preparing for an EnSite™ Array™ Catheter Study 79EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Preparing for an EnSite™ Array™ Catheter Study

Contact St. Jude Medical for a list of available RecordConnect modules.

Refer to “Using a Recording System” on page 69 for more information.

EnSite™ Array™ Catheter Study with RecordConnect

An EnSite™ Array™ Catheter study that uses a RecordConnect requires the following:






■ ECG surface electrodes

■ RecordConnect



■ GenConnect

Figure 52 on page 80 illustrates the basic components and connections required for an EnSite™ Array™ Catheter study that uses RecordConnect.

Table 15 on page 81 describes the basic tasks required in an EnSite™ Array™ Catheter study.





Figure 52. The basic components and connections for an EnSite™ Array™ Catheter study when RecordConnect is used.




Table 15. EnSite™ Array™ Catheter study with RecordConnect.







4. Place the ECG surface electrodes on the patient, and then connect the electrode leads to the recording system ECG cable.


5. Connect the recording system’s ECG cable to the RecordConnect. “Connecting ECG Surface Electrodes When Using a RecordConnect” on page 63

6. Connect EP catheters to the recording system’s CIMs, and then connect the CIMs to the RecordConnect.

“Connecting Diagnostic Catheters When Using a RecordConnect” on page 70



8. Connect the EnSite™ Array™ Catheter cable and Data Module to the EnSite™ Array™ Catheter.

“ArrayLink™ Module Connections” on page 48



11. Start a new EnSite™ Array™ Catheter study. “Starting a New Study” on page 91

12. Enter the Setup task. “Setup” on page 95


14. Deploy the EnSite™ Array™ Catheter in the patient. EnSite™ Array™ Catheter Instructions for Use.



17. Perform EnSite™ Array™ Catheter setup. “Catheter Presets” on page 103


19. Create maps. “Mapping – Noncontact” on page 159 or “Mapping – Contact” on page 171






EnSite™ Array™ Catheter Study without RecordConnect

An EnSite™ Array™ Catheter study that does not use RecordConnect requires the following:






■ Jumper cables for diagnostic catheters

■ CathLink™ Module

■ ECG surface electrodes (two sets)

■ SJM ECG Cable



■ GenConnect

Figure 53 on page 83 illustrates the basic components and connections required for an EnSite™ Array™ Catheter study that does not use RecordConnect.

Table 16 on page 84 describes the basic tasks required in an EnSite™ Array™ Catheter study.





Figure 53. The basic components and connections for an EnSite™ Array™ Catheter study when RecordConnect is not used.




Table 16. EnSite™ Array™ study without RecordConnect.





3. Place the system reference surface electrode on the patient, and then connect the electrode lead to the NavLink™ Module.


4. Place the Set 1 ECG surface electrodes on the patient, and then connect the electrode leads to the SJM ECG Cable.


5. Place the Set 2 ECG surface electrodes on the patient, and then connect all electrode leads to the recording system, as per the recording system’s instructions.


6. Connect EP catheters to the recording system’s CIMs, as per the recording system’s instructions, and then jumper the EP catheters from the recording system’s CIMs to the CathLink™ Module.

“Connecting Diagnostic Catheters When Not Using a RecordConnect” on page 71





10. Start a new EnSite™ Array™ Catheter study. “Starting a New Study” on page 91

11. Enter the Setup task “Setup” on page 95


13. Deploy the EnSite™ Array™ Catheter in the patient. EnSite™ Array™ Catheter Instructions for Use.

14. Connect the EnSite™ Array™ Catheter cable and Data Module to the ArrayLink™ Module. “ArrayLink™ Module Connections” on page 48

Note: Two sets of ECG surface electrodes are required. They are referred to here as Set 1 and Set 2.



17. Perform the EnSite™ Array™ Catheter setup. “Catheter Presets” on page 103


19. Create maps. “Mapping – Noncontact” on page 159 or “Mapping – Contact” on page 171




Starting a Study
CHAPTER 5
Starting the System

Before starting the system, verify the following:

■ The ArrayLink™ Module, if it is being used, is securely fastened to a rail on the patient table.

■ The CathLink™ Module, if it is being used, is securely fastened to a rail on the patient table.

■ All cable connections to the EnSite™ Amplifier are secure.

■ The fiber-optic cable connection between the DWS and the EnSite™ Amplifier is secure.

Use the following procedure to start the system:

NOTE: If the system will only be used to review previously recorded data in Offline Review mode, the EnSite™ Amplifier does not need to be powered on.

NOTE: If the EnSite™ Amplifier is already powered on when setting up the system for a new study, power cycle the EnSite™ Amplifier before starting a new study. The EnSite™ Amplifier self-test provides important information about the status of the EnSite™ Amplifier components that may not be available unless the EnSite™ Amplifier is power cycled.

1. Press the EnSite™ Amplifier power switch to the ON position.

2. When the system is powered on, the status lights may change state for approximately two minutes while the system performs self-testing. After two minutes, check the EnSite™ Amplifier status lights. The green light should illuminate and remain lit. If the amber light flashes or is steadily illuminated, there is a problem. To resolve the problem, refer to “Troubleshooting” on page 215 or contact EnSite™ Velocity™ Cardiac Mapping System Technical Support before proceeding.

3. Power on the power conditioner.

4. Press and release the workstation power switch (located on the front of the workstation) to power on the workstation. When powered on, the workstation begins automated self-testing. When self-testing is complete, the system login screen appears on the monitor.

86 Chapter 5. Starting a Study

Keyboard and Screen Languages


Keyboard and Screen Languages

Languages can be selected for the keyboard and the screens. The default keyboard language and screen language is U.S. English. If a different keyboard language is to be used, follow the steps in “Selecting a Keyboard Language” on page 86 to select the keyboard language. If a different screen language is to be used, follow the steps in “Selecting a Screen Language” on page 86 to select the screen language.

Selecting a Keyboard Language

NOTE: The keyboard language applies to all users of the system.

NOTE: The keyboard language selected must match the language of the keyboard.

To select a keyboard language, click the keyboard icon in the upper-right corner of the Login screen, and select the language from the displayed list that matches the keyboard to be used.

Selecting a Screen Language

NOTE: The screen language is associated with the login name.

NOTE: The Login screen is always in English.

NOTE: If the screen language selected is Chinese or Japanese, the user can toggle between English characters and Chinese characters, or between English characters and Japanese characters, by holding down the Ctrl key and pressing the space bar.

1. Log in to the system (see “Logging In” on page 87).

2. Click on the Language icon in the lower right corner of the screen.

3. Select a language from the displayed list, and then click the [Change Language] button. During login, the system will ask if the screen language selection is to be used for only the current session or for all sessions.

NOTE: The user must log out and log back in to the system for the change to take effect.

Chapter 5. Starting a Study

Logging In 87EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Logging In

NOTE: The login name and password must be entered as lowercase letters with no spaces.

1. Type the login name in the Username: text box and press Enter. The default login name is all lower-case “ensite” and is case-sensitive. After the login name has been entered, the text box text changes to Password.

2. Type the password in the Password text box and press Enter. The password is sjm3000. In a few seconds the Title Screen appears.

NOTE: The Training Database can be used to review practice cases. The login name is training and the password is sjm3000.

NOTE: If the password is changed from the initial password above, the Login screen will not display. Contact your system administrator for the current password.

Title Screen

The Title Screen allows you to access the Clinical and Services menus of the EnSite™ Cardiac Mapping System, as well as other functions (depending on the DWS license configuration, not all functions may be available).

■ Click an icon to access that function or menu item.

■ Select system language , view system information , and access SJM Connect from the tool bar at the bottom of the screen.

■ Click the Back button to return to the previous menu.

■ Click to log out of the session.

Figure 54. The Login Screen.


Getting Started


Getting Started

After logging in, access the desired menu:

1. From the Title Screen, access the Clinical or Services menus:

Figure 55. The Title Screen.


Getting Started 89EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Clinical Menu

Figure 56. The Clinical Menu.

■ New Study, to start a new study (go to “Starting a New Study” on page 91).

■ Last Study, to access the last study (go to “Past Studies” on page 93).

■ Past Studies, to access a previously-recorded study in Offline Review model (go to “Offline Review” on page 199).

■ Archive

■ Import

■ Verismo, to access the EnSite™ Verismo™ Segmentation Tool, if the tool has been installed.

■ EnSite™ Courier™ PACS Module, if it has been installed.


Getting Started


Services Menu

Figure 57. The Services Menu.

■ Collect Logs: to export logs to CD/DVD or USB device.

■ Verismo Cleanup: to cleanup unneeded files.

■ Install License From Media: to install product licenses on the DWS. Administrator access.

■ Upgrade Software: to upgrade DWS system software. Administrator access.

■ Manage License: to add or remove product licenses. Administrator access.

■ [About the System] to display a variety of system information, including the software release notes, controls for setting the system clock, controls for establishing the hospital name, utilities for advanced technical support, and notices. See “Troubleshooting” on page 215 and “Setting Environmental Information” on page 228 for further information.

■ [Logout] to log off the system.


Starting a New Study 91EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Starting a New Study

New Patient

To begin a new study for a new patient:

1. Click [New Study] from the Clinical Menu (Figure 56 on page 89) to display the Study Setup screen.

2. Click [New Patient]. (Default)

3. Fill in the patient information: Last Name, First Name, M.I., Patient ID, Date of Birth, Gender, Weight.

NOTE: Weight (in kilograms) is the minimum required field to proceed. However, you will need to enter the remainder of the required information before you can end the study. See “Ending a Study” on page 203.

4. Click [Next] to display the next Study Setup screen.

5. Select a study type: EnSite NavX or EnSite Array. (Default is NavX).

6. Enter the study information: Diagnosis, Procedure, and Physician.

7. Select the appropriate Recording System.

8. Click [Begin Study] to begin the study.

NOTE: After starting a new study, signal parameters need to be set, as described in “Setup” on page 95.

Figure 58. Study Start up for a New Patient.

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3

4

5

6

8

7


Starting a New Study


Existing Patient

To begin a new study for an existing patient:

1. Click [New Study] from the Title Screen to display the New Study Patient Information screen.

2. Click [Existing Patient].

3. Select a patient from the list. A summary of patient information and a list of past studies are displayed on the screen.

4. Click [Next] to display the Study Setup screen.

5. Select a study type: EnSite NavX or EnSite Array.

6. Enter the study information: Diagnosis, Procedure, and Physician.

7. Click [Begin Study] to begin the study.

NOTE: After starting a new study, signal parameters need to be set, as described in “Setup” on page 95.

Figure 59. Study Setup for an Existing Patient.

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Past Studies 93EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Past Studies

Resuming a Study

NOTE: Studies may only be continued using the same data module.

NOTE: When a study is resumed, all settings will be loaded from the cursor position in the segment being reviewed.

NOTE: A study can be resumed even after a system has been shut down, either intentionally or unintentionally.

To resume a study, follow these steps:

1. Return to the Login Screen and Log in.

2. Click on the Clinical icon to access the Clinical Menu (Figure 56 on page 89).

3. Click on the Past Studies icon to display the list of studies.

4. Select the Patient Name and the study date that are associated with the data module that was used during that study; ensure that the data module is still viable (does not exceed the 18-hour time stamp [from initial validation]).

5. Click Open Study. The study will be opened in the Model task and the last recorded segment will begin to play. To play a different segment, select the segment from the Segment drop-down menu at the bottom of the screen (Figure 60 on page 93).

6. Verify that the EnGuides and model are displayed, and that the catheter is properly aligned with the model. If they are not, it may be necessary to load a different segment or move the cursor to a different location in the segment.

7. Select File > Resume Study.

8. Click [Yes] in the dialog box (Figure 61 on page 93) to continue.

Figure 60. Load Segment Window for RealTime Review.

Figure 61. Resume Study dialog box


Past Studies



Setup
CHAPTER 6
Checking ECG Signals

Figure 62. ECG Signals Display. A: Trace name; B: ECG waveform; C: Data type; D: Amplitude control; E: Filter controls.

A

B

C

D E

96 Chapter 6. Setup

Validation


Verifying ECG Signal Quality

(All studies)

1. Verify ECG signal quality by examining the traces (Figure 62 on page 95). Traces should be smooth lines that are free of excessive noise. If traces contain excessive noise, check all electrode and cable connections between the patient and the EnSite™ Amplifier.

2. If signal filtering is desired, verify that the Display Filter Data checkbox has the Noise, High Pass, and Low Pass filters set accordingly.

3. Use the Amplitude slider to adjust the waveform as desired.

Validation

(All studies)

The Data Module must be validated before catheter navigation can begin. Validation should be performed as close as possible to creating the first model, map or 3D point.

NOTE: It is recommended to validate again just prior to model or map creation. Validation can be performed more than once.

CAUTION: The EnSite™ Array™ and the EnSite™ Velocity™Surface Electrode Kits are intended for single use only. Device integrity will be compromised by any reuse, which may compromise patient safety and system performance.

Prior to validating the Data Module:

■ For EnSite™ Array™ Catheter studies, the EnSite™ Array™ catheter and data module must be connected to the ArrayLink™ Module, and the catheter must be deployed in the chamber of interest. The Data Module is tethered to the EnSite™ Array™ catheter.

Once the above actions have been completed, validate the Data Module as follows:

1. Insert the Data Module into the Data Module connection on either the ArrayLink™ or NavLink™ modules, as appropriate.

Note: The Data Module cable connectors and their corresponding connections for the ArrayLink™ or NavLink™ module look completely different from one another.

2. Click on the Catheter Setup subtask in order to see the yellow Validation window. The yellow Validation window will appear in the upper left corner of the screen.

3. Click on [Validate], in the yellow message window, to begin the validation process. When validation is complete, a message appears in the lower right side of the screen. Set up the catheters.

Note: Because the default position for located catheters may be outside the model display, right-click in the model display background, select Center Model At:, and then select one of the following from the submenu:

■ Center of Surface(s)

■ Surface Point

■ Active Electrode

■ Catheter Tip (brings up submenu of the chosen catheters from list)

4. If validation fails, check that the ArrayLink™ or NavLink™ Module connections are correct. To attempt to revalidate, from the menu bar, select Amplifier > Validate (re-validation can be done as many times as necessary, within the 18-hour Data Module time frame).

Chapter 6. Setup

EP Catheter Setup 97EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


EP Catheter Setup

(All studies)

1. CIM – Graphic representation of the catheter input modules (CIMs) used to connect catheters to the EnSite™ Velocity™ Cardiac Mapping System. Shown is the CathLink, which is connected directly to the EnSite™ Amplifier. Also available are CIMS that match some recording systems, and are connected to the EnSite™ Velocity™ Cardiac Mapping System with specific RecordConnects.

2. Catheter List – List of the catheters included in this study. Click on a line item in the catheter list to select that catheter. The selected catheter’s properties will be displayed below the list.

3. Catheter Visibility – Show or hide a catheter in the navigation area.

4. Catheter Color – Click the colored box to change the color of the catheter.

5. Sheath Filer – Detects and provides visual feedback when all or part of a catheter is in the sheath. When an electrode is detected to be within the sheath, both visibility and data collection from the electrode will suspend. See “Sheath Filter Setup” on page 105.

6. Electrode Numbers Checkbox – Requires Show Electrode Numbers to be selected from the Display Settings menu.

7. Electrode Spacing – The electrode spacing of the selected catheter is displayed here. Electrode spacing is calculated from the edges of the electrodes, not the center.

NOTE: Enter proper spacing prior to collecting model points.

Figure 63. The Catheter Setup Screen.

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98 Chapter 6. Setup

EP Catheter Setup


8. Catheter Representation – This is a representation of the selected catheter. It shows the electrodes and how they map to the input channels.

■ To show/hide the mapping lines, right-click and turn the Show Lines checkbox On or Off.

■ To show/hide the catheter representation, right-click and turn the Show Catheter checkbox On or Off.

9. Filter Controls – The Noise Filter can be turned on or off and the High Pass and Low Pass filters can be adjusted as needed for bipolar and unipolar signals. Separate controls are available for ECG, and the EnSite™ Array™ Catheter under the model workflow. In addition, the EnSite™ Array™ Catheter has a Spatial filter.

10. Waveforms – The waveforms of the selected catheter are displayed here.

11. Catheter Properties – Catheter properties are Name, Brand Name, Type, Manufacturer, Model Number, Number of Electrodes, Diameter, Distal Length, Electrode Length, Type, and Electrode Spacing.

12. Signal Order – These checkboxes dictate the order in which the waveforms are displayed. (Distal to Proximal or Proximal to Distal).

NOTE: This does not apply to the Mapping Waveforms.

13. Polarity – This drop-down menu is used to set the selected catheter’s polarity: Paired Bipolar, All Bipolar, or All Unipolar.

14. Add a Trace – Clicking the [+] button will add a trace. By default, it will be a unipolar electrogram configured with the Distal electrode set as positive (left column), with the reference set as the System Reference (or Aux Ref, if chosen) (right column).

■ You can also configure this trace as a bipole by changing the electrode configuration to any combination of electrodes on the same catheter.

■ To remove a trace, left-click and drag the trace to the left of the window.

NOTE: Cryo Ablation connections can be made through the CIM or RecordConnect.

15. GenConnect Panel – This panel serves as the software connection for the ablation catheter. When adding an RF catheter, this panel must be used rather than the CIM representation shown above it. Note that the ablation catheter should only be visualized using these inputs. If the EGM output from the generator is input to the CIM to see cardiac signals on the recording system, those channels should not be used to visualize a catheter in the EnSite System.

Chapter 6. Setup



Adding a Catheter to a Study

Before adding catheters to the study, ensure that the appropriate RecordConnect has been specified for the study. This is important because the CIM that is displayed in Catheter Setup is determined by the RecordConnect.

NOTE: If any catheters have been defined, the RecordConnect (and therefore the CIM) cannot be changed unless the catheters are first undefined by clicking the [-] button in the Catheter Setup or loading the Nominal Preset.

To select a different CIM for the study, from the menu bar select Amplifier > Settings > RecordConnect. Ensure that the corresponding checkbox is checked for the recording system being used for the study.

There are multiple ways to add a catheter to a study:

■ “Defining a Catheter” on page 100.

■ “Selecting a Catheter from the Catheter Catalog” on page 100.

■ “Loading a Catheter Preset” on page 101.

■ “Catheter Signal Settings” on page 101.

Figure 64. The Amplifier Settings RecordConnect window.

100 Chapter 6. Setup

EP Catheter Setup


Defining a Catheter

1. Click the + button beneath the Catheter List.

2. Enter a catheter name (up to four alphanumeric characters) or choose a system default name from the drop-down menu.

NOTE: When typing in the text area for Name, Manufacturer, Model Number, Brand Name, and Electrode Spacing, the text area turns yellow. Text entry is not complete and accepted until the <Enter> key has been pressed and the text area returns to blue. To return to the previously accepted data, press the <ESC> key.

3. Select a color for the catheter body. The color of the waveforms for the catheter defaults to the color selected for the catheter body.

4. Specify the catheter properties: number of electrodes, catheter diameter, distal length, electrode length, electrode spacing. When specifying the number of electrodes, the electrodes will be assigned to consecutive Input Channels starting with the distal electrode assigned to the first available channel.

NOTE: Electrode spacing is calculated from the edges of the electrodes, not the centers of the electrodes.

NOTE: If the catheter is to be used as an ablation catheter, move it to the GenConnect panel by right-clicking on the first GenConnect input channel and then selecting Set Distal.

NOTE: If a catheter is to be used to collect Model points, and Field Scaling is to be applied, the electrode size and spacing information entered into the catheter description must match the information provided by the catheter manufacturer. Model points collected with catheters that are inappropriately described may yield unexpected Field Scaling results. This cannot be corrected by re-entering correct information after the fact. However, Field Scaling is an option which can be unapplied if unexpected results occur.

5. From the Polarity drop-down menu, specify whether signals should be collected from paired bipoles, all possible bipoles, or all possible unipoles.

6. Set the filters using the filter controls.

7. (Optional) To add the catheter to the Catheter Catalog, click [Add to Catalog]..

Selecting a Catheter from the Catheter Catalog

To add a catheter to the Catheter List from the Catheter Catalog:

1. Click the [Catheter Catalog] button. The catalog window opens.

2. Choose the desired catheter from the catalog list.

3. Click the [Add New] at the lower right of the catalog window.

4. Choose more catheters or close the catalog window with the [Close] button at the lower right corner of the catalog window.

– The selected catheter's attributes will populate the applicable property setting fields, and the catheter's distal electrode will be automatically assigned to the first available input. Subsequent electrodes will be placed in consecutive inputs, if available.

To redefine a catheter already in the Catheter List using the Catheter Catalog:

1. Highlight the catheter to be redefined in the Catheter List.

2. Click the [Catheter Catalog] button. The catalog window opens.

3. Select the desired catheter in the catalog list.

4. Click [Apply to Current] at the lower right corner of the catalog window.

Chapter 6. Setup



5. Choose more catheters or close the catalog window with the [Close] button at the lower right corner of the catalog window.

– The selected catheter's attributes will populate the applicable property setting fields, and the catheter's distal electrode will be automatically assigned to the first available input. Subsequent electrodes will be placed in consecutive inputs, if available.

■ The catheter name can be modified by double clicking on the name in the Catheter List or in the Name field (four character limit). The name can also be modified by selecting a system default name from the drop down list in the Name field.

■ Modify any editable properties, if necessary. (Note: only diagnostic catheters added via the catalog can be modified.)

■ Reassign any input channels, if necessary.

For more information about using the Catheter Catalog, refer to “Catheter Catalog” on page 102.

Loading a Catheter Preset

To load a preset for the current physician, open the Preset menu in the upper-right corner of the control panel and select a preset from the list. The menu lists all of the presets for the current physician.

To load a preset belonging to another physician, open the Preset menu in the upper-right corner of the control panel and select Load Preset... The Load Preset window lists the presets for all physicians on the system. Select the desired preset and then click [OK].

For more information about using catheter presets, refer to “Catheter Presets” on page 103.

Catheter Signal Settings

The Setup task workflow must be selected to access catheter signals. In addition, the Catheter Setup icon, in the upper right side of the screen must be selected. Signals from the selected catheters in the Catheter List appear in the waveform display. Next to each trace are the electrodes that comprise the signal. In the instance of a bipolar signal, two numbers will appear. The number in the left column is the positive pole, and the right column is the negative pole. A trace can be configured as unipolar by setting the right electrode to the dash. The unipolar reference is the System Reference by default, but can be set to the Auxiliary Reference in the [Amplifier>Settings>References>Unipolar References] Menu.

One or more waveforms can be selected for trace height adjustment. Traces should be smooth lines that are free of excessive noise. If traces contain excessive noise, check all electrode and cable connections between the patient and the EnSite™ Amplifier. Also, try the Noise Filter (see “Signal Filters” on page 117 and “Patient Signal Problems” on page 222).

NOTE: Saturated waveforms appear purple in the waveform display. Should this occur, it is advisable to initiate Saturation Recovery. Refer to “Saturation Recovery” on page 116 for instruction.


Catheter Catalog


Catheter Input Settings

Catheter Input Settings can only be accessed and displayed in the Setup task workflow with the Catheter Setup icon selected.

Right click on an electrode input channel in the CIM to display the options for the catheter representation:

■ The Visible checkbox shows/hides the selected electrode.

NOTE: Making an electrode not visible will cause the system to not use the electrode's location information for EnGuide related functions such as collecting model points, making map tags, or 3D mapping information. Electrograms from the electrode will be available for viewing and measurement with calipers, but the electrograms will have “No Location” if displayed in Mapping Waveforms. Mapping points will not be taken from electrodes with “no Location.”

NOTE: The visibility of non-functional electrodes on any catheter should be turned off.

■ The Connected checkbox connects/disconnects the selected electrode. When an electrode is disconnected, its channel becomes available. To reconnect a disconnected electrode, click on the electrode on the catheter image in the CIM.

■ The Set Distal checkbox moves all electrodes on a selected catheter to new input channels. To move the electrodes, select the catheter in the Catheter List, position the mouse over the new distal input channel of choice, right-click and check the Set Distal checkbox. The input channel positions can also be manually moved by clicking and dragging the displayed electrode lines.

■ The Show Lines checkbox shows the mapping lines between the input channels and the electrodes on the catheter representation.

■ The Show Catheter checkbox shows/hides the display representation of the catheter in the CIM.

■ By right-clicking on an electrode in the CIM, it can be checked/unchecked to be Visible or not. An electrode can also be chosen (checkbox) to be Connected (available) or not.

Catheter Catalog

The Catheter Catalog contains the most commonly-used SJM catheters. These catheters can be selected from the catalog, or additional catheters can be added to the Catheter Catalog, for use in a study. See “Selecting a Catheter from the Catheter Catalog” on page 100.

Figure 65. Catheter settings right-click

menu.

Figure 66. Catheter Catalog.

Chapter 6. Setup

Catheter Presets 103EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Adding a Catheter to the Catheter Catalog

Any catheter in the Catheter List can be added to the Catheter Catalog.

1. Click the appropriate catheter from the catheter list, in the control panel, to add to the Catheter Catalog.

2. Click [Add to Catalog] in the catheter control panel.

3. To manually add a catheter to the Catheter Catalog, follow Steps 1-7 of “Defining a Catheter” on page 100.

Sorting the Catheter Catalog

The Catheter Catalog may contain a large number of catheters, making it difficult to easily locate a desired catheter. The catalog can be sorted by column headings, or searched for specific text in specific column.

■ To sort the catalog by a column heading, click on the column heading.

■ To search for specific text, select the column heading from the Add Filter drop-down menu then type the desired search text in the text box.

■ To find the most recently used catheters in the list, click on Last 20 Used.

Deleting a Catheter from the Catheter Catalog

NOTE: Default catheters cannot be deleted from the Catalog. Only user-defined or added catheters can be deleted.

1. Select the catheter to delete from the Catheter Catalog.

2. Click the [ - ] button, and the catheter will be deleted from the Catheter Catalog list.

Catheter Presets

Catheter presets allow for the quick recall of routinely used catheter definition and setups. Certain types of studies may consistently use the same catheter setup, or defined catheters of the same type. Catheter presets allow for a one time setup of these parameters for use in multiple studies.

A catheter preset stores all the information needed for each catheter defined in the setup. This information includes:

■ Catheter List

■ Input and Channel Configuration

■ Catheter Signal Settings

The Catheter Presets include catalog or user definitions for each catheter in the list including:

NOTE: Waveform height (amplitude) is stored with a preset.

The preset input channel configuration includes corresponding channel numbers to catheter electrodes. A message is displayed if a preset is loaded after Catheter Setup.

■ Name ■ Type

■ Color ■ Diameter (display in either mm or french size)

■ Number of Electrodes ■ Distal Length

■ Manufacturer ■ Electrode Length

■ Model Number ■ Electrode Spacing

■ Brand Name


Catheter Presets


Loading a Catheter Preset

(Realtime Only)

To load a preset, open the Preset menu in the upper-right corner of the control panel and select a preset from the list. The menu lists all of the presets in the system.

After the preset is loaded the Catheter List is populated with the catheter names. To modify a catheter in the list, select the catheter.

Saving a Catheter Preset

To save the current catheter setup as a preset, open the Preset menu in the upper-right corner of the control panel and select Save Preset. In the Save Preset window, type a name for the preset, and then click [OK].

Deleting or Renaming a Catheter Preset

To delete or rename a preset for the current physician, open the Preset menu in the upper-right corner of the control panel and select Manage Presets. In the Manage Presets window, select a preset from the list. To delete the preset, click [Delete]. To rename the preset, double-click on the name then type the new name, or select the preset to be renamed then click on [Rename]. To add a note for the preset, type in the Note text area. When renaming is complete, click [Close].

Figure 67. Loading a catheter preset.

Figure 68. Saving a catheter preset.

Figure 69. Managing catheter presets.

Chapter 6. Setup

Sheath Filter Setup 105EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Sheath Filter Setup

Description

The Sheath Filter detects and provides visual feedback when all or part of a catheter is in the sheath. When an electrode is detected to be within the sheath, both visibility and data collection from the electrode will suspend.

A sheath graphic is drawn around the proximal catheter shaft to indicate that the sheath filter is active. The Sheath Filter has three states:

Enable and Baseline the Catheter

NOTE: The Sheath Filter is automatically baselined for enabled catheters when model creation begins from that catheter.

To use the Sheath Filter with a traditional catheter:

1. Enable the Sheath Filter by:

■ Selecting the checkbox in Catheter Setup (Figure 70)

OR

■ Selecting the catheter from the Sheath Filter option in the Display Settings right-click menu (Figure 70).

NOTE: This procedure does not require a contact vs. non-contact position as when using a TactiCath™ Quartz ablation catheter, but rather requires that all electrodes be out of the sheath.

2. Perform the baseline procedure by first positioning the catheter with all electrodes out of the sheath.

Table 17. Sheath Filter States

Disabled Enabled Configured

Inactive. Amber colored sheath graphic. A baseline procedure for the selected catheter is

required.

Blue colored sheath graphic. Sheath Filter is active; both enabled and baselined.

Figure 70. Enable Sheath Filter: from right-click Display menu (left) or Catheter Setup (right)


Sheath Filter Setup


3. Begin the baselining procedure by:

■ Selecting Set Baseline from the right-click Display Menu (Figure 71)

OR

■ Right-clicking on the Sheath Filter icon in the catheter list item and selecting Set Baseline (Figure 71).

– During the baselining process, a progress bar display in the lower-right area of the window.

NOTE: The baselining procedure may fail if the system determines that electrodes are in the sheath. This automatic determination can be overridden by clicking Ignore if it is confirmed by other means that all of the electrodes are out of the sheath during the baselining process (Figure 72).

NOTE: The baselining procedure may also fail if there is an impedance error condition in the incoming data (Figure 73). There is no user override for this condition.

NOTE: If the Sheath Filter is falsely triggering, a new baseline may be required.

Figure 71. Set Baseline: from right-click Display menu (left) or Catheter Setup (right)

Figure 72. Baseline Fail Message

Figure 73. Baseline Impedance Error Fail Message

Chapter 6. Setup

EnSite™ Array™ Catheter Setup 107EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


EnSite™ Array™ Catheter Setup


CAUTION: The EnSite™ Array™ Catheter is intended for single use only. Device integrity will be compromised by any reuse, which may compromise patient safety and system performance.

NOTE: A connected EnSite™ Array™ Catheter must be deployed in the chamber of interest and validated before it can be used to gather data. Refer to “Validation” on page 96.

1. Use the Amplitude slider to adjust trace height as desired. Evaluate the signals in the fly-eye display. Traces should be smooth lines that are free of excessive noise. If traces contain excessive noise, check the EnSite™ Array™ Catheter and system reference patch connections between the patient and the EnSite™ Amplifier.

The Fly-Eye is divided into 64 labeled frames containing EnSite™ Array™ Catheter traces. The A1-A8 column on the left side of the display has electrodes that progress from the proximal to the distal end of the electrode array. Each of the other columns, B through H, are arranged in the same manner.

Note: For EnSite™ Array™ Catheter signals, saturated data is also indicated by magenta traces for those signals which are saturated. Should this occur, it is advisable to initiate Saturation Recovery.

Figure 74. The EnSite™ Array™ Catheter Setup screen.

Fly-Eye

Bar Chart


EnSite™ Array™ Catheter Setup


2. In the fly-eye, evaluate the electrode status and deselect any noisy electrodes. Click on a frame in the fly-eye display to manually activate or inactivate electrodes. The catheter may have a maximum of eight inactive electrodes. Signals that are either excessively noisy or display an excessively low signal should typically be turned off. The frame border and label color in each frame indicates the electrode status:

■ Blue indicates an active electrode.

■ Pink indicates an inactive electrode that was automatically disabled by the system. The EnSite™ Velocity™ Cardiac Mapping System employs an automatic detection scheme for determining when an electrode on the EnSite™ Array™ Catheter is not functioning properly. The automatic detection scheme can inactivate or activate EnSite™ Array™ Catheter electrodes as the signal quality changes. If a number of electrodes are automatically disabled, verify that the system reference electrode is properly connected to the patient’s abdomen and to the NavLink™ Module. Also verify that the EnSite™ Array™ Catheter is properly connected to the ArrayLink™ Module.

■ Red indicates an inactive electrode that has been manually disabled.

■ Magenta indicates an electrode that has been disabled during the manufacturing process. Up to three electrodes may be disabled during the manufacturing of a valid catheter. These electrodes cannot be activated.

The EnSite™ Array™ Catheter Bar Chart is a second method of evaluating electrode status. The chart displays the signals A1 through H8 as a progression of resistance measurements. For example, the electrodes on column A of the EnSite™ Array™ Catheter appear in red; the electrodes A1 to A8 (proximal to distal) appear in the chart from left to right.

The values (displayed with the mean subtracted) start at a high positive value, for the proximal electrodes, and progress to lower resistances until they become high negative values for the distal electrodes (Figure 75 on page 108).

Each column of electrodes on the EnSite™ Array™ Catheter should form a smooth step-like pattern.

1. Visualize a line that intersects the value of each column, similar to the green line shown in Figure 76 on page 108. Adjust the Amplitude slider as necessary to visualize the pattern.

2. Identify inappropriate values. Typically, an inappropriate value is represented by any column that deviates from the expected pattern by over 2 Ohms or over 50% of the column height, whichever is greater.

3. Use the EnSite™ Array™ Catheter fly-eye display to inactivate electrodes with inappropriate values.

Figure 75. The EnSite™ Array Catheter bar chart.

Figure 76. The EnSite™ Array

Catheter bar chart for EnSite Array electrode column A. A green line

intersects each column; this is an

appropriate pattern.

Chapter 6. Setup

EnSite™ NavX™ Navigation and Visualization Technology Setup 109EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


EnSite™ NavX™ Navigation and Visualization Technology Setup

CAUTION: The EnSite™ Velocity™ Surface Electrode Kit is intended for single use only. Device integrity will be compromised by any reuse, which may compromise patient safety and system performance.

1. Click [Collect Respiration Data] to collect Respiration Compensation data. When respiration data has been collected, Apply Respiration Compensation and Apply Respiration Rejection are automatically turned on. Refer to “Respiration Compensation” on page 114 for more information.

2. During EnSite™ NavX™ Navigation and Visualization Technology studies, the displayed position of all electrodes is relative to the location of the positional reference.

Click on the System Reference drop-down menu to select an in vivo electrode that will remain stable during a study.

Choosing the Positional Reference

System Reference- Use of an in vivo electrode as the positional reference is not required for an EnSite NavX Navigation and Visualization study. The default setting of System Reference may be used. System Reference is best used when a controlled and regular respiration pattern and minimal patient movement is expected such as when general anesthesia is used for patient sedation.

Intracardiac Electrode- When available, an electrode on a stable catheter such as a Coronary Sinus catheter, may be chosen to serve as the positional reference. Because an intracardiac electrode moves with the heart during respiration and patient movement, it is best used when there is the potential for irregular respiration or patient movement such as when conscious sedation is used.

Note: The positional reference electrode must remain in a stable position. A shadow may be placed to help determine stability. The positional reference electrode should not be used for pacing.

Positional Reference Tool

The Positional Reference Tool is a software feature available during EnSite™ NavX™ Navigation and Visualization Technology procedures that alerts the user when there has been acute movement of the positional reference catheter. It is designed to detect sudden movement of the positional reference catheter along its long axis that exceeds a preset distance threshold of 4mm.

Figure 77. The EnSite™ NavX™ Navigation and Visualization Technology setup window.

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This feature requires that the positional reference catheter be located in a stable location throughout the procedure. It is recommended that the coronary sinus (CS) catheter be used for this purpose. The Positional Reference Tool is intended to be used with a multi-electrode positional reference catheter, and requires that the positional reference catheter consist of at least 4 electrodes. The Positional Reference Tool detects positional reference catheter movement by comparing the current position of the positional reference electrode to its past position. The Positional Reference Tool examines all the electrodes on the positional reference catheter to confirm that the detected movement is due to actual physical catheter dislodgement.

By default, this feature is not enabled; however, the user can enable or disable this feature at any time during the procedure. If positional reference catheter movement is detected, the user is provided with several methods to manage the repositioning of the catheter.

NOTE: The Positional Reference Tool can only be enabled if the positional reference catheter has at least 4 electrodes. If fewer than 4 visible electrodes are defined, the Positional Reference Tool will not activate, even if the user attempts to set up and enable the feature.

Chapter 6. Setup

Positional Reference Tool 111EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Setting Up the Positional Reference Tool

NOTE: The Positional Reference Tool requires that the positional reference catheter be located in a stable location. It is recommended that the coronary sinus (CS) catheter be used for this purpose.

The Positional Reference Tool requires a minimum of 4 visible electrodes on the positional reference catheter. The visibility of bad electrodes on the positional reference catheter should be turned off. Refer to the EnSite™ Velocity™ Cardiac Mapping System Instructions for Use for information about changing the visibility of electrodes.

Follow these steps to set up the Positional Reference Tool:

1. Select the positional reference catheter and positional reference electrode from the Positional Reference drop-down menu (Figure 78, right).

2. Check the Catheter in desired location box.

3. Check the Enable Positional Reference Tool box.

The system will display a message (Figure 80, below) and a progress bar while

the Positional Reference Tool is being enabled, and another message when the Positional Reference Tool is enabled (Figure 80, below). The catheter must be kept in a stable position and not disturbed for the duration of the Positional Reference Tool’s initialization.

NOTE: Initializing the Positional Reference Tool takes approximately 10 seconds from the time that the [Accept] button is clicked.

Figure 78. A: These controls are used to set up the Positional Reference Tool. B: These controls are used to correct dislodgement.

A

B

Figure 79. Progress bar monitors percent completion of catheter repositioning

Figure 80. The message on the left appears when Positional Reference Tool is being enabled. The message on the right appears after the

Positional Reference Tool is enabled.




Positional Reference Catheter Dislodgement

When the Positional Reference Tool detects that the positional reference catheter has moved at least 4mm from its previous location, a message will be displayed (see Figure 81, right).

CAUTION: Model points, mapping points, and map tags (labels, lesions, shadows, etc.) placed at EnGuide within approximately 15 seconds prior to notification of dislodgement may not be based on the previous location of the positional reference catheter. The user should confirm whether these points are valid.After a dislodgement has been detected, the Positional Reference Tool gives users the option to take immediate action (click [Adjust Now]) or to take action later (click [Adjust Later]).

CAUTION: If the [Adjust Later] button is selected, the user must be aware that any tasks that rely on the positional reference catheter’s location may be affected. These tasks include collecting model points, collecting mapping points, placing labels, placing lesions, etc.

CAUTION: The Positional Reference Tool will not monitor positional reference catheter dislodgements if [Adjust Later] is selected. To re-enable the Positional Reference Tool and accept the new location of the positional reference electrode after a dislodgement has been detected, click on [Accept] (see Figure 78 on page 111).

NOTE: If the user wants to reset the Positional Reference Tool and not accept the new location, they should uncheck then recheck the Positional Reference Tool enabled checkbox shown in Figure 78 on page 111.

CAUTION: In the event that the system notifies the user of both an EnSite™ Velocity™ patch error and a Positional Reference Tool dislodgement message, the EnSite™ Velocity™patch error should be addressed first.

CAUTION: In the event that the system notifies the user of both an EnSite™ Velocity™patch error and a Positional Reference Tool dislodgement message, the user should verify that the positional reference catheter has physically moved.

CAUTION: Sudden impedance changes of the body or catheter electrodes caused by the connection of other devices (e.g., stimulator, defibrillator, and other devices) may trigger the Positional Reference Tool. The user should verify the movement before accepting the adjustment.

How to Verify Positional Reference Catheter Dislodgement

The user should assess the validity of the positional reference catheter dislodgement prior to clicking the [Accept] button in the Positional Reference Tool window. Once the Positional Reference Tool window is open (see Figure 78 on page 111), the map display will show a preview of the catheter locations as if the [Accept] button was clicked. If the user wants to reset the Positional Reference Tool and not accept the new locations, the user should uncheck and recheck the Positional Reference Tool via the check box shown in Figure 78 on page 111.

The steps below discuss how to assess the validity of the dislodgement prior to accepting the new positional reference electrode location. With the Positional Reference Tool window open:

1. Assess the position of all the catheters within the EnSite™ NavX™ Navigation and Visualization Technology field relative to the created geometry and other known landmarks.

2. Validate against fluoro (if needed).

3. If the catheters are shown in appropriate positions, the user should click [Accept] and the Positional Reference Tool will adjust and re-initialize. If the user does not think the catheters are shown in the appropriate locations, the user can disable and then re-enable the Positional Reference Tool by using the check box shown in Figure 78 on page 111. This will disregard the notification and will not update the position of the catheters.

NOTE: Whenever the user clicks [Accept] the positional reference must be kept in a stable position and not be disturbed for the duration of the Positional Reference Tool’s re-initialization.

Figure 81. This message is displayed when the positional reference electrode becomes dislodged.

Chapter 6. Setup

Positional Reference Tool 113EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Managing Positional Reference Catheter Dislodgement

Managing the dislodgement of the positional reference catheter is done in the EnSite™ NavX™ Navigation and Visualization Technology Setup task. If [Adjust Now] was clicked at the time of dislodgement notification, the system will immediately enter the EnSite™ NavX™ Navigation and Visualization Technology Setup task. If [Adjust Later] was clicked at the time of dislodgement notification, the user will need to manually enter the EnSite™ NavX™ Navigation and Visualization Technology Setup task. When the EnSite™ NavX™ Navigation and Visualization Technology Setup task is entered (either by selecting [Adjust Now] or manually selecting the EnSite™ NavX™ Navigation and Visualization Technology Setup task in the Setup Workflow section) the display will show the current location of the positional reference catheter as well as a preview of where the other catheters will be located if the adjustment is accepted. A yellow sphere will surround the previous location of the selected electrode on the positional reference catheter and a dashed line will connect the current location of the selected electrode with the previous location of that same electrode (see Figure 82 below).

The user can choose to manually reposition the positional reference electrode using the yellow sphere and dashed line as a guide (catheter movement will appear damped). To return the positional reference electrode to its previous position, move the positional reference catheter until the positional reference electrode moves into the yellow sphere and the sphere turns green (see Figure 82 below). The yellow sphere will turn green once the selected electrode is within 4mm of the previous location. When satisfied with the readjusted position, click [Accept]. This will reset the Positional Reference Tool with the new coordinates of the selected electrode. When the user selects [Accept] the new location of the positional reference catheter is set. All other catheters will be displayed relative to this new position.

The user can also choose to click [Accept] without manually repositioning the positional reference catheter. This will also reset the Positional Reference Tool with the new coordinates of the selected electrode. When the user selects [Accept] the new location of the positional reference catheter is set. All other catheters will be displayed relative to this new position. The user should ensure that the positional reference catheter is in a clinically appropriate, stable location before clicking [Accept].

