EnSite Velocity Cardiac Mapping System EE3000 Instructions for Use Sw Rel 2.2 June 2018

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

2

Symbol

Description

21” Monitor

21” Monitor

24” Monitor

24” Monitor

Symbol

Description Auxiliary Reference Cable Connector Cable Accessory Kit

Cable from RecordConnect to EnSiteTM Amplifier

Ablation Cable Kit, EPT Ablation Cable Kit, IBI, T9

Cable to Clearsign™ Amplifier Ablation Cable Kit, Stockert Ablation Cable Kit, JLL

Cable to Bard™ Stamp Amplifier

Ablation catheter cable connector

Cable to GE-Cardiolab™ recording system Cable to St. Jude Medical EPWorkmate™ recording system

Ablation catheter cable connector

Cardiac Mapping System

ACT

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

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

Symbol

Description

3

Symbol

Description

Dispersive Patch Cable Connector

Catheter Interface Module cable connection for catheter inputs 1-56

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 Do not use if package is damaged Contents DWS Hard Disk Drive Data Module Connector DWS Kit Data Network Connection ECG cable connector Date of Manufacture ECG or RecordConnect ECG Cable Connector Defibrillator-proof Type BF applied part ECG Surface Electrode

Defibrillator-proof Type CF Applied Part

ELDI Field Upgrade Kit

ELDI Field Upgrade Kit

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

Dispersive Patch Cable Connector

EnSiteTM VelocityTM Amplifier

EnSiteTM VelocityTM Cardiac Mapping System Amplifier

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

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Symbol

Equipotential Cable

Description

Symbol

Description Hardware

Equipotential Cable

HN Equipotential jack Hospital Network Connection

Consult Instructions for Use on Website

Humidity Limitation

Includes

Intertek Safety Agency Certification

European Customer Service

Input Voltage, Input Frequency and Replacement fuse information

European Customer Service

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

Interface between Biosense Webster Stockert ablation generator and the EnSiteTM Amplifier

EXP

Interface between diagnostic catheters and the EnSiteTM Amplifier

Field

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

Field Frame Bracket Field Frame Cable

Interface between EnSite Precision™ Cardiac Mapping System EnSiteTM ArrayTM catheter / data module and the EnSiteTM Amplifier

Follow Instructions For Use

Interface between EPT ablation generator and the EnSiteTM Amplifier

For Use With

Interface between manufacturerspecific generators and the EnSiteTM Amplifier 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

Intl Power Kit

International Power Kit

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

Symbol

Intl Rail Clamp

Description

5

Symbol

Description Mounting Kit

International Rail Clamp

Multi-electrode Diagnostic Catheter

Multi-electrode Diagnostic Catheter

Keep Dry Non Sterile Keep Dry

Kit

Link

Not for direct patient contact

Kit, WetLab

Laptop Review Station

Laptop Review Station

Link

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.

Local Monitor Connection

Lot number

Made in U.S.A.

Made in U.S.A. Patient Reference Sensor Field Frame

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

EnSite Precision™ Field Frame Patient Orientation

On ArrayLink™ cable: ArrayLink™ Data Module cable connector

Manufactured By

On carton: Transport/storage temperature limitation

Medical Electrical Equipment

MODEL

Model Number

Module

Monitor Arm

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.

