EnSite Precision Cardiac Mapping System EE3000 Instructions for Use SW ver 2.2

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

2

Symbol

Description

21” Monitor

21” Monitor

24” Monitor

24” Monitor

Symbol

Description Cable Accessory Kit

Cable from RecordConnect to EnSiteTM Amplifier

Ablation Cable Kit, EPT

Cable to Clearsign™ Amplifier

Ablation Cable Kit, IBI, T9 Cable to Bard™ Stamp Amplifier

Ablation Cable Kit, Stockert Ablation Cable Kit, JLL

Cable to GE-Cardiolab™ recording system

Ablation catheter cable connector

Cable to St. Jude Medical EPWorkmate™ recording system Cardiac Mapping System

Ablation catheter cable connector AC Power

Catalog Number

Adapter Assembly, ECG/NavX Catheter Amplifier Network Connection Catheter Catalog Installation Amp and Chassis

Amplifier

Amplifier Accessory Kit

Amp and Chassis Catheter Impedance Checker Amplifier

Amplifier Accessory Kit Amplifier and Display Workstation

Amplifier Cart

Amplifier Cart

Amplifier Kit

Amplifier Kit

CIM Certificate

CIM

Catheter Input Module (for the recording system in use)

Catheter Input Module Cable Connector

Catheter Input Module Cable Connector

Bedrail Mount Kit

Catheter Input Module Cable Connector

Bedrail Clamp Catheter Input Module Cable Connector Authorized representative in the European community Auxiliary Reference Cable Connector

Catheter Interface Module cable connection for catheter inputs 1-56

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

Symbol

Description

3

Symbol

Description Display Workstation

Catheter Interface Module cable connection for catheter inputs 57-120

Display Workstation Kit Affixed to this device in accordance with European Council Directives 2012/19/EU and 2006/66/EC. These directives call for separate collection and disposal of electrical and electronic equipment and batteries. Sorting such waste and removing it from other forms of waste lessens the contribution of potentially toxic substances into municipal disposal systems and into the larger ecosystem.

Caution

Warning

Class II equipment

Do not reuse

Consult Instructions for Use

Contents

Do not use if package is damaged

Data Module Connector

DWS Hard Disk Drive DWS Kit

Data Network Connection DWS Velocity v. 2.0 Date of Manufacture

DWS Velocity v. 2.1 DWS Velocity v. 3.0.1.1

Defibrillator-proof Type BF applied part ECG cable connector Defibrillator-proof Type CF Applied Part ECG or RecordConnect ECG Cable Connector Dispersive Patch Cable Connector ECG Surface Electrode

Dispersive Patch Cable Connector

ELDI Field Upgrade Kit

ELDI Field Upgrade Kit

Dispersive Patch Cable Connector EnSiteTM ArrayTM Catheter cable connector Dispersive Patch Cable Connector

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

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Symbol

EnSiteTM VelocityTM Amplifier

Equipotential Cable

Description

Symbol

EnSiteTM VelocityTM Cardiac Mapping System Amplifier

Description

Humidity Limitation

Equipotential Cable Includes Equipotential jack Input Voltage, Input Frequency and Replacement fuse information Consult Instructions for Use on Website

Interface between Biosense Webster Stockert ablation generator and the EnSiteTM Amplifier Interface between diagnostic catheters and the EnSiteTM Amplifier

Intertek Safety Agency Certification

Interface between EnSite™ surface electrodes / system reference and the EnSiteTM Amplifier European Customer Service

European Customer Service

Interface between EnSiteTM VelocityTM Cardiac Mapping System EnSiteTM ArrayTM catheter / data module and the EnSiteTM Amplifier

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

Interface between EPT ablation generator and the EnSiteTM Amplifier Follow Instructions For Use Interface between manufacturerspecific generators and the EnSiteTM Amplifier

For Use With

Interface between manufacturerspecific recording systems and the EnSiteTM Amplifier

Fragile

Interface between Medtronic Atakr™ ablation generator and the EnSiteTM Amplifier

Fragile

Interface between Siemens AXIOM™ Sensis™ XP recording system and the EnSiteTM Amplifier

Fuse

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

GenConnect

GenConnect Cable Connector, to EnSiteTM Amplifier

Hardware HN

Hospital Network Connection

Intl Power Kit

International Power Kit

Intl Rail Clamp

International Rail Clamp

Keep Dry

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

Symbol

Description

Keep Dry

Kit

5

Symbol

Description Confirmité Européenne (European Conformity). Affixed in accordance with European Council Directive 93/42/EEC and 2011/65/EU. Hereby, St. Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive.