A progress bar (beneath the control panel) can be seen while the re-initialization is in progress (see Figure 83, right). When complete, the system will be ready for continued operation. During that time, some catheters may temporarily appear to have shifted.

Re-initializing the Positional Reference Tool takes approximately 10 seconds from the time that the [Accept] button is selected.

A

C

D

B E

Figure 82. A and B show the previous position of the positional reference catheter and electrode. C and D show the current position of the positional reference catheter and electrode.To return the positional reference electrode to its previous position, move catheter

C until electrode D is within the yellow sphere, in which case the yellow sphere will turn green. E shows the positional reference electrode properly adjusted.

Figure 83. Progress bar monitors percent completion of catheter repositioning


Respiration Compensation


Respiration Compensation

(All studies)

The Respiration Compensation feature is used to compensate for catheter movement caused by a patient’s breathing. It may facilitate more consistent model creation and lesion marking, and improve navigation stability while placing lesions.

Before Respiration Compensation can be used, the system needs to briefly monitor the patient’s respiration in order to collect respiration data and calculate a respiration range.

During respiration data collection, all catheters must be in stable positions; then, over a period of 12 seconds, the system collects the x-y-z coordinate of all located electrodes and the impedance values of all EnSite™ Velocity™surface electrodes. The system identifies respiration by a gradual rise in intrathoracic impedance of the EnSite™ Velocity™surface electrodes. The lowest and highest impedance values sampled during data collection define the respiration range. This range is referred to as the Respiration Compensation range.

When respiration data collection is complete, an automatic segment is recorded and Respiration Compensation monitors the EnSite™ Velocity™surface electrodes for the impedance pattern of respiration; when respiration occurs, navigation on each electrode is gradually compensated in correlation with the degree of the impedance change.

When respiration compensation is applied, the system will continually monitor the respiration motion of the catheters and gradually update the compensation values throughout the study when the individual catheters are in a stable position.

NOTE: If a new electrode or catheter is defined after respiration data collection completes, the user should manually recollect respiration compensation data.

NOTE: Visibility of bad electrodes on a catheter should be turned off in order to have Respiration Compensation applied to a catheter. Refer to “Catheter Input Settings” on page 102 for instruction).

NOTE: Respiration Compensation is not applied to the Positional Reference electrode.

NOTE: Respiration Compensation can be turned on and off. If it is turned off and then turned on, it uses the previously collected respiration data.

NOTE: Respiration Compensation data can be manually collected at any time during a study.

Collecting Respiration Data

(All studies)

The [Collect Respiration Data] button appears on the NavX Utilities subtask on the Setup Task or in the Meters Display in the Tool Bar.

To collect Respiration Compensation data:

1. Be sure that the patient is in a stable respiration pattern and that all catheters are in stable positions.

2. Click [Collect Respiration Data]. Data collection takes approximately 12 seconds. During this time, a progress box is displayed (see Figure 84, right). When data collection is complete, Respiration Compensation is applied and Apply Respiration Compensation and Apply Respiration Rejection are turned on.

To disable Respiration Compensation, turn off the Apply Respiration Compensation checkbox. Compensation values are saved, and can be re-applied at any time.

Figure 84. Respiration Compensation progress bar.

Chapter 6. Setup

Respiration Compensation 115EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


To cancel Respiration Compensation Data collection. click the Cancel button on the progress box (see Figure 84, right). When Respiration Compensation Data collection is canceled, Apply Respiration Compensation and Apply Respiration Rejection are turned off.

NOTE: If desired, a respiratory waveform computed from surface electrode impedances can be displayed in the Waveform Display.

Respiration data can be re-collected at any time during a study. To do so, click on the Meter Displays icon on the tool palette and then click the Collect Respiration Compensation button, or click the Collect Respiration Compensation button on the control panel in the EnSite™ NavX™ Navigation and Visualization Technology Setup task. The re-computed Respiration Compensation values replace all previous Respiration Compensation values.

Re-collecting respiration data is recommended in all of the following situations:

■ After adding electrodes that were not present during Respiration Compensation data collection.

■ After significantly moving a catheter within the heart (e.g., left atrium to right atrium).

■ After significant changes in respiration, such as moving the patient onto or off of a ventilator.

■ Any time that respiratory motion is visible on EnGuide navigation.

■ After the user resolves any EnSite™ Velocity™ errors.

Adaptive Respiration Compensation

Select the Update Respiration Compensation check box to enable. Once enabled, Respiration Compensation will continue to monitor respiration and adapt the compensation applied to any slow changes in the respiratory pattern. Deselect this feature to unapply the update of Respiration Compensation if desired, making Respiration Compensation static rather than adaptive.

Adaptive Respiration compensation is best used when a controlled and regular respiration pattern is expected such as when general anesthesia is used for patient sedation.

Adaptive Respiration should be disabled when there is the potential for irregular respiration such as coughing or sleep apnea such as when conscious sedation is used.

Respiration Rejection

(All studies)

NOTE: Respiration data must be collected to use the Respiration Rejection feature.

The Respiration Rejection feature is used to suspend model point collection and labeling functions when the patient’s respiration falls outside of a percentage of the Respiration Compensation range.

When the Respiration Rejection criteria is met, the Respiration Meter outline flashes red, and all displayed electrodes flash yellow, and the following functions are suspended:

■ Model point collection

■ Map labels at the Active Electrode

■ Lesion markers at the Active Electrode

■ Shadow at selected EnGuide

■ Map points

When patient respiration returns to within the Respiratory Rejection threshold, the Respiration Meter outline and displayed electrodes return to their normal color and the suspended functions resume.

To set the Respiration Rejection threshold, drag the purple bar in the Respiration Meter up or down.

To turn off Respiration Rejection, uncheck the Apply Respiration Rejection checkbox.


EnGuide Alignment


Respiration Meter

(EnSite™ NavX™ Navigation and Visualization Technology studies, Realtime only)

The Respiration Meter (Figure 85, right) shows the current level of respiration, as computed by the relative impedance on the EnSite™ NavX™ Navigation and Visualization Technology surface electrodes. The data in this display is identical to the respiration waveform available in the Waveform Display. The units on the meter are a percentage of the Respiration Compensation range based on the Respiration Rejection sensitivity setting. The Respiration Meter is turned on by selecting the Meter Displays icon on the Tool Palette and checking the Respiration Meter checkbox. The Respiration Meter will display by default when Respiration Data has been collected.

If Respiration Rejection is turned on, when the Respiration Rejection criteria is met, the Respiration Meter outline flashes red, all displayed electrodes flash yellow, model point collection stops, and labeling is disabled. When patient respiration returns to within the Respiratory Rejection threshold, the Respiration Meter outline and displayed electrode return to their normal color and the suspended functions resume.

EnGuide Alignment

(EnSite™ NavX™ Navigation and Visualization Technology studies only)

In the control panel, click [Show EnGuide Alignment] to initiate EnGuide Alignment. If there are changes in catheter location that cannot be adapted by navigating the positional reference electrode, EnGuide Alignment allows for visually realigning the catheter to the model along the x-y-z- axes.

EnGuide Alignment is used to visually adjust the alignment of EnGuides relative to the model. To align the EnGuides in the workspace, hold down the <Shift> key and the middle mouse button, and drag the mouse. While dragging the mouse, the EnGuides will move, but the model remains stationary. Use the middle mouse button to rotate the model. Use the [Apply] checkbox to switch between the aligned (checkbox on) and unaligned (checkbox off) states. When satisfied with the alignment, click [Accept].

Saturation Recovery

(All studies)

Signals may become saturated by high energy sources such as a defibrillation pulse. Saturation Recovery allows the quick recovery of signals to facilitate identification of post-therapy complexes.

1. From the menu bar, select Amplifier > Settings > Saturation Recovery.

2. Use the Duration in Seconds slider bar to set the duration of the recovery period from 0.2 to 2.0 seconds.

3. Click [Recover Now] to Start Saturation Recovery.

Hot key: <F8> starts Saturation Recovery.

NOTE: Signals in the Waveforms Display turn purple during Saturation Recovery.

Figure 85. Respiration Meter.

Figure 86. Saturation Recovery controls.

Chapter 6. Setup

Signal Filters 117EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Signal Filters

Table 18. Signal filter descriptions and default settings.

Filter Description Settings Default Setting

ECG EP Catheter EnSite™ Array™

Bipolar Unipolar NavX

Unipolar Array

Noise Noise filters are 50 - 60 Hz notch filters that reduce powerline noise. Available settings are On/Off. To adjust the powerline frequency and filter, see “Setting the Powerline Frequency” on page 228.

OFF, ON OFF OFF OFF OFF OFF

Highpass Highpass filters reduce low-frequency signals (i.e., repolarization signals) and baseline drift.

0.05, 0.5, 1, 2, 5, 10, 20, 30, 40

Hz

0.5 Hz 30 Hz 2 Hz 2 Hz 2 Hz

Lowpass Lowpass filters reduce high-frequency signals commonly caused by electronic interference.

500, 400, 300, 200, 100, 60,

50, 40, 30, 20, 10 Hz

50 Hz 300 Hz 300 Hz 100 Hz 100 Hz

Spatial (EnSite™ Array™ signals only) Spatial Filters optimize signals based on the placement of the EnSite™ Array™. For right atrial placements, the spatial filter should be turned on.

OFF, ON — — — ON


Signal Filters



Model
CHAPTER 7
The EnGuide Navigation System

The EnGuide navigation system is used to display catheters and electrodes. The display of an EP catheter in the model window display is called an EnGuide.

NOTE: The maximum catheter Navigation Accuracy error is 2.0mm in an EnSite™ NavX™ field scaled model.

The EnGuide navigation system is turned on and off with the Active EnGuide control. See Figure 87 on page 119.

■ To turn the EnGuide navigation system on, set the Active EnGuide control to any catheter.

■ To turn the EnGuide navigation system off, set the Active EnGuide to None. When the EnGuide navigation system is off, no EnGuides are displayed. Turning off the EnGuide navigation system can remove the appearance of the EnGuide signal on recording systems. The EnGuide signal may appear on the other recording systems on the located catheter when using the Array application and on the surface ECG when using the NavX application.

Hot key: <Shift>+<F5> switches the EnGuide signal between off and the most recently used active catheter. In NavX, using this Hot key toggles all located and visible catheters.

Setting up EnGuide Navigation

(Realtime mode only)

The EnGuide navigation system can be used to locate one or more conventional EP catheters. The maximum number of electrodes that can be located varies by study type. For EnSite™ NavX™ Navigation and Visualization Technology studies, the maximum number of electrodes that can be located is 132, and the maximum number of electrodes per catheter is 32. For EnSite Array studies, the maximum number of electrodes that can be located is 4, and the maximum number of electrodes per catheter is 32. See “Connecting Diagnostic Catheters” on page 66 for information about which catheter inputs can be located in Array studies.EnGuide setup is typically done as a part of the Setup task at the beginning of a study. Refer to “EP Catheter Setup” on page 97 for more information.

If an EnGuide is displaying fewer electrodes than expected (based on catheter settings), the electrodes may be too close to one another for the EnGuide to display different electrodes, or there may be a problem with an electrode, such as a short.

Active EnGuide and Active Electrode

The Active EnGuide and Active Electrode are the catheter and electrode that are used for creating surfaces, placing labels, placing lesions, and collecting points for maps.

The controls for selecting the Active EnGuide and Active Electrode are located at the left side of the Tool Bar. Use the drop-down menus to change these values. The Active Electrode is green; all other electrodes are silver (Figure 87 on page 119).

Figure 87. The Active EnGuide and Active Electrode controls. The Active Electrode is green.

120 Chapter 7. Model

The EnGuide Navigation System


EnGuide Responsiveness

The response speed between catheter motion and the EnGuide navigation display is adjustable using the EnGuide Responsiveness slider on the EnGuide Displays on the Tool Palette, as shown in Figure 88 on page 120.

Faster response settings show all catheter motion, while more stable settings may reduce the influence of respiration and cardiac motion. The default setting for EnSite™ NavX™ Navigation and Visualization Technology is mid-range. For EnSite Array™ Catheter studies, the default setting is “Fast”.

EnGuide Proximity Indicator

The EnGuide proximity indicator represents the position of the Active Electrode. The position of the indicator is size scaled based upon the distance from the Active Electrode to the closest model surface. The proximity indicator is drawn on the surface as a colored translucent spot, matching the color of the Active Electrode (Figure 89 on page 120). The maximum diameter of the proximity indicator can be displayed based on either the current lesion size or by checking the Fixed Proximity Indicator box, located under the drop-down menu in the map display under the eyeball. See “Map Settings Properties” on page 141 for more information on the Fixed Proximity Indicator.

NOTE: The Proximity Indicator only displays on finished surfaces.

Surface Proximity

The surface proximity distance is the distance from the Active Electrode to the model or DIF surface (Fusion must be applied). To display this measurement on an EnSite™ NavX™ Navigation and Visualization Technology model, field scaling must be applied. The proximity distance is displayed at the bottom of the map display in the following fashion: the current value, followed by the average calculated value over 12 seconds, shown in parentheses. A negative value indicates that the electrode is inside the model surface, while a positive value indicates the electrode is outside the model surface. The surface distance can be disabled by unchecking the Proximity to Surface checkbox, located under the Meter Displays menu on the Tool Palette.

NOTE: The surface distance is displayed even if the EnGuide proximity indicator is not displayed.

R Value and Z Value


When the EnGuide navigation system is on, R values and Z values appear at the bottom of the map display. (Refer to labels A and B in Figure 90 on page 120).

■ R Value (label A) - is the distance in millimeters from the center of the electrode array on the EnSite Array to the Active Electrode.

NOTE: For the most accurate electrogram reconstruction, the R Value should be within 40 mm.

■ Z Value (label B) - is the distance in millimeters of the Active Electrode above or below the equator of the electrode array on the EnSite Array. When the Active Electrode is nearer to the distal end of the EnSite™ Array™ Catheter, the Z value is negative. When the Active Electrode is nearer to the proximal end of the electrode array, the Z value is positive.

Figure 88. The EnGuide Displays settings menu.

Figure 89. The proximity indicator is a green spot on the surface nearest the Active Electrode.

A

B

Figure 90. A: R value; B: Z value.

Chapter 7. Model

The EnGuide Navigation System 121EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


EnGuide Navigation Indicators

EnGuide electrodes change color to indicate various conditions.

■ Green or silver – Conditions are normal.

■ Blinking Yellow/Green – (EnSite Array studies only) This condition only occurs if a problem is indicated in the Active Electrode.

■ Yellow – (EnSite™ Array™ Catheter studies only) The preselected EP catheter electrode is more than 6 cm from the EnSite™ Array™ Catheter, or the EnGuide signal is weak. If electrodes within 6 cm of the array appear in yellow, there may be a problem with the catheter. A new catheter or connecting cable may display better results.

■ Yellow – (All studies) The Respiratory Rejection threshold has been met when the Active Electrode is blinking yellow and the electrodes on all EnGuides are colored yellow.

■ Yellow – (All studies) The Velocity Filter threshold has been exceeded when electrodes on any catheter are colored yellow.

■ Blinking red – There is a significant error. The location may be unreliable and 3D graphics (labels, lesions) cannot be placed at the Active EnGuide.

– EnSite™ Array™ Catheter studies: If the Active Electrode is red, the locator points straight out of the end of the array.

– EnSite™ NavX™ Navigation and Visualization Technology studies: If the EnGuide electrodes turn red and point upward, there is a problem with one of the following: A surface electrode, the Active Electrode, a Non-Active EnGuide at the distal electrode. A warning appears indicating which electrode is causing the problem. See “Troubleshooting” on page 215.

Velocity Filter and Velocity Meter

(All studies)

The Velocity Filter prevents model point collection during rapid catheter movements. When the velocity of any electrode used to collect model points exceeds a user-specified percentage of the electrode’s velocity (the velocity threshold), model point collection is suspended only for those electrodes exceeding the threshold for a user-specified period of time.

Model point collection resumes after the lockout period only if the velocity of all electrodes has returned to a value below the velocity threshold. Velocity Filter settings are active only during model creation.

The Velocity Meter shows the relative velocity of the Active Electrode (green bar) and the velocity threshold (purple bar). The meter’s border, normally white, flashes red if the velocity exceeds the velocity threshold during model edit or OneMap.

To display the Velocity Filter controls, click on the Meter Display icon in the Tool Palette. Put a check in the Velocity Filter checkbox to turn the Velocity Filter on. Uncheck the box to turn the filter off. Use the Filter Lockout in Seconds slider to set the collection lockout period. The Velocity threshold value can be set by dragging the purple threshold line, in the Velocity meter, to the desired location.

Figure 91. Velocity Meter and Velocity Filter controls.


Modeling


Modeling

The EnSite™ Velocity™ Cardiac Mapping System displays contoured, three-dimensional surface models of the patient’s cardiac anatomy. The purpose of creating a model is to collect and label the anatomic locations within the chamber. The software does not assume a specific chamber shape; therefore, it is important to collect enough points to provide sufficient chamber definition. A single model may consist of multiple surfaces.

A surface is created by dragging a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points. This process can be repeated to create multiple surfaces. If surfaces in the same group overlap, the surfaces combine and the overlapping section is clipped away.

WARNING: The EnSite™ Velocity™ Cardiac Mapping System model display should be used in conjunction with conventional EP techniques to confirm catheter location.

NOTE: A model is not required for EnSite™ NavX™ Navigation and Visualization Technology studies, but is required in order to use Field Scaling. Field Scaling is based on model points collected and requires that model points collected include representations of all 3 axes in all areas of the model. Known interelectrode spacing used to create the model is used to adjust the dimensions of the navigation field.

CAUTION: (EnSite™ Array™ Catheter studies) If the EnSite™ Array™ Catheter is repositioned or unintentionally moved, a new model must be created. If a new EnSite™ Array™ Catheter is introduced, the new catheter must be validated and a new study started.

Respiration Gating

The Respiration Compensation algorithm (“Respiration Compensation” on page 114) is used to compensate for the changes in the impedance field.

Model Presets

Model presets are used to initialize a model using a predefined list of surfaces. When a model preset is loaded, the surfaces don't exist, but they have properties such as names and colors. This list can serve as a starting point for which surfaces to collect points. Model presets tend to fall into two categories. A study-type model preset is for surfaces that are appropriate for a specific study type. An anatomy study-type model preset is for surfaces that refer to a specific anatomical group.

The following attributes are included in model preset: color, name, grid type, show, detail level (surface type), fill level, group.

Loading a Model Preset

(Realtime Only)

To load a Model Preset, open the Preset menu in the upper-right corner of the control panel and select a preset from the list.

After the preset is loaded, the Surface List is populated with surface names saved in the model preset. To modify a surface in the list, select the surface.

Figure 92. Respiration Gating Display

Figure 93. Model Preset Menu.

Chapter 7. Model

Modeling 123EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Saving a New Model Preset

To save the current model setup as a preset, open the Preset menu in the upper-right corner of the control panel and select Save Preset. In the Save Preset window, type a name for the preset, and then click [OK].

Deleting or Renaming a Model Preset

To delete or rename a preset for the current physician, open the Preset menu in the upper-right corner of the control panel and select Manage Presets. In the Manage Presets window, select a preset from the list. To delete the preset, click [Delete]. To rename the preset, double-click on the name then type the new name, or select the preset to be renamed then click on [Rename]. To add a note for the preset, type in the Note text area. When renaming is complete, click [Close].

Figure 94. Save Preset.

Figure 95. Manage Presets.


Modeling


Model Control Panel

From. Points can be collected using the active electrode, all electrodes on the active EnGuide, or all electrodes on all EnGuides. Select from the drop-down menu.

Collect Points. Clicking on this button allows the user to continually collect points to create a surface model.

Name. The name of the surface. Select a name from the drop-down menu, or type a name.

Group. The Group drop-down menu allows a surface to be associated, generally in terms of blood pool. Selections are Left, Right, and Other. Overlapping surfaces from the same group are automatically cut away. Overlapping surfaces from different groups are not cut away.

Type. These radio buttons control the level of surface detail. Select High or Low when not creating the model with the OneModel tool. Select OneModel when using the OneModel tool to create the model.

Center. (For Type set to High or Low only) Controls how the center of the model is defined.

■ Auto – The center of the model is based on the average location of the points collected. Auto is the default setting.

■ EnGuide – The center of a model is at the Active Electrode.

■ Fixed – In EnSite Array studies, the first surface uses the Fixed setting and cannot be changed. The surface uses the EnSite Array as the center point.

Fill. Controls the level of surface detail. As the slider is dragged to the right, the surface detail smooths.

Points. This dropdown menu shows/hides the collected points. Hiding points is useful if they begin to obscure navigation. Showing points is useful for evaluating areas requiring further collection.

[Delete Points]. When enabled, the [Delete Points] function allows the user to use the mouse to erase selected points from the model.

[Discard Changes]. Discards model point editing on the selected surface except for a reassigned or copied point.

CAUTION: Discard Changes will delete all surfaces if the model has not been finished at least once.

Show/Hide Field Scaling. Field Scaling can be computed and applied if point collection is not in progress and catheter electrode spacing has been specified.

Edit Surface – When selected, the currently selected surface can be edited.

Edit Points – When selected, point editing is active. To select points in the selected surface, click and drag to create a closed loop around the desired points. Once the loop is closed the selected points will be highlighted. These points can then be deleted, assigned to another surface, or copied to another surface.

The delete operation can be undone by clicking [Undo].

Color Picker – Next to the surface Name drop-down menu, there is a colored square. Click this button to bring up a menu of color options for the surface.

Figure 96. Model control panel.

Chapter 7. Model

Collecting Surface Points 125EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Color Chart and Visibility Selector

A. Group. The name of the group to which the surfaces belong.

B. Color Chart. Use the color chart to select a color for the item. Click on the colored square to open the color chart, and then click on the desired color.

C. Grid. The number of clicks (1, 2, or 3) on cylinder will determine where a surface grid is placed on the model. Clicking once, places the grid on the interior of the model, clicking twice, places the grid on the exterior of the surface. Clicking a third time turns the grid off.

D. Include/Exclude. This checkbox controls whether a surface is displayed in the model. When the check mark is visible, the surface is displayed for labeling, intersecting, and overlapping surfaces. When the checkbox is unchecked, the entire surface is excluded from view.

E. Show/Hide. Use the visibility icon to show or hide the item. When the icon is showing, the item is visible. To hide the item, click on the icon. Hiding an item does not delete the item.

Collecting Surface Points

(Realtime mode only and requires that the EnGuide navigation system be enabled.)

NOTE: For studies where Field Scaling is used, be sure that appropriate interelectrode spacing and size are specified for any catheter that is used for collecting points.


NOTE: For optimal use of the Field Scaling feature, the points collected should represent all 3 axes (x-y-z) in all areas of the model.

Collect Points

1. Set the Active EnGuide that is to be used to collect points.

2. Click the [+] button in the control panel to create a new surface.

3. Use the Name drop-down to select an existing surface name, or type the name of the new surface.

4. Use the Group drop-down to associate the surface with a group: Left, Right, or Other.

5. Click [Collect Points] to begin collecting points on and between electrodes of the Active EnGuide. Drag the catheter along the chamber walls and throughout the interior to create a surface.

A surface appears:

■ For an EnSite™ Array™ Catheter study, the first surface appears around the wireframe of the EnSite™ Array™ Catheter.

■ For subsequent surfaces of EnSite™ Array™ Catheter and all EnSite™ NavX™ Navigation and Visualization Technology studies, the surface begins at the center of the Active EnGuide. This does not apply to surfaces created with the OneModel tool.

6. Click [Stop Collecting Points] to stop collecting points.

7. Click [Finish Model] when model creation is complete. Otherwise, repeat steps 1-6 for all additional surfaces.

Figure 97. Color Chart & Visibility Selector.


Collecting Surface Points


Edit Points

As the model is created, use the following controls in the control panel to inspect and adjust the model.

■ To delete points, click the [Delete Points] button (which then changes to [Stop Deleting]). The mouse pointer becomes a square eraser. Move the eraser over the points to be deleted, and click the left-mouse button to delete. Clicking and holding the mouse button erases points by dragging. To return recently deleted points to the surface, click [Undo Delete]. To stop deleting points, click the [Stop Deleting] button; once this is done, [Undo Delete] is not possible.

■ Use the Edit Points tool to move or copy points from the current surface to another surface, or to delete a large group of points. Click the Edit Points icon, and then click on the map display to form a closed shape around the group of points to be reassigned. The points on the interior of the closed shape turn red. The map can then be rotated to confirm appropriate selection. Use the Assign to drop-down menu to move the points, or the Copy to drop-down menu to copy the points, to one of the available options:

– New assigns the points to a new surface.

– Delete removes the points.

– Existing surface. Selecting the name of an existing surface assigns the points to that surface.

NOTE: Reassigned and copied points cannot be undone by the [Discard Changes] function.

Figure 98. The Reassign tool can be used to move points from one surface to another.

Chapter 7. Model

OneModel Tool 127EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


OneModel Tool

(All studies)

The OneModel tool is a cardiac model creation tool that wraps the model surface tightly around collected points without tying it back to a center point. It provides enhanced anatomic detail of the cardiac model when creating a single surface model, and reduces the time required to create a finished model without requiring the user to change the point collection techniques.

Type. These checkboxes determine the method used by the system to create a model with the collected points. Select the OneModel checkbox to use the OneModel Tool to create the model.

NOTE: When creating the model, the user can switch back and forth between definition Types: High, Low, and OneModel. Items projected onto the surface may adjust their positions based on the surface generated by each type.

Fill. (with OneModel) When using the OneModel Tool, a higher Fill value (shown in the box to the right of the slider) results in more space between collected points being filled in, but with less detail. A lower Fill value has less space filled in, but with finer detail. More points may need to be collected to fill in the gaps.

NOTE: When OneModel is selected, the Center options are grayed out because they are not applicable to the OneModel Tool.

NOTE: Moving surfaces to separate surface groups can help in situations where visible separation between surfaces is desired.

Figure 99. Model control panel


Using the Surface List


Using the Surface List

After creating a model and/or importing a DIF model, the name of each available structure appears in the control panel surface list. The list can contain one model with up to 16 created surfaces and one DIF model with up to 16 surfaces.

NOTE: See EnSite™ Verismo™ Segmentation Tool Instructions For Use for further information on creating multiple-structure DIF models. Structures from DIF models are identified with “DIF.” If the DIF icon is selected, only the DIF control displays.

You can adjust and edit surfaces independently of one another. To adjust a surface attribute, follow these actions:

Figure 100. A: The LSPV is included and shown; B: The LSPV is included, but not shown. The result is a hole in the left atrial body at the points of intersection.

Table 19. Points Display


A Show Surface Click the eyeball icon to show or hide a surface.Note: A created surface can be included, but not shown. This combination leaves a hole at the intersection between surfaces. See Figure 100 on page 128.

B Surface Color Double-click the color and select a color from the color picker.

C Grid (Created surfaces only) Click the grid icon to toggle through the display states:1. Grid off (default)2. Display the Grid on the inside of the surface3. Display the Grid on the outside of the surface

D Name Double-click a surface name and type in the field.

E Include Surface

(Created surfaces only) • Select a checkbox to include a surface.• Deselect a checkbox to not include a surface.• A surface that is not included is not displayed, used for labeling, or intersecting overlapping surfaces.Note: Excluding unnecessary surfaces optimizes performance.

F + Add a surface.

- Delete the selected surface.

A B C D E

F

A B

Chapter 7. Model

Field Scaling 129EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Field Scaling

(EnSite™ NavX™ Navigation and Visualization Technology only and requires a model.)

Field Scaling can be configured to automatically scale model, map, and EnGuide catheter locations and facilitates distance measurements.

EnSite™ NavX™ Navigation and Visualization Technology Field Scaling (NavX)

Field Scaling is based on model points collected in continuous mode by catheters with defined interelectrode spacing.

Average measured interelectrode spacing is collected for all locations within the model. Adjustments to the dimensions of the navigation field are made to match the known interelectrode spacing of the catheters used to create the model.

As the catheter is moved during model creation, the system records the location of the electrodes on the active catheter, as well as the relative change in displayed interelectrode locations.

Field Scaling allows for straight line and surface tape measures in EnSite™ NavX™ Navigation and Visualization Technology. If Field Scaling is not applied, the EnSite™ NavX™ Navigation and Visualization Technology tape measure length is not displayed in the marker area.

NOTE: For studies where Field Scaling is used, be sure that appropriate interelectrode spacing and size are specified for any catheter that is used for collecting points.


NOTE: For optimal use of the Field Scaling feature, the points collected should represent all 3 axes (x-y-z) in all areas of the model.

To apply Field Scaling:

1. Click [Compute] to compute field scaling.

2. The Apply checkbox is automatically checked. To unapply Field Scaling, uncheck the Apply box.

3. (Optional) Select the [Auto] checkbox to enable automatic Field Scaling updates. When sufficient new NavX points are collected, Field Scaling is automatically updated.

Model points are not used for Field Scaling under the following conditions:

■ Electrodes having spacing greater than 11.25 mm (center to center)

■ Collecting with a single electrode

■ Catheters without defined interelectrode spacing or electrode length

Figure 101. NavX Field Scaling controls.


Digital Image Fusion (DIF)



Three-dimensional models created from digital images collected from Spiral CT, MRI, and DEMRI (Delayed Enhancement MRI) can be imported into the EnSite™ Velocity™ Cardiac Mapping System for display.

Creating a Model to Import

Models for import into the EnSite™ Velocity™ Cardiac Mapping System can be created using segmentation tools such as the EnSite™ Verismo™ Segmentation Tool. Refer to “EnSite™ Verismo™ Segmentation Tool Module” on page 265 for information on using Verismo.

When using the EnSite™ Verismo™ Segmentation Tool, the creation of a model involves the following steps.

■ The patient is scanned. See the EnSite™ Verismo™ Segmentation Tool Instructions for Use for the optimal EnSite™ Verismo™ Segmentation Tool scan file characteristics.

■ The scanned image is exported to a CD/DVD in DICOM3 format.

■ The CD/DVD is imported into an EnSite™ Velocity™ Cardiac Mapping System workstation with the EnSite™ Verismo™ Segmentation Tool, and the segmentation process is used to create a DIF file according to the EnSite™ Verismo™ Segmentation Tool Instructions for Use.

■ If the DIF file is created on the same EnSite™ Velocity™ Cardiac Mapping System DWS that will be used during the clinical study, the DIF file can be accessed from the hard drive. If the DIF file will be used on a separate EnSite™ Velocity™ Cardiac Mapping System, the DIF file can be exported to a USB device or CD/DVD for import into the clinical EnSite™ Velocity™

Cardiac Mapping System.

In addition to the DIF file format, the EnSite™ Velocity™ Cardiac Mapping System also supports CardEP file format for digital images, as well as Siemens, Phillips, Toshiba (Vital Images), and Terra Recon formats; however, formats other than DIF may not be able to use all DIF-related functions, such as the ability to show or hide individual chamber surfaces.

Importing a Digital Image

1. Click the DIF icon at the top of the Model control panel.

2. From the DIF control panel, click [Load DIF...]. The Import DIF window appears (Figure 103 on page 130).

NOTE: For loading DIF files before validation, select File > Load DIF...

3. From the Load DIF window, select a DIF file for import. Select a source, either HardDrive or DVD/CD, for import from the drop-down menu at the top left corner of the window.

■ HardDrive – DIF files created by the EnSite™ Verismo™ Segmentation Tool on the same EnSite™ Velocity™ Cardiac Mapping System DWS are stored on the workstation’s hard drive. As additional models are added, the oldest models are deleted first. Models can also be manually deleted by selecting a model from the list and clicking [Delete]. (Figure 103 ).

Figure 102. An imported DIF left atrium.

Figure 103. The Import Digital Images window, Hard Drive.

Chapter 7. Model

Digital Image Fusion (DIF) 131EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


■ DVD/CD – Digital image models can be imported via DVD and CD. Models can be formatted as Digital Image Fusion (.xml), or GE DICOM3 models processed using CardEP software. For GE CardEP models, the original CD/DVD from the GE workstation is required for import, not just the file of the model itself. Select an image type to display the appropriate models. (Figure 104 ).

4. Select [Load] to load the model.

NOTE: The colors applied to the DIF model are the EnSite™ Velocity™ Cardiac Mapping System software model colors, not the colors that were used during segmentation.

Additional Options for DIF Files

Models created by the EnSite™ Verismo™ Segmentation Tool have additional features:

Patient information. In the Import Digital Image window, models are displayed with information from the patient, scan, and saved model name. Clicking on the category name at the top of a column sorts the data by that column.

DIF viewer – A viewer is available for previewing DIF models. Select [View] to display the selected DIF model. The following controls are available in the viewer:

■ Rotate – Hold down the middle mouse button and drag.

■ Zoom – Use the roller wheel on the mouse.

■ Wireframe – Options > Wireframe.

■ Bounding box display – Options > Bounding Box.

■ Default views – Views > AP/PA/LL/RL/CRA/CAU.

Viewing a DIF Image for Reference

DIF models can be shown or hidden by clicking on the Show DIF Model checkbox in Map Settings.

■ The digital image appears in the map display.

■ To compare the two models, select Dual View. The EnSite™ Velocity™ Cardiac Mapping System model appears on the left side of the screen, and the DIF model appears on the right side of the screen.

Digital images are saved with rotational information included. The orientation reference will automatically appear for the digital image.

■ In an EnSite™ Array™ Catheter study, the EnSite™ Velocity™ Cardiac Mapping System model and DIF model rotate together when an AP view is saved for the map display.

■ In an EnSite™ NavX™ Navigation and Visualization Technology study, the EnSite™ Velocity™ Cardiac Mapping System model and DIF model rotate together when EnSite™ NavX™ Navigation and Visualization Technology is validated.

NOTE: Clipping, Map Scale, rotation, spin, Edge Enhancement, and panning can be used to change the appearance of the model.

Figure 104. The Import Digital Images window, DVD/CD.




DEMRI (Delayed Enhancement MRI) Image Integration

The use of delayed enhancement MRI is sometimes used to analyze areas of electrically nonviable tissues such as areas of fibrosis, scar, or ischemia. The import of this model type into the EnSite™ Velocity™ System may provide a faster, higher resolution of substrate over traditional voltage mapping. The system can now accept Visualization Tool Kit files, or VTK files, and Visualization Toolkit Polygons, or VTP files. These files are created from a third-party application rather than through the EnSite™ Verismo™ Segmentation Tool.

Once imported, interaction is similar to a DIF file, with options to view or use with the EnSite™ Fusion™ Registration module. The DIF list (Figure 106 - 1) shows both surfaces and associated maps as defined in the third party application. The color spectrum bar on the left (Figure 106 - 2) is displayed just as it is for timing and voltage maps within the system. One map tool data set (Figure 106 - 3) can be displayed on the surface at a time.

NOTE: If using this model in the EnSite™ Fusion™ Registration process, in single map display, you’ll be able to either visualize the associated imported map or project a contact map on the surface, but not both.

In Split Screen mode, you can display an EnSite model in one screen and the DEMRI in the other.

File limitations for VTK or VTP files include:

■ Total number of vertices cannot exceed 1,000,000

■ Total number of polygons cannot exceed 2,000,000

■ Polygons are limited to only containing three points (triangles)

■ Only one occurrence of the <Piece> tag is supported

Figure 105. DEMRI Image

Figure 106. Imported DEMRI Image

1

2

3


Waveforms
CHAPTER 8
Using the Waveform Display

A typical waveform display that is used in the Model, Therapy, and RealReview tasks is shown in Figure 107 below.

Figure 107. Waveform display for Model, Therapy, and RealReview tasks.

A. Waveforms – Signals can be simultaneously displayed as waveforms. Each waveform consists of a label and a trace. The label identifies the source of the signal, and includes whether the signal is unfiltered, whether contact catheters are unipolar, the signal label, and the signal amplitude. If the traces turn purple, then the data should not be used. Purple signal traces are also used to indicate a blanking period and saturation recovery.

B. Time cursor – The time cursor is a vertical yellow line in the waveform display that indicates the time represented by the map display. The specific time represented by the time cursor appears in the lower right corner of the waveform display. The following controls are available for the time cursor in review mode:

■ Left-clicking in the waveform display background (not on a trace) makes the time cursor appear at the mouse pointer.

■ Dragging the time cursor moves the cursor across the waveform display.

NOTE: In Realtime, the cursor is not shown when one or more waves are visible.

C. Time scale – The time scale (in milliseconds) appears at the top edge of the waveform display. Right-click between waveforms in the window to display a menu for setting the sweep speed, font size, and waveform thickness.

D. Calipers – Calipers are used to measure timing between signal features in the waveform display during review mode. See “Using Calipers” on page 135 for information about using calipers.

A

C

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134 Chapter 8. Waveforms




Waveforms can be selected and adjusted by clicking on the waveform in the waveform display.

Selecting waveforms – Shift-left-clicking on a waveform makes the selected trace bold and displays a dotted white line at 0 mV. Selecting a virtual waveform trace highlights the virtual electrode for that trace in the map display and displays the color calipers (Figure 108 on page 134). The color calipers are rail lines indicating the current Color High and Color Low values. Shift-left-click on a waveform again to remove the rail lines and color calipers.

Moving waveforms – To move a waveform, left-click on the waveform and drag up or down.

Adding waveforms – To add a waveform to the waveform display, turn on the waveform’s checkbox in the Traces control panel.

Removing waveforms – To remove a waveform from the waveform display, turn off the waveform’s checkbox in the Traces control panel, or left-click on the waveform and drag it off the left edge of the screen.

Adjusting amplitude – To adjust the waveform amplitude, middle-click the waveform and drag up or down to increase or decrease the amplitude for all waveforms of that signal type. To adjust the amplitude for a single waveform, hold <Shift> + middle-click and drag up or down.

Right click in the black background for waveform options menu:

Sweep Speed – Adjusts the number of mm/sec. in the waveform display (time scale).

Reset Offsets – Evenly spaces all visible waveforms vertically in the waveform display, without changing the order of the display.

Reorder Waveforms – Rearranges the waveforms according to the trace number and types as defined by the order in the Traces control panel (Figure 109 on page 135).

Font Size – Used to select a font size for the label text in the waveform display.

Thickness – Used to adjust the thickness of all waveforms in the waveform display.

Hi/Lo Lines – Doing a shift-left-click on a selected virtual waveform, causes the waveform to bold and for color calipers to display. The color calipers are horizontal rail lines that indicate the current Color High and the current Color Low values of the selected waveform. Doing a shift-left-click again will remove them.

Figure 108. Rails on virtual waveforms correspond to current color bar settings.

Chapter 8. Waveforms

Displaying and Filtering Traces 135EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Displaying and Filtering Traces

Use :the Traces tab (Figure 109 a.) to select the signals to display and the Filters tab (Figure 109 b.) to select the filtering options for the displayed traces. Signals are listed in a tree-like structure and can be checked to be visible or hidden in the Waveform display. The settings for each signal, including the color, d/dt, and filtering can be adjusted. Filters can be turned on or off for individual signals. If the filter settings are changed, the filter settings for all signals in that group are changed. By default, ECG signals, EP catheters, and (for EnSite™ Array™ Catheter studies) Virtuals are included in the Signals List.

(EnSite™ Array™ Catheter studies only) Use the Virtuals control panel to set the properties for virtual electrodes. (For more information refer to “Virtuals” on page 161).

Calipers

How to Create a Caliper

In RealReview or Offline Review, while playing a segment of interest, select the [ll] pause button beneath the waveforms. Then select the caliper button and select the beat of interest in the waveform display. The cursor will change to a plus sign and ”H”.

Using Calipers

Calipers are used to measure timing between signal features in the waveform display during review mode.

■ The caliper is a set of two vertical lines with a horizontal line between them. The time between the vertical lines is displayed above the horizontal line in milliseconds. The frequency is displayed beneath the caliper measurement is greater than 1m Sec.

■ Ten calipers can be placed in a recorded segment, and ten per mapping point in the Mapping Task. The calipers in the Mapping points are saved with the points. Calipers placed in a recorded segment are not saved.

■ To move vertical caliper lines, click on the lines to move that side of the caliper.

■ To move the entire caliper without changing the distance between the vertical lines, middle-click the caliper and drag left or right.

■ To move a horizontal caliper line, left-click and drag the horizontal line up or down.

■ To add a caliper, click the caliper button, next to the [Show/Hide Wave Controls] button.

■ To remove a caliper, left-click and drag the horizontal line past the top or the bottom of the waveform display.

■ Calipers move with the waveform display. When a vertical line or caliper moves outside of the display area, a small arrow appears at the edge of the screen. This arrow can be left-clicked to select the vertical caliper line then dragged to bring the caliper back into the waveform display. The relative caliper position also appears in the segment overview.

Figure 109. A: Waves Control Tab; B: Filters Control Tab

A B

136 Chapter 8. Waveforms

Calipers


Figure 110. Waveform display for Model, Therapy, and RealReview tasks.

Figure 111. Waveform display for Mapping task.

Figure 112. Waveform display for Setup task.


Recording and Playing Segments

CHAPTER 9

Recording Segments

Segment recording is used to save a segment of information to the Notebook for future review. The recording controls are available in Realtime mode and RealReview mode.

1. From the control bar, click the green [Record] button to begin recording. The [Record] button will change to a orange [Stop] button. The recorded segment begins approximately 10 seconds before the [Record] button was clicked. The length of the segment being recorded and the number of segments recorded during the study appear at the top of the Notebook.

Hot key: <F4> key can be used in place of [Record] and [Stop].

2. Click [Stop] to stop recording.

3. An annotation can be added to the segment by typing in the text area on the control bar. Annotations can be added or modified at a later time from the Notebook.

Automatically Recorded Segments

The system automatically records segments. These automatically recorded segments are added to the Notebook where they are identified as Auto Segments. Automatic recording occurs under the following circumstances:

■ After validating

■ When the positional reference is changed

■ When positional reference dislodgement is detected

■ When positional reference dislodgement is adjusted and accepted

■ When the user collects Respiration Compensation data

■ Right-click and select Sheath Filter Baseline

■ When the model is finished

■ Before and after EnGuide Alignment

■ Every 15 minutes

■ At the end of a study

NOTE: Auto segments do not appear in the segment drop down menu.

138 Chapter 9. Recording and Playing Segments

Accessing Recorded Segments


Accessing Recorded Segments

The purpose of the RealReview task and Offline Review mode is to review data recorded during Realtime mode.

To access a recorded segment (RealReview or Offline Review modes) from the same study, use the notebook:

1. From the list, select a recorded segment or bookmark.

2. Select [Load] or double click on the segment or bookmark name, if doing it from the Notebook in Realtime.

A recorded segment can also be accessed from the Segment drop-down menu in the control bar.

Playing Recorded Segments

Figure 113. Play Bar

[] / []. By default, when RealReview mode is first entered, the system waits for the user to select a segment in that study.

