EnSite Velocity Cardiac Mapping System EE3000 Instructions for Use Sw V 5.0 Rev A

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN100151580 Rev. A

2

Symbol

Description

21” Monitor

21” Monitor

24” Monitor

24” Monitor

Symbol

Description

Cable from RecordConnect to EnSiteTM Amplifier

Cable to Bard-Clearsign recording system Ablation Cable Kit, EPT Cable to Bard-Stamp recording system Ablation Cable Kit, IBI, T9 Cable to GE-Cardiolab recording system

Ablation Cable Kit, Stockert Ablation Cable Kit, JLL

Cable to St. Jude Medical EPWorkmate recording system

Ablation catheter cable connector Cardiac Mapping System

Ablation catheter cable connector

Catalog Number

AC Power Catheter Adapter Assembly, ECG/NavX Catheter Catalog Installation Amplifier Network Connection Catheter Impedance Checker Amp and Chassis

Amplifier

Amplifier Accessory Kit

Amp and Chassis CIM Certificate Amplifier

CIM

Catheter Input Module (for the recording system in use)

Amplifier Accessory Kit Catheter Input Module Cable Connector Amplifier and Display Workstation

Amplifier Cart

Amplifier Cart

Amplifier Kit

Amplifier Kit

Catheter Input Module Cable Connector

Catheter Input Module Cable Connector

Bedrail Mount Kit Catheter Input Module Cable Connector Authorized representative in the European community Auxiliary Reference Cable Connector Cable Accessory Kit

Catheter Interface Module cable connection for catheter inputs 1-56

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN100151580 Rev. A

Symbol

Description

3

Symbol

Description Display Workstation

Catheter Interface Module cable connection for catheter inputs 57-120

Display Workstation Kit

Caution

Dispose of hardware in accordance with local law

Warning Do not reuse Class II equipment Do not use if package is damaged Consult Instructions for Use DWS Hard Disk Drive Contents

DWS Kit DWS Velocity v. 2.0

Data Module Connector DWS Velocity v. 2.1 Data Network Connection

DWS Velocity v. 3.0.1.1

Date of Manufacture

ECG cable connector

Defibrillator-proof Type BF applied part

ECG or RecordConnect ECG Cable Connector

Defibrillator-proof Type CF Applied Part

ECG Surface Electrode

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

Dispersive Patch Cable Connector Equipotential Cable

Equipotential Cable

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN100151580 Rev. A

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Symbol

Description

Symbol

Equipotential jack

Humidity Limitation

Includes

Consult Instructions for Use on Website

Input Voltage, Input Frequency and Replacement fuse information

ETL Listed Conforms to UL STD 60601-1 IEC STD 60601-1-1 Certified to CAN/CSA STD C22.2 NO. 601.1ETL Listed Conforms to AAMI ES 60601-1 Certified to CSA G 22,2 NO. 60601-1

European Customer Service

Description

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

European Customer Service

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

Interface between EnSiteTM VelocityTM 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

Fragile

Interface between manufacturerspecific recording systems and the EnSiteTM Amplifier

Fragile

Interface between Medtronic Atakr ablation generator and the EnSiteTM Amplifier

Fuse

Interface between Siemens-Sensis recording system and the EnSiteTM Amplifier

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

GenConnect Cable Connector, to EnSiteTM Amplifier

Intl Power Kit

International Power Kit

Intl Rail Clamp

International Rail Clamp

Hardware

HN Keep Dry Hospital Network Connection

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN100151580 Rev. A

Symbol

Description

Keep Dry

Kit

5

Symbol

Description On ArrayLink™ cable: ArrayLink™ Data Module cable connector

On carton: Transport/storage temperature limitation

Kit, WetLab

Laptop Review Station

Laptop Review Station

Link

On CathLink™ or RecordConnect cable: CathLink™ or RecordConnect catheter channels 1 to 64 cable connector On the EnSiteTM Amplifier: ArrayLink Data Module cable connector

Local Monitor Connection

Lot number

Made in U.S.A.