Kit, WetLab

Laptop Review Station

Laptop Review Station Link Local Monitor Connection

Lot number

Made in U.S.A.

Confirmité Européenne (European Conformity). Affixed in accordance with European Council Directive 93/42/EEC (NB 0086) and 2011/65/EU. Hereby, St. Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive. On ArrayLink™ cable: ArrayLink™ cable connector or CathLink™, or RecordConnect catheter channels 65 to 128 cable connector

Made in U.S.A. On ArrayLink™ cable: ArrayLink™ Data Module cable connector Manufactured By

Medical Electrical Equipment

MODEL

Model Number

Module

Monitor Arm

Monitor Arm

Monitor

24-inch Monitor Mounting Kit

Multi-electrode Diagnostic Catheter

Multi-electrode Diagnostic Catheter

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

Non Sterile

Link

Not for direct patient contact

On the EnSiteTM Amplifier: Fiber optic Cable Connector

On the EnSiteTM Amplifier: GenConnect cable connector

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

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Symbol

Description

Symbol

Description Research Workstation

On the EnSiteTM Amplifier: NavLink™ Module cable connector

RF Filter On GenConnect: GenConnect cable connector

RF Filter Trap for Stockert

On NavLink™ Module: NavLink™ Module cable connector

Serial Number

Small Surface Electrode Kit

Small Surface Electrode Kit

Operating Temperature Software Power Plug Software Installation Power Switch Software Upgrade Kit

Printed Circuit Assembly

Printer

Standby Power

Printer

Atmospheric Pressure Limits

Software Upgrade Kit

Status

STERILE EO

Surface Electrode Kit

Sterilized Using Ethylene Oxide

Surface Electrode Kit

Quantity System Reference Patch Connector

Training Media

Quantity

Universal RecordConnect RecordConnect US Customer Service

US Customer Service

US Power Kit

US Power Kit

US Rail Clamp

US Rail Clamp

Recorder Interconnect Kit, EPMED V5.0

Catalog number

Remote Monitor Connection Use By Date Remote Monitor Stand

Remote Monitor Stand Utility Upgrade Kit Research Switch

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

Symbol

Description

Weight

Workstation

Workstation

Workstation Accessory Kit

Workstation Accessory Kit

Workstation Cart

Workstation Cart

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EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

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Table of Contents

Chapter 1. Introduction 13 Indications for Use 13 System Description 13 Key System Features 14 System Components 17 EnSite™ Amplifier 17 Display Workstation (DWS) 17 Components Not Included 18 EnSite™ Cardiac Mapping System Diagram 19 Typical EnSite™ Velocity™ Cardiac Mapping System Lab Setup 19 20 Signal and Power Connections 20 Warnings and Cautions 21 Best Practices and Recommendations 24

Chapter 2. Using the Graphical User Interface 27 Operating Modes 27 Main Workspace 28 Common Controls 29 Menu Bar 29 Tool Palette 31 Using the Mouse 32 Common Interface Elements 34 Mapping Control Panel Settings 35 Dual View 37 Split Screen 38 Screen Layout Controls 40 Screen Layout Presets 41 System Messages 44 Information Message 44 Advisory Message 44 System Busy Message 44 Warning Message 44 Notebook 45 Saving an Event 46 Saving a Bookmark 46 Presets 47 Load a preset 47 Save a preset 47

Chapter 3. External Connections 49 EnSite™ Amplifier Connections 49 NavLink™ Module Connections 50 ArrayLink™ Module Connections 50 CathLink™ Module Connections 51 SJM™ ECG Cable Connections 51 RecordConnect Connections 52 GenConnect Connections 53 Connecting the EnSite™ Amplifier to the DWS 53