■ [] starts the time cursor moving to the right. When the cursor reaches the right edge of the waveform display, segment playback starts over again. After clicking [], the label on the button changes to [].

■ [] pauses playback. After clicking [], the label on the button changes to [].

Time cursor. The time cursor is a vertical yellow line in the waveform display that indicates the time represented by the map display. The specific time represented by the time cursor appears in the lower right corner of the waveform display.

■ Clicking in the waveform display background (not on a trace) makes the time cursor appear at the mouse pointer.

■ Dragging the time cursor moves the cursor across the waveform display.

■ Moving the time cursor in the waveform display also affects the time represented by the map display.

Arrow buttons. While the waveform display is frozen, the left and right arrow buttons move the time cursor one sample to the left or right, respectively. Holding down an arrow button causes the time cursor to scroll. To set a sample (in 1, 10, or 100ms), right click on the right or left arrow keys and make a selection from the windows.

Hot key: The arrow keys on the keyboard can be used to scroll the time cursor left or right.

Review Speed. In Review modes, the Review Speed drop-down menu controls the speed of the time cursor as it moves to the right, which controls how fast the waveforms scroll across the screen. To choose a speed, click on the drop-down menu button and select a speed from the available list: 1:1 (real time speed), 1:2 (half speed), 1:4 (quarter speed), 1:10, 1:25, 1:50, 1:100, 1:200, 1:500, 1:1000, 2:1 (double speed), TurboMap (maximum speed).

Overview – The segment overview shows the length of the entire recorded segment in black. The portion of the entire recorded segment that is shown in the waveform display appears in gray in the Overview.

■ Click and drag the gray area of the Overview to display that area in the waveform display.

■ The time cursor and any placed calipers also appear in the Overview.


Adjusting and Labeling Maps

CHAPTER 10

Table 20. Map Features

Caption Item Description

A Active EnGuide and Active Electrode

The catheter and electrode to use for creating a model, placing labels, and placing lesions.

B Map Selection (Applies to contact maps only, not shown above) Click button to display the list of map names created during a study.

C Dual Views/Single View

Click on this button to select a dual view map/model display or a single view map/model display. The default setting is a single view display.

D Map Settings Click to display a list of checkboxes that control how information is displayed in the map display area.

E Orientation Reference This torso-shaped icon indicates the current orientation of the model by rotating as the model rotates. Select different map views by right-clicking the torso, then selecting from a menu. Refer to “Views and the Orientation Reference” on page 144.

F Color Controls The color bar depicts how the map display translates numerical data into color. The data varies by map type. Refer to “Mapping – Noncontact” on page 159 and “Mapping – Contact” on page 171. • Color High and Color Low handles allow adjustment of current color bar settings. • Double-click numeric values to directly enter values.By right-clicking on the color controls the user is able to change to a Grey Scale.

Figure 114. A Noncontact Isopotential map (left) and (right). Refer to chapters 11 & 12.

AC

B D

EF

G

H

I

J

K

L M

N

140 Chapter 10. Adjusting and Labeling Maps EnSite™ Velocity™ Cardiac Mapping System Instructions for UseARTEN100151580 Rev. A

G Model The model is the representation of the patient’s cardiac chamber. There are several options for adjusting the features of the model. A map can be displayed on the model surface.

H Translucency Slider Adjust the translucency of the image for optimal visualization of objects behind other surfaces.

I Edge Enhancement When enabled, provides a rendering of the model where the body can be translucent but the edge remains distinctly defined.

J Clipping Plane Clipping planes allow for a view of the interior and rear of the closed model by cutting a plane away from the viewing space. The slider provides a smooth, controlled way of adjusting the clipping plane. Unlocking the Clipping Plane deletes it.

K Plane Lock Clipping planes can be locked in the model/map display window. When locked, the orientation remains fixed relative to the model. When unlocked, the orientation is parallel to the screen. To change the orientation of a locked clipping plane, unlock it, rotate, and lock it again.

L Tracking Virtual (EnSite™ Array™ Catheter studies only) The Tracking Virtual indicates the Peak-Negative location on an isopotential map. The tracking virtual waveform displays 100 milliseconds of data, based on the location of the Tracking Virtual. The waveform display can be adjusted by middle-clicking the waveform and dragging up or down.

M Voltage Caliper The Voltage Caliper displays the measured potential at the selected signal of the Active Electrode. To select the signal displayed, right click on the Voltage Caliper and select Select Signal.Select Auto Adjust and the caliper automatically adjusts to the peak to peak value of the waveform.

N Map Highlight When Split Screen is activated, the active view is outlined with a yellow border. To make the other view active, click once on the black background of the non-highlighted view. The following features are available only for the highlighted, active view:• Using the mouse to rotate the model• Hold <Shift> and rotate the mouse wheel to zoom at the pointer position• Adjusting the clipping plane • Adjusting the view scale• Edge Enhancement• Saving or loading a Map View• Using the mouse to delete surface points or place map labels, lesion markers, anatomic markers, tape

measures, or virtual electrodes can only be done in the highlighted view; however, the result of these actions appear in both views.

Table 20. Map Features

Caption Item Description

Chapter 10. Adjusting and Labeling Maps

Map Settings Properties 141EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Map Settings Properties

Label Text On. This checkbox shows/hides the label text for all map labels, anatomic markers, tape measures, lesions, virtuals, and EnGuide Shadows.

Label Show Through. This checkbox allows or prevents label text for all map labels, anatomic markers, tape measures, lesion markers, virtuals, and EnGuide Shadows from showing through other objects.

Show EnSite Model. This checkbox enables/disables the display of the contoured, three-dimensional surface model(s) of a patient’s cardiac anatomy.

Show DIF Model. This checkbox allows the DIF model (i.e., CT scan or MRI) to either be hidden or displayed.

Project on DIF. (After EnSite™ Fusion™ Registration has been performed) Enabling this checkbox allows the user to project or unproject 3D Labels and/or Lesions (referred to as 3DP), and map data onto the DIF surface rather than onto the EnSite™ Velocity™ Cardiac Mapping System model surface.

Show Mapping. Causes surfaces to be colored using the current map color.

Hide Non-Map Surface Groups – Hide surfaces that have no maps projected on them.

Map Transparency On – Check this box to display map colors with values greater than Color High as transparent instead of purple, or (in EnSite™ Array™ Catheter only) charcoal gray in the gray scale scheme. Areas of the contact map that are not colored will be hidden.

NOTE: Do not check the Map Transparency On box unless a map is currently displayed.

Confidence Region – (EnSite™ Array™ Catheter studies only) This checkbox enables or disables a red highlight on areas of the grid that are more than 4cm from the center of the EnSite™ Array™ Catheter. Signal and tape measure accuracy can be decreased in these areas.

Show Proximity Indicator – (EnSite™ NavX™ Navigation and Visualization Technology studies only) This checkbox enables the proximity indicator.

Fixed Proximity Indicator – Enabling this checkbox allows the diameter of the proximity indicator to be set to a maximum of 10mm, regardless of the current lesion size.

Show EnSite Array – (EnSite™ Array™ Catheter studies only) This checkbox shows the EnSite™ Array™ Catheter.

Zoom – Increases/decreases the size of the model in the display window. The middle mouse / scroll wheel can also be used to zoom.

Color Contour – This slider adjusts the gradation between colors on the map. At low Color Contour values, colors appear as distinct bands. At high Color Contour values, there is a smooth transition between colors.

Figure 115. Map settings menu.

142 Chapter 10. Adjusting and Labeling Maps

EnGuide Display Settings


EnGuide Display Settings

Show EnGuides – Select this checkbox to show EnGuides in the map display. It does not disable the EnGuide navigation system. To disable the EnGuide navigation system, set the Active EnGuide to None, or use the <Ctrl>+<F5> Hot Key. The EnGuide navigation system must be enabled in order to display EnGuides.

Electrode Numbers – Select this checkbox to show catheter electrode numbers on the map display to facilitate navigating the ablation catheter to specific electrodes. You can show electrode numbers on all, some, or none. In Dual View, Split Screen, and RealReview, this checkbox affects each view independently.

Stabilize ABL – Select this checkbox to enable Stabilize ABL; default setting is off, or unselected. Stabilize ABL is applied to Ablation catheters or catheters placed in GenConnect.

NOTE: If Stabilize ABL is enabled for the catheter, NavX points cannot be collected.

Stabilize ABL corrects the location of the distal electrode based on the properties of the catheter. ABL electrodes 2, 3, and 4 need to be displayed for Stabilize ABL to be enabled.

WARNING: Do not use Stabilize ABL in situations where electrodes 2, 3, or 4, on the ablation catheter, are covered by a sheath.

NOTE: If Stabilize ABL is enabled and the display of electrodes 2, 3, or 4 is turned off, Stabilize ABL is disabled and a message displays to alert the user.

NOTE: If multiple ablation catheters are setup, Stabilize ABL is applied to each catheter independently and only when appropriate.

Active EnGuide Silhouette – Select this checkbox to produce an outline of the Active EnGuide, which displays over the model, showing where it resides inside the chamber. The silhouette is displayed in the color selected for the Active EnGuide. Select “Off”, “Normal”, or “Enhanced”.

EnGuide Responsiveness – This slider controls the response speed between catheter motion and EnGuide navigation.

ActiveEnGuideSilhouette

Figure 116. Active EnGuide silhouette feature.


Information Display Settings 143EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Information Display Settings

Velocity Meter. Displays a meter that shows the relative velocity of catheter movement as calculated by the Velocity Filter during model creation.

Filter Lockout in Seconds. Adjusts the time in which point collection is suspended (collection lockout period), in the event that the velocity of the catheter exceeds the velocity threshold and point collection is disabled. Once the Filter Lockout time is met, point collection will resume.

Velocity Filter. Calculates the velocity of a catheter as it collects points during model creation.

Respiration Meter. Displays a meter that shows the current level of respiration, as computed by the relative impedance on the EnSite™ NavX™ Navigation and Visualization Technology surface electrodes.

Voltage Caliper. This checkbox enables/disables the display of the waveform from the Active Electrode, located in a window within the lower right corner of the map display.

Tracking Virtual. (EnSite™ Array™ Catheter studies only) This checkbox enables/disables the display of the red Tracking Virtual icon on the map and the Tracking Virtual waveform window in the lower right corner of the map display.

Electrode Spacing. When this checkbox is enabled, the spacing of electrode locations, both nominal and measured, (during model creation) are displayed.

Proximity to Surface. This checkbox enables/disables the display of the distance from the Active Electrode to the closest surface. The distance information is displayed in text at the bottom of the Map Display. A positive number expresses locations outside the chamber, and a negative number expresses locations inside the chamber.

Figure 117. Information display settings right-click menu.


Views and the Orientation Reference



(Any mode)

A view is a saved orientation of a model or map (rotation and panning) that is accessible by clicking a button. The current rotation of the display is indicated by the orientation reference icon in the upper right of the model or map display (Figure 118 on page 144).

Four predefined views and up to three custom views are available. The predefined views are AP, LAO, RAO, and PA. The three custom views are user-named.

To access the view controls and the orientation reference settings, right-click on the orientation reference icon (see Figure 119).

NOTE: In Array mode, the orientation reference icon is gray, until the AP view is defined.

Orientation Toolbar

The Orientation Toolbar provides one-click access to several model/map views:

Table 21. Orientation Toolbar

Icon Name

Center on surface. Double-click to follow.

Center on Active Electrode. Double-click to follow.

AP view.

LOA view.

RAO view.

PA view.

Figure 118. The orientation reference icon.


Views and the Orientation Reference 145EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Creating and Saving Map Views

NOTE: If a DIF model is highlighted, map views cannot be saved unless EnSite™ Fusion™ Registration is applied.

To save the current view and settings as the AP view, select Save New AP View from the right-click menu. Saving the AP view automatically saves the LAO, RAO, and PA views. In the default settings, LAO is set at -45 degrees from AP, and RAO is set at 30 degrees from AP. These angles can be adjusted using the LAO Angle Setting and RAO Angle Setting slider bars under the “View Angles” tab, or the up and down arrows on the keyboard or my manual text entry.

■ For EnSite Array studies, saving an AP, LAO, RAO, or PA map view automatically establishes the other three views and enables the orientation reference.

■ For EnSite™ NavX™ Navigation and Visualization Technology studies, the orientation reference and AP view are automatically established at the time of system validation. If a model is created, and LAO and RAO are undefined, the LAO and RAO views are automatically established when the model is completed. Saving AP, LAO, RAO, or PA views also adjusts the orientation reference. The system does not overwrite custom views.

To save the current view and settings as a custom view, select Save Views from the right-click menu. In the Save View window, select View1, View2, or View3, and then rename the view if desired. The custom view name will be added to the right-click menu.Up to three custom views can be created. The custom views are independent and do not compute automatically.

To access a view, select AP, LAO, RAO, PA, or a custom view from the right-click menu.

Figure 119. The Views and orientation reference settings

right-click menu.

Figure 120. The Save View window.




Additional Map Controls

Perspective On. Perspective View displays distant objects appearing smaller than close objects, thereby enabling improved visualization of the 3D image with a clearer representation of the catheter positions. When Perspective On is selected, zooming in on the map view transforms a view of the outside surface to that of the inside surface of a chamber. When zooming out, the view of the inside surface, likewise, changes back to a view of the outside surface of the chamber. In Dual View, Perspective On works independently for each map.

Show Torso. Shows/hides the orientation reference icon.

Synchronize Dualviews. When in Dual View, turn this checkbox on to synchronize the orientation of the two views and allow both models or maps to be rotated at the same time.

Centering – A view can be established by centering. Right click on the main display space (on the model). A menu will come up that includes Center Model At. Selecting this option will display a submenu with 4 options for recentering.

■ Center of Surface(s) – Centers the model within the view. In Dual View, it works independently for each model.

■ Surface Point – Centers the model at a selected point. When Surface Point is selected, the cursor changes to a red box with a dot in the center. With a left mouse click, select the point of interest on the model. The view is recentered to this point, and a small marker appears at this point. Exit this mode by selecting off the model surface.

■ Active Electrode – Centers the map display to the active electrode.

■ Catheter Tip – Centers the model on the desired EnGuide.

Translucence – To support the image integration of co-located models, surface translucency can be applied independently to each surface. Translucency is applied to All Surfaces as the default setting.

Select the Translucence menu item, then select one or more options:

■ All Surfaces

■ Per EnSite Surface

■ Per EnSite Group

■ All EnSite Surfaces

■ Per DIF Surface

■ All DIF Surfaces

NOTE: When one of these modes is selected, adjustment of the translucency slider in the map display will apply to the surface, DIF, or Group currently selected within the Model or DIF list.

Figure 121. Center Model menu.

Figure 122. Translucence menu


Labels 147EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Labels

Labels (Figure 123 on page 147) are used to identify points on the model. Up to 1024 labels can be placed during a study.

NOTE: The labels have no intrinsic meaning to the EnSite™ Velocity™ Cardiac Mapping System. Users can assign their own meaning to labels.

Placing a Map Label

1. Select the Label tool on the Tool Palette.

2. Type the label’s name in the Name text area on the Tool Bar or select a name from the drop-down menu. By selecting the drop-down menu after a name appears in the text area, commonly used names can be added or removed from the drop-down menu. Note that once a label name is automatically added to the list, it cannot be manually removed.

NOTE: The list in the drop down is cleared at the end of each study.

3. Use the Projection slider (or spin box) to set the projection distance if the label is to be projected.

4. Place the label using one of the following methods:

■ Click on the map or DIF surface to place the label at the pointer location. Clicking repeatedly places multiple labels.

Note: When placing labels with the mouse, labels can be placed on either the DIF model or the created model surface. For multiple-surface models, the label appears on the surface beneath the pointer.

■ Click [Label at EnGuide] to place a label at a point on the surface nearest to the Active Electrode. For multiple-surface models, the label appears on the nearest included surface. Label location is projected from the 3D center of the Active Electrode to the nearest surface. If the surface is edited and the projection distance is exceeded, the label re-projects from the original 3D catheter location, because the original 3D catheter location is preserved.

■ Click [3D Label at EnGuide] to place a label at the Active Electrode location. This label is not connected to the surface of the map, but rotates with the model. This function is useful for labeling the location of catheters outside of the chamber.

Note: When a label is placed, it is also added to the Label List in the RealReview task.

Figure 123. A model with labels.

Figure 124. Label controls. A: Label Name; B: Projection Slider and Spin Box; C: Label at EnGuide button; D: 3D Label at EnGuide buttonE: Right-click in black background for menu.

A

B C D

E


Labels


Selecting and Modifying Labels

Labels can be modified after a model is created by using the Tool Palette and Tool Bar controls, the Label List and control panel in the RealReview task, or the Label right-click menu.

NOTE: Labels can only be modified once they have been created.

■ To select a single Label, click on the Label tool in the Tool Palette, hold down <Shift>, and then click on the item’s name.

■ To select multiple Labels, click the Label tool in the Tool Palette, hold down <Ctrl>, and then click on each item. Alternatively, click on the Label tool in the Tool Palette, hold down <Shift> or <Ctrl>, hold down the left mouse button, and then drag a box around the Labels.

■ To deselect a Label, hold down <Shift> and click away from the Label’s name.

NOTE: When Label is selected, the color of its name changes to white in the model/map display area.

■ To select Labels in a list:

– To select a single Label in the list, click on the Label in the list.

– To select multiple Labels in the list, hold down <Ctrl> and click on each label

– To select multiple consecutive Labels in the list, hod down <Shift>, click on a Label, and then click on another Label. Alternatively, click on a Label and drag to select additional consecutive Labels.

NOTE: When a Label is selected, the color of its name changes to white in the model/map display area.

■ To modify a label using the Tool Palette and Tool Bar, select the Label tool on the Tool Palette, select the label, and then use the Tool Bar controls to change the label’s name and projection.

■ To modify a label using the Label List and control panel in the Review task, select the Label icon in the control panel, select the label in the Label List, and then use the control panel controls to modify the label’s visibility, or click [Delete] to delete the label from the map and the Label List.

■ To show/hide, delete, move, or project a label using the Label right-click menu, select the Label tool on the Tool Palette, select the label, right-click in the display area to display the Label menu, and then select one of the following:

– Show All Labels shows all labels.

– Hide Selected Labels hides/shows the selected labels. The labels are only hidden, not deleted.

– Delete Selected Labels deletes the selected labels from the map and the Label List.

– Move Selected Label moves the selected mouse placed label only. To move a label, select the label, click Move Selected Label, and then click on the map at the desired location. Only mouse placed labels can be moved.

– Project Selected Labels changes a label’s projection. A label placed with [Label at EnGuide] is already projected. To move the label to the original 3D location where the label was placed, turn off Project Selected Labels. A label placed with [3D Label at EnGuide] is placed at the Active Electrode. To project the label onto the closest surface, turn on Project Selected Labels.

– Show Labels Through Map makes labels visible regardless of the map orientation.

NOTE: Displayed 3D (D3D) labels can be renamed, deleted, and hidden, but the changes are not saved when the study is ended.

Figure 125. The Label List is available in the Review task. Use it to modify labels.

Use the Tool Palette and Tool Bar controls to create labels.


Anatomic Markers 149EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Label Colors

The color of a label indicates the label’s relationship to the surface (Figure 126 on page 149).

■ Green indicates that the label is on the nearest surface.

■ Amber indicates that the label is on the surface, but something is obstructing the label. This could indicate that the label is on the far side of the model or behind an object such as an EnGuide electrode.

■ Blue indicates that the label is not tied to the surface (such as 3D labels and EnGuide Shadows).

■ White indicates that the label is selected.

Anatomic Markers

Anatomic markers connect points on the surface of the model with lines. Closed anatomic markers are useful for drawing valve or vessel openings on the model; these circular markers can be cut out of the map to show these openings. Up to 256 anatomic markers can be placed on the map.

Marker display is dependent upon the surfaces that it crosses.

■ If a surface that the marker crosses is deleted, the marker is deleted.

■ If a surface that the marker crosses is not included, the marker is hidden.

The method of calculating the area differs depending on whether or not the marker is cut out.

■ For markers that have not been cut out, the area is calculated for the entire surface encompassed by the marker.

■ For markers that have been cut out, the area is calculated for an averaged plane across the open marker.

Value Display for Markers

■ Shown in the map display next to the marker and in the table. Values are in cm2.

NOTE: Field Scaling must be applied for values to be displayed (EnSite™ NavX™ Navigation and Visualization Technology only).

The Marker List in the RealReview and Review tasks includes the name of every anatomic marker in use.

Figure 126. Map label colors.


Anatomic Markers


Placing Anatomic Markers

Figure 127. Anatomic marker controls. A: color control; B: thickness control; C: marker name; D: cutout checkbox; E: right-click menu.

To place an anatomic marker:

1. Select the Anatomic Marker tool on the Tool Palette.

2. Create the marker by clicking at desired locations on the surface. The marker will be formed by connecting consecutive points.

3. Complete the marker.

■ For closed markers, click near the first point in the marker to close and complete the marker. To remove the center of the closed marker, turn on the Cutout checkbox.

Note: If the marker encompasses the center of the model, the wrong portion of the model may be cut out.

■ For open markers, right-click in the display area to display the Marker menu, and then select Complete Open Marker or deselect the Anatomic Marker tool

4. Set the marker’s color and thickness with the Color and Thickness controls on the Tool Bar.

5. Type a name for the marker in the Name text area, or select a name from the drop-down list.

Note: When an anatomic marker is placed on the map, it is also added to the Marker List in the RealReview task.

A B C D

E


Anatomic Markers 151EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Selecting and Modifying Anatomic Markers

Anatomic markers can be modified using the Tool Palette and Tool Bar controls, the Marker List in the RealReview and Review tasks, and the Marker right-click menu.

■ To select a single Anatomic Marker, click on the Anatomic Marker tool in the Tool Palette, hold down <Shift>, and then click on the Anatomic Marker’s name.

■ To select multiple Anatomic Markers, click on the Anatomic Marker tool in the Tool Palette, hold down <Ctrl>, and then click on the Anatomic Marker. Alternatively, click on the Anatomic Marker tool in the Tool Palette, hold down <Shift> or <Ctrl>, hold down the left mouse button, and then drag a box around the Anatomic Markers.

■ To deselect an Anatomic Marker, hold down <Shift> and click away from the Anatomic Marker’s name.

NOTE: When Anatomic Marker is selected, the color of its name changes to white in the model/map display area.

■ To select Anatomic Markers in a list:

– To select a single Anatomic Marker in the list, click on the Anatomic Marker in the list.

– To select multiple Anatomic Markers in the list, hold down <Ctrl> and click on each Anatomic Marker.

– To select multiple consecutive Anatomic Markers in the list, hold down <Shift>, click on an Anatomic Marker, and then click on another Anatomic Marker, Alternatively, click on an Anatomic Marker and drag to select additional consecutive Anatomic Markers.

NOTE: When an Anatomic Marker is selected, the color of its name changes to white in the model/map display area.

■ To modify a marker using the Tool Palette and Tool Bar: select the Anatomic Marker tool on the Tool Palette, select the marker, and then use the Tool Bar controls to modify the marker’s color, thickness, name, and cutout.

■ To modify a marker using the Marker List and control panel in the RealReview task: select the Marker icon in the control panel, select the marker in the Marker List, and then use the control panel controls to modify the marker’s visibility, or click [Delete] to delete the marker.

■ To modify a marker using the right-click menu, select the Marker tool on the Tool Palette, select the marker, right-click in the display area to display the Marker menu, and then select one of the following:

– Show All Markers shows/hides all markers. The markers are only hidden, not deleted.

– Hide Selected Markers hides/shows the selected markers. The markers are only hidden, not deleted.

– Delete Selected Markers deletes the selected markers from the map and the Marker List.

– Move Selected Marker moves the selected marker. Click on one of the displayed marker points to select the marker point to move, then click the location on the map where the selected marker point is to be moved.

– Complete Open Marker completes the open marker being created.


EnGuide Shadows


Figure 128. Anatomic markers list and Tool Bar.

EnGuide Shadows

(Any mode)

EnGuide Shadows display a three-dimensional historic image of an EnGuide catheter position. EnGuide Shadows can be useful in returning a catheter to a previous position or for confirming that a catheter has remained in position (Figure 129 on page 152). Up to 256 EnGuide Shadows can be placed in the map display.

Figure 129. An EnGuide Shadow.


EnGuide Shadows 153EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Placing EnGuide Shadows

Figure 130. Shadow controls. A: shadow name; B: right-click menu.

1. Select the EnGuide Shadows tool on the Tool Palette.

2. Select a catheter from the Catheter drop-down menu on the Tool Bar.

Note: EnGuide Shadow keeps the color of the displayed catheter.

3. Right-click in the display area to display the EnGuide Shadows menu, and then select Add Shadow to place an EnGuide Shadow at the location of the selected catheter, or select Add Shadow At All EnGuides to place an EnGuide Shadow at the locations of all catheters.

4. Type a name for the EnGuide shadow in the Name text area or select a name from the drop-down menu. Names appear at the middle of the EnGuide Shadow display.

Note: When a shadow is placed on the map, it also appears in the EnGuide Shadow List in the RealReview task.

A

B


EnGuide Shadows


Selecting and Modifying EnGuide Shadows

An EnGuide Shadow can be modified using the Tool Palette and Tool Bar controls, the right-click menu, or the EnGuide Shadows control panel in the RealReview and Review tasks.

For information about selecting EnGuide shadows, refer to “Common Interface Elements” on page 32.

■ To select a single EnGuide Shadow, click on the EnGuide Shadow tool in the Tool Palette, hold down <Shift>, and then click on the EnGuide Shadow’s name.

■ To select multiple EnGuide Shadows, click on the EnGuide Shadow tool in the Tool Palette, hold down <Ctrl>, and then click on the EnGuide Shadow. Alternatively, click on the EnGuide Shadow tool in the Tool Palette, hold down <Shift> or <Ctrl>, hold down the left mouse button, and then drag a box around the EnGuide Shadows.

■ To deselect an EnGuide Shadow, hold down <Shift> and click away from the EnGuide Shadow’s name.

NOTE: When EnGuide Shadow is selected, the color of its name changes to white in the model/map display area.

■ To select EnGuide Shadows in a list:

– To select a single EnGuide Shadow in the list, click on the Anatomic Marker in the list.

– To select multiple EnGuide Shadows in the list, hold down <Ctrl> and click on each EnGuide Shadow.

– To select multiple consecutive EnGuide Shadows in the list, hold down <Shift>, click on an EnGuide Shadow, and then click on another EnGuide Shadow, Alternatively, click on an EnGuide Shadow and drag to select additional consecutive EnGuide Shadows.

■ When an EnGuide Shadow is selected, the color of its name changes to white in the model/map display area.To modify an EnGuide Shadow using the Tool Palette and Tool Bar: select the EnGuide Shadow tool on the Tool Palette, select the EnGuide Shadow, and then use the Name text area on the Tool Bar to change the name.

■ To modify an EnGuide Shadow using the EnGuide Shadow List and control panel in the Review task: select the EnGuide Shadow in the EnGuide Shadow List, and then use the checkbox to control visibility or the Delete button to delete the EnGuide Shadow.

■ To show, hide, and delete a shadow using the EnGuide Shadow right-click menu, select the EnGuide Shadow tool on the Tool Palette, select the shadow, right-click in the display area to display the EnGuide Shadow menu, and then select one of the following:

– Show All Shadows shows/hides all shadows.

– Hide Selected Shadows hides/shows the selected shadows. The shadows are only hidden, not deleted.

– Delete Selected Shadows deletes the selected shadows from the map and the EnGuide Shadow List.

Figure 131. The EnGuide Shadow list and Tool Bar.


EnGuide Shadows 155EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Verifying Catheter Stability

EnSite™ Array™ Catheter. EnSite™ Array™ Catheter stability can be verified using a catheter (such as a CS catheter) that has been placed in a stable position.

1. Early in the study, use the EnGuide navigation system to display one or more electrodes on a stable catheter.

2. Place an EnGuide Shadow on the stable catheter.

3. Periodically check the position of the EnGuide electrodes and the EnGuide Shadow for the stable catheter. If the EnGuide electrodes move away from the EnGuide Shadow, suspect that either the EnSite Array or the stable catheter has moved. Use conventional techniques to determine if the stable catheter has moved.

EnSite™ NavX™ Navigation and Visualization Technology. The stability of diagnostic catheters can be verified using EnGuide Shadows.

1. Use the EnGuide navigation system to display one or more electrodes on a stable catheter.

2. Early in the study, place an EnGuide Shadow on the stable catheter electrodes.

3. If the catheter moves away from the Shadows, suspect catheter movement (Figure 132 on page 155).

Note: A shadow placed on an intracardiac positional reference does not move away from the positional reference electrode. In the event of a positional reference dislodgement, all other electrodes move from previous shadows.

Figure 132. An example of a catheter that has moved in an

EnSite™ NavX™ study. The arrow points to the EnGuide Shadow.


Tape Measures


Tape Measures

(EnSite™ Array™ Catheter, EnSite™ NavX™ Navigation and Visualization Technology with field scaling applied, DIF surfaces)

Tape measures are used to measure the distance (in mm) between points on the model of the endocardial surface (Figure 133 on page 156). Up to 12 tape measures can be placed on the map.

NOTE: Tape measure values can only be as accurate as the contoured chamber model that they measure.

Figure 133. This map shows two tape measure lines across the endocardial surface.


Tape Measures 157EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Placing a Tape Measure

1. Select the Tape Measure tool on the Tool Palette.

2. Set the tape measure’s color with the Color control on the Tool Bar.

3. Click the desired Type button:

■ [Surface] – connects two selected points on the map with the shortest possible line along the endocardial surface.

■ [Straight Line] – connects two selected points on the map with a straight line.

■ [Radial (RL)] – (EnSite™ Array™ Catheter only) connects a single selected point on the endocardium with the center of the EnSite Array.

4. Place the tape measure:

■ For surface or straight measures: click on the map at the point to begin measuring, and then drag the mouse to position the other end of the tape measure.

■ For radial measures: click on the map once to place a tape measure between the selected point and the center of the EnSite™ Array™ Catheter.

The tape measure appears on the map as a colored line. The tape measure’s type and the distance between the points in mm, appear at the beginning of the tape measure. Up to 12 tape measures (yellow, green, cyan, orange, red, and magenta) can be used.

NOTE: In an EnSite™ NavX™ Navigation and Visualization Technology study, measurements will not be shown if Field Scaling is not enabled (the line will still show through).

Figure 134. Tape measure controls. A: color control; B: type buttons; C: right-click menu.

A B

C


Tape Measures


Selecting and Modifying Tape Measures

Tape measures can be modified using the Tool Palette and Tool Bar controls, the Tape Measure List and control panel in the RealReview task, and the Tape Measure right-click menu.

■ To select a single Tape Measure, click on the Tape Measure tool in the Tool Palette, hold down <Shift>, and then click on the Tape Measure’s name.

■ To select multiple Tape Measures, click on the Tape Measure tool in the Tool Palette, hold down <Ctrl>, and then click on the Tape Measure. Alternatively, click on the Tape Measure tool in the Tool Palette, hold down <Shift> or <Ctrl>, hold down the left mouse button, and then drag a box around the Tape Measures.

■ To deselect a Tape Measure, hold down <Shift> and click away from the EnGuide Shadow’s name.

NOTE: When Tape Measure is selected, the color of its name changes to white in the model/map display area.

■ To select Tape Measures in a list:

– To select a single Tape Measure in the list, click on the Tape Measure in the list.

– To select multiple Tape Measures in the list, hold down <Ctrl> and click on each Tape Measure.

– To select multiple consecutive Tape Measures in the list, hold down <Shift>, click on a Tape Measure, and then click on another Tape Measure, Alternatively, click on a Tape Measure and drag to select additional consecutive Tape Measures.

NOTE: When a Tape Measure is selected, the color of its name changes to white in the model/map display area.

■ To modify a tape measure using the Tool Palette and Tool Bar: select the Tape Measure tool on the Tool Palette, select the tape measure, and then use the Tool Bar controls to modify the tape measure’s color and type.

■ To modify a tape measure using the Tape Measure control panel in the RealReview task: select the Tape Measure icon in the control panel, select the tape measure in the Tape Measure List, and then use the control panel controls to modify the tape measure’s visibility, or click [Delete] to delete the tape measure

■ To modify a tape measure using the Tape Measure right-click menu, select the Tape Measure tool on the Tool Palette, select the tape measure, right-click in the display area to display the Tape Measure menu, and then select one of the following:

– Show All Tape Measures shows/hides all tape measures. The tape measures are only hidden, not deleted.

– Hide Selected Tape Measures hides/shows the selected tape measures.

– Delete Selected Tape Measures deletes the selected tape measures from the map and the Tape Measure List.

– Move Selected Tape Measure moves the selected tape measure. To move a tape measure, select the tape measure, click Move Selected Tape Measure, and then click on the map at the desired location.

Figure 135. Tape measures list and Tool Bar.


Mapping – Noncontact
CHAPTER 11
Types of Noncontact Maps

The EnSite™ Array™ Catheter study Mapping task is used to create noncontact maps. Three types of noncontact maps are available: isopotential, substrate, and isochronal.

■ An Isopotential map shows voltages sensed by the EnSite™ Array™ Catheter as a three-dimensional map that uses color to represent a range of electrical potentials across the surface of the heart chamber’s endocardium. This type of map contains the electrical potentials at thousands of sites on the endocardial surface. As dynamic cardiac signals are viewed in the waveform display, the same information is animated in the display of the isopotential map.

■ A Substrate map shows relative peak-negative unipolar voltage over a user-specified beat, throughout the chamber. Color in a substrate map represents relative unipolar voltage levels at each location on the first surface.

■ An Isochronal map shows the progression of activation through the first surface. This type of map is especially useful in locating functional block or lines of block created by ablation. Color in an isochronal map represents activation time (in milliseconds) rather than voltage measurements.

160 Chapter 11. Mapping – Noncontact

Interpreting Isopotential Maps


Interpreting Isopotential Maps

The EnSite™ Array™ Catheter study uses the dynamic isopotential map and the unipolar electrogram interpretation, in combination, to identify the earliest activation sites. Map color is used to identify the areas of interest; virtual waveforms are used for confirmation.

NOTE: For multiple surface models, non-contact mapping can only be performed on the first surface.

1. Place virtual electrodes across an area of interest.

2. Locate a beat of interest in the waveform display. Reposition the virtual electrodes on the map if necessary.

3. Place the time cursor within the beat of interest.

4. Use the left arrow button to step the time cursor backward one frame at a time.

5. Adjust the High Pass filter (if necessary) to reduce baseline drift and low-frequency repolarization. Raise the filter as little as possible, to preserve slow conduction sensitivity.

6. Adjust the color controls to identify isopotential color in the map display and reposition virtual electrodes within the color. Review the virtual waveform traces to confirm activation.

7. Follow activation through the beat of interest, using color to identify general areas of interest and unipolar electrograms for diagnosis. Label sites of interest.

8. Use conventional methodologies to confirm diagnosis.

Figure 136. The noncontact mapping screen.

Chapter 11. Mapping – Noncontact

Virtuals 161EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Virtuals


By using the mouse to select a pattern of virtual electrodes on the map, virtual waveforms can be displayed based on signals from the EnSite™ Array™ Catheter. Virtual waveforms are analogous to contact electrograms from conventional EP catheter electrodes.

Virtual waveform parameters can be adjusted as described below. Two sets of parameters for virtual electrograms are available, Virtuals 1 and Virtuals 2.

A single virtual waveform, called the EnGuide Virtual, can be created from the site on the map surface where a vector going from the center of the model through the distal tip of the Active EnGuide intersects the first map surface. As the EP catheter moves, so does the signal location.

Setting Virtual Waveform Parameters

1. Select the Virtuals 1 or Virtuals 2 tab in the Virtuals control panel.

2. Use the Number spin box to select the total number of traces. The total number of traces is the number of virtual electrodes that appear in the pattern. The number of waveforms to display can be selected in the Virtuals control panel. A maximum of 16 traces can be used per trace pattern, for a total of 32 for Virtuals 1 and 2.

3. Use the Polarity drop-down menu to select the polarity for the virtual electrogram signal:

■ Unipolar is a unipolar computation that simulates a signal between the selected point and the unipolar reference.

■ Longitudinal is a bipolar computation that simulates a conventional EP catheter (5 mm spacing) aligned with the long axis of the balloon.

■ Latitudinal is a bipolar computation that simulates a conventional EP catheter (5 mm spacing) aligned with the short axis of the balloon.

■ Laplacian is an omnidirectional computation that simulates a bipolar catheter pointing directly into the endocardial surface. Laplacian subtracts the surrounding potentials from the selected point. It has excellent far-field rejection. Amplitude in Laplacian waveform traces may vary significantly from conventional bipolar computations.

4. Use the Pattern drop-down menu to select the pattern of virtual electrodes that is to appear on the map:

■ To place a line of virtual electrodes (to simulate an EP catheter), select Line.

■ To place a block of virtual electrodes (to simulate a plaque) select Block.

■ To distribute the virtual electrodes over the entire chamber surface, select Global. Recommended for use with 10 or more virtual electrodes, this pattern facilitates searching for an area of interest on the map by evaluating waveform traces for the first surface.

Figure 137. The Virtuals waveform control panel.


Virtuals


Placing Virtuals

1. Set the virtual parameters as described in “Setting Virtual Waveform Parameters” on page 161.

2. Select the Virtuals tool on the Tool Palette.

3. Select Virtuals 1 or Virtuals 2 on the Tool Bar.

4. Use the mouse to place the virtual electrodes on the first surface. Each virtual electrode on the map is labeled with a number. This number corresponds to the trace number in the waveform display.

■ To place a line of virtual electrodes, click, hold down the left mouse button and drag the mouse from the location where virtuals will begin to where virtuals will end. Release the left mouse button. Virtual electrodes will be evenly distributed along the entire path between the start and end points.

■ To place a block of virtual electrodes, click, hold down the left mouse button and drag the mouse from the location where virtuals will begin to where virtuals will end. Release the left mouse button. Virtual electrodes will be evenly distributed in a rectangle with the corners determined by the start and end points.

■ To distribute the virtual electrodes over the entire chamber surface (Global Virtuals - see below), click on the map to place the first virtual electrode. Virtual electrodes are distributed across the first surface.

CAUTION: When placing bipolar virtual electrodes near the poles of the map, select latitudinal orientations. Failure to do so may cause the electrograms to be computed improperly, resulting in inaccurate traces.

Using Global Virtuals


The global virtuals technique offers an approach to localizing areas of electrical interest, by creating virtual electrograms throughout the first surface, simulating numerous multipolar catheters.

1. After recording a segment of focal arrhythmia, set up Global Virtuals.

2. Use global virtuals to identify a region of focal activation on the map.

a. Select Pattern: Global.

b. Adjust the number of virtual waveforms to be displayed.

c. Click on the first surface to distribute the global virtuals.

3. After identifying several points that display unipolar activation, use block virtuals to locate early activation.

a. Select Pattern: Block and swipe a block of virtual electrodes to encompass the area of interest.

b. Evaluate virtual traces to locate the earliest activation.

4. Confirm the early activation site using isopotential analysis.

5. Use conventional methodologies to confirm diagnosis.


Interpreting Isopotential Color 163EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Interpreting Isopotential Color

Isopotential maps use color to represent voltage. Color on the surface of the map is interpreted by using the color bar to the left of the main workspace, or the Color High and Color Low controls on top of the workspace.

The color bar (Figure 138 on page 163) appears as a scale, ranging from +5 mV to -5 mV. Color in the color bar represents the progression of color values in the map display. In the default color scheme, colors on an isopotential map’s surface and in the color bar indicate the following:

■ The Color High value appears on the Color Bar and is represented on the color bar by the purple caliper.

■ The Color Low value appears on the Color Bar and is represented on the color bar by the white caliper.

■ Other colors represent the range of voltages between the Color High and Color Low values.

NOTE: Right-click on the Color Bar to invert the color spectrum.

Color adjustments do not change the underlying data, only the sensitivity of the display. In Dual View, color controls affect both maps simultaneously.

See Figure 139 on page 163, for the color bar representations (1-3, in yellow) described below (from left to right):

1. Color bar representing data collected for either an isopotential Local Activation Time (LAT) or a Voltage Map.

A - Purple caliper - indicates color high

B - White caliper - indicates color low

C - Green caliper - midpoint between high and low

D - Shows the unit of measure (millivolts in this case)

2. Color bar showing an isochronal LAT based color scale (in milliseconds)

3. Color bar shows a color scale, using a Low-V ID, P-P setting where gray shows the areas where voltage is below the set value.

Figure 138. Color values in the map display.

Higher thanColor High

Lower thanColor Low

Color High

Color Low

Figure 139. Interpreting the color bars.

1 2 3

A

B

C

D


Interpreting Isopotential Color


Using Manual Color Controls

Manual color controls provide the greatest amount of control in adjusting map color.

Color bar calipers – The color bar calipers are used to adjust the map color. Use the mouse to drag the calipers:

■ The top caliper (purple) adjusts the Color High value.

■ The bottom caliper (white) adjusts the Color Low value.

■ The middle caliper (green) adjusts both the Color High and Color Low values while preserving the difference between these values.

Color bar scale – The scale of the color bar can be adjusted by selecting the gray triangular arrows above and below the color bar (Figure 140 on page 164).

NOTE: By right-clicking on the color controls the use is able to change to a Gray Scale.

Using AutoFocus Color Controls

(EnSite™ Array™ Cather studies only)

The AutoFocus color controls are designed to automate the adjustment of the Color High and Color Low values to highlight early focal activation or small diastolic or pre-systolic potentials.

The AutoFocus algorithm computes Color High and Color Low values for each time cursor location. First, the algorithm detects the Peak-Negative voltage on the map. Then, the algorithm adjusts the color bar calipers to percentages from the Upper Limit to the Peak-Negative, the percentages are based on the AutoFocus sensitivity setting (Figure 141 on page 164). The effect of AutoFocus settings on the map display can be seen in Figure 142 on page 165.

Figure 140. An adjusted color bar scale.

Figure 141. This diagram shows how the AutoFocus algorithm adjusts


Interpreting Isopotential Color 165EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


NOTE: Because the AutoFocus algorithm adjusts the color controls for each sample, it is important to observe the behavior of the calipers on the color bar. AutoFocus may occasionally focus on areas of the isopotential map that are not relevant to the diagnostic process. These areas represent electrical signals that are farther below the Color High setting than the area of physiologic interest. Such areas may be generated by repolarization, baseline drift, EnSite™ Amplifier recovery, etc., and are differentiated by examining virtual electrograms at this location. When this occurs, either adjust the Upper Limit to display the area of interest, switch to manual color control, or adjust the High Pass filter.