Monitor Arm

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

Monitor

24-inch Monitor

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

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

6

Symbol

Description

Symbol

On the EnSiteTM Amplifier: ECG or RecordConnect ECG cable connector

Description

Quantity

On the EnSiteTM Amplifier: Fiber optic Cable Connector

Quantity

On the EnSiteTM Amplifier: GenConnect cable connector

RecordConnect

On the EnSiteTM Amplifier: NavLink™ Module cable connector

Recorder Interconnect Kit, EPMED V5.0

On GenConnect: GenConnect cable connector

Catalog number

On NavLink™ Module: NavLink™ Module cable connector

Remote Monitor Connection

Remote Monitor Stand

Remote Monitor Stand

Operating Temperature Research Switch Research Workstation

Power Plug

RF Filter Power Switch RF Filter Trap for Stockert Serial Number

Printed Circuit Assembly

Printer

Printer

Small Surface Electrode Kit

Small Surface Electrode Kit

Port 1

Software

Port 2

Software Installation

Port 3 Software Upgrade Kit

Software Upgrade Kit

Port 4 Standby Power Power Status Atmospheric Pressure Limits

STERILE EO

Sterilized Using Ethylene Oxide

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

Symbol

Surface Electrode Kit

Description Surface Electrode Kit

System Reference Patch Connector

Training Media

Universal RecordConnect

US Customer Service

US Customer Service

US Power Kit

US Power Kit

US Rail Clamp

US Rail Clamp

Use By Date

Utility Upgrade Kit

Weight

Workstation

Workstation

Workstation Accessory Kit

Workstation Accessory Kit

Workstation Cart

Workstation Cart

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EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

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Table of Contents

Chapter 1. Introduction 15 Indications for Use 15 System Description 15 Key System Features 16 System Components 19 EnSite™ Amplifier 19 Display Workstation (DWS) 19 Components Not Included 20 EnSite™ Cardiac Mapping System Diagram 21 Typical EnSite Precision™ Cardiac Mapping System Lab Setup 21 Signal and Power Connections 22 Warnings and Cautions 23 Best Practices and Recommendations 27

Chapter 2. Using the Graphical User Interface 29 Operating Modes 29 Main Workspace 30 Common Controls 31 Menu Bar 31 Tool Palette 33 Using the Mouse 34 Common Interface Elements 36 Mapping Control Panel Settings 37 Dual View 39 Split Screen 40 Screen Layout Controls 42 Screen Layout Presets 43 System Messages 46 Information Message 46 Advisory Message 46 System Busy Message 46 Warning Message 46 Notebook 47 Saving an Event 48 Saving a Bookmark 48 Presets 49 Load a preset 49 Save a preset 49

Chapter 3. External Connections 51 EnSite™ Amplifier Connections 51 EnSite Precision™ Link, Sensor Enabled™ Connections 52 EnSite Precision™ Field Frame Connections 52 NavLink™ Module Connections 53 ArrayLink™ Module Connections 53 CathLink™ Module Connections 54 SJM™ ECG Cable Connections 54 RecordConnect Connections 55 GenConnect Connections 56

Connecting the EnSite™ Amplifier to the DWS 56 Connecting the Local Monitor to the DWS 56 Connecting the Remote Monitor to the DWS 57 Opticis Video Extender 57 Avenview Video Extender 59 Using the Remote Monitor Configuration Tool 61 Connecting Cables to the EnSite™ Amplifier 62 Color-Coded Connections 62 Connecting a System Reference Surface Electrode 63 Connecting the EnSite Precision™ Patient Reference Sensors (PRS) 64 Patient Reference Sensors 64 Patient Reference Sensor and Patch Placement 64 Patch Removal 64 Connecting the EnSite Precision™ Field Frame 66 EnSite Precision™ Field Frame Assembly 66 Assemble the Field Frame 67 Attach the Bracket to the Table 67 Attach the EnSite Precision™ Field Frame to the Bracket 68 Performing an EnSite Precision™ Module Functional Check 70 Connecting EnSite™ Surface Electrodes 72 Surface Electrode Description 72 Placement Considerations 72 Surface Electrode Placement 73 Connecting ECG Surface Electrodes 75 Connecting ECG Surface Electrodes When Using a RecordConnect 76 Connecting ECG Surface Electrodes When Not Using a RecordConnect 77 Connecting an RF Ablation Catheter and Generator 78 Connecting Diagnostic Catheters 79 Connecting the EnSite™ Array™ Catheter 80 Connecting an Auxiliary Unipolar Reference 81 Using a Recording System 82 Connecting Diagnostic Catheters When Using a RecordConnect 83 Connecting Diagnostic Catheters When Not Using a RecordConnect 84