Connecting the Local Monitor to the DWS 53 Connecting the Remote Monitor to the DWS 54 Opticis Video Extender 54 Avenview Video Extender 56 Using the Remote Monitor Configuration Tool 58 Connecting Cables to the EnSite™ Amplifier 59 Color-Coded Connections 59 Connecting a System Reference Surface Electrode 60 Connecting EnSite™ Surface Electrodes 61 Surface Electrode Description 61 Placement Considerations 61 Surface Electrode Placement 62 Connecting ECG Surface Electrodes 64 Connecting ECG Surface Electrodes When Using a RecordConnect 65 Connecting ECG Surface Electrodes When Not Using a RecordConnect 66 Connecting an RF Ablation Catheter and Generator 67 Connecting Diagnostic Catheters 68 Connecting the EnSite™ Array™ Catheter 69 Connecting an Auxiliary Unipolar Reference 70 Using a Recording System 71 Connecting Diagnostic Catheters When Using a RecordConnect 72 Connecting Diagnostic Catheters When Not Using a RecordConnect 73

Chapter 4. Preparing for a Study 75 Preparing for an EnSite™ NavX™ Navigation and Visualization Technology Study 75 EnSite™ NavX™ Navigation and Visualization Technology Study with RecordConnect 75 EnSite™ NavX™ Navigation and Visualization Technology Study without RecordConnect 78 Preparing for an EnSite™ Array™ Catheter Study 81 EnSite™ Array™ Catheter Study with RecordConnect 81 EnSite™ Array™ Catheter Study without RecordConnect 84

Chapter 5. Starting a Study 87 Starting the System 87 Keyboard and Screen Languages 88 Selecting a Keyboard Language 88 Selecting a Screen Language 88 Logging In 89 Title Screen 89 Getting Started 90 Starting a New Study 93 New Patient 93 Existing Patient 94 Past Studies 95

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Table of Contents

Resuming a Study 95

Chapter 6. Setup 97 Checking ECG Signals 97 Verifying ECG Signal Quality 98 Validation 98 EP Catheter Setup 99 Adding a Catheter to a Study 101 Catheter Signal Settings 103 Catheter Input Settings 104 Catheter Catalog 104 Adding a Catheter to the Catheter Catalog 105 Sorting the Catheter Catalog 105 Deleting a Catheter from the Catheter Catalog 105 Catheter Presets 105 Loading a Catheter Preset 106 Saving a Catheter Preset 106 Deleting or Renaming a Catheter Preset 106 Sheath Filter Setup 107 Description 107 Enable and Baseline the Catheter 107 EnSite™ Array™ Catheter Setup 109 EnSite™ NavX™ Navigation and Visualization Technology Setup 111 Positional Reference Tool 111 Setting Up the Positional Reference Tool 113 Positional Reference Catheter Dislodgement 114 Respiration Compensation 116 Collecting Respiration Data 116 Respiration Rejection 117 Respiration Meter 118 EnGuide Alignment 118 Saturation Recovery 118 Signal Filters 119

Chapter 7. Model 121 The EnGuide Navigation System 121 Setting up EnGuide Navigation 121 EnGuide Navigation Indicators 123 Modeling 125 Model Presets 125 Loading a Model Preset 125 Saving a New Model Preset 126 Deleting or Renaming a Model Preset 126 Model Control Panel 127 Color Chart and Visibility Selector 128 Collecting Surface Points 128 Collect Points 128 Edit Points 129 OneModel Tool 130 Using the Surface List 131 Field Scaling 132 EnSite™ NavX™ Navigation and Visualization Technology Field Scaling (NavX) 132 Digital Image Fusion (DIF) 133 Creating a Model to Import 133 Importing a Digital Image 133 Additional Options for DIF Files 134 Viewing a DIF Image for Reference 134 DEMRI (Delayed Enhancement MRI) Image Integration 135

Chapter 8. Waveforms 137 Using the Waveform Display 137 Selecting and Adjusting Waveforms 138 Displaying and Filtering Traces 139

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

Calipers 139 How to Create a Caliper 139 Using Calipers 139

Chapter 9. Recording and Playing Segments 141 Recording Segments 141 Automatically Recorded Segments 141 Accessing Recorded Segments 142 Playing Recorded Segments 142

Chapter 10. Adjusting and Labeling Maps 143 Map Settings Properties 145 EnGuide Display Settings 146 Information Display Settings 147 Views and the Orientation Reference 148 Orientation Toolbar 148 Creating and Saving Map Views 149 Additional Map Controls 150 Labels 151 Placing a Map Label 151 Selecting and Modifying Labels 152 Label Colors 153 Anatomic Markers 153 Placing Anatomic Markers 154 Selecting and Modifying Anatomic Markers 155 EnGuide Shadows 156 Placing EnGuide Shadows 157 Selecting and Modifying EnGuide Shadows 158 Verifying Catheter Stability 159 Tape Measures 160 Placing a Tape Measure 161 Selecting and Modifying Tape Measures 162