Enabling AutoFocus color controls – In the control panel, select a sensitivity level from the AutoFocus drop-down menu:

■ Off – AutoFocus is disabled and manual controls are active.

■ Discrete – The discrete setting may be useful for fine localization of early activation sites or highlighting a gap in a line of block.

■ Nominal – The nominal setting provides a balance between finding sites of earliest activation and tracking activation through the cycle.

■ Broad – The broad setting may be useful for tracking chamber activation through the entire cardiac cycle.

NOTE: The AutoFocus color controls adjust the color bar pointers; however, AutoFocus does not adjust the High Pass Filter.

Adjusting the Upper Limit – The Upper Limit is the highest voltage that the AutoFocus algorithm will consider. The range is 1.00 to -0.20 mV (default -0.03). Use the Upper Limit slider in the control panel to make fine adjustments to the AutoFocus algorithm.

Adjusting the high pass filter – During isopotential analysis, the high pass filter can be useful for reducing low-frequency signals (such as repolarization signals) and baseline drift in waveform traces based on EnSite™ Array™ Catheter signals (such as virtual waveforms). Use the High Pass Filter drop-down menu in the control panel to adjust the highpass filter settings.

CAUTION: If the high pass filter is set to low frequencies (< 2Hz), signals may be subject to low-frequency baseline drift.

To disable AutoFocus and use the manual controls, select [Off] from the AutoFocus drop-down menu in the control panel.

Figure 142. These maps show the same timepoint with different AutoFocus settings.


Using the Tracking Virtual


Using the Tracking Virtual

(EnSite™ Array™ Catheter studies, RealReview, and Offline Review modes only)

The Tracking Virtual tool is used to locate and interpret the Peak-Negative location in the chamber of interest. The Tracking Virtual appears on the map as a small red icon comprised of eight short lines converging at the Peak-Negative position. The unipolar virtual waveform from this location appears in a window in the lower right side of the map display. The window is sized to display 100 milliseconds of data, and the amplitude can be adjusted by middle-clicking the waveform and dragging up or down.

NOTE: In Review mode, the Tracking Virtual and Voltage calipers can be displayed simultaneously.

NOTE: Tracking Virtual is displayed only on the first surface.

Labels can be placed at the tracking virtual location by selecting [Label at Tracking Virtual] in the control panel. Labels are placed as surface labels with the default text being “Label,” which will appear in the label list in Review task (see “Labels” on page 147).

Substrate Mapping


Substrate maps display voltages from noncontact electrograms as ratiometric maps.

A substrate ratiometric map is a single color map that displays relative peak-negative unipolar voltage over a user-specified beat, throughout the chamber. Color in a substrate map represents relative unipolar voltage levels at each first surface location.

Figure 143. The Tracking Virtual (left) and Tracking Virtual Waveform.

Figure 144. A substrate ratiometric map of right atrial sinus rhythm, with substrate map

markers applied.


Substrate Mapping 167EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


To understand the substrate mapping algorithm, it is important to remember that every point on the surface represents a virtual electrogram, each of which could be represented by a waveform trace. For each noncontact electrogram, the substrate mapping algorithm locates the most negative signal within a user-defined caliper range. The system displays the relative voltages as a ratiometric map of voltage in one of two ways (Figure 145 on page 167):

■ Global – In a Global substrate map, the system displays relative color, from 0% (0mV) to 100% of the peak-negative map value, throughout the first surface.

■ Absolute – In an Absolute substrate map, the system displays relative color, from 0% (0mV) to 100% of a user-defined threshold, throughout the first surface.

Figure 145. Definition of Global and Absolute ratiometric substrate map scales.


Substrate Mapping


Creating a Substrate Map

1. Select the Substrate tab.

2. If the segment is playing, click [Freeze].

3. Adjust the green caliper to select a single activation sequence.

Note: In the caliper measurement, do not use saturated data, or portions of the waveform display that have a purple virtual waveform.

4. Use the Type drop-down menu to select Global or Absolute. When using an absolute setting, use the Absolute Peak Negative mV slider to adjust the threshold.

5. Click the [Apply] button to display a substrate map.

■ A substrate map is a ratiometric voltage map which displays relative voltage values, based on noncontact electrograms. Color on the first surface represents relative voltage. The scale of the color bar represents a relative (percentage) voltage range between the smallest voltage deflection in the chamber and either the (global) Peak-Negative voltage deflection or a user-specified (absolute) negative value of interest.

Virtual electrograms may be useful in identifying local morphology changes, such as fractionation. The map can be modified by adjusting the caliper range or absolute/global map type.

NOTE: Click Apply after adjusting the calipers to update the map.

■ To add a substrate map marker:

a. Adjust the Peak Negative% slider to a percentage of interest.

b. Click [+]. A marker appears at all map locations that match the selected voltage. Markers appear as a double line. Identifying the high-voltage side of the marker is a thick line in the selected color. Identifying the low-voltage side of the marker is a thinner darker line.

c. (Optional) Adjust the marker’s visibility, color, and name using the controls in the marker list. Adjust the marker’s thickness using the Thickness slider. Names for substrate map markers only appear in the marker list, not in the map display.

Note: The model surface must be stable before adding a substrate map marker. If the model is modified after a substrate map marker is added, the marker keeps its 3-dimensional position, which may not be on the revised model surface.

6. Use conventional methodologies to confirm diagnosis from substrate mapping.

Figure 146. The Substrate Mapping control panel.


Isochronal Mapping 169EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Isochronal Mapping

(EnSite™ Array™ Catheter studies only; RealReview and Offline modes only)

An isochronal map is a map that represents the progression of activation through the first surface. This type of map is especially useful in locating functional block or lines of block created by ablation. In an isochronal map, color represents activation time (in milliseconds) rather than voltage measurements.

To understand the isochrone algorithm, it is important to remember that every point (2048 points in isochrone maps) on the first surface represents a virtual electrogram, each of which could be represented as a waveform trace. The isochrone algorithm maps the activation time for each point on the model.

■ Based on a user-defined caliper range, the isochrone algorithm defines the baseline as the average value (mean) within the caliper range. The calipers should encompass a single activation sequence.

■ The isochrone algorithm locates Peak-Negative, which is the lowest negative signal within the caliper range.

■ The isochrone algorithm uses the multiple event sensitivity to locate the event that is used to display activation time.

– An event is defined as a negative deflection in the waveform trace, from the point where the trace crosses below baseline to the point where the trace crosses above the baseline.

– Multiple event sensitivity is a user-adjustable value representing a percentage between baseline and Peak-Negative (default 40%). The isochrone map displays the first event with a negative deflection that is larger than the multiple event sensitivity.

– Activation time is defined at the midpoint voltage between the baseline and the Peak-Negative of the event. In virtual waveform traces, this point is displayed as a white tick mark.

■ For each point on the first surface, the activation time is displayed as a color value representing time on the color bar.

Figure 147. A noncontact isochronal map.

Figure 148. Example of a virtual waveform trace used in an isochrone algorithm. Events 1 and 2 are defined by the points where the trace crosses the baseline. Event 1 is used to display activation, because it is the first event that crosses

the multiple event sensitivity level.


Isochronal Mapping


Creating an Isochronal Map

1. Select the Isochronal tab.

2. If the segment is playing, click [Freeze].

3. Place virtual electrodes on the map (“Placing Virtuals” on page 162).

4. Adjust the caliper to select a single activation sequence in a virtual waveform. Best results are obtained by including flat baseline portions at the ends of the chosen data selection.

Caution: In the caliper measurements for noncontact isochronal maps and Substrate Mapping, do not use portions of the waveform display that have purple waveforms.

5. Use the Multiple Event Sensitivity slider to adjust the event size that qualifies as activation.

6. Click [Apply] to display the isochronal map.

Note: On virtual waveforms, green tick marks in the virtual waveform traces indicate where the isochrone algorithm declares an activation, if waveform d/dt is enabled

7. Adjust the color settings to highlight the relevant range of activation times on the map.

The map can be modified by adjusting the caliper range, or the Multiple Event Sensitivity slider. Adjusting either the caliper range or the Multiple Event Sensitivity slider requires that the [Apply] button be clicked again.

NOTE: When reviewing maps or virtuals created using the EnSite™ Array™ Catheter, be sure that the distance between the catheter and the location of interest is within the desired distances. Figure 149. The isochronal map control

panel.


Mapping – Contact
CHAPTER 12
Figure 150. The contact mapping screen.

172 Chapter 12. Mapping – Contact

Types of Contact Maps


Types of Contact Maps

The mapping tool organizes data collected during conventional electrophysiology procedures and displays the data in three-dimensional maps. During mapping, the clinician samples various heart locations (points) in a stable rhythm using EnGuide-located conventional catheters. The 3D location of each sampled location (point) is saved along with voltage and activation data, which can be displayed on the nearest surface as color. A single set of collected data can be used to display several types of maps.

Cardiac Triggered Maps

Cardiac triggered maps use a surface electrocardiogram or an intra-cardiac electrogram as the reference to which collected points are measured. There are four types of cardiac triggered maps:

■ Local Activation Time (LAT) isochronal maps display color-coded activation times for each collected location (or nearest surface). The local activation time is the difference in milliseconds between detected activation on the roving waveform and the reference waveform. Colors range from white (early) to purple (late).

■ Peak-to-Peak (P-P) voltage maps display color-coded voltage values for each collected location (or nearest surface). The P-P voltage is the difference in millivolts between the peak positive and Peak-Negative components of the detected activation complex on the roving waveform. Colors range from gray (low voltage) to purple (high voltage).

■ Peak Negative (P-Neg) voltage maps display color-coded voltage values for each collected location (or nearest surface). The P-Neg voltage is the difference in millivolts between baseline and the Peak-Negative component of the detected activation complex on the roving waveform. Colors range from gray (low voltage) to purple (high voltage).

■ CFE Mean maps provide a fractionation index based on the cycle length between multiple, discrete, local activations in an electrogram. Collected points with a lower value are mapped toward the white end of the color spectrum.

■ CFE Standard Deviation maps provide a fractionation index based on the cycle length between multiple, discrete, local activations in an electrogram. The CFE standard deviation calculates the standard deviation between activations. Collected points with a lower value are mapped toward the white end of the color spectrum.

■ Fractionation map, indicates the number of CFE detections.

■ Point Count map. Indicates the number of points co-located with that point on the map.

NOTE: For Peak-to-Peak and Peak Negative, the user can select the Unipole box to display unipole maps. Unipole waveforms display on the right. Deselect the Unipole box to display bipole maps.

NOTE: At least one LAT point must be mapped and saved in order for Peak-to-Peak and Peak-Negative, and CFE Mean options to become available. Prior to this action, these options are grayed out.

Non-Cardiac Triggered Maps

Non-cardiac triggered maps collect points at one second intervals.

■ CFE Mean maps provide a fractionation index based on the cycle length between multiple, discrete, local activations in an electrogram. Collected points with a lower value are mapped toward the white end of the color spectrum.

■ CFE Standard Deviation maps provide a fractionation index based on the cycle length between multiple, discrete, local activations in an electrogram. The CFE standard deviation calculates the standard deviation between activations. Collected points with a lower value are mapped toward the white end of the color spectrum.

■ Fractionation map, indicates the number of CFE detections.

■ Point Count map. Indicates the number of points co-located with that point on the map.

Chapter 12. Mapping – Contact

Signals Collection 173EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Signals Collection

Reference Signal Source

Cardiac triggered maps require a reference signal. The reference signal is provided by a surface electrocardiogram or an intra-cardiac electrogram. Multiple ECGs can be selected. The electrodes that provide the reference signal must remain in a stable position throughout the mapping procedure. The reference signal is set once before beginning a mapping procedure, and is used for timing of the roving signals.

Non-cardiac triggered maps do not use any part of the cardiac signal as a reference. Instead, the waveform window refreshes once each second.

Roving Signal Source

Both cardiac triggered and non-cardiac triggered maps require a roving signal. The roving signal is used for sampling local activation times and voltages from various locations in the heart. The roving signal source can be any intracardiac electrode; it can be changed during a procedure, and data can be sampled from one or from multiple electrodes.

Detection Algorithm

Both reference signals and roving signals require a detection algorithm. Detection algorithms locate the best point on the waveform signal to use to identify activation. The detection algorithm first uses a P-P sensitivity to identify activation complexes in the signal. A detection marker is then placed on the activation complex according to the Detection Marker Placement.

P-P Sensitivity – (Applies to the map that has focus when in Split Screen mode.) The minimum peak-to-peak voltage required for the detection algorithm to operate. Incoming signal complexes must be larger in amplitude than the P-P Sensitivity in order to be considered activations by the system. While changing the P-P Sensitivity, red amplitude lines will appear on the related signal in the acquisition panel to indicate the current setting. Set this sensitivity to just above the noise floor. If 1.5 seconds has elapsed since the last reference signal detection, the algorithm will identify an optimal activation complex, even if it does not meet the P-P Sensitivity.

NOTE: For the Reference Signal, there is auto sensitivity. Auto Sensitivity is used Roving only for first and last deflection.

Detection Marker Placement – The available selections are:

■ -dVdt – Sharpest negative slope

■ +dV/dt – Sharpest positive slope

■ abs dVdt – Sharpest slope, regardless of positive or negative

■ Max – Peak positive

■ Min – Peak negative

■ abs Peak – Largest peak (difference from baseline) regardless of positive or negative

■ First Deflection – First deflection from baseline

■ Last Deflection – Last deflection from baseline

Setting up the Detection Method

1. Select a reference signal.

2. Set the P-P sensitivity slightly above the noise floor.

3. Select the appropriate detection parameter.

4. Repeat for the roving signal.

Figure 151. Collection tab.


Considerations


NOTE: The user can drag the green Reference Offset line to the desired position, and the system calculates the timing automatically from that position. The aqua-colored line is the reference line placed by the detection algorithm and cannot be moved.

NOTE: Do not change the reference offset after saving the first beat when using Score Map. Changing of the reference offset after the first beat may lead to an incorrect mapping display.

NOTE: Cardiac triggered CFE maps use the same detection algorithm as LAT, P-P, and P-Neg. Non-cardiac CFE maps use the one second window refresh signal as a trigger. The detection algorithm is not selectable.

NOTE: Detection on the roving waveform takes place within the Roving Activation Interval (“Roving Activation Interval (RAI)” on page 180).

Additional Signals

Additional ECG or intracardiac signals can be selected to facilitate confirmation of rhythm stability. These signals are only for visualization and are not involved in detection.

Considerations

Non-Cardiac Triggered CFE Maps

■ Multiple detections are possible in a single sample.

■ Tick marks in CFE maps are not individually adjustable.

■ In CFE maps, some detection settings can be adjusted retrospectively and affect all points in the current map, including P-P Sensitivity, Width, Refractory, the RAI, and Segment Length.

■ P-P Sensitivity is set independently for CFE maps and other map types.

■ The Width slider controls the minimum complex width to consider for activation.

■ The Refractory slider controls the minimum amount of time between detections.

■ The Segment Length slider controls the number of seconds per sample.

Figure 152. Signals control panel.


Considerations 175EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Reentrant Maps

■ Reentrant maps present the mapping of reentrant arrhythmias and are displayed in a manner similar to activation maps. The color displayed within the map is linked to the cardiac cycle length (CL) and allows the adjacent display of “early” (white) and “late” (purple) activation times.

■ The CL of a Reentrant LAT map is determined by the spacing between the curtains. Adjustment of the CL can be made by clicking and dragging the edge of the curtains to the desired location. The CL will not take effect until the Reentrant checkbox is turned on.

NOTE: Adjusting the CL and then collecting points may invalidate the map.

Propagation Maps

■ These maps display areas of activation times that fall within a specific time interval. The interval, represented by a white band on a purple background, can be moved forward through one heart cycle either automatically or by user control.

■ A button beneath the Propagation checkbox controls automatic motion of the activation interval with [Play] and [Freeze] options. These options are available in Review mode only.

■ [Play] loops over the user-selected cycle length.

■ Propagation maps can be played in Realtime or RealReview but recordings can only be exported in Offline Review.

■ When Propagation is enabled, the colors of the map change to purple and white only. The leading edge of the white stripe is brighter than the trailing edge of the stripe to indicate the direction of travel activation.

■ Using the side color bar, the stripe can be widened (increasing the interval in milliseconds [ms]), by clicking and dragging above the white stripe. This action can also be accomplished by clicking to the right of the stripe in the color bar at the top of the window.

SparkleMap

■ The SparkleMap feature allows you to view the activation sequence on top of another map (ex. Voltage map) which allows the physician to simultaneously view multiple datasets on the same anatomic model. The SparkleMap shows the propagation sequence via a series of circular flashes.

■ Click the SparkleMap button in the Mapping Control Panel (“Mapping Control Panel” on page 176) to activate.


Mapping Control Panel



Cardiac Triggered Mapping Settings

Table 22. Cardiac Triggered Map Settings


A Map Name Name of the map that has focus. Edit the map name by double-clicking in the name and typing a new name.

B Cardiac Triggered Reference

Determines which map types are available for use.

C Current Map Type

Checkboxes control the type of data displayed on the map that has focus. When the checkbox is changed, the scale, values, and colors on the color bar will change in the map display. The numeric display type for the waveforms under the Points tab will also change to the current map type. The following display types are available:• LAT: Local Activation Time isochrone• Peak-to-Peak: Peak-to-Peak voltage• Peak-Negative: Peak-negative voltage• CFE Mean: Complex Fractionated Electrogram Mean

activation between complexesCFE Std. Dev.: Complex Fractionated Electrogram Standard Deviation between complexes. (Available only if Cardiac Triggered Reference is unchecked).

D Project Map to Project the map to the desired surface group in the list. Closest projects the map to the surface closest to the point(s).

E Low-V ID (Applies to the map that has focus when in Split Screen mode.)Identifies low-voltage zones in LAT or CFE maps (see Figure 153). If a collected point’s P-P value is lower than the specified Low-V ID value, then that point will display a gray area instead of the color-coded scale for the current map type. Grey points do not interpolate with color points. The Low-V ID control and the Color Low value of a P-P map are linked, and adjusting one will adjust the other to the same value.

F Fractionation Threshold

Renders points that are fractionated as larger spheres. Default value=3 (renders points with a fractionation value of >= 3

G Map Display (LAT maps only) The type of LAT map: Standard LAT, Reentrant Map, or Propagation Map.Sparkle Map: When any map type other than Propagation Map is selected, the Play button is marked SparkleMap and activates the SparkleMap feature.

Figure 153. Cardiac Triggered Mapping control panel.

ABCD

EFG

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Mapping Control Panel 177EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


H Map Appearance: Includes slider controls that modify various features of the map.

Interior Projection(Applies to both maps when Split Screen mode is active.) This slider controls the maximum distance that an interior 3D Point (represented as a triangle) can project to a location on the surface (represented by a square). For multiple-surface models, points will project to the nearest surface.

Exterior Projection (Applies to both maps when Split Screen mode is active.) This slider controls the maximum distance that an exterior 3D Point (represented as a triangle) can project to a location on the surface (represented by a square). For multiple-surface models, points will project to the nearest surface.

Interpolation(Applies to the map that has focus when in Split Screen mode.) This slider controls the minimum distance between surface points necessary for the system to interpolate color. For multiple surface models, points will interpolate between surfaces in the same group.

Use Last DuplicateUses the most recent duplicate.

Use Best DuplicateUses duplicate with the best combined timing and voltage. Favors points with large voltages that are close to the average timing.

I Points/Labels: Includes controls to hide or display points and labels.

Show Selected Points OnlyWhen selected, the system draws only the selected points in the 3D display.

3D Points(Applies to the map that has focus when in Split Screen mode.) Enables/disables the display of collected points as triangular markers. The triangular markers are placed on the positive electrode of the roving signal channel (Figure 154 on page 178).

3D Labels(Applies to the map that has focus when in Split Screen mode.) Allows data to be numerically displayed adjacent to the triangular 3D points. 3D Points must be enabled in order to show 3D labels (Figure 154 on page 178).

3D Annotation(Applies to the map that has focus when in Split Screen mode.) Displays or hides the user-defined annotations associated with 3D points.

Surface Points(Applies to the map that has focus when in Split Screen mode.) Enables/disables the display of small square points on the surface. These squares represent the point on the surface closest to a collected 3D point (Figure 154 on page 178).

Flash New PointsNew points flash as collected.






Figure 154. A: An LAT isochrone with Low-V ID; B:A collected point displayed as A: surface point; B: 3D point; C: 3D label.

J Appearance

Show Mapping Metric(Applies to the map that has focus when in Split Screen mode.) Enables/disables the display of the reference cycle length in mm (CL), and the measurement of the current roving point (LAT) in a box in the lower right corner of the map display. The reference rate and cycle length are computed from detections on the reference catheter.• CL and LAT display in yellow when points are frozenThe live heart rate (HR) displays in the lower-left status bar and is calculated on the reference you are using

Auto Color• (Applies to the map that has focus when in Split Screen mode.) Controls whether

the system automatically controls the pointers on the color bar during mapping. If Auto Color is enabled, the pointers will adjust to the minimum and maximum data values for all points in the current map. Auto Color applies separately for each display type. Auto Color will be disabled if any color is manually adjusted.



A B


Mapping Control Panel 179EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Non-Cardiac Triggered Mapping Settings

Notice that in the Mapping Settings control panel (see Figure 155) the available settings have changed slightly from those shown in Figure 153 on page 176. The Map Display controls have been replaced with the following slider controls:

■ The Width slider (CFE maps only) determines the minimum complex width to consider for activation. Applies to the map that has focus when in Split Screen mode.

■ The Refractory slider (CFE maps only) determines the minimum amount of time between detections. Applies to the map that has focus when in Split Screen mode.

■ The Segment Length slider (CFE maps only) determines the duration of the selected segment length. Applies to the map that has focus when in Split Screen mode.

Figure 155. Non Cardiac Triggered Mapping control panel.


Collecting Points


Collecting Points

The waveform display is used to evaluate waveforms and collect points.



A Time scale The time scale (in milliseconds) at the top edge of the waveform display. The detected timing reference appears at 0 msec. Right-click on the Time Scale to display a menu to set the sweep speed, font size, and waveform thickness.

B Color bar (LAT maps only) When collecting or displaying LAT isochronal data, the color bar displays above the waveform display. The function of the color bar duplicates the color bar in the map display. Dragging the pointers on the color bar will adjust the range.

C Roving Activation Interval (RAI)

The Roving Activation Interval is a timing parameter that is used in the detection of roving catheter activation. The RAI is defined by the black area between the curtains. The curtains appear as shaded areas on either side of the RAI. Roving catheter activation will not be reliably detected unless the beat falls within the black-background portion of the waveform display. To adjust the RAI, click and drag the edge of the shaded background. The current RAI value appears in the lower right of the waveform display. For non-cardiac CFE maps, the RAI is equivalent to the segment length, and appears as a left curtain only. For cardiac triggered CFE maps, the RAI is set independently for CFE maps and other contact map types.

D RAI Curtain Click and drag the curtain to adjust the RAI.

E Reference Activation Tic Mark

Reference catheter activation as defined by the selected reference detection algorithm. The reference caliper will always appear at 0 msec on the time scale.

NOTE: If the current rhythm does not meet the reference detection settings, this caliper will be magenta. Points can still be collected and adjusted.

Figure 156. The waveform display for contact maps.

A

B

C

DE

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Collecting Points 181EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


F Reference Offset Caliper (Green)

Drag to place the Reference Offset Caliper to the desired point in the waveform. Waveform timing calculations will be based upon the offset location.

G Roving Activation Tic Mark

Roving catheter activation as defined by the selected roving detection algorithm, within the Roving Activation Interval. When adjusting this caliper, the associated location in the map display will move to reflect the roving position at the time of the caliper measurement.

NOTE: If the current rhythm does not meet the roving detection settings, this caliper will be magenta. Points can still be collected and adjusted. If a time is adjusted and there are error conditions in the signal and the reference caliper is not purple, the caliper will turn yellow.

NOTE: For CFE maps, multiple tick marks may appear on the roving waveform. Activation tick marks for CFE maps are not adjustable.

H Voltage Low Caliper

Roving catheter low voltage. This voltage caliper is set to the lowest voltage within 100 msec of detected roving activation, within the RAI. This caliper is used in determining peak-to-peak (P-P) voltage and peak-negative voltage.

I Voltage High Caliper

Roving catheter high voltage. This voltage caliper is set to the highest voltage within 100 msec of detected roving activation, within the RAI. This caliper is used in determining peak-to-peak (P-P) voltage.

J Time Interval The RAI time interval.

K [Freeze]/[Save] When data is being collected (gated to detection of the timing reference), click the [Freeze] button to stop the display and review data. • After pressing [Freeze], the label on the button changes to [Save]. Clicking [Save] allows you to save the

current point and point display to the current map, a different map, or a new map using the pulldown menu.• The following data is saved with each collected beat: electrode position, current waveforms (reference, roving,

signal1, signal2, signal3), buffered waveforms and related roving electrode locations, timing, and voltage. Performance may begin to slow after 1000 points.

• When mapping is used in Review mode, [Freeze] will also freeze the waveform display and [Save] will cause the waveform display to play.

Hot key: <F11> duplicates the function of the [Freeze] and [Save] buttons.

L [Cancel]/[Resume] When the waveform display is frozen, [Cancel] will remove the currently displayed beat and resume gated data collection without adding information to the map. [Resume] will resume gated data collection.Hot key: <F12> duplicates the function of the [Cancel] button.

M Collected point buffer

As data is collected, each detected beat is temporarily saved in a buffer. When the waveform display is frozen, buffered data can be accessed using the buffer controls below the waveform display (Figure 156 on page 180). The beat that was present at the time that [Freeze] was selected is represented by [0]. Previous beats can be accessed by selecting the buttons for [-1], [-2], etc. When reviewing beats in the buffer, the associated location in the map display will change to reflect the roving location at each selected beat.Hot key: The left and right arrow buttons in the beat buffer are duplicated by the left and right arrow keys on the keyboard.

N Points list This is a list of the points that have been collected for the map.See the Help Menu for the Points List keyboard shortcut list.

O Timing Caliper Click the icon to place a Timing Caliper on the waveform. Up to ten calipers can be placed for each collected point.

P Home Scrolls the list to the selected point.

Q Scope Locates the selected point in 3D space.

R Duplicates Show duplicates of the selected point.

S Points Show all points or only the used points.




Collecting Points


Waveform Shadows

Shadows behind the waveform indicate morphology of previous beats.

NOTE: Shadows will be stored for all 12 surface ECG leads even if not displayed when the first point is collected.

Amplitude – The amplitude for ganged waveforms can be adjusted by middle-clicking the waveform and dragging up or down. To adjust the amplitude of an individual waveform, Shift + middle-click on the waveform.

Sweep Speed – To adjust the sweep speed for waveforms, right-click in the waveform area and then select the sweep speed from the pop-up menu.


Item Description

Reference Shadows The first point saved in a map will store the displayed Reference and “extra” waveforms as gray shadows, and will be displayed in the RAI behind subsequent detected beats. If the first saved point is deleted, the next point saved will generate the shadows.

NOTE: Changing the reference signal of the waveform will remove the shadow.

NOTE: Shadows will be stored for all 12 surface ECG leads even if not displayed when the first point is collected.

Roving Shadows A dark red shadow appears behind the current waveform for the roving catheter. This waveform indicates the morphology of the previous beat for this catheter. This shadow is used to confirm beat-to-beat stability.

NOTE: If data does not exist for the previous beat (earliest beat in the buffer, etc.), then the dark red shadow will not appear.

All Roving Waves Select/deselect to display all roving waves.

Unipole Waves Select to display unipolar waves (this selection must be made to display unipolar electrograms in the Waveform Display).

Figure 157. Waveform Shadows Checkboxes


Points Display 183EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Points Display

Click the Points tab to display the collected points. The display is a combined waveform segment, synchronized in time, of every roving catheter waveform incorporated into the map. Each waveform includes a tick mark indicating the activation point and a numeric metric that is determined by the current map type.

Selecting a waveform in the Points display shows the original data for that heartbeat in the waveform display including all saved waveforms, up to ten timing calipers per point (timing calipers can be adjusted), voltage calipers, and all buffered data. The beat of interest and voltage caliper settings can be adjusted. All changes are saved automatically. The point in the map display that is related to the highlighted waveform will flash red.

NOTE: The first point(s) in the map are highlighted green to indicate that they are the template beat for the map. These points, while first chronologically, may appear at different places in the list with other sort orders. These template beats are colored green so they are not inadvertently deleted, as doing so would change the map.


CALLOUT ITEM Description

A Home Scroll list to the selected point.

B Scope Locates the selected point in 3D space.

C Sort Sort waveforms by order of collection, current map type, and cycle length.(After making timing adjustments, the user must select sort by LAT again.)

D Time scale • The time scale, in milliseconds (msec), displays at the top edge of the waveform display. The timing reference of all waveforms is synchronized to 0 msec.

• Adjust the Sweep Speed by right-clicking in the black background and selecting Sweep Speed. The available options are 40, 50, 100, 200, and 400 mm/sec.

E Waveform number

Indicates the order of waveform collection. When multiple points are acquired simultaneously, all of the related points have the same waveform number.

F Electrode Polarity

Polarity of the electrodes on the catheter.Unipolar is indicated with the single electrode preceded by a “+” sign.

G Hide point checkbox

When checked, this checkbox indicates that this point on the map may show. Clear the check mark to hide this point. When unchecked, the point is hidden, and a red circle displays.

H Duplicate Points

A star above the check box indicates a duplicate point. There are 3 types of duplicate points:• Blue outline star - duplicate point, but not used• Solid blue star - point has duplicates, but this point is used by the

system• Solid gold start - point has duplicates, but the user chose to use

this point

Dashed line A dashed waveform line indicates that a point is not used to color the map (not shown). The following types of points are drawn as dashed: hidden points, duplicate points, points outside the projection distances, and points with no locations.

Figure 158. The Points display.

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Points Display


Amplitude – Waveform amplitude can be adjusted by middle-clicking the waveform and dragging up or down. For the Points display, amplitudes are ganged for all waveforms.

Panning – The Points display will default to centering on the timing reference. The display can be panned by <Shift> + middle-clicking in the background and dragging left or right.

Waveform indicators – The type of line used in the waveform indicates the effect of the waveform on the map.

■ Solid, bold with blue background – The waveform is selected. The original data for this waveform is currently displayed in the waveform display. If displayed in the map display, the 3D point, 3D text, and surface point for this waveform flash red.

■ Solid – The waveform is used by the map.

■ Dashed – The point is a duplicate or is degraded.

Delete Hidden Points – To delete points that were hidden using the Show checkbox, right-click in the waveform display or Points display and select Delete Hidden Points.

Delete Unused Points – To delete all points that are not displayed due to the current projection settings, right-click in the waveform display or Points display and select Delete Unused Points.

NOTE: Due to the potential collection of duplicate points, the action to “Delete Unused Points” may cause more unused points to appear. To delete duplicates, sort by point status, then select and delete all of the unused duplicates.

Scroll bar – Use this control to scroll through all activation points.

Hot key: When the Points display is open, the up and down arrow keys select the previous or next point, respectively.

When the Points display is open, [Delete] will remove the current beat in the waveform display.

Solid line Indicates a point that is used in the map (not shown).

I Blue background

Indicates the selected waveform. The data for the waveform is shown in the waveform display. If the corresponding point is used in the map, the 3D point, its projection on the map surface, and its text, flash red.

J Timing caliper Indicates the roving activation time.

K Map point measurement

The Timing (in ms) or Voltage (in mV) of the map point.

L Number of points

The number of points that have been used/collected. The list may have to be scrolled to see all of the waveforms.

M Delete To delete a waveform from the Points display and its corresponding point from the map, select the waveform and click [Delete].

N Delete Group Removes the selected group of points.

O Delete last Removes the selected group of point(s) last saved.


CALLOUT ITEM Description


The OneMap Tool 185EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


The OneMap Tool

The OneMap Tool is used to simultaneously create a model and a map. By default, the OneMap Tool is disabled. To use the OneMap Tool, click the [OneMap] button at the top of the Mapping control panel.

If no model surfaces have been created, a default surface will be created. If model surfaces have already been created, the currently selected surface is chosen by default.

To create a new map, click on the drop-down menu in the top right of the control panel or choose No Map Selected in the Mapping Window. Click on [New Map]. Enter a name for the new map and click [OK]. Refer to “Creating a Map” on page 186.

There are three tabs located above the catheter selections (Settings, Points, and Model). The Model tab is only available when [One Map] is selected. The Model tab displays the entire menu that is available under the Model task, including Show/Hide Field Scaling. This permits the user to easily edit the model without the need to return to the Model task.

There is no need to click on the [Finish Model] button. When exiting the OneMap Tool, the model finishes automatically.

NOTE: When [OneMap] is enabled, model surfaces may appear to be modified because intersecting surfaces are no longer being calculated.

NOTE: In the OneMap Tool mode, the Active EnGuide is automatically changed to be the same as the Roving catheter. The Active EnGuide control is not selectable in the OneMap Tool mode.

Figure 159. The OneMap Tool - Model control panel.


Creating a Map


Creating a Map

Setting up a New Map

1. Select the Mapping task from the tool bar. The Mapping screen displays.

2. Select New Map from the drop-down menu, in the upper right of the Mapping control panel or choose No Map Selected in the Mapping Window.

3. Name the map, and click [OK].

4. Select the reference timing signal. In the Collection control panel (lower left corner) Reference section:

a. Select a timing reference source from the drop-down menu.

b. Select a detection algorithm from the Detection drop-down men.

c. Adjust the Sensitivity to a level just outside of baseline noise.

After the timing reference and detection algorithms have been selected, waveforms will begin to refresh in the waveform display, gated to detected activation on the timing reference.

5. Adjust the Roving Activation Interval by clicking and dragging the edge of the shaded boundary. Generally, the Roving Activation Interval should be set to encompass one activation sequence on the roving catheter.

6. Select an initial roving catheter signal. The roving catheter can be any intracardiac electrogram that is actively being located (hidden electrodes cannot be used as Roving). In the Collection control panel Roving section:

a. Select a roving source from the drop-down menu. The roving signal can be changed during mapping, allowing any intracardiac electrode to be used as part of the mapping process.

b. Select a detection algorithm from the Detection drop-down men.

c. Adjust the Sensitivity to a level just outside of baseline noise. Sensitivity is set independently for CFE and other map types.

7. (OneMap Tool only) Select the source for collecting model points from the From drop-down menu: select Active EnGuide to use the Active EnGuide to collect points, or Active Electrode to use the active electrode to collect points.

Collecting Points

In the OneMap Tool mode, the Active EnGuide is automatically changed to be the same as the Roving catheter. The Active EnGuide control is not selectable in the OneMap Tool mode.

1. With the patient in the clinical rhythm, place the roving catheter to collect data. When a beat of interest appears in the RAI, select [Freeze].

NOTE: (OneMap Tool only) Selecting [Freeze] will automatically enable [Collect Points] when model type is set to OneModel.

2. In the frozen mapping window, review the morphology of the beat and placement of the caliper lines. If necessary, select an optimal beat from the collected point buffer and/or adjust calipers.

3. Click [Save] or select a New Map or an existing map from the pulldown menu to save the point; otherwise, select [Cancel]. The waveform display will return to acquisition mode.


Creating a Map 187EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


To Map from a Segment

1. Click the Split Screen Mode button in the upper right corner of the Mapping screen.

NOTE: You will need to switch the secondary screen from Live to Review mode (see Table 6 on page 37 for details).

2. Select the appropriate segment from the drop-down list at the bottom of the right display.

3. If necessary, use the Waveform control panel in the right display to set the roving catheter and electrode.

4. Reference K through N under “Collecting Points” on page 180. (Refer to Figure 156 on page 180).

NOTE: Points can be added to either the left or right display and will be applied to both displays. Offline Review only.

Figure 160. Map from Segment (example).


Managing Maps


Managing Maps

New Map – New Map can be selected from the drop-down menu in the upper right corner of the Mapping control panel. Select New Map; the Map Name window comes up with a prompt to name the map. Type a name in the Name field and click [OK].

Copy Open Map - Copy Open Map can be selected from the drop-down menu in the upper right corner of the Mapping control panel. Select Copy Open Map; the Map Name window comes up with a prompt to name the map. Type a name in the Name field and click [OK].

NOTE: You can rename a map by double-clicking in the Map Name field at the top of the Control Panel and typing in the new name.

Mapping Controls

Access these Mapping controls by clicking on the eye ball icon in the upper right of the map workspace.

Label Text On – Turns Label text on and off.

Label Show Through – Projects the labels through surfaces that may be obscuring them.

Show EnSite Model – Turns the entire model on and off during mapping.

Show DIF Model – This checkbox allows the DIF model (i.e., CT scan or MRI) to either be hidden or displayed.

Project on DIF – (After EnSite™ Fusion™ Registration has been performed) Enabling this checkbox allows the user to project or unproject 3D Labels and/or Lesions (referred to as 3DP), and map data onto the DIF surface rather than onto the EnSite model surface.

Show Mapping – Causes surfaces to be colored using the current map color.

Hide Non-Map Surfaces – When turned on, hides surfaces that are not assigned to a map.

Map Transparency On – Turn the map Transparency on and off.

NOTE: Do not turn on Transparency unless a map is currently displayed.

Show Proximity Indicator – This checkbox enables the proximity indicator.

Fixed Proximity Indicator – Turning this checkbox on sets the diameter of the Proximity Indicator to a maximum of 10mm, regardless of the current lesion size.

Figure 161. Map Displays.


Therapy
CHAPTER 13
The Therapy task is used to place lesion markers on the map and perform ablation therapy. The Therapy control panel contains a list of lesion markers and controls for modifying their appearance. When using the Lesion Marker tool, you can place lesion markers with the mouse or use the tool bar to place surface and 3D lesions at the Active Electrode.

A. Lesion Marker Tool – Use this tool to place lesion markers on the model.

B. Color – Use this color picker to set a lesion marker’s color.

C. Diameter – Use this spin box to set a lesion marker’s diameter.

D. Projection – Use this slider to set a lesion marker’s projection.

Figure 162. Therapy Screen.

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190 Chapter 13. Therapy

Lesion Markers


E. Lesion at EnGuide – Click this button to place a lesion marker on the surface at the Active Electrode.

F. 3D Lesion Marker at EnGuide – Click this button to place a 3D lesion marker at the Active Electrode.

G. Lesion List – This is a list of all the lesion markers that have been placed.

H. Properties – Use these controls to modify a lesion marker’s color, diameter, 3D projection, or to show/hide lesion markers.

I. Therapy Display – Use to show/hide lesion marker text.

Lesion Markers

(Any mode)

Lesion markers (Figure 163 on page 190) are used to identify ablation lesion marker sites. Up to 1024 lesions can be placed in the map display.

Lesion markers are projected from the 3D center of the Active Electrode to the nearest surface. The original 3D catheter location is preserved. If the surface is edited, the lesion is re-projected from the original 3D catheter location.

An adjustable distance control allows you to edit the distance allowed for projection. Lesion markers that are present and do not meet the 3D distance requirement are displayed as 3D objects (without being tied to a surface). You have the option to project, or not to project the lesion.

Each lesion marker has a numeric name that is displayed in a list. This number increments each time a lesion marker is placed on the map. If a lesion marker is deleted, the numeric list is updated to keep numbers consecutive.

Figure 163. A map with lesion markers on the surface.

Chapter 13. Therapy

Lesion Markers 191EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Placing Lesion Markersf

To place a lesion marker:

1. Select the Lesion Marker tool on the Tool Palette.

2. Set the lesion marker’s color and diameter with the Color and Diameter controls on the Tool Bar.

NOTE: The diameter control also adjusts the maximum diameter of the proximity indicator on the EnGuide electrode (refer to “EnGuide Proximity Indicator” on page 120 for more information).

3. Place the lesion marker using one of the following methods:

■ Click on the map to place the lesion marker at the mouse pointer. Clicking repeatedly places multiple lesion markers. For multiple-surface models, the lesion marker appears on the surface beneath the pointer.

■ Click [Lesion at EnGuide] to place the lesion marker on the point on the endocardial surface that is highlighted by the EnGuide proximity indicator. For multiple-surface models, the lesion marker appears on the nearest included surface. A lesion marker placed with [Lesion at EnGuide] is already projected. To move the lesion marker to the Active Electrode, turn off the Project Selected Lesions checkbox from the right-click menu.

Hot key: <F6> places a lesion marker at the Active Electrode.

■ Click [3D Lesion at EnGuide] to place the lesion marker at the Active Electrode. This lesion marker appears as a sphere and is not connected to the surface of the map, but rotates with the model. To project the lesion marker onto the closest surface, turn on the Project Selected Lesions checkbox from the right-click menu.

Hot key: <Shift>+<F6> places a 3D lesion marker at the Active Electrode.

NOTE: The last lesion marker placed is outlined in yellow. If this lesion marker is deleted, the next to last lesion marker is outlined.

NOTE: When a lesion marker is placed on the map, it is added to the Lesion List.

Figure 164. Lesion marker controls. A: lesion tool; B: color control; C: size control; D: projection control; E: placement buttons; F: right-click menu.

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Lesion Markers


Selecting and Modifying Lesion Markers

Lesion markers can be modified using the Tool Palette and Tool Bar controls, the Lesion Markers control panel in the RealReview task, or the right-click menu.

For information about selecting lesion markers, refer to “Common Interface Elements” on page 32.

■ To select a single Lesion Marker, click on the Lesion Marker tool in the Tool Palette, hold down <Shift>, and then click on the Lesion Marker’s label.

■ To select multiple Lesion Markers, click on the Lesion Marker tool in the Tool Palette, hold down <Ctrl>, and then click on the each Lesion Marker.Alternatively, click on the Lesion Marker tool in the Tool Palette, hold down <Shift> or <Ctrl>, hold down the left mouse button, and then drag a box around the Lesion Markers.

■ To deselect a Lesion Marker, hold down <Shift> and click away from the Lesion Marker's label.

To select Lesion Markers in a list:

■ To select a single Lesion Marker in the list, click on the Lesion Marker in the list.

■ To select multiple Lesion Markers in the list, hold down <Ctrl> and click on each Lesion Marker.

■ To select multiple consecutive Lesion Markers in the list, hold down <Shift>, click on a Lesion Marker and then click on another Lesion Marker. Alternatively, click on a Lesion Marker and drag to select additional consecutive Lesion Markers.

NOTE: When a Lesion Marker is selected, the color of its label changes to white in the model/map display area.

■ To modify a lesion using the Tool Palette and Tool Bar: select the Lesion Marker tool on the Tool Palette, shift and click on the lesion marker’s label, and then use the Tool Bar controls to modify the lesion marker’s color and size.

■ To modify a lesion marker using the Lesion Marker control panel in the RealReview task: select the lesion in the Lesion Marker List, and then use the control panel controls to modify the lesion’s color, size, and projection.