Made in U.S.A.

Manufactured By

MODEL

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

Model Number On the EnSiteTM Amplifier: Fiber optic Cable Connector Module

Monitor Arm

Monitor Arm

Mounting Kit

Multi-electrode Diagnostic Catheter

On the EnSiteTM Amplifier: GenConnect cable connector

On the EnSiteTM Amplifier: NavLink™ Module cable connector

Multi-electrode Diagnostic Catheter

Non Sterile

On GenConnect: GenConnect cable connector

Link

On NavLink™ Module: NavLink™ Module cable connector

Not for direct patient contact

Operating Temperature

Notified Body CE Mark

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

Power Plug

Power Switch

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN100151580 Rev. A

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Symbol

Description Printed Circuit Assembly

Printer

Printer

Symbol

STERILE EO

Surface Electrode Kit

Description Sterilized Using Ethylene Oxide

Surface Electrode Kit

System Reference Patch Connector

Atmospheric Pressure Limits

Training Media Quantity Universal RecordConnect

Remote Monitor Stand

RecordConnect

US Customer Service

US Customer Service

Recorder Interconnect Kit, EPMED V5.0

US Power Kit

US Power Kit

Remote Monitor Connection

US Rail Clamp

US Rail Clamp

Remote Monitor Stand

Use By Date

Research Switch

Utility Upgrade Kit

Research Workstation Weight RF Filter RF Filter Trap for Stockert

Workstation

Workstation

Serial Number

Small Surface Electrode Kit

Workstation Accessory Kit

Workstation Cart

Workstation Cart

Small Surface Electrode Kit

Software

Software Installation

Software Upgrade Kit

Workstation Accessory Kit

Software Upgrade Kit

Standby Power

Status

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN100151580 Rev. A

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Table of Contents

Chapter 1. Introduction 11 Indications for Use 11 System Description 11 Key System Features 12 System Components 15 EnSite™ Amplifier 15 Display Workstation (DWS) 15 Components Not Included 16 EnSite™ Cardiac Mapping System Diagram 17 Typical EnSite™ Velocity™ Cardiac Mapping System Lab Setup 17 18 Signal and Power Connections 18 Warnings and Cautions 19 Best Practices and Recommendations 22

Chapter 2. Using the Graphical User Interface 25 Operating Modes 25 Main Workspace 26 Common Controls 27 Menu Bar 27 Tool Palette 29 Using the Mouse 30 Common Interface Elements 32 Mapping Control Panel Settings 33 Dual View 35 Split Screen 36 Screen Layout Controls 38 Screen Layout Presets 39 System Messages 42 Information Message 42 Advisory Message 42 System Busy Message 42 Warning Message 42 Notebook 43 Saving an Event 44 Saving a Bookmark 44 Presets 45 Load a preset 45 Save a preset 45

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

Connecting the Local Monitor to the DWS 51 Connecting the Remote Monitor to the DWS 52 Opticis Video Extender 52 Avenview Video Extender 54 Using the Remote Monitor Configuration Tool 56 Connecting Cables to the EnSite™ Amplifier 57 Color-Coded Connections 57 Connecting a System Reference Surface Electrode 58 Connecting EnSite™ Surface Electrodes 59 Surface Electrode Description 59 Placement Considerations 59 Surface Electrode Placement 60 Connecting ECG Surface Electrodes 62 Connecting ECG Surface Electrodes When Using a RecordConnect 63 Connecting ECG Surface Electrodes When Not Using a RecordConnect 64 Connecting an RF Ablation Catheter and Generator 65 Connecting Diagnostic Catheters 66 Connecting the EnSite™ Array™ Catheter 67 Connecting an Auxiliary Unipolar Reference 68 Using a Recording System 69 Connecting Diagnostic Catheters When Using a RecordConnect 70 Connecting Diagnostic Catheters When Not Using a RecordConnect 71