Chapter 11. Mapping – Noncontact 163 Types of Noncontact Maps 163 Interpreting Isopotential Maps 164 Virtuals 165 Setting Virtual Waveform Parameters 165 Placing Virtuals 166 Using Global Virtuals 166 Interpreting Isopotential Color 167 Using Manual Color Controls 168 Using AutoFocus Color Controls 168 Using the Tracking Virtual 170 Substrate Mapping 170 Creating a Substrate Map 172 Isochronal Mapping 173 Creating an Isochronal Map 174

Chapter 12. Mapping – Contact 175 Types of Contact Maps 176 Cardiac Triggered Maps 176 Non-Cardiac Triggered Maps 176 Signals Collection 177 Reference Signal Source 177 Roving Signal Source 177 Detection Algorithm 177 Additional Signals 178 Considerations 178 Non-Cardiac Triggered CFE Maps 178 Reentrant Maps 179 Propagation Maps 179 SparkleMap 179 Mapping Control Panel 180 Cardiac Triggered Mapping Settings 180

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

Non-Cardiac Triggered Mapping Settings 183 Collecting Points 184 Points Display 187 The OneMap Tool 189 Creating a Map 190 Setting up a New Map 190 Collecting Points 190 To Map from a Segment 191 Managing Maps 192 Mapping Controls 192

Chapter 13. Therapy 193 Lesion Markers 194 Placing Lesion Markers 195 Selecting and Modifying Lesion Markers 196 Lesion Control Panel 197

Chapter 14. RealReview 199 Reviewing Segments 200 Reviewing Bookmarks 200 Reviewing Images 200 Reviewing Annotations 200

Chapter 15. Reviewing and Editing Past Studies 201 Past Studies 201 Reviewing Past Studies 202 Editing Past Studies 202 Offline Review 203 Offline Review – Model 203 Offline Review – Mapping 204 Offline Review – Therapy 204 Offline Review – Review 204 Managing Patient and Study Records 204 Searching for Patient Records 204 Modifying Patient Information 204 Removing Patient Records 205 Modifying Study Records 205 Deleting Studies 205

Chapter 16. Ending a Study 207

Table of Contents

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Troubleshooting Tools 219 Using SJM™ Connect 220 If You Need SJM Technical Support 220 Sending Files with SJM™ Connect 221 Uploading Logs with SJM™ Connect 222 Uploading Studies 222 Proxy Configuration 223 Notifying SJM 223 Troubleshooting Common Problems 224 System Hardware Problems 224 Patient Signal Problems 226 EnGuide Stability Problems 227 Software Interface Problems 228

Appendix B. Care and Service 231 Service and Technical Support 231 Setting Environmental Information 232 Setting the System Clock 232 Setting the Powerline Frequency 232 Setting the Owner Information 232 Customer-Performed Maintenance 233 EnSite™ Amplifier 233 EnSite™ Velocity™ System DWS 234 Field Service Representative Performed Maintenance 235 Replacement Parts 235 Moving the System 236 Installing EnSite™ Cardiac Mapping System Software Licenses 236 Preparing to Install 236 Retrieve License(s) and Create Media 237 Verify the Contents of a License File 240 Install Licenses 241 Verify Installed Licenses 241 Re-Creating Licenses 242 Manage Licenses 243 Installation Report 243 Base license has not been installed 243 Installing a base license 244 Warranty Policy 244 General Notices 244 Australian Warranty 244

Ending a Study 207

Appendix C. Technical Specifications 247 Chapter 17. Capturing, Exporting, and Importing Information 209 Exporting Data to External Devices 209 Selecting an Area for Capture 209 Saving and Accessing Individual Images 210 Saving an Image 210 Accessing an Image 210 Creating Animations 211 Creating an MPEG movie 211 Creating a JPEG image sequence 211 Data Export 212 Waveform Data 212 Directory Name 212 Export Interval Options 212 Exporting 213 Presets 213 Archiving Studies 214 Archiving Media 215 Importing Studies 216