Chapter 4. Preparing for a Study 87 Preparing for an EnSite™ NavX™ Navigation and Visualization Technology Study 87 EnSite™ NavX™ Navigation and Visualization Technology Study with RecordConnect 87 EnSite™ NavX™ Navigation and Visualization Technology Study without RecordConnect 90 EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ Study with RecordConnect 93 EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ Study without RecordConnect 97 Preparing for an EnSite™ Array™ Catheter Study 101

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Table of Contents

EnSite™ Array™ Catheter Study with RecordConnect 101 EnSite™ Array™ Catheter Study without RecordConnect 104

Chapter 5. Starting a Study 107 Starting the System 107 Keyboard and Screen Languages 108 Selecting a Keyboard Language 108 Selecting a Screen Language 108 Logging In 109 Title Screen 109 Getting Started 110 Starting a New Study 113 New Patient 113 Existing Patient 114 Past Studies 115 Resuming a Study 115

Chapter 6. Setup 117 Checking ECG Signals 117 Verifying ECG Signal Quality 118 Validation 118 EP Catheter Setup 119 Adding a Catheter to a Study 121 EnSite Precision™ System Data Quality Indicators 123 Catheter Signal Settings 124 Catheter Input Settings 125 Catheter Catalog 125 Adding a Catheter to the Catheter Catalog 126 Sorting the Catheter Catalog 126 Deleting a Catheter from the Catheter Catalog 126 Catheter Presets 126 Loading a Catheter Preset 127 Saving a Catheter Preset 127 Deleting or Renaming a Catheter Preset 127 Sheath Filter Setup 128 Description 128 Enable and Baseline the Catheter 128 EnSite™ Array™ Catheter Setup 130 EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ Setup 132 Positional Reference Tool 132 Setting Up the Positional Reference Tool 134 Positional Reference Catheter Dislodgement 135 Respiration Compensation 137 Collecting Respiration Data 137 Respiration Rejection 138 Respiration Meter 139 EnGuide Stability Monitor 139 Metal Distortion and Distortion Meter 139 Metal Distortion Meter 140 Baseline Distortion Measurement 140 EnGuide Alignment 140 Saturation Recovery 141 Signal Filters 141

Chapter 7. Model 143 The EnGuide Navigation System 143 Setting up EnGuide Navigation 143 EnGuide Navigation Indicators 145 Modeling 147 Impedance and Magnetic Data 147 EnSite™ NavX™ SE Points 147 Model Presets 149 Loading a Model Preset 149 Saving a New Model Preset 150

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

Deleting or Renaming a Model Preset 150 Model Control Panel 151 Color Chart and Visibility Selector 152 Collecting Surface Points 152 Flexible Workflow Options 152 Collect Points 153 Edit Points 153 OneModel Tool 155 Using the Surface List 156 Field Scaling 157 EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ Field Scaling (NavX SE) 158 EnSite™ NavX™ Navigation and Visualization Technology Field Scaling (NavX) 159 Digital Image Fusion (DIF) 160 Creating a Model to Import 160 Importing a Digital Image 160 Additional Options for DIF Files 161 Viewing a DIF Image for Reference 161 DEMRI (Delayed Enhancement MRI) Image Integration 162

Chapter 8. Waveforms 163 Using the Waveform Display 163 Selecting and Adjusting Waveforms 164 Displaying and Filtering Traces 165 Calipers 165 How to Create a Caliper 165 Using Calipers 165

Chapter 9. Recording and Playing Segments 167 Recording Segments 167 Automatically Recorded Segments 167 Accessing Recorded Segments 168 Playing Recorded Segments 168

Chapter 10. Adjusting and Labeling Maps 169 Map Settings Properties 171 EnGuide Display Settings 172 Information Display Settings 173 Views and the Orientation Reference 174 Orientation Toolbar 174 Creating and Saving Map Views 175 Additional Map Controls 176 Labels 177 Placing a Map Label 177 Selecting and Modifying Labels 178 Label Colors 179 Anatomic Markers 179 Placing Anatomic Markers 180 Selecting and Modifying Anatomic Markers 181 EnGuide Shadows 182 Placing EnGuide Shadows 183 Selecting and Modifying EnGuide Shadows 184 Verifying Catheter Stability 185 Tape Measures 186 Placing a Tape Measure 187 Selecting and Modifying Tape Measures 188