Chapter 4. Preparing for a Study 73 Preparing for an EnSite™ NavX™ Navigation and Visualization Technology Study 73 EnSite™ NavX™ Navigation and Visualization Technology Study with RecordConnect 73 EnSite™ NavX™ Navigation and Visualization Technology Study without RecordConnect 76 Preparing for an EnSite™ Array™ Catheter Study 79 EnSite™ Array™ Catheter Study with RecordConnect 79 EnSite™ Array™ Catheter Study without RecordConnect 82

Chapter 5. Starting a Study 85 Starting the System 85 Keyboard and Screen Languages 86 Selecting a Keyboard Language 86 Selecting a Screen Language 86 Logging In 87 Title Screen 87 Getting Started 88 Starting a New Study 91 New Patient 91 Existing Patient 92 Past Studies 93

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Table of Contents

Resuming a Study 93

Chapter 6. Setup 95 Checking ECG Signals 95 Verifying ECG Signal Quality 96 Validation 96 EP Catheter Setup 97 Adding a Catheter to a Study 99 Catheter Signal Settings 101 Catheter Input Settings 102 Catheter Catalog 102 Adding a Catheter to the Catheter Catalog 103 Sorting the Catheter Catalog 103 Deleting a Catheter from the Catheter Catalog 103 Catheter Presets 103 Loading a Catheter Preset 104 Saving a Catheter Preset 104 Deleting or Renaming a Catheter Preset 104 Sheath Filter Setup 105 Description 105 Enable and Baseline the Catheter 105 EnSite™ Array™ Catheter Setup 107 EnSite™ NavX™ Navigation and Visualization Technology Setup 109 Positional Reference Tool 109 Setting Up the Positional Reference Tool 111 Positional Reference Catheter Dislodgement 112 Respiration Compensation 114 Collecting Respiration Data 114 Respiration Rejection 115 Respiration Meter 116 EnGuide Alignment 116 Saturation Recovery 116 Signal Filters 117

Chapter 7. Model 119 The EnGuide Navigation System 119 Setting up EnGuide Navigation 119 EnGuide Navigation Indicators 121 Modeling 122 Model Presets 122 Loading a Model Preset 122 Saving a New Model Preset 123 Deleting or Renaming a Model Preset 123 Model Control Panel 124 Color Chart and Visibility Selector 125 Collecting Surface Points 125 Collect Points 125 Edit Points 126 OneModel Tool 127 Using the Surface List 128 Field Scaling 129 EnSite™ NavX™ Navigation and Visualization Technology Field Scaling (NavX) 129 Digital Image Fusion (DIF) 130 Creating a Model to Import 130 Importing a Digital Image 130 Additional Options for DIF Files 131 Viewing a DIF Image for Reference 131 DEMRI (Delayed Enhancement MRI) Image Integration 132

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

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN100151580 Rev. A

Calipers 135 How to Create a Caliper 135 Using Calipers 135

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

Chapter 10. Adjusting and Labeling Maps 139 Map Settings Properties 141 EnGuide Display Settings 142 Information Display Settings 143 Views and the Orientation Reference 144 Orientation Toolbar 144 Creating and Saving Map Views 145 Additional Map Controls 146 Labels 147 Placing a Map Label 147 Selecting and Modifying Labels 148 Label Colors 149 Anatomic Markers 149 Placing Anatomic Markers 150 Selecting and Modifying Anatomic Markers 151 EnGuide Shadows 152 Placing EnGuide Shadows 153 Selecting and Modifying EnGuide Shadows 154 Verifying Catheter Stability 155 Tape Measures 156 Placing a Tape Measure 157 Selecting and Modifying Tape Measures 158