Appendix A. Troubleshooting 219 Contacting Technical Support 219

Specifications 247 Electromagnetic Emissions – Declaration 249

Appendix D. EnSite™ Derexi™ Module 253 Indications for Use 253 Introduction 253 Minimum System Requirements 253 EnSite™ Cardiac Mapping System / EP-WorkMate™ System Signal Connections 254 Connecting to the EnSite™ Cardiac Mapping System 255 HP xw6400 255 HP xw6400 or HP Z600 255 Connection States 256 Maps and Integration 257 Number of Maps / Map Points 257 Map Point Analysis 257 Mapping Constraints 257 Patient Connections 257 Dual System Start-up Procedure using the EnSite™ Derexi™ Module 258 Interface Features & Descriptions 259 EP-WorkMate™ Recording System Mapping Controls 260

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Table of Contents

Appendix E. EnSite™ Verismo™ Segmentation Tool Module 261 Indications for Use 261 Description 261 Contraindications 262 Warnings and Precautions 262 Operator Requirements 262 System Requirements and Considerations 262 Overview of Segmentation 262 Optimal Characteristics for the EnSite™ Verismo™ Segmentation Tool Image Files 263 Loading Files for Segmentation 264 Starting the EnSite™ Verismo™ Segmentation Tool 264 Verismo Cleanup 264 Loading DICOM Files 264 Using DICOM Files from Saved Data 264 Using the Wizard 265 Introduction to the Patient Screen 265 Selecting a Series for Segmentation 265 Viewing Options 266 Subregioning the Series 266 Loading the Series for Segmentation 266 Using the Segmentation Interface 267 Introduction to the Segmentation Screen 267 Menu Bar Summary 268 Using Basic Interface Controls 268 Navigating in Slice Views 269 Using the Zoom Control 269 Using the Pan Control 269 Using the Intensity (W/L) Controls 270 Rotating the 3D Model 270 Using Templates 270 Performing Segmentation 271 Overview of Segmentation Tools 271 Additional Controls: Delete, Undo, Cancel 271 Using the Structure List 272 Structure Attributes 272 Modifying Structures 272 Using the Region Grow Tool 273 Using the Chamber Tool 275 Using the Vessel Tool 276 Using the Separator Tool 277 Using the Trace Tool 278 Using Trace in a Slice View 278 Using Trace in the 3D View 278 Using the Barrier Tool 279 Using the Reassign Tool 280 Reassigning a Structure 280 Placing Labels 281 Using the Measurement Tools 281 Measuring Distances 282 Measuring Volumes 282 Saving and Exporting 283 Key Points About Saving Models 283 Saving the Model to the Hard Drive 283 Exporting Models to CD or DVD 283 Saving Work in Progress 284 Reviewing the Final Model 284 Using the DIF Viewer 284 Viewing Segmentation Contours 285 Printing Images 286 Troubleshooting 286 Contacting Technical Support 286 Troubleshooting Tools 286 Troubleshooting Common Problems 287

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

Appendix F. EnSite™ Fusion™ Registration Module 289 Indications for Use 289 Warnings, Cautions, and Disclaimers 289 Introduction 289 Performing Registration 290 Importing a DIF Model 290 Scaling the EnSite™ NavX™ Navigation and Visualization Technology Navigation Field 291 Placing Fiducial Point Pairs 292 Display Options 295 The EnSite™ Fusion™ Registration Module Control Panel Display Options 295 Map Settings Menu 296

Appendix G. Glossary 299 Appendix H. Index 309

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

Introduction

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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 for use in electrophysiology studies to aid the electrophysiologist in diagnosing cardiac arrhythmia. 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 13) 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 threedimensional 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).

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Chapter 1. Introduction Key System Features

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

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 135. 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.

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

Chapter 1. Introduction Key System Features

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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).

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Chapter 1. Introduction Key System Features

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

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.

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

Chapter 1. Introduction System Components

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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 EnSite™ 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.

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Chapter 1. Introduction System Components

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

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 Covidien™ Valleylab™ Non-REM Polyhesive™ Patient Return Electrodes (see below).

Figure 2. Covidien™ Valleylab™ Non-REM Polyhesive™ 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™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

Chapter 1. Introduction EnSite™ Cardiac Mapping System Diagram

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).

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Chapter 1. Introduction EnSite™ Cardiac Mapping System Diagram

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN600035011 A

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.