■ To modify a lesion marker using the right-click menu, click on the lesion marker, right-click in the display area to display the Lesion Marker menu, and then select one of the following:

– Show All Lesions shows all lesion markers.

– Hide Selected Lesions hides the selected lesion markers. The lesion markers are only hidden, not deleted.

– Delete Selected Lesions deletes the selected lesion markers from the map and the Lesion Markers List.

– Move Selected Lesion moves the selected lesion marker. To move a lesion marker, select the lesion marker, click Move Selected Lesion, and then click on the map at the desired location. Moving a lesion marker changes it to a mouse-placed lesion.

– Project Selected Lesions A lesion marker placed with [Lesion at EnGuide] is already projected. Project Selected Lesions moves the lesion to the Active Electrode. A lesion marker placed with [3D Lesion at EnGuide] is placed at the Active Electrode. Project Selected Lesions projects the lesion marker onto the closest surface.

– Show Lesion Text shows/hides the name of all lesion markers.

Figure 165. Lesion Marker list control panel. Use this control panel to modify lesion

markers.

Chapter 13. Therapy

Lesion Markers 193EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Lesion Control Panel

A. Lesion Marker Visibility – When the box is checked this lesion marker is visible

B. Color – Clicking on this icon allows you to select a color for the lesion marker.

C. Lesion Number – The lesions are numbered in order of placement.

■ Time Stamp: When the lesion marker is placed, a time stamp is recorded. Hover over to display the time stamp.

D. Annotation – Double-click on an annotation item to annotate.

E. 3D Lesion Marker – Clicking on the box icon changes the lesion from projected to 3D.

Lesion markers created in Review mode will have a brown background.

Figure 166. Lesion control panel.

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Lesion Markers



RealReview
CHAPTER 14
RealReview is the task that allows the user to review study notebook recorded in the current study.

The RealReview screen can be divided into two display areas via the Split Screen icon (Figure 167 on page 195). The control panel displays a Notebook (A) that contains recorded data that can be listed by Time or Type (Segments, Bookmarks, Images, Animations, and Events).

Below the saved study content is a collection of annotation lists (B). While direct manipulation of annotations on the model will be the most common way of interacting with annotations, these lists provide redundant access to labels, markers, measurements, lesion markers, and shadows. To display the list for labels, tape measure, lesion markers or shadow for the specific display, select the corresponding icon in the tool palette.

A. Notebook Listings – Refer to “Notebook” on page 43.

B. Annotation Listings – Displays a list of map tags corresponding to the selected icon on the tool palette. Refer to “Tool Palette” on page 29.

Figure 167. RealReview screen. A: Notebook listings; B: Annotation lists.

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196 Chapter 14. RealReview EnSite™ Velocity™ Cardiac Mapping System Instructions for UseARTEN100151580 Rev. A

Reviewing Segments

Selecting a segment from the notebook (by double clicking it with the left mouse button) will display it in the right pane. Playback controls become enabled beneath the view.

Reviewing Bookmarks

Selecting a bookmark from the control panel list (by double clicking it with the left mouse button) opens the recorded segment with the time cursor frozen at the bookmarked location. This point is marked by a yellow line in the waveform display and segment overview.

Reviewing Images

By double clicking on an image listed in the control panel, the image is displayed in the middle of the display. The image size can be adjusted by dragging the lower right corner of the window.

Reviewing Annotations

The annotation list area can be used to view and modify the annotations (labels, anatomic markers, tape measures, lesion markers, and EnGuide shadows). Select a type icon from the Tool Palette. Annotations created in Offline Review will have a brown background in the control panel. To modify an annotation, select the annotation in the list (it will be selected in the model) then use the controls to show/hide, delete, and change the appearance of the annotation.

Figure 170 on page 196 shows the individual lists and controls.

Figure 168. Reviewing a segment in the right pane of dual view.

Figure 169. Reviewing a dual view segment with waveforms turned on.

Figure 170. Annotation lists and controls. A: labels; B: anatomic markers; C: tape measures; D: lesion annotations; E: EnGuide shadows.


Reviewing and Editing Past Studies

CHAPTER 15

Past Studies

Figure 171. Offline Review screen. A: Notebook listings; B: Annotation lists.

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198 Chapter 15. Reviewing and Editing Past Studies

Past Studies


Reviewing Past Studies

To review a past study:

1. Click [Past Studies] from the Clinical Menu (1) to display the Offline Review screen, which provides a list of all studies saved on the system.

2. Select a row in the list (2) to display a summary of the study, which includes high-level information, saved content, and a list of the equipment used in the study. The Past Studies list is searchable by all fields or by individual fields.

3. Click [Open Study] (3) to open the study in Offline Review mode.

Editing Past Studies

To edit a past study:

■ Click [Edit] (4) to change the Diagnosis, Procedure Type, or Physician information.

■ Click [Edit Patient] (5) to update patient information.

■ Click [Delete] (6) to delete the study.

Figure 172. Reviewing a past study.

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Chapter 15. Reviewing and Editing Past Studies

Offline Review 199EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Offline Review

Opening a study from the Past Studies screen opens the study in the Model task. The last recorded segment will automatically be played. The brown status bars indicate Offline Review mode (Figure 173 on page 199).

Offline Review – Setup

The setup section shows a historical view of the study setup. This section is largely read-only.

When viewing a segment or bookmark, the setup section will display:

■ The final model for the study

■ Catheter locations at time of recording

Other displays will display as they appeared at the time of recording

Offline Review – Model

Users can perform basic operations in the Model section such as changing surface colors, names, and visibility. However, surface editing functions are unavailable.

Figure 173. Offline Review screen. Note the brown status bars.


Managing Patient and Study Records


Offline Review – Mapping

The Mapping section in review mode offers the full set of controls as a realtime study. Users can open maps, review map points, and collect points from the recorded catheter locations. Switching to Split Screen mode allows side-by-side comparison of the Review items.

Offline Review – Therapy

The Therapy section in review mode allows users to modify lesion markers.

NOTE: Lesion markers added in offline review will be given a brown background in the list.

Offline Review – Review

When in the Review task, the study’s saved content is listed in the control panel. Switching to Split Screen mode allows side-by-side comparison of the Review items.


Searching for Patient Records

The Past Studies list in the Offline Review screen can be searched by column headings: Patient, ID, Date, Weight, Physician, or Diagnosis. This text-based search is not case sensitive. Partial spellings are supported by using a partial beginning of the unknown text. For example, in a search by last name, typing the letters “An” would list all patients with last names that begin with “An,” including names such as “Anton” or “Andersen.”

To search the Past Studies list:

1. Select the column heading from the Search By drop-down menu.

2. Type the text to search for in the text box. As text is typed, records that do not match the search text are eliminated from the list.

3. When the desired record appears, click on the record to select it.

Modifying Patient Information

1. Select a patient.

2. Click [Edit Patient...]. The Edit Patient window will appear with the information for the selected patient in the text areas.

3. Modify the text areas for the patient record.

NOTE: The Patient ID cannot be modified.

4. Click [OK] to store the modified patient record.

NOTE: If the patient has more than one study and the user wants the change to apply to only the selected study, check the Apply Changes box for the selected study only.

Chapter 15. Reviewing and Editing Past Studies

Managing Patient and Study Records 201EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Removing Patient Records

A patient and all related study data can be removed from the database.

1. Select a patient.

2. Click [Edit Patient].

3. Click [Delete] to remove. A confirmation will appear.

4. Click [Yes] to remove the patient record.

Modifying Study Records

NOTE: Only records on the hard drive can be modified.

1. From the Study Review screen, select Source > Hard Disk.

2. Select a study.

3. Click [Edit] in the upper right corner of the screen. The Diagnosis Type, Procedure, and Physician Name display.

4. Modify this text by typing into the text area or using the adjacent drop-down menu buttons. Click [Save] to save changes.

Deleting Studies

Removing study information from the DWS hard drive will make more drive space available for future studies.

NOTE: If the hard drive becomes full during a study, the system will delete the oldest backed up studies first.

NOTE: Studies that have been removed from the hard drive can still be loaded from removable media for future reference.

NOTE: Multiple studies can be deleted.

1. From the Study Review screen, select Source > Hard Disk.

2. Select a study.

3. Click [Delete]. A confirmation window will appear.

4. Click [Yes] to delete the study.





Ending a Study
CHAPTER 16
Ending a Study

WARNING: If the DWS is powered off by the user, rather than shutdown by the operating system, data on the hard drive may become corrupted and the EnSite™ Velocity™ Cardiac Mapping System may cease to be operational.

CAUTION: When removing the system reference surface electrode from the patient’s abdomen, disconnect the patch from the patient before disconnecting its connection from the NavLink™ Module.

Use the following procedure to end a study:

1. From the menu bar, select File > End Study. The system will prompt the user with “End the current study? Yes/No.” Click Yes. If study and patient information has already been specified, go to step 3.

2. If study and patient information has not been specified, the system will prompt the user with “Cannot end study without entering study and patient information. Enter study and patient information? Yes/No.” Click Yes. The system will display the Study and Patient Information screen (Figure 174 on page 203). Fill in the required information and click OK.

3. The system will prompt the user with ”Remember to backup study information”.

4. Click OK to continue.

NOTE:

5. The system will return to the Login screen.

NOTE: To backup, or archive, the study, see “Archiving Studies” on page 210.

Figure 174. Study and Patient Information screen.

204 Chapter 16. Ending a Study

Ending a Study



Capturing, Exporting, and Importing Information

CHAPTER 17

Exporting Data to External Devices

Images and study data can be stored to a USB device, a network drive, or CD/DVD for reuse on PC or Macintosh computers with a compatible CD or DVD drive. Compatible CD/DVD formats are: CD-R, CD+R, CD-RW, CD+RW, DVD-R, DVD+R, DVD+RW, and DVD-R Dual Layer.

NOTE: CD/DVDs must be handled with care. Do not allow a CD/DVD to fall on a hard surface. To label a CD/DVD, never use a paper label, always write directly onto the CD/DVD using a permanent marker.

NOTE: Information can only be exported to a CD/DVD from outside of a study.

NOTE: A CD/DVD may contain multiple images, but only one study.

NOTE: If export to a USB device fails, try an alternate external storage device, a network location, or CD/DVD.

NOTE: Network File System (NFS) versions prior to NFSv3 may experience limitations to the addressable file system size to less than 4.2GB. (This is a protocol limitation.)

NOTE: File system access errors may be experienced when using Server Message Block (SMB) versions prior to 2.0. Some files may become inaccessible.

NOTE: USB devices having FAT32 file systems may be unable to store Velocity studies, due to the number of files, file name length, or file size limitations of FAT32. NTFS or ext3 file systems are recommended to be used.

When images are stored to external media, they are listed by their annotation and an index number to differentiate duplicate annotations. Images are stored as JPEG files.

Selecting an Area for Capture

When capturing images or creating animations, the entire screen or a selected area of the screen can be captured. In addition, the images and animations can be captured with a white background. The user specifies what is to be captured in the Capture Image, Record Movie, and Capture Images windows.

■ To capture the entire screen, select Full Screen.

■ To define the area of the screen to be captured, select Selected Area. To define the area to be captured, Click and hold down the left mouse button and drag a box around the desired area of the screen. Adjust the box if necessary.

■ To capture the entire screen or selected area with a white background, select White Background. A white background is beneficial if the images are going to be printed on a printer.

When the desired area has been selected, click [Capture Image] to capture an individual image, or click [Start] to capture an animation. The captured image or animation is stored in the Notebook.

206 Chapter 17. Capturing, Exporting, and Importing Information

Saving and Accessing Individual Images


NOTE: Individual images can be captured at any time during a study.

NOTE: MPEG and JPEG animations can only be captured in Offline Review.

Saving and Accessing Individual Images

Images of entire screens can be saved. These images can also be viewed.

Saving an Image

To save an individual image:

1. Select File > Save Image to display the Capture Image window.

2. Type a description of the image in the text area.

3. Indicate the screen area to be captured:

■ Select Full Screen to capture the entire screen.

■ Select Selected Area to manually select the screen area to capture. Refer to “Selecting an Area for Capture” on page 205 for more information about selecting the screen area.

4. Select White Background if a white background is desired.

5. Click [Capture Image]. The image is captured and saved as a part of the patient study, and is added to the Notebook.

Accessing an Image

NOTE: Images are saved with their appropriate study. If a study containing images created in Offline Review mode is removed from the workstation hard drive, the images are removed as well. Be sure to backup studies so the images are saved.

1. Access the Notebook in RealReview.

2. Select an annotation from the list. Use the buttons described below to view or manage image files:

■ [Load] displays the image.

NOTE:This is the only location where printing can be done.

■ [Delete] erases the selected image.

■ [Edit] allows the user to edit the annotation of the image

3. Click [Close] to exit the window.

Figure 175. The Capture Image dialog is used to capture individual JPEG images.

Chapter 17. Capturing, Exporting, and Importing Information

Creating Animations 207EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Creating Animations

(Offline Review mode only)

A series of continuous images of the entire screen can be exported from the system as either an mpeg movie file or a sequence of jpeg images.

Creating an MPEG movie

To start recording an MPEG movie:

1. Select File > Save Animation > Start Capturing MPEG Movie to display the Record Movie window.





4. Click Start to start recording a movie.

To stop recording an MPEG movie:

1. Click the Animation Recording icon located in the bottom right corner of the screen.

or

Select File > Stop Capturing Animation.

2. A dialog box will appear in the center of the screen. Enter a description for the movie in Description field.

3. Click [Create Movie] to create the movie or [Cancel] to cancel the operation.

Creating a JPEG image sequence

To start recording a JPEG image sequence:

1. Select File > Save Animation > Start Capturing JPEG Images to display the Capture Images window.





4. Click Start to start recording a movie.

To stop recording a JPEG movie:

1. Click the Animation Recording icon located in the bottom right corner of the screen.

or

Select File > Stop Capturing Animation.

2. Enter a description for the movie in Description field.

3. Click [OK] to save the images or [Discard Images] to discard the captured images.

Figure 176. The Record Movie window is used to record an MPEG movie.

Figure 177. The Capture Images window is used to capture a series of individual JPEG images.


Data Export


Data Export

(Offline Review only)

NOTE: This option exports data only to the DWS hard drive.

To begin Data Export, select File > Export to bring up the Data Export window (Figure 178 on page 208).

Waveform Data

Near the top of the window is a list of the types of data that can be exported (A). Any or all of them can be selected using the check boxes, and each will be written to its own file. When the user selects any type of data that changes over time (e.g. Waveforms, or Electrode Locations), the Export Interval options become available (C) to choose the time interval for the export.

The Displayed Waveforms option is a special shortcut selection that exports only those waveforms (of any type) that are currently displayed, over the current span of the waveform window. The Export Data and Export Interval options do not apply to this selection.

If Use System Reference at the top of the window is checked, the Positional Reference will be set to System Reference before the export begins, regardless of its setting during the study. This can standardize the positions of electrodes and labels, but also export them in positions different than how they appear on the screen. If this option is checked, the user must revert the Positional Reference manually after the export is complete.

Directory Name

A directory prefix is assigned in the Directory Name field of the Data Export window (see Figure 178, B). Each time the Export button is clicked, a folder is created using this name and the current date and time of the button click, and the exported data files are saved into this folder.

Export Interval Options

NOTE: The caliper and the cursor are only available in the following workflows: Model, Therapy, RealReview, or Non-Contact Mapping.

Caliper. Select this option to use the green calipers in the waveform display to capture the time interval desired.

Displayed Window. Selecting this option captures the visible time interval in the waveform display.

Cursor Location . Selecting this option exports the segment beginning at the cursor. This option requires that one of two sub-options also be selected:

■ Export until segment end, which will continue exporting data until the segment ends.

■ Duration (in seconds), in which the exact segment interval is determined by the user and is manually entered in the field supplied.

NOTE: Selecting [Clear Selections], at the top of the Data Export window, will clear all Export Option check marks. De-selecting items can be done anytime prior to Export.

Figure 178. Data Export window. List of options (A); Directory Name (B); Export Interval options (C); Comments (D); Export

button (E)

A

B

C

D

E


Data Export 209EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Exporting

When [Export] is clicked, a progress bar is displayed for each option selected. If Export Data: All is selected (see Figure 178, A), all available data for the selected type(s) will be exported from the study (e.g., all EP Catheter Unipole Waveform channels). In contrast, when Export Data: Displayed is selected, only those channels currently displayed in the waveform window will be exported.

Once an Export begins:

■ All graphical user interface objects are disabled, except [Cancel]

■ A progress bar is displayed for each option selected

■ Application configuration changes recorded as part of the segment are inhibited

■ The configuration at the start of the Export will be maintained for the duration of the Export

NOTE: When the progress bar(s) is displayed, [Cancel] can be selected to stop the Export. The Export may not stop immediately; a slight delay can be expected.

Export is not available if Segment: None is selected

When exporting EnSite™ NavX™ Navigation and Visualization Technology data, the segment playback speed is automatically set to 1:4. This ratio allows for internal processing and the Export of data. When exporting non-contact data, if the Virtuals Grid option is chosen, the playback speed is automatically set to 1:10; this ratio allows for the additional processing requirements.

Presets

The user can choose to save a Preset for application configurations that will be used in more than one Export.

Once all the desired parameters are set, click on the Preset icon located in the upper right of the Data Export window. Click on Save Preset to bring up the Save Preset window. Type in a name for the preset and click [OK].

To reapply a Preset, click on the Preset icon and click on the appropriate Preset name.

NOTE: Export Presets can be applied to any segment in the study in which they are defined. However, Export Presets cannot be applied to a different study.

Save Preset…

Manage Presets...

Figure 179. Preset icon and Preset menu selections


Archiving Studies


Archiving Studies

This option allows the user to archive entire studies to a USB device, a network drive, CD/DVD, or to the DWS to remove later via SJM Connect.

1. Click Archive from the Clinical Menu (1).

2. Select the Archive Study tab.

Figure 181. Archive Study Window.

3. Highlight the desired study (3).

4. Insert the desired media, and select the Archive Destination (USB, CD/DVD, network drive,DICOM Server, or SJM Connect) (4).

5. Select the Identifier (name of the USB device or enter the name of the CD/DVD) (5),

6. Select one or both options (6):

■ “Delete the selected studies from the local drive after successful archiving”

■ “Overwrite the previous archive on the selected destinations” (does not apply to CD/DVD media)

7. Click Archive (7).

1

Figure 180. Clinical Menu.

3

6

4 5

2

7


Archiving Media 211EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


8. The system prompts the user to anonymize the archived patient data. Click Yes or No.

■ A progress bar displays “Store in Progress.”

■ The study is archived on the selected media when the progress bar finishes.

Archiving Media

This option allows the user to archive individual images and animations from a study, rather than the entire study.

1. Click Archive from the Clinical Menu (1).

2. Select the Archive Media tab (2).

3. Highlight the study that contains the desired images and animations (3)

Figure 183. Archive Media Window.

4. Select a File Name in the right section of the screen (4).

■ The selected image or animation displays below (4b).

5. Insert the desired media, and select the Archive Destination (USB, CD/DVD, network drive, or DICOM Server) (5).


11

3

5 6

24

4b

7


Importing Studies


6. Select the Identifier (name of the USB device or enter the name of the CD/DVD) (6),

7. Click [Archive] (7).



■ The images and animations are archived on the selected media when the progress bar finishes.

Importing Studies

The user can import studies to the DWS from a USB device, a network drive, or CD/DVD.

1. Click Import from the Clinical Menu (1).

2. Select a source from the Import From: pulldown menu

Figure 185. Import Study Window.

■ If importing from USB or CD/DVD, make sure the media is present in the USB port or CD/DVD drive.

1


32


Importing Studies 213EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


3. Click the [Query] or [Browse] button.

■ For CD/DVD, only [Browse] is available

■ The list of studies on the media displays:

Figure 186. Import Study Window Contents List.

4. Select a study from the list (4) and click the [Import Study] button.



■ The study is imported to the DWS when the progress bar finishes.

4

3


Importing Studies



Troubleshooting
APPENDIX A
Contacting Technical Support

The following troubleshooting guide is intended to help resolve problems with the system. If problems cannot be resolved by using the suggestions presented here, contact your EnSite™ Velocity™ Cardiac Mapping System field representative or distributor.

WARNING: Service and Technical Support

651-756-6985Toll Free: 800-374-8038, Option 1

Troubleshooting Tools

Technical Support may ask that the user access one or more of the following software resources:

EnSite™ Connect – Technical Support is able to electronically access your EnSite™ Velocity™ Cardiac Mapping System to perform troubleshooting. See “Using SJM™ Connect” on page 216.

About the EnSite™ Velocity™ Cardiac Mapping System – This information provides your EnSite™ Velocity™ Cardiac Mapping System Technical Support representative with general information about your DWS and EnSite™ Amplifier. There are two ways to access this information:

■ During a study, from the menu bar, select Help > About.

■ From the title screen, Select [About EnSite Velocity].

Amplifier Logs – This function displays messages from the EnSite™ Amplifier during a study. From the menu bar, select Amplifier > Log. A window appears that displays all of the collected logs.

Collect Log Files – This function collects all the log files from the DWS and exports them to external media. From the title screen, select [Services], then [Collect Logs] from the Services menu. [Follow the on-screen prompts to complete the process. This operation can take several minutes to complete.

Viewing recorded settings – Some settings used in Realtime mode can be viewed (but not changed) in Offline Review mode.

■ Hardware settings can be viewed by selecting Amplifier > Settings from the menu bar.

■ Catheter settings can be viewed in the Setup task.

■ EnSite™ NavX™ Navigation and Visualization Technology settings can be viewed in the Setup task.

Run external program – This function allows utilities to be accessed. From the title screen, select [About EnSite Velocity] > Utilities > [Run External Program]. Follow the on-screen prompts to complete the process.

Study Files – Record a segment that shows relevant information (if possible) and save the study using the anonymize option to extrenal media.

216 Troubleshooting

Using SJM™ Connect



SJM™ Connect is a feature that is available on the EnSite™ Velocity™ Cardiac Mapping System. It allows an EnSite™ Velocity™

Cardiac Mapping System Technical Support representative to connect to your DWS through a broadband Internet connection. When connected to your DWS, the EnSite™ Velocity™ Cardiac Mapping System Technical Support representative is able to see the interface. You will also be able to chat with the Technical Support Representative through a chat window.

NOTE: SJM™ Connect is intended for troubleshooting purposes. SJM™ Connect is not intended to be used in lieu of an on-site system operator.

NOTE: Personal patient information is automatically deleted from uploaded studies. The Technical Support representative uses these anonymous studies to research any technical issues. When possible, record and annotate segments of any unusual behavior for analysis.

If You Need SJM™ Technical Support

1. Call SJM™ Technical Support (see “Contacting Technical Support” on page 215).

2. SJM™ Technical Support will assess the issue over the phone and may need additional information from Collect Logs or remote access to the DWS.

3. If SJM™ Technical Support requires remote access to the DWS, click the SJM™ Connect icon on the EnSite™ Cardiac Mapping System’s tool bar.

Figure 187. The SJM™ Connect Icon

NOTE: An Ethernet cable with Internet access must be plugged into the hospital network port on the back of the DWS. This is an encrypted, secure connection used by SJM™ Technical Support.

NOTE: Only enable SJM™ Connect if instructed to do so by SJM™ Technical Support.

4. The SJM™ Connect window displays. Select the timeout from drop down list and click the [Enable]. The SJM™ Connect icon will turn bronze.

NOTE: SJM™ Connect will be enabled for the selected amount of time, ranging from 0.1 hour (6 minutes), 1 hour, 2 hours, 24 hours, and 48 hours. The default timeout is 0.1 hour (6 minutes). The timeout determines how long the session can remain idle before being terminated. The session will not timeout at any time during a study.

Figure 188. SJM™ Connect Window

Troubleshooting

Using SJM™ Connect 217EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


5. If Technical Support initiates a remote connection to the DWS, a prompt displays requesting to view and control your computer (Figure 189).

Figure 189. SJM™ Technical Support Access Request Example

6. Click [Allow]. If nothing is selected after 15 seconds, Technical Support will automatically connect. The SJM™ Connect icon will turn green.

7. Technical Support will now have access to the system to troubleshoot the problem. A chat window will display if Technical Support initiates a chat session (Figure 190).

Figure 190. SJM™ Technical Support Chat Window

8. If necessary, drag this window to the side of the monitor or click on the SJM Connect icon (Figure 205) and select “Show / Hide Chat” in the SJM Connect dialog (Figure 187 on page 216) Figure 190. The minimized chat window will pop up if Technical Support initiates a chat. Click [Show Chat] to bring window back on the display.

9. If Tech Support requests any logs, click [Upload Logs] from the SJM™ Connect window (Figure 188).

10. After the Technical Support session has ended, click the SJM™ Connect icon on the EnSite™ Mapping System’s tool bar and click [Disable] button in the SJM™ Connect window. The SJM™ Connect icon will turn gray.

NOTE: The default status of SJM™ Connect on system startup is disabled. SJM™ Connect should only be enabled when a Technical Support session is necessary.

If not disabled manually, SJM™ Connect will stay enabled until the specified timeout irrespective of user logouts or system shutdown. It will disable automatically after the specified timeout if no Technical Support is connected at that time. If a Technical Support is connected and the timeout expires, the SJM™ Connect session will stay enabled until Technical Support terminates the connection.

Whenever SJM™ Connect window is not active window on the screen, it will close itself. It can always be launched by clicking the SJM™ Connect icon on the EnSite™ Mapping System’s tool bar.

Sending Files with SJM™ Connect

The chat function allows you to send files from the DWS to SJM™ Technical Support.

218 Troubleshooting



1. Click [Send File] from the chat window:

Figure 191. SJM™ Connect Chat Window

2. Browse the folders and select the desired file to send, and click [OK].

Figure 192. SJM™ Connect File Browser

NOTE: Do not click [Close] (Red X) button from the chat window, it will terminate the ongoing session with Tech Support. Do not click any buttons from the chat window until Technical Support instructs you to.

Uploading Logs with SJM™ Connect

If SJM™ Technical Support requests that you upload logs:

1. Click [Upload Logs] from the SJM™ Connect window (Figure 188).

2. Select the logs to upload.

NOTE: The logs will not be uploaded automatically. They will remain on the DWS until SJM™ Technical Support connects to the DWS to collect them.

Uploading Studies

If SJM™ Technical Support requests that you upload patient studies:

1. Click the [Clinical] button, then the [Archive] button from the EnSite™ Cardiac Mapping System main page.

2. Select the study or studies to upload.

3. Select the [SJM Connect] checkbox and click [Archive].

Troubleshooting

Using SJM™ Connect 219EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


4. Click [Close].

NOTE: The studies will not be uploaded automatically. They will remain on the DWS until SJM™ Technical Support connects to the DWS to collect them.

Proxy Configuration

SJM™ Technical Support may request that you configure the proxy server in order to establish a connection to the DWS:

1. Click [Configure Proxy] in the SJM™ Connect window (Figure 188).

NOTE: The [Configure Proxy] button will be inactive if SJM™ Connect is enabled.

Figure 193. The SJM™ Connect Proxy Configuration Window

2. Click the [Enable Proxy] checkbox and enter the proxy server and proxy port information.

3. If the proxy server requires authentication, click the [Authorization Required] checkbox and enter the authorized user name and password.

4. Click [Save] to save the proxy configuration.

NOTE: Do not configure a proxy if the hospital network does not require a proxy for Internet access. By default, no proxy is configured and all the fields from the Proxy Configuration window will be inactive.

Notifying SJM

When system logs or patient studies have been prepared for uploading, contact SJM by telephone or e-mail.

To contact SJM by telephone:

Toll free: 1-800-374-8038; option 1

In Europe: 32-2-774-68-11

■ To contact SJM by email: [email protected]

220 Troubleshooting

Troubleshooting Common Problems



When a problem occurs perform the following steps:

1. Identify the problem source and use the guides below:

■ “System Hardware Problems” on page 220

■ “Patient Signal Problems” on page 222

■ “Software Interface Problems” on page 224

2. If the problem cannot be resolved, contact EnSite™ Velocity™ Cardiac Mapping System Technical Support (“Contacting Technical Support” on page 215).

System Hardware Problems

In general: Many hardware problems can be identified/resolved by checking status lights and cable connections.

Check all status lights• EnSite™ Amplifier: When the system is powered on, the status lights may change state for approximately two

minutes while the system performs self-testing. If after the two minute power on self-test, the amber light flashes or illuminates steadily, the EnSite™ Amplifier has detected a problem. The EnSite™ Amplifier status and any fault information can be uploaded by the workstation after the EnSite™ Amplifier connects to the workstation.

• EnSite™ Velocity™ Cardiac Mapping System Workstation: The power LED on the front of the workstation should be on.

Verify proper cable connections:• Turn the system power off.• Unplug the system components from power outlets.• Check all connections for damage (such as bent or broken pins).• Verify there are no loose connections.• Check the integrity of the wall power outlet.• Power the system on according to “Starting the System” on page 85.

Power Failures: A power blackout will cause a total system shutdown. In the case of a brownout, the system may totally shutdown or may show signs of abnormal system behavior.

If there is reason to believe that some type of power failure has occurred, turn the EnSite™ Amplifier power switch to OFF immediately. Try to end the study and shutdown the workstation, as described in “Ending a Study” on page 203. If the normal shutdown procedure is unsuccessful:• Try Ctrl-Alt-Delete• Try Alt-F10 > [Exit EnSite Velocity] > [Exit]• Try momentarily pressing the power button on the front of the DWS• As a last resort, press and hold the power button on the front of the DWS.When the power resumes and appears to be stable, power up the system as described in “Starting the System” on page 85. Monitor the automated system check during the power-up procedure. If any system problems occur, contact SJM Technical Support immediately. To continue the study, see “Past Studies” on page 93.

There is a problem with the EnSite™ amplifier, indicated by an amber LED on the amplifier front panel after the two-minute power on self-test.

• A solid amber LED indicates a self-test problem in the EnSite™ Amplifier. • A flashing amber LED indicates an error in the EnSite™ Amplifier.• Contact EnSite™ System Tech Support.

The EnSite™ Amplifier is not communicating with the workstation.

The EnSite™ Amplifier is unresponsive or is not collecting data in Realtime mode or RealReview mode. Try to re-establish communication with the EnSite™ Amplifier by selecting Amplifier > Reconnect. If communication is not reestablished, do the following:• Check the fiber-optic cable connection at the EnSite™ Amplifier and at the workstation.• Power on the EnSite™ Amplifier and all peripherals.• Power on the workstation.• Check the 3 indicator lights on the Media Converter (inside the back door of the DWS).

- Fiber - green - Media Converter is receiving the signal from the EnSite™ Amplifier - via the Fiber- Optic cable.- Power (Pwr) - green - Media Converter is receiving power from the Workstation.- Copper - green - Media converter is receiving the signal from the DWS

Troubleshooting

Troubleshooting Common Problems 221EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


There is a problem with the EnSite™ Amplifier indicated by the workstation.

The workstation displays a yellow warning dialog: “Amplifier Error.” The user should Contact EnSite™ System Technical Support.

The workstation will not turn on, will not boot, or turns off unexpectedly.

• Verify that the power conditioner switch is on.• Verify that the power cable is properly connected between the workstation and the power conditioner.• If the system should cease to function due to a power outage or other failure, turn off all power switches. Then restart

the system as described in “Starting the System” on page 85. System recovery may take up to 6 minutes. • Try momentarily pressing the power button on the front of the DWS• As a last resort, press and hold the power button on the front of the DWS.• To continue the study, refer to “Past Studies” on page 93.

Hard drive has run out of space.

If there is insufficient space on the hard drive to load a study from the external media, delete studies from the hard drive, then load the study.

There is a broken connector pin.

Contact EnSite™ System Technical Support or Customer Service.

The printer does not print images.

• Ensure the printer is enabled. To do this, go to the Services menu and select [Select Printer]. Select the desired printer and click “Apply.”

• Ensure that printer ink cartridges are not depleted; replace depleted cartridges. Ensure that there is paper in the printer.

222 Troubleshooting



Patient Signal Problems

There is a problem with EnSite™ Array™ Catheter validation or signal check (including “too many bad electrodes”).

If noise levels are excessive on EnSite™ Velocity™ Cardiac Mapping System signals or the “Too many inactive electrodes” message appears, check the following:• Verify cable connections. • Ensure that the EnSite™ Array™ Catheter connector and data module are firmly inserted into the ArrayLink™

Module. • Ensure that the System Reference Patch is properly connected to the NavLink™ Module and the patient. After

verifying cable connections, wait for 10 seconds and then verify signal fidelity from the EnSite™ Array™ Catheter bar chart Setup mode.

• Verify that none of the ring electrodes on either the EnSite™ Array™ Catheter or the roving catheter are covered by an insulator (such as a sheath) or obstructed by tissue.

There is a need to validate virtual electrogram morphology to contact electrograms

If the validity of a virtual electrogram signal or a map is in question, compare the EnGuide virtual electrogram to the EP catheter electrode in contact with the endocardium at the same site. Similarity between these signals suggests validity of the virtual electrogram or map at the same site. This can be done in any mode. However, in review mode the EnGuide locator must have been enabled before the segment was recorded.• Set an electrode on an EP catheter to Active EnGuide.• Under model controls, display the EnGuide locator as a vector with a single electrode.• Under catheter setup / waveform controls, set EnGuide virtual polarity to Unipolar.• In Waveform, set up two traces. Set one trace source to EP catheter and set the second trace source as EnGuide.

Use the electrode that is selected for EnGuide on both traces.The d/dt checkbox and Amplitude filtering should be identical between the EP catheter and EnGuide traces.

• Verify that the EP catheter electrode is in contact with the chamber wall. Use the EnGuide locator to determine the location of the EP catheter electrode.Caution: If the EP catheter electrode is not in contact with the endocardium, the comparison between the EnGuide virtual electrogram and the EP catheter electrode may not accurately reflect the relationship between these signals.

• Compare the traces in the waveform display. Similarity between the signals indicates validity of the virtual electrogram.

Interference between devices is evident.

This equipment has been tested and found to comply with the limits for medical devices to EN 60601-1-2: 2001. This testing shows the device provides reasonable protection against harmful interference in a typical medical installation. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices or is negatively impacted by other devices, try to correct the interference by one or more of the following measures:• Reorient or relocate the devices.• Increase the separation between the devices.• Connect the equipment to an outlet on a different circuit.• Contact Technical Support for further assistance (“Contacting Technical Support” on page 215).

There is excessive waveform noise.

If noise levels are excessive in general, check the following:• Under catheter setup / waveform controls, evaluate signals with noise filters enabled and disabled. • Ideally, the power source for the EnSite™ Amplifier should be a properly grounded, dedicated 15 amp circuit.

Avoid using hospital emergency power for either the workstation or EnSite™ Amplifier.

An EnSite™ NavX™ Navigation and Visualization Technology surface electrode has become disconnected or loose, indicated by a warning message.

• Verify that all cable connections between the surface electrodes and the NavLink™ Module are secure.• Verify that none of the surface electrodes have come loose. If a surface electrode has come loose from the patient,

re-apply the electrode in the same location and verify that navigation is accurate, compared to fluoroscopy and signals. It may be necessary to re-validate.

ECG signals are not functioning properly.

• Verify that the system reference patch is connected to the patient.• Verify that the ECG cables are connected properly.• If not using a RecordConnect, verify that the ECG cable was labeled by St. Jude Medical.

Troubleshooting



EnGuide Stability Problems

An EnGuide locator position seems to be incorrect:• The EnGuide locator

intermittently displays jumps in location or changes in color.

• Displayed location of the roving catheter on the Cardiac Mapping System differs from the displayed catheter location on fluoroscopy or another mapping system.

• The movement of the EnGuide locator is inconsistent with the movement of the roving catheter.

• The EnGuide locator “jitters.”

• Verify that the ablation catheter is connected to the GenConnect interconnect.• Verify that EnGuide is locating the intended electrode.• Verify that none of the ring electrodes on the roving catheter (or EnSite™ Array™ Catheter) are covered by an

insulator (such as a sheath) or obstructed by tissue. If the proximal electrodes of the ABL catheter are covered with a sheath and ABL Distal Stabilize is enabled, turn off ABL Distal Stabilize to allow for location of the distal electrode.

• Verify that catheter jumpers are connected properly.• Verify that the surface electrodes are properly adhered to the patient and connected to the system.• Verify that the wires for the surface electrodes are positioned in a way that there is no tension on the wire.• Attempt to use the EnGuide system on a different catheter. Signal improvement may indicate a damaged EP

catheter or connecting cable.• Select Amplifier > Reset Amplifier.• For EnSite™ Array™ Catheter studies, verify that electrode rings E1 and E2 are in the same chamber.

An EnGuide locator appears kinked or displays fewer electrodes than expected.

• In an EnSite™ NavX™ Navigation and Visualization Technology study, if EnGuide locators appear kinked, there may be a problem with the catheter. A new catheter or extension cable may display better results.

• If EnGuide is displaying fewer electrodes than expected (based on EnGuide settings) the electrodes may be spaced too close to one another for EnGuide to display different electrodes, or there may be a problem with the roving catheter, such as a weak electrode or short.

Patient Irregular Respiration Patterns Patient – sleep apnea, coughs, snoring

Follow these steps:

1. Wait for the respiration pattern to stabilize. The EnGuide may return to its original expected location

2. Manually recollect respiration compensation data. See “Respiration Compensation” on page 114.

3. Switch to manual to prevent additional collection (disable adaptive respiration compensation). See page “Respiration Compensation” on page 114.

4. If multiple shadows have been placed use EnGuide Alignment tool to adjust the visually realign the catheter to the model. See “EnGuide Alignment” on page 116.

5. Build a new model if steps above do not resolve the problem.

Patient Rate or Rhythm change • Heart rate or rhythm changes have the potential to change the physical anatomical volume of the heart chamber. If the rate or rhythm changes occur after a model has been created, new model may need to be created for the new rate or rhythm.

Patient Isoproterenol bolus • Wait for the respiration pattern to stabilize. The EnGuide may return to its original expected location.

Patient Heart Motion • If the heart has physically moved from its original position, create a new model if necessary.

Device Interaction Cardioversion Follow these steps:

1. Wait for the EnGuide to return to its original expected location


3. Build a new model if steps above do not resolve the problem.

Device Interaction Introduction of a Guide Wire • Remove the guidewire if it is not in use.

Device Interaction Pacing – connection of a stimulation channel to electrodes

• If there is no active pacing on the electrode pair, remove the connection of the stimulation channels.

224 Troubleshooting



Software Interface Problems

Surface Electrode Changes

Surface Electrode Detachment Follow these steps:

1. Replace the detached surface electrode a new surface electrode

2. Build a new model.


Surface Electrode movement relative to the location of the heart

Follow these steps:

1. Switch to an intracardiac reference if available to prevent additional instability due to surface electrode movement.


3. Build a new model if use of the alignment tool is not successful.


Pushing on a patch - Inflation of a blood pressure cuff

Try the following options:• Avoid pushing on the patch or remove the object pushing on the patch• Switch to an intracardiac reference if available


Adding or removing patient bedding materials

• Avoid moving bedding materials such as a pillow that have the potential to disturb the surface electrode

System Related Positional Reference Moves Try the following options:• Move catheter to original location as observed on Fluoroscopy images. If Positional

Reference Tool is enabled use the tool to realign the reference.• Switch from the intracardiac Positional Reference to the System Reference. Then choose

a different electrode for positional reference.• Build a new model if use of the Positional Reference Tool is not successful.

Unable to enter Review Mode or end study.

An action is incomplete. Verify that the model has been completed. Verify that recorded segments have been completed and annotated.

Unable to access controls to export information to the external media.

• Verify that Offline Review mode is selected; the external media is not intended to be used to export data or animations during a study.

The study screen display freezes.

If the system appears to be running but does not respond to keyboard or mouse input, press and hold the <Alt> key on your keyboard, then press the <Tab> key. The system should then return to normal operation.The study screen freezes after a manual reset of the EnSite™ Amplifier or an inadvertent reset following a defibrillation. Possible messages include: Data rate is out of range or No data is being received from the EnSite™ Amplifier. When one or both of these messages appear, click [OK]. If the screen remains frozen, perform the following steps:• Power cycle the EnSite™ Amplifier by turning the EnSite™ Amplifier power switch off and (after five seconds) then

on.• Select Amplifier > Reconnect and wait up to 2 minutes for the EnSite™ Amplifier to complete its self-test

routines.• Select <Alt> + <Tab> to see if the study screen starts responding.• To force the system to shut down, select <Alt> + <F10> YES, REALLY EXIT VELOCITY.• To end the current session, or to force the system to shutdown or restart, select <Ctrl> + <Alt> + <Del>, and

choose the desired option.If the problem still persists, contact EnSite™ Velocity™ Cardiac Mapping System Technical Support.

Troubleshooting



An on-screen warning message has appeared.

A number of problems are reported by displaying a message in a window. One or more buttons are available, which specify the action to take to remedy the identified problem.A desktop manager window may also pop up on-screen when an application is not responding. It will have two options - “Terminate” or “Keep Running.” Select the desired option.Note: Further details on problems related to the current version of the software can be viewed by selecting Release Notes under the Help menu.Other information may be displayed along with these messages indicating what caused the problem. Note this information for future reference should you wish to contact support personnel.Caution: Always respond to warning messages as soon as possible. Failure to do so may cause an inability to record data or to communicate properly with the EnSite™ Amplifier.Different buttons may appear based upon the severity of the identified problem. Some examples of these button options are:• [Reconnect] reconnects to the EnSite™ Amplifier.

226 Troubleshooting




Care and Service
APPENDIX B
Service and Technical Support

Due to the complexity of this system, service may be performed only by trained personnel. Contact your EnSite™ Velocity™ Cardiac Mapping System representative or distributor for service and technical support.

St. Jude MedicalOne St. Jude Medical DriveSt. Paul, MN55117-9913 USA+1 855 478 5833+1 651 756 5833sjm.com

St. Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium+32 2 774 68 11sjm.com

Australian Sponsor:St. Jude Medical Australia Pty Limited17 Orion Rd.,Lane Cove NSW 2066AUSTRALIA+61 (02) 9936 1200

228 Care and Service

Setting Environmental Information


Setting Environmental Information

Setting the System Clock

1. Login as the Service user.

2. From the title screen, click [Services] and select Utilities.

3. Adjust the System Time section on the left side of the screen using the arrow buttons to set the current time.

NOTE: This is a 24 hour clock. The clock can only be set to a time that is at least 18 hours later than the time that the last study ended.

NOTE: After the user sets the system clock, the system prompts the user to confirm system shutdown.

Setting the Powerline Frequency

The powerline frequency can be set to either 50 Hz or 60 Hz. For North American locations, 60 Hz is generally appropriate. For European locations, 50 Hz is generally appropriate.