Chapter 11. Mapping – Noncontact 189 Types of Noncontact Maps 189 Interpreting Isopotential Maps 190 Virtuals 191 Setting Virtual Waveform Parameters 191 Placing Virtuals 192 Using Global Virtuals 192

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

Interpreting Isopotential Color 193 Using Manual Color Controls 194 Using AutoFocus Color Controls 194 Using the Tracking Virtual 196 Substrate Mapping 196 Creating a Substrate Map 198 Isochronal Mapping 199 Creating an Isochronal Map 200

Chapter 12. Mapping – Contact 201 Types of Contact Maps 202 Cardiac Triggered Maps 202 Non-Cardiac Triggered Maps 202 Signals Collection 203 Reference Signal Source 203 Roving Signal Source 203 Detection Algorithm 203 Additional Signals 204 Considerations 204 Non-Cardiac Triggered CFE Maps 204 Reentrant Maps 205 Propagation Maps 205 SparkleMap 205 Mapping Control Panel 206 Cardiac Triggered Mapping Settings 206 Non-Cardiac Triggered Mapping Settings 209 Collecting Points 210 Points Display 213 The OneMap Tool 215 Creating a Map 216 Setting up a New Map 216 Collecting Points 216 To Map from a Segment 217 Managing Maps 218 Mapping Controls 218

Chapter 13. Therapy 219 Lesion Markers 220 Placing Lesion Markers 221 Selecting and Modifying Lesion Markers 222 Lesion Control Panel 223

Chapter 14. RealReview 225 Reviewing Segments 226 Reviewing Bookmarks 226 Reviewing Images 226 Reviewing Annotations 226

Chapter 15. Reviewing and Editing Past Studies 227 Past Studies 227 Reviewing Past Studies 228 Editing Past Studies 228 Offline Review 229 Offline Review – Model 229 Offline Review – Mapping 230 Offline Review – Therapy 230 Offline Review – Review 230 Managing Patient and Study Records 230 Searching for Patient Records 230 Modifying Patient Information 230 Removing Patient Records 231 Modifying Study Records 231 Deleting Studies 231

Table of Contents

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Chapter 16. Ending a Study 233 Ending a Study 233

Chapter 17. Capturing, Exporting, and Importing Information 235 Exporting Data to External Devices 235 Selecting an Area for Capture 235 Saving and Accessing Individual Images 236 Saving an Image 236 Accessing an Image 236 Creating Animations 237 Creating an MPEG movie 237 Creating a JPEG image sequence 237 Data Export 238 Waveform Data 238 Directory Name 238 Export Interval Options 238 Exporting 239 Presets 239 Archiving Studies 240 Archiving Media 241 Importing Studies 242

Appendix A. Troubleshooting 245 Contacting Technical Support 245 Troubleshooting Tools 245 Using SJM™ Connect 246 If You Need SJM Technical Support 246 Sending Files with SJM™ Connect 247 Uploading Logs with SJM™ Connect 248 Uploading Studies 248 Proxy Configuration 249 Notifying SJM 249 Troubleshooting Common Problems 250 System Hardware Problems 250 Patient Signal Problems 252 EnGuide Stability Problems 253 Magnetic Tracking Problems 255 Software Interface Problems 255

Appendix B. Care and Service 257 Service and Technical Support 257 Setting Environmental Information 258 Setting the System Clock 258 Setting the Powerline Frequency 258 Setting the Owner Information 258 Customer-Performed Maintenance 259 EnSite™ Amplifier 259 EnSite Precision™ System DWS 260 EnSite Precision™ Link, Sensor Enabled™ 260 EnSite Precision™ Patient Reference Sensors (PRS) 261 Field Service Representative Performed Maintenance 262 Replacement Parts 262 Moving the System 263 Installing EnSite™ Cardiac Mapping System Software Licenses 263 Preparing to Install 263 Retrieve License(s) and Create Media 264 Verify the Contents of a License File 267 Install Licenses 268 Verify Installed Licenses 268 Re-Creating Licenses 269 Manage Licenses 270 Installation Report 270 Base license has not been installed 270