Chapter 11. Mapping – Noncontact 159 Types of Noncontact Maps 159 Interpreting Isopotential Maps 160 Virtuals 161 Setting Virtual Waveform Parameters 161 Placing Virtuals 162 Using Global Virtuals 162 Interpreting Isopotential Color 163 Using Manual Color Controls 164 Using AutoFocus Color Controls 164 Using the Tracking Virtual 166 Substrate Mapping 166 Creating a Substrate Map 168 Isochronal Mapping 169 Creating an Isochronal Map 170

Chapter 12. Mapping – Contact 171 Types of Contact Maps 172 Cardiac Triggered Maps 172 Non-Cardiac Triggered Maps 172 Signals Collection 173 Reference Signal Source 173 Roving Signal Source 173 Detection Algorithm 173 Additional Signals 174 Considerations 174 Non-Cardiac Triggered CFE Maps 174 Reentrant Maps 175 Propagation Maps 175 SparkleMap 175 Mapping Control Panel 176 Cardiac Triggered Mapping Settings 176

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN100151580 Rev. A

Non-Cardiac Triggered Mapping Settings 179 Collecting Points 180 Points Display 183 The OneMap Tool 185 Creating a Map 186 Setting up a New Map 186 Collecting Points 186 To Map from a Segment 187 Managing Maps 188 Mapping Controls 188

Chapter 13. Therapy 189 Lesion Markers 190 Placing Lesion Markersf 191 Selecting and Modifying Lesion Markers 192 Lesion Control Panel 193

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

Chapter 15. Reviewing and Editing Past Studies 197 Past Studies 197 Reviewing Past Studies 198 Editing Past Studies 198 Offline Review 199 Offline Review – Model 199 Offline Review – Mapping 200 Offline Review – Therapy 200 Offline Review – Review 200 Managing Patient and Study Records 200 Searching for Patient Records 200 Modifying Patient Information 200 Removing Patient Records 201 Modifying Study Records 201 Deleting Studies 201

Table of Contents

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Troubleshooting Tools 215 Using SJM™ Connect 216 If You Need SJM™ Technical Support 216 Sending Files with SJM™ Connect 217 Uploading Logs with SJM™ Connect 218 Uploading Studies 218 Proxy Configuration 219 Notifying SJM 219 Troubleshooting Common Problems 220 System Hardware Problems 220 Patient Signal Problems 222 EnGuide Stability Problems 223 Software Interface Problems 224

Appendix B. Care and Service 227 Service and Technical Support 227 Setting Environmental Information 228 Setting the System Clock 228 Setting the Powerline Frequency 228 Setting the Owner Information 228 Customer-Performed Maintenance 229 EnSite™ Amplifier 229 EnSite™ DWS 230 Field Service Representative Performed Maintenance 231 Replacement Parts 231 Moving the System 232 Installing EnSite™ Cardiac Mapping System Software Licenses 232 Preparing to Install 232 Retrieve License(s) and Create Media 233 Verify the Contents of a License File 236 Install Licenses 237 Verify Installed Licenses 237 Re-Creating Licenses 238 Manage Licenses 239 Installation Report 239 Velocity license has not been installed 239 Installing a base license 240 Warranty Policy 240 General Notices 240

Chapter 16. Ending a Study 203 Ending a Study 203

Chapter 17. Capturing, Exporting, and Importing Information 205 Exporting Data to External Devices 205 Selecting an Area for Capture 205 Saving and Accessing Individual Images 206 Saving an Image 206 Accessing an Image 206 Creating Animations 207 Creating an MPEG movie 207 Creating a JPEG image sequence 207 Data Export 208 Waveform Data 208 Directory Name 208 Export Interval Options 208 Exporting 209 Presets 209 Archiving Studies 210 Archiving Media 211 Importing Studies 212