1. During a study, select Amplifier > Amplifier Settings > Power Line.

2. Use the Powerline Frequency checkboxes to select a powerline frequency.

Setting the Owner Information

Information about the hospital can be entered into the software. The saved hospital name is displayed on the title screen and saved with studies on the external media. From the title screen, select [Services] and then click the Hospital tab. Complete the available fields and select [Apply]. See Figure 195 on page 228.

The owner information is used to administer support tools such as EnSite Connect.

NOTE: If multiple EnSite™ Velocity™ Cardiac Mapping Systems are present at the same location, enter an identifier such as “LAB A.”

Figure 194. Setting the powerline frequency.

Figure 195. The owner information helps EnSite Support organize information.

Care and Service

Customer-Performed Maintenance 229EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Customer-Performed Maintenance

EnSite™ Amplifier

Cleaning

WARNING: Cleaning is recommended after each use. All surfaces should be cleaned with a dry, lint free cloth, gently applied. Where necessary, alcohol can be applied on such a cloth to remove grease and stains. The monitor screens can be cleaned with an appropriate solution.

CAUTION: Do not clean the system components with disinfectants that contain surfactants.

CAUTION: Do not clean system components with bleach.

CAUTION: Do not apply cleaners while the system is warm to the touch.

CAUTION: Do not sterilize system components.

CAUTION: Do not immerse system components in liquid.

Periodic Inspection

The system components should be inspected by the customer on a monthly basis:

■ Ensure that the fans on system components are operating when power is on. Periodic fan filter cleaning or replacement is recommended.

■ Check the components, cables, and connections for mechanical damage.

■ Check cables and connectors for damaged pins.

■ Verify that inscriptions and labels on the system components are properly and completely fixed.

■ Visually inspect that this Instructions for Use document is undamaged and complete.

Cleaning/Replacing the EnSite™ Amplifier Air Filter

Important: Clean the EnSite™ Amplifier air filter every 30 days.

1. Use a Phillips screwdriver to remove the fastener holding the filter handle in place (Figure 196 on page 229).

2. Slide the handle and filter out of the EnSite™ Amplifier by pulling away from the EnSite™ Amplifier. Do not remove the filter from the handle unless you are replacing the filter.

3. Clean or replace the filter:

To clean the filter, pick off the lint layer and vacuum out the remaining dust.

To replace the filter:

a. Remove the filter from the handle by unscrewing the two mounting screws (Figure 197 on page 230).

b. Discard the filter.

Figure 196. Removing the filter handle.


Customer-Performed Maintenance


c. Mount a new filter in the handle using the two screws. The gestated side of the filter should be oriented as shown.

4. Slide the filter into the channels in the EnSite™ Amplifier until the handle is flush with the side of the EnSite™ Amplifier.

5. Fasten the handle to EnSite™ Amplifier using the Phillips screw.

Replacing Fuses

The EnSite™ Amplifier power supply is protected by two replaceable fuses located near the power cord connection.

Use only 5x20mm type, 5 amp, 250 VAC fuses (T5AL250V). Always replace both fuses.

To remove the fuses, remove the power cord, flip up the fuse cover, and pull out the red fuse holder. The fuses are located on opposite sides of the fuse holder. Replace both fuses, reinsert the red fuse holder, flip down the fuse cover, and reattach the power cord.

EnSite™ DWS

Cleaning

The DWS should be inspected for excessive dust build-up every 3 months. Dry air should be used to remove any excessive dust. Perform this away from other equipment.

Figure 197. Removing the filter.

Care and Service

Field Service Representative Performed Maintenance 231EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Field Service Representative Performed Maintenance

The EnSite™ Amplifier should be tested annually. These tests require specialized equipment and training. Contact an EnSite™ Velocity™ Cardiac Mapping System-trained field service representative to schedule testing.

Replacement Parts

Table 26. EnSite™ Velocity™ Replacement Parts

Part Name Part Number

Amplifier EE3000

Amplifier Accessory KitDWS Accessory kit

100012711100026253

NavLink 100003063

ArrayLink 100014469

Display WorkstationDisplay Workstation (DWS 6) Model - Z620Display Workstation (DWS 7) Model - Z640

EE3000

GenConnect • IBI - 100011877• Stockert - 100040090• EPT - 100011879• ATAKR - 100011880

RecordConnect • GE - 1000005745• WorkMate - 100005746• Siemens - 100005747• Bard-Stamp - 100013362• Bard Clear Sign - 100018069• Universal 100010720

Monitor - DWS and remote, 24” or 21” 100022163 (24”) or 100017757 (21”)

ECG Cable 100013101

Fiber Optic Cable 42-04659-001


Moving the System


Moving the System

Do not disconnect any cables other than those mentioned below. These are not user-serviceable connections.

If the system must be moved, adhere to the following guidelines:

1. Disconnect external equipment (NavLink™ Module, ArrayLink™ Module, CathLink™ Module, SJM ECG Cable, RecordConnect, and GenConnect) from the EnSite™ Amplifier.

2. Disconnect any catheters, external stimulator, system reference, ECG electrodes, unipolar reference, recording system, and ablation system connected to the NavLink™ Module, ArrayLink™ Module, CathLink™ Module, SJM ECG Cable, RecordConnect, and GenConnect.

3. Disconnect power cords from external power sources. Any cords connected to an isolation transformer secured to a cart can remain connected.

4. Disconnect the fiber-optic cable from the EnSite™ Amplifier.

5. For dual monitor systems, disconnect the second monitor cables from the DVI extender at the back of the DWS.

6. Secure all cables on the carts to which they are attached.

7. After moving the system, inspect all connections for damage, reconnect the system. Damaged cables or components must be replaced.

NOTE: When reconnecting the fiber-optic cable to the EnSite™ Amplifier, be sure to align the tabbed edge of the cable connector to the slotted edge of the jack.

8. Power ON the system. Monitor the startup procedure as described in “Starting the System” on page 85.

Installing EnSite™ Cardiac Mapping System Software Licenses

EnSite™ products are activated by installing appropriate licenses. A base license must be installed before installing any optional module such as EnSite™ Fusion™ or EnSite™ Verismo™.

NOTE: Attempts to install EnSite™ optional modules on a system without a base license for the EnSite™ Cardiac Mapping System will fail.

Preparing to Install

Required equipment:

■ A computer with Internet connection

■ Software Upgrade Kit

■ USB Flash Drive

or

■ CD Writer, needed in order to burn the license(s) to CD

These processes have been validated using Internet Explorer 6.0 through Internet Explorer 9.0.

NOTE: Retrieve licenses before the site visit, if Internet access could pose an issue. The EnSite™ computer hostname will be required for the license.

Requirements

A Software Upgrade Kit, which includes:

Care and Service

Installing EnSite™ Cardiac Mapping System Software Licenses 233EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


NOTE: The host name is always of the forms:

■ esiXXXX for EnSite™ Velocity™ v.5.x or newer

■ mwsGXXXXXX for LRSs or

■ dwsGXXXXXX for EnSite™ Velocity™ v.5.x or newer where XXXXXX is a number and G is a capital letter.

Retrieve License(s) and Create Media

The Web site requires that a base system license is created first before creating optional module licenses.

The following steps must be performed on a computer with an Internet connection and CD writer or USB flash drive to acquire the licenses.

1. Go to the SJM licensing server website at: https://ensite-license.sjm.com/

NOTE: The Activation ID for the base license is the same as the hostname. Use the hostname from the DWS as the activation ID and not what is on the box.

2. Enter the Activation ID in the Activation ID text box.

3. Click validate.

Figure 198. Activation ID text box.

4. Enter the Hostname of the computer

5. Click validate.

Figure 199. Hostname text box

6. Fill in license information: If you already have a base license, please go to step b otherwise please complete step a, to generate a new base license.

For a base license, fill in license information as follows. It is recommended that a copy of the license is emailed to you for future reference.

Table 27.

Name Description

Software Certificates

Necessary to retrieve software licenses. The Certificate contains an Activation ID, which is a code used to log onto the license server website and retrieve a license

CD Media for copying and transferring licenses

Installation Report

Installation Report is used to document the installation and maybe returned to St Jude Medical




a. Select Yes, Download and Email License when finished

Figure 200.

■ Start Date: the intended date of install.

■ PIU/Amplifier Serial #: The serial number on the rear of the Patient Interface Unit (PIU). Enter ‘unknown’ or ‘none’ if the PIU/Amplifier Serial # is unknown, or if it is for a LRS.

■ Installer Name: Full Name

■ Installer Email: SJM email address

■ Email License? choose how to deliver the license.

– Yes, Download and Email, to have the license downloaded immediately and emailed

– No, Just Download, to have the license downloaded immediately

b. Click Yes, Download and Email License when finished.

Care and Service



NOTE: For an optional module license, fill in license information as follows. It is recommended that a copy of the license is emailed to you for future reference.

Figure 201. Optional Module License

■ Start Date: the intended date of install.

■ Installer Name: full name.

■ Installer Email: SJM email address.

■ Email License? choose how to deliver the license.

Yes, Download and Email, to have the license downloaded immediately and emailed

– No, Just Download, to have the license downloaded immediately

■ Click Yes. The license file will begin downloading.

7. Save the license information to media. Do not change the, .lic, file extension. More than one file may be saved to the media.

Figure 202. Save License Information to Media




Verify the Contents of a License File

Once the license has been downloaded and saved onto the media, it is recommended to validate the contents of the license media.

1. Click on Validate/Check License CD link, as shown below

Figure 203. Validate/Check License CD Link.

This utility can be used to check the license file for following:

■ Hostname

■ Product

■ Start Date and Expiry (for demo licenses)

■ License filename format

■ Validity of the license data

2. Click Browse button, to locate the license file on the system.

Figure 204.

Care and Service



3. Click Check File, button to verify the file.

A results screen will appear. Verify that the hostname and the product ID are correct.

Figure 205. Check File Results.

Install Licenses

For EnSite Software version 5.0 or Newer:

1. Take the license media created in Retrieve License(s) and Create Media on page 3 to the Display Workstation

2. Login as user service

3. Click Service > Install License From Media

4. Follow the prompts

Verify Installed Licenses

For EnSite™ Velocity™ v.5.x or Newer:

1. Log in as user service.

2. Click About System > Software Inventory tab




3. Scroll through Software Inventory:

Figure 206. Software Inventory Screen.

The status of all currently licensed features for this system is displayed. The system example, above, has a permanent base EnSite System license. This section will also display:

■ Status of any optional modules

■ Demo software

■ Demo days remaining

Re-Creating Licenses

If a license was created earlier and another copy of the existing needs to download use the same page to retrieve another copy.

1. Go to the SJM licensing server website at: https://ensite-license.sjm.com/lserv/

2. Enter the old Activation ID and hostname of the EnSite computer for the license created earlier

NOTE: This will not work if the Activation ID and hostname combination do not match any existing licenses.

■ The Web page will download the old license file and then it can be emailed.

Care and Service



Manage Licenses

For EnSite™ Velocity™ v.5.x or Newer:

1. Log in as service

2. Click Services > Manage Licenses, from the title screen. The Manage Licenses window displays the licenses on the system.

Figure 207. Manage Licenses Window.

3. Click INSTALL FROM MEDIA, to install licenses or upgrade software from media.

4. Click OK or CANCEL to close the window.

5. Click SHOW ERRORS to display errors encountered during the license install process.

Installation Report

Fill out the installation report supplied with the kit once the installation is complete.

Velocity license has not been installed

All EnSite systems require a base license to be installed to unlock the software.

Figure 208. License Not Installed Message.


Warranty Policy


1. Confirm that the system base license is installed as shown in the Verify Installed Licenses section.

2. Contact SJM Tech support, if the proper version of the base license is not installed

SJM Tech support numbers:

Toll Free: 800.374.8038

Phone Number: 651.523.6985

Installing a base license

Create and install a base system license for the EnSite™ Cardiac Mapping System before or at the same time as the optional module licenses is installed.

For a new EnSite Velocity System or DWS replacement, use the system hostname as the Activation ID when logging into the SJM licensing web site at: https://ensite-license.sjm.com/lserv/

Follow these Steps:

1. Connect with a web browser to : https://ensite-license.sjm.com/lserv/

2. Select Login with Activation ID

3. Enter the hostname of the DWS as the Activation ID (hostname example: dwsG123456)

4. Create the base system license

5. Save it to media or email to yourself

6. Install the base license first

7. Install option licenses, such as the Verismo or Fusion license.

Warranty Policy

For warranty information, contact your EnSite™ Velocity™ Cardiac Mapping System representative or distributor for a description of warranty coverage, service agreements, and replacement/upgrade component costs.

General Notices

EnSite™ products are returnable only with prior authorization from St. Jude Medical.

St. Jude Medical reserves the right to change or discontinue products without notice.


Technical Specifications
APPENDIX C
Specifications

Table 28. EnSite™ Amplifier Specifications

Safety

Classification Class IIAmplifier 100014514

Leakage Conforms with IEC 60601-1

Defibrillator Protection

Conforms to IEC 60601-2-27Type CF, Type BFDefibrillator-proof applied parts

Isolation > 4000 volts; > 5000 volts surge

Protection against the ingress of water

IPX0

Input from patient

ECG 12 lead

Catheter 2 mm patient-safe jacks

EnSite™ Array™

Custom assembly

EnSite™ Velocity™ Surface Electrodes

Custom assembly

Recording System

Custom assembly

Input from other equipment

Ablation generator

Custom assemblies

Table 29. Signal Processing Specifications

Sampling rate 2kHz nominal

Resolution 24 bits

Gain accuracy ± 2%

Input signal DC offset

± 1500 mV

Input amplitude accuracy

Absolute 10%; channel to channel 5%

EnGuide signal 8.138 kHz signal to up to four EP catheter electrodes

Table 30. Display Workstation (DWS) Specifications

Workstation Multi core CPU PC, PCI Express graphics, and DVD/CD writer

Display monitor Refer to the product literature provided with the monitor for connector characteristics.

Table 31. Software Specifications

Operating system

Linux

Mapping system

St. Jude Medical proprietary software

Table 32. AC/MAINS Power Input Specifications

Input voltage 100, 110/120, 220/240 V 50/60 Hz

Power inputs (nominal)

DWS components

450 W maximum

EnSite™ Amplifier

400 W maximum

Mode of operation

Continuous

242 Technical Specifications

Specifications


Table 33. Environmental Conditions

EnSite™ Amplifier Operating

+18 to +27 °C to 90% relative humidity, non-condensing

EnSite™ Amplifier Transport/storage

-25 to +55 °C to 90% relative humidity, non-condensing

EnSite™ Velocity™ Surface Electrode Kit –Storage Conditions -10°C to 40°C

Table 34. System Component Physical Characteristics

Component Dimension in cm (nominal)

Weight in kg (lb)

EnSite™ Amplifier 49 H, 46 W, 51 D 31 (68)

EnSite™ Amplifier cart

94 H, 62 W, 58 D 42 (92)

EnSite™ Velocity™ Cardiac Mapping System Workstation computer

DWS6 & DWS744.45 cm H17.15 cm W46.48 cm D

DWS6: 15.5 (34.2)

DWS7: 15 (33.1)

EnSite™ Velocity™ Cardiac Mapping System Workstation cart

86 H, 63 W, 83 D 41 (90)

Table 35. Standards of Compliance

Conforms to ANSI/AAMI STD ES60601-1, IEC STDS 60601-1-1, 60601-1-4 & 60601-1-6Certified to CAN/CSA STD C22.2 NO. 60601-1

Conforms to UL STD 60601-1Certified to CAN/CSA STD C22.2 NO. 601.1

All configurations shall comply with the system standard IEC 60601-1-1. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system and is, therefore, responsible that the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult the technical services department or your local representative.


Electromagnetic Emissions – Declaration 243EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Electromagnetic Emissions – Declaration

Table 36. Electromagnetic Emissions Declaration

Declaration – Electromagnetic Emissions

The EnSite™ Amplifier / Workstation are intended for use in the electromagnetic environment specified below. The customer or the user of the EnSite™ Amplifier / Workstation should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment – Guidance

RF emissionsCISPR 11

Group 1 The EnSite™ Amplifier / Workstation uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any

interference in nearby electronic equipment.

RF emissionsCISPR 11

Class A The EnSite™ Amplifier / Workstation is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply

network that supplies buildings used for domestic purposes.

Harmonic emissionsIEC 61000-3-2

Not applicable

Voltage fluctuations/flicker emissionsIEC 61000-3-3

Not applicable




Table 37. Electromagnetic Immunity Declaration I

Declaration – Electromagnetic Immunity


Immunity Test IEC 60601Test Level

Compliance Level Electromagnetic Environment –Guidance

Electrostatic discharge (ESD)IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material the relative

humidity should be at least 30%.

Electrical fasttransient/burstIEC 61000-4-4

±2 kV for power supply lines

±1 kV for input/output lines

±2 kV

±1 kV

Mains power quality should be that of a typical commercial or hospital environment.

SurgeIEC 61000-4-5

±1 kV differential mode±2 kV common mode

±1 kV

±2 kV

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage

variations on power supply input lines.

IEC 61000-4-11

<5% UT

>95% dip in UT

for 0.5 cycle

40% UT

60% dip in UT

for 5 cycles

70% UT

30% dip in UT

for 25 cycles

<5% UT

>95% dip in UT

for 5 sec

>95% dip in VNOM for 0.5 line cycle

60% dip in VNOM for 5 line cycles

30% dip in VNOMfor 25 line cycles

>95% of VNOMfor 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of

the EnSite™ Amplifier / Workstation requires continued operation during power mains

interruptions, it is recommended that the EnSite™ Amplifier / Workstation be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz)

magnetic fieldIEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical

commercial or hospital environment.

Note UT is the a.c. mains voltage prior to application of the test level.


Electromagnetic Emissions – Declaration 245EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Table 38. Electromagnetic Immunity Declaration II

Declaration – Electromagnetic Immunity


Immunity Test IEC 60601Test Level

ComplianceLevel

Electromagnetic Environment – Guidance

Conducted RFIEC 61000-4-6

Radiated RFIEC 61000-4-3

3 Vrms150kHz to 80 MHz

3 V/m80 MHz to 2.5 GHz

3 Vrms

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the EnSite™ Amplifier / Workstation, including cables, than the recommended

separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

80 MHz to 800 MHz

800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation

distance in meters (m)

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the

compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the EnSite™ Amplifier / Workstation is used exceeds the applicable RF compliance level above, the EnSite™ Amplifier / Workstation should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the EnSite™ Amplifier / Workstation.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1]V/m.

V1 3=

E1 3=

d3.5V1------- P=

d3.5E1------- P=

d7

E1------- P=




Table 39. Separation Distances

Recommended separation distances betweenportable and mobile RF communications equipment and the

EnSite™ Amplifier / Workstation

The EnSite™ Amplifier / Workstation are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the EnSite™ Amplifier / Workstation can help prevent electromagnetic interference by maintaining a minimum

distance between portable and mobile RF communications equipment (transmitters) and the EnSite™ Amplifier / Workstation as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

W

Separation distance according to frequency of transmitterm

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

0.01 .117 .117 .233

.10 .369 .369 .737

1 1.167 1.167 2.33

10 3.69 3.69 7.37

100 11.67 11.67 23.33

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacture.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

d3.5V1------- P= d

3.5E1------- P= d

7E1------- P=


APPENDIX D
EnSite™ Fusion™ Registration Module
Indications for Use

The EnSite™ Fusion™ Registration Module is indicated for registering the EnSite™ NavX™ Navigation and Visualization Technology system to anatomic models of any of the four individual cardiac chambers.

Warnings, Cautions, and Disclaimers

■ This IFU is a supplement to the EnSite™ Cardiac Mapping System Instructions for Use. Refer to the IFU for a full list of Warnings, Cautions, and specifications.

■ The equipment is intended for use by qualified medical personnel and only after they have been trained in the proper use of this equipment.

■ This system should be used by or under the supervision of physicians thoroughly trained in techniques of intracardiac electrophysiology.

■ The IFU is recyclable. Dispose of all packaging materials as appropriate.

Introduction

The EnSite™ Fusion™ Registration Module is a software expansion module for the EnSite™ Cardiac Mapping System that provides non-fluoroscopic navigation registered to a model of patient anatomy generated by CT or MR scanners. The EnSite™ Fusion™ Registration Module is intended for use with the EnSite™ Velocity Surface Electrode Kit and cardiac models from CT or MR scans segmented into a compatible file format.

Once the registration is applied, EnSite™ NavX™ Navigation and Visualization Technology mapping and labeling functions can be applied to the Digital Image Fusion (DIF) surface, including Contact Mapping, Map Labels, Lesion Markers, and Anatomic Markers.

NOTE: For information on the indications for EnSite™ NavX™ Navigation and Visualization Technology and compatible file formats, see the EnSite™ Cardiac Mapping System Instructions for Use.

NOTE: The features associated with the EnSite™ Fusion™ Registration Module are available for EnSite™ NavX™ Navigation and Visualization Technology studies only. The EnSite™ Fusion™ Registration Module is not available for EnSite™ Array™ Catheter studies.

248 EnSite™ Fusion™ Registration Module

Performing Registration



The EnSite™ Fusion™ Registration Module provides non-fluoroscopic navigation, mapping, and labeling on a DIF model. The dynamic registration process involves the following steps:

■ Importing a DIF model

■ Scaling the EnSite™ NavX™ Navigation and Visualization Technology navigation field

■ Placing fiducial point pairs

Importing a DIF Model

When used for registration, a DIF model is a surface rendering segmented from slice-based CT or MR data using the EnSite™ Verismo™ Segmentation Tool. A DIF model is imported in the Model task (Figure 209 on page 248). For information on importing DIF models and compatible formats, see the EnSite™ Cardiac Mapping System Instructions for Use.

Figure 209. Importing a DIF model

NOTE: Registration should be performed for one cardiac chamber at a time. A high quality scan is necessary for the creation of an accurate registration. The quality of the scan is fundamental to the user’s ability to create a highly detailed model during the segmentation process. In turn, a detailed segmentation is essential to the user’s ability to identify precise fiducial points during the registration process.


Performing Registration 249EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Scaling the EnSite™ NavX™ Navigation and Visualization Technology Navigation Field

Field Scaling, available in EnSite™ Cardiac Mapping System software, compensates for local changes in impedance fields (Figure 210). For further information on Field Scaling, see the EnSite™ Cardiac Mapping System Instructions for Use.

NOTE: Field Scaling the EnSite™ NavX™ Navigation and Visualization Technology field is optional, but recommended.

Figure 210. An EnSite™ NavX™ Navigation and Visualization Technology model before (left) and after field scaling.




Placing Fiducial Point Pairs

Fiducial point pairs are markers that link matching locations between an EnSite™ Cardiac Mapping System model and a DIF model. The points are connected by a spring-shaped icon (Figure 211).

Figure 211. Fiducial point pairs linked by a spring-shaped icon.

The EnSite™ Fusion™ Registration Module Control Panel

The EnSite™ Fusion™ Registration Module control panel (Figure 212 on page 250) is used to place and edit fiducial point pairs. To display the EnSite™ Fusion™ Registration Module control panel, click the EnSite™ Fusion™ Registration Module icon in the Model control panel.

Table 40. The EnSite™ Fusion™ Registration Module Control Panel


A EnSite™ Fusion™ Registration Module

Display the EnSite™ Fusion™ Registration Module control panel.

B Fiducials The name of the fiducial.

C Used A check mark in this column indicates that the fiducial is being used. No check mark indicates that the fiducial is not being used.

D Add At Surface Select to place a fiducial point at the mouse location on the EnSite™ NavX™ Navigation and Visualization Technology model and DIF model.

E Add At EnGuide Select to place a fiducial point at the Active EnGuide on the EnSite™ NavX™ Navigation and Visualization Technology model and mouse location on the DIF model.

F Move Select to move one end of a fiducial point pair.

G Select Select to select individual fiducial points.

H [Compute] Click to compute registration. The Apply button must also be selected to see the registration.

I Apply Select to show the registration. Deselect to remove the registration.

J [Delete Fiducials] Click to delete the selected fiducial point.

K Use Fiducials Select to use the selected fiducial point. Deselect to not use the selected fiducial point.

L Show Fiducials Select to show all fiducial points; deselect to hide all fiducial points.

B

G

I

J

H

F

E

D

C

K

L

M

A

Figure 212. The EnSite™ Fusion™ Registration Module control panel


Performing Registration 251EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Placing Fiducial Points

NOTE: The buttons referred to in the following instructions are located on the EnSite™ Fusion™ Registration Module control panel (Figure 212 on page 250).

1. Display the models in Dual Views display (Figure 213).

Figure 213. A scaled EnSite™ NavX™ Navigation and Visualization Technology model adjacent to a DIF model of the same patient.

2. Click the EnSite™ Fusion™ Registration Module icon in the Model control panel to display the EnSite™ Fusion™ Registration Module control panel (Figure 212 on page 250).

3. Place fiducial points to link common locations between the EnSite™ NavX™ Navigation and Visualization Technology and DIF model.

■ To place a fiducial point at the mouse:

a. Select the Add at Surface button. While this button is selected, the left mouse button is used to place fiducial points on both the EnSite™ NavX™ Navigation and Visualization Technology and DIF surfaces. When the cursor is over the EnSite™ NavX™ Navigation and Visualization Technology map display, it will be cross-hair shaped.

b. On the EnSite™ NavX™ Navigation and Visualization Technology model surface, left-click on a model location that is also recognizable on the DIF surface. After placing a fiducial point on the EnSite™ NavX™ Navigation and Visualization Technology side of the screen, the cursor will change to a cross-hair inside a square.

NOTE: When a fiducial point is placed on the EnSite™ NavX™ Navigation and Visualization Technology model surface, the fiducial point will link to the nearest model point, not the model surface. This ensures that the location is tied to a previous catheter position.

c. Left-click on the matching anatomic location on the DIF model. A spring-shaped icon will appear to connect the paired fiducial points (Figure 214).

M Show Points Select to show the EnSite™ NavX™ Navigation and Visualization Technology model point cloud; deselect to hide.

Table 40. The EnSite™ Fusion™ Registration Module Control Panel





■ To place a fiducial point at the Active EnGuide:

a. Manipulate the Active EnGuide catheter so that the Active Electrode is at an anatomic location on the EnSite™ NavX™ Navigation and Visualization Technology model that can also be easily recognized on the DIF side of the screen.

b. Select the Add at EnGuide button.

c. Left-click on the matching anatomic location on the DIF geometry. A spring-shaped icon displays to connect the paired fiducial points.

NOTE: A point is created at the active EnGuide position when the mouse is clicked on the DIF model.

4. Click [Compute] to compute an initial registration. The model surfaces, point cloud, and DIF model will be superimposed (Figure 216). If three or fewer fiducial point pairs are in use, the registration will be a rigid overlapping registration. Spring-shaped icons connecting fiducial points will not necessarily collapse to a common location. However, if four or more fiducial point pairs are in use the system will use a non-rigid dynamic registration to fuse the linked fiducial locations together. In this scenario, registered points will appear as dots instead of springs.

Figure 214. Adding fiducial point pairs

Figure 215. Placing fiducial point pairs at the Active EnGuide

Figure 216. The overlapping point cloud, DIF model, and EnSite™ NavX™ Navigation and

Visualization Technology model


Display Options 253EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


5. Evaluate the registration and continue placing fiducial points if necessary (Figure 217). When defining fiducials in the overlapping view, the first point will be placed on the EnSite™ NavX™ Navigation and Visualization Technology model, and the second point will be placed on the DIF model.

NOTE: After any change to fiducial point pairs, click [Compute] to apply the change.

NOTE: Select the Apply button to see the results of any changes.

Editing Fiducial Points

Several options are available for editing placed fiducial points. The controls for editing fiducial points are located on the EnSite™ Fusion™ control panel (Figure 212 on page 250).

To move one end of a fiducial point pair:

1. Select the Move button and click on one end of the fiducial. If the points are registered and overlapping, the end of the point that is connected to the EnSite™ NavX™ Navigation and Visualization Technology model will be selected.

2. Drag the point to a new location.

Disabling/enabling individual points – To disable or enable an individual fiducial point pair:

1. Select the Select button, and click on either the fiducial in the map display or select it in the fiducial list. The selected fiducial will turn red in the map display.

2. Select or deselect the Use Fiducial button to enable or disable the selected fiducial. In the fiducials list, all fiducials in use will have a check mark in the Used column.

3. Click [Compute] to recompute the registration.

4. Confirm the catheter position relative to the anatomy using conventional means (e.g., fluoroscopy, intracardiac echocardiography).

Deleting a point – To delete a fiducial point, select the point in the fiducial list, and then click [Delete Fiducials].

Removing a registration – Select the Apply button to remove a registration. When registration is removed, navigation and labeling at EnGuide will apply to the EnSite™ NavX™ Navigation and Visualization Technology model.

Display Options

Several controls are available to manage the display of the DIF and EnSite™ NavX™ Navigation and Visualization Technology models. These controls are located on “The EnSite™ Fusion™ Registration Module control panel,” Figure 212. on page 250, the “Map Settings menu,” Figure 218. on page 254, and the “Map Display Sliders,” Figure 219. on page 255.

The EnSite™ Fusion™ Registration Module Control Panel Display Options

Show Fiducials – (The EnSite™ Fusion™ Registration Module control panel) Use this button to show/hide fiducials.

Show Points – (The EnSite™ Fusion™ Registration Module control panel) Use this button to show/hide the EnSite™ NavX™ Navigation and Visualization Technology model point cloud. The point cloud will include all surfaces included in the EnSite™ NavX™ Navigation and Visualization Technology model.

Figure 217. The DIF model and registered EnSite™ NavX™ Navigation and Visualization Technology

point cloud


Display Options


Map Settings Menu

Table 41. The Map Settings Menu

Selection Description

Label Text On Shows/hides the label text for all map labels, anatomic markers, tape measures, lesions, virtuals, and EnGuide Shadows.

Label Show Through

Allows or prevents label text for all map labels, anatomic markers, tape measures, lesion markers, virtuals, and EnGuide Shadows from showing through other objects.

Show EnSite™ Model

Enables/disables the display of the contoured, three-dimensional surface model(s) of a patient’s cardiac anatomy.

Show DIF Model

Allows the DIF model (i.e., CT scan or MRI) to either be hidden or displayed.

Project on DIF (After EnSite™ Fusion™ Registration has been performed) Project or unproject 3D Labels and/or Lesions (referred to as 3DP), and map data onto the DIF surface rather than onto the EnSite™ Cardiac Mapping System model surface.NOTE: Before registration, the Surface Distance is the distance from the Active Electrode to the EnSite™ NavX™ Navigation and Visualization Technology model surface. After registration, the Surface Distance is the distance from the Active Electrode to the DIF model surface.

Show Mapping Causes surfaces to be colored using the current map color.

Hide Non-Map Surfaces

Hide surfaces that have no maps projected on them.

Map Transparency On

Display map colors with values greater than Color High as transparent instead of purple, or (in EnSite™ Array™ Catheter only) charcoal gray in the gray scale scheme. Areas of the contact map that are not colored will be hidden (EnSite™ Array™ Catheter or EnSite™ NavX™ Navigation and Visualization Technology studies).

NOTE: Do not select the Map Transparency On box unless a map is displayed.

Low Accuracy Grid On

(EnSite™ Array™ Catheter studies only) Enables or disables a red highlight on areas of the grid that are more than 4cm from the center of the EnSite™ Array™ Catheter. Signal and Tape Measure accuracy may be decreased in these areas.

Show Proximity Indicator

(EnSite™ NavX™ Navigation and Visualization Technology studies only) Enables the proximity indicator.

Fixed Proximity Indicator

Allows the diameter of the proximity indicator to be set to a maximum of 10mm, regardless of the current lesion size.

Show EnSite Array

(EnSite™ Array™ Catheter studies only) Shows the EnSite™ Array™ Catheter.

Zoom Increases/decreases the size of the model in the display window. The middle mouse/scroll wheel can also be used to zoom.

Color Contour Adjusts the gradation between colors on the map. At low Color Contour values, colors appear as distinct bands. At high Color Contour values, there is a smooth transition between colors.

Figure 218. Map Settings menu


Display Options 255EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Table 42. Map Display Sliders


A Translucency Slider

Adjusts the density of the surface model between translucent and opaque. This control works independently for each view in dual map displays.Refer to the EnSite™ Cardiac Mapping System Instructions for Use for more information.

B Edge Enhancement

When enabled, provides a rendering of the model where the body can be translucent but the edge remains distinctly defined.

C Clipping Plane Slider

Clipping planes allow for a view of the interior and rear of the closed model by cutting a plane away from the viewing space. The slider provides a smooth, controlled way of adjusting the clipping plane. Unlocking the Clipping Plane deletes it.

D Plane Lock Clipping planes can be locked in the model/map display window. When locked, the orientation remains fixedrelative to the model. When unlocked, the orientation is parallel to the screen. To change the orientation of alocked clipping plane, unlock it, rotate, and lock it again.

A

C

Figure 219. Map Display Sliders

D

B


Display Options



APPENDIX E
EnSite™ Derexi™ Module
Indications for Use

Refer to the EnSite™ Cardiac Mapping System Instructions for Use for Indications for Use.

Introduction

The EnSite™ Derexi™ Module consists of software features that uniquely integrate the EP-WorkMate™ Recording System with the EnSite™ Cardiac Mapping System. This integration was introduced to consolidate patient and clinical information and to reduce the duplication of work effort. The interface between the two systems allows for the sharing of information, which promotes ease of use and a clearer representation of the case events.

NOTE: Refer to the EnSite™ Cardiac Mapping System IFU and the EP-WorkMate™ Recording System IFU for additional information and regulatory considerations.

Minimum System Requirements

■ EnSite™ Velocity™ Cardiac Mapping System V. 2.0.1 or greater

■ EP-WorkMate™ Recording System V. 4.3 or greater

258 EnSite™ Derexi™ Module

EnSite™ Cardiac Mapping System / EP-WorkMate™ System Signal Connections


EnSite™ Cardiac Mapping System / EP-WorkMate™ System Signal Connections

A RecordConnect is required to route the ECG and EP Catheter signals from the patient to both the EnSite™ Amplifier and the EP-WorkMate™ Recording System Signal Conditioning Unit (SCU). The EP catheters are connected to the EP-WorkMate™ Recording System’s Catheter Input Module (CIM), and the CIM is connected to the RecordConnect. The RecordConnect routes EP catheter signals from the CIM to the EnSite™ Amplifier and to the EP-WorkMate™ Recording System SCU.

Figure 220. EnSite™ Cardiac Mapping System to the EP-WorkMate™ Recording System basic signal connections.


Connecting to the EnSite™ Cardiac Mapping System 259EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Connecting to the EnSite™ Cardiac Mapping System

A hardware connection must be made between the EP-WorkMate™ Recording System and the EnSite™ Cardiac Mapping System, using an Ethernet cable and an Ethernet Isolator.

1. Connect the Ethernet cable to the EP-WorkMate™ Recording System CPU (either an HP xw6400 or HP xw6600), using the port shown at right:

2. Optional, if using a switch. Connect the other end of the EP-Workmate™ Recording System Ethernet cable to switch port #1, and connect another Ethernet cable to switch port #2:

3. Connect the 1’ Ethernet cable (B) into the 2nd Ethernet port from the right (C) on the back of the EnSite™ Cardiac Mapping System Workstation:

4. Connect the Ethernet cable from the EP-Workmate™ Recording System CPU or switch (optional) to the Ethernet Isolator (A).

HP xw6400 HP xw6400 or HP Z600

Right-most Ethernet portOnly Ethernet port

EP-Workmate ™ Recording System CPU

Optional switch

EnSite ™ Cardiac Mapping System Workstation

A

B

C


Connecting to the EnSite™ Cardiac Mapping System


Connection States

On the EnSite™ Cardiac Mapping System, there are three possible connection states for the communication between the EnSite™ Cardiac Mapping System and EP-WorkMate™ Recording System (Disabled, Ready, and Connected). The following table shows and describes the icons that display at the bottom of the EnSite™ Cardiac Mapping System screen during each of the following states.

NOTE: The EnSite™ Derexi™ Module license must be installed on the EnSite™ Cardiac Mapping System before the icons will display.

Table 40.

NOTE: This is an active icon that the user can use to disable or enable the connection at any time.

State Description

Disabled Communication between the two systems is disabled. In this state, communication between the two systems can only be enabled by the user. Note: Each system is still fully functional as a stand-alone system.

Ready An unselected checkbox indicates that the EnSite ™ Cardiac Mapping System is ready to accept a connection from the EP-WorkMate ™ Recording System. Note: Each system is still fully functional as a stand-alone system.

Connected The systems are connected and communication is active.


Maps and Integration 261EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Maps and Integration

Number of Maps / Map Points

When the EnSite™ Cardiac Mapping System and EP-WorkMate™ Recording System are connected, the number of remote EnSite™ Cardiac Mapping System maps is unlimited. The EP-WorkMate™ Recording System user is not allowed to change or delete an active map while in Connected mode.

Signals are defined by the EnSite™ Cardiac Mapping System and are provided to the EP-WorkMate™ Recording System along with the map point data.

Map Point Analysis

While connected, no signals are analyzed or measured by the EP-WorkMate™ Recording System; the Reference signal and Local Activation Time (LAT) and peak-to-peak voltage values are calculated by the EnSite™ Cardiac Mapping System. Upon receipt of a new map point, the new mapping point’s waveform is centered in the MAPPING WINDOW (in the EP-WorkMate™ Recording System) and the data from the EnSite™ Cardiac Mapping System displays.

Mapping Constraints

■ Map names can only be Edited, Renamed, or Deleted via the EnSite™ Cardiac Mapping System Notebook in the RealReview task.

■ The EnSite™ Cardiac Mapping System will only accept a Point-Save request from the EP-WorkMate™ Recording System if both systems are in Realtime mode.

■ When creating a new map, it is required that the EnSite™ Cardiac Mapping System take the first mapping point. Any Point-Save requests from the EP-WorkMate™ Recording System, prior to the EnSite™ Cardiac Mapping System taking the first point, will be rejected.

■ The EP-WorkMate™ Recording System is only allowed to change the annotation string of an EnSite™ Cardiac Mapping System mapping point.

■ Only the EnSite™ Cardiac Mapping System can create a new map or change the active map.

Patient Connections

The connections between the patient and the two systems consist of a 12 lead ECG and intra-cardiac catheter connections. Connecting the catheters and the 12 lead ECG cable is the same process for the standalone or integrated systems and has not been changed by the data integration. For detailed patient connections, consult the Instructions for Use (IFU) for the EnSite™ Cardiac Mapping System and the EP-WorkMate™ Recording System IFU.


Dual System Start-up Procedure using the EnSite™ Derexi™ Module


Dual System Start-up Procedure using the EnSite™ Derexi™ Module

The following procedure shows the steps required to setup a case study with the integration of the EP-WorkMate™ Recording System and the EnSite™ Cardiac Mapping System, via the EnSite™ Derexi™ Module.

1. Ensure that both the EnSite™ Cardiac Mapping System and the EP-WorkMate™ Recording System are powered up.

2. Install license on the EnSite™ Cardiac Mapping System and configure the EP-WorkMate™ Recording System.

3. In the EnSite™ Cardiac Mapping System, fill in at least the patient weight from the Patient Information screen.

4. In the EnSite™ Cardiac Mapping System, select the EP-WorkMate™ Recording System from the RecordConnect drop-down menu.

5. Begin a study from the EnSite™ Cardiac Mapping System:

a. Check that the EP-WorkMate™ Recording System heart icon (in the bottom right of the EnSite™ Cardiac Mapping System Mapping window) is yellow.

b. As long as the EnSite checkbox in the EP-WorkMate™ Recording System is checked, the icon will turn green, meaning that a connection between EnSite™ Cardiac Mapping System and the EP-WorkMate™ Recording System has been made (see Figure 221 on page 264).

c. A pop-up message is generated: “Accept the Connection to EP-WorkMate™ for patient “First” “Middle Initial” “Last Name,” “Patient ID”? [ACCEPT] [REJECT].”

6. In the EnSite™ Cardiac Mapping System, click the appropriate button to either [ACCEPT] or [REJECT] the connection:

a. Demographic data is sent from the EP-WorkMate™ Recording System to the EnSite™ Cardiac Mapping System.

b. A pop-up message is generated: “Updated Demographics Received from EP-WorkMate™: “First” “Middle Initial” “Last Name,” “Patient ID” “Birthdate” “Gender” Physician” Diagnosis” “Procedure” [ACCEPT] [REJECT].

Note: If both the Patient Information and the Diagnostic Information received from the EP-WorkMate™ Recording System is an exact match to the EnSite™ Cardiac Mapping System data, no pop-up message is generated.

7. In the EnSite™ Cardiac Mapping System, click the appropriate button to either [ACCEPT] or [REJECT] the demographic data.

NOTE: All data fields are updated in the EnSite™ Cardiac Mapping System database except the patient’s weight.

8. Create a model (if needed) in EnSite™ Cardiac Mapping System, either within the Model Workflow or from the One Map tool in the Mapping Workflow.

9. Depending on which workflow was used in the EnSite™ Cardiac Mapping System, follow step (9.a.[Model task] or 9.b.[Mapping task]) to proceed with the case study:

a. If a model was created while in the Model task, the user must then select the Mapping task and access the Mapping Workflow of the EnSite™ Cardiac Mapping System to take the first point. (The [Freeze]/[Save] feature is required to capture points.) After a first point is taken by the EnSite™ Cardiac Mapping System, it will begin accepting mapping point requests from the EP-WorkMate™ Recording System for the current active map.

b. If the points or the model were created using the One Map tool, the system is already in the Mapping task and is using the Mapping Workflow. (The [Freeze]/[Save] feature is required to capture points.) After a first point is taken by the EnSite™ Cardiac Mapping System, it will begin accepting mapping point requests from the EP-WorkMate™ Recording System for the current active map.

10. Proceed with the case in the EnSite™ Cardiac Mapping System.

11. Exit Study from the EnSite™ Cardiac Mapping System (if the demographic data and/or diagnostic data for the patient profile has not been completed, a message will pop-up requesting that the patient demographic be updated. The user will not be allowed to exit the study until all Patient Information and Diagnostic Information is complete).


Interface Features & Descriptions 263EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Interface Features & Descriptions

The following definitions describe features specific to the EnSite™ Derexi™ Module. Some of these features are only accessible from the EnSite™ Cardiac Mapping System, some are only accessible from the EP-WorkMate™ Recording System, and some are accessible on both systems. Except for the features exclusive to the EP-WorkMate™ Recording System, the feature descriptions given in this document are specific to the EnSite™ Cardiac Mapping System only.

NOTE: For instructions on how these features are enabled from the EP-WorkMate™ Recording System, refer to the EP-WorkMate™ Recording System IFU.