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Table of Contents

Installing a base license 271 Warranty Policy 271 General Notices 271 Australian Warranty 271

Appendix C. Technical Specifications 273 Specifications 273 Electromagnetic Emissions – Declaration 275

Appendix D. EnSite™ Derexi™ Module 279 Indications for Use 279 Introduction 279 Minimum System Requirements 279 EnSite™ Cardiac Mapping System / EP-WorkMate™ System Signal Connections 280 Connecting to the EnSite™ Cardiac Mapping System 281 HP xw6400 281 HP xw6400 or HP Z600 281 Connection States 282 Maps and Integration 283 Number of Maps / Map Points 283 Map Point Analysis 283 Mapping Constraints 283 Patient Connections 283 Dual System Start-up Procedure using the EnSite™ Derexi™ Module 284 Interface Features & Descriptions 285 EP-WorkMate™ Recording System Mapping Controls 286

Appendix E. EnSite™ Verismo™ Segmentation Tool Module 287 Indications for Use 287 Description 287 Contraindications 288 Warnings and Precautions 288 Operator Requirements 288 System Requirements and Considerations 288 Overview of Segmentation 288 Optimal Characteristics for the EnSite™ Verismo™ Segmentation Tool Image Files 289 Loading Files for Segmentation 290 Starting the EnSite™ Verismo™ Segmentation Tool 290 Verismo Cleanup 290 Loading DICOM Files 290 Using DICOM Files from Saved Data 290 Using the Wizard 291 Introduction to the Patient Screen 291 Selecting a Series for Segmentation 291 Viewing Options 292 Subregioning the Series 292 Loading the Series for Segmentation 292 Using the Segmentation Interface 293 Introduction to the Segmentation Screen 293 Menu Bar Summary 294 Using Basic Interface Controls 294 Navigating in Slice Views 295 Using the Zoom Control 295 Using the Pan Control 295 Using the Intensity (W/L) Controls 296 Rotating the 3D Model 296 Using Templates 296 Performing Segmentation 297 Overview of Segmentation Tools 297 Additional Controls: Delete, Undo, Cancel 297 Using the Structure List 298

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

Structure Attributes 298 Modifying Structures 298 Using the Region Grow Tool 299 Using the Chamber Tool 301 Using the Vessel Tool 302 Using the Separator Tool 303 Using the Trace Tool 304 Using Trace in a Slice View 304 Using Trace in the 3D View 304 Using the Barrier Tool 305 Using the Reassign Tool 306 Reassigning a Structure 306 Placing Labels 307 Using the Measurement Tools 307 Measuring Distances 308 Measuring Volumes 308 Saving and Exporting 309 Key Points About Saving Models 309 Saving the Model to the Hard Drive 309 Exporting Models to CD or DVD 309 Saving Work in Progress 310 Reviewing the Final Model 310 Using the DIF Viewer 310 Viewing Segmentation Contours 311 Printing Images 312 Troubleshooting 312 Contacting Technical Support 312 Troubleshooting Tools 312 Troubleshooting Common Problems 313

Appendix F. EnSite™ Courier™ PACS Module Appendix 315 Introduction 315 Operator Requirements 315 Requirements 315 Connections 315 Configuring the EnSite™ Courier™ PACS Module 316 Configure DWS Network Settings 317 Connect the DWS to the Network 317 Configure the IP Address 317 Configure the EnSite™ Courier™ PACS Module 323 Configure PACS Server Settings 323 Description of PACS Server Settings 324 Configure the EnSite™ Courier™ PACS Module Application Entity Settings 325 Description of EnSite™ Courier™ PACS Module Settings 325 Storage Attributes 326 History Management 326 Query Configuration 326 Register the EnSite™ Courier™ PACS Module on the PACS Server 328 Import Image Data into the EnSite™ Verismo™ Segmentation Tool for Segmentation 328 Launch the EnSite™ Courier™ PACS Module 328 Perform a Query 328 Import a Study 329 Receive Study or CT/MR Scans 330 Archive Segmented 3D Model/Map to PACS Server 330 Delete Study after Archiving 331 Import Pre-segmented 3D Models for Use in the EnSite™ Cardiac Mapping System 331 Retrieve Pre-segmented 3D Models from the PACS Server 331 Receive Pre-Segmented 3D Models 331 Store EnSite™ Cardiac Mapping System Studies on PACS Server 332 Import EnSite™ Cardiac Mapping System Studies from a PACS