Appendix A. Troubleshooting 215 Contacting Technical Support 215

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

Appendix D. EnSite™ Fusion™ Registration Module 247 Indications for Use 247 Warnings, Cautions, and Disclaimers 247 Introduction 247 Performing Registration 248 Importing a DIF Model 248 Scaling the EnSite™ NavX™ Navigation and Visualization Technology Navigation Field 249 Placing Fiducial Point Pairs 250 Display Options 253 The EnSite™ Fusion™ Registration Module Control Panel Display Options 253 Map Settings Menu 254

Appendix E. EnSite™ Derexi™ Module 257 Indications for Use 257 Introduction 257 Minimum System Requirements 257 EnSite™ Cardiac Mapping System / EP-WorkMate™ System

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Table of Contents

Signal Connections 258 Connecting to the EnSite™ Cardiac Mapping System 259 HP xw6400 259 HP xw6400 or HP Z600 259 Connection States 260 Maps and Integration 261 Number of Maps / Map Points 261 Map Point Analysis 261 Mapping Constraints 261 Patient Connections 261 Dual System Start-up Procedure using the EnSite™ Derexi™ Module 262 Interface Features & Descriptions 263 EP-WorkMate™ Recording System Mapping Controls 264

Appendix F. EnSite™ Verismo™ Segmentation Tool Module 265 Indications for Use 265 Description 265 Contraindications 266 Warnings and Precautions 266 Operator Requirements 266 System Requirements and Considerations 266 Overview of Segmentation 266 Optimal Characteristics for the EnSite™ Verismo™ Segmentation Tool Image Files 267 Loading Files for Segmentation 268 Starting the EnSite™ Verismo™ Segmentation Tool 268 Verismo Cleanup 268 Loading DICOM Files 268 Using DICOM Files from Saved Data 268 Using the Wizard 269 Introduction to the Patient Screen 269 Selecting a Series for Segmentation 269 Viewing Options 270 Subregioning the Series 270 Loading the Series for Segmentation 270 Using the Segmentation Interface 271 Introduction to the Segmentation Screen 271 Menu Bar Summary 272 Using Basic Interface Controls 272 Navigating in Slice Views 273 Using the Zoom Control 273 Using the Pan Control 273 Using the Intensity (W/L) Controls 274 Rotating the 3D Model 274 Using Templates 274 Performing Segmentation 275 Overview of Segmentation Tools 275 Additional Controls: Delete, Undo, Cancel 275 Using the Structure List 276 Structure Attributes 276 Modifying Structures 276 Using the Region Grow Tool 277 Using the Chamber Tool 279 Using the Vessel Tool 280 Using the Separator Tool 281 Using the Trace Tool 282 Using Trace in a Slice View 282 Using Trace in the 3D View 282 Using the Barrier Tool 283 Using the Reassign Tool 284 Reassigning a Structure 284 Placing Labels 284 Using the Measurement Tools 285 Measuring Distances 286

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN100151580 Rev. A

Measuring Volumes 286 Saving and Exporting 287 Key Points About Saving Models 287 Saving the Model to the Hard Drive 287 Exporting Models to CD or DVD 287 Saving Work in Progress 288 Reviewing the Final Model 288 Using the DIF Viewer 288 Viewing Segmentation Contours 289 Printing Images 290 Troubleshooting 290 Contacting Technical Support 290 Troubleshooting Tools 290 Troubleshooting Common Problems 290

Appendix G. Glossary 293 Appendix H. Index 303

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN100151580 Rev. 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 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 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 ARTEN100151580 Rev. 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 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.

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN100151580 Rev. 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 ARTEN100151580 Rev. 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 ARTEN100151580 Rev. 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 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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EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN100151580 Rev. A

Chapter 1. Introduction 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™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN100151580 Rev. 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 ARTEN100151580 Rev. 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

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN100151580 Rev. A

Chapter 1. Introduction Warnings and Cautions

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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.

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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.

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Chapter 1. Introduction Warnings and Cautions

EnSite™ Velocity™ Cardiac Mapping System Instructions for Use ARTEN100151580 Rev. A

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.

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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 nonfunctioning 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.