Active Map Change – This feature can only be executed from the EnSite™ Cardiac Mapping System. When a new map is created, the active map name/ID is automatically sent to the EP-WorkMate™ Recording System. If the EP-WorkMate™ Recording System does not already possess this map, one is created. The same process takes place when changing to a different map.

Add/Edit Annotation – This feature may be executed by either the EnSite™ Cardiac Mapping System or the EP-WorkMate™ Recording System. In the EnSite™ Cardiac Mapping System, mapping points are automatically labeled with the Tag and Type, but additionally comments/annotations may be added by right-clicking on the trace point of interest and selecting Edit Annotation. This new text will be added to the Points list. The annotation will also be sent to the EP-WorkMate™ Recording System, where it is saved as a Procedure Log entry and in the Mapping Window as Notes.

Delete Map – This can only be done in the EnSite™ Cardiac Mapping System from the Notebook in the RealReview task. Click on the map name to delete (this map cannot be open at this time) and click on the [Delete] button on the bottom right below the Notebook entries. The map will also be deleted from the EP-WorkMate™ Recording System Mapping Window and the Procedure Log.

Delete Points – This feature may be executed by either the EnSite™ Cardiac Mapping System or the EP-WorkMate™ Recording System. To delete a point in the EnSite™ Cardiac Mapping System, go to the Points tab in the Control Panel and select a point. Click on the [Delete] button located at the bottom of the Control Panel. Points can also be deleted by right clicking in the black background of the trace display and selecting Delete Point from the menu. The system that issues this request, sends the identifier of the selected map point to delete to the other system.

NOTE: The same process can be used to Delete Hidden Points, and to Delete Unused Points, which are also in the menu.

Edit Mapping Points – In the EnSite™ Cardiac Mapping System only, the calipers and voltage levels can be edited in the waveform display below the map by simply clicking and dragging the calipers and/or the voltage levels. As explained below, the annotation may also be edited.

Reload Map – This request can only be issued from the EP-WorkMate™ Recording System. With the appropriate map identifier present in the Map field of the Mapping Control Bar (EP-WorkMate™ Recording System), click on the [Reload Map] button. The map is sent to the EnSite™ Cardiac Mapping System and the EnSite™ Cardiac Mapping System returns the map to the EP-WorkMate™ Recording System with all previous points plus any new points that have been added.

Rename Map – This change can only be made in the EnSite™ Cardiac Mapping System from the Notebook in the RealReview task. Click on the map name to be changed and click on the [Edit] button. The Edit Event window is displayed. Here the map name can be changed. The updated name is then sent to the EP-WorkMate™ Recording System.

Save Image – When requested by the EP-WorkMate™ Recording System, an image will be captured by the EnSite™ Cardiac Mapping System. The image is then saved to the Notebook, on the EnSite™ Cardiac Mapping System, and then sends the single image (in jpeg format) to the EP-WorkMate™ Recording System where it is stored in the Mapping window. Images requested by the EnSite™ Cardiac Mapping System alone, are saved to the EnSite™ Cardiac Mapping System only. These images are not sent to the EP-WorkMate™ Recording System.


EP-WorkMate™ Recording System Mapping Controls


Save Mapping Points – The first point of a map must be defined by the EnSite™ Cardiac Mapping System. Points are captured by clicking on the [Freeze] then [Save] buttons at the bottom of the EnSite™ Cardiac Mapping System Mapping window. Once the first point is saved, the point is also sent to the EP-WorkMate™ Recording System where it is stored in the procedure Log file and displayed. After the initial point is created in the EnSite™ Cardiac Mapping System, the EP-WorkMate™ Recording System can also request that points be taken. (Refer to the EP-WorkMate™ Mapping System Interface for EnSite™ Derexi™ Module IFU for more information).

NOTE: When creating a new map, the EnSite™ Cardiac Mapping System must take the first mapping point. Any Point-Save requests made by the EP-WorkMate™ Recording System will be rejected prior to the first point taken by the EnSite™ Cardiac Mapping System.

Select Mapping Points – This feature may be executed by either the EnSite™ Cardiac Mapping System or the EP-WorkMate™ Recording System. In the EnSite™ Cardiac Mapping System, selecting a point can be accomplished by clicking on the trace of interest under the Points tab. Clicking on the trace will highlight the trace and, if shown on the model, will cause the surface points/3D points to flash on the anatomic model. The checkbox feature will toggle on/off the model points. The system that issues this request, sends the identifier of the selected map point to the other system.

Sort Map – Mapping points can be sorted by either system. In the EnSite™ Cardiac Mapping System, select the Points tab in the Control Panel and click on the down arrow of the drop-down Sort menu. Here the mapping points can be sorted according to Order of Collection, Cycle length, or map type (e.g., LAT, Peak to Peak, Peak Negative, CFE Mean, CFE Std. Dev.).

Start Recording of Electrograms – In the EnSite™ Cardiac Mapping System, click the [Record] button below the Realtime data pane on the left side of the screen to start recording segment data. The EnSite™ Cardiac Mapping System also sends a Start Recording request to the EP-WorkMate™ Recording System, which also starts recording. If the EP-WorkMate™ Recording System is not already recording, a new recording will begin.

Stop Recording – In the EnSite™ Cardiac Mapping System, click the [Stop] button below the Realtime data pane on the left side of the screen to stop recording segment data. The EnSite™ Cardiac Mapping System also sends the Stop Recording request to the EP-WorkMate™ Recording System.

Updating Demographics – To share patient demographics between the systems, the updates must be made on the EP-WorkMate™ Recording System. When patient demographics are changed on the EP-WorkMate™ Recording System, the updated information is automatically sent to the EnSite™ Cardiac Mapping System. The EnSite™ Cardiac Mapping System user will be prompted to [Accept] or [Reject] the updated patient demographics.

Patient demographics can also be updated on the EnSite™ Cardiac Mapping System, but these changes are not sent to the EP-WorkMate™ Recording System. In the EnSite™ Cardiac Mapping System, click File and click Study/Patient Information. This displays a patient demographics window, which can then be completed as needed. The case cannot be exited on the EnSite™ Cardiac Mapping System until all required demographic information has been completed. Once all the fields are filled in, the [OK] button becomes active. Clicking on the [OK] button will end the case.

EP-WorkMate™ Recording System Mapping Controls

The EP-WorkMate™ Recording System Mapping Control Bar has features that coincide with the EnSite™ Cardiac Mapping System controls. These features are functional when the EnSite™ Derexi™ Module is connected and the EnSite box is checked (see Figure 221. below).

NOTE: Refer to The EP-WorkMate™ Mapping System Interface for the EnSite™ Derexi™ Module for descriptions of these controls and how they are used in conjunction with the controls in the EnSite™ Cardiac Mapping System.

Figure 221. EP-WorkMate™ Recording System Mapping Control Bar.


EnSite™ Verismo™ Segmentation Tool Module

APPENDIX F

Indications for Use

The EnSite™ Verismo™ Segmentation Tool (H702504) is indicated for use in generating 3D models from CT, MR, or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite™ Velocity™ Cardiac Mapping System.

Description

The EnSite™ Verismo™ Segmentation Tool is a software utility used to convert large volumes of sliced-based images into a manageable 3D model of cardiac structures.

The EnSite™ Verismo™ Segmentation Tool accepts DICOM™ images from most CT and MRI scanners, including enhanced CT/MR images. Once image data are imported into the EnSite™ Verismo™ Segmentation Tool, a 3D model can be extracted from the images in a process called segmentation. Segmentation is the process of isolating an object of interest from a digital image using the greyscale intensity of slice-based data. This model (see Figure 222) can be easily viewed and manipulated during an electrophysiology procedure using the EnSite™ Velocity™ Cardiac Mapping System software. See the EnSite™ Velocity™ Cardiac Mapping System Instructions for Use for information about viewing models.

Figure 222. Example of a segmented model.

266 EnSite™ Verismo™ Segmentation Tool Module

Contraindications


Contraindications

There are no known contraindications to use.

Warnings and Precautions

There are no known warnings or precautions specific to this product. Refer to the EnSite™ Velocity™ Cardiac Mapping System Instructions for Use for warnings and precautions pertaining to the EnSite™ Velocity™ Cardiac Mapping System.

Operator Requirements

The EnSite™ Verismo™ Segmentation Tool must be operated by, or under the supervision of, an electrophysiologist trained in the operation of the EnSite™ Verismo™ Segmentation Tool and supported by other qualified personnel trained in the field of cardiac EP.

System Requirements and Considerations

EnSite™ Velocity™ Cardiac Mapping System requirements – the EnSite™ Verismo™ Segmentation Tool v.2.0.1 can only be installed on an EnSite™ Velocity™ Cardiac Mapping System workstation with EnSite™ Velocity™ Cardiac Mapping System v.3.0.1 Software or higher.

Verification – To ensure model accuracy, segmentation results should be compared to the original slice data by (or under the supervision of) a physician.

DICOM conformance – the EnSite™ Verismo™ Segmentation Tool allows importation of slice-based images in DICOM 3.0 (2009) data sets from CD/DVD or a PACS network.

■ The EnSite™ Verismo™ Segmentation Tool does not support direct connection to a PACS network. DICOM data sets located on a PACS network are retrieved by the EnSite™ Courier™ Module and written to the EnSite™ Velocity™ Cardiac Mapping System Display Workstation (DWS) hard drive.

■ The EnSite™ Verismo™ Segmentation Tool does not support image export.

■ The EnSite™ Verismo™ Segmentation Tool does not accept non-orthogonal enhanced CT/MR images.

■ The EnSite™ Verismo™ Segmentation Tool does not accept non-orthogonal cine images with missing or inconsistent timing information within each volume.

Refer to the EnSite™ Verismo™ Segmentation Tool v.2.0.1 DICOM Conformance Statement for details.

Overview of Segmentation

The following list provides an overview of the common segmentation tasks.

1. Power on the DWS and start the EnSite ™ Verismo ™ Segmentation Tool. “Indications for Use” on page 265


Optimal Characteristics for the EnSite™ Verismo™ Segmentation Tool 267EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Optimal Characteristics for the EnSite™ Verismo™ Segmentation Tool Image Files

The following minimum requirements are provided to optimize the quality of the cardiac model generated through the EnSite™ Verismo™ Segmentation Tool segmentation process:

2. Select an image series to segment. “Selecting a Series for Segmentation” on page 269

3. Subregion the series and begin segmentation. “Subregioning the Series” on page 270“Loading the Series for Segmentation” on page 270

4. Grow a structure using either the Region Grow or Chamber tool. “Using the Region Grow Tool” on page 277“Using the Chamber Tool” on page 279

5. Edit the model:• Separate chambers or remove extraneous information using the Separator or Trace tool.• Grow tubular structures with the Vessel tool.• If necessary, use the Barrier tool to help the EnSite™ Verismo™ Segmentation Tool identify the

edge of a structure.

“Using the Separator Tool” on page 281“Using the Trace Tool” on page 282“Using the Vessel Tool” on page 280“Using the Barrier Tool” on page 283

6. Perform any final cleanup:• Hide extraneous structures in the structure list.• Use the Reassign tool to remove any small debris surrounding the model.• If the surface of the model has distracting complexity, consider smoothing the surface.

“Using the Structure List” on page 276“Using the Reassign Tool” on page 284“Key Points About Saving Models” on page 287

7. Save and review the model:• Save the model.• If the model will be used on a different workstation, export the DIF model to CD/DVD.• Review the model before exiting.

“Saving the Model to the Hard Drive” on page 287“Exporting Models to CD or DVD” on page 287“Reviewing the Final Model” on page 288

■ Missing Slices The EnSite™ Verismo™ Segmentation Tool cannot segment images with missing slices

■ Slice Orientation Do not use oblique slice orientations

■ Slice Spacing Must be uniform, .5mm increments, such as .5mm, 1.0mm, and 1.5mm.

■ DICOM Header Use only standard letters and numbers in the DICOM header. Do not use special characters, such as: ^ " & % $ # @ !


Loading Files for Segmentation


Loading Files for Segmentation

Starting the EnSite™ Verismo™ Segmentation Tool

The manner in which DICOM files are loaded depends on whether the EnSite™ Courier™ Module is installed. If it is installed, DICOM files may be loaded from a PACS network or from CD/DVD. If it is not installed, DICOM files may be loaded only from CD/DVD.

Verismo Cleanup

Upon launching Verismo, the system allows you to perform a cleanup procedure before Verismo launches. Click the [Clean Verismo] button. This procedure removes all temporary files. Perform a Cleanup procedure if Verismo fails to launch. See “Troubleshooting Common Problems” on page 290 for more information.

NOTE: Performing a Cleanup will remove any data currently in the Verismo workspace, such as work in progress files. DIF files will not be deleted.

Loading DICOM Files

1. Power on the EnSite™ Velocity™ Cardiac Mapping System and login as described in the EnSite™ Velocity™ Cardiac Mapping System Instructions for Use manual.

2. From the title screen, click [Clinical], then [Verismo].

3. Select an Import From: source.

4. Click [Query] to display a list of files.

5. Select the desired file and click [Launch Verismo].

Using DICOM Files from Saved Data

To load DICOM files from data that you have previously saved:

1. Power on the EnSite™ Velocity™ Cardiac Mapping System, as described in the previous section, “Loading DICOM Files”.

A pop-up message window will be displayed.

2. Select Use Saved Data and press Continue.

The previously saved patient will be displayed.

3. Click on the patient to display and select a desired image series for new segmentation, or select File > Resume Previous Segmentation to resume the most recent segmentation series.

Figure 223. The selection window.


Using the Wizard 269EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Using the Wizard

The Wizard is intended to guide the clinician through the segmentation process (see Figure 224). The Wizard will describe how to load files and provides an overview of the segmentation tools.

■ Follow the suggested task at the top of the Wizard.

■ Below the task are several options. Selecting the option will provide additional details and describe how to access the controls.

■ When a step is complete, click [Next].

Note: Clicking [Back] will access the previous step.

Note: The Wizard may be closed by clicking [Close] or [Finish]. To access the Wizard again, select File > Resume Wizard.

Introduction to the Patient Screen

The patient screen is the interface for loading DICOM data (see Figure 225). It includes the following features:

A. Menu bar – The menu bar provides access to commonly used tools.

B. Wizard – The Wizard guides the clinician through the process of segmentation.

C. Progress bar – The progress bar indicates when the workstation is processing data. If the progress bar is labeled Cancel, clicking the progress bar will cancel the current task.

D. Slice view – The slice view contains images from the selected data set. Data in the slice view can be manipulated. See the appropriate section under “Using Basic Interface Controls” on page 272.

E, F, G. Patient, Study, and Series panels – These panels provide an interface for selecting a data series. See “Selecting a Series for Segmentation” on page 269.

Selecting a Series for Segmentation

A DICOM data disk may contain multiple patients, multiple radiology studies for each patient, and multiple series per study. Use the panels on the lower half of the screen to select a series for segmentation.

1. From the Patient panel, select a patient name.

2. From the Study panel, click on the study of interest.

Figure 224. The Wizard window.

A

B

C

D

E F

G

Figure 225. The patient screen.


Subregioning the Series


3. From the Series panel, click on the series of interest.

Note: Series that can be loaded for segmentation appear in black. If a series cannot be used for segmentation, the information for that series appears in gray in the series panel, and an explanation of why the series may not be usable appears in the Usability Indicator column. Refer to the appropriate section under “Troubleshooting Common Problems” on page 290.

Viewing Options

The following options are available for sorting patient data:

■ To add or remove columns of information from the patient, study, or series panels, click [List Options]. A window will appear with display options. Select display options and click [Close].

■ Clicking on the heading at the top of a column will sort the data by that column.

Subregioning the Series

Subregioning is a process of identifying a region of interest within the scan for segmentation. Subregioning can improve the performance of the segmentation tool by processing only the regions of interest. The goal of subregioning is to minimize the volume to maximize processing speed.

1. A green bounding box appears in the image display. Left-click on any handle of the bounding box and drag to outline the region of interest (see Figure 226).

Note: During subregioning, the Zoom, Pan, and W/L controls may help visualize the slice data. See “Using Basic Interface Controls” on page 272.

2. Drag the Slice slider upward until the region of interest is no longer visible; then drag the upper Range slider to the same position (e.g., slice 180).

3. Drag the Slice slider downward until the region of interest is no longer visible; then drag the lower Range slider to the same position (e.g., slice 33).

Note: The number of recommended slices is greater than 10.

Loading the Series for Segmentation

After subregioning the series, the data may need to be preprocessed, filtered, and loaded into the segmentation interface.

Filtering removes grainy artifacts and non-uniformities that may affect thresholding operations. By default, filters are applied to CT, but not to MR images. To adjust filter defaults, select Advanced > Settings and select the desired filter settings before loading the series for segmentation.

Loading a subregioned series – To load the subregioned data series, click [Segment Series]. A progress bar is shown while the subregioned volume is preprocessed, filtered, and then loaded.

Figure 226. Using the bounding box to subregion the slice data.


Using the Segmentation Interface 271EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Note: If the size of the subregioned series is larger than 60Mb, a message will appear providing the following options (see Figure 227):

■ Subregion – Return to the subregioning tools and identify a smaller region of interest.

■ Resample – Resampling will reduce the size of the data by adjusting the resolution of the images until the subregioned series is less than 60MB. Resampling may decrease accuracy of measurement tools. See “Using the Measurement Tools” on page 285.

■ Continue – Use the identified data set without further subregioning or resampling. Processing speed may not be optimal.

Note: If the image to be loaded for segmentation is not a CT or MR image, the Preprocess window will appear (see Figure 228). Click [CT] to preprocess the image as a CT image, [MR] to preprocess the image as an MR image, or [Skip] to not preprocess the image. For XA (rotational angiography) series, process the images as CT.

Using the Segmentation Interface

Introduction to the Segmentation Screen

The segmentation screen (see Figure 229) is used to segment the scanned volume and render an output image for 3D visualization. It includes the following features:

A. Menu bar – The menu bar provides access to commonly used tools.

B. Control panel – The control panel contains segmentation tools. The icons on the control panel indicate which tool is currently active.

C. Structure list – The structure list, featured in several tools, selects which structures are affected by segmentation.

D. 3D view – The 3D view shows the result of the current segmentation.

E, F, G. Slice views – The slice views contain images from the selected data series in transverse, coronal, and sagittal planes.

Figure 227. Message indicating the volume size exceeds 60.0 Mb.

Figure 228. PreProcess window.

CBA

E D

F G

Figure 229. The segmentation screen.


Using Basic Interface Controls


Menu Bar Summary

Using Basic Interface Controls

The EnSite™ Verismo™ Segmentation Tool interface provides controls for navigating in slice views, zooming, panning, and adjusting the intensity of the image. These controls are located in the lower left and lower right corners of the slice and 3D panels.

Note: After segmentation, if the Slice control is active, moving the mouse over the Zoom, Pan, or W/L controls will deactivate the Slice control. If the Zoom, Pan, or W/L controls is active, moving the mouse over the Slice control will deactivate the Zoom, Pan, or W/L controls.

Menu Option Function

File New Segmentation Start a new segmentation session.

Resume Wizard Continue the next step of the wizard.

Import DICOM Files Import ccurrently saved DICOM files into the EnSite ™ Verismo ™ Segmentation Tool.

Resume Previous Segmentation Resume the most recent segmentation session.

Save As Save the displayed 3D model to the hard drive as a DIF file.

Save Work in Progress Save the segmentation results during a segmentation session, without creating a DIF file.

Load Work in Progress Reload a segmentation session from a previous Save Work in Progress.

Save Template Save the current settings as a template.

Load Template Load a previously saved template.

Export to CD/DVD Save models to a CD/DVD.

Print Print the full segmentation screen, 3D heart model, or any of the slice views.

Exit Exit the EnSite ™ Verismo ™ Segmentation Tool and return to the EnSite ™ Velocity ™ Cardiac Mapping System title screen.

Edit Modify Structure Modify the current structure.

Load Default Threshold Restore the default threshold after manual adjustments have been made.

Clear Segmentation Result Clear all segmented results.

Display Info Select preferences for displaying patient, study, and series information on the Slice views. Allows access to information from the DICOM header.

Options Set options for crosshairs display and the number of undo levels.

View Segmentation Model Show the 3D heart model.

View Segmentation Contours Compare tiled model, rendered model, and slice contours.

Advanced Smooth All Structures Refine all visible structures.

Settings Set preferences for filters and the Growth Limit for the Vessel tool.

Help About EnSite Verismo Display the software version.

Release Notes Display information about the software not contained in the IFU.


Using Basic Interface Controls 273EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Navigating in Slice Views

Each Slice view can be independently manipulated to find the slices and plane most suitable for segmentation.

Use any of the following methods to select a slice in a single view:

■ Navigate slices from within a slice view.

– Middle-click in a slice view, then drag up or down to browse through the set of scanned slices.

– With the cursor over a slice view, pressing the up or down arrow keys will allow scanning through adjacent slices.

– Left-clicking Slice (in the lower left corner of a slice view) will also allow navigation of slices by holding down the left mouse button and moving the mouse. To exit this mode, left-click Slice again.

– Right-clicking Slice will display a menu with options to go to the first, middle, or last slice.

■ Use the crosshairs. The crosshairs facilitate navigation between slices and show the relationship between the slice views and the 3D model (see Figure 230). In the slice views, the cursors indicate the position of the slice displayed in the other two views.

– To move crosshairs in a slice view, move the cursor near a crosshair. The cursor will change to a crosshair cursor, indicating whether one or both crosshairs are highlighted. Left-click and drag the mouse to move the crosshair.

– To move crosshairs in the 3D view, move the cursor near the intersection of the crosshair lines. The cursor will change to a small cross. Left-click and drag to move the crosshairs.

Note: When dragging the crosshairs in 3D, the crosshairs can only be positioned to a surface location on the model.

– To disable the display of crosshairs in a single view, right-click in the view and deselect the crosshairs toggle. To disable the display of all crosshairs, select Display > Options, and disable the Crosshairs toggle.

Using the Zoom Control

The zoom control appears in the lower right corner of the slice and 3D panels. By default, the zoom will be set to fit the image to the panel in each view. Use the following controls to adjust the zoom level:

■ Left-click on Zoom to activate the zoom cursor. Then, left-click and drag the mouse up or down to zoom in or out. Left-click on Zoom again to disable the zoom cursor.

■ Hold down the right mouse button on Zoom to display a menu, and select a zoom level:

– 0.25x – 4.00x – various magnifications.

– Fit Window – fits to panel.

– Fit Width – fits to panel width.

– Fit Height – fits to panel height.

Using the Pan Control

The pan control appears in the lower right corner of the slice and 3D panels. By default, the image will be centered. Use the following controls to adjust the pan:

■ Left-click on Pan to activate the pan cursor. Then, left-click and drag the mouse in any direction to pan the image. Left-click on Pan again to disable the pan cursor.

■ To center the image, hold down the right mouse button on Pan and select Reset.

Figure 230. Transverse image with crosshairs indicating coronal (yellow) and sagittal (red) slice orientations.


Using Templates


Using the Intensity (W/L) Controls

The window Width/Level (W/L) control appears in the lower right corner of the slice panels. The W/L controls adjust the intensity of the displayed slice data. This adjustment allows visualization of structures in the data. By default, the W/L will be set to a range encompassing the minimum and maximum intensity values in the subregioned images. Adjusting W/L in any view will affect all three slice panels.

Note: W/L adjustments do not affect the result of automated segmentation tools. To adjust intensities for automated segmentation, use the thresholding and boundary emphasis controls under the related tools.

Use the following controls to adjust W/L:

■ To manually control W/L, left-click on W/L to display the W/L cursor. Then left-click and drag the mouse to adjust window (left to right) and level (up and down). Left- click on W/L again to disable the intensity cursor.

■ To select a defined W/L, hold down the right mouse button on W/L and select a setting:

– Intensity values that were saved as a part of the DICOM data set appear as numeric values.

– Reset sets the W/L to a range encompassing the minimum and maximum intensity values in the subregioned images.

Rotating the 3D Model

The 3D model can be rotated to view the heart from various angles. The torso-shaped Orientation Reference in the upper right corner shows the current rotation. Use the following controls to adjust the rotation angle:

■ To manually adjust the rotation, middle-click on the 3D model, and drag to rotate.

■ To select a pre-defined angle, left-click one of the rotation angles listed at the top of the panel.

– AP: Anterior to posterior, correlates to coronal slice view

– PA: Posterior to anterior

– LL: Left lateral, correlates to sagittal slice view

– RL: Right lateral

– CRA: Cranial

– CAU: Caudal, correlates to transverse slice view

Using Templates

Interface preferences may be saved in templates. The following attributes can be saved in templates:

■ Structure names and colors

■ Default structure

■ Information displayed in the upper left corner of slice and 3D views.

■ Show crosshairs on/off

■ Growth limit for vessel tool

■ Font size for labels and tape measure

■ Number of undo levels

To create a template – Modify the above attributes, and select File > Save Template.

To load a template – Select File > Load Template.

Note: Templates can only be saved or loaded from the segmentation screen, not the patient screen.


Performing Segmentation 275EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Performing Segmentation

Overview of Segmentation Tools

Segmentation is the process of isolating an object of interest using the gray-scale intensity of slice-based data. The EnSite™ Verismo™ Segmentation Tool uses two common segmentation techniques to create an accurate model for 3D visualization of cardiac structures.

■ Thresholding is a method of selecting any values within a range of intensities.

■ Boundary emphasis identifies sharp transitions in intensity.

Each segmentation tool is represented by an icon in the control panel. Clicking the icon will display the tool.

Additional Controls: Delete, Undo, Cancel

The following controls appear at the bottom of the control panel and apply to multiple tools:

■ [Delete] – For the current tool, start a delete mode that will allow items (seed point, barrier, trace, label, or measurement) to be highlighted with the cursor and deleted with a left-mouse click.

■ [Delete All] – Delete all items placed on slice views or the 3D model, for example, all seed points, labels, measurements, or barriers.

■ [Undo] – Undo the last segmentation process. The default number of Undo levels is 10. The number of levels is adjustable under Display > Options.

■ [Redo] – Restore the last process reversed with Undo.

■ [Cancel] – Cancel all unapplied actions of the current segmentation tool and close the tool.

Region Grow – Segment a region that consists of many connected structures, such as the blood pool.

Chamber – Segment a heart chamber.

Vessel – Segment a cardiac vessel.

Separator – Separate connected structures from one another.

Trace – Manually trace a region.

Barrier – Enhance boundaries between structures to improve the use of the Region Grow, Chamber, Vessel, and Separator tools.

Reassign – Reassign a structure that was previously defined.

Label – Label the heart model.

Measure – Measure linear distances and volumes.


Using the Structure List


Using the Structure List

The Structure list manages the display of up to 16 structures (see Figure 231). It features a drop-down menu of 16 structures and an ***Undefined*** option. One structure may be selected from this list to be used by segmentation tools.

The ***Undefined*** option is used to remove information from the segmented model. All other structures add information to the segmented model. Undefined cannot be locked, displayed, colored, or renamed.

Structure Attributes

Each structure has the following attributes (see Figure 231):

■ Lock – Locking a structure prevents modifications. To lock or unlock a structure, click on the lock icon. The icon for an unlocked and modifiable structure appears in green (default), and the icon for a locked structure appears in red.

■ Display – Display controls whether the structure will be displayed in the 3D view. If the display is enabled (default), the display icon appears as a small monitor, and the structure is shown in 3D view. If the display is disabled, the icon appears as a monitor with a red slash, and the structure is hidden from 3D view. If a structure is not displayed, no part of that structure can be removed or assigned to a different structure; however, a structure that is not displayed can still have additional information added to it by other segmentation tools.

Note: Structures that are not displayed when a model is saved will not be available when the model is displayed on the EnSite™ Velocity™ Cardiac Mapping System software.

■ Color – The color controls the display color for the structure in the slice and 3D views.

Modifying Structures

Structure attributes may be modified.

1. Select a structure from the list to modify.

2. Select the [Modify] button adjacent to the structure list (see Figure 232), or select Edit > Modify Structure. The Modify Structure window will appear.

3. Modify the structure attributes.

■ Name – Type a name using up to 16 characters, or select a name from the list.

■ Color – Type a color name (“red”) or select [...] to display a color selection tool.

■ Lock – Lock or unlock the structure.

■ Display – Display or hide the structure.

4. Select [OK].

Figure 231. The structure list.

Figure 232. The structure list and Modify Structure window.


Using the Region Grow Tool 277EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Using the Region Grow Tool

The Region Grow tool (see Figure 233) is used to quickly isolate a larger region of the scanned volume such as the blood pool. Other segmentation tools can then be used to separate individual structures from the blood pool. Region Grow requires the placement of one or more seed points and manual adjustment of the threshold range.

1. Select the Region Grow icon.

2. Select a structure of interest from the list.

3. In the desired Slice view, left-click to place one or more seed points in the middle of the structure.

Note: If seed points are placed incorrectly, use the [Delete] or [Delete All] buttons. See “Additional Controls: Delete, Undo, Cancel” on page 275.

4. Adjust the Min. Threshold, Max. Threshold, and Boundary Emphasis sliders:

■ Lower the Min. Threshold until the structures of interest fill in with translucent color. If boundaries between structures begin to fill with color, the Min Threshold may be too low (see Figure 234).

■ The Max. Threshold generally does not need to be adjusted unless a hard structure (bone, implanted metal) is present.

■ Drag the Boundary Emphasis slider to emphasize the boundaries between structures. Raise the slider until a thin boundary appears around the structures in the slice views (see Figure 235).

Note: If thresholding and boundary emphasis do not identify separations that can be visually identified, consider using the Barrier tool before proceeding. See “Using the Barrier Tool” on page 283.

5. Optional: To limit the area affected by Region Grow, select [Local Region] and adjust the bounding box in the slice views.

Figure 233. The Region Grow tool.

Figure 234. While the threshold sliders are adjusted, the affected portion of the model will be indicated with a translucent overlay of the

structure color.


Using the Region Grow Tool


6. Click [Apply] to segment the defined structure. The segmented structure is shown in the 3D view (Figure 236).

Note: If the effect of the segmentation is undesirable, use the [Undo] button to undo the last change to the 3D model. See “Additional Controls: Delete, Undo, Cancel” on page 275.

Figure 235. While the Boundary Emphasis slider is adjusted, areas with a sharp change in

intensity are indicated in translucent white.

Figure 236. Initial 3D model from region grow.


Using the Chamber Tool 279EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Using the Chamber Tool

The Chamber tool (Figure 237) is used to quickly isolate a heart chamber from the scanned volume. This tool requires the placement of a seed point in the middle of the chamber of interest and manual adjustment of the threshold range. The Chamber tool emphasizes the segmentation of a single chamber using an erosion algorithm. The erosion algorithm uses thresholding and boundary emphasis values to automatically break thin connections to other structures. The Chamber tool is often faster than Region Grow for segmenting a single chamber, but generally has slightly less resolution.

1. Select the Chamber icon.

2. Select the chamber of interest from the list.

3. In the desired slice view, left-click to place a seed point in the middle of the chamber.


4. Adjust the Min. Threshold, Max. Threshold, and Boundary Emphasis sliders:

■ Adjust the Min. Threshold until a dotted line appears around the structure of interest. If the dotted line surrounds multiple structures, the Min. Threshold may be too low.


■ Drag the Boundary Emphasis slider to emphasize the boundaries between structures. Raise the slider until a thin boundary appears around the structures in the slice views.

Note: If thresholding and boundary emphasis do not identify separations that can be visually identified, consider using the barrier tool before proceeding. See “Using the Barrier Tool” on page 283.

5. Click [Apply] to segment the defined chamber (Figure 238). The segmented structure is shown in the 3D view.

Note: The segmented structure will not precisely match the initial dotted line because of the erosion algorithm described above.


Figure 237. The Chamber tool.

Figure 238. A model produced by the Chamber tool.


Using the Vessel Tool


Using the Vessel Tool

The Vessel tool (see Figure 239) is used to quickly isolate a vessel from the scanned volume. This tool grows a vessel on adjacent slices, using a seed point and a threshold range.

1. Select a structure from the list.

2. In the desired slice view, left-click to place a seed point in a vessel. The seed point should generally be placed in a plane perpendicular to the vessel, such as the sagittal view for pulmonary veins.

Note: The growth of structures using the Vessel tool is controlled by the Growth Limit. The Growth Limit, available under Advanced > Settings, is user adjustable, but defaults to 1.5 times the size of the original slice.


3. Adjust the Min. Threshold and Max. Threshold sliders:

■ Adjust the Min. Threshold until a dotted line appears around the structure of interest. If the dotted line surrounds multiple structures, the Min. Threshold may be too low.


Note: If thresholding does not identify separations that can be visually identified, consider using the Barrier tool before proceeding. See “Using the Barrier Tool” on page 283.

4. Select one of the following directions to grow the vessel:

■ (Superior/Anterior/Left) to grow the vessel in the specified direction.

■ Both directions to grow the vessel in both directions.

■ (Inferior/Posterior/Right) to grow the vessel in the specified direction.

5. Click [Apply] to segment the vessel (see Figure 240).


Figure 239. The Vessel tool.

Figure 240. A completed vessel model of the descending aorta.


Using the Separator Tool 281EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Using the Separator Tool

The Separator tool (see Figure 241) is used to separate structures for individual visualization, for example, separating the left ventricle from the left atrium. This tool can also be used to remove a portion of the 3D model if too much detail was segmented. Structures are separated between two or more seed points placed on the surrounding structures.

1. Select the Separator icon.

2. Select a structure to separate (e.g. Left Atrium).

Note: Selecting “Undefined” from the structure list allows the separator tool to delete portions of the segmented model.

3. In the desired Slice or 3D view, left-click to place one or more seed points on the appropriate structure (e.g. left atrium).


4. Repeat steps 2 and 3 as needed to continue identifying surrounding structures.

Note: To preserve the original structure, be sure to place at least one point in the original structure. For example, if the “Left Atrium” structure also contains portions of the left ventricle and aorta, place points not only in the left ventricle and aorta, but also in the left atrium.

5. Drag the Boundary Emphasis slider to emphasize the boundaries between structures.

6. Click [Apply] to separate the defined structures (see Figure 242).

Note: If separations do not occur at locations that can be visually identified, consider using the barrier tool before proceeding. See “Using the Barrier Tool” on page 283.


Figure 241. The Separator tool.

Figure 242. Before (left) and after (right) using separator.


Using the Trace Tool


Using the Trace Tool

The Trace tool (see Figure 243) is used to manually outline a structure. It can be used to create structures from slice views or reassign portions of the segmented model to a different structure.

Using Trace in a Slice View

1. Select the Trace icon.

2. Select the structure to be traced, such as “Esophagus.”

3. In the desired slice view, left-click along an edge of the structure to be traced.

4. Left-click and drag around the edge of the contour to trace the structure (red line, Figure 244). Release the mouse button to complete the trace, and connect the starting point of the line to the ending point. The structure will be created on a single slice.

Note: To remove a trace from a single slice, use the [Delete] or [Delete All] buttons. See “Additional Controls: Delete, Undo, Cancel” on page 275.

5. Advance to a parallel slice in the same view, and trace the structure again.

6. To grow the structure through adjacent slices, click [Propagate].


Using Trace in the 3D View

1. Select the Trace icon.

2. Select a structure.

Note: Selecting “Undefined” from the structure list allows the Trace tool to delete portions of the segmented model.

3. In the 3D view, left-click and drag the cursor around the structure to be reassigned.

4. Release the mouse button to complete the trace.


Figure 243. The Trace tool.

Figure 244. Using the Trace Tool


Using the Barrier Tool 283EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Using the Barrier Tool

The Barrier tool (see Figure 245) is used to place divisions between structures that can be visually identified, but may be difficult to automatically identify for a variety of reasons. The Barrier tool improves the use of the Region Grow, Chamber, Vessel, and Separator tools.

To create a barrier:

1. Select the Barrier icon.

2. In the desired Slice view, left-click and drag to draw a line (see Figure 246).

3. Advance to another slice in the same view and draw another line. Repeat this process until the barrier has progressed from one side of the structures to the other.

■ When drawing barriers, always draw in the same general direction (left-to-right, top-to-bottom, etc.)

■ Slices do not need to be consecutive.

■ The barrier tool will create an estimated line on all of the slices between user-drawn lines. These estimated lines are displayed in purple; drawing a new line on this slice will remove the estimated line.

■ Drawing a new line on a slice that already contains a line will replace the previous line.

4. Click [Create Barrier] to grow the barrier through adjacent slices (see Figure 245).

Note: After creating a barrier, additional barriers may be drawn.

Note: To remove barriers, use the [Delete] or [Delete All] buttons. Refer to “Additional Controls: Delete, Undo, Cancel” on page 275.

5. Continue segmentation using the appropriate tools.

Note: Barriers are not affected by Undo or Redo. Undo and Redo only affect changes to the segmented model; barriers only appear in the 2D view. Figure 245. The Barrier Tool

Figure 246. A drawn barrier line Figure 247. A created barrier


Using the Reassign Tool


Using the Reassign Tool

The Reassign tool (see Figure 248) is used to reassign a structure that has already been defined. It is an efficient way to segment the remaining structures from the slice or 3D views.

Reassigning a Structure

1. Select the Reassign icon.

2. Select the structure to be reassigned.

3. Select from the following assignment methods:

■ Entire Structure reassigns all components of one structure to a different structure. For example, if a model of the left atrium was inadvertently assigned to the Left Ventricle structure, use Entire Structure to reassign the entire model to the Left Atrium structure.

■ Contiguous 3D reassigns all connected 3D regions to the defined structure. For example, if a model in the Blood Pool structure contained the anatomy of the descending aorta and the rest of the heart, and the aortic anatomy was not connected to the posterior wall of the heart, this option would allow the descending aorta to be reassigned to the Aorta structure.

■ Components less than 125 mm3 reassigns connected 3D regions less than 125 mm3. A new number can be typed if desired. For example, if the Left Atrium structure includes many small disconnected and undesirable pieces, this option can be used to reassign the small pieces to the Unassigned structure.

4. In the desired slice or 3D view, left-click to place a seed point on the structure to reassign.


5. Click [Apply] to reassign the defined structure.

Placing Labels

The Label tool (see Figure 249) is used to label the 3D heart model. All labels are saved with the 3D model and will be included on models imported into an EnSite™ Velocity™ Cardiac Mapping System study.

Figure 248. The Reassign tool.


Using the Measurement Tools 285EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


1. Select the Label icon.

2. Type a label (up to 16 characters), select a predefined label from the list, or select Location from the list. When Location is selected, a placed label will display Cartesian coordinates for the selected map location.

3. Select a font size for the label.

■ Small – 10 point

■ Medium – 12 point (default)

■ Large – 14 point

4. Left-click in a slice view or on the 3D model to place a label.

Note: If labels are placed incorrectly, use the [Delete] or [Delete All] buttons. See “Additional Controls: Delete, Undo, Cancel” on page 275.

Using the Measurement Tools

The Measure tool (see Figure 251) is used to measure linear and screen distances between two user-selected points. Measurement accuracy is based on the original scan data +/- one slice space.

Note: Resampling may decrease the accuracy of measurement tools. See “Loading the Series for Segmentation” on page 270.

Figure 249. The Label tool.

Figure 250. Using the Label tool.


Using the Measurement Tools


Measuring Distances

1. Select the Measure icon.

2. Select a font size for displaying the measured distance.

■ Small – 10 point

■ Medium – 12 point (default)

■ Large – 14 point

3. In any slice view or the 3D view, left-click and drag on the area to be measured.

■ Straight (slice or 3D views) is the shortest distance across the structure.

■ Screen (3D view only) is the projected screen distance, which changes as the 3D model is rotated. The screen measurement may be useful for analyzing a distance at various angles.

Note: Measurements are shown on a model only when the Measure tool is selected. Measurements are not saved with the final DIF file.

Note: To delete tape measures, use the [Delete] or [Delete All] buttons. See “Additional Controls: Delete, Undo, Cancel” on page 275. When using the delete tool with tape measures, click on the red ends of a tape measure.

Measuring Volumes

Click [Measure Volume] to display the calculated volumes for all structures.

Figure 252. Using the Measurement ToolFigure 251. The Measurement Tool.


Saving and Exporting 287EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


Saving and Exporting

Key Points About Saving Models

The following points are important considerations in saving a model:

■ At the time that the model is saved, each visible structure is included in the final model. Disabling the view of a structure in the Structure List will prevent that structure from being included. See “Using the Structure List” on page 276.

Note: When saving a model with more than one structure displayed in the structure list, the resolution of each individual structure will be slightly reduced. The greater the number of displayed structures, the lower the resolution on each individual structure.

■ When segmentation is complete, the model must be saved to the hard drive, regardless of whether the model will be used on a different workstation. The model may be exported after saving.

■ During the saving process, the final model is constructed by creating a thin shell around each visible structure in the 3D view. A viewer will appear to display the surface of this shell. A contour viewer is also available to compare the shape of this shell directly to the model in the 3D view and the original slice data.

■ To save partially completed segmentations or return to a previous segmentation, use the Save Work in Progress option.

Saving the Model to the Hard Drive

1. Select File > Save As.

2. Enter a file name.

3. In the Operator field, type the name of the clinician who performed the segmentation.

Note: The operator name may also be accessed from a list. Use the drop-down menu to access an operator from the list. To add new operator names to the list, type the new operator name, and from the drop-down menu, select Add.

4. Optionally, notes about the segmentation session may be saved with the model in the Comments section. Comments will be available during the EnSite™ Velocity™ Cardiac Mapping System study.

5. Select [Save] to save the file on the EnSite™ Velocity™ Cardiac Mapping System. When a model is saved, the system creates a tiled surface of each displayed structure. The tiled model in DIF format is the version that will be accessed by the EnSite™ Velocity™ Cardiac Mapping System. When saving a model, the model viewer window will appear automatically. See “Using the DIF Viewer” on page 288.

Note: During saving, a message may appear stating that the complexity of the model may slow the EnSite™ Velocity™ Cardiac Mapping System application. If this occurs, consider the following methods of reducing the complexity of the model:

■ Hide additional structures in the Structure List and save again.

■ Remove small debris from the model using either the Trace or Reassign tool, and save again.

■ Reduce the surface complexity by selecting Advanced > Smooth All Structures and save the model again.

Exporting Models to CD or DVD

To save the DIF file to a CD/DVD:

1. Select File > Export to CD/DVD. A list of saved models will appear.

2. Select saved files to back up on the CD/DVD.

3. Click OK to copy the files to the disk.


Saving Work in Progress


Saving Work in Progress

Saving work in progress will help preserve the model in various stages of segmentation by returning to a previous point in the segmentation process.

Note: Barriers, labels, and tape measures are not saved with work-in-progress files.