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

Server 333 Display EnSite™ Cardiac Mapping System Study Screenshots 334 Troubleshooting 334 Courier Log 334 Query Failed 335 Retrieve Failed 335 Image Incompatibility 335 Receive Failed 336 Storage Failed 336 Storage Commitment Failed 336

Appendix G. EnSite™ Fusion™ Registration Module 337 Indications for Use 337 Warnings, Cautions, and Disclaimers 337 Introduction 337 Performing Registration 338 Importing a DIF Model 338 Scaling the EnSite™ NavX™ Navigation and Visualization Technology Navigation Field 339 Placing Fiducial Point Pairs 340 Display Options 343 The EnSite™ Fusion™ Registration Module Control Panel Display Options 343 Map Settings Menu 344

Appendix H. Glossary 347 Appendix I. Index 357

Table of Contents

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EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

Introduction

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CHAPTER 1

Indications for Use The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite Precision™ System interfaces to either the MediGuide™ Guided Medical Positioning System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and orientation mapping information. ■

When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended for use in electrophysiology studies to aid the electrophysiologist in diagnosing cardiac arrhythmia. OR

■

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

System Description The EnSite Precision™ Cardiac Mapping System (Figure 1 on page 15) is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional and Sensor Enabled™ 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).

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Chapter 1. Introduction Key System Features

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 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.

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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 Precision™ Cardiac Mapping System computer.

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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 162. 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 Precision™ Cardiac Mapping System for display. EnGuide Stability Monitor – The EnSite Precision™ Cardiac Mapping System has the ability to check for unexpected changes in Sensor Enabled™ EnGuide locations. Sensor Enabled™ catheter required. Field Scaling. – Field Scaling can be configured to automatically scale model, map, and EnGuide catheter locations and facilitates distance measurements. Two Field Scaling options are available: ■

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.

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EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ (NavX SE): Known offsets between the position and orientation of sensor(s) and electrodes on St Jude Medical™ Sensor Enabled™ catheters are 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.

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

Chapter 1. Introduction Key System Features

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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. Metal Distortion Meter – Displays the magnitude of the largest metal distortion deviation, indicating possible interference of the magnetic field due to the proximity of a metal object. Models of Cardiac Chambers. The EnSite Precision™ 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. Noncontact Mapping. (EnSite™ Array™ Catheter studies only) When the EnSite Precision™ 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.

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

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

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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.

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Loops over the cycle length.

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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 Precision™ and EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ 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, Sensor Enabled™ 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.

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Chapter 1. Introduction Key System Features

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

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). Signal Recording and Display. The EnSite Precision™ 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

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LAT

■

Peak to Peak

■

Peak Negative

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CFE Mean

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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 Precision™ 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 Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

Chapter 1. Introduction System Components

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System Components The EnSite Precision™ 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. EnSite Precision™ Module, Sensor Enabled™. Consists of the EnSite Precision™ Link, Sensor Enabled™, the EnSite Precision™ Field Frame, and two (2) Patient Reference Sensors. 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

Precision™ 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 Precision™ Cardiac

Mapping System monitors.

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Chapter 1. Introduction System Components

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN600035008 A

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. Ethernet Switch. The Ethernet Switch allows users to use multiple modules that require Ethernet connections in conjunction with the

EnSite Precision™ Cardiac Mapping System.

Components Not Included The following components are required for EP studies but are not included with the EnSite Precision™ Cardiac Mapping System. EnSite™ Array™ Catheter. This noncontact multi-electrode catheter collects cardiac electrical information. Conventional and Sensor Enabled™ 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. Patient Reference Sensor Patches – Two patches are used to place the two Patient Reference Sensors (PRS) that are used with the EnSite Precision™ 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 Precision™ 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.