1. Select File > Save Work in Progress.

2. To recover this saved model at any time, select File > Load Work in Progress.

Reviewing the Final Model

Using the DIF Viewer

The DIF viewer (see Figure 253) displays the final 3D model surface as it will appear on the EnSite™ Velocity™ Cardiac Mapping System.

The viewer may be accessed by two methods:

■ After saving a model by selecting File > Save As. The viewer will appear with the model loaded.

■ The viewer may also be accessed by selecting Display > View Segmentation Model. A list of available models will appear. Select a model from the list.

Figure 253. The DIF viewer.


Printing Images 289EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


The following controls are available in the viewer:

■ Rotate – Hold down the middle mouse button and drag.

■ Zoom – Use the roller wheel on the mouse.

■ Wireframe – Options > Wireframe.

■ Bounding box display – Options > Bounding Box.

■ Default views – Views > AP/PA/LL/RL/CRA/CAU.

■ Close viewer – File > Exit.

Viewing Segmentation Contours

The segmentation contour viewer (see Figure 254) allows the clinician to compare a DIF surface model to the current rendered model from the 3D view and the current slice data.

To access the segmentation contour viewer, select Display > View Segmentation Contour.

■ The rendered model from the 3D view appears as shaded solid areas.

■ The surface of the DIF model appears as thick opaque lines.

■ The slice images appear in a single view, which may be navigated using the same controls as the other slice views.

Printing Images

1. Select File > Print.

Figure 254. The segmentation contour viewer.


Troubleshooting


2. Select from the following options:

■ Full Screen prints the entire Segmentation screen

■ 3D Rendering prints the 3D heart model

■ Transverse (CAU) prints the transverse Slice view

■ Coronal (AP) prints the coronal Slice view

■ Sagittal (LL) prints the sagittal Slice view

Troubleshooting

Contacting Technical Support

The following troubleshooting guide is intended to help users resolve common problems with the system. If problems cannot be resolved by using the suggestions below, contact your EnSite™ Velocity™ Cardiac Mapping System field representative or distributor.

WARNING: Service and Technical Support

651-756-6985Toll Free: 800-374-8038, Option 1

www.sjm.com

Troubleshooting Tools

Technical Support may ask you to access one or more of the following software resources:

About EnSite Verismo – This information will provide technical support with general information about your software version. From the EnSite™ Verismo™ Segmentation Tool menu bar, select Help > About EnSite Verismo.

Collect Log Files – This function collects all the log files from the system and exports them to a disk. Place a blank disk in the DVD/CD writable drive. From the EnSite™ Velocity™ Cardiac Mapping System title screen, click on the [About EnSite ...] button. Click on the Utilities tab then click on the [Collect Log Files] button. Follow the on-screen prompts to complete the process. This operation can take several minutes to complete.


When a problem occurs, perform the following steps:

Series will not load – Verify that the data was created in accordance with the “Optimal Characteristics for the EnSite™ Verismo™ Segmentation Tool Image Files” on page 267. If the series information displays but the series will not load, check the usability indicator.

■ OK – No problems were detected.

■ Bad Dircos – Coordinate information is missing, or vectors are not at right angles.

■ Rot### – Volume is not orthogonal - direction cosines are reported.

■ NOT_3D – Only one section, or no slice locations, missing coordinate information, or all slices are at the same location.

■ Unsupported orientation – Volume is not a standard orthogonal.

■ GantryTilt – Gantry tilt field is nonzero.

■ IRREGULAR_SPACING – Spacing conflicts cannot be resolved.


Troubleshooting 291EnSite™ Velocity™ Cardiac Mapping System Instructions for Use


EnSite Verismo is not responding – If the EnSite™ Verismo™ Segmentation Tool is not responding, press <Alt> + <F10>.

EnSite Verismo Cleanup – If the EnSite™ Verismo™ Segmentation Tool fails to start, consider clearing out all temporary files. On the EnSite™ Velocity™ Cardiac Mapping System title screen, click [About EnSite ] to display the System Information window (see Figure 255). On the System Information window, click the Utilities tab. Select the type of files to delete, and then click [Delete].

■ Database – Delete the currently loaded DICOM files and all Work In Progress files.

■ Templates – Delete the user-defined templates.

■ Work in Progress – Delete all Work in Progress files.

Note: The cleanup tool will not delete created DIF files. These models may be deleted from within the Load DIF window in the EnSite™ Velocity™ Cardiac Mapping System software.

EnSite™ Velocity™ Cardiac Mapping SystemEnSite™ Velocity™ Cardiac Mapping System

Figure 255. Use the Utilities tab to delete temporary files.


Troubleshooting



Glossary
APPENDIX G
3D – Three-dimensional.

ABL – Ablation.

Abstract Syntax – the information agreed to be exchanged between applications, generally equivalent to a Service/Object Pair (SOP) Class. Examples: Verification SOP Class, Modality Worklist Information Model Find SOP Class, Computed Radiography Image Storage SOP Class.

Accession Number – Sequential numbers assigned by imaging vendors as unique identifiers of an examination.

AE – see Application Entity.

Application Entity (AE) – an end point of a DICOM information exchange, including the DICOM network or media interface software; i.e., the software that sends or receives DICOM information objects or messages. A single device may have multiple Application Entities.

AE Title – see Application Entity Title.

Active Electrode – The electrode on the active EnGuide that is used for creating surfaces, placing labels, placing lesions, and collecting points for maps.

Active EnGuide – The the catheter that is used for creating surfaces, placing labels, placing lesions, and collecting points for maps.

Active EnGuide Silhouette – A silhouette outline of the Active EnGuide where it resides inside the chamber of interest. The outline takes on the color of the assigned Active EnGuide color.

Anatomic marker – A tool that is used to connect points on the surface of the model with lines.

Animations – Recorded segments from a study.

Application Context – the specification of the type of communication used between Application Entities. Example: DICOM network protocol.

Application Entity Title (AE Title) – the externally known name of an Application Entity, used to identify a DICOM application to other DICOM applications on the network.

AP – Anterior Posterior.

ArrayLink™ Module – Used to connect the EnSite™ Array™ Catheter and Data Module to the EnSite™ Amplifier.

Asynchronous – Asynchronous Storage Commitment is returned to the requestor in a different DICOM association than the one by which the request was sent (see Synchronous).

Auto Segment – The system automatically records segments to periodically store study information. These automatically recorded segments are added to the Notebook where they are identified as type Auto Segment.

294 Glossary EnSite™ Velocity™ Cardiac Mapping System Instructions for UseARTEN100151580 Rev. A

AutoFocus – A tool that automates the dithering of the Color High and Color Low values to highlight early focal activation or small diastolic or pre-systolic potentials.

Bio Impedance Scaling – A feature that corrects for the slow drift of the EnSite™ NavX™ Navigation and Visualization Technology positions caused by a change in the saline concentration within body fluids over the course of a study.

Bookmark – A feature that allows the system to return to a specific time in review mode.

Boundary emphasis – Segmentation technique used to sharpen the edges of a structure so that the computer can identify what the user sees as boundaries.

Calipers – A tool that is used to measure and adjust timing between signal features in the waveform display.

Cardiac Triggered Maps – Maps that use a surface electrocardiogram or an intra-cardiac electrogram as the reference to which collected points are measured.

CAT5e – Category 5 cable.

Catheter Catalog – A collection of predefined catheters that can be used in a study.

CathLink™ Module – Used to connect diagnostic catheters to the EnSite™ Amplifier.

CFE – Complex Fractionated Electrogram.

CFE Mean maps – Maps that provide a fractionation index based on the cycle length between multiple, discrete, local activations in an electrogram.

CFE Standard Deviation map – A map that provides a fractionation index based on the cycle length between multiple, discrete, local activations in an electrogram.

CIFS – Common Internet File System

CIM – Catheter input module.

CL – Cycle Length. Cardiac Cycle Length.

Clipping Plane – Clipping planes allow for a view of the interior and rear of the closed map by cutting a plane away from the viewing space.

Color High – A specific map value to be displayed as purple.

Color Low – A specific map value to be displayed as white.

Coronal plane – Image plane that divides the body vertically into a front and back. Also called the frontal plane.

CT – Computed Tomography.

CT scan – Imaging technique that provides a 3D computer model of a patient’s anatomy. CT (computed tomography) scanners use detectors rather than film to collect and digitize x-ray images. CT images are used to examine cross-sections (slices) of the heart from all angles.

D3D – DIF three-dimensional.

Data Module – The Data Module is included in the EnSite™ Array™ Catheter Kit and the EnSite™ Surface Electrode Kit. It contains an EEPROM that must be validated prior to the start of a study.

DHCP – see Dynamic Host Configuration Protocol.

DICOM – see Digital Imaging and Communications in Medicine.

Glossary 295EnSite™ Velocity™ Cardiac Mapping System Instructions for UseARTEN100151580 Rev. A

DICOM Header – a text based portion of a DICOM file that describes the image dimensions and other information about the scan.

DIF – Digital Image Fusion.

Digital Imaging and Communications in Medicine (DICOM) – an industry standard that facilitates interoperability of medical imaging equipment.

Digital Image Fusion – A three-dimensional model created from digital images collected from Spiral CT or MRI scans.

Distal Length – The length of the distal electrode, which is located at the tip of the catheter.

DVI – Digital Visual Interface.

DWS – Display Workstation.

Dynamic Host Configuration Protocol (DHCP) – used to automatically assign IP addresses, deliver TCP/IP configuration parameters (such as the subnet mask and default router) and provide other configuration information such as the addresses of time servers. DICOM requires fixed IP addresses and the configuration of AE Titles at each individual device.

ECG – Electrocardiogram.

ECG electrodes – Patch electrodes on the patient's skin, used to collect extra-thoracic cardiac signals.

Electrode – A conductor which collects voltage signals from a patient.

Electrogram – A waveform which represents a voltage signal generated from a patient.

EEPROM – Electrically Erasable Programmable Read-Only Memory. Also referred to as a Data Module.

Electrode Spacing – The distance from the edges of the electrodes on a catheter (not the distance from the centers of the electrodes).

EnGuide Alignment – A tool used to manually adjust the alignment of EnGuides relative to the model.

EnGuide navigation system – Is used to display catheters and electrodes.

EnGuide Shadows – A three-dimensional historic image of an EnGuide position.

EnGuide – The display of an EP catheter in the map display.

Enhanced CT and MR images – This refers to the multi-frame image objects defined by the DICOM standard for CT and MR. The new multi-frame image objects collect frames into a single file with a standard structured header. This reduces the data size and file transfer overhead.

Enhanced DICOM Object – the new enhanced objects for MR, CT, XA and RF (radiography/fluoroscopy) accommodate new developments and acquisition techniques. As an example, for MR, the image data will be exchanged not only as individual images, but as multiframe objects. Multiframe objects are a convenient way to package all the pixel data of a complete acquisition in one message (or envelope). The differences between the individual frames of the multiframe object, such as the frame-rate, are described in the multiframe header.

EnSite™ Array™ Catheter – The entire catheter from the proximal handle to the distal tip. The stainless steel braid, with the 64 electrodes, which is supported by the inflated balloon in the cardiac chamber.

EnSite™ Amplifier – The EnSite™ Amplifier accepts signals from the NavLink™, ArrayLink™, CathLink™, SJM ECG Cable, RecordConnect, and GenConnect, converts these signals to digital format, and sends them to the DWS for processing. The EnSite™ Amplifier is connected to the DWS through a fiber optic cable.

EnSite™ Connect – A feature that enables an EnSite™ Velocity™ Cardiac Mapping System Technical Support representative to connect to an EnSite DWS through a broadband Internet connection.


EnSite™ Connect™ Remote Service Module – a tool to perform remote technical support of the DWS.

EnSite™ Courier™ Module – The EnSite™ Courier™ Module is a software expansion module to the EnSite™ Velocity™ Cardiac Mapping System Software. It enables the EnSite™ Velocity™ Cardiac Mapping System user to communicate with the hospital PACS server for the purposes of storing and retrieving patient data in DICOM format.

EnSite™ NavX™ Navigation and Visualization Technology – The EnSite™ NavX™ Navigation and Visualization Technology feature supports the tracking of EP Catheter locations from sensed potential on each axis of an orthogonal electric field generated by body surface patches.

EnSite™ Verismo™ Segmentation Tool – a software utility used to convert large volumes of slice-based images into a manageable 3D model of cardiac structures.

EP – Electrophysiology.

EP catheter electrodes – The tip or ring electrodes on the shaft of an EP catheter which must be in contact with the endocardial wall to collect good signals.

EPS – a DICOM modality type for basic cardiac electrophysiology, the specification for digitalized electrical signals from the patient cardiac conduction system collected in the heart. EPS is the modality type used to store EnSite™ Velocity™ Cardiac Mapping System studies.

Field Scaling – A feature that provides patient-specific scaling of EnSite™ NavX™ Navigation and Visualization Technology dimensions to allow for distance measurements in EnSite™ NavX™ Navigation and Visualization Technology studies.

Fly-Eye – In an EnSite™ Array™ study, the display is divided into 64 labeled frames containing EnSite™ Array™ Catheter traces.

F.O. cable – Fiber optic cable. The fiber optic cable provides the data connection between the The EnSite™ Amplifier and the DWS.

Ganged Signals – A group of signals in which a specific function is performed on all of them at once (e.g., a high pass filter setting is set for all of the ECG signals simultaneously).

GenConnect – GenConnect is used to connect the ablation catheter and dispersive surface electrodes to the The EnSite™ Amplifier.

Highpass Filter – A filter that reduces low-frequency signals (i.e., repolarization signals) and baseline drift.

HR – Heart Rate.

Information Object Definition (IOD) – the specified set of Attributes that comprise a type of data object; does not represent a specific instance of the data object, but rather a class of similar data objects that have the same properties. The Attributes may be specified as Mandatory (Type 1), Required but possibly unknown (Type 2), or Optional (Type 3), and there may be conditions associated with the use of an Attribute (Types 1C and 2C). Examples: MR Image IOD, CT Image IOD, Print Job IOD.

Intra-Cardiac Electrogram – An electrogram produced using catheters placed within the heart.

IOD – see Information Object Definition.

IP Address – a numerical label that is assigned to devices participating in a computer network that uses the Internet Protocol for communication between its nodes. An IP address serves two principal functions: host or network interface identification and location addressing. An IP Address can either be fixed or dynamic (see DHCP).

Isochronal Map – A map that shows the progression of activation through the first surface.

Isopotential Map – A map of voltages on the endocardial surface where similar voltages are represented by similar colors.

Labels – Markers that are used to identify points on the model.

LAO – Left Anterior Oblique.


LAT – Local Activation Time.

LED – Light Emitting Diode.

Lesion – Markers that are used to identify ablation points on the model.

Local Activation Time (LAT) Isochronal Map – A map that shows color-coded activation times for each collected location (or nearest surface).

Local Activation Time – The difference in milliseconds between detected activation on the roving waveform and the reference waveform.

Lowpass Filter – A filter that reduces high-frequency signals commonly caused by electronic interference.

Low-V ID – An adjustable low voltage identification option (Low -V ID) allows low-voltage potentials to appear in gray instead of affecting the color pattern. Low-V ID is available for Local Activation Time (LAT) isochronal maps and Complex Fractionated Electrogram (CFE) maps.

Model – The geometric surface model which describes the size, shape, and orientation of a heart chamber in relation to the EnSite™ Array™ Catheter and including the location of the EnSite™ Array™ Catheter or EnSite™ Velocity™ surface electrodes and any EP catheter electrodes with location signals.

MRI – Magnetic Resonance Imaging.

MRI Scan – Imaging technique that uses magnetic signals rather than x-rays to provide a 3D model of the patient’s anatomy. MRI (magnetic resonance imaging) is based on the absorption and emission of radiowave pulses of energy. MRI images are used to examine cross-sections (slices) of the heart from all angles.

Navigation Accuracy – The error in navigating a catheter back to a defined location.

NavLink™ Module – Used to connect EnSite™ surface electrodes and the system reference surface electrode to the The EnSite™ Amplifier.

Negotiation – first phase of Association establishment that allows Application Entities to agree on the types of data to be exchanged and how that data will be encoded.

NFS – Network File System

Noise Filter – A notch filter that reduces powerline noise.

Non-Cardiac Triggered Maps – Maps that are created by collecting points at one second intervals.

Non-Contact Map – A map that is created with the EnSite™ Array™ Catheter.

Notebook – A feature that allows recorded data and study information to be filed and annotated for future access.

Offline Review – An operating mode in which data from a previous study is viewed and edited. The EnSite™ Amplifier does not need to be connected or powered on.

Omnidirectional Polarity – The voltage is an arithmetic combination of unipolar measurements between the source of interest, a specific electrode, and 4 or more other sources from equally spaced directions surrounding this electrode.

OneMap Tool – A tool that is used to simultaneously create a model and a map.

OneModel Tool – Default type for model creation. The OneModel tool wraps the model surface tightly around collected points without tying back to a center point and may provide enhanced anatomic detail of the cardiac model.


Orientation Reference – A torso-shaped icon in the upper right of a map that indicates the current orientation of the map by rotating as the map rotates.

Orthogonal – Intersecting or lying at right angles. The axes of scanned orthogonal images are perpendicular to each other and to the coronal (frontal), transverse (horizontal), and sagittal (medial) planes of the body.

PACS – see Picture Archiving and Communication Systems.

PDU – see Protocol Data Unit.

Picture Archiving and Communication System (PACS) – an electronic and ideally filmless information system for acquiring, sorting, transporting, storing, and electronically displaying medical images.

P-Neg – Peak Negative.

P-P – Peak-to-Peak.

Past Study – A study that was completed and recorded.

Peak-Negative (P-Neg) Voltage Map – A map that displays color-coded voltage values for each collected location (or nearest surface).

Peak-to-Peak (P-P) Voltage Map – A map that displays color-coded voltage values for each collected location (or nearest surface).

Perspective View – A feature that allows the field of view, or perspective of the model, to be changed to increase the understanding of the model, the position of the catheters and/or the identification of points of interest.

Pixel – Smallest distinguishable element of a digital image. See also voxel.

Polarity – A voltage is the difference between positive and negative poles. The polarity defines these poles.

Port Number – a numerical identifier for the data structures of the endpoints for host-to-host communications.

Positional Reference – An electrode that will remain stable during an EnSite™ NavX™ Navigation and Visualization Technology study. The displayed position of all electrodes is relative to the location of the positional reference.

Presentation Context – the set of DICOM network services used over an Association, as negotiated between Application Entities; includes Abstract Syntaxes and Transfer Syntaxes.

Presets – Store setting preferences for catheters, models, and maps.

Protocol Data Unit (PDU) – a packet (piece) of a DICOM message sent across the network. Devices must specify the maximum size packet they can receive for DICOM messages.

Proximal Electrode – Any catheter electrode other than the distal electrode.

Proximity Indicator – Represents the position of the Active Electrode. The position of the indicator is size scaled based upon the distance from the Active Electrode to the closest surface. The proximity indicator is drawn on the surface as a colored translucent spot, matching the color of the Active Electrode.

Query / Retrieve – DICOM Query/Retrieve allows for querying a database from an archive, workstation, or other device for the information it has available. It also allows for the retrieval (“pull”) of those objects, such as images.

R Value – The distance in millimeters from the center of the electrode array on the EnSite™ Array™ Catheter to the Active Electrode.

RAO – Right Anterior Oblique.

RealReview – A task in which recorded segments can be viewed.


Realtime mode – An operating mode in which data is gathered, displayed, and recorded simultaneously while a patient is being studied. Patient connections to the EnSite™ Amplifier are required, and the EnSite™ Amplifier must be powered on.

RecordConnect – RecordConnect is used to connect a recording system to the The EnSite™ Amplifier. A different RecordConnect model is required for each make of recording system.

Reference Signal – The reference signal monitors a specific voltage point, based on the detection algorithm, of a specific waveform to aid in the collection of activation data.

Render – To translate and regenerate an image. In the EnSite™ Verismo™ Segmentation Tool, heart structures are isolated from a volume of scanned images and rendered for 3D visualization.

Resolution – Minimum distance at which two adjacent objects can be distinguished as separate.

Respiration Compensation – A feature that is used to compensate for catheter movement caused by a patient's breathing.

Respiration Meter – A meter that shows the current level of respiration, as computed by the relative impedance on the EnSite™ surface electrodes.

Respiration Rejection – A feature that is used to suspend model point collection and labeling functions when the patient's respiration falls outside of a percentage of the Respiration Compensation range.

RF – Radio Frequency.

Rotational Angiography (RA) – A type of X-ray angiography where a series of images is acquired while the RA modality C-arm performs a continuous rotation around the region of interest.

Roving Activation Interval – A timing parameter that is used in the detection of roving catheter activation.

Roving Signal – The roving signal is used for sampling local activation times (relative to the timing reference signal) and voltages from various locations in the heart.

Sagittal plane – Image plane that divides the body into a right and left half. Also called medial plane.

Saturated Waveform – When a signal amplitude has reached its maximum value.

Saturation Recovery – A feature that allows for the quick recovery of signals to facilitate identification of post-therapy complexes.

SCP – see Service Class Provider.

SCU – see Service Class User.

Seed point – Reference point used by the EnSite™ Verismo™ Segmentation Tool to identify the heart structure of interest.

Segment – A recorded part of a study.

Segmentation – In digital image analysis, segmentation is the process of isolating the object of interest (foreground) from the rest of the objects in the image (background).

Service Class Provider (SCP) – role of an Application Entity that provides a DICOM network service; typically, a server that performs operations requested by another Application Entity (Service Class User). Examples: Picture Archiving and Communication System (image storage SCP, and image query/retrieve SCP), Radiology Information System (modality worklist SCP).

Service Class User (SCU) – role of an Application Entity that uses a DICOM network service; typically, a client. Examples: imaging modality (image storage SCU, and modality worklist SCU), imaging workstation (image query/retrieve SCU).


Service/Object Pair (SOP) Class – the specification of the network or media transfer (service) of a particular type of data (object); the fundamental unit of DICOM interoperability specification. Examples: Ultrasound Image Storage Service, Basic Grayscale Print Management.

Service/Object Pair (SOP) Instance – an information object; a specific occurrence of information exchanged in a SOP Class. Examples: a specific x-ray image.

Setup task – The task used to define the catheters used in a study.

SJM™ – St. Jude Medical.

SMB – Server Message Block

SM – Substrate Map.

SOP – see Service/Object Pair (SOP) Class and Service/Object Pair (SOP) Instance.

Spatial Filter – A filter that optimizes signals based on the placement of the EnSite™ Array™ Catheter.

Stabilize ABL – Stabilize ABL corrects the location of the distal electrode based on the properties of the catheter. ABL electrodes 2, 3, and 4 need to be displayed for Stabilize ABL to be enabled.

WARNING: Do not use Stabilize ABL in situations where electrodes 2, 3, or 4, on the ablation catheter, are covered by a sheath.

NOTE: If Stabilize ABL is enabled and the display of electrodes 2, 3, or 4 is turned off, Stabilize ABL is disabled and a message displays to alert the user.

NOTE: If multiple ablation catheters are setup, Stabilize ABL is applied to each catheter independently and only when appropriate.

NOTE: If Stabilize ABL is enabled for the catheter, NavX points cannot be collected.

Static Map – A map which is created by performing computations on a number of isopotential maps (e.g., an isochronal map).

Std Dev – Standard Deviation.

Storage Commitment – The DICOM storage commitment service is used by the modality or workstation to confirm that an image has been permanently stored by a device, usually a server and/or archive station, and it is safe to delete the images locally.

Study – A medical session occurring in a single day, where EP procedures are performed on a patient.

Substrate map – A map that shows relative peak-negative unipolar voltage over a user-specified beat throughout the chamber.

Surface Proximity Distance – The distance from the Active Electrode to the model or DIF surface.

Sweep Speed – The number of mm/sec in the waveform display (time scale).

Synchronous – Synchronous Storage Commitment is returned using the same DICOM association (a DICOM communication session) as the one by which the Storage Commitment request was sent (see Asynchronous).

System Reference Surface Electrode – A surface electrode that is required for proper system operation for both EnSite™ Array™ and EnSite™ NavX™ Navigation and Visualization Technology studies. The system reference surface electrode connects to the NavLink™ Module.

Tape Measure – A tool that is used to measure the distance between points on the model of the endocardial surface.

Threshold – A voltage level at which an event is detected.


Thresholding – Segmentation technique that uses intensity values to distinguish between the foreground and background objects of a digital image. The intensity threshold is chosen from a histogram of intensity values for the image.

Time Cursor – A vertical yellow line in the waveform display that indicates the time represented by the map display.

Traces – Waveforms.

Tracking Virtual – A tool that is used to locate and interpret the Peak-Negative location in the chamber of interest.

Transfer Syntax – the encoding used for exchange of DICOM information objects and messages. Examples: JPEG compressed (images), Little Endian explicit value representation.

Transverse Plane – Image plane that divides the body into upper and lower portions. The transverse plane is perpendicular to the coronal and sagittal planes. Also called horizontal plane, axial plane, or transaxial plane.

Trigger Event – The detection event plus a user selectable time offset.

Triggering – To 'phase lock' both the waveform and the map displays, providing a view of the data which is synchronized with each triggering event. Thus, when the triggering event is a heartbeat the waveforms and maps shall be repeatedly displayed, frozen at the same point in time of each heart cycle.

Unipolar Reference – The signal return path for unipolar diagnostic catheter and EnSite™ Array™ Catheter signals.

UID – see Unique Identifier.

Unique Identifier (UID) – a globally unique “dotted decimal” string that identifies a specific object or a class of objects; an ISO-8824 Object Identifier. Examples: Study Instance UID, SOP Class UID, SOP Instance UID.

Velocity Filter – A feature that prevents model point collection during rapid catheter movements.

Velocity meter – A meter that shows the relative velocity of the Active Electrode (blue bar) and the velocity threshold (purple bar).

Verismo – A software utility used to convert large volumes of sliced-based images into a manageable 3D model of anatomic structures.

Virtual Electrogram – An electrogram from a selected site on the endocardium computed from map potentials over the specified timeframe

Virtuals – See virtual electrogram.

Virtual Electrode – A simulated electrode.

Virtual Waveform – A waveform based on simulated electrodes placed on the map display.

Voltage Caliper – A tool that displays the measured potential at the distal signal of the Active Electrode.

Volume – Set of cross sectional images obtained when scanned slices are stacked in computer memory. A volume or volumetric data set is based on inter-pixel and inter-slice distances that represent a real-world volume.

Voxel – Short for volume and pixel. A voxel is a pixel with depth, thus it is the smallest distinguishable volume element of a digital image. See also pixel.

Waveform – A representation on the screen of all the data from a signal within a defined timeframe where time moves from left to right and the height of the waveform represents the amplitude of the signal.

Waveform Display – The area on the screen in which waveforms are displayed.


Z Value – The distance in millimeters of the Active Electrode above or below the equator of the electrode array on the EnSite™ Array™ Catheter.

XA – X-ray angiography images.


APPENDIX H
Index
Numerics3D Annotation

Mapping Control Panel 1773D Labels

Mapping Control Panel 1773D Lesion Marker at EnGuide 1903D Points

Mapping Control Panel 177

AABL Distal Stabilize 142ablation catheter

connecting to GenConnect 65about EnSite menu 290Add a Caliper 29Adding a Catheter to a Study 99All Roving Waves 182Amplifier Connections 47Amplitude 182, 184Anatomic Markers 149anatomic markers

description 14, 149placing 150selecting and modifying 151

animationscreating and exporting 207

AP view 144Archiving Media 211Archiving Studies 210ArrayLink

connecting the EnSite Array Catheter 67description 48

Arrow 29Auto Color

Mapping Control Panel 178auto segment 137AutoFocus

feature description 13methodology 164settings 165using to adjust color levels 164

Avenview Video Extender 54

BBad Dircos 291barrier 277, 279, 283Barrier - segmentation tool 275Best Duplicate 33best practices and recommendations

compatible components 22operating environment 22power source 22

bookmarkssaving 44

boundary emphasis 275, 277, 279, 280, 281

Ccables

icons on connectors 57inspection and damage 19

caliperscreating 135Reference Activation Caliper 180Roving Activation Caliper 181using 135Voltage High Caliper 181Voltage Low Caliper 181

Cancel - segmentation tool 275Cardiac Triggered Mapping Settings 176cardiac triggered maps 172Cardiac Triggered Reference

Mapping Control Panel 176Catheter Catalog

adding a catheter 103deleting a catheter 103description 12, 102sorting 103

Catheter Input Settings 102Catheter Preset

Deleting or Renaming a Catheter Preset. 104Loading 104

catheter presetsdeleting 104description 103loading 104renaming 104saving 104

Catheter Signal Settings 101catheters

adding to a study 99loading a preset 101manually defining 100selecting from the catheter catalog 100settings 102verifying catheter stability 155

CathLinkdescription 49

cautions 19CD/DVD drive

304 Index EnSite™ Velocity™ Cardiac Mapping System Instructions for UseARTEN100151580 Rev. A

using 205CFE mean maps 172chamber 279Chamber - segmentation tool 275Cleanup Display 29clear segmentation result 272Clinical Menu 89Clipping Plane

description 12clipping plane

description 140clock

setting 228collect log files 290Collect Points 125Collected point buffer 181Collecting Respiration Data 114Collecting Surface Points 125Color 189color 276Color bar 180color bar

adjusting manually 164adjusting using AutoFocus 164interpreting 163

Color Contour 141comments 287Common Interface Elements 32Compatible Components 23Compatible Modules 23components

recommendations 22Connections

ArrayLink™ Module 48Auxiliary Unipolar Reference 68Auxiliary unipolar reference 68Avenview Video Extender 54CathLink™ Module 49Diagnostic Catheters 66ECG Surface Electrodes 62EnSite™ Amplifier 57EnSite™ Array™ Catheter 67GenConnect 51NavLink™ Module 48Opticis Video Extender 52RecordConnect 50Remote Monitor 52RF Ablation Catheter and Generator 65SJM ECG Cable 49Surface Electrodes 59System Reference Surface Electrode 58

contiguous 3D 284contour viewer 287Contraindications

Verismo 266Controls 27create barrier 283Current Map Type

Mapping Control Panel 176

DDashed line 183Data

export 208Waveform 208

data

export 12storage 12

data modulevalidating 96

Delayed Enhancement Magnetic Resonance Imaging (DEMRI) 12Delete 184

Verismo 275Delete All

Verismo 275Delete Group 184Delete Hidden Points 184Delete last 184Delete Unused Points 184Delete Unused Points. 184Deleting a Catheter from the Catheter Catalog 103DEMRI (Delayed Enhancement MRI) 12DEMRI (Delayed Enhancement MRI) Image Integration 132Diameter 189DICOM conformance 266digital image

importing 130Digital Image Fusion (DIF) 130

displaying DIF models 131feature description 12

Digital Image Infusion map (DIF Map) 12Directory Name 208disk handling 21display 276Display Settings 29Display Workstation (DWS) 15Dual View 35Duplicate Points 183

EECG

setting signal parameters 95troubleshooting 222

ECG Cablecable connections 49description, system components 15

ECG surface electrodesconnecting 62

Edit Points 126Electrode Polarity 183Enable and Baseline the Catheter 105ending a study 203EnGuide

Alignment 116Catheter Silhouette 142color navigation indicators 121display settings 142interpreting R value and Z value 120proximity indicator 120Responsiveness 142surface proximity distance 120

EnGuide Displays 29EnGuide Navigation Indicators 121EnGuide Navigation System 119EnGuide Responsiveness 120EnGuide Shadow 29EnGuide Shadows

placing 153selecting and modifying 154

EnSite Amplifierconnecting cables to 57connecting the fiber-optic cable 51

Index 305EnSite™ Velocity™ Cardiac Mapping System Instructions for UseARTEN100151580 Rev. A

description 47powering on 85

EnSite Arrayfly-eye display 107

EnSite Array Catheterconnecting to ArrayLink 67

EnSite Array Kitdescription 16

EnSite Surface Electrodesconnecting to NavLink 61positioning on patient 59

EnSite™ Amplifier 15EnSite™ Array™ Catheter Setup 107EnSite™ Cardiac Mapping System

Diagram 17EnSite™ NavX™ Navigation and Visualization Technology Study withoutRecordConnect 76EnSite™ NavX™ Navigation and Visualization Technology, Sensor En-abled™ Setup 109Environmental conditions 242EP catheter setup 97export

data 12Verismo models to DVD/CD 287

Export Interval Options 208Export to USB fails 205Exporting 209Exporting Data to External Devices 205

Ffiber-optic cable

connecting to the EnSite Amplifier 51Field Scaling 12, 129field scaling

applying 129filtering 270filters

highpass 117lowpass 117noise 117spatial 117

First Deflection 12Flash New Points

Mapping Control Panel 177fly-eye display

description 107font size 285, 286Fractionation Threshold

Mapping Control Panel 176Freeze

display button 181

GGantryTilt 291GenConnect

connecting an ablation catheter 65description 51

global virtualsusing to locate focal activation 162

Gray Scale 139growth limit 280

Hhard drive

out of space, troubleshooting 221Head

Interpreting Isopotential Color 163Hide point checkbox 183highpass filter

description 117Home 181, 183Hot key

184

Iimages

saving and accessing 206Imported DEMRI Image 132Importing Studies 212Indications for Use

EnSite Cardiac Mapping System 11EnSite Derexi 257EnSite Fusion 247EnSite Verismo 265

information display settings 143Interior Projection

Mapping Control Panel 177Interpolation

Mapping Control Panel 177Interpreting Isopotential Color 163IRREGULAR_SPACING 291Isochronal Mapping 169Isochronal maps

creating 170description 159LAT 172methodology 169Single-Beat 13

Isopotential mapsdescription 159interpreting 160

LLabel 29Label - segmentation tool 275Label Colors 149labels

description 147placing 147

LAO view 144Laplacian 161Laplacian bipole

polarity type 161Last Deflection 12Last Duplicate 33LAT maps 172Lesion 29Lesion at EnGuide 190Lesion control panel 193Lesion List 190Lesion list 192Lesion Marker Tool 189Lesion Markers 190lesions

control panel 193description 190list 192placing 191selecting and modifying 192


LicensesInstalling 232

load work in progress 272, 288local region grow 277lock, a structure, Verismo 276log files 290

collecting and exporting 215Logging In 87lowpass filter

description 117Low-V ID

Mapping Control Panel 176Low-VID 12

MMagnifying Glass 29Main Workspace Elements 26maintenance

customer-performed 229Field Service Representative Performed 231

Managing Positional Reference Catheter Dislodgement 113manual segmentation 282map clipping 140map color

interpreting 160Map Display

Mapping Control Panel 176map display menu 141Map Name

Mapping Control Panel 176Map point measurement 184Map Settings Properties 141Mapping Control Panel Settings 33Maps

Placing a Map Label 147Translucence 146

mapspanning 31zooming 31

Maps -- Centering 146Maps -- Synchronize Dualviews 146maps (contact)

cardiac triggered maps 172CFE mean maps 172CFE standard deviation maps 172collecting points 180, 186control panel 176controlling the display 188creating 186LAT maps 172managing 188non-cardiac triggered maps 172P-Neg voltage maps 172points display 183P-P voltage maps 172propagation maps 175reentrant maps 175reference signal 173roving signal 173types of maps 172waveform shadows 182

maps (noncontact)Isochronal maps 159Isopotential maps 159, 160Substrate maps 159, 166types 159

max threshold 277, 279, 280measure

distance 286segmentation tool 275

measuring volumes 286Menu Bar

EnSite Cardiac Mapping System 27menu bar 272Messages

System 42Meter Displays 29min threshold 277, 279, 280model

creating multiple surfaces 125presets 122using the surface list 128viewer window, Verismo 287

Model Control Panel 124Model Presets 122monitors

connecting the remote monitor to the workstation 52description 15

mouseusing 30

moving points on a model 126MultiPoint Technology 12

Nnavigation

warnings and cautions 20NavLink

connecting a system reference surface electrode 58connecting a unipolar reference 68connecting EnSite surface electrodes 59description 48

NavLink™ Module 15Network File System (NFS) versions prior to NFSv3 205new study

existing patient 92new patient 91operation overview 79preparing for 73

noisereducing 222

noise filterdescription 117

noise floorSee upper limit

Non-Cardiac Triggered CFE Maps 174Non-Cardiac Triggered Mapping Settings 179NOT_3D 291Notebook 43Number of points 184

OOneMap

control panel 185description 185

OneModel Tool 127operating environment

recommendations 22operator 287Opticis Video Extender 52orientation reference

displaying 144


owner informationsetting 228

Ppan 273Panning 184panning maps 31password 87Past Studies 93past study

reviewing 198patient records

creating 91managing 200modifying 200removing 201searching for 200

patient safety requirements 19pattern

types for virtual electrodes 161perspective view 146playing recorded segments 138P-Neg voltage maps 172Points 181Points display 183Points list 181Points/Labels

Mapping Control Panel 177polarity

types for virtual waveforms 161Positional Reference Catheter Dislodgement 112Positional Reference Tool 109power source

recommendations 22specifications 241

powerline frequencysetting 228

P-P voltage maps 172Preparing for a Study 73Preparing for an EnSite™ Array™ Catheter Study 79Presets

Export 209Export configuration 209Load, Save 45

presetsmodel 122

printVerismo menu bar 272Verismo options 290

progress bar 269, 271Project Map to

Mapping Control Panel 176propagate 282propagation maps 175Properties 190proximity indicator 120proximity to surface 143

RR value 120RAI Curtain 180RAO view 144RealReview task

annotations 196bookmark 196

images 196lists and controls 196screen 195

Realtime mode 25Reassign - segmentation tool 275Reassign Tool, Verismo 284reassigning points on a model 126RecordConnect

description 50recording

feature description 14recording segments 137Recording System 69recording system

using 69Redo

Verismo 275reentrant maps 175Reference Activation Caliper 180Reference Offset Caliper 181Reference Shadows 182reference signal

detection algorithm 173setting 173

Refractory 174Refractory slider (CFE maps only) 179region grow 277Region Grow - segmentation tool 275remote monitor

connecting to the workstation 52Remote Monitor Configuration Tool 56Replacement Parts 231Respiration Compensation 114respiration compensation

collecting 114definition 114feature description 13respiration meter 116respiration rejection 115

Respiration Gating 122respiration meter 13

description 116respiration rejection 13

description 115resuming a study 93review speed

adjusting 138reviewing past studies 198RF filtering

description 13Rot### 291Rotate/Pan 29rotating 274roving activation interval

description 180Roving Activation Tic Mark 181Roving Shadows 182roving signal

detection algorithm 173setting 173

run external program 215

SSaturation Recovery 116saturation recovery

description 13, 116


setting the controls 116Save

data after freeze 181save work in progress 272, 288Saving

Catheter Preset 104saving

key points 287Scope 181, 183Screen Layout

Controls 38Presets 39

Segment Length slider (CFE maps only) 179segmentation interface 271segments

accessing 138automatically recorded 137playing 138recording 137

Selecting a LanguageKeyboard 86Screen 86

Selecting an Area for Capture 205Selecting and Modifying Labels 148separator 281Separator - segmentation tool 275series 269service

contacting technical support 227Services Menu 90Setting Up the Positional Reference Tool 111settings

EnGuide display 142information display 143map properties 141, 254

Sheath Filter Setup 105Show Mapping Metric

Mapping Control Panel 178Show Selected Points Only

Mapping Control Panel 177Show Torso 146shutting down

end of study procedure 203Signal Filters 117SJM Connect 216

Connect Window 216description 216File Browser 218Proxy configuration 219Technical Support Chat Window 217Updoading Studies 218Uploading Logs 218Using 216

slice view 269, 271Software Inventory Screen 238Solid, bold with blue background 184Sort 183Sort Options

collected map points 14Sorting the Catheter Catalog 103Sparkle Map

description 14SparkleMap

view activation sequence 175spatial filter

description 117

Split Screen 36Stabilize ABL 14Starting a New Study

Existing Patient 92New Patient 91

Starting the System 85stop button

using 137storage

data 12structure

list 276name 276

structure listSegmentation Interface 271

studyending 203

study recordsdeleting a study 201managing 201modifying 201

Substrate MapCreating 168

Substrate Mapping 166Substrate maps

absolute 167creating 166description 159global 167

Surface Electrode Placement 60Surface Electrode Placement Order 61Surface Electrodes 16Surface Points

Mapping Control Panel 177surface proximity distance 120Sweep Speed 182synchronizing viewports 146system

components 15description 11features 12moving 232starting 85

system diagram 17system reference surface electrode

description 16

TTape Measure 29tape measures

description 13, 156measuring distance, Verismo 286placing 157selecting and modifying 158

technical specifications 241Technical support

Contacting 215templates 274The Surface List 128Therapy Display 190Therapy task 189thresholding 275time cursor

adjusting 133using in review 138

Time Interval 181


Time scale 180, 183Timing Caliper 181Timing caliper 184Title Screen 87, 88To place a lesion marker

191Torso Rotate 31trace 282Trace - segmentation tool 275traces

displaying and filtering 135Translucence 146troubleshooting 290

common problems 220contacting technical support 215EnGuide Stability Problems 223on-screen messages 225patient signal problems 222print 221software interface problems 224system hardware problems 220tools 215troubleshooting guide 215

TurboMap 14

Uundefined 276Undo

Verismo 275Unipole Waves 182Unsupported orientation 291usability indicator 291USB device FAT32 file systems 205Use Best Duplicate

Mapping Control Panel 177Use Last Duplicate

Mapping Control Panel 177username 87

VValidation 96validation

description 96Valleylab™ Single Use Patient Return Electrode 16velocity filter 121Velocity Meter 121velocity meter 121Verifying ECG Signal Quality 96Verismo file cleanup 291vessel 280Vessel - segmentation tool 275video extender

description 15viewports

synchronizing 146views

creating and saving 145Views and Orientation Reference 144virtual electrodes

number of and pattern 161Virtual Waveforms 161

Placing 162Using the Tracking Virtual 166

virtual waveformsfeature description 13

Virtuals 29Voltage High Caliper 181Voltage Low Caliper 181volume, selecting 269

WW/L 274Warnings and Precautions

EnSite Cardiac Mapping System 19Verismo 266

warranty 240Waveform Display 29Waveform number 183waveform traces

description 14waveforms

adjusting amplitude 134basic controls 134display features 133indicators 184mouse controls for 134moving 31rearranging traces 134removing from display 31, 134selecting 31shadows 182traces turn purple 133

Width 174, 177Width slider (CFE maps only) 179Window/Level 274Workspace

EnSite Cardiac Mapping System 26workstation

powering on 85unexpected shutdown 221

ZZ value 120zoom 273zooming maps 31


EnSite™ Velocity™ Cardiac INSTRUCTIONS USE …/media/manuals/product-manual-pdfs/7/7/...On the EnSiteTM Amplifier: ECG or RecordConnect ECG cable connector On the EnSiteTM Amplifier:

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